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Oluwadara Olatoke,1 Vladimir Zah,1 Filip Stanicic,1 Djurdja Vukicevic,1 Platonas Yfantopoulos,1 Christy Thompson,2 Michael K DeGeorge,2 Steven Passik2 1HEOR Department, ZRx Outcomes Research, Mississauga, Ontario, Canada; 2Medical Department, Collegium Pharmaceutical Inc., Stoughton, MA, USACorrespondence: Oluwadara Olatoke, HEOR Department, ZRx Outcomes Research Inc., 3450 Cawthra Road, Mississauga, ON, L5A 2X7, Canada, +1 416 953 4427, Email dara@outcomesresearch.caPurpose: Opioid therapy for managing chronic pain remains a challenge, as providers must weigh the medical benefit to the patient with the risk of adverse events. Manipulation of many extended-release (ER) opioid formulations may lead to increased serious medical outcomes or death. The economic burden of opioid use disorders due to opioid misuse and abuse may vary depending on which abuse deterrent opioid formulation is prescribed. The study aimed to compare demographic and clinical characteristics and healthcare costs of chronic pain patients treated with two different abuse-deterrent opioid formulations, Xtampza ER and reformulated OxyContin.Methods: The source of data was IBM® MarketScan® Commercial Claims and Encounters Medicare Supplemental database, from January 2016 through February 2020. Patients with chronic pain were assigned to either the Xtampza ER or the OxyContin cohort based on the initial ER opioid prescription set as the index date. Continuous healthcare coverage was required during a minimum 3-month pre-index and 9-month post-index periods. Pre-index patients’ characteristics were analyzed. Healthcare costs of Xtampza ER vs OxyContin were assessed in the post-index period.Results: After applying selection criteria, 464 patients were observed in the Xtampza ER cohort versus 1927 patients in the OxyContin cohort. In unmatched patients, ER opioid costs were lower for Xtampza ER than OxyContin ($2645 vs $3141; p< 0.001), which ultimately led to lower total prescription costs for the Xtampza ER cohort compared to the OxyContin cohort ($7492 vs $8754; p=0.016). In matched patients, the total healthcare costs were significantly lower in the Xtampza ER cohort than in the OxyContin cohort, $22,630 vs $28,386 (p=0.005), respectively.Conclusion: This study suggests that Xtampza ER may result in lower healthcare costs than OxyContin for a population of chronic pain patients switching from immediate release oxycodone based on real-world data.Keywords: chronic pain, opioids, abuse-deterrent, short-acting, long-acting, cost

Aim: Exploring the healthcare costs and resource use among privately insured US patients with post-traumatic stress disorder (PTSD). Methods: This study used Merative MarketScan data. The index date was defined as the first PTSD claim. Study period included a 1-year pre-index and 2-year post-index follow-up. Cases with only acute PTSD, cancer, or insurance gap during the study period were excluded. The PTSD with (PwC) and PTSD without comorbidities (PwoC) cohorts were defined by the presence/absence of comorbid mental health conditions (schizophrenia, bipolar and major depressive disorder). Baseline PTSD (BP) cohort included PwoC cases with only index PTSD event and without FDA-approved PTSD medications or psychotherapy. Sub-analysis is conducted among patients with PTSD and substance/alcohol use disorder. Study cohorts were matched in a 1:1:1 ratio. Results: The matched sample included 5076 patients (1681 PwC, 1681 PwoC, 1714 BP). PwC patients had higher 2-year PTSD-related costs than PwoC and BP patients ($3762 vs $1750 and $841; all p < 0.001). The same trend was noted among all-cause and anxiety-related costs. PwC patients had higher 2-year PTSD-related inpatient and emergency department (ED) rates than PwoC (10.2% vs 1.7% and 6.8% vs 2.6%, all p < 0.001) and inpatient and outpatient rates than BP (10.2% vs 2.1% and 98.0% vs 93.1%; all p ≤ 0.004). The sub-analysis had 3776 patients (3154 PwC, 537 PwoC, 85 BP). PwC had higher 2-year PTSD-related costs than PwoC and BP ($7668 vs $2919 and $1,483; all p < 0.001). The same trend was noted in all-cause and anxiety-related costs. PwC also had higher 2-year PTSD-related inpatient and ED rates than PwoC (25.6% vs 10.4% and 12.7% vs 5.2%; all p < 0.001) and inpatient and outpatient rates than BP (25.6% vs 8.2% and 95.5% vs 84.7%; all p < 0.001). Conclusion: PTSD is associated with high healthcare costs and resource use. The highest economic burden was observed in patients with PTSD and mental health comorbidities.

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.)

