Serious treatment-emergent adverse events in chronic low back pain patients treated with buprenorphine or oral opioids: a retrospective commercial claims analysis.

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.

Economic burden and dosing trends of buprenorphine buccal film and transdermal patch in chronic low back pain.

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.

What is this article about? This retrospective study included patients with chronic low back pain (cLBP) and commercial insurance in the USA. Only patients treated with Belbuca®, a buprenorphine buccal film, or a buprenorphine transdermal patch were included. Patients were observed 6 months prior to and 12 months after the first buprenorphine prescription. Healthcare costs, cost trends, resource use and buprenorphine treatment characteristics were explored.What were the results? Patients with cLBP on buccal film had lower costs, stable cost trends and less healthcare resources used. Also, they had higher buprenorphine daily doses.What do the results mean? The results imply that buccal film is less costly for cLBP patients than patches. The buccal film had more flexible dosing with higher daily doses, which might be associated with better pain control.

Treatment characteristics of chronic low back pain patients treated with buprenorphine buccal film or transdermal patch.

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.

What is this article about? The analysis explored treatment patterns in chronic low back pain patients treated with different buprenorphine drugs. The use of other pain medications was also evaluated. Buprenorphine buccal film (Belbuca^®) was compared with transdermal patches. This study used commercial insurance data of US patients. What were the results? The most relevant findings were: Patients using buccal film had about two-times higher buprenorphine daily doses. About 12% of patch patients switched to film, while approximately 4% of film patients switched to patch. Initiation of both buprenorphine drugs led to reduced usage of opioids and other pain drugs. Despite a shorter buprenorphine treatment, the film was associated with a greater reduction in opioid use than the patch. What do the results of the study mean? The results showed that patients prescribed buprenorphine buccal film would be able to achieve higher daily doses required for appropriate chronic low back pain management. The buccal film will also lead to a great reduction in concomitant opioid use. These advantages may explain why more patients switched from buprenorphine transdermal patch to buccal film than the other way around.

Accuracy of Noninvasive Diagnostic Tests for the Detection of Significant and Advanced Fibrosis Stages in Nonalcoholic Fatty Liver Disease: A Systematic Literature Review of the US Studies.

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.

Real-world Medicare Healthcare Costs of Patients with Dupuytren's Contracture Treated with Collagenase or Fasciectomy.

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.

A US Retrospective Claims Analysis Comparing Healthcare Costs of Patients Transitioning from Immediate-Release Oxycodone to Two Different Formulations of Extended-Release Oxycodone: Xtampza ER or OxyContin.

Purpose: 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.