Implementation of time-limited parenteral hydromorphone in people with treatment-resistant injecting opioid use disorder: a protocol for a single-site, uncontrolled, open-label study to assess feasibility, safety and cost.

INTRODUCTION: Supervised injectable opioid treatment (SIOT) is an evidence-based intervention targeting opioid-dependent people for whom existing treatments have been ineffective. This project will primarily assess the feasibility and the acceptability of time-limited SIOT using injectable hydromorphone delivered in an existing Australian public opioid treatment programme, with secondary outcomes of safety, cost, changes in drug use and other health outcomes. If feasible, the goal is to scale up the intervention to be more widely available in Australia. METHODS AND ANALYSIS: Between 20 and 30 participants will be offered two times per day hydromorphone to inject under direct observation, in addition to their current opioid agonist treatment (OAT), for up to 2 years. At the end of 2 years of supervised hydromorphone treatment, participants will be continued on standard OAT only. Informed consent will be obtained from all participants included in the study. This is a single-site, uncontrolled, open-label study where quantitative and qualitative interview data will be collected at baseline, 12 months and lastly at 3 months following their final hydromorphone dose. The main outcome measures are feasibility, as assessed by recruitment, retention and participation in treatment, and acceptability to participants, clinic staff and other stakeholders assessed by qualitative interviews. Secondary outcome measures of safety, as assessed by adverse events, and cost will also be assessed, as well as a range of other drug and health outcomes. ETHICS AND DISSEMINATION: This study received ethical approval from the St Vincent's Hospital Human Research Ethics Committee (2019/ETH00418). This will be the first study of time-limited SIOT in the Australian setting. All results will be submitted to peer-reviewed journals, scientific conferences and local practice meetings. A preliminary report on outcomes will also be presented to local health policy makers. A consumer and community forum will also be held to feedback results to a broader audience. TRIAL REGISTRATION NUMBER: ACTRN12621001729819.

Medicare Payment for Opioid Treatment Programs.

Importance: Medicare began paying for medications for opioid use disorder (MOUD) at opioid treatment programs (OTPs) that dispense methadone and other MOUD in January 2020. There has been little research describing the response to this payment change and whether it resulted in more patients receiving MOUD or just a shift in who pays for this care. Objective: To describe how many and which Medicare beneficiaries receive care from OTPs and how this compares to those receiving MOUD in other settings. Design, Setting, and Participants: This cross-sectional study included all patients receiving MOUD care identified in 2019-2022 100% US Medicare Parts B and D claims. Patients receiving care in an OTP who were dually insured with Medicare and Medicaid in the 2019-2020 Transformed Medicaid Statistical Information System were also included. Exposure: Receiving MOUD care in an OTP. Main Outcomes and Measures: Comparisons of 2022 beneficiaries treated in OTPs vs other non-OTP settings in 2022. Results: The share of Medicare beneficiaries treated by OTPs rose steadily from 4 per 10 000 (14 160 beneficiaries) in January 2020 to 7 per 10 000 (25 596 beneficiaries) in August 2020, then plateaued through December 2022; of 38 870 patients (23% ≥66 years; 35% female) treated at an OTP in 2022, 96% received methadone. Patients in OTPs, compared to those receiving MOUD in other settings, were more likely be 65 years and younger (65% vs 62%; P < .001), less likely to be White (72% vs 82%; P < .001), and more likely to be an urban resident (86% vs 74%; P < .001). When Medicare OTP coverage began, there was no associated drop in the number of dually insured patients with Medicaid with an OTP claim. Of the 1854 OTPs, 1115 (60%) billed Medicare in 2022, with the share billing Medicare ranging from 13% to 100% across states. Conclusions and Relevance: This study showed that since the initiation of Medicare OTP coverage in 2020, there has been a rapid increase in the number of Medicare beneficiaries with claims for OTP services for MOUD, and most OTPs have begun billing Medicare. Patients in OTPs were more likely to be urban residents and members of racial or ethnic minority groups than the patients receiving other forms of MOUD.

Payment-related barriers to medications for opioid use disorder: A critical review of the literature and real-world application.

