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Pharmacy Prior Authorization
Title 19/21 SMI
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
General Guidelines
Authorization Requirements/Criteria
Non-Formulary
Medication
Guideline
Requests for Non-Formulary Medications that do not have specific Prior Authorization Guidelines will be
reviewed based on the following:
• An appropriate diagnosis/indication for the requested medication,
• An appropriate dose of medication based on age and indication,
• Documented trial of 2 formulary agents for an adequate duration have not been effective or tolerated
OR
• All other formulary medications are contraindicated based on the patient’s diagnosis, other medical
conditions or other medication therapy
OR
• There are no other medications available on the formulary to treat the patient’s condition
Mercy Maricopa Integrated Care Plan determines patient medication trials and adherence by a review of
pharmacy claims data over the preceding twelve months. Additional information may be requested on a
case-by-case basis to allow for proper review.
Duration of Approval if
Requirements Are Met
Initial Approval:
• Minimum of 3 months,
depending on the
diagnosis, to determine
adherence, efficacy and
patient safety
monitoring
Renewal:
• Minimum of 6 months
• Maintenance
medications may be
approved indefinitely
Medications
requiring Prior
Authorization
Requests for Medications requiring Prior Authorization (PA) will be reviewed based on the PA
Guidelines/Criteria for that medication. Scroll down to view the PA Guidelines for specific medications.
Medications that do not have a specific PA guideline will follow the Non-Formulary Medication Guideline.
Additional information may be required on a case-by-case basis to allow for adequate review.
As documented in the
individual guideline
Medications
requiring Step
Therapy
Medications that require Step Therapy (ST) require trial and failure of formulary agents prior to their
authorization. If the prerequisite medications have been filled within the specified time frame, the
prescription will automatically process at the pharmacy. Prior Authorization will be required for
prescriptions that do not process automatically at the pharmacy.
Initial Approval:
• Indefinite
Brand Name
Medication
Requests
Aetna Medicaid requires use of generic agents that are considered therapeutically equivalent by the FDA.
For authorization of a brand name medication, please submit a copy of the FDA MedWatch form detailing
trial and failure of, or intolerance/adverse side effect to generic formulations made by 2 different
manufacturers. The completed form should also be submitted to the FDA. The FDA MedWatch form is
Initial Approval:
• Indefinite
Last Update: 09/07/2016
1
Pharmacy Prior Authorization
Title 19/21 SMI
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
General Guidelines
Specialist
Prescriber
Medication
Requests
Behavioral Health
Medications
Behavioral Health
Guidelines
Non-Formulary
Behavioral Health
Medications
Authorization Requirements/Criteria
available at:
http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/UCM082725.pdf
Some medications are covered when prescribed by a Specialist provider. If the medication is prescribed by
the appropriate Specialist, the prescription will automatically process at the pharmacy. Prior Authorization
will be required for prescriptions that do not process automatically at the pharmacy. In those cases,
authorization will be given upon receipt of a Specialist Consult or after trial and failure of 2 formulary
medications.
Primary care providers, within the scope of their practice, who wish to provide psychotropic medications
and medication adjustment and monitoring services may do so for members diagnosed with Attention
Deficit Disorder/Attention Deficit Hyperactivity Disorder, depressive (including postnatal depression)
and/or anxiety disorders. AHCCCS provides guidance in two appendices, Appendix E for children and
adolescents and Appendix F for adults. For each of the three named diagnoses there are clinical guidelines
that include assessment tools and algorithms. The clinical guidelines are to be used by the PCPs as an aid in
treatment decisions. http://www.azahcccs.gov/shared/Downloads/MedicalPolicyManual/Chap300.pdf
For treatment of other behavioral or mental health conditions, members will be referred to the Regional
Behavioral Health Authority (RBHA).
Authorization Requirements/Criteria
Guidelines for Approval:
• The patient must have a diagnosis for which the requested medication is FDA approved for or the
requested medication is included in treatment guidelines.
• The patient has previously tried and had an inadequate response, experienced adverse reactions, or
developed breakthrough symptoms with at least 2 other formulary mediations in the same class at
maximum tolerated doses.
• The dose of the requested medication must not be greater than the FDA recommended maximum
daily dosage.
o If the dose requested exceeds the FDA recommended maximum, documentation to support
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
• Indefinite
N/A
Duration of Approval if
Requirements Are Met
Hospital Discharge:
• 60 days
Initial Approval:
• 12 months
Initial Approval for HighDose:
• 3 months
2
Pharmacy Prior Authorization
Title 19/21 SMI
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
Behavioral Health
Guidelines
Authorization Requirements/Criteria
the following must also be submitted:
 The dosing requested must be supported by peer-reviewed literature.
 The Behavioral Health Medical Provider (BHMP) has evaluated and determined that
medication non-adherence is not the reason for the dose escalation.
 Supporting documentation indicates that use of the medication at a lower dose (or
within the plan quantity limit) has been ineffective and a clinically significant trial was
completed.
 The BHMP has ruled out a non-response due to an unrecognized or under-treated comorbid disorder.
 The treatment plan must include ongoing safety monitoring.
Brand Name
Behavioral Health
Medications i
FDA Approved Indication: For adults, BHR has a diagnosis for which requested medication is an FDA
approved treatment indication. For individuals under the age of 18, the BHR must have a diagnosis for
which the requested medication meets the community standard of care.
Aplenzin
Edluar
Emsam
Fanapt
Gralise
Horizant
Intermezzo SL
Intuniv
Lamictal XR
Pexeva
Quillivant XR
Saphris
Seroquel XR
Silenor
Guidelines for Approval:
• Documentation of intolerance, nonresponse or non-adherence to a formulary generic equivalent
formulation of the requested medication at maximal tolerated doses for at least 4 weeks.
• Documentation of intolerance, nonresponse or non-adherence to a formulary generic pharmaceutical
alternative formulation of the requested medication at maximal tolerated doses for at least 4 weeks.
• Documentation of intolerance, non-adherence, or non-response to at least two generic formulary
medications in the same medication class at maximal tolerated doses for at least 4 weeks.
Duration of Approval if
Requirements Are Met
Renewal:
• 12 months
Hospital Discharge:
• 60 days
Initial Approval
• Indefinite
Guidelines for Exceptions:
• Documentation of intolerance/contraindication to other formulary medications (including
documentation of the risk of metabolic syndrome, obesity, diabetes), and documentation for the
reason why the requested medication will ameliorate the risks
• Documentation that the individual has responded to a generic immediate release formulary
Last Update: 09/07/2016
3
Pharmacy Prior Authorization
Title 19/21 SMI
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
Behavioral Health
Guidelines
Suboxone Film
Viibryd
Zolpimist
ADHD medications
for children under
6 years old
Stimulants
(amphetamines,
methylphenidate)
Strattera
guanfacine ER
Kapvay
Clonidine ER
Authorization Requirements/Criteria
medication, but requires the brand name extended release formulation to maintain adherence.
Duration of Approval if
Requirements Are Met
Additional Requirements:
• If BHR preference interferes with compliance to generic equivalent formulation or generic
pharmaceutical alternative formulation, brand name request will be reviewed on a case by case basis.
• If a BHR has been stabilized in another setting on a brand only medication for which there is no generic
equivalent or generic pharmaceutical alternative formulation, then the brand name medication will be
approved.
Coverage is Not Authorized for:
• Indications that have not received FDA approval.
• Doses greater than FDA recommended maximum daily dosage without meeting prior authorization
guidelines for exceeding maximum daily dosage.
FDA Approved Indication: Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
Guidelines for Approval:
• The requesting clinician has documented that the child has a diagnosis of ADHD
• Psychosocial issues and non-medical interventions are being addressed by the clinical team.
• Documentation of psychosocial evaluation occurring before request for ADHD medications.
• Documentation of non-medication alternatives that have been attempted before request for ADHD
medications.
Initial Approval:
6 months
Renewal:
12 months
Additional Requirements: Children under 6 years old will be monitored in accordance with the ADHS/DBHS
Clinical Practice Protocol on Psychiatric Best Practice Guidelines for Children: Birth to Five Years of Age.
Coverage is Not Authorized for:
• Indications other than ADHD
• Doses greater than FDA recommended maximum daily dosage.
Last Update: 09/07/2016
4
Pharmacy Prior Authorization
Title 19/21 SMI
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
Behavioral Health
Guidelines
Antidepressants
with CYP450
mediated drug
interactions ii
TCA with
fluoxetine (strong
2D6 inhibitor)
TCA with
paroxetine (strong
2D6 inhibitor) TCA
with bupropion
(moderate 2D6
inhibitor) TCA with
duloxetine
(moderate 2D6
inhibitor)
TCA with sertraline
(moderate-weak
2D6 inhibitor)
Clomipramine with
fluvoxamine
(strong 1A2
inhibitor)
Bupropion,
clomipramine,
duloxetine,
fluoxetine,
fluvoxamine,
paroxetine,
Authorization Requirements/Criteria
Approved Behavioral Health Indications:
• Treatment Resistant Depression
• Obsessive Compulsive Disorder (clomipramine with fluvoxamine)
Guidelines for Approval:
•
•
•
•
•
Approval will be granted when a member is transitioning from one medication to another.
Evidence of adequate trials of at least three (3) individual formulary antidepressants, from at least two
(2) different therapeutic classes, for 4-6 weeks at maximum tolerated doses.
o Failure is due to:
 Break through symptoms or an inadequate response at maximum tolerated doses, or
 Adverse reaction(s)
Documentation confirming that trials of at least two (2) evidenced based augmentation strategies have
been tried for an adequate trial and failed, resulted in significant side effects, or arec ontraindicated.
Examples of augmentation strategies include lithium, thyroid hormone, bupropion, mirtazapine,
quetiapine, or aripiprazole.
o Failure is due to:
 Inadequate response at maximum tolerated doses,
 Adverse reaction(s), or
 Break through symptoms
Initial TCA treatment should be initiated at the lowest possible dosage.
Supporting clinical documentation must be provided with the initial prior authorization request. These
parameters include the following:
o Assessment showing there is no evidence of cardiovascular conduction delays,
o Heart rate,
o Blood pressure and
o TCA levels.
Additional Requirements:
• Provider must provide supporting documentation that adherence to the treatment regimen is not a
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
Hospital Discharge:
• 60 days
Initial Approval:
• 6 months
Renewal:
• 1 year
5
Pharmacy Prior Authorization
Title 19/21 SMI
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
Behavioral Health
Guidelines
sertraline, tricyclic
antidepressants
Authorization Requirements/Criteria
contributing factor to the inadequate response to the medication trials
Duration of Approval if
Requirements Are Met
Coverage is Not Authorized for:
• Members with known hypersensitivity to the requested medication(s).
• Prior Authorization Requests that do not meet the above stated criteria.
• Members currently taking an MAOI medication.
Antipsychotic
medications in
children under 6
years old
FDA Approved Indication: With the exception of risperidone, antipsychotics have not been approved for use Initial Approval:
in children less than 6 years old. There are few randomized controlled trials to demonstrate safety and
6 months
efficacy in this population.
Renewal:
12 months
Guidelines for Approval:
• Child diagnosed, per current DSM criteria, with one of the following disorders:
o Bipolar Spectrum Disorder
o Schizophrenic Spectrum Disorder
o Tourette’s or other tic disorder
o Autism Spectrum Disorder
• Psychosocial issues and non-medical interventions are being addressed by the clinical team.
• Documentation of psychosocial evaluation occurring before request for antipsychotic medications.
• Documentation of non-medication alternatives that have been attempted to address symptoms before
request for antipsychotic medications.
• Documentation must include information on the expected outcomes and an evaluation of potential
adverse events.
Additional Requirements: Children under 6 years old will be monitored in accordance with the
ADHS/DBHS Clinical Practice Protocol on Psychiatric Best Practice Guidelines for Children: Birth to Five
Years of Age.
Coverage is Not Authorized for:
Last Update: 09/07/2016
6
Pharmacy Prior Authorization
Title 19/21 SMI
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
Behavioral Health
Guidelines
Concomitant
Antidepressant
Treatment iii
2 SSRIs
an SSRI in
combination with
an SNRI
2 SNRIs
2 Tricyclics (TCAs)
Authorization Requirements/Criteria
• Members with known hypersensitivity to requested agent.
• Members not meeting above stated criteria.
Approved Indication: Treatment Resistant Depression
Special Considerations:
• Cross tapers may be approved for up to 60 days per each RBHA’s policy. For greater than 60 days,
Providers must submit a prior authorization request for continued utilization of concomitant use of
two (2) antidepressants for the following:
o Two SSRIs
o An SSRI in combination with an SNRI
o Two SNRIs
o Two Tricyclics (TCAs)
Duration of Approval if
Requirements Are Met
Hospital Discharge:
• 60 days
Initial Approval:
• 60 days for cross taper
• 6 months for non-cross
taper
Renewal:
• 1 year
Guidelines for Approval:
• Approval will be granted when a member is transitioning from one medication to another.
• Evidence of adequate trials of at least three (3) individual formulary antidepressants, from at least two
(2) different therapeutic classes, for 4-6 weeks at maximum tolerated doses.
o Failure is due to:
 An inadequate response at maximum tolerated doses,
 Adverse reaction(s), or
 Break through symptoms.
• Documentation confirming that trials of at least four (4) evidenced based augmentation strategies have
been tried for an adequate trial and failed, resulted in significant side effects, orare contraindicated.
Examples of augmentation strategies include lithium, thyroid hormone, bupropion, mirtazapine,
quetiapine, or aripiprazole).
o Failure is due to:
 Inadequate response at maximum tolerated doses,
 Adverse reaction(s), or
 Break through symptoms
Last Update: 09/07/2016
7
Pharmacy Prior Authorization
Title 19/21 SMI
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
Behavioral Health
Guidelines
Authorization Requirements/Criteria
Duration of Approval if
Requirements Are Met
Additional Requirements:
• Provider must provide supporting documentation that:
o Adherence to the treatment regimen is not a contributing factor to the inadequate response to
the medication trials,
o Appropriate clinical monitoring of target symptoms, adverse reactions including signs and
symptoms of serotonin syndrome, adherence to treatment, suicide risk, heart rate, blood
pressure, and weight has been completed, and
o Appropriate clinical monitoring has been completed for TCAs, which includes but isnot limited
to, pupillary reactive response, thyroid function, liver function, abdominal girth, TCA levels and
an ECG at baseline and follow up.
Concomitant
Antipsychotic
Treatment iv
Coverage is Not Authorized for:
• Members with known hypersensitivity to the requested agent(s).
• Members not meeting the above stated criteria.
• Members currently taking an MAOI medication.
Approved Indications:
• Treatment Refractory
• Schizophrenia spectrum disorders or
• Bipolar disorder, with psychosis and/or severe symptoms
Special Considerations: Cross tapers will automatically be approved for 60 days. Providers must submit a
prior authorization request for continued utilization of concomitant use of any 2 antipsychotics beyond the
60 days allowed for cross tapering.
Guidelines for Approval for refractory schizophrenia spectrum disorder:
• Evidence of adequate trials of at least three (3) individual formulary antipsychotics, one of which is
clozapine, 4-6 weeks of maximum tolerated doses, and failure due to:
o Inadequate response to maximum tolerated dose
Last Update: 09/07/2016
Hospital Discharge:
• 60 days
Initial Approval:
• 60 days for cross taper
• 6 months for non-cross
taper
Renewal:
• 1 year
8
Pharmacy Prior Authorization
Title 19/21 SMI
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
Behavioral Health
Guidelines
Authorization Requirements/Criteria
o
o
Adverse reaction(s),
Break through symptoms
Duration of Approval if
Requirements Are Met
Guidelines for Approval for refractory bipolar disorder with psychosis and/or severe symptoms:
• Evidence of adequate trials of at least four (4) evidence based treatment options dependent upon the
episode type. Trials may include lithium, divalproex, atypical antipsychotic monotherapy,
carbamazepine, haloperidol, lamotrigine, lithium + an anticonvulsant, lithium + an antipsychotic, or an
anticonvulsant + an antipsychotic. Trials should be 4-6 weeks of maximum tolerated doses, with failure
due to:
o Inadequate response to maximum tolerated dose
o Adverse reaction(s),
o Break through symptoms
Additional Requirements: Provider must provide supporting documentation that adherence to the
treatment regimen has not been a contributing factor to the lack of response in the medication trials.
Coverage is Not Authorized for:
• Members with known hypersensitivity to requested medication(s).
• Prior Authorization Requests not meeting the above stated criteria.
Injectable
antipsychotics v
Abilify Maintenna
Invega Sustenna
FDA Approved Indication: BHR has a diagnosis for which the requested medication has an approved FDA
indication. These medications are not approved for use in individuals under the age of 18.
Guidelines for Approval:
• BHR must demonstrate sustained clinical improvement and tolerability on the short acting form of the
requested Brand Name Long Acting agent, and
• Documentation of noncompliance on oral medications, and/or documentation supporting the benefit
of long acting medication in achieving clinical stability.
Last Update: 09/07/2016
Hospital Discharge:
• 60 days
Initial Approva:
• 6 months
Renewal:
9
Pharmacy Prior Authorization
Title 19/21 SMI
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
Behavioral Health
Guidelines
Authorization Requirements/Criteria
Additional Requirements: Prior Authorization for medications covered under this guideline will not
continue beyond 60 days for members receiving oral antipsychotics concomitantly with Brand Name Long
Acting Injectable Antipsychotics
Duration of Approval if
Requirements Are Met
• 1 year
Initial Prior Authorization for Abilify Maintena and Invega Sustenna will be for 6 months. Subsequent Prior
Authorization frequency may be determined by the (T)RBHA, and will be contingent upon evidence of
clinical efficacy and appropriate clinical monitoring.
Coverage is Not Authorized for:
• Doses greater than FDA recommended maximum daily dosage without meeting prior
authorization guidelines for exceeding maximum daily dosage.
• Concomitant use of cytochrome p450 inducers (eg, carbamazepine) and Abilify Maintena
• Individuals under the age of 18
Vivitrol
Physical Health
Guidelines
Actemra vi
Patient must have a diagnosis of alcohol or opioid use disorder and either:
• Patient has failed a trial of oral medication indicated for alcohol or opioid use disorder; or
• The patient’s clinical status indicates instability or non-adherence such that oral medication will not be
taken consistently or a trial will likely fail.
Initial Approval:
• 3 months
Authorization Requirements/Criteria
Duration of Approval if
Requirements Are Met
Initial Approval:
4 months
General Criteria for All Indications:
• Patient is NOT on another biological DMARD or other anti-TNF agent
• Prescribed by, or consultation with, a rheumatologist
• Patient is up to date with all recommended vaccinations
• Patient has been screened for latent TB and hepatitis B
Last Update: 09/07/2016
Renewal:
• 12 months
Renewal:
Indefinite
10
Pharmacy Prior Authorization
Title 19/21 SMI
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
Physical Health
Guidelines
Authorization Requirements/Criteria
•
•
•
Patient has an absolute neutrophil count (ANC) >2000 per mm3.
Patient has a platelet count >100,000 per mm3.
Patient does NOT have elevated ALT or AST >1.5× ULN.
Additional Criteria for Systemic Juvenile Idiopathic Arthritis (SJIA):
• Patient is at least 2 years old
• Patient has continued synovitis in >1 joint despite treatment for at least 1 month with methotrexate or
leflunomide
• Request is for IV use (SQ use is not FDA approved for this indication)
Additional Criteria for Polyarticular Juvenile Idiopathic Arthritis (PJIA):
• Patient is at least 2 years old
• Patient has moderate to severe disease despite an adequate 3-month trial of methotrexate and BOTH
Enbrel and Humira (Note: anti-TNF’s require PA)
• Request is for IV use (SQ use is not FDA approved for this indication)
Additional Criteria for Rheumatoid Arthritis (RA):
• Patient is at least 18 years old
• Patient has moderate or high disease activity despite an adequate 3-month trial of BOTH of the
following:
o 2 different non-biologic DMARD regimens (1 of which must include methotrexate (MTX) unless
contraindicated)
 Monotherapy: MTX, sulfasalazine (SSZ), or leflunomide (LEF)
 Combination: MTX+SSZ+hydroxychloroquine (HCQ), MTX+HCQ, MTX+LEF, MTX+SSZ,
SSZ+HCQ
o BOTH Enbrel and Humira (Note: anti-TNF’s require PA)
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
Requires:
• At least 20% symptom
improvement
• ANC >500 per mm3
• Platelets >50,000 per
mm3
• ALT and AST are <5×
ULN
Dosing:
• SJIA (<30kg): 12mg/kg
every 2 weeks
• SJIA (>30kg): 8mg/kg
every 2 weeks
• PJIA (<30kg): 10mg/kg
every 2 weeks
• PJIA (>30kg): 8mg/kg
every 2 weeks
• RA (IV infusion): initial is
4mg/kg every 4 weeks.
Can be increased to
8mg/kg given every 4
weeks
• RA (SQ, <100kg): 162mg
every other week. Can
be increased to weekly.
• RA (SQ, >100kg): 162mg
weekly
11
Pharmacy Prior Authorization
Title 19/21 SMI
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
Physical Health
Guidelines
Afinitor vii
Ampyra viii
Authorization Requirements/Criteria
Afinitor may be authorized when the following criteria are met:
• Prescribed by an oncologist
• Patient has one of the following diagnoses:
o Recurrent or stage IV hormone receptor positive (ER/PR +) breast cancer that progressed or
recurred while on letrozole or anastrozole:
 Patient is postmenopausal OR premenopausal and has had ovarian
ablation/suppression
 Must be used in combination with exemestane
o Pancreatic neuroendocrine tumors (PNET) that are locally advanced, metastatic or
unresectable
o Tuberous sclerosis complex (TSC) with ONE of the following manifestations:
 Renal angiomyolipoma
 Subependymal giant cell tumor that is unresectable
o Relapsed or stage IV, unresectable, renal cell carcinoma (RCC) of predominant clear cell
histology following treatment with a tyrosine kinase inhibitor (i.e., Sutent, Nexavar, Inlyta, or
Votrient)
o Relapsed or stage IV, unresectable, renal cell carcinoma (RCC) of non-clear cell histology
Afinitor Disperz may be authorized when the following criteria are met:
• Prescribed by an oncologist
• Pediatric patient at least 1 year old
• Diagnosis of tuberous sclerosis complex (TSC) with subependymal giant cell tumor that is unresectable
May be approved when the following criteria are met:
• Prescribed by, or in consultation with a neurologist
• Patient is between 18 and 70 years old
• Diagnosis of multiple sclerosis with impaired walking ability defined as a baseline 25-ft walking test
between 8 and 45 seconds OR Expanded Disability Status Scale (EDSS) between 4.5 and 6.5
• Patient is stabilized on disease modifying therapy for MS (i.e., no recent exacerbations)
• Patient is NOT wheelchair-bound
• Patient does not have a history of seizures
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
1 year
Renewal:
1 year
Continued authorization will
be granted for members
with stable disease (tumor
size within 25% of baseline).
Discontinuation is
appropriate when there is
evidence of disease
progression.
Initial Approval:
• 2 months
Renewal:
• 1 year
Requires:
At least 20% improvement in
12
Pharmacy Prior Authorization
Title 19/21 SMI
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
Physical Health
Guidelines
Authorization Requirements/Criteria
•
Patient does not have moderate to severe renal impairment (Crcl < 50 ml/min)
Anticoagulants Injectable ix
Fragmin, fondaparinux, and enoxaparin should pay at the point of sale for an initial duration of 21 days
without a PA.
