Health technology assessment in traditional and complementary medicine: a scoping review of international activity and examples of acupuncture.

BACKGROUND: Traditional therapies are crucial in maintaining and improving human well-being. China's healthcare policymakers are attempting to use health technology assessment (HTA) as a decision-making supportive tool. The value assessment framework for Chinese patent medicine (CPM) has been developed and is being adopted and validated widely by research institutions. Subsequently, the healthcare decision-makers particularly hanker for the value framework of traditional non-pharmacological therapies. METHODS: To construct a practical value framework for traditional non-pharmacological therapies, a scoping review methodology was adopted to identify the evaluation domains and obstacles. A search, screening, and analysis process was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). Evidence was retrieved from scientific databases and HTA agencies' websites. RESULTS: The search strategy identified 5 guidelines records and 17 acupuncture HTA reports. By synthesizing the valuable reports of CPM and acupuncture evaluation in representative countries, this study found that Mainland China was promoting the comprehensive value assessment of CPM, whereas the United Kingdom, Singapore, Canada, the United States, and Malaysia had carried out the HTA evaluation of acupuncture for various conditions among which chronic pain was the most common. UK and Singapore applied the HTA results to support acupuncture reimbursement decisions. Three domains, including safety, effectiveness, and economy, were commonly adopted. The identified biggest challenge of evaluating traditional non-pharmacological therapies is the scarce high-quality clinical evidence. CONCLUSIONS: This study identified value domains and issues of traditional therapies, and pointed out future research implications, to promote the development value framework of traditional therapies.

Expertise, experience, and excellence. Twenty years of patient involvement in health technology assessment at NICE: an evolving story.

From its inception in 1999, the National Institute for Health and Care Excellence (NICE) committed to including the expertise, experiences, and perspectives of lay people, patients and carers, and patient organizations in its health technology assessments (HTAs). This is our story of patient involvement in HTA: from early methods designed for use when assessing medicines, widening to address the different requirements of HTAs for interventional procedures, medical technologies, and diagnostic technologies. We also chart the evolution and development of all our patient involvement methods over the past 20 years through regular evaluation and by responding to external challenge. However, we know that processes and methods alone are not enough. Through case studies we demonstrate the value of patient involvement in HTA and highlight the unique perspectives and experiences that patients bring to HTA committees. Finally, we discuss the underpinning principles and commitments that have made NICE a world leader in delivering meaningful and legitimate patient involvement.

Demonstrating the influence of HTA: INAHTA member stories of HTA impact.

A central function of health technology assessment (HTA) agencies is the production of HTA reports to support evidence-informed policy and decision making. HTA agencies are interested in understanding the mechanisms of HTA impact, which can be understood as the influence or impact of HTA report findings on decision making at various levels of the health system. The members of the International Network of Agencies for HTA (INAHTA) meet at their annual Congress where impact story sharing is one important activity. This paper summarizes four stories of HTA impact that were finalists for the David Hailey Award for Best Impact Story.The methods to measure impact include: document review; claims analysis and review of reimbursement status; citation analysis; qualitative evaluation of stakeholders' views; and review of media response. HTA agency staff also observed changes in government activities and priorities based on the HTA. Impact assessment can provide information to improve the HTA process, for example, the value of patient and clinician engagement in the HTA process to better define the assessment question and literature reviews in a more holistic and balanced way.HTA reports produced by publicly funded HTA agencies are valued by health systems around the globe as they support decision making regarding the appropriate use, pricing, reimbursement, and disinvestment of health technologies. HTAs can also have a positive impact on information sharing between different levels of government and across stakeholder groups. These stories show how HTA can have a significant impact, irrespective of the health system and health technology being assessed.

Community engagement in Health Technology Assessment and beyond: from guests in the process to hosts.

