1.Cost-utility analysis of bevacizumab combined with erlotinib in the first-line treatment of advanced EGFR mutant non-squamous NSCLC
Wenxiang JU ; Yingying ZHAO ; Luolan LU ; Xiaohan ZHANG ; Aizong SHEN
China Pharmacy 2024;35(11):1357-1362
OBJECTIVE To evaluate the cost-effectiveness of bevacizumab combined with erlotinib in the first-line treatment of advanced EGFR mutant non-squamous non-small cell lung cancer (NSCLC) from the perspective of China’s health system. METHODS A dynamic Markov model was established based on BEVERLY study data, with a cycle of 3 weeks, a research deadline until 99% of patients die, and an annual discount rate of 5%. The model outputs were total cost, quality-adjusted life year (QALY), and incremental cost-effectiveness ratio (ICER). Taking 3 times China’s per capita gross domestic product (GDP) in 2023 as the willingness-to-pay (WTP) threshold, the cost-utility analysis was used to evaluate the cost-effectiveness of bevacizumab combined with erlotinib (observation group) versus erlotinib alone (control group) in the first-line treatment of advanced EGFR mutant non-squamous NSCLC, and the single factor sensitivity analysis and probability sensitivity analysis were used to verify the robustness of the basic analysis results. RESULTS The results of the basic analysis showed that compared with the erlotinib therapy plan, ICER of bevacizumab combined with erlotinib was 1 452 243.01 yuan/QALY, which was more than 3 times China’s per capita GDP in 2023 (268 074 yuan/QALY) as the WTP threshold, indicating that bevacizumab combined with erlotinib was not cost-effective. The results of single factor sensitivity analysis showed that the cost of bevacizumab, the utility value of progression-free survival and progressed disease status had a great influence on the results. The results of probability sensitivity analysis showed that when the WTP threshold was 1 740 000 yuan/QALY, the probability of cost-effective of bevacizumab combined with erlotinib plan was 50%. CONCLUSIONS Compared with erlotinib alone, bevacizumab combined with erlotinib is not cost-effective in the first-line treatment of advanced EGFR mutant non-squamous NSCLC, when using 3 times China’s per capita GDP in 2023 as the WTP threshold.
2.Cost-utility analysis of bevacizumab combined with erlotinib in the first-line treatment of advanced EGFR mutant non-squamous NSCLC
Wenxiang JU ; Yingying ZHAO ; Luolan LU ; Xiaohan ZHANG ; Aizong SHEN
China Pharmacy 2024;35(11):1357-1362
OBJECTIVE To evaluate the cost-effectiveness of bevacizumab combined with erlotinib in the first-line treatment of advanced EGFR mutant non-squamous non-small cell lung cancer (NSCLC) from the perspective of China’s health system. METHODS A dynamic Markov model was established based on BEVERLY study data, with a cycle of 3 weeks, a research deadline until 99% of patients die, and an annual discount rate of 5%. The model outputs were total cost, quality-adjusted life year (QALY), and incremental cost-effectiveness ratio (ICER). Taking 3 times China’s per capita gross domestic product (GDP) in 2023 as the willingness-to-pay (WTP) threshold, the cost-utility analysis was used to evaluate the cost-effectiveness of bevacizumab combined with erlotinib (observation group) versus erlotinib alone (control group) in the first-line treatment of advanced EGFR mutant non-squamous NSCLC, and the single factor sensitivity analysis and probability sensitivity analysis were used to verify the robustness of the basic analysis results. RESULTS The results of the basic analysis showed that compared with the erlotinib therapy plan, ICER of bevacizumab combined with erlotinib was 1 452 243.01 yuan/QALY, which was more than 3 times China’s per capita GDP in 2023 (268 074 yuan/QALY) as the WTP threshold, indicating that bevacizumab combined with erlotinib was not cost-effective. The results of single factor sensitivity analysis showed that the cost of bevacizumab, the utility value of progression-free survival and progressed disease status had a great influence on the results. The results of probability sensitivity analysis showed that when the WTP threshold was 1 740 000 yuan/QALY, the probability of cost-effective of bevacizumab combined with erlotinib plan was 50%. CONCLUSIONS Compared with erlotinib alone, bevacizumab combined with erlotinib is not cost-effective in the first-line treatment of advanced EGFR mutant non-squamous NSCLC, when using 3 times China’s per capita GDP in 2023 as the WTP threshold.
