ICER Releases Draft Evidence Report on Treatments for Transthyretin Amyloid Cardiomyopathy


Public comment period now open until August 13, 2024; Requests to make oral comment during public meeting also being accepted  


BOSTON, July 17, 2024 – The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of acoramidis (BridgeBio Pharma, Inc.), tafamidis (Vyndamax®/Vyndaqel®, Pfizer Inc.), and vutrisiran (Amvuttra®, Alnylam Pharmaceuticals, Inc.) for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM).

 

This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.


Register for ICER’s Early Insights Webinar


On July 31, 2024, as part of ICER’s Early Insights Webinar Series, ICER’s Chief Medical Officer David Rind, MD, MSc 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 August 13, 2024. 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 Patient Portal and Manufacturer Engagement Guide 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 September 5, 2024. 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 September 20, 2024. 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 August 13, 2024. 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 conducts evidence-based reviews of health care interventions, including prescription drugs, other treatments, and diagnostic tests. In collaboration with patients, clinical experts, and other key stakeholders, ICER analyzes the available evidence on the benefits and risks of these interventions to measure their value and suggest fair prices. ICER also regularly reports on the barriers to care for patients and recommends solutions to ensure fair access to prescription drugs. For more information about ICER, please visit www.icer.org.