Pending Federal Action Could Lead to “Chilling Effect” on Alzheimer’s Research

The following statement was issued today by Stacy Pagos Haller, President and CEO BrightFocus Foundation:

The federal government’s preliminary decision to limit Medicare coverage for an entire class of Alzheimer’s drugs – monoclonal antibodies (mAB) targeting amyloid for the treatment of Alzheimer’s – would significantly curb patient access to new treatments for this 100% fatal disease.

Several promising mABs are currently in development, so if this preliminary decision is adopted and made final in April 2022 it would restrict access for all of these new therapeutics to a small group of patients who 1) live near a large academic center or clinical trial facility; 2) are able to find a specialist to give them a specific diagnosis; 3) meet rigorous eligibility criteria to enroll in a clinical trial and 4) meet all the requirements of participating in a long-term study. These restrictions raise disturbing health equity concerns, as it creates potential roadblocks to those with geographic, economic, and logistical barriers to participation. It creates a series of hoops to jump through for beleaguered families who are looking for more – not less – access to care for their loved ones.

More than 6 million Americans currently suffer from Alzheimer’s disease, which has no effective treatment or cure to stop its progression. A decision to require “Coverage with Evidence Development” would send a chilling effect across the fields of science and drug development. Whenever an entire class of drugs is limited in this way, it slows down scientific progress and could preclude a promising treatment reaching the public in a timely manner.

The federal agency involved, the Centers for Medicare and Medicaid Services (CMS), is poised to throw a wet blanket on scientific innovation and discovery in what is otherwise a tremendously exciting time for cutting-edge research in brain health. This is no time to narrow our sights on better treating a disease that is only growing in magnitude.

This announcement starts a 30-day comment period to CMS. I encourage all impacted by this disease to make their voices heard during this time.

Contact Information:

Michael Buckley
mbuckley@brightfocus.org
202-330-1913