Decision Drivers in Health Technology Assessment in Hepatitis C

Abstract

Recent advances in treating Hepatitis C (HCV) have prompted significant debate about affordability. The objective of this research was to investigate Health Technology Assessment (HTA) agencies’ approach to assessment and the impact of evidence criteria on recommendations. HTA reports published on HCV since 2014 were reviewed. The four most frequently assessed drugs were further scrutinized in terms of clinical benefit, costs and recommendation. Forty-two assessments were published. Of these, sofosbuvir was the focus of 29% of assessments, followed by simeprevir (26%), daclatasvir (12%) and ledipasvir + sofosbuvir (12%). These 33 HTAs met the criteria for further analysis. Eleven recommendations were positive without restriction (33%); 20 were positive with restrictions (60%) and two were negative (6%). Ledipasvir + sofosbuvir received the lowest proportion of positive recommendations without restriction (20%). Simeprevir and daclatasvir had the highest proportions, with 41% and 41%, respectively. Sofosbuvir, the first marketed and highest priced, was the only drug to receive negative recommendations. Clinical benefit was recognised as being an important criteria in 19 (58%) of the 33 reports. The main negative critique (reported in 11/33 cases) was lack of direct comparative evidence and the resulting uncertainty around cost-effectiveness. In three cases, positive recommendations were based on price negotiations with the manufacturer. The 20 positive recommendations were restricted to subpopulations where the cost-effectiveness was highest (progressed patients, with fibrosis and facing transplantation). Recently, 4 effective, but costly HCV drugs were launched. No clear trend was observed regarding order of market entry and HTA recommendation. However, in most cases, agencies restricted access to subpopulations. Cost seemed to be a key decision driver: simeprevir and daclatasvir most often received a positive recommendation.