Medicare officially limits Aduhelm coverage to patients in clinical trials

Since Medicare proposed severely reducing coverage for controversial Alzheimer’s drug Aduhelm, the agency has been inundated with impassioned pleas.

Groups representing patients have insisted that the federal insurance program pay for the drug. Many Alzheimer’s experts and physicians cautioned against broadly covering 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 around 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 for the Centers for Medicare and Medicaid Services (CMS), said the decision is aimed at protecting patients while collecting data to indicate whether Aduhelm, an expensive monoclonal antibody given as a monthly infusion administered might actually help them by slowing the rate 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 approximately 10,000 comments the agency has received on its website, she said, advocate “really limiting coverage of Aduhelm to a truly controlled area where we can continue to evaluate its appropriateness for the Medicare population.” “.

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

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 a January proposal, Medicare said it would cover them the same way Aduhelm did because it typically makes coverage decisions 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, the Medicare agency’s chief medical officer, said the two-pronged approach to the rapidly evolving field of Alzheimer’s therapies, a program called Coverage with Evidence Development, “is intended to be rapid and truly responsive to any new drugs in this class, that are in the pipeline and showing clinical benefit.”

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 when it approved Aduhelm last June, allowing it for people with mild cognitive decline associated with Alzheimer’s, it was unclear if the drug was beneficial.

FDA-reviewed clinical trial evidence showed that patients in one study using Aduhelm 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 the agency’s Independent Advisory Committee had said there was insufficient evidence for approval.

Rather than granting the drug full approval, the FDA gave it the green light under a program called “accelerated approval,” which allows approval of drugs of uncertain benefit if they are intended for serious diseases with few treatments and if the drug has a biological potential Mechanism influenced in some way, it is assumed that they are more likely to help patients.

The agency justified this by saying 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 reducing amyloid can slow cognitive decline.

Questions about approval and whether the FDA was working too closely with Biogen have led to 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 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 director of reporting and analysis for the Medicare agency’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.

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

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, without knowing what the coverage decision would be, the Medicare actuarial division imposed one of the largest increases in Medicare Part B premiums for 2022, due in part to the possibility of coverage for Aduhelm, which was added to this Priced at the time its manufacturer was $56,000 a year.

Since then, in the face of weak sales of the drug after many hospitals and doctors failed to prescribe it, Biogen has lowered the price to $28,800 a year, which is still much higher than many analysts thought 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 into this and we will participate in the process of reviewing the Part B premium.”

Advocacy groups, some of which are funded by Biogen and other drug companies, had campaigned 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.

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

Medicare officials said the decision was an attempt to establish what they believe to be important limitations on Aduhelm’s coverage, while not necessarily subjecting future anti-amyloid monoclonal antibody drugs to similar limitations.

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

“If a drug were approved tomorrow under traditional approval, we’re ready,” Ms Jensen said, adding that such a drug would be available “in a real-world setting” and patients would be enrolled in a registry or other program that would doing so would allow Medicare to monitor whether they are benefiting from the drugs.

“It’s so important to really understand what’s happening that we want to make sure we’re providing all of this additional or appropriate clinical care,” said Ms. Brooks-LaSure, Medicare administrator. “So we’re going to make sure we continue to follow what’s happening so we can develop that evidence around a treatment.”

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