The Centers for Medicare and Medicaid Services finalized its decision to limit the coverage of Alzheimer's drug Aduhelm and future monoclonal antibodies.
In February of this year, the Centers for Medicare and Medicaid Services (CMS) released a confusing proposal to dramatically limit insurance coverage for Aduhelm, the anti-amyloid drug developed by Eisai and Biogen. Though Aduhelm was publicly available following the Food and Drug Administration’s (FDA) approval in summer 2021, but due to controversy around its efficacy, patients have hit snag after snag in terms of both access and insurance coverage.
The drafted plan suggested that Medicare won’t cover the drug for the general public. It also stipulated that Aduhelm and future anti-amyloid monoclonal antibody treatments might need to undergo additional clinical trials, even after FDA approval, before Medicare coverage would be green-lit.
Now, after receiving and reviewing more than 10,000 publicly submitted comments — both in support of and against the proposal — the CMS has loosened some restrictions in its final decision.
Ultimately, however, the final outcome is to indeed deny Medicare insurance coverage of Alzheimer’s drug Aduhelm to the general public. People who want to take Aduhelm are left with three options: finding other insurance coverage; covering the approximately $28,000/year cost out of pocket; or participating in Biogen’s ongoing, FDA-mandated Phase 4 clinical trials. In the latter case, the drug is provided, and Medicare helps cover this cost.
Changes from the draft CMS proposal on Aduhelm
The CMS originally provided coverage to randomized controlled trials approved by the CMS. It has changed and clarified that it will also cover any trials approved by the FDA or the National Institutes of Health (NIH). It also expanded eligibility requirements so that some individuals with Down Syndrome can receive coverage for the drug.
The CMS expanded coverage for some future monoclonal antibodies that show meaningful clinical benefits in FDA trials to facilities outside of hospital settings.
“This final National Coverage Determination reflects CMS’s commitment to provide the American public with a transparent, trusted, evidence-based decision — without regard to cost — that is made only after a thorough analysis of public feedback,” said CMS Administrator Chiquita Brooks-LaSure. “Through this decision, we are creating a pathway for people with Medicare to quickly access drugs the FDA determines have shown a clinical benefit.”
Per their press release, these restrictions also ensure that clinical trials recruit racially diverse participants. Importantly, CMS also announced that they will support participants enrolled in Aduhelm’s newest trials which are approved by the FDA and NIH which includes related costs like PET scans.
“Through this decision, we are creating a
pathway for people with Medicare to quickly
access drugs the FDA determines have
shown a clinical benefit.”
“We looked at the very unique circumstances around this class of treatments and made a decision that weighed the potential for patient benefit against the significance of serious unknown factors that could lead to harm,” Fleisher, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality, said in a press release. However, the release did not comment on the impact this decision would have on the cost of Medicare premiums.
Earlier this year, it was reported that Aduhelm was responsible in part for the unprecedented 14.5-percent spike in the cost of Medicare Premium B.
Since then, Biogen slashed the price of the drug from $58,000 to $28,800 per year. Xavier Becerra, secretary of health and human services, is considering lowering the premiums: “We’re going to make sure that seniors don’t pay more than they have to,” he said.
Alzheimer’s advocacy groups respond
The Alzheimer’s Association organized social media campaigns and advertisements to increase public participation during the public comment period.
“At no time in history has CMS imposed such drastic
barriers to access FDA-approved treatments
for people facing a fatal disease.”
“Denying access to FDA-approved Alzheimer’s treatments is wrong,” Harry Johns, CEO of the organization. said in a statement. “At no time in history has CMS imposed such drastic barriers to access FDA-approved treatments for people facing a fatal disease.”
Meanwhile, the Alliance for Aging Research, rallied against restrictions for Aduhelm coverage. In protest, nine of its 17 board members resigned, signifying a clear difference in opinions between the directors and the alliance.
Biogen will continue with its Phase 4 clinical trials, which attempt to determine whether the drug provides sufficient clinical benefits. If these ongoing trials are successful, then Aduhelm will also receive broader insurance coverage.