After complaints of discrimination, federal officials are backing off a plan that would have kept people with Down syndrome from accessing a new Alzheimer’s treatment even though they’re predisposed to the disease.

The lifetime risk of developing Alzheimer’s disease is over 90% for people with Down syndrome, advocates say. So, when the Centers for Medicare and Medicaid Services proposed a plan for coverage of Aduhelm, a controversial new Alzheimer’s drug, advocates were aghast that the proposal precluded people with Down syndrome.

Aduhelm was approved by the Food and Drug Administration last year despite questions from many experts about how effective it truly is. However, CMS makes its own coverage decisions and since most people with Down syndrome are covered by Medicare or Medicaid, the agency’s determination is significant.

Under a proposal released in January, CMS sought to make Aduhelm available to people with Medicare only if they were participating in clinical trials, citing concerns about potential harm to patients from the treatment. People with Down syndrome and any other conditions that “may significantly contribute to cognitive decline” would be excluded from such trials, the CMS proposal said.

“This would mean that anyone with Down syndrome and Alzheimer’s who, in consultation with their medical and support teams, wanted to try this very expensive drug as a treatment option, would not have had their costs been covered by Medicare because they were not allowed to be part of the clinical trials,” said Heather Sachs, policy and advocacy director at the National Down Syndrome Congress.

The Down syndrome community flooded CMS with more than 1,800 comments blasting the proposal for explicitly excluding people with intellectual and developmental disabilities. Not only would the policy prevent people with Down syndrome from accessing Aduhelm, but without clinical trial data on this population, advocates feared that doctors would lack important information to guide treatment decisions for those with the chromosomal disorder.

Now the agency is changing course. In its final determination issued earlier this month, CMS removed the exclusion for people with Down syndrome.

“The proposed (National Coverage Determination) included criteria that would have excluded some key patient subpopulations (e.g., Down syndrome patients). Based on public comment, we are not finalizing the patient exclusion criteria to allow appropriate access to patient subpopulations that may need treatment based on ongoing research,” reads a fact sheet from CMS that was released alongside the determination.

The move doesn’t guarantee access to Aduhelm, but allows individuals with Down syndrome the opportunity to participate in clinical trials. Advocates note, however, that drug companies have been reluctant to include people with Down syndrome in trials.

“We are one step closer to our goal of making sure adults with Down syndrome have equitable access to treatment options for Alzheimer’s disease,” reads a joint statement from Down Syndrome Affiliates in Action, GiGi’s Playhouse Down Syndrome Achievement Centers, the Global Down Syndrome Foundation, the LuMind IDSC Foundation, the National Down Syndrome Congress and the National Down Syndrome Society. “The next phase of our collective advocacy must be focused on supporting the inclusion of people with Down syndrome in clinical trials for Alzheimer’s treatments.”

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