Diagnosis: Psoriasis.
Treatment: Skyrizi, Pre-service.

The insurer denied the Skyrizi, Pre-service. The denial is overturned.

The patient is a male with severe psoriasis affecting 65% body surface area and involving sensitive areas of the face and genitals. He has tried and failed topical steroids, topical antifungals, and tar shampoo. He has no significant comorbidities and does not drink alcohol. The request is for Skyrizi.

Yes, the proposed treatment with Skyrizi is medically necessary.

The patient has severe psoriasis for which systemic therapy is indicated. In the era of biologic therapies for psoriasis, the use of methotrexate, cyclosporine or acitretin is not the most appropriate first-line treatment because their long-term safety and efficacy are inferior to biologic therapies. Because of involvement of sensitive areas, phototherapy is not appropriate.

Skyrizi (also known by its generic name risankizumab-rzaa) was approved by the Food and Drug Administration (FDA) for the treatment of moderate-to-severe plaque psoriasis in adults. Skyrizi works within weeks. Three out of 4 of patients saw 90% clearer skin within four months (16 weeks). In clinical trials, Skyrizi helped people achieve both clearer skin and psoriasis symptom relief. A majority achieved 100% clear skin at one year. At four months (16 weeks), on average, people reported a significant improvement in the pain, itching, burning, and redness of psoriasis.

Biologics show superior results to conventional systemic therapies (70% improvement versus 40% improvement) for the treatment of patients with moderate to severe psoriasis, as measured by decrease in S-MAPA (physician's global assessment [PGA] multiplied by body surface area [BSA]) at week 24. These results were observed despite the fact that patients on biologics had a greater baseline severity and had a greater number of previous treatments.

Based on this data, Skyrizi is medically necessary.

The patient has severe psoriasis for which systemic therapy is indicated. In the era of biologic therapies for psoriasis, the use of methotrexate, cyclosporine or acitretin is not the most appropriate first-line treatment because their long-term safety and efficacy are inferior to biologic therapies.