CMS: Medicare Will Cover Aduhelm, Future Monoclonal Antibodies

The Centers for Medicare & Medicaid Services announced a national policy for Medicare coverage of aducanumab and any future monoclonal antibodies to fight against amyloid in the treatment of Alzheimer disease (AD).

According to the CMS press release, Medicare will cover monoclonal antibodies that target amyloid for the treatment of AD, which was finalized in this 2-part National Coverage Determination (NCD).

The agency conducted a transparent, evidence-based process, which incorporated more than 250 peer-reviewed documents and more than 10,000 stakeholder comments into determination for this new policy decision.

Individuals with Medicare participating in CMS-approved studies such as data collection through registries or routine clinical practice will be provided coverage and enhanced access.

According to CMS, new drugs that receive US Food and Drug Administration (FDA) traditional approval may be available to individuals with Medicare in additional care settings like an infusion center or outpatient department. Furthermore, CMS will aid the FDA and cover any related services or the drug for people participating in these trials with Medicare.

“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,” 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 and encourages manufacturers and trial administrators to ensure that the clinical trials recruit racially diverse participants.”

CMS reported future developments in this class of treatments will be monitored as they are committed to ways of improving care for people with AD.

Reference:
The Centers for Medicare & Medicaid Services. CMS finalized Medicare coverage policy for monoclonal antibodies directed against amyloid for the treatment of Alzheimer disease. April 7, 2022. Accessed April 8, 2022. https://www.cms.gov/newsroom/press-releases/cms-finalizes-medicare-coverage-policy-monoclonal-antibodies-directed-against-amyloid-treatment