1.Clinical value assessment of innovative drugs in Canada’s health insurance access
Tianyi SHENG ; Rong JIANG ; Rong SHAO
China Pharmacy 2024;35(24):2972-2976
OBJECTIVE To introduce the clinical value assessment model for innovative drugs in Canada’s health insurance access, providing a reference for improving the clinical value assessment system for innovative drugs in China. METHODS The clinical value assessment system for innovative drugs in Canada’s health insurance access was organized from four aspects: the assessment body, the assessment process, the assessment dimensions, and the application of assessment results. A deep analysis was also conducted with the clinical value assessment of health insurance access for blinatumomab as an example. Then the suggestions were proposed for the improvement of relevant work in China. RESULTS & CONCLUSIONS Canada has established an independent clinical value assessment agency, the Canadian Agency for Drug and Technologies in Health (CADTH), which is responsible for the health technology assessment of innovative drugs. The health insurance access to clinical value assessment system for innovative drugs is built with patient needs as the guide, and the review process includes stages such as opinion review and expert assessment. Different evaluation dimensions are set for oncology and non-oncology drugs, and the assessment is based on sufficient evidence and a transparent process. The assessment results include four types: reimbursement, conditional reimbursement, time-limited reimbursement, and non-reimbursement, balancing efficacy and accessibility. It is suggested that China should strengthen the clinical value assessment system for innovative drugs in health insurance access from four aspects: establishing a specialized institution for the clinical value assessment of innovative drugs, increasing the clarity of policy expectations, including patient benefit assessment indicators, and adding special reimbursement pathways for drugs.
2.Analysis of the cost of hospital delivery for postpartum women in large public hospitals in Beijing
Zhuoqi SHENG ; Shan WANG ; Wenyi ZHANG ; Jianchao LIU ; Tianyi ZHANG ; Runda JIAO ; Lihua LIU
Chinese Journal of Hospital Administration 2023;39(5):358-362
Objective:To analyze the hospitalization costs of delivery for postpartum women with different delivery methods, ages and comorbidities or complications, for references for medical institutions and medical insurance management departments to develop payment and compensation standards for inpatient delivery.Methods:The first page of medical records of hospitalized delivery women admitted to 8 large tertiary hospitals in Beijing from January 2018 to December 2021 were selected. Descriptive analysis was made on the mode of delivery, age, hospitalization expenses and cost structure of puerpera, as well as the hospitalization expenses of puerpera with different complications or complications. Wilcoxon rank sum test, Kruskal-Wallis H test, and Chi-squared test were used to statistically compare the level and structure differences between groups. Results:A total of 23 320 pregnant women were included, with an average age of 32.3 years. There were 13 605 cases of natural delivery and 9 715 cases of caesarean section. The median cesarean section rate in the right age group (<35 years old) and the elderly group (35-50 years old) were 36.73% and 56.58%, respectively, and the median hospital expenses were 5 865 yuan and 7 042 yuan, respectively. The median hospital expenses for natural delivery and caesarean section were 4 452 yuan and 10 033 yuan, respectively. The highest proportion of hospitalization expenses for natural delivery and cesarean section were treatment expenses (23.45%) and medicine expenses (29.19%), respectively. The median of hospitalization cost for women with≥2 comorbidities or complications (6 736 yuan) was higher than that for women with 1 comorbidities or complications (5 794 yuan).Conclusions:The hospitalization cost of cesarean section was significantly higher than that of natural delivery and the rate of cesarean section and the cost of delivery in women aged 35 and above were higher than those under 35 years old. The structure of hospitalization cost was different in different delivery modes, and the complications or complications had a greater impact on the average hospitalization expenses.
3.Hybrid coronary revascularization versus off-pump coronary artery bypass grafting for treatment of multivessel coronary artery diseases
Wei SHENG ; Liyue ZHAO ; Tianyi WANG ; Zhaozhuo NIU ; Wenfeng ZHANG ; Jiantao WU ; Haoyou LI ; Haiqin YANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2021;28(07):801-805
Objective To investigate the feasibility and safety of hybrid coronary revascularization (HCR) in patients with multivessel coronary artery disease (MVCAD). Methods A total of 50 patients with MVCAD who underwent HCR technique in our heart center from May 2016 to April 2019 were included in this study (a HCR group), including 38 patients who underwent two-stage HCR and 12 patients one-stop HCR. There were 39 males and 11 females, with an average age of 62.4 (46-82) years. Another 482 patients who underwent conventional median incision under off-pump coronary artery bypass grafting (OPCAB) at the same period were selected as control (an OPCAB group), including 392 males and 90 females, with an average age of 64.2 (48-84) years. The safety and feasibility of HCR were evaluated and compared with conventional OPCAB technique. Results There was no perioperative death in both groups. Compared with the OPCAB, HCR was associated with shorter operation time, less chest tube drainage, lower requirement of blood transfusion, shorter mechanical ventilation time and shorter postoperative intensive care unit (ICU) stay (P<0.05). There was no statistical difference in the incidence of major adverse cardiac or cerebrovascular events during the follow-up of 6 to 36 months between the two groups. Conclusion HCR provides favorable short and mid-term outcomes for selected patients with MVCAD compared with conventional OPCAB.
