ABSTRACT
This study systematically sorted out the existing studies about Tianshu Capsules in the treatment of migraine(syndrome of blood stasis blocking collaterals, syndrome of ascendant hyperactivity of liver Yang), and conducted comprehensive clinical evaluation through "6+1" dimensions of safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine(TCM) to embody the advantages and characteristics and clarify the precise clinical position of Tianshu Capsules. The value of each dimension was calculated via health technology assessment, the multi-criteria decision analysis(MCDA) mo-del and CSC v2.0 software. The results were graded into four levels of A, B, C, or D from high to low. According to the available studies, Tianshu Capsules had low and controllable risks, with the safety rated as A. The drug has obvious clinical significance in the treatment of migraine(syndrome of blood stasis blocking collaterals, syndrome of ascendant hyperactivity of liver Yang), with the effectiveness rated as A. It has clear economic results, with the economy rated as B. The clinical innovation, service system innovation, and industrial innovation are all good, and thus the innovation of Tianshu Capsules is grade A. The drug can meet clinical medication demand of medical care and patients, and thus its suitability is grade A. In view of the reasonable drug price, affordability, and availability, the accessibility is grade A. The prescription originated from the Daxiong Pills recorded in the classic Comprehensive Recording of Sage-like Benefit. In clinical trials, 4 675 patients have used Tianshu Capsules, which indicates rich experience in human administration, and the characteristics of traditional Chinese medicine is grade B. The statutory drug information complies with national stan-dards, and the non-statutory information is standard and accurate. Based on the comprehensive evaluation results of various dimensions of evidence, the clinical value of Tianshu Capsules in the treatment of migraine(syndrome of blood stasis blocking collaterals and syndrome of ascendant hyperactivity of liver Yang) is class A. According to the Comprehensive Clinical Evaluation Management Guidelines of Drugs(trial version 2021) issued by the National Health Commission of the People's Republic of China, we recommend that Tianshu Capsules treating migraine can be transformed into relevant policy results for clinical medication management according to procedures.
Subject(s)
Humans , Capsules , Liver , Medicine, Chinese Traditional , Migraine Disorders/drug therapy , SyndromeABSTRACT
Evidence and value：impact on DEcisionMaking （EVIDEM） framework was developed by EVIDEM collaboration. Its core is the combination of multiple criteria decision analysis （MCDA） model and standardized health technology assessment （HTA） report， which aims to evaluate the overall value of medical interventions. It has been tested and implemented in the real-world evaluation environments. After more than 10 years of development， EVIDEM framework has been updated to version 10， and the relevant operation manuals have been published. More than 40 countries have joined the collaboration and more than 20 countries have carried out relevant studies. The framework is constructed with patients， population and sustainability as the overall goals， combing the evidence and value， forming a relatively complete decision-making framework system composed of 2 levels， 7 dimensions and 20 criteria. The two levels include normative universal criteria and contextual criteria. The normative universal criteria， namely EVIDEM core model， is the quantitative evaluation， consisting of 5 dimensions and 13 criteria. Contextual criteria， namely contextual tools， are qualitative evaluation， consisting of 2 dimensions and 7 criteria. The specific operation steps of EVIDEM framework include selecting and constructing criteria， assigning weights， integrating and evaluating evidence， quantitative and qualitative evaluation of value， comprehensive value estimation and ranking based on value estimation. EVIDEM framework is applicable to disease diagnosis， treatment， management and other fields. Its application scope includes medical insurance reimbursement， clinical practice decision-making， drug selection and so on， which can provide a method for more systematic， transparent and scientific healthcare decision-making. At present， the framework has been introduced into the field of traditional Chinese medicine and can provide a scientific and feasible evaluation tool and methodology system for the clinical comprehensive evaluation of Chinese patent medicine.
