On Thursday, February 10th the Alzheimer’s Disease Policy Task Force (Task Force) submitted feedback to the Centers for Medicare and Medicaid Services (CMS) on their draft Medicare coverage determination for the use of monoclonal antibodies (mABs) targeting amyloid for the treatment of Alzheimer’s disease (AD). Collectively, the Task Force represents people living with Alzheimer’s disease and related dementias (“ADRD”); family caregivers; healthcare providers; researchers; coalitions and advocacy organizations focused on chronic disease, aging, and minority and women’s health; private-sector leaders; and clinical trial sites.
In June 2021, the U.S. Food and Drug Administration (FDA) approved the first mAB Alzheimer’s therapy, Aduhelm, under the FDA’s Accelerated Approval Program. The Accelerated Approval pathway is used frequently in oncology and has been used for other life-threatening conditions such as multiple sclerosis and rare diseases, where patients and physicians have run out of, or lack entirely, options to treat a fatal illness. Under FDA regulations, sponsors conduct post-marketing studies that verify and describe the expected clinical benefit of the drug.
In July 2021, CMS announced the launch of a Medicare national coverage analysis (NCA) for the entire class of mAB drugs, which includes Aduhelm, as well as several additional drugs in clinical development that could be available very soon. The Alliance’s comments on the NCA can be found here.
In January 2022, CMS released its draft Medicare coverage determination requiring “coverage with evidence development” (CED), which if finalized, would severely limit coverage for the currently-approved mAB and future similar drugs only to Medicare beneficiaries that participate in a follow on randomized clinical trial. For context, this means that the new treatments would only be available to a few thousand beneficiaries, rather than broadly to the affected population.
The Task Force comment letter asks CMS to issue a final coverage decision that removes the CED requirement, and allow coverage for FDA-approved uses of these mAB Alzheimer’s disease drugs for Medicare beneficiaries nationwide. The Task Force shared the following concerns with the coverage restrictions proposed in the draft decision. The proposal:
- Denies Medicare beneficiaries generally, and minority populations specifically, access to new and future, safe, and effective mAB when there are no meaningful alternatives;
- Is contrary to FDA’s judgment that confirms aducanumab is safe and effective, and under CMS’ guidance is “reasonable and necessary”;
- Inappropriately restricts access to the entire class of anti-amyloid mABs without having sufficient evidence or data to reach such a conclusion;
- Imposes duplicative, unnecessary, and impracticable mandatory clinical trial requirements;
- Extends insufficient coverage for diagnostic scans; and
- Sets a harmful precedent to severely restrict Medicare coverage of future therapies approved through the FDA’s Accelerated Approval Program for other serious and life-threatening conditions.