MMIT Reality Check on Crohn’s Disease

Payer Coverage:

A review of market access for Crohn’s disease treatments shows that under the pharmacy benefit, about 53% of the lives under commercial formularies are covered with utilization management restrictions. Around 48% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 71% of the lives under commercial policies are covered with utilization management restrictions. Almost 52% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.

For about 30% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 39% require multiple steps. Around 81% 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.

Trends:

FDA Approves Yusimry

In December 2021, the FDA approved Coherus BioSciences, Inc.’s Yusimry (adalimumab-aqvh) for the treatment of adults with moderately to severely active rheumatoid arthritis, people at least 2 years old with juvenile idiopathic arthritis, adults with active psoriatic arthritis, adults with active ankylosing spondylitis, people at least 6 with moderately to severely active Crohn’s disease, adults with moderately to severely active ulcerative colitis 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. It is the seventh biosimilar of AbbVie’s Humira (adalimumab) that the agency has approved. Coherus says it will launch Yusimry on or after July 1, 2023.

FDA Gives Cyltezo Interchangeable Status

In October 2021, the FDA gave Boehringer Ingelheim Pharmaceuticals, Inc.’s biosimilar Cyltezo (adalimumab-adbm) interchangeable status for all the indications it’s approved for: moderately to severely active rheumatoid arthritis in adults, juvenile idiopathic arthritis in people at least 2 years old, Crohn’s disease in people at least 6 years old and ulcerative colitis in adults; active psoriatic arthritis and ankylosing spondylitis in adults; and moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate. It is the first approved biosimilar of AbbVie Inc.’s Humira (adalimumab) to which the agency has given interchangeable status. Dosing varies across the indications. Website Drugs.com lists the price of two Humira 40 mg/0.4 mL pens as approximately $6,000. The drug is cleared to launch July 1, 2023, per a deal between the two manufacturers.

FDA Grants Interchangeable Status to Humira Biosimilar; Payers Should Prepare Now for 2023 Launches

Less than three months after granting interchangeable status to a biosimilar for the first time, the FDA has approved that status for a second biosimilar, Boehringer Ingelheim Pharmaceuticals, Inc.’s Cyltezo (adalimumab-adbm). It and multiple other biosimilars of AbbVie Inc.’s Humira (adalimumab) are slated to come onto the U.S. market in 2023, but plans should be preparing now for the drugs’ launches, say industry experts. Still, a handful of factors could pose an issue with the agents’ taking market share from the reference product.

Key Findings:

Market Events Drive Changes

The FDA has approved seven biosimilars of AbbVie Inc.’s Humira (adalimumab). Most recently, the agency in December 2021 approved Coherus BioSciences, Inc.’s Yusimry (adalimumab-aqvh) for the treatment of adults with moderately to severely active rheumatoid arthritis, people at least 2 years old with juvenile idiopathic arthritis, adults with active psoriatic arthritis, adults with active ankylosing spondylitis, people at least 6 with moderately to severely active Crohn’s disease, adults with moderately to severely active ulcerative colitis 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. In October 2021, the FDA gave Boehringer Ingelheim Pharmaceuticals, Inc.’s biosimilar Cyltezo (adalimumab-adbm) interchangeable status for the same indications. It is the first approved biosimilar of Humira to which the agency has given interchangeable status. None of the biosimilars can come onto the U.S. market before 2023 per the settlement of patent litigation with AbbVie. Also in October 2021, Janssen Biotech, Inc., a division of Johnson & Johnson, made an unbranded infliximab — the same product as its Remicade but with a wholesale acquisition price 59% lower — available for multiple indications, including Crohn’s disease.

Competitive Market Landscape

New-to-market products should expect stiff competition due to the number of originator biologics and biosimilars available and in the pipeline. Also, with most products demonstrating similar clinical efficacy, with the exception of anti-tumor necrosis factor agents, which stand out as preferred biologics in clinical guidelines, patient cost will be a determining factor for prescribers; therefore, contracting remains extremely important for market success.

Pharmacy, Medical Benefit Implications

Coverage is primarily through the medical benefit, but pharmacy coverage is also available. 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. Additionally, policies typically require prescribing be done by or in consultation with a specialist and usually require documentation of proven clinical response for re-authorization.

Key Players in Market:

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