Markov model is one of the decision analysis models, which is widely used in pharmacoeconomic evaluation studies. In terms of dealing with changes of disease risks during different times, the transition probabilities among different Markov health states becomes hard to calculate. Nevertheless, survival analysis is an available resolution. In this paper, we introduced how to apply survival analysis in calculation of transition probability in time-dependent model based on cumulative probability with a case analysis on advanced gastric cancer Markov model, and provide more information for researchers to build models.
This paper used the application of health technology assessment (HTA) in medical insurance directory adjustment as an example, introduced NICE’s HTA in UK from seeking legislative support for HTA, established the system of HTA, improved the process of HTA and increasing awareness of using HTA among decision-maker, and provided suggestions for the development and advancement of HTA in China.
Objectives To determine the health benefit of elbasvir/grazoprevir versus peginterferon combing with ribavirin (PR regimen) for Chinese chronic hepatitis C patients with genotype 1b infection. Methods Markov cohort state-transition models were constructed to conduct cost utility analysis. Sensitivity analyses were performed based on base-case analysis. Results Elbasvir/grazoprevir was dominant versus PR, resulting in higher QALYs and lower costs for both noncirrhotic patients (13.867 5 QALYs, 82 090.82 RMB vs. 12.696 2 QALYs, 122 791.55 RMB) and cirrhotic patients (12.841 6 QALYs, 225 807.70 RMB vs. 8.892 4 QALYs, 326 545.01 RMB). Elbasvir/grazoprevir was economically dominant in nearly 100% among all patients within the range of threshold from 0 to 161 805 RMB/QALY. Conclusions Elbasvir/grazoprevir was dominant in treatment of genotype 1b chronic hepatitis C infection in China.
ObjectiveTo systematically review the efficacy and safety of capecitabine combined with irinotecan (CAPIRI) versus capecitabine combined with oxaliplatin (CAPOX) for patients with advanced/metastatic colorectal cancer.MethodsPubMed, EMbase, The Cochrane Library, VIP, WanFang Data and CNKI databases were electronically searched to collect randomized controlled trials (RCTs) on CAPIRI versus CAPOX for patients with advanced/metastatic colorectal cancer from inception to August 2018. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 12 RCTs involving 1 049 patients were included. The results of meta-analysis showed that: there were no significant differences in complete response (CR), partial response (PR), stable disease (SD), progression disease (PD), overall respond rate (ORR), median progression-free survival (mPFS), and median overall survival (mOS) between two groups (P>0.05). However, CARIRI group was lower on the disease control rate (RR=0.93, 95%CI 0.86 to 1.00, P=0.04) than CAPOX group. Incidence of diarrhea was higher in CAPIRI group (RR=1.83, 95%CI 1.37 to 2.45, P<0.000 1). However, the incidence rate of peripheral neurotoxicity in CAPOX group was higher (RR=0.13, 95%CI 0.05 to 0.35, P<0.000 1). There were no significant differences between two groups in the incidence rates of nausea and vomiting, hand-foot syndrome, anemia, thrombocytopenia, leukocytopenia and alopecia (P>0.05).ConclusionsCurrent evidence shows that two groups are equivalent in terms of curative effects. CAPIRI has a higher incidence rate of diarrhea, while CAPOX has a higher risk of peripheral neurotoxicity. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
ObjectivesTo compare and analyze existing pharmaceutical economic evaluations quality assessment instruments, and to provide suggestions on how to choose the most appropriate instrument.MethodsPubMed, EMbase, ScienceDirect, Web of Science, CNKI, WanFang Data and VIP databases were electronically searched to collect studies on existing pharmaceutical economic evaluations quality assessment instruments from inception to December, 2017. Two reviewers independently screened literature, extracted data and analyzed studies in terms of items, design methods, scopes and characteristics.ResultsTwelve original checklists with good reliability and validity were found. The first quality assessment method was designed in 1987 and the latest one was published in 2013. The number of checklist items ranged from 11 to 61.ConclusionThere is no consolidated method for assessing the quality of pharmaceutical economics evaluations. Evaluators can choose appropriate evaluation tools according to the purpose, type and operability of evaluation.
