Step Therapy Approval Criteria
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- Nicholas Waters
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1 Effective Date: 07/01/2015 This document contains for the following medications: 1. Ambien CR (zolpidem ER) 2. Chantix Continuing Month (varenicline) 3. Chantix Starting Month (varenicline) 4. Cymbalta (duloxetine) 5. Differin (adapalene) 6. Enbrel (etanercept) 7. Fenofibrate 8. Humira (adalimumab) 9. Imitrex Injection vial and STATdose (sumatriptan succinate) 10. Intuniv (guanfacine extended-release) 11. Lidoderm (lidocaine extended-release patch) 12. Nexium (esomeprazole) 13. Relpax (eletriptan)
2 14. Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir) 15. Tivicay (dolutegravir) 16. Xifaxan (rifaximin)
3 Ambien CR (zolpidem ER) zolpidem extended-release Ambien CR Nonbarbiturate hypnotic Insomnia Previous failure of zolpidem (immediate-release tablet) in the past 180 days Quantity limit (QL) of 30 tablets per 30 days Initial: 10/01/2013 Revision:
4 Chantix Continuing Month (varenicline) varenicline Chantix Continuing Month Smoking cessation agent Smoking cessation assistance Previous claim for Chantix Starting Month in the past 90 days Quantity limit of 2 months total Initial: 12/10/2013 Revision:
5 Chantix Starting Month (varenicline) varenicline Chantix Starting Month Smoking cessation agent Smoking cessation assistance Previous failure of bupropion or nicotine replacement therapy (gum, lozenge or patch) in the past 365 days Quantity limit of 1 month total Initial: 12/10/2013 Revision: 04/01/2015
6 Cymbalta (duloxetine) duloxetine Cymbalta Serotonin-Norepinephrine reuptake inhibitor Chronic musculoskeletal pain Diabetic peripheral neuropathic pain Fibromyalgia Generalized anxiety disorder Major depressive disorder Previous failure of one of the following in the past 365 days: o Gabapentin o Venlafaxine ER o Formulary NSAID Step 2: Previous failure of one of the following in the past 365 days: o Formulary SSRI o Formulary TCA o Formulary muscle relaxant Quantity Limit (QL) of 60 capsules per 30 days Initial: 01/01/2015 Revision: 04/01/2015
7 Differin (adapalene) adapalene Differin Retinoid; antiacne Acne vulgaris Previous failure of a formulary topical acne medication (benzoyl peroxide, clindamycin, erythromycin or tretinoin) in the past 365 days Initial: 10/01/2013 Revision:
8 Enbrel (etanercept) etanercept Enbrel TNF inhibitor; immune suppressant Ankylosing spondylitis Juvenile idiopathic arthritis Plaque psoriasis Psoriatic arthritis Rheumatoid arthritis Previous failure of one of the following in the past 365 days: o Asacol o Balsalazide o Dipentum o Methotrexate o Rowasa Step 2: Previous failure of one of the following in the past 365 days: o Azathioprine o Cyclosporine o Hydroxychloroquine o Hydroxyurea o Leflunomide o Mercaptopurine o Soriatane o Sulfasalazine Quantity limit (QL) of 4 injections per 28 days Page 1 of 2
9 References: Beukelman T, Patkar NM, Saag KG, et al Amercian College of Rheumatology recommendation for the treatment of juvenile idiopathic arthritis: initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features. Arthritis Care and Research 2011;63(4): Braun J, van den Berg R, Baraliakos X, et al update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Annals of the Rheumatic Diseases 2011;70: Enbrel Prescribing Information. Immunex Corp, Thousand Oaks, CA: Kornbluth A, Sachar DB, The Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis in adults. American Journal of Gastroenterology 2010; available online at Accessed August 27, Lichtenstein GR, Hanauer SB, Sandborn WJ and The Practice Parameters Committee of the American College of Gastroenterology. Management of Crohn s disease in adults. American Journal of Gastroenterology 2009; available online at Accessed August 27, Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. Journal of the American Academy of Dermatology 2009;61: Singh JA, Furst DE, Bharat A, et al 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 and Research 2012;64(5): Initial: 10/01/2013 Revision: 04/01/2015 Page 2 of 2
10 Fenofibrate Brand names: fenofibrate 54 mg, 134 mg and 160 mg Lofibra Fibric acid; antihyperlipidemic Hypercholesterolemia Previous failure of gemfibrozil in the past 180 days Quantity limit of 30 pills per month Initial: 04/01/2014 Revision:
