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Shroom Shmooz

ICER draft update with little change. In a follow-up to Shroom Shmooz: How Valid Are ICER’s Concerns about MAPS’ MDMA-AT Trials? , we highlight the amended ICER report published on May 14, 2024, which incorporates the public comments it received. In short, there is no substantive difference between the updated and initial drafts. The skeptical tone of the integrity of the Phase III trial outcomes and conclusion that the current publicly available evidence is insufficient to assess the overall net benefit of MDMA-AT remain. The main difference between the two reports is that the revised version contains more discussion on comorbidities commonly associated with PTSD. The revised draft also incorporates corrections and additional inputs in the report’s supplemental information section. Public comments were elicited across the gamut of stakeholders. These include comments from Lykos, clinical experts, patients, and patient advocacy groups. In the following bullet points, we highlight the key takes from the public comments and ICER’s responses. The full summary of comments and responses released by ICER can be found here. Lykos and ICER not on the same page. We find the most contentious of Lykos’ public comments is that its management held three meetings with ICER prior to the publication of the latter’s draft report during which the issues contained in the draft report were not raised. ICER counterclaims that two of the meetings were held too early in its review process (August and September 2023), while outreaches in and around the third meeting held in March 2024 to receive input and feedback from Lykos received no substantive response. Otsuka backs ICER. Japan's Otsuka Pharmaceuticals, the only other pharma company to comment on the draft, agrees with ICER’s concerns about the integrity of Lykos’ Phase III trials. It should be pointed that Otsuka and Sweden’s Lundbeck recently submitted a supplemental NDA to the FDA to review for approval the use of Otsuka’s antipsychotic drug Brexpiprazole (Rexulti) combined with Lundbeck’s SSRI Sertraline (Zoloft) for PTSD. Could it be that Otsuka’s support for ICER’s evidence report may be a little self-serving? Clinical experts feedback – insiders versus outsiders. This includes the comment letter authored by the 72 signatories who were involved in the trials, which we highlighted in our report last week. ICER laid the blame on Lykos for its lack of engagement with trial insiders, which the letter had accused it of. There were additional comments from two of the signatories addressing ICER concerns of functional unbinding, investigator bias, and research oversight. Comments were also received from a couple of ‘experts’ who did not contribute to the trials. They tended to validate ICER concerns. Other stakeholders. There is a mishmash of other comments with some questioning ICER’s economic model and evaluation methodologies, the timing of the report prior to MDMA-AT PDUFA date, and the underrepresentation in the report of perspectives from people living with PTSD. Next steps/key dates. May 30: Virtual public meeting to review ICER evidence report. June 4: FDA Advisory Committee meeting to review investigational MDMA-AT for PTSD. June 27: ICER to release Final Evidence Report and Meeting Summary. August 11: Prescription Drug User Fee Act (PDUFA) date for MDMA-AT.