Interventions of Interest:
- aducanumab (Aduhelm™, Biogen)
During the public meeting, an independent appraisal committee voted unanimously (15-0) that the evidence was not adequate to demonstrate that aducanumab plus supportive care provides a net health benefit when compared to supportive care alone.
In light of substantial uncertainty of patient benefit, policy recommendations call for:
- Reducing the price to avoid strain on Medicare and Medicaid budgets and to avert financial toxicity for patients
- Urging experts and policymakers to avoid overstating the potential benefits of treatment
- Exploring options for insurance coverage criteria
- Suggesting specific rigorous research designs that should be considered as part of any potential Medicare coverage decision with requirements for further evidence development
“The clinical trial history and evidence regarding aducanumab are complex. We have spent eight months analyzing the study results, talking with patient groups and clinical experts, and working with the manufacturer to understand their position. At the conclusion of this effort, despite the tremendous unmet need for new treatments for Alzheimer’s disease, we have judged the current evidence to be insufficient to demonstrate that aducanumab slows cognitive decline, while it is clear that it can harm some patients.
Nonetheless, the FDA has approved this drug, and if Medicare and private insurers choose to provide coverage, millions of patients and families will face the question of whether to use it — which means many patients and families will suffer financial toxicity without knowing whether they are taking a drug more likely to help them than hurt them. The company had another path open to them. They could have priced in line with our current best estimate of clinical value at a tenth of their current list price and still expected to make billions of dollars each year. It is unfortunate that they did not choose such a path.”