BACKGROUND: The national opioid crisis continues to intensify, despite the fact that opioid use disorder (OUD) is treatable and opioid overdose deaths are preventable through first-line treatment with medications for opioid use disorder (MOUD). This study identifies and categorizes payment-related barriers that impact MOUD access and retention from both the provider and patient perspectives and provides insight into how these barriers can be addressed. METHODS: We performed a critical review of the literature (peer-reviewed studies and relevant documents from the gray literature) to identify payment-related access and retention barriers to MOUD. We used the results of this review to develop an analytic framework to understand how payment impacts MOUD access and retention for both providers and patients. In addition, we reviewed action plans developed by Massachusetts communities that participated in the Healing Communities Study (HCS) to analyze which payment-related barriers were addressed through the study. RESULTS: We identified 18 payment-related barriers that patients or providers face when initiating or continuing MOUD with either methadone or buprenorphine in Opioid Treatment Programs (OTP) and non-OTP settings. Patient-related barriers mainly relate to health insurance coverage or the design of health plans (e.g., cost sharing, covered benefits) resulting in direct (medical and non-medical) and indirect costs that can affect both access and retention, especially as they relate to services provided in OTPs. Provider-related barriers include low reimbursement and administrative burden and are most likely to impact access to MOUD. Evidence-based strategies to expand MOUD as part of the HCS in Massachusetts targeted about half of the patient and provider payment-related barriers identified. CONCLUSION: Patients and providers face an array of payment-related barriers that impact access to and retention on MOUD, most of which relate to inadequate health insurance coverage, features of health plans, and key federal and state policies. As new regulatory policies are enacted that expand access to MOUD, such as greater flexibility in OTPs and MOUD delivered via telehealth, it will be important to align these delivery changes with payment reform involving payers, providers, and policymakers.

Association Between Cost-Sharing and Buprenorphine Prescription Abandonment.

BACKGROUND: Prior studies suggest cost-sharing decreases buprenorphine dispensing. However, these studies used databases that only report prescriptions filled by patients, not those that were "abandoned." Consequently, the studies could not calculate the probability of buprenorphine prescription abandonment or evaluate whether cost-sharing is associated with abandonment. OBJECTIVE: To evaluate the association between cost-sharing and buprenorphine prescription abandonment. DESIGN: Cross-sectional analysis of the IQVIA Formulary Impact Analyzer, a pharmacy transaction database representing 63% of U.S. retail pharmacies. The database includes transaction records ("claims") for prescriptions even if they are not filled. PARTICIPANTS: Buprenorphine claims in 2022 among commercially insured and Medicare patients. MAIN MEASURES: We evaluated the association between cost-sharing per 30-day supply and abandonment using logistic regression, controlling for patient characteristics, product type, and buprenorphine use in the prior 180 days. We assessed for effect modification by prior buprenorphine use. KEY RESULTS: Analyses included 2,346,994 and 1,242,596 buprenorphine prescription claims for commercially insured and Medicare patients, respectively. Among these claims, mean (SD) cost-sharing per 30-day supply was $28.1 (46.4) and $8.4 (20.2), and 1.5% and 1.2% were abandoned. Each $10 increase in cost-sharing per 30-day supply was associated with a 0.09 (95% CI: 0.09, 0.10) and 0.09 (95% CI: 0.08, 0.10) percentage-point increase in abandonment among commercially insured and Medicare patients. Among commercially insured and Medicare patients without prior buprenorphine use, respectively, a $10 increase in cost-sharing per 30-day supply was associated with a 0.12 (95% CI: 0.11, 0.14) and 0.13 (95% CI: 0.07, 0.18) percentage-point higher increase in the probability of abandonment compared with patients with > 90 days of prior buprenorphine use. CONCLUSIONS: Among commercially insured and Medicare patients, buprenorphine prescription abandonment is rare and only minimally associated with cost-sharing. Findings suggest elimination of buprenorphine cost-sharing should only be one component of a larger, multi-faceted campaign to increase buprenorphine dispensing.

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.

Barriers and facilitators to use of buprenorphine in state-licensed specialty substance use treatment programs: A survey of program leadership.

