Katherine Ellen Foley, PoliticoPro, January 18, 2023
For the second time in two years, government officials and public health advocates are grappling with how to make a newly approved Alzheimer’s drug affordable for millions of desperate patients.
The FDA approved a new Alzheimer’s treatment earlier this month under its accelerated approval pathway, but a Medicare coverage decision means that of the millions of adults potentially eligible for the novel treatment, only those who can afford the $26,500 annual price tag will be able to access it.
Unless or until the Centers for Medicare and Medicaid Services changes its coverage determination that only patients in trialscan get the drug paid for by Medicare, the treatment may remain out of reach financially for many Americans. Eisai and Biogen, developers of the drug, have no plans for further trials. Meanwhile, the Alzheimer’s Association, the powerful advocacy group, is in the process of a full-court press to meet with every lawmaker in the House and Senate, urging them to pressure CMS to change its coverage decision.
“There is rapidly growing pressure on CMS to reconsider their decision, even with the evidence available now at the time of the accelerated approval,” said Sean Tunis, a senior fellow at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center.
A host of smaller advocacy groups argue against the drug’s widespread distribution because trial data shows that its benefits are at best modest for early-stage patients while the risks of severe side effects, like brain swelling and bleeding, are troubling. But those findings don’t deter patients willing to pay almost anything for any hope of relief from the inevitable and devastating cognitive decline caused by the disease.
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Advocacy groups are meeting with CMS, HHS and White House officials to push for a change in coverage. Eisai is also meeting with Medicare representatives. “Eisai is currently working with CMS to determine the most expeditious pathway to Medicare coverage,” Christopher Vancheri, a company spokesperson, wrote in an email to POLITICO.
But not all patient groups are convinced that expanding Medicare coverage of anti-amyloid therapies is the right move for patients.
Diana Zuckerman, president of non-profit health policy research group National Center for Health Research, said the data behind Leqembi doesn’t show the drug meaningfully slows progression of the disease. In an 18-month Phase III trial, patients who received Leqembi declined an average of 1.21 points on an 18-point scale measuring cognitive health; those who received the placebo declined 1.66 percent.
“These small increases can be statistically significant, but they don’t mean anything,” Zuckerman said. “People vary day to day.”
Zuckerman also noted that if CMS elected to cover Leqembi without restrictions, Medicare would incur massive costs. “If it doesn’t bankrupt Medicare, it could once again result in substantial [Medicare] premium increases,” she said.
The National Center for Health Research and 12 other advocacy groups wrote to CMS administrator Chiquita Brooks-LaSure on Jan. 6, the day Leqembi received accelerated approval, urging the agency to keep its limited coverage of the drug. “We understand that CMS is under pressure from industry-backed groups and providers to reconsider this policy and instead provide coverage based on preliminary results from a clinical trial regardless of the quality of the evidence regarding safety or clinically meaningful benefits,” they wrote.
“We will continue to expeditiously review the data on these products as they become available and are committed to timely access to treatments … that improve clinically meaningful outcomes,” LaSure said in a statement issued later that day.
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