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Step Therapy Criteria Paramount Medicare Enhanced Formulary 2011 Formulary ID 11110, Ver 23. CMS Approved 10-25-2011. Last Updated: 10-05-2011 ANTIDEPRESSANT THERAPY Products Affected • • • • • • • • • Celexa Cymbalta Effexor Effexor Xr Lexapro Luvox Cr Paxil Paxil Cr Pexeva • • • • • • • • • Pristiq Prozac Prozac Weekly Rapiflux Savella Savella Titration Pack Venlafaxine Hcl Er TB24 Viibryd Zoloft Details Criteria If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given. Step 1 Drug(s): Citalopram Hbr, Fluoxetine Hcl, Fluoxetine DR, Fluvoxamine Maleate, Paroxetine Hcl, Paroxetine ER, or Sertraline Hcl. Step 2 Drug(s): Cymbalta, Celexa, Effexor, Effexor Xr, Lexapro, Luvox Cr, Paxil, Paxil Cr, Pexeva, Pristiq, Prozac, Prozac Weekly, Rapiflux, Savella, Venlafaxine ER, Viibryd, Zoloft. Number of days for claims review for select or first line drugs: 130 days. History effective date: 130 days prior to effective date. Grandfathering: 130 days. Grandfathering includes all SSRI/SNRI products as well as second-line drugs listed above. On-line Pharmacy Message: "Use generic SSRI/SNRIs first". Override allowed: Yes. Override NCPCP number: 75. This step therapy program applies to new utilizers only. ANTIDEPRESSANTS - BUPROPION Products Affected • • Aplenzin Wellbutrin Sr • Wellbutrin XL Details Criteria If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given. Step 1 Drug(s): Budeprion Sr, Budeprion Xl, Bupropion Hcl Sr. Step 2 Drug(s): Aplenzin, Wellbutrin XL, Wellbutrin SR. Number of days for claims review for select or first line drugs: 130 days. History effective date: 130 days prior to effective date. Grandfathering: 130 days. On-line Pharmacy Message: "Use generic bupropion XR/XL first". Override allowed: Yes. Override NCPCP number: 75. This step therapy program applies to new utilizers only. Authorization may be given for a step 2 drug if the patient is currently taking the requested agent. 2 ANTIDEPRESSANTS - SARAFEM Products Affected • Sarafem Details Criteria If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given. Step 1 Drug(s): Fluoxetine Hcl. Step 2 Drug(s): Sarafem. Number of days for claims review for select or first line drugs: 130 days. History effective date: 130 days prior to effective date. Grandfathering: 130 days. On-line Pharmacy Message: "Use generic fluoxetine first". Override allowed: Yes. Override NCPCP number: 75. This step therapy program applies to new utilizers only. Authorization may be given for step 2 Sarafem if the patient is currently taking the requested agent. 3 ANTIHISTAMINE THERAPY Products Affected • • • • • Allegra Cetirizine Hcl SYRP Clarinex Clarinex Reditabs Clarinex-d 12 Hour • • • • Clarinex-d 24 Hour Fexofenadine Hcl Levocetirizine Dihydrochloride Xyzal Details Criteria OTCs: "LORATADINE", "LORATADINE HIVES RELIEF", "CETIRIZINE HCL", "LORATADINE-D 12HR" or "24HR", "CETIRIZINE HCL/PSEUDOEPHEDRINE HCL ER", "CETIRIZINE HCL CHILDRENS ALLERGY". If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given. Step 1 Drug(s): OTC Cetirizine Hcl, OTC Loratadine. Step 2 Drug(s): Fexofenadine, Cetirizine Syr 5mg/5ml. Step 3 Drug(s): Allegra, Allegra-D 12 Hour, Allegra-D 24 Hour, Clarinex, Clarinex-D 12 Hour, Clarinex-D 24 Hour, Levocetirizine, Xyzal. Number of days for claims review for select or first line drugs: 130 days. History effective date: 130 days prior to effective date. Grandfathering: 130 days. On-line Pharmacy Message: "Generic OTC cetirizine or loratadine 1st". Override allowed: Yes. Override NCPCP number: 75. 4 BISPHOSPHONATES Products Affected • • • Actonel Atelvia Boniva TABS • • Fosamax Fosamax Plus D Details Criteria If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given. Step 1 Drug(s): Alendronate Sodium. Step 2 Drug(s): Actonel, Actonel With Calcium, Atelvia, Boniva. Fosamax, Fosamax Plus D. Number of days for claims review for select or first line drugs: 130 days. History effective date: 130 days prior to effective date. Grandfathering: 130 days. On-line Pharmacy Message: "Use generic alendronate first". Override allowed: Yes. Override NCPCP number: 75. Authorization may be given for Fosamax oral solution for adult patients with a gastrostomy tube, who cannot swallow, or who have difficulty swallowing tablets. Authorization may be given for Fosamax oral solution for children who require an oral solution. 