Aducanumab July 6, 2021 Update

Two additional pieces of information provided further clarification for aducanumab. In the first update, the FDA posted the review of aducanumab by the FDA’s Office of Biostatistics on the FDA page of documents used for aducanumab approval. The review concluded that a new aducanumab trial was needed, because of the conflicting evidence seen in EMERGE and ENGAGE. Use of only favorable results in Emerge would lead to a biased conclusion. Because of this, a future non-inferiority trial comparing a new drug to aducanumab would have unclear results. The availability of aducanumab would also hinder recruitment for future Alzheimer’s Disease trials, which may be evaluating more efficacious drugs.
 
ICER provided a revised evidence report for aducanumab in late June 2021. In the report ICER found the evidence to be insufficient to support efficacy in patients with mild disease. The report also stated that efficacy was not shown in patients with moderate to severe disease and no previous amyloid reducing drug trials have shown a benefit in moderate to severe disease. Most of positive benefits identified in ENGAGE and EMERGE were from post-hoc analyses, so there is a reduction in the applicability of the findings, due to loss of randomization. ICER also noted that ARIA was seen in over a third of patients and questions whether it can be adequately monitored in practice. ICER estimates the cost-effective range of $2,950 to $8,360.
 
We have updated our review of aducanumab and the revised report can be downloaded on our sample drug review web page.
 
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