MMIT Reality Check on Psoriatic Arthritis (3Q 2023)

Payer Coverage:

A review of market access for psoriatic arthritis treatments shows that under the pharmacy benefit, about 73% of the lives under commercial formularies are covered with utilization management restrictions. Around 40% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 55% of the lives under commercial policies are covered with utilization management restrictions. Almost 49% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.

For about 40% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 45% of the lives require multiple steps. Around 87% of payer-controlled pharmacy benefit covered lives require prior authorization, with 33% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

Several Biosimilars of Humira Launched This Month With Varying WACs

As expected, early July saw the launch of multiple biosimilars of AbbVie Inc.’s Humira (adalimumab). Most of them launched with wholesale acquisition costs (WACs) just slightly less than that of the reference drug, but a few undercut that price fairly significantly.

FDA Approves Yuflyma

In May 2023, the FDA approved Celltrion USA’s Yuflyma (adalimumab-aaty) for the treatment of eight conditions: (1) adults with moderately to severely active rheumatoid arthritis, (2) people at least 2 years old with moderately to severely active juvenile idiopathic arthritis, (3) adults with active psoriatic arthritis, (4) adults with active ankylosing spondylitis, (5) people at least 6 years old with moderately to severely active Crohn’s disease, (6) adults with moderately to severely active ulcerative colitis, (7) 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, and (8) adults with moderate to severe hidradenitis suppurativa. The tumor necrosis factor (TNF) inhibitor is the ninth FDA-approved biosimilar of AbbVie Inc.’s Humira (adalimumab), and it is a high-concentration and citrate-free formulation. It will be available in a 40 mg/0.4 mL pre-filled syringe and 40 mg/0.4 mL autoinjector and is cleared to launch on July 1 following the settlement of patent litigation with AbbVie. Celltrion says it plans to launch two additional dosage forms: 80 mg/0.8 mL and 20 mg/0.2 mL.

FDA Approves New Formulation of Hyrimoz

In March 2023, the FDA approved a new citrate-free, high-concentration formulation of Sandoz’s Hyrimoz (adalimumab-adaz) for all of its indications: the treatment of adults with moderately to severely active rheumatoid arthritis and ulcerative colitis; people at least 2 years old with moderately to severely active polyarticular juvenile idiopathic arthritis; adults with active psoriatic arthritis and ankylosing spondylitis; 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 Oct. 30, 2018. Dosing of the subcutaneous injectable varies depending on the indication. The company said it intends to launch this new version on July 1. Drugs.com lists the price of two kits of Humira, each containing two 40 mg/0.4 mL pens, as more than $7,299.

Key Findings:

Market Events Drive Changes

Multiple biosimilars of AbbVie Inc.’s Humira (adalimumab) launched in July 2023: Biocon Biologics Limited’s Hulio (adalimumab-fkjp), Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), Novartis Pharmaceuticals Corp.’s Hyrimoz (adalimumab-adaz), Celltrion USA’s Yuflyma (adalimumab-aaty), Fresenius Kabi’s Idacio (adalimumab-aacf), Coherus BioSciences, Inc.’s Yusimry (adalimumab-aqvh) and Organon & Co.’s Hadlima (adalimumab-bwwd). In May 2023, the FDA approved Yuflyma for the treatment of eight conditions, including adults with active psoriatic arthritis. The tumor necrosis factor inhibitor is the ninth FDA-approved biosimilar of Humira, and it is a high-concentration and citrate-free formulation. In January 2023, Amgen Inc.’s Amjevita (adalimumab-atto) became the first Humira biosimilar to launch in U.S. markets.

Competitive Market Landscape

New-to-market products will have to compete with a crowded market of recently approved biosimilars and their reference products, which currently occupy preferred status on most plans, as well as targeted synthetic agents, such as Janus kinase inhibitors.

Pharmacy, Medical Benefit Implications

Most products in this indication are injectables with coverage available under both the pharmacy and medical benefit. Oral and self-administered injectable agents are covered primarily via the pharmacy benefit, while provider-administered medications are covered under the medical benefit. Policies will require trial and failure or evidence of intolerance to conventional therapy and preferred biologics, usually Humira and Amgen Inc.’s Enbrel (etanercept). Policies with defined prior authorization criteria for biologic disease-modifying anti-rheumatic drugs will require a documented negative tuberculosis test.

Key Players in Market:

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