INTRODUCTION: Medications for opioid use disorder (MOUD), including buprenorphine, reduce overdose risk and improve outcomes for individuals with opioid use disorder (OUD). However, historically, most non-opioid treatment program (non-OTP) specialty substance use treatment programs have not offered buprenorphine. Understanding barriers to offering buprenorphine in specialty substance use treatment settings is critical for expanding access to buprenorphine. This study aims to examine program-level attitudinal, financial, and regulatory factors that influence clients' access to buprenorphine in state-licensed non-OTP specialty substance use treatment programs. METHODS: We surveyed leadership from state-licensed non-OTP specialty substance use treatment programs in New Jersey about organizational characteristics, including medications provided on- and off-site and percentage of OUD clients receiving any type of MOUD, and perceived attitudinal, financial, and regulatory barriers and facilitators to buprenorphine. The study estimated prevalence of barriers and compared high MOUD reach (n = 36, 35 %) and low MOUD reach (n = 66, 65 %) programs. RESULTS: Most responding organizations offered at least one type of MOUD either on- or off-site (n = 80, 78 %). However, 71 % of organizations stated that fewer than a quarter of their clients with OUD use any type of MOUD. Endorsement of attitudinal, financial, and institutional barriers to buprenorphine were similar among high and low MOUD reach programs. The most frequently endorsed government actions suggested to increase use of buprenorphine were facilitating access to long-acting buprenorphine (n = 95, 96 %), education and stigma reduction for clients and families (n = 95, 95 %), and financial assistance to clients to pay for medications (n = 90, 90 %). CONCLUSIONS: Although non-OTP specialty substance use programs often offer clients access to MOUD, including buprenorphine, most OUD clients do not actually receive MOUD. Buprenorphine uptake in these settings may require increased financial support for programs and clients, more robust education and training for providers, and efforts to reduce the stigma associated with medication among clients and their families.

Co-located Heroin Assisted Treatment within primary care: A preliminary analysis of the implications for healthcare access, cost, and treatment delivery in the UK.

BACKGROUND: The UK is experiencing its highest rate of drug related deaths in 25 years. Poor and inconsistent access to healthcare negatively impacts health outcomes for people who use drugs. Innovation in models of care which promote access and availability of physical treatment is fundamental. Heroin Assisted Treatment (HAT) is a treatment modality targeted at the most marginalised people who use drugs, at high risk of mortality and morbidity. The first service-provider initiated HAT service in the UK ran between October 2019 and November 2022 in Middlesbrough, England. The service was co-located within a specialist primary care facility offering acute healthcare treatment alongside injectable diamorphine. METHODS: Analysis of anonymised health records for healthcare costs (not including drug treatment) took place using descriptive statistics prior and during engagement with HAT, at both three (n=15) and six (n=12) months. Primary outcome measures were incidents of wound care, skin and soft tissue infections (SSTIs), overdose (OD) events, unplanned overnight stays in hospital, treatment engagement (general and within hospital care settings) and ambulance incidents. Secondary outcome measures were costs associated with these events. RESULTS: A shift in healthcare access for participants during HAT engagement was observed. HAT service attendance appeared to support health promoting preventative care, and reduce reactive reliance on emergency healthcare systems. At three and six months, engagement for preventative wound care and treatment for SSTIs increased at the practice. Unplanned emergency healthcare interactions for ODs, overnight hospital stays, serious SSTIs, and ambulance incidents reduced, and there was an increase in treatment engagement (i.e. a reduction in appointments which were not engaged with). There was a decrease in treatment engagement in hospital settings. Changes in healthcare utilisation during HAT translated to a reduction in healthcare costs of 58% within six months compared to the same timeframe from the period directly prior to commencing HAT. CONCLUSION: This exploratory study highlights the potential for innovative harm reduction interventions such as HAT, co-located with primary care services, to improve healthcare access and engagement for a high-risk population. Increased uptake of primary healthcare services translated to reductions in emergency healthcare use and associated costs. Although costs of HAT provision are substantial, the notable cost-savings in health care should be an important consideration in service implementation planning.

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.

Estimate cost of providing methadone maintenance treatment at a methadone clinic in Nairobi Kenya: direct costs.

