Compared implementation of the long-acting buprenorphine treatment buvidal in four European countries.

BACKGROUND: Buvidal is the only depot buprenorphine currently available in Europe. Buvidal offers a new treatment paradigm, which may require some adjustment in the national regulatory frameworks for opioid agonist treatments (OATs), as well as the national care systems. RESEARCH DESIGN AND METHODS: Data on the national dissemination of Buvidal, types of populations treated, and the national regulatory framework and care organization system through which Buvidal has been implemented were compared between the UK, Finland, Spain, and France, using a qualitative survey. RESULTS: In 2022, the proportion of people on OAT who received Buvidal was 2.1% in the UK, 60-65% in Finland, 1% in Spain, and 0.3% in France. In both Finland and the UK, the cost of the medication is covered by the national health system, whereas, in Spain and France, Buvidal is accessible only in specialized centers, which must carry its cost. Other national features may explain the gaps in Buvidal use, including the baseline level of OAT coverage, which was high in both France and Spain. CONCLUSIONS: Important national discrepancies are found regarding Buvidal dissemination among people on OAT.

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.

Variation in Initiation, Engagement, and Retention on Medications for Opioid Use Disorder Based on Health Insurance Plan Design.

BACKGROUND: The association between cost-sharing and receipt of medication for opioid use disorder (MOUD) is unknown. METHODS: We constructed a cohort of 10,513 commercially insured individuals with a new diagnosis of opioid use disorder and information on insurance cost-sharing in a large national deidentified claims database. We examined 4 cost-sharing measures: (1) pharmacy deductible; (2) medical service deductible; (3) pharmacy medication copay; and (4) medical office copay. We measured MOUD (naltrexone, buprenorphine, or methadone) initiation (within 14 d of diagnosis), engagement (second receipt within 34 d of first), and 6-month retention (continuous receipt without 14-d gap). We used multivariable logistic regression to assess the association between cost-sharing and MOUD initiation, engagement, and retention. We calculated total out-of-pocket costs in the 30 days following MOUD initiation for each type of MOUD. RESULTS: Of 10,513 individuals with incident opioid use disorder, 1202 (11%) initiated MOUD, 742 (7%) engaged, and 253 (2%) were retained in MOUD at 6 months. A high ($1000+) medical deductible was associated with a lower odds of initiation compared with no deductible (odds ratio: 0.85, 95% confidence interval: 0.74-0.98). We found no significant associations between other cost-sharing measures for initiation, engagement, or retention. Median initial 30-day out-of-pocket costs ranged from $100 for methadone to $710 for extended-release naltrexone. CONCLUSIONS: Among insurance plan cost-sharing measures, only medical services deductible showed an association with decreased MOUD initiation. Policy and benefit design should consider ways to reduce cost barriers to initiation and retention in MOUD.

Real-world changes in US health system hospital-based services following treatment with a prescription digital therapeutic for opioid use disorder.

Outcomes associated with buprenorphine therapy for the treatment of opioid use disorder (OUD) are suboptimal. reSET-O is an FDA-authorized prescription digital therapeutic (PDT) delivering neurobehavioral therapy via mobile devices to patients with OUD treated with buprenorphine. This analysis evaluated the net impact of reSET-O on medical costs among actively-engaged reSET-O patients using real-world observations. This real-world retrospective analysis of health care claims between October 2018 and October 2019 evaluated health care resource utilization up to 6 months before and 6 months after the initiation of a reSET-O prescription after accounting for the subset of patients not continuing on therapy after week 1 (non-engaged patients). Repeated-measures negative binomial models compared incidences of hospital-based encounters/procedures adjusted for days in each period as well as associated costs. The number needed to treat (NNT) to avoid an inpatient visit was calculated. Of the 351 patients who were prescribed reSET-O, 321 met the criteria of active engagement. Treatment with reSET-O was associated with a substantial reduction in medical costs of -$765,450 (-$2,385/patient, $235/patient greater than a previous analysis in which non-engaged patients were included) in the 6-month period after initiation. The gross reSET-O prescription cost of $584,415 ($1,665/patient) was substantially offset by $49,950 ($142.31/patient) in refunds to payers. The medical cost reduction in engaged patients offset the cost of the therapeutic resulting in an overall cost reduction of -$230,985 in this cohort (net savings of -$720 per patient). The number needed to treat to avoid an inpatient visit was 4.8. Engagement and continued treatment with reSET-O in patients with OUD treated with buprenorphine is associated with substantial real-world reductions in medical costs in the 6-month period following the initiation of the reSET-O prescription.

Cost-effectiveness of Treatments for Opioid Use Disorder.

