Pharmacoeconomics of ivabradine in the treatment of CHF in the context of “Quadruple Therapy” / 中国药房

OBJECTIVE To evaluate the cost-effectiveness of ivabradine in the treatment of chronic heart failure （CHF） in the context of “Quadruple Therapy” from the perspective of the health system. METHODS Based on real-world cohort data， the Markov model was constructed according to the natural progression of CHF， with a cycle time of 3 months， a study timeframe of 20 years， and a discount rate of 5%. Using quality-adjusted life year （QALY） and incremental cost-effectiveness ratios （ICER） as the output indexes， the cost-utility analysis was used to evaluate the cost-effectiveness of ivabradine in combination with the “Quadruple Therapy” regimen， compared with the “Quadruple Therapy” regimen for the treatment of CHF， and the robustness of the results of the base analysis was verified by univariate sensitivity analysis and probabilistic sensitivity analysis. RESULTS The results of the base analysis showed that the ICER of ivabradine combined with the “Quadruple Therapy” regimen was 165 065.54 yuan/QALY， compared with the “Quadruple Therapy” regimen， which was lower than the willingness-to-pay （WTP） threshold （257 094 yuan/QALY） based on 3 times of China’s gross domestic product （GDP） per capita in 2022. The results of the univariate sensitivity analysis showed that the discount rate had the greatest impact on the robustness of the model. The probabilistic sensitivity analysis showed that the probability that the ivabradine combined with the “Quadruple Therapy” regimen was cost-effective under the WTP threshold in this study was 59.50%. CONCLUSIONS When using 3 times China’s 2022 GDP per capita （257 094 yuan/ QALY） as the WTP threshold， the combination of ivabradine and the “Quadruple Therapy” regimen for treating CHF is cost- effective.

Pharmacoeconomics study of rosuvastatin single daily dose versus alternate day dosing in hyperlipidemia patients

Background: In country like India, therapy with rosuvastatin recommended dose may cost between Rs. 400.00 and Rs. 800.00/month. The lower and middle income groups of Indian society are rapidly becoming major sufferers of cardiovascular disease, among all non-communicable diseases, the economic burden of rosuvastatin therapy may be substantial for this large section of population. Aims and Objectives: The aim of the study was to study the cost-effectiveness of rosuvastatin on alternate day versus daily dosing regimen in hyperlipidemia patients. Materials and Methods: The research was carried out at MNR Medical College and Hospital’s department of pharmacology in association with general medicine. According to the inclusion criteria, 50 patients aged 30–60 years of both sexes were included in this prospective open label trial. The research lasted 6 weeks. All the participants were included in study after obtaining the informed consent and approval of the Institutional Ethics Committee was obtained before enrolment of participants. All patient data were obtained using a pre-designed proforma and put into an excel spreadsheet. Results: A total of 42 patients are included with 16 females (38%) and 26 men (62%). Cost of daily rosuvastatin for 6 weeks is Rs. 1087.80 (yearly daily dosing expenses 9453.50%) accounting for mean reduction of LDL-cholesterol (LDL-C) of 33.50% and for alternate day rosuvastatin for 6 weeks is 543.90% (yearly alternate day dosing expense 4713.80%) accounting for mean reduction of LDL-C of 31%. Conclusion: Treatment with alternate day dose of rosuvastatin is comparably cost-effective when compared to currently practicing daily dose rosuvastatin therapy.

A pharmacoeconomic study on cost variation of dyslipidemic drugs available in Indian market

Background: Dyslipidemic drugs are widely prescribed drugs in atherosclerosis, as it is a chronic illness the long term need of this medication creates a financial burden on the patient, especially with patients of low socioeconomic status. Considering this government of India established Jan Aushadhi medical store with a view to provide cheaper generic medicines, so that a good patient compliance is achieved. Aims and Objectives: The aim of the study was to analyze the cost variation of the dyslipidemic drugs available in Indian market under generic and various brand names manufactured by different pharmaceutical industries. Materials and Methods: This was a cross-sectional study conducted to analyze the cost variation of dyslipidemic drugs available in different formulations in our Indian market. The information on cost of each drug with its dosage and formulation was obtained from “Current index of medical specialties” October 2021–January 2022 India and from Jan Aushadhi Price list W.E.F October 2015. Cost ratio and percentage variation among different strength and formulation in dyslipidemic drugs were calculated. Results: The highest cost difference was seen between the minimum cost brand of simvastatin 20 mg tab with its generic drug cost (142.8). Lowest cost differences between minimum brand cost and generic drug was observed for atorvastatin 10 mg tab (17.48). Conclusion: Knowledge about wide cost difference between branded and Jan Aushadhi dyslipidemic drugs helps clinicians to select budget friendly drugs for patients with low socioeconomic status.

Rapid health technology assessment of Xuesaitong injection in the treatment of stroke / 中国药房

OBJECTIVE To evaluate the efficacy， safety and economical efficiency of Xuesaitong injection in the treatment of stroke by rapid health technology assessment，so as to provide evidence for clinical rational drug use. METHODS Retrieved from Wanfang database， CBM， CNKI，PubMed，Cochrane Library，Embase， INAHTA and HTAI databases or organization websites， health technology assessment （HTA） reports， meta-analysis/systematic reviews and pharmacoeconomic studies related to Xuesaitong injection in the treatment of stroke were summarized and analyzed. RESULTS A total of 29 pieces of literature were included. Among them， 14 studies were conducted on meta-analysis/systematic reviews，15 studies were conducted on pharmacoeconomics， HTA was not obtained. The results of meta-analysis/systematic reviews showed that Xuesaitong injection had certain advantages for stroke in improving the total effective rate， clinical symptoms and related scale scores compared with blank control group and some drug control groups. Safety studies had shown that the adverse reactions of Xuesaitong injection were mainly allergic-like reactions. The results of pharmacoeconomic evaluation are quite different， which may also be related to the long time span among various studies and the adjustment of some drug prices. CONCLUSIONS Xuesaitong injection in the treatment of stroke is helpful to improve the clinical efficacy and evaluation indexes， but there are some serious adverse reactions， and it is not economically superior to some chemical drugs.

