— Registration now open for January 5 “Early Insights” webinar —
— Public comment period now open until February 2, 2023; Requests to make oral comment during public meeting also being accepted —
BOSTON, December 22, 2022 – The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of emerging treatments donanemab (Eli Lilly & Co.) and lecanemab (Leqembi, Eisai Inc.) for the treatment of Alzheimer’s disease. This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions.
ICER typically does not provide health-benefit price benchmarks (HBPBs) as part of draft reports because results may change with revision following receipt of public comments. We caution readers against assuming that the values provided in the “Threshold Prices” section of this draft report will match the health benefit price benchmarks that will be presented in the next version of this Report. Given that we rate the current evidence for donanemab as “insufficient”, we do not anticipate providing HBPBs for donanemab even in later versions of this report.
In our draft analyses, the prices needed to meet traditional cost-effectiveness thresholds for lecanemab, across various analytic perspectives and measures of benefit, range between $8,500 and $20,600 for a year’s course of treatment.
Register for ICER’s Early Insights Webinar
On January 5, 2023, as part of ICER’s Early Insights Webinar Series, ICER’s Chief Medical Officer David Rind, MD will present the initial findings of this draft report. This webinar is exclusively available to users of the ICER Analytics platform; registration for the webinar is now open.
Submit a Public Comment
The Draft Evidence Report and Draft Voting Questions are now open to public comment. All stakeholders are invited to submit formal comments by email to email@example.com, which must be received by 5 PM ET on February 2, 2023. Please submit public comments as a Word document in the following format:
- 12-point Times New Roman font
- Five-page maximum (not including references or appendices)
ICER’s Manufacturer Engagement Guide and Patient Portal provide additional detail on what types of information may be most informative to the report.
ICER will review all comments and incorporate any necessary changes in the Evidence Report and Revised Voting Questions that will be posted on or about March 1, 2023. All comments and ICER’s response to comments will be posted publicly along with the Evidence Report.
Register for the Virtual Public Meeting
The Evidence Report will be the subject of a virtual public meeting of the CTAF on March 17, 2023. During the meeting, the independent council will vote on key questions raised in the report. Registration for the virtual public meeting is now open.
Register to Make an Oral Comment
During the virtual public meeting, there will be a limited amount of time available for interested stakeholders to make an oral comment on the report. Requests to submit oral comments must be emailed to firstname.lastname@example.org by 5 PM ET on February 2, 2023. Individuals who wish to deliver oral comments must separately register to attend the meeting. For more information about registering for oral comment, please visit our website.
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.