Objectives Functional dyspepsia (FD) is characterised by epigastric pain and burning with a significant negative impact on quality-of-life and productivity. Prokinetic agents are widely used to treat FD in many Asian countries such as Vietnam. However, little is known with respect to cost-effectiveness and budget impact of these drugs as they are not approved for this indication in the Western world. The aim of this study is to investigate if the prokinetic itopride hydrochloride is a cost-effective option for the treatment of FD and the financial implication for broadening subsidised access in Vietnam.

Methods A 3-stage Markov model (health states: health states: controlled FD, uncontrolled FD, dead) with a 10-year time horizon using 8-week cycles was used to assess itopride versus no treatment and mosapride. The budget impact was examined over 5-years by capturing treatment costs, health resource utilisation, societal costs, and savings from funding itopride for patients in the target population. Vietnamese specific costs and quality-of-life input were obtained from published sources and expert advice. Both models were developed in Excel.

Results The incremental cost effectiveness ratio (ICER) per quality-adjusted-life-year for itopride was estimated to be VND49.8M vs no treatment. Itopride was dominant vs mosapride with 0.18 incremental QALY gain at an incremental cost of -VND3.0M. More than 80% of the simulations in the probabilistic sensitivity analysis were cost-effective at the 1xGDP (VND64.1M) threshold. Over 5 years, the health care spending was increased by 2.3% from VND1.80T to VND1.84T with an estimated increase of 13.7% patients being treated for FD.

Conclusions This study shows that itopride is a cost-effective medication and would likely impose only a small budget impact if the subsidised access was widened in Vietnam.