MMIT Reality Check on Ulcerative Colitis (3Q2023)

Payer Coverage:

A review of market access for ulcerative colitis treatments shows that under the pharmacy benefit, about 54% of the lives under commercial formularies are covered with utilization management restrictions. Around 32% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 59% of the lives under commercial policies are covered with utilization management restrictions. Almost 46% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.

For about 42% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 32% of the lives require multiple steps. Around 83% of payer-controlled pharmacy benefit covered lives require prior authorization, with 27% 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 moderately to severely active ulcerative colitis. The tumor necrosis factor (TNF) 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 should expect stiff competition due to the number of originator biologics and biosimilars currently available and more expected in the pipeline. With most products demonstrating similar clinical efficacy, with the exception of anti-TNF agents, which stand out as preferred biologics in clinical guidelines, costs to patients will be a determining factor for prescriber and patient choice; therefore, contracting remains extremely important for market success.

Pharmacy, Medical Benefit Implications

Most products in this indication are injectables with coverage available under the pharmacy and medical benefits. Oral and self-administered injectable products are covered primarily via the pharmacy benefit, while provider-administered products are covered under the medical benefit. Partial coverage is available for originator products and biosimilars with a prior authorization. Initial coverage requirements often include a recent trial and failure of conventional therapy, such as corticosteroids and immunomodulators at their maximum doses. Policies typically require prescribing be done by or in consultation with a specialist and may require documentation of proven clinical response for reauthorization.

Key Players in Market:

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