Methadone maintenance treatment is reported as cost-effective in treatment of opioid use disorder. Estimated cost of providing methadone varies widely in different regions but there is no data regarding cost of methadone treatment in Kenya. The aim of this study was to estimate the cost of methadone maintenance treatment at a methadone maintenance treatment clinic in Nairobi, Kenya from the perspective of the government, implementing partner and the clients. Data was collected for the period of February 2017 to September 2018 for 700 enrolled clients. The cost of providing methadone treatment was estimated as the sum of salaries, laboratory test, methadone and other commodities costs. The outcome was daily cost of methadone per client. The costs are given in Kenya Shillings (Ksh). The cost of treating one client is approximately Ksh. 149 (US$1.49) per day which amounts to Ksh 4500 (US$ 45) per month. This is from the estimated direct costs such as salaries which accounted for 86.4%, methadone 9.6%, tests and other consumables at 4%. The estimated average dose per patient per day is 60mg.This excludes indirect costs such as capital and set up cost, maintenance cost, training, drug import and distribution and other bills. The findings of this study show that the estimate cost of providing methadone at Nairobi, Kenya is comparable to that in other centers. This can help to inform policy makers on continued provision of methadone treatment in the country.

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.

The effectiveness and value of digital health technologies as an adjunct to medication-assisted therapy for opioid use disorder.

DISCLOSURES: Funding for this summary was contributed by Arnold Ventures, California Health Care Foundation, The Donaghue Foundation, Harvard Pilgrim Health Care, and Kaiser Foundation Health Plan 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 AbbVie, Aetna, America's Health Insurance Plans, Anthem, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Boehringer-Ingelheim, Cambia Health Services, CVS, Editas, Evolve Pharmacy, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, HealthFirst, Health Partners, Humana, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Pfizer, Premera, Prime Therapeutics, Regeneron, Sanofi, Spark Therapeutics, uniQure, and United Healthcare. Whittington, Campbell, and Pearson are employed by ICER. Tice reports contracts to his institution, University of California, San Francisco, from ICER during the conduct of this study.

Payer strategies to ensure access to care for individuals with opioid use disorder during COVID-19.

As the coronavirus disease 2019 (COVID-19) pandemic threatens to worsen the opioid crisis, payers must rapidly deploy policies to ensure care for individuals with opioid use disorder.

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.

Economic Evaluation in Opioid Modeling: Systematic Review.

OBJECTIVES: The rapid increase in opioid overdose and opioid use disorder (OUD) over the past 20 years is a complex problem associated with significant economic costs for healthcare systems and society. Simulation models have been developed to capture and identify ways to manage this complexity and to evaluate the potential costs of different strategies to reduce overdoses and OUD. A review of simulation-based economic evaluations is warranted to fully characterize this set of literature. METHODS: A systematic review of simulation-based economic evaluation (SBEE) studies in opioid research was initiated by searches in PubMed, EMBASE, and EbscoHOST. Extraction of a predefined set of items and a quality assessment were performed for each study. RESULTS: The screening process resulted in 23 SBEE studies ranging by year of publication from 1999 to 2019. Methodological quality of the cost analyses was moderately high. The most frequently evaluated strategies were methadone and buprenorphine maintenance treatments; the only harm reduction strategy explored was naloxone distribution. These strategies were consistently found to be cost-effective, especially naloxone distribution and methadone maintenance. Prevention strategies were limited to abuse-deterrent opioid formulations. Less than half (39%) of analyses adopted a societal perspective in their estimation of costs and effects from an opioid-related intervention. Prevention strategies and studies' accounting for patient and physician preference, changing costs, or result stratification were largely ignored in these SBEEs. CONCLUSION: The review shows consistently favorable cost analysis findings for naloxone distribution strategies and opioid agonist treatments and identifies major gaps for future research.

Associations Between Copays, Coverage Limits for Opioid Use Disorder Medications, and Prescribing in Medicaid, 2018.