Importance: Opioid use disorder (OUD) is a significant cause of morbidity and mortality in the US, yet many individuals with OUD do not receive treatment. Objective: To assess the cost-effectiveness of OUD treatments and association of these treatments with outcomes in the US. Design and Setting: This model-based cost-effectiveness analysis included a US population with OUD. Interventions: Medication-assisted treatment (MAT) with buprenorphine, methadone, or injectable extended-release naltrexone; psychotherapy (beyond standard counseling); overdose education and naloxone distribution (OEND); and contingency management (CM). Main Outcomes and Measures: Fatal and nonfatal overdoses and deaths throughout 5 years, discounted lifetime quality-adjusted life-years (QALYs), and costs. Results: In the base case, in the absence of treatment, 42 717 overdoses (4132 fatal, 38 585 nonfatal) and 12 660 deaths were estimated to occur in a cohort of 100 000 patients over 5 years, and 11.58 discounted lifetime QALYs were estimated to be experienced per person. An estimated reduction in overdoses was associated with MAT with methadone (10.7%), MAT with buprenorphine or naltrexone (22.0%), and when combined with CM and psychotherapy (range, 21.0%-31.4%). Estimated deceased deaths were associated with MAT with methadone (6%), MAT with buprenorphine or naltrexone (13.9%), and when combined with CM, OEND, and psychotherapy (16.9%). MAT yielded discounted gains of 1.02 to 1.07 QALYs per person. Including only health care sector costs, methadone cost $16 000/QALY gained compared with no treatment, followed by methadone with OEND ($22 000/QALY gained), then by buprenorphine with OEND and CM ($42 000/QALY gained), and then by buprenorphine with OEND, CM, and psychotherapy ($250 000/QALY gained). MAT with naltrexone was dominated by other treatment alternatives. When criminal justice costs were included, all forms of MAT (with buprenorphine, methadone, and naltrexone) were associated with cost savings compared with no treatment, yielding savings of $25 000 to $105 000 in lifetime costs per person. The largest cost savings were associated with methadone plus CM. Results were qualitatively unchanged over a wide range of sensitivity analyses. An analysis using demographic and cost data for Veterans Health Administration patients yielded similar findings. Conclusions and Relevance: In this cost-effectiveness analysis, expanded access to MAT, combined with OEND and CM, was associated with cost-saving reductions in morbidity and mortality from OUD. Lack of widespread MAT availability limits access to a cost-saving medical intervention that reduces morbidity and mortality from OUD. Opioid overdoses in the US likely reached a record high in 2020 because of COVID-19 increasing substance use, exacerbating stress and social isolation, and interfering with opioid treatment. It is essential to understand the cost-effectiveness of alternative forms of MAT to treat OUD.

Changes in For-Profit Medication-Assisted Therapy Clinics in an Appalachian City.

OBJECTIVES: This study is a follow-up to previous research regarding buprenorphine medication-assisted therapy (MAT) in Johnson City, Tennessee. For-profit MAT clinics were surveyed to determine changes in tapering practice patterns and insurance coverage during the last 3 years. METHODS: Johnson City for-profit MAT clinics; also called office based opioid treatment centers, were surveyed by telephone. Clinic representatives were asked questions regarding patient costs for therapy, insurance coverage, counseling offered onsite, and opportunities for tapering while pregnant. RESULTS: All of the MAT clinics representatives indicated that tapering in pregnancy could be considered even though tapering in pregnancy is contrary to current national guidelines. Forty-three percent of the clinics now accept insurance as compared with 0% in the 2016 study. The average weekly cost per visit remained consistent. CONCLUSIONS: The concept of tapering buprenorphine during pregnancy appears to have become a standard of care for this community, as representatives state it is offered at all of the clinics that were contacted. Representatives from three clinics stated the clinics require tapering, even though national organizations such as the American College of Obstetricians and Gynecologists and the American Society of Addiction Medicine do not recommend this approach. Although patients who have government or other insurance are now able to obtain buprenorphine with no expense at numerous clinics, the high cost for uninsured patients continues to create an environment conducive to buprenorphine diversion.

Factors Affecting Buprenorphine Utilization and Spending in Medicaid, 2002-2018.