ABSTRACT
Objetivo: A incorporação de tecnologias em saúde por hospitais afeta o desempenho financeiro e assistencial do sistema de saúde de todo um país, e faltam informações na literatura sobre a aplicação de Avaliação de Tecnologias em Saúde (ATS) em hospitais no Brasil. Adicionalmente, há indícios de que a aplicação de ATS em hospitais pode melhorar o uso dos investimentos financeiros de todo o setor de saúde. O objetivo deste trabalho foi analisar a aplicação dos métodos de ATS na tomada de decisão em hospitais vinculados à Rebrats (Rede Brasileira de Avaliação de Tecnologias em Saúde). Métodos: Optou-se por utilizar o método da Grounded Theory, ou Teoria Fundamentada nos Dados, e os dados foram analisados com o uso do software ATLAS.ti. Foram realizadas entrevistas com gestores de 11 Núcleos de ATS (NATS), baseadas em roteiro semiestruturado preparado a partir dos 15 princípios orientadores para boas práticas de ATS em hospitais. Resultados: Os resultados indicaram que a ATS é aplicada de maneira incipiente no processo de tomada de decisão em hospitais. Conclusão: A análise do conteúdo das entrevistas permitiu, ainda, concluir que o sucesso dos NATS para a incorporação e desincorporação de tecnologias em saúde depende de uma cadeia de ações estratégicas relacionadas, e a falta de qualquer uma das etapas enfraquece, ou mesmo inviabiliza, a plena aplicação da ATS para a tomada de decisões em hospitais.
Objective: The incorporation of health technologies by hospitals affects the financial and healthcare performance of the health system of a whole country, and there is a lack in literature about the use of Health Technology Assessment (HTA) for decision making in Brazilian's hospitals. In addition, there is evidence that the application of HTA in hospitals can improve the use of financial investments of the whole health sector. The objective of this study was to analyze the application of HTA methods in decision making in hospitals linked to REBRATS (Brazilian Network for the Health Technologies Assessment). Methods: Grounded Theory methodology has been applied, and the interviews data were analyzed using the ATLAS.ti software. Interviews were conducted with managers of 11 hospital-based HTA units (called "NATS", Núcleo de Avaliação de Tecnologias em Saúde), based on a semi- -structured script prepared from the 15 guiding principles for good practices in hospital-based HTA units. Results: The results indicated that HTA is applied in an incipient way in the decision making process in hospitals. Conclusion: The analysis of the interviews' content also allowed us to conclude that the success of the hospital-based HTA units for the incorporation and disincorporation of health technologies depends on a chain of related strategic actions, and the lack of any of the stages weakens or even impedes the full application of HTA for decision-making in hospitals.
Subject(s)
Humans , Technology Assessment, Biomedical , Decision Making , HospitalsABSTRACT
There are about 7000 kinds of rare diseases in the world;the estimated number of patients with rare diseases is 4.3% of the world population and it is therefore a serious public health issue. For rare diseases, two questions are critical: (1)research and development for innovative treatments/medicines(orphan drugs);(2)access to launched orphan drugs in terms of availability and affordability. Many countries, including China, have paid significant attentions to the first question in terms of the regulatory review policy and financial incentive. As to the second question, there is a great difference in access to orphan drugs in different countries and regions due to many factors, including the different medical care systems and high drug expenses. Recently, health technology assessment(HTA)has played an important role in evaluating clinical and economic value of innovative medicines, including orphan drugs. This paper discusses how to do HTA evaluation on orphan drugs in China with several policy suggestions.
ABSTRACT
Rare diseases are usually defined as diseases with a low incidence in the population. According to re-ports, there were 6084 rare diseases found worldwide in 2016, involving 3715 related genes. 80% of rare diseases are caused by heredity, dominant or recessive inheritance or mutations. The definition of rare diseases by”incidence”in the population varies from country to country, like the EU <1/2000 and the United States <1/2500. A drug used to prevent, treat, or diagnose a rare disease is called an orphan drug. Due to the difficulty of research and development in this small target population, the high investment risk and the high R&D cost, the problem associated with high price of orphan drugs is very prominent. In the cost-effectiveness evaluation, the resulting incremental cost-effectiveness ratio(ICER)is likely to exceed the willingness to pay threshold adopted by most countries and regions, resulting in multiple countries raising its willingness to pay threshold reference standard(3-25 times GDP per capital)for orphan drugs, or simply ex-empting health technology assessment(HTA)assessment for orphan drugs and only evaluating the impact on medical in-surance fund. This paper systematically reviewed the various internationally accepted orphan drug HTA assessment meth-odologies. Based on the characteristics of rare diseases, the paper discusses the establishment of a model for the evalua-tion of orphan drugs and the multi-dimensional value assessment framework for HTA. At the same time, according to the internationally accepted norm, the paper also explores the way to determine the willingness to pay threshold in HTA as-sessment for orphan drugs in China.
