Medicare plans to restrict access to controversial, pricey Alzheimer’s drug Aduhelm to patients in clinical trials

 Medicare plans to cover the controversial, pricey Alzheimer’s drug Aduhelm, but only for certain patients enrolled in clinical trials, the agency announced on Tuesday.

The proposed move would likely mean some patients will not be able to access the Biogen drug, which is the first Alzheimer’s treatment approved in nearly two decades. Since it got the green light this summer, doctors and scientists have raised questions about whether it actually works, government watchdogs have begun investigating whether the Food and Drug Administration followed proper procedure to approve it, and policy experts have questioned whether it is effective enough to justify its hefty price tag.

Medicare officials don’t require participation in clinical studies for beneficiaries very often — there are only about two dozen other health care products with a similar designation, called a Coverage with Evidence Development, listed on Medicare’s website. Most are for medical devices or diagnostic imaging, and are less restrictive than the policy Medicare announced Tuesday.

But it would also serve to limit the patient population for the drug considerably, since clinical trials are usually run mostly out of major medical centers that are equipped to jump through the additional bureaucratic hoops required.

“In a clinical trial, where only certain centers participate, there would be a geographic component to patient access,” said James Chambers, an associate professor of medicine at Tufts University who studies coverage policies.

Medicare will also limit those who can get the drug to people who have mild forms of cognitive impairment.

The new proposal is not final, and could still change substantially before it’s finalized later this spring.

Even if it’s finalized, it’s not clear yet whether the policy will improve the drug’s abysmal sales numbers. A number of prominent hospitals and academic medical centers have refused to administer the drug at all.

https://www.statnews.com/2022/01/11/medicare-aduhelm-proposed-decision/