Systematic evaluation of pharmacoeconomic studies on acute ischemic stroke population in China / 中国药房

OBJECTIVE To systematically evaluate pharmacoeconomic studies （modeling approach） based on the Chinese acute ischemic stroke （AIS） population， and to provide the suggestions for improving the pharmacoeconomic evaluation method of AIS. METHODS Retrieved from CNKI， Wanfang Data Knowledge Service Platform， VIP， PubMed， Embase， the Cochrane Library， ScienceDirect， and Web of Science databases， relevant literature on pharmacoeconomic evaluation of AIS were collected from January 2014 to February 2022. Basic information of included study， basic information and outcome indicators of the model were analyzed statistically. The quality of the included literature was evaluated using CHEERS 2022， and problems in the existing literature were identified and suggestions were made. RESULTS Twelve papers were finally included， involving five in Chinese and seven in English. All studies reported the study perspective， mainly from the perspective of health system； the age of the target population was mainly distributed around 60 years old； the main interventions in the included studies were pharmacotherapy， including single-drug regimens and combination drug regimens； nine papers used decision trees combined with Markov models， and three papers used Markov models alone， but the classification of health status was inconsistent； all papers reported study time frame and cycle period， with most studies choosing a study time frame of 30 years and a cycle period of 1 year； all studies used modified Rankin scale scores as an indicator of clinical effectiveness， which were mainly derived from clinical trials； utility values in most literature were derived from published studies， and costs were mainly direct medical costs； all studies performed cost-utility analyses using quality-adjusted life years and/or incremental cost-effectiveness ratios as outcome indicators， and single-factor sensitivity analyses and probabilistic sensitivity analyses were performed， but no contextual analyses were conducted for the different model structures that may exist. CONCLUSIONS The overall report of the included studies is relatively complete， but the methodology is relatively uniform， and there are still deficiencies in terms of study perspective， study time frame， parameter sources， and contextual analysis. Future AIS pharmacoeconomic evaluations should further improve the report content in accordance with the CHEERS list entries， conduct contextual analysis of multiple health state classification approaches from a society-wide perspective， while using data from real- world sources and standardizing the uncertainty analysis process of the study results to increase the authenticity and reliability of the study results.

Cost-utility analysis of sintilimab combined with chemotherapy in first-line treatment of advanced，recurrent or metastatic esophageal squamous cell carcinoma / 中国药房

OBJECTIVE To evaluate the cost-effectiveness of sintilimab combined with chemotherapy than single-use chemotherapy in the first-line treatment of advanced， recurrent or metastatic esophageal squamous cell carcinoma （ESCC） from the perspective of health system of our country， and provide reference for rational use of drug in clinic. METHODS Based on ORIENT-15 study data， TreeAge Pro 2011 software was used to establish a three-state Markov model of non-progressive survival （PFS）， disease progression and death for cost-utility analysis. The model period was 3 weeks， the research time limit was 10 years， and the discount rate was 5%. The main outputs of the model were total cost， quality-adjusted life year （QALY） and incremental cost-effectiveness ratio （ICER）. The 1-3 times of China’s GDP per capita in 2021 was taken as the threshold of willing- ness to pay （WTP）. The uncertainty of the parameters was analyzed by single factor sensitivity analysis and probability sensitivity analysis， and the cost-effectiveness of the two schemes was discussed under three situations： different discount rates， comparison with other similar treatment schemes and charitable drug donation schemes. RESULTS The results of basic analysis showed that compared with chemotherapy plan alone， the ICER of sintilimab combined with chemotherapy was 64 208.75 yuan/QALY， which was less than WTP threshold. The results of single factor sensitivity analysis show that PFS state utility value， cycle cost of sintilimab and discount rate had relatively great influence on the results. Probability sensitivity analysis showed that when WTP≥120 000 yuan， the economic probability of sintilimab combined with chemotherapy plan was 100%. The results of situational analysis showed that sintilimab combined chemotherapy was more cost- effective than single-use chemotherapy. CONCLUSIONS Sintilimab combined with chemotherapy is more cost-effective than single-use chemotherapy in the first-line treatment of advanced， recurrent or metastatic ESCC.