OBJECTIVE: Buprenorphine is an essential medication for the treatment of opioid use disorder (OUD), but studies show it has been underused over the last 2 decades. We sought to evaluate utilization of and spending on buprenorphine formulations in Medicaid and to evaluate the impact of key market and regulatory factors affecting availability of different formulations and generic versions. METHODS: We first identified all buprenorphine formulations approved by the Food and Drug Administration for OUD using Drugs@FDA. We then used National Drug Codes to identify each drug in the Medicaid State Drug Utilization Data and extracted annual utilization rates and spending between 2002 and 2018 by drug and according to whether a brand-name or generic version was dispensed. We compared these trends to market and regulatory factors that affected competition, which we identified through searching the Federal Register, Westlaw, PubMed, and Google News. RESULTS: Brand-name buprenorphine-naloxone sublingual tablet and film formulations (Suboxone) were dispensed 2.7 times more (n = 634 213 140) and reimbursed 4.4 times more (n = $4 440 556 473) than all other formulations combined (n = 237 769 689; $1 018 988 133). We identified numerous market and regulatory factors that contributed to an estimated 9-year delay in generic versions of the tablet formulation and 6-year delay for generic versions of the film formulation. CONCLUSIONS: Brand-name buprenorphine formulations have been widely used in Medicaid, leading to substantial costs, in part because generic versions were delayed by multiple years owing to market and regulatory factors. Timely availability of low-cost generics could have helped encourage OUD treatment with buprenorphine during the height of the opioid crisis.

Financing Buprenorphine Treatment in Primary Care: A Microsimulation Model.

PURPOSE: We sought to determine the financial impact to primary care practices of alternative strategies for offering buprenorphine-based treatment for opioid use disorder. METHODS: We interviewed 20 practice managers and identified 4 approaches to delivering buprenorphine-based treatment via primary care practice that differed in physician and nurse responsibilities. We used a microsimulation model to estimate how practice variations in patient type, payer, revenue, and cost across primary care practices nationwide would affect cost and revenue implications for each approach for the following types of practices: federally qualified health centers (FQHCs), non-FQHCs in urban high-poverty areas, non-FQHCs in rural high-poverty areas, and practices outside of high-poverty areas. RESULTS: The 4 approaches to buprenorphine-based treatment included physician-led visits with nurse-led logistical support; nurse-led visits with physician oversight; shared visits; and solo prescribing by physician alone. Net practice revenues would be expected to increase after introduction of any of the 4 approaches by $18,000 to $70,000 per full-time physician in the first year across practice type. Yet physician-led visits and shared medical appointments, both of which relied on nurse care managers, consistently produced the greatest net revenues ($29,000-$70,000 per physician in the first year). To ensure positive net revenues with any approach, providers would need to maintain at least 9 patients in treatment, with a no-show rate of <34%. CONCLUSIONS: Using a simulation model, we estimate that many types of primary care practices could financially sustain buprenorphine-based treatment if demand and no-show rate requirements are met, but a nurse care manager-based approach might be the most sustainable.

Responses among substance abuse treatment providers to the opioid epidemic in the USA: Variations in buprenorphine and methadone treatment by geography, operational, and payment characteristics, 2007-16.

OBJECTIVE: To identify the geographic, organisational, and payment correlates of buprenorphine and methadone treatment among substance abuse treatment (SAT) providers. METHODS: Secondary analyses of the National Survey of Substance Abuse Treatment Services (NSSATS) from 2007-16 were conducted. We provide bivariate descriptive statistics regarding substance abuse treatment services which offered buprenorphine and methadone treatment from 2007-16. Using multiple logistic regression, we regressed geographic, organisational, and payment correlates on buprenorphine and methadone treatment. RESULTS: Buprenorphine is increasingly offered at SAT facilities though uptake remains comparatively low outside of the northeast. SAT facilities run by tribal governments or Indian Health Service which offer buprenorphine remain low compared to privately operated SAT facilities (AOR = 0.528). The odds of offering buprenorphine among facilities offering free or no charge treatment (AOR = 0.838) or a sliding fee scale (AOR = 0.464) was lower. SAT facilities accepting Medicaid payments showed higher odds of offering methadone treatment (AOR = 2.035). CONCLUSIONS: Greater attention towards the disparities in provision of opioid agonist therapies is warranted, especially towards the reasons why uptake has been moderate among civilian providers. Additionally, the care needs of Native Americans facing opioid-related use disorders bears further scrutiny.

Opioid use disorder in Germany: healthcare costs of patients in opioid maintenance treatment.

