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

Nature of Statutory Criteria/ Case Summary:  The enrollee is requesting authorization and coverage for Otezla. The enrollee has psoriasis affecting 10% of body surface area (BSA) including the scalp, chest, right forearm and forehead. Her dermatologist indicates the enrollee has tried and failed Lidex, Clobetasol, Calcipotriene, Enstilar, Mometasone, and multiple over-the-counter topicals. Biologics, such as Humira, Enbrel, Stelara, Simponi, and others have been avoided due to their immunosuppressive properties and side effects. Phototherapy is contraindicated due to the sensitive location of the psoriasis. Systemic disease-modifying anti-rheumatic drugs (DMARDs) have been avoided, as well, due to a history of anxiety and her childbearing age. Review of the literature indicates there are no formal head-to-head comparative studies of Otezla (apremilast) to other FDA approved medications for psoriasis. However, in parallel comparisons, the data strongly suggests that Otezla has a Psoriasis Area and Severity Index (PASI) 75 reduction rate that is similar to methotrexate. Acitretin (Soriatane) and cyclosporine have similar to greater treatment responses compared to Otezla. Otezla has inferior PASI 75 reduction rate (29-33%) compared to Enbrel, Humira and Cosentyx. Cyclosporine A (CsA) is one of the most effective systemic drugs available for the treatment of psoriasis, as evidenced by the results of several randomized studies and by a prolonged experience in dermatological setting. Methotrexate is an anti-inflammatory agent used to treat psoriasis, psoriatic arthritis, and other immune mediated disorders. Methotrexate remains a first-line systemic therapy for many patients with disorders of chronic inflammation and has proven efficacy. Biologic therapies like adalimumab (Humira) are the gold standard for psoriasis treatment with efficacy and safety profiles allowing for long-term treatment. Observations on pregnant or lactating women did not result in the identification of novel safety signals. Thus, expert opinion and the majority of physicians agree that adalimumab is a safe treatment option at least for the first trimester of pregnancy. Review of the record indicates insufficient evidence of the enrollees trial and failure or contraindications to alternatives, including biologic therapies, acitretin, cyclosporine, or methotrexate. The enrollee does not have elevated liver function tests, liver disease or uncontrolled hypertension. She does not have a demyelinating disorder, congestive heart failure, lupus-like syndrome or active infection. The enrollee is not immunosuppressed or immunocompromised. While she does have anxiety, this is a co-morbidity that can be effectively managed, even while treating the enrollee with preferred therapy. The requested therapy with Otezla is not superior to the formulary alternative medications in terms of safety and efficacy. 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.