1.Cost-utility analysis of anlotinib combined with penpulimab in first-line treatment of unresectable hepatocellular carcinoma
Wenying YAN ; Na YANG ; Ranran ZHANG ; Xinyue TAO ; Shengnan GAO ; Guoqiang LIU
China Pharmacy 2026;37(3):344-349
OBJECTIVE To evaluate the cost-effectiveness of anlotinib combined with penpulimab versus sorafenib as first- line treatment for unresectable hepatocellular carcinoma (uHCC) from the perspective of China’s healthcare system. METHODS Based on data from the APOLLO study, a partitioned survival model was established with a 21-day model cycle to simulate patient survival status over 10 years under anlotinib combined with penpulimab regimen or sorafenib monotherapy. Quality-adjusted life year (QALY) was used as the core evaluation parameter to assess the incremental cost-effectiveness ratio (ICER) of different treatment regimens. Using 3 times China’s per capita gross domestic product (GDP) in 2024 (287 247 yuan/QALY) as the willingness-to-pay (WTP) threshold, cost-utility analysis was performed to evaluate the cost-effectiveness of the treatment regimens. Sensitivity analysis was conducted to validate the robustness of the baseline analysis conclusion. Scenario analysis was performed to consider the impact of anlotinib and penpulimab assistance programs on the results; the price reduction of penpulimab to ensure the cost-effectiveness of the combination regimen was examined under varying WTP thresholds (specifically, 1, 2, and 3 times China’s per capita GDP in 2024). RESULTS The baseline analysis revealed that the ICER of anlotinib combined with penpulimab regimen relative to the sorafenib regimen was 338 611.20 yuan/QALY, which exceeded the WTP threshold set in this study. Univariate sensitivity analysis indicated that the utility value of progression free survival and penpulimab price significantly influenced the baseline analysis results. Probabilistic sensitivity analysis validated the robustness of the baseline results. The results of scenario analysis indicated that when considering the assistance programs for anlotinib and penpulimab, the obtained ICER values were all below the WTP threshold set at 3 times China’s per capita GDP in 2024. When the price of penpulimab was reduced by 58%, 35%, and 13%, the ICER values were below the WTP threshold, which was 1, 2 and 3 times the per capita GDP of China in 2024, respectively. CONCLUSIONS From the perspective of China’s healthcare system, anlotinib combined with penpulimab regimen for first-line treatment of uHCC lacks cost-effectiveness compared to sorafenib regimen. However, this conclusion would be reversed if the anlotinib and penpulimab assistance programs are taken into account or if the price of penpulimab is reduced by more than 13% and above.
2.Cost-utility analysis of amivantamab combined with lazertinib in the first-line treatment of EGFR-mutated advanced NSCLC
Ran LIU ; Shengnan GAO ; Yuxi ZHANG ; Ranran ZHANG ; Congxin LI ; Guoqiang LIU
China Pharmacy 2026;37(5):633-638
OBJECTIVE To evaluate the cost-effectiveness of amivantamab combined with lazertinib (hereinafter referred to as “AL”) regimen as first-line treatment for EGFR -mutated advanced non-small cell lung cancer (NSCLC) from the perspective of China’s healthcare system. METHODS A partitioned survival model was established based on updated data from the MARIPOSA study, with a 10-year time horizon and 28-day cycles. The primary outcome index was quality adjusted life year (QALY), and the willingness-to-pay (WTP) threshold was set at three times China’s per capita GDP in 2024 (287 247 yuan/QALY). Cost-utility analysis was used to calculate the incremental cost-effectiveness ratio (ICER) of AL regimen versus osimertinib monotherapy regimen as first-line treatment for EGFR -mutated advanced NSCLC. One-way and probabilistic sensitivity analyses were performed to test model robustness. Scena rio analyses were conducted to explore the impact of utility values for different health states on the outcomes and determine the required price reductions of amivantamab and lazertinib to achieve cost-effectiveness. RESULTS Compared with the osimertinib monotherapy regimen, the ICER for the AL regimen as first-line treatment for advanced EGFR -mutated NSCLC was 2 062 096.15 yuan/QALY, significantly exceeding the WTP threshold established in this study. One-way sensitivity analysis revealed that the utility value of progression-free survival state and the price of amivantamab were the primary factors influencing the ICER. Probabilistic sensitivity analysis revealed that the AL regimen only became cost-effective when the WTP threshold was set at 2 050 000 yuan/QALY. Scenario analysis indicated that altering the utility value still rendered the AL regimen non-cost-effective. When amivantamab (350 mg) prices decreased by 80%, 85%, and 90% respectively, lazertinib (80 mg) prices would need to decrease by 95.97%, 40.63%, 5.29%, respectively. This would enable the AL regimen’s ICER to consistently fall within the WTP threshold established in this study. CONCLUSIONS At the WTP threshold established in this study, the AL regimen does not demonstrate cost-effectiveness for first-line treatment of advanced EGFR -mutated NSCLC compared to the osimertinib monotherapy regimen. Significant price reductions for both drugs would be required to alleviate the financial burden on patients.