Enoxaparin
Fondaparinux
Fragmin
Iprivask
For prescriptions of enoxaparin, fondaparinux, and Fragmin that do not pay at the point of sale, prior
authorization requests can be authorized for the following indications:
• All 3 agents:
o VTE prophylaxis in patients undergoing hip or knee replacement or hip fracture surgery
o VTE treatment in patients who are taking warfarin until the INR is in therapeutic range for 2
days
o Bridge therapy for perioperative warfarin discontinuation
o Prophylaxis or treatment of thrombotic complications in a high risk pregnancy
o VTE prophylaxis in patients with restricted mobility during acute illness
o Treatment of superficial vein thrombosis (SVT) of the lower limb of at least 5 cm in length
o Treatment of acute upper-extremity DVT (UEDVT) that involves the axillary or more proximal
veins
•
Last Update: 09/07/2016
Fragmin and enoxaparin only:
o VTE treatment after trial and failure of warfarin or for patients who are not candidates for
warfarin
o VTE treatment in patients who have cancer
o VTE prophylaxis in cancer patients with solid tumors who are at high risk of thrombosis (i.e.,
previous VTE, immobilization, hormonal therapy, angiogenesis inhibitors, thalidomide, and
lenalidomide)
o VTE prophylaxis in patients with AFib undergoing cardioversion (up to 3 weeks before and 4
weeks after)
o VTE prophylaxis in patients with acute ischemic stroke and restricted mobility
o VTE prophylaxis in patients undergoing general and abdominal-pelvic surgery who are at
Duration of Approval if
Requirements Are Met
timed walking speeds on 25ft walk within 4 weeks of
starting medication
Initial Approval:
• Prophylaxis post ortho
surgery) - Up to 35 days
• Prophylaxis (non-ortho
surgery and major
trauma) - Up to 14 days
• Prophylaxis (postsurgery with CA)- 4
weeks
• VTE treatment, bridge
therapy, acute illness 10 days or as requested
• High risk pregnancy Until 6 weeks after
delivery (EDC required
for authorization)
• Prophylaxis in cancer - 6
months
• Upper extremity DVT - 3
months
• Lower-limb SVT - 45
days
• VTE treatment for
warfarin failure or in
cancer - 6 months
13
Pharmacy Prior Authorization
Title 19/21 SMI
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
Physical Health
Guidelines
Authorization Requirements/Criteria
o
Antidementia
Drugs
galantamine
galantamine ER
memantine soln
rivastigmine caps
rivastigmine patch
moderate to high risk for VTE
VTE prophylaxis in patients with major trauma
Iprivask may be authorized if all the following criteria are met:
• VTE prophylaxis in patients undergoing hip replacement surgery
• Patient had therapeutic failure or intolerance to enoxaparin or Fragmin and fondaparinux
OR
• Patient has contraindication to enoxaparin, fondaparinux, and Fragmin (i.e., allergic to pork, history of
heparin induced thrombocytopenia)
For Patients who meet all of the following:
• Diagnosis of Alzheimer’s disease
• Potential causes for cognitive dysfunction. (eg, cerebrovascular disease, cobalamin [vitamin B-12]
deficiency, syphilis, thyroid disease) has been ruled out.
• Cognitive assessment to evaluate for the presence of dementia;
o Mini-Mental Status Exam (MMSE) score below 22
OR
o Mini-Cog score of ≤ 2 and abnormal CDT (clock drawing test)
o Age restriction: must be at least 18 years old
Anti-TNF Agents
Enbrel, Humira, Remicade, Cimzia, Simponi
Note: Enbrel and Humira are the formulary preferred agents
See Detailed document:
https://www.mercymaricopa.org/assets/pdf/providers/pharmacy/PA%20Guidelines/Anti-TNFs-MMIC.PDF
ARBs x
Non-preferred ARBs can be approved for members who have failed THREE formulary preferred ARBs AND
meet one of the following:
• Treatment of HTN with chronic kidney disease (CKD);
OR
• Treatment of HTN without CKD for patients who have failed a trial with a formulary agent from
Benicar
Edarbi
Eprosartan
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
Renewal:
Length of renewal
authorization based on
anticipated length of
therapy, indication and/or
recent INR if on warfarin
Initial Approval:
• Indefinite
Initial Approval:
Indefinite
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Telmisartan
Botulinum Toxins
Authorization Requirements/Criteria
another class that is considered a first-line treatment per JNC8 (i.e., thiazide-type diuretic, calcium
channel blocker, angiotensin-converting enzyme inhibitor) or require combination therapy to achieve
BP goal
Botox, Myobloc, Dysport, Xeomin
Duration of Approval if
Requirements Are Met
See Detailed document:
https://www.mercymaricopa.org/assets/pdf/providers/pharmacy/PA%20Guidelines/Botulinum-ToxinsMMIC.pdf
Cambia xi
Capecitabinexii
May be authorized for patients who meet the following criteria:
• Diagnosis of migraine headaches
• 18 years of age or older
• Tried and failed at least 2 formulary triptans (e.g., sumatriptan, naratriptan) or has a contraindication
to triptans
• Tried and failed at least 2 formulary NSAIDs (e.g., Ibuprofen, naproxen, diclofenac)
May be authorized when prescribed by an oncologist for patients who are at least 18 years old who
have ANY of the following indications:
• Metastatic colorectal cancer
• Adjuvant (post-surgery) treatment of Dukes’ C colon cancer
• Metastatic breast cancer that is refractory to both paclitaxel and an anthracycline-containing
chemotherapy regimen
• Metastatic breast cancer that is refractory to paclitaxel when the patient is not appropriate for
anthracycline therapy
• Metastatic breast cancer that has progressed on an anthracycline-containing chemotherapy when
used in combination with docetaxel
• Locally advanced anal/rectal cancer when used in combination with radiation
• Pancreatic cancer when used in combination with radiation
• HER2 positive advanced/recurrent or metastatic breast cancer:
o Disease has progressed after receiving prior therapy with an anthracycline (doxorubicin,
Last Update: 09/07/2016
Initial approval:
Indefinite
Limit of 9 packets (1 box per
month)
Initial Approval:
1 year
Renewal:
3 years based on therapeutic
response.
Requires:
• Crcl >30mL/min
• neutrophils >1 × 109/L
• platelets >50 × 109/L
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Authorization Requirements/Criteria
o
daunorubicin, epirubicin, idarubicin), a taxane (paclitaxel, docetaxel), AND trastuzumab
(Herceptin)
Must be used in combination with Tykerb
Duration of Approval if
Requirements Are Met
Note: Capecitabine is contraindicated in severe renal impairement (Crcl <30mL/min).
Caprelsa xiii
Celecoxibxiv
Note: Patients with baseline neutrophil counts of <1.5 × 109/L or platelet counts of <100 × 109/L should
not be treated with capecitabine
May be authorized for adults when the following criteria are met:
• Prescribed by an oncologist
• Patient is at least 18 years old
• No history of congenital long QT syndrome (Black Box Warning)
• Patient meets ONE of the following:
o Diagnosis of locally recurrent or metastatic differentiated thyroid carcinoma (including
papillary, follicular, and Hurthle cell) after surgical resection that is progressive or
symptomatic AND is refractory to radioactive iodine treatment AND Nexavar or Lenvima
o Diagnosis of medullary thyroid cancer and one of the following:
 Local disease progression or recurrence after surgery which is unresectable
 Symptomatic disease progression or recurrence after surgery with distant metastases
 Asymptomatic disease progression or recurrence after surgery with distant metastases
that is unresectable
Celecoxib should pay at the point of sale when ONE of the following step therapy criteria are met
without requiring a PA:
• Patient has filled 3 formulary NSAIDs or tramadol in the previous 180 days
• Patient has filled a PPI, H2 receptor antagonist, prednisone, warfarin, Xarelto, Pradaxa, or Eliquis in the
previous 90 days
Prescriptions that do not pay at the point of sale require prior authorization and may be authorized for
patients who meet the following criteria:
Last Update: 09/07/2016
Initial approval:
1 year
Renewal:
3 years
Initial Approval:
Indefinite
Dose limits:
• OA: 200 mg/day
• RA, acute pain,
dysmenorrhea,
ankylosing spondylitis,
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Authorization Requirements/Criteria
•
•
•
Cialis xv
No recent history (in the past 6 months) of acute coronary syndrome (ACS) or CABG
Age >2 years old for juvenile rheumatoid arthritis (JRA) OR >18 years old for all other indication
Patient meets ONE of the following:
o Was unable to achieve clinical benefit with 3 formulary NSAIDs
o Has a history of NSAID-induced gastritis confirmed by EGD
o Is at high-risk for adverse GI events (e.g., >65 years of age, concomitant corticosteroid or
anticoagulant use, or history of GI bleed, PUD, GERD, or gastritis) AND not currently taking a
daily aspirin
For male patients who meet the following:
• Diagnosis of BPH
• Trial and failure of ALL of the following:
o Alfuzosin
o Tamsulosin
o Finasteride (for at least 6 months) in combination with an alpha-blocker (e.g., alfuzosin,
tamsulosin, doxazosin, terazosin) unless the patient is unable to tolerate an alpha-blocker
NOTE: Use of Cialis for treatment of erectile dysfunction is not a covered benefit.
Colony-Stimulating
Factors (CSF)
Leukine, Neupogen, Neulasta
Cometriq xvi
May be authorized when the following criteria are met:
Duration of Approval if
Requirements Are Met
psoriatic arthritis: 400
mg/day
• JRA:
o >25 kg: 100mg
BID
o 10-25 kg: 50mg
BID
Initial Approval: 3 months
Renewal: 6 months
Requires:
Demonstration of
improvement in BPH
symptoms
QLL: 2.5mg or 5mg; #30
tablets per 30 days (Note:
10mg and 20mg are not
indicated for BPH and not
covered)
See Detailed document:
https://www.mercymaricopa.org/assets/pdf/providers/pharmacy/PA%20Guidelines/Colony_Stimulating_F
actors.pdf
Last Update: 09/07/2016
Initial Approval:
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Authorization Requirements/Criteria
•
•
•
•
•
Cystic Fibrosis
(pulmonary)
Medications xvii
Pulmozyme
Tobi Podhaler
Bethkis
Cayston
Kalydeco
Orkambi
Prescribed by an oncologist
Patient is at least 18 years old
Documented diagnosis of medullary thyroid cancer AND ONE of the following:
o Local disease progression or recurrence after surgery which is unresectable
o Symptomatic disease progression or recurrence after surgery with distant metastases
o Asymptomatic disease progression or recurrence after surgery with distant metastases that is
unresectable
No evidence of moderate or severe hepatic impairment
Patient is not currently taking a strong CYP3A4 inducer or inhibitor
Note: Kitabis and Bethkis are the formulary preferred agents
Pulmozyme will be authorized for patients that meet the following:
• Age >/= 5 years (Per label: Pulmozyme was studied in patients 3 months to 5 years of age; while
clinical trial data are limited in patients <5 years, the use of Pulmozyme should be considered for
pediatric patients with CF who may experience potential benefit in pulmonary function or who may be
at risk of respiratory tract infection.
• Diagnosis of moderate to severe cystic fibrosis OR
• Diagnosis of mild cystic fibrosis after failure of inhaled hypertonic saline
Kitabis and Bethkis are the preferred formulary agents and may be authorized when the following are
met:
• Diagnosis of cystic fibrosis
• Age >/= 6 years
• FEV1 between 25-80% predicted
• Sputum cultures positive for P.aeruginosa
• NOT colonized with Burkholderia cepaciaTobi Podhaler and tobramycin inhaled solution are nonformulary and require trial and failure of Kitabis AND Bethkis
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
1 year - Recommended
dose: 140 mg ORALLY once
daily
Renewal:
3 years - Discontinuation is
appropriate upon disease
progression or drug toxicity
Initial Approval:
Kalydeco/Orkambi:
3 months
All other: indefinite
Renewal
(Kalydeco/Orkambi):
6 months
Requires documentation to
support response to therapy
including current lab results
to support ALT/AST and
bilirubin levels (for Orkambi)
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Requirements Are Met
Cayston will be authorized for patients that meet the following:
• Diagnosis of cystic fibrosis
• Age >/= 7 years
• FEV1 between 25-75% predicted
• Sputum cultures positive for P.aeruginosa
• NOT colonized with Burkholderia cepacia
• Contraindication/intolerance to tobramycin
Kalydeco can be recommended for approval for patients who meet the following:
• Diagnosis of cystic fibrosis with one of the following CFTR gene mutations: G551D, G1244E, G1349D,
G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H
• NOT homozygous for the F508del mutation in the CFTR gene
• Age >/=2 years
Orkambi can be recommended for approval for patients who meet the following:
Prescribed by a pulmonologist
Member is 12 years of age and older
Diagnosis of Cystic Fibrosis and lab results to support homozygous F508Del at the CFTR gene. (If the
patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence
of the F508del mutation on both alleles of the CFTR gene)
• Current lab results to support normal ALT/AST and bilirubin
• NOT taking strong CYP3A inducers such as rifampin, rifabutin, phenobarbital, carbamazepine,
phenytoin, and St. John’s wort
• NOTE: Patients should be on other CF agents to manage and control symptoms (i.e., dornase alpha,
tobramycin, hypertonic saline, or Cayston)
•
•
•
Note: Children under 21 should be referred to CRS
Last Update: 09/07/2016
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Duration of Approval if
Requirements Are Met
Daliresp xviii
For patients who meet all of the following:
• Adult 40 years of age or older
• Prescribed by or in consultation with a pulmonologist
• Diagnosis of severe COPD with chronic bronchitis with FEV1<50% predicted based on postbronchodilator FEV1
• Documented symptomatic exacerbations within the last year while compliant with dual long-acting
bronchodilator treatment [long-acting beta-agonist (LABA) plus long-acting muscarinic antagonist
(LAMA)] for at least 3 months
• Daliresp will be used in conjunction with a LABA and LAMA unless contraindicated/intolerant
• Will not be used in combination with theophylline
Daraprim may be authorized for the treatment and secondary prevention of Toxoplasmosis in patients
with HIV:
• Dose for initial treatment of Toxoplasmosis is 50-75mg per day for 6 weeks
• Dose for secondary prophylaxis after completing initial 6-week treatment is 25-50mg per day to
prevent relapse.
• Secondary prophylaxis may be discontinued when the following apply:
o Patient is asymptomatic
o Patient is receiving antiretroviral therapy (ART)
o Patient has a suppressed HIV viral load
o Patient has maintained a CD4 count >200 cells/microL for at least six months
• Maintenance therapy may be reinitiated if the CD4 cell count declines to <200 cells/microL
Initial Approval:
6 months
Daraprim xix
Daraprim may also be authorized for Pneumocystis Pneumonia (PCP) when the following criteria are
met:
• Patient is allergic to sulfa or has another contraindication to TMP/SMX use
• For PCP prophylaxis in patients with HIV:
o Patient has ONE of the following:
 CD4 count <200 cells/microL
Last Update: 09/07/2016
Renewals:
Indefinite; requires
improvement in the number
of COPD exacerbations
Initial Approval:
• Acute Toxoplasmosis - 6
weeks
• Acute PCP - 21 days
• PCP prophylaxis - 3
months
Renewals:
• Secondary Prophylaxis
after Acute
Toxoplasmosis
treatment - 6 months
• PCP prophylaxis - 3
month; If CD4 count is
<200 or CD4 count % is
<14%
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Oropharyngeal candidiasis
CD4 count percentage <14 percent
CD4 cell count between 200 and 250 cells/microL when frequent monitoring (e.g.,
every three months) of CD4 cell counts is not possible
o Patient has a trial and failure or contraindication to atovaquone AND dapsone
For PCP treatment:
o Patient is diagnosed PCP infection
o Patient has a trial and failure or contraindication to atovaquone
Duration of Approval if
Requirements Are Met



•
Diabetic Testing
Supplies
Daraprim is not covered for treatment or prevention of malaria:
• Daraprim is no longer recommended for malaria treatment or prophylaxis.
• Treatment of malaria is VERY individualized.
• Refer to the CDC website for recommendations for acute treatment of malaria.
o http://www.cdc.gov/malaria/resources/pdf/algorithm.pdf
o http://www.cdc.gov/malaria/diagnosis_treatment/treatment.html
http://www.cdc.gov/malaria/resources/pdf/treatmenttable.pdf.
• Refer to the CDC website for recommendations for prevention of malaria
o http://www.cdc.gov/malaria/travelers/country_table/a.html
Diabetic Test Strip and Glucometer Quantity Limits:
• All diabetic test strips are limited to 150ct/30 days
• Glucometers are limited to 1 glucometer/12 months
Initial Approval:
• Indefinite
Criteria to Receive Non-Formulary Diabetic Supplies
• Member with hematocrit level that is chronically less than 30% or greater than 55%
o Accu-Chek Aviva Plus and Nano SmartView are accurate for Hct 10-65%
o One Touch Verio IQ is accurate for Hct 20-60%
• Member with physical limitation (manual dexterity or visual impairment) that limits utilization of
formulary product
• Member with an insulin pump that requires a specific test strip
Last Update: 09/07/2016
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Duration of Approval if
Requirements Are Met
Criteria to Receive >150 Test Strips Per Month
• Members newly diagnosed with diabetes or with gestational diabetes
• Children with diabetes (age ≤ 12 )
• Members on insulin pump
• Members on high intensity insulin therapy with documentation of need to routinely test more than
4-5 times daily
Direct Renin
Inhibitors xx
Tekturna
Tekturna HCT
Tekamlo
Amturnide
Duavee xxi
Criteria to Receive >1 Glucometer Per Year
• Current glucometer is unsafe, inaccurate, or no longer appropriate based on patients medical
condition
• Current glucometer no longer functions properly, has been damaged, or was lost or stolen.
For patients that meet the following:
• Treatment of HTN
• At least 18 years old
• Inadequate response or inability to tolerate a trial of a formulary ARB AND an ACE inhibitor and at
least one other formulary antihypertensive agent from a different class:
o Thiazide-type diuretic
o Calcium channel blocker
o Beta-blocker
• Will not be used in combination with an ACE inhibitor or an ARB
Note: The long-term benefit on major cardiovascular or renal outcomes with direct renin inhibitors in the
treatment of HTN has not been established, therefore it is recommended to use medications from other
classes first.
Duavee can be approved for adult women under the age of 75 who have an intact uterus and who meet
the following criteria based on indication:
• Treatment of vasomotor symptoms associated with menopause (VMS):
o Patient has failed or has an intolerance to at least 2 formulary estrogen/progestin products
Last Update: 09/07/2016
Initial Approval:
Indefinite
Initial Approval:
5 years
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Authorization Requirements/Criteria
(e.g., estradiol tablets/patch, Prempro, Estrace)
Prevention of postmenopausal osteoporosis:
o Patient has tried and failed (or has contraindication/intolerance to) raloxifene AND
alendronate
o Patient has osteopenia (T-score between -1.0 and -2.5) OR is at high risk for OP fracture (as
defined by any of the following):
 FRAX risk ≥3.0% for hip fracture OR ≥20% for any major OP-related fracture; OR
 Patient has >1 risk factor for fracture:
a. low body mass index
b. previous fragility fracture
c. parental history of hip fracture
d. glucocorticoid treatment
e. current smoking
f. alcohol intake of 3 or more units per day
g. rheumatoid arthritis
h. secondary causes of osteoporosis
May be authorized for treatment of excess abdominal fat in HIV-infected patients with lipodystrophy
when the following are met:
• Patient is 18-65 years of age
• No evidence of active neoplastic disease
• No evidence of acute critical illness
• No disruption of the hypothalamic-pituitary axis (e.g. hypothalamic-pituitary-adrenal (HPA)
suppression) due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, radiation therapy of
the head or head trauma
• Patient is not using Egrifta for weight loss
• Patient is at risk for medical complications due to excess abdominal fat
• If female, patient is not pregnant and is using a reliable form of birth control (pregnancy category X)
Epogen, Procrit, Aranesp
Duration of Approval if
Requirements Are Met
•
Egrifta
ErythropoiesisStimulating Agents
See Detailed document:
Last Update: 09/07/2016
Initial Approval:
1 year
Renewal:
3 years with documentation
of a clinical response
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Duration of Approval if
Requirements Are Met
https://www.mercymaricopa.org/assets/pdf/providers/pharmacy/PA%20Guidelines/ESA-(AranespEpogen-Procrit)-MMIC.pdf
GnRH Analogs xxii
For patients who meet the following based on diagnosis:
Leuprolide acetate
Lupron Depot
Lupron Depot-PED
Eligard
Trelstar
Vantas
Synarel
Supprelin LA
Zoladex
Endometriosis
(Lupron Depot, Synarel, Zoladex [3.6 mg dose only])
• Prescribed by or in consultation with a gynecologist or obstetrician
• 18 years of age or older
• Trial and failure of at least one formulary hormonal cycle control agent (such as Portia, Ocella,
Previfem), medroxyprogesterone, or Danazol
• Patient is not pregnant or breastfeeding
Uterine Leiomyoma (fibroids)
(Lupron Depot, Synarel, Zoladex [3.6 mg dose only])
• Prescribed by or in consultation with a gynecologist or obstetrician
• 18 years of age or older
• Prescribed to improve anemia and/or reduce uterine size for 3-6 months prior to planned surgical
intervention
• Patient is not pregnant or breastfeeding
Dysfunctional Uterine Bleeding
(Zoladex [3.6mg dose only])
• Prescribed by or in consultation with a gynecologist or obstetrician
• 18 years of age or older
• Prescribed to thin endometrium prior to planned endometrial ablation or hysterectomy within the
next 4-8 weeks
• Patient is not pregnant or breastfeeding
Last Update: 09/07/2016
Initial Approval:
Central Precocious Puberty
• Supprelin LA: 12 months
• All others: 6 months
Endometriosis
• 6 months
Uterine Leiomyoma
(fibroids)
• 6 months
Dysfunctional uterine
bleeding
• 2 months
Prostate/Breast Cancer
• 2 years
Renewal:
Central Precocious Puberty
• 6 months - 1 year (up to
age 11 for females and
age 12 for males)
Requires:
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Authorization Requirements/Criteria
Central Precocious Puberty (CPP)
(Lupron Depot-PED, leuprolide acetate solution, Synarel, Supprelin LA)
• Prescribed by, or in consultation with an Endocrinologist
• MRI or CT Scan has been performed to rule out lesions
• Onset of secondary sexual characteristics earlier than 8 years in females and 9 years in males
• Response to a GnRH stimulation test (or if not available, other labs to support CPP such as luteinizing
hormone levels, estradiol and testosterone level)
• Bone age advanced 1 year beyond the chronological age
• Baseline height and weight
• Age restriction (leuprolide acetate solution for injection [once daily regimen]): must be at least 1 year
old
• Age restriction (Lupron Depot-Ped [1-month or 3-month regimen]): must be at least 2 years old
Advanced Prostate Cancer
(Lupron Depot, Leuprolide acetate solution, Eligard, Zoladex,Vantas Trelstar)
• Prescribed by, or in consultation with oncologist or urologist
• Age restriction: must be at least 18 years old
Advanced Breast Cancer
(Zoladex [3.6mg dose only])
• Prescribed by, or in consultation with oncologist
• Age restriction: must be at least 18 years old
Growth Hormone
Genotropin, Humatrope, Norditropin, Nutropin, Omnitrope, Saizen, Tev-Tropin, Zorbtive
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
• Clinical response to
treatment (i.e., pubertal
slowing or decline,
height velocity, bone
age, LH, or estradiol and
testosterone level)
Endometriosis Retreatment
• Lupron only (treatment
with Synarel and
Zoladex not
recommended beyond 6
months): 6 months
Requires:
• Bone mineral density
within normal limits
• Use in combination with
norethindrone acetate
Uterine Leiomyoma
(fibroids) or Dysfunctional
Uterine Bleeding
• Long-term use is not
recommended
• Retreatment may be
considered on a case by
case basis
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Growth Hormone
Antagonists
Somavert
See Detailed document:
https://www.mercymaricopa.org/assets/pdf/providers/pharmacy/PA%20Guidelines/Growth-HormoneAntagonists-MMIC.pdf
Hepatitis C Agents
Please click here for full Policy:
https://www.mercymaricopa.org/assets/pdf/providers/pharmacy/Hepatitis_C_Treatment_Criteria_MMIC.
pdf
Hetlioz xxiii
For patients that meet all of the following:
• At least 18 years old
• Diagnosis of non-24 sleep-wake disorder
• Completely blind with NO light perception
• History of at least 3 months of difficulty initiating sleep, difficulty awakening in the morning, or
excessive daytime sleepiness
• No other concomitant sleep disorder (i.e., sleep apnea, insomnia)
HP Acthar can be authorized for adults when the following criteria are met:
• Prescribed by a neurologist
• Prescribed for ACUTE exacerbation of MS
• Symptoms of current exacerbation include functionally disabling symptoms with objective evidence of
neurologic impairment such as loss of vision, motor symptoms (i.e., partial or full paralysis, spasticity,
clonus), and/or cerebellar symptoms (i.e., gait imbalance, difficulty with coordinated movement,
slurred speech, intention tremor, nystagmus)
• Patient meets ONE of the following:
o Continues to have functionally disabling symptoms despite a 7 day course of high dose IV
HP Acthar for
MS xxiv
HP Acthar
Note that Genotropin, Norditropin and Nutropin are the formulary preferred agents.
