PNS62 Keeping up with the Rest of the World or Setting a New PACE: China’S Expansion into Evidence-Based Health Technology Assessment in Healthcare Policy-Making

Abstract

Despite the absence of institutionalising Health Technology Assessment (HTA), the Chinese government has set up clear goals to strengthen the national pharmacoeconomic evaluation capabilities and capacity so that a standardised HTA process can be integrated in drug pricing and reimbursement policy-making. This study aims to discuss the opportunities and challenges posed by the evolution of HTA in China and explore tangible solutions to succeed when the need for robust clinical and pharmacoeconomic evidence increases. Literature and policy documents were reviewed. Expert opinions via quantitative survey (n=60) and semi-structured in-depth qualitative interviews (n=10) were utilised to explore the recent evolution of HTA in China, during which payers were probed on details of policy trends, evidence requirements, and ways for global manufacturers to stay ahead of the curve. China has made significant progress in integrating HTA in the pricing and reimbursement policy-making processes, which can be seen in recent National Reimbursement Drug List (NRDL) and National Essential Drug List (NEDL) updates. Payers have highlighted the importance of developing robust clinical & economic evidence package to support national listing and price negotiation of high cost, high value drugs. Specifically, four types of evidence should be clearly demonstrated, namely clinical necessity, incremental clinical value vs. standard of care, robust pharmacoeconomic evaluation (cost-effectiveness and budget impact) and drug international reference prices/global sales information. In addition, in order to enable swift access of much needed innovative assets, the government is also actively exploring the possibility of ad-hoc review of an innovative drug upon company proactive submission. When it comes to pricing and reimbursement decisions, China is rapidly moving from an expert consensus-based evaluation framework to an evidence-based framework. Robustness in demonstrating clinical necessity, clinical and economic value are likely have a great impact on both likelihood and speed of access in China.