Federal officials have made their final decision: Medicare will only pay for patients to get the new Alzheimer's drug aducanumab (Aduhelm) if the patients are participating in clinical trials.
for aducanumab and other similar drugs that target beta-amyloid in the brain, which is considered a hallmark of Alzheimer's disease.
CMS set far less restrictive conditions for potential coverage of anti-amyloid drugs that may get full FDA approval in the future. In such cases, coverage would be pegged to participation in CMS-approved studies, such as a data collection through routine clinical practice or registries, not only clinical trials.
"Although this is an improvement, it would have been preferable for CMS to include patient registries, which collect real-world evidence that more closely reflects the actual population "Drugs in the same class are not necessarily equal and each should be evaluated and made available to patients on its own merits," Fillit said.
Biogen and other critics of the CMS decision contend it denies patients access to a medication that might slow Alzheimer’s-related mental decline, while supporters question whether showing the drug removed beta-amyloid from the brain means it helps patients’ symptoms.
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