Budget impact tool for the incorporation of medications for opioid use disorder into jail/prison facilities.

BACKGROUND: Given the personal and public consequences of untreated/undertreated OUD among persons involved in the justice system, an increasing number of jails and prisons are incorporating medication for opioid use disorder (MOUD) into their system. Estimating the costs of implementing and sustaining a particular MOUD program is vital to detention facilities, which typically face modest, fixed health care budgets. We developed a customizable budget impact tool to estimate the implementation and sustainment costs of numerous MOUD delivery models for detention facilities. METHODS: The aim is to describe the tool and present an application of a hypothetical MOUD model. The tool is populated with resources required to implement and sustain various MOUD models in detention facilities. We identified resources via micro-costing techniques alongside randomized clinical trials. The resource-costing method is used to assign values to resources. Resources/costs are categorized as (a) fixed, (b) time-dependent, and (c) variable. Implementation costs include (a), (b), and (c) over a specified timeframe. Sustainment costs include (b) and (c). The MOUD model example entails offering all three FDA-approved medications, with methadone and buprenorphine provided by vendors, and naltrexone by the jail/prison facility. RESULTS: Fixed resources/costs are incurred only once, including accreditation fees and trainings. Time-dependent resources/costs are recurring, but fixed over a given time-period; e.g., medication delivery and staff meetings. Variable resources/costs are those that are a direct function of the number of persons treated, such as the medication provided to each patient. Using nationally representative prices, we estimated fixed/sustainment costs to be $2919/patient, over 1 year. This article estimates annual sustainment costs to be $2885/patient. CONCLUSION: The tool will serve as a valuable asset to jail/prison leadership, policymakers, and other stakeholders interested in identifying/estimating the resources and costs associated with alternative MOUD delivery models, from the planning stages through sustainment.

Cost-effectiveness of extended-release injectable naltrexone among incarcerated persons with opioid use disorder before release from prison versus after release.

INTRODUCTION: Opioid use disorder (OUD) is highly prevalent among incarcerated populations, and the risk of fatal overdose following release from prison is substantial. Despite efficacy, few correctional facilities provide evidence-based addiction treatment. Extended-release injectable naltrexone (XR-NTX) administered prior to release from incarceration may improve health and economic outcomes. METHODS: We conducted an economic evaluation alongside a randomized controlled trial testing the effectiveness of XR-NTX before release from prison (n = 38) vs. XR-NTX referral after release (n = 48) of incarcerated participants with OUD, both groups continuing treatment at a community addiction treatment center. The incremental cost-effectiveness ratio (ICER) assessed the cost-effectiveness of XR-NTX before release compared to referral after release for three stakeholder perspectives at 12- and 24-week periods: state policymaker, health care sector, and societal. Effectiveness measures included quality-adjusted life-years (QALYs) and abstinent years from opioids. In addition, we categorized resources as OUD-related and non-OUD-related medical care, state transfer payments, and other societal costs (productivity, criminal justice resources, etc.). RESULTS: Results showed an association between XR-NTX and greater OUD-related costs and total costs from the state policymaker perspective. QALYs gained were positive but statistically insignificant between arms; however, results showed XR-NTX had an estimated 15.5 more days of opioid abstinence over 24 weeks and statistically significant at a 95 % confidence level based on the distribution of bootstrapped samples. We found that estimated ICERs to be > $500,000 per QALY for all stakeholder perspectives. For the abstinent-year effectiveness measure, we found XR-NTX before release to be cost-effective at a 95 % confidence level for willingness-to-pay values >$49,000 per abstinent-year, across all perspectives. CONCLUSIONS: XR-NTX administered to persons who are incarcerated with OUD before release may provide value for stakeholders and bridge a well-known treatment gap for this vulnerable population. Lower than expected participant engagement and missing data limit our results, and study outcomes may be sensitive to methods that address missing data if replicated.

Diagnostic Coding of Elder Mistreatment: Results From a National Database of Medicare Advantage and Private Insurance Patients, 2011-2017.