See Detailed document:
https://www.mercymaricopa.org/assets/pdf/providers/pharmacy/PA%20Guidelines/Growth_Hormon
e.pdf
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
Initial Approval
Full course/ treatment
duration dependent upon
genotype
Initial Approval
Indefinite
Initial Approval:
3 weeks
Prolonged use may lead to
adrenal insufficiency or
recurrent symptoms which
make it difficult to stop the
treatment, therefore
treatment beyond 3 weeks
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o
Hyperlipidemia
Medications xxv
Rosuvastatin
Lovaza
Vascepa
Epanova
Juxtapid
Kynamro
corticosteroids (i.e., methylprednisolone 1000mg per day) for the CURRENT exacerbation
Had significant side effects with high dose IV corticosteroids
Rosuvastatin can be approved when the following criteria are met:
• Patient is at least 10 years old; AND
• Patient has failed to achieve LDL goal on a compliant regimen of maximum tolerated dose of
atorvastatin;
OR
• Patient requires a high intensity statin (i.e., diagnosis of familial hypercholesterolemia or high ASCVD
risk per provider evaluation) AND patient had a trial and failure of atorvastatin
Non-formulary medications for hypertriglyceridemia (Lovaza, Vascepa, and Epanova) can be approved
when the following criteria are met:
• Patient is at least 18 years old
• Drug will be used as an add-on to lifestyle interventions to include diet and exercise
• Treatment of severe hypertriglyceridemia (triglyceride level greater than or equal to 500 mg/dL)
• Trial and failure of OTC fish oil and at least ONE other formulary medication such as fenofibrate,
fenofibric acid, gemfibrozil, or niacin or contraindication to all formulary agents
Duration of Approval if
Requirements Are Met
for the same episode is not
recommended.
Initial Approval:
Juxtapid, Kynamro:
• 3 months
• All others: 6 months
Renewal:
Juxtapid, Kynamro:
• 6 months
• All others: indefinite
Requires:
Improvement in fasting
lipids and documentation of
recommended safety
monitoring parameters
(such as liver enzymes)
Juxtapid and Kynamro can be approved when ALL of the following criteria are met:
• Diagnosis of homozygous familial hypercholesterolemia with a documented LDL of >300 mg/dl
(within the past 90 days)
• Failure of a compliant, 60 day trial of 2 different high potency statins* (atorvastatin and Crestor) at
maximum tolerated doses used in combination with Zetia, niacin, or a bile acid sequestrant
• Juxtapid or Kynamro will be used in combination with maximum tolerated doses of a statin* in
combination with Zetia, niacin, or a bile acid sequestrant AND lifestyle interventions to include diet
and exercise (low-fat diet recommended, <20% of calories from fat)
• Patient has tried and failed or is not a candidate for LDL apheresis
• Patient is at least 18 years old
Last Update: 09/07/2016
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Authorization Requirements/Criteria
•
•
IL-17
Antagonists xxvi
Cosentyx
Idiopathic
Pulmonary Fibrosis
Agents xxvii
Esbriet
Recommended baseline labs are submitted: Fasting lipid panel, ALT, AST, alk phos, total bili, and
negative pregnancy test (if applicable)
Patient does not have moderate to severe hepatic impairment (Child-Pugh B or C) or active liver
disease
* Exception to statin therapy trials requires documentation of intolerance to at least 2 statins (at least one
trial being a moderate to high potency statin). Documentation will include chart notes supporting skeletal
muscle related symptoms that resolved when statin therapy was discontinued; and documentation the
member has been rechallenged at a lower dose or with a different statin.
May be authorized for Plaque Psoriasis when the following criteria is met:
• Patient is at least 18 years old
• Prescribed by a dermatologist
• Patient is up to date with all recommended vaccinations
• Patient has been screened for latent TB
• Symptoms are not controlled with topical therapy
• Disease has a significant impact on physical, psychological or social wellbeing
• Patient has failed a 3-month compliant trial with MTX or cyclosporine or has a true contraindication to
both
• Psoriasis is severe and extensive (for example, more than 10% of body surface area affected or a PASI
score of more than 10)
• Phototherapy has been ineffective, cannot be used or has resulted in rapid relapse (rapid relapse is
defined as greater than 50% of baseline disease severity within 3 months)
• Patient has failed a compliant, 3-month trial of BOTH Enbrel and Humira or has contraindications to
both
Non-formulary use of Esbriet or Ofev can be approved when the following are met:
• Diagnosis of mild to moderate idiopathic pulmonary fibrosis
o Confirmed by high resolution computed tomography (HRCT), lung biopsy, or bronchoscopy
o Interstitial lung disease cannot be attributed to another cause (i.e., rheumatoid arthritis,
lupus, systemic sclerosis, asbestos exposure, or hypersensitivity pneumonitis)
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
6 months
Renewal:
2 years, with clinical notes
documenting an
improvement (e.g.,
reduction in PASI, decreased
swollen/painful joints)
Initial Approval:
3 months
Renewal:
6 months
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Ofev
Authorization Requirements/Criteria
•
•
•
•
o Forced vital capacity (FVC) between 50 and 80% predicted
Documentation of baseline liver function tests (LFT’s) prior to initiating treatment
Patient age must be 18 years or greater
Patient is not a current smoker
Prescribed by, or in consultation with, a pulmonologist
Note: There is no conclusive evidence to support the use of any drugs to increase the survival of people
with idiopathic pulmonary fibrosis.
Ilaris xxviii
General Criteria for All Indications:
• Patient is NOT on another biological DMARD or other anti-TNF agent
• Prescribed by, or consultation with, a rheumatologist
• Patient is up to date with all recommended vaccinations
• Patient has been screened for latent TB and hepatitis B
Additional Criteria for Systemic Juvenile Idiopathic Arthritis (SJIA):
• Patient is at least 2 years old
• Patient weighs at least 7.5kg
• Patient currently has ACTIVE systemic features (i.e., fever, evanescent rash, lymphadenopathy,
hepatomegaly, splenomegaly, or serositis)
• Patient has continued synovitis in >1 joint despite treatment for at least 1 month with Kineret or
Actemra AND methotrexate or leflunomide (Note: both Kineret and Actemra are also non-formulary
and require PA)
Additional Criteria for Cryopyrin-Associated Periodic Syndromes (CAPS)
• Diagnosis has been confirmed by positive genetic test for NALP3, CIAS1, or NLRP3 mutation
• Patient is at least 4 years old
• Patient weighs at least 15kg
• Patient has failed a 3-month minimum trial of Kineret (Note: Kineret is also non-formulary and requires
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
Requires:
• Documentation of stable
FVC (recommended to
discontinue if there is a
>10% decline in FVC
over a 12 month period)
• Attestation that LFT’s
are being monitored
Initial Approval:
4 months
Renewal:
2 years
Requires:
At least 20% symptom
improvement
Dosing/QLL:
CAPS (>40 kg): 150mg every
8 weeks, 1 vial per 56 days
CAPS (<40 kg): 2mg/kg every
8 weeks, 1 vial per 56 days.
Dose may be increased to
3mg/kg given every 8 weeks
SJIA: 4mg/kg (max 300mg)
every 4 weeks
• QLL for <180mg: 1 vial
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Authorization Requirements/Criteria
Imatinib xxix
Can be authorized for patients who meet the following:
• Prescribed by an oncologist
• Prescribed to treat one of the following FDA-approved or NCCN compendium listed indications:
o Primary treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML)
o Newly diagnosed Ph+ acute lymphoblastic leukemia (Ph+ ALL) in combination with
chemotherapy or corticosteroids
o Relapsed or refractory acute lymphoblastic leukemia (Ph+ ALL)
o Myelodysplastic / myeloproliferative diseases (MDS/MPD) associated with PDGFR (plateletderived growth factor receptor) gene rearrangements in adults
o Aggressive systemic mastocytosis (ASM)
o Adults with Hypereosinophilic syndrome (HES) and / or chronic eosinophilic leukemia (CEL)
o Unresectable, recurrent and / or metastatic dermatofibrosarcoma protuberans (DFSP) in
adults
o Soft tissue sarcoma – Desmoid tumors
o Recurrent bone cancer- chordoma
o Unresectable, recurrent, or metastatic gastrointestinal stromal tumors (GIST)
o Kit (CD117) positive gastrointestinal stromal tumors (GIST) after surgical resection
Increlex
PA)
*This list is not inclusive. All off-label use will be reviewed in nationally recognized compendia for the
determination of medically-accepted indications.
For patients that meet the following:
• Prescribed by or in consultation with pediatric endocrinologist
• Patient is ≥ 2 years old
• No evidence of epiphyseal closure
• No evidence of neoplastic disease
• Documentation supports diagnosis of Growth hormone (GH) gene deletion and development of
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
per 28 days
• QLL for >180mg: 2 vials
per 28 days
Approval Duration:
• GIST, CML, ASM, or
HES/CEL: Yearly
In the presence of
disease progression or a
demonstrated
insufficient response to
therapy, a dose increase
may be considered in
the absence of severe
adverse reactions
and/or cytopenias.
•
All other indications:
Yearly as long as there
is no evidence of
progressive disease or
unacceptable toxicity.
Initial Approval:
6 months
Renewal:
• 6 months if at least
doubling of
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Injectable
Osteoporosis
Agents
Inlyta xxx
Insulin Pens
Authorization Requirements/Criteria
neutralizing antibodies to GH
OR
• Documentation supports a diagnosis of Severe, Primary IGF-1 deficiency
o Height standard deviation score less than or equal to −3
o Basal IGF-1 standard deviation score less than or equal to −3
o Normal or elevated growth hormone levels
o No evidence of secondary forms of IGF-1 deficiency, such as GH deficiency, malnutrition,
hypothyroidism, or chronic treatment with pharmacologic doses of corticosteroids
Forteo, Prolia, Zoledronic
Duration of Approval if
Requirements Are Met
pretreatment growth
velocity
• 1 year if growth velocity
≥ 2.5 cm/yr and
epiphyses are open
See Detailed document:
https://www.mercymaricopa.org/assets/pdf/providers/pharmacy/PA%20Guidelines/Injectable-OP-AgentsMMIC.PDF
May be authorized when the following criteria are met:
• Patient is 18 years of age or older
• Prescribed by an oncologist
• Patient does not have uncontrolled blood pressure
• Patient is not taking a strong CYP3A4 inducer or inhibitor
• Patient has relapsed or stage IV, unresectable, renal cell carcinoma (RCC) of predominant clear cell
histology and has failed treatment with a formulary tyrosine kinase inhibitor (Nexavar, Sutent, or
Votrient). Note: the formulary TKI’s require PA.
Note: Formulary insulin pens will process without PA for members under the age of 19
Humulin N
For patients with diabetes mellitus who meet the following:
Humulin 70/30
• Request is for an insulin that is formulary preferred
Novolog
o Requests for NON-formulary insulins require T/F of 2 formulary insulins within the same class
Humalog
(i.e. rapid, regular, or basal)
Last Update: 09/07/2016
Initial Approval:
1 year
Renewal:
3 years
Requires:
Evidence of stable disease
(tumor size within 25% of
baseline)
Initial Approval:
Indefinite
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Apidra
Toujeo
Tresiba
Ryzodeg
Lantus
Levemir
Authorization Requirements/Criteria
•
•
Duration of Approval if
Requirements Are Met
In addition, for children:
o Patient is a school-aged child requiring multiple daily injections of insulin
In addition, for adults must meet ONE of the following:
o Patient is homeless; OR
o Patient does not have a caregiver who can administer insulin using vials and syringes and is
unable to effectively use insulin vials and syringes to self-administer insulin due to ANY of the
following:
 Patient has uncorrectable visual disturbances (e.g., macular degeneration, retinopathy,
vision uncorrectable by prescription glasses)
 Patient has a physical disability or dexterity problems due to stroke, peripheral
neuropathy, trauma, or other physical condition
 Patient is a brittle diabetic
NOTE: Requests for Toujeo may be approved for patients who require >100 units per day of BASAL insulin
(i.e., Lantus or Levemir). Since Toujeo is not available in vials, patient does NOT need to meet the other
insulin pen criteria.
Interferons xxxi
α-Interferon
Infergen
Intron A
Pegasys
Pegintron
Sylatron
β-Interferon
See Multiple
Sclerosis Agents
Chronic Hepatitis B Infection: (Intron A, Pegasys)
• Patient has HBeAg-positive or HBeAg-negative chronic hepatitis B (HBsAg positive for more than six
months)
• Prescribed by, or in consultation with an infectious disease physician, HIV specialist,
gastroenterologist, hepatologist, or transplant physician
• Patient has compensated liver disease (e.g., normal bilirubin, albumin within normal limits, no
cytopenias)
• There is evidence of viral replication (HBeAg titer and/or HBV DNA levels >20,000 IU/mL for HBeAgpositive patients and >2000 IU/mL for HBeAg-negative patients)
• There is evidence of liver inflammation (e.g., elevated ALT, inflammation or fibrosis on liver biopsy)
• Age restriction (Pegasys): Must be at least 18 years old
• Age restriction (Intron A): Must be at least 1 year old
Last Update: 09/07/2016
Initial Approval:
Hepatitis B:
• Intron A – 16 weeks
• Pegasys – 48 weeks
Malignant Melanoma:
• Intron A: 1 year
• Sylatron: up to 5 years
Osteopetrosis, CGD,
Kaposi’s sarcoma:
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γ-Interferon
Actimmune
Authorization Requirements/Criteria
AIDS-related Kaposi's sarcoma: (Intron A [powder for solution ONLY])
• Prescribed by, or in consultation with an infectious disease physician or HIV specialist
• Not being used for the treatment of visceral AIDS-related Kaposi's sarcoma associated with rapidly
progressive disease
• Patient must be at least 18 years old
Hairy-cell Leukemia: (Intron A)
• Prescribed by, or in consultation with a hematologist/oncologist
• Patient has demonstrated less than complete response to cladribine or pentostatin or has relapsed
within 1 year of demonstrating a complete response
• Patient has indications for treatment such as:
o Systemic symptoms – fatigue, weakness, weight loss, fever, night sweats, recurrent infection
o Symptomatic splenomegaly or adenopathy
o Significant cytopenias – hemoglobin < 12 g/dL, platelets < 100,000/mcL, or ANC < 1000/mcL
• Patient is at least 18 years old
Malignant Melanoma: (Intron A, Sylatron)
• Prescribed by, or in consultation with a hematologist/oncologist
• Patient has undergone surgical resection AND is at high risk for recurrence (e.g., primary tumor > 4
mm thick, presence of ulceration, lymph node involvement)
• Patient is at least 18 years old
Chronic Granulomatous Disease: (Actimmune)
• Prescribed by, or in consultation with an immunologist or infectious disease specialist
• Patient is also receiving antifungal and antibacterial prophylaxis (such as itraconazole and
trimethoprim/sulfamethoxazole)
• Patient is at least 1 year old
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
• 6 months
Hairy cell leukemia:
• 6 months
Condylomata acuminate:
• 3 weeks
All other indications:
• 1 year
Renewal:
Hepatitis B:
• Intron A: additional 16
weeks if still HBeAgpositive
• Intron A: up to 2 years
for HBeAg-negative
patients
Osteopetrosis:
• 1 year if no evidence of
disease progression
CGD:
• 1 year if number and/or
severity of infections has
decreased
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Authorization Requirements/Criteria
Malignant Osteopetrosis: (Actimmune)
• Prescribed by, or in consultation with a hematologist/oncologist
• Prescribed for the treatment of severe, malignant osteopetrosis
• Patient is at least 1 year old
Condylomata acuminata (genital or venereal warts): (Intron A, Alferon N-HPV)
• Patient at least 18 years old
• For intralesional use
• Lesions are small and limited in number
• Trial and failure of topical treatments or surgical technique ( ie imiquimod cream, Condylox,
cryotherapy, laser surgery, electrodessication, surgical excision)
Integrin Receptor
Antagonists for
Inflammatory
Bowel Diseases xxxii
Entyvio
Tysabri
This list is not inclusive. All off-label use will be reviewed in nationally recognized compendia for the
determination of medically-accepted indications.
This guideline describes the criteria for use of Tysabri and Entyvio in inflammatory bowel diseases. To
see the criteria for use in of Tysabri in MS, refer to the section titled, “MS Agents.”
Duration of Approval if
Requirements Are Met
Condylomata acuminate:
• 16 weeks
All other indications:
• 1 year
Initial Approval:
3 months
General Criteria:
• Prescribed by a gastroenterologist
• 18 years of age or older
• Will be used as monotherapy and NOT in combination with antineoplastic, immunosuppressive, or
immunomodulating agents (e.g., azathioprine, 6-mercaptopurine cyclosporine, methotrexate, TNFinhibitors)
First Renewal:
3 months
Additional Criteria for Inducing Remission in Crohn’s Disease: (Tysabri or Entyvio)
STEROID-DEPENDENT CROHN’S :
• Patient meets ONE of the following:
o Relapse occurs within three months of stopping glucocorticoids
o Glucocorticoids cannot be tapered to <10 mg/day within three months without symptom
Additional Renewals:
6 months (if patient is
responding)
Last Update: 09/07/2016
Requires:
At least 20% symptom
improvement
NOTE: If member is unable
34
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Authorization Requirements/Criteria
•
•
recurrence
Patient has failed a compliant, 3-month trial of ONE of the following:
o 6-mercaptopurine(6-MP) or azathioprine (AZA)
o Methotrexate (for patients with a contraindication to 6-MP and AZA)
Patient has failed a compliant, 3-month trial of ONE formulary anti-TNF
Duration of Approval if
Requirements Are Met
to taper off of steroids in the
first 6-months, d/c Tysabri
STEROID-REFRACTORY CROHN’S:
• Inadequate response to IV glucocorticoids within 7-10 days (NOTE: it is recommended to switch to IV
glucocorticoids for patients who are not responding to oral glucocorticoids)
• Patient has failed a compliant, 3-month trial of ONE formulary anti-TNF
Additional Criteria for Steroid-Dependent Ulcerative Colitis: (Entyvio)
• Relapse occurs within three months of stopping glucocorticoids OR tapering prednisone to <10 mg/day
• Patient has failed a compliant, 3-month trial of ONE of the following:
o 6-mercaptopurine(6-MP) or azathioprine (AZA)
o Sulfasalazine 4-6g per day, mesalamine 4.8g per day, or balsalazide 6.75g per day (if patient
has a contraindication to 6-MP and AZA)
• Patient has failed a 3-month trial of ONE formulary anti-TNF
Additional Criteria for Steroid-Refractory Ulcerative Colitis: (Entyvio)
• Inadequate response to IV glucocorticoids within 7-10 days (NOTE: it is recommended to switch to IV
glucocorticoids FIRST for patients who are not responding to oral glucocorticoids)
• Patient meets ONE of the following:
o Patient had a previous failure on 6-MP and AZA or a contraindication to both medications and
is therefore not a candidate for treatment with these agents for current episode
o Patient has symptoms after surgical intervention
o Patient is not a surgical candidate or refuses surgery AND had an inadequate response to
cyclosporine (NOTE: Switching to anti-TNF’s after cyclosporine failure is not recommended by
clinical practice guidelines
Last Update: 09/07/2016
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Authorization Requirements/Criteria
Patient has a contraindication to cyclosporine (NOTE: cyclosporine is used as a bridge therapy
for patients who will be started on the slower acting 6-MP or AZA)
o Patient has failed a 3-month trial of ONE formulary anti-TNF
For patients that meet the following:
• Prescribed by, or in consultation with, a provider of obstetrical care
• Patient is not on Makena (17-hydroxyprogesterone)
• Patient is pregnant with singleton gestation and meets either of the following:
o History of spontaneous preterm birth (i.e. delivery of an infant < 37 weeks gestation)
o Cervical length < 25 mm before 24 weeks of gestation
Duration of Approval if
Requirements Are Met
o
Intravaginal
Progesterone
Products xxxiii
Crinone
Endometrin
First-progesterone
suppositories
Jakafi xxxiv
Criteria for the use in myelofibrosis:
• Patient is at least 18 years old
• Prescribed by, or in consultation with, a hematologist/oncologist
• Diagnosis of primary myelofibrosis, post-polycythemia vera myleofibrosis or post-essential
thrombocythemia myelofibrosis
• Intermediate or high risk disease defined as having two or more of the following risk factors
o Age > 65 years
o Constitutional symptoms (weight loss > 10% from baseline or unexplained fever or excessive
sweats persisting for more than 1 month)
o Hemoglobin < 10g/dL
o WBC count > 25 x 109/L
o Peripheral Blood blasts > 1%
• Baseline complete blood count (CBC) with platelet count of at least 100 X 109/L prior to initiating
therapy
Criteria for the use in polycythemia vera:
• Patient is at least 18 years old
• Prescribed by, or in consultation with, a hematologist/oncologist
Last Update: 09/07/2016
Initial Approval:
Approve as requested until
37 weeks gestation
Begin progesterone use no
earlier than 16 weeks, 0
days and no later than 23
weeks, 6 days
Initial Approval:
6 months
Renewal:
1 year; if benefit is
demonstrated, as evidenced
by spleen size reduction (at
least 35% decrease),
symptom improvement and
absence of disease
progression.
