Establishing a Protocol for Determining the Costs of an Integrated Set of Evidence-based Practices Aimed at Reducing Opioid Overdose Deaths.

OBJECTIVES: In the midst of the opioid overdose crisis, local jurisdictions face a choice of public health interventions. A significant barrier when considering evidence-based practices (EBPs) is the lack of information regarding their implementation cost. This protocol paper provides the methodological foundation for the economic cost evaluations of community-wide strategies on the scale of a national study. It can serve as a resource for other communities, local policymakers, and stakeholders as they consider implementing possible public health strategies in their unique settings. METHODS: We present a protocol that details (1) the process of identifying, reviewing, and analyzing individual strategies for study-funded and non-study-funded costs; (2) prospective costing tool designation, and; (3) data collection. To do this, we set up working groups with community stakeholders, reviewed financial invoices, and surveyed individuals with detailed knowledge of their community implementation. DISCUSSION: There were 3 main challenges/limitations. The first was the lack of a standard structure for documenting nonfunded costs associated with each strategy. The second was the need for timely implementation of cost data. The third was generalizability because our study designed its strategies for selected communities due to their high opioid overdose mortality rates. Future steps include more tailored questions to ask during the categorization/filter process and establishing realistic expectations for organizations regarding documenting. CONCLUSIONS: Data collected will provide a critical methodological foundation for costing large community-based EBP strategies and provide clarity for stakeholders on the cost of implementing EBP strategies to reduce opioid overdose deaths.

Out-of-pocket spending and health care utilization associated with initiation of different medications for opioid use disorder: Findings from a national commercially insured cohort.

INTRODUCTION: Buprenorphine and naltrexone are effective medications for opioid use disorder (MOUD). Naltrexone requires complete detoxification from opioids before initiation while buprenorphine does not, which leads to a differential clinical induction challenge. Few studies have evaluated economic costs associated with MOUD initiation. METHODS: We conducted a retrospective cohort analysis using the 2014-2019 Merative MarketScan database. We included individuals diagnosed with opioid use, abuse, or dependence from 2014 to 2019 who initiated one of three MOUD types: 1) buprenorphine, 2) extended-release naltrexone, or 3) oral naltrexone. We calculated total and monthly out-of-pocket spending, for overall and MOUD-specific claims, for the three months prior through three months after MOUD initiation. We also calculated utilization of detoxification, inpatient, and outpatient services monthly over this period. RESULTS: Our cohort included 27,133 individuals; 19,536, 1886, and 5711 initiated buprenorphine, extended-release naltrexone, and oral naltrexone, respectively. Individuals who initiated naltrexone had the highest out-of-pocket spending over the study period. MOUD-specific spending did not contribute substantially to total out-of-pocket spending. Difference in overall spending by MOUD type was driven by a subset of individuals who initiated naltrexone and had very high out-of-pocket spending in the month prior to MOUD initiation. In this month, mean monthly out-of-pocket spending for high-spenders (above 90th percentile within MOUD type category) was $5734 (95 % confidence interval [CI]: $5181-$6286) and $4622 (95 % CI: $4161-$5082) for those who initiated oral and extended-release naltrexone, respectively, compared with $1852 (95 % CI: $1754-$1950) for those who initiated buprenorphine. In the month prior to MOUD initiation, those who initiated naltrexone also had higher detoxification, inpatient, and outpatient episode/visit frequency. In the month prior to initiation, 28.8 % (95 % CI: 27.7 %-30.0 %) and 25.5 % (95 % CI: 23.6 %-27.5 %) of individuals who initiated oral and extended-release naltrexone had detoxification episodes, compared with 9.7 % (95 % CI: 9.3 %-10.1 %) of those who initiated buprenorphine. CONCLUSION: Findings suggest that individuals who initiated naltrexone utilized more intensive health services, including detoxification, in the period prior to MOUD initiation, resulting in significantly higher out-of-pocket spending. Out-of-pocket spending is a patient-centered outcome reflecting potential patient burden. Our results should be considered as part of the shared decision-making process between patients and providers when choosing treatment for OUD.

