Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Download Aetna Commercial Formulary for Self
Document related concepts
Transcript
2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria DRUG_NAME PA_GROUP_NAME COVERED USES ADRENACLICK EPI emergency treatment of severe allergic reactions including anaphylaxis EXCLUSION CRITERIA REQUIRED MEDICAL INFORMATION AGE RESTRICTIO N PRESCRIB COVERAGE DURATION ER RESTRICTI ON 1 year OTHER CRITERIA STEP_GR STEP_ALTS OUP_NA ME EPI Trial of 1 of Auvi-Q, Epipen, Epipen JR ELIQUIS PRADAXA XARELTO 2/ day 2/ day 35/365 days, 15mg 42/30Day s, 20mg 2/day ADVICOR ALTOPREV STATIN Trial of 1 generic statin, atorvastatin, fluvastatin, lovastatin, pravastatin, simvastatin (NSO) ATORVASTATIN CRESTOR FLUVASTATIN LESCOL STATIN LESCOL XL STATIN LIPITOR STATIN Trial of 1 generic statin, atorvastatin, fluvastatin, lovastatin, pravastatin, simvastatin (NSO) Trial of 1 generic statin, atorvastatin, fluvastatin, lovastatin, pravastatin, simvastatin (NSO) Trial of 1 generic statin, atorvastatin, fluvastatin, lovastatin, pravastatin, simvastatin (NSO) LIPTRUZET LIVALO STATIN LOVASTATIN MEVACOR PRAVACHOL PRAVASTATIN SIMCOR SIMVASTATIN VYTORIN ZETIA ZOCOR APLENZIN BRINTELLIX BUDEPRION SR BUPROPION BUPROPION XL QL Major Depressive Disorder MDD as defined in DSM V 1 year For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose.) Covered for fully insured member in the state of CT who requires the prescribed drug for the diagnosis of gender dysphoria, as defined in the most recent edition DSM V. For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) Trial of 1 generic statin, atorvastatin, fluvastatin, lovastatin, pravastatin, simvastatin (NSO) ANTIDEP Trial of 1 month of 1 of RESSION budeprion SR/XL, 1 bupropion/SR/XL, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine/sr, mirtazapine, selfemra, sertraline, venlafaxine, venlafaxine sr cap 1/ day 1/ day 2/ day 2/ day 1/ day 1/ day 1/ day 1/ day 2/ day 2/ day 1/ day 1/ day 2/ day 1/ day 1/ day 1/ day 1/ day 1/ day 1/ day ANTIDEP Trial of 3 different RESSION antidepressants from at least 2 two different therapeutic subclasses, i.e., SSRIs (fluoxetine, citalopram), SNRIs (duloxetine, venlafaxine), TCAs (amitriptyline, nortriptyline), heterocyclic antidepressants (mirtazapine, trazodone) (NSO) 2/ day 6/ day 1/ day 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria CELEXA CITALOPRAM DESVENLAFAXINE ER DEPRESSION Major Depressive Disorder 1 year EFFEXOR XR EMSAM ESCITALOPRAM FETZIMA CAP/ TITRATION PACK FLUOXETINE CAP/ TAB/ SOL DEPRESSION Major Depressive Disorder 1 year For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) 1/ day ANTIDEP Trial of 3 different 1/ day RESSION antidepressants from at least 2 two different therapeutic subclasses, i.e., SSRIs (fluoxetine, citalopram), SNRIs (duloxetine, venlafaxine), TCAs (amitriptyline, nortriptyline), heterocyclic antidepressants (mirtazapine, trazodone) (NSO) 37.5, 75 mg 1/ day; 150 mg 2/ day 1/ day 1/ day; 20 ml/ day ANTIDEP Trial of 3 different 1/ day; 1 RESSION antidepressants from at least pack/ 28 2 two different therapeutic days subclasses, i.e., SSRIs (fluoxetine, citalopram), SNRIs (duloxetine, venlafaxine), TCAs (amitriptyline, nortriptyline), heterocyclic antidepressants (mirtazapine, trazodone) (NSO) 10 mg 1/ day; 40 mg 2/ day; 20 mg 4/ day; 20 ml/ day; delayed release 4/ 28 days 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria FLUOXETINE 60MG FLUVOXAMINE FLUVOXAMINE ER KHEDEZLA LEXAPRO LUVOX OLEPTRO PAROXETINE/ ER DEPRESSION Major Depressive Disorder 1 year For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) FLUOXETI Trial of fluoxetine (NSO) NE 1/ day 25, 50 mg 1/ day; 100 mg 3/day 2/ day 1/ day ANTIDEP Trial of 3 different RESSION antidepressants from at least 2 two different therapeutic subclasses, i.e., SSRIs (fluoxetine, citalopram), SNRIs (duloxetine, venlafaxine), TCAs (amitriptyline, nortriptyline), heterocyclic antidepressants (mirtazapine, trazodone) (NSO) 1/ day; 20 ml/ day 2/ day OLEPTRO- Trial of 1 month of trazodone PRE (NSO) 150 mg 1.5/ day; 300 mg 1/ day 10, 20 mg 1/ day; 30, 40, 60 mg 2/ day; 30 ml/ day 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria PAXIL CR PAROXETINE SR PAXIL PEXEVA PRISTIQ PROZAC CAP/ TAB SARAFEM CAP/ TAB SERTRALINE VENLAFAXINE/ ER DEPRESSION Major Depressive Disorder 1 year For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) OR Member requires continuous daily dosing for premenstrual dysphoric disorder (PMDD) – For Sarafem, Selfemra, fluoxetine PMDD (10mg - 30 tabs/caps in 30 days are For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) 12.5 mg 25 mg 37.5 mg : 2/day 10, 20 mg 1/ day; 30, 40, 60 mg 2/ day; 30 ml/ day PAXIL Trial of paroxetine (NSO) 10, 20 mg 1/ day; 30, 40, 60 mg 2/ day; 30 ml/ day 1/ day ANTIDEP Trial of 3 different RESSION antidepressants from at least 2 two different therapeutic subclasses, i.e., SSRIs (fluoxetine, citalopram), SNRIs (duloxetine, venlafaxine), TCAs (amitriptyline, nortriptyline), heterocyclic antidepressants (mirtazapine, trazodone) (NSO) 14/ 30 days 25 mg 1/ day; 50 mg 1.5/ day; 100 mg 2/ day; 10 ml/ day 37.5 mg, 75 mg 1/ day; 150 mg 2/ day 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria VENLAFAXINE ER TAB VIIBRYD DEPRESSION Major Depressive Disorder 1 year WELLBUTRIN WELLBUTRIN SR WELLBUTRIN XL ZOLOFT ABILIFY ABILIFY Major depressive disorder Bipolar disorder Schizophrenia Psychomotor agitation associated with autistic disorder 1 year For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit); except Risperdal/risperidone 4mg OR Member has had intolerance to drug administered as a single daily dose (Abilify 10mg, 15mg; Zyprexa/Zyprexa Zydis/olanzapine/olanzapine ODT 5mg, 7.5mg, 10mg) OR Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fanapt 12 mg; Fazaclo 100mg; Geodon/ziprasidone 60mg, 80mg capsules; Invega 6 VENLAFA Trial of venlafaxine (NSO) XINE 1/ day ANTIDEP Trial of 3 different 1/ day; 1 RESSION antidepressants from at least kit/ 30 2 two different therapeutic days subclasses, i.e., SSRIs (fluoxetine, citalopram), SNRIs (duloxetine, venlafaxine), TCAs (amitriptyline, nortriptyline), heterocyclic antidepressants (mirtazapine, trazodone) (NSO) 6/ day 2/ day 1/ day 25 mg 1/ day; 50 mg 1.5/ day; 100 mg 2/ day; 10 ml/ day ANTIPSYC Trial of 1 atypical generic HOTICS2- antipsychotic, i.e. olanzapine, PRE quetiapine, risperidone, ziprasidone, AND Latuda (NSO) 1/ day 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria ABILIFY SOLUTION CLOZAPINE CLOZARIL FANAPT FAZACLO GEODON For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit); except Risperdal/risperidone 4mg OR Member has had intolerance to drug administered as a single daily dose (Abilify 10mg, 15mg; Zyprexa/Zyprexa Zydis/olanzapine/olanzapine ODT 5mg, 7.5mg, 10mg) OR Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fanapt 12 mg; Fazaclo 100mg; Geodon/ziprasidone 60mg, 80mg capsules; Invega 6 For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit); except Risperdal/risperidone 4mg OR Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fanapt 12 mg; Fazaclo 100mg; Geodon/ziprasidone 60mg, 80mg capsules; Invega 6 mg, 9 mg; Latuda 160mg; Risperdal/Risperdal M/risperidone/risperidone odt 3mg, 4mg tablets; Saphris 10mg, Seroquel/quetiapine 200mg, 300mg, 400mg; Seroquel XR 300mg, For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit); except Risperdal/risperidone 4mg OR Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fanapt 12 mg; Fazaclo 100mg; Geodon/ziprasidone 60mg, 80mg capsules; Invega 6 mg, 9 mg; Latuda 160mg; Risperdal/Risperdal M/risperidone/risperidone odt 3mg, 4mg tablets; Saphris 10mg, Seroquel/quetiapine 200mg, 300mg, 400mg; Seroquel XR 300mg, For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit); except Risperdal/risperidone 4mg OR Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fanapt 12 mg; Fazaclo 100mg; Geodon/ziprasidone 60mg, 80mg capsules; Invega 6 mg, 9 mg; Latuda 160mg; Risperdal/Risperdal M/risperidone/risperidone odt 3mg, 4mg tablets; Saphris 10mg, Seroquel/quetiapine 200mg, 300mg, 400mg; Seroquel XR 300mg, For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit); except Risperdal/risperidone 4mg OR Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fanapt 12 mg; Fazaclo 100mg; Geodon/ziprasidone 60mg, 80mg capsules; Invega 6 mg, 9 mg; Latuda 160mg; Risperdal/Risperdal M/risperidone/risperidone odt 3mg, 4mg tablets; Saphris 10mg, Seroquel/quetiapine 200mg, 300mg, 400mg; Seroquel XR 300mg, For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit); except Risperdal/risperidone 4mg OR Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fanapt 12 mg; Fazaclo 100mg; Geodon/ziprasidone 60mg, 80mg capsules; Invega 6 mg, 9 mg; Latuda 160mg; Risperdal/Risperdal M/risperidone/risperidone odt 3mg, 4mg tablets; Saphris 10mg, Seroquel/quetiapine 200mg, 300mg, 400mg; Seroquel XR 300mg, ABILIFY SOLN Trial of Abilify tablet (NSO) 900 ml/ 30 days 25 mg, 50 mg 3/ day; 100 mg 9/ day 25 mg, 50 mg 3/ day; 100 mg 9/ day ANTIPSYC Trial of 1 atypical generic HOTICS2- antipsychotic, i.e. olanzapine, PRE quetiapine, risperidone, ziprasidone, AND Latuda (NSO) 2/ day; 1 pack/ 30 days 12.5 mg 1/day; 25 mg 3/ day; 100 mg 9/ day; 150 mg 6/ day; 200 mg 4/ day ANTIPSYC Trial of 1 month of Latuda HOTICS1PRE 2/ day 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria INVEGA LATUDA OLANZAPINE/ ODT QUETIAPINE RISPERDAL RISPERIDONE/ ODT For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit); except Risperdal/risperidone 4mg OR Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fanapt 12 mg; Fazaclo 100mg; Geodon/ziprasidone 60mg, 80mg capsules; Invega 6 mg, 9 mg; Latuda 160mg; Risperdal/Risperdal M/risperidone/risperidone odt 3mg, 4mg tablets; Saphris 10mg, Seroquel/quetiapine 200mg, 300mg, 400mg; Seroquel XR 300mg, For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit); except Risperdal/risperidone 4mg OR Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fanapt 12 mg; Fazaclo 100mg; Geodon/ziprasidone 60mg, 80mg capsules; Invega 6 mg, 9 mg; Latuda 160mg; Risperdal/Risperdal M/risperidone/risperidone odt 3mg, 4mg tablets; Saphris 10mg, Seroquel/quetiapine 200mg, 300mg, 400mg; Seroquel XR 300mg, For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit); except Risperdal/risperidone 4mg OR Member has had intolerance to drug administered as a single daily dose (Abilify 10mg, 15mg; Zyprexa/Zyprexa Zydis/olanzapine/olanzapine ODT 5mg, 7.5mg, 10mg) OR Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fanapt 12 mg; Fazaclo 100mg; Geodon/ziprasidone 60mg, 80mg capsules; Invega 6 For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit); except Risperdal/risperidone 4mg OR Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fanapt 12 mg; Fazaclo 100mg; Geodon/ziprasidone 60mg, 80mg capsules; Invega 6 mg, 9 mg; Latuda 160mg; Risperdal/Risperdal M/risperidone/risperidone odt 3mg, 4mg tablets; Saphris 10mg, Seroquel/quetiapine 200mg, 300mg, 400mg; Seroquel XR 300mg, For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit); except Risperdal/risperidone 4mg OR Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fanapt 12 mg; Fazaclo 100mg; Geodon/ziprasidone 60mg, 80mg capsules; Invega 6 mg, 9 mg; Latuda 160mg; Risperdal/Risperdal M/risperidone/risperidone odt 3mg, 4mg tablets; Saphris 10mg, Seroquel/quetiapine 200mg, 300mg, 400mg; Seroquel XR 300mg, For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit); except Risperdal/risperidone 4mg OR Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fanapt 12 mg; Fazaclo 100mg; Geodon/ziprasidone 60mg, 80mg capsules; Invega 6 mg, 9 mg; Latuda 160mg; Risperdal/Risperdal M/risperidone/risperidone odt 3mg, 4mg tablets; Saphris 10mg, Seroquel/quetiapine 200mg, 300mg, 400mg; Seroquel XR 300mg, ANTIPSYC Trial of 1 atypical generic HOTICS2- antipsychotic, i.e. olanzapine, PRE quetiapine, risperidone, ziprasidone, AND Latuda (NSO) 1.5 mg; 3 mg; 6 mg 2/ day; 9 mg 1/ day 20 mg; 40 mg; 60 mg; 120 mg 1/ day; 80 mg 2/ day 2.5 mg 2/ day; 5 mg; 7.5 mg; 10 mg; 15 mg; 20 mg 1/ day 25 mg 6/ day; 50 mg; 100 mg 3/ day; 200 mg 4/ day; 300 mg; 400 mg 2/ day ANTIPSYC Trial of 1 month of Latuda HOTICS1PRE 0.25 mg; 0.5 mg; 1 mg; 2 mg; 3 mg 2/ day; 4 mg 4/ day 0.25 mg; 0.5 mg; 1 mg; 2 mg; 3 mg 2/ day; 4 mg 4/ day 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria SAPHRIS SEROQUEL SEROQUEL XR VERSACLOZ ZIPRASIDONE ZYPREXA/ ZYDIS For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit); except Risperdal/risperidone 4mg OR Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fanapt 12 mg; Fazaclo 100mg; Geodon/ziprasidone 60mg, 80mg capsules; Invega 6 mg, 9 mg; Latuda 160mg; Risperdal/Risperdal M/risperidone/risperidone odt 3mg, 4mg tablets; Saphris 10mg, Seroquel/quetiapine 200mg, 300mg, 400mg; Seroquel XR 300mg, For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit); except Risperdal/risperidone 4mg OR Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fanapt 12 mg; Fazaclo 100mg; Geodon/ziprasidone 60mg, 80mg capsules; Invega 6 mg, 9 mg; Latuda 160mg; Risperdal/Risperdal M/risperidone/risperidone odt 3mg, 4mg tablets; Saphris 10mg, Seroquel/quetiapine 200mg, 300mg, 400mg; Seroquel XR 300mg, For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit); except Risperdal/risperidone 4mg OR Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fanapt 12 mg; Fazaclo 100mg; Geodon/ziprasidone 60mg, 80mg capsules; Invega 6 mg, 9 mg; Latuda 160mg; Risperdal/Risperdal M/risperidone/risperidone odt 3mg, 4mg tablets; Saphris 10mg, Seroquel/quetiapine 200mg, 300mg, 400mg; Seroquel XR 300mg, For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit); except Risperdal/risperidone 4mg OR Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fanapt 12 mg; Fazaclo 100mg; Geodon/ziprasidone 60mg, 80mg capsules; Invega 6 mg, 9 mg; Latuda 160mg; Risperdal/Risperdal M/risperidone/risperidone odt 3mg, 4mg tablets; Saphris 10mg, Seroquel/quetiapine 200mg, 300mg, 400mg; Seroquel XR 300mg, For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit); except Risperdal/risperidone 4mg OR Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fanapt 12 mg; Fazaclo 100mg; Geodon/ziprasidone 60mg, 80mg capsules; Invega 6 mg, 9 mg; Latuda 160mg; Risperdal/Risperdal M/risperidone/risperidone odt 3mg, 4mg tablets; Saphris 10mg, Seroquel/quetiapine 200mg, 300mg, 400mg; Seroquel XR 300mg, For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit); except Risperdal/risperidone 4mg OR Member has had intolerance to drug administered as a single daily dose (Abilify 10mg, 15mg; Zyprexa/Zyprexa Zydis/olanzapine/olanzapine ODT 5mg, 7.5mg, 10mg) OR Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fanapt 12 mg; Fazaclo 100mg; Geodon/ziprasidone 60mg, 80mg capsules; Invega 6 ANTIPSYC Trial of 1 atypical generic HOTICS2- antipsychotic, i.e. olanzapine, PRE quetiapine, risperidone, ziprasidone, AND Latuda (NSO) 2/ day ANTIPSYC Trial of 1 month of Latuda HOTICS1PRE 25 mg 6/ day; 50 mg; 100 mg 3/ day; 200 mg 4/ day; 300 mg; 400 mg 2/ day 50 mg 6/ day; 150 mg; 200 mg 1/ day; 300 mg; 400 mg 2/ day VERSACL Trial of clozapine (NSO) OZ 2/ day ANTIPSYC Trial of 1 month of Latuda HOTICS1PRE 2.5 mg 2/ day; 5 mg; 7.5 mg; 10 mg; 15 mg; 20 mg 1/ day 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria CYMBALTA Major depressive disorder (MDD) Diabetic peripheral neuropathic pain (DPN) Generalized anxiety disorder (GAD) FibromyalgiaChronic musculoskeletal pain due to osteoarthritis Chronic musculoskeletal pain due to chronic low back pain 1 year For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) OR Member has a diagnosis of Diabetic Peripheral Neuropathy -For Cymbalta or duloxetine (60mg; 60 capsules in 30 days are 20, 30 mg 2/ day; 60 mg 1/ day DULOXETINE For coverage of additional quantities: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's dose cannot be achieved with proposed qty limits for a given strength (ex. Mm needs 375mg per day and would require 5 capsules of venlafaxine sr cap or Effexor XR 75mg to achieve dose ) OR Member has a diagnosis of Diabetic Peripheral Neuropathy -For Cymbalta or duloxetine (60mg; 60 capsules in 30 days are 20, 30 mg 2/ day; 60 mg 1/ day GABAPENTIN TAB/ CAP For coverage of additional quantities: Member's dose is being titrated by physician (3 month limit) OR Member is taking Neurontin or gabapentin 300mg caps/tabs, using three caps/tabs, three times daily for a total daily dose of 2700mg (gabapentin, Neurontin - 300mg tablets/capsules only) OR Member has been titrated up to 3600mg and requires additional/higher dosing up to 4800mg due to lack of response (gabapentin, Neurontin only) 6/ day GRALISE For coverage of additional GRALISE quantities: One additional Gralise Starter Pack will be allowed within 365 days for those members that might need a second course for titration HORIZANT LIDODERM LYRICA CAP/ SOL LIDODERM LYRICA Pain associated with post-herpetic neuralgia Partial-onset seizures Diabetic Peripheral Neuropathy (DPN) Postherpetic Neuralgia (PHN) Fibromyalgia Neuropathic pain associated with spinal cord injury 1 year 1 year NEURONTIN TAB/ CAP For coverage of additional quantities: Member's dose is being titrated by physician (3 month limit) OR Member is taking Neurontin or gabapentin 300mg caps/tabs, using three caps/tabs, three times daily for a total daily dose of 2700mg (gabapentin, Neurontin - 300mg tablets/capsules only) OR Member has been titrated up to 3600mg and requires additional/higher dosing up to 4800mg due to lack of response (gabapentin, Neurontin only) SAVELLA AVINZA For coverage of additional quantities: Member's dose is being titrated by physician (3 month limit) Trial of gabapentin (NSO) 300mg 5/ day; 600 mg 3/ day HORIZAN Trial of 1 of cabergoline, T gabapentin, or pramipexole (NSO) 2/ day LYRICA 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg 3/day; 225 mg, 300 mg 2/ day; 30 ml/ day 6/ day Trial of 1 month each of 3 of the following drugs/ drug classes: 1 tricyclic antidepressant (i.e., amitriptyline), 1 muscle relaxant (i.e., cyclobenzaprine), SSRI (i.e., citalopram), 1 SNRI (i.e., venlafaxine), gabapentin, or tramadol 2/ day; 1 pack/ 30 days 2/ day LA Trial of 1 month each of OPIOIDS- morphine sulfate cr tablets PRE (MS Contin) and oxymorphone extended release (Opana ER) LA OPIODS-PRE moderate to severe pain when a continuous, around-theclock opioid analgesic is needed for an extended period of time 1 year DURAGESIC LA OPIOIDS-PRE 1 year 20/ 30 days KADIAN LA OPIOIDS-PRE moderate to severe pain when a continuous, around-theclock opioid analgesic is needed for an extended period of time moderate to severe pain when a continuous, around-theclock opioid analgesic is needed for an extended period of time 1 year LA Trial of 1 month each of 2/ day OPIOIDS- morphine sulfate cr tablets PRE (MS Contin) and oxymorphone extended release (Opana ER) BUTRANS MORPHINE SUL ER CAP/ BEADS MORPHINE SUL ER TAB 12 HR MS CONTIN NUCYNTA NUCYNTA ER OPANA ER OXYCONTIN OXYMORPHONE ER TRAMADOL HCL ER ULTRAM ER 4/ 30 days 2/ day 4/ day NUCYNTA Trial of 2 days of immediate release oxycodone or morphine 4/ day 6/ day 2/ day 4/ day 4/ day 4/ day 2/ day 2/ day 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria BUPRENORPHINE TABLET OPIOID DEPENDENCEPRE opioid dependence Prescriber provides verbal verification of patient’s current and ongoing enrollment in an outpatient drug addiction treatment program/ counseling (NSO) Note: Medical literature does not support the concurrent use of opioids/Tramadol as part of opioid drug dependence treatment. Abstinence of opioids/Tramadol is required both during and following therapy with Suboxone/ Subutex/ Zubsolv/ Bunavail/ buprenorphine, and will only be covered when determined to be medically necessary**. Physicians can contact (855) 746-0013 with any information related to the medical necessity for opioid/Tramadol therapy. 6 months For coverage of additional quantities: Member is pregnant or breastfeeding (Up to 120 tablets in 30 days) Member has a documented contraindication or intolerance or allergy to buprenorphine-naloxone sublingual tablet (allow up to 90 tablets per month for max length of approval of 6 months) 2 mg 24/ 30 days (for induction therapy); 8 mg 8/ 30 days (for induction therapy) 6 months For coverage of additional quantities: Member’s dose is being titrated by physician for 7 day induction therapy (max dose 12 mg/daily for total of 42 tablets/films in 7 days) 2 mg/0.5 mg; 4 mg/1 mg; 8 mg/2 mg 3/ day (for maintenan ce therapy); 12 mg/3 mg 2/ day 6 months For coverage of additional quantities: Member’s dose is being titrated by physician for 7 day induction therapy (max dose 12 mg/daily for total of 42 tablets/films in 7 days) 2 mg/0.5 mg; 4 mg/1 mg; 8 mg/2 mg 3/ day (for maintenan ce therapy); 12 mg/3 mg 2/ day 6 months For coverage of additional quantities: Member’s dose is being titrated by physician for 7 day induction therapy (max dose 12 mg/daily for total of 42 tablets/films in 7 days) 2 mg/0.5 mg; 4 mg/1 mg; 8 mg/2 mg 3/ day (for maintenan ce therapy); 12 mg/3 mg 2/ day 6 months For coverage of additional ZUBSOLV- Trial of 1 month of PRE buprenorphine-naloxone quantities: sublingual tablet or Suboxone Member’s dose is being Film titrated by physician for 7 day induction therapy (max dose 8.4 mg/daily for total of 42 tablets/films in 7 days) 3/ day (for maintenan ce therapy) 1 year STIMULAN Trial of 14 days each of 3 of TS 1-PRE amphetamine/dextroampheta mine/ sr, dexmethylphenidate/ sr, dextroamphetamine, methamphetamine, methylphenidate/ er/ sr, Strattera, or Vyvanse 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 30 mg 2/day; 20 mg 3/ day 1 year STIMULAN Trial of 14 days each of 3 of TS 1-PRE amphetamine/dextroampheta mine/ sr, dexmethylphenidate/ sr, dextroamphetamine, methamphetamine, methylphenidate/ er/ sr, Strattera, or Vyvanse 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg 1/ day **Medically necessary will be defined as: BUPRENORPHINENALOXONE TABLET OPIOID DEPENDENCEPRE opioid dependence 1. Short-term use during and following opioid dependence treatment: for the treatment of acute pain related to surgery, dental procedure, or an emergency situation. 2. Long-term use following opioid dependence treatment: for the treatment of chronic pain. In this case, 1) the member must be treated by a pain management specialist, 2) opioids will only be covered when prescribed by the treating pain specialist, and 3) the treating pain specialist is aware of past buprenorphine use for opioid dependence treatment in which an opioid dependence diagnosis (304.00) and enrollment in a drug addiction Prescriber provides verbal verification of patient’s current and ongoing enrollment in an outpatient drug addiction treatment program/ counseling (NSO) Note: Medical literature does not support the concurrent use of opioids/Tramadol as part of opioid drug dependence treatment. Abstinence of opioids/Tramadol is required both during and following therapy with Suboxone/ Subutex/ Zubsolv/ Bunavail/ buprenorphine, and will only be covered when determined to be medically necessary**. Physicians can contact (855) 746-0013 with any information related to the medical necessity for opioid/Tramadol therapy. **Medically necessary will be defined as: SUBOXONE FILM OPIOID DEPENDENCEPRE opioid dependence 1. Short-term use during and following opioid dependence treatment: for the treatment of acute pain related to surgery, dental procedure, or an emergency situation. 2. Long-term use following opioid dependence treatment: for the treatment of chronic pain. In this case, 1) the member must be treated by a pain management specialist, 2) opioids will only be covered when prescribed by the treating pain specialist, and 3) the treating pain specialist is aware of past buprenorphine use for opioid dependence treatment in which an opioid dependence diagnosis (304.00) and enrollment in a drug addiction Prescriber provides verbal verification of patient’s current and ongoing enrollment in an outpatient drug addiction treatment program/ counseling (NSO) Note: Medical literature does not support the concurrent use of opioids/Tramadol as part of opioid drug dependence treatment. Abstinence of opioids/Tramadol is required both during and following therapy with Suboxone/ Subutex/ Zubsolv/ Bunavail/ buprenorphine, and will only be covered when determined to be medically necessary**. Physicians can contact (855) 746-0013 with any information related to the medical necessity for opioid/Tramadol therapy. **Medically necessary will be defined as: SUBOXONE TABLET OPIOID DEPENDENCEPRE opioid dependence 1. Short-term use during and following opioid dependence treatment: for the treatment of acute pain related to surgery, dental procedure, or an emergency situation. 2. Long-term use following opioid dependence treatment: for the treatment of chronic pain. In this case, 1) the member must be treated by a pain management specialist, 2) opioids will only be covered when prescribed by the treating pain specialist, and 3) the treating pain specialist is aware of past buprenorphine use for opioid dependence treatment in which an opioid dependence diagnosis (304.00) and enrollment in a drug addiction Prescriber provides verbal verification of patient’s current and ongoing enrollment in an outpatient drug addiction treatment program/ counseling (NSO) Note: Medical literature does not support the concurrent use of opioids/Tramadol as part of opioid drug dependence treatment. Abstinence of opioids/Tramadol is required both during and following therapy with Suboxone/ Subutex/ Zubsolv/ Bunavail/ buprenorphine, and will only be covered when determined to be medically necessary**. Physicians can contact (855) 746-0013 with any information related to the medical necessity for opioid/Tramadol therapy. **Medically necessary will be defined as: ZUBSOLV TABLET OPIOID DEPENDENCEPRE opioid dependence 1. Short-term use during and following opioid dependence treatment: for the treatment of acute pain related to surgery, dental procedure, or an emergency situation. 2. Long-term use following opioid dependence treatment: for the treatment of chronic pain. In this case, 1) the member must be treated by a pain management specialist, 2) opioids will only be covered when prescribed by the treating pain specialist, and 3) the treating pain specialist is aware of past buprenorphine use for opioid dependence treatment in which an opioid dependence diagnosis (304.00) and enrollment in a drug addiction Prescriber provides verbal verification of patient’s current and ongoing enrollment in an outpatient drug addiction treatment program/ counseling (NSO) Note: Medical literature does not support the concurrent use of opioids/Tramadol as part of opioid drug dependence treatment. Abstinence of opioids/Tramadol is required both during and following therapy with Suboxone/ Subutex/ Zubsolv/ Bunavail/ buprenorphine, and will only be covered when determined to be medically necessary**. Physicians can contact (855) 746-0013 with any information related to the medical necessity for opioid/Tramadol therapy. **Medically necessary will be defined as: ADDERALL STIMULANTS 1-PRE Attention deficit hyperactivity disorder (ADHD) Narcolepsy ADDERALL XR STIMULANTS 1-PRE Attention deficit hyperactivity disorder (ADHD) Narcolepsy 1. Short-term use during and following opioid dependence treatment: for the treatment of acute pain related to surgery, dental procedure, or an emergency situation. 2. Long-term use following opioid dependence treatment: for the treatment of chronic pain. In this case, 1) the member must be treated by a pain management specialist, 2) opioids will only be covered when prescribed by the treating pain specialist, and 3) the treating pain specialist is aware of past buprenorphine use for opioid dependence treatment in which an opioid dependence diagnosis (304.00) and enrollment in a drug addiction AMPHETAMINE/DEXTR OAMPHETAMINE 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 30 mg 2/day; 20 mg 3/ day AMPHETAMINE/DEXTR OAMPHETAMINE ER 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg 1/ day 4/ day CLONIDINE ER 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria CONCERTA STIMULANTS 1-PRE Attention deficit hyperactivity disorder (ADHD) Narcolepsy 1 year STIMULAN Trial of 14 days each of 3 of 18 mg, 27 TS 1-PRE amphetamine/dextroampheta mg, 54 mg mine/ sr, dexmethylphenidate/ 1/ day sr, dextroamphetamine, methamphetamine, methylphenidate/ er/ sr, Strattera, or Vyvanse DAYTRANA STIMULANTS 1-PRE Attention deficit hyperactivity disorder (ADHD) Narcolepsy 1 year STIMULAN Trial of 14 days each of 3 of 36 mg 2/ TS 1-PRE amphetamine/dextroampheta day mine/ sr, dexmethylphenidate/ sr, dextroamphetamine, methamphetamine, methylphenidate/ er/ sr, Strattera, or Vyvanse DESOXYN STIMULANTS 1-PRE Attention deficit hyperactivity disorder (ADHD) Narcolepsy 1 year STIMULAN Trial of 14 days each of 3 of 4/ day TS 1-PRE amphetamine/dextroampheta mine/ sr, dexmethylphenidate/ sr, dextroamphetamine, methamphetamine, methylphenidate/ er/ sr, Strattera, or Vyvanse DEXEDRINE STIMULANTS 1-PRE Attention deficit hyperactivity disorder (ADHD) Narcolepsy 1 year STIMULAN Trial of 14 days each of 3 of TS 1-PRE amphetamine/dextroampheta mine/ sr, dexmethylphenidate/ sr, dextroamphetamine, methamphetamine, methylphenidate/ er/ sr, Strattera, or Vyvanse DEXMETHYLPHENIDAT E DEXMETHYLPHENIDAT E XR DEXTROAMPHETAMINE SOLN DEXTROAMPHETAMINE ER DEXTROAMPHETAMINE STIMULANTS 1-PRE TAB 3/ day (for maintenan ce therapy) 2/ day 1/ day 40 ml/ day 3/ day Attention deficit hyperactivity disorder (ADHD) Narcolepsy 1 year 4/ day FOCALIN STIMULANTS 1-PRE Attention deficit hyperactivity disorder (ADHD) Narcolepsy 1 year STIMULAN Trial of 14 days each of 3 of 2/ day TS 1-PRE amphetamine/dextroampheta mine/ sr, dexmethylphenidate/ sr, dextroamphetamine, methamphetamine, methylphenidate/ er/ sr, Strattera, or Vyvanse FOCALIN XR STIMULANTS 1-PRE Attention deficit hyperactivity disorder (ADHD) Narcolepsy 1 year STIMULAN Trial of 14 days each of 3 of 1/ day TS 1-PRE amphetamine/dextroampheta mine/ sr, dexmethylphenidate/ sr, dextroamphetamine, methamphetamine, methylphenidate/ er/ sr, Strattera, or Vyvanse INTUNIV STIMULANTS 2-PRE Attention deficit hyperactivity disorder (ADHD) 1 year 1/ day STIMULAN Trial of 14 days each of 3 of TS 2-PRE clonidine/ sr, guanfacine, amphetamine/dextroampheta mine/ sr, dexmethylphenidate/ sr, dextroamphetamine, methamphetamine, methylphenidate/ er/ sr, Strattera, or Vyvanse KAPVAY STIMULANTS 2-PRE Attention deficit hyperactivity disorder (ADHD) 1 year 4/ day; 1 STIMULAN Trial of 14 days each of 3 of pack/ 30 TS 2-PRE clonidine/ sr, guanfacine, amphetamine/dextroampheta days mine/ sr, dexmethylphenidate/ sr, dextroamphetamine, methamphetamine, methylphenidate/ er/ sr, Strattera, or Vyvanse METADATE CD CAP STIMULANTS 1-PRE Attention deficit hyperactivity disorder (ADHD) Narcolepsy 1 year 1/ day STIMULAN Trial of 14 days each of 3 of TS 1-PRE amphetamine/dextroampheta mine/ sr, dexmethylphenidate/ sr, dextroamphetamine, methamphetamine, methylphenidate/ er/ sr, Strattera, or Vyvanse METADATE ER TAB METHAMPHETAMINE METHYLIN CHEW/ SOLN STIMULANTS 1-PRE Attention deficit hyperactivity disorder (ADHD) Narcolepsy 1 year STIMULAN Trial of 14 days each of 3 of TS 1-PRE amphetamine/dextroampheta mine/ sr, dexmethylphenidate/ sr, dextroamphetamine, methamphetamine, methylphenidate/ er/ sr, Strattera, or Vyvanse METHYLPHENIDATE SOLN METHYLPHENIDATE TAB (generic Ritalin) METHYLPHENIDATE ER CAPS METHYLPHENIDATE ER CAPS (generic RITALIN LA) 20 mg, 40 mg 1/ day; 30 mg 2/ day 4/ day 6/ day; 60 ml/ day 60 ml/ day 3/ day 3/ day 20 mg, 40 mg 1/ day; 30 mg 2/ day 18 mg, 27 mg, 54 mg 1/ day 3/ day METHYLPHENIDATE ER TAB (generic Concerta) METHYLPHENIDATE ER TAB (generic METADATE ER, RITALIN SR) PROCENTRA STIMULANTS 1-PRE Attention deficit hyperactivity disorder (ADHD) Narcolepsy 1 year STIMULAN Trial of 14 days each of 3 of 40 ml/ day TS 1-PRE amphetamine/dextroampheta mine/ sr, dexmethylphenidate/ sr, dextroamphetamine, methamphetamine, methylphenidate/ er/ sr, Strattera, or Vyvanse QUILLIVANT XR STIMULANTS 1-PRE Attention deficit hyperactivity disorder (ADHD) Narcolepsy 1 year 12 ml/ day STIMULAN Trial of 14 days each of 3 of TS 1-PRE amphetamine/dextroampheta mine/ sr, dexmethylphenidate/ sr, dextroamphetamine, methamphetamine, methylphenidate/ er/ sr, Strattera, or Vyvanse RITALIN STIMULANTS 1-PRE Attention deficit hyperactivity disorder (ADHD) Narcolepsy 1 year STIMULAN Trial of 14 days each of 3 of 3/ day TS 1-PRE amphetamine/dextroampheta mine/ sr, dexmethylphenidate/ sr, dextroamphetamine, methamphetamine, methylphenidate/ er/ sr, Strattera, or Vyvanse RITALIN LA STIMULANTS 1-PRE Attention deficit hyperactivity disorder (ADHD) Narcolepsy 1 year STIMULAN Trial of 14 days each of 3 of TS 1-PRE amphetamine/dextroampheta mine/ sr, dexmethylphenidate/ sr, dextroamphetamine, methamphetamine, methylphenidate/ er/ sr, Strattera, or Vyvanse RITALIN SR STIMULANTS 1-PRE Attention deficit hyperactivity disorder (ADHD) Narcolepsy 1 year STIMULAN Trial of 14 days each of 3 of 3/ day TS 1-PRE amphetamine/dextroampheta mine/ sr, dexmethylphenidate/ sr, dextroamphetamine, methamphetamine, methylphenidate/ er/ sr, Strattera, or Vyvanse 20 mg, 40 mg 1/ day; 30 mg 2/ day STRATTERA 10 mg, 18 mg, 25 mg, 40 mg, 60 mg 2/ day; 80 mg, 100 mg 1/ day VYVANSE 1/ day 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria ZENZEDI 2.5/7.5/10/20/30 MG STIMULANTS 1-PRE Attention deficit hyperactivity disorder (ADHD) Narcolepsy MODAFINIL NARCOLEPSY-PRE Narcolepsy Obstructive sleep apnea/hypopnea syndrome (OSAHS) NUVIGIL NARCOLEPSY-PRE Narcolepsy Obstructive sleep apnea/hypopnea syndrome (OSAHS) PROVIGIL NARCOLEPSY-PRE Narcolepsy Obstructive sleep apnea/hypopnea syndrome (OSAHS) 1 year STIMULAN Trial of 14 days each of 3 of TS 1-PRE amphetamine/dextroampheta mine/ sr, dexmethylphenidate/ sr, dextroamphetamine, methamphetamine, methylphenidate/ er/ sr, Strattera, or Vyvanse ZENZEDI 5/10 MG Narcolepsy, confirmed by sleep lab evaluation OR OSAHS) confirmed by polysomnography (a study on sleep cycles and behavior) AND one of the following: Member is currently using an oral/dental appliance Member has undergone an uvulopalatopharyngoplasty (UPPP) Member is greater than or equal to 65 yrs of age Member has already had an adequate therapeutic trial of twelve weeks of continuous positive airway pressure (CPAP)/ bilevel positive airway pressure (BiPAP) treatment and meets ALL of the following: Member is compliant with and currently using CPAP/BiPAP treatment Member is experiencing excessive sleepiness despite Narcolepsy, confirmed by sleep lab evaluation OR OSAHS) confirmed by polysomnography (a study on sleep cycles and behavior) AND one of the following: Member is currently using an oral/dental appliance Member has undergone an uvulopalatopharyngoplasty (UPPP) Member is greater than or equal to 65 yrs of age Member has already had an adequate therapeutic trial of twelve weeks of continuous positive airway pressure (CPAP)/ bilevel positive airway pressure (BiPAP) treatment and meets ALL of the following: Member is compliant with and currently using CPAP/BiPAP treatment Member is experiencing excessive sleepiness despite Narcolepsy, confirmed by sleep lab evaluation OR OSAHS) confirmed by polysomnography (a study on sleep cycles and behavior) AND one of the following: Member is currently using an oral/dental appliance Member has undergone an uvulopalatopharyngoplasty (UPPP) Member is greater than or equal to 65 yrs of age Member has already had an adequate therapeutic trial of twelve weeks of continuous positive airway pressure (CPAP)/ bilevel positive airway pressure (BiPAP) treatment and meets ALL of the following: Member is compliant with and currently using CPAP/BiPAP treatment Member is experiencing excessive sleepiness despite 5 mg, 10 mg 4/ day 2/ day 1 year 1 year 50 mg 2/day; 150 mg; 200 mg; 250 mg 1/ day 1 year 2/ day TRIPTANS- Trial of 1 month of 3 of the PRE following: naratriptan, rizatriptan, sumatriptan, zolmitriptan (NSO) ALSUMA AMERGE AXERT TRIPTANS- Trial of 1 month of 3 of the PRE following: naratriptan, rizatriptan, sumatriptan, zolmitriptan (NSO) TRIPTANS- Trial of 1 month of 3 of the PRE following: naratriptan, rizatriptan, sumatriptan, zolmitriptan (NSO) FROVA IMITREX TAB IMITREX INJ IMITREX SPR MAXALT MAXALT MLT NARATRIPTAN HCL RELPAX TRIPTANS- Trial of 1 month of 3 of the PRE following: naratriptan, rizatriptan, sumatriptan, zolmitriptan (NSO) RIZATRIPTAN SUMATRIPTAN INJ SUMATRIPTAN SPR SUMATRIPTAN TAB SUMAVEL DOSEPRO TRIPTANS- Trial of 1 month of 3 of the PRE following: naratriptan, rizatriptan, sumatriptan, zolmitriptan (NSO) TREXIME Trial of 1 month of 3 of the T-PRE following: naratriptan, rizatriptan, sumatriptan, zolmitriptan AND concurrent use of prescription strength naproxen >/= 500mg (NSO) TREXIMET ZOLMITRIPTAN ZOLMITRIPTAN ODT ZOMIG/ NASAL ABSORICA ISOTRETINOINS-PRE severe recalcitrant nodular or cystic acne Member is enrolled in the FDA iPLEDGE program (females of childbearing potential ONLY) 6 months AMNESTEEM ISOTRETINOINS-PRE severe recalcitrant nodular or cystic acne Member is enrolled in the FDA iPLEDGE program (females of childbearing potential ONLY) 6 months CLARAVIS ISOTRETINOINS-PRE severe recalcitrant nodular or cystic acne Member is enrolled in the FDA iPLEDGE program (females of childbearing potential ONLY) 6 months MYORISAN ISOTRETINOINS-PRE severe recalcitrant nodular or cystic acne Member is enrolled in the FDA iPLEDGE program (females of childbearing potential ONLY) 6 months ZENATANE ISOTRETINOINS-PRE severe recalcitrant nodular or cystic acne Member is enrolled in the FDA iPLEDGE program (females of childbearing potential ONLY) 6 months ALDARA imiquimod cream PICATO GEL 2.5 mg, 7.5 mg 4/ day; 13 mg, 20 mg, 30 mg 2/ day TRIPTANS- Trial of 1 month of 3 of the PRE following: naratriptan, rizatriptan, sumatriptan, zolmitriptan (NSO) ISOTRETI Trial of 1 generic oral NOINSantibiotic prescribed for the PRE treatment of acne (i.e., minocycline or doxycycline) ISOTRETI Trial of 1 generic oral NOINSantibiotic prescribed for the PRE treatment of acne (i.e., minocycline or doxycycline) ISOTRETI Trial of 1 generic oral NOINSantibiotic prescribed for the PRE treatment of acne (i.e., minocycline or doxycycline) ISOTRETI Trial of 1 generic oral NOINSantibiotic prescribed for the PRE treatment of acne (i.e., minocycline or doxycycline) ISOTRETI Trial of 1 generic oral NOINSantibiotic prescribed for the PRE treatment of acne (i.e., minocycline or doxycycline) 4 kits (8 syringes) in 30 days 9 tablets in 30 days 6 tablets in 30 days 9 tablets in 30 days 10 cartridge( s) per month 6 sprays in 30 days 9 tablets in 30 days 12 tablets in 30 days 12 tablets in 30 days 9 tablets in 30 days 6 tablets in 30 days 12 tablets in 30 days 10 cartridge( s) per month 6 sprays in 30 days 9 tablets in 30 days 6 (3 ml) syringes in 30 days 9 tablets in 30 days 6 tablets in 30 days 6 tablets in 30 days 6 tablets/ sprays in 30 days 2/ day 2/ day 2/ day 2/ day 2/ day 16 weeks of treatment per 365 days 16 weeks of treatment per 365 days 0.015% gel 18 tubes (6 boxes) per year; 0.05% gel 12 tubes (6 boxes) per year 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria ZYCLARA FREESTYLE ONE TOUCH PRECISION All Other Test Strips TEST STRIPSPRE Trial of 1 month each of 2 of the preferred alternative test strip products, Onetouch, Freestyle Test Strips, or Precision Xtra Test Strips JANUMET JANUMET XR JANUVIA JENTADUETO KAZANO DIABETES type 2 diabetes mellitus in adults 1 year KAZANOPRE Trial of 1 month each of Jentadueto AND Kombiglyze XR AND Janumet or Janumet XR KOMBIGLYZE XR NESINA DIABETES type 2 diabetes mellitus in adults 1 year NESINAPRE Trial of 1 month each of metformin, AND Januvia AND Onglyza AND Tradjeta ONGLYZA OSENI DIABETES type 2 diabetes mellitus in adults 1 year OSENIPRE TRADJENTA ANDRODERM TESTOSTERONE-PRE Hypogonadism female members A. Testosterone replacement for androgen deficiency in men is considered medically necessary only for persons with one or more of the symptoms and signs listed: incomplete sexual development, eunuchoidism, aspermia; reduced sexual desire (libido) and activity; decreased spontaneous erections; breast discomfort, gynecomastia; loss of body (axillary and pubic) hair, reduced shaving; very small or shrinking testes; inability to father children, low or zero sperm counts; height loss, low trauma fracture, low bone mineral density; reduced muscle bulk and strength; or hot flushes, sweats. 