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Ever since Medicare proposed to sharply limit the coverage of the controversial Alzheimer’s drug Aduhelm, the agency has been flooded with fiery pleas.

Groups representing patients insisted that the federal insurance program pay for the drug. Many Alzheimer’s experts and doctors have warned against broadly considering a treatment with uncertain benefits and serious safety risks.

On Thursday, Medicare officials final decision. Although the Food and Drug Administration has approved Aduhelm for approximately 1.5 million people, Medicare will only cover it for people participating in a clinical trial.

Chiquita Brooks-LaSure, director of the Centers for Medicare and Medicaid Services, or CMS, said the decision is aimed at protecting patients while collecting data to show whether Aduhelm, an expensive monoclonal antibody given as a monthly infusion, can actually help them. slows the rate of cognitive decline.

“It’s our responsibility as CMS to make sure this is really reasonable and necessary,” Ms Brooks-LaSure said in an interview Thursday. “The vast majority” of about 10,000 people comments Taken on its website, the agency said it was in favor of “really limiting Aduhelm’s coverage to a truly controlled area where we can continue to assess eligibility for the Medicare population.”

Aduhelm’s manufacturer, Biogen, said the decision “effectively blocks all Medicare beneficiaries from accessing Aduhelm” and that “Biogen is carefully considering its options and will provide updates as the company further evaluates the commercial impact of this decision.”

A key issue for Medicare was how to deal with other similar drugs for Alzheimer’s, and many of them are expected to be evaluated for FDA approval soon. Inside offer in JanuaryMedicare said it would cover them in the same way as Aduhelm because it typically makes coverage decisions for an entire class of drugs.

But after experts and advocacy groups alike expressed their concerns, Medicare officials said Thursday they won’t automatically apply the same restrictions to every new drug. Unlike Aduhelm, if the FDA finds that there is clear evidence that a drug can help patients, Medicare will cover it for all eligible patients and only require that patients’ experience be tracked.

The chief medical officer of the Medicare agency, Dr. Lee Fleisher said that the two-pronged way to tackle the rapidly evolving field of Alzheimer’s therapies, a program called Coverage by Enhancement of Evidence, “means being agile and genuinely responsive. To all new drugs in this class that are in production and are of clinical benefit.”

This decision is extremely unusual for Medicare, which almost always automatically pays for FDA-approved drugs, at least for the medical conditions listed on the labels.

But Aduhelm’s path was also very unusual. The FDA itself acknowledged that it was unclear whether the drug would be beneficial when it approved Aduhelm last June, authorizing it for people with mild cognitive decline related to Alzheimer’s.

Clinical trial evidence reviewed by the FDA showed that patients in one trial of Aduhelm experienced a slight slowdown in cognitive decline, whereas patients in a nearly identical trial experienced no benefit. About 40 percent of patients at the dosage later confirmed to have experienced brain swelling or cerebral hemorrhage, which is usually mild, but sometimes serious. A council of both senior FDA officials and your agency independent advisory committee He said there wasn’t enough evidence for confirmation.

Rather than grant full approval to the drug, the FDA gave the green light under a program called “accelerated approval,” which allows for the licensing of drugs whose benefit is unclear if they are for serious diseases with few treatments and if the drug somehow affects a biological mechanism. It is accepted that the probability of helping patients is quite high.

The agency’s rationale was that Aduhelm targeted amyloid, a protein that forms plaques in the brains of Alzheimer’s patients. But many Alzheimer’s experts say years of data have not shown that reducing amyloid can slow cognitive decline.

Questions about approval and whether the FDA is working very closely with Biogen, congressional committees, the inspector general of the Health and Human Services division, the Federal Trade Commission and the Securities and Exchange Commission. Major medical centers including Cleveland ClinicAduhelm refused to offer.

As a result of concerns expressed by Alzheimer’s experts and some groups, Medicare officials have announced a few more changes to their earlier proposals. Medicare will cover participants in any trial approved by the FDA or the National Institutes of Health, rather than randomized controlled trials approved by the CMS. This would allow trials to be conducted in a wider range of locations, not just in hospital settings, and include people with other neurological conditions, such as Down syndrome, many of whom developed Alzheimer’s but were excluded from the previously proposed scheme.

Unlike Aduhelm’s previous trials, where most participants were white, trials will need to comply with a Medicare requirement to recruit a racially and ethnically diverse group of participants.

In trials, “manufacturers will have to come to us on how to include all patients who represent the Medicare population and how to ensure that all these patients receive appropriate medical treatment and their treatment is monitored. Tamara Syrek Jensen, director of coverage and analysis for the Medicare agency’s Center for Clinical Standards and Quality, said in an interview.

The FDA has also asked Biogen to conduct another clinical trial to determine if the drug provides any evidence of benefit, but said Aduhelm will be available to patients in the years necessary for this trial to be completed. According to Thursday’s ruling, Medicare will cover the costs of those involved in Biogen’s lawsuit.

“At the end of the day, both agencies have a common goal of ensuring that safe and effective medical products are available to Americans,” the FDA said in a statement following the Medicare announcement.

Medicare’s coverage assessment team makes decisions without considering the cost of a drug, but the Aduhelm decision may ease some concerns about how the drug’s coverage will affect the wallets of millions of Medicare beneficiaries across the country.

Last year, Medicare’s actuarial division, acting without knowing what the coverage decision would be, One of the biggest-ever increases in Medicare Part B premiums For 2022, in part because of the possibility of covering Aduhelm, which was priced at $56,000 per year by its manufacturer at the time.

Since then, facing poor sales of the drug, with many hospitals and doctors not prescribing the drug, Biogen has slashed the price to $28,800 a year, though. much higher than many analysts say.

Minister of Health and Human Services, Xavier Becerra, stated that he will consider reducing the premiums after the final guarantee decision is made for Aduhelm, adding, “We will ensure that the elderly do not pay more than necessary. ”

“The secretary told us to look into this and we will be in the process of reviewing the Part B premium,” CMS director Ms. Brooks-LaSure said in an interview Thursday.

advocacy groups, some of which have received some funding from Biogen and other pharmaceutical companies, vigorously campaigned for extensive Medicare coverage. These groups said patients should be able to decide with their doctors whether to try an FDA-approved drug, and argued that simply reimbursing participation in clinical trials that are not easily accessible for many patients is discriminatory.

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

After the Medicare decision was announced on Thursday, Mr. Johns said the association was still evaluating the decision, but added, “At initial review, we are very disappointed with the immediate impact it will have on Americans living with Alzheimer’s today and their families. While we note that some of the advice provided by people living with Alzheimer’s and the Alzheimer’s Association was included in the CMS decision, it is wrong to deny access to FDA-approved Alzheimer’s treatments.”

Medicare officials said the decision is Aduhelm’s attempt to provide what they consider to be significant limitations to its scope, but not necessarily to subject future anti-amyloid monoclonal antibody drugs to similar restrictions.

Medicare officials would point out that if another drug in this class wins full or conventional FDA approval, which usually requires two convincing clinical trials, it’s convincing evidence that the drug can help patients and that its benefits outweigh its risks. .

“If a drug is approved under conventional approval tomorrow, we’re ready,” Ms Jensen said, adding that such a drug would be available in a “real world setting” and patients would be registered in a registry or other program. Let Medicare monitor you for benefiting from the medication.

“We really need to understand what’s going on and we want to make sure we provide all that additional or appropriate clinical care,” said Ms Brooks-LaSure, director of Medicare. “So we’re going to make sure we continue to monitor what’s going on so we can continue to develop this evidence around a cure.”