Are Published Health Economic Models for Chronic Hepatitis B Appropriately Capturing the Benefits of HBsAg Loss? A Systematic Literature Review

Abstract

Objectives Sustained hepatitis B surface antigen (HBsAg) loss or 'functional cure' (FC) is considered an optimal treatment endpoint by international clinical guidelines for chronic hepatitis B (CHB), yet rarely is this achieved with current standard of care (SoC). This leads to an under-reporting of FC in clinical trials, observational studies and health economic (HE) models. This paper systematically identifies and assesses how FC is incorporated in published HE models of CHB. Methods A systematic literature review was conducted in PubMed and Embase (conducted February 2019) to review how HBsAg loss is captured in HE models. The following items were extracted: rate of (and transition probabilities to) HBsAg loss, HBsAg loss health state costs, and HBsAg loss health state utilities. Results Sixty-five economics evaluations were identified, and < 50% of these (27/65) incorporated HBsAg loss in their models. Only 15/27 stated HBsAg loss health state costs, 15/27 stated HBsAg loss health state utilities, and 11/27 mentioned treatment-specific transition probabilities to HBsAg loss. The majority of sources these inputs were derived from are not transparent. Conclusions The benefits of FC in current HE models are not well captured, as FC is often not reported or not directly related to modelled treatments. This has the potential for novel agents with higher efficacy compared with SoC to be overlooked and undervalued if their worth is not appropriately communicated. In order to ensure optimal access for patients to new and effective therapies, it is important that the benefits of FC are better assessed and captured within HE models.Peter Wigfield and Urbano Sbarigia contributed equally to the work.The benefits of functional cure in current health economic models are not well captured, as functional cure is often not reported or not directly related to modelled treatments.In order to ensure optimal access for patients to new and effective therapies, it is important that the benefits of functional cure are better assessed and captured within health economic models.

Systematic Literature Review and Critical Appraisal of Health Economic Models Used in Cost-Effectiveness Analyses in Non-Alcoholic Steatohepatitis: Potential for Improvements

“…A lack of transparency relating to some aspects of health economic models in other liver disease areas, such as chronic hepatitis B, has also been reported [57]. One approach to enhancing transparency and validation is the formation of informal networks within disease areas to actively promote this.…”

Predictors of therapeutic response to peginterferon α‑2a and nucleos(t)ide analog combination therapy for HBeAg‑negative chronic hepatitis B: 1‑year follow‑up after treatment

“…Chronic hepatitis B (CHB) is a major global health concern. The main goal of CHB treatment is to reduce the risk of chronic liver disease and related complications and improve the quality of life and survival (1). Guidelines for the management of hepatitis B virus (HBV) infection indicate that hepatitis B surface antigen (HBsAg) loss is a key endpoint of interest and is strongly recommended (2).…”