Medicare officials on Thursday said that the government will cover a new class of Alzheimer’s drugs for patients who participate in a health agency database if the medicines win full approval. It’s a sharp policy shift for the federal health insurer, though one predicted by some analysts following fierce lobbying by patient advocates and drug companies.
Among the firms that would benefit from the shift is Cambridge-based Biogen, which developed a drug called Leqembi with the Japanese firm Eisai that won conditional approval from the Food and Drug Administration in January. Like other Alzheimer’s medicines in the same class, Medicare had only agreed to pay for it if patients participated in clinical trials, making the treatment unavailable to most.
Leqembi costs $26,500 a year, not including costly brain scans and visits every other week to infusion centers where it is administered intravenously.
The head of the Centers for Medicare and Medicaid Services said in a statement that the agency plans to broaden access to the new medications, the first to demonstrate in clinical trials that they can slow cognitive decline in patients with early symptoms of the memory-robbing condition.
“Alzheimer’s disease takes a toll on not just the people suffering from the disease but also on their loved ones and caregivers in a way that almost no other illness does,” said Administrator Chiquita Brooks-LaSure. “If the FDA grants traditional approval, CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered.”
An advisory committee to the FDA is scheduled to consider recommending full approval of Leqembi on June 9, and regulators are expected to make a decision by July 6. The FDA had granted conditional approval in January based on evidence that the drug removed clumps of sticky proteins known as amyloid in the brains of people in the early stages of Alzheimer’s. Leqembi’s developers said that indicated it would likely slow down progression of the disease.
After Medicare’s announcement Thursday morning, a Biogen spokesperson said, “While we are encouraged to see CMS’ intention to broaden access to these therapies, more details are needed to understand the implications of the proposed registries.”
Eisai also said it wanted more information about the database. “Historically, registries have not equally or comprehensively served all patients, especially those in underserved communities and geographical regions that have barriers to medical care,” the company said in a statement.
Eli Lilly, which hopes to win approval of a rival experimental Alzheimer’s drug, donanemab, was more critical. It said Medicare should cover FDA-approved Alzheimer’s medicines without requiring patient enrollment in registries.
“We strongly believe that mandating patient enrollment in registries will continue to pose unnecessary barriers and contradicts CMS’ promise of broad coverage to all Medicare beneficiaries,” the Indianapolis-based firm said in a statement. “Establishing a precedent where the agency can restrict coverage for new medicines, singling out groups of patients and exacerbating health disparities, is not in the best interest of patients.”
Last week, the new head of the national Alzheimer’s Association, Dr. Joanne Pike, visited Massachusetts and called on CMS to reimburse all patients eligible for the new class of drugs immediately, even if they only have conditional approval. The association estimates that more than 6.7 million Americans, mostly older, are living with Alzheimer’s, a progressive disease that destroys memory and other mental functions.
“It’s unfair for individuals who could benefit from those treatments to not have access,” she said in an interview at the Waltham offices of the association’s Massachusetts and New Hampshire chapter.
Medicare’s announcement stems from a controversy that erupted in June 2021 when the FDA gave conditional approval to another amyloid-clearing drug, Aduhelm, which had also been developed by Biogen and Eisai. Aduhelm was the first new approved Alzheimer’s treatment since 2003.
The authorization came over the objections of an independent panel of scientific advisers who cited scant evidence that the drug works and concerns about serious potential side effects, including swelling and tiny hemorrhages in the brain. Three members of the panel quit in protest.
An 18-month congressional investigation later found significant problems with how the FDA approved Aduhelm, calling it “highly atypical” and deviating from “guidance and procedures in significant respects.” The two committees also criticized Biogen’s pricing of Aduhelm, which originally cost $56,000 a year, “despite a lack of demonstrated clinical benefit in a broad patient population.” Biogen later slashed the price in half.
Early last year CMS ruled it would pay for Aduhelm — and similar so-called monoclonal antibodies in the same drug class — only for patients enrolled in clinical trials, as the FDA awaited more evidence of clinical benefit.
That decision doomed Aduhelm in the marketplace. It has also cast a shadow over Leqembi, the second Alzheimer’s drug to win conditional approval, and Lilly’s experimental drug donanemab. Leqembi and donanemab have generated stronger clinical data than Aduhelm in ongoing trials, and many analysts predict both will win full approval.
In that context, Brian Skorney, an analyst with Baird Equity Research, said Medicare’s announcement seemed like a prudent middle step. The agency won’t limit amyloid-clearing drugs to patients in clinical trials. But Medicare won’t let patients take such medicines unless they receive them in what the agency called “appropriate settings” and unless safety and efficacy data is collected in a federal computerized registry.
In a note to Biogen investors, Skorney said, “these hurdles are relatively insignificant, and virtually all clinics that would be capable of treating a patient with Leqembi will also be able to sign up for the registry.”
Another analyst, Myles Minter, of William Blair, agreed and said in a note to investors that broader reimbursement will “be a tailwind” for Biogen and Eisai as well as Lilly and other firms developing amyloid-clearing drugs.
Jonathan Saltzman can be reached at firstname.lastname@example.org.