Medicare Officially Determines Aduhelm Coverage for Patients in Clinical Trials

Since Medicare proposed sharply reducing coverage of the controversial Alzheimer’s drug Aduhelm, the agency has been inundated with enthusiastic appeals. Groups representing patients insisted that the federal insurance program pay for the drug. Several Alzheimer’s disease experts and clinicians have warned about the broad coverage of the treatment, which has uncertain benefits and serious safety risks. Individual patients and families weighed with emotional data on 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 Lashore, in charge of the Centers for Medicare and Medicaid Services He said the decision was aimed at protecting patients while collecting data to indicate whether Aduhelm, an expensive monoclonal antibody given as a monthly infusion, could actually help them by slowing their cognitive decline.

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

One of Medicare’s major problems has been how to treat other similar Alzheimer’s drugs, many of which will likely be considered for FDA approval soon. In a proposal in January, CMS said it would cover it in the same way as Aduhelm because it usually makes coverage decisions for an entire class of drugs.

But after both experts and advocacy groups raised concerns, Medicare officials said Thursday they would not automatically apply the same restrictions to every new drug. If the Food and Drug Administration, other than Aduhelm, finds there is clear evidence that a drug can help patients, Medicare will cover it for all eligible patients and will only impose a requirement that it tracks patients’ experience.

A two-track approach to the rapidly developing field of Alzheimer’s treatments, a program called Coverage with Evidence Development, said Dr. Lee Fleischer, CMS’s chief medical officer, “is intended to be smart and truly responsive to any new drugs in this class in preparation, which show Indeed a clinical benefit.”

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

But Aduhelm’s path was also very unusual. The Food and Drug Administration itself acknowledged that it wasn’t clear if the drug was helpful when it approved Aduhelm last June. He has green-lighted the drug under a program called “Expedited Approval,” which allows drugs of uncertain benefit to be licensed if they are for serious diseases with few treatments and if the drug affects a biological mechanism in a way that is reasonably reasonable to help patients.

Clinical trial evidence reviewed by the Food and Drug Administration showed that patients in one trial appeared to experience a slight slowdown in cognitive decline, while patients in a nearly identical trial did not benefit at all. About 40 percent of patients who took the dose later agreed to have brain swelling or bleeding in the brain, often mild, but sometimes serious. Both a board of senior FDA officials and the agency’s independent advisory committee said there was not enough evidence to agree.

Questions about approval, and whether the Food and Drug Administration has worked too closely with Biogen, the maker of Aduhelm, have prompted investigations by committees of Congress, the Inspector General for the Department of Health and Human Services, the Federal Trade Commission and the Securities and Exchange Commission. Major medical centers, including the Cleveland Clinic, declined to provide Aduhelm.

As a result of concerns raised by Alzheimer’s disease experts and some groups, Medicare officials announced several more changes to their previous proposal. Rather than ordering randomized controlled trials approved by CMS, Medicare will cover participants in any trial approved by the FDA or the National Institutes of Health. It would allow these trials to be carried out in a wide variety of locations, not just in hospitals, and include people with other neurological conditions such as Down syndrome, many of whom had Alzheimer’s disease but were excluded from the previously proposed plan.

The trials would still need to comply with Medicare requirements to recruit a racially and ethnically diverse group of participants, in contrast to previous Aduhelm trials, in which most participants were white.

In the trials, “manufacturers will have to come to us on how they will include all patients that make up the clinical care group, and how they will ensure that all of these patients receive appropriate medical treatment and monitor their treatment,” said Tamara Sirek Jensen, director of coverage and analysis for the Center for Clinical Standards and Quality at CMS, in an interview. While they are in each of these studies.

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

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

Last year, Medicare’s actuarial department, which acts without knowledge of the coverage decision, imposed one of the largest ever increases in Medicare Part B premiums for 2022, driven in part by the possibility of Aduhelm coverage, which was priced at the time by its manufacturer at 56,000. dollars a year.

Biogen, which is facing poor sales of the drug after many hospitals and doctors refused to prescribe it, has since slashed the price to $28,800 a year, still much higher than many analysts said is justified.

Xavier Becerra, Secretary of Health and Human Services, had said he would consider lowering premiums after making the final coverage decision for Adholm, adding, “We’ll make sure seniors don’t pay more than they have to.”

In an interview on Thursday, Ms Brooks Lachure, director of the CMS, said, “The secretary told us to look into it, and we’ll engage in the Part B bonus review process.”

Advocacy groups, many of which receive some funding from Biogen and other drug companies, have campaigned vigorously for widespread medical coverage. These groups said patients should be able to decide with their doctors whether to try an FDA-approved drug and claimed that it’s only discriminatory to pay to participate in clinical trials that may not be affordable for many patients.

“We can’t just let it stand as it is,” Harry Jones, chief executive 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 noted that the association would not be satisfied if Medicare’s restrictions only applied to Aduhelm, saying: “We fully believe there is sufficient evidence to provide coverage for approved first treatment.”

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