Medicare Officially Limits Aduhelm’s Coverage To Patients In Clinical Trials

Ever since Medicare proposed to severely limit coverage of the controversial Alzheimer’s drug Aduhelm, the agency has been inundated with passionate pleas.

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

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 only cover it for people who receive it as participants in a clinical trial.

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

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

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

A key issue for Medicare has been how to handle other similar Alzheimer’s drugs, some of which are likely to be considered for FDA approval soon. In a proposal in January, 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 they wouldn’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 would cover this for all eligible patients and only require that the patient’s experience be followed.

dr. Lee Fleisher, the chief medical officer at the Medicare bureau, said the two-pronged approach to dealing with the rapidly evolving field of Alzheimer’s therapies, a program called Coverage with Evidence Development, “is designed to be agile and truly responsive. on all new drugs in this class that are in the pipeline and that demonstrate clinical benefits.”

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 its labels.

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

The FDA-reviewed clinical trial showed that patients in one study of Aduhelm appeared to experience a slight delay in cognitive decline, while patients in a nearly identical study appeared to have no benefit at all. About 40 percent of patients on the later approved dose experienced brain swelling or hemorrhage, often mild, but sometimes severe. Both a board of senior FDA officials and the agency’s independent advisory committee had said there was not enough evidence for approval.

Rather than give the drug full approval, the FDA has given the green light under a program called “accelerated approval,” which allows for authorization of drugs that have an uncertain benefit if they are for serious diseases with few treatments and if the drug affects a biological mechanism in a way considered reasonably likely to help patients.

The agency’s justification 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 haven’t shown that reducing amyloid can slow cognitive decline.

Questions about the approval and whether the FDA was working too closely with Biogen have led to investigations by 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 the Cleveland Clinic, have refused to offer Aduhelm.

As a result of concerns from Alzheimer’s experts and some groups, Medicare officials announced several other changes to their earlier proposal. Rather than requiring randomized controlled trials approved by CMS, Medicare covers participants in any trial approved by the FDA or the National Institutes of Health. It will make it possible to conduct those trials 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 disease but were 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, unlike Aduhelm’s previous trials, in which most of the participants were white.

In the studies, “the manufacturers will have to come to us and ask how they are going to include all the patients representing the Medicare population, and how they are going to make sure all of these patients are getting the right medical treatment and overseeing their treatment while they are doing it.” are in each of these studies,” Tamara Syrek Jensen, the director of coverage and analysis for the Medicare Office of Clinical Standards and Quality, said in an interview.

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

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

Medicare’s evaluation team makes decisions without considering the cost of a drug, but the Aduhelm decision could allay some concerns about how hedging the drug could affect the wallets of the nation’s millions of Medicare beneficiaries.

Last year, the actuarial department of Medicare, acting unknowingly what the coverage decision would be, imposed one of the largest-ever increases in Medicare Part B premiums for 2022, driven in part by the possibility of coverage for Aduhelm, which at the time was priced by the manufacturer at $56,000 per year.

Since then, Biogen, faced with weak sales of the drug after many hospitals and doctors declined to prescribe it, has slashed its price to $28,800 a year, still much higher than many analysts believe is warranted.

Xavier Becerra, Minister of Health and Human Services, had said he would consider cutting premiums after the final decision on coverage for Aduhelm was made, adding: “We are going to make sure seniors don’t pay more than necessary. is. †

In Thursday’s interview, Ms. Brooks-LaSure, the CMS administrator, said, “The secretary said we should look into it, and we’re going to be in the business of reviewing the premium for Part B.”

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

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

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

Medicare officials said the decision was an effort to provide for what they consider important limits on Aduhelm’s coverage, while future anti-amyloid monoclonal antibody drugs will not necessarily be subject to similar restrictions.

If another drug in that class were to receive full or traditional FDA approval, which usually requires two conclusive clinical trials, that would indicate that there is compelling evidence that the drug can help patients and that its benefits outweigh its risks. , said Medicare officials. †

“If a drug is approved under traditional approval tomorrow, we’ll be ready,” said Ms. Jensen, 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 let Medicare check whether they are benefiting from the medication.

“There’s such a need to really understand what’s happening that we want to make sure we’re providing all of that additional or appropriate clinical care,” said Ms. Brooks-LaSure, Medicare’s administrator. “So we’re going to make sure we keep monitoring what’s happening so we keep developing that evidence around a treatment.”

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