CMS Proposal Limits Access to Alzheimer Drug

The Alzheimer's Association called the CMS draft "a shocking discrimination against everyone with Alzheimer’s disease."

Medicare would pay for a limited class of pricey and controversial anti-amyloid drugs used to treat Alzheimer's disease, but only for seniors already enrolled in qualified clinical trials, under a proposed National Coverage Determination decision memorandum issued Tuesday by the Centers for Medicare and Medicaid Services.

The proposed NCD would cover only Food and Drug Administration-approved monoclonal antibodies -- such as Biogen's Aduhelm -- that target amyloid protein aggregates in early stage Alzheimer's patients with mild cognitive impairment.

Adulelm costs about $28,000-a-year per patient, and results so far have been mixed. While CMS and FDA do not take a drug's price into consideration when determining coverage, federal officials in November said the high cost of the drug was partially to blame for the $21-a-month increase in Medicare Part B premiums. However, Health and Human Services Secretary Xavier Becerra this week ordered Medicare to reassess the increase. CMS officials stressed that the proposal had no bearing on Becerra's comments.

CMS Administrator Chiquita Brooks-LaSure said the proposed NCD will give the public "a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients."

"CMS has proposed an evidence-based coverage policy after experts reviewed all relevant publicly available evidence and feedback received from stakeholders," she said.

Public comments on the NCD will be accepted over the next 30 days, and a final decision is expected by April 11.

The pharmaceutical lobby and Alzheimer's patient advocates let their disapproval be known within minutes of CMS's announcement late Tuesday afternoon.

Biogen said the draft "denies nearly all Medicare beneficiaries" from accessing its product and future amyloid-targeting therapies.

"It is imperative to change this draft decision to be aligned with reimbursement for other therapies for progressive diseases, where patients have immediate and equal access to medicines approved by the FDA," Biogen said in a media release.

PhRMA spokesperson Nicole S. Longo called the draft "another setback for patients suffering from Alzheimer's disease and their caregivers."

"With this proposal, CMS is writing off an entire class of medicines before multiple products have even been reviewed by FDA, positioning itself and not FDA as the key arbiter of clinical evidence," she said

The Alzheimer's Association called the CMS draft "a shocking discrimination against everyone with Alzheimer’s disease, especially those who are already disproportionately impacted by this fatal disease, including women, Blacks and Hispanics."

"With this approach, access to treatment would now only be available to a privileged few, those with access to research institutions, exacerbating and creating further health inequities," the association said.

"Critically, this draft decision is not about one treatment but about this class of potential future treatments targeting amyloid for the treatment of Alzheimer's disease. This draft decision appears focused on an individual treatment rather than a class, which is not what CMS set out to do."

George Vradenburg, chairman and co-founder of UsAgainstAlzheimer's, called the proposal "absolutely unacceptable" and noted that CMS's limiting Medicare coverage for an FDA-approved drug shows that "HHS is clearly at war with itself."

"If this decision stands, for the first time in history, millions of Americans will be denied coverage not just to a drug, but to a whole class of drugs—not by the agency that regulates drugs but by the federal insurance bureaucracy," Vradenburg said.

"Why are treatments for Alzheimer's patients being held to a different standard than those treating cancer, HIV, and other illnesses," he said. "Is it because there are so many of us? Is it because we’re old? CMS should be ashamed of the way it is discriminating against this one group of patients."

At a media teleconference Monday afternoon, CMS CMO Lee Fleisher, MD, director of the Center for Clinical Standards, said the NCD is limited in scope because "our obligation is to ensure that we look at approved treatments that are shown that benefits and those benefits outweigh the harms."

"We are making sure that the patients in this clinical trial will reflect the population of patients who have Alzheimer's in the Medicare population."