COST-EFFECTIVENESS OF METHYLONE-ASSISTED THERAPY VERSUS STANDARD OF CARE FOR MODERATE-TO-SEVERE POST-TRAUMATIC STRESS DISORDER: A HYBRID DECISION TREE--MARKOV MODEL
Author(s)
Saran Ahluwalia, BS, MSc1, Emmanuel Fulgence Drabo, PhD2.
1Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA, 2Erasmus School of Health Policy & Management, Rotterdam, Netherlands.
1Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA, 2Erasmus School of Health Policy & Management, Rotterdam, Netherlands.
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 non-medical 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 $56,398 (healthcare, 5-year; 91.5% 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 non-medical 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 $56,398 (healthcare, 5-year; 91.5% 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
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EE653
Topic
Economic Evaluation, Health Policy & Regulatory, Methodological & Statistical Research
Topic Subcategory
Trial-Based Economic Evaluation
Disease
Injury & Trauma, Mental Health (including addiction)