Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/ Case Summary:  The enrollee is requesting authorization and coverage for the medication Otezla. The enrollee has psoriasis vulgaris. She has pink papules with collarette located on the scalp. She has used Clobetasol, 0.05% scalp solution, and Derma-Smoothe/FS Scalp oil, 0.01% but these treatments have failed. Psoriasis is affecting eight percent of her body surface area (BSA), including the scalp. The dermatologist is requesting authorization of Otezla. The dermatologist notes Otezla is Food and Drug Administration (FDA)-approved for the treatment of persons with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Additionally, the FDA does not require a trial of any specific medications prior to Otezla initiation. The provider further notes methotrexate carries a black box warning regarding risks for the development of malignant lymphomas. It is also associated with substantial risks for hepatoxicity and has been known to cause liver failure. Likewise, cyclosporine has black box warnings regarding the possible development of lymphoma and other neoplasms, including skin malignancies. It also carries a black box warning for systemic hypertension and nephrotoxicity. Cyclosporine is associated with significant risks for developing serious bacterial, viral, fungal, and protozoal infections. Cyclosporine-induced hepatoxicity has been known to cause liver failure and fatal outcomes.  By contrast, Otezla has a vastly superior safety profile. The enrollee has tried and failed topical corticosteroids but has not trialed systemic medications. Documentation does not demonstrate why the enrollee cannot use methotrexate, cyclosporine, or acitretin; and cannot trial two of the following biologic injectable medications: Cosentyx, Enbrel, Humira. Literature notes treatment-limiting adverse effects from the use of methotrexate, such as aberrations in liver function tests and nausea, are rare. Nausea was reported in two out of twenty trials; reducing the statistical significance of incidence. A meta-analysis of liver injury in methotrexate users found individuals on methotrexate are not at increased risk of liver cirrhosis or liver failure. In terms of efficacy, the meta-analysis finds that approximately 40% of individuals achieve a Psoriasis Area and Severity Index (PASI) 75 by 12 weeks of treatment. Many persons with psoriasis who require systemic therapy are likely to benefit from methotrexate, as flexible dose adjustment and adaptations to dosing route are applied under real-world conditions; increasing efficacy and reducing treatment-limiting adverse events. Literature describes how current treatment recommendations for those with psoriasis depend on the severity of disease. Mild disease is treated with topical therapies, such as corticosteroids, vitamin D analogues, or tazarotene, as the sole agent. With increasing disease severity, these agents are used in combination with phototherapy and/or traditional nonbiologic systemic therapy; such as methotrexate, cyclosporine, or acitretin. Moderate-to-severe disease typically necessitates the use of systemic agents; either traditional agents or biologics; e.g., tumor necrosis factor-alpha [TNF-] inhibitors and ustekinumab. Further literature reaffirms this treatment modality, stating persons with moderate-to-severe plaque psoriasis graduate to systemic therapy, such as methotrexate, cyclosporine, acitretin, and apremilast (Otezla); with topical products relegated to occasional adjunctive use. Biologic therapies are utilized if systemic agents fail to produce an adequate response.Final Result: The reviewer determined that the requested service is not medically necessary for the treatment of the enrollees medical condition. Credentials/Qualifications: The physician reviewer is board certified in dermatology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or similar medical condition.