Association of haematological cancer drugs recommendation levels in Chinese Society of Clinical Oncology guideline with different approval approaches: a cross-sectional study.

Abstract

To evaluate the associations between approval approaches and the Chinese Society of Clinical Oncology (CSCO) guidelines for haematological cancer drug indications. Haematological cancer drug indications approved via different approaches between 2015 and 2023 were retrieved from the National Medical Products Administration (NMPA) website, and their CSCO guideline recommendation levels were analysed. Basic characteristics were analysed descriptively. Fisher's test and t-tests were used to respectively explore the associations of the approval approaches and the recommendation level, and the time difference between the indications obtaining the recommendation level and being approved by the NMPA. Changes in recommendation levels were also analysed. The NMPA approved 52 haematological cancer drug indications (33 anticancer drugs) from 2015 to 2023. 5 indications were approved via routine approval (RA) and 47 were approved via accelerated approval (AA). 39 indications obtained CSCO guideline recommendation level I. Indications approved via the AA and RA were similarly likely to obtain level I. The average time for the indications approved via the RA to obtain the recommendation level is 7.6 months before the indications were approved by the NMPA. And the average time for the indications approved via AA to obtain the recommended level is -5.51 months. For indications approved via priority review and RA, there was a difference in the average time from obtaining recommendation level to obtaining NMPA approval. Compared with CSCO's initial recommendation levels, 15 indications obtained higher recommendation level in the updated CSCO guideline. Most haematological cancer drug indications obtained CSCO guideline recommendation level I, with no significant difference between AA and RA in the recommendation level. Indications approved via RA obtained recommendation level more quickly. Some indications obtained a higher recommendation level in the updated guideline. Strengthening communication between the NMPA and CSCO and ensuring timely integration of emerging evidence may improve the alignment between approval decisions and recommendation level.