ICER issues final evidence report and recommendations re: MDMA-assisted therapy; Lykos responds

Psychedelic Alpha issued a helpful discussion of both the Institute for Clinical & Economic Review's Final Evidence Report and Lykos Therapeutic's response: "The Institute for Clinical and Economic Review (ICER) published its Final Evidence Report on Lykos Therapeutics’ MDMA-assisted therapy for PTSD. There’s no substantive change from its draft evidence report’s determination, or from the vote of its independent panel which resoundingly rejected the intervention. That is, ICER finds the current evidence inadequate to demonstrate a net health benefit of MDMA-assisted therapy. Given the perceived inadequacy of the data, the organisation—which generally makes recommendations around the value for money of novel interventions—said that it was not possible to provide a health-benefit price benchmark for the drug at this time: a big blow to Lykos’ chances of achieving widespread reimbursement should they gain FDA’s approval in August. For more on the report and panel’s findings, see our earlier coverage ... Aside from issuing its final report (which we don’t discuss in detail here owing to its similarity to that discussed in our earlier coverage, above), ICER has today shared three policy recommendations with respect to MDMA-assisted therapy, and psychedelic therapies more broadly. The first states that any approval of a psychedelic therapy should be paired with “an expansive Risk Evaluation and Mitigation Strategies (REMS) program”, which would track adverse events and require “rigorous certification” of providers involved in the treatment. That certification and oversight should not be carried out by Lykos alone, the recommendation continues, due to potential conflicts of interest ... Instead, ICER prescribes, groups like the American Psychiatric Association and American Psychological Association should be involved, and other stakeholders such as payors might have a role to play here, too.  In practice, this could entail the manufacturer (Lykos, in this case) certifying providers before a separate entity (a speciality society, for example) provides a second sign-off. This certification and oversight should extend to both the prescriber and the therapists, ICER argues. Payors might also consider identifying “a limited network of centers of excellence for the provision of psychedelic treatments”, it continues. Its second recommendation suggests that, as soon as possible following any regulatory approval, both clinical specialty societies and large integrated provider systems like the VA should develop clinical practice guidelines. Its final recommendation for psychedelic treatments is directed toward payors themselves. ICER urges them to “translate the findings from pivotal trials of psychedelic treatments and the recommendations from available clinical guidelines into transparent, evidence-based coverage policies”. If MDMA-assisted therapy does receive approval in August, ICER says that it would “be reasonable for payers to draw relatively tight boundaries around coverage”, given what it characterises as “the context of the uncertainty at this time”. ICER also made more direct recommendations for future research, aside from suggesting that MDMA be tested in combination with evidence-based trauma-focused psychotherapies. It suggests, for example, conducting head-to-head trials that compare MDMA-assisted therapy with first-line trauma-focused psychotherapies. Evaluating different models of delivering MDMA-assisted therapy, such as in a 1:1 therapist:patient context, or with fewer or more frequent therapy sessions."

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