You are currently viewing ICER Panel Rejects MDMA-Assisted Therapy, Highlights Evidence Gaps and Study Flaws in 14-1 Vote

ICER Panel Rejects MDMA-Assisted Therapy, Highlights Evidence Gaps and Study Flaws in 14-1 Vote

Yesterday, ICER’s independent appraisal committee, the New England Comparative Effectiveness Public Advisory Council (NE-CEPAC) met to discuss the effectiveness and value of Lykos Therapeutics’ MDMA-assisted therapy for PTSD.

We have covered ICER’s ongoing appraisal of MDMA-assisted therapy since late March, when the initial draft evidence report was published. As such, we won’t rehash those elements here, so please do review this earlier coverage if you’re getting up to speed.

NE-CEPAC was tasked with imbibing the report’s contents along with public and expert comments presented at the meeting, and arriving at decisions on a set of voting questions.

Much of the meeting’s first half consisted of ICER representatives presenting the clinical evidence review and economic model that was contained in the revised evidence report, but thereafter we heard new content in the form of public comments and discussion, the council’s deliberation on voting questions, a policy roundtable that took a more forward-looking approach, and the council’s closing reflections.

Here, we review some of the notable moments and comments from yesterday’s meeting.


  • CEPAC, Commenters Critique Lykos’ Study Design, Conduct
  • ICER and CEPAC Weigh In
  • Public Comments
  • No Change to ICER’s Exploratory Economic Analysis
  • ICER Faces Criticisms from Psychedelics Field
  • Current Evidence Inadequate, CEPAC Votes
  • ‘Policy Roundtable’ Looks Ahead at Potential Roll-Out Challenges
  • Closing Thoughts from CEPAC
  • Next Steps

To continue reading, please log in or join Pα+…

Join Pα+ Today

Independent data-driven reporting, analysis and commentary on the psychedelics space: from business and drug development through to policy reform and culture.

Already a member? Log In

   Regular Bulletins covering key topics and trends in the psychedelics space
   Regular articles and deep dives across psychedelic research, policy and business
   Interviews with insiders
   Monthly interactive database and commentary on psychedelic patents
   Quick-take analysis of major developments
   A Library of primers and explainers
   Access to our full back catalogue

Learn more about Pα+