Healthcare value of implementing hepatitis C screening in the adult general population in Spain

Abstract

Background: Elimination of hepatitis C virus (HCV) infection requires high diagnostic rates and universal access to treatment. Around 40% of infected individuals are unaware of their infection, which indicates that effective screening strategies are needed. We analyzed the efficiency (incremental cost-utility ratio, ICUR) of 3 HCV screening strategies: a) general population of adults, b) high-risk groups, and c) population with the highest anti-HCV prevalence plus high-risk groups.

Methods: An analytical decision model, projecting progression of the disease over a lifetime, was used to establish the candidate population for HCV screening. HCV data were obtained from the literature: anti-HCV prevalence (0.56%-1.54%), viremic patients (31.5%), and percentage of undiagnosed persons among those with viremia (35%). It was assumed that most patients would be treated and have HCV therapy response (98% SVR); transition probabilities, utilities, and disease management annual costs were obtained from the literature. Efficiency over the life of patients under the National Health System perspective was measured as quality-adjusted life years (QALY) and total cost (screening, diagnosis, pharmacological and disease management). A discount rate of 3% was applied to costs and outcomes.

Results: Screening of the adult population would identify a larger number of additional chronic hepatitis C cases (N = 52,694) than screening the highest anti-HCV prevalence population plus high-risk groups (N = 42,027) or screening high-risk groups (N = 26,128). ICUR for the general population vs. high-risk groups was €8914/QALY gained per patient (€18,157 incremental cost and 2.037 QALY). ICUR for the general population vs. population with highest anti-HCV prevalence plus high-risk groups was €7,448/QALY gained per patient (€7,733 incremental cost and 1.038 QALY). These ICUR values are below the accepted efficiency threshold (€22,000-€30,000).

Conclusion: HCV screening and treatment of the general adult population is cost-effective compared to screening of high-risk groups or the population with the highest anti-HCV prevalence plus high-risk groups.

Conflict of interest statement

Maria Buti is an advisor for Gilead Sciences, Abbvie and MSD. Rafael Esteban is an advisor for Gilead Sciences, Abbvie and MSD. Raquel Domínguez-Hernández, Eliazar Sabater and Miguel Ángel Casado are employees of Pharmacoeconomics & Outcomes Research Iberia, a consultancy firm specialising in the economic evaluation of healthcare interventions, which has received unconditional funding from Gilead Sciences. There are no patents, products in development or marketed products to declare. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials, as detailed online in the guide for authors.

Figures

Fig 1. Decision tree.

HC, hepatitis C; HCV, hepatitis C virus; RNA +, ribonucleic acid positive; RNA -, ribonucleic acid negative. Decision tree showing the decision of whether or not to screen. Target populations were tested only once at the beginning of the analysis. The population eligible for screening was estimated after excluding the population already diagnosed with HCV infection. All screened patients were assumed to undergo antibody testing by ELISA (enzyme-linked immunosorbent assay), following by polymerase chain reaction (PCR) in those testing antibody-positive to confirm the diagnosis of the disease. In patients testing positive on ELISA but negative on PCR, it was assumed that the infection had resolved or spontaneously cleared. Only chronic hepatitis C patients were entered in the Markov model and progressed in the disease until death.

Fig 2. Screening flow chart.

Screening flow chart showing the derivation of the number of individuals screened, HCV-diagnosed, eligible for treatment, and achieving SVR in the general population, the highest anti-HCV prevalence population plus high-risk groups, and high-risk-groups.

Fig 3. Annual impact on the number of clinical events with each population.

HCV, hepatitis C virus; HR, High Risk. a. HCV related decompensated cirrhosis, b. HCV related hepatocellular carcinoma, c. HCV related liver transplants, d. HCV related death.

Fig 4. One-way sensitivity analyses.

Scenario 1 (general population vs high-risk groups) and Scenario 2 (general population vs population with the highest anti-HCV prevalence plus high-risk groups), using a tornado diagram. ICUR for the upper and lower limits of each parameter examined are shown on the horizontal axis of the diagram.