Análise farmacoeconômica do uso de omeprazol por idosos em uma das unidades básicas de saúde do Brasil / Pharmacoeconomic Analysis of the Use of Omeprazole by Elderly Patients in One of the Primary Healthcare Centers in Brazil

O omeprazol é inibidor de bomba de prótons mais prescrito no Brasil e é indicado para o tratamento de doenças por refluxos gastroesofágicos, úlcera péptica, esofagite erosiva, erradicação de Helicobacter pylori, síndrome de Zollinger-Ellison, gastrinomas, gastrite e distúrbios hipersecretores e prevenção de úlcera péptica. O uso indiscriminado e desnecessário, principalmente por idosos, é uma importante questão de saúde pública a ser tratada. Apesar de ser conhecida a existência do uso indiscriminado do omeprazol, identifica-se a necessidade de se verificar como ocorre a prescrição desse medicamento no contexto do Sistema Único de Saúde (SUS) do Brasil. Além disso, acredita-se que estudos que analisam de modo famacoeconômico a prescrição do omeprazol podem contribuir para a revisão ou implementação de diretrizes e protocolos que envolvam o uso desse medicamento. O objetivo foi caracterizar e realizar análise farmacoeconômica do uso do omeprazol em Unidade de Atenção Primária a Saúde (UAPS) em Minas Gerais, Brasil. Trata-se de estudo descritivo com análise das prescrições de 41 pacientes idosos atendidos no período de abril/maio de 2018 e foram identificadas as seguintes variáveis: idade, sexo, dose, indicação, realização de endoscopia, demais medicamentos em uso e custo do tratamento. Na análise farmacoeconômica realizou-se o cálculo do custo médio da quantidade de omeprazol prescrita por paciente e considerou-se a realização ou não de endoscopia. Na população estudada, 29 (70,3%) do sexo feminino com mediana de idade: 69 anos. Apenas em 4 prontuários (9,8%) havia indicação para uso e em 18 (43,9%) pacientes, a utilização era feita há mais de dois anos e em 7 (17,1%) a mais de cinco anos. Apenas 3 (7,3%) realizaram endoscopia e foram utilizados 371 meses totalizando um valor financeiro de R$35.657,23. Os achados sugerem prescrições em longo prazo e sem registro da indicação em prontuário. O custo referente às prescrições poderia ser otimizado com a realização de endoscopia e suspensão do uso, quando constatada ausência de indicação.

Omeprazole is the most prescribed proton pump inhibitor in Brazil and is indicated for the treatment of diseases caused by gastroesophageal reflux, peptic ulcer, erosive esophagitis, eradication of Helicobacter pylori, Zollinger-Ellison syndrome, gastrinomas, gastritis, and hypersecretory disorders, as well as peptic ulcer prevention. The indiscriminate and unnecessary use, mainly by the elderly, is an important public health issue to be addressed. Despite the existence of indiscriminate use of omeprazole being known, there is a need to verify how this medication is prescribed in the context of the Unified Health System (UHS) in Brazil. In addition, it is believed that studies that aim to analyze the prescription of omeprazole in a pharmacoeconomic way can contribute to the review or implementation of guidelines and protocols involving the use of this drug. The objective of this study was to characterize and perform a pharmacoeconomic analysis of the use of omeprazole in a Primary Healthcare Centers (PHC) in Minas Gerais, Brazil. This is a descriptive study analyzing the prescriptions of 41 elderly patients treated in the period of April/May 2018 and the following variables were identified: age, sex, dose, indication, endoscopy, other medications in use, and cost of treatment. In the pharmacoeconomic analysis, the average cost of the amount of omeprazole prescribed per patient was calculated and whether or not endoscopy was performed was considered. In the studied population, 29 (70.3%) were female with a median age: 69 years. Only in 4 medical records (9.8%) was there indication for use, and 18 (43.9%) patients had been using omeprazole for more than two years and 7 (17.1%) for more than five years. Only 3 (7.3%) patients underwent endoscopy, and 371 months-worth of omeprazole were used, totaling a financial value of R$35,657.23. The findings suggest long-term prescriptions and no record of their indication on medical records. The cost related to prescriptions could be optimized by performing endoscopy and discontinuing its use when no indication is found.

Study on pharmacoeconomic evaluation of vericiguat in the treatment of heart failure with reduced ejection fraction / 中国药房

OBJECTIVE To evaluate the cost-effectiveness of vericiguat combined with standard treatment in the treatment of heart failure with reduced ejection fraction （HFrEF）. METHODS Based on the results of the VICTORIA trial and related literature， a three-state （including stable state of heart failure， hospitalized state of heart failure and death state） Markov model was constructed. The cycle length was 1 month， the time horizon was 20 years， the discount rate was 5%， and one time China’s per capita gross domestic product （GDP） in 2021 was the willing-to-pay （WTP） threshold. Cost-utility analysis was performed to evaluate the cost-effectiveness of vericiguat combined with standard treatment in the treatment of HFrEF. The output indicators included quality-adjusted life year （QALY） and incremental cost-effectiveness ratio （ICER）. The robustness of the results of the basic analysis was verified by one-way sensitivity analysis and probability sensitivity analysis. RESULTS The ICER of vericiguat combined with the standard treatment plan compared to the standard treatment plan alone was 444 341.95 yuan/QALY， which was more than WTP of this study （80 976 yuan/QALY）. One-way sensitivity analyses showed that the probability of cardiovascular death in both groups was the main influencing parameter for the robustness of the model， but they had little influence on the results of the basic analysis. The probabilistic sensitivity analysis displayed that under the WTP threshold of this study， the possibility of vericiguat combined with the standard treatment plan being more cost-effective was 2.6%. CONCLUSIONS Compared with the standard treatment plan， vericiguat combined with the standard treatment plan is not cost-effective in patients with HFrEF.

