As with the controversial drug Aduhelm, coverage is limited to people enrolled in clinical trials. The Alzheimer’s Association had petitioned for a change.
For now, CMS is sticking to the coverage decision it made for Aduhelm (aducanumab) and applying it Leqembi (lecanemab). The decision limits Medicare coverage of the two Alzheimer disease’s drugs to Medicare beneficiaries who have enrolled in clinical trials of the drugs
The decision, which was announced in a press release yesterday, was denounced in strong language by the Alzheimer’s Association.
“CMS’ role is to provide health care coverage” said Joanne Pike, Dr.Ph., the organization’s president and CEO, in a prepared statement. “Their role is not to single out people living with Alzheimer’s and decide that their lives, their independence and their memories are not necessary.”
Related: FDA Approves New Alzheimer's Drug, Leqembi. Can It Escape Aduhelm's Fate?
CMS’ decision was in response to request by the association to revise its coverage decision with request to Leqembi. Earlier this month, 74 members of Congress signed a letter addressed to Health and Human Services Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure asking for the coverage decision to be changed.
Aduhelm and Leqembi are both monoclonal antibodies that target the beta-amyloid deposits in the brain that many experts believe are instrumental in causing Alzheimer’s disease. Both agents were approved by the FDA on its accelerated approval pathway, which allows drug developers to prove efficacy using surrogate endpoints rather than direct clinical benefit.
The FDA’s approval of Aduhelm in June 2021 was controversial, partly because the clinical trial results for Aduhelm were ambiguous and open to conflicting interpretation. Members of an FDA advisory board resigned in protest. Congress launched an investigation, resulting in a December 2022 report that faulted the agency for frequent, “atypical interactions” with officials at Biogen, the drug’s maker, and switching Aduhelm from the traditional approval pathway to the accelerated one on an “abbreviated timeline” and then approval after just three weeks of review.
Biogen initially priced Aduhelm at $56,000. The Congressional report says Biogen officials calculated that Aduhelm could cost Medicare $12 billion in one year, which worked to be 36% of the Part B budget in 2018.
When the FDA announced that it had approved Leqembi on Jan. 6, 2023, there was little if any controversy even though Biogen is co-marketing the drug along with Eisai, a Japanese company, that led its development and is shepherding it through regulatory approval. Although Leqembi’s accelerated approval was, like Aduhelm’s, based on surrogate endpoints, a company-sponsored, phase 3 study of the drug used a measure of cognitive decline as its primary endpoint, not a surrogate endpoint. Those results, published in November 2022, also carried the imprimatur of publication in the prestigious New England Journal of Medicine. In addition, Eisai and Biogen priced Leqembi at roughly $26,000, or about half of Aduhelm’s original price.
When CMS announced its “coverage with evidence development” for Aduhelm in April 2022, it said the policy would apply not just to Aduhelm but to “any future monoclonal antibodies directed against amyloid approved by the FDA with an indication for use in treating Alzheimer’s disease.” That announcement said CMS believes “important questions still need to be answered to support people with Medicare, caregivers, and their referring and treating physicians to make informed, appropriate decisions about use of any drug in this particular class” and that the data collected from having people enroll in trials “may be used to assess whether outcomes seen in carefully controlled clinical trials (e.g., FDA trials) are reproduced in the real-world and in a broader range of patients.”
Commercial insurers don’t have to follow CMS’ example and are free to cover Aduhelm. But because most people with Alzheimer’s and its precursor condition, mild cognitive impairment, are older, Medicare coverage is essential for Alzheimer’s drugs. Aduhelm, once billed as surefire blockbuster, has had feeble sales. Biogen reported recently that the annual sales in 2022 totaled $4.8 million, a small fraction of the company’s drug sales of $3.4 billion,
Yesterday’s CMS announcement noted the difference between CMS’s “reasonable and necessary” standard for covering drugs and FDA’s “safe and effective” standard for approving them.
But the announcement did leave the door ajar for a reconsidering the coverage decision, noting that the agency was “aware” of additional publications that may be relevant to the coverage decision and promising that it would “expeditiously review any new evidence that becomes available that could lead to a reconsideration and change” in the agency’s payment policies.