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.

Cost-effectiveness of hepatitis C screening and treatment linkage intervention in US methadone maintenance treatment programs.

BACKGROUND: We evaluated the cost-effectiveness of a hepatitis C (HCV) screening and active linkage to care intervention in US methadone maintenance treatment (MMT) patients using data from a randomized trial conducted in New York City and San Francisco. METHODS: We used a decision analytic model to compare 1) no intervention; 2) HCV screening and education (control); and 3) HCV screening, education, and care coordination (active linkage intervention). We also explored an alternative strategy wherein HCV/HIV co-infected participants linked elsewhere. Trial data include population characteristics (67% male, mean age 48, 58% HCV infected) and linkage rates. Data from published sources include treatment efficacy and HCV re-infection risk. We projected quality-adjusted life years (QALYs) and lifetime medical costs using an established model of HCV (HEP-CE). Incremental cost-effectiveness ratios (ICERs) are in 2015 US$/QALY discounted 3% annually. RESULTS: The control strategy resulted in a projected 35% linking to care within 6 months and 31% achieving sustained virologic response (SVR). The intervention resulted in 60% linking and 54% achieving SVR with an ICER of $24,600/QALY compared to no intervention from the healthcare sector perspective and was a more efficient use of resources than the control strategy. The intervention had an ICER of $76,500/QALY compared to the alternative strategy. From a societal perspective, the intervention had a net monetary benefit of $511,000-$975,600. CONCLUSIONS: HCV care coordination interventions that include screening, education and active linkage to care in MMT settings are likely cost-effective at a conventional $100,000/QALY threshold for both HCV mono-infected and HIV co-infected patients.

The structural and health policy environment for delivering integrated HIV and substance use disorder treatments in Puerto Rico.

BACKGROUND: HIV prevalence in Puerto Rico is nearly twice that of the mainland United States, a level that was substantially fueled by injection drug use. Puerto Rico has a longstanding history of health provision by the public sector that directly affects how HIV and substance use disorder (SUD) treatment services are provided and funded. As part of pre-implementation research for a randomized trial of a community-level intervention to enhance HIV care access for substance users in San Juan, Puerto Rico, we sought to understand the structural and health policy environment for providing HIV and SUD treatments. METHODS: We conducted semi-structured qualitative interviews (n = 8) with government and program administrators in English and Spanish. Data were analyzed to identify dominant and recurrent themes. RESULTS: Participants discussed how lack of integration among medical and mental health service providers, lack of public transportation, and turnover in appointed government officials were barriers to integrated HIV and SUD treatment. Federal funding for support services for HIV patients was a facilitator. The Affordable Care Act has limited impact in Puerto Rico because provisions related to health insurance reform do not apply to U.S. territories. DISCUSSION AND CONCLUSIONS: Implications for intervention design include the need to provide care coordination for services from multiple providers, who are often physically separated and working in different reimbursement systems, and the potential for mobile and patient transportation services to bridge these gaps. Continuous interaction with political leaders is needed to maintain current facilitators. These findings are relevant as the current economic crisis in Puerto Rico affects funding, and may be relevant for other settings with substance use-driven epidemics.

On-site bundled rapid HIV/HCV testing in substance use disorder treatment programs: study protocol for a hybrid design randomized controlled trial.

BACKGROUND: More than 1.2 million people in the United States are living with human immunodeficiency virus (HIV), and 3.2 million are living with hepatitis C virus (HCV). An estimated 25 % of persons living with HIV also have HCV. It is therefore of great public health importance to ensure the prompt diagnosis of both HIV and HCV in populations that have the highest prevalence of both infections, including individuals with substance use disorders (SUD). METHODS/DESIGN: In this theory-driven, efficacy-effectiveness-implementation hybrid study, we will develop and test an on-site bundled rapid HIV/HCV testing intervention for SUD treatment programs. Its aim is to increase the receipt of HIV and HCV test results among SUD treatment patients. Using a rigorous process involving patients, providers, and program managers, we will incorporate rapid HCV testing into evidence-based HIV testing and linkage to care interventions. We will then test, in a randomized controlled trial, the extent to which this bundled rapid HIV/HCV testing approach increases receipt of HIV and HCV test results. Lastly, we will conduct formative research to understand the barriers to, and facilitators of, the adoption, implementation, and sustainability of the bundled rapid testing strategy in SUD treatment programs. DISCUSSION: Novel approaches that effectively integrate on-site rapid HIV and rapid HCV testing are needed to address both the HIV and HCV epidemics. If feasible and efficacious, bundled rapid HIV/HCV testing may offer a scalable, potentially cost-effective approach to testing high-risk populations, such as patients of SUD treatment programs. It may ultimately lead to improved linkage to care and progress through the HIV and HCV care and treatment cascades. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02355080 . (30 January 2015).

