How to implement quality use of medicines in developing countries - an example from China

In this thesis, we aimed to evaluate the feasibility to apply the concept of quality use of medicine in developing country at the micro level using China as an example. When evaluating the technical feasibility of applying quality use of medicine (QUM) principles in a developing country, firstly, we attempted to identify and summarise the clinical evidence on the efficacy and safety of different drugs, to provide the scientific data for formulation of clinical recommendation. Then considering the limitations of the decision making in chronic diseases based on efficacy and safety, we translated and validated a health utility measure (Quality of Well-Being Scale Self-Administered, QWB-SA) in Chinese epileptic patients. Furthermore, to prove the value for money, cost-effectiveness analysis (CEA) studies were performed to ascertain the clinical and economic consequences. Fourthly, for purpose of providing a more transparent CEA threshold to interpret Incremental Cost-effectiveness Ratio (ICER) from CEA studies, an empirical study was carried out to quantify the Willingness-to-Pay per Quality-adjusted Life Year (WTP/QALY) value in epileptic and general populations. Lastly, with the intention to aid the healthcare planning, disease prioritising, and benefit assessment, we undertook a holistic burden of disease study by gauging the economic burden of epilepsy in China. In these studies, we made several useful findings. First, via the meta-analysis, we found that newer generation of antiepileptic drugs (AEDs) as the adjunctive treatment were more effective than placebo while with higher incidence of adverse effects. Second, we also found out that as a preference-based utility measure, QWB-SA outperformed EuroQol (EQ-5D) in terms of better sensitivity and fewer ceiling effects. Third, even with increased life expectance, QALYs, lower incidences in diabetes-related complications comparing with glimepiride, using the WTP/QALY threshold of CNY 100,000, administration of liraglutide was not costeffectiveness in China. Fourth, we found that it is feasible to construct the CEA threshold by valuing the utility and WTP simultaneously, and the 1 to 3 times GDP/Capita could potentially serve as the CEA threshold reference in the Asian region. Fifth, we found that epilepsy is a cost-intensive disease in China from a societal perspective. In conclusions, this thesis has illustrated how to realise the quality use of medicine at the micro-level in a developing country. Our findings are useful in informing the clinicians and decision-makers to better understanding the importance of quality drug uses and strategies to realise it, particularly for developing countries.