BACKGROUND: Opioid Use Disorder (OUD) is a substance use disorder with a chronic course associated with comorbid mental and somatic disorders, a high burden of psychosocial problems and opioid maintenance treatment (OMT) as a standard treatment. In the US, OUD imposes a significant economic burden on society, with annual societal costs estimated at over 55 billion dollars. Surprisingly, in Europe and especially in Germany, there is currently no detailed information on the healthcare costs of patients with OUD. The goal of the present research is to gather cost information about OUD patients in OMT with a focus on maintenance medication and relapses. METHODS: We analysed health claims data of four million persons covered by statutory health insurance in Germany, applying a cost-of-illness approach and aimed at examining the direct costs of OMT patients in Germany. Patients with an ICD-10 code F11.2 and at least one claim of an OMT medication were stratified into the treatment groups buprenorphine, methadone or levomethadone, based on the first prescription in each of the follow-up years. Costs were stratified for years with and without relapses. Group comparisons were performed with ANOVA. RESULTS: We analysed 3165 patient years, the total annual sickness funds costs were on average 7470 € per year and patient. Comparing costs of levomethadone (8400 €, SD: 11,080 €), methadone (7090 €, SD: 10,900 €) and buprenorphine (6670 €, SD: 7430 €) revealed significant lower costs of buprenorphine compared to levomethadone (p < 0.0001). In years with relapses, costs were higher than in years without relapses (8178 € vs 7409 €; SD: 11,622, resp. 10,378 €). In years with relapses, hospital costs were the major cost driver. CONCLUSIONS: The present study shows the costs of OUD patients in OMT for the first time with a German dataset. Healthcare costs for patients with an OUD in OMT are associated with more than two times the cost of an average German patients. Preventing relapses might have significant impact on costs. Patients in different OMT were dissimilar which may have affected the cost differences.

Methadone, Buprenorphine, or Detoxification for Management of Perinatal Opioid Use Disorder: A Cost-Effectiveness Analysis.

OBJECTIVE: To estimate whether methadone, buprenorphine, or detoxification treatment is the most cost-effective approach to the management of opioid use disorder (OUD) during pregnancy. METHODS: We created a decision analytic model that compared the cost effectiveness (eg, the marginal cost of the strategy in U.S. dollars divided by the marginal effectiveness of the strategy, measured in quality-adjusted life-years [QALYs]) of initiation of methadone, buprenorphine, or detoxification in treatment of OUD during pregnancy. Probabilities, costs, and utilities were estimated from the existing literature. Incremental cost-effective ratios for each strategy were calculated, and a ratio of $100,000 per QALY was used to define cost effectiveness. One-way sensitivity analyses and a Monte Carlo probabilistic sensitivity analysis were performed. RESULTS: Under base assumptions, initiation of buprenorphine was more effective at a lower cost than either methadone or detoxification and thus was the dominant strategy. Buprenorphine was no longer cost effective if the cost of methadone was 8% less than the base-case estimate ($1,646/month) or if the overall costs of detoxification were 121% less than the base-case estimate for the detoxification cost multiplier, which was used to increase the values of both inpatient and outpatient management of detoxification by a factor of 2. Monte Carlo analyses revealed that buprenorphine was the cost-effective strategy in 70.5% of the simulations. Direct comparison of buprenorphine with methadone demonstrated that buprenorphine was below the incremental cost-effective ratio in 95.1% of simulations; direct comparison between buprenorphine and detoxification demonstrated that buprenorphine was below the incremental cost-effective ratio in 45% of simulations. CONCLUSION: Under most circumstances, we estimate that buprenorphine is the cost-effective strategy when compared with either methadone or detoxification as treatment for OUD during pregnancy. Nonetheless, the fact that buprenorphine was not the cost-effective strategy in almost one out of three of simulations suggests that the robustness of our model may be limited and that further evaluation of the cost-effective approach to the management of OUD during pregnancy is needed.

A comparison of adherence, outcomes, and costs among opioid use disorder Medicaid patients treated with buprenorphine and methadone: A view from the payer perspective.

Medication-assisted treatment (MAT) with methadone or buprenorphine has been shown to be more effective at reducing the use of illicit opioids, the risk of drug-related overdose, and overall healthcare costs, on average, compared to abstinence-based addiction treatments for individuals with an opioid use disorder (OUD). Individuals who are adherent to MAT are more likely to experience positive outcomes. We used physical and behavioral Medicaid claims data of individuals newly treated with methadone (n = 212) and buprenorphine (n = 972) to examine the overall predictors of adherence, differences in adherence to each medication, the relationship between adherence and ED nonfatal drug-related overdose, and differences in total cost of care between the two medications. We found that older individuals and women had significantly lower risk of non-adherence. At six months, only 3.6% of individuals who were adherent to either treatment experienced a nonfatal drug-related overdose in the ED, compared to 13.2% of individuals who were non-adherent. We found no significant difference between methadone and buprenorphine on nonfatal drug-related overdose. Non-adherence to methadone was associated with a significant increase in total cost of care. Implications for how these results could be used to improve the overall impact of MAT are discussed.

