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.
Primary economic evaluations are needed in the case that the systematic review of existing economic evidence is not capable of informing economic profiles of marketed medicines. Following the first section of this programs, we presented the principles of designing a study, measuring costs and outcomes, and performing sensitivity analyses. Generally, four designs of economic evaluations are available to perform economic evaluations, each of which has specific strengths and weaknesses. Valuation of outcomes and costs may differ in methods, mainly based on the requirements and applicability of study. The possible factors leading to variation of results should be analyzed using analytic methods with different techniques.
Objective To critically appraise and systematically reviewe the economic evaluations of all alternative interventions for hepatitis B in China. Methods We searched MEDLINE and the four largest Chinese electronic databases. The references of eligible studies were also screened. Economic evaluations of any type, which studied interventions for hepatitis B, were eligible for inclusion. A 25-item quality checklist modified from a BMJ checklist was used to appraise the quality of studies. The overall quality score was calculated against 100 points to indicate the risk of bias. Quality appraisal and data extraction were conducted by two independent reviewers. Results Nineteen full economic evaluations and two cost studies were included of which fourteen studies were scored 25-44 points, and seven scored 45-61 points. Most studies adequately documented effectiveness of interventions. However, the costs of interventions were not well reported in over 50% of studies. Many studies inadequately conducted data analysis, particular in sensitivity analysis and discounting. Ten studies compared lamivudine with interferon or conventional therapy for 1-year (or 6-month) effects, which indicated that lamivudine was generally cost-effective. Three evaluations studied 30-year outcomes of interferon compared with conventional therapy, which suggested that interferon usually saved additional costs and years of life. Another three studies compared interferon with less frequently used antiviral agents, however the comparative cost-effectiveness varied. Two cost studies showed the total costs and the percentage of medical costs increased rapidly in proportion to disease severity.Conclusions Of alternative interventions, lamivudine is cost effective for short-term effects. Interferon is superior to conventional therapy for long-term outcomes. However, the long-term economic outcomes cannot be justified by the current evidence. Quality of methods, particularly, that of costing and analytical methods, is a major limitation. There remains a b need to improve the quality of reporting. Careful considerations should be paid before applying the results to decision making.
ObjectiveTo assess the health effectiveness, cost and cost effectiveness of different oral anticoagulation (OAT) therapies in China, including warfarin plus international normalized ratio (INR) test in hospital labs (Lab test), warfarin plus patient self-management (PSM) with point of care device, and novel anticoagulant (Dabigatran) alone. MethodsA Markov model containing four states (no complication, hemorrhagic event, thrombotic event and death) was developed to account for long-term cost and outcomes of warfarin/novel anticoagulant users including atrial fibrillation patients and deep venous thrombosis patients. Direct medical cost was taken into consideration, covering expenses of drugs, OAT monitoring and complication management. Both clinical and cost parameters were mainly derived from literatures. ResultsCompared with hospital lab test, the PSM pattern obtained a prolonged 8.48 years and 5.08 QALYs with the larger amount of cost, CNY 47 482. The incremental cost-effectiveness ratio (ICER) of PSM versus hospital lab test came to CNY 19 240 per QALY gained, lower than GDP China per capita in 2014 (CNY 46 628). And the novel anticoagulant pattern was dominated by PSM pattern due to shortened QALYs while increased cost. The sensitivity analysis demonstrated the results were not sensitive to main indicators, including utility in different health status, complication probability, and disease management cost. ConclusionPSM can generate more QALYs by reducing the risk of major thrombotic and bleeding events with acceptable incremental cost, which turns to be the most cost effective way among the 3 patterns and demonstrates promising future in OAT management.
Objective To evaluate the cost effectiveness of human papillomavirus vaccine (HPV) for treating cervical cancer. Methods We constructed a Markov model to evaluate the cost-effectiveness of HPV versus Chinese healthy women aged 18 to 25 for treating Cervical Cancer. We calculated the clinical benefits and cost-effectiveness and judged the results based on willing to pay. Sensitivity analysis was made for parameters like cost, discounting rate and vaccine efficacy. Results HPV vaccination was a cost-effective option under the local willing to pay value with the incremental cost utility ratio 43 489 per QALY gained. It proved that vaccination was an economic and effective solution. Conclusion Given the results of Markov model, the cost effectiveness of HPV vaccination of Chinese women aged 18 to 25 is positive. Considering the data sources and model hypothesis, this report has some limitations. Further studies are warranted.
