Regulatory Decision on Class of Alzheimer’s Drugs Has the Potential to Upend Drug Development as We Know It

Feb 10, 2022

By Joe Boncore, CEO, MassBio

On January 11, 2022, the Centers for Medicare and Medicaid Services (CMS) released a draft National Coverage Determination (NCD) for a whole class of drugs designed to treat Alzheimer’s disease (AD). If approved as-is, it would mean that CMS will pay for FDA approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease only if a Medicare patient is enrolled in a randomized controlled trial. In reality, this would mean that virtually all patients suffering from AD would have no access to a therapy that the FDA has deemed to be safe and efficacious. With more than 6 million Americans living with Alzheimer’s, we need every solution available to all patients. 

This is a troubling and far-reaching decision. The ability to treat the underlying causes of AD was once only a dream because the science has been so challenging. Now that one treatment has been approved by the FDA – the gold standard that a therapy is safe and efficacious – and others are within reach, we should be celebrating, not restricting, coverage of therapeutics that can provide relief to those who are suffering and their families.

Yet, CMS’ NCD would have an impact beyond patient access to Alzheimer’s treatments. Companies researching new cures and therapies would no longer be able to plan on FDA approval being the final step to getting their new medicine to patients. This is especially troubling to our Massachusetts biotech ecosystem where most companies are small and emerging. These companies rely on regulatory certainty to secure the necessary investment to carry-out complicated and life-changing science they are pursuing. For areas of unmet medical need where new breakthroughs are on the horizon, we should collectively be pursuing policies that encourage the development of breakthrough therapies instead of putting up pre-emptive roadblocks.

We urge CMS to follow the expert recommendations for appropriate use of therapies from the FDA, and to align coverage for the class of amyloid-directed therapies with the criteria used in the respective clinical trials. Following an increase in Alzheimer’s related deaths during the pandemic, patients and their families are counting on timely and efficient access to care. Limiting the potential of crucial treatments deprioritizes patients and devalues the once inconceivable milestones that scientists and researchers have accomplished to finally provide hope to the Alzheimer’s community.

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