Therapy should be gradually
tapered if patient fails to
achieve at least 35%
decrease from baseline in
spleen volume or
experiences unacceptable
toxicities
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Kineret xxxv
Authorization Requirements/Criteria
• Previous treatment failure with hydroxyurea
• Patient has splenomegaly and requires phlebotomy to control symptoms
• Baseline Hct of 40-45%
General Criteria for All Indications:
• Patient is NOT on another biological DMARD or other anti-TNF agent
• Prescribed by, or consultation with, a rheumatologist
• Patient is up to date with all recommended vaccinations
• Patient has been screened for latent TB and hepatitis B
Additional Criteria for Systemic Juvenile Idiopathic Arthritis (SJIA):
• Patient is at least 2 years old
• Patient currently has ACTIVE systemic features (i.e., fever, evanescent rash, lymphadenopathy,
hepatomegaly, splenomegaly, or serositis) AND synovitis in at least 1 joint; OR
• Patient does NOT have currently ACTIVE systemic features but has continued synovitis in >1 joint
despite treatment for 3 months with MTX or leflunomide
Duration of Approval if
Requirements Are Met
Initial Approval:
4 months
Renewal:
Indefinite
Requires:
At least 20% symptom
improvement
QLL:
30 syringes per 30 days
Additional Criteria for Cryopyrin-Associated Periodic Syndromes (CAPS):
• Diagnosis has been confirmed by positive genetic test for NALP3, CIAS1, or NLRP3 mutation
• Patient is at least 2 years old
Additional Criteria for Rheumatoid Arthritis (RA):
• Patient is at least 18 years old
• Patient has moderate or high disease activity despite an adequate 3-month trial of BOTH of the
following:
o 2 different non-biologic DMARD regimens (1 of which must include methotrexate (MTX) unless
contraindicated)
 Monotherapy: MTX, sulfasalazine (SSZ), or leflunomide (LEF)
 Combination: MTX+SSZ+hydroxychloroquine (HCQ), MTX+HCQ, MTX+LEF, MTX+SSZ,
SSZ+HCQ
Last Update: 09/07/2016
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Authorization Requirements/Criteria
o
Long Acting
Opioids xxxvi
Oxycontin
Butrans Patch
Exalgo
Zohydro ER
Xartemis XR
Nucynta ER
Lyricaxxxvii
BOTH Enbrel and Humira (Note: anti-TNF’s require PA)
Duration of Approval if
Requirements Are Met
Note: Women of reproductive age should be counseled about opioid use during pregnancy and neonatal
abstinence syndrome (NAS)
Initial Approval:
1 year
Criteria for Oxycontin and Non-Formulary Long-Acting Opioids:
• Treatment of malignant pain and pain due to sickle cell anemia (Oxycontin)
OR
• Treatment of chronic non-malignant pain:
o At least 18 years old
o Failed a minimum of 2 week trials of maximum tolerated doses of at least THREE formulary
long-acting agents (i.e., fentanyl patch, morphine sulfate ER, methadone, oxymorphone ER)
one of which must be oxymorphone ER
OR
• Treatment of diabetic peripheral neuropathy (Nucynta ER only):
o At least 18 years old
o Failed an adequate trial (at least 4 weeks at maximum tolerated doses) of duloxetine and
tramadol and at least ONE additional formulary medication (i.e., gabapentin, amitriptyline,
nortriptyline, or topical capsaicin)
o
Lyrica is authorized for members who are 18 years of age or older with a diagnosis of post herpetic
neuralgia and partial onset seizures.
Renewal:
1 year
NOTE: QL’s may exist
Initial Approval:
Indefinite
Criteria for the diagnosis of fibromyalgia:
• Patient is 18 years of age or older
• Failure of a compliant 3-month trial of BOTH of the following:
o Duloxetine at maximum tolerated doses
o Gabapentin OR a tricyclic antidepressant (i.e., amitriptyline or nortriptyline) at maximum
tolerated doses
Last Update: 09/07/2016
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Authorization Requirements/Criteria
Duration of Approval if
Requirements Are Met
Criteria for the diagnosis of neuropathic pain associated with diabetic peripheral neuropathy, spinal
cord injury, or cancer-related neuropathic pain:
• Patient is 18 years of age or older
• Trial and failure of a compliant 3-month trial of duloxetine AND at least 1 other generic formulary
agent such as topical capsaicin, tricyclic antidepressants, tramadol, venlafaxine, or gabapentin at
maximum tolerated doses
Makena xxxviii
Modafinil
Armodafinil xxxix
For members who meet the following criteria:
• Prescribed by, or in consultation with, a provider of obstetrical care
• Patient is currently pregnant with singleton gestation
• Patient has a history of a spontaneous preterm singleton delivery (i.e. delivery of an infant < 37 weeks
gestation)
Initial Approval:
Until 37 weeks gestation
Modafanil is the preferred formulary agent, however still requires PA. Armodafinil is non-formulary and
may be authorized if the patient meets criteria and also has a documented trial and failure of modafanil.
Initial Approval:
6 months
May be authorized for patients at least 17 years old for excessive daytime sleepiness associated with
narcolepsy when the following is met:
• Diagnostic testing, such as multiple sleep latency test (MSLT) or polysomnography, supports
diagnosis of narcolepsy
Renewal:
1 year
May be authorized for patients at least 17 years old for excessive daytime sleepiness associated with
Obstructive Sleep Apnea (OSA) when the following is met:
• Prescribed by, or in consultation with, a sleep specialist
• Polysomnography has confirmed the diagnosis of OSA
• Patient remains symptomatic despite compliance with CPAP or BIPAP for at least 1 month
Last Update: 09/07/2016
Injections begin no earlier
than 16 weeks, 0 days and
no later than 23 weeks, 6
days
Requires:
• Response to treatment
• For OSA: patient must
be compliant with CPAP
or BIPAP
• For SWD: patient must
still be a shift-worker
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•
•
Duration of Approval if
Requirements Are Met
CPAP or BIPAP will be continued after modafinil or armodafinil is started
The daytime fatigue is significantly impacting, impairing, or compromising the patient’s ability to
function normally
May be authorized for patients at least 17 years old for excessive daytime sleepiness associated with
Shift-Work Disorder (SWD) when the following is met:
• Prescribed by, or in consultation with, a sleep specialist
• Polysomnography has ruled out other types of sleep disorders
• Symptoms have been present for >3 months
• The sleepiness is significantly impacting, impairing, or compromising the patient’s ability to function
normally
May be authorized for patients at least 17 years old for the treatment of excessive sleepiness
associated with idiopathic hypersomnia when the following criteria is met:
• Prescribed by, or in consultation with, a sleep specialist
• Trial and failure of 2 formulary stimulants (e.g., amphetamine/dextroamphetamine,
methylphenidate)
• Diagnosis is supported by polysomnography, MSLT, and clinical evaluation including the following:
o Daily periods of irrepressible need to sleep or daytime lapses into sleep for at least three
months
o MSLT documents fewer than two sleep-onset rapid eye movement periods (SOREMPs), or no
SOREMPs if the REM sleep latency on the preceding polysomnogram was ≤15 minutes
o The presence of at least one of the following:
 MSLT shows a mean sleep latency of ≤8 minutes
 Total 24-hour sleep time is ≥660 minutes (typically 12 to 14 hours) on 24-hour
polysomnography or by wrist actigraphy in association with a sleep log
o Other causes of sleep disorder have been ruled out
• The sleepiness is significantly impacting, impairing, or compromising the patient’s ability to function
normally
Last Update: 09/07/2016
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Multaq xl
Multiple Sclerosis
Agents
Authorization Requirements/Criteria
May be authorized for adult patients, 18 years of age and older, who meet the following criteria:
• Must be prescribed by, or in consultation with a cardiologist
• Patient does not have any contraindications to Multaq
• Diagnosis of paroxysmal or persistent atrial fibrillation with intent of cardioversion to normal sinus
rhythm
• Trial and failure of, or contraindication to amiodarone
• Patient is not currently using the following medications:
o Statin > 10mg, sirolimus, tacrolimus,
o Class I antiarrhythmics: quinidine, procainamide, disopyramide, lidocaine, mexiletine,
flecainide, propafenone
o Class III antiarhythmics: dofetilide, sotalol, ibutilide
Aubagio, Avonex, Betaseron, Copaxone, Extavia, Gilenya, Lemtrada, Mitoxantrone, Plegridy, Rebif,
Tecfidera, Tysabri
Duration of Approval if
Requirements Are Met
Initial Approval:
6 months
See Detailed document: https://www.mercymaricopa.org/assets/pdf/providers/pharmacy/MS-DiseaseModifying-Agents-MMIC.pdf
Neumega
May be authorized for the treatment of chemotherapy-induced thrombocytopenia when the following
are met:
• Prescribed by a hematologist/oncologist
• Patient is at least 12 years old
• Patient has a non-myeloid malignancy and is receiving myelosuppressive chemotherapy
• Patient is at high risk of severe thrombocytopenia or has experienced severe thrombocytopenia with a
previous chemotherapy cycle
• Administered 6 – 24 hours after the completion of chemotherapy
• NOT being used in the following situations:
o After myeloablative therapy
o Chemotherapy regimen longer than 5 days
o Concurrently with agents associated with delayed myelosuppression (e.g., nitrosoureas,
Last Update: 09/07/2016
Initial Approval:
• Up to 21 days’ supply
• Refills if number of
cycles provided
Renewal:
• Approval up to 1 year
• Requires recent platelet
count
41
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Authorization Requirements/Criteria
Nexavar xli
Nexavar, when prescribed by an oncologist for patients at least 18 years old, can be authorized for the
following indications:
• Treatment of relapsed or unresectable stage IV predominantly clear cell renal cell carcinoma (RCC)
after treatment failure with Sutent or Votrient
• Treatment of relapsed or unresectable stage IV NON-clear cell renal cell carcinoma (RCC) after
treatment failure with Sutent
• Treatment of unresectable hepatocellular carcinoma in a patient who is not a transplant candidate
• Treatment of metastatic hepatocellular carcinoma
• Treatment of differentiated thyroid carcinoma that is refractory to radioactive iodine treatment
mitomycin C)
Duration of Approval if
Requirements Are Met
Initial Approval:
1 year
Renewal:
3 years if evidence of stable
disease (tumor size within
25% of baseline)
Note: Patients with advanced cardiac conditions should not receive Nexavar
Non-Calcium Based
Phosphate
Binders xlii
Fosrenol
Velphoro
Onychomycosis
and Tinea xliii
Luzu
Jublia
Note: Nexavar should not be used in combination with a strong CYP3A4 inducer (e.g., dexamethasone,
phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's Wort) unless there is
no alternative to the CYP3A4 inducer
For patients that meet all of the following:
• Treatment of hyperphosphatemia due to ESRD
• Receiving dialysis
• At least 18 years old
• Failed Renvela or Renagel (sevelamer) AND failed a calcium-based phosphate binder or has
contraindications to both. (Note: Patients with elevated total serum calcium after correcting for
albumin should not receive a calcium-based product)
Luzu can be approved as non-formulary for members who meet the following:
• Topical treatment of tinea pedis, tinea cruris, and tinea corporis.
• At least 18 years old
• Failure of OR contraindication to terbinafine cream
• Failure of at least 1 other formulary topical antifungal agents (i.e. clotrimazole, ciclopirox, econazole,
Last Update: 09/07/2016
Initial Approval:
Indefinite
Initial Approval:
• Jublia or Kerydin: 48
weeks
• Luzu: 30 days
42
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Kerydin
Orencia[viii]
Authorization Requirements/Criteria
ketoconazole, miconazole, etc.) OR contraindication to all formulary agents
Jublia or Kerydin can be approved as non-formulary for members who meet the following:
• Treatment of onychomycosis of the toenails with ONE of the following comorbidities:
o Diabetes
o HIV
o Immunosuppression (i.e. receiving chemotherapy, taking long term oral corticosteroids,
taking anti-rejection medications)
o Peripheral vascular disease
o Pain caused by the onychomycosis
• At least 18 years old
• Failure of 2 OR contraindication to all formulary antifungal agents indicated for onychomycosis (i.e.
ciclopirox, griseofulvin, itraconazole and terbinafine tablets)
General authorization criteria for all indications:
• Prescribed by a rheumatologist
• Patient is NOT on another biological DMARD
• Patient is up to date with all recommended vaccinations
• Patient has been screened for latent TB and hepatitis B
In addition, May be authorized for Rheumatoid Arthritis (RA) when the following are met:
• Patient is at least 18 years old
• If patient has COPD, the prescriber confirms that the benefit of using Orencia outweighs the risk in the
patient
• Patient has moderate or high disease activity despite an adequate 3-month trial of BOTH of the
following:
o 2 different oral DMARD regimens (1 of which must include methotrexate (MTX) unless
contraindicated)
 Monotherapy: MTX, sulfasalazine (SSZ), or leflunomide (LEF)
 Combination: MTX+SSZ+hydroxychloroquine (HCQ), MTX+HCQ, MTX+LEF, MTX+SSZ,
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
Renewal:
• Luzu: 30 days if
responding to therapy
Initial Approval: 4 months
Renewals: Indefinite
Requires:
At least 20% symptom
improvement
43
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Authorization Requirements/Criteria
o
Otezlaxliv
SSZ+HCQ
Humira AND Enbrel (Note: these agents also require PA)
In addition, May be authorized for Juvenile Idiopathic Arthritis (JIA) when the following are met:
• Patient is at least 6 years old
• Request is for the IV formulation
• For SEVERE Polyarticular JIA:
o Patient has failed an adequate 3-month trial with BOTH Humira and Enbrel
• For MODERATE Polyarticular JIA:
o Patient has failed an adequate 3-month trial of MTX
o Patient has failed an adequate 3-month trial of BOTH Enbrel and Humira
• For Systemic JIA:
o Patient does NOT have currently ACTIVE systemic features (i.e., fever, evanescent rash,
lymphadenopathy, hepatomegaly, splenomegaly, or serositis)
o Patient has continued synovitis in >1 joint despite treatment for 3 months with MTX or
leflunomide AND both Humira and Enbrel
Criteria for Psoriatic Arthritis (PsA):
• Patient is at least 18 years old
• Prescribed by or in consultation with a rheumatologist
• Patient is currently on an NSAID and will be continued when Otezla is initiated OR has a
contraindication to NSAID use
• Patient has active PsA (>3 swollen/tender joints) despite a 3-month trial of adequate dose MTX (or
leflunomide or sulfasalazine if MTX is contraindicated) AND Enbrel AND Humira
Criteria for Plaque Psoriasis:
• Patient is at least 18 years old
• Prescribed by or in consultation with a dermatologist
• Symptoms are not controlled with topical therapy
• Disease has a significant impact on physical, psychological or social wellbeing
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
• 4 months
Renewal:
• 12 months
Requires:
• At least 20% symptom
improvement
• Patient is not
experiencing depression
and/or suicidal
thoughts.
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Authorization Requirements/Criteria
•
PCSK9’s xlv
Repatha
Praluent
Patient has failed a 3-month compliant trial with MTX or cyclosporine or has a true contraindication to
both
• Patient has failed a 3-month compliant trial with Enbrel AND Humira
• Psoriasis is severe and extensive (for example, more than 10% of body surface area affected or a PASI
score of more than 10)
• Phototherapy has been ineffective, cannot be used or has resulted in rapid relapse (rapid relapse is
defined as greater than 50% of baseline disease severity within 3 months)
Criteria for all patients and indications:
• Current lipid panel results within the past 90 days
• Failed an adequate 60 day trial of 2 high intensity statins* ( e.g., atorvastatin ≥ 40 mg and rosuvastatin
≥ 20 mg) at maximum tolerated doses and in combination with other lipid lowering therapies such as
Zetia (ezetimibe), bile acid sequestrants or niacin
• Will be used in combination with maximum tolerated dosed statin* and other lipid lowering therapies
such as Zetia (ezetimibe), bile acid sequestrants or niacin or LDL apheresis
Additional Criteria based on Indication:
• ASCVD (For Repatha or Praluent):
o There is supporting evidence of high CVD risk (i.e., history of acute coronary syndrome, history
of MI, stable or unstable angina, coronary or other revascularization (PCI/CABG), stroke, TIA,
Peripheral Arterial Disease (PAD) presumed to be of atherosclerotic origin)
o Lab results to support an LDL ≥ 70 mg/dL (treated)
• Heterozygous Familial Hypercholesterolemia (HeFH) (For Repatha or Praluent):
o There is evidence of ONE of the following:
 LDL-C > 190 mg/dL (age ≥ 18 years) either pretreatment or highest on treatment and
physical evidence of tendon xanthomas or evidence of these signs in a 1st or 2nd
degree relative
 DNA based evidence of an LDL receptor (LDLR) mutation, APO-B100, or PCSK9
mutation or
 Who/Dutch Lipid Network Criteria result with a score of > 8 points
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
• Patient’s BMI is >18.5
QLL (after initial 5 day
titration): 60 tablets per 30
days
Initial Approval: 3 months
Renewal: 6 months
Requires:
• Current Lipid Panel
within the past 3
months
• Claims history to
support compliance or
adherence
• LDL reduction from
baseline
Age Restriction:
• Praluent: at least 18
years old
• Repatha for HeFH or
ASCVD: at least 18 years
old
• Repatha for HoFH: at
least 13 years old
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Authorization Requirements/Criteria
•
o Lab results to support a current LDL ≥ 70 mg/dL on treatment
Homozygous Familial Hypercholesterolemia (HoFH) (For Repatha only):
o Genetic confirmation of 2 mutant alleles at LDLR, APO-B100, or PCSK9
OR
o History of untreated LDL at 500mg/dL or LDL 300mg/dL on maximum dosed statin AND
evidence of ONE of the following:
 Presence of cutaneous xanthoma before the age of 10
 HeFH in both parents
o LDL reduction was <50% on current lipid lowering therapy (high intensity statin + another
treatment)
* Exception to statin therapy trials requires documentation of intolerance to at least 2 statins (at least one
trial being a moderate to high potency statin). Documentation will include chart notes supporting skeletal
muscle related symptoms that resolved when statin therapy was discontinued; and documentation the
member has been rechallenged at a lower dose or with a different statin.
Pulmonary Arterial
Hypertension
(PAH)
Adcirca, Adempas, epoprostenol, Letairis, Opsumit, Remodulin, Revatio (sildenafil), Tracleer, Tyvaso,
Ventavis, Uptravi
Platelet
Inhibitors xlvi
Effient or Brilinta can be approved for patients who meet the following:
• Diagnosis of ACS (unstable angina, STEMI, NSTEMI)
• Failure or contraindication/intolerance to clopidogrel, including patients identified as CYP2C19 poor
metabolizers
• No active pathological bleeding, history of intracranial hemorrhage, or planned CABG
Effient
Brilinta
Duration of Approval if
Requirements Are Met
QLL:
• Praluent: 2 syringes per
28 days
• Repatha (for ASCVD or
HeFH): 2 syringes per 28
days. May be increased
to 3 (140mg) syringes
OR 1 (420mg) syringe
per 28 days if LDL is >70
after initial trial
• Repatha (for HoFH): 3
(140mg) syringes OR 1
(420mg) syringe per 28
days
See Detailed Document:
https://www.mercymaricopa.org/assets/pdf/providers/pharmacy/PA%20Guidelines/Pulmonary_Hyperten
sion.pdf
Last Update: 09/07/2016
Initial Approval:
Effient and Brilinta:
• 12 months
• Indefinite approval can
46
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Zontivity
Authorization Requirements/Criteria
•
•
Promactaxlvii
In addition, for Effient:
o Age <75 unless patient is considered high thromboembolic risk
o Taking concomitant 75-325mg/day aspirin
o No history of TIA or stroke
In addition, for Brilinta:
o Taking concomitant 75-100mg/day aspirin
o No severe hepatic impairment
o No concomitant use with medications known to interact with Brilinta (i.e., potent CYP3A4
inhibitors/inducers and simvastatin or lovastatin in doses >40mg/day) without provider
documentation that benefit outweighs the risk
Zontivity can be approved for patients who meet the following:
• Prescribed for the secondary prevention of atherothrombosis in patients with PAD or history of MI
(drug NOT indicated for ACS)
• Must be used with aspirin and/or clopidogrel according to the standard of care for the patient’s
diagnosis
• No evidence of contraindications: history of stroke, transient ischemic attack (TIA), or intracranial
hemorrhage (ICH); or active pathological bleeding
Chronic idiopathic thrombocytopenic purpura (ITP):
• Patient is at least 1 year old
• Patient had insufficient response to corticosteroids, immunoglobulins, or splenectomy
• Promacta is being used to prevent major bleeding in a patient with a platelet count of <30,000/mm3
and NOT in an attempt to achieve platelet counts in the normal range i.e., 150,000-450,000/mm3
Hepatitis C with thrombocytopenia:
• Patient is at least 18 years old
• Patient has chronic hepatitis C with baseline thrombocytopenia (platelet count < 90,000/mm3) which
prevents initiation of interferon-based therapy when interferon is required
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
be given to patients with
history of stent
thrombosis or restenosis
Zontivity:
• Indefinite
Renewals:
Effient and Brilinta:
• 12 months
Requires:
Documentation from
cardiologist that risk of
thrombosis outweighs
bleeding risk with long-term
use of antiplatelets
Initial Approval: 4 weeks
Renewal:
• ITP (with PLT increase to
>50,000): Indefinite at
current dose.
• ITP (without PLT
increase to >50,000): 4
additional weeks with
dose increase to 75mg.
• HCV (with PLT increase
47
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Severe aplastic anemia:
• Patient is at least 18 years old
• Diagnosis of severe aplastic anemia is confirmed by ONE of the following:
o Bone marrow biopsy showing <25% of normal cellularity; OR
o Bone marrow biopsy showing <50% of normal cellularity AND at least TWO of the following:
 Absolute neutrophil count <500/mm3
 Platelet count <20,000/mm3
 Absolute reticulocyte count <40,000/mm3 (value may be given as percent of RBCs)
• Anemia is refractory to a previous first line treatment including hematopoietic cell transplantation or
immunosuppressive therapy with a combination of cyclosporine A and antithymocyte globulin (ATG)
When to Discontinue Promacta:
• Decrease dose if PLT >200,000 and stop if >400,000.
• ITP: If PLT is NOT >50,000 after 4 weeks of 75mg dose, discontinue treatment.
• HCV: If PLT is NOT >90,000 after 8 weeks or on max dose of 100mg, discontinue treatment.
• Aplastic Anemia: Discontinue if NONE of the following occur after 16 weeks; 1) platelet increase by
20,000 above baseline; 2) Stable platelet counts with transfusion independence for >8 weeks; 3)
hemoglobin increase by >1.5 g/dL; 4) Decrease of >4 units of RBC transfusions for 8 consecutive weeks;
5) Doubling of baseline ANC or an increase >500.
Ranexa xlviii
For patients age 18 years of age or older who meet all of the following:
• Diagnosis of chronic angina
• Patient meets ONE of the following:
o Ranexa is prescribed as ADD-on therapy after failure to achieve therapeutic benefit on at
least 1 formulary agent from EACH of the following 3 drug classes:
 Beta blockers: acebutolol, atenolol, carvedilol, metoprolol, nadolol, propranolol
 Calcium channel blockers: amlodipine, diltiazem, felodipine, isradipine, nifedipine,
nicardipine, verapamil
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
to >90,000): Duration of
Peg-INF treatment
• HCV (without PLT
increase to >90,000): 4
additional weeks with a
dose increase of 25mg
every 2 weeks until
platelets are >90,000 or
to a maximum of
100mg.