1 year 3.75% cream packets 56 packets of treatment per 365 days; 2.5%, 3.75% cream pump dispenser 2 pumps (15gm) per 365 days 10/ day 10/ day 10/ day 10/ day 2/ day 1/ day 1/ day 2/ day 2/day 1/ day 1/ day 1/ day Trial of 1 month each of 1/ day metformin (single entity or combination) AND pioglitazone in combination with Januvia AND Onglyza AND Tradjenta 1/ day TESTOST Documentation of trial and failure 1/ day of the preferred topical ERONEtestosterone products (Testim and PRE Androgel) is required prior to coverage of other topical products (Androderm, Axiron, Fortesta, Striant, Testosterone gel pump, Vogelxo) B. Member must be male with a symptomatic androgen deficiency as defined by one of the follwoing: - Having two consecutive low total fasting serum testosterone levels (below the testing laboratory's reference range or below 300ng/dl if reference ranges are not available), OR - For persons with low normal total testosterone levels (above 300 ng/dL but below 400 ng/dL), two consecutive low free or bioavailable fasting serum testosterone levels (below the testing laboratory's reference range or less than 225 picomoles per liter (pmol/L) (6 ng/dL) if reference ranges are not available) C. Two morning samples drawn between 7:00 a.m. and 10:00 a.m. obtained on two consecutive days is required. ANDROGEL TESTOSTERONE-PRE Hypogonadism female members A. Testosterone replacement for androgen deficiency in men is considered medically necessary only for persons with one or more of the symptoms and signs listed: incomplete sexual development, eunuchoidism, aspermia; reduced sexual desire (libido) and activity; decreased spontaneous erections; breast discomfort, gynecomastia; loss of body (axillary and pubic) hair, reduced shaving; very small or shrinking testes; inability to father children, low or zero sperm counts; height loss, low trauma fracture, low bone mineral density; reduced muscle bulk and strength; or hot flushes, sweats. 1 year 1.62% pump/ 2 month; 1.62% packet (20.25mg/ 1.25gm) 1/ day; 1.62% packet (40.5mg/ 2.5gm) 2/ day; 1% pump 4/ month; 1% packet (25mg/ 2.5gm) 1/ day; 1% packet (50mg/ 5gm) 2 day B. Member must be male with a symptomatic androgen deficiency as defined by one of the follwoing: - Having two consecutive low total fasting serum testosterone levels (below the testing laboratory's reference range or below 300ng/dl if reference ranges are not available), OR - For persons with low normal total testosterone levels (above 300 ng/dL but below 400 ng/dL), two consecutive low free or bioavailable fasting serum testosterone levels (below the testing laboratory's reference range or less than 225 picomoles per liter (pmol/L) (6 ng/dL) if reference ranges are not available) C. Two morning samples drawn between 7:00 a.m. and 10:00 a.m. obtained on two consecutive days is required. AXIRON Hypogonadism female members A. Testosterone replacement for androgen deficiency in men is considered medically necessary only for persons with one or more of the symptoms and signs listed: incomplete sexual development, eunuchoidism, aspermia; reduced sexual desire (libido) and activity; decreased spontaneous erections; breast discomfort, gynecomastia; loss of body (axillary and pubic) hair, reduced shaving; very small or shrinking testes; inability to father children, low or zero sperm counts; height loss, low trauma fracture, low bone mineral density; reduced muscle bulk and strength; or hot flushes, sweats. 1 year 2 pumps/ TESTOST Documentation of trial and ERONEfailure of the preferred topical month PRE testosterone products (Testim and Androgel) is required prior to coverage of other topical products (Androderm, Axiron, Fortesta, Striant, Testosterone gel pump, Vogelxo) 1 year TESTOST Trial of 1 month each of ERONEAndroGel AND Testim PRE B. Member must be male with a symptomatic androgen deficiency as defined by one of the follwoing: - Having two consecutive low total fasting serum testosterone levels (below the testing laboratory's reference range or below 300ng/dl if reference ranges are not available), OR - For persons with low normal total testosterone levels (above 300 ng/dL but below 400 ng/dL), two consecutive low free or bioavailable fasting serum testosterone levels (below the testing laboratory's reference range or less than 225 picomoles per liter (pmol/L) (6 ng/dL) if reference ranges are not available) C. Two morning samples drawn between 7:00 a.m. and 10:00 a.m. obtained on two consecutive days is required. FORTESTA TESTOSTERONE-PRE Hypogonadism female members A. Testosterone replacement for androgen deficiency in men is considered medically necessary only for persons with one or more of the symptoms and signs listed: incomplete sexual development, eunuchoidism, aspermia; reduced sexual desire (libido) and activity; decreased spontaneous erections; breast discomfort, gynecomastia; loss of body (axillary and pubic) hair, reduced shaving; very small or shrinking testes; inability to father children, low or zero sperm counts; height loss, low trauma fracture, low bone mineral density; reduced muscle bulk and strength; or hot flushes, sweats. B. Member must be male with a symptomatic androgen deficiency as defined by one of the follwoing: - Having two consecutive low total fasting serum testosterone levels (below the testing laboratory's reference range or below 300ng/dl if reference ranges are not available), OR - For persons with low normal total testosterone levels (above 300 ng/dL but below 400 ng/dL), two consecutive low free or bioavailable fasting serum testosterone levels (below the testing laboratory's reference range or less than 225 picomoles per liter (pmol/L) (6 ng/dL) if reference ranges are not available) C. Two morning samples drawn between 7:00 a.m. and 10:00 a.m. obtained on two consecutive days is required. 2 canisters/ month 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria STRIANT TESTOSTERONE-PRE Hypogonadism female members A. Testosterone replacement for androgen deficiency in men is considered medically necessary only for persons with one or more of the symptoms and signs listed: incomplete sexual development, eunuchoidism, aspermia; reduced sexual desire (libido) and activity; decreased spontaneous erections; breast discomfort, gynecomastia; loss of body (axillary and pubic) hair, reduced shaving; very small or shrinking testes; inability to father children, low or zero sperm counts; height loss, low trauma fracture, low bone mineral density; reduced muscle bulk and strength; or hot flushes, sweats. 1 year TESTOST Documentation of trial and 2/ day ERONEfailure of the preferred topical PRE testosterone products (Testim and Androgel) is required prior to coverage of other topical products (Androderm, Axiron, Fortesta, Striant, Testosterone gel pump, Vogelxo) 1 year 2/ day 1 year 50mg/ 5gm packet/ tube 2/ day; 12.5mg/ pump actuation 4 pumps/ month B. Member must be male with a symptomatic androgen deficiency as defined by one of the follwoing: - Having two consecutive low total fasting serum testosterone levels (below the testing laboratory's reference range or below 300ng/dl if reference ranges are not available), OR - For persons with low normal total testosterone levels (above 300 ng/dL but below 400 ng/dL), two consecutive low free or bioavailable fasting serum testosterone levels (below the testing laboratory's reference range or less than 225 picomoles per liter (pmol/L) (6 ng/dL) if reference ranges are not available) C. Two morning samples drawn between 7:00 a.m. and 10:00 a.m. obtained on two consecutive days is required. TESTIM TESTOSTERONE-PRE Hypogonadism female members A. Testosterone replacement for androgen deficiency in men is considered medically necessary only for persons with one or more of the symptoms and signs listed: incomplete sexual development, eunuchoidism, aspermia; reduced sexual desire (libido) and activity; decreased spontaneous erections; breast discomfort, gynecomastia; loss of body (axillary and pubic) hair, reduced shaving; very small or shrinking testes; inability to father children, low or zero sperm counts; height loss, low trauma fracture, low bone mineral density; reduced muscle bulk and strength; or hot flushes, sweats. B. Member must be male with a symptomatic androgen deficiency as defined by one of the follwoing: - Having two consecutive low total fasting serum testosterone levels (below the testing laboratory's reference range or below 300ng/dl if reference ranges are not available), OR - For persons with low normal total testosterone levels (above 300 ng/dL but below 400 ng/dL), two consecutive low free or bioavailable fasting serum testosterone levels (below the testing laboratory's reference range or less than 225 picomoles per liter (pmol/L) (6 ng/dL) if reference ranges are not available) C. Two morning samples drawn between 7:00 a.m. and 10:00 a.m. obtained on two consecutive days is required. Testosterone Gel (generic) TESTOSTERONE-PRE Hypogonadism female members A. Testosterone replacement for androgen deficiency in men is considered medically necessary only for persons with one or more of the symptoms and signs listed: incomplete sexual development, eunuchoidism, aspermia; reduced sexual desire (libido) and activity; decreased spontaneous erections; breast discomfort, gynecomastia; loss of body (axillary and pubic) hair, reduced shaving; very small or shrinking testes; inability to father children, low or zero sperm counts; height loss, low trauma fracture, low bone mineral density; reduced muscle bulk and strength; or hot flushes, sweats. B. Member must be male with a symptomatic androgen deficiency as defined by one of the follwoing: - Having two consecutive low total fasting serum testosterone levels (below the testing laboratory's reference range or below 300ng/dl if reference ranges are not available), OR - For persons with low normal total testosterone levels (above 300 ng/dL but below 400 ng/dL), two consecutive low free or bioavailable fasting serum testosterone levels (below the testing laboratory's reference range or less than 225 picomoles per liter (pmol/L) (6 ng/dL) if reference ranges are not available) C. Two morning samples drawn between 7:00 a.m. and 10:00 a.m. obtained on two consecutive days is required. VOGELXO TESTOSTERONE-PRE Hypogonadism female members A. Testosterone replacement for androgen deficiency in men is considered medically necessary only for persons with one or more of the symptoms and signs listed: incomplete sexual development, eunuchoidism, aspermia; reduced sexual desire (libido) and activity; decreased spontaneous erections; breast discomfort, gynecomastia; loss of body (axillary and pubic) hair, reduced shaving; very small or shrinking testes; inability to father children, low or zero sperm counts; height loss, low trauma fracture, low bone mineral density; reduced muscle bulk and strength; or hot flushes, sweats. 1 year TESTOST Documentation of trial and ERONEfailure of the preferred topical PRE testosterone products (Testim and Androgel) is required prior to coverage of other topical products (Androderm, Axiron, Fortesta, Striant, Testosterone gel pump, Vogelxo) 50mg/ 5gm packet/ tube 2/ day; 12.5mg/ pump actuation 2/ month B. Member must be male with a symptomatic androgen deficiency as defined by one of the follwoing: - Having two consecutive low total fasting serum testosterone levels (below the testing laboratory's reference range or below 300ng/dl if reference ranges are not available), OR - For persons with low normal total testosterone levels (above 300 ng/dL but below 400 ng/dL), two consecutive low free or bioavailable fasting serum testosterone levels (below the testing laboratory's reference range or less than 225 picomoles per liter (pmol/L) (6 ng/dL) if reference ranges are not available) C. Two morning samples drawn between 7:00 a.m. and 10:00 a.m. obtained on two consecutive days is required. BYDUREON BYETTA TANZEUM TANZEUM Type II diabetes no personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) 1 year Trial of 1 month each of Bydureon and Victoza VICTOZA INVOKANA INVOKAMET FARXIGA XIGDUO Trial of 1 month of metformin Trial of 1 month of metformin Trial of 1 month of metformin Trial of 1 month of metformin JARDIANCE Trial of 1 month of metformin AND Invokana ACTIVELLA ANGELIQ CENESTIN FEMHRT MIMVEY NORETHINDRONE PREFEST ALORA CLIMARA CLIMARA PRO COMBIPATCH ELESTRIN ESTRADIOL PATCH ESTRASORB ESTROGEL EVAMIST MENOSTAR MINIVELLE VIVELLE-DOT FEMRING balsalazide CANASA suppository COLAZAL 1.2 mg 2 /month; 1.8mg 3/ 30 days 1/ day 2/ day 1/day 5/500 mg: 1/day, 5/1000 mg: 2/day, 10/500 mg: 1/day, 10/1000mg : 1/day 1/day 1/ day 1/ day 0.3mg, 0.45mg, 0.625mg, 0.9mg 1 per day; 1.25mg 2/day 1/ day 0.3mg, 0.45mg, 0.625mg, 0.9mg 1 per day; 1.25mg 2/day 1/ day 1/ day 2/ day 1/ day 8/ month 1/ week 1/ week 8/ month 1/ fill 1/ week 2/ day 1/ fill 1/ fill 1/ week 8/ month 8/ month 1/ 90 days DUAVEE ENJUVIA APRISO ASACOL ASACOL HD AZULFIDINE/ EN TABS 4/ month 1/ month 4/ month 5ASAPRE Trial of 1 month of Apriso, Asacol, Asacol HD, Delzicol, Lialda, or Pentasa (NSO) 5ASAPRE Trial of 1 month of Apriso, Asacol, Asacol HD, Delzicol, Lialda, or Pentasa (NSO) 4/ day 12/ day 6/ day 8/ day 9/ day 1/ day 9/ day 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria DELZICOL DIPENTUM 5ASAPRE GIAZO ulcerative colitis female members covered in patients 18 years of age and older 1 year 5ASAPRE Trial of 1 month of Apriso, Asacol, Asacol HD, Delzicol, Lialda, or Pentasa (NSO) Trial of 1 month of Apriso, Asacol, Asacol HD, Delzicol, Lialda, or Pentasa (NSO) LIALDA PENTASA Sulfasalazine sulfasalazine DR sulfazine sulfazine EC AMITIZA Trial of 1 month of 1 prescription generic laxative alternative (i.e., lactulose) (NSO) LINZESS Cialis 2.5/5 MG Trial of 1 month of 1 prescription generic laxative alternative (i.e., lactulose) (NSO) CIALIS_BPH-PRE For BPH (Benign Prostatic Hyperplasia) Member has diagnosis of BPH (Benign Prostatic Hyperplasia) AND ALL of the following: Member is not currently on nitrite/nitrate therapy ** Member is not currently on another phosphodiesterase5 inhibitor Member has a documented contraindication or intolerance or allergy or failure of a one month trial of one of the preferred drugs alfuzosin, finasteride, tamsulosin, Avodart, Jalyn or Rapaflo 1 year Cialis 10/20 MG 1 year Levitra 1 year Staxyn 1 year Stendra 1 year For Fully Insured members of contract state New York: A documented primary diagnosis of erectile dysfunction in adult males over 18 years of age AND a documented secondary diagnosis of one of the following: Diabetes Hypertension Spinal cord injury Multiple sclerosis Stroke Radical surgery of genital tract, urinary tract, or rectum Hypogonadism AND Member is not receiving any of the following organic nitrate product: Isosorbide mononitrate (Ismo), isosorbide dinitrate (Sorbitrate, Isordil, DilatrateSR), Nitroglycerin (NTG, For Fully Insured members of contract state New York: A documented primary diagnosis of erectile dysfunction in adult males over 18 years of age AND a documented secondary diagnosis of one of the following: Diabetes Hypertension Spinal cord injury Multiple sclerosis Stroke Radical surgery of genital tract, urinary tract, or rectum Hypogonadism AND Member is not receiving any of the following organic nitrate product: Isosorbide mononitrate (Ismo), isosorbide dinitrate (Sorbitrate, Isordil, DilatrateSR), Nitroglycerin (NTG, For Fully Insured members of contract state New York: A documented primary diagnosis of erectile dysfunction in adult males over 18 years of age AND a documented secondary diagnosis of one of the following: Diabetes Hypertension Spinal cord injury Multiple sclerosis Stroke Radical surgery of genital tract, urinary tract, or rectum Hypogonadism AND Member is not receiving any of the following organic nitrate product: Isosorbide mononitrate (Ismo), isosorbide dinitrate (Sorbitrate, Isordil, DilatrateSR), Nitroglycerin (NTG, For Fully Insured members of contract state New York: A documented primary diagnosis of erectile dysfunction in adult males over 18 years of age AND a documented secondary diagnosis of one of the following: Diabetes Hypertension Spinal cord injury Multiple sclerosis Stroke Radical surgery of genital tract, urinary tract, or rectum Hypogonadism AND Member is not receiving any of the following organic nitrate product: Isosorbide mononitrate (Ismo), isosorbide dinitrate (Sorbitrate, Isordil, DilatrateSR), Nitroglycerin (NTG, For Fully Insured members of contract state New York: A documented primary diagnosis of erectile dysfunction in adult males over 18 years of age AND a documented secondary diagnosis of one of the following: Diabetes Hypertension Spinal cord injury Multiple sclerosis Stroke Radical surgery of genital tract, urinary tract, or rectum Hypogonadism AND Member is not receiving any of the following organic nitrate product: Isosorbide mononitrate (Ismo), isosorbide dinitrate (Sorbitrate, Isordil, DilatrateSR), Nitroglycerin (NTG, Trial of 1 month of Cialis (NSO, if ED rider applies to plan) Trial of 1 month of Cialis (NSO, if ED rider applies to plan) Trial of 1 month of Cialis (NSO, if ED rider applies to plan) 12/ day 4/ day 6/ day 4/ day 250mg 16/ day; 500mg 8/ day 8/ day 8/ day 8/ day 8/ day 2/ day 1/ day 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria Viagra 1 year DETROL DETROL LA DITROPAN XL ENABLEX GELNIQUE 3% GELNIQUE 10% MYRBETRIQ SANCTURA/ XR TOVIAZ VESICARE For Fully Insured members of contract state New York: A documented primary diagnosis of erectile dysfunction in adult males over 18 years of age AND a documented secondary diagnosis of one of the following: Diabetes Hypertension Spinal cord injury Multiple sclerosis Stroke Radical surgery of genital tract, urinary tract, or rectum Hypogonadism AND Member is not receiving any of the following organic nitrate product: Isosorbide mononitrate (Ismo), isosorbide dinitrate (Sorbitrate, Isordil, DilatrateSR), Nitroglycerin (NTG, Trial of 1 month of Cialis (NSO, if ED rider applies to plan) OAB-PRE Trial of 1 month of 1 of trospium/ er, tolteridine/ er AND 1 of Enablex, Myrbetriq, Vesicare OAB-PRE Trial of 1 month of 1 of trospium/ er, tolteridine/ er AND 1 of Enablex, Myrbetriq, Vesicare OAB-PRE Trial of 1 month of 1 of trospium/ er, tolteridine/ er AND 1 of Enablex, Myrbetriq, Vesicare OAB-PRE Trial of 1 month of 1 of trospium/ er, tolteridine/ er AND 1 of Enablex, Myrbetriq, Vesicare OAB-PRE Trial of 1 month of 1 of trospium/ er, tolteridine/ er AND 1 of Enablex, Myrbetriq, Vesicare OAB-PRE Trial of 1 month of 1 of trospium/ er, tolteridine/ er AND 1 of Enablex, Myrbetriq, Vesicare OAB2Trial of 1 month of trospium/ PRE er or tolteridine/ er OAB-PRE Trial of 1 month of 1 of trospium/ er, tolteridine/ er AND 1 of Enablex, Myrbetriq, Vesicare OAB-PRE Trial of 1 month of 1 of trospium/ er, tolteridine/ er AND 1 of Enablex, Myrbetriq, Vesicare OAB2Trial of 1 month of trospium/ PRE er or tolteridine/ er latanoprost LUMIGAN RESCULA OPHTHPRE Trial of 1 week of latanoprost AND 1 week of Travatan Z OPHTHPRE OPHTHPRE ANOROPRE Trial of 1 week of latanoprost AND 1 week of Travatan Z Trial of 1 week of latanoprost AND 1 week of Travatan Z Trial of 1 month of Symbicort AND Spiriva TRAVATAN Z travoprost XALATAN ZIOPTAN ANORO ELLIPTA COPD Chronic Ostructive Pulmonary Disease (COPD) 1 year SPIRIVA TUDORZA COPD Chronic Ostructive Pulmonary Disease (COPD) 1 year AEROSPAN ALVESCO BUDESONIDE INHALATION SUS (Respules) FLOVENT DISKUS FLOVENT HFA PULMICORT FLEXHALER PULMICORT RESPULES QVAR ADVAIR DISKUS ADVAIR HFA BREO TUDORZA- Trial of 1 month of Spiriva PRE ICS-PRE Trial of 1 month of Asmanex, Qvar, or Flovent/HFA ICS-PRE Trial of 1 month of Asmanex, Qvar, or Flovent/HFA ICS-PRE COPD Chronic Ostructive Pulmonary Disease (COPD) 1 year Trial of 1 month of Asmanex, Qvar, or Flovent/HFA BREOPRE Trial of 1 month of Symbicort AND Spiriva NASAL SPRAYSPRE Trial of 2 weeks each of 2 of Nasonex, Veramyst, budesonide, flunisolide, fluticasone, or triamcinolone Trial of 2 weeks each of 2 of Nasonex, Veramyst, budesonide, flunisolide, fluticasone, or triamcinolone Trial of 2 weeks each of 2 of Nasonex, Veramyst, budesonide, flunisolide, fluticasone, or triamcinolone ZETONNA NASAL SPRAYSPRE COPD COPD Chronic Ostructive Pulmonary Disease (COPD) Chronic Ostructive Pulmonary Disease (COPD) 1 year 1 year COPD Chronic Ostructive Pulmonary Disease (COPD) 1 year COPDPRE Trial of 1 month each of Foradil AND Serevent COPDPRE Trial of 1 month each of Foradil AND Serevent FORADIL VENTOLIN HFA XOPENEX HFA 1/ month 1/ fill 1/ fill 1/ fill 1/ fill 1/ fill 1/ fill 1/ fill 1/ fill 1/ fill 1/ fill 1/ month 1/ fill 1/ fill NASAL SPRAYSPRE SEREVENT PROAIR HFA PROVENTIL HFA 1/ day 1/ fill NASACORT AQ PERFOROMIST 90 days max/ fill 3ml/ fill 3ml/ fill 1/ fill DULERA SYMBICORT BECONASE AQ ARCAPTA BROVANA 3ml/ fill 3ml/ month 1/ day PROVENT Trial of 1 week each of IL HFAVentolin HFA AND Proair PRE PROVENT Trial of 1 week each of IL HFAVentolin HFA AND Proair PRE 1/ day 60vials/ fill 2caps/ day 60vials/ fill 1/ fill 2/ fill 2/ fill 2/ fill 2/ fill Cervical Caps (Femcap, Prentif) Combination Contraceptives - Oral Combination Contraceptives Transdermal (OrthoEvra) Combination Contraceptives - Vaginal (Nuvaring) Contraceptive Sponge Diaphragms (Ortho-Flex, Wideseal,Omniflex) 1/ year Emergency Contraceptives(Ella, Plan B) Female Condoms (Reality, FC Female) Intrautarine Device -IUD (Paragard, ) Progenstin contraceptives -Oral Progestin Contraceptives Implants (Implanon,Nexplanon) Progestin Contraceptives Injectable - (DepoProvera) Progestin Contraceptives - IUD (Mirena, Skyla) Spermicides Bupropion Chantix 0.5 and 1 mg Nicotine Inhaler (Nicotrol) 2/ fill 1.5/ day 12/ year 12/ year 15/ month 1/ year 15/ month 1/ year 1/5/ day 1/ year 4/ year 1/ year 15/ month 2/ day 2/ day 3units/ month 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria Nicotine Nasal Solution (Nicotrol NS) Nicotine polacrilex Gum (Nicorette) Nicotine polacrilex Lozenge (Nicorette) Transdermal Nicotine Patch (Nicoderm) Zyban LOVAZA 12/ month 24/ day 20/ day 1/ day omega-3-acid Lunesta Insomnia, in members over age 18 Eszopiclone Insomnia, in members over age 18 not covered < 18 years of age not covered < 18 years of age 1 year >5 1 year 1 year Actonel RISEDRONATE SODIUM TAB 150 MG (Active) EPANED ATRALIN RETIN-A TRETIN-X VELTIN FABIOR ACEI-PRE Acne-PRE hypertension Acne vulgaris A documented diagnosis of hypertension (HTN), AND Member has a documented inability to swallow a tablet or capsule and no other route of administration exists (i.e., NG-tube, G-tube, J-tube) A documented diagnosis of any one of the following: Acne vulgaris (includes comedonal, cystic, nodular & papular acne) -Actinic keratoses AND Lesions are on the face OR Lesions are not on the face and therapy includes the use of 5-fluorouracil in conjunction with tretinoin >35 1 year >35 1 year -Hypertrophic scars or keloids AND Intralesional injection of corticosteroids is ineffective or not tolerated avita ZIANA EPIDUO RETIN-A MICRO tretinoin 2/ day Trial of 1 month of fenofibrate 4/ day or Vascepa 4/ day LUNESTA- Trial of 1 month of a generic 1/ day PRE hypnotic, i.e., zolpidem, temazepam, triazolam LUNESTA- Trial of 1 month of a generic 1/ day PRE hypnotic, i.e., zolpidem, temazepam, triazolam 35 mg 4/ month; 75 mg 2/ month; 150 mg 1/ month 35 mg 4/ month; 75 mg 2/ month; 150 mg 1/ month 1200 ml in EPANED- A documented trial of one 30 days PRE month each of three preferred generic alternative angiotensin-converting enzyme inhibitors (ACEI) or hydrochlorothiazide combinations (ACEI/ HCTZ) LOVAZAPRE Acne-PRE Acne vulgaris -Keratosis follicularis (Darier's disease, Darier-White disease) -Facial flat warts -Multiple flat warts (includes common warts and plantar warts) A documented diagnosis of any one of the following: Acne vulgaris (includes comedonal, cystic, nodular & papular acne) -Actinic keratoses AND Lesions are on the face OR Lesions are not on the face and therapy includes the use of 5-fluorouracil in conjunction with tretinoin ACNEPRE Note: Trial of a single entity ACEI and its own hydrochlorothiazide combination does not qualify for meeting the requirement of trying three alternatives. Trial requires three different drugs (different chemical entities), either as single entity or in combination. A documented trial of one month tretinoin and one of the following: adapalene, benzoyl peroxide, topical clindamycin, topical erythromycin, sulfacetamide w/sulfur, DIFFERIN 0.3% GEL or EPIDUO or RETIN-A MICRO or ZIANA -Hypertrophic scars or keloids AND Intralesional injection of corticosteroids is ineffective or not tolerated PLEXION ARALAST ARALAST NP GLASSIA PROLASTIN PROLASTIN-C ZEMAIRA PLEXION-PRE ARALAST-PRE acne or seborrheic dermatitis alpha 1-antitrypsin (AAT) inhibitor therapy -Keratosis follicularis (Darier's disease, Darier-White disease) -Facial flat warts -Multiple flat warts (includes common warts and plantar warts) A documented diagnosis of acne or seborrheic dermatitis AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of two preferred generic sulfacetamide sodium with sulfur products Aetna considers alpha 1-antitrypsin (AAT) inhibitor therapy (e.g., Aralast NP, Glassia, Prolastin-C, and Zemaira) medically necessary for selected adult members with emphysema due to AAT deficiency when all of the following criteria are met: 1. Member has a low serum concentration of AAT less than 80 mg/dL or less than 11 uM/L or less than 0.8 g/L (35 % of normal), which is considered the threshold thought to protect against emphysema; and 1 year PLEXION- A documented trial of one month each of two preferred generic PRE sulfacetamide sodium with sulfur products 1 year 2. Member has PiZZ, PiZ(null) or Pi(null, null) phenotype (homozygous) AAT deficiency or other phenotypes associated with serum AAT concentrations of less than 80 mg per deciliter (mg/dL). (AAT inhibitor is considered not medically necessary for use in individuals with the PiMZ or PiMS phenotypes of AAT deficiency because these individuals appear to be at small risk of developing panacinar emphysema); and 3. Member has progressive panacinar emphysema with a documented rate of decline in forced expiratory volume in 1 second (FEV1); and RILUTEK RILUTEK-PRE amyotrophic lateral sclerosis (ALS) A documented diagnosis of amyotrophic lateral sclerosis (ALS) AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of the preferred generic quivalent alternative, riluzole 1 year RILUTEKPRE A documented trial of one month of the preferred generic quivalent alternative, riluzole A documented diagnosis of amyotrophic lateral sclerosis (ALS) A documented diagnosis of one of the following: -Hypertension AND -A documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of any three preferred generic alternatives from the following as a single entity or hydrochlorothiazide combination product: candesartan, eprosartan, irbesartan, losartan, valsartan, OR telmisartan OR -Heart failure AND -A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of the preferred generic alternative, candesartan A documented diagnosis of hypertension, AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of any three preferred alternatives from the following: candesartan/hctz, eprosartan/hctz, irbesartan/hctz, losartan/hctz, telmisartan/hctz, OR valsartan/hctz 1 year riluzolePRE ATACAND- A documented trial of one 2 tablets/da PRE month each of any three preferred alternatives from the y following as a single entity or hydrochlorothiazide combination product: candesartan eprosartan irbesartan losartan valsartan telmisartan riluzole riluzole-PRE myotrophic lateral sclerosis (ALS) ATACAND DIOVAN ATACAND-PRE hypertension Atacand HCT Atacand HCT -PRE hypertension Azor Twynsta Azor-PRE hypertension A documented diagnosis of hypertension, ANDA documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of any two preferred alternatives from the following: candesartan, in combination with amlodipine, eprosartan, in combination with amlodipine, irbesartan, in combination with amlodipine, losartan, in combination with amlodipine, valsartan, in combination with amlodipine, telmisartan, in combination with amlodipine, telmisartan/ amlodipine OR Exforge 1 year 1 year 2 Atacand A documented trial of one HCT -PRE month each of any three tablets/da preferred alternatives from the y following: candesartan/hctz, eprosartan/hctz, irbesartan/hctz, losartan/hctz, telmisartan/hctz, OR valsartan/hctz 1 year Azor-PRE A documented trial of one 1 month each of any two tablet/day preferred alternatives from the following: candesartan, in combination with amlodipine, eprosartan, in combination with amlodipine, irbesartan, in combination with amlodipine, losartan, in combination with amlodipine, valsartan, in combination with amlodipine, telmisartan, in combination with amlodipine, telmisartan/ amlodipine OR Exforge 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria Tribenzor Tribenzor-PRE hypertension 1 year 1 Tribenzor- A documented trial of one tablet/day PRE month each of any two preferred alternatives from the following: candesartan/hctz, in combination with amlodipine, eprosartan/hctz, in combination with amlodipine, irbesartan/hctz, in combination with amlodipine, losartan/hctz, in combination with amlodipine, telmisartan/hctz in combination with amlodipine, valsartan/hctz in combination with amlodipine, telmisartan/ amlodipine in combination with hctz OR Exforge HCT A documented diagnosis of hypertension, AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of any two preferred alternatives from the following: candesartan/hctz, in combination with amlodipine, eprosartan/hctz, in combination with amlodipine, irbesartan/hctz, in combination with amlodipine, losartan/hctz, in combination with amlodipine, telmisartan/hctz in combination with amlodipine, valsartan/hctz in combination with amlodipine, telmisartan/ amlodipine in combination with hctz OR Exforge HCT Benicar-PRE hypertension o A documented diagnosis of hypertension, AND o A documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of any three preferred generic alternatives from the following