OBJECTIVES: To determine the policy changes and market nuances in China and how this affects the future market access landscape of China. The aim of this study is to determine how to best position new drug launches given the frequency of updates in the National Reimbursement Drug List (NRDL) to be more inclusive of innovative western medicine that can be accessed within China. This study will also help standardize the decision-making process during phases of pre-launch, launch and post-launch.

METHODS: Through primary and qualitative research with key stakeholders, we will look at the new policy changes (updates directly from the Chinese Government) and interpret the evolving market landscape and understand the implications of pricing and reimbursement in China.

RESULTS: Our research identified key opportunities and challenges in the evolving market access landscape in China which can be used to formulate a successful China-specific strategy. We have provided a launch strategy toolbox for global biopharmaceutical executives to help create a standardized decision-making process. The toolbox will encompass key stakeholder dynamics including the registration agency, public reimbursement process, local competitors and new emerging players influencing the reimbursement landscape, such as city benefit insurance and Chinese IT companies reshaping the distribution space.

CONCLUSIONS: China has established a mature systematic national coverage and reimbursement process, and policy shaping opportunities are closed for major changes to the current system. However, smaller adjustments are ongoing, for example, the recent central government emphasis on improving access to rare disease treatment. As a result, successful planning and implementation of new product launch strategies in China requires in-depth and agile understanding of the market to precisely position the product and seize the opportunities.