— Registration now open for June 16 “Early Insights” webinar —

— Public comment period now open until July 13, 2022; Requests to make oral comment during public meeting also being accepted —

BOSTON, June 14, 2022 – The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of AMX0035 (Amylyx Pharmaceuticals, Inc.) and oral edaravone (Mitsubishi Tanabe Pharma Development America, Inc.) for the treatment of amyotrophic lateral sclerosis (ALS). 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.

“Throughout this review process, we have heard concerns from patient groups that cost-effectiveness analyses can underestimate the value that people with ALS place on therapies that extend life,” said David Rind, MD, ICER’s Chief Medical Officer. “ICER includes analyses using a measure called the equal value of life-years (evLY) that does not have this problem. The evLY values life extension in ALS equal to that of an average 45-year-old in full health; it does not undervalue therapies for ALS.”

Register for ICER’s Early Insights Webinar

On June 16, 2022, 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 all 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 publiccomments@icer.org, which must be received by 5 PM ET on July 13, 2022. 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 August 4, 2022. 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 Midwest CEPAC on August 19, 2022. 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 publiccomments@icer.org by 5 PM ET on July 13, 2022. 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.

About ICER

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.