OBJECTIVES : The changing demographics of the Chinese population has contributed to the growth in the pharmaceutical market. However, MNCs operating in China may face challenges given the complex and changing P&MA environment. Lately, the government has implemented a raft of reforms to upgrade the pharmaceutical sector. This study aims to discuss opportunities and challenges posed by these reforms and explore tangible solutions to succeed when the need for robust clinical and economic evidence increases in China.

METHODS : Literature and policy documents was reviewed. Expert opinion via quantitative survey (n=50) and semi-structured in-depth qualitative interviews (n=10) was utilised to explore the impact and implications of recent P&MA policy evolution in China, during which payers at all levels were probed on details of policy trends and ways for manufacturers to stay ahead of the curve.

RESULTS : A changing P&MA policy environment brings new challenges. Domestic companies are rapidly filling their innovative pipelines, which intensifies competition and price pressure. A pilot centralised procurement program aims to reduce drug prices and consolidate the generic industry. Recent reforms failed to curb the pursuit of profit by public hospitals, encouraging hospitals to negotiate confidential discounts to fill the budget impact shortfalls. Conversely, opportunities exist, such as accelerated drug approvals, expanded national reimbursement coverage and the emergence of a more evidence-based pricing mechanism. Following policy changes, payers highlighted the importance of developing robust clinical & economic evidence package to support national listing and price negotiation, by including IRP, health economics data (CUA, CEA and preferably budget impact) and real-world evidence.

CONCLUSIONS : MNC’s pricing strategy and robustness of clinical and economic evidence will have an impact on both likelihood and speed of access. To succeed in national listing, companies should evaluate IRP and SoC pricing, quantify clinical and economic burden of illness, and leverage pharmaco-economics and real-world evidence as negotiation levers.