Drug Rebates

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.

Seven of Amgen, Inc.’s medications made the list, including its blockbuster bone cancer treatment Prolia, cancer medications Kyprolis, Vectibix and Blincyto, and Nplate for immune thrombocytopenia.

Upcoming changes in the Medicare Part D benefit that involve increasing the risk borne by insurers in the catastrophic phase may boost pressure on plans to control costs in the six protected classes, and manufacturers are worried about what that might lead to.

Under the Inflation Reduction Act (IRA), Part D plan obligations for drug costs will increase from 15% to 60% in the catastrophic phase beginning in 2025, while Medicare’s will decrease from 80% to 20% for brands.

Manufacturers will supplement coverage in the catastrophic phase with a new 20% mandatory discount on brands but plans are still expected to look for ways to lower drug spending because they won’t be able shift costs to enrollees in the usual ways. As part of the redesign, cost sharing will be capped at $2,000 a year and annual premium increases will be limited.

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.

Seven of Amgen, Inc.’s medications made the list, including its blockbuster bone cancer treatment Prolia, cancer medications Kyprolis, Vectibix and Blincyto, and Nplate for immune thrombocytopenia.

Alex Oshmyansky, M.D., the CEO of Mark Cuban Cost Plus Drug Co. (MCCPDC), the online cash pharmacy funded by the eponymous billionaire investor, said the company has become a licensed drug wholesaler nationwide and has plans to roll out quasi-PBM business lines including a retail pharmacy network. Oshmyansky discussed these new ventures — and addressed criticism by health care experts that his firm can’t lower specialty pharma costs — during a June 13 keynote at the 2023 AHIP Conference in Portland, Oregon.

“I think it was always our ambition” to work with retail pharmacies, Oshmyanksy said. “I think there’s a variety of products where it just doesn’t necessarily make sense for them to be mail-order products,” citing “cold supply chain” and “acute care medications” as examples.

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.

One manufacturer recently revealed that it would launch its biosimilar of AbbVie Inc.’s Humira (adalimumab) at a huge discount not seen before in the U.S. While it almost certainly will be able to get some uptake in a market that’s about to become highly competitive, commercial payers who favor high list price/high rebate therapies are likely to not cover the agent, say industry experts.

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 (adalimumab) $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.

The FDA recently approved an expanded patient population for Novo Nordisk’s Sogroya (somapacitan-beco), a long-acting growth hormone requiring weekly administration, as opposed to daily administration of short-acting agents. Payers and endocrinologists have expressed a willingness to manage and prescribe the new agents, according to Zitter Insights. Nevertheless, this is a class where agents have not shown clinical differentiation, so payer coverage of the agents likely will come down to cost, industry experts say.

On April 28, the FDA expanded the patient population for Sogroya to include the treatment of people at least 2 1/2 years old who have growth failure due to inadequate secretion of endogenous growth hormone. The agency initially approved the drug on Aug. 28, 2020, for the replacement of growth hormone in adults with growth hormone deficiency. With the newest approval, the injectable becomes the first and only once-weekly growth hormone treatment for both children and adults.

The FDA has so far approved nine biosimilars of AbbVie Inc.’s Humira (adalimumab), and all of them — as well as some others in the pipeline — have settled patent litigation with AbbVie that allows them to launch onto the U.S. markets by a certain date.

But it’s not just the launch dates that are different. Some are low-concentration versions of Humira, while some are high-concentration versions, the latter of which has about 85% of current Humira prescribing. The FDA approved a high-concentration, citrate-free version of Humira in November 2015, but AbbVie waited until July 2018 to launch it. This formulation requires half the volume of drug injected compared with the original formulation, and it has fewer excipients that often cause discomfort when injected, as well as a thinner needle.

The traditional pharmacy benefit market is seeing a challenge to its model from patient-paid prescriptions, contended longtime industry expert Adam J. Fein, Ph.D., CEO of Drug Channels Institute, during a recent webinar. While some generics of specialty drugs are being sold via these routes, the potential exists for disruption in crowded biologic-treated classes facing a lot of competition, particularly via biosimilars.

And with some industry developments such as the Inflation Reduction Act likely to impact the uptake of high-price/high-rebate drugs, patient-paid prescriptions could become an even bigger disruption within the market than they already are.

When the Federal Trade Commission (FTC) announced on May 17 that it ordered Zinc Health Services, LLC, and Ascent Health Services, LLC, to turn over their business records, it was just the latest salvo in a rising tide of scrutiny directed at PBM-affiliated group purchasing organizations (GPOs).

One former FTC official says the agency has a range of powers it can wield to find out more about PBM-linked GPOs — and even potentially change how they do business. Yet the PBMs that own and use such rebate-aggregating organizations say their reputation as shadowy, overseas entities belies the GPOs’ simple goal of extracting larger drug discounts from manufacturers.