CMS Proposes Medicare Coverage of Therapy for Alzheimer Disease, but Only for Patients in Clinical Trials

The Centers for Medicare & Medicaid Services (CMS) shared a proposed National Coverage Determination (NCD) decision memorandum for which FDA-approved monoclonal antibodies that target amyloid for the treatment of Alzheimer disease (AD) would be covered by Medicare through a coverage with evidence development (CED) policy.

This stipulation means only patients enrolled in qualifying clinical trials would have access to the treatment and not those with early-stage disease or mild cognitive impairment.

“CMS has proposed an evidence-based coverage policy after experts reviewed all relevant publicly available evidence and feedback received from stakeholders,” said CMS Administrator Chiquita Brooks-LaSure. “Before finalizing this proposal, we will have more opportunities to hear from people with Medicare living with mild cognitive impairment due to [AD] or mild [AD] dementia, their family members and caregivers, as well as many other stakeholders, including patient advocacy groups, medical experts, states, payers, and industry professionals.”

CMS is requesting public comment for the next 30 days and expects to make a final decision by April.

If the NCD is finalized, CMS will evaluate each clinical trial for the necessary inclusion criteria and all approved, eligible trials will be posted on the agency’s website. Participants with Medicare in the approved trials would be eligible for coverage of the drug, as well as related services and other routine costs—including PET scans if required via the trial protocol.

At present, aducanumab is the only monoclonal antibody FDA-approved for the treatment of amyloid beta and AD.

“This proposed [NCD] is the result of robust evidence analysis conducted through a thorough review process that found while there may be the potential for promise with this treatment, there is also the potential for harm to patients. This harm may range from headaches, dizziness, and falls, to other potentially serious complications such as brain bleeds,” said Dr Lee Fleisher, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality. “We believe that any appropriate assessment of patient health outcomes must weigh both harm and benefit before arriving at a final decision."

Reference:
Centers for Medicare & Medicaid Services. CMS proposes Medicare coverage policy for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease. January 11, 2022. https://www.cms.gov/newsroom/press-releases/cms-proposes-medicare-coverage-policy-monoclonal-antibodies-directed-against-amyloid-treatment