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.

For our previous coverage on the ICER report, see:

• • ICER Draft Evidence Report on Lykos’ MDMA-Assisted Psychotherapy Deems Clinical Evidence “Insufficient” (Mar 27);
  • Exclusive: Therapists and Trialists from Lykos’ Phase 3 MDMA-Assisted Therapy Studies Push Back on ICER’s Critical Draft Report (Apr 29);
  • Industry and Researchers Respond to ICER Report on MDMA-Assisted Therapy, Which Maintains Lykos’ Clinical Evidence Is “Insufficient” (May 14).

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...