ECONOMIC VALUE OF METHYLONE-ASSISTED THERAPY FOR MODERATE-TO-SEVERE PTSD
Author(s)
Saran Ahluwalia, BS, MSc1, Emmanuel Fulgence Drabo, PhD2.
1Department of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA, 2Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
1Department of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA, 2Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
OBJECTIVES: Post-traumatic stress disorder (PTSD) affects ~13 million U.S. adults, with excess costs of $232 billion (2018 USD). First-line SSRIs achieve remission in only 20-30% of patients. In the IMPACT-1 trial (NCT05741710), TSND-201 (methylone) achieved higher loss-of-diagnosis (60.7% vs 30.8%) and remission (32.1% vs 11.5%) than placebo at day 64. This study evaluates the cost-effectiveness of TSND-201 versus SSRI-based standard of care for a hypothetical cohort of U.S. adults (≥18 years) with moderate-to-severe PTSD (Clinician-Administered PTSD Scale for DSM-5 [CAPS-5] ≥ 35).
METHODS: We developed a hybrid decision tree-Markov cohort model to assess the cost and benefit tradeoffs of TSND-201 vs the standard of care. The decision tree assigned patients to health states at day 64, linked to a Markov model that simulated monthly transitions through five health states: asymptomatic, mild, moderate, severe PTSD, and death. Base case analyses were conducted from healthcare sector and societal perspectives, over a five-year time horizon. Costs included direct medical costs, direct nonmedical costs, and indirect costs (patient time costs, caregiver time costs, and productivity costs). Effectiveness was measured in quality-adjusted life-years (QALYs), using EQ-5D-5L-based health state utility weights derived from multiple Phase III and clinical studies. Uncertainty in model input parameters was assessed through one-way deterministic and probabilistic sensitivity analyses (PSA). Scenario analyses were conducted with different time horizons, methylone costs, and alternative endpoints.
RESULTS: TSND-201 was dominant across both perspectives and time horizons. At $150,000/QALY, the 5-year incremental net monetary benefit (INMB) was $61,959 per patient (healthcare) and $121,638 (societal); at 10 years, these rose to $125,707 and $238,346, respectively. The PSA yielded a mean INMB of $56,713 (healthcare, 5-year; 91.4% probability of positive net value) and $211,257 (societal, 10-year; 91.7%). The break-even drug cost was $17,274 (5-year) and $34,911 (10-year).
CONCLUSIONS: Results suggest that TSND-201 may represent a good value-for-money treatment alternative to standard care.
METHODS: We developed a hybrid decision tree-Markov cohort model to assess the cost and benefit tradeoffs of TSND-201 vs the standard of care. The decision tree assigned patients to health states at day 64, linked to a Markov model that simulated monthly transitions through five health states: asymptomatic, mild, moderate, severe PTSD, and death. Base case analyses were conducted from healthcare sector and societal perspectives, over a five-year time horizon. Costs included direct medical costs, direct nonmedical costs, and indirect costs (patient time costs, caregiver time costs, and productivity costs). Effectiveness was measured in quality-adjusted life-years (QALYs), using EQ-5D-5L-based health state utility weights derived from multiple Phase III and clinical studies. Uncertainty in model input parameters was assessed through one-way deterministic and probabilistic sensitivity analyses (PSA). Scenario analyses were conducted with different time horizons, methylone costs, and alternative endpoints.
RESULTS: TSND-201 was dominant across both perspectives and time horizons. At $150,000/QALY, the 5-year incremental net monetary benefit (INMB) was $61,959 per patient (healthcare) and $121,638 (societal); at 10 years, these rose to $125,707 and $238,346, respectively. The PSA yielded a mean INMB of $56,713 (healthcare, 5-year; 91.4% probability of positive net value) and $211,257 (societal, 10-year; 91.7%). The break-even drug cost was $17,274 (5-year) and $34,911 (10-year).
CONCLUSIONS: Results suggest that TSND-201 may represent a good value-for-money treatment alternative to standard care.
Conference/Value in Health Info
2026-09, ISPOR Asia Pacific 2026, Bangkok, Thailand
Value in Health, Volume 55, Issue S1
Code
EE88
Topic
Economic Evaluation
Disease
STA: Biologics & Biosimilars, STA: Multiple/Other Specialized Treatments