ObjectivesTo systematically review the efficacy and safety of pegylated interferon α-2a (Peg-IFNα-2a) combined with entecavir (ETV) versus Peg-IFNα-2a alone in treatment of HBeAg-positive chronic hepatitis B (CHB) patients.MethodsThe Cochrane Library, PubMed, Web of Science, EMbase, CNKI, VIP and WanFang Data databases were electronically searched to collect randomized controlled trials (RCTs) on Peg-IFNα-2a combined with ETV for HBeAg-positive CHB from inception to March, 2019. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 12 RCTs involving 1 130 patients were included. The results of meta-analysis showed that: compared with Peg-IFNα-2a monotherapy, Peg-IFNα-2a combined with ETV could improve the rate of serum HBV-DNA clearance (RR=2.55, 95%CI 1.83 to 3.55, P<0.000 01), ALT normalization (RR=2.37, 95%CI 1.76 to 3.20, P<0.000 01) and HBeAg seroconversion (RR=2.88, 95%CI 1.18 to 7.03, P=0.02) after 12 weeks of treatment. Additionally, it could improve the rate of serum HBV-DNA clearance (RR=2.10, 95%CI 1.74 to 2.53, P<0.000 01), AST normalization (RR=1.87, 95%CI 1.15 to 3.04, P=0.01), ALT normalization (RR=1.70, 95%CI 1.46 to 1.99, P<0.000 01), serum HBeAg clearance (RR=2.14, 95%CI 1.62 to 2.83, P<0.000 01), HBeAg seroconversion (RR=2.51, 95%CI 1.65 to 3.82, P<0.000 01) and serum HBsAg clearance (RR=2.78, 95%CI 1.06 to 7.31, P=0.04) after 24 weeks of treatment. It could also improve the rate of serum HBV-DNA clearance (RR=1.63, 95%CI 1.32 to 2.02, P<0.000 01), AST normalization (RR=2.75, 95%CI 1.82 to 4.16, P<0.000 01), ALT normalization (RR=1.47, 95%CI 1.33 to 1.63, P<0.000 01), serum HBeAg clearance (RR=1.65, 95%CI 1.42 to 1.91, P<0.000 01), HBeAg seroconversion (RR=1.91, 95%CI 1.51 to 2.41, P<0.000 01) and serum HBsAg clearance (RR=1.57, 95%CI 1.07 to 2.31, P=0.02) after 48 weeks of treatment. There was no statistically significance of adverse reactions in groups.ConclusionsCurrent evidence shows that Peg-IFNα-2a combined with ETV is superior to Peg-IFNα-2a monotherapy in the treatment of HBeAg-positive CHB, and does not increase the incidence of adverse reactions. Due to the limited quality and quantity of the included studies, more high quality studies are required to verify the above conclusion.
Traditional randomized controlled trial and real-world study have different advantages in internal validity and external extensibility, respectively. With the development of evidence-based health decisions, randomized controlled trial was no longer the only golden standard of interventional study, the research evidence of the real world was gradually involved in health decisions. This study mainly analyzed the requirements of evidence and actual application of evidence in the evaluation of the effectiveness of NICE in the UK. It was found that NICE still used the results of randomized controlled trials as a primary basis. Although real-world research has developed rapidly in recent years, it was limited used in health decision because of its bias by design and other factors. However, in recent years, real-world evidence has played a significant role in the field of innovative drugs or diseases that lack therapeutic drugs. With the improvement of real-world research in experimental design and data analysis, it is expected that it will play a more important role in health decision-making.
ObjectiveTo systematically review the efficacy of irbesartan combined with metoprolol plus conventional treatment compared with single drug (irbesartan, metoprolol) plus conventional treatment or conventional treatment for elderly patients with severe heart failure.MethodsPubMed, The Cochrane Library, Web of Science, CNKI, WanFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) on irbesartan combined with metoprolol in the treatment of elderly patients with severe heart failure from January 2009 to September 2019. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Network meta-analysis was then performed using gemtc package of R software.ResultsA total of 58 RCTs involving 5 064 patients were included. The results of meta-analysis showed that the efficiency, left ventricular ejection fraction (LVEF) and brain natriuretic peptide (BNP) of combination group were significantly superior to single drug group.ConclusionsThe current evidence shows that under the premise of conventional treatment, the combination of irbesartan and metoprolol is more effective than irbesartan or metoprolol alone in the treatment of elderly patients with severe heart failure. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
The R software bmeta package is a package that implements Bayesian meta-analysis and meta-regression by invoking JAGS software. The program is based on the Markov Chain Monte Carlo (MCMC) algorithm to combine various effect quantities (OR, MD and IRR) of different types of data (dichotomies, continuities and counts). The package has the advantages of fewer command function parameters, rich models, powerful drawing function, easy of understanding and mastering. In this paper, an example is presented to demonstrate the complete operation flow of bmeta package to implement bayesian meta-analysis and meta-regression.
Objective To systematically review the pharmacoeconomic evaluation related to relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), and to summarize its model structure, parameter inclusion and other methodological parts for future r/r B-ALL-related interventions, and to provide references for conducting pharmacoeconomic evaluations. Methods PubMed, EMbase, The Cochrane Library, CNKI and WanFang Data databases were electronically searched to collect relevant literature on the pharmacoeconomic evaluation model of r/r B-ALL from inception to August 6th, 2021. Two reviewers independently screened literature, extracted data, and assessed the quality of the included studies. The data on the model structure, methods, and parameter inclusion were then summarized. Results A total of 10 studies using different modeling methods were included. Due to the lack of head-to-head trials, most of the efficacy parameters for the intervention and control groups were derived from different clinical trials and compared indirectly. All studies used quality-adjusted life years (QALYs) as output indicators, and some used life years (LYs) as output indicators and reported the incremental cost effectiveness ratio (ICER). All studies measured the cost of treatment and hematopoietic stem cell transplantation; a few studies also conducted subgroup analysis. Conclusion The number of studies on the economic evaluation of r/r B-ALL is relatively small, and there are large differences in model types, health status, and parameter inclusion. It is suggested that researchers should guarantee the integrity of the report format and normative according to available data choice drug economics evaluation model and establish the reasonable hypothesis under the condition of the patient population heterogeneity uncertainty, perform subgroup analysis especially on the subgroup which did not receive salvage therapy. In the absence of head-to-head clinical trials, appropriate indirect comparison methods are adopted according to the data obtained to reduce methodological differences and improve the quality of relevant pharmacoeconomic research in China.