MMIT Reality Check on Rheumatoid Arthritis (1Q2023)

Payer Coverage:

A review of market access for rheumatoid arthritis treatments shows that under the pharmacy benefit, about 65% of the lives under commercial formularies are covered with utilization management restrictions. Around 50% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 62% of the lives under commercial policies are covered with utilization management restrictions. Almost 48% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.

For about 21% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 53% require multiple steps. Around 85% of payer-controlled pharmacy benefit covered lives require prior authorization, with 57% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

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.

FDA Approves Citrate-Free, High-Concentration Formulation of Hadlima

In August 2022, the FDA approved a citrate-free, high-concentration formulation of Samsung Bioepis Co., Ltd. and Organon & Co.’s Hadlima (adalimumab-bwwd) for all of its indications: the treatment of adults with moderately to severely active rheumatoid arthritis and ulcerative colitis; adults with active psoriatic arthritis and ankylosing spondylitis; people at least 2 years old with moderately to severely active polyarticular juvenile idiopathic arthritis; 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 July 23, 2019. Dosing of the subcutaneous injectable varies according to the indication. Following the settlement of patent litigation with AbbVie, Hadlima is cleared to launch on June 30, 2023. Drugs.com lists the price of two kits of Humira, each containing two 40 mg/0.4 mL pens, as more than $6,759.

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 in the U.S. In December 2022, the FDA approved Fresenius Kabi’s Idacio (adalimumab-aacf) for the treatment of multiple conditions, including adults with moderately to severely active rheumatoid arthritis (RA). It is the eighth biosimilar of Humira and is a low-concentration, citrate-free formulation of the reference drug.

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, manufacturers 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. Oral and self-administered injectable products are covered primarily via the pharmacy benefit, while provider-administered products are covered under the medical benefit. 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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