BOSTON, February 10, 2021 – The Institute for Clinical and Economic Review (ICER) announced today it has extended its timeline for assessing the comparative clinical effectiveness and value of aducanumab (Biogen) for the treatment of Alzheimer’s disease.
On January 29, 2021, Biogen announced that the US FDA had extended the agency’s review period for aducanumab, delaying the investigational treatment’s Prescription Drug User Fee Act (PDUFA) action date to June 7, 2021. Biogen has submitted a response to an information request by the FDA, including additional analyses and clinical data, which the FDA considered a Major Amendment to the application that will require additional time to review.
Given the delay in the PDUFA date, ICER will extend its own timeline in order to continue its evaluation of data on aducanumab and seek to understand any important new information. ICER’s website provides an updated timeline for the assessment. Key date changes include:
- Draft Evidence Report: May 5, 2021
- Public Comment Period: May 5, 2021 – June 2, 2021
- Revised Evidence Report: June 30, 2021
- Public Meeting and Evidence Presentation: July 15, 2021
- Final Evidence Report, Meeting Summary, and Policy Recommendations: August 5, 2021
The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.
ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.