as a single entity or hydrochlorothiazide combination product: candesartan, eprosartan, irbesartan, losartan, valsartan, OR telmisartan 1 year BenicarPRE Avapro Avapro-PRE hypertension A documented diagnosis of one of the following: Hypertension AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of any three preferred generic alternatives from the following as a single entity or hydrochlorothiazide combination product: candesartan, eprosartan, irbesartan, losartan, valsartan, OR telmisartan OR Diabetic nephropathy AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of the preferred generic alternatives, irbesartan and losartan 1 year Note: Trial of a single entity Avaprofrom the above and its own PRE hydrochlorothiazide combination does not qualify for meeting the requirement of trying two alternatives. Trial requires two different drugs (different chemical entities), either as single entity or in combination. Benicar HCT Diovan HCT Edarbyclor Avalide Micardis HCT Benicar HCT-PRE hypertension A documented diagnosis of hypertension, AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of any three preferred alternatives from the following: candesartan/hctz, eprosartan/hctz, irbesartan/hctz, losartan/hctz, telmisartan/hctz, OR valsartan/hctz 1 year Benicar A documented trial of one 1 HCT-PRE month each of any three tablet/day preferred alternatives from the following: candesartan/hctz, eprosartan/hctz, irbesartan/hctz, losartan/hctz, telmisartan/hctz, OR valsartan/hctz Teveten HCT Teveten HCT-PRE hypertension A documented diagnosis of hypertension, AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of any three preferred alternatives from the following: candesartan/hctz, eprosartan/hctz, irbesartan/hctz, losartan/hctz, telmisartan/hctz, OR valsartan/hctz 1 year Teveten A documented trial of one HCT-PRE month each of any three preferred alternatives from the following: candesartan/hctz, eprosartan/hctz, irbesartan/hctz, losartan/hctz, telmisartan/hctz, OR valsartan/hctz Tevten Tevten-PRE hypertension o A documented diagnosis of hypertension, AND o A documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of any three preferred generic alternatives from the following as a single entity or hydrochlorothiazide combination product: candesartan, eprosartan, irbesartan, losartan, valsartan, OR telmisartan 1 year TevtenPRE Cozaar Cozaar-PRE hypertension A documented diagnosis of one of the following: Hypertension AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of any three preferred generic alternatives from the following as a single entity or hydrochlorothiazide combination product: candesartan, eprosartan, irbesartan, losartan, valsartan, OR telmisartan OR Diabetic nephropathy AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of the preferred generic alternatives, irbesartan and losartan 1 year Note: Trial of a single entity Cozaarfrom the above and its own PRE hydrochlorothiazide combination does not qualify for meeting the requirement of trying two alternatives. Trial requires two different drugs (different chemical entities), either as single entity or in combination. XOLAIR XOLAIR-PRE IgE-mediated allergic asthma 6 months APTIOM APTIOM-PRE partial-onset seizures Moderate-to-severe persistent allergic asthma for at least 3 months, as second line treatment for children 6 years of age and older, adolescents, and adults, who meet all of the criteria below: Member demonstrates atopy (has a positive skin test or in-vitro reactivity (e.g., positive radioallergosorbent (RAST) test)) to a perennial aeroallergen; and Member's baseline serum IgE level is between 30 and 1500 IU/ml; and Member's symptoms are inadequately controlled with a moderate dose of inhaled corticosteroids (e.g., Asmanex, QVAR) plus long-acting beta-agonists (LABAs)* or leukotriene inhibitors for at least 3 months; and Member has daily symptoms (e.g., coughing, wheezing, and dyspnea) and/or exacerbations affecting activity (e.g., exercise) and sleep; and Members who smoke are engaged in smoking cessation efforts; and Member exhibits any of the following signs of poor asthma control: Daily use of short-acting inhaled beta2-agonists; or Diurnal variation in peak expiratory flow (PEF) of greater than 30 %; or Forced expiratory volume in 1 second (FEV1) less than 60 % predicted; or PEF less than 80 % of personal best; or A documented diagnosis of partial-onset seizures AND Documented concurrent therapy with one of the following: carbamazepine, divalproex dr/er/sprinkle, gabapentin, lamotrigine, levetiracetam/ER, oxcarbazepine, phenytoin, topiramate, valproic acid, or zonisamide 1 year For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. A prior authorization will be granted for coverage of additional quantities of Aptiom, Fycompa, gabapentin, Lyrica (capsules only), Neurontin, Potiga, Qudexy, Sabril, and Vimpat for those members who meet the following criterion: Member's dose is being titrated by physician (3 month limit) OR BANZEL ONFI BANZEL-PRE Lennox-Gastaut syndrome A documented diagnosis of seizures associated with Lennox-Gastaut syndrome or refractory (therapy resistant) epilepsy AND Concomitant use of an anticonvulsant drug 1 year Member is taking Neurontin or gabapentin 300mg caps/tabs, using three caps/tabs, three times daily A documented trial of one month each of any three preferred alternatives from the following as a single entity or hydrochlorothiazide combination product: candesartan eprosartan irbesartan losartan valsartan telmisartan A documented trial of one month each of any three preferred alternatives from the following as a single entity or hydrochlorothiazide combination product: candesartan eprosartan irbesartan losartan valsartan telmisartan 1 tablet/day Benicar Edarbi Micardis A documented trial of one month each of any three preferred alternatives from the following as a single entity or hydrochlorothiazide combination product: candesartan eprosartan irbesartan losartan valsartan telmisartan A documented trial of one month each of any three preferred alternatives from the following as a single entity or hydrochlorothiazide combination product: candesartan eprosartan irbesartan losartan valsartan telmisartan 75 mg and 150 mg = 1 tablets/da y 2 tablets/da y 25 mg and 50 mg = 2 tablets/da y 200 mg, 400 mg, 800 mg: 1/day 600 mg: 2/day 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria VIMPAT VIMPAT-PRE partial-onset seizures A documented diagnosis of partial-onset seizures 1 year For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. A prior authorization will be granted for coverage of additional quantities of Aptiom, Fycompa, gabapentin, Lyrica (capsules only), Neurontin, Potiga, Qudexy, Sabril, and Vimpat for those members who meet the following criterion: 50mg 6/day, 100, 150, 200mg 2/day, 10mg/mL 40mL/day Member's dose is being titrated by physician (3 month limit) OR FYCOMPA POTIGA FYCOMPA-PRE partial-onset seizures A documented diagnosis of partial-onset seizures AND Documented concurrent therapy with one of the following: carbamazepine, divalproex dr/er/sprinkle, gabapentin, lamotrigine, levetiracetam/ER, oxcarbazepine, phenytoin, topiramate, valproic acid, or zonisamide 1 year Member is taking Neurontin or gabapentin 300mg caps/tabs, using three caps/tabs, three times daily For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. A prior authorization will be granted for coverage of additional quantities of Aptiom, Fycompa, gabapentin, Lyrica (capsules only), Neurontin, Potiga, Qudexy, Sabril, and Vimpat for those members who meet the following criterion: Member's dose is being titrated by physician (3 month limit) OR Gabitril tiagabine Gabitril-PRE partial-onset seizures A documented diagnosis of partial-onset seizures AND Concomitant use of an anticonvulsant drug 1 year Sabril tablets Sabril-PRE refractory complex partial seizures A documented diagnosis of refractory complex partial seizures AND Documented concurrent therapy with one of the following: carbamazepine, divalproex dr/er/sprinkle, gabapentin, lamotrigine, levetiracetam/ER, oxcarbazepine, phenytoin, topiramate, valproic acid, or zonisamide 1 year Member is taking Neurontin or gabapentin 300mg caps/tabs, using three caps/tabs, three times daily For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. A prior authorization will be granted for coverage of additional quantities of Aptiom, Fycompa, gabapentin, Lyrica (capsules only), Neurontin, Potiga, Qudexy, Sabril, and Vimpat for those members who meet the following criterion: Member's dose is being titrated by physician (3 month limit) OR BRISDELLE BRISDELLE-PRE menopause, ALOXI ANZEMET injectable EMEND injectable Antiemetic Inj.-PRE Chemotherapy-induced nausea and vomiting Postoperative nausea and vomiting Brisdelle is not indicated for A documented diagnosis of moderate to severe the treatment of any vasomotor symptoms associated with menopause, AND psychiatric condition. A documented contraindication to menopausal hormone therapy (i.e., estradiol, Premarin), such as current, past or suspected breast cancer, estrogen-dependent neoplasia, genital bleeding, endometrial hyperplasia, thromboembolic disease, liver dysfunction, hypersensitivity to menopausal hormone therapy, or porphyria cutanea tarda, AND A documented contraindication or intolerance or allergy to the preferred generic alternative, paroxetine I. Cancer Chemotherapy: 1 year Member is taking Neurontin or gabapentin 300mg caps/tabs, using three caps/tabs, three times daily BRISDELL A documented trial of one 7.5mg: 1 E-PRE month of the preferred generic capsule/d alternative, paroxetine ay 1 year Aetna considers palonosetron (Aloxi) or fosaprepitant dimeglumine (Emend) antiemetic intravenous therapy medically necessary for the following indications: (i) the prevention of acute nausea or vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy, including high-dose cisplatin; and (ii) for treatment of chemotherapy-induced nausea or vomiting from low or minimally emetogenic cancer chemotherapy in persons who have an inadequate response or contraindication to intravenous granisetron (Kytril) or ondansetron (Zofran) at the Food and Drug Administration (FDA) recommended dose (see table in Appendix). DICLEGIS DICLEGIS-PRE Nausea and vomiting MARINOL dronabinol MARINOL-PRE Chemotherapy-induced nausea and vomiting Aetna considers granisetron (Kytril) and ondansetron (Zofran) antiemetic intravenous therapy medically necessary for the following indications: (i) prevention of acute and delayed nausea and/or vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy including high-dose displatin; and (ii) for treatment of chemotherapy-induced nausea and/or vomiting of low or minimally emetogenic cancer chemotherapy in persons who have an inadequate A documented diagnosis of nausea and vomiting in pregnant women who do not respond to conservative management (i.e. trigger avoidance, small frequent meals, etc) AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one week of any of the following: otc doxylamine, or otc pyridoxine (vit B6), or metoclopramide, or promethazine, or ondansetron A documented diagnosis of one of the following: Nausea and vomiting associated with cancer chemotherapy following previous failure of ondansetron or granisetron OR Anorexia associated with weight loss in patients with AIDS following failure (one month trial) of megestrol or oxandrolone 1 year 1 year DICLEGIS- A documented trial of one 4/day PRE week of any of the following: otc doxylamine, or otc pyridoxine (vit B6), or metoclopramide, or promethazine, or ondansetron 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria JUXTAPID JUXTAPID-PRE homozygous familial hypercholesterolemia (HoFH) KYNAMRO KYNAMRO-PRE homozygous familial hypercholesterolemia (HoFH) VECAMYL VECAMYL-PRE severe essential hypertension uncomplicated malignant hypertension A documented diagnosis of homozygous familial hypercholesterolemia (HoFH) in patients 18 years of age or older AND documentation of ALL of the following: Total LDL >/= 300mg/dl while on a maximum tolerated dose of atorvastatin OR Crestor, both taken in combination with any of the following: Zetia (ezetimibe), or a bile acid sequestrant (cholestyramine, Welchol (colesevelam), or colestipol), or niacin Juxtapid will be taken in combination with a maximum tolerated dose of atorvastatin OR Crestor, both taken in combination with any of the following: Zetia (ezetimibe), or a bile acid sequestrant (cholestyramine, Welchol (colesevelam), or colestipol), or niacin Verbal confirmation that appropriate dietary counseling has/will be provided to the patient that includes all of the following: Starting/maintaining a low-fat diet (<20% calories from fat) Concomitant vitamin supplementation (i.e., 400 international units vitamin E, 210 mg alpha-linolenic acid (ALA), 200 mg linoleic acid, 110 mg eicosapentaenoic acid (EPA), and 80 mg docosahexaenoic acid (DHA)) Avoidance of grapefruit juice during therapy Prescriber is a cardiologist enrolled in REMS program and is certified to prescribe Juxtapid Juxtapid 5mg: 2 week approval at a time (additional approval will require call in to verify 5 mg is still needed; approvals will be only for 2 weeks at a time) Verbal confirmation of patient enrollment in a lipid clinic or disease management program Negative pregnancy test, if female Confirmation that patient is not starting/currently on or has discontinued or will be discontinuing therapy if they are on any of the drugs listed below before initiating therapy with Juxtapid: Agenerase (amprenavir) Biaxin (clarithromycin) Juxtapid Calan SR, Isoptin SR 10mg and (verapamil) 20mg: 4 Cardizem, Tiazac (diltiazem) weeks Cipro (ciprofloxacin) (approvals Crixivan (indinavir) will only be Diflucan (fluconazole) for 4 weeks, Emend (aprepitant) pending liver Ery-tab (erythromycin) function test Gleevec (imatinib) results) Incivek (telaprevir) Invirase (saquinavir) Prescriber 4 weeks Verbal confirmation of is a (approvals patient enrollment in a lipid cardiologist will only be clinic or disease enrolled in for 4 weeks, management program REMS pending liver program function test AND and is results) certified to A documented prescribe contraindication or Kynamro intolerance or allergy or failure of an adequate trial of one month each of the maximum tolerated dose of atorvastatin AND Crestor, both taken in combination with any of the following: Zetia (ezetimibe), or a bile acid sequestrant (cholestyramine, Welchol (colesevelam), or colestipol), or niacin Liver function tests (alanine aminotransferase (ALT), aspartate aminosferase (AST), alkaline phosphastase, and total bilirubin level) should be performed at all of the A documented diagnosis of homozygous familial hypercholesterolemia (HoFH) in patients 18 years of age or older AND documentation of ALL of the following: Total LDL >/= 300mg/dl while on a maximum tolerated dose of atorvastatin OR Crestor, both taken in combination with any of the following: Zetia (ezetimibe), or a bile acid sequestrant (cholestyramine, Welchol (colesevelam), or colestipol), or niacin Kynamro will be taken in combination with a maximum tolerated dose of atorvastatin OR Crestor, both taken in combination with any of the following: Zetia (ezetimibe), or a bile acid sequestrant (cholestyramine, Welchol (colesevelam), or colestipol), or niacin Kynamro will not be given as an adjunct to LDL apheresis therapy Liver function tests (alanine aminotransferase (ALT), aspartate aminosferase (AST), alkaline phosphastase, and total bilirubin level) should be performed at all of the following stages: Prior to initiation of therapy of Kynamro to rule out active liver disease Monthly for the first year of Kynamro therapy Every 3 months thereafter JUXTAPID- A documented trial of one PRE month each of maximum tolerated doses of atorvastatin AND Crestor, both taken in combination with any of the following: Zetia (ezetimibe), or a bile acid sequestrant (cholestyramine, Welchol (colesevelam), or colestipol), or niacin KYNAMR O-PRE 5 mg = 14 tablets/14 days, 10 mg = 28 tablets/28 days, 20 mg = 84 tablets/28 days 4 vials/28 days A documented trial of one month each of maximum tolerated doses of atorvastatin AND Crestor, both taken in combination with any of the following: Zetia (ezetimibe), or a bile acid sequestrant (cholestyramine, Welchol (colesevelam), or colestipol), or niacin Lipid panel every 3 months 1 year A documented diagnosis of moderately severe to severe essential hypertension or uncomplicated malignant hypertension AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of a triple-drug combination from the preferred alternatives from the following classes: Diuretics Angiotensin-Converting Enzyme Inhibitors Angiotensin II Receptor Antagonists Beta-Adrenergic Blockers Calcium Channel Blockers Note: Selection of three medications must each be from a different class. TAZORAC TAZORAC-PRE acne vulgaris plaque psoriasis A documented diagnosis of acne vulgaris, OR A documented diagnosis of plaque psoriasis STRIBILD STRIBILD-PRE human immunodeficiency virus (HIV) A documented diagnosis of human immunodeficiency virus (HIV) A documented resistance test within the past 3 months demonstrating virologic susceptibility to all of the following components of Stribild: elvitegravir, emtricitabine, and tenofovir AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of Atripla (efavirenz-emtricitabine-tenofovir) or a documented resistance test within the past 3 months demonstrating virologic resistance to efavirenz OR A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of Truvada, Reyataz, and Norvir (emtricitabine-tenofovir, atazanavir, ritonavir) in combination or documented resistance test within the past 3 months demonstrating virological resistance to atazanavir OR 10/day VECAMYL- A documented trial of one PRE month of a triple-drug combination from the preferred alternatives from the following classes: Diuretics Angiotensin-Converting Enzyme Inhibitors Angiotensin II Receptor Antagonists Beta-Adrenergic Blockers Calcium Channel Blockers Note: Selection of three medications must each be from a different class. >35 years old 1 year 1 year A documented viral load assay AND CD4 count indicating that the patient is stable on Stribild (stable or increase in CD4 counds AND viral load <50 copies/ml) (FOR renewals ONLY) TRUVADA TRUVADA-PRE human immunodeficiency virus (HIV) A documented diagnosis of human immunodeficiency virus (HIV) OR A documented diagnosis of initiating therapy for preexposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk AND documentation of all of the following: A negative HIV antibody test taken: Immediately before starting Truvada for PrEP AND Every 3 months thereafter while on therapy Confirmation that creatinine clearance value >/=60 mL/min before initiating Truvada for PrEP AND Serum creatinine and calculate creatinine clearance checks performed at 3 months after initiation and then every 6 months thereafter (PrEP diagnosis) - 3 months (renewals approved pending HIV testing and creatinine clearance value) (HIV diagnosis) one year NOTE: Members may receive a 30 days’ supply of medication upon initial request of Truvada for PrEP diagnosis. After 30 days, above criteria must be met. ARAVA leflunomide ARAVA-PRE rheumatoid arthritis psoriatic arthritis A documented diagnosis of rheumatoid arthritis OR A documented diagnosis of psoriatic arthritis 6 months AND A negative pregnancy test for females of childbearing age within the last 14 days, unless it is documented that the member is sterile (e.g. hysterectomy, unable to achieve pregnancy) or in menopause OTREXUP OTREXUP-PRE Juvenile idiopathic arthritis Psoriasis Rheumatoid arthritis A documented diagnosis of one of the following: A documented diagnosis of severe, active rheumatoid arthritis (RA) in adults who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs) OR A documented diagnosis of active polyarticular juvenile idiopathic arthritis (pJIA) in children who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs) OR A documented diagnosis of severe, recalcitrant, disabling psoriasis that has been established, as by biopsy and/or after dermatologic consultation, and is not adequately responsive to other forms of therapy AND A documented failure of an adequate trial of one month of a preferred generic alternative methotrexate OR A documented mental or physical handicap or other clinical reason preventing the reasonable use of an available generic injectable or oral methotrexate medication 1 year OTREXUP- A documented trial of one PRE month of a preferred generic alternative methotrexate 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria ADOXA Dynacin Minocin Monodox ADOXA-PRE Acinetobacter infection Rosacea Acne vulgaris Documented to be 8 years of age or older (Note: see >8 years old section above under ALL tetracyclines if less than 8 years of age) AND ONE of the following: 1 year A documented diagnosis of acne or rosacea and a documented contraindication or intolerance or allergy or failure of an adequate trial of one month of the preferred generic alternative, doxycycline (for Adoxa or Monodox) or minocycline (for Dynacin or Minocin) OR A documented diagnosis of infection other than acne or rosacea and a documented contraindication or intolerance or allergy or failure of an adequate trial of three days of the preferred generic alternative, doxycycline (for Adoxa or Monodox) or minocycline (for Dynacin or Minocin) DIFICID DIFICID-PRE Clostridium difficile infection Dificid (A AND B OR C) AND D 1 month (If less than 8 years of age) A documented rare infectious diagnosis that requires use of tetracyclines in young children (examples include juvenile periodontitis or Mediterranean spotted fever) (Note: Tetracyclines should not be used in children younger than 8 years of age unless other appropriate drugs are ineffective or are contraindicated. American Academy of Pediatrics (AAP), US Centers for Disease Control and Prevention (CDC), and Infectious Diseases Society of America (IDSA) state that use of tetracyclines in children younger than 8 20 tablets/ 30 day supply A. A documented diagnosis of Clostridium difficile associated diarrhea in adults > 18 years of age AND B. A documented: Contraindication to preferred agents metronidazole or oral vancomycin hydrochloride indicated for the member's condition OR Intolerance to metronidazole or oral vancomycin hydrochloride indicated for member’s condition OR Allergy to metronidazole or oral vancomycin hydrochloride indicated for the member's condition OR Failure of an adequate trial of 10 days of metronidazole or 7 days of oral vancomycin hydrochloride OR C. Discharge from hospital or medical facility due to a documented diagnosis from A above AND documented initial treatment with Dificid while in the hospital/medical facility. AND avidoxy DORYX ORAXYL demeclocycline DORYX doxycycline DYNACIN MINOCIN minocycline MONODOX SOLODYN tetracycline vibramycin DORYX-PRE Infection For ALL tetracyclines ORACEA ORACEA-PRE Rosacea, Avelox Cipro Cipro XR Ciprofloxacin ciprofloxacin er Factive Levaquin Levofloxacin Moxifloxacin Noroxin ofloxacin Avelox-PRE Infection A documented diagnosis of cystic fibrosis with pulmonary < 10 years infection due to P. aeruginosa, OR old A documented diagnosis of a life-threatening infection due to P. aeruginosa untreatable by other first line antibiotics, OR A documented diagnosis of recurrent resistant urinary tract infection due to P. aeruginosa, OR Member needs prophylaxis or treatment of anthrax after known or suspected exposure (Cipro/ ciprofloxacin only), OR A documented diagnosis of complicated UTI and Pyelonephritis due to E. coli and is being used as second line treatment (Cipro/ ciprofloxacin only) ^ 30days Member’s physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for medical use in females Female Members- A AND (B OR C) 1 year ^ Note: Cipro tablets or oral suspension received FDA approval as second-line treatment of complicated urinary tract infections (cUTI) and pyelonephritis in pediatric patients 1 to 17 years of age. Per the manufacturer's package labeling, Cipro is not a drug of first choice in the pediatric population due to an increased incidence of adverse events related to joints and/or surrounding tissues. Member is female 1 year Member is female 1 year Member is female < 8 years old 1 year (If less than 8 years of age) A documented rare infectious diagnosis that requires use of tetracyclines in young children (examples include juvenile periodontitis or Mediterranean spotted fever) alfuzosin alfuzosin-PRE Benign prostatic hyperplasia CASODEX bicalutamide CASODEX-PRE Metastatic prostate cancer (Note: Tetracyclines should not be used in children younger than 8 years of age unless other appropriate drugs are ineffective or are contraindicated. American Academy of Pediatrics (AAP), US Centers for Disease Control and Prevention (CDC), and Infectious Diseases Society of America (IDSA) state that use of tetracyclines in children younger than 8 years of age can be considered in certain circumstances when the benefits outweigh the risks) >8 years old A documented diagnosis of Rosacea, AND Age > 8 years old, AND A documented contraindication or intolerance or allergy or failure of an adequate trial of fourteen days of the preferred alternative topical metronidazole OR generic doxycycline 1 year 1 capsule/d ay A. Member is NOT pregnant AND B. Documented diagnosis of hirsutism secondary to ovarian or adrenal dysfunction (for example, polycystic ovary syndrome, adrenal or ovarian tumor) OR AVODART Jalyn AVODART-PRE Benign prostatic hyperplasia Proscar Finasteride Proscar-PRE Benign prostatic hyperplasia C. Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for medical use in females Member is NOT pregnant AND Member’s physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for medical use in females. (Member is male) Age > 50 yrs old OR Member has diagnosis of BPH (Benign Prostatic Hyperplasia) 1 year (Member is female) Member is NOT pregnant AND Member has documented diagnosis of hirsutism secondary to ovarian or adrenal dysfunction (for example, polycystic ovary syndrome, adrenal or ovarian tumor) OR Member’s physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for medical use in females Flomax Flomax-PRE Benign prostatic hyperplasia Uroxatral RAPAFLO-PRE Benign prostatic hyperplasia RAPAFLO alfuzosin RAPAFLO-PRE Benign prostatic hyperplasia Member has documented diagnosis of Urethral syndrome (urinary hesitancy, frequency, and dysuria) OR Member has documented diagnosis of intractable micturition difficulties (difficulty passing urine) OR Member has documented diagnosis of Ureteral calculi/Kidney stones OR Member’s physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for medical use in females Member’s physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for medical use in females Member’s physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for medical use in females 1 year Member is female FlomaxPRE A documented trial of one month of the drug’s generic equivalent tamsulosin 1 year Member is female Uroxatral- A documented trial of one PRE month of the drug’s generic equivalent alfuzosin 1 year Member is female 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria tamsulosin Flomax-PRE Benign prostatic hyperplasia Member has documented diagnosis of Urethral syndrome (urinary hesitancy, frequency, and dysuria) OR Member has documented diagnosis of intractable micturition difficulties (difficulty passing urine) OR Member has documented diagnosis of Ureteral calculi/Kidney stones OR Member’s physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for medical use in females A documented diagnosis of hypertension AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of the preferred generic alternative, propanolol 1 year INDERAL XL INDERAL XL-PRE Hypertension Hemangeol Hemangeol-PRE Proliferating infantile hemangioma A documented diagnosis of proliferating infantile hemangioma requiring systemic therapy AND documented all of the following: Member was not born prematurely with a corrected age of less than 5 weeks AND Member does not weigh less than 2kg, have sustained heart rate < 80 beats per minute, have greater than first degree heart block, or have decompensated heart failure AND Member does not have sustained blood pressure < 50/ 30mmHg AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of the preferred generic alternative, propranolol 1 year ACTEMRA ACTEMRA-PRE Rheumatoid arthritis Juvenile idiopathic arthritis Polyarticular juvenile rheumatoid arthritis 6 months AMEVIVE AMEVIVE-PRE Plaque psoriasis Adult Moderate to Severe Active Rheumatoid Arthritis AND A documented Contraindication or Intolerance or Allergy or an inadequate response to a trial of one month each of two preferred alternatives indicated for Rheumatoid Arthritis one of which must include Remicade and one from the following: Enbrel or Humira or Simponi or Simponi ARIA (IV and SQ formulations) Active systemic onset juvenile idiopathic arthritis in patients with a disease duration of 6 or more months, who have had an inadequate response to high-dose corticosteroids and non-steroidal anti-inflammatory drugs (IV formulation ONLY) Moderate to severely active polyarticular juvenile idiopathic arthritis (juvenile rheumatoid arthritis) in persons 2 years of age and older (IV formulation ONLY) A documented Diagnosis of Chronic Moderate to Severe Plaque psoriasis in adults aged 18 years and older AND documented to be a candidate for systemic therapy or phototherapy when the following selection criteria are met: 10 % or more body surface area is affected by plaque psoriasis (or 5 percent or more of body surface area if psoriasis involves sensitive areas (hands, feet, face, or genitals)) or member has a Psoriasis Area and Severity Index (PASI) score of 10 or more AND Member has failed to adequately respond to or is intolerant to a 3-month trial of one of the following phototherapies (unless contraindicated) Psoralens (methoxsalen, trioxsalen) with UVA light (PUVA) UVB with coal tar or dithranol UVB (standard or narrow-band) 1 year 6 months AND A documented Contraindication or Intolerance or Allergy or an inadequate response to a trial of one month each of two preferred alternatives indicated for Plaque Psoriasis such as Enbrel or Humira or Remicade or Stelara CIMZIA CIMZIA-PRE Ankylosing spondylitis Crohn's disease Psoriatic arthritis Rheumatoid arthritis ENBREL ENBREL-PRE Ankylosing spondylitis Juvenile idiopathic arthritis Plaque psoriasis Psoriatic arthritis Rheumatoid arthritis ENTYVIO ENTYVIO-PRE Crohn's disease Ulcerative colitis A documented Diagnosis of one of the following: Active Crohn’s Disease that has remained active despite treatment with either 6-mercaptopurine, azathioprine, or corticosteroids AND A documented Contraindication or Intolerance or Allergy or an inadequate response to a trial of one month each of two preferred alternatives indicated for Crohn’s Disease such as Humira and Remicade Adult Moderate to Severe Active Rheumatoid Arthritis as monotherapy or in combination with methotrexate (MTX) AND A documented Contraindication or Intolerance or Allergy or an inadequate response to a trial of one month each of two preferred alternatives indicated for Rheumatoid Arthritis such as Enbrel, Humira, Remicade, Simponi, or Simponi ARIA Active non-axial psoriatic arthritis AND a documented failure of two or more non-biologic disease-modifying antirheumatic drugs (DMARDs) (e.g., anti-malarials, cyclosporine, gold compounds, methotrexate, or sulfasalazine) AND a documented contraindication or intolerance or allergy or an inadequate response to a trial of one month each of two preferred alternatives indicated for active psoriatic arthritis such as Enbrel, Humira, Remicade, Simponi, or Stelara Active axial psoriatic arthritis and an inadequate response to 2 or more NSAIDs AND a documented contraindication or intolerance or allergy or an inadequate response to a documented Diagnosis of one of the following: Active non-axial psoriatic arthritis AND a documented failure of two or more non-biologic disease-modifying antirheumatic drugs (DMARDs) (e.g., anti-malarials, cyclosporine, gold compounds, methotrexate, or sulfasalazine) Active axial psoriatic arthritis and an inadequate response to 2 or more NSAIDs Adult Moderate to Severe Active Rheumatoid Arthritis Ankylosing spondylitis AND a documented failure of two or more non-steroidal anti-inflammatory drugs (NSAID) (e.g. naproxen, ibuprofen, meloxicam) Behcet’s Disease AND documented refractory to glucocorticoids and azathioprine Chronic Moderate to Severe Plaque psoriasis in adults aged 18 years and older AND documented to be a candidate for systemic therapy or phototherapy when the following selection criteria are met: 10 % or more body surface area is affected by plaque psoriasis (or 5 percent or more of body surface area if psoriasis involves sensitive areas (hands, feet, face, or genitals)) or member has a Psoriasis Area and Severity Index (PASI) score of 10 or more AND Member has failed to adequately respond to or is intolerant to a 3-month trial of one of the following phototherapies (unless contraindicated) Psoralens A documented diagnosis of one of the following: Moderately to severely active Ulcerative Colitis (UC) in adults 18 years of age or older who meet either of the following criteria: Member is hospitalized with fulminant ulcerative colitis (i.e., persons with severe ulcerative colitis who have more than 10 stools per day, continuous bleeding, abdominal pain, and distension, and acute, severe toxic symptoms including fever and anoxia); or Member has moderate-to-severe active ulcerative colitis and meets all of the following criteria: Member is refractory to or requires continuous immunosuppression with corticosteroids (e.g., methylprednisolone, prednisone) at a dose of prednisone 40 to 60 mg/day (or equivalent) for 30 days for oral therapy or 7 to 10 days for IV therapy); and Member is refractory to or has a contraindication to 5aminosalicylic acid agents (e.g., balsalazide, mesalamine, sulfasalazine); and Member is refractory to or has a contraindication to immunosuppressants (azathioprine and 6mercaptopurine). AND A documented contraindication or intolerance or allergy or 6 months 6 months 6 months Member is female INDERAL XL-PRE A documented trial of one month of the preferred generic alternative, propanolol 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria Otezla Otezla-PRE Plaque psoriasis Psoriatic arthritis Active non-axial psoriatic arthritis AND a documented failure of two or more non-biologic disease-modifying antirheumatic drugs (DMARDs) (e.g., anti-malarials, cyclosporine, gold compounds, methotrexate, or sulfasalazine) AND a documented contraindication or intolerance or allergy or an inadequate response to a trial of one month each of two preferred alternatives indicated for active psoriatic arthritis such as Enbrel, Humira, Remicade, Simponi, or Stelara Active axial psoriatic arthritis and an inadequate response to 2 or more NSAIDs AND a documented contraindication or intolerance or allergy or an inadequate response to a trial of one month each of two preferred alternatives indicated for active psoriatic arthritis such as Enbrel, Humira, Remicade, Simponi, or Stelara 6 months ENTYVIO ENTYVIO-PRE Crohn's disease Ulcerative colitis A documented diagnosis of one of the following: Moderately to severely active Ulcerative Colitis (UC) in adults 18 years of age or older who meet either of the following criteria: Member is hospitalized with fulminant ulcerative colitis (i.e., persons with severe ulcerative colitis who have more than 10 stools per day, continuous bleeding, abdominal pain, and distension, and acute, severe toxic symptoms including fever and anoxia); or Member has moderate-to-severe active ulcerative colitis and meets all of the following criteria: Member is refractory to or requires continuous immunosuppression with corticosteroids (e.g., methylprednisolone, prednisone) at a dose of prednisone 40 to 60 mg/day (or equivalent) for 30 days for oral therapy or 7 to 10 days for IV therapy); and Member is refractory to or has a contraindication to 5aminosalicylic acid agents (e.g., balsalazide, mesalamine, sulfasalazine); and Member is refractory to or has a contraindication to immunosuppressants (azathioprine and 6mercaptopurine). 