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Medicare to expand coverage for a new class of costly Alzheimer’s drugs

Eli Lilly Lilly has filed a lawsuit in federal courts spanning several states that accuses four businesses of selling compounded versions of Mounjaro.  (Daniel Acker/Bloomberg)
By Laurie McGinley and Rachel Roubein Washington Post

Medicare officials announced plans Thursday to broadly cover a new class of Alzheimer’s drugs following an intense lobbying campaign by patient advocates and drugmakers pressing for access to the first medications shown to slow cognitive decline from the disease.

In a statement, the Centers for Medicare and Medicaid Services, which runs the federal health program for seniors and those with disabilities, said it would cover the costly drugs – a move foreshadowed in previous agency statements – for anyone who was enrolled in the outpatient part of the program who meets the criteria for coverage.

The first drug potentially covered by the expanded plan could be granted full approval from the Food and Drug Administration as soon as this summer, a necessary step before Medicare will start paying.

The new policy marks a sharp change from an earlier one, which required patients to be in clinical trials for coverage.

The plan would provide coverage to patients whose doctors take part in registries that provide information on how the drugs work.

The medications target amyloid plaque in the brain, a signature characteristic of Alzheimer’s, and have stirred enthusiasm as an advance in treating early-stage disease.

But they have also generated controversy involving safety and effectiveness.

Medicare’s new policy expands the number of patients eligible to receive the drugs after they get FDA approval while allowing the agency to collect critical information on how the medications affect patients, which could yield valuable information, said a CMS official who spoke on the condition of anonymity to describe a decision that had yet to be made public.

The decision by CMS is the latest development in a high-stakes struggle over how to handle the emergence of disease-modifying therapies that studies show provide some benefit.

Critics of the drugs say they are not highly effective, pose serious safety risks, including bleeding in the brain, and could imperil Medicare’s finances if widely used.

Alzheimer’s advocates counter that the drugs are the first glimmer of hope in treating a disease that robs patients of their memories and identities and devastates families and their finances.

About 6.7 million people in the United States are diagnosed with Alzheimer’s, and the number is expected to rise sharply as the population ages.

Medicare, in its statement Thursday, said it would cover the drugs only after they receive traditional approvals from the FDA.

Such approvals require more clinical evidence than necessary for accelerated approvals, which are based on a marker or sign that suggest a clinical benefit.

The drugs also must be administered in “appropriate settings” – those in which doctors collect clinical evidence for a registry showing how a therapy works in the real world, as opposed to the tightly controlled environment of a clinical trial.

The new drug class is made up of monoclonal antibodies, which are produced in a lab and can bind to certain molecules.

None has won traditional approval from the FDA.

But one, Leqembi, which is made by Eisai of Tokyo and Biogen of Cambridge, Mass., is widely expected to receive such approval by early July.

Clinical trials have shown that the drug, which is administered twice a month intravenously and priced at $26,500 a year, can modestly slow progression of early Alzheimer’s.

Outside FDA experts – the agency’s Peripheral and Central Nervous System Advisory Committee – are expected to meet June 9 to discuss Leqembi, which received accelerated approval from the agency in January.

The FDA’s deadline for deciding on full approval is July 6.

A similar drug made by Eli Lilly may get traditional approval from the FDA by the end of this year or early next year.

A third medication, Aduhelm, received accelerated approval in June 2021 but failed in the marketplace amid controversy over contradictory data.

Groups such as the Alzheimer’s Association have pushed Medicare to cover the new Alzheimer’s drugs – including those cleared on an expedited basis – saying that the FDA should be the final arbiter of safety and efficacy of drugs.

But critics say the FDA was too quick to approve the therapies and that Medicare has provided an important brake.

Advocates for the drugs are sure to welcome a Medicare policy that does not link coverage to participation in clinical trials.

But, depending on the details, some may feel that registries are still too burdensome and could curtail access.

Registries can be time-consuming for some medical practices, especially in rural and underserved communities, they have previously said.

The CMS official countered that the data requirements of the agency will be simple.

Doctors and their staffs won’t be paid for additional work, which is consistent with past practice, the official said.

On Capitol Hill, lawmakers in both parties during the past year have pressed Medicare to consider broader coverage for the Alzheimer’s drugs.

In an April hearing, Rep. Anna G. Eshoo (Calif.) – the ranking Democrat on the House Energy and Commerce health subcommittee – pressed CMS Administrator Chiquita Brooks-LaSure on how a registry would be structured to allow for broader access to Leqembi.

Eshoo quizzed the CMS chief on whether patients and physicians know about the potential for broader coverage if an Alzheimer’s drug gets full FDA approval this summer and expressed concern the agency wasn’t ready.

“If doctors don’t know, patients don’t know, and Medicare doesn’t really seem to know what this registry entails, how are Medicare patients going to get the drug potentially beginning in July?” Eshoo asked. “That’s really the $64,000 question in my mind.”

Brooks-LaSure told Congress that her agency intended to publish details about the upcoming registry.

But there were few in the statement issued Thursday, in which Brooks-LaSure said CMS “is prepared to ensure anyone with Medicare Part B who meets the criteria is covered.”

The CMS statement said the broader coverage would begin on the day the FDA grants Leqembi traditional approval and would apply to other drugs in the class that receive similar approval in the future.

The statement also said that physicians and their staffs would be able to submit data on the drugs through a CMS-facilitated portal and that several private organizations are preparing to open their own registries.

The agency did not explain exactly how the two would work together and said more information would be released as they come online.

Registries have been used before to collect information about a drug or medical device, including for a transcatheter aortic valve replacement, CMS said.

The previous Medicare coverage plan was announced in April 2022, and its clinical-trial requirement caused an uproar.

Weeks before the announcement, Alzheimer’s advocacy groups had waged a pressure campaign to push the agency to more broadly cover the first drug cleared for Alzheimer’s in nearly 20 years, but to no avail.

CMS officials have said they base their coverage decisions on whether a drug is “reasonable and necessary” for treating a disease – and that the answer determines whether Medicare pays for the expensive drug.

Top CMS officials contended there wasn’t enough clinical evidence on Aduhelm to meet that threshold, while Alzheimer’s groups framed the decision as denying access to treatment.

The agency shared its revamped policy with The Washington Post ahead of public release and on the condition the announcement not be shared.