Medicare Officially Limits Coverage of Aduhelm to Patients in Clinical Trials

Ever since Medicare proposed drastically limiting coverage of the controversial Alzheimer’s drug Aduhelm, the agency has been inundated with impassioned pleas. Groups representing patients insisted that the federal insurance program pay for the drug. Many doctors and Alzheimer’s experts have warned against broad coverage of a treatment that has uncertain benefits and serious safety risks. Individual patients and families weighed in with emotional statements from both sides.

On Thursday, Medicare officials announced their final decision. Although the Food and Drug Administration has approved Aduhelm for about 1.5 million people, Medicare will cover it only for people who receive it as participants in a clinical trial.

Chiquita Brooks-LaSure, Administrator, Centers for Medicare & Medicaid Services he said the decision was intended to protect patients while data was collected to indicate whether Aduhelm, an expensive monoclonal antibody given as a monthly infusion, might actually help them by slowing the rate of their cognitive decline.

“It’s our obligation at CMS to really make sure it’s reasonable and necessary,” Ms. Brooks-LaSure said in an interview Thursday. She said “the vast majority” of the roughly 10,000 comments the agency received on its website were in favor of “really limiting Aduhelm’s coverage to a really controlled space where we could continue to assess his suitability for the Medicare population.”

A major issue for Medicare had been how to deal with other similar Alzheimer’s drugs, several of which are likely to be considered for FDA approval soon. In a January proposal, CMS had said it would cover them in the same way as Aduhelm because it typically made coverage decisions for an entire class of drugs.

But after both experts and advocacy groups raised concerns, Medicare officials said Thursday that they wouldn’t automatically apply the same restrictions to every new drug. If, unlike Aduhelm, the FDA determines that there is clear evidence that a drug can help patients, Medicare would cover it for all eligible patients and only impose a requirement that patient experience tracking be done.

Dr. Lee Fleisher, CMS medical director, said the two-way approach to dealing with the rapidly developing field of Alzheimer’s therapies, a program called Coverage with Evidence Development, “is meant to be nimble and really respond to any new drugs in this class that are in development and demonstrate clinical benefit.”

The decision is extremely unusual for Medicare, which almost always automatically pays for drugs that the FDA has approved, at least for medical conditions designated on the labels.

But Aduhelm’s path has also been highly unusual. The FDA itself acknowledged that it was unclear whether the drug was beneficial when it approved Aduhelm last June. It gave the drug the green light under a program called “accelerated approval,” which allows approval of drugs that are of uncertain benefit if they are for serious conditions with few treatments and the drug affects a biological mechanism in a way that is considered reasonably likely to occur. help patients.

Clinical trial evidence reviewed by the FDA showed that patients in one trial appeared to experience a slight decrease in cognitive decline, while patients in a nearly identical trial did not appear to benefit at all. About 40 percent of patients taking the approved dose later experienced brain swelling or bleeding in the brain, often mild but sometimes severe. Both a council of top FDA officials and the agency’s independent advisory committee had said there was not enough evidence for approval.

Questions about the approval and whether the FDA worked too closely with Biogen, the maker of Aduhelm, have prompted investigations by congressional committees, the inspector general of the Department of Health and Human Services, the Federal Trade Commission and the Commission. Stock Market and Securities. Major medical centers, including the Cleveland Clinic, have refused to offer Aduhelm.

As a result of concerns raised by Alzheimer’s experts and some groups, Medicare officials announced several other changes to their earlier proposal. Instead of requiring CMS-approved randomized controlled trials, Medicare will cover participants in any trial approved by the FDA or the National Institutes of Health. It will allow those trials to take place in a broader range of places, not just hospital settings, and to include people with other neurological conditions such as Down syndrome, many of whom develop Alzheimer’s but had been excluded from the previously proposed plan. .

The trials will still have to meet a Medicare requirement to recruit a racially and ethnically diverse group of participants, in contrast to Aduhelm’s earlier trials, in which the majority of participants were white.

In trials, “manufacturers are going to have to come to us with how they are going to include all the patients who represent the Medicare population, and how they are going to ensure that all of these patients receive appropriate medical treatment and monitor their treatment. while they’re in each of these studies,” Tamara Syrek Jensen, director of coverage and analysis for the CMS Center for Clinical Standards and Quality, said in an interview.

The FDA also required Biogen to conduct another clinical trial to determine if the drug provided any evidence of benefit, but said that in the years it will take to complete that trial, Aduhelm would be available to patients. Under Thursday’s decision, Medicare would cover the costs of participants in the Biogen trial.

The Medicare coverage review team makes decisions without considering the cost of a drug, but Aduhelm’s decision could alleviate some concerns about how drug coverage could hit the pockets of the nation’s millions of Medicare beneficiaries.

Last year, the actuarial division of Medicare, acting without knowing what the coverage decision would be, imposed one of the largest increases ever seen in Medicare Part B premiums for 2022, in part driven by the possibility of coverage for Aduhelm , which at the time was priced from its manufacturer at $56,000 a year.

Since then, Biogen, faced with weak sales of the drug after many hospitals and doctors failed to prescribe it, has lowered the price to $28,800 a year, still much higher than many analysts have said is justified.

Xavier Becerra, secretary of health and human services, had said he would consider lowering premiums after the final coverage decision for Aduhelm is made, adding that “we will make sure seniors don’t pay more than they owe. ”

In Thursday’s interview, Ms. Brooks-LaSure, a CMS administrator, said, “The secretary told us to look at it and we’re going to participate in the Part B premium review process.”

Advocacy groups, several of which receive some funding from Biogen and other pharmaceutical companies, had campaigned vigorously for broad Medicare coverage. These groups said patients should be able to decide with their doctors whether to try an FDA-approved drug and said it was discriminatory to only reimburse participation in clinical trials that may not be readily accessible to many patients.

“We just can’t leave it as it is,” Harry Johns, executive director of the Alzheimer’s Association, told the organization’s staff, according to a recording of the meeting obtained by The New York Times.

In an interview before the Medicare announcement, Mr. Johns indicated that the association would not be satisfied if Medicare restrictions applied only to Aduhelm, saying, “We absolutely believe there is sufficient evidence to provide coverage for the first approved treatment.”

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