3.Pharmacoeconomic evaluation of culmerciclib combined with fulvestrant in the second-line treatment of HR+/HER2− locally advanced or metastatic breast cancer
Ran LIU ; Shengnan GAO ; Congxin LI ; Yuxi ZHANG ; Ranran ZHANG ; Yue WANG ; Ziyi LIU ; Guoqiang LIU
China Pharmacy 2026;37(8):1033-1038
OBJECTIVE To evaluate the cost-effectiveness of culmerciclib combined with fulvestrant as second-line treatment for patients with hormone receptor-positive(HR+)/human epidermal growth factor receptor 2-negative (HER2–) locally advanced or metastatic breast cancer, within the context of the Chinese healthcare system. METHODS A partitioned survival model was established based on the CULMATE-1 study, with a simulation time horizon set at 15 years and a cycle length of 28 days. The incremental cost-effectiveness ratio (ICER) of culmerciclib combined with fulvestrant versus fulvestrant monotherapy as second-line treatment for HR+/HER2– breast cancer was calculated. One-way sensitivity analysis and probabilistic sensitivity analysis were performed to assess the robustness of the model. Meanwhile, scenario analysis of culmerciclib price reduction was conducted; the required price reduction and price to reach the willingness-to-pay (WTP) threshold in this study were calculated. RESULTS The results of the base-case analysis indicated that, compared with the fulvestrant monotherapy regimen, culmerciclib combined with fulvestrant yielded an additional 0.823 quality-adjusted life year (QALY), with a corresponding ICER of 371 696.26 yuan/QALY, which exceeded the WTP threshold (199 330 yuan/QALY). The results of the univariate sensitivity analysis indicated that the cost of culmerciclib, the discount rate, the utility values for progression disease and progression free survival status were significant factors influencing the ICER; both the univariate sensitivity analysis and the probabilistic sensitivity analysis validated the robustness of the model results. Scenario analysis indicated that when the price of culmerciclib was reduced by 30%, 55% and 85% respectively, the corresponding ICER values fell below 3, 2, and 1 times China’s per capita GDP in 2025, with the probability of cost-effectiveness being 3.00%, 94.90%, 100%. When the cost of culmerciclib (60 mg) was reduced by 52.6% to 50.96 yuan, the ICER value met the WTP threshold established in this study. CONCLUSIONS When the WTP threshold is set at twice China’s per capita GDP in 2025, second-line treatment with culmerciclib combined with fulvestrant for HR+/HER2– locally advanced or metastatic breast cancer does not exhibit cost-effectiveness advantage over fulvestrant monotherapy. Therefore, a reasonable price reduction is required to alleviate the financial burden on patients.
4.Cost-effectiveness analysis of onradivir and oseltamivir for the treatment of influenza A in adults
Yongzan ZHANG ; Shengnan GAO ; Xianying WANG ; Guoqiang LIU
China Pharmacy 2026;37(12):1579-1583
OBJECTIVE To evaluate the cost-effectiveness of onradivir versus oseltamivir in the treatment of influenza A in adults from the perspective of the Chinese healthcare system. METHODS Based on data from a phase Ⅲ clinical trial (NCT04683406), a decision tree model was constructed to simulate the efficacy and cost of using onradivir versus oseltamivir in treating adult patients with influenza A, with a cycle length of 5 days and a simulation period of 29 days. The two drug prices correspond to the median listing prices published by Yaozhi Network and the national negotiated prices. Patient characteristics and influenza utility values were derived from the phase Ⅲ clinical trial of onradivir, and medical costs and complication utility values were sourced from published literature. Quality-adjusted life year(QALY) was used as an effect indicator, and the incremental cost-effectiveness ratio(ICER) of onradivir versus oseltamivir was calculated, using China’s per capita disposable income in 2025 (43 377 yuan) as the willingness-to-pay (WTP) threshold to evaluate the cost-effectiveness of the results. One-way and probabilistic analyses were performed to verify the robustness of the results. RESULTS Compared with the oseltamivir regimen, the onradivir regimen yielded an incremental 0.000 67 QALY with direct medical cost savings of 12.41 yuan, thus being a dominant strategy. One-way sensitivity analysis showed that the utility values on day 15 of oseltamivir treatment, the incidence of influenza pneumonia in the oseltamivir group and the costs of the two drugs significantly affected the results. Probabilistic sensitivity analysis indicated that at the pre-specified WTP threshold, onradivir had a 70.6% probability of being cost-effective. CONCLUSIONS At a WTP threshold set at the 2025 per capita disposable income of China, compared with oseltamivir, onradivir can improve the health outcomes of adult patients with influenza A and reduce costs, demonstrating greater cost-effectiveness.