6 months HUMIRA HUMIRA-PRE Ankylosing spondylitis Crohn's disease Juvenile idiopathic arthritis Plaque psoriasis Psoriatic arthritis Rheumatoid arthritis KINERET KINERET-PRE Chronic infantile neurologica Rheumatoid arthritis ORENCIA ORENCIA-PRE Juvenile idiopathic arthritis Rheumatoid arthritis AND A documented contraindication or intolerance or allergy or A documented Diagnosis of one of the following: Active Crohn’s disease that has remained active despite treatment with either 6-mercaptopurine, azathioprine, or corticosteroids Active Crohn's disease in children and adolescents who do not respond to Remicade (infliximab) or develop infusion reactions to Remicade (infliximab) Active non-axial psoriatic arthritis AND a documented failure of two or more non-biologic disease-modifying antirheumatic drugs (DMARDs) (e.g., anti-malarials, cyclosporine, gold compounds, methotrexate, or sulfasalazine) Active axial psoriatic arthritis and an inadequate response to 2 or more NSAIDs Adult Moderate to Severe Active Rheumatoid Arthritis as monotherapy or in combination with methotrexate or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs) Ankylosing spondylitis AND a documented failure of two or more non-steroidal anti-inflammatory drugs (NSAID) (e.g. naproxen, ibuprofen, meloxicam) Chronic Moderate to Severe Plaque psoriasis in adults aged 18 years and older AND documented to be a candidate for systemic therapy or phototherapy when the following selection criteria are met: 10 % or more body surface area is affected by plaque psoriasis (or 5 percent documented Diagnosis of one of the following: Adult Moderate to Severe Active Rheumatoid Arthritis as monotherapy or in combination with DMARDs other than tumor necrosis factor (TNF) blocking agents AND A documented Contraindication or Intolerance or Allergy or an inadequate response to a trial of one month each of two preferred alternatives indicated for Rheumatoid Arthritis such as Enbrel, Humira, Remicade, Simponi, or Simponi ARIA Neonatal-onset multisystem inflammatory disease (NOMID) Adult-onset Still's disease when after failure of glucocorticoids, methotrexate and a TNF-alpha inhibitor Systemic onset juvenile idiopathic arthritis with active systemic features and varying degrees of synovitis in patients who have failed to respond to systemic glucocorticoid monotherapy or non-steroidal antiinflammatory drug (NSAID) monotherapy Systemic onset juvenile idiopathic arthritis without active systemic features and with varying degrees of active synovitis in patients who have failed intra-articular injection or NSAID monotherapy (for individuals with an active joint count (AJC) greater than 4) or have failed methotrexate or leflunomide (for individuals with an AJC A documented Diagnosis of one of the following: 6 months 6 months 6 months Adult Moderate to Severe Active Rheumatoid Arthritis AND a documented Contraindication or Intolerance or Allergy or an inadequate response to a trial of one month each of two preferred alternatives indicated for Rheumatoid Arthritis (note: for Orencia IV, one preferred alternative must include Remicade; and one from the following: Enbrel, Humira, Simponi, or Simponi ARIA) Moderate or Severely active polyarticular juvenile rheumatoid arthritis (juvenile idiopathic arthritis) AND a documented Contraindication or Intolerance or Allergy or an inadequate response to a trial of one month each of two preferred alternatives indicated for juvenile rheumatoid arthritis (note: for Orencia IV, one preferred alternative must include Remicade; and one from the following: Enbrel or Humira) REMICADE REMICADE-PRE Ankylosing spondylitis Crohn's disease Plaque psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis For Remicade A documented Diagnosis of one of the following: Active Crohn’s Disease that has remained active despite treatment with either 6-mercaptopurine, azathioprine, or corticosteroids Active non-axial psoriatic arthritis AND a documented failure of two or more non-biologic disease-modifying antirheumatic drugs (DMARDs) (e.g., anti-malarials, cyclosporine, gold compounds, methotrexate, or sulfasalazine) Active axial psoriatic arthritis and an inadequate response to 2 or more NSAIDs Adult Moderate to Severe Active Rheumatoid Arthritis Ankylosing Spondylitis and Other Spondyloarthropathies AND a documented inadequate response to two or more non-steroidal anti-inflammatory drugs (NSAIDS) (e.g., celecoxib, diclofenac, ibuprofen, indomethacin, meloxicam, naproxen, sulindac) Refractory Behcet's uveitis Chronic Moderate to Severe Plaque psoriasis in adults aged 18 years and older AND documented to be a candidate for systemic therapy or phototherapy when the following selection criteria are met: 10 % or more body surface area is affected by plaque psoriasis (or 5 percent or more of body surface area if psoriasis involves 6 months OtezlaPRE documented trial of one month each of two preferred alternatives indicated for active psoriatic arthritis such as Enbrel, Humira, Remicade, Simponi, or Stelara Up to 1 starter pack in 1 year; Up to 60 tablets in 30 days 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria SIMPONI SIMPONI-PRE Ankylosing spondylitis Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis Simponi ARIA Simponi ARIA-PRE Ankylosing spondylitis Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis STELARA STELARA-PRE Plaque psoriasis Psoriatic arthritis A documented Diagnosis of one of the following: Active ankylosing spondylitis with evidence of inflammatory disease in members who have had an inadequate response to NSAIDS (e.g., celecoxib, diclofenac, ibuprofen, indomethacin, meloxicam, naproxen, sulindac, or valdecoxib) (unless contraindicated) Active non-axial psoriatic arthritis AND a documented failure of two or more non-biologic disease-modifying antirheumatic drugs (DMARDs) (e.g., anti-malarials, cyclosporine, gold compounds, methotrexate, or sulfasalazine) Active axial psoriatic arthritis and an inadequate response to 2 or more NSAIDs Adult Moderate to Severe Active Rheumatoid Arthritis in combination with methotrexate Active Ulcerative Colitis AND Member is hospitalized with fulminant ulcerative colitis (i.e., persons severe ulcerative colitis who have more than 10 stools per day, continuous bleeding, abdominal pain, and distension, and acute, severe toxic symptoms including fever and anoxia) OR Member has moderate to severe active ulcerative colitis and meets all of the following criteria: Member is refractory to or requires continuous immunosuppression with corticosteroids (e.g., methylprednisolone, prednisone) at a dose of prednisone 40 to 60 mg/day (or equivalent) for A documented diagnosis of moderately-to-severely active 18 or greater rheumatoid arthritis in adult members 18 years of age or older in combination with methotrexate 6 months A documented diagnosis of one of the following: Chronic Moderate to Severe Plaque psoriasis in adults aged 18 years and older AND documented to be a candidate for systemic therapy or phototherapy when the following selection criteria are met: 10 % or more body surface area is affected by plaque psoriasis (or 5 percent or more of body surface area if psoriasis involves sensitive areas (hands, feet, face, or genitals)) or member has a Psoriasis Area and Severity Index (PASI) score of 10 or more AND Member has failed to adequately respond to or is intolerant to a 3-month trial of one of the following phototherapies (unless contraindicated) Psoralens (methoxsalen, trioxsalen) with UVA light (PUVA) UVB with coal tar or dithranol UVB (standard or narrow-band) 6 months 6 months Active non-axial psoriatic arthritis AND a documented failure of two or more non-biologic disease-modifying antirheumatic drugs (DMARDs) (e.g., anti-malarials, cyclosporine, gold compounds, methotrexate, or sulfasalazine) Active axial psoriatic arthritis and an inadequate response XELJANZ XELJANZ-PRE Rheumatoid arthritis A documented diagnosis of moderately to severely active rheumatoid arthritis in patients who have had an inadequate response or intolerance to methotrexate AND A documented confirmation that Xeljanz will not be used in combination with other biologic therapy (i.e. Enbrel, Humira) or potent immunosuppressants (i.e. azathioprine, cyclosporine) AND A documented recent Tuberculin skin test (within 6 months) to check for latent Tuberculosis AND A documented contraindication or intolerance or allergy or inadequate response to a trial of one month each of two preferred alternatives indicated for rheumatoid arthritis such as Enbrel, Humira, Remicade, Simponi, or Simponi ARIA 6 months Alprolix Alprolix-PRE Bleeding A documented diagnosis of hemophilia B (endogenous factor IX level of ≤2 IU per deciliter, or ≤2% of normal levels) for the following indications: control and prevention of bleeding episodes; or perioperative management; or routine prophylaxis to prevent or reduce the frequency of bleeding episodes. 1 year Kcentra Kcentra-PRE Reversal of acquired coagulation factor deficiency 1 year Wilate Wilate-PRE Bleeding Tretten Tretten-PRE Bleeding Corifact Corifact-PRE Bleeding A documented diagnosis of urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (e.g., warfarin) therapy in adults with acute major bleeding. A documented diagnosis of treatment of spontaneous and/ or trauma-induced bleeding episodes in individuals with severe von Willebrand disease (VWD) or individuals with mild or moderate VWD when there is failure, contraindication or intolerance to desmopressin. A documented diagnosis of routine prophylaxis of bleeding in persons with congenital factor XIII A-subunit deficiency. A documented diagnosis of the prevention of bleeding and for the peri-operative management of surgical bleeding in persons with congenital factor XIII deficiency. Feiba NF Feiba-PRE Bleeding 1 year Humate-P Alphanate HEMOFIL M KOATE-DVI MONOCLATE-P ADVATE HELIXATE FS KOGENATE FS RECOMBINATE REFACTO XYNTHA BEBULIN VH PROFILNINE ALPHANINE SD BENEFIX MONONINE RIXUBIS INJ Coagulants-PRE Bleeding A documented diagnosis of hemophilia A and B with inhibitors for the control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. A documented diagnosis of one of the following: Prevent or treat hemorrhagic complications in adults and children with hemophilia A, hemophilia B or von Willebrand's disease according to the following criteria limitation: Standard dose therapy (dose until bleeding stops or up to 14 days after surgery) when both of the following criteria are met: 2 tablets/da y 1 year 1 year 1 year Immune Tolerance Induction - 6 months All others - 1 year Member has a diagnosis of hemophilia A, hemophilia B, or von Willebrand's disease (only Humate-P or Alphanate may be used in von Willebrand’s disease); and Member is hemorrhaging or physical trauma such as surgery is anticipated (secondary short-term prophylaxis). Continuous (long-term) prophylactic therapy when either of the following criteria is met: Primary prophylactic therapy: Member has severe hemophilia A or hemophilia B (less than 1% of normal factor (less than 0.01 IU/mL)); or NOVOSEVEN NOVOSEVEN-PRE Bleeding COMBIVENT COMBIVENT-PRE Chronic Ostructive Pulmonary Disease (COPD) NYMALIZE NYMALIZE-PRE Subarachnoid hemorrhage documented diagnosis of prevention of bleeding in surgical interventions or invasive procedures and for the control of bleeding events in members with any of the following indications: Members with hemophilia A or hemophilia B who have developed inhibitor antibodies to factor VIII or factor IX; or Members with acquired hemophilia or congenital FVII deficiency; or Members with Glanzmann's thrombasthenia with antibodies to glycoprotein IIb-IIIa and/or human leukocyte antigen (HLA), and with past or present refractoriness to platelet transfusions. A documented diagnosis of chronic obstructive pulmonary disease (COPD) AND A documented trial of one month of Combivent Respimat (propellant-free inhaler) 1 year A documented diagnosis of subarachnoid hemorrhage (SAH) in adults AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one week of the preferred generic alternative, nimodipine ORMember is unable to tolerate oral capsule or tablet 21 days 1 year 120ml/day for 21 days maximum 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria XYREM XYREM-PRE Cataplexy and narcolepsy Narcolepsy, to treat excessive daytime sleepiness (A or B or C) and D and E 1 year 9 gm/day (540ml/30 day supply) A. Member has a documented diagnosis of narcolepsy confirmed by sleep lab evaluation OR B. Member has episodes of cataplexy including hypnagogic hallucinations and/or sleep paralysis OR C. Member has excessive daytime sleepiness with symptoms that limit the ability to perform normal daily activities AND D. Member and physician are enrolled in the Xyrem Success Program. AND LOSEASONIQUE SEASONIQUE LOSEASONIQUE-PRE Contraception ACTHAR ACTHAR-PRE West syndrome (infantile spasms) CLARINEX desloratidine Antihistamines -PRE Idiopathic urticaria, chronic Perennial allergic rhinitis Seasonal allergic rhinitis E. Quantity limits: According to the manufacturer, Xyrem can be dosed up to a maximum daily dose at the interval(s) as indicated in the table below. A quantity of the drug will be considered medically necessary as indicated in the table below A documented diagnosis of pregnancy prevention in women AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of one generic equivalent alternative A documented diagnosis of West syndrome (infantile spasms) A documented** diagnosis of one of the following : FDA-approved indications: Allergic conjunctivitis Chronic idiopathic urticaria (hives) Rhinitis (allergic perennial or seasonal, vasomotor) 1 year 3 months 1 year Note: levocetirizine, loratadine, Alavert, cetirizine, Claritin, Xyzal and Zyrtec are designated as Pregnancy Category B; Allegra, Clarinex, desloratadine and fexofenadine are designated as Pregnancy Category C 2.5 mg and 5 mg =1 tablet/day Syrup = 10 ml/day 1 year Note: levocetirizine, loratadine, Alavert, cetirizine, Claritin, Xyzal and Zyrtec are designated as Pregnancy Category B; Allegra, Clarinex, desloratadine and fexofenadine are designated as Pregnancy Category C 1 tablet/day 2.5 mg/5 ml solution = 10 ml/day 1 year Note: levocetirizine, loratadine, Alavert, cetirizine, Claritin, Xyzal and Zyrtec are designated as Pregnancy Category B; Allegra, Clarinex, desloratadine and fexofenadine are designated as Pregnancy Category C 2.5mg and 5mg = 1 reditab/ day 1 year Note: levocetirizine, loratadine, Alavert, cetirizine, Claritin, Xyzal and Zyrtec are designated as Pregnancy Category B; Allegra, Clarinex, desloratadine and fexofenadine are designated as Pregnancy Category C 2.5 mg/120 mg = 2 tablets/da y5 mg/240 mg = 1 tablet/day 1 year Note: levocetirizine, loratadine, Alavert, cetirizine, Claritin, Xyzal and Zyrtec are designated as Pregnancy Category B; Allegra, Clarinex, desloratadine and fexofenadine are designated as Pregnancy Category C 4 capsules/ day Accepted unlabeled indications listed in the pharmaceutical compendia (United States Pharmacopeia Drug Information or American Hospital Formulary Service): allergies angioedema asthma atopic dermatitis(eczema) dermatographism mastocytosis pruritus can be caused for example by (atopic dermatitis i.e eczema, or contact dermatitis ) urticaria (hives) transfusion reactions urticarial, anaphylactic/anaphylactoid reactions XYZAL levocetirizine Antihistamines -PRE Idiopathic urticaria, chronic Perennial allergic rhinitis Seasonal allergic rhinitis AND A documented:**contraindication or intolerance or allergy or failure of two weeks each of TWO of the following nonprescription (OTC) products (single entity or combination product); one containing loratadine, one containing fexofenadine or one containing cetirizine OR A documented** diagnosis of one of the following : FDA-approved indications: Allergic conjunctivitis Chronic idiopathic urticaria (hives) Rhinitis (allergic perennial or seasonal, vasomotor) Accepted unlabeled indications listed in the pharmaceutical compendia (United States Pharmacopeia Drug Information or American Hospital Formulary Service): allergies angioedema asthma atopic dermatitis(eczema) dermatographism mastocytosis pruritus can be caused for example by (atopic dermatitis i.e eczema, or contact dermatitis ) urticaria (hives) transfusion reactions urticarial, anaphylactic/anaphylactoid reactions desloratidine desloratadine odt tab Antihistamines -PRE Idiopathic urticaria, chronic Perennial allergic rhinitis Seasonal allergic rhinitis AND A documented:**contraindication or intolerance or allergy or failure of two weeks each of TWO of the following nonprescription (OTC) products (single entity or combination product); one containing loratadine, one containing fexofenadine or one containing cetirizine OR A documented** diagnosis of one of the following : FDA-approved indications: Allergic conjunctivitis Chronic idiopathic urticaria (hives) Rhinitis (allergic perennial or seasonal, vasomotor) Accepted unlabeled indications listed in the pharmaceutical compendia (United States Pharmacopeia Drug Information or American Hospital Formulary Service): allergies angioedema asthma atopic dermatitis(eczema) dermatographism mastocytosis pruritus can be caused for example by (atopic dermatitis i.e eczema, or contact dermatitis ) urticaria (hives) transfusion reactions urticarial, anaphylactic/anaphylactoid reactions CLARINEX-D Antihistamines -PRE Idiopathic urticaria, chronic Perennial allergic rhinitis Seasonal allergic rhinitis AND A documented:**contraindication or intolerance or allergy or failure of two weeks each of TWO of the following nonprescription (OTC) products (single entity or combination product); one containing loratadine, one containing fexofenadine or one containing cetirizine OR A documented** diagnosis of one of the following : FDA-approved indications: Allergic conjunctivitis Chronic idiopathic urticaria (hives) Rhinitis (allergic perennial or seasonal, vasomotor) Accepted unlabeled indications listed in the pharmaceutical compendia (United States Pharmacopeia Drug Information or American Hospital Formulary Service): allergies angioedema asthma atopic dermatitis(eczema) dermatographism mastocytosis pruritus can be caused for example by (atopic dermatitis i.e eczema, or contact dermatitis ) urticaria (hives) transfusion reactions urticarial, anaphylactic/anaphylactoid reactions SEMPREX-D Antihistamines -PRE Idiopathic urticaria, chronic Perennial allergic rhinitis Seasonal allergic rhinitis AND A documented:**contraindication or intolerance or allergy or failure of two weeks each of TWO of the following nonprescription (OTC) products (single entity or combination product); one containing loratadine, one containing fexofenadine or one containing cetirizine OR A documented** diagnosis of one of the following : FDA-approved indications: Allergic conjunctivitis Chronic idiopathic urticaria (hives) Rhinitis (allergic perennial or seasonal, vasomotor) Accepted unlabeled indications listed in the pharmaceutical compendia (United States Pharmacopeia Drug Information or American Hospital Formulary Service): allergies angioedema asthma atopic dermatitis(eczema) dermatographism mastocytosis pruritus can be caused for example by (atopic dermatitis i.e eczema, or contact dermatitis ) urticaria (hives) transfusion reactions urticarial, anaphylactic/anaphylactoid reactions AND A documented:**contraindication or intolerance or allergy or failure of two weeks each of TWO of the following nonprescription (OTC) products (single entity or combination product); one containing loratadine, one containing fexofenadine or one containing cetirizine OR LOSEASO A documented adequate trial NIQUEof one month of one generic PRE equivalent alternative 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria promethazine promethazine-PRE tab/cap/supp/syrup, promethazine w/codeine, phenylephrinepromethazine-codeine, promethazine-dm, Prometh VC, promethegan and Phenergan Administration of analgesic; Prophylaxis Allergic condition Motion sickness Nausea and vomiting Postoperative pain Sedation A AND C – For promethazine tab/cap/supp/syrup, promethazine-dm, Prometh VC, promethegan and Phenergan 1 year B AND C – For promethazine w/codeine, phenylephrinepromethazine-codeine A. Member is less than 2 years of age OR B. Member is less than 6 years of age FDA alert6 Use of Phenergan/promethazine is contraindicated in Infants and Children < 2 years of age, due to risks for fatal respiratory depression. In addition the use of promethazine and codeine (with or without phenylephrine) is contraindicated in pediatric patients less than 6 years of age AND SIGNIFOR SIGNIFOR-PRE Pituitary dependent hypercortisolism C. Member's physician provides documentation (controlled clinical trial) from the peer reviewed medical literature that supports use in specified indication for this age group. A documented diagnosis of Cushing’s disease (i.e., pituitary-dependent elevated production of cortisol) in adults AND a documented all of the following: Pituitary surgery is not an option or has not been curative Assessment of anti-diabetic therapy for patients with poorly controlled diabetes prior to initiating therapy Established baseline values of the following prior to initiating therapy: Fasting plasma glucose (FPG) Hemoglobin A1c (HbA1c) Liver function tests (i.e., alanine aminotransferase (ALT), aspartate aminosferase (AST)) Electrocardiogram (EKG) and gallbladder ultrasound Pituitary function (i.e., TSH/free T4, GH/IGF-1) 6 months 60 ampules/ 30 days 2/day Ongoing patient evaluation to monitor appropriate treatment response and adverse events, including the following: Monitoring of blood glucose and/or FPG assessments will be done every week for the first three months and as clinically appropriate thereafter Liver function tests will be done after 1 to 2 weeks on treatment, then monthly for 3 months, and every 6 months thereafter gallbladder ultrasound at 6 to 12 month intervals KALYDECO KALYDECO-PRE Cystic fibrosis A documented diagnosis of cystic fibrosis in patients aged ≥6 6 years and older who have 1 of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R 1 year PULMOZYME PULMOZYME-PRE Cystic fibrosis A documented diagnosis of one of the following: Cystic fibrosis Primary ciliary dyskinesia 1 year AND A documented concurrent use of at least one standard therapy of treatment. Standard cystic fibrosis treatments include: oral, inhaled and/or parenteral antibiotics (examples: Tobi, Cayston, azithromycin), bronchodilators (examples: albuterol solution, ProAir HFA, Proventil HFA, Maxair Autohaler, Ventolin HFA, Xopenex solution/HFA), enzyme supplements (examples: Creon, Lipram, Pancrelipase, Digex, Pancreaze, Zenpep), vitamins, oral or inhaled corticosteroids (examples: Pulmicort, Symbicort, prednisone) and analgesics. PROCYSBI PROCYSBI-PRE Cystinosis ≥6 A documented diagnosis of nephropathic cystinosis in adults and children ages 6 years and older AND Member will not be using Cystagon concomitantly AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of the preferred alternative, Cystagon 1 year SYMLIN SYMLIN PEN SYMLIN-PRE Diabetes A documented diagnosis of type I or type II diabetes AND Concurrent use of a rapid or short-acting insulin i.e., Humalog or regular insulin 1 year Avandia Avandamet Avandaryl Avandia-PRE Diabetes A documented diagnosis of type 2 diabetes mellitus in adults, AND A documented HbA1C lab value greater than 6.5%, AND Members must be enrolled in the Avandia-Rosiglitazone Medicines Access Program, AND Member is already taking Avandia and has been advised by a healthcare professional of the risks and benefits of Avandia including the potential increased risk of myocardial infarction, OR Member is not already taking Avandia and is: Unable to achieve adequate glycemic control (HbA1C lab value greater than 6.5%) on other diabetes medications, and Has been advised of the risks and benefits of Avandia, including the potential increased risk of myocardial infarction, and In consultation with their healthcare provider, has decided not to take pioglitazone for medical reasons 1 year PROCYSB I-PRE A documented trial of one month of the preferred alternative, Cystagon 25 mg = 120 capsules /30 days. 75 mg = 750 capsules / 30 days. AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of metformin AND a GLP-1 agonist (i.e., Bydureon), or a DPP-4 inhibitor (i.e., Januvia), or insulin KORLYM KORLYM-PRE Diabetes A documented diagnosis of type 2 diabetes mellitus or glucose intolerance in adults with Cushing’s syndrome who have failed surgery or not a candidate for surgery AND A negative pregnancy test for females of childbearing age within the last 14 days, unless it is documented that the member is sterile (e.g. hysterectomy, unable to achieve pregnancy) or in menopause 1 year 4 tablets/da y FABRAZYME BRAVELLE chorionic gonadotropin novarel pregnyl Ovidrel Follistim AQ Gonal-F/Gonal-F RFF Menopur Repronex FABRAZYME-PRE BRAVELLE-PRE Fabry disease Ovulation induction Assisted reproductive technology A documented diagnosis of Fabry disease A documented diagnosis of any of the following: Clomiphene plus gonadotropins may be considered medically necessary in women who do not ovulate using clomiphene alone For use in pituitary down-regulation as part of in vitro fertilization treatment (Note: coverage of gonadotropins for this indication is limited to plans that cover advanced reproductive technologies. Please check benefit plan descriptions for details.) Pulsatile administration of gonadotropins are considered medically necessary for women with WHO Group I ovulation disorders (hypothalamic pituitary failure, characterized by hypothalamic amenorrhea or hypogonadotropic hypogonadism) Women with WHO Group II ovulation disorders such as polycystic ovary syndrome who do not ovulate with clomiphene citrate or tamoxifen 1 year 1 year Female 1 year Male 1 year Female AND Bravelle Follistim AQ Gonal-F Gonal-F RFF Menopur Repronex Follistim Ovulation induction Assisted reproductive technology Ganirelix AC Cetrotide Ganirelix-PRE Ovulation induction A documented Contraindication or Intolerance or Allergy or Failure of an adequate trial of one month each of two preferred gonadotropins - For Repronex and Follistim AQ A documented diagnosis of use with human chorionic gonadotropin (hCG) for the induction of spermatogenesis in men with primary or secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of 2 preferred gonadotropins (For Follistim AQ and Repronex only) A documented diagnosis of prevention of premature LH surge in women undergoing assisted reproduction techniques (ART) i.e. allowing the follicles to mature for planned oocyte collection 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria novarel pregnyl novarel-PRE Cryptorchidism Hypogonadotropic hypogonadism DIFLUCAN DIFLUCAN-PRE Bone marrow transplant - Candidiasis; Prophylaxis Candidal vulvovaginitis Candidiasis Cryptococcal meningitis Oropharyngeal candidiasis Diflucan 150mg not included A documented diagnosis of one of the following: male infertility due to hypogonadotropic hypogonadism (select cases of hypogonadism secondary to pituitary deficiency); or prepubertal cryptorchidism not due to anatomic obstruction. 1 year Male A documented Diagnosis of one of the below indications and specified criteria AND A documented contraindication or intolerance or allergy or failure of an adequate trial of preferred generic fluconazole (if request is for brand Diflucan) Blastomycosis Bone Marrow Transplant (prophylaxis) Candidiasis (Systemic); Chronic cutaneous candidal infection Coccidoidmycosis (valley fever) or Coccidiomeningitis Chronic Candidal Paronychia Cryptococcus Cutaneous dermatophyte infection: NOTE: tinea pedis (athletes foot), tinea cruris (jock itch), or tinea corporis (ringworm on the body), does NOT include tinea versicolor] ANDA documented contraindication or intolerance or allergy or failure of an adequate trial of one topical antifungal AND preferred generic oral terbinafine 1 year For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. A prior authorization will be granted for coverage of additional quantities of Diflucan, fluconazole, or Oravig for those members who meet ANY of the following criteria: For member that has a diagnosis of vulvovaginal candidiasis (VVC)/Vaginal Yeast Infection complicated with any of the following: antibiotic use or an immune compromised state such as HIV/AIDS or diabetes, or cancer, or chronic corticosteroid use: or recurrent (4 or more episodes per year) or severe VVC as determined Fungal Otitis externa ANDA documented Contraindication or Intolerance or allergy OR Failure of an adequate trial of one week of one preferred topical alternative ONMEL ONMEL-PRE onychomycosis (Tinea unguium) Histoplasmosis HIV or Cancer Mastitis or a candidal infection of the breast (due to breast A documented diagnosis of onychomycosis (Tinea unguium) due to dermatophyte AND 1 year A documented positive laboratory test such as (potassium hydroxide-KOH preparation, fungal culture, or nail biopsy) to confirm the diagnosis of onychomycosis (NOTE: This positive test should be recent (within the last 3-6 months) and associated with the current infection) AND A documented contraindication or intolerance or allergy or failure of an adequate trial of 6 weeks of preferred generic terbinafine OR any of the following: Presence of hepatic dysfunction or increased risk for liver disease Fungal culture indicating lack of sensitivity to terbinafine Non-dermatophyte fungal infection (mixed infection, a mold or yeast infection) AND A documented contraindication or intolerance or allergy or failure of an adequate trial of 6 weeks of the preferred generic, itraconazole LAMISIL terbinafine LAMISIL-PRE Cutaneous leishmaniasis Cutaneous sporotrichosis Paracoccidioidomycosis Seborrheic dermatitis Tinea capitis Onychomycosis (Tinea unguium) A documented Diagnosis of one of the below indications and specified criteria AND A documented contraindication or intolerance or allergy or failure of an adequate trial of preferred generic terbinafine (if request is for brand Lamisil) Chromoblastomycosis Cutaneous dermatophyte infection: NOTE: tinea pedis/manuum(athletes foot/hand), tinea cruris (jock itch), or tinea corporis (ringworm on the body), does NOT include tinea versicolor] ANDA documented contraindication or intolerance or allergy or failure of an adequate trial of one topical antifungal 1 year A Documented Diagnosis of Tinea capitis AND A documented contraindication or intolerance or allergy or failure of two weeks of preferred generic terbinafine OR Cutaneous leishmaniasis Cutaneous sporotrichosis Paracoccidioidomycosis Seborrheic dermatitis Tinea capitis Onychomycosis (Tinea unguium) due to dermatophyte ANDA documented positive laboratory test such as (potassium hydroxide-KOH preparation, fungal culture, or nail biopsy) to confirm the diagnosis of onychomycosis (NOTE: This positive test should be recent (within the last 3-6 months) and associated with the current infection) itraconazole SPORANOX ciclodan ciclopirox JUBLIA PENLAC SPORANOX-PRE Fungal-PRE Aspergillosis, Invasive, salvage therapy Blastomycosis Candidiasis of the esophagus Histoplasmosis, Disseminated Onychomycosis due to dermatophyte Oropharyngeal candidiasis Pulmonary histoplasmosis Onychomycosis due to dermatophyte A documented Diagnosis of one of the below indications and specified criteria AND A documented contraindication or intolerance or allergy or failure of an adequate trial of preferred generic itraconazole (if request is for brand Sporanox) Aspergillosis Blastomycosis Treatment of oropharyngeal/esophageal candidiasis in HIV-infected persons Chromoblastomycosis Coccidioidomycosis associated with AIDS, treatment and prophylaxis Cryptococcosis Cryptococcal meningitis - HIV infection Cutaneous dermatophyte infection: NOTE: tinea pedis/manuum (athletes foot/hand), tinea cruris (jock itch), or tinea corporis (ringworm on the body), does NOT include tinea versicolor] ANDA documented contraindication or intolerance or allergy or failure of an adequate trial of one topical antifungal AND preferred generic oral terbinafine Febrile neutropenia Histoplasmosis Penicillium marneffei infection Prophylaxis of invasive fungal infections in persons with A documented diagnosis of onychomycosis confirmed by either a positive KOH stain (potassium hydroxide), positive PAS stain (para-aminosalicylic acid), a positive DTM (dermatophyte test medium) or positive fungal culture (positive test should be recent (within the last 3 - 6 months) and associated with the current infection) Member requires a liquid dosage form 1 year 1 year AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one systemic (oral) alternative either terbinafine (6 weeks for fingernail infections; 12 weeks for toenail infections); fluconazole (6 months); griseofulvin (6 months); itraconazole (60 days (PulsePak) for fingernail infections; 90 days for toenail) OR Presence of hepatic dysfunction or increased risk for liver disease (for example, has a history of alcohol abuse or a history of hepatitis) OR Member is female and is pregnant and/or breastfeeding AND Member is NOT receiving a systemic (oral) antifungal agent – terbinafine, fluconazole, griseofulvin, itraconazole for onychomycosis at the same time CEREZYME ELELYSO VPRIV ZAVESCA Gaucher-PRE Gaucher's disease, Type 1 A documented diagnosis of Type 1 Gaucher disease in adults members who have any of the symptoms below; or A documented diagnosis of neuronopathic Type 3 Gaucher disease in children and adults who have any of the symptoms below and have neurologic findings consistent with Type 3 Gaucher disease (encephalopathy, ophthalmoplegia, progressive myoclonic epilepsy, cerebellar ataxia, spasticity, or dementia) (Cerezyme, Elelyso, and VPRIV ONLY) Moderate to severe anemia (hemoglobin less than or equal to 11.5 g/dL (adult women) or 12.5 g/dL (adult men) or less than or equal to 1.0 g/dL or more below the lower limit of normal for age and sex); or Significant hepatomegaly (liver size 1.25 or more times normal (1,750 cc in adults)) or splenomegaly (spleen size 5 or more times normal (875 cc in adults)); or Skeletal disease beyond mild osteopenia and Erlenmeyer flask deformity; or Symptomatic disease, including abdominal or bone pain, fatigue, exertional limitation, weakness, or cachexia; or Thrombocytopenia (platelet count less than or equal to 120,000/mm3); or A documented diagnosis of Type 1 Gaucher disease in children and adolescents less than 18 years of age For Lamisil oral granules 1 year 150 mg only = 1 dose/30 day supply 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria KRYSTEXXA KRYSTEXXA-PRE Gout A documented diagnosis of symptomatic gout; AND At least 3 gout flares in the previous 18 months that were inadequately controlled by colchicine [Colcrys] and nonsteroidal anti-inflammatory drugs (i.e., ibuprofen, naproxen, indomethacin), or at least 1 gout tophus or gouty arthritis; AND Failure to normalize serum uric acid to less than 6 mg/dL after 3 months of maximum medically appropriate dose of xanthine oxidase inhibitors (maximum recommended dosage of allopurinol [Zyloprim] is 800 mg/day and febuxostat [Uloric] is 80 mg/day or when xanthine oxidase inhibitors are contraindicated; AND Member has undertaken appropriate life style modifications, i.e. limiting of alcohol consumption and other medications known to precipitate gout attacks have been discontinued/changed when possible; AND Member does not have G6PD deficiency. (Persons at higher risk for G6PD deficiency (e.g., those of African and Mediterranean ancestry) should be screened due to the risk of hemolysis and methemoglobinemia. G6PD deficiency is a contraindication for Krystexxa therapy.) 