In Health Technology Assessment (HTA), clinical and economic evidence are assessed in the regulatory and reimbursement environments, with community input considered as complementary to this. Stakeholders are calling for more meaningful community engagement, but this will not be reached without a significant shift. The Centre for Community-Driven Research (CCDR) is a nonprofit organization bringing much needed change to the way we think about community engagement in health. This article is based on CCDR's experience and outlines three system changes needed to advance community engagement in decisions about health and HTA. This paper comes from the perspective of engaging everyday people in the process as opposed to representation on panels and committees. The three key areas of change that are discussed include building holistic evidence, creating supportive environments, and infrastructure for community engagement, with the term community referring to people affected by disease or health conditions and their carers/families.

Integrating Formal Technology Assessment into an Integrated Healthcare Delivery System: Smart Innovation.

OBJECTIVES: We designed, developed, and implemented a new hospital-based health technology assessment (HB-HTA) program called Smart Innovation. Smart Innovation is a decision framework that reviews and makes technology adoption decisions. Smart Innovation was meant to replace the fragmented and complex process of procurement and adoption decisions at our institution. Because use of new medical technologies accounts for approximately 50 percent of the growth in healthcare spending, hospitals and integrated delivery systems are working to develop better processes and methods to sharpen their approach to adoption and management of high cost medical innovations. METHODS: The program has streamlined the decision-making process and added a robust evidence review for new medical technologies, aiming to balance efficiency with rigorous evidence standards. To promote system-wide adoption, the program engaged a broad representation of leaders, physicians, and administrators to gain support. RESULTS: To date, Smart Innovation has conducted eleven HB-HTAs and made clinician-led adoption decisions that have resulted in over $5 million dollars in cost avoidance. These are comprised of five laboratory tests, three software-assisted systems, two surgical devices, and one capital purchase. CONCLUSIONS: Smart Innovation has achieved cost savings, avoided uncertain or low-value technologies, and assisted in the implementation of new technologies that have strong evidence. The keys to its success have been the program's collaborative and efficient decision-making systems, partnerships with clinicians, executive support, and proactive role with vendors.

Role of Culture, Values, and Politics in the Implementation of Health Technology Assessment in India: A Commentary.

India is a diverse land with different cultures, social norms, castes, religions, faiths, languages, politics, and a complex healthcare system. As a step to enhance healthcare, the government of India announced a move toward universal health coverage to increase accessibility and affordability of health-related services. Recently, there has been an introduction of health technology assessment (HTA) in India to help inform evidence-based decision making in cases of limited resources and budgets. Nevertheless, there are challenges related to biased decision making, an unregulated healthcare framework, and the lack of data and capacity that will (directly or indirectly) affect the use of HTA in India. For HTA to be successful in India and in similar low- and middle-income countries, it is important that the decision makers acknowledge these challenges and embrace differences in ideologies, cultures, and politics instead of ignoring them. Drawing lessons from countries with well-developed HTA bodies may help, but these need to be modified for the country-specific context. Ensuring quality and transparency is key to building trust in medical decision making. Improved coordination at all levels of healthcare is vital to ensure the long-term success of HTA in India. This is challenging but achievable by spreading awareness among stakeholders and achieving moderate health-sector regulation that can combat corruption. HTA will prosper in India if it incorporates cultural and institutional diversity, alongside tackling socioeconomic inequalities.

Exploring the Application of Cost-Effectiveness Evaluation in the Japanese National Health Insurance System.