• Aplastic anemia (with
PLT increase to
>50,000): Indefinite at
current dose.
• Aplastic Anemia
(without PLT increase to
>50,000): Every 4 weeks
with a dose increase of
50mg every 2 weeks
until PLT >50,000 or to a
maximum of 150mg.
Initial Approval:
Indefinite
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Authorization Requirements/Criteria
 Long acting nitrates: Isosorbide dinitrate, isosorbide mononitrate, nitroglycerin patch
Has a documented contraindication or intolerance to beta blockers, calcium channel blockers, AND
long-acting nitrates
Rectiv may be authorized when the following criteria are met:
• Patient has a diagnosis of pain associated with anal fissures.
Duration of Approval if
Requirements Are Met
•
Rectiv
Revlimid xlix
Savella l
May be authorized when prescribed by an oncologist for patients at least 18 years old for any of the
following diagnoses:
• Multiple myeloma (MM) when used with dexamethasone
• Mantle cell lymphoma (MCL) after relapse or progression with two prior therapies, one of which
includes Velcade®(bortezomib)
• Transfusion-dependent anemia associated with low- or intermediate-1 risk myelodysplastic
syndrome (MDS) POSITIVE for the del(5q) cytogenetic abnormality. (Transfusion dependence is
defined as having ≥ 2 units of red blood cells within 8 weeks of treatment)
• Transfusion-dependent anemia associated with low- or intermediate-1 risk MDS that is NEGATIVE for
the del(5q) cytogenetic abnormality AND
o serum EPO >500 mU/mL AND
o Patient has any of the following characteristics:
 Age >60 years old
 >5% marrow blasts
 Non-hypocellular marrow
 HLA-DR15 negative
 PNH clone negative
For Patients who meet all of the following:
• 13 years of age or older
• Diagnosis of fibromyalgia or juvenile fibromyalgia
• Failure of a 2-month, consecutive trial of at least ONE formulary medication used in fibromyalgia such
Last Update: 09/07/2016
Initial Approval:
6 months
Renewal:
1 year
Initial Approval:
6 months
Renewal:
MDS:
6 months if benefit is
demonstrated, as evidenced
by transfusion
independence within the
past two months.
Multiple Myeloma, Mantle
Cell Lymphoma:
6 months if benefit is
demonstrated, as evidenced
by absence of disease
progression.
Initial Approval: Indefinite
QLL: 200mg per day
49
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Authorization Requirements/Criteria
Second Generation
Tyrosine Kinase
Inhibitors for CML
and ALL li
Imatinib (a first generation TKI) is the preferred agent for CML and ALL (see imatinib guideline for
coverage criteria). Imatinib should NOT be used in patients who have had a treatment failure with a
second generation TKI. Tasigna is the formulary preferred second generation TKI.
Bosulif
Iclusig
Sprycel
Tasigna
as duloxetine, amitriptyline/nortriptyline, gabapentin, cyclobenazeprine, or tramadol
Non-preferred TKI’s when prescribed for adult patients (at least 18 years of age) by an oncologist may
be authorized when the following criteria are met:
• Patient has ONE of the following diagnoses:
o Philadelphia chromosome positive or BCR-ABL1 positive chronic myeloid leukemia (Ph+ CML)
in chronic phase or accelerated phase
o Relapsed, refractory Ph+ CML in blast phase when it is of lymphoid type (not myeloid)
o Relapsed, refractory Ph+ acute lymphoblastic leukemia (Ph+ ALL)
• In addition for Tasigna (formulary with PA) patient has ONE of the following:
o Intolerance, disease progression, or resistance to prior therapy with imatinib
o Presence of any of the following mutations that are resistant to imatinib: F317L/V/I/C,
T315A, V299L
o Intolerance, disease progression, or resistance to prior therapy with a second generation TKI
(Sprycel, Bosulif, or Iclusig)
• In addition for Sprycel or Bosulif (non-formulary) patient has ONE of the following:
o Intolerance, disease progression, or resistance to prior therapy with imatinib AND Tasigna
o Presence of any of the following mutations that are resistant to imatinib and Tasigna: Y253H,
E255K/V, F359V/C/I
o Intolerance, disease progression, or resistance to prior therapy with a second generation TKI
(Tasigna, Bosulif, Sprycel or Iclusig)
• In addition for Iclusig (non-formulary) patient has ONE of the following:
o Presence of the T315I mutation that is resistant to other TKI’s
o Intolerance, disease progression, or resistance to prior therapy with 2 different TKI’s
(imatinib, Tasigna, Sprycel, or Bosulif)
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
1 year
Renewal:
• 3 years approved as long
as there is no evidence
of disease progression or
unacceptable toxicity.
• Renewals should be
based on documentation
of major cytogenetic
response (≤35% Ph+
metaphases) and until
disease progression or
death.
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Somatostatin
Analogs
Authorization Requirements/Criteria
Octreotide, Sandostatin LAR, Signifor, Signifor LAR
Duration of Approval if
Requirements Are Met
See Detailed document:
Somatostatin-Analog
s-MMIC.pdf
Stelara lii
May be authorized for Plaque Psoriasis when the following criteria is met:
• Patient is at least 18 years old
• Prescribed by a dermatologist
• Symptoms are not controlled with topical therapy
• Disease has a significant impact on physical, psychological or social wellbeing
• Patient has failed a 3-month compliant trial with MTX or cyclosporine or has a true contraindication to
both
• Psoriasis is severe and extensive (for example, more than 10% of body surface area affected or a PASI
score of more than 10)
• Phototherapy has been ineffective, cannot be used or has resulted in rapid relapse (rapid relapse is
defined as greater than 50% of baseline disease severity within 3 months)
• Patient has failed a compliant, 3-month trial of BOTH Enbrel and Humira
May be authorized for Psoriatic Arthritis when the following criteria is met:
• Patient is at least 18 years old
• Prescribed by a dermatologist or rheumatologist
• Patient is currently on an NSAID which will be continued when Stelara is initiated OR has a
contraindication to NSAID use
• Patient meets ONE of the following:
o Has active PsA despite a 3-month trial of adequate dose MTX (or leflunomide or sulfasalazine if
MTX is contraindicated)
Last Update: 09/07/2016
Initial Approval:
6 months
Renewal:
2 years, with clinical notes
documenting an
improvement (e.g.,
reduction in PASI, decreased
swollen/painful joints)
NOTE: Safety and efficacy of
ustekinumab have not been
established beyond 2 years
of use
51
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Authorization Requirements/Criteria
Patient has predominantly axial disease AND active PsA despite a 3-month trial of TWO
different NSIADs at an adequate dose OR has a contraindication to NSAID use
• Patient has failed a compliant, 3-month trial of at BOTH Enbrel and Humira
May be authorized when the following criteria is met:
• Prescribed by a gastroenterologist, endocrinologist, or genetic specialist
• Member does not have secondary (acquired) disaccharidase deficiencies
• Documentation to support the diagnosis of congenital sucrose-isomaltase deficiency has been
submitted:
o Diagnosis of congenital sucrose-isomaltase deficiency has been confirmed by low sucrose
activity on duodenal biopsy and other disaccharidases normal on same duodenal biopsy
o If small bowel biopsy is clinically inappropriate, difficult, or inconvenient to perform, the
following diagnostic tests are acceptable alternatives (all must be performed and results
submitted):
 Stool pH less than 6; AND
 Breath hydrogen increase greater than 10 ppm following fasting sucrose challenge;
AND
 Negative lactose breath test
Can be authorized when prescribed by an oncologist for adult patients (at least 18 years old), for the
following indications:
• Treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to
imatinib
• Treatment of relapsed or unresectable stage IV renal cell carcinoma (RCC)
• Treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients
with unresectable locally advanced or metastatic disease in combination with or after disease
progression on a somatostatin analog (i.e. octreotide, Sandostatin LAR)
o Patients with an insulinoma do not require treatment with a somatostatin analog for approval
Duration of Approval if
Requirements Are Met
o
Sucraid
Sutent liii
Initial Approval: 2 months
Renewal: 12 months
Requires:
Documentation to support a
response to treatment with
Sucraid (weight gain,
decreased diarrhea,
increased caloric intake,
decreased gassiness,
abdominal pain).
Initial: 1 year
Renewal: 3 years if stable
disease (tumor size within
25% of baseline)
Note: Patients with advanced cardiac conditions should not receive Sutent.
Last Update: 09/07/2016
52
Pharmacy Prior Authorization
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Physical Health
Guidelines
Symlin
liv
Tarceva lv
Authorization Requirements/Criteria
Note: Sutent should not be used in combination with a strong CYP3A4 inducer (e.g., dexamethasone,
phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's Wort) unless there is
no alternative to the CYP3A4 inducer
Note: Patients receiving strong CYP3A4 inhibitors may require a lower dose to avoid toxicity.
For patients that meet all of the following:
• Diagnosis of Type 1 or Type 2 DM
• Prescribed by, or in consultation with an endocrinologist
• Patient is 18 years of age or older
• Patient is currently on mealtime bolus insulin (e.g., Novolog, Humalog)
• Patient failed to achieve desired glucose control with optimal insulin therapy
• Patient does not have any of the following:
o Hypoglycemia unawareness or recurrent episodes of hypoglycemia
o Gastroparesis
o Poorly controlled diabetes (e.g., A1c > 9%)
o Poor adherence to current insulin regimen
When prescribed by an oncologist for patients at least 18 years old, can be authorized for the following
indications:
• Metastatic pancreatic cancer when used in combination with gemcitabine (Gemzar) in patients with a
good performance status
• Metastatic non-small cell lung cancer (NSCLC) that is positive for a sensitizing epidermal growth factor
receptor (EGFR) mutation [i.e., exon 19 deletions or exon 21 (L858R) substitution]
• Locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen
• Locally advanced or metastatic NSCLC that remains stable (no disease progression) after 4 to 6 cycles
of platinum-based first-line chemotherapy since platinum-based chemotherapy is NOT recommended
beyond 6 cycles
• Treatment of relapsed or unresectable stage IV NON-clear cell renal cell carcinoma (RCC)
Note: Tarceva should not be used with PPI’s. If taken concomitantly with H2-receptor antagonists (i.e.,
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
Indefinite
Initial: 1 year
Renewal: 3 years if benefit
(control of tumor growth, or
disease-related symptom
improvement)
Tx should be discontinued if
any of the following occur:
• Interstitial Lung Disease
(ILD)
• Severe hepatic toxicity
that does not resolve
53
Pharmacy Prior Authorization
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Physical Health
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Thalomidlvi
Topical Calcineurin
Inhibitors lvii
Elidel
Authorization Requirements/Criteria
ranitidine), Tarceva should be dosed 10 hours after and 2 hours before taking the H2-receptor antagonist.
May be authorized when prescribed by an oncologist for patients at least 12 years old for any of the
following diagnoses:
• Multiple myeloma (MM) when used with dexamethasone OR
• Erythema nodosum leprosum OR
• Chronic or subacute cutaneous systemic lupus erythematosus (SLE) after trial and failure of topical
corticosteroids AND 2 of the following for a duration of at least 12 weeks:
o Hydroxychloroquine
o Chloroquine
o Methotrexate
o Azathioprine
o Cyclosporine
o Cyclophosphamide
o Mycophenolate
o Sulfasalazine
Elidel and tacrolimus are covered for patients between 2 and 10 years of age.
For other age groups, Elidel and tacrolimus require step therapy with topical corticosteroids.
• If patient has filled 2 topical corticosteroids in the last 60 days, the prescription will automatically
process at the pharmacy.
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
• Severe renal failure
• Severe bullous,
blistering or exfoliating
skin conditions
• Corneal perforation or
severe ulceration
QLL (25mg tablets): #60 per
30 days
QLL (100 and 150mg
tablets): #30 per 30 days
Initial Approval: 6 months
Renewal:
3 years based on therapeutic
response
Initial Approval:
Indefinite
54
Pharmacy Prior Authorization
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Physical Health
Guidelines
Tacrolimus
Authorization Requirements/Criteria
Topical Hyaluronic
Acid Agents
When used for treatment of burns, dermal ulcers, wounds, radiation dermatitis:
• Prescriber must be a dermatologist
• Patient must be at least 18 years old
Intial Approval:
Burns or dermatitis:
• 3 fills of generic agent
When used for treatment of xerosis:
• Prescriber must be a dermatologist
• Trial and failure of ammonium lactate or a topical corticosteroid
• Patient must be at least 18 years old
Xerosis:
• Up to 1,000 grams of
equivalent generic agent
per 30 days for three
months
Bionect
HyGel
Hylira
XClair
Topical NSAIDs lviii
Diclofenac 1% gel
Pennsaid
Flector patch
•
Prior Authorization will be required for prescriptions that do not process automatically at the
pharmacy. In those cases, Elidel and tacrolimus will be reviewed for the treatment of eczema or
atopic dermatitis based upon the affected area being treated:
o Body/extremities – authorized after trial and failure or intolerance to at least 2 different
formulary topical corticosteroids.
o Face – authorized after trial and failure of one formulary low-potency topical corticosteroid
o Eyelid or other sensitive area – authorized without trial and failure of topical corticosteroids
May be approved for adults, age 18 and older, who meet the following criteria:
• Diclofenac 1% gel: Diagnosis of OA of knee or hand
• Pennsaid: Diagnosis of OA of knee
• History of, or high risk for, adverse GI effects associated with oral NSAID use AND trial and failure of
celecoxib; OR
• High risk for other adverse effects associated with oral NSAID use (i.e., CHF, renal failure,
concomitant use of lithium); OR
• Failure on TWO formulary NSAIDs
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
Renewal:
3 months
Initial Approval:
Flector Patch: 1 month
All others: 1 year
Renewal:
Flector Patch: 1 month
All others: 1 year
55
Pharmacy Prior Authorization
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Physical Health
Guidelines
Tranexamic acid
tablets lix
Authorization Requirements/Criteria
The risk factors that correlate strongly to adverse GI effects of oral NSAID use are:
• History of GERD, GI bleed, or ulcer
• Chronic oral steroid use
• Current anticoagulant or antiplatelet use
• Age 65 or greater
Criteria for the treatment of cyclic heavy menstrual bleeding:
• Trial and failure, intolerance or contraindication to oral NSAIDs
• Trial and failure, intolerance or contraindication to ANY of the following: oral hormonal cycle control
combinations, oral progesterone, Mirena, Depo Provera
• Age restriction: 12 years of age or older
Tranexamic acid may also be authorized for the treatment of acute bleeding episodes in patients with
hemophilia.
Tykerb lx
May be authorized when prescribed by an oncologist for patients at least 18 years old who have ONE of
the following indications:
• Hormone-receptor positive, HER2 positive metastatic breast cancer:
o Used in combination with letrozole
o Patient is postmenopausal
• HER2 positive advanced/recurrent or metastatic breast cancer:
o Disease has progressed after receiving prior therapy with an anthracycline (doxorubicin,
daunorubicin, epirubicin, idarubicin), a taxane (paclitaxel, docetaxel), AND trastuzumab
(Herceptin)
o Used in combination with capecitabine or Herceptin
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
• 90 days for menstrual
bleeding
• Indefinite for hemophilia
Renewal:
• Indefinite
QLL:
• 30 tablets per 30 days
for menstrual bleeding
• 84 tablets per 30 days
for hemophilia
Initial: 1 year
Renewal: 3 years based on
therapeutic response or
until disease progression or
unacceptable toxicity
Requires no evidence of:
• severe hepatotoxicity
• interstitial lung disease
56
Pharmacy Prior Authorization
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Physical Health
Guidelines
Viscosupplements
Authorization Requirements/Criteria
Note: Tykerb should not be given to patients with an abnormal LVEF.
Duration of Approval if
Requirements Are Met
Note: Tykerb should not be used in combination with a strong CYP3A4 inducer (e.g., dexamethasone,
phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's Wort) unless there is
no alternative to the CYP3A4 inducer
Hyalgan, Gel-One, Euflexxa, Synvisc, Orthovisc
See Detailed document:
https://www.mercymaricopa.org/assets/pdf/providers/pharmacy/Viscosupplements-MMIC.pdf
Votrient lxi
Votrient can be authorized when prescribed by an oncologist for a patient at least 18 years old for any of
the following indications:
• Diagnosis of relapsed or unresectable stage IV predominantly clear-cell renal cell carcinoma (RCC)
• Diagnosis of advanced soft tissue sarcoma after treatment with a prior chemotherapy
Note: Votrient should not be used in combination with a strong CYP3A4 inducer (e.g., dexamethasone,
phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's Wort) unless there is
no alternative to the CYP3A4 inducer
Note: Patients receiving strong CYP3A4 inhibitors may require a lower dose to avoid toxicity.
Weight Reduction
Medications lxii
Belviq
benzphetamine
phentermine
phendimetrazine
diethylpropion
For patients who meet all of the following:
• BMI ≥ 30 kg/m 2 (obese); OR
• BMI ≥ 27kg/m2 (overweight) and ONE of the following obesity-related risk factors:
o Coronary heart disease
o Dyslipidemia:
 HDL <35mg/dl or
 LDL ≥ 160mg/dL, or
 Triglycerides ≥ 400mg/dl
Last Update: 09/07/2016
Initial: 1 year
Renewal: 3 years if evidence
of stable disease (tumor size
within 25% of baseline) and
ALT is <8 times ULN. Patients
with ALT between 3 and 8
times ULN should have ALT
monitored weekly until <3
times ULN
Initial Approval:
4 months (Saxenda)
3 months for all others
First Renewal:
9 months
57
Pharmacy Prior Authorization
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Physical Health
Guidelines
Qsymia
Contrave
Saxenda
Xenical/Alli
Authorization Requirements/Criteria
•
•
•
•
o Hypertension
o Type II diabetes mellitus
o Sleep apnea
o Polycystic ovary syndrome
o Osteoarthritis
Patient is not pregnant (confirmed by negative pregnancy test for women of childbearing age) or
breastfeeding
Patient is not receiving other medications for weight loss
Patient will be using the requested drug as an adjunct to diet, exercise, and behavioral modification
Age restrictions:
o Xenical/Alli or benzphetamine: > 12 years old
o Phentermine: >16 years old
o Phendimetrazine or diethylpropion: >17 years old
o Qsymia, Belviq, Contrave, Saxenda: >18 years old
Patients with the following contraindications should not receive phentermine, phendimetrazine,
benzphetamine, diethylpropion, or Qsymia:
• Hyperthyroidism
• Glaucoma
• Agitation or uncontrolled anxiety
• MAOI use within 14 days
• History of drug abuse
• Concomitant use with CNS stimulants
• Uncontrolled hypertension
• Advanced arteriosclerosis (diethylpropion and benzphetamine only)
• History of cardiovascular disease (stroke, coronary artery disease, arrhythmias, and congestive heart
failure) (phentermine, phendimetrazine, and Qsymia only)
In addition for Xenical/Alli:
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
Requires documentation of
weight loss of >5% of
baseline weight
Note: Use of phentermine,
phendimetrazine,
benzphetamine, and
diethylpropion beyond 3
months is not recommended
and should be reviewed on a
case by case basis
Additional Renewal:
Requirements for renewal:
1. Documentation showing
member continues
weight loss plan
2. Patient has maintained
at least 67% of their
initial weight loss
3. Patient’s BMI is >24
kg/m2
Xenical/Alli and Belviq:
1 year (no more than 4
years)
All others: Use beyond 1
year has not been studied.
58
Pharmacy Prior Authorization
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Physical Health
Guidelines
Authorization Requirements/Criteria
•
•
•
Patient does not have any of the following contraindications:
o Chronic malabsorption syndrome
o Cholestasis
o Hepatic disease
o Concomitant use with warfarin or antiepileptic medications
Patients receiving levothyroxine must separate medications by >4 hours
Patient must be able to adhere to a low fat diet (<30% of calories from fat)
In addition for Belviq:
• Patient does not have any of the following contraindications:
o Concomitant use with SSRIs, SNRIs, MAOIs, linezolid, triptans, tramadol, bupropion,
dextromethorphan, St. John’s wort
o CHF
o Severe renal impairment
Duration of Approval if
Requirements Are Met
Requests should be
reviewed on a case by case
basis considering patient
response, safety, and
current guidelines
Note: Other than
Xenical/Alli and Saxenda,
available weight loss drugs
are controlled substances
and should therefore not be
granted indefinite approval
In addition for Saxenda:
• Patient does not have any of the following contraindications:
o Family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2.
o Concomitant use with insulin
Xeljanz lxiii
In addition for Contrave:
• Member must be abstinent from opioids for a minimum of 7 – 10 days (up to 14 days if taking longacting opioid) prior to starting naltrexone/bupropion
• Patient does not have any of the following contraindications:
o MAOI use within 14 days
o Uncontrolled hypertension
o Seizure disorder
May be authorized for Rheumatoid Arthritis (RA) when the following are met:
• Patient is at least 18 years old
Last Update: 09/07/2016
Initial Approval:
3 months
59
Pharmacy Prior Authorization
Title 19/21 SMI
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Physical Health
Guidelines
Authorization Requirements/Criteria
•
•
•
•
•
Xolair lxiv
Prescribed by a rheumatologist
Patient is NOT on a biological DMARD or azathioprine or cyclosporine
Patient is up to date with all recommended vaccinations
Patient has been screened for latent TB and hepatitis B
Patient has moderate or high disease activity despite an adequate 3-month trial of BOTH of the
following:
o 2 different non-biologic DMARD regimens (1 of which must include methotrexate (MTX) unless
contraindicated)
 Monotherapy: MTX, sulfasalazine (SSZ), or leflunomide (LEF)
 Combination: MTX+SSZ+hydroxychloroquine (HCQ), MTX+HCQ, MTX+LEF, MTX+SSZ,
SSZ+HCQ
o BOTH Enbrel and Humira (Note: anti-TNF’s require PA)
For the treatment of moderate-severe persistent asthma:
• Prescribed by, or after consultation with a pulmonologist, or allergist/immunologist
• 12 years of age or older
• Baseline IgE levels between 30-700 IU/ml
• Weight is less than 150 kg (330 lbs.)
• Allergic sensitization demonstrated by positive skin testing or in vitro testing for allergen-specific IgE
to an allergen that is present year round (a perennial allergen), such as dust mite, animal dander,
cockroach, or molds
• Evidence of reversible disease (12% or greater improvement in FEV1 with at least a 200-ml increase or
20% or greater improvement in PEF as a result of a short-acting bronchodilator challenge)
• Patient should be non-smoking or actively receiving smoking cessation treatment
• Patient has tried and failed conventional immunotherapy or immunotherapy is not indicated.
(Immunotherapy has demonstrated efficacy against dust mites, animal dander, and pollens but not
against molds and cockroach allergies).