1 year GATTEX GATTEX-PRE Short bowel syndrome A documented diagnosis of short bowel syndrome in adults AND all of the following: Member has been dependent on parenteral nutrition/intravenous support for at least 12 months Member requires parenteral nutrition at least 3 times per week 6 months HELIDAC HELIDAC-PRE Helicobacter pylori infection Peptic ulcer disease A documented diagnosis of Helicobacter pylori infection and peptic ulcer disease (gastric or duodenal ulcer disease) 1 year HELIDAC- A documented trial of two weeks of the preferred generic PRE alternatives, metronidazole, tetracycline, and over-thecounter bismuth subsalicylate, all taken concomitantly with an H2-blocker or PPI (i.e., ranitidine, omeprazole, lansoprazole) 1 year PREVPAC- A documented trial of two PRE weeks of the preferred generic alternatives, lansoprazole, amoxicillin, and clarithromycin, all taken concomitantly PREVPAC PREVPAC-PRE Helicobacter pylori infection Peptic ulcer disease AND A documented contraindication or intolerance or allergy or failure of an adequate trial of two weeks of the preferred generic alternatives, metronidazole, tetracycline, and overthe-counter bismuth subsalicylate, all taken concomitantly with an H2-blocker or PPI (i.e., ranitidine, omeprazole, lansoprazole) A documented diagnosis of Helicobacter pylori infection and peptic ulcer disease (gastric or duodenal ulcer disease) AND A documented contraindication or intolerance or allergy or failure of an adequate trial of two weeks of the preferred generic alternatives, lansoprazole, amoxicillin, and clarithromycin, all taken concomitantly ARANESP PROCRIT EPOGEN ESA-PRE Anemia from myelodysplastic syndrome; or Anemia of prematurity; or Special circumstance members who will not or can not receive whole blood or components as replacement for traumatic or surgical loss; or Treatment of anemic members scheduled to undergo high-risk surgery who are at increased risk of or intolerant to transfusions; or Treatment of anemia associated with chronic renal failure, whether or not on dialysis; or Treatment of anemia in members receiving chemotherapy for hepatitis C; or Treatment of anemia of chronic disease other than cancer when an underlying chronic disease associated with anemia has been identified (see appendix); or Treatment of anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphomas and lymphocytic leukemia; or Treatment of anemia due to zidovudine in HIV-infected members. OMONTYS OMONTYS-PRE Anemia PROMACTA PROMACTA-PRE Thrombocytopenia A documented diagnosis of one of the following: Anemia from myelodysplastic syndrome; or Anemia of prematurity; or Special circumstance members who will not or can not receive whole blood or components as replacement for traumatic or surgical loss; or Treatment of anemic members scheduled to undergo highrisk surgery who are at increased risk of or intolerant to transfusions; or Treatment of anemia associated with chronic renal failure, whether or not on dialysis; or Treatment of anemia in members receiving chemotherapy for hepatitis C; or Treatment of anemia of chronic disease other than cancer when an underlying chronic disease associated with anemia has been identified (see appendix); or Treatment of anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphomas and lymphocytic leukemia; or Treatment of anemia due to zidovudine in HIV-infected members. A documented diagnosis of anemia due to chronic kidney disease in adults with dialysis A documented diagnosis of one of the following: Thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy OR Thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy 4 months 4 months 1 year AND Documented measure of serum ALT, AST, and bilirubin prior to initiation of therapy, every 2 weeks during dose adjustment phase, and monthly following establishment of a stable dose AND Documented current platelet count of less than 75 x 109/L AND Documented complete blood count (CBC) with differentials (including platelet counts) weekly during the dose adjustment phase of therapy, then monthly following establishment of a stable dose, then again weekly for at least 4 weeks following discontinuation of therapy FIRAZYR FIRAZYR-PRE Hereditary angioedema Member must have a diagnosis of HAE, where diagnosis is ≥18 based on evidence of a low C4 level (C4 less than 14 mg/dL; normal range 14 to 40 mg/dL, or C4 below the lower limit of normal as defined by the laboratory performing the test) plus: A low C1 inhibitor (C1INH) antigenic level (C1INH less than 19 mg/dL normal range 19 to 37 mg/dL, or C1INH antigenic level below the lower limit of normal as defined by the laboratory performing the test); or A normal C1INH antigenic level (C1INH greater than or equal to 19 mg/dL) and a low C1INH functional level (functional C1INH less than 50 %,) or Below the lower limit of normal as defined by the laboratory performing the test) 1 year Aetna considers Firazyr experimental and investigational for prophylaxis against angioedema attacks and other indications (e.g., acute pancreatitis, airways disease, thermal injury, drug-induced angioedema, use in combination with Berinert or Kalbitor, and refractory ascites in persons with liver cirrhosis) because its effectiveness for these indications has not been established. 1 year Aetna considers Cinryze medically necessary for prophylaxis against angioedema attacks in adolescents and adults with hereditary angioedema (HAE) AND Member must be experiencing at least one symptom of the moderate or severe attack (e.g., airway swelling, severe abdominal pain, facial swelling, nausea and vomiting, painful facial distortion); and CINRYZE CINRYZE-PRE Hereditary angioedema Medications known to cause angioedema (i.e. ACEMember has a history of at least 1 HAE attack per month; and Diagnosis of HAE is documented based on evidence of a low C4 level (C4 < 14 mg/dL; normal range 14 to 40 mg/dL), or C4 below the lower limit of normal as defined by the laboratory performing the test) plus: A low C1 inhibitor (C1INH) antigenic level (C1INH < 19 mg/dL normal range 19 to 37 mg/dL, or C1INH antigenic level below the lower limit of normal as defined by the laboratory performing the test); or A normal C1INH antigenic level (C1INH ≥ 19 mg/dL) and a low C1INH functional level (functional C1INH < 50% or C1INH functional level below the lower limit of normal as defined by the laboratory performing the test); or A known HAE-causing C1INH mutation. AND Medications known to cause angioedema (i.e. ACEInhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate; and Member has tried and failed or is intolerant 30 vials/30 days For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. Up to 30 additional vials will be granted for those members who meet any of the following criteria: Member's body weight exceeds 76 kg 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria BERINERT BERINERT-PRE Hereditary angioedema Member must have a diagnosis of HAE; and where ≥13 diagnosis is documented by documented based on evidence of a low C4 level (C4 < 14 mg/dL; normal range 14 to 40 mg/dL, or C4 below the lower limit of normal as defined by the laboratory performing the test) plus: a) A low C1 inhibitor (C1INH) antigenic level (C1INH < 19 mg/dL normal range 19 to 37 mg/dL, or C1INH antigenic level below the lower limit of normal as defined by the laboratory performing the test); or b) A normal C1INH antigenic level (C1INH ≥ 19 mg/dL) and a low C1INH functional level (functional C1INH < 50%, or below the lower limit of normal as defined by the laboratory performing the test); and Member must be experiencing at least one symptom of the moderate or severe attack (e.g., airway swelling, severe abdominal pain, facial swelling, nausea and vomiting, painful facial distortion); and Medications known to cause angioedema (i.e. ACEInhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate. 1 year Aetna considers Berinert experimental and investigational for prophylaxis against angioedema attacks, for use in combination with Kalbitor or Firazyr, and for other indications because its effectiveness for these indications has not been established. KALBITOR KALBITOR-PRE Hereditary angioedema ≥12 Member must have a diagnosis of HAE; and where diagnosis is documented by documented based on evidence of a low C4 level (C4 < 14 mg/dL; normal range 14 to 40 mg/dL, or C4 below the lower limit of normal as defined by the laboratory performing the test) plus: A low C1 inhibitor (C1INH) antigenic level (C1INH < 19 mg/dL normal range 19 to 37 mg/dL, or C1INH antigenic level below the lower limit of normal as defined by the laboratory performing the test); or A normal C1INH antigenic level (C1INH ≥ 19 mg/dL) and a low C1INH functional level (functional C1INH < 50%, or below the lower limit of normal as defined by the laboratory performing the test) 1 year Aetna considers Kalbitor experimental and investigational for all other indications (e.g., reduction of blood loss during surgery, hereditary angioedema with normal C1INH inhibitor (previously called type III hereditary angioedema, and characterized by normal C1INH antigenic and functional levels), use in combination with Berinert or Firazyr) because its effectiveness for these indications has not been established. AND Member must be experiencing at least one symptom of the moderate or severe attack (e.g., airway swelling, severe abdominal pain, facial swelling, nausea and vomiting, painful facial distortion); and Medications known to cause angioedema (i.e. ACEInhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate. FULYZAQ FULYZAQ-PRE HIV infection A documented diagnosis of treatment of symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS AND ALL of the following: Currently stable on anti-retroviral therapy History of diarrhea for one month or more Diarrhea is documented to be persistent loose stools despite regular use of anti-diarrheal medication (ADM) (i.e., loperamide, diphenoxylate, bismuth subsalicylate) or one or more watery bowel movements per day without regular ADM use Negative GI culture or stool test for ALL of the following: bacteria, bacteria toxin, ova, parasites, or viruses No history of other GI diseases associated with diarrhea (i.e. ulcerative colitis, Crohn’s disease, celiac sprue (gluten-enteropathy), chronic pancreatitis, malabsorption) 1 year 2/day MAKENA MAKENA-PRE Preterm labor The documented indication of prevention of preterm birth (defined as delivery at less than 37 weeks, 0 days gestation) in women who are pregnant with a singleton pregnancy and have history of a prior spontaneous preterm birth of a singleton delivery. Consistent with FDAapproved labeling, Makena should be initiated between 16 weeks, 0 days and 20 weeks, 6 days of gestation and should continue though 37 weeks, 0 days gestation 6 months Up to 5 vials per yea ELAPRASE ELAPRASE-PRE Mucopolysaccharidosis XENAZINE-PRE Huntington's disease A documented diagnosis of Hunter syndrome (mucopolysaccharidosis II) A documented diagnosis of chorea associated with Huntington's disease OR A documented diagnosis of Tourette's syndrome (TS) 1 year XENAZINE ADAGEN ADAGEN-PRE Adenosine deaminase deficiency A documented diagnosis of adenosine deaminase deficiency (ADA) in patients with severe combined immunodeficiency disease (SCID) AND The patient is not a candidate or has failed a bone marrow transplantation 1 year BIVIGAM CARIMUNE NANOFILTERED FLEBOGAMMA GAMASTAN S/D GAMMAGARD GAMMAGARD S/D GAMMAKED GAMMAPLEX GAMUNEX GAMUNEX-C HIZENTRA OCTAGAM PRIVIGEN VIVAGLOBIN IVIG-PRE Acquired red cell aplasia Aetna considers the use of intravenous immunoglobulin (IVIG) therapy medically necessary in members with the conditions specified below: 1 year ELIDEL ELIDEL-PRE atopic dermatitis PROTOPIC PROTOPIC-PRE atopic dermatitis ARCALYST ARCALYST-PRE Cryopyrin-Associated Periodic Syndrome (CAPS) familial cold auto-inflammatory syndrome (FCAS) Muckle-Wells Syndrome (MWS) 1. Acquired red cell aplasia 2. Acute disseminated encephalomyelitis (see Appendix) 3. Autoimmune mucocutaneous blistering diseases: IVIG is considered medically necessary for members with pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid (a.k.a., cicatrical pemphigoid), and epidermolysis bullosa acquisita if the member has either failed or has contraindications to conventional therapy, or the member has rapidly progressive disease in which a clinical response could not be affected quickly enough using conventional agents. When indicated for rapidly progressive disease, accepted guidelines indicate that IVIG should be given along with conventional treatment(s) and IVIG should be used only until conventional therapy could take effect. (See Appendix) Note: IVIG for the treatment of autoimmune mucocutaneous blistering disease is considered medically necessary only for shortterm therapy and not as a maintenance therapy 4. B-cell chronic lymphocytic leukemia (CLL): for persons with hypogammaglobulinemia associated with CLL and recurrent infections or specific antibody deficiency (see A documented diagnosis of mild to moderate atopic dermatitis in patients (eczema) less than 2 years of age for short-term use (up to 3 months) (Note: requirement of a trial of topical corticosteroid is not required) OR A documented diagnosis of atopic dermatitis (eczema) in an adult or child 2 years of age or older, AND one of the following: A documented contraindication, intolerance or allergy to one preferred alternative topical corticosteroid indicated for the patient’s condition, OR A documented failure of an adequate trial of 2 weeks (14 days) of one preferred alternative topical corticosteroid indicated for the patient’s condition, OR Treatment is in an area at high risk for skin atrophy such as face, eyelids, or genital areas For Protopic 0.1% ≥16 FOR A documented diagnosis of atopic dermatitis (eczema) in 0.1% an adult or an adolescent 16 years of age or older, AND one of the following: A documented contraindication, intolerance or allergy to one preferred alternative topical corticosteroid indicated for the patient’s condition, OR A documented failure of an adequate trial of 2 weeks (14 days) of one preferred alternative topical corticosteroid indicated for the patient’s condition, OR Treatment is in an area at high risk for skin atrophy such as face, eyelids, or genital areas. For Protopic 0.03% A documented diagnosis of mild to moderate atopic dermatitis (eczema) in patients less than 2 years of age for short-term use (up to 3 months) (Note: requirement of a trial of topical corticosteroid is not required) OR A documented diagnosis of atopic dermatitis (eczema) in an adult or child 2 years of age or older, AND one of the following: A documented contraindication, intolerance or allergy to one preferred alternative topical corticosteroid indicated for the patient’s condition, OR A documented failure of an adequate trial of 2 weeks (14 A documented diagnosis of Cryopyrin-Associated Periodic Syndrome (CAPS), including only subtypes familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells Syndrome (MWS 1 year 3 months if applied to face, eyelids, genital areas; 6 months if applied to other areas of body; 3 months for patients less than 2 years of age 3 months if applied to face, eyelids, genital areas; 6 months if applied to other areas of body; 3 months for patients less than 2 years of age 1 year II. Aetna considers subcutaneously administered immunoglobulins as an alternative to intravenous immunoglobulin therapy medically necessary for members who meet the criteria for IVIG set forth above. III. Aetna considers intramuscularly administered immunoglobulins (e.g., GamaSTAN S/D) medically necessary as an alternative to intravenous immunoglobulin therapy for conditions associated with hypogammaglobulinemia that meet the criteria for IVIG set forth above. Intramuscular formulations of immune globulin are also considered medically 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria ILARIS ILARIS-PRE Cryopyrin-Associated Periodic Syndrome (CAPS) familial cold auto-inflammatory syndrome (FCAS) Muckle-Wells Syndrome (MWS) Active Systemic Juvenile Idiopathic Arthritis (SJIA) A documented diagnosis of one of the following: CryopyrinAssociated Periodic Syndrome (CAPS), including only subtypes familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells Syndrome (MWS) OR Active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older ELMIRON UCERIS ELMIRON-PRE interstitial cystitis. A documented diagnosis of interstitial cystitis. 6 months UCERIS-PRE ulcerative colitis A documented diagnosis of active, mild to moderate ulcerative colitis AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of two preferred 5-ASA therapies (i.e., balsalazide, Canasa, Delzicol) AND one preferred generic corticosteroid therapy (i.e., budesonide sr, prednisone, prednisolone) 2 months LOTRONEX LOTRONEX-PRE Irritable bowel syndrome Diagnosis of severe** irritable bowel syndrome (IBS) with primary symptom of diarrhea with: 6 months Female 1 year Coverage of additional quantities may be requested by the member's treating physician through the Aetna Pharmacy Management Precertification Unit. Additional quantities of Myalept will be considered medically necessary for members who meet any of the following criteria: 1 year 3 capsules/ day 1/day chronic IBS symptoms (generally lasting 6 months or longer) AND anatomic or biochemical abnormalities of the gastrointestinal tract have been excluded AND failure of response to at least one conventional therapy agent for at least one month **Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following: (1) frequent and severe abdominal pain/discomfort; or (2) frequent urgency or fecal incontinence; or (3) disability or restriction of daily activities due to IBS. MYALEPT MYALEPT-PRE Lipodystrophy A documented diagnosis of complications of leptin deficiency (serum leptin levels less than the 7th percentile of normal values reported by the 3rd National Health and Nutrition Examination survey (less than 7.0 ng/mL in females and less than 3.0 ng/mL in males)) in persons with congenital generalized or acquired generalized lipodystrophy with at least one of the following: Type 2 diabetes mellitus Hypertriglyceridemia as defined by fasting triglyceride concentrations greater than 300 mg/ dL Hyperinsulinemia as defined by fasting serum insulin greater than 20 uU/ Up to 15 vials in 30 days For Myalept Member weighs >40 kg and is on maximal dose Member weighs >40 kg and is titrating to the maximal dose Member is an infant and Myalept will be reconstituted with preservative-free water for injection LUPANETA ARALEN chloroquine LUPANETA-PRE ARALEN-PRE Endometriosis Malaria Members who meet above criteria may be eligible to A documented diagnosis of endometriosis A documented diagnosis of one of the following: Maximum Time of Approval for Malaria: 30 days Maximum Time of Approval for all other indications: One year malaria rheumatoid arthritis systemic and discoid lupus erythematosus scleroderma pemphigus lichen planus polymyositis sarcoidosis DARAPRIM DARAPRIM-PRE Malaria Toxoplasmosis A documented diagnosis of one of the following: -malaria -toxoplasmosis Differin gel/cream/lotion 0.1% Differin-PRE acne vulgaris A documented diagnosis of acne vulgaris COARTEM MALARONE mefloquine atovaquone/proguanil COARTEM-PRE Malaria A documented diagnosis of malaria PLAQUENIL hydroxychloroquine PLAQUENIL-PRE QUALAQUIN quinine sulfate COARTEM-PRE >35 Maximum Time of Approval for Malaria: 30 days Maximum Time of Approval for all other indications: One year 1 year DifferinPRE A documented trial of one month of the preferred generic equivalent alternative, adapalene cream or gel 0.1% Maximum Time of Approval for Malaria: 30 days Maximum Time of Approval for all other indications: One year Malaria Rheumatoid arthritis Systemic lupus erythematosus A documented diagnosis of one of the following: malaria rheumatoid arthritis systemic lupus erythematosus Malaria A documented diagnosis of malaria Maximum Time of Approval for Malaria: 30 days Maximum Time of Approval for all other indications: One year Maximum Time of Approval for Malaria: 30 days Maximum Time of Approval for all other indications: One year For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. Additional quantities of this drug will be considered medically necessary for those members who meet ANY of the following criteria: Diagnosis of uncomplicated Plasmodium falciparum malaria necessitating one additional treatment- may approve an additional 42 capsules one time 42 capsules/y ear 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria SIVEXTRO SIVEXTRO-PRE Infection of skin AND/OR subcutaneous tissue 30 Days Up to 6 tablets in 30 days Hepatic encephalopat hy: One year Traveler's Diarrhea: 1 Week 200 mg = 9 tablets/30 day supply, 550 mg = 2 tablets/da y A documented diagnosis of acute bacterial skin and skin structure infections (ABSSSI), and Culture and susceptibility information or, in the absence of such data, local epidemiology and susceptibility patterns indicate that the current infection is caused by one of the following Gram-positive microorganisms: Staph. aureus (including methicillin-resistant [MRSA] and methicillinsusceptible [MSSA] isolates), or Strep. pyogenes, or Strep. agalactiae, or Strep. anginosus Group (including Strep. anginosus, Strep. intermedius, and Strep. constellatus), or E. faecalis XIFAXAN XIFAXAN-PRE A documented diagnosis of traveler's diarrhea caused by noninvasive strains of Escherichia coli (non-bloody diarrhea without fever) OR A documented diagnosis of hepatic encephalopathy Small intestinal bacterial overgrowth (SIBO) A documented: Contraindication to one preferred alternative agent indicated for the member's condition OR Intolerance to one preferred alternative agent indicated for the member's condition OR Allergy to one preferred alternative agent indicated for the member's condition OR Failure of an adequate trial of two weeks of one preferred alternative agent indicated for the member's condition DDAVP (all forms) desmopressin minirin STIMATE DDAVP-PRE ≤17 Diagnosis of central diabetes insipidus (neurohypophyseal diabetes insipidus) including polydipsia and polyuria OR Diagnosis of hemophilia A or mild to moderate von Willebrand's disease (vWd) 1 year DDAVPPRE Under some plans, including plans that use an open or closed formulary, DDAVP nasal/injection/tablets are subject to step-therapy. Aetna considers DDAVP nasal/injection/tablets to be medically necessary for those members who meet the following step-therapy criterion: A documented trial of one month of the generic alternative agent desmopressin -the alternative on the Preferred Drug List. ALDURAZYME ALDURAZYME-PRE urler and Hurler-Scheie forms of mucopolysaccharidosis I (MPS I) NAGLAZYME NAGLAZYME-PRE Mucopolysaccharidosis VI (MPS VI) AMPYRA AMPYRA-PRE Multiple sclerosis A documented diagnosis of Hurler and Hurler-Scheie forms of mucopolysaccharidosis I (MPS I) and for members diagnosed with the Scheie form who have moderate to severe symptoms A documented diagnosis of mucopolysaccharidosis VI (MPS VI) A documented diagnosis of multiple sclerosis AND ALL of the following: Normal creatinine clearance (> 50 ml/min) No past medical history of seizures One of the following criteria: Has completed two 25-foot walk test with no more than 5 minutes break between the two rest with an average time of 45 seconds (walking speed of 0.55 ft/s) or faster, prior to treatment with Ampyra, or Has achieved a 20% increase in walking speed from baseline* after starting treatment with Ampyra 1 year 1 year 18 or greater 6 months For renewal at 6 weeks and every 6 months thereafter Member has continued therapeutic response defined as at least 20% increase in walking speed from baseline* *Baseline walking speed (ft/s) is the average walking speed before member takes Ampyra, obtained from two trials of 25-foot walk with no more than 5 minutes break between the two tests; it is calculated by dividing 25 by the average time (in seconds) of the two tests) For Aubagio AUBAGIO AUBAGIO-PRE Multiple sclerosis A documented diagnosis of relapsing remitting multiple sclerosis AND documentation of ALL of the following: Discontinuation of other therapies used for treating multiple sclerosis (Note: This does NOT require having to discontinue Ampyra) Recent (within 6 months) complete blood count (CBC) Recent (within 6 months) liver transaminase and bilirubin levels Recent Tuberculin skin test (within 6 months) to check for latent Tuberculosis Blood pressure monitoring at initiation and during treatment If Female, confirmation of negative pregnancy test at initiation of therapy and confirmation that reliable contraception will be used during treatment with Aubagio A documented contraindication or intolerance or allergy or failure of an adequate trial* of both preferred alternatives, Copaxone 20 or 40 mg and Rebif 1 year AVONEX AVONEX-PRE Multiple sclerosis A documented diagnosis of relapsing remitting multiple sclerosis AND documentation of all of the following: Discontinuation of other therapies used for treating multiple sclerosis (Note: This does NOT require having to discontinue Ampyra) A documented contraindication or intolerance or allergy or failure of an adequate trial* of both preferred alternatives, Copaxone 20 or 40 mg and Rebif 1 year * For purposes of this policy, failure of an adequate trial of therapy for multiple sclerosis is defined as follows: The member has increasing relapses (defined as two or more relapses in a year, or one severe relapse associated with either poor recovery or MRI lesion progression); OR The member has lesion progression by MRI (increased number or volume of gadoliniumenhancing lesions, T2 hyperintense lesions or T1 hypointense lesions); OR The member has worsening disability (sustained worsening of Expanded Disability Status Scale (EDSS) score or neurological examination findings) * For purposes of this policy, failure of an adequate trial of therapy for multiple sclerosis is defined as follows: The member has increasing relapses (defined as two or more relapses in a year, or one severe relapse associated with either poor recovery or MRI lesion progression); OR The member has lesion progression by MRI (increased number or volume of gadoliniumenhancing lesions, T2 hyperintense lesions or T1 hypointense lesions); OR The member has worsening disability (sustained worsening of Expanded Disability Status Scale (EDSS) score or neurological examination findings) * For purposes of this policy, failure of an adequate trial of therapy for multiple sclerosis is defined as follows: The member has increasing relapses (defined as two or more relapses in a year, or one severe relapse associated with either poor recovery or MRI lesion progression); OR The member has lesion progression by MRI (increased number or volume of gadoliniumenhancing lesions, T2 hyperintense lesions or T1 hypointense lesions); OR The member has worsening disability (sustained worsening of Expanded Disability Status Scale (EDSS) score or neurological examination findings) 2/day 1/day 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria BETASERON EXTAVIA BETASERON-PRE Multiple sclerosis A documented diagnosis of relapsing remitting multiple sclerosis AND documentation of all of the following: Discontinuation of other therapies used for treating multiple sclerosis (Note: This does NOT require having to discontinue Ampyra) A documented contraindication or intolerance or allergy or failure of an adequate trial* of both preferred alternatives, Copaxone 20 or 40 mg and Rebif 1 year COPAXONE COPAXONE-PRE Multiple sclerosis A documented diagnosis of one of the following AND discontinuation of other therapies used for treating multiple sclerosis (Note: This does NOT require having to discontinue Ampyra) Clinically isolated syndrome (CIS) suggestive of multiple sclerosis(MS) (i.e. persons who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with MS)) Relapsing, remitting multiple sclerosis (Note: Does not include diagnosis of chronic progressive multiple sclerosis(MS)) 1 year GILENYA GILENYA-PRE Multiple sclerosis 1 year REBIF REBIF-PRE Multiple sclerosis For new starts or restarts after 6 months or more of treatment interruption: A documented diagnosis of relapsing, remitting multiple sclerosis AND documentation of ALL of the following: Discontinuation of other therapies used for treating multiple sclerosis (Note: This does NOT require having to discontinue Ampyra) Recent (within 6 months) complete blood count (CBC) Recent (within 6 months) liver transaminase and bilirubin levels A documented EKG (i.e. electrocardiogram that measures rate and regularity of heartbeats) prior to the first dose AND a documented EKG at the end of the observation period AND documented to have NONE of the following: Recent (within the last 6 months) occurrence of myocardial infarction (i.e. heart attack), unstable angina, stroke, transient ischemic attack (i.e. mini stroke), decompensated heart failure requiring hospitalization, or Class III/IV heart failure* History or presence of Mobitz Type II 2nd degree or 3rd degree AV block or sick sinus syndrome syndrome (these are specific types of heart rhythm problems), unless patient has a pacemaker Baseline QTc interval ≥500 ms (as measured on most recent EKG) Treatment with Class Ia or Class III anti-arrhythmic drugs** A documented diagnosis of relapsing remitting multiple sclerosis AND discontinuation of other therapies used for treating multiple sclerosis (Note: This does NOT require having to discontinue Ampyra) TECFIDERA TECFIDERA-PRE Multiple sclerosis A documented diagnosis of relapsing remitting multiple sclerosis AND documentation of all of the following: Discontinuation of other therapies used for treating multiple sclerosis while on therapy with Tecfidera (Note: This does NOT require having to discontinue Ampyra) Recent (within 6 months) complete blood count (CBC) A documented contraindication or intolerance or allergy or failure of an adequate trial* of both preferred alternatives, Copaxone 20 or 40 mg and Rebif 1 year TYSABRI TYSABRI-PRE Crohn's disease Multiple sclerosis A documented diagnosis of one of the following Relapsing, remitting multiple sclerosis (Note: Does not include diagnosis of treatment of chronic progressive multiple sclerosis (MS) AND documentation of ALL of the following: A Documented performance of JCV Antibody ELISA testing (NOTE: Presence of anti-JCV antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML), a fatal brain infection. Identifying risk factors along with this test can help reduce adverse events. Specific timing of administration of test (before, during/ therapy--thereafter) or test results (positive or negative) will not result in a coverage denial.) Discontinuation of other therapies used for treating multiple sclerosis (Note: This does NOT require having to discontinue Ampyra) A documented contraindication or intolerance or allergy or failure of an adequate trial* of both preferred alternatives, Copaxone 20 or 40 mg and Rebif 1 year Crohn’s disease AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of one preferred alternative Cimzia or Humira or Remicade 1 year * For purposes of this policy, failure of an adequate trial of therapy for multiple sclerosis is defined as follows: The member has increasing relapses (defined as two or more relapses in a year, or one severe relapse associated with either poor recovery or MRI lesion progression); OR The member has lesion progression by MRI (increased number or volume of gadoliniumenhancing lesions, T2 hyperintense lesions or T1 hypointense lesions); OR The member has worsening disability (sustained worsening of Expanded Disability Status Scale (EDSS) score or neurological examination findings) * For purposes of this policy, failure of an adequate trial of therapy for multiple sclerosis is defined as follows: The member has increasing relapses (defined as two or more relapses in a year, or one severe relapse associated with either poor recovery or MRI lesion progression); OR The member has lesion progression by MRI (increased number or volume of gadoliniumenhancing lesions, T2 hyperintense lesions or T1 hypointense lesions); OR The member has worsening disability (sustained worsening of Expanded Disability Status Scale (EDSS) score or neurological examination findings) * For purposes of this policy, failure of an adequate trial of therapy for multiple sclerosis is defined as follows: The member has increasing relapses (defined as two or more relapses in a year, or one severe relapse associated with either poor recovery or MRI lesion progression); OR The member has lesion progression by MRI (increased number or volume of gadoliniumenhancing lesions, T2 hyperintense lesions or T1 hypointense lesions); OR The member has worsening disability (sustained worsening of Expanded Disability Status Scale (EDSS) score or neurological examination findings) * For purposes of this policy, failure of an adequate trial of therapy for multiple sclerosis is defined as follows: The member has increasing relapses (defined as two or more relapses in a year, or one severe relapse associated with either poor recovery or MRI lesion progression); OR The member has lesion progression by MRI (increased number or volume of gadoliniumenhancing lesions, T2 hyperintense lesions or T1 hypointense lesions); OR The member has worsening disability (sustained worsening of Expanded Disability Status Scale (EDSS) score or neurological examination findings) * For purposes of this policy, failure of an adequate trial of therapy for multiple sclerosis is defined as follows: The member has increasing relapses (defined as two or more relapses in a year, or one severe relapse associated with either poor recovery or MRI lesion progression); OR The member has lesion progression by MRI (increased number or volume of gadoliniumenhancing lesions, T2 hyperintense lesions or T1 hypointense lesions); OR The member has worsening disability (sustained worsening of Expanded Disability Status Scale (EDSS) score or neurological examination findings) * For purposes of this policy, failure of an adequate trial of therapy for multiple sclerosis is defined as follows: The member has increasing relapses (defined as two or more relapses in a year, or one severe relapse associated with either poor recovery or MRI lesion progression); OR The member has lesion progression by MRI (increased number or volume of gadoliniumenhancing lesions, T2 hyperintense lesions or T1 hypointense lesions); OR The member has worsening disability (sustained worsening of Expanded Disability Status Scale (EDSS) score or neurological examination findings) 1/day 120mg = 14 capsules/ 28 day; 240mg = 2 capsules/ day 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria BOTOX DYSPORT MYOBLOC XEOMIN BOTOX-PRE Strabismus Blepharospasm Headache; Prophylaxis Bladder muscle dysfunction 1. OnabotulinumtoxinA (Botox Brand of Botulinum Toxin Type A): Aetna considers onabotulinumtoxinA (Botox) medically necessary for any of the following conditions: 1 year (6 times within year only) A. Strabismus (including gaze palsies accompanying diseases, such as neuromyelitis optica and Schilder's disease), for deviations less than 50 prism diopters. Note: Strabismus repair is considered cosmetic in adults with uncorrected congenital strabismus and no binocular fusion. B. Blepharospasm, characterized by intermittent or sustained closure of the eyelids caused by involuntary contractions of the orbicularis oculi muscle. C. Post-facial (7th cranial) nerve palsy synkinesis (hemifacial spasms), characterized by sudden, unilateral, synchronous contractions of muscles innervated by the facial nerve. D. Laryngeal spasm. ACTIMMUNE ACTIMMUNE-PRE Chronic granulomatous E. Cervical dystonia (spasmodic torticollis) of moderate or 6 months A documented diagnosis of one of the following: Chronic granulomatous disease, to reduce the frequency and severity of infections; or Chronic recalcitrant atopic dermatitis; or Mycosis fungoides and Sezary syndrome; or Severe, malignant osteopetrosis, to delay time to disease progression Currently, the only FDAapproved indications for interferon gamma (Actimmune) is for treatment of chronic granulomatous disease, and for delaying time to disease progression in patients with severe, malignant osteopetrosis. Interferon gamma has also been shown to be effective for the treatment of atopic dermatitis Aetna considers interferon gamma experimental and investigational for the following: treatment of brain tumors, idiopathic pulmonary fibrosis, malignant neoplasm of peritoneum, pulmonary tuberculosis, Waldenstrom's macroglobulinemia and all other indications because its effectiveness for indications other than the ones listed above has not been established . AFINITOR AFINITOR-PRE Renal cell carcinoma Subependymal giant cell astrocytoma Progressive neuroendocrine tumors Renal angiomyolipoma and tuberous sclerosis complex (TSC) ARIMIDEX FEMARA ARIMIDEX-PRE Breast cancer anastrozole AROMASIN letrozole exemestane ARIMIDEX-PRE Breast cancer BOSULIF BOSULIF-PRE All FDA and NCCN 1, 2a and 2b approved indications COMETRIQ COMETRIQ-PRE Medullary thyroid carcinoma A documented diagnosis of one of the following: Advanced renal cell carcinoma AND a documented resistance or intolerance to prior therapy with sunitinib (Sutent) or pazopanib (Votrient) Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TSC) that can not be treated with surgery Progressive neuroendocrine tumors located in the pancreas (PNET) that cannot be removed by surgery or that have spread to other parts of the body (metastatic) Waldenström’s macroglobulinemia/lymphoplasmacytic lymphoma, as a single agent for salvage therapy for disease that does not respond to primary therapy or for progressive or relapsed disease Renal angiomyolipoma and tuberous sclerosis complex (TSC) not requiring immediate surgery Advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+BC) in combination with exemestane (Aromasin) after failure of treatment with letrozole (Femara) or anastrozole (Arimidex) Documented diagnosis of one of the following: Breast cancer AND post-menopausal OR Infertility * *(Note: Coverage is limited to plans with infertility coverage; please check benefit plan descriptions) Documented diagnosis of one of the following: Breast cancer AND post-menopausal OR Infertility * *(Note: Coverage is limited to plans with infertility coverage; please check benefit plan descriptions) 1. Patients diagnosed with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase, accelerated phase, or blast phase; AND 2. Patients who are intolerant or resistant to prior imatinib (Gleevec®) therapy. 