Alzheimer’s patient groups protest U.S. Medicare coverage proposal limiting use of new drugs

Alzheimer’s patient groups, disappointed by Medicare’s plan to sharply limit coverage of new drugs for the brain-wasting disease, are planning publicity and lobbying campaigns to protest a proposal they say could delay their use for 10 years.

“Congress has to know how bad this will be for patients,” said John Dwyer, president of Global Alzheimer’s Platform Foundation (GAP) advocacy group.

In  a preliminary decision  last week, the U.S. Centers for Medicaid and Medicare Services (CMS), which runs the government health plan for people age 65 and older, said it would cover Biogen Inc’s  (BIIB.O)  already approved Aduhelm, and similar Alzheimer’s disease treatments in development, only for patients enrolled in approved clinical trials.Report ad

That plan would severely limit the number of patients receiving the treatment, undercutting the Food and Drug Administration’s accelerated approval of Aduhelm for patients in the early stages of the memory-robbing condition.

The public disagreement over the drug’s use is unusual for the agencies, both part of the U.S. Department of Health and Human Services.

Alzheimer’s Association Chief Executive Harry Johns said Medicare’s plan “usurps FDA’s role in drug approvals,” calling it “an unprecedented and terrible draft decision.”Report ad

His group, as well as UsAgainstAlzheimer’s and GAP – three of the biggest Alzheimer patient organizations – said they plan to fight the decision by appealing to lawmakers, the Biden administration and the U.S. Health Secretary.

The Alzheimer’s Association said it is using “all avenues of communication” to make its case.

Biogen is also fighting the decision and in a statement said it is “supportive of the community in raising their voices on this important issue of access.”Report ad

The Medicare agency could alter its plan before it is finalized in April, but it is unclear what new evidence or facts would cause it to soften its stance.

“There are only two clinical studies … There isn’t any real-world experience to convince CMS,” said James Chambers, a researcher at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center in Boston. “They will receive a lot of outrage as opposed to new information.”

Medicare has opened a 30-day comment period with a final decision due by April 11.

“If the (CMS) decision changes, it will be because of political pressure,” said Raymond James analyst Chris Meekins.

CONTROVERSIAL DECISION

The FDA’s  June decision  was the first approval of an Alzheimer’s drug in nearly two decades, but was a controversial one not supported by the agency’s outside advisers. It relied on evidence that the drug can reduce amyloid brain plaques, a likely contributor to Alzheimer’s, rather than proof that it slows progression of the disease.

Only one of Biogen’s two large-scale trials showed that Aduhelm had an impact on cognition.

The three Alzheimer’s patient groups said Medicare’s plan unfairly penalizes people with the disease – probably because there are so many of them and the cost could be enormous.

Aduhelm’s price – cut recently to $28,200 from $56,000 per year – sparked concerns about Medicare’s budget since Alzheimer’s is an age-related disease and around 85% of people eligible for the drug are in the government plan.

The number of Americans with Alzheimer’s is expected to rise to 13 million by 2050 from more than 6 million currently. Biogen has estimated that around 1 million would currently be eligible for Aduhelm.

Other companies, including Biogen partner Eisai Co Ltd and Eli Lilly and Co  (LLY.N) , also are pursuing accelerated approval from the FDA for similar medications.

“This decision was not about Aduhelm alone. This was a decision about drugs still in trials,” said UsAgainstAlzheimer’s chairman George Vradenburg. “It is stunning preemption.”

Medicare typically pays for FDA-authorized medications, but by law is required to cover only products and services deemed “reasonable and necessary” for diagnosis or treatment.

Vradenburg said his organization is “communicating with Congress and the Biden Administration” about its dismay.

