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.

Georgia Life Sciences Designates City of Atlanta as Newest BioReady® Community

By Sheran Brown • February 21, 2025
Georgia Life Sciences Designates City of Atlanta as Newest BioReady® Community

Bipartisan PBM Reform Back in Focus as House Committee Plans Hearing

By Sheran Brown • February 20, 2025
A renewed push for prescription drug cost reform is gaining momentum in Congress, with the House Energy and Commerce Committee's health subcommittee planning a hearing on pharmacy benefit manager (PBM) reform for late February. The hearing, to be led by Rep. Buddy Carter (R-Ga.), signals a revival of bipartisan efforts to regulate these pharmaceutical intermediaries. PBMs, which negotiate drug prices for insurers and employers, have become a focal point in the broader discussion of healthcare costs. A previous bipartisan agreement to regulate these entities was crafted by Carter and Rep. Diana DeGette (D-Colo.) in the last Congress, though it ultimately stalled when the larger spending bill it was attached to faced opposition. The reform efforts enjoy broad support from both parties and the president, making it one of the few areas with potential for bipartisan cooperation. However, new complications have emerged as Republicans consider using PBM regulations to generate savings for their broader policy agenda, potentially requiring up to $880 billion in cost reductions. The path forward remains uncertain, with ongoing debates about whether such reforms would qualify for budget reconciliation and whether using PBM regulations as a funding mechanism could derail bipartisan cooperation. Meanwhile, stakeholders continue to disagree on the impact of additional PBM regulation, with pharmaceutical companies arguing that PBMs inflate drug costs while PBMs contend that new regulations would increase prices.

Council on State Biotechnology Associations says NIH funds are a critical component of innovation ecosystem

By Sheran Brown • February 20, 2025
The Council of State Biotechnology Associations (CSBA) has issued a strong warning about proposed cuts to National Institutes of Health (NIH) funding, emphasizing the critical role these grants play in America's biotech innovation ecosystem. The statement, below , comes amid concerns over recent guidance that would reduce NIH funding to key research institutions. ----------------------- “Today, the US biotech industry employs nearly 2.3 million people across the US and is making positive contributions to economic impact and national security across all 50 states. In fact, for every dollar the National Institutes of Health (NIH) contributes to a successful drug, the private sector invests over $65, underscoring the agency’s unparalleled return on investment. As the associations representing the bioscience industry across the nation, the Council on State Biotechnology Associations (CSBA) is concerned by recent guidance that would cut funding provided by the NIH to universities, hospitals, and other institutions that perform critical early-stage research. NIH grant funds are a critical component of our innovation ecosystem. Grants for basic research are the spark that leads to university-driven discoveries, with public-private partnerships and tech transfers that bridge early-stage research to industry-sponsored drug development and ultimately to FDA approved medical advances for hundreds of diseases. While the administration looks for greater efficiency in the use of taxpayer dollars, it cannot be overstated - once scientific innovation moves abroad, it may never return. In the race for scientific innovation around the world, as our adversaries continue to increase government investments in research, we encourage President Trump to follow suit and ensure that we maintain our global leadership in an industry that was created and thrives across the US.”
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