Economic Evaluation of Extended-Release Buprenorphine for Persons With Opioid Use Disorder.

Importance: In 2017, the US Food and Drug Administration (FDA) approved a monthly injectable form of buprenorphine, extended-release buprenorphine; published data show that extended-release buprenorphine is effective compared with no treatment, but its current cost is higher and current retention is lower than that of transmucosal buprenorphine. Preliminary research suggests that extended-release buprenorphine may be an important addition to treatment options, but the cost-effectiveness of extended-release buprenorphine compared with transmucosal buprenorphine remains unclear. Objective: To evaluate the cost-effectiveness of extended-release buprenorphine compared with transmucosal buprenorphine. Design, Setting, and Participants: This economic evaluation used a state transition model starting in 2019 to simulate the lifetime of a closed cohort of individuals with OUD presenting for evaluation for opioid agonist treatment with buprenorphine. The data sources used to estimate model parameters included cohort studies, clinical trials, and administrative data. The model relied on pharmaceutical costs from the Federal Supply Schedule and health care utilization costs from published studies. Data were analyzed from September 2021 to January 2023. Interventions: No treatment, treatment with transmucosal buprenorphine, or treatment with extended-release buprenorphine. Main Outcomes and Measures: Mean lifetime costs per person, discounted quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). Results: The simulated cohort included 100 000 patients with OUD receiving (61% male; mean [SD] age, 38 [11] years) or not receiving medication treatment (58% male, mean [SD] age, 48 [18] years). Compared with no medication treatment, treatment with transmucosal buprenorphine yielded an ICER of $19 740 per QALY. Compared with treatment with transmucosal buprenorphine, treatment with extended-release buprenorphine yielded lower effectiveness by 0.03 QALYs per person at higher cost, suggesting that treatment with extended-release buprenorphine was dominated and not preferred. In probabilistic sensitivity analyses, treatment with transmucosal buprenorphine was the preferred strategy 60% of the time. Treatment with extended-release buprenorphine was cost-effective compared with treatment with transmucosal buprenorphine at a $100 000 per QALY willingness-to-pay threshold only after substantial changes in key parameters. Conclusions and Relevance: In this economic evaluation of extended-release buprenorphine compared with transmucosal buprenorphine for the treatment of OUD, extended-release buprenorphine was not associated with efficient allocation of limited resources when transmucosal buprenorphine was available. Future initiatives should aim to improve retention rates or decrease costs associated with extended-release buprenorphine.

Buprenorphine Out-of-Pocket Costs and Discontinuation in Privately Insured Adults With Opioid Use Disorder.

This cohort study examined the association between out-of-pocket costs for an initial buprenorphine prescription and its discontinuation among commercially insured US adults with opioid use disorder.

Evaluating equity in community-based naloxone access among racial/ethnic groups in Massachusetts.

BACKGROUND: Racial/ethnic minorities have experienced disproportionate opioid-related overdose death rates in recent years. In this context, we examined inequities in community-based naloxone access across racial/ethnic groups in Massachusetts. METHODS: We used data from: the Massachusetts Department of Public Health on community-based overdose education and naloxone distribution (OEND) programs; the Massachusetts Office of the Chief Medical Examiner on opioid-related overdose deaths, and; the United States Census American Community Survey for regional demographic/socioeconomic details to estimate community populations by race/ethnicity and racial segregation between African American/Black and white residents. Race/ethnicity groups included in the analysis were African American/Black (non-Hispanic), Hispanic, white (non-Hispanic), and "other" (non-Hispanic). We evaluated racial/ethnic differences in naloxone distribution across regions in Massachusetts and neighborhoods in Boston descriptively and spatially, plotting the race/ethnicity-specific number of kits per opioid-related overdose death per jurisdiction. Lastly, we constructed generalized estimating equations models with a negative binomial distribution to compare the race/ethnicity-specific naloxone distribution rate by OEND programs. RESULTS: From 2016-2019, the median annual rate of naloxone kits received from OEND programs in Massachusetts per racial/ethnicity group ranged between 160 and 447 per 100,000. In a multivariable analysis, we found that the naloxone distribution rates for racial/ethnic minorities were lower than the rate for white residents. We also found naloxone was more likely to be distributed in racially segregated communities than non-segregated communities. CONCLUSION: We identified racial/ethnic inequities in naloxone receipt by individuals in Massachusetts. Additional resources focused on designing and implementing OEND programs for racial/ethnic minorities are warranted to ensure equitable access to naloxone.

