OBJECTIVES

The mass of recent reform to China’s market access environment has understandably generated considerable interest. Annual updates to the National Reimbursement Drug List (NRDL) are at the forefront of these changes, as are Chinese health authorities’ targets to increase drug access for patients. This study analysed the characteristics of rare disease drugs placed on the NRDL (2017-2019) to investigate which selection criteria may have influenced which drugs are accepted onto the list.

METHODS

This study relied on primary and secondary research to accrue relevant data. Key opinion leaders with knowledge of China’s reimbursement processes were interviewed for primary research, while publicly available government resources and grey literature formed the basis of secondary research.

RESULTS

The National Rare Disease list encompasses 121 rare diseases. As of 2019, 61 of these diseases have treatments available on the Chinese market while the National Healthcare Security Administration (NHSA) reimburses 31 through the NRDL. Beyond pricing considerations, the 31 reimbursed drugs were found likely to meet the following criteria: (1) availability of local data; (2) larger trial population; (3) high level of perceived need; (4) holding approval and reimbursement status in EU5; (5) presence on the Drug Evaluation Centre’s (DEC) list of ‘clinically urgent drugs’.

CONCLUSIONS

This study presents an empirical analysis of rare disease drugs accepted onto the NRDL, delineating comparable criteria that indicate a methodology of selection criteria used by the committee responsible for NRDL updates. This provides insights into why certain rare disease drugs are accepted onto the NRDL while others are not.