Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Plaque psoriasis.

Treatment: Otezla. 

The insurer denied coverage for Otezla to treat plaque psoriasis. 

The denial is upheld. 

This is a male patient with psoriasis affecting 12% of his body surface area (BSA). The patient has used topical steroids. The request is for Otezla.

According to the 2018 American College of Rheumatology and National Psoriasis Foundation guidelines oral agents for psoriasis (i.e., acitretin, cyclosporine, and methotrexate (MTX)) may be used first-line in various clinical situations.  For example, acitretin is a first-line systemic drug for palmoplantar or pustular psoriasis and is especially useful in those with severely sun damaged skin, in which it may suppress actinic keratoses and even invasive malignant neoplasms. Cyclosporine may be effective long-term, but is normally reserved for intermittent use (up to 12 weeks) to control a flare so the patient can transition to another drug for long-term maintenance.  When used intermittently, a course of cyclosporine can induce an average decrease of greater than 75% in psoriasis severity.  MTX is considered a first-line systemic agent for plaque psoriasis that may be used continuously for many years or decades with durable benefits.  

Per Chiricozzi et al. (2017), "Acitretin is one of the systemic agents used for the treatment of psoriasis. Because different acitretin dosages resulted therapeutically successful, there is no general agreement on the optimal dose regimen. To report acitretin efficacy and safety in a real-life setting, wherein patient-tailored dose regimen is usually prescribed, a retrospective analysis evaluating charts of all plaque-type psoriasis patients treated with acitretin from the clinic database was performed. [Psoriasis Area and Severity Index (PASI)] score improvement, as well as PASI 50, 75, 90, and 100 responses were assessed throughout the observational period. Overall, 52% PASI score reduction and a satisfactory safety profile were detected. PASI 50, 75, 90, and 100 response was achieved by 53%, 48%, 28%, and 14%, respectively. Treatment consisted on a mean daily acitretin dose of 25.01 mg [milligrams]. The initial dose was increased (51.2% of cases) or decreased (48.8%) prescribing a mean daily dose of 29.8 mg and 20.02 mg, respectively. This study proposed a dose regimen customized on clinical response and patient's needs, to optimized acitretin benefit."

Methotrexate has proven efficacy, per West et al (2016), "in terms of efficacy, the present meta-analysis finds that approximately 40% of patients achieve a PASI 75 by 12 weeks of treatment. Nonetheless, it means that many psoriasis patients requiring systemic therapy are likely to benefit to methotrexate, even more so, as flexible dose adjustment and adaptation of route of dosing are applied under real-world conditions which would be expected to increase efficacy and reduce limiting adverse events." In this case, while the patient does consume alcohol, there is no documentation of alcoholism or elevated liver function test (LFT) or liver disease. Weekly ingestion of less than 14 units of alcohol a week has not been associated with transaminitis. However, it is expected that the patient will discontinue alcohol consumption in order to comply with preferred therapy. The patient does not have elevated LFTs or liver disease or uncontrolled hypertension. The patient is not immunosuppressed or immunocompromised. The patient has no documented contraindication to systemic disease-modifying antirheumatic drugs (DMARDs). There is no exception for Otezla.         

The health plan acted reasonably with sound medical judgment, and in the best interest of the patient. 

Based on the above, the medical necessity for Otezla to treat plaque psoriasis is not substantiated.  The insurer's denial should be upheld.