5 BRANDED NSAID THERAPY Products Affected • • • • • • • • • • • Anaprox Anaprox Ds Arthrotec 50 Arthrotec 75 Cataflam Clinoril Daypro Ec-naprosyn Feldene Flector Mobic • • • • • • • • • • • Nalfon Naprelan TB24 375MG, 500MG, 750MG Naprosyn Pennsaid Ponstel Sprix Vimovo Voltaren GEL Voltaren TBEC Voltaren-xr Zipsor Details Criteria If the patient has tried two Step 1 drugs, then authorization for a Step 2 drug may be given. Step 1 Drug(s): Diclofenac Potassium, Diclofenac Sodium, Diflunisal, Etodolac, Fenoprofen Calcium, Flurbiprofen, Ibuprofen, Indomethacin, Ketoprofen, Ketorolac Tromethamine, Meclofenamate Sodium, Mefenamic Acid, Meloxicam, Nabumetone, Naproxen, Naproxen Sodium, Oxaprozin, Piroxicam, Sulindac, Tolmetin Sodium. Step 2 Drug(s): Anaprox, Anaprox Ds, Arthrotec 50, Arthrotec 75, Cambia, Cataflam, Clinoril, Daypro, Ec-Naprosyn, Feldene, Flector, Indocin, Indocin Sr, Mobic, Nalfon, Naprelan, Naprosyn, Pennsaid, Ponstel, Sprix, Voltaren, Voltaren-XR, Vimovo, Zipsor. Number of days for claims review for select or first line drugs: 130 days. History effective date: 130 days prior to effective date. Grandfathering: 130 days. On-line Pharmacy Message: "Use 2 generic NSAIDs first". Override allowed: Yes. Override NCPCP number: 75. Post effective date coverage rule: 120 days. Allow continuous users of second line drugs who have met first line criteria. Authorization for a step 2 drug may be given if the patient has tried two unique generic prescription strength non-steroidal antiinflammatory drugs (NSAIDs) for the current condition. Authorization may be given for Flector or Voltaren Gel for patients with difficulty swallowing or cannot swallow. Authorization may be given for Voltaren Gel for patients with a chronic musculoskeletal pain condition (eg, osteoarthritis) in 3 or fewer joints/sites (ie, hand, wrist, elbow, knee, ankle, or foot each count as 1 joint/site) who are at risk of NSAIDassociated toxicity (eg, previous gastrointestinal [GI] bleed, history of peptic ulcer disease, impaired renal function, cardiovascular disease, 6 hypertension, heart failure, elderly patients with impaired hepatic function, or those taking concomitant anticoagulants). 7 COX II THERAPY Products Affected • Celebrex Details Criteria If the patient has tried two Step 1 drugs, then authorization for a Step 2 drug may be given. Step 1 Drug(s): Diclofenac Potassium, Diclofenac Sodium, Diflunisal, Etodolac, Fenoprofen Calcium, Flurbiprofen, Ibuprofen, Indomethacin, Ketoprofen, Ketorolac Tromethamine, Meclofenamate Sodium, Mefenamic Acid, Meloxicam, Nabumetone, Naproxen, Naproxen Sodium, Oxaprozin, Piroxicam, Sulindac, Tolmetin Sodium. Step 2 Drug(s): Celebrex. Number of days for claims review for select or first line drugs: 130 days. History effective date: 130 days prior to effective date. Grandfathering: 130 days. On-line Pharmacy Message: "Use 2 generic NSAIDs first". Override allowed: Yes. Override NCPCP number: 75. Post effective date coverage rule: 120 days. Allow continuous users of second line drugs who have met first line criteria. This step therapy program will exclude participants with a claims history of warfarin (Coumadin) within the last 130 days. Authorization for Celebrex may be given for patients who are currently taking chronic systemic corticosteroid therapy, warfarin (Coumadin), clopidogrel (Plavix), chronic aspirin therapy, or low molecular weight heparins. Authorization for Celebrex may be given for patients with reduced platelet counts or other coagulation disorders. Authorization for Celebrex may be given for patients with familial adenomatous polyposis (FAP) or attenuated adenomatous polyposis coli (AAPC) who have adenomatous colorectal polyps. Authorization for Celebrex may be given if used for the treatment of cancer as part of a cancer-chemotherapy regimen (e.g., in combination with chemotherapeutic agents). Authorization for Celebrex may be given for patients who have had a documented upper gastrointestinal bleed from a duodenal or gastric ulcer. Authorization for Celebrex may be given for patients with a past hypersensitivity, anaphylactic or allergic-type reaction (e.g., erythema, hives, urticaria, angioedema) to aspirin or NSAIDs. Authorization for Celebrex may be given to patients with aspirin-sensitive asthma (also known as aspirininduced asthma, aspirin-exacerbated respiratory disease) or NSAIDinduced asthma. 8 INTRANASAL STEROIDS Products Affected • • • • Beconase Aq Flonase Nasacort Aq Nasonex • • • Omnaris Rhinocort Aqua Veramyst Details Criteria If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given. Step 1 Drug(s): Flunisolide, Fluticasone Propionate, Triamcinolone. Step 2 Drug(s): Beconase Aq, Flonase, Nasacort Aq, Nasonex, Omnaris, Rhinocort Aqua, Veramyst. Number of days for claims review for select or first line drugs: 130 days. History effective date: 130 days prior to effective date. Grandfathering: 130 days. On-line Pharmacy Message: "Use generic nasal steroid first". Override allowed: Yes. Override NCPCP number: 75. 