Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Plaque Psoriasis. 
Treatment: Skyrizi (Risankizumab). 

The insurer denied coverage for Skyrizi. 

The denial is overturned. 

This is the case of a male patient with plaque psoriasis. The patient has plaques to the scalp, face, groin, abdomen, arms, and legs. He has been suffering for more than one year, and condition is worsening over time. Symptoms include itching, irritations, and flaking. Previous therapies include mometasone (Elocon) ointment 0.1%, Tazorac 0.1% gel, and Eucrisa ointment.  More than 10% of his body surface area (BSA) is affected and the patient has failed topicals. 

Risankizumab is a Food and Drug Administration (FDA) approved interleukin 23 (IL-23) inhibitor that is efficacious and safe. Methotrexate is indicated in mild/moderate disease, and does carry potential side effects. Additionally, it is not recommended for methotrexate to be used in males/females of child bearing age due to the risk on fertility. The patient does not have both psoriasis and arthritis so medications such as Cosentyx are not necessary. 

"We utilized data on treatment preferences and treatment satisfaction from 35,388 psoriasis patients based on 60 articles from the years 2010 to 2017. Treatment preferences were heterogeneous and changed over time among psoriasis patients. Across all treatment modalities, the most important treatment attributes were treatment location, probability of improvement, and delivery method. For biologics specifically, the most important attributes were risk of adverse events and probability of treatment benefit. Factors that influenced patients' preferences for certain treatments included age, sex, comorbidities, disease duration, and prior treatments. Notably, some psoriasis patients placed higher importance on a treatment's process attributes (e.g., access and delivery) over its outcome attributes (e.g., efficacy). Overall, patient satisfaction with existing therapies remains modest; however, those treated with biologic agents exhibited highest treatment satisfaction over oral therapy, phototherapy, and topical therapy." (Florek et al 2018) 

"Risankizumab (Skyrizi; risankizumab-rzaa) is a humanized immunoglobulin (Ig) G1 monoclonal antibody that specifically targets the p19 subunit of interleukin (IL)-23, thereby inhibiting IL-23-dependent cell signaling. Subcutaneous risankizumab is approved for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy (in the EU), those who are candidates for systemic therapy or phototherapy (in the USA) and those who have an inadequate response to conventional therapies (in Japan). In pivotal phase III trials (UltIMMa-1, UltIMMa-2, IMMvent and IMMhance), risankizumab was more effective than placebo, ustekinumab and adalimumab with regard to the proportion of patients achieving  90% improvement from baseline in Psoriasis Area and Severity Index score (PASI 90) and a static Physician's Global Assessment score of 0 or 1 at week 16, with these benefits maintained over the longer term. In supportive head-to-head trials, risankizumab was also superior to secukinumab and fumaric acid esters in terms of PASI 90 response rate. In an ongoing open-label extension study (LIMMitless), risankizumab was associated with durable and improved efficacy after switching from ustekinumab or adalimumab, as well as durable maintenance of efficacy through >2.5 years of continuous exposure. Treatment with risankizumab improved health-related quality of life and was generally well tolerated, both in the short- and longer-term. In conclusion, risankizumab represents a useful new treatment option for patients with moderate to severe plaque psoriasis." (Blair 2020) 

"Articles written in English between January 2000 and October 2019 discussing phase II and phase III clinical trials were evaluated. Data Synthesis: By the primary end point at week 16 in phase III trials, more patients achieved Psoriasis Area and Severity Index 90 receiving 150 mg risankizumab (72%-75%) compared with placebo (2.0%-4.9%, P < 0.001), 45 or 90 mg ustekinumab (42.0%-48%, P < 0.0001), and 40 mg adalimumab (47%, P < 0.0001). More patients achieved a static Physician's Global Assessment score of 0 or 1 receiving 150 mg risankizumab (84%-88%) compared with placebo (5.1%-7.8%, P < 0.001), 45 or 90 mg ustekinumab (62%-63%, P < 0.0001), and 40 mg adalimumab (60%, P < 0.0001). Risankizumab was well tolerated across all studies." (Li et al 2020) 

The health plan did not act reasonably with sound medical judgment in the best interest of the patient. 

The insurer's denial of coverage for Skyrizi is reversed. Medical necessity is substantiated.