ICER Releases Draft Evidence Report on Treatment for Post-Traumatic Stress Disorder

— Public comment period now open until April 22, 2024; Requests to make oral comment during public meeting also being accepted —

BOSTON, March 26, 2024 – The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of 3,4-Methylenedioxymethamphetamine-assisted psychotherapy (MDMA-AP; Lykos Therapeutics) for the treatment of post-traumatic stress disorder (PTSD).

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.

“PTSD can be a severe condition affecting nearly all aspects of an individual’s life,” said ICER’s Chief Medical Officer David Rind, MD. “Current therapeutic options are insufficient for many people with PTSD. While MDMA-AP may be a promising therapy for PTSD, functional unblinding in the clinical trials and additional concerns around trial design and conduct leave many uncertainties about the balance of benefits and harms. It will be incumbent on regulators with complete access to primary data to carefully assess whether MDMA-AP has been proven safe and effective.”

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 April 22, 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 May 14, 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 May 30, 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 April 22, 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 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.