MMIT Reality Check on Crohn’s Disease (1Q2023)

Payer Coverage:

A review of market access for Crohn’s disease treatments shows that under the pharmacy benefit, about 51% of the lives under commercial formularies are covered with utilization management restrictions. Around 46% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 66% of the lives under commercial policies are covered with utilization management restrictions. Almost 50% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.

For about 36% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 31% require multiple steps. Around 81% of payer-controlled pharmacy benefit covered lives require prior authorization, with 31% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

Biosimilar Amjevita Wins Spot on Major Formularies, but Humira Proves Tough to Dislodge

When Amgen Inc.’s Amjevita (adalimumab-atto) landed on the U.S. market late last month, it became the first of several biosimilars to Humira that will finally be available to patients this year — and which will aim to topple the lucrative franchise of AbbVie’s blockbuster autoimmune condition drug. According to health care industry experts, early indications of how major PBMs are covering Amjevita speak volumes about the power of rebates and the largely untested potential for biosimilars to drive down biologic prices and capture market share.

Amjevita, First Biosimilar of Humira, Launches With Two-Tiered Pricing Strategy

More than six years after the FDA approved it, the first biosimilar of AbbVie Inc.’s Humira (adalimumab) has finally launched in the U.S. On Jan. 31, Amgen Inc.’s Amjevita (adalimumab-atto) became available at two different wholesale acquisition costs — one 55% below Humira’s WAC and one 5% below it — a strategy that acknowledges the lure of rebates within the U.S. market. It remains to be seen whether additional adalimumab biosimilars launching this year will follow suit or explore a different strategy to differentiate themselves.

Initially approved Sept. 23, 2016, Amjevita was the first of eight Humira biosimilars that the FDA had OK’d as of early February. The tumor necrosis factor (TNF) inhibitor is approved for seven of Humira’s nine indications, including rheumatoid arthritis, plaque psoriasis and Crohn’s disease, although the biosimilar is indicated for ulcerative colitis in adults, while Humira is approved for UC in people at least 5 years old. The two Humira indications not on Amjevita’s label are hidradenitis suppurativa and uveitis.

FDA Approves Idacio

In December 2022, the FDA approved Fresenius Kabi’s Idacio (adalimumab-aacf) for the treatment of multiple conditions: (1) adults with moderately to severely active rheumatoid arthritis, (2) moderately to severely active polyarticular juvenile idiopathic arthritis in people at least 2 years old, (3) adults with active psoriatic arthritis, (4) adults with active ankylosing spondylitis, (5) moderately to severely active Crohn’s disease in people at least 6 years old, (6) adults with moderately to severely active ulcerative colitis and (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. It is the eighth biosimilar of AbbVie Inc.’s Humira (adalimumab) and is a low-concentration, citrate-free formulation of the reference drug. The tumor necrosis factor (TNF) inhibitor is cleared to launch on July 1, 2023, per a patent settlement agreement with AbbVie.

Key Findings:

Market Events Drive Changes

On Jan. 31, 2023, Amgen Inc.’s Amjevita (adalimumab-atto) became the first biosimilar of AbbVie Inc.’s Humira (adalimumab) to launch on the U.S. market. In December 2022, the FDA approved Fresenius Kabi’s Idacio (adalimumab-aacf) for the treatment of multiple conditions, including moderately to severely active Crohn’s disease in people at least 6 years old. It is the eighth biosimilar of Humira and is a low-concentration, citrate-free formulation of the reference drug. In July 2022, the agency expanded the use of Pfizer Inc.’s Humira biosimilar Abrilada (adalimumab-afzb) and Amjevita to include the treatment of Crohn’s disease in people at least 6 years old. In June 2022, the agency expanded the use of Samsung Bioepis Co., Ltd.’s Hadlima (adalimumab-bwwd), another Humira biosimilar, to include the treatment of polyarticular juvenile idiopathic arthritis in people at least 2 years old and the treatment of Crohn’s disease in people at least 6 years old.

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

Most products in this indication are injectables with coverage available under the pharmacy and the medical benefit. Self-administered oral and injectable products are covered primarily via the pharmacy benefit, while provider-administered products are primarily covered under the medical benefit. 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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