Monoclonal antibodies targeting amyloid beta in Alzheimer’s disease, including the newly approved drug aducanumab (Aduhelm), would be covered for people with Medicare only if they are enrolled in qualifying clinical trials, according to CMS plans announced Tuesday.

The proposed CMS National Coverage Determination would cover FDA-approved monoclonal antibodies targeting amyloid in Alzheimer’s disease through coverage with evidence development (CED). To date, the only such approved treatment is aducanumab.

“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,” CMS Administrator Chiquita Brooks-LaSure said in a statement.

“CMS has proposed an evidence-based coverage policy after experts reviewed all relevant publicly available evidence and feedback received from stakeholders,” Brooks-LaSure added. “Before finalizing this proposal, we will have more opportunities to hear from people with Medicare 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.”

If the proposed National Coverage Determination is finalized, CMS will review each submitted clinical trial to determine whether it meets specific criteria. Trials must address whether using anti-amyloid antibodies in Alzheimer’s results in a statistically significant and clinically meaningful difference in decline in cognition and function, in addition to studying adverse events associated with treatment.

Of note, the diversity of patients included in each trial must be representative of the national population diagnosed with Alzheimer’s disease, the agency said. All trials must be conducted in a hospital-based outpatient setting.

In addition to CMS-approved trials, NIH-sponsored clinical trials also would be covered under the proposed determination. Medicare patients in the trials would be eligible to receive coverage of the drug, related services, and other routine costs, including PET scans.

“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,” said CMS Chief Medical Officer Lee Fleisher, MD.

“We believe that any appropriate assessment of patient health outcomes must weigh both harm and benefit before arriving at a final decision,” added Fleisher, who is also the director of the Center for Clinical Standards and Quality at CMS. “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.”

The proposed determination is open to public comment for 30 days. CMS plans to announce its final decision by April 11, 2022.

Last Updated January 11, 2022

  • Judy George covers neurology and neuroscience news for MedPage Today, writing about brain aging, Alzheimer’s, dementia, MS, rare diseases, epilepsy, autism, headache, stroke, Parkinson’s, ALS, concussion, CTE, sleep, pain, and more. Follow

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