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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., Competing Interests: Filip Stanicic, Vladimir Zah, and Dimitrije Grbic are employees of ZRx Outcomes Research Inc., which received funding from Lykos Therapeutics for this work. Debra De Angelo is an employee of and owns stocks/stock options in Lykos Therapeutics., (Copyright: © 2024 Stanicic et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objective: This retrospective claims analysis explored the treatment utilization and characteristics among patients with post-traumatic stress disorder (PTSD) of different severity., Methods: The index date was the first PTSD claim. The analysis observed 12 months pre- and 24 months post-index. Adults with insurance gaps, cancer, or acute PTSD during the observation were excluded. Patients were categorized into three severity cohorts based on treatment and healthcare services utilization for PTSD: 1. Baseline PTSD (BP) (no PTSD visits post-index, no FDA-approved medications/ psychotherapy, and no severe mental health comorbidities); 2. PTSD without Comorbidities (PwoC) (≥1 PTSD visits post-index and no severe mental health conditions); 3. PTSD with Comorbidities (PwC) (≥1 PTSD visits post-index and severe mental health comorbidities present). For the primary analysis, cohorts were propensity-score matched. A sub-analysis examined patients with PTSD and Substance or Alcohol Use Disorder (SUD/AUD)., Results: The primary analysis observed 1714 BP, 1681 PwoC, and 1681 PwC patients. Treatment utilization rates were highest among PwC vs. other cohorts (84.5% psychotherapy, 76.1% off-label medications, and 26.1% FDA-approved medications [p<0.001]). PwC cohort also had the highest number of psychotherapy sessions and medication prescriptions per patient (20.1 sessions, 12.6 off-label prescriptions, and 2.0 FDA-approved prescriptions [p<0.001]). The proportion of days covered (PDC) indicated low medication adherence (0.25-0.40) with adherent patient rates (PDC ≥0.80) between 8.0-17.5%. The SUD/AUD sub-analysis identified 85 BP, 537 PwoC, and 3154 PwC patients. Conclusions were similar, with PwC cohort having highest treatment utilization rates (87.1% psychotherapy, 85.0% off-label medications, 28.2% FDA-approved medications [p≤0.013] with 24.4 sessions, 16.1 off-label prescriptions, and 2.0 FDA-approved prescriptions per patient [p≤0.002]). Only 4.7-11.4% of patients were adherent., Conclusions: PwC patients received psychotherapy and pharmacotherapy more frequently than PwoC and BP patients. Medication adherence among treated patients was low. Patients with SUD/AUD had numerically higher treatment utilization and lower medication adherence., Competing Interests: The authors have read the journal’s policy and have the following competing interests: FS, VZ, and DG are employees of ZRx Outcomes Research Inc., which received funding from Lykos for this work. DDA is an employee of Lykos. WB was an employee of Lykos at the time of the study conduction and manuscript submission. Lykos is developing 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy, which has not been approved by any regulatory agency. The safety and efficacy of MDMA-assisted therapy have not been established for the treatment of PTSD. This does not alter our adherence to PLOS ONE policies on sharing data and materials. There are no additional patents, products in development, or marketed products associated with this research to declare.", (Copyright: © 2024 Stanicic et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Purpose: Lintuzumab (HuM195) is an unconjugated humanized murine monoclonal antibody directed against the cell surface myelomonocytic differentiation antigen CD33. In this study, the efficacy of lintuzumab in combination with induction chemotherapy was compared with chemotherapy alone in adults with first relapsed or primary refractory acute myeloid leukemia (AML)., Patients and Methods: Patients with relapsed or primary resistant AML (duration of first response, zero to 12 months) were randomly assigned to receive either mitoxantrone 8 mg/m(2), etoposide 80 mg/m(2), and cytarabine 1 g/m(2) daily for 6 days (MEC) in combination with lintuzumab 12 mg/m(2), or MEC alone. Overall response, defined as the rate of complete remission (CR) and CR with incomplete platelet recovery (CRp), was the primary end point of the study, with additional analyses of survival time and toxicity., Results: A total of 191 patients were randomly assigned from November 1999 to April 2001. The percent CR plus CRp with MEC plus lintuzumab was 36% v 28% in patients treated with MEC alone (P = .28). The overall median survival was 156 days and was not different in the two arms of the study. Apart from mild antibody infusion-related toxicities (fever, chills, and hypotension), no differences in chemotherapy-related adverse effects, including hepatic and cardiac dysfunction, were observed with the addition of lintuzumab to induction chemotherapy., Conclusion: The addition of lintuzumab to salvage induction chemotherapy was safe, but did not result in a statistically significant improvement in response rate or survival in patients with refractory/relapsed AML.