CMS Releases Alzheimer’s Treatment National Coverage Determination

CMS has finalized its national coverage determination for monoclonal antibodies directed against amyloid, a new potential treatment for Alzheimer’s disease.

The agency moved forward with its determination to reimburse for the Alzheimer’s disease treatment under coverage with evidence development. Medicare will cover the costs of individuals participating in studies of monoclonal antibodies directed against amyloid treatments. The studies have to receive CMS approval.

This provides a pathway for new drugs in this class with Food and Drug Administration (FDA) approval to be used in care settings including outpatient departments. Earlier in the determination process, other stakeholders expressed concerns that the national coverage determination, as drafted, would limit access to treatment by failing to account for outpatient departments.

Beneficiaries who participate in trials approved by the FDA or National Institutes of Health (NIH) will receive coverage for drugs that do not demonstrate clinical benefits. 

Coverage also extends to related services, such as PET scans. Participants in CMS-approved studies will be able to access a multidisciplinary team to support their disease management and decisionmaking with care coordination. 

CMS review over 10,000 stakeholder comments and 250 peer-reviewed documents prior to finalizing the determination and included these perspectives in its decision.

“Science, evidence, and stakeholder input led our team of career civil servants and clinicians through this national coverage determination process. There is the potential for promise with this treatment; however, there is not currently enough evidence of demonstrating improved health outcomes to say that it is reasonable and necessary for people with Medicare, which is a key consideration for CMS when making national coverage determinations,” said Lee Fleisher, MD, chief medical officer at CMS and director of the Center for Clinical Standards and Quality. 

CMS Administrator Chiquita Brooks-LaSure also vocalized her support for the decision.

“Alzheimer’s disease is a highly destructive illness that affects millions of Americans and their families. CMS has a responsibility to ensure that people with Medicare have equitable and appropriate access to therapies that are reasonable and necessary for use in the Medicare population,” said Administrator Brooks-LaSure. 

“This final National Coverage Determination reflects CMS’ 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.” 

There is currently only one drug in this class that has received FDA-approval, Aduhelm. However, this drug’s approval was a source of controversy across the industry.

“In arriving at this final decision, 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,” explained Fleisher.

“If a drug in this class shows evidence of clinical benefit through the traditional FDA approval process, then CMS will provide broad access and ensure the results from the rigorous trials are generalizable for people with Medicare participating in a CMS-approved study, such as a registry. Lastly, we structured this decision to provide flexibility and assurance that CMS can respond quickly to providing coverage for any new drugs in this class when a clinical benefit is determined.” 

The Alliance for Community Health Plans (ACHP) responded to the determination with affirmation. But the organization also pointed out remaining concerns, echoing payers’ comments from earlier in the coverage determination process.

“We commend the Administration’s decision today to limit Aduhelm coverage to Medicare beneficiaries participating in clinical trials. The Centers for Medicare and Medicaid Services has shown that its coverage decisions are guided by science and quality care for beneficiaries, and we applaud CMS for letting evidence and effectiveness prevail,” Ceci Connolly, president and chief executive officer of ACHP, said in an emailed statement.

“Yet the work is not done. This unproven, expensive drug contributed to a price hike in Part B premiums—not to mention an increase in total health spending in the health care system. We urge CMS to reconsider premiums to remove this significant burden on the 60 million seniors in Medicare. Our seniors deserve no less.”