CMS proposes limiting Medicare coverage for the treatment of Alzheimer's to clinical trials
Currently, Aduhelm, made by Biogen, is the only monoclonal antibody approved by the FDA for the treatment of Alzheimer's disease.
Photo: FatCamera/Getty Images
The Centers for Medicare and Medicaid Services has released a proposed National Coverage Determination decision memorandum to cover Alzheimer's treatment for people with Medicare only if they are enrolled in clinical trials.
The proposed National Coverage Determination would cover FDA-approved monoclonal antibodies that target amyloid for the treatment of Alzheimer's disease through coverage with evidence development, meaning for Medicare recipients enrolled in qualifying clinical trials.
Currently, Aduhelm (aducanumab), made by Biogen, is the only monoclonal antibody approved by the Food and Drug Administration for the treatment of Alzheimer's disease.
Medicare patients participating in these trials would be eligible to receive coverage of the drug, related services and other routine costs, which may include positron emission tomography (PET) scans if required by a clinical trial protocol.
The proposed National Coverage Determination is open to public comment for 30 days. After reviewing all comments received on the proposed determination, CMS will announce its final decision by April 11.
WHY THIS MATTERS
The treatment has promise, but there are also risks, according to Dr. Lee Fleisher, CMS chief medical officer and director of the Center for Clinical Standards and Quality.
"This proposed National Coverage Determination 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," Fleisher said by statement.
"We believe that any appropriate assessment of patient health outcomes must weigh both harm and benefit before arriving at a final decision. Therefore, based on the public comments submitted previously and evidence CMS reviewed, the potential for harm and important questions that remain, we have determined that coverage with evidence development through clinical trials is the right decision for Medicare patients, clinicians and caregivers, and we look forward to receiving feedback on the proposal," Fleisher continued.
If the proposed National Coverage Determination is finalized, CMS will review each submitted clinical trial to determine whether it meets the criteria specified in the proposed National Coverage Determination. In addition to CMS-approved trials, National Institutes of Health-sponsored clinical trials would also be covered under this proposed National Coverage Determination.
THE LARGER TREND
Currently, in the absence of a national coverage policy, the Medicare Administrative Contractors, local contractors that pay Medicare claims, decide whether the drug is covered for a Medicare patient on a claim-by-claim basis.
Today's proposed National Coverage Determination follows an evidence-based analysis CMS initiated in July 2021 to examine whether Medicare will establish a national policy for coverage of monoclonal antibodies directed against amyloid for the treatment of Alzheimer's disease. During the 2021 national coverage analysis public comment period, CMS held two national listening sessions, in which each session was attended by more than 360 people, and reviewed 131 public comments and more than 250 relevant peer-reviewed documents.
This is a separate process, CMS said, from the announcement yesterday by Health and Human Services Secretary Xavier Becerra directing CMS to reassess its recommendations for a significant increase in 2022 Medicare Part B premiums, due to Biogen reducing the wholesale acquisition cost of Aduhelm by 50%, from about $56,000 a year to $28,200. The drug cost was one reason premiums increased. CMS said today it would announce further information on the reassessment when it is available.
ON THE RECORD
"Alzheimer's disease is a devastating illness that has touched the lives of millions of American families. Throughout this National Coverage Determination process, CMS has been and remains committed to providing the American public with 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," said CMS Administrator Chiquita Brooks-LaSure. "CMS has proposed an evidence-based coverage policy after experts reviewed all relevant publicly available evidence and feedback received from stakeholders.
"Before finalizing this proposal, we will have more opportunities to hear from people with Medicare [who are] living with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia, their family members and caregivers, as well as many other stakeholders, including patient advocacy groups, medical experts, states, payers and industry professionals," Brooks-LaSure said.
Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com
