Overview and changes of Guiding Principles of Clinical Application of Novel Anti -tumor Drugs over the years / 中国药房

ABSTRACT

OBJECTIVE To provide the suggestions and reference for the follow-up update of Guiding Principles of Clinical Application of Novel Anti -tumor Drugs （hereinafter referred to as “Guiding Principles ”）. METHODS The update of 2018-2021 editions of Guiding Principles were compared ；the changes of its style ，the variety and quantity of novel anti-tumor drugs ，the classification of indications ，the target ，the inclusion of medical insurance and other aspects were analyzed. Its change trend and possible problems were summarized. RESULTS There was a great change in the style of Guiding Principles in 2020 edition，i.e. deleting the item of “clinical application management ”and adding the item of “attached table ”. Totally 33 novel anti-tumor drugs were included in the 2018 edition of Guiding Principles ，and the number of novel anti-tumor varieties increased to 46，60 and 77 in 2019，2020 and 2021 editions，respectively. The time when the new varieties were included in Guiding Principles was the same year or one year after the domestic market time. Totally 26 varieties of national medical insurance negotiation were included in the 2018 edition of Guiding Principles ，and 8，10 and 12 varieties were added respectively in 2019，2020 and 2021 editions on the basis of the previous edition . Novel anti-tumor drug in the 2018 edition of Guiding Principles mainly focused on traditional targets such as EGFR，HRE2 and VEGFR. However ，since 2019，the number of new targets such as PD-1，PARP，ALK and CDK had been increasing，among which domestic original drugs accounted for a large proportion. CONCLUSIONS The revision of Guiding Principles aims to further guide the clinical application of novel anti-tumor drugs from the professional level of health technology. The new varieties and indications conform to the principles of scientificity and dynamics ；domestic original varieties have developed rapidly ，and innovative varieties to novel target have emerged. The follow-up update of Guiding Principles should refer to authoritative medical guidelines and high-quality evidence- based evidence. Attention should be paid to the types of tumors lacking therapeutic drugs and the clinical value of oushun- novel anti-tumor drugs.