Cost–effectiveness analysis of simeprevir with daclatasvir for non-cirrhotic genotype-1b-naïve patients plus chronic hepatitis C

Abstract

Background: The cost of interferon-free combination therapies remains high to provide widespread access to treatment, regardless of fibrosis stage. Aim: To estimate the cost–effectiveness of simeprevir/daclatasvir (SMV/DCV) therapy in treatment-naïve chronic hepatitis C genotype-1b patients with moderate fibrosis. Methods: A Markov model was developed to simulate the natural history of chronic hepatitis C progression. The model estimated lifetime healthcare costs and quality-adjusted life-years (QALY) for a cohort of patients from the Spanish National Healthcare System perspective. The cost–effectiveness threshold considered was €40,000/QALY. The treatment strategies analyzed were SMV/DCV, peginterferon/ribavirin/telaprevir, and peginterferon/ribavirin/boceprevir. A sensitivity analysis was carried out. Results: The incremental cost–effectiveness ratios of the SMV/DCV strategy were €23,774/QALY and €28,524/QALY compared with that of telaprevir or boceprevir triple therapy, respectively, for genotype-1b patients with moderate fibrosis. Conclusions: SMV/DCV combination compared with the standard of care previous to the arrival of second-generation direct-acting antivirals fell below generally accepted willingness-to-pay threshold. Results obtained should be supported by ongoing clinical trials.

Keywords:

• boceprevir
• chronic hepatitis C
• cost–effectiveness
• daclatasvir
• direct acting antivirals
• pegylated interferon
• protease inhibitors
• ribavirin
• simeprevir
• telaprevir

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. This manuscript represents the personal opinion of the authors and does not necessarily represent the views or policy of the Institutions they belong to.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Second-generation direct-acting antivirals introduction represents an important therapeutic improvement for chronic hepatitis C treatment.

• Estimated incremental cost–effectiveness ratios of simeprevir/daclatasvir combination for genotype-1b patients with moderate fibrosis are situated below the cost–effectiveness threshold in comparison to boceprevir and telaprevir regimes.

• Regardless of the incremental cost–effectiveness ratio values, the financial burden considering the acquisition costs and its budgetary impact can compromise access to treatment.

• The rapid emergence of the new treatments for chronic hepatitis C makes necessary the accomplishment of a correct drug positioning by searching the most efficient therapy with the smallest budgetary impact.

• Simulation models are very interesting tools in pathologies such as chronic hepatitis C where the treatment costs are focused in the first 12 weeks and the benefits are obtained in the long term.