5.Cost-Effectiveness Analysis of Deucravacitinib in the Treatment of Moderate to Severe Plaque Psoriasis
Bing FENG ; Ning GAO ; Shengnan GAO ; Ranran ZHANG ; Yuxi ZHANG ; Guoqiang LIU
Herald of Medicine 2025;44(6):955-960
Objective To evaluate the cost-effectiveness of deucravacitinib in the treatment of moderate to severe plaque psoriasis from the perspective of the Chinese health system.Methods Based on POETYK PSO-1 study and related cost and utility data,a decision tree combined with Markov model was established.The model period was 10 years,and the output indicators of the model were cost and quality-adjusted life year(QALY).The evaluation index of the model was the incremental cost-effectiveness ratio(ICER).The willingness-to-pay threshold(WTP)was 3 times of China's per capita GDP in 2023.Sensitivity analysis was performed to evaluate the robustness of the model results.Results The incremental utility and incremental cost were 0.598QALYs and 130 677.51 yuan(RMB),respectively.The ICER of the two strategies was 218 487.11 yuan(RMB)per QALY gained,which was less than 3 times GDP per capita in 2023.Sensitivity analyses confirmed the robustness of the model.Conclusion Under the threshold of 3 times the GDP per capita in China,deucravacitinib is cost-effective in the treatment of moderate to severe plaque psoriasis.
6.Cost-utility analysis of benmelstobart plus anlotinib and chemotherapy as first-line treatment for extensive-stage small cell lung cancer
Bing FENG ; Ning GAO ; Shengnan GAO ; Yuxi ZHANG ; Ranran ZHANG ; Guoqiang LIU
China Pharmacy 2025;36(5):579-583
OBJECTIVE To evaluate the cost-utility of benmelstobart combined with anlotinib and chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) from the perspective of China’s healthcare system. METHODS Based on the data from the ETER 701 study, a partitioned survival model was constructed with a cycle of 3 weeks to simulate the total cost, quality-adjusted life years (QALY), and incremental cost-effectiveness ratio (ICER) over 10 years for patients with ES- SCLC treated with benmelstobart plus anlotinib and chemotherapy, or chemotherapy alone. One-way sensitivity analysis and probability sensitivity analysis were performed to verify the robustness of the simulation results. The willingness-to-pay (WTP) threshold was set at 3 times the per capita gross domestic product (GDP) of China in 2023, which amounted to 268 074 yuan/QALY. RESULTS Compared with chemotherapy alone, benmelstobart combined with anlotinib and chemotherapy gained 0.438 QALY more at the cost of 403 505.55 yuan more, with an ICER of 922 031.37 yuan/QALY, which was higher than the WTP threshold set in this study. One-way sensitivity analysis showed that benmelstobart’s cost and utility value of the progression-free survival state had a greater impact on the ICER value; probabilistic sensitivity analysis confirmed the robustness of the model; only when the price of benmelstobart was reduced by 75.4%, the combined regimen would be cost-effective. CONCLUSIONS The first-line treatment of ES-SCLC with benmelstobart combined with anlotinib and chemotherapy is not cost-effective from the perspective of China’s healthcare system at present.
7.Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
Qi WANG ; Yongyan WANG ; Wei XIAO ; Jinzhou TIAN ; Shilin CHEN ; Liguo ZHU ; Guangrong SUN ; Daning ZHANG ; Daihan ZHOU ; Guoqiang MEI ; Baofan SHEN ; Qingguo WANG ; Xixing WANG ; Zheng NAN ; Mingxiang HAN ; Yue GAO ; Xiaohe XIAO ; Xiaobo SUN ; Kaiwen HU ; Liqun JIA ; Li FENG ; Chengyu WU ; Xia DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):445-450
Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
8.Meteorological factor-driven prediction of high-use days of budesonide: construction and comparison of ensemble learning models
Qitao CHEN ; Yue ZHOU ; Xiaojun ZHANG ; Jingwen NI ; Guoqiang SUN ; Fenfei GAO ; Lizhen XIA ; Zihao LI
China Pharmacy 2025;36(21):2723-2726
OBJECTIVE To construct ensemble learning models for predicting high-use days of budesonide based on meteorological factors, thereby providing reference for hospital pharmacy management. METHODS Meteorological data for 2024 and outpatient budesonide usage data from the jurisdiction of Sanming Hospital of Integrated Traditional Chinese and Western Medicine were collected. High-use days were defined as the 75th percentile of outpatient budesonide usage, and a corresponding dataset was established. The prediction task was formulated as a classification problem, and three ensemble learning models were developed: Random Forest, Extreme Gradient Boosting (XGBoost), and Histogram-based Gradient Boosting Classifier. Model performance was evaluated using accuracy, precision, recall, F1-score, and log-loss. Model interpretability was analyzed using Shapley Additive Explanations (SHAP). RESULTS The Histogram-based Gradient Boosting Classifier achieved the best performance (accuracy=0.75, F1-score=0.48), followed by XGBoost (accuracy=0.74, F1-score=0.43) and Random Forest (accuracy=0.72, F1-score=0.22). SHAP results suggested that the prediction results of the last two models have the highest correction. CONCLUSIONS Ensemble learning models can effectively predict high-use days of budesonide, with the Histogram- based Gradient Boosting Classifier demonstrating the best predictive performance. Low temperature, high humidity, and low atmospheric pressure show significant positive impacts on the prediction of daily budesonide usage.
