Megan Wilson, Politico, April 9th, 2022
Experts are divided over the impact of Medicare’s decision for Alzheimer’s drugs and other difficult diseases.
The Biden administration’s contentious decision to only partially cover Aduhelm could reach well beyond the world of Alzheimer’s drugs, potentially affecting efforts to develop treatments for devastating diseases.
The Centers for Medicare and Medicaid Services on Thursday finalized a decision to narrowly cover Aduhelm, a $28,000-per-year treatment, creating dissension among experts and advocates about the implications for patients of the disease and, more broadly, the future development of crucial medicines.
At the same time, the decision put an unflattering spotlight on the Food and Drug Administration’s accelerated approval process and underscored the power of CMS — in ways that could affect how quickly other new drugs go to market.
Lee Fleisher, CMS’ chief medical officer, said the agency “looked at the very unique circumstances around this class of treatments and made a decision that weighed the potential for patient benefit against the significance of serious unknown factors that could lead to harm.”
The agency, which decides what to cover for the more than 60 million Americans on Medicare, wasn’t sold on the drug’s effectiveness and is requiring additional clinical trials or studies of treatments — after they’ve received FDA approval. There are at least three similar Alzheimer’s drugs in development. Two are moving forward with accelerated approval.
“Accelerated approval, as we know it, is gone,” said George Vradenburg, who leads UsAgainstAlzheimer’s, an advocacy group. “Medicare is taking the view that it has both the legal authority and the responsibility of assuring that drugs that are covered for the Medicare population have clinical benefit. And since accelerated approval is only a ‘reasonable likelihood of clinical benefit,’ they are not going to release to the Medicare population any drug that does not show clinical benefit.”
CMS disagreed with comments saying that it would stifle innovation in other Alzheimer’s drugs.
“We believe by defining the criteria by which a forthcoming therapy for Alzheimer’s disease could be covered would actually facilitate innovation. The CMS final decision gives the public a clear definition of where the goal line is for what constitutes success in a trial (and thus what meets the standard for ‘reasonable and necessary’ required by law),” the agency said in its decision memo.
Chris Meekins, a former official at the Department of Health and Human Services who is now a policy analyst at Raymond James, said it’s too early to tell what impacts the CMS decision is going to have in the investment of new drugs. He points to the agency calling this class of drug “unique.”
“CMS is showing it has the tool in the toolbox,” he said. “For folks to really change their investment behavior, you’re going to need another example or two going forward.”
The CMS proposal was the subject of intense advocacy, and CMS reviewed more than 10,000 comments, including thousands of form letters. The agency said roughly 65 percent of the responses agreed that there wasn’t enough evidence to cover anti-amyloid antibody drugs like Aduhelm.
Aduhelm, which is manufactured by Biogen, was the first treatment intended to slow cognitive decline. There were, however, mixed results about whether the drug effectively reduces memory loss and some patients experienced brain swelling or bleeding. Whether drugs, generally, that target amyloid plaques in the brain are able to lessen cognitive decline is also up for debate.
“Now that CMS made their decision, I can say it was a defining moment for the White House and they passed with flying colors,” said Diana Zuckerman, the president of the National Center for Health Research, who called the move science-based. “Everything that’s happened in the last almost a year or maybe even more than a year has sent a message to industry and to patient groups, and also to the FDA, that the standards had gotten too loose.”
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