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 41% of the lives under health exchange formularies are not covered for at least one of the drugs.
Under the medical benefit, about 46% of the lives under commercial policies are covered with utilization management restrictions. Almost 57% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.
For about 23% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, 35% require multiple steps. Around 87% of payer-controlled pharmacy benefit covered lives require prior authorization, with 40% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.
In October 2021, the FDA approved the supplemental Biologics License Application (sBLA) for Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) as the first interchangeable biosimilar with AbbVie Inc.’s Humira (adalimumab). The drug was approved by the FDA in August 2017 for the treatment of multiple chronic inflammatory diseases including rheumatoid arthritis, psoriasis and Crohn’s disease, and this latest approval designates it as interchangeable across all of these indications.
In July 2020, the FDA approved Mylan N.V. and Fujifilm Kyowa Kirin Biologics Co., Ltd.’s Hulio (adalimumab-fkjp) for the treatment of plaque psoriasis, rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease and ulcerative colitis. The agency approved the biosimilar of AbbVie Inc.’s Humira (adalimumab) — the sixth one that the agency has approved — in both prefilled syringe and auto-injector presentations.
In December 2019, the FDA approved Cumberland Pharmaceuticals Inc.’s RediTrex (methotrexate) injection for the treatment of adult and pediatric patients with rheumatoid arthritis, as well as adults with psoriasis.
Market Events Drive Changes
In October 2021, the FDA approved the supplemental Biologics License Application (sBLA) for Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) as the first Interchangeable biosimilar with AbbVie Inc.’s Humira (adalimumab). In July 2020, the agency approved Mylan N.V. and Fujifilm Kyowa Kirin Biologics Co., Ltd.’s Hulio (adalimumab-fkjp) for the treatment of plaque psoriasis, among other conditions. It is the sixth biosimilar of Humira that the agency has approved, but the drugs are not able to launch in the U.S. until 2023 due to settlement agreements with AbbVie.
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).
Key Players in Market: