ADDF Statement of CMS Coverage Determination for Aduhelm

ADDF supports the need to collect more clinical data on Aduhelm, but would have preferred a less restrictive process

On Thursday, April 7, the Centers for Medicare and Medicaid (CMS) formalized its plan to cover the anti-amyloid drug Aduhelm only for patients enrolled in clinical trials. However, in response to concerns raised by the Alzheimer’s community, CMS will not have to approve these trials. Medicare will cover patients enrolled in any FDA- or NIH-approved trial. This is an important change that will allow more patients to access the drug in additional settings.

The Alzheimer’s Drug Discovery Foundation (ADDF) supports the need to gather more evidence about the clinical effectiveness of Aduhelm, a question that was left unanswered in its clinical trials. While the CMS final policy is less restrictive, and an improvement over its earlier proposal, the ADDF would have preferred that CMS include patient registries as an alternative to clinical trials.

“Patient registries collect real-world evidence that more closely reflects the actual population living with Alzheimer’s, compared to the limited populations that enroll in clinical trials,” explained Dr. Howard Fillit, Co-Founder and Chief Science Officer at ADDF. “This approach would also have extended coverage of Aduhelm to more patients currently living with Alzheimer’s disease.”

In another positive change, CMS will not automatically impose the same coverage restrictions for similar drugs coming down the pipeline if they present data showing they can improve clinical outcomes and receive traditional FDA approval instead of the accelerated approval granted to Aduhelm. The ADDF strongly supports this change. “If you’ve seen one anti-amyloid antibody, then you’ve seen one anti-amyloid antibody," said Dr. Fillit. “Drugs in the same class are not necessarily equal and each should be evaluated and made available to patients on its own merits.”

How FDA and CMS evaluate, cover, and make Alzheimer’s drugs available is more important than ever. We are in a new era of Alzheimer’s drug development with many promising new drugs on the horizon that go beyond the traditional targets of amyloid and tau and work against the many underlying causes of Alzheimer’s.

Anti-amyloid treatments are just one piece of a complex Alzheimer’s puzzle

Alzheimer’s drugs currently being studied are driven by the biology of aging approach, which is based on the many biological processes that go awry in the aging brain. Aduhelm, and the anti-amyloid approach, is just one piece of this complex puzzle. More than three in four drugs in clinical trials today address non-amyloid targets, like inflammation, vascular dysfunction, and genetic alterations that contribute to the development of Alzheimer’s as we age.

“It is vital that we deliver on our promise to develop new therapies that target all of the underlying factors,” said Dr. Fillit. “Only by adopting a personalized approach that combines multiple therapies against a variety of targets tailored to each patient’s individual needs will we be able to effectively conquer Alzheimer’s.”

An essential part of bringing these drugs to market is validation of target-specific biomarkers, which is the sole focus of the ADDF’s Diagnostics Accelerator. Biomarker PET scans, blood tests, and even eye scans are being developed to measure how well the body responds to drug treatments in clinical trials. These same tests will eventually be available in doctors’ offices for rapid, non-invasive diagnosis of Alzheimer’s disease.

Although anything short of full coverage may be disappointing for some patients and families, there is more reason for optimism today than ever before. We are in a modern age of Alzheimer’s research that will deliver not just anti-amyloid drugs, but drugs that work against the many other factors that contribute to Alzheimer’s disease.

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NOTE: The ADDF will continue to update this statement in the coming days once a full review of the decision has been completed.