Prevalence of HIV Preexposure Prophylaxis Prescribing Among Persons With Commercial Insurance and Likely Injection Drug Use.

Importance: Although HIV preexposure prophylaxis (PrEP) implementation among persons who inject drugs has been inadequate, national HIV monitoring programs do not include data on PrEP, and specific trends in PrEP use are not well understood. Objective: To estimate HIV PrEP uptake among commercially insured persons with opioid or stimulant use disorder by injection drug use (IDU) status. Design, Setting, and Participants: This cross-sectional study used deidentified data from the MarketScan Commercial Claims and Encounters Database to identify a sample of 547 709 commercially insured persons without HIV but with opioid and/or stimulant use disorder, including 110 592 with evidence of IDU between January 1, 2010, and December 31, 2019. Data were analyzed from November 1, 2020, to July 1, 2021. Exposures: Persons with opioid and/or stimulant use disorder and evidence of IDU were identified through claims data. Main Outcomes and Measures: The outcome was receipt of tenofovir disoproxil fumarate and emtricitabine for PrEP as identified from filled pharmacy claims. Multivariable logistic regression was used to assess the association of demographic and clinical characteristics with receipt of PrEP. Results: The study cohort included 211 609 (28.6%) females and 336 100 (61.4%) males with a combined mean (SD) age of 34.8 (13.1) years, including 110 592 individuals with evidence of IDU. During the study period, 508 (0.09%) persons with opioid and/or stimulant use disorder, including 170 (0.15%) with evidence of IDU, received PrEP. Receipt of PrEP increased from 0.001 to 0.243 per 100 person-years from 2010 through 2019 among the entire cohort and from 0.000 to 0.295 per 100 person-years among those with IDU. In multivariable analysis, PrEP use was more likely among males (adjusted odds ratio [aOR] 8.72; 95% CI, 6.39-11.89), persons with evidence of IDU (aOR, 1.47; 95% CI, 1.21-1.79), and persons with evidence of sexual risk indications for PrEP (aOR, 23.68; 95% CI, 19.57-28.66). Conclusions and Relevance: In this cross-sectional study of commercially insured persons with opioid and/or stimulant use disorder, HIV PrEP delivery remained low, including among those with evidence of IDU. PrEP should be consistently offered alongside substance use disorder treatment and other harm reduction and HIV prevention services.

Estimating Absenteeism Related to Nonalcohol Substance Use in a US National Cohort of Full-Time Employees.

OBJECTIVE: We aimed to estimate absenteeism due to substance use disorder among full-time employees. METHODS: We used the 2018 National Survey on Drug Use and Health to identify a sample of individuals employed full time. We used a survey-weighted multivariable negative binomial model to evaluate the association between absenteeism and type of substance use disorder controlling for available demographic information. RESULTS: In the adjusted model, we estimated that opioid use without a disorder had the highest absenteeism for use, and polysubstance use disorder had the highest absenteeism among use disorders. In a hypothetical firm of 10,000 employees, we estimate $232,000 of lost wage value annually. CONCLUSIONS: Substance use is associated with absenteeism and presents a compelling argument for employers to promote programs that support treatment for employees and reduce downstream costs associated with absenteeism and turnover.

Medicaid Hepatitis C Virus Treatment Policies: Impact on Testing and Treatment in the Commercially Insured.

