MMIT Reality Check on Rheumatoid Arthritis

Payer Coverage:

A review of market access for rheumatoid arthritis treatments shows that under the pharmacy benefit, about 63% 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 54% 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 22% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 47% require multiple steps. Around 84% of payer-controlled pharmacy benefit covered lives require prior authorization, with half 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.

Payers Should Prepare Now for Humira Biosimilars’ 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

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, among other indications. It is the seventh biosimilar of AbbVie’s Humira (adalimumab) that the agency has approved. In October 2021, the agency 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 Humira to which the agency has given interchangeable status. 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 rheumatoid arthritis.

Competitive Market Landscape

The increasingly crowded market boasts many different targeted agents representing several distinct drug classes, including blockbuster tumor necrosis factor alpha inhibitors, a few non-TNFa biologics and oral Janus kinase (JAK) inhibitors. The TNFa inhibitors are the most widely prescribed biologics for RA refractory to conventional disease-modifying antirheumatic drugs (DMARDs), and the non-TNFa biologics and JAK inhibitors largely compete for use in the TNFa refractory population. With the impending entry of several TNFa and non-TNFa biologic biosimilars, marketers are facing fierce competition and increasing challenges to gain market share.

Pharmacy, Medical Benefit Implications

The medical and pharmacy benefits are both present for many products. TNFa inhibitors are the first-line biologic agents in the treatment pathway after the generic, but there are instances where other types have gotten to that option. Humira has a majority of preferred lives as the first-line biologic.

Key Players in Market:

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