Cost-effectiveness analysis of rifaximine-α for the prevention of hepatic encephalopathy relapses in France

Abstract

Context: Hepatic encephalopathy (HE) is a neuropsychiatric syndrome occurring concomitantly to a hepatic disease. Rifaximine-α is the first treatment indicated in the prevention of overt HE (OHE) in adult patients. Objective: To estimate, using the French National Insurance perspective, the cost-effectiveness ratio of rifaximine-α + lactulose versus lactulose in cirrhotic patients who have experienced at least two prior OHE events. Methods: A five states Markov model was developed and used to estimate the effectiveness of rifaximine-α + lactulose relative to lactulose alone, over a 5 years’period. Clinical data were extracted from two randomized controlled trial, RFHE3001 and RFHE3002, and one French observational study. Costs data were estimated using French tariffs and the 2014 PMSI database. Utility was measured as quality adjusted life year. A 4% actualization rate was applied. Uncertainty was investigated through a probabilistic sensitivity analysis. results: Incremental cost-effectiveness ratio of rifaximine-α + lactulose versus lactulose alone is equal to 13507€/Qaly (8887€–21733€/Qaly) at 5 years. Using a 28500€ cost-effectiveness threshold, rifaximine-α + lactulose is found to be cost-effective in 91,8% of the simulations, and in 100% for a 43000€ threshold. Conclusion: Use of rifaximine-α implies a reduction of the number of hospitalizations as well as an increase of patients’ quality of life. Given a 28500€ threshold, considering this molecule cost-effective implies an error rate below 1%.