Medicine is a very important health resource in China. Although numerous efforts are paid to pre-marketed medicines, little is done to address practical problems in marketed medicines. The rational use and allocation of marketed medicines remain a major concern for decision-makers in China. It has been recognized that economic evaluation is an efficient tool for prioritizing the choice, and optimizing the use of medicines. This paper has explored the methods and principles for conducting economic evaluation of marketed medicines. Different strategies will be adopted for economic evidence for marketed medicines in terms of adequacy and sufficiency.However, a standard study pathway should be applied in economic evaluation of marketed medicines. Besides, the aspects for developing economic framework and the methods for reviewing existing economic evidence are also introduced in this paper, particularly, for marketed medicines within the same therapeutic group.
ObjectiveTo evaluate the efficacy and cost-effectiveness of thymalfasin (Tα1) as an adjuvant therapy for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) after surgery.MethodsPatients with HBV-related HCC who underwent hepatectomy from February 2007 to December 2015 in West China Hospital of Sichuan University, Chengdu Military General Hospital, or the Third Affiliated Hospital of Sun Yat-sen University were retrospectively collected and divided into the Tα1 group and the observation group. Log-rank test and Kaplan-Meier curve were used to assess the overall survival, recurrence-free survival, and safety of patients. A Markov model was used to calculate the quality-adjusted life years (QALYs) and incremental cost-effectiveness ratio (ICER) of the Tα1 group compared with the observation group. Cost data was from the hospital information system of the three hospitals. Utility scores mainly came from published data. Sensitivity analyses were applied to explore the impact of essential variables.ResultsA total of 208 patients with HCC after liver resection were enrolled, among them 48 received Tα1 treatment (the Tα1 group) and 160 were only followed up (the observation group). There was no significant difference between the two groups in the baseline characteristics. The median overall survival of the Tα1 group and the observation group was 102.0 months [95% confidence interval (CI) (74.8, 129.2) months] and 81.6 months [95%CI (65.7, 97.6) months], respectively, and the difference was statisitically significant (P=0.047); the median recurrence-free survival was 66.7 months [95%CI (17.3, 116.1) months] and 37.4 months [95%CI (28.7, 46.2) months], respectively, and the difference was statistically significant (P=0.044). There were no grade Ⅲ-Ⅳ adverse events and no treatment-related death occurred. The ICER of Tα1 group was ￥108 050.02/QALY, which was less than the willingness to pay (￥177 785.25/QALY).ConclusionsTα1, as an adjuvant therapy for HBV-related HCC patients, can improve the prognosis of the patients, and the cost is within the acceptable level in our country, so this strategy is likely to be a cost-effective option compared with the observation group.
Objective To investigate cost-effectiveness of no indwelling urinary catheter in pulmonary lobectomy patients and to confirm the advances of no indwelling urinary catheter. Methods We recruited 148 lung cancer patients who were scheduled for pulmonary lobectomy under general anesthesia in West China Hospital from July through December 2015. These patients were divided into two groups including an indwelling urinary catheter group (74 patients, 45 males and 29 females, at age of 52.55±19.87 years) and a no indwelling urinary catheter group (74 patients, 42 males and 32 females, at age of 54.03±16.66 years). Indexes of cost-effectiveness of the two groups were compared. Results There was no statistical difference between the two groups in duration of indwelling catheter (1.56±0.0.65 d versus 1.68±0.91 d, P=0.077). Material expense(4 811.48 yuan versus 296.74 yuan, P=0.045), cost of nursing care (7 413.32 yuan versus 457.32 yuan, P=0.013), and total expense (12 224.8 yuan versus 754.06 yuan, P=0.000) in the indwelling catheter group were higher than those in the no indwelling catheter group. Material expense per patient (65.02±5.62 yuan/patient-time versus 4.01±0.00 yuan/patient-time, P=0.000), cost of nursing care per patient (100.18±7.19 yuan/patient-time versus 6.18±1.22 yuan/patient-time, P=0.000), and total cost per patient (165.20±12.81 yuan/patienttime versus 10.19±1.22 yuan/patient-time, P=0.000) in the indwelling catheter group were higher than those in the no indwelling catheter group. Conclusion Both costs and labor of nurse can be cut down for appropriate lung cancer patients undergoing lobectomy without routine indwelling urinary catheter.