1 year female For Breast Cancer: One year For Infertility: 3 months CAPRELSA-PRE Medullary thyroid carcinoma A documented diagnosis of one of the following: Symptomatic or progressive medullary thyroid cancer in patients with unresectable (i.e. cannot be treated with surgery), locally advanced, or metastatic disease FIRMAGON FIRMAGON-PRE Prostate cancer ERIVEDGE ERIVEDGE-PRE Basal cell carcinoma of skin A documented diagnosis of advanced prostate cancer in male members A documented diagnosis of one of the following: Locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation Metastatic basal cell carcinoma GILOTRIF GILOTRIF-PRE Non-small cell lung cancer GLEEVEC GLEEVEC-PRE Chronic Myelogenous Leukemia (CML) Philadelphia chromosome positive chronic myeloid leukemia HERCEPTIN HERCEPTIN-PRE Breast cancer Gastric cancer A documented diagnosis of metastatic, non-small cell lung cancer (NSCLC) in patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDAapproved test Gleevec A documented diagnosis of one of the following: Chronic Myelogenous Leukemia (CML) documented as any one of the following: Newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase Primary therapy for newly diagnosed CML confirmed by Ph+ or BCR-ABL+gene Pediatric patients with Ph+ CML in chronic phase who are newly diagnosed or whose disease has recurred after stem cell transplant or who are resistant to interferonalpha therapy Philadelphia chromosome positive (Ph+ CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy Follow-up therapy for CML patients with molecular or cytogenetic relapse, or patients not in cytogenetic remission, after hematopoietic stem cell transplant (HSCT) Patient is stable on the medication Acute lymphoblastic leukemia (Ph+ ALL) documented as any one of the following: Newly diagnosed Ph+ ALL in combination with chemotherapy Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ Aetna considers trastuzumab (Herceptin, Genentech, Inc.) medically necessary for use in members with breast cancer, advanced esophageal adenocarcinomas, gastric adenocarcinomas, gastroesophageal junction adenocarcinomas, or non-small cell lung adenocarcinomas that over-express the HER2 (human epidermal growth factor receptor 2) protein (i.e., level 3+ on an immunohistochemical assay) or where HER2 gene amplification is detected using FIS, a HER2 gene/chromosome 17 ratio greater than 2, or HER2 gene copy number greater than 6 signals/nucleus. FEMARA- A documented trial of one PRE month of a preferred generic alternative For Breast Cancer: One year For Infertility: 3 months 1 YEAR 30 day supply (Up to 84 tablets) 1 year All strengths = 30 day supply All strengths = 30 day supply A documented diagnosis of progressive, metastatic medullary thyroid cancer CAPRELSA All strengths = 30 day supply 1 year 1 year 1 year All strengths = 30 day supply 1 year All strengths = 30 day supply 1 year All strengths = 30 day supply 6 months 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria TASIGNA TASIGNA-PRE Accelerated phase chronic myeloid leukemia Chronic phase chronic myeloid leukemia o A documented diagnosis of one of the following: Newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia (Ph+CML) in chronic phase AND resistance or intolerance to imatinib (Gleevec) Chronic phase (CP) or accelerated phase (AP) Philadelphia chromosome positive chronic myelogenous leukemia (Ph+CML) AND resistance or intolerance to imatinib (Gleevec) Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in patients who achieve complete response to induction chemotherapy following HSCT AND resistance or intolerance to imatinib (Gleevec) Relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in patients with F317L/V/I/C, T315A. or V299L mutations AND resistance or intolerance to imatinib (Gleevec) Gastrointestinal Stromal Tumor (GIST), for treatment of progressive disease after failure of imatinib (Gleevec) 1 year All strengths = 30 day supply ICLUSIG ICLUSIG-PRE Chronic myeloid leukemia Philadelphia chromosome-positive acute lymphoblastic leukemia A documented diagnosis of one of the following: Chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) AND Documented confirmation of the presence of the T315i mutation OR No other tyrosine kinase inhibitor (TKI) therapy is indicated (i.e., imatinib (Gleevec), nilotinib (Tasigna)) 1 year All strengths = 30 day supply 1 year All strengths = 30 day supply All strengths = 30 day supply All strengths = 30 day supply Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) AND Documented confirmation of the presence of the T315i mutation OR No other tyrosine kinase inhibitor (TKI) therapy is indicated (i.e., imatinib (Gleevec), dasatinib (Sprycel)) AND Patient will be monitored for evidence of thromboembolism and vascular occlusion Patient will be monitored for evidence of heart failure Patient will be monitored for hepatic function A documented diagnosis of one of the following: Mantle cell lymphoma (MCL) in patients who have received at least one prior therapy Chronic lymphocytic leukemia (CLL) in patients who have received at least one prior therapy Chronic lymphocytic leukemia (CLL) in patients with a 17p deletion Waldenström’s macroglobulinemia, for disease that does not respond to primary therapy or for progressive or relapsed disease IMBRUVICA IMBRUVICA-PRE Chronic lymphoid leukemia Mantle cell lymphoma INLYTA INLYTA-PRE Renal cell carcinoma A documented diagnosis of advanced renal cell carcinoma AND a documented resistance or intolerance to prior therapy with sunitinib (Sutent) or pazopanib (Votrient) 1 year JAKAFI JAKAFI-PRE Myelofibrosis 6 months JEVTANA JEVTANA-PRE Hormone refractory prostate cancer A documented diagnosis of myelofibrosis that can include any of the following: either primary myelofibrosis, or postpolycythemia vera myelofibrosis or post-essential thrombocythemiayelofibrosis OR A. Diagnosis of polycythemia vera, AND B. Failure of or intolerance to hydroxyurea A. Documented diagnosis of hormone refractory metastatic prostate cancer AND documented failure with docetaxel containing regimens KADCYLA KADCYLA-PRE Metastatic breast cancer MEKINIST MEKINIST-PRE Malignant melanoma 1 year AND B. Concomitant use of prednisone Aetna considers ado-trastuzumab emtansine (Kadcyla) medically necessary for the treatment of members with HER2-positive recurrent or metastatic breast cancer who were previously treated with trastuzumab. A documented diagnosis of one of the following: As a single agent in unresectable or metastatic melanoma in adult patients with BRAF V600E or V600K mutations as detected by an FDA approved test AND Member has not received prior BRAF inhibitor therapy (i.e., vemurafenib (Zelboraf), dabrafenib (Tafinlar)) 6 months 1 year All strengths = 30 day supply In combination with dabrafenib (Tafinlar) in unresectable or metastatic melanoma in adult patients with BRAF V600E or V600K mutations as detected by an FDA approved test NEXAVAR NEXAVAR-PRE Liver carcinoma Malignant tumor of thyroid gland Renal cell carcinoma A documented diagnosis of one of the following: Unresectable (i.e. cannot be treated with surgery), hepatocellular carcinoma (HCC) Advanced renal cell carcinoma (RCC) AND a documented resistance or intolerance to prior therapy with sunitinib (Sutent) or pazopanib (Votrient) Progressive or symptomatic metastatic thyroid carcinoma in patients with nonradioiodineresponsive tumors at sites other than central nervous system, with any of the following histologic types: follicular, Hürthle cell, or papillary Disseminated symptomatic medullary thyroid carcinoma Progressive gastrointestinal stromal tumor (GIST) when patient is no longer receiving benefit from imatinib or sunitinib Angiosarcoma as a single agent, in the following soft tissue OR sarcoma (STS) subtypes: STS of extremity, retroperitoneal/intra-abdominal STS Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment 1 year All strengths = 30 day supply OFORTA OFORTA-PRE B-cell chronic lymphocytic leukemia 1 year All strengths = 30 day supply PERJETA PERJETA-PRE Breast cancer A documented diagnosis of B-cell chronic lymphocytic leukemia (CLL) whose disease has not responded to or has progressed during or after treatment with at least one standard alkylating agent-containing regimen Aetna considers pertuzumab (Perjeta) medically necessary when used in combination with trastuzumab for recurrent or metastatic HER2-positive breast cancer and for neoadjuvant treatment of HER2-positive breast cancer. POMALYST POMALYST-PRE Multiple myeloma 6 months Because of the embryofetal risk, POMALYST is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called “POMALYST REMS.” Prescribers and pharmacists must be certified with the program; patients must sign an agreement form and comply with the requirements PURIXAN PURIXAN-PRE Acute lymphoid leukemia A documented diagnosis of multiple myeloma and documentation of ALL of the following: - Two prior therapies that include lenalidomide (Revlimid) and bortezomib (Velcade) before initiating therapy with Pomalyst - Disease progression on or within 60 days of completion of the last therapy - If Female-of reproductive potential, documentation of all of the following: --Two negative pregnancy tests obtained prior to initiating therapy with Pomalyst -- Monthly negative pregnancy tests during therapy -- Patient has been counseled about the use of reliable contraception and must use 2 forms of contraception before, during, and 1 month after initiation of therapy with Pomalyst - Patient assessment to determine if prophylactic aspirin or anti-thrombotic treatment (warfarin, clopidogrel) will need to be taken to reduce the risk of VTE (embolism, stroke). - Confirmation of enrollment in the restricted distribution program called POMALYST REMS (refer to special notes below) A documented diagnosis acute lymphoblastic leukemia 1 year For coverage of additional quantities, a member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit. Additional quantities will be considered medically necessary for those members who meet the following criteria: Documentation that the (ALL) AND A documented contraindication, intolerance, allergy, or failure of an adequate trial of one month of the preferred generic alternative, mercaptopurine 6 months All strengths = 30 day supply PURIXAN- A documented trial of one All PRE month of the preferred generic strengths alternative, mercaptopurine = 30 day supply 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria REVLIMID REVLIMID-PRE Mantle cell lymphoma Multiple myeloma Myelodysplastic syndrome RITUXAN RITUXAN-PRE Lymphoid leukemia Microscopic polyarteritis nodosa Non-Hodgkin's lymphoma Corticosteroid-refractory autoimmune blistering diseases Wegener's granulomatosis SPRYCEL SPRYCEL-PRE Acute lymphoid leukemia Accelerated phase chronic myeloid leukemia Blastic phase chronic myeloid leukemia Chronic phase chronic myeloid leukemia STIVARGA STIVARGA-PRE Metastatic colorectal cancer Gastrointestinal stromal tumor SUTENT SUTENT-PRE SYLATRON A documented diagnosis of one of the following: Myelodysplastic syndrome (MDS) documented as any one of the following: Transfusion-dependent anemia due to Low- or Intermediate (INT)-1-risk myelodysplastic syndrome (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities Low or INT-1 risk MDS with deletion 5q cytogenetic abnormality with symptomatic anemia and clinically significant cytopenias Low or INT-1 risk MDS without deletion 5q cytogenetic abnormality with symptomatic anemia and serum erythropoietin levels > 500 mU/mL and a low probability of response to immunosuppressive therapy Low or INT-1 risk MDS without deletion 5q cytogenetic abnormality with symptomatic anemia and no response to initial treatment with epoetin alfa or darbepoetin alfa Multiple myeloma documented as any one of the following: Will be taken in combination with dexamethasone in patients who have received at least one prior therapy Multiple myeloma (including symptomatic smoldering myeloma and progressive solitary plasmacytoma) in combination with dexamethasone as primary therapy Will be taken as monotherapy for disease relapse or for progressive or refractory disease A documented Diagnosis of one of the following: - Acute lymphoid leukemia (induction/consolidation therapy for Philadelphia chromosone-negative ALL for patients aged greater than or equal to 40 years) - Anti-neutrophil cytoplasmic antibody-associated (ANCAassociated) vasculitides (Wegener granulomatosis, ChurgStrauss syndrome, microscopic polyangiitis, and pauciimmune glomerulonephritis) in persons with an inadequate response to cyclophosphamide - Antibody mediated rejection in heart transplant recipients, prevention of recurrence - CD20-positive chronic lymphocytic leukemia - Chronic graft versus host disease (last resort treatment) - Corticosteroid-refractory autoimmune blistering diseases (pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, cicatricial pemphigoid, epidermolysis bullosa acquisita and paraneoplastic pemphigus) - Cryoglobulinemia refractory to corticosteroids and other immunosuppressive agents - Multi-centric Castleman's disease (angiofollicular lymph node hyperplasia) - Non-Hodgkin's lymphoma - Opsoclonus-myoclonus-ataxia associated with neuroblastoma, that is refractory to steroids, chemotherapy and intravenous immunoglobulins - Post-transplant lymphoproliferative disorder • A documented diagnosis of one of the following: - Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia AND resistance or intolerance to prior therapy with imatinib (Gleevec) - Chronic, accelerated, or myeloid or lymphoid blast phase Philadelphia chromosome-positive chronic myeloid leukemia (CML) AND resistance or intolerance to prior therapy with imatinib (Gleevec) - Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) AND resistance or intolerance to prior therapy with imatinib mesylate (Gleevec) 1 year 6 months 1 year All strengths = 30 day supply A documented diagnosis of one of the following: o Metastatic colorectal cancer AND documentation of prior therapy with ALL of the following: - (fluoropyrimidine-, oxaliplatin-, and irinotecan)-based chemotherapy (i.e. FOLFIRI/FOLFOX/CapOx, others) - bevacizumab (Avastin) - panitumumab (Vectibix) OR cetuximab (Erbitux) ( FOR KRAS mutation-negative patients only) • Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) AND documentation of prior therapy with imatinib mesylate (Gleevec) AND sunitinib (Sutent) 6 months All strengths = 30 day supply Advanced Renal Cell Carcinoma Gastrointestinal Stromal Tumor • A documented diagnosis of one of the following: o Advanced Renal Cell Carcinoma o Gastrointestinal Stromal Tumor (GIST) AND a documented disease progression while on therapy with imatinib mesylate/Gleevec OR documented intolerance to imatinib mesylate /Gleevec o Progressive neuroendocrine tumors located in the pancreas (pNET) that cannot be removed by surgery or that have spread to other parts of the body (metastatic) 1 year All strengths = 30 day supply SYLATRON-PRE Malignant melanoma A documented diagnosis of melanoma with microscopic or gross nodal involvement within 84 days of surgery including complete lymphadenectomy 1 year TARCEVA TARCEVA-PRE Carcinoma of pancreas ◾Non-small cell lung cancer 1 year TAFINLAR TAFINLAR-PRE Malignant melanoma TEMODAR TEMODAR-PRE Anaplastic astrocytoma of brain Glioblastoma multiforme of brain A documented diagnosis of one of the following: Non-small cell lung cancer (NSCLC) AND any one of the following: Locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen Locally advanced or metastatic non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first line chemotherapy Non-small cell lung cancer in members with known active EGFR mutation or gene amplification Advanced, unresectable, or metastatic pancreatic cancer in combination with gemcitabine A documented diagnosis of one of the following: As a single agent in unresectable or metastatic melanoma in adult patients with BRAF V600E mutation as detected by an FDA approved test In combination with trametinib (Mekinist) in unresectable or metastatic melanoma in adult patients with BRAF V600E or BRAF V600K mutations as detected by an FDA approved test AND o Documentation that Tafinlar will not be used in patients with wild-type BRAF melanoma due to the potential risk of tumor promotion in these patients A documented diagnosis of one of the following: Newly diagnosed glioblastoma multiforme (GBM), taken concomitantly with radiotherapy and then as maintenance treatment Refractory anaplastic astrocytoma (i.e. patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine) Ewing's Sarcoma Family of Tumors – for progressive, relapsed ormetastatic disease Adult Low-Grade Infiltrative Supratentorial Astrocytoma/Oligodendroglioma (excluding pilocytic astrocytoma) –adjuvant chemotherapy, or for recurrent or progressive disease Adult Medulloblastoma and Supratentorial Primitive Neuroectodermal Tumors (PNET) – progression or recurrence (salvage therapy) Anaplastic Gliomas – adjuvant treatment, and treatment of recurrent disease or salvage therapy Glioblastoma – treatment following resection, or for recurrent disease or salvage therapy Central Nervous System Cancers - Limited (1-3) Metastatic Lesions – for brain metastases in disseminated or recurrent disease Central Nervous System Cancers - Multiple (>3) Metastatic Lesions – for brain metastases in recurrent stable systemic disease All strengths = 30 day supply All strengths = 30 day supply 1 year 1 year All strengths = 30 day supply For coverage of additional quantities, a member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit. Additional quantities will be considered medically necessary for those members who meet the following criteria: Member is being treated in the concomitant phase for newly diagnosed glioblastoma multiforme (in combination with radiotherapy) for 42 days (with a maximum of 49 days) All strengths = 30 day supply 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria TYKERB TYKERB-PRE Breast cancer A documented diagnosis of one of the following: Breast cancer, Advanced or metastatic, HER2 overexpression in combination with capecitabine after prior therapies Breast cancer -Inflammatory, relapsed or refractory Metastatic breast cancer, HER2 overexpression, firstline Metastatic breast cancer, HER2 overexpression, refractory, monotherapy Breast cancer, Advanced, hormone positive and HER2positive in combination with letrozole (Femara) Breast cancer in combination with trastuzumab (without cytotoxic therapy) or capecitabine for trastuzumabexposed HER2 positive recurrent metastatic disease Hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor in postmenopausal women for whom hormonal therapy is indicated Breast cancer in combination with aromatase inhibitor for the treatment if recurrent or stage IV estrogen receptorpositive, HER2-positive disease in postmenopausal women who have received no prior endocrine therapy within one year VALCHLOR VALCHLOR-PRE Stage IA and IB mycosis fungiodes-type cutaneous Tcell lymphoma VOTRIENT VOTRIENT-PRE Renal cell carcinoma Soft tissue sarcoma A documented diagnosis of stage IA and IB mycosis fungiodes-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy A documented diagnosis of one of the following: o Advanced renal cell carcinoma with clear cell hisotology o Advanced soft tissue sarcoma after failure of one prior chemotherapy regimen o Clinically progressive or symptomatic metastatic thyroid carcinoma - follicular carcinoma, Hürthle cell carcinoma, or papillary carcinoma in patients with nonradioiodineresponsive tumors at sites other than central nervous system o Medically inoperable uterine sarcoma limited to the uterus XALKORI XALKORI-PRE Non-small cell lung cancer XELODA XELODA-PRE Colon cancer Metastatic breast cancer Metastatic colorectal cancer XTANDI XTANDI-PRE Metastatic prostate cancer YERVOY YERVOY-PRE Malignant melanoma ZELBORAF ZELBORAF-PRE Malignant melanoma ZOLINZA ZOLINZA-PRE ZYTIGA 1 year All strengths = 30 day supply 1 year 1 year All strengths = 30 day supply A documented diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as detected by an FDA approved test o A documented diagnosis of one of the following: Breast cancer • HER (-) Recurrent, metastatic alone or in combination with docetaxel • HER (+) Recurrent, metastatic in combination with trastuzumab or lapatinib CNS lesions (1-3 and > 3), alone or in combination with lapatinib Colon cancer • Adjuvant chemotherapy in advanced or metastatic disease, alone or in combination with oxaliplatin • Neoadjuvant or adjuvant chemotherapy in advanced or metastatic disease, in combination with oxaliplatin • Neoadjuvant chemotherapy in advanced or metastatic disease, in combination with oxaliplatin and bevacizumab • Advanced or metastatic disease, in combination with bevacizumab Esophageal cancer, locally advanced or metastatic disease alone or in combination with other chemotherapeutic agents Gastric cancer, alone or in combination with other chemotherapeutic agents Head and neck cancer, advanced, recurrent, or persistent disease Intrahepatic or extrahepatic cholangiocarcinoma, resectable, unresectable, or metastatic disease, alone or • A documented diagnosis of metastatic castrationresistant prostate cancer in patients who have previously received docetaxel AND • A documented resistance or intolerance to prior therapy with (abiraterone) Zytiga OR o A medical contraindication to corticosteroids 1 year All strengths = 30 day supply A documented trial of one All month of the preferred generic strengths equivalent alternative, = 30 day capecitabine supply A documented diagnosis of the treatment of the following malignant melanomas: o Unresectable stage III in-transit metastases o Local, satellitosis, and/or in-transit unresectable recurrence o Incompletely resected nodal recurrence o Limited recurrence or metastatic disease o Disseminated recurrence or metastatic disease in persons with good performance status (Eastern Cooperative Oncology Group [ECOG] performance status 0 to 2) o Disseminated recurrence with brain metastases in persons with good performance status (ECOG performance status 0 to 2) o Reinduction in persons who experienced no significant systemic toxicity during prior medically necessary ipilimumab therapy and who relapse after initial clinical response or progress after stable disease greater than three months. A documented diagnosis of unresectable or metastatic melanoma with BRAFV600E mutation as detected by an FDA approved test. One year (4 times within one year) Primary cutaneous T-cell lymphoma A documented diagnosis of one of the following: Cutaneous manifestations in patients with T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies (e.g. oral tretinoin AND oral bexarotene (Targretin) Primary systemic biologic therapy for mycosis fungoides (MF)/Sezary syndrome documented as any one of the following: Early–stage MF (stage IA, IB-IIA) with blood involvement or with folliculotropic/large cell transformation Advanced-stage MF (stage IIB, stage III) or Sezary syndrome Adjuvant systemic biologic therapy for MF/Sezary syndrome After total skin electron beam therapy in patients with stage IIB MF After chemotherapy in patients with stage IV disease Systemic biologic therapy for refractory or progressive early-stage or stage IIB disease with patch/plaque lesions 1 year ZYTIGA-PRE Metastatic prostate cancer A documented diagnosis of late-stage (metastatic) castration-resistant prostate cancer and documentation of ALL of the following: Will be taking Zytiga in combination with prednisone Will NOT be used in combination with Xtandi 1 year All strengths = 30 day supply ZYKADIA ZYKADIA-PRE metastatic non-small cell lung cancer A documented diagnosis of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) AND Documented disease progressed on, or intolerance to, crizotinib (Xalkori) 1 year All strengths = 30 day supply EVZIO EVZIO-PRE Overdose of opiate 6 months RELISTOR RELISTOR-PRE Opioid-induced constipation Aetna considers Evzio medically necessary for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/ or central nervous system depression A documented diagnosis of opioid-induced constipation, AND A documented diagnosis of an advanced illness (i.e., incurable cancer, end-stage COPD/emphysema, cardiovascular disease/heart failure, Alzheimer's disease/dementia, HIV/AIDS), AND Member is receiving palliative care, AND Concomitant use of opioid therapy (i.e., codeine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, oxycodone, oxymorphone, propoxyphene or tramadol), AND Trial and failure of two (2) laxatives (i.e., docusate sodium, Miralax, bisacodyl, lactulose, senna) CYSTARAN CYSTARAN -PRE ◾Cystinosis A document diagnosis of treatment of corneal cystine crystal accumulation in patients with cystinosis 1 year XELODAPRE 1 year XTANDIPRE 1 year 1 year 1 year A documented diagnosis of metastatic castration-resistant prostate cancer in patients who have previously received docetaxel AND A documented resistance or intolerance to prior therapy with (abiraterone) Zytiga OR A medical contraindication to corticosteroids All strengths = 30 day supply All strengths = 30 day supply All strengths = 30 day supply For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. Additional quantities of Relistor will be considered medically necessary for those members who meet ANY of the following criteria: Member requires dosing of one vial/syringe every other day (maximum quantity of 15 vials or 2 kits per 30 days). Inj = 10 syringes per month Kit = 1 kit (7 syringes) per month 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria EUFLEXXA GEL-ONE HYALGAN MONOVISC ORTHOVISC SUPARTZ SYNVISC SYNVISC ONE Osteoarthritis-PRE AREDIA pamidronate Osteoarthritis Bone metastasis Hypercalcemia of malignancy Paget's disease BONIVA (inj only) ibandronate (inj only) BONIVA-PRE Postmenopausal osteoporosis FORTEO FORTEO-PRE Osteoporosis Postmenopausal osteoporosis MIACALCIN (inj only) MIACALCIN -PRE Hypercalcemia Paget's disease Postmenopausal osteoporosis PROLIA PROLIA-PRE Bone metastasis Osteoporosis Postmenopausal osteoporosis For Members Starting Therapy: o A documented diagnosis of symptomatic osteoarthritis of the knee and member meets ALL of the following: o Conservative therapy (including physical therapy, pharmacotherapy (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen (up to 1 g 4 times/day) and/or topical capsaicin cream) has been attempted in each joint to be treated with viscosupplements and has not resulted in functional improvement after at least 3 months or the member is unable to tolerate conservative therapy because of adverse side effects; AND o The clinical diagnosis is supported by radiologic evidence of osteoarthritis of the knee such as joint space narrowing, subchondral sclerosis, osteophytes and subchondral cysts, or, if radiographs are not available, the member has documented symptomatic osteoarthritis of the knee according to American College of Rheumatology (ACR) clinical and laboratory criteria, which requires knee pain and at least 5 of the following: Bony enlargement Bony tenderness Crepitus (noisy, grating sound) on active motion Erythrocyte sedimentation rate (ESR) less than 40 mm/hr Less than 30 minutes of morning stiffness No palpable warmth of synovium A documented diagnosis of one of the following: Chronic nonbacterial osteomyelitis Hypercalcemia of malignancy Low bone mass or osteoporotic fractures following organ transplantation Osteolytic bone metastases or bone pain from cancer Refractory immobilization hypercalcemia Osteogenesis imperfecta, severe cases presenting with bone pain and repeated fractures Paget's disease (osteitis deformans), symptomatic and characterized by abnormal and accelerated bone metabolism in one or more bones, where oral bisphosphonates have been ineffective. (Signs and symptoms may include bone pain, deformity, and/or fractures; increased concentrations of serum alkaline phosphatase and/or urinary hydroxyproline; neurologic disorders associated with skull lesions and spinal deformities; and elevated cardiac output and other vascular disorders associated with increased vascularity of bones) Osteopenia in quadriplegic cerebral palsy Complex regional pain syndrome refractory to other treatments A documented diagnosis of one of the following: Treatment of bone metastases or bone pain presumed due to bone metastases from breast cancer Treatment of hypercalcemia of malignancy Treatment of osteoporosis in post-menopausal women who are unable to tolerate either 2 oral bisphosphonates (e.g., alendronate (Fosamax), risedronate (Actonel)) or 1 oral bisphosphonate plus 1 selective estrogen receptor modulator (SERM) (e.g., raloxifene (Evista)), or for whom oral bisphosphonate therapy is contraindicated (e.g., due to inability to swallow, or inability to remain in an upright position after oral bisphosphonate administration for the required length of time) Three months Aetna considers daily injection of teriparatide (Forteo) medically necessary for women with post-menopausal osteoporosis^ AND documentation of the following: o High risk for fractures (e.g., those who have had an osteoporotic fracture, or have certain risk factors for fracture***) AND o Failed* or unable to tolerate two oral bisphosphonates (e.g., alendronate (Fosamax), risedronate (Actonel)), or one oral bisphosphonate plus one selective estrogen receptor modulator (SERM) (e.g., raloxifene (Evista) OR o Oral bisphosphonate therapy is contraindicated (e.g., due to inability to swallow, or inability to remain in an upright position after oral bisphosphonate administration for the required length of time). Aetna considers daily injection of teriparatide (Forteo) medically necessary for the treatment of men with primary or hypogonadal osteoporosis^ AND documentation of the following: o High risk for fractures (e.g., those who have had an osteoporotic fracture, or have certain risk factors for fracture***), AND o Failed* or are unable to tolerate two oral bisphosphonates (e.g., alendronate [Fosamax], risedronate [Actonel]), OR o Oral bisphosphonate therapy is contraindicated (e.g., documented diagnosis of one of the following: Hypercalcemia Individuals who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms suggesting an acute injury (0 to 5 days after identifiable event or onset of symptoms) and who are neurologically intact. (Note: Calcitonin treatment is considered medically necessary for 4 weeks for this indication). Paget’s disease of bone (osteitis deformans) Treatment of Osteoporosis in postmenopausal women AND documentation of any of the following: Unable to tolerate two oral bisphosphonates (e.g., alendronate (Fosamax), risedronate (Actonel), or one oral bisphosphonate plus one selective estrogen receptor modulator (SERM) (e.g., raloxifene (Evista) Oral bisphosphonate therapy is contraindicated (e.g., due to inability to swallow, or inability to remain in an upright position after oral bisphosphonate administration for the required length of time). 