Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Psoriasis
Treatment: Otezla 30 milligram tablet
The insurer denied coverage for Otezla 30 milligram tablet.
The denial is upheld.
This is a male patient with a history of psoriasis affecting 40% body surface area (BSA). The patient has previously used medium to high potency topical steroids. The requested medication is for Otezla (apremilast). The submitted clinical notes are hand written and illegible.

Per Armstrong, et al (2020), "This study provides an assessment of the comparative efficacy among treatments for moderate to severe plaque psoriasis. The meta-analysis suggests that brodalumab, guselkumab, ixekizumab, and risankizumab-rzaa were associated with the highest PASI response rates in both short-term and long-term therapy." And as per Nast, et al (2015), "With respect to PASI 75 (psoriasis area and severity index), pooled risk ratios for infliximab (13.07, 95% confidence interval (CI): 8.60-19.87), secukinumab (11.97, 95% CI: 8.83-16.23), ustekinumab (11.39, 95% CI: 8.94-14.51), adalimumab (8.92, 95% CI: 6.33-12.57), etanercept (8.39, 95% CI: 6.74-10.45), and apremilast (5.83, 95% CI: 2.58-13.17) show superiority of biologics and apremilast in long-term therapy compared with placebo. With respect to the addressed safety parameters, no differences were seen between adalimumab, etanercept, or infliximab versus placebo. No placebo-controlled data on conventional treatments was identified. Head-to-head
studies showed superior efficacy of secukinumab and infliximab versus etanercept and of infliximab versus methotrexate. A clear ranking is limited by the lack of long-term head-to-head trials. From the available evidence, infliximab, secukinumab, and ustekinumab are the most efficacious long-term treatments."

The available preferred plan alternative formularies are FDA-approved for moderate-severe plaque psoriasis and have shown good efficacy with acceptable safety profiles when used to treat plaque psoriasis. Although there has been a documented trend towards an increased risk in serious infections compared to non-biologic therapy with the use of Humira and Enbrel for plaque psoriasis, Stelara, Skyrizi, Cosentyx, and Tremfya have not demonstrated a similar increased risk. In this case, the patient has no documentation of history of a serious infection, or that the patient has an immunocompromised status that puts him at increased risk of infection. Furthermore, Otezla (apremilast) has shown inferior efficacy rates at achieving PASI-75, PASI-90, or PASI-100 compared to the all of the available preferred plan alternative treatments. For example, a recent analysis of phase III clinical trials involving Otezla and methotrexate separately found no statistical evidence of greater efficacy for apremilast versus
methotrexate. (Armstrong et al, 2016).

Based on the review of the medical chart and literature, Otezla is not considered medically necessary for this patient. The patient had not attempted therapy with disease-modifying antirheumatic drugs (DMARDs) or biologics, and does not have any listed contraindication to the plan preferred medications.

The health plan acted reasonably with sound medical judgment, and in the best interest of the patient.
The carrier's denial of coverage for Otezla 30 milligram tablet should be upheld. The medical necessity is not substantiated.