Institute for Clinical and Economic Review Releases Draft Evidence Report on Treatment for Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease

— Public comment period now open until October 8, 2024; Requests to make oral comment during public meeting also being accepted —

BOSTON, September 12, 2024 – The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of tabelecleucel (“tab-cel”®, Pierre Fabre) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).

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.

On September 17, 2024, as part of ICER’s Early Insights Webinar Series, ICER’s Vice President of Research Foluso Agboola, MBBS, MPH 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 October 8, 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 October 31, 2024. All comments and ICER’s response to comments will be posted publicly along with the Evidence Report.

The Evidence Report will be the subject of a virtual public meeting of the New England CEPAC on November 14, 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.

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 October 8, 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.