Cost-effectiveness of midomafetamine-assisted therapy (MDMA-AT) in chronic and treatment-resistant post-traumatic stress disorder of moderate or higher severity: A health-economic model
Using a health state-transition model, midomafetamine-assisted therapy for chronic, moderate-or-higher PTSD produced a 0.377 QALY gain over five years at an incremental cost of $31,613, yielding an ICER of $83,845 per QALY. These results indicate MDMA-AT is likely cost-effective versus placebo with therapy at a $150,000 willingness-to-pay threshold (assuming a $12,000 per-session drug price).
Abstract
Objective
To explore the cost-effectiveness of midomafetamine-assisted therapy (MDMA-AT) compared to placebo with therapy (PT) in US healthcare settings.
Methods
A health state-transition model was used to analyze the cost-effectiveness of MDMA-AT for treating patients with chronic PTSD of moderate or higher severity. Both treatment arms consisted of 3 preparation (90-min), 3 interventional (8-h), and 9 integration (90-min) sessions, lasting ~4 months total. All sessions included psychotherapy, with interventional also including MDMA or placebo. After receiving treatment, patients were distributed across health states of No PTSD (not meeting PTSD diagnostic criteria), Non-Severe PTSD (treatment responders), Severe PTSD (treatment non-responders), and death. Each state had unique healthcare costs and utilities sourced from real-world data analysis and patient data from MDMA-AT clinical trials (including long-term follow-up). The base-case analysis considered the payer’s perspective with a 5-year horizon, 3.5% annual cost and effect discounts, and an assumed MDMA medication price of $12,000 per session. Trial-derived utilities and US life tables mortality data were used to calculate quality-adjusted life years (QALY). The main outcome was an incremental cost-effectiveness ratio (ICER) with a $150,000 willingness-to-pay (WTP) threshold.
Results
The base-case ICER was $83,845 per QALY. Total direct costs were $64,745 in the MDMA-AT and $33,132 in the PT arms ($31,613 increment). The costs of intervention were $48,376 for MDMA-AT and $12,376 for PT. The highest MDMA medication cost to fit under the WTP threshold was $20,314 per session. Costs related to PTSD healthcare visits and other PTSD treatments were lower with MDMA-AT than PT (-$2,511 and -$1,877 increments, respectively). Utility benefits were higher in MDMA-AT than PT, with 3.691 and 3.314 QALYs generated over 5 years, respectively (0.377 QALY increment).
Conclusion
These data suggest MDMA-AT may be a cost-effective treatment compared to PT for patients with chronic PTSD of moderate or higher severity.
Research Summary of 'Cost-effectiveness of midomafetamine-assisted therapy (MDMA-AT) in chronic and treatment-resistant post-traumatic stress disorder of moderate or higher severity: A health-economic model'
Introduction
PTSD is a common and burdensome psychiatric condition arising after exposure to traumatic events; prevalence estimates in the US reach up to 9.1% among civilians and 50.2% among military personnel. The condition is heterogeneous in onset and course, with certain subgroups (for example, females, those with childhood adversity, comorbid mental illness, low socioeconomic status or poor social support) at higher risk. Chronic PTSD carries substantial clinical comorbidity (depression, anxiety, substance use), increased premature mortality, and a sizeable economic burden: an incremental per-patient cost in the US was estimated at about $19.6k in 2018, higher among military cohorts. Stanicic and colleagues note that existing pharmacotherapies and psychotherapies have important limitations, including need for long-term use, adverse events, treatment discontinuation and substantial non-response. Midomafetamine-assisted therapy (MDMA-AT) combines manually delivered psychotherapy with MDMA sessions and has shown efficacy in Phase III randomized trials versus placebo with therapy. The present study therefore aims to evaluate the cost-effectiveness of MDMA-AT compared to placebo with therapy for adults with chronic PTSD of moderate or higher severity in a US payer context, using trial and real-world economic data to populate a state-transition model.
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Study Details
- Study Typeindividual
- Journal
- Compound
- Topics
- APA Citation
Stanicic, F., Zah, V., Grbic, D., & De Angelo, D. (2024). Cost-effectiveness of midomafetamine-assisted therapy (MDMA-AT) in chronic and treatment-resistant post-traumatic stress disorder of moderate or higher severity: A health-economic model. PLOS ONE, 19(11), e0313569. https://doi.org/10.1371/journal.pone.0313569
References (6)
Papers cited by this study that are also in Blossom
Wagner, M. T., Mithoefer, M. C., Mithoefer, A. T. et al. · Journal of Psychopharmacology (2017)
Mitchell, J., Ot’alora G, M., van der Kolk, B. et al. · Nature Medicine (2023)
Mitchell, J., Bogenschutz, M. P., Lilienstein, A. et al. · Nature Medicine (2021)
Marseille, E., Mitchell, M. J., Khan, J. G. · PLOS ONE (2022)
Marseille, E., Kahn, J. G., Yazar-Klosinski, B. et al. · PLOS ONE (2020)
Mithoefer, M. C., Wagner, M. T., Mithoefer, A. T. et al. · Journal of Psychopharmacology (2012)
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Marseille, E., Chernoloz, O., Orlov, |. O. · World Medical & Health Policy (2025)
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