INTRODUCTION: A total of 23 state Medicaid programs continue to restrict hepatitis C virus (HCV) medication access by liver disease or substance-use criteria, creating obstacles to HCV elimination and significant care disparities. Because public insurers often set precedents for private insurer coverage and clinician practice patterns, this study sought to analyze whether spillover occurs from state Medicaid HCV treatment restrictions to HCV screening and treatment rates in commercially insured individuals. METHODS: Investigators analyzed 2014‒2017 commercial claims data across 48 U.S. states (721,961,965 person-months) and used an interrupted times series design to compare hepatitis C virus screening and treatment rates before and after state Medicaid HCV treatment policy changes, adjusting for state-level random effects, Medicaid expansion status, and state drug overdose incidence rates, in states that relaxed Medicaid policy over the study period. Analysis occurred during 2019‒2021. RESULTS: Hepatitis C virus screening rates among commercially insured individuals increased after the corresponding state Medicaid program relaxed HCV treatment policy. Among states that changed Medicaid policy, those that reduced fibrosis or both fibrosis and abstinence restrictions experienced increased HCV screening rates by the study end compared with states that changed only abstinence restrictions (rate ratio=1.29; 95% CI=1.15, 1.44; and rate ratio=1.32; 95% CI=1.17, 1.50, respectively). Similar patterns did not occur in HCV treatment rates, which declined after 2015 across groups. CONCLUSIONS: These data show that HCV screening rates increased among commercially insured individuals after the removal of Medicaid HCV treatment restrictions in the same state. This suggests that Medicaid treatment policies can spill over to affect health outcomes among commercially insured populations.

Population-level impact of initiating pharmacotherapy and linking to care people with opioid use disorder at inpatient medically managed withdrawal programs: an effectiveness and cost-effectiveness analysis.

BACKGROUND AND AIMS: Medications for opioid use disorder (MOUD) are shown to reduce opioid use and the risk of overdose. People with opioid use disorder (OUD) who exit inpatient medically managed withdrawal programs (detox) without initiating MOUD and linking to outpatient care have high rates of overdose. While detox encounters provide a theoretical opportunity for MOUD initiation, this is not ubiquitous in the United States. We used simulation modeling to estimate the population-level health effects and cost-effectiveness of a policy encouraging MOUD initiation during inpatient detox encounters. DESIGN, SETTING AND PARTICIPANTS: We employed a dynamic population state-transition model to evaluate the effectiveness and cost-effectiveness of using detox programs as venues for initiating MOUD in Massachusetts, United States. We compared standard of care, where no detox patients initiate MOUD or link to outpatient MOUD providers, to strategies of offering MOUD to detox patients and linking those patients to outpatient MOUD. MEASURES: Budgetary impact to the Massachusetts health-care sector, incremental cost-effectiveness ratios (ICER) and total counts and percentage differences of fatal overdoses prevented. FINDINGS: Initiating MOUD in detox with perfect linkage to outpatient MOUD would reduce fatal overdoses by 4.5% [95% confidence interval (CI) = 2.3-5.9], at an ICER of $56 000 per quality-adjusted life-year (QALY) gained, compared with the standard of care. With moderate linkage, fatal overdoses would be reduced by 2.3% (95% CI= 1.2-3.1) with an ICER of $78 500 per QALY gained, compared with standard of care. Budgetary increase to Massachusetts health-care spending ranged from 0.5-1%. CONCLUSION: A simulation model indicates that initiation of medications for opioid use disorder and linkage policies among detox patients in Massachusetts, USA could prevent fatal opioid overdoses in the opioid use disorder population and would be cost-effective from a health-care sector perspective.

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.

Community-based naloxone coverage equity for the prevention of opioid overdose fatalities in racial/ethnic minority communities in Massachusetts and Rhode Island.

