Medicare officially limits Aduhelm coverage to patients in clinical trials

Ever since Medicare proposed to sharply limit the coverage of the controversial drug for Alzheimer’s Aduhelm, the agency has been flooded with passionate requests. Patient groups demanded that the federal insurance program pay for the drug. Many Alzheimer’s experts and doctors warn against covering a wide range of treatments that have uncertain benefits and serious safety risks. Individual patients and families are weighed down with emotional statements from both sides.

Medicare employees announced their final decision on Thursday. 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, Administrator of Medicare and Medicaid Service Centers said the decision aims to protect patients while collecting data to show whether Aduhelm, an expensive monoclonal antibody given as a monthly infusion, can actually help them by slowing the pace of their cognitive decline.

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

A major problem for Medicare was how to deal with other similar Alzheimer’s drugs, some of which are likely to be considered for FDA approval soon. In a January proposal, CMS said it would cover them in the same way as Aduhelm, because it usually makes coverage decisions for a whole class of drugs.

But after both experts and advocacy groups expressed concerns, Medicare officials said Thursday they would not automatically apply the same restrictions to each new drug. If, unlike Aduhelm, the FDA finds that there is clear evidence that the drug can help patients, Medicare will cover it for all eligible patients and will only require that patients’ experience be monitored.

Dr Lee Fleischer, chief medical officer at CMS, said the two-way approach to Alzheimer’s rapidly evolving field of therapies, a program called Evidence-Based Coverage, “is designed to be agile and truly responsive to any new drugs in this class that are under development and show clinical benefit.

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

But Aduhelm’s path was also very unusual. The FDA itself acknowledged that it was unclear whether the drug was useful when it approved Aduhelm last June. He highlighted the drug as part of a program called “accelerated approval”, which allows the authorization of drugs that have uncertain benefits if they are for serious illnesses with little treatment and if the drug affects a biological mechanism in a way considered reasonable to help patients. .

Evidence from clinical trials reviewed by the FDA shows that patients in one study appeared to have had a slight delay in cognitive decline, while patients in an almost identical study did not appear to benefit. About 40 percent of patients on the dose later approved of experience with swelling of the brain or cerebral hemorrhage, often mild but sometimes severe. Both the FDA’s board of senior officials and the agency’s independent advisory committee said there was not enough evidence of approval.

Questions about approval and whether the FDA works too closely with Biogen, the manufacturer of Aduhelm, have sparked investigations by congressional committees, the inspector general of the Department of Health and Human Services, 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 expressed 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 the CMS, Medicare will cover participants in any study approved by the FDA or National Institutes of Health. This will allow these trials to take place in a wider range of locations, not just hospital settings, and involve people with other neurological conditions such as Down syndrome, many of whom develop Alzheimer’s disease but have been excluded from more early proposed plan.

However, the trials will have to meet Medicare’s requirement to recruit a racially and ethnically diverse group of participants, unlike previous Aduhelm studies, in which most participants were white.

In the trials, “manufacturers will need to contact us about how to include all patients who make up the Medicare population and how to ensure that all of these patients receive appropriate medical treatment and monitoring of their treatment while in each of these studies. “, Said in an interview Tamara Sirek Jensen, Director of Coverage and Analysis at the Center for Clinical Standards and Quality at CMS.

The FDA also asked Biogen to conduct another clinical trial to determine if the drug provides any evidence of benefit, but said that in the years that will be needed to complete this study, Aduhelm will be available to patients. According to Thursday’s decision, Medicare will cover the costs of participants in the Biogen process.

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

Last year, the actuarial department of Medicare, acting unaware of the coverage decision, imposed one of the largest increases in Medicare premiums so far, Part B for 2022, partly driven by the possibility of coverage for Aduhelm, which time was priced by its manufacturer at $ 56,000 a year.

Since then, Biogen, facing weak sales of the drug after many hospitals and doctors did not prescribe it, has lowered the price to $ 28,800 a year, which is still much higher than many analysts say is justified.

Xavier Besera, Minister of Health and Human Services, said he would consider reducing premiums once the final decision is made to cover Aduhelm, adding that “We will make sure that the elderly do not pay more than they should. ”

In an interview Thursday, Ms. Brooks-LaSure, the CMS administrator, said: “The Secretary told us to look into it and we will be involved in the process of reviewing the Part B premium.”

Advocacy groups, some of which receive some funding from Biogen and other pharmaceutical companies, have been campaigning vigorously for Medicare’s broad coverage. These groups said patients should be able to decide with their physicians whether to try an FDA-approved drug, and argued that it was discriminatory to reimburse only participation in clinical trials, which may not be readily available to many patients.

“We just can’t leave things as they are,” said Harry Jones, chief executive of the Alzheimer’s Association, to the organization’s staff, according to a recording of the meeting from The New York Times.

In an interview before the announcement of Medicare, Mr Jones said the association would not be satisfied if Medicare restrictions applied only to Aduhelm, saying: “We absolutely believe there is enough evidence to provide coverage for the first approved treatment. “

Leave a Comment

Your email address will not be published.