MMIT Reality Check on Psoriasis (Oct 2022)

Payer Coverage:

A review of market access for psoriasis treatments shows that under the pharmacy benefit, about 70% of the lives under commercial formularies are covered with utilization management restrictions. Around 12% of the lives under health exchange formularies are not covered for at least one of the drugs.

Under the medical benefit, about 48% of the lives under commercial policies are covered with utilization management restrictions. Almost 48% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.

For about 24% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, 39% require multiple steps. Around 88% of payer-controlled pharmacy benefit covered lives require prior authorization, with 47% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Approves Sotyktu

In September 2022, the FDA approved Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The agent is a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor. The recommended dosage of the tablet is 6 mg once daily. The list price for a 30-day supply is $6,164.

FDA Approves Spevigo

In September 2022, the FDA approved Boehringer Ingelheim’s Spevigo (spesolimab-sbzo) for the treatment of generalized pustular psoriasis flares in adults. The interleukin-36 receptor (IL-36R) antagonist is the first approved treatment for the condition. The FDA gave the drug breakthrough therapy designation for this indication. Dosing is 900 mg via a 90-minute intravenous infusion, with an additional dose possible one week later if flare symptoms persist.

FDA Approves High-Concentration Hadlima

In August 2022, the FDA approved a citrate-free, high-concentration formulation of Samsung Bioepis Co., Ltd. and Organon & Co.’s Hadlima (adalimumab-bwwd) for all of its indications: the treatment of adults with moderately to severely active rheumatoid arthritis and ulcerative colitis; adults with active psoriatic arthritis and ankylosing spondylitis; people at least 2 years old with moderately to severely active polyarticular juvenile idiopathic arthritis; people at least 6 years old with moderately to severely active Crohn’s disease; and adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate. The agency initially approved a low-concentration formulation of the biosimilar of AbbVie Inc.’s Humira (adalimumab) on July 23, 2019. Dosing of the subcutaneous injectable varies according to the indication. Following the settlement of patent litigation with AbbVie, Hadlima is cleared to launch on June 30, 2023. Drugs.com lists the price of two kits of Humira, each containing two 40 mg/0.4 mL pens, as more than $6,759.

Key Findings:

Market Events Drive Changes

In September 2022, the FDA approved Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. That same month, the agency approved Boehringer Ingelheim’s Spevigo (spesolimab-sbzo) for the treatment of generalized pustular psoriasis flares in adults.

Competitive Market Landscape

New-to-market products should expect stiff competition due to the number of originator biologics and biosimilars currently available and more expected in the pipeline. With limited head-to-head studies showing significant effectiveness of one biologic over another, lower copays will make products more appealing to patients; therefore, contracting remains extremely important for market success.

Pharmacy, Medical Benefit Implications

Many products are covered under both the medical and pharmacy benefits, with even infusions covered under the pharmacy benefit. Coverage is available for originator products and biosimilars with a prior authorization. Initial coverage requirements often include recent trial and failure of conventional therapy and phototherapy. Some policies require a specific affected Body Surface Area (BSA) and a minimum severity classification.

Key Players in Market:

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