Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Skin Disorders.
Treatment: Pharmacy/Prescription Drugs.
The insurer Denied: Otezla.
The denial is: Upheld, in whole.

The patient is a male with a history of several years of psoriasis on the elbows and legs. The patient has used topical steroids. The provider requests Otezla. The subject under review is the medical necessity for the requested Otezla.

The health plan's determination is upheld, in whole.

The patient has psoriasis on the elbows and legs but there is no clear indication in the medical record visit that this is determined to be greater than 10% body surface area (BSA) which would be consistent with moderate to severe psoriasis. Additionally, the patient has no documented contraindication, intolerance, or failure (CIF) to systemic disease modifying anti-rheumatic drug (DMARD.)
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.
As stated by authors 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 of a mean daily acitretin dose of 25.01 milligrams (mg). 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."
Per Colombo et al. (2013), "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. In clinical practice, CsA is usually used for the induction of psoriasis remission at a daily dose included in the range of 2.5-5mg/kg and with intermittent short-term regimens, lasting on average 3-6 months."
Per authors Greb et al. (2016), "Methotrexate is an anti-inflammatory agent used to treat psoriasis, psoriatic arthritis, and other immune mediated disordersThe folic acid analogue methotrexate is used as an anti-neoplastic agent and treatment for inflammatory disorders including psoriasis, dermatomyositis, lupus erythematous, sarcoidosis, and systemic sclerosis. Despite the introduction of newer biologic agents, methotrexate remains a first-line systemic therapy for many patients with disorders of chronic inflammation."
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."
There are no formal head-to-head comparative studies of Otezla to other Food and Drug Administration (FDA) approved medications for psoriasis. However, in parallel comparisons the data strongly suggests that Otezla (29-33%) has a PASI 75 reduction rate that is similar to methotrexate. Acitretin and cyclosporine have similar to greater treatment responses compared to Otezla. The patient does not have elevated out these or liver disease or uncontrolled hypertension. While the prior authorization form indicates a BSA greater than 10% this is not reflected in the office visit records submitted. Medical necessity for Otezla has not been established. There is no reason the patient cannot consider use of one of the plan's preferred medications.