9 LEUKOTRIENE INHIBITOR THERAPY Products Affected • • Accolate Singulair • Zafirlukast Details Criteria OTCs: "LORATADINE", "LORATADINE HIVES RELIEF", "CETIRIZINE HCL", "LORATADINE-D 12HR" OR "24HR", "CETIRIZINE HCL/PSEUDOEPHEDRINE HCL ER", "CETIRIZINE HCL CHILDRENS ALLERGY". If the patient has tried two Step 1 drugs, then authorization for a Step 2 drug may be given. Step 1 Drug(s): Intranasal flunisolide, fluticasone propionate, Beconase, Nasacort AQ, Nasonex, Omnaris, Rhinocort, or Veramyst plus either OTC cetirzine, OTC loratadine, fexofenadine, or Clarinex. Step 2 Drug(s): Singulair, Accolate. This step therapy program will exclude participants with a claims history of inhaled beta 2 agonists or inhaled corticosteroids within the last 130 days. Number of days for claims review for select or first line drugs: 130 days. History effective date: 130 days prior to effective date. Grandfathering: 130 days. On-line Pharmacy Message: "Nas ster+OTC cetirizine or lorat 1st". Override allowed: Yes. Override NCPCP number: 75. 10 PPI THERAPY Products Affected • • • • • Aciphex Dexilant Nexium Pantoprazole Sodium Prevacid • • • • Prevacid Solutab Prilosec CPDR Protonix Zegerid Details Criteria OTCs: "OMEPRAZOLE" and "LANSOPRAZOLE". If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given. If the patient has tried a Step 2 drug, then authorization for a Step 3 drug may be given. Step 1 Drug(s): OTC, omeprazole, or lansoprazole. Step 2 Drug(s): pantoprazole. Step 3 Drug(s): Aciphex, Dexilant, Nexium, Prevacid, Prilosec, Protonix, Zegerid. Number of days for claims review for select or first line drugs: 130 days. History effective date: 130 days prior to effective date. Grandfathering: 130 days. Injectables are not included in the drug groups nor in the look back period. On-line Pharmacy Message: "Use generic OTC PPI first". Override allowed: Yes. Override NCPCP number: 75. Post effective date coverage rule: Allow pantoprazole for Plavix users. Allow continuous users of second line drugs who have met first line criteria. Authorization may be given for lansoprazole SoluTabs for patients with a feeding tube (eg, nasogastric tube, gastric tube). Authorization may be given for lansoprazole SoluTabs for children less than 2 years old. 11 SEDATIVE HYPNOTICS Products Affected • • • • Ambien Ambien Cr Edluar Lunesta • • • • Rozerem Silenor Sonata Zolpimist Details Criteria If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given. Step 1 Drug(s): Zaleplon, Zolpidem Tartrate. Step 2 Drug(s): Ambien, Ambien CR, Edular, Lunesta, Rozerem, Silenor, Sonata, Zolpimist. Number of days for claims review for select or first line drugs: 130 days. History effective date: 130 days prior to effective date. Grandfathering: 130 days. On-line Pharmacy Message: "Use generic zolpidem IR or generic zaleplon 1st". Override allowed: Yes. Override NCPCP number: 75. Rozerem will be covered for members equal to or over the age of 65 years. For those under 65 years of age, the step therapy will apply. Authorization for Rozerem may be given if the patient has a documented history of addiction to controlled substances. Authorization for Edluar may be given if the patient has difficulty swallowing or cannot swallow tablets. 12 TOPICAL IMMUNOMODULATOR THERAPY Products Affected • Elidel • Protopic Details Criteria If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given. Step 1 Drug(s): Ala-cort, Alclometasone Dipropionate, Amcinonide, Augmented Betamethasone, Betamethasone Dipropionate, Betamethasone Valerate, Beta-val, Clobetasol Emollient, Clobetasol Propionate, Del-beta, Desoximetasone, Diflorasone Diacetate, Fluocinolone Acetonide, Fluocinonide, Fluocinonide Emollient, Fluticasone Propionate, Halobetasol Propionate, Hydrocortisone, Hydrocortisone Butyrate, Hydrocortisone Valerate, Mometasone Furoate, Nystatin/Triamcinolone, Prednicarbate, Triamcinolone Acetonide, Triderm, Step 2 Drug(s): Elidel, Protopic. Number of days for claims review for select or first line drugs: 60 days. History effective date: 130 days prior to effective date. Grandfathering: 130 days. On-line Pharmacy Message: "Use generic Rx topical steroid first". Override allowed: Yes. Override NCPCP number: 75. Authorization may be given for Elidel or Protopic, if the patient has tried one generic prescription strength topical corticosteroid for atopic dermatitis or eczema in the previous 60 days. Authorization for Protopic or Elidel may be given for patients with a dermatologic condition on or around the eyes, eyelids or genitalia. Authorization for Protopic or Elidel may be given for patients with the following conditions after a trial of a prescription strength generic topical corticosteroid: lichen planus, seborrheic dermatitis, chronic hand dermatitis, cutaneous lupus erythematosus or dermatomyositis or discoid lupus erythematosus, psoriasis, and vitiligo. Authorization for Protopic may be given for patients with the following conditions after a trial of a prescription strength generic topical corticosteroid: dyshidrotic palmar eczema, pyoderma gangrenosum, orofacial or perineal Crohn’s disease, erosive pustular dermatosis, chronic cutaneous graft-vs-host disease (GVHD), chronic actinic dermatitis, allergic contact dermatitis, and bullous pemphigoid. Authorization may be given for Elidel or Protopic, for steroid-induced rosacea if the patient has tried two therapies for rosacea (e.g., azelaic acid, topical metronidazole, topical tretinoin products, oral antibiotics [e.g., tetracycline, metronidazole, doxycycline, minocycline, clarithromycin], or oral isotretinoin). Authorization may be given for Protopic, for severe uremic pruritus if the patient has tried two other therapies for this condition (e.g., emollients, capsaicin, topical corticosteroids, ultraviolet B irradiation). 