Pharmacoeconomic evaluation of sugemalimab consolidation therapy for stage Ⅲ non-small cell lung cancer / 中国药房

OBJECTIVE To evaluate the cost-effectiveness of sugemalimab in patients with stage Ⅲ non-small cell lung cancer （NSCLC） whose disease had not progressed after concurrent or sequential chemoradiotherapy from the perspective of the Chinese healthcare system. METHODS Based on the GEMSTONE-301 clinical trial，a three-health state partitioned survival model （PartSA） was developed to simulate the progression of disease，with model cycle of 3 weeks and a lifetime time range； the main output indicators of the model were total cost，quality-adjusted life year （QALY），and incremental cost-effectiveness ratio （ICER）； the cost and health output were discounted using 5% discount rate. Using 1-3 times China’s per capita gross domestic product （GDP） in 2022 as the willingness-to-pay （WTP） threshold，the cost-utility analysis method was used for analysis，and sensitivity analysis and scenario analysis were conducted to assess model robustness. RESULTS Compared with placebo，ICER for sugemalimab consolidation therapy was 59 872.57 yuan/QALY，which was less than one time China’s per capita GDP in 2022 （85 698 yuan） as the WTP threshold. The scenario analysis results further confirmed the robustness of the model. The results of single factor sensitivity analysis indicated that the cost of drugs （pembrolizumab，sugemalimab，docetaxel） and the utility value of disease progression status had a significant impact on ICER； the results of the probabilistic sensitivity analysis showed that sugemalimab had 67.2% probability of being cost-effective at one time China’s GDP per capita in 2022 as the WTP threshold； when 20 000 yuan （less than 3 times GDP per capita in China of 257 094 yuan） was used as the WTP threshold，the probability of sugemalimab consolidation therapy being cost-effective was greater than 98%. CONCLUSIONS The consolidation therapy with sugemalimab is cost-effective for stage Ⅲ NSCLC whose disease had not progressed after concurrent or sequential chemoradiotherapy.

Comprehensive Clinical Evaluation of Xueshuantong for Injection（Lyophilized） in Treatment of Acute Cerebral Infarction / 中国实验方剂学杂志

ObjectiveTo systematically review the existing studies on Xueshuantong for injection（lyophilized） in the treatment of acute cerebral infarction（ACI）， and to clarify the clinical value of Xueshuantong for injection（lyophilized） through comprehensive clinical evaluation， so as to promote clinical rational drug use and relevant policy transformation. MethodEvidence of Xueshuantong for injection（lyophilized） in terms of safety， effectiveness， economy， innovation， suitability， accessibility， traditional Chinese medicine（TCM） characteristics（6+1 dimensions） and information service was comprehensively collected. Evidence-based medicine， questionnaire survey， health technology assessment， pharmacoeconomic evaluation and other research methods were used， and the multi-criteria decision analysis model was used to measure each dimension， in order to comprehensively evaluate the clinical value of Xueshuantong for injection（lyophilized）. ResultSpontaneous reporting system， Meta-analysis of adverse reactions， and active safety monitoring study showed that the main adverse reactions of Xueshuantong for injection（lyophilized） were rash， pruritus， chest tightness， headache， dizziness and other general adverse reactions， the incidence of serious adverse reactions was judged to be rare， the known risk was small， the evidence was sufficient， and the safety evaluation was grade A. The results of Meta-analysis showed that Xueshuantong for injection（lyophilized） combined with conventional treatment for ACI was superior to conventional treatment in terms of improving neurological deficit score， improving daily activity score and clinical efficacy， and the effectiveness evaluation was grade B. The results of pharmacoeconomic evaluation showed that Xueshuantong for injection（lyophilized） combined with conventional treatment was relatively economic compared with conventional treatment alone， with the total clinical effective rate as the effect parameter， but the incremental effect was not significant， the economic evaluation was grade B. In addition to ACI and unstable angina of coronary heart disease， the drug also had good clinical efficacy in central retinal vein occlusion， and had a wider range of indications and awarded 16 patents， and its innovation evaluation was grade B. The suitability of medical personnel and patients was good without special technical and management requirements， and the suitability was evaluated as grade B. Xueshuantong for injection（lyophilized） had reasonable price， good affordability， certain prescription restrictions and general availability， the accessibility evaluation was grade B. Since the drug is an injection of effective parts of TCM， no grade evaluation of its TCM characteristics is conducted. The legal and non-legal information evaluation results of Xueshuantong for injection（lyophilized） showed that all the information was complete and in accordance with the requirements of national standards. Based on the grade scores of the 6 dimensions， the clinical comprehensive evaluation of Xueshuantong for injection（lyophilized） in the treatment of ACI was calculated as category B by CSC 2.0. ConclusionThe clinical value of Xueshuantong for injection（lyophilized） is good， and it is suggested that it can be directly translated into relevant policy outcomes for basic clinical medication management.

Study on cost-utility threshold based on the preference of population in Liaoning province / 中国药房

OBJECTIVE To study the cost-utility threshold （WTP/Q） based on the preference of the population in Liaoning province with willingness-to-pay（WTP） survey method， and to provide reference for decision-making. METHODS Using the method of questionnaire survey， quota sampling combined with snowball sampling were used to conduct telephone interviews with the general population in Liaoning province， collect data and analyze it. Probit regression combined with generalized linear model was used to analyze the relevant factors affecting WTP/Q. RESULTS A total of 755 general people were recruited. The WTP/Q of Liaoning population was 119 175 yuan，the average WTP/Q for improving the quality of life was 84 902 yuan， and the average WTP/Q for extending the survival period was 188 005 yuan. The analysis of influential factors showed that the older the age， the lower the probability of people purchasing medical interventions； the higher the education level and income， the greater the WTP/ Q； at the same time， the physical feelings of the interviewee， such as pain and depression， could also affect the WTP/Q results； compared with the scenario of improving quality of life， the WTP/Q for the extended survival period was higher. CONCLUSIONS The WTP/Q of Liaoning province based on the WTP survey method is about 2.07 times of the per capita gross domestic product of Liaoning province in the same period. The WTP/Q for extending survival period is about 2.21 times that of improving the quality of life. Therefore， interventions to improve quality of life and to extend the survival period need to be treated differently， in measurement or decision-making.

