On behalf of all those living with Alzheimer's disease, their caregivers, and their families, we appreciate the Centers for Medicare & Medicaid Services (CMS) thoughtful consideration on coverage considerations for monoclonal antibodies targeting amyloid for the treatment of Alzheimer's disease, including aducanumab, which was recently approved by the Food and Drug Administration (FDA).
We welcome today's announcement of a National Coverage Determination (NCD) analysis, consistent with the Alzheimer's Association position. An NCD would help prevent regional and community level disparities due to barriers that would be difficult to overcome, particularly by those who have greater challenges accessing health care services.
As the leading voluntary health organization in Alzheimer's care, support and research, the Alzheimer's Association looks forward to providing comment as part of the NCD process. In addition, the Alzheimer's Association supports an NCD outcome that includes Coverage with Evidence Development (CED) to ensure confirmatory data is collected in a timeframe and manner that meaningfully informs important near term decision making by policymakers, payers, health care providers, and patients and their families.
As the only patient advocacy group with experience in leading neurology CED programs, the Association believes a well constructed CED study would create rapid, open access to crucial information regarding efficacy, safety and equity to help ensure that everyone who might benefit has access.
We're committed to working with CMS -- and with the private payer community -- to ensure coverage for those who would benefit from this treatment. Additionally, we call on CMS to provide immediate guidance to help our community navigate access to coverage as the NCD process moves forward over the next several months. Patients and their families are understandably eager for treatment to begin now; providers need to understand what will be covered as we wait for an eventual NCD.
The Alzheimer's Association position remains, coverage should include the appropriate population as represented by those studied in the clinical trials -- people with mild cognitive impairment (MCI) due to Alzheimer's or early stage Alzheimer's dementia.
If you or a loved one is experiencing memory changes, the Alzheimer's Association strongly encourages speaking with a health care provider for a thorough evaluation, diagnosis and to discuss treatment options. For more information on diagnosis or to find a local health care provider, visit the Alzheimer's Association at alz.org, or the Helpline 24/7 at 800.272.3900.