It is potential for N-of-1 trials to evaluate economics of health care, however, it is still in the exploratory stage. With the advantage of accurate estimation of costs and effects, it is beneficial to promote the application of N-of-1 trials for economic evaluation in the era of precision medicine. In this study, we introduce the necessity, feasibility, selection, calculation of indicators and influence factors of N-of-1 trials for economic evaluation, and in order to provide references for researchers to perform related studies.
ObjectivesTo systematically review the methods of pharmacoeconomic evaluation model for hepatitis C therapies and to identify shortcomings of the existing modeling research by comparing the model structure, hypothesis and methodological differences, and to provide suggestions for the construction of high-quality hepatitis C pharmacoeconomic evaluation models.MethodsPubMed, EMbase, The Cochrane Library, CNKI and WanFang Data databases were electronically searched to collect relevant literatures on the pharmacoeconomic evaluation models for hepatitis C therapies from August 2014 to August 2019. Two reviewers independently screened literature, extracted data, and evaluated the quality of the included studies. Then, the data related to the model structure, methods, and assumptions were compared and summarized.ResultsMost of the 46 studies that finally included used similar modeling methods. Ignoring different modeling elements would cause overestimation or underestimation of the value of hepatitis C therapies. Model structure of all studies were similar and key parameters were from the same source. Forty-five studies measured the cost of drugs and medical cost of health status. All studies used quality-adjusted life years as the outcome and reported incremental cost-effectiveness ratio. Thirty studies conducted one-way sensitivity analysis and probability sensitivity analysis.ConclusionsThe included studies share similar methodological designs and have high quality in general. However, there are some differences and deficiencies in research perspective, model types, model assumptions and model verification. Future pharmacoeconomic evaluation model of hepatitis C therapies should report the results of the whole society, establish dynamic model to consider the impact of transmission, make half-cycle correction for long periods, consider the recurrence after cure, model liver transplantation, and verify the model.
ObjectiveTo systematically review the health economic evaluation studies in which externalities of antibacterial drug uses were identified.MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and VIP databases were electronically searched to collect health economic evaluation studies in which externalities of antibacterial drug uses were identified from inception to December 31st, 2020. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Descriptive analysis was then performed.ResultsA total of 14 studies were included. Negative externalities and their impacts on costs and/or effectiveness were examined in 13 literature, and positive externalities in terms of an improvement in disease control were included in only one study. No study was found in which both negative and positive externalities were included. The methods used to quantify negative externalities included: only costs associated with drug resistance per prescription or per unit were calculated; both costs and health impacts associated with the second/third line treatments followed a treatment failure (due to drug resistance) were calculated using a decision tree. In one study in which positive externalities were measured, both health gain and cost reduction from an improvement in disease control (as a benefit of antibacterial drug uses) were calculated by constructing a dynamic model at the population level.ConclusionsWe propose that both the positive and negative externalities should be included in health economic evaluation. This can be achieved by measuring the relevant costs and health impacts in a broader perspective, using a disease-transmission dynamic model. In addition, to achieve an improved health utility measurement, disability-adjusted-life years rather than quality-adjusted-life years should be encouraged for use. Finally, both costs and effectiveness should be discounted.
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.
ObjectiveTo systematically review the economic evaluations of anaplastic lymphoma kinase (ALK)-tyrosine kinase inhibitors (TKIs) in the treatment of ALK-positive non-small cell lung cancer (NSCLC). MethodsPubMed, Web of Science, The Cochrane Library, CNKI, VIP and WanFang Data databases were electronically searched to collect economic evaluations of ALK-TKIs in the treatment of ALK-positive NSCLC from inception to July 2022. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies; then, a systematic review was performed. ResultsA total of 20 studies were included. 18 of the included studies were cost-utility analyses based on the models. The method of survival data extrapolation involved the standard parameter model and the standard parameter model with a hazard ratio adjusting. 10 studies considered or included the disutility value of adverse events. 18 studies performed cost estimation on direct costs. In China, 45% of the included studies were first-line treatment, the results showed that ALK-TKIs were less economical than chemotherapy, and second-/third-generation ALK-TKIs were less economical than crizotinib. Only 1 studies were second-line treatment, the result showed that crizotinib was more economical than chemotherapy. ConclusionThe economic evaluation results of ALK-TKIs in ALK-positive NSCLC vary according to treatment stage and national scenario, and there is also room for optimization of methodological application in this field.