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The Center for Medicaid and Medicare Services and its chief administrator, Chiquita Brooks-LaSure, look increasingly isolated over Alzheimer’s drug lecanemab after their counterparts at the Veterans Health Administration just publicly approved the drug for patients.
“VA has added lecanemab (also known as Leqembi), which recently received accelerated approval from the FDA, to its list of nonformulary drugs,” said the VA in a statement. It added: “Based on the clinical evidence that was available at the time of the FDA’s accelerated approval, the committee believes that there are potential patients who could benefit from this therapy.”
It also said it monitors each dose given “for safety and appropriateness of use, in real time.”
(Nonformulary drugs are those that need special approval by a doctor.)
The Biogen
BIIB
and Eisai
4523
drug, with the brand name Leqembi, was approved for use by the Food and Drug Administration in January, after research showed it slowed the progress of dementia among those with early stage Alzheimer’s by an average of 27% over 18 months.
The public support from the Veterans Health Administration comes just a few weeks after Brooks-LaSure and the CMS said once again that they will not pay for lecanemab for the estimated 700,000 Americans who develop early-stage dementia every year—meaning about 2,000 people a day.
The CMS says it wants more evidence of effectiveness and potential health risks before approving payment for the drug, which costs $26,000 per person.
Admittedly this comes in the wake of the Aduhelm saga, which may have left the CMS reluctant to approve payment for another Alzheimer’s drug speedily approved by the FDA. Aduhelm (also developed by Biogen and Eisai) was approved by the FDA two years ago, despite little or no evidence of its clinical effectiveness and an initial $56,000 price tag. Three FDA advisers immediately resigned in protest, and the FDA’s handling of the approval process has since been denounced by congressional committee after an 18-month investigation. At the time Medicare announced higher premiums to pay for the drug, but then changed tack and declined to as further questions emerged about the drugs effectiveness and health risks.
Notably, the Veterans Health Administration turned down Aduhelm at the time.
Already a chorus of voices in the Alzheimer’s field have called on the Center to rethink its decision on lecanemab, ranging from the Alzheimer’s Association to the American Academy of Neurology to 92 bipartisan members of Congress, including one fifth of the U.S. Senate. The Alzheimer’s Association in a statement said it was “appalled” at the decision, which it blamed squarely on “the Biden administration.”
Even the National Institutes of Health has given the drug the green flag. “The results showed lecanemab produced a clear yet modest clinical benefit in people who were in the early stages of Alzheimer’s,” said the director, Dr. Richard Hodes, in January. He added: “In comparison with a placebo, the drug slowed the rate of cognitive decline over 18 months and reduced the levels of brain amyloid.”
But the CMS refuses to approve payment, noting that the drug had benefited from fast-track FDA approval, and last month repeated its refusal.
In a statement to MarketWatch, the CMS says that it remains open to reconsidering its position if and when it gets more data.
“[A]pproval through FDA’s accelerated approval pathway does not necessarily indicate that the drug is effective at treating a condition,” it said. But there is a “coverage pathway for broader access to these drugs if they receive FDA traditional approval. CMS is committed to being nimble when reconsidering this coverage framework in light of any new evidence related to the clinical benefit of this drug, and we continue to encourage clinicians, patients and caregivers to send relevant evidence.”
Some say the CMS is worried about the cost. Lecanemab treatment costs $26,500 per person. Paying for 80% of the cost of the drug for about 2,000 new patients a day would run to about $15 billion a year.
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