A newly approved drug intended to slow the progression of Alzheimer’s disease offers patients hope, but it will come with a steep price tag: $26,500 a year.
The drug, Leqembi, from drugmakers Eisai and Biogen, was approved by the Food. And Drug Administration on Friday for use in people with mild cognitive impairment or early’s disease.
It is the second drug approved in the US – behind Biogen’s Aduhelm. Which is believed to attack one of the underlying causes of the disease – the build-ups in the brain called amyloid plaques.
Leqembi’s annual price of $26,500 is below the price set for Aduhelm — which was approved by the FDA in 2021 despite strong objections from. A panel of outside advisers. The drug initially cost $56,000 per year before Biogen cut the price in half to $28,000 per year.
Still, Lakembi’s price is much higher than recommended by the Institute for Clinical and Economic Review. A Boston-based research group that helps determine fair drug pricing. Dr. David Rhind, the institute’s chief medical officer, said the appropriate cost for the drug is $8,500 to $20,600 a year.
“We think it’s overpriced right now,” he said.
Because of the high price tag, experts say. The number of people who can take the drug after it becomes available — expected the week of January 16 — will be extremely limited. According to the Alzheimer’s Association, more than 6 million people in the United States have Alzheimer’s disease.
As a rule, the Centers for Medicare and Medicaid Services limits coverage for. New Alzheimer’s treatments that target amyloid. Including Lekambi, to only patients who participate in clinical trials.
John Domek, 60, of Aurora, Ohio, is currently enrolled in a Phase 3 clinical trial of Lakembi. Because of that, he gets free medicine every two weeks.
But his wife, Ann Domek, said she doesn’t know if the trial will continue in the next two years, even though John qualifies for Medicare.
“I don’t know if we could afford it,” he said, “but we’re going to cross that bridge when we come to it.”
Holly Fernandez Lynch, assistant professor of medical ethics at the University of Pennsylvania. Said the CMS standards for new ‘s treatments are higher than those the FDA uses to get new treatments to market faster.
Lakembi was approved under the FDA’s accelerated track. Which gives early approval to new drugs that “fill an unmet medical need” and are found to be safe and effective. In its review for accelerated approval of Lakembi, the FDA looked at one phase of data. 2 clinical trials of over 800 patients Eisai. And Biogen still need to submit data from an additional Phase 3 clinical trial
that confirms the drug’s benefits. In order to receive full approval.
“The standard for CMS coverage is not that the drug is safe and effective,” Lynch said. “It’s ‘is it reasonable and necessary for the Medicare population’.”
Lynch said CMS can’t determine that until it sees full data from both clinical trials.
Arthur Kaplan, chief of medical ethics at NYU Langone Medical Center in New York City. Said CMS needs to be especially careful about which drugs it covers because drugs like Lakembi can cost billions. About 6.5 million people over age 65 have ‘s and will qualify for Medicare.
If the drug is shown to provide many benefits for patients, CMS may be willing to absorb that cost, he said.
But right now, Lakembi’s clinical trials show that the drug “provides modest efficacy at a large, large cost,” Kaplan said.
It’s possible, Lynch said, that CMS would consider covering Lakembi if the drug gets full approval. Eisai announced late Friday that it had submitted an application for full approval. Eisai’s U.S. chairman and CEO Evan Cheung told NBC News that the FDA could reach a decision within six months.
But, so far, it seems CMS is unwilling to budge on its policy position, Lynch said.
“CMS said, ‘Look, something may be safe and effective from the FDA’s perspective, but we have a lot of doubts about the merits of the evidence,'” he said.
Meanwhile, many patients who want the drug won’t be able to afford. Said Dr. Alberto Espe, a neurologist at the University of Cincinnati College of Medicine.
That’s “very unfortunate,” he said, noting that doctors. Have to explain to patients the potential benefits — a slight slowing of the disease — alongside the risks. Which can include a large financial burden.