Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Severe psoriasis 
Treatment: Skyrizi 150 Dose Inj
The insurer denied the Skyrizi 150 Dose Inj. 
The denial is overturned. 

The patient is a man with severe psoriasis for whom Skyrizi is requested. He has tried and failed multiple topical steroids.

Yes, the treatment with Skyrizi is medically necessary.

Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. As such, it is a medically appropriate choice for this patient's severe psoriasis. It does not carry an increased risk of malignancy and has excellent efficacy data.

Risankizumab (Skyrizi; risankizumab-rzaa) is a humanized immunoglobulin G subclass 1 (IgG1) 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 [European Union]), those who are candidates for systemic therapy or phototherapy (in the USA [United States of America]) and those who have an inadequate response to conventional therapies (in Japan). 

In pivotal phase III trials (UltIMMa-1 [BI 655066/ABBV-066 (Risankizumab) Versus Ustekinumab and Placebo Comparators in a Randomized Double Blind trial for Maintenance Use in Moderate to Severe Plaque Type Psoriasis], UltIMMa-2 [BI 655066 Versus Ustekinumab and Placebo Comparators in a Randomized Double Blind trial for Maintenance Use in Moderate to Severe Plaque Type Psoriasis-2], IMMvent [BI 655066/ABBV-066 (Risankizumab) Versus Adalimumab in a Randomized, Double Blind, Parallel Group Trial in Moderate to Severe Plaque Psoriasis to Assess Safety and Efficacy After 16 Weeks of Treatment and After Inadequate Adalimumab Treatment Response] and IMMhance [BI 655066 / ABBV-066 (Risankizumab) Versus Placebo In a Multicenter Randomized Double-blind Study in Patients With Moderate to Severe Chronic Plaque Psoriasis Evaluating the Efficacy and Safety With Randomized Withdrawal and Re-treatment]), risankizumab was more effective than placebo, ustekinumab and adalimumab with regard to the proportion of patients achieving greater than or equal to 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 [A Multicenter, Open Label Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis]), 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. 

Methotrexate and acitretin carry a much higher risk of adverse events, while not offering an advantage in efficacy. Cyclosporine is not an appropriate long-term solution due to the side effect profile and is used as a bridge or rescue treatment while another treatment's effect is waited upon to "kick in." Biologics show superior results to conventional systemic therapies (70% improvement versus 40% improvement) for the treatment of patients with moderate to severe psoriasis. Since the patient has lesions on the face, phototherapy is not a good choice as the disease is obviously refractory to ultraviolet light, to which it is exposed daily.

Therefore, Skyrizi is medically appropriate and necessary.