BACKGROUND AND AIMS: Opioid-related overdose death rates continue to rise in the United States, especially in racial/ethnic minority communities. Our objective was to determine if US municipalities with high percentages of non-white residents have equitable access to the overdose antidote naloxone distributed by community-based organizations. METHODS: We used community-based naloxone data from the Massachusetts Department of Public Health and the Rhode Island non-pharmacy naloxone distribution program for 2016-18. We obtained publicly available opioid-related overdose death data from Massachusetts and the Office of the State Medical Examiners in Rhode Island. We defined the naloxone coverage ratio as the number of community-based naloxone kits received by a resident in a municipality divided by the number of opioid-related overdose deaths among residents, updated annually. We used a Poisson regression with generalized estimating equations to analyze the relationship between the municipal racial/ethnic composition and naloxone coverage ratio. To account for the potential non-linear relationship between naloxone coverage ratio and race/ethnicity we created B-splines for the percentage of non-white residents; and for a secondary analysis examining the percentage of African American/black and Hispanic residents. The models were adjusted for the percentage of residents in poverty, urbanicity, state and population size. RESULTS: Between 2016 and 2018, the annual naloxone coverage ratios range was 0-135. There was no difference in naloxone coverage ratios among municipalities with varying percentages of non-white residents in our multivariable analysis. In the secondary analysis, municipalities with higher percentages of African American/black residents had higher naloxone coverage ratios, independent of other factors. Naloxone coverage did not differ by percentage of Hispanic residents. CONCLUSIONS: There appear to be no municipal-level racial/ethnic inequities in naloxone distribution in Rhode Island and Massachusetts, USA.

Eligibility for cervical cancer screening exit: Comparison of a national and safety net cohort.

OBJECTIVE: To determine eligibility for discontinuation of cervical cancer screening. METHODS: Women aged 64 with employer-sponsored insurance enrolled in a national database between 2016 and 2018, and those aged 64-66 receiving primary care at a safety net health center in 2019 were included. Patients were evaluated for screening exit eligibility by current guidelines: no evidence of cervical cancer or HIV-positive status and no evidence of cervical precancer in the past 25 years, and had evidence of either hysterectomy with removal of the cervix or evidence of fulfilling screening exit criteria, defined as two HPV screening tests or HPV plus Pap co-tests or three Pap tests within the past 10 years without evidence of an abnormal result. RESULTS: Of the 590,901 women in the national claims database, 131,059 (22.2%) were eligible to exit due to hysterectomy (1.6%) or negative screening (20.6%). Of the 1544 women from the safety net health center, 528 (34.2%) were eligible to exit due to hysterectomy (9.3%) or negative screening (24.9%). Most women did not have sufficient data available to fulfill exit criteria: 382,509 (64.7%) in the national database and 875 (56.7%) in the safety net hospital system. Even among women with 10 years of insurance claims data, only 41.5% qualified to discontinue screening. CONCLUSIONS: Examining insurance claims in a national database and electronic medical records at a safety net institution led to remarkably similar findings: two thirds of women fail to qualify for screening exit. Additional steps to ensure eligibility prior to screening exit may be necessary to decrease preventable cervical cancers among women aged >65. CLINICAL TRIAL REGISTRATION: N/A.

Health economic design for cost, cost-effectiveness and simulation analyses in the HEALing Communities Study.

BACKGROUND: The HEALing Communities Study (HCS) is designed to implement and evaluate the Communities That HEAL (CTH) intervention, a conceptually driven framework to assist communities in selecting and adopting evidence-based practices to reduce opioid overdose deaths. The goal of the HCS is to produce generalizable information for policy makers and community stakeholders seeking to implement CTH or a similar community intervention. To support this objective, one aim of the HCS is a health economics study (HES), the results of which will inform decisions around fiscal feasibility and sustainability relevant to other community settings. METHODS: The HES is integrated into the HCS design: an unblinded, multisite, parallel arm, cluster randomized, wait list-controlled trial of the CTH intervention implemented in 67 communities in four U.S. states: Kentucky, Massachusetts, New York, and Ohio. The objectives of the HES are to estimate the economic costs to communities of implementing and sustaining CTH; estimate broader societal costs associated with CTH; estimate the cost-effectiveness of CTH for overdose deaths avoided; and use simulation modeling to evaluate the short- and long-term health and economic impact of CTH, including future overdose deaths avoided and quality-adjusted life years saved, and to develop a simulation policy tool for communities that seek to implement CTH or a similar community intervention. DISCUSSION: The HCS offers an unprecedented opportunity to conduct health economics research on solutions to the opioid crisis and to increase understanding of the impact and value of complex, community-level interventions.