4.Effects of levosimendan on patients undergoing valve replacement
SHENG Wei ; LI Na ; CHI Yifan ; NIU Zhaozhuo ; ZHANG Wenfeng ; WU Jiantao ; LI Haoyou ; WANG Tianyi ; HUANG Qiang
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2019;26(7):693-697
Objective To investigate the effect of postoperative use of levosimendan on patients with valve replacement. Method Patients with valvular diseases who underwent valve replacement were prospectively enrolled during Jan 2014 to May 2018 in Qingdao Municipal Hospital, randomized to a levosimendan-treated group (n=93) and a control group (n=92) preoperatively. Patients in both groups underwent the same routine treatment preoperatively and postoperatively. In addition, patients in the levosimendan-treated group underwent levosimendan intravenous infusion 24 hours after entering ICU postoperatively. The clinical effect of the two groups was compared. Results Compared to the control group, the cardiac output(CO, 5.2±1.0 L/min vs. 4.4±1.1 L/min on the seventh day after surgery) and left ventricular ejection fraction (LVEF, 55.7%±2.5% vs. 50.5%±2.2% on the seventh day after surgery) of levosimendan-treated group were increased significantly at different time points(1 day, 3 days and 7 days after surgery)(P<0.05), and the brain natriuetic peptid (BNP) level (312.5±34.6 pg/ml vs. 455.4±45.2 pg/ml on the seventh day after surgery) was less than that of the control group (P<0.05). The dosage (11.5±1.8 mg/kg vs. 20.4±2.1 mg/kg) and administration time of vasoactive agents in the levosimendan-treated group were significantly lower or shorter than those in the control group (70.4±11.2 h vs. 110.5±12.1 h, P<0.05). The ICU stay length, and the total incidence of adverse events were less than those of the control group (P<0.05). Conclusion Postoperative use of levosimendan immediately after surgery can significantly improve the cardiac function status of patients who underwent valve replacement, reduce the dosage of vasoactive agents, shorten the time of ICU hospitalization, reduce the incidence of adverse events and enhance the patient’s recovery after valve replacement.
5.Predictive risk factors for prolonged mechanical ventilation after surgery for stanford type A acute aortic dissection
Wei SHENG ; Tian LUAN ; Yifan CHI ; Zhaozhuo NIU ; Wenfeng ZHANG ; Jiantao WU ; Tianyi WANG ; Haoyou LI ; Long SUN
Chinese Journal of Thoracic and Cardiovascular Surgery 2019;35(2):72-75
To identify the predictors of prolonged mechanical ventilation in patients undergoing surgery for stanford type A acute aortic dissection. Methods 202 patients who underwent surgery for acute aortic dissection type A from May 2009 to May 2016 were divided into two groups based on their mechanical ventilation time after surgery, including 70 patients with mechanical ventilation 48 hours or more(group A), 132 patients with mechanical ventilation less than 48 hours (group B). Univariate and multivariate analysis(logistic regression) were used to identify the predictive risk factors. Results The mechanical ventilation time was(146. 8 ±78. 5)h and(21. 7 ±9. 5)h in group A and group B respectively. Overall inhospital mortality was 8. 6% and 2. 3%. Multivariate logistic analysis showed that BMI(OR = 5. 956, 95% CI: 2. 585 - 13. 723, P =0. 000), CPB time(OR =1. 108, 95%CI: 1. 052 -1. 166, P =0. 000), DHCA(OR =4. 562, 95% CI: 1. 250 - 16. 640, P =0. 022), red blood cell transfusion intraoperative and in 24 hours postoperatively(OR =2. 625, 95% CI: 1. 515 -4. 549, P =0. 001) were the independent predictors for prolonged mechanical ventilation. Conclusion The incidence of prolonged mechanical ventilation is high after surgery for stanford type A acute aortic dissection. It can be predicted based on above factors, for patients with these risk factors, more perioperative care strategies are needed in order to shorten the mechanical ventilation time.
6.Preoperative uses of levosimendan in patients with low LVEF undergoing OPCABG
Wei SHENG ; Yifan CHI ; Zhaozhuo NIU ; Wenfeng ZHANG ; Jiantao WU ; Haoyou LI ; Tianyi WANG ; Na LI
Chinese Journal of Thoracic and Cardiovascular Surgery 2019;35(2):91-93
To investigate the effect of preoperative uses of levosimendan in patients with low LVEF(≤0. 40) undergoing off-pump coronary artery bypass grafting(OPCABG). Methods 63 patients with low LVEF coronary artery diseases were prospectively enrolled during June 2015 to May 2018, randomized to levosimendan-treated group(n =32) and control group(n =31)preoperatively. Patients in levosimendan-treated group underwent levosimendan intravenous infusion 24 h before OPCABG. All patients underwent OPCABG at normal temperature. Internal mammary artery and great saphenous vein were used as bypass materials. Hemodynamics and cardiac function were compared between the two groups after OPCABG. Results Compared to control group, the systemic vascular resistance(SVR) and central venous pressure(CVP) of levosimendan- treated group were decreased significantly and the CO and LVEF increased significantly at 12h and 24h after surgery(P < 0. 05). The heart rate and mean artery pressure had no statistical difference between the two groups(P >0. 05). The dosage and administration time of vasoactive agents in levosimendan-treated group were significantly smaller than those in control group (P <0. 05). The time of mechanical ventilation, the ICU stay length, the BNP level in the first two days after operation, and the incidence of new atrial fibrillation were less than those of the control group(P <0. 05). The perioperative intra-aortic balloon pump implantation rate in levosimendan-treated group was significantly lower than that of the control group(P < 0. 05). Conclusion Preoperative use of levosimendan can significantly improve the hemodynamic and cardiac function status of patients with low LVEF after OPCABG, shorten the time of ventilator assisted and ICU hospitalization, and reduce the incidence of adverse events.

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