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ICER pours cold water on MAPS’ MDMA-AT candidate for treating PTSD. In March, the Institute for Clinical and Economic Review (ICER) published its draft evidence report on MAPS’ (aka Lykos Therapeutics) Phase III clinical trials. The draft report, which is not the final version, controversially questions the integrity of the studies and validity of MAPS’ reported results. Thus, the draft evidence report goes against the overwhelming enthusiasm for the trial results from mental health practitioners and the subsequent anticipatory excitement surrounding the prospect of MDMA-AT for PTSD becoming legal later this year. In view of ICER’s influence in determining payor reimbursement policies for new drugs, critical to patient access, it is important to review and assess its concerns. ICER’s key concerns. ICER deems the clinical evidence of MAPS’ Phase III studies to be of ‘low certainty’ and therefore ‘insufficient’ to compare the effectiveness of MDMA-AT with trauma-focused psychotherapies. In arriving at this conclusion, the draft report highlights functional unblinding in the clinical trials and additional concerns about trial design and conduct as causes for many uncertainties about the balance of benefits and harms. Why ICER’s overall critique is underwhelming. The principal weakness of ICER’s preliminary assessment is its heavy reliance on secondhand ‘expert’ opinion, while its firsthand sources of information appear to have been limited to a small number of the 194 moderate-to-severe PTSD patients who enrolled in the trials. Importantly, a comment letter to the ICER draft, with 72 signatories who contributed to MAPS’ Phase III trials, states that none of the 109 therapists and investigators who worked in the Phase III trials was consulted in the preparation of the ICER assessment, which would indicate a large knowledge gap. The main body of our report below reviews ICER’s concerns and the pushback its assessment has received. Overall, it appears that ICER’s weight of argument is underwhelming and should not stand in the way of MDMA-AT for PTSD’s progress toward FDA approval. Next steps/key dates. May 14: ICER to post any changes to evidence report draft. May 30: Virtual public meeting to review ICER evidence report draft. June 4: FDA Advisory Committee meeting to review investigational MDMA-AT for PTSD. August 11: Prescription Drug User Fee Act (PDUFA) date for MDMA-AT.