CHICAGO, July 11, 2021
— Aduhelm has been approved for use for those with Mild Cognitive Impairment (MCI) or early stage Alzheimer’s dementia. This treatment offers a marginal but potentially meaningful slowing of decline for this subpopulation of individuals with Alzheimer’s disease, a terminal disease with no survivors. Though approved, access to the treatment is at risk of being impeded by significant barriers which may further deepen issues of health equity.
To proactively and definitively address several of these barriers to appropriate and equitable access, the Alzheimer’s Association supports the Centers for Medicare & Medicaid Services (CMS) undertaking a national coverage analysis culminating in a National Coverage Determination (NCD), that provides coverage to those specified in the Food and Drug Administration’s revised label. Among other benefits, an NCD can help prevent regional and community level disparities due to barriers that would be difficult to overcome, particularly by those who have greater challenges accessing healthcare services.
In addition, the Alzheimer’s Association encourages CMS to couple an NCD with Coverage with Evidence Development (CED). From the Association’s very first comment on aducanumab, we have stressed the importance of post-approval surveillance through a confirmatory trial. However, we remain concerned that the subsequently announced confirmatory trial will not be conducted in a timeframe and manner that meaningfully informs important near term decision making by policymakers, payers, healthcare 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.
The Alzheimer’s Association is committed to working with CMS and the private payer community to expedite access for the appropriate population, which has such significant need.
The Alzheimer's Association leads the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia®. For more information, visit www.alz.org or call the 24/7 Helpline at 800.272.3900.