1.Evidence-based medical evidence change of the payment limitation of antitumor drugs in national medical- insurance negotiation
Shunlong OU ; Jing LUO ; Hui LIU ; Jin DI ; Qian JIANG
China Pharmacy 2022;33(3):271-274
OBJECTIVE To study the changes in medical-insuran ce payme nt limitations of anti tumor drugs in national medical- insurance negotiation (hereinafter referred to as “national negotiation ”)and recommendations of diagnosis and treatment guidelines corresponding to tumor issued by Chinese Society of Clinical Oncology (CSCO),so as to provide reference for the performance of national negotiation. METHODS The annual list of anti tumor drugs in national negotiation were summarized ;CSCO diagnosis and treatment guidelines were searched according to the tumor types restricted by the medical- insurance payment limitations of antitumor drugs in national negotiation ;the evidence evolution of the payment limitations of medical insurance for anti tumor drugs and CSCO diagnosis and treatment guidelines were analyzed quantitatively. RESULTS & CONCLUSIONS Finally,46 antitumor drugs in the agreement period were included ;seven of their payment limitations of medical insurance had changed ;and there were differences among the payment limitation of medical insurance ,drug labels and recommendations of CSCO diagnosis and treatment guidelines for 13 varieties;the recommendations ,strength of evidence ,recommendation level of CSCO diagnosis and treatment guidelines were changing for 28 varieties anti tumor drugs in different years ;the number of anti tumor drugs recommended by CSCO diagnosis and treatment guidelines differed significantly among different cancer varieties. The medical insurance payment limitations of anti tumor drugs in national negotiation have been gradually expanded ,and the corresponding recommendations ,strength of evidence, recommendation level in guidelines have been constantly improved. However , the payment limitation of B-19-H-20200622) medical insurance for most drugs are limited to the indicationsof drug labels and drugs for some cancers are scarce ,such as 85420393。E-mail:oushunlong@sohu.com esophageal cancer and nasopharyngeal carcinoma.
2.Overview and changes of Guiding Principles of Clinical Application of Novel Anti -tumor Drugs over the years
Shunlong OU ; Jing LUO ; Song WANG ; Rao SONG ; Qian JIANG
China Pharmacy 2022;33(11):1392-1396
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.
3.Evidence-based evaluation of the global cancer-associated thromboembolism risk assessment tools
Xiaoli QIN ; Xiurong GAO ; Qin HE ; Shunlong OU ; Jing LUO ; Hua WEI ; Qian JIANG
China Pharmacy 2024;35(3):333-338
OBJECTIVE To evaluate the global cancer-associated thromboembolism risk assessment tools based on evidence- based methods, and to provide methodological reference and evidence-based basis for constructing a specific tool in China. METHODS A comprehensive search was conducted on 6 databases, including CNKI, Wanfang data, VIP, CBM, PubMed, and Embase, as well as on the websites of NCCN, ASCO, ESMO and so on with a deadline of June 30, 2022. Furthermore, a supplementary search was conducted in January 2023. The essential characteristics and methodological quality of included risk assessment tools were described and analyzed qualitatively, focusing on comparing each assessment stratification ability. RESULTS Totally 14 risk assessment tools were included in the study, with a sample size of 208-18 956 cases and an average age distribution of 53.1-74.0 years. The applicable population included outpatient cancer student@sina.com patients, lymphoma patients, and multiple myeloma patients,etc. The common predictive factors were body mass index, venous thromboembolism history, and tumor site. All tools had undergone methodological validation, with 9 presented in a weighted scoring format. Only seven tools were used simultaneously for specificity, sensitivity, negative predictive value (NPV), positive predictive value (PPV) and area under the curve (AUC) or C statistical analysis. CONCLUSIONS The risk of bias in constructing existing tools is high, and the heterogeneity of tool validation results is significant. The overall methodological quality must be improved, and its risk stratification ability must also be investigated. There are still certain limitations in clinical practice in China.