OBJECTIVES: Advances in health care due to the development and introduction of new drugs and medical devices have brought considerable benefits to people and patients in terms of upgraded quality of life and extended years of survival. However, some are concerned that the very advancement of health care would increase further the inflation of national healthcare costs. In response to these concerns, Japan's Central Social Insurance Medical Council ("Chuikyo") began in 2012 to examine how cost-effectiveness evaluation might be applied to the national health insurance system, and has been working toward establishing a system for its usage. METHODS: Cost-effectiveness evaluation was adopted on a trial basis in fiscal year (FY) 2016, targeting seven drugs and six medical devices. Analyses and re-analyses were performed by manufacturers and a public expert organization, respectively. Based on these analyses, a cost-effectiveness evaluation expert organization conducted an overall assessment ("appraisal"). Results of the evaluation were used to adjust the prices of the target items. RESULTS: Following the trial adoption of cost-effectiveness evaluation, price adjustments were performed for three items in April 2018. Meanwhile, a decision was also made to examine seven items for which technical requirements were identified due to differences in the understanding of analysis methods between involved parties. CONCLUSIONS: The Chuikyo will examine how to meet the newly identified technical requirements and discuss specific details with regard to establishing a system that incorporates cost-effectiveness evaluation. The Chuikyo plans to reach a conclusion by the end of FY 2018.

Outcomes and Impacts of 10-Year HTA Implementation in Taiwan.

OBJECTIVES: In 2007, Taiwan began conducting health technology assessments (HTA) to support the National Health Insurance Administration (NHIA) in its reimbursement decisions for drugs, medical devices, and medical services. METHODS: In this study, the development, missions, and procedures of the implementation of HTA in Taiwan are briefly introduced. Moreover, the value of HTA is examined by reviewing the outcomes and impacts of recent HTA-related research projects, which are classified into five categories: (i) pharmaceutical products, (ii) medical procedures, (iii) medical devices, (iv) health policy, and (v) social care. RESULTS: Overall, the 10-year implementation of HTA has not only supported the government's decision making but also enhanced patient care. Furthermore, patient evidence has been highlighted, and patient care pathways have been transformed through patient involvement in HTA. CONCLUSIONS: In conclusion, HTA's value has been determined by both government and social aspects in Taiwan.

ENVIRONMENTAL IMPACT ASSESSMENT OF A HEALTH TECHNOLOGY: A SCOPING REVIEW.

INTRODUCTION: The Health Technology Expert Review Panel is an advisory body to Canadian Agency for Drugs and Technologies in Health (CADTH) that develops recommendations on health technology assessments (HTAs) for nondrug health technologies using a deliberative framework. The framework spans several domains, including the environmental impact of the health technology(ies). Our research objective was to identify articles on frameworks, methods or case studies on the environmental impact assessment of health technologies. METHODS: A literature search in major databases and a focused gray literature search were conducted. The main search concepts were HTA and environmental impact/sustainability. Eligible articles were those that described a conceptual framework or methods used to conduct an environmental assessment of health technologies, and case studies on the application of an environmental assessment. RESULTS: From the 1,710 citations identified, thirteen publications were included. Two articles presented a framework to incorporate environmental assessment in HTAs. Other approaches described weight of evidence practices and comprehensive and integrated environmental impact assessments. Central themes derived include transparency and repeatability, integration of components in a framework or of evidence into a single outcome, data availability to ensure the accuracy of findings, and familiarity with the approach used. CONCLUSIONS: Each framework and methods presented have different foci related to the ecosystem, health economics, or engineering practices. Their descriptions suggested transparency, repeatability, and the integration of components or of evidence into a single outcome as their main strengths. Our review is an initial step of a larger initiative by CADTH to develop the methods and processes to address the environmental impact question in an HTA.

INTEGRATE-HTA: A LOW- AND MIDDLE-INCOME COUNTRY PERSPECTIVE.

OBJECTIVES: The INTEGRATE-HTA project recommends that complexity be taken into account when conducting health technology assessments (HTAs) and suggests a five-step process for doing that. This study examines whether the approach suggested by INTEGRATE-HTA could be useful, appropriate, and feasible in the context of low- and middle-income countries (LMIC) given some of the typical challenges that healthcare systems face in those countries. METHODS: A nonexhaustive literature review was performed on the implementation in low and middle income countries of the five aspects recommended by the INTEGRATE-HTA project, using the following search terms: national health planning, health sector strategy, health sector performance, assessment criteria, health (management) information, complexity, context, stakeholder consultation. RESULTS: HTA is being practiced in LMIC in various ways and through different mechanisms, for example in health sector reviews, even though it is usually not referred to as HTA. It does not necessarily follow the five steps distinguished in the INTEGRATE-HTA model (scoping; defining the initial logic model; providing concepts and methods to identify, collect, and synthesize evidence in relation to various dimensions; extracting and presenting evidence in respect of agreed assessment criteria; providing guidance to draw conclusions and formulate recommendations). CONCLUSIONS: The conditions for functional HTA are not always fulfilled in LMICs. At least four aspects would require special attention: (a) the scope and quality of routine health information that can support and be fed into health technology assessments and strategic planning; (b) consensus on health system performance assessment frameworks and their main criteria, in particular the inclusion of social disparities/equity and sustainability;

