Medicare proposal would limit Aduhelm coverage to those enrolled in clinical trials
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CMS has proposed a National Coverage Determination decision memorandum specifying “coverage with evidence development” for FDA-approved monoclonal antibodies targeting amyloid for treating Alzheimer’s disease.
This means Medicare would cover FDA-approved drugs in this class only for individuals who are enrolled in qualifying clinical trials, according to a CMS press release. Aduhelm (aducanumab, Biogen/Eisai) is the only currently FDA-approved monoclonal antibody directed against amyloid beta for treating AD.
“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 the release. “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 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.”
If the proposed National Coverage Determination (NCD) is finalized, CMS will examine submitted clinical trials to see whether they meet criteria outlined in the NCD proposal. Clinical trials that receive CMS approval will be posted on the CMS Coverage website. NIH-sponsored clinical trials also would be covered under this proposal. Patients with Medicare who participate in these trials would be eligible for coverage of the drug, associated services and other routine costs, such as PET scans if deemed necessary by a clinical trial protocol.
“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,” Lee Fleisher, MD, CMS chief medical officer and director of the Center for Clinical Standards and Quality, said in the release. “This harm may range from headaches, dizziness and falls, to other potentially serious complications such as brain bleeds.
“We believe that any appropriate assessment of patient health outcomes must weigh both harm and benefit before arriving at a final decision,” Fleisher added. “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.”
According to CMS, the proposed NCD follows an evidence-based analysis CMS initiated in July 2021 to determine whether Medicare will establish a national policy for coverage of monoclonal antibodies directed against amyloid for treating AD. Without a current national coverage policy, local contractors that pay Medicare claims will decide whether the drug is covered for a Medicare patient on a claim-by-claim basis.
CMS said it will announce its final decision by April 11 after it has reviewed all comments received on the proposal.
Harry Johns, CEO of the Alzheimer’s Association, emphasized the association’s disapproval of the CMS proposal in a press release.
“The Alzheimer’s Association unequivocally believes that people living with Alzheimer’s disease deserve the same access to therapies given to those living with other conditions like cancer, heart disease and HIV/AIDS,” Johns said. “For those in the administration to treat those with Alzheimer’s disease differently than those with other diseases is simply unacceptable.
“Critically, this draft decision is not about one treatment but about this class of potential future treatments targeting amyloid for the treatment of Alzheimer’s disease,” Johns added. “This draft decision appears focused on an individual treatment rather than a class, which is not what CMS set out to do.”
References:
Alzheimer’s Association. Alzheimer’s Association statement on CMS draft decision. https://www.alz.org/news/2022/alzheimers-association-statement-on-cms-draft-deci. Published Jan. 11, 2022. Accessed Jan. 12, 2022.
CMS. CMS proposes Medicare coverage policy for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s Disease. https://www.cms.gov/newsroom/press-releases/cms-proposes-medicare-coverage-policy-monoclonal-antibodies-directed-against-amyloid-treatment. Published Jan. 11, 2022. Accessed Jan. 12, 2022.
Perspective
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The proposal by CMS to limit coverage of Aduhelm to clinical trials should not come as a huge surprise. It is evidence-based and it makes good sense. Why should taxpayer money be used to cover a product when we don’t even know if it works? While this may be an unusual decision by CMS, there is nothing about the case of Aduhelm that is typical, including its approval by the FDA in the absence of evidence that it is safe and effective.
Perspective
Back to TopI laud CMS for supporting the collection of the type of evidence we all hope can be generated for these agents.
The CMS decision is promoting support and access around scientific principles. It is requiring approved trials that meet 13 principles of design to yield meaningful and reliable results, and it is requiring an answer to both effectiveness and safety.
One note of concern is that coverage with evidence development should offer information relevant to all beneficiaries and to be sure that we have data on “real life” populations. The proposal I have seen describes access only to a very restrictive population, which could really limit the ability to access that breadth of the beneficiaries that CMS serves. In some ways, CMS may not go far enough to ensure that the applications actually engage the under-represented population. The proposed coverage statement permits that a study may simply “discuss beneficiary subpopulations that are underrepresented in clinical studies, and how the inclusion and exclusion criteria affect enrollment of these populations.”
While a “plan for the retention and reporting of said populations in the trial” is required, more emphasis could be placed on outreach and engagement of these groups. It seems like this approach undermines the value of evaluating within the CMS population.
Nevertheless, this is a start to collect the needed scientific evidence that so many have craved. Whether it achieves this operationally, we will need to wait and see.
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