Health care providers may play an important role in detection of elder mistreatment, which is common but underrecognized. We used the Health Care Cost Institute insurance claims database to describe elder mistreatment diagnosis among Medicare Advantage (MA) and private insurance patients in the United States from 2011 to 2017. We used International Classification of Diseases (ICD) coding to identify cases, examining the impact of transition from ICD-9 (Ninth Revision) to ICD-10 (Tenth Revision), which occurred in October 2015 and added 14 new codes for "suspected" mistreatment. 8,127 patients (0.051% of all aged ≥ 65), including 6,304 with MA (0.058%) and 1,823 with private insurance (0.026%) received elder mistreatment diagnosis. Transition from ICD-9 to ICD-10 was associated with a small increase in diagnosis rate, with "suspected" codes used in 45.3% of ICD-10 versus 9.7% of ICD-9 cases. Overall rates remained low. Rates, settings, and types of diagnosis differed between MA and private insurance patients.

Robust Prescription Monitoring Programs and Abrupt Discontinuation of Long-term Opioid Use.

INTRODUCTION: This study assesses the associations between the recent implementation of robust features of state Prescription Drug Monitoring Programs and the abrupt discontinuation of long-term opioid therapies. METHODS: Data were from a national commercial insurance database and included privately insured adults aged 18-64 years and Medicare Advantage enrollees aged ≥65 years who initiated a long-term opioid therapy episode between Quarter 2 of 2011 and Quarter 2 of 2017. State Prescription Drug Monitoring Programs were characterized as nonrobust, robust, and strongly robust. Abrupt discontinuation was measured on the basis of high daily morphine milligram equivalents over the last 30 days of a long-term opioid therapy episode or no sign of tapering before discontinuation. Difference-in-differences models were estimated in 2019‒2020 to assess the association between robust Prescription Drug Monitoring Programs and abrupt discontinuation. RESULTS: Among nonelderly privately insured adults, robust Prescription Drug Monitoring Programs were associated with an increase from 14.8% to 15.4% (4% relative increase, p=0.02) in the rate of ending long-term opioid therapy with ≥60 daily morphine milligram equivalents. For older Medicare Advantage enrollees, strongly robust Prescription Drug Monitoring Programs were associated with a reduction from 4.8% to 4.3% (10.4%, p=0.01) and from 3.0% to 2.4% (17.3%, p=0.001) in the rate of ending long-term opioid therapy with ≥90 and 120 daily morphine milligram equivalents, respectively. Prescription Drug Monitoring Programs robustness was not associated with clinically meaningful changes in the rate of discontinuing long-term opioid therapy without tapering. CONCLUSIONS: Discontinuation without tapering was the norm for long-term opioid therapies in the samples throughout the study years. Findings do not support the notion that policies aimed at enhancing Prescription Drug Monitoring Program use were associated with substantial increases in abrupt long-term opioid therapy discontinuation.

Cost-effectiveness implications of increasing the efficiency of the extended-release naltrexone induction process for the treatment of opioid use disorder: a secondary analysis.

BACKGROUND AND AIMS: In a US randomized-effectiveness trial comparing extended-release naltrexone (XR-NTX) with buprenorphine-naloxone (BUP-NX) for the prevention of opioid relapse among participants recruited during inpatient detoxification (CTN-0051), the requirement to complete opioid detoxification prior to initiating XR-NTX resulted in lower rates of initiation of XR-NTX (72% XR-NTX versus 94% BUP-NX). DESIGN: This was a retrospective secondary analysis of CTN-0051 trial data, including follow-up data over 24-36 weeks. SETTING: Eight community-based, inpatient-detoxification and follow-up outpatient treatment facilities in the United States. PARTICIPANTS: A total of 283 participants randomized to receive XR-NTX. MEASUREMENTS: Efficiency was estimated using a multivariable generalized structural equation model to explore simultaneous determinants of XR-NTX induction and induction duration (detoxification + residential days). Cost-effectiveness was estimated from the health-care sector perspective and included expected costs and quality-adjusted life-years (QALYs). FINDINGS: Treatment site was the only modifiable factor that simultaneously increased the likelihood of XR-NTX induction and decreased induction duration. Incorporating the higher predicted probability of XR-NTX induction, and fewer predicted days of detoxification and subsequent residential treatment into the cost-effectiveness framework, reduced the incremental average 24-week total cost of XR-NTX treatment from $5317 more than that of BUP-NX (P = 0.01) to a non-statistically-significant difference of $1016 (P = 0.63). QALYs gained remained similar across arms. CONCLUSION: Adopting an efficient model of extended-release naltrexone initiation could result in extended-release naltrexone and buprenorphine-naloxone being of comparable economic value from the health-care sector perspective over 24-36 weeks for patients seeking treatment for opioid use disorder at an inpatient detoxification facility.

