New research provides evidence that MDMA-assisted psychotherapy can improve and extend lives of patients with chronic and severe posttraumatic stress disorder while also reducing healthcare costs. The findings have been published in the journal PLOS One.
“Based on the encouraging results of multiple clinical trials of psychedelic-assisted therapies, it has become a cliche to say that we may be on the ‘cusp of a revolution in psychiatry,'” said Health Strategies International founder Elliot Marseille, the corresponding author of the new study.
“But like many cliches, there is substantial truth in this. About 10 months ago, along with colleagues at UCSF and UC Berkeley, we were inspired by the promise of these novel therapies to launch the Global Initiative for Psychedelic Science Economics (GIPSE).”
“Our mission is to provide rigorous and policy-relevant economic analyses on these emerging therapies,” Marseille explained. “In part because of its relevance to the decisions of health care payers, and thus to large scale access to the new therapies, cost-effectiveness analysis features importantly among GIPSE’s analytic approaches. Since MDMA is the closest of the psychedelic therapies to receiving FDA approval as a legal medicine, it made sense to devote analytic resources to this therapy.”
The researchers used a Markov model to calculate expected medical costs, mortality, and incremental cost-effectiveness ratio of MDMA-assisted therapy over 30 years. The data for the model came from a phase 3 clinical trial of MDMA-assisted psychotherapy for PTSD.
During the trial, treatment was administered to 90 participants over the course of 18 weeks. Patients underwent three 90-minute preparatory psychotherapy sessions, three 8-hour active MDMA or placebo sessions, and nine 90-minute integrative psychotherapy sessions. MDMA was well tolerated in patients with severe PTSD, and there was a robust reduction in symptoms among MDMA patients compared to patients receiving a placebo combined with a similar therapy.
The cost of the MDMA-assisted therapy was $11,537 per patient. The researchers estimated that utilizing the treatment would save $132.9 million while averting 61.4 premature deaths over the course of 30 years in a cohort of 1,000 hypothetical patients.
“The results we reported are based on the outcomes of the first phase 3 trial of a psychedelic therapy,” Marseille told PsyPost. “The most important findings are that MDMA-assisted therapy for severe, chronic PTSD can save health care dollars while providing clinical benefits far in excess of continued standard treatment. This should encourage health care payers to include MDMA-assisted therapy as a benefit to its members suffering from severe PTSD who did not benefit from standard first-line treatments.”
The researchers previously examined the cost-effectiveness of MDMA-assisted psychotherapy using data from phase 2 clinical trials. “This regimen featured two 8-hour MDMA sessions,” Marseille explained. “The regimen used in the phase 3 trial portrayed in our just-published 2022 paper features a third 8-hour MDMA session. Naturally, this makes the regimen more expensive. We therefore asked the question, ‘Is the additional benefit afforded by the third MDMA session sufficient to justify its cost?’ The answer is yes. The third session saves additional healthcare dollars over time, while conferring substantial additional clinical benefit.”
But Marseille noted that the phase 3 trial only evaluated the short-term efficacy of MDMA-assisted psychotherapy. “There are currently no published data on the long term benefits of MDMA therapy for PTSD, although the Multidisciplinary Association for Psychedelic Studies (MAPS), which sponsored the trials, is currently working on such a study,” he explained. “However, one small follow-up study from the phase 2 trials found that over an average follow-up period of 3.54 years, the benefit of MDMA-assisted therapy increased over time. Although the increase was not statistically significant, the sustained benefit was statistically significant. While we await more definitive information, this early finding is encouraging.”
Marseille also said that the costs associated with MDMA-assisted therapy for PTSD could change by the time it is approved by the U.S. Food and Drug Administration.
“The final cost may be substantially higher than the figure used in our base-case estimates,” Marseille told PsyPost. “However, the intervention would remain cost-saving over a standard 30-year horizon for any plausible MDMA-assisted therapy cost; but the time to financial ‘break-even’ for payers becomes longer, the higher the cost.”
“So far, the trials for MDMA-assisted therapy are limited almost entirely to people with severe or extreme, chronic and treatment-resistant forms of the disorder,” the researcher added. “It is hugely important that we have an effective new treatment for this group of patients. What is not yet known is how beneficial MDMA-assisted therapy might be for people with less severe and chronic PTSD. Thus, the cost-effectiveness of MDMA treatment for less severely-affected patients is also unknown.”
The study, “Updated cost-effectiveness of MDMA-assisted therapy for the treatment of posttraumatic stress disorder in the United States: Findings from a phase 3 trial“, was published by Elliot Marseille, Jennifer M. Mitchell, and James G. Kahn.
