Natl. DS Organizations Launch Joint Effort to Change CMS Proposal for Alzheimer’s Treatments

Atlanta, GA., Bismarck, ND., Burlington, MA., Denver, CO., Hoffman Estates, IL., New York, NY., Plymouth, MN., Rockport, ME (February 4, 2022) – Down Syndrome Affiliates in Action (DSAIA), Down Syndrome Medical Interest Group-USA (DSMIG-USA), GiGi’s Playhouse Down Syndrome Achievement Centers, Global Down Syndrome Foundation (Global), LuMind IDSC Foundation (LuMind IDSC), National Down Syndrome Congress (NDSC), National Down Syndrome Society (NDSS), and National Task Group on Intellectual Disabilities and Dementia Practices (NTG) have launched a coordinated effort to catalyze a community-wide response to the recent Centers for Medicare & Medicaid Services (CMS) proposal concerning coverage for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease.

Last summer, the FDA approved a new drug, aducanumab, one of the first treatments meant to address the cause of Alzheimer’s disease and the first in a new class of treatments. CMS is currently making decisions about coverage for this new class of treatments and has proposed coverage only for people in a specific new set of clinical trials. People with intellectual and developmental disabilities, including Down syndrome, cannot be included in those trials, discriminating now and casting doubt on future coverage. While research has not revealed the extent to which this class of drugs will ultimately benefit individuals with Down syndrome, we want to make sure the community will have every opportunity to access the best possible treatments now and in the future.

“This collaboration among national Down syndrome organizations is particularly important given how prevalent Alzheimer’s disease is in our community,” said a spokesperson for the group. “By working together, we’re able to bring the expertise of each organization together to mobilize self-advocates, families, caregivers, medical professionals and the general public to push for inclusion of individuals with Down syndrome in this critical process.”

Alzheimer’s disease is a critical issue for the Down syndrome community because having a third copy of chromosome 21 greatly increases the risk of developing the disease. People with Down syndrome represent the single largest group with early onset dementia due to Alzheimer’s disease, yet they have not been adequately included in Alzheimer’s research or clinical trials for treatments. The proposed decision by CMS only furthers this inequity.

Since most people with Down syndrome rely upon Medicare or Medicaid for health insurance, their only hope of accessing these potentially lifesaving but very expensive drugs – if their doctor recommends this course of treatment – would be to self-pay or have secondary insurance. Additionally, excluding people with Down syndrome from clinical trials will make it harder for physicians to have the information they need to care for our community.

This exclusion by CMS sets a dangerous precedent that will slow the development of these treatments and make it harder for physicians to make informed decisions related to courses of treatment for their patients with Down syndrome. CMS must abandon its current course and identify a different methodology that ensures that people with Down syndrome and other similarly situated disabilities will have meaningful access to current and future advancements in treatments for Alzheimer’s disease. Through concerted effort and collaboration with other agencies and stakeholders, we are confident CMS can ensure those treatments will be safe, effective and affordable for patients with Down syndrome.

CMS is accepting comments on their proposed action until February 9th, and the group of national Down syndrome organizations are collaborating to share a common message: CMS cannot exclude the Down syndrome community now because it is likely to restrict access in the future. More information, including instructions for submitting a comment to CMS, is available at www.ndss.org/cms-comment.