Medicare officially limits the coverage of Aduhelm to patients in clinical trials

Ever since Medicare sharply proposed limiting coverage of the controversial Alzheimer’s drug Aduhelm, the agency has been inundated with passionate prayers.

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

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

Chiquita Brooks-LaSure, administrator of the Centers for Medicare and Medicaid Services, or CMS, said the decision was intended to protect patients while collecting data to indicate whether Aduhelm, an expensive monoclonal antibody given as a monthly infusion, could actually help them by slowing down the pace of their cognitive decline.

“It is our commitment at CMS to truly ensure that it is fair and necessary,” Ms. Brooks-LaSure in an interview Thursday. The “majority” of the roughly 10,000 comments the agency received on its website, she said, were in favor of “really limiting the coverage of Aduhelm to a truly controlled space where we could continue to evaluate its suitability for the Medicare population.” . “

Aduhelm’s producer, Biogen, said the decision “effectively denies all Medicare beneficiaries access to Aduhelm,” adding that “Biogen is carefully considering its options and will provide updates as the company further assesses the business impact of this decision.”

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, Medicare 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 would not automatically apply the same restrictions to each new drug. If the FDA, unlike Aduhelm, finds that there is clear evidence that a drug can help patients, Medicare will cover it for all eligible patients and only require that the patients’ experience be tracked.

Dr. Lee Fleisher, Chief Medical Officer at the Medicare Agency, said the two-track way of dealing with the rapidly evolving field of Alzheimer’s therapies, a program called Coverage with Evidence Development, is designed to be flexible and truly responsive. to any new medicinal product of this class which is in the pipeline and which shows clinical benefit. “

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

But Aduhelm’s path has also been very unusual. The FDA itself acknowledged that it was unclear whether the drug was beneficial when it approved Aduhelm in June last year, and approved it for people with mild Alzheimer’s-related cognitive decline.

The evidence from the clinical trial reviewed by the FDA showed that patients in a trial with Aduhelm appeared to experience a slight slowdown in cognitive decline, while patients in an almost identical trial did not appear to benefit from it at all. . About 40 percent of patients who received the approved dose later experienced swelling of the brain or cerebral hemorrhage, often mild but sometimes severe. Both a council of senior FDA officials and the agency’s independent advisory committee had said there was not enough evidence for approval.

Instead of giving the drug full approval, the FDA gave the green light for it under a program called “accelerated approval,” which allows the approval of drugs that have uncertain benefit if they are for serious diseases with few treatments and if the drug affects a biological mechanism in a way is considered reasonably likely to help patients.

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

Questions about the approval, and whether the FDA worked too closely with Biogen, have prompted investigations by congressional committees, the Health and Human Services Department Inspector General, the Federal Trade Commission and the Securities and Exchange Commission. 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 previous proposals. Instead of requiring randomized controlled trials approved by the CMS, Medicare will cover participants in any trial approved by the FDA or the National Institutes of Health. It will allow these trials to be performed in a wider range of locations, not just hospital settings, and to include people with other neurological conditions such as Down syndrome, many of whom develop Alzheimer’s but who had been excluded from the previously proposed plan.

The trials still have to meet a Medicare requirement to recruit a racially and ethnically diverse group of participants, unlike the previous trials with Aduhelm, where most participants were white.

In the trials, “manufacturers will need to come to us with how they will include all patients representing the Medicare population and how they will ensure that all of these patients receive appropriate medical treatment and monitoring of their treatment while in each of these studies, ”said Tamara Syrek Jensen, Director of Coverage and Analysis at the Medicare Agency’s Center for Clinical Standards and Quality, in an interview.

The FDA has also required Biogen to conduct another clinical trial to determine if the drug provided evidence of benefits, but it said that in the years it will take before the trial is completed, Aduhelm will be available to patients. According to Thursday’s decision, Medicare would cover the cost of participating in Biogen’s trial.

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

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

Last year, Medicare’s actuarial department, which acted without knowing what the coverage decision would be, imposed one of the largest increases so far in Medicare Part B premiums for 2022, driven in part by the possibility of coverage for Aduhelm, which at the time was priced per . its producer to $ 56,000 a year.

Since then, Biogen, which is facing weak sales of the drug after many hospitals and doctors would not 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 the premiums after the final coverage decision for Aduhelm was made, adding that “We want to make sure seniors do not pay more than they should.”

In the interview Thursday, Ms. Brooks-LaSure, CMS Administrator, “The Secretary asked us to look into it and we will begin the process of reviewing the Part B award.”

Lawyers’ groups, several of which receive some funding from Biogen and other pharmaceutical companies, had fought hard for broad Medicare coverage. These groups said patients should be able to work with their doctors to decide whether to try an FDA-approved drug, arguing that reimbursing only clinical trials that may not be readily available to them is discriminatory. many patients.

“We just can not 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 given to The New York Times.

After the Medicare decision was announced Thursday, Mr. Johns that the association was still evaluating it, but he added, “At first glance, we are very disappointed with the immediate impact it will have on Americans living with Alzheimer’s and their families today. Although we note that some of the recommendations from people living with Alzheimer’s and Alzheimers Association have incorporated into the CMS decision, it is wrong to deny access to FDA-approved Alzheimer’s treatments. “

Medicare officials said the decision was an attempt to provide what they consider important limits to Aduhelm’s coverage, without necessarily sending future anti-amyloid monoclonal antibodies to similar restrictions.

If another drug in that class wins full or traditional FDA approval, which usually requires two convincing clinical trials, it would signal that there is compelling evidence that the drug can help patients and that its benefits outweigh its risks, Medicare indicated. officials.

“If a drug was approved under traditional approval tomorrow, we’re ready,” Ms. Jensen said, adding that such a drug would be available “in a real world” and patients would be enrolled in a registry or other program that would allow Medicare to monitor whether they benefit from the medication.

“There is such a need to really understand what’s going on that we want to make sure we provide all the additional or appropriate clinical treatment,” Ms. Brooks-LaSure, Medicares Administrator. “So we want to make sure we keep track of what’s going on, so we keep developing the evidence around a treatment.”

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