1 year A documented diagnosis of one of the following: Treatment of women with post-menopausal osteoporosis who are at high-risk for fractures (e.g., those who have had an osteoporotic fracture, or have multiple risk factors for fracture (including parental history of hip fracture and alcohol intake of 4 or more units per day), and AND documentation of any of the following: Unable to tolerate two oral bisphosphonates (e.g., alendronate (Fosamax), risedronate (Actonel)), or one oral bisphosphonate plus one selective estrogen receptor modulator (SERM) (e.g., raloxifene (Evista) Oral bisphosphonate therapy is contraindicated (e.g., due to inability to swallow, or inability to remain in an upright position after oral bisphosphonate administration for the required length of time). Prevention of osteoporosis in persons receiving aromatase inhibitors (e.g., anastrozole (Arimidex), letrozole (Femara), exemestane (Aromasin) AND documentation of any of the following: Unable to tolerate two oral bisphosphonates (e.g., alendronate (Fosamax), 1 year 1 year 1 year 1 year Notes: Since the effects of long-term treatment with Forteo are not known at this time, therapy for more than 2 years duration is considered experimental and investigational. 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria RECLAST RECLAST-PRE Bone metastasis Hypercalcemia of malignancy Osteoporosis Paget's disease Postmenopausal osteoporosis XGEVA XGEVA-PRE Prevention of skeletal-related events in patients with bone metastases from solid tumors Giant cell tumor of the bone ZOMETA ZOMETA-PRE Bone metastasis Hypercalcemia of malignancy Osteoporosis Paget's disease Postmenopausal osteoporosis zoledronic acid ABSTRAL ZOMETA-PRE PAIN-PRE Bone metastasis Hypercalcemia of malignancy Osteoporosis Paget's disease Postmenopausal osteoporosis Breakthrough cancer pain General anesthesia A documented diagnosis of one of the following: Bone metastases or bone pain presumed due to bone metastases from breast cancer, lung cancer, neuroendocrine tumors, prostate cancer*, thyroid cancer, and other solid tumor types; Hypercalcemia of malignancy; Multiple myeloma, including smoldering multiple myeloma and solitary plasmacytomas; Osteogenesis imperfecta in persons who have failed or are intolerant of pamidronate; Paget disease of bone; Prevention of osteoporosis in post-menopausal women with osteopenia AND documentation of any of the following: Unable to tolerate two oral bisphosphonates (e.g., alendronate (Fosamax), risedronate (Actonel)), or one oral bisphosphonate plus one selective estrogen receptor modulator (SERM) (e.g., raloxifene (Evista) Oral bisphosphonate therapy is contraindicated (e.g., due to inability to swallow, or inability to remain in an upright position after oral bisphosphonate administration for the required length of time). Prevention of osteoporosis in persons receiving aromatase inhibitors (e.g., anastrozole (Arimidex), letrozole (Femara), exemestane (Aromasin) AND documentation of any of the following: Unable to tolerate A documented diagnosis of one of the following: Prevention of skeletal-related events in patients with bone metastases from solid tumors (e.g., breast cancer, kidney cancer, ovarian cancer, thyroid cancer, non-small cell lung cancer, and prostate cancer; not an all inclusive list) Giant cell tumor of the bone A documented diagnosis of one of the following: Bone metastases or bone pain presumed due to bone metastases from breast cancer, lung cancer, neuroendocrine tumors, prostate cancer*, thyroid cancer, and other solid tumor types; Hypercalcemia of malignancy; Multiple myeloma, including smoldering multiple myeloma and solitary plasmacytomas; Osteogenesis imperfecta in persons who have failed or are intolerant of pamidronate; Paget disease of bone; Prevention of osteoporosis in post-menopausal women with osteopenia AND documentation of any of the following: Unable to tolerate two oral bisphosphonates (e.g., alendronate (Fosamax), risedronate (Actonel)), or one oral bisphosphonate plus one selective estrogen receptor modulator (SERM) (e.g., raloxifene (Evista) Oral bisphosphonate therapy is contraindicated (e.g., due to inability to swallow, or inability to remain in an upright position after oral bisphosphonate administration for the required length of time). Prevention of osteoporosis in persons receiving aromatase inhibitors (e.g., anastrozole (Arimidex), letrozole (Femara), exemestane (Aromasin) AND documentation of any of the following: Unable to tolerate A documented diagnosis of one of the following: Bone metastases or bone pain presumed due to bone metastases from breast cancer, lung cancer, neuroendocrine tumors, prostate cancer*, thyroid cancer, and other solid tumor types; Hypercalcemia of malignancy; Multiple myeloma, including smoldering multiple myeloma and solitary plasmacytomas; Osteogenesis imperfecta in persons who have failed or are intolerant of pamidronate; Paget disease of bone; Prevention of osteoporosis in post-menopausal women with osteopenia AND documentation of any of the following: Unable to tolerate two oral bisphosphonates (e.g., alendronate (Fosamax), risedronate (Actonel)), or one oral bisphosphonate plus one selective estrogen receptor modulator (SERM) (e.g., raloxifene (Evista) Oral bisphosphonate therapy is contraindicated (e.g., due to inability to swallow, or inability to remain in an upright position after oral bisphosphonate administration for the required length of time). Prevention of osteoporosis in persons receiving aromatase inhibitors (e.g., anastrozole (Arimidex), letrozole (Femara), exemestane (Aromasin) AND documentation of any of the following: Unable to tolerate A documented diagnosis of cancer AND concomitant use of long acting opioid therapy** OR Member's resident state or contract state is California and the member is terminally ill 1 year PAIN-PRE Breakthrough cancer pain General anesthesia A documented diagnosis of cancer AND concomitant use of long acting opioid therapy* OR Member's resident state or contract state is California and the member is terminally ill RECLASTPRE A documented trial of one dose of the preferred generic equivalent alternative, zoledronic acid 5mg = 1 bottle/ 1 year Note: Consistent with Zometa’s Food and Drug Administration (FDA)approved labeling, zoledronic acid is considered medically necessary for bone metastases from prostate cancer if cancer has progressed after treatment with at least 1 hormonal therapy. ZOMETA- A documented trial of one PRE dose of the preferred generic equivalent alternative, zoledronic acid 4mg = 1 bottle/ 3 weeks 1 year 1 year 1 year 1 year AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one week each of the preferred generic alternative, fentanyl transmucosal lozenge AND two other short acting opioids (i.e., morphine, hydrocodone, oxycodone, hydromorphone) FENTORA Note: Consistent with Zometa’s Food and Drug Administration (FDA)approved labeling, zoledronic acid is considered medically necessary for bone metastases from prostate cancer if cancer has progressed after treatment with at least 1 hormonal therapy. 1 year 5mg = 1 bottle/ 1 year or 4mg = 1 bottle/ 3 weeks A Documented diagnosis of cancer and prescription is written by an oncologist or pain specialist OR Member is enrolled in a hospice program or meets hospice criteria OR Member's resident state or contract state is California and the member is terminally ill OR Patient has signed opioid agreement in support of clinical guidelines by the American Pain Society and the American Academy of Pain Medicine (Note: ALL additional quantities above what is allowed in the chart above require that a Patient have a signed opioid agreement in support of clinical guidelines by the American Pain Society and the American Academy of Pain A Documented diagnosis of cancer and prescription is written by an oncologist or pain specialist OR Member is enrolled in a hospice program or meets hospice criteria OR Member's resident state or contract state is California and the member is terminally ill OR Patient has signed opioid agreement in support of clinical guidelines by the American Pain Society and the American Academy of Pain Medicine (Note: ALL additional quantities above what is allowed in the chart above require that a Patient have a signed opioid agreement in support of clinical guidelines by the American Pain Society and the American Academy of Pain ABSTRAL- A documented trial of one PRE week each of the preferred generic alternative, fentanyl transmucosal lozenge AND two other short acting opioids (i.e., morphine, hydrocodone, oxycodone, hydromorphone)e 15 tablets/30 day supply ABSTRAL- A documented trial of one PRE week each of the preferred generic alternative, fentanyl transmucosal lozenge AND two other short acting opioids (i.e., morphine, hydrocodone, oxycodone, hydromorphone)e 15 lollipops/3 0 day supply 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria CELEBREX fentanyl lozenge CELEBREX-PRE PAIN-PRE Breakthrough cancer pain General anesthesia Breakthrough cancer pain General anesthesia Should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs and aspirin have been reported in such patients. Should not be given to patients who have experienced allergic-type reactions to sulfonamides. Age greater than 60 OR Diagnosis of Juvenile Rheumatoid Arthritis [JRA] OR Concomitant use of warfarin (Coumadin®) or other anticoagulant/antiplatelet therapy OR Concomitant use of chronic oral (systemic) corticosteroid therapy (>60 days) OR Documented history of ulcer disease** or GI bleed; OR Documented use of an H2 receptor antagonist (cimetidine/Tagamet®, famotidine/Pepcid®, nizatidine/Axid®, ranitidine/ Zantac®) or a proton pump inhibitor (AcipHex®, Nexium®, omeprazole/Prilosec®, Prevacid®, Protonix®), or misoprostol (Cytotec®) due to one of the following: History of significant GI disease** OR NSAID GI adverse effects, necessitating discontinuation of NSAID therapy A documented diagnosis of cancer AND concomitant use of long acting opioid therapy** OR Member's resident state or contract state is California and the member is terminally ill 1 Year for chronic diagnosis 1 Month for acute pain 1 week LAZANDA LAZANDA-PRE Breakthrough cancer pain General anesthesia A documented diagnosis of cancer AND concomitant use of long acting opioid therapy* OR Member's resident state or contract state is California and the member is terminally ill 1 year ONSOLIS PAIN-PRE Breakthrough cancer pain General anesthesia A documented diagnosis of cancer AND concomitant use of long acting opioid therapy** OR Member's resident state or contract state is California and the member is terminally ill 1 year AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one week each of the preferred generic alternative, fentanyl transmucosal lozenge AND two other short acting opioids (i.e., morphine, hydrocodone, oxycodone, hydromorphone) SUBSYS -PRE Breakthrough cancer pain General anesthesia A documented diagnosis of cancer AND concomitant use of long acting opioid therapy* OR Member's resident state or contract state is California and the member is terminally ill ACTIQ PAIN-PRE Breakthrough cancer pain General anesthesia A documented diagnosis of cancer AND concomitant use of long acting opioid therapy** OR Member's resident state or contract state is California and the member is terminally ill AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one week each of the preferred generic alternative, fentanyl transmucosal lozenge AND two other short acting opioids (i.e., morphine, hydrocodone, oxycodone, hydromorphone) Documented diagnosis of rheumatoid arthritis (RA) or Juvenile Rheumatoid Arthritis [JRA] (approvable dose is 200 mg twice daily or 60 capsules (200mg) per 30 days) OR Failure of 200mg total daily dose (approvable dose is 200 mg twice daily or 60 capsules (200mg) per 30 days) OR, AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one week each of the preferred generic alternative, fentanyl transmucosal lozenge AND two other short acting opioids (i.e., morphine, hydrocodone, oxycodone, hydromorphone) SUBSYS SPRAY 50 mg and 100 mg = 60 capsules/ 30 day supply 200 mg = 30 capsules/ 30 day supply 400 mg = 60 capsules/ 30 day supply For Celebrex 100 mg and 200 mg 1 year Documented diagnosis of acute pain (approvable dose is 200 mg twice daily or 60 capsules (200 mg) per 30 days; 30diagnosis day limit) of A Documented cancer and prescription is written by an oncologist or pain specialist OR Member is enrolled in a hospice program or meets hospice criteria OR Member's resident state or contract state is California and the member is terminally ill OR Patient has signed opioid agreement in support of clinical guidelines by the American Pain Society and the American Academy of Pain Medicine (Note: ALL additional quantities above what is allowed in the chart above require that a Patient have a signed opioid agreement in support of clinical guidelines by the American Pain Society and the American Academy of Pain A Documented diagnosis of cancer and prescription is written by an oncologist or pain specialist OR Member is enrolled in a hospice program or meets hospice criteria OR Member's resident state or contract state is California and the member is terminally ill OR Patient has signed opioid agreement in support of clinical guidelines by the American Pain Society and the American Academy of Pain Medicine (Note: ALL additional quantities above what is allowed in the chart above require that a Patient have a signed opioid agreement in support of clinical guidelines by the American Pain Society and the American Academy of Pain A Documented diagnosis of cancer and prescription is written by an oncologist or pain specialist OR Member is enrolled in a hospice program or meets hospice criteria OR Member's resident state or contract state is California and the member is terminally ill OR Patient has signed opioid agreement in support of clinical guidelines by the American Pain Society and the American Academy of Pain Medicine (Note: ALL additional quantities above what is allowed in the chart above require that a Patient have a signed opioid agreement in support of clinical guidelines by the American Pain Society and the American Academy of Pain A Documented diagnosis of cancer and prescription is written by an oncologist or pain specialist OR Member is enrolled in a hospice program or meets hospice criteria OR Member's resident state or contract state is California and the member is terminally ill OR Patient has signed opioid agreement in support of clinical guidelines by the American Pain Society and the American Academy of Pain Medicine (Note: ALL additional quantities above what is allowed in the chart above require that a Patient have a signed opioid agreement in support of clinical guidelines by the American Pain Society and the American Academy of Pain A Documented diagnosis of cancer and prescription is written by an oncologist or pain specialist OR Member is enrolled in a hospice program or meets hospice criteria OR Member's resident state or contract state is California and the member is terminally ill OR Patient has signed opioid agreement in support of clinical guidelines by the American Pain Society and the American Academy of Pain Medicine (Note: ALL additional quantities above what is allowed in the chart above require that a Patient have a signed opioid agreement in support of clinical guidelines by the American Pain Society and the American Academy of Pain 15 buccal tablets/30 day supply LAZANDA- A documented trial of one PRE week of the preferred generic alternative, fentanyl transmucosal lozenge 4 bottles per 30 day supply ABSTRAL- A documented trial of one 15 tabs/30 PRE week each of the preferred day generic alternative, fentanyl supply transmucosal lozenge AND two other short acting opioids (i.e., morphine, hydrocodone, oxycodone, hydromorphone)e LAZANDA- A documented trial of one PRE week of the preferred generic alternative, fentanyl transmucosal lozenge 15 units/30 day supply ABSTRAL- A documented trial of one PRE week each of the preferred generic alternative, fentanyl transmucosal lozenge AND two other short acting opioids (i.e., morphine, hydrocodone, oxycodone, hydromorphone)e 15 lollipops/3 0 day supply 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria XARTEMIS XR XARTEMIS-PRE acute pain A documented diagnosis of acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate AND A documented contraindication or intolerance or allergy or failure of an adequate trial of two days each of two preferred generic short-acting opioid alternatives, i.e., morphine, hydrocodone, oxycodone, hydromorphone 1 year ZORVOLEX ZORVOLEX-PRE mild to moderate acute pain in adults A documented diagnosis of mild to moderate acute pain in adults, AND 1 year For coverage of additional XARTEMI S-PRE quantities, member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit. Additional quantities of the above medications will be considered medically necessary for those members who meet the following criterion: A Documented diagnosis of cancer and prescription is written by an oncologist or pain specialist OR Member is enrolled in a hospice program or meets hospice criteria OR Member's resident state or contract state is California and the member is terminally ill OR Patient has signed opioid agreement in support of ZORVOLE X-PRE A documented trial of two days 4 each of two preferred generic tablets/da short-acting opioid y alternatives, i.e., morphine, hydrocodone, oxycodone, hydromorphone A documented trial of two weeks of the preferred generic alternative, dicolfenac A documented contraindication or allergy or intolerance or failure of an adequate trial of two weeks of the preferred generic alternative, dicolfenac ZOHYDRO ER KADIAN-PRE moderate to severe pain when a continuous, around-theclock opioid analgesic is needed for an extended period of time A documented diagnosis of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time, AND A documented progression through the World Health Organization analgesic ladder*, AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month each of the following preferred generic alternatives: morphine sr cap 24hr (Kadian CR), AND morphine sr tab 12hr (MS Contin), AND oxymorphone er (Opana ER) 1 year SOLIRIS SOLIRIS-PRE Hemolytic uremic syndrome Paroxysmal nocturnal hemoglobinuria A documented diagnosis of paroxysmal nocturnal hemoglobinuria (PNH), with flow cytometric confirmation of at least 10% PNH type III red cells or greater than 50% of glycosylphosphatidylinositol-anchored proteins (GPI-AP)deficient polymorphonuclear cells (PMNs); ANDMember has been vaccinated against meningococcal infection (at least 2 weeks prior to eculizumab treatment, if not previously vaccinated); AND Member does not meet diagnostic criteria for severe aplastic anemia (see special notes); AND Member meets either of the following criteria: Member is transfusion-dependent (i.e., has at least 1 transfusion in the 24 months prior to initiation of eculizumab due to documented hemoglobin less than 7 g/dL in persons without anemic symptoms or less than 9 g/dL in persons with symptoms from anemia) and has platelet counts of at least 30,000/microliter prior to initiation of eculizumab treatment; or Member has a documented history of major adverse vascular events from thromboembolism (see special notes). 1 year LUMIZYME LUMIZYME-PRE A documented diagnosis of individuals aged 8 years and older with late-onset (non-infantile) Pompe disease who do not have evidence of cardiac hypertrophy MYOZYME MYOZYME-PRE NUEDEXTA NUEDEXTA-PRE A documented diagnosis of infantile-onset Pompe disease Pseudobulbar affect ADCIRCA PHA-PRE Pulmonary hypertensive arterial disease A documented diagnosis of the treatment of atypical hemolytic uremic syndrome without serious unresolved A Documented diagnosis of LA cancer and prescription is OPIOIDSwritten by an oncologist or PRE pain specialist OR Member is enrolled in a hospice program or meets hospice criteria OR Member's resident state or contract state is California and the member is terminally ill OR Patient has signed opioid agreement in support of clinical guidelines by the American Pain Society and the American Academy of Pain Medicine (Note: ALL additional quantities above what is allowed in the chart above require that a Patient have a signed opioid agreement in support of clinical guidelines by the American Pain Society and the American Academy of Pain 2 Trial of 1 month each of capsules/ morphine sulfate cr tablets (MS Contin) and oxymorphone day extended release (Opana ER) 1 year 1 year A documented diagnosis of pseudobulbar affect 1 year A documented diagnosis of pulmonary hypertension with World Health Organization (WHO) Class II to IV symptoms* (Adcirca, Letairis, Tracleer, Opsumit, Revatio inj, Revatio tab, and sildenafil ONLY) or WHO Class III to IV symptoms* (epoprostenol, Flolan, Remodulin, Tyvaso, Veletri, Ventavis ONLY) and a mean pulmonary artery pressure greater than 25 mm Hg at rest or greater than 30 mm Hg with exertion, documented by right-heart catheterization or echocardiography; AND 1 year 2 capsules/ day 2 tablets/da y Member has primary pulmonary hypertension, or has pulmonary hypertension secondary to any of the following conditions: Group 1 pulmonary hypertension: Anorectic agents (diet drugs); or Congenital heart disease with shunting; or Connective tissue diseases; or HIV infection; or Portopulmonary hypertension; or Familial pulmonary hypertension. Chronic thromboembolic pulmonary hypertension not adequately responsive to anticoagulants or surgical thromboendarterectomy; or Congenital diaphragmatic hernia; or Sarcoidosis. sildenafil REVATIO PHA-PRE Pulmonary hypertensive arterial disease A documented diagnosis of pulmonary hypertension with World Health Organization (WHO) Class II to IV symptoms* (Adcirca, Letairis, Tracleer, Opsumit, Revatio inj, Revatio tab, and sildenafil ONLY) or WHO Class III to IV symptoms* (epoprostenol, Flolan, Remodulin, Tyvaso, Veletri, Ventavis ONLY) and a mean pulmonary artery pressure greater than 25 mm Hg at rest or greater than 30 mm Hg with exertion, documented by right-heart catheterization or echocardiography; AND Member has primary pulmonary hypertension, or has pulmonary hypertension secondary to any of the following conditions: Group 1 pulmonary hypertension: Anorectic agents (diet drugs); or Congenital heart disease with shunting; or Connective tissue diseases; or HIV infection; or Portopulmonary hypertension; or Familial pulmonary hypertension. Chronic thromboembolic pulmonary hypertension not adequately responsive to anticoagulants or surgical thromboendarterectomy; or Congenital diaphragmatic hernia; or Sarcoidosis. 1 year 3 tablets/da y 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria ADEMPAS ADEMPAS-PRE Pulmonary hypertensive arterial disease A documented diagnosis of pulmonary hypertension with World Health Organization (WHO) Class II to IV symptoms* and a mean pulmonary artery pressure greater than 25 mm Hg at rest or greater than 30 mm Hg with exertion, documented by right-heart catheterization or echocardiography; AND Member has primary pulmonary hypertension, or has pulmonary hypertension secondary to any of the following conditions: Group 1 pulmonary hypertension: Anorectic agents (diet drugs); or Congenital heart disease with shunting; or Connective tissue diseases; or HIV infection; or Portopulmonary hypertension; or Familial pulmonary hypertension. 1 year 3 tablets/day 1 year 1 tablet/day Congenital diaphragmatic hernia; or Sarcoidosis; AND Member is NOT concurrently using organic nitrates (i.e., isosorbide mononitrate, isosorbide dinitrate, nitroglycerin) OR PDE inhibitors (i.e., sildenafil, Adcirca, dipyridamole, or theophylline); AND Member is not pregnant; AND OPSUMIT PHA-PRE Pulmonary hypertensive arterial disease Member has a documented contraindication or intolerance A documented diagnosis of pulmonary hypertension with World Health Organization (WHO) Class II to IV symptoms* (Adcirca, Letairis, Tracleer, Opsumit, Revatio inj, Revatio tab, and sildenafil ONLY) or WHO Class III to IV symptoms* (epoprostenol, Flolan, Remodulin, Tyvaso, Veletri, Ventavis ONLY) and a mean pulmonary artery pressure greater than 25 mm Hg at rest or greater than 30 mm Hg with exertion, documented by right-heart catheterization or echocardiography; AND Member has primary pulmonary hypertension, or has pulmonary hypertension secondary to any of the following conditions: Group 1 pulmonary hypertension: Anorectic agents (diet drugs); or Congenital heart disease with shunting; or Connective tissue diseases; or HIV infection; or Portopulmonary hypertension; or Familial pulmonary hypertension. Chronic thromboembolic pulmonary hypertension not adequately responsive to anticoagulants or surgical thromboendarterectomy; or Congenital diaphragmatic hernia; or Sarcoidosis. epoprostenol FLOLAN TRACLEER TYVASO VELETRI VENTAVIS PHA-PRE Pulmonary hypertensive arterial disease LETAIRIS REMODULIN A documented diagnosis of pulmonary hypertension with World Health Organization (WHO) Class II to IV symptoms* (Adcirca, Letairis, Tracleer, Opsumit, Revatio inj, Revatio tab, and sildenafil ONLY) or WHO Class III to IV symptoms* (epoprostenol, Flolan, Remodulin, Tyvaso, Veletri, Ventavis ONLY) and a mean pulmonary artery pressure greater than 25 mm Hg at rest or greater than 30 mm Hg with exertion, documented by right-heart catheterization or echocardiography; AND 1 year Member has primary pulmonary hypertension, or has pulmonary hypertension secondary to any of the following conditions: Group 1 pulmonary hypertension: Anorectic agents (diet drugs); or Congenital heart disease with shunting; or Connective tissue diseases; or HIV infection; or Portopulmonary hypertension; or Familial pulmonary hypertension. Chronic thromboembolic pulmonary hypertension not adequately responsive to anticoagulants or surgical thromboendarterectomy; or Congenital diaphragmatic hernia; or Sarcoidosis. ORENITRAM ORENITRAM-PRE Pulmonary hypertensive arterial disease A documented diagnosis of pulmonary hypertension with World Health Organization (WHO) Class II to IV symptoms* and a mean pulmonary artery pressure greater than 25 mm Hg at rest or greater than 30 mm Hg with exertion, documented by right-heart catheterization or echocardiography; AND 1 year Member has primary pulmonary hypertension, or has pulmonary hypertension secondary to any of the following conditions: Group 1 pulmonary hypertension: Anorectic agents (diet drugs); or Congenital heart disease with shunting; or Connective tissue diseases; or HIV infection; or Portopulmonary hypertension; or Familial pulmonary hypertension. Chronic thromboembolic pulmonary hypertension not adequately responsive to anticoagulants or surgical thromboendarterectomy; or Congenital diaphragmatic hernia; or Sarcoidosis. SYNAGIS SYNAGIS-PRE Respiratory syncytial virus infection AND 1.Early Preterm Infants: 1.In the first year of life, palivizumab prophylaxis is considered medically necessary for infants born before 29 weeks, 0 days’ gestation. 2.Palivizumab prophylaxis is considered not medically necessary for otherwise healthy infants born at or after 29 weeks, 0 days’ gestation. 2.Chronic Lung Disease (CDL) of Prematurity: INTERMEZZO INTERMEZZO-PRE Insomnia 1.In the first year of life, palivizumab prophylaxis is considered medically necessary for preterm infants with chronic lung disease (CLD) of prematurity (formerly known as broncho-pulmonary dysplasia or BPD), defined as birth at <32 weeks, 0 days’ gestation and a requirement for greater than 21% oxygen for at least 28 days after birth. 2.Palivizumab prophylaxis is considered medically necessary in the second year of life for children with CLD who required at least 28 days of supplemental oxygen after birth and who continue to require medical intervention (supplemental oxygen, chronic corticosteroid, or diuretic therapy) during the 6-month period before the start of the second RSV season. 3.Palivizumab prophylaxis is considered not medically For Intermezzo 1.75 mg - (for males or females) A documented diagnosis of treatment of insomnia when middle-of-the-night awakening is followed by difficulty returning to sleep See dosing in Dosing of Palivizumab: other criteria 1.Up to a maximum of 5 monthly doses of palivizumab (15 mg/kg per dose) are considered medically necessary during the RSV season for infants who qualify for prophylaxis in the first year of life. For infants born during the RSV season, fewer than 5 monthly doses are considered medically necessary. (For example, infants born in January would receive their last dose in March.) 2.Palivizumab prophylaxis for sporadic RSV infections outside of RSV season is considered not medically necessary. 3.A postoperative dose of palivizumab (15 mg/kg) is considered medically necessary after cardiac 1 year SedativePRE A documented trial of 7 days 1 (one week) of the preferred tablet/day generic alternative zolpidem or zolpidem er. For Intermezzo 3.5mg – (for males only) A documented diagnosis of treatment of insomnia when middle of the night awakening is followed by difficulty returning to sleep AND ALL of the following: Member is male Member is less than or equal to 65 years of old It is documented they will NOT taking Intermezzo concomitantly with other CNS depressants (e.g. benzodiazepines, opioids, tricyclic antidepressants, alcohol) HETLIOZ HETLIOZ-PRE Non-24 hour sleep-wake cycle A documented diagnosis of non-24 sleep-wake disorder AND Member is documented to be totally blind and has no light perception AND Member has a history of at least 3 months of difficulty initiating sleep, difficulty awakening in the morning, or excessive daytime sleepiness AND Member has no other concomitant sleep disorder, i.e., sleep apnea, insomnia 1 year 1 tablet/day 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria DALIRESP DALIRESP-PRE COPD BENLYSTA BENLYSTA-PRE Systemic lupus erythematosus ACIPHEX ESOMEPRAZOLE PREVACID PREVACID SOLUTAB PRILOSEC PROTONIX ZEGERID PPI-PRE Gastroesophageal reflux disease Duodenal ulcer disease Gastric hypersecretion A documented diagnosis of severe (Stage III) or very severe (Stage IV) chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and a history of exacerbations AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one week of one preferred alternative bronchodilator, albuterol/ ipratropium, ipratropium inhalation solution, or Combivent Respimat AND Spiriva AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of the preferred alternative bronchodilator, Symbicort A documented diagnosis of active Systemic Lupus Erythematosus (SLE) in adults aged 18 or older based on ACR criteria*; and Positive autoantibody test (e.g., anti-nuclear antibody [ANA] greater than or equal to 1:80 and/or anti-doublestranded DNA [anti-dsDNA] greater than or equal to 30 IU/ml); and At least one of the following 3 baseline measurement scores**: SELENA-SLEDAI score, British Isles Lupus Assessment Group (BILAG) scores or Physician’s Global Assessment (PGA) score; and An insufficient response to two (2) standard of care drug classes: Glucocorticoids (e.g., prednisone, methylprednisolone, dexamethasone) Antimalarials (e.g., hydroxychloroquine) Immunosuppressives (e.g., azathioprine, methotrexate, mycophenolate, cyclosporine, cyclophosphamide, chlorambucil, nitrogen mustard) Aetna does NOT consider prescription PPIs to be medically necessary for members with the following indications: 1. Uncomplicated heartburn of greater than 1-month duration, with a frequency of at least 2 heartburn episodes per week when all of the following criteria are met: a. The heartburn can be controlled by use of OTC medications AND b. There is no diagnosis of more complicated acid reflux disease, such as erosive esophagitis AND c. There are no symptoms of a more complicated GI condition.* AND Member does not have active nephritis or severe active lupus nephritis (proteinuria greater than 6 g/24 hour or equivalent using spot urine protein to creatinine ratio, or serum creatinine greater than 2.5 mg/dL); and A. Documented diagnosis listed below (no requirement for nonprescription Prilosec OTC) Indication Ulcers Gastrojejunal ulcer - active; maintenance Healing of NSAID-associated gastric ulcer Maintenance of healed duodenal ulcers Stress ulcer/surgical prophylaxis Treatment of benign gastric ulcer Treatment of duodenal ulcers Other GI Conditions Gastric residual reduction Gastrointestinal bleed GERD - moderate to severe with symptoms GERD- with atypical symptoms or complications (ex dysphagia, hoarseness, asthma exacerbations, noncardiac chest pain, esophageal stricture) Healing erosive esophagitis Helicobacter pylori eradication to reduce risk of duodenal ulcer recurrence (Additional documentation of two concurrent antibiotics that will be used in the treatment regimen combined with the requested PPI as part of the therapy are required. Examples of antibiotics include: amoxicillin or Member has a documented diagnosis of hyponatremia AND Therapy is being initiated or re-initiated in a hospital within the past month where serum sodium can be monitored closely AND Member has no underlying liver disease, including cirrhosis AND Member will not concurrently take any strong CYP 3A inhibitor medications, such as the following: clarithromycin indinavir itraconazole ketoconazole nefazodone nelfinavir ritonavir saquinavir telithromycin 1 year DALIRESP- A documented trial of one PRE week of one preferred alternative bronchodilator, albuterol/ ipratropium, ipratropium inhalation solution, or Combivent Respimat AND Spiriva AND a documented trial of one month of the preferred alternative bronchodilator, Symbicort Initial authorization is for one year. Additional therapy will be authorized at 6 month intervals if there is documentatio n of continued improvement in disease activity indicating a therapeutic response/ stability of the disease. 