Cost-effectiveness of Early Treatment of Hepatitis C Virus Genotype 1 by Stage of Liver Fibrosis in a US Treatment-Naive Population.

IMPORTANCE: Novel treatments for hepatitis C virus (HCV) infection are highly efficacious but costly. Thus, many insurers cover therapy only in advanced fibrosis stages. The added health benefits and costs of early treatment are unknown. OBJECTIVE: To assess the cost-effectiveness of (1) treating all patients with HCV vs only those with advanced fibrosis and (2) treating each stage of fibrosis. DESIGN, SETTING, AND PARTICIPANTS: This study used a decision-analytic model for the treatment of HCV genotype 1. The model used a lifetime horizon and societal perspective and was representative of all US patients with HCV genotype 1 who had not received previous treatment. Comparisons in the model included antiviral treatment of all fibrosis stages (METAVIR [Meta-analysis of Histological Data in Virial Hepatitis] stages F0 [no fibrosis] to F4 [cirrhosis]) vs treatment of stages F3 (numerous septa without cirrhosis) and F4 only and by specific fibrosis stage. Data were collected from March 1 to September 1, 2014, and analyzed from September 1, 2014, to June 30, 2015. INTERVENTIONS: Six HCV therapy options (particularly combined sofosbuvir and ledipasvir therapy) or no treatment. MAIN OUTCOMES AND MEASURES: Cost and health outcomes were measured using total medical costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs), calculated as the difference in costs between strategies divided by the difference in QALYs. RESULTS: We simulated 1000 individuals, but present the results normalized to a single HCV-infected person. In the base-case analysis, among patients receiving 8 or 12 weeks of sofosbuvir-ledipasvir treatment, treating all fibrosis stages compared with treating stages F3 and F4 adds 0.73 QALYs and $28,899, for an ICER of $39,475 per QALY gained. Treating at stage F2 (portal fibrosis with rare septa) costs $19,833 per QALY gained vs waiting until stage F3; treating at stage F1 (portal fibrosis without septa), $81,165 per QALY gained compared with waiting until stage F2; and treating at stage F0, $187,065 per QALY gained compared with waiting until stage F1. Results for other regimens show a similar pattern. At base-case drug prices, treating 50% of all eligible US patients with HCV genotype 1 would cost $53 billion. In sensitivity analyses, the ICER for treating all stages vs treating stages F3 and F4 was most sensitive to cohort age, drug costs, utility values in stages F1 and F2, and percentage of patients eligible for 8-week therapy. Except for patients aged 70 years, the ICER remains less than $100,000 per QALY gained. A 46% reduction in cost of sofosbuvir-ledipasvir therapy decreases the ICER for treating at all fibrosis stages by 48%. CONCLUSIONS AND RELEVANCE: In this simulated model, treating HCV infection at early stages of fibrosis appeared to improve health outcomes and to be cost-effective but incurred substantial aggregate costs. The findings may have implications for health care coverage policies and clinical decision making.

Case management to improve adherence for HIV-infected patients receiving antiretroviral therapy in Ethiopia: a micro-costing study.

BACKGROUND: Adherence to antiretroviral medication regimens is essential to good clinical outcomes for HIV-infected patients. Little is known about the costs of case management (CM) designed to improve adherence for patients identified as being at risk for poor adherence in resource-constrained settings. This study analyzed the costs, outputs, unit costs and correlates of unit cost variation for CM services in 14 ART sites in Ethiopia from October 2008 through September 2009. METHODS: This study applied standard micro-costing methods to identify the incremental costs of the CM program. We divided total CM-attributable costs by three output measures (patient-quarters of CM services delivered, number of patients served and successful patient exits) to derive three separate indices of unit costs. The relationships between unit costs and two operational factors (scale and service-volume to staff ratios) were quantified through bivariate analyses. RESULTS: The CM program delivered 4,598 patient-quarters of services, serving 5,056 patients and 1,995 successful exits at a cost of $167,457 over 12 months, or $36 per patient-quarter, $33 per patient served and $84 per successful exit from the CM program. Among the 14 sites, mean costs were $11,961 (sd, $3,965) for the 12-month study period, and $51 (sd, $36) per patient-quarter; $48 (sd, $32) per patient served; and $183 (sd, $157) per successful exit. Unit costs varied inversely with scale (r, -0.70 for cost per patient-quarter versus patient-quarters of service) and with the service-volume to staff ratio (r, -0.68 for cost per patient-quarter versus staff per patient-quarter). CONCLUSIONS: For those receiving CM, the program adds 0.52% to the lifetime cost of ART. These data reflect wide variation in unit costs among the study sites and suggest that high patient volume may be a major determinant of CM program efficiency. The observed variations in unit costs also indicate that there may be opportunities to identify staffing patterns that increase overall program efficiency.

Cost-effectiveness of antiretroviral therapy for prevention.

Recent empirical studies and analyses have heightened interest in the use of expanded antiretroviral therapy (ART) for prevention of HIV transmission. However, ART is expensive, approximately $600 per person per year, raising issues of the cost and cost-effectiveness of ambitious ART expansion. The goal of this review is to equip the reader with the conceptual tools and substantive background needed to understand and evaluate the policy and programmatic implications of cost-effectiveness assessments of ART for prevention. We provide this review in six sections. We start by introducing and explaining basic concepts of health economics as they relate to this issue, including resources, costs, health metrics (such as Disability-Adjusted Life Years), and different types of economic analysis. We then review research on the cost and cost-effectiveness of ART as treatment, and on the cost-effectiveness of traditional HIV prevention. We describe critical issues in the epidemic impact of ART, such as suppression of transmission and the role of the acute phase of infection. We then present a conceptual model for conducting and interpreting cost-effectiveness analyses of ART as prevention, and review the existing preliminary estimates in this area. We end with a discussion of future directions for programmatic demonstrations and evaluation.