HEALTH TECHNOLOGY ASSESSMENT IN SERBIA.

OBJECTIVES: This study provides an overview of the Republic of Serbia healthcare system and describes the process of developing and conducting health technology assessment (HTA). METHODS: The authors performed pragmatic, nonsystematic literature review based on available statistical data, legislation, and studies. RESULTS: Healthcare law creates conditions that allow implementation of the principle "value for money." The institutions directly vested in the implementation of HTA are the National Health Insurance Fund (NHIF) and the Ministry of Health (MoH). There are some reflections of the efforts by NHIF and MoH toward achieving this goal. CONCLUSIONS: Despite the highly set objectives, there is still a lot of work to be done to build an adequate model to support decision-making processes to bridge the discrepancies between broadly defined rights to health care and limited resources in the country.

Building inclusive health innovation systems: lessons from India.

This article presents an overview of the changes that are taking place within the public and private health innovation systems in India including delivery of medical care, pharmaceutical products, medical devices, and Indian traditional medicine. The nature of the flaws that exist in the health innovation system is pinpointed. The response by the government, the health, technology and medical institutions, and the evolving industry is addressed on a national level. The article also discusses how the alignment of policies and institutions was developed within the scope of national health innovation systems, and how the government and the industry are dealing with the challenges to integrate health system, industry, and social policy development processes. Resumo: O artigo apresenta um panorama das mudanças atualmente em curso dentro dos sistemas público e privado de inovação em saúde na Índia, incluindo a prestação de serviços médicos, produtos farmacêuticos, dispositivos médicos e medicina tradicional indiana. É destacada a natureza das falhas que existem nos sistemas de inovação em saúde. As respostas do governo, das instituições médicas, de saúde e tecnologia e indústrias envolvidas, são abordadas em nível nacional. O artigo também discute como foi desenvolvido o alinhamento de políticas e instituições no escopo dos sistemas nacionais de inovação em saúde, e como governo e indústria estão lidando com os desafios para integrar o sistema de saúde, a indústria e o desenvolvimento de políticas sociais.

Building inclusive health innovation systems: lessons from India / Creación de sistemas inclusivos de innovación en salud: lecciones desde la India / A criação de sistemas inclusivos de inovação em saúde: lições da Índia

Abstract: This article presents an overview of the changes that are taking place within the public and private health innovation systems in India including delivery of medical care, pharmaceutical products, medical devices, and Indian traditional medicine. The nature of the flaws that exist in the health innovation system is pinpointed. The response by the government, the health, technology and medical institutions, and the evolving industry is addressed on a national level. The article also discusses how the alignment of policies and institutions was developed within the scope of national health innovation systems, and how the government and the industry are dealing with the challenges to integrate health system, industry, and social policy development processes.

Resumen: El artículo presenta el panorama de los cambios actualmente en curso dentro de los sistemas públicos y privados de innovación en salud en la India, incluyendo la prestación de servicios médicos, productos farmacéuticos, dispositivos médicos y medicina tradicional india. Se destaca la naturaleza de las carencias que existen en los sistemas de innovación en salud. Los autores abordan la respuesta existente, a nivel nacional, por parte del gobierno, instituciones médicas y de salud y tecnología, y por la industria en este proceso de evolución. El artículo también discute cómo se desarrolló la alineación de políticas e instituciones en el alcance de los sistemas nacionales de innovación en salud, y cómo el gobierno, así como la industria, están enfrentando los desafíos que se presentan, con el fin de integrar sistema de salud, industria y desarrollo de políticas sociales.