Payments for outpatient joint replacement surgery: A comparison of hospital outpatient departments and ambulatory surgery centers.

OBJECTIVE: To compare commercial insurance payments for outpatient total knee and hip replacement surgeries performed in hospital outpatient departments (HOPDs) and in ambulatory surgery centers (ASCs). DATA SOURCES: A large national claims database that contains information on actual prices paid to providers over the period 2014-2017. DATA COLLECTION: We identified all patients receiving total knee replacement surgery and total hip replacement surgery in HOPDs and in ASCs for each of the 4 years. STUDY DESIGN: For each year, we conducted descriptive and statistical patient-level analyses of the facility component of payments to HOPDs and to ASCs. PRINCIPAL FINDINGS: For each procedure and for each year, ASC payments exceeded HOPD payments by a wide margin; however, the gap across settings declined over time. In 2014, knee replacement payments to HOPDs (n = 67) were $6016 compared to $23 244 in ASCs (n = 68). By 2017, payments to HOPDs (n = 223) had grown to $10 060 compared to $18 234 in ASCs (n = 602). Similarly, for hip replacements, HOPD payments (n = 43) rose from $6980 in 2014 to $11 139 in 2017 (n = 206) and in ASCs fell from $28 485 in 2014 (n = 82) to $18 595 in 2017 (n = 465). CONCLUSIONS: Results suggest that for total joint replacement, common perceptions of cost savings from transition of services from hospitals to ASCs may be misguided.

Patient Outcomes Following Total Joint Replacement Surgery: A Comparison of Hospitals and Ambulatory Surgery Centers.

BACKGROUND: For several years, many orthopedic surgeons have been performing total joint replacements in hospital outpatient departments (HOPDs) and more recently in ambulatory surgery centers (ASCs). In a recent shift, the Centers for Medicare and Medicaid Services began reimbursing for total knee replacement surgery in HOPDs. Some observers have expressed concerns over patient safety for the Medicare population particularly if Centers for Medicare and Medicaid Services extends the policy to include total hip replacement surgery and coverage in ASCs. METHODS: This study used a large claims database of non-Medicare patients to examine inpatient and outpatient total knee replacement and total hip replacement surgery performed on a near-elderly population during 2014-2016. We applied propensity score methods to match inpatients with ASC patients and HOPD patients with ASC patients adjusting for risk using the HHS Hierarchical Condition Categories risk adjustment model. We conducted statistical tests comparing clinical outcomes across the 3 settings and examined relative costs. RESULTS: Readmissions, postsurgical complications, and payments were lower for outpatients than for inpatients. Within outpatient settings, readmissions and postsurgical complications were lower in ASCs than in HOPDs but payments for ASC patients were higher than payments for HOPD patients. CONCLUSION: Our findings support the argument that outpatient total joint replacement is appropriate for select patients treated in both HOPDs and ASCs, although in the commercially insured population, the latter services may come at a cost. Until further study of outpatient total joint replacement in the Medicare population becomes available, how this will extrapolate to the Medicare population is unknown.

Cost-effectiveness of Hepatitis C Virus Treatment Models for People Who Inject Drugs in Opioid Agonist Treatment Programs.