State Opioid Limits and Volume of Opioid Prescriptions Received by Medicaid Patients.

BACKGROUND: Since early 2016, an increasing number of states passed legislations that limit the duration and/or dosage of initial opioid prescriptions or opioids for acute pain. OBJECTIVE: The objective of this study was to assess changes in the number of opioid prescriptions covered by Medicaid and received by Medicaid patients associated with state implementation of legislative limits on initial opioid prescriptions. RESEARCH DESIGN: We explored the natural experiment resulting from the staggered implementation of state legislative limits. The analysis adopted a Difference-in-Differences framework and controlled for other major state policies bearing implications for prescription opioid use. The main analysis included 26 states that implemented limits from early 2016 to late 2018. A secondary analysis included all 50 states and the District of Columbia. MEASURES: Population-adjusted state-quarter level counts of Schedule II and III opioid prescriptions received by Medicaid patients, based on data from the Medicaid State Drug Utilization Data and state Medicaid enrollment reports for 2013-2018. RESULTS: Implementation of legislative limits on initial opioid prescriptions was associated with a 7% reduction in the number of opioid prescriptions per 100 Medicaid enrollees. Such reduction was largely attributable to a reduction in Schedule II opioid prescriptions. Secondary analysis by including all jurisdictions and sensitivity checks supported the robustness of results. CONCLUSION: The recent implementation of state legislative limits on initial opioid prescriptions was associated with meaningful reductions in the volume of Schedule II opioid prescriptions received by Medicaid patients.

Health and economic outcomes of treatment with extended-release naltrexone among pre-release prisoners with opioid use disorder (HOPPER): protocol for an evaluation of two randomized effectiveness trials.

BACKGROUND: Persons with an opioid use disorder (OUD) who were incarcerated face many challenges to remaining abstinent; concomitantly, opioid-overdose is the leading cause of death among this population, with the initial weeks following release proving especially fatal. Extended-release naltrexone (XR-NTX) is the most widely-accepted, evidence-based OUD pharmacotherapy in criminal justice settings, and ensures approximately 30 days of protection from opioid overdose. The high cost of XR-NTX serves as a barrier to uptake by many prison/jail systems; however, the cost of the medication should not be viewed in isolation. Prison/jail healthcare budgets are ultimately determined by policymakers, and the benefits/cost-offsets associated with effective OUD treatment will directly and indirectly affect their overall budgets, and society as a whole. METHODS: This protocol describes a study funded by the National Institute of Drug Abuse (NIDA) to: evaluate changes in healthcare utilization, health-related quality-of-life, and other resources associated with different strategies of XR-NTX delivery to persons with OUD being released from incarceration; and estimate the relative "value" of each strategy. Data from two ongoing, publicly-funded, randomized-controlled trials will be used to evaluate these questions. In Study A, (XR-NTX Before vs. After Reentry), participants are randomized to receive their first XR-NTX dose before release, or at a nearby program post-release. In Study B, (enhanced XR-NTX vs. XR-NTX), both arms receive XR-NTX prior to release; the enhanced arm receives mobile medical (place of residence) XR-NTX treatment post-release, and the XR-NTX arm receives referral to a community treatment program post-release. The economic data collection instruments required to evaluate outcomes of interest were incorporated into both studies from baseline. Moreover, because the same instruments are being used in both trials on comparable populations, we have the opportunity to not only assess differences in outcomes between study arms within each trial, but also to merge the data sets and test for differences across trials. DISCUSSION: Initiating XR-NTX for OUD prior to release from incarceration may improve patient health and well-being, while also producing downstream cost-offsets. This study offers the unique opportunity to assess the effectiveness and cost-effectiveness of multiple strategies, according to different stakeholder perspectives.

