PMID- 35213554
OWN - NLM
STAT- MEDLINE
DCOM- 20220309
LR  - 20220602
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 17
IP  - 2
DP  - 2022
TI  - Updated cost-effectiveness of MDMA-assisted therapy for the treatment of 
      posttraumatic stress disorder in the United States: Findings from a phase 3 
      trial.
PG  - e0263252
LID - 10.1371/journal.pone.0263252 [doi]
LID - e0263252
AB  - 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 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.
FAU - Marseille, Elliot
AU  - Marseille E
AUID- ORCID: 0000-0001-8518-1143
AD  - Global Initiative for Psychedelic Science Economics, University of California, 
      Berkeley, CA, United States of America.
FAU - Mitchell, Jennifer M
AU  - Mitchell JM
AD  - Department of Neurology, University of California, San Francisco, San Francisco, 
      CA, United States of America.
FAU - Kahn, James G
AU  - Kahn JG
AD  - University of California, San Francisco, CA, United States of America.
LA  - eng
PT  - Journal Article
DEP - 20220225
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - KE1SEN21RM (N-Methyl-3,4-methylenedioxyamphetamine)
SB  - IM
EIN - PLoS One. 2022 Jun 2;17(6):e0269623. PMID: 35653357
MH  - Adaptation, Physiological/physiology
MH  - Adult
MH  - Clinical Trials, Phase III as Topic/economics
MH  - Cost-Benefit Analysis/*economics
MH  - Female
MH  - Humans
MH  - Male
MH  - Markov Chains
MH  - N-Methyl-3,4-methylenedioxyamphetamine/adverse effects/*therapeutic use
MH  - Psychiatric Status Rating Scales
MH  - Stress Disorders, Post-Traumatic/*drug therapy/*economics/epidemiology
MH  - Treatment Outcome
MH  - United States/epidemiology
PMC - PMC8880875
COIS- The authors have declared that no competing interests exist.
EDAT- 2022/02/26 06:00
MHDA- 2022/03/11 06:00
PMCR- 2022/02/25
CRDT- 2022/02/25 17:15
PHST- 2021/06/07 00:00 [received]
PHST- 2022/01/14 00:00 [accepted]
PHST- 2022/02/25 17:15 [entrez]
PHST- 2022/02/26 06:00 [pubmed]
PHST- 2022/03/11 06:00 [medline]
PHST- 2022/02/25 00:00 [pmc-release]
AID - PONE-D-21-18785 [pii]
AID - 10.1371/journal.pone.0263252 [doi]
PST - epublish
SO  - PLoS One. 2022 Feb 25;17(2):e0263252. doi: 10.1371/journal.pone.0263252. 
      eCollection 2022.