Spotlight on Market Access

Following the launch of Amgen Inc.’s Amjevita (adalimumab-atto), a slew of other FDA-approved Humira (adalimumab) biosimilars entered the U.S. market in July under settlement agreements with Humira originator AbbVie Inc. Major PBMs quickly announced that they would add more biosimilars to their formularies to compete with Humira.

At the end of June, UnitedHealth Group’s Optum Rx said it will place Boehringer Ingelheim's Cyltezo (adalimumab-adbm) and Sandoz's Hyrimoz (adalimumab-adaz) on its formulary at parity with Humira starting July 1. The Cigna Group’s Express Scripts then said it would add three biosimilars — Cyltezo, Hyrimoz and adalimumab-adaz (the unbranded equivalent of Hyrimoz) — to its list of preferred drugs.

CMS on June 9 revealed a list of 43 Medicare Part B drugs that will be sanctioned for having their prices increase faster than the rate of inflation, as part of the Inflation Reduction Act (IRA). The number of drugs affected is almost double the number that made CMS’s initial list, which the agency made public in March. Starting in July, beneficiaries who normally pay 20% coinsurance under Part B for the 43 drugs will see their cost sharing decline based on an inflation-adjusted price. The federal government will invoice manufacturers for 2023 and 2024 Part B inflation rebates no later than fall 2025, and those funds will be deposited into the Medicare Trust Fund.

As plan sponsors continue to grapple with the high costs of specialty drugs, they have undertaken various strategies to deal with them. The use of copayment accumulators, copay maximizers and alternative funding companies has been a fairly recent trend, noted longtime industry expert Adam J. Fein, Ph.D., CEO of Drug Channels Institute, during a recent webinar. But as that use continues to increase, multiple questions exist around the practices and what the future holds for them.

Fein explained that he chose the focus of the June 23 webinar, titled PBMs and the Battle Over Patient Support Funds: Accumulators, Maximizers, and Alternative Funding, because the entities are a hot industry topic currently. “And I think this is a topic of great relevance to manufacturers, to PBMs, to plan sponsors, to patients, to pharmacies, to everyone in the channel. And it’s one that I found is not well understood,” he stated.

In 2021, almost all commercial, Medicare Advantage and Medicaid health plans covered at least one immediate-release buprenorphine, a medication for treating opioid use disorder (OUD), according to a recent Health Affairs study. Also, since 2017, fewer health plans have been requiring prior authorization and quantity limits for those medications.

However, fewer than half of commercial formularies and one-fifth of MA formularies covered extended-release buprenorphine products in 2021. Comparatively, 82.8% of Medicaid formularies covered such medications, and the share of Medicaid formularies without prior authorization requirements increased from 6.8% in 2018 to 63.3% in 2021.

As potentially as many as eight biosimilars of AbbVie Inc.’s Humira (adalimumab) could launch onto the U.S. market in July, the manufacturer of one of those drugs recently revealed that it would launch its product at a huge discount not seen before in the United States for biosimilar agents. While that highly competitive price certainly will appeal to some payers, commercial payers that favor high-list-price/high-rebate therapies are likely to not cover the agent, say industry experts. In addition, it remains to be seen whether the move signals the beginning of more affordable biologics or the destabilization of the market, they maintain.

On June 1, Coherus BioSciences, Inc. revealed that it would launch Yusimry (adalimumab-aqvh) in July with a list price of $995 per carton — an 85% discount off reference drug Humira’s $6,922 price tag. The tumor necrosis factor (TNF) inhibitor, first approved Dec. 17, 2021, is a low-concentration, citrate-free version of Humira, and it has approval for most of the reference drug’s indications: (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.