• Asthma symptoms are not adequately controlled by high dose inhaled corticosteroids AND a longacting beta agonist (LABA) for 6 months
o Inadequate control is defined as:
Last Update: 09/07/2016
Duration of Approval if
Requirements Are Met
Renewal:
Indefinite
Renewals require at least
20% symptom improvement
Initial Approval:
Asthma: 6 months
Chronic urticaria: 3 months
Renewal:
Asthma: 1 year
Requires demonstration of
clinical improvement (e.g.,
↓ use of rescue medications
or systemic corticosteroids,
↑ in FEV1 from pretreatment baseline, ↓ in
number of ED visits or
hospitalizations) and
compliance with asthma
controller medications, and
60
Pharmacy Prior Authorization
Title 19/21 SMI
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Physical Health
Guidelines
Authorization Requirements/Criteria





Requirement for systemic corticosteroids (oral, parenteral) to treat asthma
exacerbations; OR
Daily use of rescue medications (short-acting inhaled beta-2 agonists); OR
2 ED visits or 1 hospitalization for asthma in the last 12 months; OR
2-3 unscheduled office visits with documentation of intensive care for acute asthma
exacerbation; OR
Nighttime symptoms occurring more than once a week
Duration of Approval if
Requirements Are Met
non-smoking status.
Chronic urticaria:
6 months
Requires demonstration of
adequate symptom control
(e.g., ↓ itching)
For the treatment of chronic urticaria:
• Symptoms continuously or intermittently present for at least 6 weeks.
• Prescribed by an allergist/immunologist or dermatologist
• 12 years of age or older
• Currently receiving H1 antihistamine therapy
• Failure of a 4 week, compliant trial of at least two high dose H1 antihistamines
AND
• Failure of a 4-week, compliant trial of at least one of the following medications (used in addition to H1
antihistamine therapy):
o Leukotriene inhibitor (montelukast or zafirlukast)
o H2 antihistamine (ranitidine or cimetidine)
o Doxepin
AND
• Failure of a 4 week, compliant trial of low dose cyclosporine (used in addition to H1 antihistamine
therapy) or contraindication to cyclosporine.
•
NOTE: Anti-inflammatory medications (dapsone, sulfasalazine, or hydroxychloroquine) may be useful
in treating urticaria, however the evidence is limited
**Note: Off-label and not covered for diagnosis of Allergic Rhinitis or food allergy**
Last Update: 09/07/2016
61
Pharmacy Prior Authorization
Title 19/21 SMI
Non-Formulary and Prior Authorization Guidelines
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i
Brand Name Behavioral Health References
1. ADHS/DBHS: Provider Manual Section 3.15: Psychotropic Medication: Prescribing and Monitoring
2. Manufacturer Product Information
ii
Antidepressants with CYP450 mediated drug interactions References:
1. ADHS/DBHS: Provider Manual Section 3.15: Psychotropic Medication: Prescribing and Monitoring
2.
3.
4.
5.
6.
7.
8.
9.
iii
Concomitant Antidepressant Treatment References:
1. ADHS/DBHS: Provider Manual Section 3.15: Psychotropic Medication: Prescribing and Monitoring
2.
3.
4.
5.
6.
iv
rd
American Psychiatric Association Practice Guideline for the Treatment of patients with Major Depressive Disorder, 3 edition. American Psychiatric Association; October 2010.
http://psychiatryonline.org/content.aspx?bookid=28&sectionid=1667485 accessed 7/2/13
Preskorn, Sheldon H. The Potential for Clinically Significant Drug-Drug Interactions involving the CYP 2D6 system: Effects with Fluoxetine and Paroxetine versus Sertraline. Journal of
Psychiatric Practice. Jan 2007: (1527-4160), 13(1) 5.
Spina E; Trifiro G; Caraci F. Clinically Significant Drug Interactions with Newer Antidepressants.CNS Drugs. 2012 Jan 1;26(1):39-67
Indiana University Division of Clinical Pharmacology P450 Drug Interaction Table. http://medicine.iupui.edu/clinpharm/ddis/table.aspx Accessed 7/2/13
Wagner W; Vause EW; Fluvoxamine: A Review of Global Drug-Drug Interaction Data. Clin Pharmacokinet. 1995;29 Suppl 1:26-31; discussion 31—2
Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study
Rush AJ; Trivedi MH; Stewart JW; et al. Combining Medications to Enhance Depression Outcomes (CO-MED): Acute and Long-Term Outcomes of a Single-Blind Randomized Study. Am J
Psychiatry 2011; 168:689-701.
Trivedi MH, Fava M, Wisniewski SR, et al. Medication augmentation after the failure of SSRIs for depression. N Engl J Med. 2006;354(12):1243-52.
rd
American Psychiatric Association Practice Guideline for the Treatment of patients with Major Depressive Disorder, 3 edition. American Psychiatric Association; October 2010.
http://psychiatryonline.org/content.aspx?bookid=28&sectionid=1667485 accessed 7/2/13
Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study
Rush AJ; Trivedi MH; Stewart JW; et al. Combining Medications to Enhance Depression Outcomes (CO-MED): Acute and Long-Term Outcomes of a Single-Blind Randomized Study. Am J
Psychiatry 2011; 168:689-701
Trivedi MH, Fava M, Wisniewski SR, et al. Medication augmentation after the failure of SSRIs for depression. N Engl J Med. 2006;354(12):1243-52.
Debonnel G; Saint-Andre E; Hebert C; et al. Differential Physiological Effects of a Low Dose and High Doses of Venlafaxine in Major Depression. Int J Neuropsychopharmacol. 2007 Feb;
10(1):51-61
Concomitant Antipsychotic References:
1.
2.
3.
4.
5.
ADHS/DBHS: Provider Manual Section 3.15: Psychotropic Medication: Prescribing and Monitoring
Correll CU, Rummel-Kluge C, Corves C, et al. Antipsychotic combinations vs monotherapy in schizophrenia: A meta-analysis of randomized controlled trials. Schizophrenia Bulletin,
2009;35:443-457.
Essock SM, Schooler NR, Stroup TS, et al. Effectiveness of switching from antipsychotic polypharmacy to monotherapy. Am. J. Psychiatry, 2011;168:702-708.
Tandon R, Belmaker RH, Gattaz WF, et al. World Psychiatric Association Pharmacopsychiatry Section statement on comparative effectiveness of antipsychotics in the treatment of
schizophrenia. Schizophrenia Research, 2008;100:20-38.
Tsutsumi C, Uchida H, Suzuki T, et al. The evolution of antipsychotic switch and polypharmacy in natural practice- A longitudinal perspective. Schizophr. Res. 2011;130:40-46.
Last Update: 09/07/2016
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Pharmacy Prior Authorization
Title 19/21 SMI
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
6.
7.
8.
9.
v
Zink M., Englisch S, Meyer-Lindberg A. Polypharmacy in schizophrenia. Curr. Opin. Psychiatry, 2010;23:103-111.s
Yatham LN, Kennedy SH, Schaffer A, et al, Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) collaborative update of
CANMAT guidelines for the management of patients with bipolar disorder: update 2009. Bipolar Disorder. 2009 May;11(3):225-55.
Hirschfeld R., Bowden C., Gitlin M, et al. Practice Guideline for the Treatment for Patients With Bipolar Disorder (Revision). Am J Psychiatry. 2003: 1(1) 64-110.
Crimson, L., Argo T., Bendele S., Suppes T., Texas Medication Algorithm Project Procedural Manual- Bipolar Disorder Algorithms. Texas Department of State Health Services. Web address:
http://www.pbhcare.org/pubdocs/upload/documents/TIMABDman2007.pdf Accessed July 15, 2013.
Injectable Antipsychotic References:
1. ADHS/DBHS: Provider Manual Section 3.15: Psychotropic Medication: Prescribing and Monitoring
2. Manufacturer Product Information
vi
Actemra References
1. Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations
for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Care Res.
2013;65(10):1551-1563.
2. Actemra (tocilizumab) [package insert]. South San Francisco, CA; Genetec, Inc; Revised November 2014.
3. Kimura Y. Systemic juvenile idiopathic arthritis: Treatment. Waltham, MA: UptoDate; Last modified September 29, 2015. http://www.uptodate.com/contents/systemic-juvenileidiopathic-arthritis-treatment?source=search_result&search=juvenile+idiopathic+arthritis&selectedTitle=3%7E150. Accessed February 4, 2016.
4. Nigrovic PA. Cryopyrin-associated periodic syndromes and related disorders. Waltham, MA: UptoDate; Last modified December 10, 2015. http://www.uptodate.com/contents/cryopyrinassociated-periodic-syndromes-and-related-disorders?source=search_result&search=Cryopyrin-Associated+Periodic+Syndromes&selectedTitle=1%7E23. Accessed February 4, 2016.
5. Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents
in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625-639.
vii
Afinitor References:
1. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomized placebo-controlled phase III trial. The Lancet. 2008
2. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Kidney Cancer. http://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf Version
3.2015. Accessed September 8, 2015.
3. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Breast Cancer. http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Version
3.2015. Accessed September 8, 2015.
4. Besalga J, Campone M, Piccart M, et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012 Feb 9;366(6):520-9.
5. National Guideline Clearinghouse (NGC). Guideline summary: Guidelines on renal cell carcinoma. In: National Guideline Clearinghouse (NGC).
http://www.guideline.gov/content.aspx?id=45321&search=advanced+renal+cell+carcinoma#Section420. Rockville (MD): Agency for Healthcare Research and Quality (AHRQ); cited 2015
August 10. Available: http://www.guideline.gov.
6. Owens, James. Tuberous sclerosis complex: Management. In UpToDate, Post TW (Ed.), Waltham, MA, (accessed on August 10,2015).
7. Torres, Vicente. Renal angiomyolipomas. In UpToDate, Post TW (Ed.), Waltham, MA, (accessed on August 10, 2015).
8. Chan Ang, Jennifer. Metastatic pancreatic neuroendocrine tumors and poorly differentiated gastroenteropancreatic neuroendocrine carcinomas: Systemic therapy options to control
tumor growth and symptoms of hormone hypersecretion. In UpToDate, Post TW (Ed.), Waltham, MA, (accessed August 10, 2015).
9. Ellis, Matthew. Treatment approach to metastatic hormone receptor-positive breast cancer: Endocrine therapy. In UpToDate, Post TW (Ed.), Waltham, MA, (accessed August 10, 2015).
Last Update: 09/07/2016
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10. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Neuroendocrine Tumors.
http://www.nccn.org/professionals/physician_gls/pdf/neuroendocrine.pdf. Version 1.2015. Accessed September 8, 2015.
viii
Ampyra References
1. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically
2. National Multiple Sclerosis Society Disease Management Consensus Statement-Recommendations from the MS Information Sourcebook; 2007 Update. National Multiple Sclerosis Society.
Available at: http://www.nationalmssociety.org/For-Professionals/Clinical-Care/Managing-MS. Accessed on Sept 2, 2014
ix
Injectable Anticoagulants References
1. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically
2. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
3. PL Detail-Document, Comparison of Injectable Anticoagulants. Pharmacist’s Letter/Prescriber’s Letter. August 2012,26(9):260902
4. Kahn SR., Lim W., Dunn AS., et al. Prevention of VTE in nonsurgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians EvidenceBased Clinical Practice Guidelines), Chest 2012; 141 (Suppl 2): e195S-e226S
5. Gould MK., Garcia DA., Wren SM,, et al. Prevention of VTE in Nonorthopedic Surgical Patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest
Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (Suppl 2): e227S-e277S
6. Falck-Ytter Y., Francis CW., Johanson NA,, et al. Prevention of VTE in Orthopedic Surgery Patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of
Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (Suppl 2): e278S-e325S
7. Douketis JD., Spyropoulos AC., Spencer FA., et al. Perioperative Management of Antithrombotic Therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College
of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (Suppl 2): e326S-e350S
8. Kearon C., Akl EA., Comerota AJ., et al. Antithrombotic Therapy for VTE Disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians
Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2_suppl):e419S-e494S.
9. You JJ., Singer DE., Howard PA., et al. Antithrombotic Therapy for Atrial Fibrillation: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians
Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2_suppl):e531S-e575S
10. Lansberg MG., O’Donnell MJ., Khatri P., et al. Antithrombotic and Thrombolytic Therapy for Ischemic Stroke: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American
College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2_suppl):e601S-e636S.
11. Bates SM., Greer IA., Middeldorp S., et al. VTE, Thrombophilia, Antithrombotic Therapy, and Pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College
of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2_suppl):e691S-e736S.
x
ARBs References
1. Gold Standard. (2010, April 9). Benicar. Tampa, Florida. Retrieved November 1, 2014, from http://www.clinicalpharmacologyip.com/Forms/Monograph/monograph.aspx?cpnum=2750&sec=monindi&t=0
2. Gold Standard. (2012, April 19). Tektuna. Tampa, Florida, USA. Retrieved November 1, 2014, from http://www.clinicalpharmacologyip.com/Forms/Monograph/monograph.aspx?cpnum=3555&sec=monindi&t=0
3. Gold Standard. (2014, May 29). Valsartan. Tampa, Florida, USA. Retrieved November 1, 2014, from http://www.clinicalpharmacologyip.com/Forms/Monograph/monograph.aspx?cpnum=2119&sec=monindi&t=
4. James PA, Oparil S, Carter BL, et al. 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults: Report From the Panel Members Appointed to the Eighth Joint
National Committee (JNC 8). JAMA. 2014;311(5):507-520. doi:10.1001/jama.2013.284427.
xi
Cambia References
1. Cambia [full prescribing information]. Newark, CA: Depomed Inc.; Revised 01/2014.
Last Update: 09/07/2016
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Marmura MJ, Silberstein SD, Schwedt TJ. The Acute Treatment of Migraines in Adults: The American Headache Society Evidence Assessment of Migraine Pharmacotherapies. Headache.
2015;55:3-20.
xii
Capecitabine References
1. Xeloda [capecitabine] prescribing information. South San Francisco, CA: Genentech, inc. Updated: March, 2015.
2. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Colon Cancer. http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. Version
2.2016. Accessed December 17, 2015.
3. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Anal Carcinoma. http://www.nccn.org/professionals/physician_gls/pdf/anal.pdf. Version
2.2015. Accessed November 4, 2015.
4. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Brest Cancer. http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Version
1.2016. Accessed December 17, 2015.
5. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Pancreatic Adenocarcinoma.
http://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. Version 2.2015. Accessed December 17, 2015.
xiii
Caprelsa References
1. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Thyroid Carcinoma. http://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf.
Version 2.2015. Accessed September 8, 2015.
2. Aetna CPB: Antineoplastics Accessed August 2015
3. Vandetanib. In: Clinical Pharmacology Online. Atlanta, GA: Elsevier / Gold Standard; [Updated 7/30/2014;Accessed August 2015] http://clinicalpharmacologyip.com/Forms/Monograph/monograph.aspx?cpnum=3722&sec=monindi&t=0
xiv
Celecoxib References
1. Standard, G. (2013, May 13). Celebrex. Tampa, Florida, USA. Retrieved August 27, 2015from http://www.clinicalpharmacologyip.com/Forms/Monograph/monograph.aspx?cpnum=689&sec=monindi&t=0
xv
Cialis References
1. Gold Standard. (2014, March 7). Cialis. Tampa, Florida, USA. Retrieved November 3, 2014, from http://www.clinicalpharmacologyip.com/Forms/Monograph/monograph.aspx?cpnum=2701&sec=monindi&t=0
2. Walters Kluwer Health Inc. (2014, June 1). Cialis. St Louis, Missouri, USA. Retrieved November 3, 2014, from http://online.factsandcomparisons.com/MonoDisp.aspx?monoID=fandchcp1415&quick=264475%7c5&search=264475%7c5&isstemmed=True&NDCmapping=-1&fromTop=true#firstMatch
3. Cunningham GR, Kadmon D. Medical treatment of benign prostatic hyperplasia. Waltham, MA: UptoDate; Last modified October 8, 2015. http://www.uptodate.com/contents/medicaltreatment-of-benign-prostatic-hyperplasia?source=search_result&search=benign+prostatic+hypertrophy&selectedTitle=1%7E150#H186693674. Accessed March 22, 2016.
xvi
Cometriq References
1. Cabozantinib. [Prescribing Information]. Exelixis. San Francisco, CA. November 2012.
2. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Thyroid Carcinoma. http://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf.
Version 2.2015. Accessed September 8, 2015.
3. Medullary thyroid cancer: management guidelines of the American Thyroid Association, accessed September 2015
4. American Thyroid Association Guidelines Task Force, Kloos RT, Eng C, Evans DB, Francis GL, Gagel RF, Gharib H, Moley JF, Pacini F, Ringel MD, Schlumberger M, Wells SA Jr. Thyroid.
2009;19(6):565.
xvii
Cystic Fibrosis Medications References
1. Katkin, JP. Cystic fibrosis: Clinical manifestations and diagnosis. In: UpToDate, Mallory, GB (Ed), UpToDate, Waltham, MA. (Accessed on February 24, 2014.).;
2. Simon, RH. Cystic fibrosis: Antibiotic therapy for lung disease. In: UpToDate, Mallory, GB (Ed), UpToDate, Waltham, MA. (Accessed on February 24, 2014.).;
2.
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3.
4.
5.
6.
7.
8.
Tobi Podhaler [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2013;
Cayston [package insert]. Foster City, CA: Gilead Sciences, Inc; 2012;
Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2014. URL: http://www.clinicalpharmacology.com. Updated October, 2010;
Micromedex Healthcare Series. DRUGDEX System. Greenwood Village, CO: Truven Health Analytics, 2014. http://www.thomsonhc.com/. Accessed March 21, 2014;
Fakhoury, K; Kanu, A. Management of bronchiectasis in children without cystic fibrosis. In: UpToDate, Mallory, GB (Ed), UpToDate, Waltham, MA. (Accessed on March 21, 2014.).
Amorim , A. (2013). New advances in the therapy of non-cystic fibrosis bronchiectasis. Revista Portuguesa de Pneumologia, 19(6)(266), 266-275. Retrieved from
http://www.elsevier.pt/en/revistas/revista-portuguesa-pneumologia-320/artigo/new-advances-in-the-therapy-of-non-cystic-fibrosis-90251782
9. Mogayzel P, Naureckas E, Robinson K, et al. Cystic fibrosis pulmonary guidelines. Chronic medications for maintenance of lung health. Am J Respir Crit Care Med. 2013 Apr 1;187(7):680-9.
10. Pulmozyme [package insert]. San Francisco, CA: Genentech, Inc; 2014;
11. Kalydeco [package insert]. Boston, MA: Vertex Pharmaceuticals Incorporated; 2015;
12. Tobi-tobramycin solution [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2014;
13. Bethkis-tobramycin solution [package insert]. Cary, NC: Chiesi USA, Inc.; 2014;
xviii
Daliresp References
1. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2015. Available from: http://www.goldcopd.org
xix
Daraprim References
1. Gandhi RT. Toxoplasmosis in HIV-infected patients. Waltham, MA: UptoDate; Last modified September 21, 2015. http://www.uptodate.com/contents/toxoplasmosis-in-hiv-infectedpatients?source=search_result&search=daraprim&selectedTitle=6%7E47. Accessed September 25, 2015.
2. Thomas CF, Limper AH. Treatment and prevention of Pneumocystis pneumonia in non-HIV-infected patients. Waltham, MA: UptoDate; Last modified January 6, 2015.
http://www.uptodate.com/contents/treatment-and-prevention-of-pneumocystis-pneumonia-in-non-hiv-infectedpatients?source=search_result&search=pneumocystis&selectedTitle=4%7E150. Accessed September 25, 2015.
3. Sax PE. Treatment and prevention of Pneumocystis infection in HIV-infected patients. Waltham, MA: UptoDate; Last modified August 27, 2015.
http://www.uptodate.com/contents/treatment-and-prevention-of-pneumocystis-infection-in-hiv-infectedpatients?source=search_result&search=pneumocystis&selectedTitle=2%7E150#H2384560994. Accessed September 25, 2015.
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Direct Renin Inhibitors References
1. Gold Standard. (2011, January 14). Aliskiren; Amlodipine; Hydrochlorothiazide. Tampa, Florida, USA. Retrieved March 20, 2015, from http://www.clinicalpharmacology-ip.com
2. Gold Standard. (2012, February 1). Aliskiren; Amlodipine. Tampa, Florida, USA. Retrieved March 20, 2015, from http://www.clinicalpharmacology-ip.com
3. Gold Standard. (2010, February 12). Aliskiren; Hydrochlorothiazide. Tampa, Florida, USA. Retrieved March 20, 2015, from http://www.clinicalpharmacology-ip.com
4. Gold Standard. (2013, September 18). Aliskiren. Tampa, Florida, USA. Retrieved March 20, 2015, from http://www.clinicalpharmacology-ip.com
5. James PA, Oparil S, Carter BL, et al. 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults: Report From the Panel Members Appointed to the Eighth Joint
National Committee (JNC 8). JAMA. 2014;311(5):507-520. doi:10.1001/jama.2013.284427.
xxi
Duavee References
1. Duavee ® [package insert] 10/2013. Philadelphia, PA: Wyeth Pharmaceuticals Inc.
2. Gold Standard, Inc. (2014, September 29). Duavee. Clinical Pharmacology [database online]. Retrieved from http://www.clinicalpharmacology.com
3. Daily Med [Internet database]. NIH U.S. National Library of Medicine. Duavee. Bethesda, MD. Updated 26 Nov. 2012.
4. Cosman, F., de Beur, S.J., LeBoff, M.S., et al. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Osteoprosis International. 24 Jun. 2014.
xxii
GnRH Agonists References
1. American College of Obstetricians and Gynecologists (ACOG). Management of endometriosis. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2010 Jul.
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2.
3.
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Gold Standard, Inc. Eligard, Lupron, Synarel and Supprelin. Clinical pharmacology [database online] Available at http://www.clinicalpharmacology.com Accessed Jun 2013.
Gold Standard, Inc. Trelstar, Zoladex, and Vantas. Clinical pharmacology [database online] Available at http://www.clinicalpharmacology.com Jun 2013.
Kaplowitz, MD, PhD, Paul B. Precocious Puberty. emedicine [database online] Available at http://emedicine.medscape.com/article/924002-overview. Accessed April 6, 2010.
Lupron Depot [Prescribing Information]: AbbVie Inc., North Chicago, IL; Jan 2013. http://www.rxabbvie.com/pdf/lupron3month11_25mg.pdf. and
http://www.rxabbvie.com/pdf/lupron3_75mg.pdf. Accessed Jun 2013
6. Lupron Depot Ped [Prescribing Information]: AbbVie Inc., North Chicago, IL; April 2013. http://www.rxabbvie.com/pdf/lupronpediatric.pdf. Accessed Jun 2013
7. Supprelin LA [Prescribing Information]: Endo Pharmaceuticals Inc., Malvern, PA; April, 2013. http://www.endo.com/File%20Library/Products/Prescribing%20Information/supprelinla.pdf.
Accessed Jun 2013;
8. Synarel [Prescribing Information]: Pfizer; New York, NY; Jan 2012. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019886s030lbl.pdf. Accessed June 2013
9. Eligard [Prescribing Information]: Bridgewater, NJ: Sanofi-Aventis US LLC; Feb 2013. http://products.sanofi.us/eligard/eligard.html. Accessed June 2013
10. Zoladex [Prescribing Information]: AstraZeneca Pharmaceuticals LP, Wilmington DE. 6/2013. http://www1.astrazeneca-us.com/pi/zoladex3_6.pdf. and http://www1.astrazenecaus.com/pi/zoladex10_8.pdf; Accessed Jun 2013.
11. Vantas [Prescribing Information]: Endo Pharmaceuticals Inc., Malvern, PA; Rev Apr 2013. http://www.endo.com/File%20Library/Products/Prescribing%20Information/vantas.pdf.