Quality assessment of pharmacoeconomic evaluation literature in China from 2018 to 2022 / 中国药房

OBJECTIVE To analyze existing problems of pharmacoeconomic evaluation research in China and to improve the standardization and scientificity of research， so as to provide more high-quality evidence for government decision-making. METHODS Retrieved from CNKI， Wanfang database， VIP， PubMed， Web of Science from 2018 to 2022， the literature related to pharmacoeconomic evaluation in China was collected； Excel 2016 software was used to extract the key information of the included literature which met inclusion criteria. The Quality of Health Economic Studies （QHES） scale was used to evaluate the quality of the included literature. RESULTS A total of 113 pieces of literature were included in this study， involving 85 pieces of Chinese literature and 28 pieces of English literature. The overall score of QHES included literature was 65.7， of which the average score of Chinese literature was 62.0 and English literature was 76.9. The median quality scores for the literature in 2018， 2019， 2020， 2021 and 2022 were 62.0， 70.5， 59.3， 71.0， and 73.0， respectively. Of these， 65 pieces of literature reported the research perspective； 36 reported the discount rate indistinctly； 25 provided unclear definitions of thresholds； and 53 used two sensitivity analysis methods. Among different items of the QHES scale， item 2 （research perspective）， item 8 （time range and discount rate）， item 14 （potential bias） and item 16 （sources of funding） had low percentage of scores. CONCLUSIONS From 2018 to 2022， pharmacoeconomic evaluation literature published by Chinese academics has generally shown a fluctuating upward trend in terms of quality， but there is still some room for improvement. The main problems in current pharmacoeconomics research in China include unclear understanding of the research perspective， single measurement of cost and health outcomes， unreasonable design of time horizon， indistinct description of the threshold or discount rate， and lack of sensitivity analysis.

Quality evaluation of the research literature on the pharmacoeconomics of traditional Chinese medicines in China from 2018 to 2022 / 中国药房

OBJECTIVE To evaluate the quality of research literature on pharmacoeconomics of traditional Chinese medicine （TCM） in China from 2018 to 2022， to understand the development status and problems of TCM pharmacoeconomic research in China， and to provide a reference for future standardized research on this field. METHODS The systematic search of relevant databases at home and abroad was conducted to obtain the published literature on TCM pharmacoeconomic research in China from January 1， 2018 to November 21， 2022 to summarize the basic information of the literature， the research profile， the method and content of pharmacoeconomic evaluation and to evaluate the quality of the literature by using the CHEERS 2022 checklist； calculate the total literature score by counting the scores of the specific entries of each piece of literature and classifying the quality of the literature as excellent， good， qualified， and unqualified. RESULTS A total of 71 studies were included， involving 60 in Chinese and 11 in English， and 53.52% of the literature was supported by grants； the most studied TCM dosage form was injection （31.03%）； less than half （46.48%） of the literature reported the study angle； short-term economic evaluation was predominantly used （69.01%）； the Chinese studies were dominated by cost-effectiveness analyses （70.00%）， and the English studies were dominated by cost-utility analysis （54.55%）. The average score of literature quality evaluation was 11.02， with two （2.82%） of the literature being of good quality， nine （12.68%） of the literature being of qualified quality， and the majority of the literature （84.51%） being of unqualified quality. The average score of Chinese literature was 9.98， and the average score of English literature was 16.73， with the quality of the latter being significantly better than that of the former. CONCLUSIONS At present， the pharmacoeconomic researches of TCM mainly has problems such as lack of scientific selection of intervention in the control group， nonstandard cost measurement， unreasonable selection of research time limit， quality of evidence for health output indicators to be improved， selection of evaluation methods to be improved， and lack of scientific basis for threshold selection. In order to support the implementation and development of high-level pharmacoeconomics research on TCM， policymakers need to create a favorable policy environment and formulate pharmacoeconomic evaluation guidelines that meet the characteristics of TCM， so as to promote the application and transformation of evaluation results.

Cost-effectiveness of regorafenib for hepatocellular carcinoma after failure of sorafenib / 中国药房

OBJECTIVE To evaluate the cost-effectiveness of regorafenib in the treatment of hepatocellular carcinoma after failure of sorafenib from the perspective of Chinese health system. METHODS Based on a phase Ⅲ trial（RESORCE）， the partition survival model （PSM） and Markov model were constructed. The cycle was set as four weeks， the duration of the study lasted for lifetime， the annual discount rate was 5%. Drug cost data was obtained from yaozhi.com， other cost data were obtained from Anhui Provincial Medical Insurance Bureau and related literature， and utility values were obtained from literature. The incremental cost-effectiveness ratio （ICER） was used as the evaluation index， and the value of willingness to pay （WTP） was three times of China’s gross domestic product （GDP） per capita in 2022； one-way sensitivity analysis and probabilistic sensitivity analysis were used to verify the robustness of the basic analysis results. RESULTS The incremental cost of regorafenib group versus placebo group in PSM and Markov model was 112 116.95 yuan and 96 617.19 yuan， respectively. The incremental effectiveness was 0.31 QALYs and 0.32 QALYs， respectively. The ICERs were 360 751.01 yuan/QALY and 301 114.45 yuan/QALY， which were both greater than the value of WTP； regorafenib was not cost-effective. Results of one-way sensitivity analysis showed that the utility of progression-free survival and progressive disease， the unit cost of regorafenib had the greatest influence on the results， but ICER was always greater than the WTP within the floating range of each parameter. Under the WTP of 3 times China’s per capita GDP in 2022， the probabilities of regorafenib with cost-effectiveness were 0.8% （PSM） and 11.4% （Markov）. CONCLUSIONS Under the WTP of 3 times the per capita GDP of China， regorafenib is not cost-effective in the treatment of hepatocellular carcinoma after failure of sorafenib treatment， compared with placebo.

