The U.S. Medicare program revealed that it plans to cover Alzheimer's treatments, including Biogen’s hotly-debated Aduhelm, but patients must be enrolled in a clinical trial — a decision that will likely limit access to treatment.
The proposed National Coverage Determination, if approved, would cover U.S. FDA approved monoclonal antibodies that target amyloid of treatment of Alzheimer’s disease. Contentiously, limiting treatment to patients enrolled in clinical trials will drastically reduce the number of patients able to access treatment. Medicare services would cover the cost of drugs, related services, and other costs, according to the CMS.
The decision is not yet set in stone, and subject to change pending public and company feedback. The final results will be announced April 11.
A key part of the proposed NCD is Biogen’s Aduhelm, which has sparked in the past over its high cost and inconsistent results. The yearly cost of the drug was lowered in 2021 to $28,200 but is still too high to be widely accessible. Given that 85% of people who might use Aduhelm are enrolled in Medicare, a system that serves people aged 65 and older, concerns have been raised about the financial burden the drug could bring.
Aduhelm also comes with potentially dangerous including strokes or brain hemorrhages. According to a study published by JAMA neurology, 41% of patients in the Aduhelm study were impacted by amyloid related imaging abnormalities.
Also included in the NCD proposal are experimental medicines developed by Eli Lilly & Co, Roche Holding and Eisai Co.