Cost-effectiveness of long-term outpatient buprenorphine-naloxone treatment for opioid dependence in primary care.

BACKGROUND: Primary care physicians with appropriate training may prescribe buprenorphine-naloxone (bup/nx) to treat opioid dependence in US office-based settings, where many patients prefer to be treated. Bup/nx is off patent but not available as a generic. OBJECTIVE: We evaluated the cost-effectiveness of long-term office-based bup/nx treatment for clinically stable opioid-dependent patients compared to no treatment. DESIGN, SUBJECTS, AND INTERVENTION: A decision analytic model simulated a hypothetical cohort of clinically stable opioid-dependent individuals who have already completed 6 months of office-based bup/nx treatment. Data were from a published cohort study that collected treatment retention, opioid use, and costs for this population, and published quality-of-life weights. Uncertainties in estimated monthly costs and quality-of-life weights were evaluated in probabilistic sensitivity analyses, and the economic value of additional research to reduce these uncertainties was also evaluated. MAIN MEASURES: Bup/nx, provider, and patient costs in 2010 US dollars, quality-adjusted life years (QALYs), and incremental cost-effectiveness (CE) ratios ($/QALY); costs and QALYs are discounted at 3% annually. KEY RESULTS: In the base case, office-based bup/nx for clinically stable patients has a CE ratio of $35,100/QALY compared to no treatment after 24 months, with 64% probability of being < $100,000/QALY in probabilistic sensitivity analysis. With a 50% bup/nx price reduction the CE ratio is $23,000/QALY with 69% probability of being < $100,000/QALY. Alternative quality-of-life weights result in CE ratios of $138,000/QALY and $90,600/QALY. The value of research to reduce quality-of-life uncertainties for 24-month results is $6,400 per person eligible for treatment at the current bup/nx price and $5,100 per person with a 50% bup/nx price reduction. CONCLUSIONS: Office-based bup/nx for clinically stable patients may be a cost-effective alternative to no treatment at a threshold of $100,000/QALY depending on assumptions about quality-of-life weights. Additional research about quality-of-life benefits and broader health system and societal cost savings of bup/nx therapy is needed.

The cost of integrated HIV care and buprenorphine/naloxone treatment: results of a cross-site evaluation.

BACKGROUND: Implementing integrated HIV and buprenorphine/naloxone treatment requires cost estimates to plan and obtain funding. METHODS: We identified costs incurred at HIV clinical sites participating in a cross-site evaluation of integrated care that followed patients for 1 year. Costs include labor, overhead, and urine toxicology analyses (clinic perspective), buprenorphine/naloxone (payer perspective) and patient time and transportation (patient perspective). Sites provided resource utilization quarterly, and providers estimated time required for each activity. With site as the unit of analysis, results are reported as median (range) of average site costs in 2008 US dollars. RESULTS: The median number of monthly provider encounters for integrated care patients was 3.2 (1.5-13.3) compared with 1.7 (1.1-4.2) for similar patients not in integrated care, but integrated care patients had fewer physician encounters. Median monthly clinic costs per integrated care patient were $136 ($67-$677) for labor and overhead and $8 ($2-$23) for toxicology analyses, $22 higher than clinic costs for patients not in integrated care. Median monthly costs for buprenorphine/naloxone were $209 ($165-$272), and monthly patient costs in integrated care were $11 ($1-$54) higher. CONCLUSIONS: Integrated HIV and buprenorphine/naloxone treatment requires different resources, including costs that are not third-party reimbursed. Implementing integrated care will require funding for training and for new staff such as buprenorphine coordinators, in addition to reimbursement for buprenorphine/naloxone. Further research is needed to identify potential cost offsets outside of the clinic setting.

Overcoming policy and financing barriers to integrated buprenorphine and HIV primary care.

Treatment for substance abuse and human immunodeficiency virus (HIV) infection historically have come from different providers, often in separate locations, and have been reimbursed through separate funding streams. We describe policy and financing challenges faced by health care providers seeking to integrate buprenorphine, a new treatment for opioid dependence, into HIV primary care. Regulatory challenges include licensing and training restrictions imposed by the Drug Addiction Treatment Act of 2000 and confidentiality regulations for alcohol and drug treatment records. Potential responses include the development of local training programs and electronic medical records. Addressing the complexity of funding sources for integrated care will require administrative support, up-front investments, and federal and state leadership. A policy and financing research agenda should address evidence gaps in the rationales for regulatory restrictions and should include cost-effectiveness studies that quantify the "value for money" of investments in integrated care to improve health outcomes for HIV-infected patients with opioid dependence.