13 14 ZETIA Products Affected • Vytorin TABS 10MG; 10MG, 10MG; 20MG • Zetia Details Criteria If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given. Step 1 Drug(s): 40 mg or greater of the following: Advicor, Altoprev, Caduet, Lescol, Lescol Xl, Lipitor, Lovastatin, Mevacor, Pravachol, Pravastatin Sodium, Simcor, Simvastatin, Zocor. At least 20 mg of Crestor. Livalo. Step 2 Drug(s): Zetia, Vytorin 10 10, Vytorin 10 20. Number of days for claims review for select or first line drugs: 130 days. History effective date: 130 days prior to effective date. Grandfathering: 130 days. On-line Pharmacy Message: "Titrated dose HMG first". Override allowed: Yes. Override NCPCP number: 75. Authorization for Zetia may be given if the patient is taking or will be taking a medication that has a significant drug interaction with any of the HMG-CoA reductase inhibitors [statins] (eg, cyclosporine, fibrates, niacin more than 1 g/day, itraconazole, ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, amiodarone, and verapamil). Authorization of Zetia may be given if the patient has severe renal impairment (creatinine clearance of 30 mL/minute or less). Authorization of Zetia may be given if for management of homozygous familial sitosterolemia. Authorization of Zetia may be given for use in pregnant woman. Authorization of Zetia may be given if the patient has active liver disease or unexplained persistent elevations of serum transaminases. Exceptions are NOT recommended for Zetia for use in patients with moderate or severe hepatic insufficiency. Authorization for Zetia may be given for use in patients who have been previously diagnosed with myopathy or rhabdomyolysis (either medication-related or not medication related) OR the patient has an underlying muscle/musclemetabolism-related disorder (eg, myositis, McArdle disease). 15 INDEX A D Accolate ............................................................. 10 Aciphex ............................................................. 11 Actonel ................................................................ 5 Allegra ................................................................. 4 Ambien .............................................................. 12 Ambien Cr ......................................................... 12 Anaprox ............................................................... 6 Anaprox Ds .......................................................... 6 ANTIDEPRESSANT THERAPY ................................ 1 ANTIDEPRESSANTS - BUPROPION ......................... 2 ANTIDEPRESSANTS - SARAFEM ............................ 3 ANTIHISTAMINE THERAPY .................................. 4 Aplenzin .............................................................. 2 Arthrotec 50 ......................................................... 6 Arthrotec 75 ......................................................... 6 Atelvia ................................................................. 5 Daypro ................................................................ 6 Dexilant .............................................................11 B Beconase Aq ........................................................ 9 BISPHOSPHONATES .............................................. 5 Boniva ................................................................. 5 BRANDED NSAID THERAPY .................................. 6 C Cataflam .............................................................. 6 Celebrex............................................................... 8 Celexa .................................................................. 1 Cetirizine Hcl ....................................................... 4 Clarinex ............................................................... 4 Clarinex Reditabs ................................................. 4 Clarinex-d 12 Hour .............................................. 4 Clarinex-d 24 Hour .............................................. 4 Clinoril ................................................................ 6 COX II THERAPY ................................................. 8 Cymbalta ............................................................. 1 E Ec-naprosyn ........................................................ 