1 year 30 days SAMSCA SAMSCA-PRE Hyponatremia, Hypervolemic or euvolemic INFERGEN INFERGEN-PRE hepatitis C A documented diagnosis of one of the following: Chronic hepatitis C, initial treatment Chronic hepatitis C, retreatment in patients who have failed to respond to a complete therapeutic course of pegylated interferon (Pegasys, Peg-Intron) Treatment failure is defined as less than a 2 log decline in viral load after undergoing at least 12 weeks of previous pegylated interferon plus ribavirin therapy with greater than 80% adherence, or a detectable viral load at end-of-treatment after completing at least 24 weeks of therapy Up to 48 weeks of treatment with consensus interferon is considered medically necessary for retreatment; continued treatment with consensus interferon is considered not medically necessary for persons with a poor response to re-treatment at week 12 (defined as less than 2 log10 reduction in viral load from baseline) or persons who have detectable virus at week 24 AND Member does not meet clinical criteria for Harvoni OR Member has contraindication or intolerance to Harvoni 1 year INTRON-A INTRON-PRE AIDS-associated Kaposi's sarcoma Carcinoid syndrome Chronic myelogenous leukemia Condylomata acuminata (genital warts) (intralesional only) Cutaneous T-cell lymphoma (including mycosis fungoides) Desmoid tumors (fibromatosis), for unresctable disease or gross residual disease following surgery Essential thrombocythemia Giant cell tumor of bone Hairy cell leukemia Hepatitis C (non-A, non-B hepatitis) A documented diagnosis of one of the following: AIDS-associated Kaposi's sarcoma Carcinoid syndrome Chronic myelogenous leukemia Condylomata acuminata (genital warts) (intralesional only) Cutaneous T-cell lymphoma (including mycosis fungoides) Desmoid tumors (fibromatosis), for unresctable disease or gross residual disease following surgery Essential thrombocythemia Giant cell tumor of bone Hairy cell leukemia Hepatitis C (non-A, non-B hepatitis). Up to a maximum of 24 weeks of interferon alpha is considered medically necessary for persons with HCV genotypes 2, 3, and 7 through 10 Up to a maximum of 48 weeks of interferon alpha is considered medically necessary for persons with HCV genotypes 1 and 4 through 6 Continued treatment with interferon alpha is considered not medically necessary for persons with HCV genotypes 1 and 4 through 6 who have failed to attain an early virologic response after 12 weeks of treatment (where early virologic response is indicated by achievement of at least a 100-fold (2 log10) decrease in serum HCV from pretreatment baseline) A course of standard interferon alpha in persons with 1 year For coverage of additional PPI-PRE quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. Additional quantities of proton pump inhibitors may be considered medically necessary for those members who meet ANY of the following criteria: Member has a diagnosis of a pathological hypersecretory condition [e.g., Zollinger-Ellison Syndrome, multiple endocrine neoplasia type 1 (MEN-1)] OR Member is being treated for Barrett’s esophagus OR Member is being treated for eradication of H. pylori (triple therapy only; 30-day duration) OR Under some plans, including plans that use an open or closed formulary, Harvoni, Infergen, Intron-A, Olysio, Pegasys, Peg-Intron/ Redipen/pak, Sovaldi, and Victrelis are subject to precertification. If precertification requirements apply Aetna considers these medications to be medically necessary for those members who meet all of the following precertification criteria. There are several brands of medications for the treatment of Chronic Hepatitis C on the market. For those patients meeting clinical criteria for Harvoni as outlined below, the use of Harvoni will be required unless the Under some plans, including plans that use an open or closed formulary, Harvoni, Infergen, Intron-A, Olysio, Pegasys, Peg-Intron/ Redipen/pak, Sovaldi, and Victrelis are subject to precertification. If precertification requirements apply Aetna considers these medications to be medically necessary for those members who meet all of the following precertification criteria. There are several brands of medications for the treatment of Chronic Hepatitis C on the market. For those patients meeting clinical criteria for Harvoni as outlined below, the use of Harvoni will be required unless the A documented trial of one month each of two preferred PPIs: Dexilant OR Nexium OR generic lansoprazole/ODT – alternatives on the Preferred Drug List. 1 tablet, capsule or packet/da y Prilosec powder - 2 packets/d ay 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria OLYSIO OLYSIO-PRE hepatitis C For initial authorization (6 week maximum), provider must submit medical records documenting the diagnosis of chronic hepatitis C with genotype and subtype, if applicable (i.e., genotype 1a, genotype 1b; diagnoses further defined below) AND submit medical records documenting any one of the following related to staging of liver disease: 1.Metavir scores 2.Fibroscan score 3.FibroSURE score 4.APRI score 5.Radiological imaging consistent with cirrhosis (i.e., evidence of portal hypertension) 6.Physical findings or clinical evidence consistent with cirrhosis as attested by the prescribing physician AND meet the criteria specified below: Member does not have decompensated liver disease Member is not co-infected with hepatitis B or HIV Member has a documented diagnosis of one of the following, with documented viral load taken within 6 months of beginning therapy: Chronic Hepatitis C Virus (HCV) infection, genotype 1, AND all of the following: PEGASYS PEG-INTRON PEGASYS-PRE HARVONI hepatitis C hepatitis b hepatitis C SOVALDI SOVALDI-PRE hepatitis C VICTRELIS VICTRELIS-PRE hepatitis C ACANYA BENZACLIN BENZAMYCIN DUAC RIAX AER BENZEFOAM ULTRA ARICEPT (5 mg, 10 mg and 23 mg) ARICEPT ODT (5 mg and 10mg) RANEXA DEPAKOTE DEPAKOTE ER DEPAKOTE SPRINKLE KEPPRA KEPPRA XR TOPAMAX Concurrent therapy with peginterferon alfa (PEG) and A documented diagnosis of one of the following: Chronic hepatitis C, as monotherapy or in combination with ribavirin, boceprevir (Victrelis), or simeprevir (Olysio), in patients who are interferon naïve or who have relapsed or failed to respond to prior non-pegylated interferon therapy Continued treatment with pegylated interferon alpha is considered not medically necessary for persons with HCV genotypes 1 and 4 through 6 who have failed to attain an early virologic response after 12 weeks of therapy (early virologic response is indicated by achievement of at least a 100-fold (2 log10) decrease in serum HCV RNA from pretreatment baseline) Up to 48 weeks of treatment with pegylated interferons is considered medically necessary for persons infected with HCV genotype 1 and genotypes 4 through 6 who have attained an early virologic response by 12 weeks of therapy Up to 72 weeks of treatment with pegylated interferons is considered medically necessary for persons with HCVgenotype 1 infection who have delayed virus clearance (HCV RNA test becomes negative between weeks 12 and 24) Up to 24 weeks of treatment with pegylated interferons is considered medically necessary for persons with other HCV genotypes (i.e., genotypes 2 and 3, and genotypes 7 For initial authorization, provider must submit medical records documenting the diagnosis of chronic hepatitis C with genotype and subtype, if applicable (i.e., genotype 1a, genotype 1b; diagnoses further defined below) AND submit medical records documenting any one of the following related to staging of liver disease: 1. Metavir scores 2. Fibroscan score 3. FibroSURE score 4. APRI score 5. Radiological imaging consistent with cirrhosis (i.e., evidence of portal hypertension) 6. Physical findings or clinical evidence consistent with cirrhosis as attested by the prescribing physician AND meet the criteria specified below: Member does not have decompensated liver disease, AND Member is not co-infected with hepatitis B or HIV-1, AND A documented viral load taken within 6 months of beginning therapy, AND For initial authorization (6 week maximum), provider must submit medical records documenting the diagnosis of chronic hepatitis C with genotype and subtype, if applicable (i.e., genotype 1a, genotype 1b; diagnoses further defined below) AND submit medical records documenting any one of the following related to staging of liver disease: 1. Metavir scores 2. Fibroscan score 3. FibroSURE score 4. APRI score 5. Radiological imaging consistent with cirrhosis (i.e., evidence of portal hypertension) 6. Physical findings or clinical evidence consistent with cirrhosis as attested by the prescribing physician AND meet the criteria specified below Member is not co-infected with hepatitis B Member has a documented diagnosis of one of the following, with documented viral load taken within 6 months of beginning therapy: Chronic Hepatitis C Virus (HCV) infection, genotype 1, Initiating Therapy: (Max time of approval 10 weeks) Patient will NOT be taking concurrently with any of the A documented diagnosis of hepatitis C Genotype 1 AND concurrent therapy with ribavirin AND Intron-A, Peg-Intron following: or Pegasys AND documentation of Adcirca or Revatio when used for pulmonary arterial ALL of the specified criteria listed below Patient has or will receive 4 weeks of PEG-IFN and hypertension (PAH) ribavirin prior to starting Victrelis alfuzosin Patient has NOT previously failed nor is currently on carbamazepine therapy with at reatment regimen that includes a protease drospirenone (oral inhibitor (e.g. Victrelis) contraceptive) HCV RNA levels will be assessed at weeks 4, 8, 12, and ergot derivatives (ie, 24 of treatment dihydroergotamine, ergonovine,ergotamine,met For Renewal at <10 weeks (Max time of approval 10 weeks) hylergonovine) A documented diagnosis of hepatitis C Genotype 1 AND lovastatin concurrent therapy with ribavirin AND Intron-A, Peg-Intron midazolam, oral or Pegasys AND documented ALL of the following: phenobarbital Patient has NOT previously failed with a treatment phenytoin regimen that includes a protease inhibitor (e.g. Victrelis) pimozide Patient is currently receiving and has not received rifampin Victrelis in combination with ribavirin and Intron-A or Pegsimvastatin Intron or Pegasys for ≥8 weeks after initial 4 weeks of lead St. John’s wort triazolam in therapy with interferon and ribavirin therapy. CV RNA levels will be assessed at weeks 12, and 24 of treatment. For Renewal assessment at treatment week 12 (Max time Initial Under some plans, authorization - including plans that use an 6 weeks, open or closed reauthorizatio formulary, Harvoni, n at 6 weeks Infergen, Intron-A, Olysio, Pegasys, Peg-Intron/ Redipen/pak, Sovaldi, and Victrelis are subject to precertification. If precertification requirements apply Aetna considers these medications to be medically necessary for those members who meet all of the following precertification criteria. There are several brands of medications for the treatment of Chronic Hepatitis C on the market. For those patients meeting clinical criteria for Harvoni as outlined below, the use of Harvoni will be required unless the 1 year Under some plans, including plans that use an open or closed formulary, Harvoni, Infergen, Intron-A, Olysio, Pegasys, Peg-Intron/ Redipen/pak, Sovaldi, and Victrelis are subject to precertification. If precertification requirements apply Aetna considers these medications to be medically necessary for those members who meet all of the following precertification criteria. There are several brands of medications for the treatment of Chronic Hepatitis C on the market. For those patients meeting clinical criteria for Harvoni as outlined below, the use of Harvoni will be required unless the Under some plans, For initial authorization, including plans that use an open or closed 6 week maximum for formulary, Harvoni, Infergen, Intron-A, Olysio, 12 or 24 Pegasys, Peg-Intron/ week Redipen/pak, Sovaldi, and regimen, 8 Victrelis are subject to week maximum for precertification. If precertification 8 week requirements apply Aetna regimen (in considers these order to be medications to be eligible for the maximum medically necessary for those members who meet number of all of the following tablets, member must precertification criteria. meet both There are several brands of medications for the initial and reauthorizatio treatment of Chronic Hepatitis C on the market. n For those patients meeting criteria): clinical criteria for Harvoni as outlined below, the use of Harvoni will be required unless the Initial Under some plans, authorization - including plans that use an 6 weeks, open or closed reauthorizatio formulary, Harvoni, n at 6 weeks Infergen, Intron-A, Olysio, Pegasys, Peg-Intron/ Redipen/pak, Sovaldi, and Victrelis are subject to precertification. If precertification requirements apply Aetna considers these medications to be medically necessary for those members who meet all of the following precertification criteria. There are several brands of medications for the treatment of Chronic Hepatitis C on the market. For those patients meeting clinical criteria for Harvoni as outlined below, the use of Harvoni will be required unless the Under some plans, Initial authorization including plans that use an open or closed 10 weeks, formulary, Harvoni, additonal Infergen, Intron-A, Olysio, approval available if Pegasys, Peg-Intron/ criteria is Redipen/pak, Sovaldi, and Victrelis are subject to met. See precertification. If additional criteria precertification requirements apply Aetna considers these medications to be medically necessary for those members who meet all of the following precertification criteria. There are several brands of medications for the treatment of Chronic Hepatitis C on the market. For those patients meeting clinical criteria for Harvoni as outlined below, the use of Harvoni will be required unless the 1 capsule/d ay 1 capsule/d ay 12 capsules/ day ACANYAPRE A documented trial of one month of the preferred generic alternative, benzoyl peroxide/clindamycin phosphate gel OR benzoyl peroxide/erythromycin gel BENZEFO A documented trial of one AM-PRE month of the preferred generic alternative, benzoyl peroxide foam ARICEPT- A documented one month trial PRE of the preferred generic donepezil or donepezil ODT RANEXAPRE A documented trial of one month of one agent from one of the following classes: calcium channel blockers (Norvasc, amlopidine, or diltiazem), OR beta –blockers (BUT NOT sotalol AF, sotalol, sorine, Betapace, or Betapace AF) OR a nitrate DEPAKOT A documented trial of one E-PRE month of the drug's preferred generic equivalent 500 mg = 3 tablets/da y 1000 mg = 2 tablets/da y 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria LAMICTAL XR QUDEXY XR TROKENDI XR KARBINAL ER NIACOR MIRAPEX MIRAPEX ER REQUIP XL LAMICTALPRE QUDEXY- A documented contraindication or intolerance PRE or allergy or failure of an adequate trial of one month of the preferred generic alternative, topiramate 25 mg; 50 QUDEXY- A documented trial of one month of the preferred generic mg; 100 PRE alternative, topiramate mg- 1/day 200 mg 2/day KARBINAL- A documented trial of one PRE week each of a non-sedating OTC antihistamine (i.e., Claritin, Zyrtec) AND the preferred generic alternative, carbinoxamine NIACOR- A documented trial of niacin er PRE MIRAPEX- A documented trial of one PRE month of the preferred alternative generic pramipexole REQUIP- A documented trial of one month of the preferred generic PRE equivalent ropinirole ER Combivir VIRAMUNE ZERIT ZIAGEN CALCITRENE SORILUX A documented trial of one month of the medication's preferred generic equivalent alternative CALCITR adequate trial of one month of ENE-PRE the preferred alternatives, Tazorac or calcipotriene OR Member is pregnant -- a trial of calcipotriene only VALTREX VALTREX- A documented trial of one PRE week of the preferred generic equivalent alternative, valacyclovir NEXICLON- A documented trial of one PRE month of the preferred generic alternative, clonidine LOTREL- A documented trial of one PRE month of the preferred generic equivalent amlodipine/benazepril MAXAIR- A documented trial of one PRE week of one of the following preferred alternatives, Proair HFA or Proventil HFA NORVASC- A documented trial of one PRE month of the preferred generic equivalent, amlodipine NEXICLON XR LOTREL MAXAIR AUTOHALER NORVASC NYMALIZE CADUET ANTARA FENOGLIDE FIBRICOR LIPOFEN LOFIBRA TRIGLIDE TRICOR TRILIPIX CombivirPRE NYMALIZE- A documented trial of one PRE week of the preferred generic alternative, nimodipine CADUET- A documented trial of one PRE month of preferred generic alternative, amlodipine/atorvastatin ANTARA- A documented trial of one PRE month of the following preferred generic alternative, any preferred fenofibrate product LOPID LOPIDPRE QUARTETTE QUARTET A documented trial of one TE-PRE month of one preferred generic extended-cycle 91day contraceptive alternative, i.e. Amethia, Daysee, Jolessa CLOBEX lotion/shampoo CLOBEXPRE CLODERM CLODER M-PRE CUTIVATE CUTIVATE- A documented trial of two PRE weeks of one preferred alternative generic betamethasone benzoate, betamethasone dipropionate, betamethasone valerate, desonide lotion, desonide, desoximetasone, fluocinolone acetonide, fluticasone, fluocinonide, hydrocortisone butyrate, hydrocortisone valerate, prednicarbate, OR triamcinolone acetonide LOCOID LOCOID LIPOCREAM LOCOIDPRE DESONATE VERDESO DESONAT A documented trial of two E-PRE weeks of one preferred generic desonide alternative, any dosage form LUXIQA documented trial of two PRE weeks of a preferred generic betamethasone alternative OLUXA documented trial of two PRE weeks of a preferred generic clobetasol alternative LUXIQ OLUX OLUX-E VANOS 1/day A documented trial of one month each of the following preferred generic alternatives, gemfibrozil AND any preferred fenofibrate product A documented trial of two weeks of the preferred generic equivalent alternative, clobetasol lotion OR clobetasol shampoo A documented trial of two weeks of one preferred alternative generic, any dosage form - fluocinolone acetonide, hydrocortisone valerate, mometasone furoate, OR triamcinolone acetonide A documented trial of two weeks of one preferred alternative generic betamethasone benzoate, betamethasone dipropionate, betamethasone valerate, desonide lotion, desonide, desoximetasone, fluocinolone acetonide, fluticasone, fluocinonide, hydrocortisone butyrate, hydrocortisone valerate, prednicarbate, OR triamcinolone acetonide FORFIVO XL nefazodone FORFIVO- A documented trial of one PRE month of one of budeprion SR/XL, bupropion/SR/XL, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine/sr, mirtazapine, selfemra, sertraline, venlafaxine, venlafaxine er tablet, venlafaxine sr capgeneric alternatives on the REMERON REMERON SOLUTAB REMERO N-PRE GLYCATE 25 mg; 50 mg; 100 mg- 1/day 150 mg; 200 mg 2/day A documented trial of one month of the preferred generic equivalent alternative, mirtazapine or mirtazapine ODT GLYCATE- A documented trial of one PRE month of the preferred generic alternative, glycopyrrolate 1/day 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria SIRTURO SIRTURO-PRE pulmonary multi-drug resistant tuberculosis A documented diagnosis of pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults AND all of the following: Member has failed or is failing an adequate treatment regimen* consisting of at least 4 drugs, administered under directly observed therapy (DOT) (or serum medication levels have been documented) or an adequate treatment regimen consisting of at least 4 drugs cannot otherwise be provided (Note: Treatment failure is defined as continuous or recurrently positive sputum cultures during the course of appropriate antituberculous therapy) Drug susceptibility testing for first and second-line agents will be performed and therapy will be initiated in combination with at least 3 other drugs which have shown susceptibility Treatment will be administered under directly observed therapy (DOT) An electrocardiogram (ECG) will be obtained before initiation of treatment, and at least 2, 12, and 24 weeks after starting treatment 24 weeks SIRTURO- A documented trial of at least According to the PRE three months of the preferred manufacturer, 400 mg of treatment regimen consisting Sirturo should be taken of at least 2 of the following: daily for 2 weeks, then 200 ethambutol mg of Sirturo should be taken three times weekly for pyrazinamide 22 weeks. A quantity of this Trecator (ethionamide) drug will be considered cycloserine medically necessary as Paser (aminosalicylic acid) indicated in the table below amoxicillin/ clavulanate if member fulfills above imipenem/ cilastatin criteria: clarithromycin Zyvox 68 tablets in 30 days And 1 of the following: Avelox (moxifloxacin) levofloxacin ofloxacin And 1 of the following: RAYOS RAYOSPRE ENTOCO RT-PRE ENTOCORT EC amikacin Trial of prednisone A documented trial of one 3/day month of preferred generic budesonide SR Trial of raloxifene hydrochloride A documented trial of one month each of any of the preferred topical generic alternatives, metronidazole and sulfacetamide sodium with sulfur VELPHOR A documented trial of one O-PRE month of one of the preferred alternatives, calcium acetate, Fosrenol, Phoslyra, or Renvela RENAGEL- A documented trial of one PRE month of the preferred alternative, Renvela PHOSLO- A documented trial of one month of the preferred generic PRE equivalent, calcium acetate EVISTA EVISTAPRE MIRVASOPRE MIRVASO VELPHORO RENAGEL PHOSLO PLAVIX PLAVIXPRE VIOKACE PERTZYE ULTRESA VIOKACE- A documented trial of two PRE weeks of two preferred alternative agents: CREON, ULTRASE, ULTRASE MT, ZENPEP VIMOVO- A documented trial of two PRE weeks of one preferred generic nonsteroidal antiinflammatory agent EXALGO- A documented trial of two days 2/day PRE of the preferred generic alternative, morphine sr cap 24hr VOLTAREN GEL VIMOVO PENNSAID EXALGO DUEXIS For coverage of additional quantities, member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit. Additional quantities of the above medications will be considered medically necessary for those members who meet the following criterion: A Documented diagnosis of cancer and prescription is written by an oncologist or pain specialist OR Member is enrolled in a hospice program or meets hospice criteria OR Member's resident state or contract state is California and the member is terminally ill OR Patient has signed opioid agreement in support of A documented trial of one month of the preferred generic equivalent, clopidogrel A documented trial of two weeks of one preferred generic nonsteroidal antiinflammatory agent BINOSTO- A documented trial of one PRE month each of two preferred alternatives, alendronate AND Actonel or Actonel with calcium or Atelvia BONIVA- A documented trial of one PRE month each of two preferred alternatives, ibandronate AND Actonel OR Actonel with Calcium OR Atelvia PATANOL- A documented trial of one PRE week of Pataday SILENORPRE A documented trial of 7 days (one week) each of preferred generic doxepin AND zolpidem or zolpidem er 3/day AMBIEN CR EDLUAR ROZEREM AMBIENPRE 1 tablet/day SONATA AMBIENPRE A documented trial of 7 days (one week) of the preferred generic alternative zolpidem or zolpidem er. A documented trial of 7 days (one week) of the preferred generic alternative zolpidem or zolpidem er. ZOLPIMIST AMBIENPRE 1 bottle/30 day supply AMBIEN AMBIENPRE A documented trial of 7 days (one week) of the preferred generic alternative zolpidem or zolpidem er. A documented trial of 7 days (one week) of the preferred generic alternative zolpidem or zolpidem er. AMRIX AMRIXPRE BINOSTO FOSAMAX PLUS D BONIVA tablet PATANOL SILENOR-PRE ACTOS ACTOPLUS MET /XR DUETACT Diabetic test strips (all but those made by Abbott Diabetes Care or Lifescan) PRANDIN DUEXISPRE A documented trial of one week each of two preferred alternatives (one of which should be cyclobenzaprine or cyclobenzaprine er) ACTOSA documented trial of one PRE month of pioglitazone ACTOPLU A documented trial of one S-PRE month of pioglitazone/metformin DUETACT- A documented trial of one PRE month of pioglitazone/glimeperide DTS-PRE Any two preferred blood glucose test strips: FREESTYLE, FREESTYLE INSULINX, FREESTYLE LITE, ONE TOUCH FAST TAKE, ONE TOUCH ULTRA, ONE TOUCH VERIO IQ, PRECISION QID, PRECISION SOF-TACT or PRECISION XTRA PRANDIN- A documented trial of one PRE month of the preferred generic equivalent alternative, repaglinide 4 tablets in 28 days 1/day 1/day 5 mg = 4 capsules/ day 10 mg = 2 capsules/ day 5 mg = 2 tablets/da y 10 mg = 1 tablet/day 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria NOVOLIN 70/30 RELION 70/30 NOVOLIN-PRE diabetes Only for Fully-Insured Plans: A documented diagnosis of type I or type II diabetes AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of the preferred alternative Humalog product INS1-PRE A documented trial of one month of HUMULIN 70/30 NOVOLIN N RELION N NOVOLIN-PRE diabetes Only for Fully-Insured Plans: A documented diagnosis of type I or type II diabetes AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of the preferred alternative Humalog product INS2-PRE A documented trial of one month of HUMULIN N diabetes Only for Fully-Insured Plans: A documented diagnosis of type I or type II diabetes AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of the preferred alternative, Levemir LANTUSPRE LANTUS A documented trial of one month of the preferred alternative, Levemir NOVOLIN R RELION R NOVOLIN-PRE diabetes Only for Fully-Insured Plans: A documented diagnosis of type I or type II diabetes AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of the preferred alternative Humulin product INS3-PRE A documented trial of one month of HUMULIN R APIDRA NOVOLOG NOVOLONG MIX 70/30 APIDRA-PRE diabetes Only for Fully-Insured Plans: A documented diagnosis of type I or type II diabetes AND A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of the preferred alternative Humalog product APIDRAPRE (Only for FullyInsured Plans) A documented trial of one month of the preferred alternative Humalog product LYSTEDA 1/day LYSTEDA- A documented trial of one month of the generic preferred PRE alternative, tranex acid ULORIC ULORICPRE MIGRANAL A documented trial of one month of the preferred generic alternative, allopurinol For coverage of additional MIGRANA A documented trial of the quantities, a member's L-PRE preferred generic equivalent, treating physician must dihydroergotamine nasal request prior authorization spray AND three of the through the Pharmacy following preferred generic Management alternatives for the treatment Precertification Unit. of 2 migraine episodes Additional quantities of naratriptan these anti-migraine agents rizatriptan/ mlt will be considered medically sumatriptan necessary for those zolmitriptan/ odt members who meet ANY of the following criteria: 1box per 30days Documented diagnosis of migraine AND member is receiving prophylactic migraine therapy OR Documented diagnosis of migraine AND member is being treated by a headache clinic, neurologist or specialist OR SINGULAIR GENOTROPIN HUMATROPE NORDITROPIN NUTROPIN NUTROPIN AQ SAIZEN TEV-TROPIN GENOTROPIN-PRE Growth Hormone Deficiency 1. Growth Hormone Deficiency in Children and Adolescents: 1 year Dosage: SINGULAI A documented one month trial 1/day R-PRE of the preferred generic equivalent, montelukast GENOTR A documented trial of OPIN-PRE OMNITROPE According to available guidelines, for the first 2 to 3 months dosage adjustments should be made after monthly assessments of serum levels of IGF-1, and in response to the presence of adverse effects, until a maintenance dose is achieved. As a condition of continued authorization, Aetna requires at least annual reassessment of serum levels of IGF-1 in adults and appropriate dosage adjustments, as GH requirements in adults may decrease with age. Aetna considers GH replacement medically necessary for children and adolescents with the following indications: 1. Idiopathic growth hormone deficiency (GHD): Aetna considers GH replacement medically necessary for children and adolescents with GH deficiency, i.e., insufficient GH secretion and growth failure who meet all of the following criteria: 1. Member has failed to respond to at least 2 standard GH stimulation tests†, defined as a serum GH level (peak level) of less than 10 nanograms per milliliter (ng/ml) (20 mU/liter), after stimulation with insulin, levodopa, arginine, propranolol, clonidine, or glucagon.* (However, 1 abnormal GH test is sufficient for children with defined CNS pathology, history of irradiation, multiple pituitary hormone deficiency (MPHD) or a genetic defect affecting the GH axis); and Continued Authorization: INCRELEX OMNITROPE SEROSTIM ZORBTIVE GENOTROPIN-PRE Growth Hormone Deficiency 2. For children who have insufficient GH secretion (fail to respond to stimulation tests), appropriate imaging 1. Growth Hormone Deficiency in Children and Adolescents: Aetna considers GH replacement medically necessary for children and adolescents with the following indications: 1. Idiopathic growth hormone deficiency (GHD): Aetna considers GH replacement medically necessary for children and adolescents with GH deficiency, i.e., insufficient GH secretion and growth failure who meet all of the following criteria: 1. Member has failed to respond to at least 2 standard GH stimulation tests†, defined as a serum GH level (peak level) of less than 10 nanograms per milliliter (ng/ml) (20 mU/liter), after stimulation with insulin, levodopa, arginine, propranolol, clonidine, or glucagon.* (However, 1 abnormal GH test is sufficient for children with defined CNS pathology, history of irradiation, multiple pituitary hormone deficiency (MPHD) or a genetic defect affecting the GH axis); and 1 year The continued medical necessity of GH therapy is Dosage: According to available guidelines, for the first 2 to 3 months dosage adjustments should be made after monthly assessments of serum levels of IGF-1, and in response to the presence of adverse effects, until a maintenance dose is achieved. As a condition of continued authorization, Aetna requires at least annual reassessment of serum levels of IGF-1 in adults and appropriate dosage adjustments, as GH requirements in adults may decrease with age. Continued Authorization: NORTHERA NORTHERA-PRE Orthostatic hypotension 2. For children who have insufficient GH secretion (fail to respond to stimulation tests), appropriate imaging A documented diagnosis of symptomatic neurogenic orthostatic hypotension (NOH) (i.e., dizziness, lightheadedness, faintness) caused by primary autonomic failure (i.e., Parkinson's disease, multiple system atrophy, or pure autonomic failure), dopamine beta-hydroxylase deficiency, or non-diabetic autonomic neuropathy The continued medical necessity of GH therapy is For coverage of additional NORTHER A documented trial of one quantities, a member's A-PRE month of the preferred generic treating physician must alternatives, midodrine or request prior authorization fludrocortisone through the Pharmacy Management Precertification Unit. A prior authorization will be granted for coverage of additional quantities of this medication for those members who meet the following criteria: For Northera (100, 200 mg) Prescriber is titrating dose (may allow 180 caps in 30 days for 3 months AURYXIA (FERRIC CITRA TAB 210MG) FERRICPRE A documented trial of one month of one of the preferred alternatives, calcium acetate, sevelamer, Fosrenol, or Phoslyra. 100,200m g - 3/day. 300mg 6/day 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria CERDELGA CERDELGA-PRE Type 1 Gaucher disease A documented diagnosis of Type 1 Gaucher disease who meet both of the following criteria: 1.Member has any of the following signs and symptoms: a.Moderate to severe anemia (hemoglobin less than or equal to 11.5 g/dL (adult women) or 12.5 g/dL (adult men) or less than or equal to 1.0 g/dL or more below the lower limit of normal for age and sex); or b.Significant hepatomegaly (liver size 1.25 or more times normal (1,750 cc in adults)) or splenomegaly (spleen size 5 or more times normal (875 cc in adults)); or c.Skeletal disease beyond mild osteopenia and Erlenmeyer flask deformity; or d.Symptomatic disease, including abdominal or bone pain, fatigue, exertional limitation, weakness, or cachexia; or e.Thrombocytopenia (platelet count less than or equal to 120,000/mm3); and 1 year 2/day 2.For eliglustat (Cerdelga) only, member is a CYP2D6 extensive metabolizer (EM), intermediate metabolizer (IM), or poor metabolizer (PM) (According to the FDA approved labeling, CYP2D6 ultra-rapid metabolizers (UMs) may not achieve adequate concentrations of Cerdelga to achieve a therapeutic effect.) Known hypersensitivity to colchicine. A documented diagnosis of symptomatic gout; AND The patient has had at least two acute gout attacks in one year, presence of tophi, or radiographic joint damage, AND Planned initiation of urate-lowering pharmacotherapy such as allopurinol or Uloric (Uloric requires trial/failure or contraindication to allopurinol) AND Member has undertaken appropriate life style modifications, i.e. limiting of alcohol consumption and other medications known to precipitate gout attacks have been discontinued/changed when possible. History of hypersensitivity to A documented diagnosis of relapsing remitting multiple natural or recombinant sclerosis AND documentation of all of the following: interferon beta or Discontinuation of other therapies used for treating peginterferon, or any other multiple sclerosis (Note: This does NOT require having to component of the discontinue Ampyra) A documented contraindication or intolerance or allergy or formulation. failure of an adequate trial* of both preferred alternatives, Copaxone 20 or 40 mg and Rebif 6 months MITIGARE- Trial of 1 month of Colcrys PRE 2/day 6 months PLEGRID A documented trial of both Y-PRE preferred alternatives, Copaxone 20 or 40 mg and Rebif. 2/28 days; no QL on starter kit MITIGARE MITIGARE-PRE Prophylaxis of gout flares in adults PLEGRIDY INJ PLEGRIDY-PRE Treatment of patients with relapsing forms of multiple sclerosis AKYNZEO AKYNZEO-PRE Prophylaxis of chemotherapy-induced nausea and vomiting A documented diagnosis of nausea and vomiting associated with cancer chemotherapy 1 year CONTRAVE Antiobesity -PRE Obesity A documented Body Mass Index (BMI) > 30 kg/ m2 OR A documented BMI > 27 kg/ m2 with one or more of the following obesity related risk factors considered serious enough to warrant pharmacotherapy: Hypertension (systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg on more than one occasion): Dyslipidemia LDL cholesterol >/= 160 mg/ dL HDL cholesterol < 35 mg/ dL Triglycerides >/= 400 mg/ dL Type 2 diabetes mellitus Coronary heart disease Obstructive sleep apnea 1 year TRIUMEQ TRIUMEQ-PRE HIV infection A documented diagnosis of human immunodeficiency virus (HIV). AND A documented trial of one month of the medication's preferred alternatives abacavir, lamivudine, and dolutegravir. 1 year For coverage of additional AKYNZEO- A documented trial of 1 quantities, a member's PRE generic 5-HT3 receptor treating physician must antagonist (granisetron or request prior authorization ondansetron) AND Emend. through the Pharmacy Management Precertification Unit. Additional quantities of Akynzeo will be considered medically necessary for those members who have a documented chemotherapy regimen that requires more than two cycles of antiemetic per 30 days TRIUMEQ- A documented trial of one PRE month of concomitant use of the preferred alternatives, abacavir, lamivudine, and dolutegravir. 2 tab / 30 days 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria 2015 Aetna Commercial Formulary for Self-Insured Plans_Prior Authorization and Step-Therapy Coverage Criteria