3.Evaluation of the predictive ability of individualized drug administration adjuvant decision-making system JPKD for tacrolimus blood concentration in kidney transplant recipients
Hui YAN ; Furong WU ; Peng JI ; Aizong SHEN ; Shengyu ZHANG
Organ Transplantation 2024;15(4):630-636
Objective To evaluate the predictive ability and influencing factors of individualized drug administration adjuvant decision-making system Java PK? for Desktop(JPKD)for tacrolimus blood concentration in kidney transplant recipients.Methods The monitoring data of tacrolimus blood concentration from 149 recipients early after kidney transplantation were collected.The trough blood concentration of tacrolimus was predicted by JPKD.The absolute weighted deviation and relative prediction deviation between the actual and predicted concentration were calculated.The influencing factors of the absolute weighted deviation were analyzed by univariate and multivariate logistic regression analyses,and the predictive values of these influencing factors on the accuracy of software prediction were assessed by delineating the receiver operating characteristic(ROC)curve.Results Two hundred and sixty-six samples of tacrolimus blood concentration data were collected from 149 patients.The measured blood concentration of tacrolimus was(6.5±3.0)ng/mL(1.1-16.6 ng/mL),and the predicted value calculated by JPKD was(5.6±2.5)ng/mL(1.4-14.4 ng/mL).The absolute weighted deviation of the calculated data was 28.38%,and the relative prediction deviation was-13.55%.Univariate analysis showed that gender,albumin,changes in hematocrit,cytochrome P450(CYP)3A5*3 genotype and C3435T genotype were associated with the inaccurate prediction results.Multivariate logistic regression analysis found that CYP3A5*3 genotype of AA and the changes in hematocrit were the independent risk factors affecting the accuracy of tacrolimus blood concentration predicted by JPKD.ROC curve analysis showed that when the changes in hematocrit exceeded 2.25%,the risk of inaccurate software prediction was increased.Conclusions JPKD possesses certain accuracy in predicting the blood concentration of tacrolimus in kidney transplant recipients,which may improve the qualified rate of tacrolimus blood concentration.Nevertheless,CYP3A5*3 genotype and the changes of hematocrit may affect the accuracy of predictions.
4.Formulation and Analysis on the Standard of Automation and Information Technology
Xun YU ; Jiancun ZHEN ; Liyan MIAO ; Zongqi CHENG ; Wei ZHANG ; Rongsheng ZHAO ; Lan ZHANG ; Xiaoyang LU ; Jian ZHANG ; Dong LIU ; Aizong SHEN ; Weihua LAI ; Jingcheng HE
Herald of Medicine 2024;43(7):1074-1078
To improve patient-centered pharmaceutical management and pharmaceutical service capabilities in the pharmaceutical department of medical institutions,automation and information technology are indispensable.The Pharmacy Administration-Automation and Information Technology is one of the social organization standards of the Chinese Hospital Association as part 4-4 of Pharmaceutical Administration and Pharmaceutical Practice in Healthcare,which standardizes 32 key elements in four aspects:basic requirements for automation construction in medical institutions,construction of automation hardware equipment,construction of intelligent information platform,and quality management and continuous improvement.It can be used to guide medical institutions at all levels to select and optimize pharmacy automation equipment and information platforms.This article introduced the construction methods and contents of the pharmacy automation and information technology standards,to deepen the understanding of peers on this standard and promote its implementation.This article aimed to promote the modernization,informatization,and intelligence of pharmaceutical services in medical institutions,and improve the quality and efficiency of overall medical pharmaceutical administration and service.
5.Cost-effectiveness Analysis of Furmonertinib Compared to Gefitinib in First-line Monotherapy for Advanced Non-small Cell Lung Cancer with EGFR Mutation
Guangquan SU ; Renping YI ; Pingping FANG ; Yimiao XIA ; Min PAN ; Kunkun GE ; Aizong SHEN
Herald of Medicine 2024;43(8):1245-1251
Objective From the perspective of China's health system,evaluate the cost-effectiveness of furmonertinib compared to gefitinib in first-line monotherapy for EGFR mutation-positive advanced non-small cell lung cancer.Methods Based on the FURLONG study of phase Ⅲ clinical trials,a three-state partitioned survival model was constructed and combined with parameters such as treatment cost,utility value,the incidence of adverse reactions,and discount rate;the total incremental cost-effectiveness ratio(ICER)was simulated.Then,the ICER value was compared with the willingness to pay(WTP)value to determine the economic feasibility of furmonertinib compared to gefitinib as a first-line treatment for EGFR mutation-positive advanced non-small cell lung cancer.Results The basic analysis results show that the treatment group with furmonertinib incurred an additional cost of 85 786 yuan compared to the treatment group with gefitinib,but obtained an additional 0.62 QALYs,with an incremental cost-effectiveness ratio of 138 306 yuan,which is less than three times China's per capita GDP.One-way sensitivity analysis shows that the best support treatment cost,PFS utility value,and PD utility value significantly impact the ICER results.The results of probability sensitivity analysis show that when the WTP is three times China's per capita GDP,the probability of economic viability of the furmonertinib group compared to the gefitinib group is 100.0%.The scenario analysis results verified the robustness of the underlying analysis results.Conclusion Under the willingness to pay threshold of three times China's per capita GDP in 2022,Choosing furmonertinib as a first-line monotherapy for EGFR mutation-positive advanced non-small cell lung cancer is more cost-effective than gefitinib.