ObjectiveTo evaluate the economics of duplizumab in combination with optimal supportive care versus optimal supportive care for moderate-to-severe atopic dermatitis in adults from the perspective of our health system. MethodsA Markov model embedded in a decision tree was constructed to compare the long-term cost-utility of dupilumab combined with optimal supportive care versus optimal supportive care, and a sensitivity analysis was performed on the results. ResultsThe results of the basic analysis showed that compared with the optimal supportive care, dupliyuzumab in combination with optimal supportive care resulted in 3.82 more QALYs, while its cost was 125 549.42 yuan more. The ICER was 32 854.83 yuan/QALY, which was less than one times China's per capita GDP in 2022, and was economical. Univariate sensitivity analysis showed that factors such as Dupilumab-16-week post - no response utility value, Dupilumab-52-week post response rate and Dupilumab-52-week adherence had a greater impact on the cost changes. The results of the probabilistic sensitivity analysis showed a stable model structure and good robustness. ConclusionIn adult patients with moderate-to-severe atopic dermatitis, dupliyuzumab in combination with an optimal supportive care regimen is more cost-effective compared to an optimal supportive care regimen.
Objective To evaluate the cost-effectiveness of chemotherapy in children with newly diagnosed Hodgkin lymphoma at low-, intermediate-, and high-risk. Methods From the perspective of health system, a decision-tree model was designed for cost-effectiveness analysis. The chemotherapy regimens of low-risk group included OEPA (vincristine, etoposide, prednisone, doxorubicin), AV-PC (doxorubicin, vincristine, prednisone, cyclophosphamide), and ABVD (doxorubicin, bleomycin, vincristine, dacarbazine); intermediate-risk group included OEPA, ABVE-PC (doxorubicin, bleomycin, vincristine, etoposide, prednisone, cyclophosphamide) and ABVD; high-risk group included OEPA, ABVE-PC, ABVD and BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone). The effectiveness and cost parameters were derived from the event-free survival rate reported in the literature, the drug linked reference price in Sichuan province, and treatment price of medical institutions. Univariate and probabilistic sensitivity analysis were performed to explore the impact of uncertainty. Results In the low-risk group, compared with AV-PC, the incremental cost-effectiveness ratios (ICER) of OEPA and ABVD were 80 700 yuan and 108 799 yuan, respectively. In the intermediate-risk group, compared with OEPA, the ICER of ABVE-PC and ABVD were −17 737 yuan and −4 701 yuan respectively. In the high-risk group, compared with ABVE-PC, the ICER of OEPA, ABVD and BEACOPP were 149 262, 472 090 and 64 652 yuan, respectively. Univariate sensitivity analysis showed that in low-risk group, the most influential factors were cost of OEPA and cost of ABVD; in moderate-risk group were cost of ABVE-PC and cost of OEPA; in the high-risk group were cost of OEPA, cost of ABVD, and cost of BEACOPP, respectively. The results of probabilistic sensitivity analysis are basically consistent with those of the main analysis. Conclusion If China's per capita gross domestic product in 2023 (89 358 yuan) was used as the willingness-to-pay (WTP) threshold, OEPA in the low-risk group, OEPA in the intermediate-risk group and BEACOPP in the high-risk group are cost-effective.
Objective To systematically review the cost-effectiveness of gefitinib for advanced non-small cell lung cancer (NSCLC), in order to provide the economics values of gefitinib for clinical application. Method We electronically searched databases including PubMed, Ovid, Embase, Cochrane Library, Medline, China National Knowledge Internet, VIP, and Wanfang database for articles about the cost-effectiveness of gefitinib for advanced NSCLC patients from January 1946 to October 2017, and then performed a systematic literature review of economic evaluations of geftinib. Results A total of 20 independent studies were included in the present systematic review, in which 8 were the first-line treatment, 9 were the second-line treatment, 1 was the third-line treatment, and 2 were maintenance treatment. The most common comparison was gefitinib vs. chemotherapy (n=7), and other comparisons were gefitinib vs. erlotinib (n=4), gefitinib vs. docetaxel (n=3), gefitinib vs. placebo (n=2), gefitinib vs. icotinib (n=2), gefitinib vs. afatinib (n=1), and gefitinib vs. other treatments (n=1). For the advanced NSCLC patients, the first- or second-line treatment with gefitinib compared to chemotherapy was considered to be more cost-effective, especially in patients with mutated epidermal growth factor receptor gene. As the second-line treatment, gefitinib was considered to be more economical than erlotinib and docetaxel. Conclusion Gefitinib is considered to be a cost-effective strategy for the advanced NSCLC patients as the first- or second-line therapy.
