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.

Abstract

Background Chronic posttraumatic stress disorder (PTSD) is a disabling condition that generates considerable morbidity, mortality, and both medical and indirect social costs. Treatment options are limited. A novel therapy using 3,4-methylenedioxymethamphetamine (MDMA) has shown efficacy in six phase 2 trials. Its cost-effectiveness is unknown.

Methods and findings To assess the cost-effectiveness of MDMA-assisted psychotherapy (MAP) from the health care payer’s perspective, we constructed a decision-analytic Markov model to portray the costs and health benefits of treating patients with chronic, severe, or extreme, treatment-resistant PTSD with MAP. In six double-blind phase 2 trials, MAP consisted of a mean of 2.5 90-minute trauma-focused psychotherapy sessions before two 8-hour sessions with MDMA (mean dose of 125 mg), followed by a mean of 3.5 integration sessions for each active session. The control group received an inactive placebo or 25–40 mg. of MDMA, and otherwise followed the same regimen. Our model calculates net medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. Efficacy was based on the pooled results of six randomized controlled phase 2 trials with 105 subjects; and a four-year follow-up of 19 subjects. Other inputs were based on published literature and on assumptions when data were unavailable. We modeled results over a 30-year analytic horizon and conducted extensive sensitivity analyses. Our model calculates expected medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio. Future costs and QALYs were discounted at 3% per year. For 1,000 individuals, MAP generates discounted net savings of $103.2 million over 30 years while accruing 5,553 discounted QALYs, compared to continued standard of care. MAP breaks even on cost at 3.1 years while delivering 918 QALYs. Making the conservative assumption that benefits cease after one year, MAP would accrue net costs of $7.6 million while generating 288 QALYS, or $26,427 per QALY gained.

Conclusion MAP provided to patients with severe or extreme, chronic PTSD appears to be cost-saving while delivering substantial clinical benefit. Third-party payers are likely to save money within three years by covering this form of therapy.”

Authors: Elliot Marseille, James G. Kahn, Berra Yazar-Klosinski, Rick Doblin

Notes

This paper is included in our β€˜Top 10 Articles Introducing Psychedelic-Assisted Therapyβ€˜

The data on the participant outcomes, comes from Mithoefer et al (2019) which analysed the outcomes of the MAPS phase II trials.

This paper is also discussed in a press release by MAPS.

In the US, PTSD affects 6.8% of people during their lifetime and 3.5% of the population in the last year (Kessler et al, 2005a; Kessler et al, 2005b). Women, on average, are twice as likely to suffer from PTSD than men. Bothe and colleagues (2020) estimates the costs related to PTSD (medical costs) at €43.000 whilst Von der Warth and colleagues (2020) estimate the costs at between $5.500 and $24.450 for both direct and indirect costs. The current study estimated the medical cost at $19.899 for severe PTSD.

The present study investigates if MDMA-assisted psychotherapy may be a possible cost-effective intervention to alleviate these costs and the suffering experienced by those with PTSD.

The participants, on which the cost-estimates are based, are 105 people suffering from PTSD, of which 74 were in the active treatment group. They suffered from moderate to extreme chronic PTSD for an average of 16.5 years. The mean CAPS-IV score at baseline was 84 on average.

The study used a Markov model to simulate the costs and benefits. In this study, this meant they used it to model cost and benefits into the future with (pseudo)randomly changing data such as remission rates (as so to come to an average over X numbers of simulations).

The costs of treatment were estimated at $7,543. Of this $6.194 (82%) were the costs for therapists, $997 (13%) for screening, and $353 (5%) for the lab-grade MDMA.

  • The costs for therapists could potentially fall quite significantly if a less (over)qualified (second) therapist could hold/support the sessions, and/or if group therapy (see Anderson et al, 2020) was investigated/implemented.

The benefits of the study were estimated at 25% of the medical costs, for the proportion for which the intervention was successful (versus a Markov model of the same patients but at their baselines, i.e. without the intervention).

The results from the 10.000 simulations indicate an average (projected over 30 years) saving of 43 deaths averted, 5.500 added qualitative years (QALYs), and $103 million saved, per 1000 people treated. Or 5.5 added QALYs per person, and $103.000 medical care costs saved per person. The break-even (for costs) is estimated to be at 3 years after the intervention.

The paper then also tackles different variations/estimates for the costs and resulting benefits.

The model used in this study had several limitations. On the benefit side, it did not include benefits to the family and friends (added QALYs, lower domestic abuse, substance abuse, and productivity gains) and broader society. On the costs side, the study assumed no further relapses, a reasonable assumption for this treatment, but possibly less applicable to depression (TRD, MDD) for which a variety of psychedelics (e.g. psilocybin) in combination with therapy are being investigated.

Outside what the authors mention, there can be limitations in the applicability of these results and the effectiveness of this type of therapy for PTSD. Others (Goth & Hoeijmakers, 2020, p38) have pointed out that 1) the therapy standards could be higher in the study versus when scaled up, 2) study volunteers are more likely to respond than the average PTSD case (especially since the severity was so high in this study group), 3) being part of a study can lead to social desirability bias or observer effects (Hawthorne effect), and 4) risks of these results not replicating outside of these studies (although the number of treated patients is high in this study, it’s still only 74).

When looking at the cost for each added qualitative year (QALY), the current paper estimated this at 5.5 QALYs per $6.194 or $1.126 per QALY. This is significantly lower than the $28.000 to $42.000 (converted from pounds) the UK is willing to spend on medical interventions per QALY (NICE, 2013).

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