By Maria Thacker Goethe July 28, 2025
By: Clary Estes “Small companies are the lifeblood of the industry and a lot of what they do, and what they’re experiencing, greatly affects the industry as a whole,” said Chad Wessel, Director of Industry Analysis at the Biotechnology Innovation Organization (BIO). He spoke with Bio.News in an interview about BIO’s 2025 report, “ The State of Emerging Biotech Companies: Investment, Deal, and Pipeline Trends ,” focused on the biotech industry from the early-stage perspective. As researchers found, the current landscape is challenging, but there are still opportunities. “In the last couple years, we’ve had a little bit of a contraction of the industry. During COVID, we kind of had this sugar rush for the industry,” said Wessel. “A lot of companies were being created. A lot of money was being thrown out there. A lot more companies were being funded. And in the last couple of years, there has been a little bit more of a correction, and we’re seeing funding levels going down to what we’ve seen prior to COVID.” “But when you add on other challenges, like the political landscape and everything, it is leaning towards a very challenging environment for a lot of companies,” he continued. Bearish venture capital “In venture capital, yes, you have a lot of money, but it’s going to fewer companies at higher average amounts,” explained Wessel. “It’s creating this competitive haves and have-nots type marketplace or environment. So it just makes it a lot more competitive and more challenging to raise funds.” Instead of finding new opportunities, venture capitalists are investing more in companies they are already working with. As the BIO report found, the amount of new series A-1 investment rounds into biopharma remained flat between 2023 and 2024, while the number of U.S. companies receiving their first series A-1 tranche went from 102 to 100. This is in comparison to 181 in 2021, reflecting the COVID influx to emerging biotechs. Comparatively, as the BIO report found, the average amount for A-1 transactions in the U.S. saw a remarkable increase of 700% in the last 15 years, with the average amount raised sitting at $60 million in 2024. The rest of the world stayed relatively steady in comparison to the U.S.’s persistent growth. And with the more bearish tendencies of investors, Wessel and team observed an interesting trend. “2024 was the first year that clinical programs actually raised more venture dollars than pre-clinical, which hasn’t happened in a while,” said Wessel. “I think the last time that happened was in 2018. This ties into some of the information that we’ve heard anecdotally, which is that a lot of VC firms are focusing on the companies that they currently have in their portfolio, rather than adding new companies.” Licensing and deals dip It is not too surprising, then, that as investors shore up what they already have in the pipelines, the R&D pipeline and licensing have slowed somewhat. As the BIO report observed, long-term growth in the R&D pipeline continues with an overall growth of 145% since 2010. Yet, the 2024 expansion rate (4.6%) subsided slightly, trailing the 5-year average of 6.7%. “The growth has slowed on new programs, and more of those programs are being licensed with larger companies,” explained Wessel. “There are fewer options for big companies to backfill their pipeline with products because a lot of them are already out.” The data also shows a notable slowing of the R&D typically done by large biopharma companies. “The areas that are not licensed out as much are the ones with some of the higher patient populations and subsequently the ones that are not being run by small companies,” said Wessel. “These are areas like endocrine and cardiovascular diseases, which are areas where there are a lot of things like type 2 diabetes, psoriasis , high blood pressure, etc. Those all have a lot of burden on the healthcare sector or the patient population, and those aren’t really being worked on that much by smaller companies.” Comparatively – and also not surprisingly – oncology has stayed at the top of the clinical pipeline, along with neurology and infectious disease. “Same thing with licensing,” said Wessel. “While there are deals that are still happening, the upfront amount is lower currently than it has been in years past, and most of the value is tied up into milestone payments, which may or may not happen.” This is also being felt when it comes to new companies going public, which has been an oft-discussed challenge in the biotech industry for the last few years. “The IPO market has still been challenging,” Wessel says. “We went from having 40 companies a year going public, down to 15 in 2023, and now we’re back up in 2025, but it’s still down from the pre-COVID era timeframe.” Biopharma layoffs Another notable characteristic of this year’s biopharma landscape has been uptick in layoffs. “Sometimes it’s just the nature of the economy. But the amount that we’ve seen in the last few years is quite a bit higher,” said Wessel. “To counter that, we don’t really have a way of measuring job creation, but we do know it’s happening. We just are unable to put a value on that.” The BIO report found that layoff announcements ticked up to 65 during Q1 of 2025. While two points lower than Q1 of the previous year, this still marks a jump from 2024’s Q2, Q3, and Q4, which saw the number of layoff announcements at 41, 54, and 46, respectively. All in all, Wessel noted, the biotech industry is still in a bit of a holding period when it comes to trying to navigate the coming months. “It’s too early to be able to say much about the coming years for the industry based on these numbers,” he said. “It takes a little time for reality to kind of catch up for multiple reasons. But what I can say is that we do know that companies are reducing their pipelines. We do know that companies are laying off individuals. We do know that companies are having a challenge of raising funds and continue doing their best to try to maintain operations as long as they can until they can get funds.” “We know the challenge is out there, but we’re going to have to kind of wait and see a little bit on the data side of things to understand how everything is going to catch up going forward.” Source: https://bio.news/bioeconomy/bio-2025-state-of-emerging-biotechs-report-market-trends/?mkt_tok=NDkwLUVIWi05OTkAAAGb7m5php-rTOf0a_GTaj5pj7Zl-HlpVM25WtyVvCYudM82a9GKjoazUg9sqU66hlAbhqbEuYvcX3C4EqfBG7Q
By Maria Thacker Goethe July 26, 2025
Pioneer Institute has released updated #340B state fact sheets for 2025
By Georgia Bio Admin July 24, 2025
GLS is proud to announce a new partnership with Apprenti This is a key step toward expanding Registered Apprenticeship programs across Georgia’s thriving life sciences sector. July 24, 2025
MORE POSTS