Lost cost savings to the NHS in England due to the delayed entry of multiple generic low-dose transdermal buprenorphine: a case scenario analysis.

OBJECTIVE: Originator pharmaceutical companies prolonging the patent of a medicine prevents rivals' entry to the market and competition. As the entry of generic alternatives usually results in price reduction, any delay in their entry potentially deprives the National Health Service (NHS) of much-needed savings. This study estimates the potential cost savings lost to the NHS as a result of delayed entry of generic low-dose buprenorphine (LDTB) patches in England. DESIGN: Two case scenarios were modelled to determine the savings from the entry of generic LDTB Butec only between February and August 2016 and the potential savings which could have been achieved if all generic LDTB patches had entered the market at the same time. SETTING: The volume of utilisation of branded and generic LDTB in UK primary care was derived from the NHS business services authority website for prescriptions dispensed between February 2015 and January 2018. MAIN OUTCOME MEASURES: Cost savings associated with the entry of generic LDTB. RESULTS: The cumulative cost savings from the introduction of Butec alone was £0.7 ($0.92) million. The model predicted that if all generic buprenorphine entered the market at the same time with Butec, they could have been achieved a £1.2 ($1.57) million saving. This means that approximately £0.5 ($0.65) million savings was lost to the NHS over the 6-month time period. CONCLUSIONS: The entry of Butec was associated with cost savings. We estimated that more cost savings could have been achieved if other generic LDTB patches had entered the market at the same time to drive competition between rivals. Patent protection strategies which delayed the entry of multiple generics were responsible for the reduced cost savings to the NHS in England.

A Summary from the Institute for Clinical and Economic Review's New England Comparative Effectiveness Public Advisory Council.

DISCLOSURES: Funding for this summary was contributed by the Laura and John Arnold Foundation, Blue Shield of California, and California Health Care Foundation to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from Aetna, AHIP Anthem, Blue Shield of California, CVS Caremark, Express Scripts, Harvard Pilgrim Health Care, Cambia Health Solutions, United Healthcare, Kaiser Permanente, Premera Blue Cross, AstraZeneca, Genentech, GlaxoSmithKline, Johnson & Johnson, Merck, National Pharmaceutical Council, Prime Therapeutics, Sanofi, Spark Therapeutics, Health Care Service Corporation, Editas, Alnylam, Regeneron, Mallinkrodt, Biogen, HealthPartners, and Novartis. Otuonye, Kumar, and Pearson are ICER employees. Banken received consulting fees from ICER for work on this report.

Health insurance coverage is associated with access to substance use treatment among individuals with injection drug use: Evidence from a 12-year prospective study.

OBJECTIVE: Understand how insurance impacts access to services among people who have injected drugs. METHODS: 1748 adults who have injected drugs were assessed at twice-annual study visits between 2006 and 2017 (18,869 visits). Use of specialty substance use treatment, receipt of buprenorphine, and having a regular source of medical care were assessed for association with concurrent insurance coverage. Random intercept logistic regression was used to adjust for potential confounders. RESULTS: When participants acquired insurance, they were more likely to report specialty substance use treatment (aOR 2.0, 95% CI 1.6 to 2.5), a buprenorphine prescription (aOR 3.3, 95% CI 2.0 to 5.5), and a regular source of medical care (aOR 6.3, 95% CI 5.1 to 7.8). CONCLUSION: Insurance is associated with increased use of three important services for individuals who inject drugs. IMPLICATIONS: Expanding insurance may facilitate access to substance use treatment and other needed health services.

Physicians as Mediators of Health Policy: Acceptance of Medicaid in the Context of Buprenorphine Treatment.

Increasing numbers of individuals with opioid use disorder (OUD) are insured by Medicaid. Little is known about whether providers of buprenorphine, an evidence-based OUD pharmacotherapy, accept this type of payment. Data are scant regarding whether Medicaid acceptance varies by physician and state-level characteristics. To address these gaps, national survey data from 1174 buprenorphine-prescribing physicians (BPPs) and state characteristics were examined in a multi-level model of Medicaid acceptance. Only 52.0% of BPPs accepted Medicaid for buprenorphine-related office visits. Specialists in addiction and psychiatry were significantly less likely to accept Medicaid than other specialties, as were BPPs delivering buprenorphine in individual medical practice. Perceived adequacy of Medicaid reimbursement was positively associated with accepting Medicaid. Medicaid acceptance was not associated with states' implementation of the Medicaid expansion. Individuals who are covered by Medicaid may face barriers to accessing buprenorphine treatment, which has high public health significance given the ongoing opioid epidemic.