Medicare officially limits Aduhelm coverage to patients in clinical trials

For the past few months, Medicare officials have been inundated with impassioned pleas about how to deal with coverage of controversial new Alzheimer’s drug Aduhelm.

Patient advocacy groups have said the federal insurance program for people age 65 and older must pay for a drug approved by the Food and Drug Administration. Many Alzheimer’s doctors and experts have warned against treating a treatment that’s scientifically proven with uncertain benefits and serious safety risks. Individual patients and families intervened on both sides with emotional statements.

On Thursday, Medicare officials announced their final decision. The program will only cover Aduhelm if people receive it as participants in a clinical trial, likely a small percentage of the estimated 1.5 million people in the United States who have mild cognitive decline associated with Alzheimer’s, the disease for which Treatment Aduhelm was approved.

Chiquita Brooks-LaSure, the administrator of the Centers for Medicare and Medicaid Services said the decision is designed to protect patients while gathering data to indicate whether Aduhelm, an expensive monoclonal antibody given as a monthly infusion, might actually help them by slowing the pace of their cognitive decline.

“It’s our duty at CMS to really make sure it’s appropriate and necessary,” Ms. Brooks-LaSure said in an interview Thursday. “The vast majority” of the roughly 10,000 Remarks The agency, obtained on its website, said it was in favor of “really limiting coverage of Aduhelm to a truly controlled area where we could continue to evaluate its appropriateness for the Medicare population.”

A major issue for Medicare has been how to deal with other similar Alzheimer’s drugs, some of which are likely to be considered for FDA approval soon. in one proposal in JanuaryCMS had said it would cover them the same way Aduhelm did because it typically makes decisions about coverage for an entire class of drugs.

But after concerns were raised by both experts and advocacy groups, Medicare officials said Thursday they wouldn’t automatically apply the same restrictions to every new drug. Unlike Aduhelm, if the FDA determined that there was clear evidence a drug could help patients, Medicare would adopt it for all eligible patients and impose only a requirement that patients’ experiences be tracked.

dr Lee Fleisher, chief medical officer at CMS, said the two-pronged way of dealing with the rapidly evolving field of Alzheimer’s therapies, a program called Coverage with Evidence Development, “is meant to be rapid and really responsive to new drugs in this class that are.” are in the pipeline and showing clinical utility.”

The decision is extremely unusual for Medicare, which almost always automatically pays for FDA-approved drugs, at least for the conditions noted on the 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. The drug was given the green light under a program called “accelerated approval,” which allows drugs of uncertain benefit to be approved if they are intended for serious diseases with few treatments and if the drug affects a biological mechanism in a way that reasonably likely to help patients.

The FDA-reviewed clinical trial evidence showed that patients in one study appeared to experience a slight slowdown in cognitive decline, while patients in an almost identical study did not appear to benefit at all. About 40 percent of patients on the later-approved dose experienced brain swelling or bleeding, often mild but sometimes severe. Both a council of senior FDA officials and that of the agency independent advisory board had said there was insufficient evidence to permit it.

Questions about approval and whether the FDA worked too closely with Biogen, the maker of Aduhelm, have prompted investigations congressional committees, the Inspector General of the Department of Health and Human Services, the Federal Trade Commission and the Securities and Exchange Commission. Large medical centers, including the Cleveland Clinichave declined to offer Aduhelm.

Because of concerns raised by Alzheimer’s experts and some groups, Medicare officials announced several other changes to their previous proposal. Instead of requiring randomized controlled trials approved by CMS, Medicare covers participants in any studies approved by the FDA or the National Institutes of Health. It will allow these studies to be conducted in a wider range of locations, not just hospitals, and to include people with other neurological conditions such as Down syndrome, many of whom develop Alzheimer’s but were excluded from the previously proposed plan.

The studies must still meet a Medicare requirement to recruit a racially and ethnically diverse group of participants, unlike Aduhelm’s previous studies, where most participants were white.

In the studies, “manufacturers need to tell us how they will enroll all patients who represent the Medicare population and how they will ensure that all of these patients receive appropriate medical treatment and monitoring of their treatment while they are in each of these studies.” , said Tamara Syrek Jensen, the head of reporting and analysis at CMS’s Center for Clinical Standards and Quality, in an interview.

The FDA also asked Biogen to conduct another clinical trial to see if the drug provides any evidence of benefit, but said Aduhelm will be available to patients in the years it will take for that trial to be completed would. According to Thursday’s decision, Medicare would pay for participants in Biogen’s study.

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

Last year, Medicare’s actuarial department imposed not knowing what the coverage decision would be one of the largest Medicare Part B premium increases of all time for 2022, driven in part by the possibility of coverage for Aduhelm, which was then valued at $56,000 per year by its manufacturer.

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

Xavier Becerra, Minister for Health and Social Care, had said he would consider reducing premiums after the final decision on Aduhelm coverage had been taken, adding: “We will ensure that seniors no longer pay when they have to. ”

In Thursday’s interview, Ms. Brooks-LaSure, the CMS administrator, said, “The secretary told us to look at this and we will participate in the process of reviewing the Part B premium.”

Interest groups, some of which received some funding from Biogen and other pharmaceutical companies fought vigorously for broad Medicare coverage. These groups said patients should be able to decide with their doctors whether to try an FDA-approved drug, claiming it is discriminatory to only be reimbursed for participation in clinical trials, which many patients may not find easy are accessible.

“We just can’t let it go,” Harry Johns, the Alzheimer’s Association executive director, told the organization’s staff, according to a transcript of the meeting obtained by the New York Times.

In an interview ahead of the Medicare announcement, Mr. Johns indicated that the association would not be satisfied if Medicare’s restrictions applied only to Aduhelm, saying: “We strongly believe there is enough evidence to support the first.” approved treatment.”

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