Accessed Jun 2013
12. Trelstar [Prescribing Information]: Watson Pharma, Inc., Parsippany, NJ: Mar 2013. http://pi.actavis.com/data_stream.asp?product_group=1684&p=pi&language=E. Accessed Jun 2013
13. ACOG Updates Guideline on Diagnosis and Treatment of Endometriosis. http://www.aafp.org/afp/2011/0101/p84.html. accessed 8/23/12
14. National Guideline Clearing House Management of Endometriosis. Available http://guidelines.gov/content.aspx?id=16327; accessed 8/23/12
15. National Guideline Clearing House Alternatives to hysterectomy in the management of leiomyoma. http://guidelines.gov/content.aspx?id=13318; accessed 8/23/12 for fibroids
16. Schenken, RS: Treatment of endometriosis. In UpToDate, Barbieri, RL (Ed), UpToDate, Waltham, MA, Jan 2013.
17. Saenger, P: Treatment of precocious puberty. In UpToDate, Snyder, PJ (Ed), UpToDate, Waltham, MA, April 2013.
18. ESHRE Guideline for the Diagnosis and Treatment of Endometriosis. http://guidelines.endometriosis.org/concise-pain.html; Accessed 8/23/2012
19. Pain Management of Endometrosis. http://www.acog.org/About_ACOG/News_Room/News_Releases/2010/Pain_Management_of_Endometriosis. Accessed 8/23/2012
20. Dysfunctional Uterine Bleeding: http://emedicine.medscape.com/article/257007-medication#8. Accessed 9/7/2012
21. NCCN Prostate Cancer Treatment Guidelines for Patients: http://www.psa-rising.com/download/nccnguidelines.pdf. Accessed 9/7/12
xxiii
Hetlioz References
1. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
2. Hetlioz™ [package insert]. Washington, D.C.: Vanda Pharmaceuticals, Inc.; January 2014
3. Vanda Pharmaceuticals. Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder. In: ClinicalTrials.gov [Internet].
Bethesda (MD): National Library of Medicine (US). 2000- [cited 2014 Mar 20]. Available from: http://www.clinicaltrials.gov/ct2/show/NCT01163032 NLM Identifier: NCT01163032.
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HP Acthar References
6. H.P. Acthar (corticotropin) [package insert]. Hazelwood, MO; Mallinckrodt ARD Inc; Revised January 2015.
7. Olek MJ. Treatment of acute exacerbations of multiple sclerosis in adults. Waltham, MA. UpToDate. Last modified. July 14, 2015. http://www.uptodate.com/contents/treatment-of-acuteexacerbations-of-multiple-sclerosis-in-adults?source=search_result&search=multiple+sclerosis&selectedTitle=8%7E150. Accessed August 11, 2015
xxv
Hyperlipidemia Medication References
1. Berglund L, et al. Evaluation and Treatment of Hypertriglyceridemia: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2012; 97(9): 2969–2989.
2. Cuchel M, et al. Homozygous familial hypercholesterolaemia: new insights and guidance for clinicians to improve detection and clinical management. A position paper from the Concensus
Panel on Familial Hypercholesterolaemia of the European Atherosclerosis Society. Eur Heart J. 2014;
Last Update: 09/07/2016
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3.
Goldberg AC, et al. Familial Hypercholesterolemia: Screening, diagnosis and management of pediatric and adult patients Clinical guidance from the National Lipid Association Expert Panel
on Familial Hypercholesterolemia. J Clin Lipidol. 2011;(5):S1-S8.
4. Jacobson TA, et al. National lipid association recommendations for patient-centered management of dyslipidemia: Part 1 – executive summary. J Clin Lipidol. 2014;8:473-488.
5. Robinson JG. Management of familial hypercholesterolemia: a review of the recommendations from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J
Manag Care Pharm. 2013;19(2):139-49.
6. Stone NJ, et al. 2013 ACC/AHA blood cholesterol guideline. Circulation. 2013;
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8. Crestor® [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; Revised June 2015.
9. Epanova ® [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; Revised September 2014.
10. Juxtapid ® [package insert]. Cambridge, MA: Aegerion Pharmaceuticals, Inc.; Revised April 2015.
11. Kynamro ® [package insert]. Cambridge, MA: Genzyme Corporation; Revised April 2015.
12. Livalo® [package insert]. Indianapolis, IN: Eli Lilly and Company; Revised August 2011.
13. Lovaza ® [package insert]. RTP, NC: GlaxoSmithKline; Revised September 2014.
14. Vascepa ® [package insert]. Bedminster, NJ: Amarin Pharmaceuticals; Revised May 2014.
15. Zetia ® [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; Revised September 2013.
xxvi
IL-17 Antagonist References:
1. Cosentyx (secukinumab) [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corporation; January 2015.
2. Feldman SR. Treatment of psoriasis. Waltham, MA: UptoDate; Last modified July 13, 2015. http://www.uptodate.com/contents/treatment-ofpsoriasis?source=search_result&search=psoriasis&selectedTitle=1%7E150#H42. Accessed September 25, 2015.
3. National Institute for Health and Clinical Excellence (NICE). Psoriasis: the assessment and management of psoriasis. London (UK): National Institute for Health and Clinical Excellence
(NICE); 2012 Oct. 61 p. (NICE clinical guideline; no. 153).
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Idiopathic Pulmonary Fibrosis Agents References
1. Esbriet [package insert]. Brisbane, CA: InterMune, Inc.; 2014.
2. National Clinical Guideline Centre. Idiopathic pulmonary fibrosis. The diagnosis and management of suspected idiopathic pulmonary fibrosis. London (UK): National Institute for Health
and Care Excellence (NICE); 2013 Jun. 32 p. (Clinical guideline; no. 163).
3. National Institute for Health and Care Excellence (NICE). Pirfenidone for treating idiopathic pulmonary fibrosis. London (UK): National Institute for Health and Care Excellence (NICE); 2013
Apr. 66 p.
4. Raghu G, Collard HR, Egan JJ et al. for the ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An Official ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis:
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5. Ofev [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; Revised October 2014.
xxviii
Ilaris References
8. Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations
for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Care Res.
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9. Ilaris (canakinumab) [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corporation; Revised October 2014.
10. Kimura Y. Systemic juvenile idiopathic arthritis: Treatment. Waltham, MA: UptoDate; Last modified September 29, 2015. http://www.uptodate.com/contents/systemic-juvenileidiopathic-arthritis-treatment?source=search_result&search=juvenile+idiopathic+arthritis&selectedTitle=3%7E150. Accessed February 4, 2016.
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11. Nigrovic PA. Cryopyrin-associated periodic syndromes and related disorders. Waltham, MA: UptoDate; Last modified December 10, 2015. http://www.uptodate.com/contents/cryopyrinassociated-periodic-syndromes-and-related-disorders?source=search_result&search=Cryopyrin-Associated+Periodic+Syndromes&selectedTitle=1%7E23. Accessed February 4, 2016.
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Gleevec References
1. Gleevec [full prescribing information]. East Hanover, NJ: Novartis U.S.; Revised 02/2013
2. NCCN Drugs and Biologics Compendium http://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=18 accessed 3/18/2010, 3/24/11, 3/27/12
3. National Comprehensive Cancer Network. Practice Guidelines in Oncology – Chronic Myelogenous Leukemia, Version I.2014 09/09/13.
4. National Comprehensive Cancer Network. Practice Guidelines in Oncology – Acute Lymphoblastic Leukemia, Version I.2013 03/25/13.
5. Alvarado Y, Apostolidou E, Swords R, Giles FJ. Emerging therapeutic options for Philadelphia-positive acute lymphocytic leukemia. Expert Opin Emerg Drugs. 2007 Mar;12(1):165-79
6. National Institute for Clinical Excellence (NICE). Imatinib for the treatment of unresectable and/or metastatic gastro-intestinal stromal tumours. London (UK): National Institute for Clinical
Excellence (NICE); 2004 Oct. 38 p.
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Inlyta References:
1. Inlyta (axitinib) [package insert]. NY, NY; Pfizer: Revised January 2012.
2. Rini BI, Escudier B, Tomczak P, et al. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomized phase 3 trial. Lancet 2011;378:1931-39.
3. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Kidney Cancer. http://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf Version
3.2015. Accessed September 8, 2015.
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Interferon References:
1. American Association for the Study of Liver Diseases. (2014, August 11). Recommendations for Testing, Managing, and Treating Hepatitis C. Retrieved September 13, 2014, from American
Association for the Study of Liver Diseases and the Infectious Diseases Society of America: http://www.hcvguidelines.org/fullreport
2. Gold Standard, Inc. (2013, October 13). Interferon Gamma-1b. Clinical Pharmacology. Tampa, FL, USA. Retrieved September 13, 2014, from http://www.clinicalpharmacology-ip.com
3. Gold Standard, Inc. (2014, April 22). Interferon Alfa-2b. Clinical Pharmacology. Tampa, FL, USA. Retrieved from http://www.clinicalpharmacology-ip.com
4. Gold Standard, Inc. (2014, April 22). Interferon Alfacon-1. Clinical Pharmacology. Tampa, FL, USA. Retrieved from http://www.clinicalpharmacology-ip.com
5. Gold Standard, Inc. (2014, August 18). Peginterferon Alfa-2b. Clinical Pharmacology. Tampa, FL, USA. Retrieved September 13, 2014, from http://www.clinicalpharmacology-ip.com
6. Lok, A. S., & McMahon, B. J. (2009, September). Chronic Hepatitis B: Update 2009. Retrieved September 14, 2014, from American Association for the Study of Liver Diseases:
www.aasld.org
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8. National Comprehensive Cancer Network. (2014, August 22). Non-Hodgkin's Lymphomas. Retrieved September 13, 2014, from NCCN Guidelines : http://www.nccn.org
9. Rosenzweig, S. D., & Holland, S. M. (2014, January 24). Chronic granulomatous disease: Treatment and prognosis. Retrieved September 13, 2014, from Up To Date:
http://www.uptodate.com
10. Schering Corporation. (2014, August). Infergen. Whitehouse Station, NJ, USA.
11. Sosman, J. A. (2014, June 10). Adjuvant immunotherapy for melanoma. Retrieved September 13, 2014, from Up To Date: http://www.uptodate.com
12. Tallman, M. S. (2014, February 13). Treatment of hairy cell leukemia. Retrieved September 13, 2014, from Up To Date: http://www.uptodate.com
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14. Thomson Micromedex. (2014, August 08). DRUGDEX System. Retrieved September 13, 2014, from Interferon Gamma: http://www.thomsonhc.com
Integrin Receptor Antagonist References
1. Terdiman JP, Gruss CB, Heidelbaugh JJ, Sultan S, Falck-Ytter YT. American gastroenterological association institute guideline on the use of thiopurines, methotrexate, and anti–TNF-a
biologic drugs for the induction and maintenance of remission in inflammatory crohn’s disease. Gastroenterol. 2013;145:1459–1463.
2. The Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults. Am J Gastroenterol. 2010;105:501-523.
3. Farrell RJ, Peppercorn MA. Overview of the medical management of severe or refractory Crohn disease in adults. Waltham, MA: UpToDate; Last modified June 10, 2015.
http://www.uptodate.com/contents/overview-of-the-medical-management-of-severe-or-refractory-crohn-disease-inadults?source=search_result&search=crohns&selectedTitle=2%7E150. Accessed October 1, 2015
4. Cohen RD., Stein AC. Approach to adults with steroid-refractory and steroid-dependent ulcerative colitis. Waltham, MA: UpToDate; Last modified July 2015.
http://www.uptodate.com/contents/approach-to-adults-with-steroid-refractory-and-steroid-dependent-ulcerative-colitis?source=see_link. Accessed August 11, 2015.
5. Peppercorn MA., Farrell RJ. Management of severe ulcerative colitis. Waltham, MA: UpToDate; Last modified July 2015. http://www.uptodate.com/contents/management-of-severeulcerative-colitis?source=search_result&search=ulcerative+colitis&selectedTitle=2%7E150. Accessed August 11, 2015
xxxiii
Intravaginal Progesterone Products References
1. The American College of Obstetricians and Gynecologists. Committee on Practice Bulletins – Obstetrics, Practice Bulletin: Prediction and Prevention of Preterm Birth. Obstetrics &
Gynecology. Oct 2012; 120;4: 964-973.
2. National Institute for Health and Care Excellence. Preterm labour and birth (NG25): NICE guideline. 20 Nov. 2015.
3. O’brien, J.M., DeFranco, E.A., Adair, C.D., Lewis, D.F., Hall, D.R., How, H., Bsharat, M., and Creasy, G.W. Effect of progesterone on cervical shortening in women at risk for preterm birth:
secondary analysis from a multinational, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol 2009; 34:653-659.
4. Coomarasamy, A., Williams, H., Truchanowicz, E., et al. A randomized trial of progesterone in women with recurrent miscarriages. N Engl J Med. 2015;373:2141-8.
xxxiv
Jakafi References
1. Jakafi™ (ruxolitinib) tablets prescribing information. Incyte, Corp. Greenville, NC; June, 2012.
2. Cervantes F, Dupriez B, Pereira A, et al. New prognostic scoring system for primary myelofibrosis based on a study of the International Working Group for Myelofibrosis Research and
Treatment. Blood 2009;113:2895-2901.
3. Harrison C, Kiladjian J-J, Al-Ali HK, et al. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med 2012;366:787-98.
4. Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med 2012;366:799-807.
xxxv
Kineret References
12. Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations
for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Care Res.
2013;65(10):1551-1563.
13. Kineret (anakinra) [package insert]. Stockholm, Sweden; Swedish Orphan Biovitrum AB; Revised November 2013.
14. Kimura Y. Systemic juvenile idiopathic arthritis: Treatment. Waltham, MA: UptoDate; Last modified September 29, 2015. http://www.uptodate.com/contents/systemic-juvenileidiopathic-arthritis-treatment?source=search_result&search=juvenile+idiopathic+arthritis&selectedTitle=3%7E150. Accessed February 4, 2016.
15. Nigrovic PA. Cryopyrin-associated periodic syndromes and related disorders. Waltham, MA: UptoDate; Last modified December 10, 2015. http://www.uptodate.com/contents/cryopyrinassociated-periodic-syndromes-and-related-disorders?source=search_result&search=Cryopyrin-Associated+Periodic+Syndromes&selectedTitle=1%7E23. Accessed February 4, 2016.
16. Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents
in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625-639.
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Long-Acting Opioid References
1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2014. URL: http://www.clinicalpharmacology.com. Updated October, 2013.
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2.
National Institute for Health and Care Excellence (NICE). Neuropathic pain - pharmacological management. The pharmacological management of neuropathic pain in adults in nonspecialist settings. London (UK): National Institute for Health and Care Excellence (NICE); 2013 Nov. 41 p. (Clinical guideline; no. 173).
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Lyrica References
1. Decker, J. E., & Hergenroeder, A. C. (2012, September 21). Overview of cervical spinal cord and cervical peripheral nerve injuries in the child or adolescent athlete. Retrieved from Up To
Date: http://www.uptodate.com/contents/overview-of-cervical-spinal-cord-and-cervical-peripheral-nerve-injuries-in-the-child-or-adolescentathlete?source=preview&search=pain+due+to+spinal+cord+injury&selectedTitle=7%7E150&language=en-US&anchor=H2#H13
2. Gold Standard, Inc. (2012, June 21). Pregabalin. Retrieved September 13, 2014, from Clinical Pharmacology: http://www.clinicalpharmacology-ip.com
3. Gold Standard, Inc. (2013, May 09). Gabapentin. Retrieved September 13, 2014, from http://www.clinicalpharmacology-ip.com
4. Portenoy, R. K., Ahmed, E., & Keilson, Y. Y. (2014, July 30). Cancer pain management: Adjuvant analgesics (coanalgesics). Retrieved September 13, 2014, from Up To Date:
http://www.uptodate.com/contents/cancer-pain-management-adjuvant-analgesicscoanalgesics?source=machineLearning&search=neuropathic+pain+treatment&selectedTitle=3%7E150&sectionRank=1&anchor=H18#H21
5. Thomson Micromedex. (2014, September 11). Duloxetine. DRUGDEX System. Greenwood Village, CO. Retrieved September 13, 2014, from DRUGDEX System: http://www.thomsonhc.com
6. Thomson Micromedex. (2014, September 10). Gabapentin. Greenwood Village, CO. Retrieved September 13, 2014, from http://www.thomsonhc.com
7. Thomson Micromedex. (2014, September 10). Pregabalin. Greenwood Village, CO. Retrieved September 13, 2014, from http://www.thomsonhc.com
xxxviii
Makena References
1. Makena (17- hydroxyprogesterone caproate) [package insert]. St. Louis, MO: Ther-Rx Corporation; Feb 2011.
2. Meis PJ, Klebanoff M, Thom E, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003;348(24):2379-85.
3. Makena [Daily Med]. NIH, U.S. National Library of Medicine. Updated 28 Feb. 2015. Accessed 25 Feb. 2016.
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Modafinil/Nuvigil
1. Gold Standard, Inc. Clinical Pharmacology [database online]. Available at: http://www.clinicalpharmacology.com. Accessed .August 2015
2. Fosnocht, KM. Approach to the adult patient with fatigue. In: UpToDate, Fletcher, RH (Ed), UpToDate, Waltham, MA. (Accessed on August 15, 2014.)
3. Escalante, CP. Cancer-related fatigue: Treatment. In: UpToDate, Hesketh, PJ (Ed), UpToDate, Waltham, MA. (Accessed on August 15, 2014.)
4. Lavault, S., Dauvilliers, Y., Drouot, X., Leu-Semenescu, S., Golmand, J.-L., Lecendreux, M., et al. (2011). Benefit and risk of modafinil in idiopathic hypersomnia vs. narcolepsy. Sleep
Medicine, 550-556.
5. Bruera E, Y. S. (2014, May 8). Palliative care: Overview of fatigue, weakness, and asthenia. Retrieved September 15, 2014, from Uptodate: http://www.uptodate.com
6. Chevrin R, C. (2014, April 23). Idiopathic hypersomnia. Retrieved September 15, 2014, from Up To Date: http://www.uptodate.com.
7. Nuvigil prescribing information. Cephalon, Inc. July 2008.
8. Provigil prescribing information. Cephalon, Inc. March 2008.
9. Stankoff B, Waubant E, Confavreux C,, et al. Modafinil for fatigue in MS: a randomized placebo-controlled double-blind study. Neurology. 2005;64(7):1139-1143.
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Multaq References
1. 2014 AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation: Executive Summary. Circulation. 2014; 130:2071-2104.
2. 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: Executive Summary. A Report of the American College of Cardiology/American Heart Association
Task Force on Practice Guidelines and the Heart Rhythm Society. Journal of the American College of Cardiology. Dec 2014. 64(21).
3. Teme, Tonye, Goldberger, Jeffrey J. Efficacy and tolerability of dronedarone for patients with atrial fibrillation. Cardiology Journal. 2013. 20(5): 486-490.
4. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
5. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically
6. MULTAQ Dronedarone tablets [Prescribing Information]. Sanofi-Aventics U.S., LLC Bridgewater, NJ. March 2014.
7. CORDARONE Amiodarone tablets [Prescribing Information]. Pfizer Wyeth Pharmaceuticals Inc. Philadelphia, PA. March 2015.
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Nexavar References
1. Nexavar prescribing information. Bayer Healthcare Pharmaceuticals Inc.; Wayne, NJ: December 2012.
2. Bukowski R, Cella D, Gondek K, et al. Effects of sorafenib on symptoms and quality of life: results from a large randomized placebo-controlled study in renal cancer. Am J Clin Oncol. 2007
Jun;30(3):220-7
3. Sorafenib, NCCN Drugs and Biologics Compendium. [cited 3/25/2010]. Available from: URL: http://www.nccn.org/professionals/
drug_compendium/MatrixGenerator/Matrix.aspx?AID=134.
4. NCCN Clinical Practice Guidelines in Oncology: Kidney Cancer. Fort Washington, PA: National Comprehensive Cancer Network, 2013. (Accessed March 4, 2013, at http://www.nccn.org/
professionals/ physician_gls/ PDF/kidney.pdf )
5. NCCN Clinical Practice Guidelines in Oncology: Hepatobiliary Cancer. Fort Washington, PA: National Comprehensive Cancer Network, 2012. (Accessed March 4, 2013, at
http://www.nccn.org/professionals/ physician_gls/pdf/hepatobiliary.pdf))
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Non-Cacium Based Phosphate Binder References
1. Gold Standard. (2014, April 21). Velphoro. Tampa, Florida, USA. Retrieved 19 December, 2014, from http://www.clinicalpharmacologyip.com/Forms/Monograph/monograph.aspx?cpnum=2575&sec=monindi&t=0
2. National Kidney Foundation. K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease: Am J Kidney Dis. 2003 Oct;42(4):s1-s201
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Onychomycosis and Tinea References
1. El-Gohary M, van Zuuren EJ, Fedorowicz Z, Burgess H, Doney L, Stuart B, Moore M, Little P. Topical antifungal treatments for tinea cruris and tinea corporis. Cochrane Database of
Systematic Reviews 2014, Issue 8. Art. No.: CD009992. DOI: 10.1002/14651858.CD009992.pub2.
2. Bell-Syer SEM, Khan SM, Torgerson DJ. Oral treatments for fungal infections of the skin of the foot. Cochrane Database of Systematic Reviews 2012, Issue 10. Art. No.: CD003584. DOI:
10.1002/14651858.CD003584.pub2.
3. Luzu [Prescribing Information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; June 2014.
4. Jublia [Prescribing Information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; February 2015
5. Rodgers P, Bassler M. Treating onychomycosis. Am Fam Physician. 2001;63:663-672
6. Facts and Comparisons. (2014, September 1). St Lois, Missouri, USA.
7. Gold Standard, Inc. (2013, November 20). Luzu. Retrieved April 08, 2015, from http://www.clinicalpharmacology.com: http://www.clinicalpharmacology.com
8. Gold Standard, Inc. (2015, 01 27). Jublia. Retrieved April 08, 2015, from www.clinicalpharmacology.com: http://www.clinical pharmacology.com
[viii]
Orencia References:
1. Orencia (abatacept) [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; Revised June 2015.
2. Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents
in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625-639.
3. Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations
for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Care Res.
2013;65(10):1551-1563.
4. Weiss PF. Polyarticular juvenile idiopathic arthritis: Clinical manifestations and diagnosis. Waltham, MA: UptoDate; Last modified September 29, 2015.
http://www.uptodate.com/contents/polyarticular-juvenile-idiopathic-arthritis-treatment?source=search_result&search=juvenile+arthritis&selectedTitle=8%7E150 Accessed October 5,
2015.
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Otezla References
1. Otezla (apremilast) [package insert]. Summit, NJ; Celgene Corporation; Revised December 2015.
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Gossec L, Smolen JS, Gaujoux-Viala C, et al. European League Against Rheumatism recommendations for the management of psoriatic arthritis with pharmacological therapies. Ann Rheum
Dis. 2012;71:4-12.
3. National Institute for Health and Clinical Excellence (NICE). Psoriasis: the assessment and management of psoriasis. London (UK): National Institute for Health and Clinical Excellence
(NICE); 2012 Oct. 61 p. (NICE clinical guideline; no. 153).
4. Feldman SR. Treatment of psoriasis. Waltham, MA: UptoDate; Last modified July 13, 2015. http://www.uptodate.com/contents/treatment-ofpsoriasis?source=search_result&search=psoriasis&selectedTitle=1%7E150#H42. Accessed September 25, 2015.
