Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Psoriasis
Treatment: Tremfya, Pre-service
The insurer denied the Tremfya, pre-service.
The denial is overturned. 

The patient is a male with severe psoriasis affecting the scalp and body for whom Tremfya is requested. Formulary alternatives include Cosentyx, Enbrel, Humira and Siliq. The patient has tried and failed topical triamcinolone, clobetasol, tazarotene, intralesional kenalog (ILK), ibuprofen and naproxen. He has a history of depression and drinks alcohol regularly.

Yes, the proposed treatment is medically necessary.

The patient has severe psoriasis for which systemic therapy is indicated. He is not a candidate for phototherapy because of the location of psoriasis in the scalp, which cannot be reached by phototherapy. In the era of biologic therapies for psoriasis, 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.

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 simple-measure for assessing psoriasis activity (S-MAPA) (physician global assessment [PGA] multiplied by body surface area) 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.

Guselkumab (Tremfya) is a human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that blocks the interleukin-23 (IL-23)-mediated signaling pathway and is the first in its class to be approved in adults with moderate to severe plaque psoriasis in several countries, including the United States of America (USA) and the European Union (EU). In the VOYAGE trials, guselkumab was superior to placebo and to adalimumab at week 16 in terms of the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0/1 and 90% (percent) improvement from baseline in Psoriasis Area and Severity Index score (PASI 90 response), with benefits of guselkumab over adalimumab maintained at week 24. To date, the beneficial effects of guselkumab treatment in these trials were maintained for up to two years. Inadequate responders to ustekinumab who were then randomized to guselkumab in NAVIGATE showed better responses than those randomized to ustekinumab between weeks 28-40, with a significantly greater mean number of visits at which patients had IGA 0/1 and two-grade improvement in Investigator Global Assessment (IGA) score, as well as higher proportions of patients achieving Psoriasis Area and Severity Index (PASI) 90 and Psoriasis Area and Severity Index (PASI) 100 at week 52. Treatment with guselkumab improved health-related quality of life (HR-QOL) and patient-reported outcomes in all trials and was generally well tolerated.

Guselkumab has superior safety compared to the formulary alternatives and requires no routine monitoring after initiation. None of the formulary medications are interleukin-23 (IL-23) inhibitors, so an in-class alternative is not available.