6.Exploration and practice of innovation mode of clinical pharmacists training
Yingqi WU ; Shengyu ZHANG ; Aizong SHEN
Chinese Journal of Medical Education Research 2023;22(2):289-292
In view of the current situation of the construction of clinical pharmacist system and the teaching and training of clinical pharmacist training base in China, this paper provides a reference for perfecting and improving the training mode of clinical pharmacists in China. By establishing a clinical pharmacist system that develops a "two-focus" model, it takes the "trinity" of "hierarchical teaching-innovative practice-stage assessment" as the operating mechanism of teaching management, and the innovative mode of training clinical pharmacist talents with diversified information service platform as the technical support system, thereby providing an effective model for training excellent clinical pharmaceutical care talents.
7.Clinical observation of icotinib versus gefitinib in the treatment of EGFR-mutated advanced non-small cell lung cancer
Fangyu WU ; Weidong CHEN ; Panpan XIA ; Xudong ZHANG ; Aizong SHEN
China Pharmacy 2023;34(10):1228-1232
OBJECTIVE To compare the efficacy and safety of icotinib and gefitinib in the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC). METHODS The data of 146 patients with EGFR- mutant advanced NSCLC of our Hospital from December 2015 to September 2021 were retrospectively analyzed and divided into the gefitinib group (73 cases) and the icotinib group (73 cases) according to the drug use. Patients in the gefitinib group were given 0.25 g of gefitinib tablets once a day orally by single drug or combined with conventional chemotherapy, while patients in the icotinib group were given 125 mg of icotinib hydrochloride tablets three times a day orally by single drug or combined with conventional chemotherapy. Short-term efficacy, progression-free survival (PFS) were observed; Cox regression model was used to analyze the factors affecting the prognosis of patients; the occurrence of ADR were observed in the two groups. RESULTS There was no statistically significant difference in the objective remission rate, disease control rate, and the incidence of grade 1-2 and grade 3-4 adverse drug reactions between the two groups (P>0.05); median PFS was significantly better in the icotinib group than in the gefitinib group (P=0.048). Results of subgroup analysis based on patients basic information showed that compared with the gefitinib group, PFS of female [HR=0.57,95%CI(0.34,0.96),P=0.031] and non-brain metastatic patients [HR=0.58,95%CI(0.36,0.91),P=0.017] in icotinib group were prolonged significantly. Results of regression model analysis showed that EGFR19 exon Del mutation [HR=0.50, 95%CI(0.25,1.00), P=0.049], EGFR21 exon L858R mutation [HR=0.44, 95%CI(0.21,0.89), P=0.022] and icotinib treatment [HR=0.65, 95%CI (0.44,0.96), P=0.030] were influential factors for prognosis. CONCLUSIONS The short-term efficacy and safety of icotinib and gefitinib in the treatment of EGFR- mutant advanced NSCLC are comparable, but icotinib can significantly prolong the patients’ PFS; EGFR19 exon Del, EGFR21 exon L858R mutations and icotinib treatment are factors affecting patients’ prognosis.