Resumo: O artigo apresenta um panorama das mudanças atualmente em curso dentro dos sistemas público e privado de inovação em saúde na Índia, incluindo a prestação de serviços médicos, produtos farmacêuticos, dispositivos médicos e medicina tradicional indiana. É destacada a natureza das falhas que existem nos sistemas de inovação em saúde. As respostas do governo, das instituições médicas, de saúde e tecnologia e indústrias envolvidas, são abordadas em nível nacional. O artigo também discute como foi desenvolvido o alinhamento de políticas e instituições no escopo dos sistemas nacionais de inovação em saúde, e como governo e indústria estão lidando com os desafios para integrar o sistema de saúde, a indústria e o desenvolvimento de políticas sociais.

[Health technology assessment agencies in the xxi century]. / Las agencias de evaluación de tecnología médica en el siglo xxi.

The origins of the health technology assessment (HTA) agencies date back to the 70s in the United States; in the European context, the current Agency for Quality and Health Assessment of Catalonia was among the pioneers in 1991. Epidemiological, social, technological and economic changes of recent years have led to the incorporation, by the agencies, of new functions, activities and projects that can offer better services (information and knowledge) to the various players in the healthcare system (patients, professionals, providers, insurers and policy-makers) in order to increase healthcare quality and preserve the sustainability of the health system.

FRAMEWORK FOR USER INVOLVEMENT IN HEALTH TECHNOLOGY ASSESSMENT AT THE LOCAL LEVEL: VIEWS OF HEALTH MANAGERS, USER REPRESENTATIVES, AND CLINICIANS.

OBJECTIVES: The aim of this study was to explore stakeholders' points of views regarding the applicability and relevance of a framework for user involvement in health technology assessment (HTA) at the local level. We tested this framework in the context of the assessment of alternative measures to restraint and seclusion among hospitalized adults and those living in long-term-care facilities. METHODS: Twenty stakeholders (health managers, user representatives, and clinicians) from seven regions of Quebec participated in a semi-structured interview. A thematic analysis of the transcribed interviews was performed. RESULTS: The findings highlighted the relevance and applicability of the framework to this specific HTA. According to interviewees, direct participation of users in the HTA process allows them to be part of the decision-making process. User consultation makes it possible to consider the views of a wide variety of people, such as marginalized and vulnerable groups, who do not necessarily meet the requirements for participating in HTA committees. However, some user representatives emphasized that user consultation should be integrated into a more holistic and participatory perspective. The most frequent barrier associated with user involvement in HTA was the top-down health system, which takes little account of the user's perspective. CONCLUSIONS: The proposed framework was seen as a reference tool for making practitioners and health managers aware of the different mechanisms of user involvement in HTA and providing a structured way to classify and describe strategies. However, there is a need for more concrete instruments to guide practice and support decision making on specific strategies for user involvement in HTA at the local level.

Assessment and non-clinical impact of medical devices.

Medical devices (MDs) cover a wide variety of products. They accompany changes in medical practice in step with technology innovations. Innovations in the field of MDs can improve the conditions of use of health technology and/or modify the organisation of care beyond the strict diagnostic or therapeutic benefit for the patients. However, these non purely clinical criteria seem to be only rarely documented or taken into account in the assessment of MDs during reimbursement decisions at national level or for formulary listing by hospitals even though multidimensional models for the assessment of health technologies have been developed that take into account the views of all stakeholders in the healthcare system In this article, after summarising the background concerning the assessment of health technologies in France, a definition of non-clinical criteria for the assessment of MDs is proposed and a decision tree for the assessment of MDs is described. Future lines of approach are proposed as a conclusion.