ABSTRACT
Through literature review and theoretical analysis,an initial scale was designed with five dimensions namely"evidence influence","organizational support","channel connectivity","communication and collabora-tion"and"decision-makers impetus". The reliability and validity of the scale were evaluated through questionnaire survey on HTA researchers. It is reported that the overall Cronbach's α coefficient of the questionnaire was 0.904, meanwhile the Cronbach's α coefficient of each dimension was more than 0.80 except the dimension of"decision-makers impetus". The average variance extraction of each dimension was more than 0.50. The maximum of correla-tion coefficients between each dimension was 0.571,which was less than the threshold value of 0.85. Additionally, for certain dimensions,the standardized correlation coefficients to each other dimensions was less than regarding arith-metic square root of average variance extraction.
ABSTRACT
Decision makers at the national and local level of health systems require evidence of effectiveness, safety and costs of health technologies for resource allocation. In this sense Health Technology Assessment (HTA) is a favorable tool considering it is a multidisciplinary process to evaluate the benefits as well as the social, economic, organizational and ethical issues of a health technology. The aim of this study was to review the literature in order to identify the attributes used in the process of technology acquisition. It was analyzed the attributes of HTA with the purpose of classifying them, to see which are the most recommended for acquisition in hospitals. The identified literature indicated that not only the clinical and economic attributes were considered, but also attributes related to the context of the hospital such as the effect of technology on other hospital services and others associated with the organization.
Los tomadores de decisiones a nivel nacional y local de los sistemas de salud requieren evidencia de la efectividad, seguridad y costos de las tecnologías de la salud para la asignación de recursos. En este sentido, la Evaluación de la Tecnología de la Salud (HTA, por sus siglas en inglés) es una herramienta favorable considerando que es un proceso multidisciplinario para evaluar los beneficios, así como las cuestiones sociales, económicas, organizativas y éticas de una tecnología de la salud. El objetivo de este estudio fue revisar la literatura con el fin de identificar los atributos utilizados en el proceso de adquisición de tecnología. Se analizaron los atributos de HTA con el fin de clasificarlos, para ver cuáles son los más recomendados para adquisición en hospitales. La literatura identificada indicó que no sólo se consideraron los atributos clínicos y económicos, sino también atributos relacionados con el contexto del hospital como el efecto de la tecnología en otros servicios hospitalarios y otros asociados con la organización.
Os tomadores de decisões a nível nacional e local dos sistemas de saúde requerem evidência da efetividade, segurança e custos das tecnologias de saúde para a atribuição de recursos. Neste sentido, a Avaliação da Tecnologia da Saúde (HTA) é uma ferramenta favorável considerando que é um processo multidisciplinar para avaliar os benefícios, bem como as questões sociais, económicas, organizativas e éticas de uma tecnologia da saúde. O objetivo deste estudo foi revisar a literatura com o fim de identificar os atributos utilizados no processo de aquisição de tecnologia. Analisaram-se os atributos de HTA com o fim de classificá-los, para ver quais são os mais recomendados para aquisição em Hospitais. A literatura identificada indicou que não só se consideraram os atributos clínicos e económicos, assim como também alguns atributos relacionados com o contexto do hospital como o efeito da tecnologia em outros serviços hospitalários e outros associados com a organização.
ABSTRACT
The paper takes literature in the Health Technology Assessment (HTA) field in Web of Science and " China Academic Journal Network Publishing Database" as its study subject,draws scientific knowledge map with EXCEL,CiteSpace on data like high-frequency keywords and burst terms and analyzes study hotspots and evolution trend.It suggests that HTA theoretical system be perfected,study be converted into demonstration and study cooperation be strengthened to promote study and development of China's HTA.
ABSTRACT
The private health-care system in India is effective but expensive. Due to the absence of a comprehensive and well-penetrated insurance scheme that caters to the majority of the Indian population, most of the private health care consultations are out-of-pocket (OOP), and this is pushing many people to poverty. In this article, we describe the concept of health technology assessment (HTA), and review its possible role in improving the health-care system in India. We additionally comment on its present status and possible role of its implementation in the Indian context.