BACKGROUND: Opioid use disorder (OUD) affects millions of Americans, but only a fraction receive treatment. Many patients with OUD are enrolled in Medicaid, but elements of different state Medicaid programs' drug benefit designs may impact patients' access to life-saving care. OBJECTIVE: To describe medication for OUD (mOUD) use in Medicaid and examine the relationship between mOUD use and state drug benefit design plans. DESIGN/SUBJECTS: Cross-sectional study using Medicaid State Drug Utilization Data from 2018 to quantify office-based mOUD and the Medicaid Behavioral Health Services Database to extract copay amounts and coverage limits for mOUD. We excluded states with <5% coverage and assessed for associations between copays or coverage limits and mOUD dispensing using simple linear regression. MEASURES: Proportion of mOUD prescriptions relative to all prescriptions, opioid prescriptions, and the state-level prevalence of pain reliever use disorder and association between copays, coverage limits and these proportions. RESULTS: There was substantial variability in mOUD use. Although state Medicaid drug benefit designs also varied, we found no significant relationship between copay requirements (yes/no), coverage limits (yes/no), copay amount ($0-$0.99 vs. $1 or more), and mOUD utilization measures. CONCLUSIONS: Substantial state-level variation exists in mOUD use, but we did not find a significant association between copays or coverage limits and use in Medicaid. Further research is needed to assess other potential impacts of mOUD drug benefit design elements in Medicaid.

Increasing access to medications for opioid use disorder: Policy analysis and proposals.

Opioid overdose continues to be the leading cause of accidental death in the United States, and the prevalence of OUD continues to increase. Increased access to health insurance-specifically in regard to state-funded Medicaid programs-as well as robust formularies and limited prior authorization have been demonstrated to be effective both in treating patients with OUD, as well as producing cost savings for government and commercial payors.

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.

Cost-effectiveness of syringe service programs, medications for opioid use disorder, and combination programs in hepatitis C harm reduction among opioid injection drug users: a public payer perspective using a decision tree.

BACKGROUND: The hepatitis C virus (HCV) prevalence rate among injection drug users (IDUs) in North America is 55.2%, with 1.41 million individuals estimated to be HCV-antibody positive. Studies have shown the effectiveness of syringe service programs (SSPs) alone, medications for opioid use disorder (MOUD) alone, or SSP+MOUD combination in reducing HCV transmission among opioid IDUs. OBJECTIVE: To evaluate the cost-effectiveness of SSP alone, MOUD alone, and SSP + MOUD combination in preventing HCV cases among opioid IDUs in the United States. METHODS: We used a decision tree analysis model based on published literature and publicly available data. Effectiveness was presented as the number of HCV cases avoided per 100 opioid IDUs. A micro-costing approach was undertaken and included both direct medical and nonmedical costs. Cost-effectiveness was assessed from a public payer perspective over a 1-year time horizon. It was expressed as an incremental cost-effectiveness ratio (ICER) and an incremental cost savings per HCV case avoided per 100 opioid IDUs compared with cost savings with "no intervention." Costs were standardized to 2019 U.S. dollars. RESULTS: The incremental cost savings per HCV case avoided per 100 opioid IDUs compared with no intervention were as follows: SSP + MOUD combination = $347,573; SSP alone = $363,821; MOUD alone = $317,428. The ICER for the combined strategy was $4,699 compared with the ICER for the SSP group. Sensitivity analysis showed that the results of the base-case cost-effectiveness analysis were sensitive to variations in the probabilities of injection-risk behavior for the SSP and SSP + MOUD combination groups, probability of no HCV with no intervention, and costs of MOUD and HCV antiviral medications. CONCLUSIONS: The SSP + MOUD combination and SSP alone strategies dominate MOUD alone and no intervention strategies. SSP had the largest incremental cost savings per HCV case avoided per 100 opioid IDUs compared with the no intervention strategy. Public payers adopting the SSP + MOUD combination harm-reduction strategy instead of SSP alone would have to pay an additional $4,699 to avoid an additional HCV case among opioid IDUs. Although these harm-reduction programs will provide benefits in a 1-year time frame, the largest benefit may become evident in the years ahead. DISCLOSURES: This research had no external funding. The authors declare no financial interests in this article. Ijioma is a Health Economics and Outcomes Research (HEOR) postdoctoral Fellow with Virginia Commonwealth University and Indivior. Indivior is a pharmaceutical manufacturer of opioid addiction treatment drugs but was not involved in the design, analysis, or write-up of the manuscript.

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.