ABSTRACT
OBJECTIVE To systematically evaluate pharmacoeconomic studies （modeling approach） based on the Chinese acute ischemic stroke （AIS） population， and to provide the suggestions for improving the pharmacoeconomic evaluation method of AIS. METHODS Retrieved from CNKI， Wanfang Data Knowledge Service Platform， VIP， PubMed， Embase， the Cochrane Library， ScienceDirect， and Web of Science databases， relevant literature on pharmacoeconomic evaluation of AIS were collected from January 2014 to February 2022. Basic information of included study， basic information and outcome indicators of the model were analyzed statistically. The quality of the included literature was evaluated using CHEERS 2022， and problems in the existing literature were identified and suggestions were made. RESULTS Twelve papers were finally included， involving five in Chinese and seven in English. All studies reported the study perspective， mainly from the perspective of health system； the age of the target population was mainly distributed around 60 years old； the main interventions in the included studies were pharmacotherapy， including single-drug regimens and combination drug regimens； nine papers used decision trees combined with Markov models， and three papers used Markov models alone， but the classification of health status was inconsistent； all papers reported study time frame and cycle period， with most studies choosing a study time frame of 30 years and a cycle period of 1 year； all studies used modified Rankin scale scores as an indicator of clinical effectiveness， which were mainly derived from clinical trials； utility values in most literature were derived from published studies， and costs were mainly direct medical costs； all studies performed cost-utility analyses using quality-adjusted life years and/or incremental cost-effectiveness ratios as outcome indicators， and single-factor sensitivity analyses and probabilistic sensitivity analyses were performed， but no contextual analyses were conducted for the different model structures that may exist. CONCLUSIONS The overall report of the included studies is relatively complete， but the methodology is relatively uniform， and there are still deficiencies in terms of study perspective， study time frame， parameter sources， and contextual analysis. Future AIS pharmacoeconomic evaluations should further improve the report content in accordance with the CHEERS list entries， conduct contextual analysis of multiple health state classification approaches from a society-wide perspective， while using data from real- world sources and standardizing the uncertainty analysis process of the study results to increase the authenticity and reliability of the study results.
ABSTRACT
OBJECTIVE To evaluate the cost-effectiveness of pyrotinib combined with capecitabine in the second-line treatment of human epidermal growth factor receptor- 2（HER-2）positive advanced breast cancer from the point of view of medical and health system ，and to provide reference for the selection of clinical therapy plan and national health decision. METHODS The dynamic Markov model was constructed on the basis of a multicenter ，open，randomized controlled phase Ⅲ clinical trial in 29 centers in China. The simulation time limit was 8 years，and the cycle was 21 days. The cost-effectiveness of pyrotinib combined with capecitabine （observation group ）were compared with that of lapatinib combined with capecitabine （control group ）in the second-line treatment of HER- 2 positive advanced breast cancer. The incremental cost-utility ratio （ICER）was calculated by using quality-adjusted life year （QALY）as output indicators ，and the sensitivity analysis was carried out to validate the robustness of the results of basic analysis. RESULTS The results of basic analysis showed that compared with control group ，the incremental cost per capita and incremental utility per capita of observation group were 67 953.82 yuan and 0.40 QALYs；ICER was 168 861.89 yuan/QALY，which was lower than the willing to pay （WTP）threshold（217 500 yuan/QALY）represented by 3 times of China ’s per capita GDP in 2020，indicating the treatment plan of the observation group is more cost-effective. The results of single factor sensitivity analysis showed that the proportion of patients treated with trastuzumab or pyrotinib after entering disease progression （PD）status in the control group ，the proportion of patients treated with lapatinib or trastuzumab after entering PD status in the observation group ，the cost of capecitabine and other parameters showed great impact on ICER ，but those parameters didn ’t cause the reverse of basis analysis results. The results of probabilistic sensitivity analysis showed that when the WTP threshold was 217 500 yuan/QALY，the probability that the treatment plan in the observation group was cost-effective was 94.10％. The results of partition survival model analysis were consistent with those of dynamic Markov model. CONCLUSIONS On the premise of taking 3 times of China ’s per capita GDP in 2020 as the WTP lin- threshold， the second-line treatment of HER- 2 positive wang9805@163.com advanced breast cancer with pyrotinib combined with capecitabine is more cost-effective than that with lapatinib combined with capecitabine.