Intervenções farmacêuticas em Unidade de Pronto Atendimento: uma análise farmacoterapêutica e farmacoeconômica / Pharmaceutical interventions in Emergency Care Unit: a pharmacotherapeutic and pharmacoeconomic analysis

Objetivo: Esclarecer o impacto farmacoterapêutico e farmacoeconômico das intervenções farmacêuticas em serviços de urgência e emergência. Métodos: Estudo de intervenção conduzido em uma Unidade de Pronto Atendimento. Os pacientes admitidos na pesquisa receberam acompanhamento farmacoterapêutico por meio de avaliação e intervenção na farmacoterapia. Resultados: Participaram do estudo 197 pacientes majoritariamente feminino, comórbidos, com média de idade de 43 anos ± 13. Foram realizadas intervenções em 130 destes, com aceitação de 83% por parte da equipe de assistência. As intervenções também repercutiram na farmacoeconomia, proporcionando uma redução de custos de 35% em comparação ao semestre anterior. Conclusão: Nossos resultados expressaram que a presença do farmacêutico clínico é essencial para farmacoterapias otimizadas e redução de custos hospitalares.

Objective: To clarify pharmaceutical interventions' pharmacotherapeutic and pharmacoeconomic impact on urgent and emergency services. Methods: Intervention study conducted in an Emergency Care Unit. Patients enrolled in the research received pharmacotherapeutic follow-up through evaluation and intervention in pharmacotherapy. Results: One hundred and ninety seven patients, mostly female, with comorbid conditions, with a mean age of 43 years ± 13, participated in the study. Interventions were performed in 130 of them, with an acceptance of 83% by the care team. The interventions also impacted pharmacoeconomics, providing a cost reduction of 35% compared to the previous semester. Conclusion: Our results expressed that the presence of the clinical pharmacist is essential for optimized pharmacotherapies and hospital cost reduction.

A vigilancia farmacológica no cenário brasileiro do sáculo 21 / Pharmacological surveillance in the Brazilian scenario of the 21st century / La vigilancia farmacológica en el escenario brasileño del siglo XXI

Resumo Os estudos em vigilancia farmacológica e ecofarmacológicas possibilitam o monitoramento, identificagao e minimi-zagao de efeitos nocivos advindos do uso de medicamentos. Diante disso, o presente estudo teve como objetivo descrever o cenário atual da farmacoepidemiologia e ecofarmacovigilancia no Brasil, no que se refere a produgao, registro, comerciali-zagao e uso de medicamentos. Foi realizado um levantamento sistemático, através dos bancos de dados PubMed/Medline, Lilacs e SciELO, cuja temática envolveu pesquisas em farmacoeconomia, farmacovigilancia, ecofarmacovigilancia e estudo da utilizagao de medicamentos no Brasil de 2001 a 2019. As publicagóes distribuíram-se de forma desigual entre as regióes brasileiras. Pacientes hipertensos, oncológicos e as gestantes foram os grupos de risco mais citados e os antimicrobianos, psicotrópicos e antineoplásicos os grupos farmacológicos mais discutidos. Custo de cuidados em saúde foi a temática mais abordada no contexto da farmacoeconomia e grande parte dos trabalhos destinou-se a análise e obtengao de dados referentes ao uso de medicamentos e suas reagóes adversas. Em relagao a ecofarmacovigilancia nao foram encontradas publicagóes no Brasil que contemplem essa área. Apesar dos avangos da legislagao farmacoepidemiológica e melhorias nos processos de fiscalizagao, no que tange a vigilancia da produgao, registro, comercializagao e uso de medicamentos, ainda permanecem carencias, quanto ao aporte de uma visao científica direcionada, sobretudo ao gerenciamento e diferentes usos dos recursos terapéuticos, e económicos do sistema de saúde brasileiro, bem como uma visao ambiental referente ao uso de medicamentos.

Abstract Studies in pharmacological and ecopharmacological surveillance make it possible to monitor, identify and minimize harmful effects arising from the use of drugs. Therefore, the present study aimed to describe the current scenario of pharmacoepidemiology and ecopharmacovigilance in Brazil, about the production, registration, marketing, and use of medicines. A systematic survey was carried out through the PubMed/Medline, Lilacs, and SciELO databases, whose theme involved research in pharmacoeconomics, pharmacovigilance, ecopharmacovigilance, and the study of drug use in Brazil from 2001 to 2019. Publications were unevenly distributed between Brazilian regions. Hypertensive patients, cancer patients, and pregnant women were the most cited risk groups, and antimicrobials, psychotropics, and antineoplastics were the most discussed pharmacological groups. Cost of health care was the most discussed topic in the context of pharmacoeconomics and most of the work was aimed at analyzing and obtaining data regarding the use of drugs and their adverse reactions. Regarding ecopharmacovigilance, no publications were found in Brazil covering this area. Despite advances in pharmacoepidemiological legislation and improvements in inspection processes, regarding the surveillance of the production, registration, commercialization, and use of medicines, there are still gaps regarding the contribution of a directed scientific vision, especially to the management and different uses of resources. therapeutic and economic aspects of the Brazilian health system, as well as an environmental vision regarding the use of medicines.

