Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Psoriasis. 
Treatment: Otezla 30MG Tablet. 

The insurer denied the Otezla 30MG Tablet. 
The denial is upheld. 

The patient is a female with medical history of plaque psoriasis affecting the arms, legs, and back. The patient has tried and failed topical steroids. This request for Otezla is under review. 

No, the use of Otezla is not medically necessary for this patient. 

According to the documentation provided for review, the patient has not tried and demonstrated an inadequate treatment response or intolerance to a course of therapy with acitretin, cyclosporine, or methotrexate, which are supported as standard, first-line therapy options. There is no documentation of elevated liver function tests, recurrent infections, or underlying disease or malignancies that would contraindicate the use of an oral systemic medication. Current medical literature corroborates the safety and non-inferior or superior efficacy of these preferred medications in this clinical scenario. Therefore, this request for Otezla is not medically necessary at this time. 

Methotrexate has proven efficacy, per West et al. "In terms of efficacy, the present meta-analysis finds that approximately 40% of patients achieve a PASI75 [75% reduction in Psoriasis Area and Severity Index score] by 12 weeks of treatment. ..... Nonetheless, it means that many psoriasis patients requiring systemic therapy are likely to benefit from 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." 

Strober, B. E. states, "Methotrexate and cyclosporines monotherapy or in combination with biologics or other drugs still have an important place in the roster of therapeutic options for patients with psoriasis. These medications are safe and effective in carefully selected patients and with careful monitoring." 

Per Lee et al., "Acitretin is an oral retinoid that is approved for the treatment of psoriasis. It is unique compared to other systemic therapies for psoriasis such as methotrexate and cyclosporine in that it is not immunosuppressive. It is, therefore, safe for use in psoriasis patients with a history of chronic infection such as HIV [human immunodeficiency virus], hepatitis B, hepatitis C or malignancy who have a contraindication to systemic immunosuppressive therapy and require systemic therapy because topical therapy is inadequate and they are unable to commit to phototherapy. Acitretin is one of the treatments of choice for pustular psoriasis. Even though acitretin is less effective as a monotherapy for chronic plaque psoriasis, combination therapy with other agents, especially UVB [ultraviolet B] or psoralen plus UVA [ultraviolet A] phototherapy, can enhance efficacy.  Acitretin is an effective systemic therapy for psoriasis and is generally well tolerated at low doses for long-term use. If monotherapy with acitretin is inadequate, it can be used in combination with other treatments, particularly UVB [ultraviolet B] phototherapy, to increase efficacy." 

Lastly, according to Kumar, R., et al., "Topical liposomal formulation of cyclosporine, 2.0% w/w, is effective in treatment of limited chronic plaque psoriasis with a satisfactory safety profile." 

Yes, the health plan did act reasonably, with sound medical judgment, and in the best interest of the patient.