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When biosimilars crashed to AbbVie’s Humira in 2023, the price impact was almost negligible. Now, the situation is starting to change, and the Anti-Inflation Act could further exacerbate the impact of biosimilars on branded drugs and significantly reduce drug prices. billions of From medical expenses.
A new study by researchers at Harvard University looked at what’s likely. IRA impact We predict that Medicare coverage of biosimilars will begin to cover cheaper versions of brand-name biologics by 2025. The findings come amid other reports suggesting biosimilars are finally gaining a foothold in the commercial market.
biosimilar barrier
The presence of biosimilars was still lacking as of the end of 2023, with a small number of biosimilar versions of AbbVie’s rheumatoid arthritis treatment Humira selling only in low numbers and having only a small market share. Of note is the US-based Humira biosimilar. Market share reached only 4% As of February 2024, according to a report from Samsung Bioepis, which manufactured one of these counterfeits. But after CVS Health made the following decisions: Remove Humira from your prescription This year, biosimilar prescriptions are pick upAxios reported.
Luca Maini, one of the study authors and an assistant professor of health policy at Harvard Medical School, said market penetration for biosimilars is better in the commercial arena than in Medicare and other government programs.
Why aren’t biosimilars taking off sooner? Maini says the market is still young.
“Physicians, patients, PBMs, and all stakeholders need to buy into the idea that biosimilars are…as safe and effective as the originator biologic.”
Luca Maini
Assistant Professor of Health Policy, Harvard Medical School
“There’s a bit of a (learning curve),” he said. “Physicians, patients, PBMs, and all stakeholders need to buy into the idea that biosimilars are…as safe and effective as the originator biologic.”
Doctors have so far reluctant According to a 2023 report from Spherix Global Insights, biosimilars will replace branded biologics such as Humira during the first few years of availability.
Medicare reimbursement design is another barrier to benefiting biologics over biosimilars Until 2022 Changes in Medicare Part B increased reimbursement rates for biosimilars and increased competition from brand-name biologics.
Biologics are generally more potent for patients than small molecules, Maini said, so these drugs are likely to be administered in a doctor’s office or require training by a health care professional before being administered at home. He said it is likely to be.
“It is very difficult for biosimilars to gain significant market share immediately after approval,” Maini said.
But if AbbVie’s latest earnings are any indication, biosimilars remain influential. Although AbbVie still maintains the majority of Humira’s market share, its revenue has been declining since the beginning of the year, which could cause the company to lower Humira’s price in the future.
“If a biosimilar comes out and it’s not profitable, that’s a problem because it signals to future biosimilar manufacturers that it might not be a good idea to launch the drug. ” Maini said. “Even if the biosimilar doesn’t make money, if he can ultimately lower the price of the original product by 40% or 50%, that’s some success.”
For example, the list price of Humira is 141% increase Between 2013 and 2020, according to AJMC’s Biosimilars Center.AbbVie enjoyed these “Not supported” The Institute for Clinical and Economic Reviews noted that the price was increased while the drug was under patent protection despite a lack of new clinical data.
Since the company’s patent cliff and biosimilars have become part of the equation, with nine biosimilar versions of Humira expected to hit the U.S. market by the end of 2023, AbbVie has taken a hit and the drugmaker has I’m taking a hit. Humira price reduced.This drug is worldwide Revenue decreased by 36% According to recent earnings, in the first three months of 2024.
IRA impact
The next largest impact on IRAs is expected to come from changes in Medicare Part D benefits related to disaster coverage due to reductions in federal subsidies.
“Medicare Part D generally tends to favor more expensive reference biologics over less expensive biosimilars,” Maini et al.’s co-authors wrote in their analysis. “Two important aspects of Medicare Part D benefit design may contribute to this pattern: federally mandated discounts on branded drugs for beneficiaries in coverage gaps; It is a federal grant awarded to plans at the catastrophic coverage stage.”
Currently, Medicare covers a significant portion of biologics once a patient reaches the catastrophic coverage stage where their out-of-pocket costs exceed $8,000. At that point, Medicare will cover his 80% of the drug price, but this payment scheme does not encourage cheaper drugs.
“Patients are paying more out of pocket and plans are paying more,” Maini said. “And that’s because the government ends up collecting more taxes on expensive products than on cheap ones.”
By closing the coverage gap at the catastrophic stage, the study predicted that payment shifts could realign coverage decisions in favor of biosimilars.
The law is already having an impact. After enactment of the Bipartisan Budget Act of 2018, changes in Medicare Part D drug product coverage increased biosimilar coverage by 23%, the study found. Biosimilar discounts in the law will expand coverage of these medicines, and researchers expect similar changes to occur for IRAs starting in 2025.
“We should already see the effects in the new year,” Maini said. “It will take time for companies to adapt to the new situation, but we expect to see an immediate impact.”
