CMS wants more proof of effectiveness of Alzheimer’s drug lecanemab before it OKs it for Medicare

Updated March 16, 2023

The Centers for Medicare and Medicaid Services wants more evidence about the effectiveness of the medication lecanemab before it will cover the drug for Medicare patients suffering from the early stages of Alzheimer’s disease.

The statement comes in response to the Department of Veterans Affairs' decision to cover lecanemab, and public pressure put on CMS to follow suit. A CMS spokesperson told Fierce Healthcare in an email that “when CMS makes national coverage decisions, we focus on the impact on the Medicare population. And importantly, approval through FDA’s accelerated approval pathway does not necessarily indicate that the drug is effective at treating a condition.”

The CMS spokesperson acknowledged just how much misery Alzheimer’s causes, with over six million Americans believed to have the disease. The spokesperson also added that in covering lecanemab, the VA “uses statutory authorities that are different from Medicare’s.”

The spokesperson said that in general CMS “makes coverage decisions based on whether something is reasonable and necessary for the diagnosis or treatment of an illness or injury or to improve the functioning of a malformed body member.”

The original story continues below.

Pharmacy experts said that the Centers for Medicare & Medicaid Services (CMS) isn't likely to follow the example of the Veterans Health Administration, which yesterday announced it will cover the medication lecanemab for patients suffering from the early stages of Alzheimer’s disease.

CMS could not be reached for comment at the time of publication.

CMS will want to see more clinical proof and will also watch how the drug fares in treating VA patients before it takes the plunge, Thomas Kaye, a nationally known pharmacy consultant based in Dallas, told Fierce Healthcare in an email. And that could take years.

It “will take time for the studies to be done, results calculated and evaluated for efficiency and safety,” said Kaye.

That’s just one of the reasons it makes more sense for the VA to cover lecanemab and for CMS to hold back.

“The VA has a significant population to populate a reliably large sample size to offer a statistically significant deviation from bias in this population,” Kaye said. “They also have a consistency of durability in population. The study subjects stay within the confines of the VA.”

In addition, the VA’s decision rests on manufacturers’ clinical trials showing that the monoclonal-antibody-targeting amyloid slowed cognitive decline in individuals with Alzheimer’s, a result for which “we do not have certainty,” Kaye said.

“So often in medicine, it remains unknown as to true causative factors to focus on for therapy,” said Kaye. “As we progress through technology, we expose more complex biological workings; we just think we’re smart."

In addition, said Kaye, a “trend toward clarity” constituted the favorable outcome in the lecanemab clinical trials. But what, exactly, does that mean when it comes to Alzheimer’s?

F. Randy Vogenberg, Ph.D., principal at consulting company the Institute for Integrated Healthcare, also said he believes CMS will say no to lecanemab until clearer outcomes emerge as to its effectiveness.

The VA has more at stake when it comes to coming to grips with Alzheimer’s than does CMS because “the age of [the VA’s] population is heavily weighted to over 60 years plus retired,” said Vogenberg.

In addition, CMS must now deal with the financial stress caused by the demand for the weight-loss medication Ozempic, said Vogenberg.

“Their finances are strained and could be underwater within a decade,” he said. “Congress might cut them slack given the overall national financial situation now with the run on the banks.”

Still, CMS is already feeling the heat. The Alzheimer's Association said in a press release yesterday that while it “applauds” the VA for covering lecanemab, the move is in “sharp contrast” to CMS’ stance.

“Each day CMS blocks access to treatment, more than 2,000 individuals aged 65 or older transition from mild dementia due to Alzheimer’s to a more advanced stage of the disease where they are no longer eligible,” the Alzheimer's Association stated.

Lecanemab will be sold under the brand name Leqembi by Japanese pharmaceutical company Eisai and its U.S. partner, Biogen, for $26,500 per year. That’s too high a price tag, according to a recent evidence report (PDF) by the Institute for Clinical and Economic Review (ICER).

ICER said the price range for the drug should be $8,900 to $21,500 based on the lifetime cost-effectiveness of care from the healthcare sector alone and a modified societal perspective in which the care comes from a family member or some other non-healthcare provider. That requires a discount from lecanemab’s wholesale acquisition cost of 66% and 19%, respectively.

“With the current Biden administration, the aspects of ‘fairness’ will be focused on pharma also as we have seen with insulin pricing,” said Kaye.

ICER is a not-for-profit organization founded in 2005 that assesses the cost-effectiveness of medical care, and in 2014 it included medications in those deliberations, for which it has taken some flak from the pharmaceutical industry, said Kaye.

“ICER has attained the disdain of the pharmaceutical manufacturers for evaluating a value that is often disagreeable with pharma,” Kaye said. “Pharma in my opinion has gravitated away from public health purpose to that of enlightenment of the stockholders’ dividends. Both are needed, but a better mix would be welcomed.”

Kaye also points out that the VA:

  • Has a good reputation for its clinical evaluation and development of standards of care with their populations. This offers a high degree of creditability in the results of studies, outcomes and cost evidence of treatment.
  • Will likely have significant purchasing power through the Department of Defense for the drug
  • Backs studies resulting in outcomes that are highly reliable based on the quality, design and number of patients entering the studies