State Policies for Prescription Drug Monitoring Programs and Adverse Opioid-related Hospital Events.

BACKGROUND: State policies to optimize prescriber use of Prescription Drug Monitoring Programs (PDMPs) have proliferated in recent years. Prominent policies include comprehensive mandates for prescriber use of PDMP, laws allowing delegation of PDMP access to office staff, and interstate PDMP data sharing. Evidence is limited regarding the effects of these policies on adverse opioid-related hospital events. OBJECTIVE: The objective of this study was to assess the effects of 3 PDMP policies on adverse opioid-related hospital events among patients with prescription opioid use. RESEARCH DESIGN: We examined 2011-2015 data from a large national commercial insurance database of privately insured and Medicare Advantage patients from 28 states with fully operating PDMPs by the end of 2010. We used a difference-in-differences framework to assess the probabilities of opioid-related hospital events and association with the implementation of PDMP policies. The analysis was conducted for adult patients with any prescription opioid use, a subsample of patients with long-term prescription opioid use, and stratified by older (65+) versus younger patients. RESULTS: Comprehensive use mandates were associated with a relative reduction in the probability of opioid-related hospital events by 28% among patients with any opioid and 21% among patients with long-term opioid use. Such reduction was greater (in relative terms) among older patients despite the lower rate of these events among older than younger patients. Delegate laws and interstate data sharing were associated with limited change in the outcome. CONCLUSION: Comprehensive PDMP use mandates were associated with meaningful reductions in opioid-related hospital events among privately insured and Medicare Advantage adults with prescription opioid use.

Estimated impact of supervised injection facilities on overdose fatalities and healthcare costs in New York City.

BACKGROUND: The opioid epidemic in the United States has resulted in over 42,000 U.S. opioid overdose fatalities in 2016 alone. In New York City (NYC) opioid overdoses have reached a record high, increasing from 13.6 overdose deaths/100,000 to 19.9/100,000 from 2015 to 2016. Supervised injection facilities (SIFs) provide a hygienic, safe environment in which pre-obtained drugs can be consumed under clinical supervision to quickly reverse opioid overdoses. While SIFs have been implemented worldwide, none have been implemented to date in the United States. This study estimates the potential impact on opioid overdose fatalities and healthcare system costs of implementing SIFs in NYC. METHODS: A deterministic model was used to project the number of fatal opioid overdoses avoided by implementing SIFs in NYC. Model inputs were from 2015 to 2016 NYC provisional overdose data (N = 1852) and the literature. Healthcare utilization and costs were estimated for fatal overdoses that would have been avoided from implementing one or more SIFs. RESULTS: One optimally placed SIF is estimated to prevent 19-37 opioid overdose fatalities annually, representing a 6-12% decrease in opioid overdose mortality for that neighborhood; four optimally placed SIFs are estimated to prevent 68-131 opioid overdose fatalities. Opioid overdoses cost the NYC healthcare system an estimated $41 million per year for emergency medical services, emergency department visits, and hospitalizations. Implementing one SIF is estimated to save $0.8-$1.6 million, and four SIFs saves $2.9-$5.7 million in annual healthcare costs from opioid overdoses. CONCLUSIONS: Implementing SIFs in NYC would save lives and healthcare system costs, although their overall impact may be limited depending on the geographic characteristic of the local opioid epidemic. In cities with geographically dispersed opioid epidemics such as NYC, multiple SIFs will be required to have a sizeable impact on the total number of opioid overdose fatalities occurring each year.