Objective To compare and analyze hospital operation and management models between China and foreign countries, in order to provide reference and guidance for the continuous improvement of hospital management in China. Methods The NVivo software was used to conduct a qualitative comparative analysis of domestic and foreign literature on hospital operation and management models in China National Knowledge Infrastructure, Wanfang, Web of Science, and PubMed until December 2022, and a model for the differences in operation and management between Chinese and foreign hospitals was further constructed. Results Finally, 33 Chinese literature and 21 English literature were selected as the raw materials for NVivo qualitative analysis. A comparative analysis of the operation and management models of Chinese and foreign hospitals from four dimensions: structure, process, results, and continuous improvement showed that there were differences in operation and management systems, talents, processes, finance, refinement, and innovation between Chinese and foreign hospitals. Conclusion Hospital operation and management needs to be deeply integrated with business work, improve the construction of hospital operation and management system, strengthen the competence of operation talents, pay attention to resource cost-benefit analysis, attach importance to the two-way integration of business and finance, optimize the adjustment of operation and management structure, and attach importance to the innovation drive of new technology application, in order to promote the scientific, standardized, refined, and informationalized level of hospital operation and management.
Onehealth, an evidence-based decision-making software, is based on the United Nations' epidemiological reference modules to predict the effect of health services. Onehealth is a large database. The software is using activitybased costing, simulating investment costs of health system and changes of mortality in different coverage levels. By the cost of inputs/avoid deaths, it could quantify the cost of health services effectiveness and provide an intuitive basis for the rational allocation of health resources. This study introduces the relevant concepts, model structures and applications of Onehealth. We took the study of child nutrition interventions in Sudan for example and to present Onehealth tool's operating. As a new auxiliary and evidence-based decision-making software with scientific and rigorous theoretical approach, Onehealth has practical significance on the national or regional macro decision-making.
Economic evaluation used alongside clinical trials has become a hot spot in the development of clinical studies. The definition and classification of the cost were introduced in this article. The ways to conduct cost analysis in clinical trials were introduced systematically, including the identification, collection and analysis of the data of costs, and the concern of the analysis.
Objective To investigate the clinical effectiveness of the total Flavones of Hippophae Rhamnoides L. (TFH) and compare its cost-effectiveness ratio with enalapril in patients with essential hypertension. Methods Among 3 971 staff members in two universities, 155 eligible patients with blood pressure (BP) ≥160/100 mmHg were screened and included in this study. By using a random number table, the patients were randomized to the two groups: TFH was given to the treatment group while enalapril in the control group. At the end of the six week, BP, total cost and cost-effectiveness ratio were measured in both TFH and enalapril groups. Results After six weeks, blood pressures in the TFH and enalapril groups decreased by 12.7±11.6/8.1±5.1 mmHg and 15.2±9.7/10.1±7.3 mmHg respectively, while the improvement rates of BP were 73.24% (52/71) and 74.65% (53/71) respectively. There were no differences between TFH and enalapril groups in lowering BP amplitude and total effectiveness rate. The incidence of side effect in TFH group was 11.27% (8/71), which was significantly lower than that of enalapril 29.6% (21/71). The total cost of TFH group was 9 294.6 RMB with the cost effectiveness ratio of 732/1 147 RMB per mmHg and 179 RMB per case. In the enalapril group, the total cost added up to 13 236 RMB with cost effectiveness ratio of 870/1 310 per mmHg and 250 RMB per case. Sensitivity analysis indicated that TFH was better than enalapril with respect to clinical economic value even when enalapril price dropped to 1.8 RMB for tablet (5 mg). Conclusion Compared with enalapril, TFH is an effective and economic drug in treating patients with hypertension.