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PCSK9 References
1. Repatha [Prescribing Information]. Thousand Oaks, CA: Amgen Inc.; Aug 2015
2. Praluent [Prescribing Information]. Bridgewater, NJ,: Regeneron and Sanofi Aventis LLC; Oct 2015
3. Stone, NJ, Robinson J, Lichtenstein AH, et al. 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A Report of the
American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013; doi:10.1016/j.jacc.2013.11.002.
4. Mangement of familial hypercholesterolemia http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=16222
http://www.google.com/url?url=http://www.amcp.org/WorkArea/DownloadAsset.aspx%3Fid%3D16222&rct=j&frm=1&q=&esrc=s&sa=U&ei=RJSUVf2bDsuTyATgvoHwAw&ved=0CEAQFjA
G&usg=AFQjCNEDp9VnIHhpJLov4D4lQgRPWNuQLQ
5. Cuchel M, Bruckert E, Ginsberg HN, et al. Homozygous familial hypercholesterolaemia: new insights and guidance for clinicians to improve detection and clinical management. A position
paper from the Consensus Panel on Familial Hypercholesterolaemia of the European Atherosclerosis Society. Eur Heart J. 2014 Aug 21;35(32):2146-57. doi: 10.1093/eurheartj/ehu274.
Epub 2014 Jul 22.
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Platelet Inhibitors References:
1. Gordon H. Guyatt, MD, FCCP, Elie A. Akl, MD, PhD, MPH, et al. Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical
Practice Guidelines. CHEST Journal February 2012; 141(2_suppl)
2. Simons, Michael. "Antiplatelet agents in acute non-ST elevation acute coronary syndromes." UpToDate.http://www.uptodate.com (accessed March 24, 2014).
3. Cutlip, Donald. “Antithrombotic therapy for percutaneous coronary intervention: General Use.” UpToDate.http://www.uptodate.com (accessed March 24, 2014).
4. Lincolff, Michael A. “Antiplatelet agents in acute ST elevation myocardial infarction.” UpToDate.http://www.uptodate.com (accessed March 24, 2014).
5. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically
6. Effient (prasugrel) package insert. Indianapolis, IN: Eli Lilly and Company
7. Brilinta (ticagrelor) package insert. Wilmington, DE:AstraZeneca LP
8. (O'Gara, Kushner, & Ascheim, 2013)
9. Amsterdam EA, et al. 2014 AHA/ACC Guideline for the Management of Patients With Non–ST-Elevation
10. Acute Coronary Syndromes: Executive Summary. J Am Coll Cardiol. 2014;64(24):e139-228.
11. Eikelboom JW, Hirsh J, Spencer FA, Baglin TP, Weitz JI. Antiplatelet drugs: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians EvidenceBased Clinical Practice Guidelines. CHEST Journal February 2012; 141 (2)(Suppl):e89S–e119S
12. Weitz JI, Eikelboom JW, Samama MM. New Antithrombotic Drugs: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based
Clinical Practice Guidelines. CHEST Journal February 2012; 141 (2)(Suppl) :e120S–e151S
13. Zontivity (vorapaxar) package insert.
xlvii
Promacta References
1. Promacta [package insert]. Research Triangle Park, NC: GlaxoSmithKline; Revised June 2015.
2. Neunert C, Lim W, Crowther M, Cohen A, Solberg L, Crowther MA. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood.
2011;117(16):4190-4207.
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3.
Schrier SL. Aplastic anemia: Pathogesis; clinical manifestations; and diagnosis. Waltham, MA: UptoDate; Last modified November 11, 2015. http://www.uptodate.com/contents/aplasticanemia-pathogenesis-clinical-manifestations-and-diagnosis?source=search_result&search=aplastic+anemia&selectedTitle=1%7E150#H21 Accessed March 30, 2016.
4. Judith C. W. Marsh, e. a. (2009). Guidelines for the diagnosis and management of aplastic. British Journal of Hematology.
5. Marsh, J. R. (2010). Aplastic Anemia: First-line Treatment by Immunosuppression and Sibling Marrow Transplantation. ASH Education Book.
xlviii
Ranexa References
1. Fihn SD, G. J. (December 2012). 2012 American College of Cardiology Foundation/American Heart Association/American College of Physicians/American Association for Thoracic
Surgery/Preventive Cardiovascular Nurses Association/Society for Cardiovascular Angiography and Interventions/Socie. Journal of the American College of Cardiology, Volume 60 Issue 24.
2. Gold Standard, Inc. (2013, Decemember 25). Ranexa. Retrieved August 25, 2015, from ClinicalPharmacology: http://www.clinicalpharmacology.com
3. Kannam, J. e. (201, August 12). Stable ischemic heart disease: Overview of care . Retrieved August 25, 2015, from Up to Date: http://www.uptodate.com.
4. National Institute for Health and Care Excellence (NICE). Management of stable angina. NICE Clinical Guideline 126 (July 2011). From https://www.nice.org.uk/guidance/cg126/chapter/1Guidance#anti-anginal-drug-treatment Accessed September 17, 2015.
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Revlimid References
1. Revlimid® (lenalidomide) prescribing information. Celgene Corp., June 2013.
2. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Multiple Myeloma. http://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf.
Version 2.2016. Accessed December 10, 2015.
3. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Myelodysplastic Syndrome. http://www.nccn.org/professionals/physician_gls/pdf/mds.pdf.
Version 1.2016. Accessed December 10, 2015.
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Savella References
1. Savella [package insert]. St. Louis, MO: Forest Laboratories, Inc; December 2009.
2. Gold Standard, Inc. Savella. Clinical Pharmacology [database online]. Available at: http://www.clinicalpharmacology.com. Accessed May 14, 2012.
3. Wolfe F, Smythe HA, Yunas MB, Bennett RM, Bombardier C, Goldenberg DL, et al. The American College of Rheumatology 1990 criteria for the classification of fibromyalgia. Report of the
Multicenter Criteria Committee. Arthritis Rheum 1990;33:160-72.
4. Bennett RM, Kamin M, Karim R, Rosenthal N. Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: a double-blind, randomized, placebo-controlled
study. Am J Med. 2003:114(7):537-545.
5. Arnold LM, Hess EV, Hudson JI, Welge JA, Berno SE, Keck PE Jr. A randomized, placebo-controlled, double-blind, flexible-dose study of fluoxetine in the treatment of women with
fibromyalgia. Am J Med. 2002: 112(3):191-197
6. Carette S, Bell MJ, Reynolds WJ, Haraoui B, McCain GA, Bykerk VP, Edworthy SM, Baron M, Koehler BE, Fam AG, et al. Comparison of amitriptyline, cyclobenzaprine, and placebo in the
treatment of fibromyalgia. A randomized, double-blind clinical trial. Arthritis Rheum. 1994 Jan;37(1):32-40.
7. Goldenberg DL, Mayskiy M, Mossey C, Ruthazar R, Schmid C. A randomized, double-blind crossover trial of fluoxetine and amitryptyline in the treatment of fibromyalgia. Arthritis Rheum
1996;39: 1852-9.
8. Arnold LM, Goldenberg DL, Stanford SB, Lalonde JK, Sandhu HS, Keck PE Jr, Welge JA, Bishop F, Stanford KE, Hess EV, Hudson JI. Gabapentin in the treatment of fibromyalgia: a
randomized, double-blind, placebo-controlled, multicenter trial. Arthritis Rheum. 2007 Apr;56(4):1336-44.
9. Carette S, McCain GA, Bell DA, Fam AG. Evaluation of amitriptyline in primary fibrositis. A double-blind, placebo-controlled study. Arthritis Rheum. 1986 May;29(5):655-9.
10. Goldenberg DL, Felson DT, Dinerman H. A randomized, controlled trial of amitriptyline and naproxen in the treatment of patients with fibromyalgia. Arthritis Rheum. 1986
Nov;29(11):1371-7.
11. Arnold LM, Goldenberg DL, Stanford SB, Lalonde JK, Sandhu HS, Keck PE Jr, Welge JA, Bishop F, Stanford KE, Hess EV, Hudson JI. Gabapentin in the treatment of fibromyalgia: a
randomized, double-blind, placebo-controlled, multicenter trial. Arthritis Rheum. 2007 Apr;56(4):1336-44.
12. Carette S, McCain GA, Bell DA, Fam AG. Evaluation of amitriptyline in primary fibrositis. A double-blind, placebo-controlled study. Arthritis Rheum. 1986 May;29(5):655-9.
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13. Goldenberg DL, Felson DT, Dinerman H. A randomized, controlled trial of amitriptyline and naproxen in the treatment of patients with fibromyalgia. Arthritis Rheum. 1986
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14. Goldenberg DL, Burckhardt C, Crofford L. Management of fibromyalgia syndrome. JAMA. 2004; 292(19):2388-2395
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16. Arnold LM, Bateman L, Palmer RH, Lin Y. Preliminary experience using milnacipran in patients with juvenile fibromyalgia: lessons from a clinical trial program. Pediatr Rheumatol Online J.
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Second Generation TKI References
1. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Chronic Myelogenous Leukemia.
http://www.nccn.org/professionals/physician_gls/pdf/cml.pdf. Version 1.2015. Accessed September 8, 2015.
2. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Acute Lymphoblastic Leukemia.
http://www.nccn.org/professionals/physician_gls/pdf/all.pdf. Version 1.2015. Accessed September 8, 2015.
3. Bosulif [full prescribing information]. New York, NY: Pfizer U.S.; Revised 09/2013.
4. Gleevec [full prescribing information]. East Hanover, NJ: Novartis U.S.; Revised 02/2013.
5. Cortes JE, et al, Bosutinib Versus Imatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia: Results From the BELA Trial. J Clin Oncol, 2012;30(28):3486-3492.
6. Cortes JE, et al, Safety and efficacy of bosutinib (SKI-606) in chronic phase Philadelphia chromosome-positive chronic myeloid leukemia patients with resistance or intolerance to imatinib.
Blood. 2011;118(17): 4567-4576.
7. Khoury HJ, et al, Bosutinib is active in chronic phase chronic myeloid leukemia after imatinib and dasatinib and/or nilotinib therapy failure. Blood, 2012;119(15)3403-3412.
8. Shieh MP, Mitsuhashi M, LillyM. Moving on up: Second-Line Agents as Initial Treatment for Newly-Diagnosed Patients with Chronic Phase CML. Clin Med Insights Oncol, 2011;5:185-199.
9. Antineoplastics - Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan. Aetna Clinical Pharmacy Bulletins
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Stelara References:
4. Ustekinumab. (2015) In Clinical Pharmacology online. Retrieved from http://www.clinicalpharmacology-ip.com/Forms/drugoptions.aspx?cpnum=3586&n=Stelara&t=0.
5. Stelara (ustekinumab) [package insert]. Horsham, PA: Janssen Biotech, Inc. 2014 March.;
6. Feldman SR. Treatment of psoriasis. Waltham, MA: UptoDate; Last modified July 13, 2015. http://www.uptodate.com/contents/treatment-ofpsoriasis?source=search_result&search=psoriasis&selectedTitle=1%7E150#H42. Accessed September 25, 2015.
7. National Institute for Health and Clinical Excellence (NICE). Psoriasis: the assessment and management of psoriasis. London (UK): National Institute for Health and Clinical Excellence
(NICE); 2012 Oct. 61 p. (NICE clinical guideline; no. 153).
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Sutent References
1. Sutent prescribing information. Pfizer Inc.;New York, NY; Updated 5/2015.
2. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Kidney Cancer. http://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Version
1.2016. Accessed October 30, 2015.
3. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Neuroendocrine Tumors.
http://www.nccn.org/professionals/physician_gls/pdf/neuroendocrine.pdf. Version 1.2015. Accessed October 30, 2015.
4. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Soft Tissue Sarcoma. http://www.nccn.org/professionals/physician_gls/pdf/sarcoma.pdf.
Version 1.2015. Accessed October 30, 2015.
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Symlin References
1. Micromedex Healthcare Series. DRUGDEX System. Greenwood Village, CO: Truven Health Analytics, 2014. http://www.thomsonhc.com/. Accessed February 24, 2014.
2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2014. URL: http://www.clinicalpharmacology.com. Updated December, 2009. 3. AACE Comprehensive Diabetes
Management, Endocr Pract. 2013;19(Suppl 2)
Last Update: 09/07/2016
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Pharmacy Prior Authorization
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Tarceva References
1. Tarceva® (erlotinib) prescribing information. Genentech, Inc.: South San Francisco, CA. Updated: May, 2015.
2. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Kidney Cancer. http://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Version
1.2016. Accessed October 30, 2015.
3. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Pancreatic Adenocarcinoma.
http://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. Version 2.2015. Accessed December 15, 2015.
4. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Non-Small Cell Lung Cancer.
http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Version 2.2016. Accessed December 15, 2015.
lvi
Thalomid References
4. Thalomid® (thalidomide) prescribing information. Celgene Corp., Updated 8/2015.
5. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Multiple Myeloma.
http://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf. Version 2.2016. Accessed December 10, 2015.
6. Clarke J. Management of refractory discoid lupus and subacute cutaneous lupus. Waltham, MA: UptoDate; Last modified October 22, 2015.
http://www.uptodate.com/contents/management-of-refractory-discoid-lupus-and-subacute-cutaneouslupus?source=search_result&search=thalidomide&selectedTitle=15%7E150#H1088110. Accessed December 15, 2015.
7. Schur PH, Moschella SL. Mucocutaneous manifestations of systemic lupus erythematosus. Waltham, MA: UptoDate; Last modified April 16, 2014.
http://www.uptodate.com/contents/mucocutaneous-manifestations-of-systemic-lupus-erythematosus?source=search_result&search=sle&selectedTitle=5%7E150#H18.
Accessed December 15, 2015.
8. Scollard D, Stryjewska B. Treatment and prevention of leprosy. Waltham, MA: UptoDate; Last modified December 7, 2015. http://www.uptodate.com/contents/treatmentand-prevention-of-leprosy?source=search_result&search=erythema+nodosum+leprosum&selectedTitle=2%7E11#H89888451. Accessed December 15, 2015.
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Elidel/tacrolimus References
1. Gold Standard. (2013, September 26). Elidel. Tampa, Florida, USA. Retrieved August 1, 2015, from http://www.clinicalpharmacologyip.com/Forms/Monograph/monograph.aspx?cpnum=2670&sec=monindi&t=0
2. Gold Standard. (2013, October 16). Tacrolimus. Tamp, Florida, USA. Retrieved August 1, 2015, from http://www.clinicalpharmacologyip.com/Forms/Monograph/monograph.aspx?cpnum=587&sec=monindi&t=0
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Topical NSAID References
1. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. 2000 Sep (revised
2012 Apr).
2. American Academy of Orthopaedic Surgeons clinical practice guideline on the treatment of glenohumeral joint osteoarthritis. 2009 Dec 4 (reaffirmed 2014).
3. American Academy of Orthopaedic Surgeons clinical practice guideline on the treatment of osteoarthritis of the knee, 2nd edition. 1996 (revised 2013 May 18).
4. VA/DoD clinical practice guideline for the non-surgical management of hip and knee osteoarthritis. 2014.
5. Voltaren Gel (diclofenac sodium topical gel) package insert. Parsippany, NJ: Novartis Consumer Health; 2007 Oct.
6. Pennsaid (diclofenac sodium) topical solution package insert. Hazelwood, MO: Mallinckrodt Brand Pharmaceuticals, Inc; 2013 Oct.
7. Flector (diclofenac epolamine) [prescribing information]. Bristol, TN: King Pharmaceuticals; August 2011.
8. Beers MH, Ouslander JG, Rollingher I, et al. Explicit criteria for determining inappropriate medication use in nursing home residents. UCLA Division of Geriatric Medicine. Arch Intern Med
1991;151:1825-32.
9. The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers criteria for potentially inappropriate medication use in older adults. J
Am Geriatr Soc 2012;60:616-31.
Last Update: 09/07/2016
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Pharmacy Prior Authorization
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10. Bhatt DL, Scheiman J, Abraham NS, et al. ACCF/ACG/AHA 2008 expert consensus document on reducing the gastrointestinal risks of antiplatelet therapy and NSAID use: a report of the
American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents. Circulation 2008;118:1894-909.
11. Masso Gonzalez EL, Patrignani P, Tacconelli S, Garcia Rodriguez LA. Variability among nonsteroidal anti-inflammatory drugs in risk of upper gastrointestinal bleeding. Arthritis Rheum
2010;62:1592-601.
12. Lanza FL, Chan FK, Quigley EM, Practice Parameters Committee of the American College of Gastroenterology. Guidelines for prevention of NSAID-related ulcer complications. Am J
Gastroenterol 2009;104:728-38.
13. Hernandez-Diaz S, Rodriguez LA. Incidence of serious upper gastrointestinal bleeding/perforation in the general population: review of epidemiologic studies. J Clin Epidemiol 2002;55:15763.
14. Roth SH, Fuller P. Pooled safety analysis of diclofenac sodium topical solution 1.5% (w/w) in the treatment of osteoarthritis in patients aged 75 years or older. Clin Interv Aging 2012;7:12737.
15. Derry S, Moore RA, Rabbie R. Topical NSAIDs for chronic musculoskeletal pain in adults. Cochrane Database Syst Rev 2012;(9):CD007400.
16. Altman RD. Safety advantages of topical versus oral nonsteroidal antiinflammatory drugs. J Rheumatol 2011;38:572.
17. Sprix (ketorolac tromethamine) Nasal Spray package insert. Shirley, NY: American Regent, Inc.; 2014 Apr.
lix
Tranexamic acid References
1. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically
2. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically. Product Information. Lysteda®, tranexamic acid. Ferring Pharmaceuticals, Inc., Bethesda,
MD 20814. October, 2013.
3. American College of Obstetricians and Gynecologists. Committee on Gynecologic Practice: Management of Acute Abnormal and Uterine Bleeding in Nonpregnant Reproductive-Aged
Women. Resources & Publications. Number 557. Apr 2013. Reaffirmed 2015. Accessed Feb 6. 2016. http://www.acog.org/Resources-And-Publications/Committee-Opinions/Committeeon-Gynecologic-Practice/Management-of-Acute-Abnormal-Uterine-Bleeding-in-Nonpregnant-Reproductive-Aged-Women
4. Lysteda ® [package insert] 10/2013. Parsippany, NJ. Ferring Pharmaceuticals, Inc.
5. Lukes, Andrea S, et al. Tranexamic Acid Treatment for Heavy Menstrual Bleeding. Obstetrics & Gynecology. 116(4) Oct 2010: 865-875.
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Tykerb References
1. Tykerb Prescribing Information. GlaxoSmithKline. December. 2012.
2. National Comprehensive Cancer Network. Breast Cancer Treatment Guidelines for Patients – Version 1.2013, 3/5/13. http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf
3. Wolff AC, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer.
J Clin Oncol. Jan 2007; 25(1): 118-145.
4. Geyer CE, et al. Lapatinib plus Capecitabine for HER2-Positive Advanced Breast Cancer. N Engl J Med 2006;355:2733-43.
5. Xeloda® (capecitabine) prescribing information. Roche Pharmaceuticals, Inc., 2/2011. http://www.rocheusa.com/products/xeloda/pi.pdf
6. Tykerb. DrugDex. Micromedex website. www.thomsonhc.com. Accessed 4/12/12.
7. Tykerb. Clinical Pharmacology. Clinical Pharmacology Website. www.clinicalpharmacology.com. Accessed 4/12/12.
8. Revlimid. AHFS Drug Information. Ovid website. http://ovidsp.tx.ovid.com. Accessed. 4/12/12
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Votrient References
1. Votrient prescribing information. GlaxoSmithKline; Research Triangle Park, NC; August 2013.
2. NCCN Clinical Practice Guidelines in Oncology: Kidney Cancer. Fort Washington, PA: National Comprehensive Cancer Network, Inc. 2013. (Accessed Feb. 26, 2013, at
http://www.nccn.org/professionals/physician_gls/ PDF/kidney.pdf )
3. NCCN Clinical Practice Guidelines in Oncology: Soft Tissue Sarcoma. Fort Washington, PA: National Comprehensive Cancer Network, Inc. 2013 (Accessed September 13, 2013, at
http://www.nccn.org/professionals/physician_gls/pdf/sarcoma.pdf)
Last Update: 09/07/2016
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Weight Reduction Medications:
1. American Association of Clinical Endocrinologists. (2013). Clinical Practice Guidelines for the Perioperative Nutritional, Metabolic, and Nonsurgical Support of the Bariatric Surgery
Patient—2013 Update: Cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society fo. Endocrine Practice(Volume 19, Number 2/MarchApril 2013), 337-372.
2. Thomson Micromedex. (2014, September 19). Naltrexone hydrochorlide/bupropion hydrochloride. DRUGDEX System. Greenwood Village, CO. Retrieved Spetember 22, 2014, from
DRUGDEX System: http://www.thomsonhc.com
3. Endocrine Society. Pharmacological management of obesity: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015;100(2):342-362.
4. Jensen MD, et al. 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults: A Report of the American College of Cardiology/American Heart Association
Task Force on Practice Guidelines and The Obesity Society. Circulation. 2013;00:000-000.
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Xeljanz References:
1. Xeljanz (tafacitinib citrate) [package insert]. NJ, NJ; Pfizer Labs; Revised November 2012.
2. Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents
in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625-639.
lxiv
Xolair References
1. Barnes, P. J. (May 2015 ). Anti-IgE therapy. UpToDate. (B. S. Bochner, & A. M. Feldweg, Eds.) Waltham, MA. Retrieved June 16, 2015, from http://www.uptodate.com/contents/anti-igetherapy?source=related_link#H7764932
2. DRUGDEX® Evaluations. (n.d.). Omalizumab. DRUGDEX System. Greenwood Village, CO. Retrieved June 16, 2015, from http://nvezproxy.roseman.edu:3305/micromedex2/librarian/ND_T/evidencexpert/ND_PR/evidencexpert/CS/E8C454/ND_AppProduct/evidencexpert/DUPLICATIONSHIELDSYNC/318DA6/ND_PG/e
videncexpert/ND_B/evidencexpert/ND_P/evidencexpert/PFActionId/evidencexpert.Intermedi
3. Khan, D. A. (2013, September 19). education, Chronic urticaria: Standard management and patient. UpToDate. (S. Saini, J. Callen, & A. M. Feldweg, Eds.) Waltham, MA. Retrieved from
http://www.uptodate.com/contents/chronic-urticaria-standard-management-and-patient-education?source=see_link
4. Khan, D. A. (May 2015 ). Chronic urticaria: Treatment of refractory symptoms. UpToDate. (S. Saini, J. Callen, & A. M. Feldweg, Eds.) Waltham, MA. Retrieved June 16, 2015, from
http://www.uptodate.com/contents/chronic-urticaria-treatment-of-refractory-symptoms?source=see_link#H1
5. National Heart, Blood, and Lung Institute Expert Panel Report 3 (EPR 3): Guidelines for the Diagnosis and Management of Asthma. NIH Publication no. 08-4051, 2007.
6. Gold Standard. (2015) Xolair. Retrieved http://www.clinicalpharmacology-ip.com/Forms/drugoptions.aspx?cpnum=2633&n=Xolair&t=0.
Last Update: 09/07/2016
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