BACKGROUND: Many people who inject drugs in the United States have chronic hepatitis C virus (HCV). On-site treatment in opiate agonist treatment (OAT) programs addresses HCV treatment barriers, but few evidence-based models exist. METHODS: We evaluated the cost-effectiveness of HCV treatment models for OAT patients using data from a randomized trial conducted in Bronx, New York. We used a decision analytic model to compare self-administered individual treatment (SIT), group treatment (GT), directly observed therapy (DOT), and no intervention for a simulated cohort with the same demographic characteristics of trial participants. We projected long-term outcomes using an established model of HCV disease progression and treatment (hepatitis C cost-effectiveness model: HEP-CE). Incremental cost-effectiveness ratios (ICERs) are reported in 2016 US$/quality-adjusted life years (QALY), discounted 3% annually, from the healthcare sector and societal perspectives. RESULTS: For those assigned to SIT, we projected 89% would ever achieve a sustained viral response (SVR), with 7.21 QALYs and a $245 500 lifetime cost, compared to 22% achieving SVR, with 5.49 QALYs and a $161 300 lifetime cost, with no intervention. GT was more efficient than SIT, resulting in 0.33 additional QALYs and a $14 100 lower lifetime cost per person, with an ICER of $34 300/QALY, compared to no intervention. DOT was slightly more effective and costly than GT, with an ICER > $100 000/QALY, compared to GT. In probabilistic sensitivity analyses, GT and DOT were preferred in 91% of simulations at a threshold of <$100 000/QALY; conclusions were similar from the societal perspective. CONCLUSIONS: All models were associated with high rates of achieving SVR, compared to standard care. GT and DOT treatment models should be considered as cost-effective alternatives to SIT.

Cost-effectiveness of integrating buprenorphine-naloxone treatment for opioid use disorder into clinical care for persons with HIV/hepatitis C co-infection who inject opioids.

BACKGROUND: Untreated opioid use disorder (OUD) affects the care of HIV/HCV co-infected people who inject opioids. Despite active injection opioid use, there is evidence of increasing engagement in HIV care and adherence to HIV medications among HIV/HCV co-infected persons. However, less than one-half of this population is offered HCV treatment onsite. Treatment for OUD is also rare and largely occurs offsite. Integrating buprenorphine-naloxone (BUP-NX) into onsite care for HIV/HCV co-infected persons may improve outcomes, but the clinical impact and costs are unknown. We evaluated the clinical impact, costs, and cost-effectiveness of integrating (BUP-NX) into onsite HIV/HCV treatment compared with the status quo of offsite referral for medications for OUD. METHODS: We used a Monte Carlo microsimulation of HCV to compare two strategies for people who inject opioids: 1) standard HIV care with onsite HCV treatment and referral to offsite OUD care (status quo) and 2) standard HIV care with onsite HCV and BUP-NX treatment (integrated care). Both strategies assume that all individuals are already in HIV care. Data from national databases, clinical trials, and cohorts informed model inputs. Outcomes included mortality, HCV reinfection, quality-adjusted life years (QALYs), costs (2017 US dollars), and incremental cost-effectiveness ratios. RESULTS: Integrated care reduced HCV reinfections by 7%, cases of cirrhosis by 1%, and liver-related deaths by 3%. Compared to the status quo, this strategy also resulted in an estimated 11/1,000 fewer non-liver attributable deaths at one year and 28/1,000 fewer of these deaths at five years, at a cost-effectiveness ratio of $57,100/QALY. Integrated care remained cost-effective in sensitivity analyses that varied the proportion of the population actively injecting opioids, availability of BUP-NX, and quality of life weights. CONCLUSIONS: Integrating BUP-NX for OUD into treatment for HIV/HCV co-infected adults who inject opioids increases life expectancy and is cost-effective at a $100,000/QALY threshold.

Overdose following initiation of naltrexone and buprenorphine medication treatment for opioid use disorder in a United States commercially insured cohort.