Resumen Los estudios de vigilancia farmacológica y ecofarmacológica permiten controlar, identificar y minimizar los efectos nocivos derivados del uso de los medicamentos. Ante esto, el presente estudio tuvo como objetivo describir el escenario actual de la farmacoepidemiología y la ecofarmacovigilancia en Brasil, en relación con la producción, el registro, la comercialización y el uso de los medicamentos. Se realizó una encuesta sistemática, a través de las bases de datos PubMed/Medline, Lilacs y SciELO, cuya temática involucró investigaciones sobre farmacoepidemiología, farmacovigilancia, ecofarmacovigilancia y estudio del uso de medicamentos en Brasil desde 2001 hasta 2019. Las publicaciones se distribuyeron de forma desigual entre las regiones brasileñas. Los pacientes hipertensos, los pacientes oncológicos y las mujeres embarazadas fueron los grupos de riesgo más citados y los antimicrobianos, los psicotrópicos y los antineoplásicos fueron los grupos farmacológicos más discutidos. El coste de la asistencia sanitaria fue el tema más abordado en el contexto de la farmacoeconomía y la mayoría de los trabajos estaban dirigidos a analizar y obtener datos sobre el uso de los medicamentos y sus reacciones adversas. En cuanto a la ecofarmacovigilancia, no se encontraron publicaciones en Brasil que aborden esta área. A pesar de los avances en la legislación farmacoepidemiológica y de las mejoras en los procesos de inspección, en lo que respecta a la vigilancia de la producción, registro, comercialización y uso de los medicamentos, todavía falta una visión científica dirigida, sobre todo, a la gestión y a los diferentes usos de los recursos terapéuticos y económicos del sistema de salud brasileño, así como una visión ambiental en cuanto al uso de los medicamentos.

Transição de via de linezolida endovenosa para via oral: uma análise de custo-minimização / Switching from intravenous to oral linezolid therapy: a cost-minimization analysis

Objetivo: Comparar custos da terapia endovenosa exclusiva com linezolida com os custos da terapia iniciada por via endovenosa com transição para via oral após 72 horas, como estratégia de intervenção em programas de gestão de antimicrobianos. Métodos: Avaliação econômica de custo-minimização comparando custos diretos da terapia endovenosa exclusiva com linezolida com a terapia endovenosa seguida de transição para via oral em cenário simulado, sob a perspectiva do Sistema Único de Saúde (SUS), com árvore de decisão como modelo para tomada de decisão. Resultados: A alternativa englobando a transição de via mostrou-se a mais econômica em todos os cenários analisados. Para 28 dias de tratamento com linezolida, houve redução de 22% nos custos, considerando o paciente internado. Ao considerar alta após o sexto dia de tratamento, a redução de custos variou de 26%, com financiamento pelo SUS do restante do tratamento, a 84%, com financiamento do tratamento pós-alta pelo paciente. Conclusão: Conclui-se que a transição de via de linezolida é uma importante estratégia nos programas de gerenciamento de antimicrobianos, capaz de gerar economia significativa para a instituição. As avaliações econômicas de custo-minimização, nesse contexto, são uma importante ferramenta para demonstrar o aspecto econômico com potencial para sensibilizar gestores e tomadores de decisão.

Objective: To compare the direct costs of linezolid intravenous therapy with the costs of intravenous therapy switching to oral therapy after 72 hours as an intervention strategy in antimicrobial stewardship programs. Methods: Economic evaluation cost-minimization comparing direct costs of exclusive linezolid intravenous therapy with intravenous therapy for 72 hours and after switching to oral therapy in a simulated scenario, from the perspective of the National Health Service, with a decision tree as a decision modeling. Results: The alternative encompassing the therapy transition proved to be the most economical in all analyzed scenarios. For 28 days of treatment with linezolid, there was a 22% reduction in costs, considering the hospitalized patient. When considering discharge after the sixth day of treatment, the cost reduction ranged from 26%, with funding from the National Health Service for the rest of the treatment, to 84%, with funding for the post-discharge treatment by the patient. Conclusion: It was concluded that the linezolid therapy transition is an important strategy in antimicrobial management programs, capable of generating significant savings for the institution. In this context, economic cost-minimization assessments are an important tool to demonstrate the economic aspect with the potential to raise awareness among managers and decision-makers.

Estudios farmacoeconómicos en Cuba en los últimos 20 años / Pharmacoeconomic studies in Cuba in the last 20 years