Medicina de sistemas: una nueva visión de la práctica clínica / Systems Medicine: A New Approach to Clinical Practice

La gran mayoría de las enfermedades respiratorias son consideradas patologías complejas puesto que su susceptibilidad o desenlace están influidos por la interacción entre factores dependientes del huésped (genéticos, comorbilidad, edad, etc.) y del ambiente (exposición a microorganismos y alérgenos, tratamiento administrado, etc.).El enfoque reduccionista ha sido muy importante para la comprensión de los diversos componentes de un sistema. La biología o medicina de sistemas es una aproximación complementaria cuyo objetivo es el análisis de las interacciones entre los componentes dentro de un nivel de organización (genoma, transcriptoma, proteoma) y posteriormente entre los distintos niveles. Las actuales aplicaciones de la medicina de sistemas incluyen la interpretación de la patogénesis y fisiopatología de las enfermedades, el descubrimiento de biomarcadores, el diseño de nuevas estrategias terapéuticas y la elaboración de modelos computacionales para los distintos procesos biológicos. En la presente revisión se exponen las principales nociones sobre la teoría que subyace a la medicina de sistemas así como sus aplicaciones en algunos procesos biológicos del ser humano

Most respiratory diseases are considered complex diseases as their susceptibility and outcomes are determined by the interaction between host-dependent factors (genetic factors, comorbidities, etc.) and environmental factors (exposure to microorganisms or allergens, treatments received, etc.).The reductionist approach in the study of diseases has been of fundamental importance for the understanding of the different components of a system. Systems biology or systems medicine is a complementary approach aimed at analyzing the interactions between the different components within one organizational level (genome, transcriptome, proteome), and then between the different levels. Systems medicine is currently used for the interpretation and understanding of the pathogenesis and pathophysiology of different diseases, biomarker discovery, design of innovative therapeutic targets, and the drawing up of computational models for different biological processes. In this review we discuss the most relevant concepts of the theory underlying systems medicine, as well as its applications in the various biological processes in humans

[The role of the scientific librarian in HTA:what is the status quo and what are the prospects]. / Il ruolo del bibliotecario scientifico nell'Health Technology Assessment: quale lo stato di fatto e quali le prospettive?

The first Italian experiences of HTA are born inside single hospitals and, lately, regional health care systems. In Italy, anyway, no agency had health technology assessment as an institutional duty until 2007, the year of the founding of the Italian Society of Health Technology Assessment (SIHTA). In times of "spending review", the HTA, whose purpose is to make decisions about health technologies rational and consistent with a context of scarce resources, is increasingly emerging as a priority need of the National Health System. The objective of this paper is to analyze if and how the librarian is involved in the process of health technology assessment, analyzing the results of a survey performed at a selection of Italian research organizations. The analysis of the results shows that the Italian situation is still very varied, from the point of view of HTA, and health technologies are often introduced without any preliminary analysis. The librarian is almost never represented within the HTA evaluation group and his/her knowledge of HTA should be improved.

Value-based approaches to healthcare systems and pharmacoeconomics requirements in Asia: South Korea, Taiwan, Thailand and Japan.

Asian healthcare systems are very diverse, representing cultures, political systems and economies from more than 30 countries with varying histories. Despite the diversity in the region, there has been enormous growth in health economics and outcomes research since the beginning of the 21st century. Whilst Japan has seen very limited use of health technology assessment (HTA), South Korea, Taiwan and Thailand have had remarkable success in establishing government agencies for HTA, employing HTA concepts from the UK National Institute for Health and Clinical Excellence (NICE). These three countries are driven by the following common factors: (i) a desire to establish universal healthcare insurance coverage in their respective nations; (ii) the need for rational allocation of scarce resources; (iii) a desire for government to provide leadership in HTA; and (iv) availability of HTA professionals and faculties through international networks. The HTA models introduced by these three countries are both similar to and different from those of HTA agencies in Europe, but might work well as examples for other countries in the region.