Updated cost-effectiveness of MDMA-assisted therapy for the treatment of posttraumatic stress disorder in the United States: Findings from a phase 3 trial

This study (2022) builds on previous research assessing the cost-effectiveness of MDMA-assisted therapy (MDMA-AT) for the treatment of PTSD by assessing the data from a recent phase III trial. MDMA-AT as conducted in the phase III trial costs $11,537 per patient. Compared to the standard of care for 1,000 patients, MDMA-AT generates discounted net health care savings of $132.9 million over 30 years. Ultimately, MDMA-AT for severe or chronic PTSD is cost-saving while delivering substantial clinical benefit.

Abstract

Background: Severe posttraumatic stress disorder (PTSD) is a prevalent and debilitating condition in the United States. and globally. Using pooled efficacy data from six phase 2 trials, therapy using 3,4-methylenedioxymethamphetamine (MDMA) appeared cost-saving from a payer’s perspective. This study updates the cost-effectiveness analysis of this novel therapy using data from a new phase 3 trial, including the incremental cost-effectiveness of the more intensive phase 3 regimen compared with the shorter phase 2 regimen.

Methods: We adapted a previously-published Markov model to portray the costs and health benefits of providing MDMA-assisted therapy (MDMA-AT) to patients with chronic, severe, or extreme PTSD in a recent phase 3 trial, compared with standard care. Inputs were based on trial results and published literature. The trial treated 90 patients with a clinician-administered PTSD scale (CAPS-5) total severity score of 35 or greater at baseline, and duration of PTSD symptoms of 6 months or longer. The primary outcome was assessed 8 weeks after the final experimental session. Patients received three 90-minute preparatory psychotherapy sessions, three 8-hour active MDMA or placebo sessions, and nine 90-minute integrative psychotherapy sessions. Our model calculates the per-patient cost of MDMA-AT, net all-cause medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). We reported results from the U.S. health care payer’s perspective for multiple analytic time horizons, (base-case is 30 years), and conducted extensive sensitivity analyses. Costs and QALYs were discounted by 3% annually. Costs were adjusted to 2020 U.S. dollars according to the medical component of the U.S. Bureau of Labor Statistics’ Consumer Price Index (CPI).

Results: MDMA-AT as conducted in the phase 3 trial costs $11,537 per patient. Compared to the standard of care for 1,000 patients, MDMA-AT generates discounted net health care savings of $132.9 million over 30 years, accruing 4,856 QALYs, and averting 61.4 premature deaths. MDMA-AT breaks even on cost at 3.8 years while delivering 887 QALYs. A third MDMA session generates additional medical savings and health benefits compared with a two-session regimen. Hypothetically assuming no savings in health care costs, MDMA-AT has an ICER of $2,384 per QALY gained.

Conclusions: MDMA-AT provided to patients with severe or extreme chronic PTSD is cost-saving from a payer’s perspective while delivering substantial clinical benefit.”

Authors: Elliot Marseille, Jennifer M. Mitchell & James G. Kahn

Study details

Compounds studied
MDMA

Topics studied
Equity and Ethics PTSD

Study characteristics
Literature Review Theory Building

Institutes

Institutes associated with this publication

Global Initiative for Psychedelic Science Economics
The Global Initiative for Psychedelic Science Economics (GIPSE) is a network of health economists dedicated to achieving the potential of psychedelic therapies for high-priority mental health conditions. 

University of California Berkley
The UC Berkeley Center for the Science of Psychedelics (BCSP) is exploring psychedelics as tools for understanding the brain and mind, enhancing well-being, and deepening spirituality.

University of California San Francisco
At UCSF, there are two research teams dedicated to the study of psychedelics; the Neuroscape Psychedelic Division and the Translational Psychedelic Research Program.

Linked Research Papers

Notable research papers that build on or are influenced by this paper

The cost-effectiveness of MDMA-assisted psychotherapy for the treatment of chronic, treatment-resistant PTSD
This study (2020) on the costs (and benefits) of MDMA-assisted therapy for PTSD finds it to be more cost-effective than other treatments. It's based on the data from six double-blind, placebo-controlled phase II trials (n=105) done by MAPS.

MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study
This double-blind, placebo-controlled study (n=90) finds that MDMA-assisted therapy (3x 80-120mg) is effective (d=.91, large effect size) in the treatment of PTSD. 67% of those in the MDMA-group no longer qualified for PTSD (vs 32% for the therapy-only group). This study is part of the Phase III trial to get MDMA approved by the FDA.