Prescription Drug Monitoring Program Mandates: Impact On Opioid Prescribing And Related Hospital Use.

Comprehensive mandates for prescription drug monitoring programs (PDMPs) require state-licensed prescribers and dispensers both to register with and to use the programs in most clinical circumstances. Such mandates have the potential to improve providers' participation and reduce opioid-related adverse events. Using Medicaid prescription data and hospital utilization data across the US in the period 2011-16, we found that state implementation of comprehensive PDMP mandates was associated with a reduction in the opioid prescription rate from 161.47 to 147.07 per 1,000 enrollees per quarter, a reduction in the opioid-related inpatient stay rate from 97.50 to 93.34 per 100,000 enrollees per quarter, and a reduction in the opioid-related emergency department (ED) visit rate from 74.60 to 61.36 per 100,000 enrollees per quarter. Our estimated annual reductions of approximately 12,000 inpatient stays and 39,000 ED visits could save over $155 million in Medicaid spending, a fact that deserves policy attention when states attempt to strengthen and refine PDMPs to better tackle the opioid crisis.

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.

Cost-Effectiveness of Buprenorphine-Naloxone Versus Extended-Release Naltrexone to Prevent Opioid Relapse.

Background: Not enough evidence exists to compare buprenorphine-naloxone with extended-release naltrexone for treating opioid use disorder. Objective: To evaluate the cost-effectiveness of buprenorphine-naloxone versus extended-release naltrexone. Design: Cost-effectiveness analysis alongside a previously reported randomized clinical trial of 570 adults in 8 U.S. inpatient or residential treatment programs. Data Sources: Study instruments. Target Population: Adults with opioid use disorder. Time Horizon: 24-week intervention with an additional 12 weeks of observation. Perspective: Health care sector and societal. Interventions: Buprenorphine-naloxone and extended-release naltrexone. Outcome Measures: Incremental costs combined with incremental quality-adjusted life-years (QALYs) and incremental time abstinent from opioids. Results of Base-Case Analysis: Use of the health care sector perspective and a willingness-to-pay threshold of $100 000 per QALY showed buprenorphine-naloxone to be preferable to extended-release naltrexone in 97% of bootstrap replications at 24 weeks and in 85% at 36 weeks. Similar results were obtained with incremental time abstinent from opioids as an outcome and with use of the societal perspective. Results of Sensitivity Analysis: The base-case results were sensitive to the cost of the 2 treatments and the success of randomized treatment initiation. Limitation: Relatively short follow-up for a chronic condition, substantial missing data, no information on patient out-of-pocket and social service costs. Conclusion: Buprenorphine-naloxone is preferred to extended-release naltrexone as first-line treatment when both options are clinically appropriate and patients require detoxification before initiating extended-release naltrexone. Primary Funding Source: National Institute on Drug Abuse, National Institutes of Health.

Cost-effectiveness of a Medical Care Coordination Program for People With HIV in Los Angeles County.

BACKGROUND: The Los Angeles County (LAC) Division of HIV and STD Programs implemented a medical care coordination (MCC) program to address the medical and psychosocial service needs of people with HIV (PWH) at risk for poor health outcomes. METHODS: Our objective was to evaluate the impact and cost-effectiveness of the MCC program. Using the CEPAC-US model populated with clinical characteristics and costs observed from the MCC program, we projected lifetime clinical and economic outcomes for a cohort of high-risk PWH under 2 strategies: (1) No MCC and (2) a 2-year MCC program. The cohort was stratified by acuity using social and clinical characteristics. Baseline viral suppression was 33% in both strategies; 2-year suppression was 33% with No MCC and 57% with MCC. The program cost $2700/person/year. Model outcomes included quality-adjusted life expectancy, lifetime medical costs, and cost-effectiveness. The cost-effectiveness threshold for the incremental cost-effectiveness ratio (ICER) was $100 000/quality-adjusted life-year (QALY). RESULTS: With MCC, life expectancy increased from 10.07 to 10.94 QALYs, and costs increased from $311 300 to $335 100 compared with No MCC (ICER, $27 400/QALY). ICERs for high/severe, moderate, and low acuity were $30 500/QALY, $25 200/QALY, and $77 400/QALY. In sensitivity analysis, MCC remained cost-effective if 2-year viral suppression was ≥39% even if MCC costs increased 3-fold. CONCLUSIONS: The LAC MCC program improved survival and was cost-effective. Similar programs should be considered in other settings to improve outcomes for high-risk PWH.