Introducción: Cuba es un país con desarrollo en el área biotecnológica y de medicamentos, donde los estudios farmacoeconómicos aportan evidencia significativa para la toma de decisiones, principalmente en la actualidad que el país se encuentra inmerso en la Tarea ordenamiento y a la vez es afectado por la pandemia del nuevo coronavirus. Objetivo: Caracterizar los estudios farmacoeconómicos en Cuba en los últimos 20 años. Métodos: Se realizó una investigación bibliométrica para la que se recuperó la producción científica cubana sobre farmacoeconomía en la base de datos Scopus del periodo 2001-2020. Se utilizaron indicadores bibliométricos para obtener número de documentos, años de publicación, fuentes, colaboración, tipo y patrones de colaboración institucional y de países, así como coocurrencia de palabras clave. Resultados: Se recuperaron 648 documentos. El año más productivo fue 2010. Los documentos se publicaron en 273 revistas, 17 (6,2 por ciento) cubanas y 256 (93,8 por ciento) extranjeras. Hubo 449 (69,3 por ciento) documentos en colaboración institucional y 199 (30,7 por ciento) sin colaboración. Las instituciones más productivas fueron Centro de Ingeniería Genética y Biotecnología 82 (12,7 por ciento) y Centro de Inmunología Molecular, 77 (11,9 por ciento). La red de colaboración entre países mostró tres áreas definidas, Latinoamérica, Norteamérica-Europa-India y España. Los temas más publicados fueron efectividad y seguridad de medicamentos, las vacunas y los relacionados con el cáncer. Conclusiones: Las publicaciones se caracterizaron por ser en colaboración, con ligero predominio de las nacionales sobre las internacionales. Es necesario ampliar la realización de evaluaciones económicas completas(AU)

Introduction: Cuba is a country with development in the biotechnology and medicines field, where pharmacoeconomic studies provide significant evidence for decision-making; mainly at present when the country is immersed in the Task of Ordering and at the same time is affected by the pandemic of the new coronavirus. Objective: Characterize pharmacoeconomic studies in Cuba in the last 20 years. Methods: A bibliometric research was carried out for which the Cuban scientific production on pharmacoeconomics was recovered in the Scopus database for the period 2001-2020. Bibliometric indicators were used to obtain the number of documents, years of publication, sources, collaboration, type and patterns of institutional and country collaboration, as well as co-occurrence of keywords. Results: 648 documents were retrieved. The most productive year was 2010. The documents were published in 273 journals, 17 (6.2percent) Cuban ones and 256 (93.8percent) foreign. There were 449 documents (69.3percent) in institutional collaboration and 199 (30.7percent) without collaboration. The most productive institutions were the Center for Genetic Engineering and Biotechnology with 82 (12.7percent) and the Center of Molecular Immunology, with 77 (11.9percent). The collaboration network between countries showed three defined areas: Latin America, North America-Europe-India and Spain. The most published topics were effectiveness and safety of drugs, vaccines, and those related to cancer. Conclusions: The publications were characterized by being collaborative, with a slight predominance of national over international ones. Comprehensive economic assessments need to be expanded(AU)

An Observational Study on Pharmacoeconomics and Prescription Pattern of Drugs Used in Diabetes Mellitus (Type II) in a Tertiary Care Hospital of Eastern India

Background : Diabetic patients need to consume multiple Vmedications at a time due to presence of Hyperglycemia, its pathophysiology and complications.In this context the compliance of the patient depends on the cost of therapy, The conduction of this study was faced with limitations like the COVID-19 pandemic. In spite of that, we have decided to conduct this challenging task by analyzing the pattern of prescriptions and comparing the prices of Anti-diabetic Drugs in our Tertiary Care Teaching Hospital. Objective : • To study the pattern of prescription writing in Type II Diabetes Mellitus and its association with the extent of control of the disease. • To analyze and compare the cost of different Anti-diabetic Drugs in Type II Diabetes Mellitus in a Tertiary Care Hospital. Material and Methods : This is an observational study of descriptive type. It is prospective in nature. All the demographic characteristics of the patient, disease profile, drug profile and prescription profile were included in the case report form. A photocopy of the patient’s Pharmacy Bill was collected from the indoor Pharmacy for analysis. Result : The mean number of anti-diabetic medications prescribed in Generic name was 3.0(±2.12) while the mean number of drugs prescribed in Brand name was 4.02(±1.99). The average number of prescribed injectable drugs was 0.11 (±0.31) with p- value=0.012 and the mean number of prescribed Fixed Dose Combinations (FDCs) was 0.16 (±0.42) with p-value=0.005. The total number of prescribed Anti-diabetic medications was higher in presently Hyperglycemic patients under Anti-diabetic Therapy compared to presently Normoglycemic patients under Anti-diabetic Therapy. A weak positive correlation was found between family income per capita and total cost of treatment. Conclusion: The total cost of treatment in presently Hyperglycemic patients under Anti-diabetic Therapy is relatively high due to prescription of more number of Anti-diabetic Medications. Metformin is the most common Anti-diabetic agent used in clinical practice and oral route of Drug Administration is mostly preferred in the OPD settings.

Cost analysis of drugs used for respiratory and gastrointestinal diseases – A pharmacoeconomic study

Background: Economic evaluation of pharmaceutical products is a must in developing countries like India as it helps in decision-making process and manufacture of cost-effective medicine. Pharmacoeconomic studies especially help lower socioeconomic for effective planning of their health budget. Very few studies comparing the cost-effectiveness of respiratory and gastrointestinal in our country; hence, this study was taken up to provide useful data. Aim and Objective: This study aims to evaluate existing price variations of different single used drugs under various brand names manufactured by different pharmaceutical industries in respiratory and gastrointestinal diseases. Materials and Methods: A retrospective observational study was conducted for a period of 1 year by reviewing the cost of maximum and minimum price of a particular brand, % variation in maximum and minimum price of drugs, and Jan Aushadhi for generic drugs. Results were calculated by proper statistical analysis. Results: Brand price variations were found significantly. Three drugs showed price variation of <100%, 15 drugs had price ranging from 100 to 1000%, and six drugs had price variation greater than 1000% when compared with generic brands. Conclusion: Regular checks by government authorities can ensure all brand prices within the range of patients financial resources. Commonly used drugs from essential drug list, pricing policy should be implemented by drug price control organization.