9.Cost-effectiveness analysis of sacituzumab tirumotecan versus single-agent chemotherapy in second-line and later-line treatment for metastatic triple-negative breast cancer
Ranran ZHANG ; Yuxi ZHANG ; Shengnan GAO ; Bing FENG ; Ning GAO ; Guoqiang LIU
China Pharmacy 2025;36(16):2024-2029
OBJECTIVE To evaluate the cost-effectiveness of sacituzumab tirumotecan (ST) versus chemotherapy treatment physician’s choice (TPC) as second-line and later-line treatment for metastatic triple-negative breast cancer (mTNBC) from the perspective of China’s healthcare system. METHODS A partitioned survival model was constructed based on the OptiTROP-Breast 01 trial, with a cycle length of 4 weeks and a time horizon of 10 years, applying a 5% discount rate. Quality adjusted life year (QALY) and costs were used as outcome measures, and the incremental cost-effectiveness ratio (ICER) of ST versus TPC for second-line and later-line treatment of mTNBC was calculated. Sensitivity analyses were conducted to validate the robustness of the base-case results. RESULTS At a willingness-to-pay threshold (WTP) of 3 times China’s 2024 per capita gross domestic product (GDP) (287 247 yuan/QALY), patients receiving ST gained incremental utility (0.42 QALY) at a higher cost, yielding an ICER of 205 562.07 yuan/QALY, which was lower than WTP, indicating that ST was more cost-effective compared to TPC. One-way sensitivity analysis revealed that key factors influencing the ICER included the utility value of progression-free survival and the price of ST. Probabilistic sensitivity analysis and scenario analysis showed that the base-case results were robust. CONCLUSIONS From the perspective of China’s healthcare system, at a WTP of 3 times China’s per capita GDP, ST is more cost-effective than TPC as second-line and later-line treatment for mTNBC.
10.Health economic analysis and medical cost analysis of children with severe hepatitis B in China: A retrospective study from 2016 to 2022
Qijun SHAN ; Xudong MA ; Yujie CHEN ; Guanghua ZHOU ; Sifa GAO ; Jialu SUN ; Fuping GUO ; Feng ZHANG ; Dandan MA ; Guoqiang SUN ; Wen ZHU ; Xiaoyang MENG ; Guiren RUAN ; Yuelun ZHANG ; Xutong TAN ; Dawei LIU ; Yi WANG ; Chang YIN ; Xiang ZHOU
Chinese Medical Journal 2025;138(5):562-567
Background::Hepatitis B poses a heavy burden for children in China, however, the national studies on the distributional characteristics and health care costs of children with severe hepatitis B is still lacking. This study aimed to analyze the disease characteristics, health economic effects, and medical cost for children with severe hepatitis B in China.Methods::Based on patient information in the Hospital Quality Monitoring System, cases with severe hepatitis B were divided into four groups according to age, and the etiology and symptoms of each group were quantified. The cost of hospitalization was calculated for cases with different disease processes, and severity of disease. The spatial aggregation of cases and the relationship with health economic factors were analyzed by Moran’s I analysis. Results::The total number of children discharged with hepatitis B from January 2016 to April 2022 was 1603, with an average age of 10.5 years. Liver failure cases accounted for 43.48% (697/1603) of total cases and cirrhosis cases accounted for 11.23% (180/1603). According to the grouping of disease progression, there were 1292 cases without associated complications, and the median hospitalization cost was $818.12. According to the spatial analysis, the aggregation of cases was statistically significant at the prefectural and provincial levels in 2019, 2020, and 2021 (all P <0.05). The number of severe cases was negatively correlated with gross domestic product (Moran’s I <0) and percentage of urban population (Moran’s I <0), and positively correlated with the number of pediatric beds per million population (Moran’s I >0). Conclusion::The number of severe hepatitis B cases is low in areas with high gross domestic product levels and high urban population ratios, and health care costs have been declining over the years.


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