Assessing The Impact Of State Policies For Prescription Drug Monitoring Programs On High-Risk Opioid Prescriptions.

Policies and practices have proliferated to optimize prescribers' use of their states' prescription drug monitoring programs, which are statewide databases of controlled substances dispensed at retail pharmacies. Our study assessed the effectiveness of three such policies: comprehensive legislative mandates to use the program, laws that allow prescribers to delegate its use to office staff, and state participation in interstate data sharing. Our analysis of information from a large commercial insurance database indicated that comprehensive use mandates implemented during 2011-15 were associated with a 6-9 percent reduction in opioid prescriptions with high risk for misuse and overdose. We also found delegate laws to be associated with reductions of a similar magnitude for selected outcomes. In general, the effects of all three policies strengthened over time, especially beginning in the second year after implementation. Our findings support comprehensive use mandates and delegate laws to optimize prescribers' use of drug monitoring programs, but the results will need updates in the context of evolving state opioid policies-including the increasing integration of drug monitoring data with electronic health records.

First Opioid Prescription and Subsequent High-Risk Opioid Use: a National Study of Privately Insured and Medicare Advantage Adults.

BACKGROUND: National guidelines make recommendations regarding the initial opioid prescriptions, but most of the supporting evidence is from the initial episode of care, not the first prescription. OBJECTIVE: To examine associations between features of the first opioid prescription and high-risk opioid use in the 18 months following the first prescription. DESIGN: Retrospective cohort study using data from a large commercial insurance claims database for 2011-2014 to identify individuals with no recent use of opioids and follow them for 18 months after the first opioid prescription. PARTICIPANTS: Privately insured patients aged 18-64 and Medicare Advantage patients aged 65 or older who filled a first opioid prescription between 07/01/2011 and 06/30/2013. MAIN OUTCOMES AND MEASURES: High-risk opioid use was measured by having (1) opioid prescriptions overlapping for 7 days or more, (2) opioid and benzodiazepine prescriptions overlapping for 7 days or more, (3) three or more prescribers of opioids, and (4) a daily dosage exceeding 120 morphine milligram equivalents, in each of the six quarters following the first prescription. KEY RESULTS: All three features of the first prescription were strongly associated with high-risk use. For example, among privately insured patients, receiving a long- (vs. short-) acting first opioid was associated with a 16.9-percentage-point increase (95% CI, 14.3-19.5), a daily MME of 50 or more (vs. less than 30) was associated with a 12.5-percentage-point increase (95% CI, 12.1-12.9), and a supply exceeding 7 days (vs. 3 or fewer days) was associated with a 4.8-percentage-point increase (95% CI, 4.5-5.2), in the probability of having a daily dosage of 120 MMEs or more in the long term, compared to a sample mean of 4.2%. Results for the Medicare Advantage patients were similar. CONCLUSIONS: Long-acting formulation, high daily dosage, and longer duration of the first opioid prescription were each associated with increased high-risk use of opioids in the long term.

State Medicaid Hepatitis C Treatment Eligibility Criteria and Use of Direct-Acting Antivirals.

Medicaid program criteria for accessing hepatitis C treatment are changing. Medicaid drug utilization data from 2014 to 2016 show that programs that have relaxed their criteria have seen significant increases in treatment utilization, as have states with Medicaid expansions.