BACKGROUND AND AIMS: Despite the growing opioid overdose crisis, medication treatment for opioid use disorder remains uncommon. The comparative effectiveness of buprenorphine and naltrexone treatment in reducing overdose and the comparative risks of discontinuing treatment in the real world, remain uncertain. Our aim was to examine the effectiveness of medications for opioid use disorder in preventing opioid-related overdose. DESIGN: Retrospective cohort study SETTING: United States. PATIENTS: 46,846 commercially insured individuals diagnosed with opioid use disorder and initiating medication treatment between 2010 and 2016. MEASUREMENTS: Opioid-related overdose identified by International Classification of Diseases, Ninth and Tenth Revisions. FINDINGS: In our sample, 1386 individuals were prescribed extended-release injectable naltrexone (median filled prescriptions = 9 months), 7782 were prescribed oral naltrexone (5 months), and 40,441 were prescribed buprenorphine (19 months) at least once during follow-up. Individuals receiving buprenorphine therapy were at significantly reduced risk of opioid-related overdose compared to no treatment (adjusted hazard ratio (HR) = 0.40, 95% CI 0.35-0.46), while a significant association was not observed in extended-release injectable (HR = 0.74, 95% CI 0.42-1.31) or oral (HR = 0.93, 95% CI 0.71-1.22) naltrexone. We found no association with opioid overdose within four weeks of discontinuation of any medication. CONCLUSION: Among commercially-insured patients who initiate medications for opioid use disorder, buprenorphine, but not naltrexone, was associated with lower risk of overdose during active treatment compared to post-discontinuation. More research is needed to understand the benefits and risks unique to each treatment option to better tailor therapies to patients with opioid use disorder.

Will converting naloxone to over-the-counter status increase pharmacy sales?

OBJECTIVE: To estimate the own-price elasticity of demand for naloxone, a prescription medication that can counter the effects of an opioid overdose, and predict the change in pharmacy sales following a conversion to over-the-counter status. DATA SOURCES/STUDY SETTING: The primary data source was a nationwide prescription claims dataset for 2010-2017. The data cover 80 percent of US retail pharmacies and account for roughly 90 percent of prescriptions filled. Additional covariates were obtained from various secondary data sources. STUDY DESIGN: We estimated a longitudinal, simultaneous equation model of naloxone supply and demand. Our primary variables of interest were the quantity of naloxone sold, measured as total milligrams sold at pharmacies, and the out-of-pocket price paid per milligram, both measured per ZIP Code and quarter-year. DATA COLLECTION/EXTRACTION METHODS: Primary data came directly from payers and processors of prescription drug claims. PRINCIPAL FINDINGS: We found that, on average, a 1 percent increase in the out-of-pocket price paid for naloxone would result in a 0.27 percent decrease in pharmacy sales. We predict that the total quantity of naloxone sold in pharmacies would increase 15 percent to 179 percent following conversion to over-the-counter status. CONCLUSIONS: Naloxone is own-price inelastic, and conversion to over-the-counter status is likely to lead to a substantial increase in total pharmacy sales.

Implementation of a nationwide health economic consultation service to assist substance use researchers: Lessons learned.

BACKGROUND: Health economic evaluation findings assist stakeholders in improving the quality, availability, scalability, and sustainability of evidence-based services, and in maximizing the efficiency of service delivery. The Center for Health Economics of Treatment Interventions for Substance Use Disorders, HCV, and HIV (CHERISH) is a NIDA-funded multi-institutional center of excellence whose mission is to develop and disseminate health-economic research on healthcare utilization, health outcomes, and health-related behaviors that informs substance use disorder treatment policy, and HCV and HIV care of people who use substances. METHODS: We designed a consultation service that is free to researchers whose work aligns with CHERISH's mission. The service includes up to six hours of consulting time. After prospective consultees submit their request online, they receive a screening call from the consultation service director, who connects them with a consultant with relevant expertise. Consultees and consultants complete web-based evaluations following the consultation; consultees also complete a six-month follow-up. We report on the status of the service from its inception in July 2015 through June 2017. RESULTS: We have received 28 consultation requests (54% Early Stage Investigators, 57% MD or equivalent, 28% PhD, 61% women) on projects typically related to planning a study or grant application (93%); 71% were HIV/AIDS-related. Leading topics included cost-effectiveness (43%), statistical-analysis/econometrics (36%), cost (32%), cost-benefit (21%), and quality-of-life (18%). All consultees were satisfied with their overall experience, and felt that consultation expectations and objectives were clearly defined and the consultant's expertise was matched appropriately with their needs. Results were similar for consultants, who spent a median of 3 hours on consultations. CONCLUSIONS: There is a need for health-economic methodological guidance among substance use, HCV, and HIV researchers. Lessons learned pertain to the feasibility of service provision, the need to implement systems to measure and improve service value, and strategies for service promotion.