OBJECTIVES: Intrahepatic cholestasis (IHC) is a dysfunction of hepatocytes or the lesion/obstruction of bile canaliculi or duct. Symptoms with cholestatic-specificity are jaundice, pruritus, steatorrhea, fatigue, and osteoporosis. Persistent IHC can result in fibrosis, cirrhosis, possible hepatocellular carcinoma, and subsequent liver failure. In China the treatment for IHC caused by a variety of liver diseases is S-Adenosylmethionine (SAMe). The aim of this study is to assess the cost effectiveness of SAMe in China.

METHODS: A Markov model with three health states (moderate/severe IHC, mild ICH and dead) was constructed to compare SAMe with ‘no treatment’ (noTREAT). The probability of patients moving between moderate/severe ICH and mild ICH depended on the liver function tests. Published clinical trial data was used to inform the change in liver function test for SAMe and noTREAT. Cycle length was set to 8 weeks with a time horizon of the 2 years. Costs and quality of life utilities were obtained from published sources and through surveys of experts. The incremental cost-effectiveness ratio (ICER) threshold was set to 3xGDP/capita for China which was CNY 270.000 in 2022. One sensitivity analysis and probabilistic sensitivity analysis were performed.

RESULTS: Treatment of ICH with SAMe resulted in 1.25 quality adjusted life years (QALY) at a cost of CNY 55,239 vs 1.05 QALY and CNY 44,119 for noTREAT. This resulted in an ICER of CNY 56,451/QALY. One way sensitivity analysis showed that the main driver of the model is the cost of SAMe with the ICER almost doubling to CNY 102,884/QALY with a 25% increase in the cost of SAMe. 80% of the PSA simulations were below the ICER threshold.

CONCLUSIONS: This study shows that SAMe is a cost-effective option for the treatment of liver cholestasis in China with the ICER (CNY 56,451/QALY) being lower than the threshold.