8.Cost-effectiveness of regorafenib for hepatocellular carcinoma after failure of sorafenib
Wanglong HONG ; Miaomiao ZHENG ; Guoqiang MA ; Wentao ZHU ; Aizong SHEN
China Pharmacy 2023;34(8):968-973
OBJECTIVE To evaluate the cost-effectiveness of regorafenib in the treatment of hepatocellular carcinoma after failure of sorafenib from the perspective of Chinese health system. METHODS Based on a phase Ⅲ trial(RESORCE), the partition survival model (PSM) and Markov model were constructed. The cycle was set as four weeks, the duration of the study lasted for lifetime, the annual discount rate was 5%. Drug cost data was obtained from yaozhi.com, other cost data were obtained from Anhui Provincial Medical Insurance Bureau and related literature, and utility values were obtained from literature. The incremental cost-effectiveness ratio (ICER) was used as the evaluation index, and the value of willingness to pay (WTP) was three times of China’s gross domestic product (GDP) per capita in 2022; one-way sensitivity analysis and probabilistic sensitivity analysis were used to verify the robustness of the basic analysis results. RESULTS The incremental cost of regorafenib group versus placebo group in PSM and Markov model was 112 116.95 yuan and 96 617.19 yuan, respectively. The incremental effectiveness was 0.31 QALYs and 0.32 QALYs, respectively. The ICERs were 360 751.01 yuan/QALY and 301 114.45 yuan/QALY, which were both greater than the value of WTP; regorafenib was not cost-effective. Results of one-way sensitivity analysis showed that the utility of progression-free survival and progressive disease, the unit cost of regorafenib had the greatest influence on the results, but ICER was always greater than the WTP within the floating range of each parameter. Under the WTP of 3 times China’s per capita GDP in 2022, the probabilities of regorafenib with cost-effectiveness were 0.8% (PSM) and 11.4% (Markov). CONCLUSIONS Under the WTP of 3 times the per capita GDP of China, regorafenib is not cost-effective in the treatment of hepatocellular carcinoma after failure of sorafenib treatment, compared with placebo.
9.Rapid health technology assessment of 4 kinds of drugs for membranous nephropathy
Shengyu ZHANG ; Laixinyue SHU ; Pengli ZHU ; Lijuan NING ; Yongwu CHEN ; Fei WU ; Yingqi WU ; Aizong SHEN
China Pharmacy 2023;34(8):988-992
OBJECTIVE To compare the efficacy, safety and economy of tacrolimus (TAC), cyclosporin A (CsA), cyclophosphamide (CTX) and rituximab (RTX) in the treatment of membranous nephropathy (MN). METHODS Retrieved from Pubmed, the Cochrane Library, Wanfang data, CNKI and health technology assessment (HTA) official website, HTA reports, systematic reviews/meta-analysis and pharmacoeconomic studies about TAC, CsA, CTX and RTX combined with glucocorticoid in the treatment of MN were collected during the inception and Mar. 2022. After data extraction and quality evaluation, descriptive analysis was performed on the results of the included studies. RESULTS A total of 15 articles were included, involving 13 systematic reviews/meta-analysis and 2 pharmacoeconomic studies. In terms of efficacy, TAC and CsA showed significant advantages in increasing the response rate, and could improve the levels of urine protein, serum albumin, serum creatinine and serum total cholesterol. In terms of safety, the incidence of adverse reaction induced by TAC, CsA and RTX was low and the symptoms were mild. In terms of economics, CTX cost lower but caused severe adverse reaction; TAC cost higher but showed higher remission rate and good safety. CONCLUSIONS TAC combined with glucocorticoid may be the recommended scheme for MN.
10.CHINA PH ARMACY Volume 33,Number 12,June 30,2022 Semimonthly Table of Contents Construction of total q uality managemen t system of clinica l comprehens ive evaluation of drugs in China
Rui ZHAO ; Ruofei HU ; Xiuyuan SHI ; Aizong SHEN ; Yongwu CHEN ; Fan LI ; Kun ZHAO
China Pharmacy 2022;33(12):1409-1414
OBJECTIVE To provide reference for scientifi c and standardized development of clinical comprehensive evaluation of drugs in China. METHODS Guided by the theory of total quality management (TQM),drawing lessons from the successful experience of the British and German conducting evaluation ,combining with plan-do-check-act cycle and other quality management methods and tools ,drug clinical comprehensive evaluation of total quality management system was constructed in accordance with the requirements for our country related policy and local practice. RESULTS & CONCLUSIONS To construct total quality management system of clinical comprehensive evaluation of drugs in China from 5 aspects of organization system ,management process,assessment system ,evaluation and supervision platform ,support and guarantee mechanism. The organization system included national ,provincial and medical institutions ;management process should focus on the key links in the 3 stages of theme selection,evaluation and implementation ,and result transformation and application ;assessment system ,evaluation and supervision platform,support and guarantee mechanism should be established together so as to further improve the scientificity ,rationality, practicality and standardization of total quality management of clinical comprehensive evaluation of drugs. The development of total quality management is an effective starting point to promote the continual improvement of the drug clinical comprehensive evaluation;relevant government departments and the implementation of evaluation of medical institutions should further set up quality management consciousness ,establish report quality feedback mechanism and the results co-constructing and sharing mechanism and strengthen professional personnel training and innovation synergy regulation mode to ensure that the authenticity and reliability of evaluation results.

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