11 Humira (adalimumab) adalimumab Humira TNF inhibitor; monoclonal antibody; antirheumatic Ankylosing spondylitis Crohn s disease Juvenile idiopathic arthritis Plaque psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis Previous failure of one of the following in the past 365 days: o Asacol o Balsalazide o Dipentum o Methotrexate o Rowasa Step 2: Previous failure of one of the following in the past 365 days: o Azathioprine o Cyclosporine o Hydroxychloroquine o Hydroxyurea o Leflunomide o Mercaptopurine o Soriatane o Sulfasalazine Quantity limit (QL) of 2 injections per 28 days Page 1 of 2
12 References: Beukelman T, Patkar NM, Saag KG, et al Amercian College of Rheumatology recommendation for the treatment of juvenile idiopathic arthritis: initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features. Arthritis Care and Research 2011;63(4): Braun J, van den Berg R, Baraliakos X, et al update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Annals of the Rheumatic Diseases 2011;70: Humira Prescribing Information. AbbVie Inc, North Chicago, IL: Kornbluth A, Sachar DB, The Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis in adults. American Journal of Gastroenterology 2010; available online at Accessed August 27, Lichtenstein GR, Hanauer SB, Sandborn WJ and The Practice Parameters Committee of the American College of Gastroenterology. Management of Crohn s disease in adults. American Journal of Gastroenterology 2009; available online at Accessed August 27, Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. Journal of the American Academy of Dermatology 2009;61: Singh JA, Furst DE, Bharat A, et al 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 and Research 2012;64(5): Initial: 10/01/2013 Revision: 04/01/2015 Page 2 of 2
13 Imitrex Injection vial and STATdose (sumatriptan succinate) sumatriptan Imitrex Injection vial and Imitrex STATdose 5HT-1 serotonin receptor agonist; antimigraine Acute migraine Cluster headache Previous failure of sumatriptan oral tablets or sumatriptan nasal spray in the past 365 days Quantity limit (QL) of 6 doses (3 ml) per 30 days Initial: 10/01/2013 Revision:
14 Intuniv (guanfacine extended-release) guanfacine extended-release Intuniv Alpha-2 adrenergic agonist Attention deficit hyperactivity disorder Previous failure of a formulary stimulant (amphetamine-containing product or methylphenidate-containing product) in the past 365 days Quantity limit (QL) of 30 tablets per 30 days Initial: 07/01/2015 Revision:
15 Lidoderm (lidocaine extended-release patch) lidocaine extended-release patch Lidoderm Local anesthetic Postherpetic neuralgia Previous failure of Voltaren Gel in the past 180 days Quantity limit (QL) of 30 patches per 30 days Initial: 07/01/2014 Revision:
16 Nexium (esomeprazole) esomeprazole Nexium Proton pump inhibitor H. pylori duodenal ulcer disease Erosive esophagitis Gastroesophageal reflux disease NSAID-associated gastric ulcer prophylaxis Zollinger-Ellison syndrome Previous failure of omeprazole in the past 365 days Step 2: Previous failure of pantoprazole in the past 365 days Quantity Limit (QL) of 30 capsules per 30 days Initial: 01/01/2015 Revision: 04/01/2015
17 Relpax (eletriptan) eletriptan Relpax 5-HT1 serotonin receptor agonist; antimigraine Acute migraine Previous failure of a formulary triptan medication (sumatriptan tablet, sumatriptan nasal spray, sumatriptan injection, zolmitriptan tablet or zolmitriptan oral-disintegrating tablet) in the past 180 days Quantity limit (QL) of 6 tablets per 30 days Initial: 10/01/2013 Revision:
18 Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir) elvitegravir/cobicistat/emtricitabine/tenofovir Stribild Antiretroviral HIV infection Previous failure of a regimen containing Reyataz, Prezista or Atripla in the past 365 days Initial: 10/01/2014 Revision: 04/01/2015
19 Tivicay (dolutegravir) dolutegravir Tivicay Antiretroviral HIV infection Previous failure of a regimen containing Reyataz, Prezista or Atripla in the past 365 days Quantity limit (QL) of 30 tablets per 30 days Initial: 10/01/2014 Revision: 04/01/2015
20 Xifaxan (rifaximin) rifaximin Xifaxan Rifamycin Hepatic encephalopathy, prophylaxis Traveler s diarrhea Previous failure of lactulose, ciprofloxacin or azithromycin in the past 180 days Quantity limit (QL) of 60 tablets per 30 days for the 550 mg tablets Quantity limit (QL) of 180 tablets per 30 days for the 200 mg tablets Initial: 07/01/2015 Revision:
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