OBJECTIVES:

Sorafenib significantly improve the overall survival of patients with advanced hepatocellular carcinoma (HCC). Conducted research aimed to assess the pharmaco-economic implications of sorafenib as first-line treatment for advanced HCC in comparison with best symptomatic treatment without systemic chemotherapy also known as supportive care (BSC).

METHODS:

A Markov model was developed with three health states included : progression-free survival (PFS), progressed disease, and death in order to estimate the outcomes and costs in 10-year time horizon. ((TreeAge Pro 2016 Suite Inc.Williamstown, MA). The clinical data and utility values used in the pharmacoeconomic model were taken from the pivotal SHARP study with the data from the placebo arm used as a proxy for BSC. Based on this approximation and the results obtained from the GIDEON study In Republic of Macedonia approximately 25 patient/per year are eligible for sorafenib treatment. The drug acquisition cost of sorafenib was calculated based on the mean dose per day and mean treatment duration used in the study. A range of other health state costs was integrated in the model, GP and specialists’ visits, laboratory and radiological tests, hospitalizations and specific medicinal procedures. Official publicly available data in R. Macedonia for medicinal unit cost were used in the model. Discount rate for all cost and outcomes was 3%. Sensitivity analyses evaluated the impact of several essential variables.

RESULTS:

The incremental cost-effective ratio was €14 363.00 per QALY for sorafenib versus best supportive care (BSC). The sensitivity analysis confirmed that the results were sensitive to the overall survival estimates, the cost of BSC and the utility values.

CONCLUSIONS:

Sorafenib is not a cost-effective option as a first-line treatment for patients with advanced HCC. Reduction in the price of sorafenib, or appropriate assistance program should be considered to improve the cost-effectiveness of advanced HCC treatment.