6 Edluar ................................................................12 Effexor ................................................................ 1 Effexor Xr ........................................................... 1 Elidel..................................................................13 F Feldene................................................................ 6 Fexofenadine Hcl ................................................ 4 Flector ................................................................. 6 Flonase ................................................................ 9 Fosamax .............................................................. 5 Fosamax Plus D .................................................. 5 I INTRANASAL STEROIDS....................................... 9 L LEUKOTRIENE INHIBITOR THERAPY .................10 Levocetirizine Dihydrochloride ........................... 4 Lexapro ............................................................... 1 Lunesta...............................................................12 Luvox Cr ............................................................. 1 M Mobic .................................................................. 6 N Nalfon ................................................................. 6 Naprelan.............................................................. 6 Naprosyn ............................................................. 6 Nasacort Aq ........................................................ 9 Nasonex .............................................................. 9 16 Omnaris ............................................................... 9 Silenor................................................................12 Singulair .............................................................10 Sonata ................................................................12 Sprix ................................................................... 6 P T Pantoprazole Sodium ......................................... 11 Paxil .................................................................... 1 Paxil Cr ................................................................ 1 Pennsaid .............................................................. 6 Pexeva ................................................................. 1 Ponstel ................................................................. 6 PPI THERAPY ..................................................... 11 Prevacid ............................................................. 11 Prevacid Solutab ................................................ 11 Prilosec .............................................................. 11 Pristiq .................................................................. 1 Protonix ............................................................. 11 Protopic ............................................................. 13 Prozac .................................................................. 1 Prozac Weekly ..................................................... 1 TOPICAL IMMUNOMODULATOR THERAPY .........13 R Xyzal................................................................... 4 Rapiflux ............................................................... 1 Rhinocort Aqua .................................................... 9 Rozerem............................................................. 12 Z Nexium .............................................................. 11 O S Sarafem................................................................ 3 Savella ................................................................. 1 Savella Titration Pack .......................................... 1 SEDATIVE HYPNOTICS ....................................... 12 V Venlafaxine Hcl Er .............................................. 1 Veramyst ............................................................. 9 Viibryd ................................................................ 1 Vimovo ............................................................... 6 Voltaren .............................................................. 6 Voltaren-xr .......................................................... 6 Vytorin ...............................................................15 W Wellbutrin Sr....................................................... 2 Wellbutrin XL ..................................................... 2 X Zafirlukast ..........................................................10 Zegerid ...............................................................11 ZETIA.................................................................15 Zipsor.................................................................. 6 Zoloft .................................................................. 1 Zolpimist ............................................................12 17