Aim: Explore the safety of Belbuca® (buprenorphine buccal film), buprenorphine transdermal patches and oral opioids for chronic low back pain (cLBP) treatment. Methods: The retrospective analysis of the MarketScan Commercial database (2018-2021) included treatment-naive cLBP adults. The first date of buprenorphine (Belbuca and transdermal patch) or opioid prescription was index date. Cohorts were defined based on the index medication. Observation included a 6-month pre-index period, while post-index lasted until the end of continuous insurance coverage. There were 44 relevant treatment-emergent adverse events (TEAEs) identified in the literature. Incidence rate ratio (IRR) and incidence rate difference (IRD) were used to compare serious TEAE rates (in 1000 person-years) between cohorts. Propensity-score matching minimized the selection bias. Results: Buprenorphine had lower rates of 15 serious TEAEs than oral opioids (all p ≤ 0.037), while higher rates only for serious dizziness (IRR 2.44, p = 0.011; driven by Belbuca), opioid abuse/dependence (IRR 3.13, p = 0.004; driven by patches) and cholecystitis (IRD 20.25, p = 0.044; an outlier). Additionally, a comparison between Belbuca and oral opioids showed lower rates of 13 serious TEAEs (all p ≤ 0.024) and a higher serious dizziness rate (IRR 3.17, p = 0.024). Although the rates of serious opioid abuse/dependence were similar (24.60 vs 26.93, p = 0.921), all Belbuca patients and none of the opioid patients had a positive history of these events. Belbuca also had lower rates of five serious TEAEs than transdermal patches (all p ≤ 0.018), including a serious opioid abuse/dependence (IRR 0.04, p < 0.001), but higher rates of serious cholecystitis (IRD 52.17, p = 0.035; an outlier) and suicidal ideation (IRD 156.50, p < 0.001; an outlier). Conclusion: Buprenorphine had a better safety profile than oral opioids in cLBP treatment. Belbuca showed a more favorable TEAE profile than buprenorphine transdermal patches and oral opioids.

Aim: Exploring prescribing trends and economic burden of chronic low back pain (cLBP) patients prescribed buprenorphine buccal film (Belbuca®) or transdermal patches. Methods: In the MarketScan® commercial insurance claims (employees and their spouses/dependents, 2018-2021), the first film or patch prescription date was an index event. The observation covered 6-month pre-index and 12-month post-index periods. Results: Patients were propensity-score matched (708 per cohort). Buprenorphine initiation had stable cost trends in buccal film and increasing trends in transdermal patch cohort. Between-cohort comparisons of healthcare expenditures, cost trends and resource utilization showed significant differences, mostly in favor of buccal film. Buccal film also had higher daily doses and wider dosing range. Conclusion: Buprenorphine film is more cost-effective cLBP treatment with more flexible dosing.

Aims: Retrospective insurance claims analysis exploring treatment characteristics in chronic low back pain patients prescribed buprenorphine buccal film (Belbuca ® ) or transdermal patches. Patients and methods: The first buprenorphine prescription (buccal film or transdermal patch) was an index event. Patients were observed over 6 month pre- and post-index periods. Propensity score matching minimized the selection bias. Results: Buccal film patients had a higher buprenorphine daily dose (501.7 vs 270.9 µg; p < 0.001). The patch-to-film switching rate was higher than vice versa (11.5 vs 3.8%; p < 0.001). The buccal film showed a greater reduction in opioid prescriptions (-1.1 vs -0.7; p = 0.012), daily morphine milligram equivalents (-12.6 vs -7.3; p < 0.001) and opioid treatment duration (-13.4 vs -7.6 days; p = 0.022). Conclusion: Buccal film was associated with higher buprenorphine doses and a greater reduction of opioid burden.

Background: The purpose of this systematic literature review (SLR) was to evaluate the accuracy of noninvasive diagnostic tools in detecting significant or advanced (F2/F3) fibrosis among patients with nonalcoholic fatty liver (NAFL) in the US healthcare context., Methods: The SLR was conducted in PubMed and Web of Science, with an additional hand search of public domains and citations, in line with the PRISMA statement. The study included US-based original research on diagnostic test sensitivity, specificity and accuracy., Results: Twenty studies were included in qualitative evidence synthesis. Imaging techniques with the highest diagnostic accuracy in F2/F3 detection and differentiation were magnetic resonance elastography and vibration-controlled transient elastography. The most promising standard blood biomarkers were NAFLD fibrosis score and FIB-4. The novel diagnostic tools showed good overall accuracy, particularly a score composed of body mass index, GGT, 25-OH-vitamin D, and platelet count. The novel approaches in liver fibrosis detection successfully combine imaging techniques and blood biomarkers., Conclusions: While noninvasive techniques could overcome some limitations of liver biopsy, a tool that would provide a sufficiently sensitive and reliable estimate of changes in fibrosis development and regression is still missing.

Background: Our study aimed to compare real-world healthcare resource utilization (HRU) and healthcare cost (HC) of Medicare-insured patients (≥65 years old) with Dupuytren's contracture (DC) treated with Clostridium histolyticum (collagenase) or fasciectomy., Methods: DC patients treated with collagenase or fasciectomy between July 2011 and June 2017 were identified using the IBM MarketScan Medicare Supplemental Database. The index date was the date of the first procedure. Demographic characteristics were captured on the index date, and comorbidities were assessed during the 24-month preindex period. HRU and HC were analyzed throughout the 12-month postindex period. Patients were matched using propensity score weights. Gamma log-linked generalized linear models were used to evaluate HC drivers., Results: Out of 37,374 DC patients, 2911 received collagenase, while 6258 underwent fasciectomy. Postmatching, the total average annual HC was similar between collagenase and fasciectomy ($7271 versus $6220, P = 0.357). When HCs were stratified by the service provider, outpatient facility and physician office costs were lower in the collagenase cohort ($850 versus $1284, P = 0.047 and $546 versus $1001, P < 0.001). The costs of professional services were significantly higher than in the fasciectomy cohort due to the cost of collagenase injection ($1682 versus $629, P < 0.001). The HRU was similar between cohorts, except for more frequent outpatient facility visits in fasciectomy patients (12.3 versus 22.9, P < 0.001). Generalized linear model revealed Charlson comorbidity index, plan type, patients' residence region, sleep disorder, and hyperlipidemia as significant predictors of total HC., Conclusion: This study found comparable total annual HC and HRU between collagenase- and fasciectomy-treated Medicare patients., (Copyright © 2022 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of The American Society of Plastic Surgeons.)