In early January 2022, the Centers for Medicare and Medicaid (CMS) released a draft decision that would only permit Medicare coverage for the new Alzheimer’s drug, aducanumab (AduhelmTM), for patients who are enrolled in qualifying clinical trials. According to the Alzheimer’s Association, Aduhelm is the first FDA-approved therapy that addresses the underlying biology of Alzheimer’s disease.
CMS Draft Decision
If CMS’ determination is finalized, CMS would review submitted clinical trials to determine whether specified criteria are met. In addition to the CMS-approved clinical trials, National Institutes of Health (NIH) sponsored clinical trials would also be covered. If a Medicare patient is participating in an approved clinical trial, Medicare would cover the drug, related services, and other routine costs (including PET scans, if required by a clinical trial protocol).
CMS stated that it is following a “long-standing process established by Congress to determine whether a medical item or service can be covered by Medicare, including when an item or service is reasonable and necessary for the diagnosis of and/or treatment of an illness or injury.”
“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 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.”
Reactions
Almost immediately, patients and advocacy groups spoke out against the CMS draft decision. The Alzheimer’s Association notes that Medicare has always covered FDA-approved treatments for those living with other conditions like cancer, heart disease and HIV/AIDS. For CMS to treat those with Alzheimer’s disease differently than those with other diseases is unprecedented and unacceptable.
Harry Johns, CEO of the Alzheimer’s Association, called for CMS to change course on the draft decision to “ensure equitable access for all who could benefit from FDA-approved treatments.” Johns noted that “With this approach, access to treatment would now only be available to a privileged few, those with access to research institutions, exacerbating and creating further health inequities. In issuing its decision CMS has the audacity to cite the Alzheimer’s Association 2021 Alzheimer’s Disease Facts and Figures report on the challenges and barriers underrepresented communities have in participating in clinical trials, and then turn around and propose to impose those very barriers.”
Nicole S. Longo, spokesperson for the Pharmaceutical Research and Manufacturers of America (PhRMA), released a statement saying that the “announcement by CMS is another setback for patients suffering from Alzheimer’s disease and their caregivers. With this proposal, CMS is writing off an entire class of medicines before multiple products have even been reviewed by FDA, positioning itself and not FDA as the key arbiter of clinical evidence. Instead of erecting more barriers, we encourage CMS to reconsider this ill-advised decision and work to address the significant and urgent needs facing patients with Alzheimer’s disease.”
Submit Comments
Interested parties can submit comments to CMS until February 10, 2022. CMS will then review the comments and expects to announce its final decision by April 11, 2022. Comments can be submitted here.