A newly approved drug designed to slow the progression of Alzheimer’s disease offers hope for patients, but it will come with a hefty price tag: $26,500 a year.
The drug, called Legembi, by drugmakers Eisai and Biogen, was approved by the Food and Drug Administration on Friday for use in people with mild cognitive impairment or early Alzheimer’s disease.
It is only the second drug approved in the US – after Biogen’s Aduhelm – that aims to attack the build-up in the brain, called amyloid plaques, which is thought to be one of the main causes of the disease.
Legembi’s $26,500-a-year price tag is lower than the price tag for Aduhelm — which was approved by the FDA in 2021 despite strong objections from an outside advisory panel. The drug originally cost $56,000 a year, or $28,000 a year, before Biogen cut the price in half.
Still, Legembi’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 prices. The chief medical officer of the institute, Dr. David Rind said a reasonable price for the drug is $8,500 to $20,600 a year.
“We think it’s too expensive right now,” he said.
Due to the high price tag, the number of people who will be able to get hold of the drug – expected the week of January 16 – will be extremely limited, according to experts. According to the Alzheimer’s Association, more than 6 million people in the United States suffer from Alzheimer’s disease.
Typically, the Centers for Medicare & Medicaid Services limits coverage of new Alzheimer’s treatments that target amyloid, including Legembin, to patients in clinical trials.
John Domeck, 60, of Aurora, Ohio, is currently participating in a phase 3 clinical trial testing Legembi. That’s why he gets free medicine every two weeks.
But his wife, Ann Domeck, says that even though John is eligible for Medicare, she doesn’t know if that will continue when the trial ends in the next two years.
“I don’t know if we can afford it,” he said, “but when we come to the bridge, we’ll cross it.”
Holly Fernandez Lynch, an associate professor of medical ethics at the University of Pennsylvania, said the CMS standards for covering new Alzheimer’s treatments are higher than the standards the FDA uses to get new treatments on the market quickly.
Legembi was approved through the FDA’s accelerated pathway, which allows early approval for new drugs that “meet an unmet medical need” and are found to be safe and effective. During the review for Legembi’s accelerated approval, the FDA looked at data from one phase. 2 clinical trials on more than 800 patients. Eisai and Biogen still need to submit additional phase 3 data a clinical trial confirming the benefits of the drug to obtain full approval.
“The standard for CMS coverage is not that the drug is safe and effective,” Lynch said. “Is it reasonable and necessary for the Medicare population”.
Lynch said CMS won’t be able to determine that until it sees the full data from both clinical trials.
Arthur Kaplan, chief of medical ethics at NYU Langone Medical Center in New York, said CMS needs to be especially careful about which drugs it covers because drugs like Legembi can cost billions. About 6.5 million people over age 65 have Alzheimer’s and will be eligible for Medicare.
CMS may be willing to absorb that cost if the drug is shown to provide multiple benefits for patients, he said.
But currently clinical trial For Legembi, it shows that the drug provides “modest efficacy at a great, great cost,” Kaplan said.
It’s possible, Lynch said, that CMS will consider covering Legembi once the drug receives full approval. Eisai announced late Friday that it had filed for full approval. Ivan Cheung, US chairman and CEO of Eisai, told NBC News that the FDA could make a decision within six months.
But right now, CMS appears unwilling to back down from its policy position, Lynch said.
“CMS said, ‘Look, from the FDA’s perspective, something may be safe and effective, but we have a lot of concerns about the relevance of the evidence,'” he said.
Dr. Alberto Espay, a neurologist at the University of Cincinnati College of Medicine, said many patients who want the drug in the meantime won’t be able to get it.
That’s “very unfortunate,” he said, adding that doctors will have to explain to patients the potential benefits — a modest slowing of the disease — along with the risks, which could involve a huge financial burden.
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