The Centers for Medicare & Medicaid Services is open to reconsidering how it provides coverage for promising new Alzheimer’s drug candidates like the amyloid-busting treatment lecanemab, according to Administrator Chiquita Brooks-LaSure.
At the Milken Institute’s 2022 Future of Health Summit last week, Brooks-LaSure agreed that the case of lecanemab is a weighty one. The drug, made by Eisai and Biogen, has been shown to slow some measures of cognitive decline. Yet patients may face a major access hurdle if it is approved as a treatment. CMS last year broadly restricted coverage of drugs in the anti-amyloid class to patients in clinical trials.
That coverage decision was made after the controversial approval of Aduhelm, an anti-amyloid drug whose trial data was disputed and whose benefits were questioned in light of potential side effects. Patient advocates have decried the restrictions, however, noting the time-sensitive needs of patients and the current lack of Alzheimer’s treatments.
Medicare coverage calculus
Brooks-LaSure demurred when asked if the prospect of a different, more promising anti-amyloid drug like lecanemab might change the coverage calculus. But she emphasized the flexibility Medicare has in new drug coverage decisions and the role new data plays.
“We are all in the healthcare industry really excited when new innovative products come online,” Brooks-LaSure told Rick Berke, executive editor of STAT, in a Thursday afternoon session. “I can’t speak to any specifics, but just to say that our door is really open and we will look at [lecanemab]” as the new data arrives, she said.
The Aduhelm coverage decision “was based on the information that was available at the time, and as new products come to market we will take a look and make our determination based on that,” she noted.
Historic new authority
Brooks-LaSure is the final arbiter of Medicare part B drug coverage decisions after data is reviewed by in-house clinicians and other experts. Ensuring that beneficiaries can pay for and get access to therapies is a “shared goal,” she said.
Alzheimer’s drugs are part of the much bigger picture of drug coverage and patient access, and Medicare has new tools with which to determine fair costs, she added. In August, CMS received historic new authority to negotiate drug prices under the Inflation Reduction Act.
In addition, under a White House executive order on lowering prescription drug costs, CMS in October was directed to use its Innovation Center authority to help increase access to and affordability of drugs and “high-cost novel therapies.”
The CMS Innovation Center supports development and testing of healthcare payment and service delivery models.
“It is my job and responsibility to do what I think is best for the programs, and most importantly for the people served under those programs,” Brooks-LaSure said. “And that’s how I try to approach my decision-making.”
Related articles:
CMS restricts coverage of Alzheimer’s drug Aduhelm to clinical trials
Alzheimer’s drug lecanemab has ‘moderate’ effect on cognitive decline, new trial data show
CMS to weigh national Medicare coverage for Aduhelm, other Alzheimer’s drugs
