A regulatory governance perspective on Health Technology Assessment (HTA) in Sweden

Independent regulatory agencies (IRAs) for Health Technology Assessment (HTA) are a key means by which national governments have responded to the challenge of ensuring equitable public access to a new range of medicines and treatment options within the context of limited national budgets for healthcare. In this paper, we apply a regulatory governance frame to the study of the Swedish process for HTA. Based on qualitative interviews with key institutional stakeholders, we suggest that the major challenge for Swedish IRAs for HTA is successfully communicating nationally produced research outputs to the regional authorities responsible for the delivery of health services. We conclude that a regulatory governance approach to the analysis of national processes for HTA has the capacity to draw attention to a new range of challenges and issues which have direct relevance to improving the conduct of HTA within national regulatory spaces.     

Patient-based health technology assessment: a vision of the future

BACKGROUND: In conjunction with other important movements in contemporary medicine, including evidence-based medicine (EBM), health technology assessment (HTA) has promoted a culture of critical evaluation. Despite this impact, institutional and methodological challenges are associated with HTA. For example, only in recent years has HTA attempted an open dialogue with patients; however, this is normally done by giving them a "seat" at the HTA decision-making table, rather than by more scientific means. OBJECTIVES: The aim of this study was to develop a working definition of patient-based HTA, to identify the current barriers to adopting a patient-based model, and to formulate a vision of how a patient-based HTA could be used to promote patient empowerment and patient-centered care. RESULTS: In the ideal setting, a patient-based HTA would promote patient knowledge by providing access to information and promoting an informed dialogue between patients and their healthcare professionals. To implement a patient-based HTA, the focus must turn to the patient's issues and incorporate each patient's unique perspective and preferences. Processes must change to increase patient participation in all levels of HTA and aim to promote empowered patients who can make informed decisions. CONCLUSIONS: Present-day HTA is broad and has numerous stakeholders, with none so important as the patient. By asking patient-oriented questions in HTA and better involving patients throughout the entire process, we can easily promote patient empowerment, and as such make patients more capable to play a more active role in healthcare decision making.     

Health technology assessment in Denmark

The Danish healthcare services are mainly provided by public sector institutions. The system is highly decentralized. The state has little direct influence on the provision of healthcare services. State influence is exercised through legislation and budget allocations. The main task of the state is to initiate, coordinate, and advise. Counties, which run the hospitals, also decide on the placement of services. The hospital sector is controlled within the framework of legislation and global budgets. General practitioners occupy a central position in the Danish healthcare sector, acting as gatekeepers to the rest of the system. The system works well, and its structure has resulted in steady costs of health care for a long period. There is no regulatory mechanism in the Danish health services requiring use of health technology assessment (HTA) as a basis for policy decisions, planning, or administrative procedures. However, since the late 1970s a number of comprehensive assessments of health technology have formed the basis for national health policy decisions. In 1997, after years of public criticism of the quality of hospital care and health technologies, and on the basis of a previously developed national HTA strategy, a national institute for HTA (DIHTA) was established. There seems to be a growing awareness of evidence-based healthcare among health professionals and a general acceptance of health economic analyses as a basis for health policy decision making. This progress is coupled with growing regional HTA activity in the health services. HTA seems to have a bright future in Denmark.     

New model for prioritised adoption and use of hospital medicine in Denmark since 2017: Challenges and perspectives

Technological innovation creates new treatment opportunities, while also putting healthcare budgets under strain. To deal with the rising costs of hospital medicines, the regional governments in Denmark have developed a new model for prioritising the adoption and use of hospital medicine. Marking a shift from previous policies, the new model formalises the evaluation of clinical benefit, adds an assessment of treatment costs and ensures a relatively high degree of direct stakeholder involvement. In international comparison, the new model is ambitious in terms of stakeholder involvement and adherence with principles advocated to ensure procedural justice and fair decision-making processes. However, these procedural innovations have also created new challenges. Notably, the newly formed assessment body, the Danish Medicines Council, is faced with a very high caseload and limited options to prioritise the use of its analytical resources.     

Health technology assessment in The Netherlands

The Dutch healthcare system is not a single overall plan, but has evolved from a constantly changing mix of institutions, regulations, and responsibilities. The resulting system provides high-quality care with reasonable efficiency and equal distribution over the population. Every Dutch citizen is entitled to health care. Health insurance is provided by a mix of compulsory national insurance and public and private insurance schemes. Hospitals generally have a private legal basis but are heavily regulated. Supraregional planning of high-tech medical services is also regulated. Hospitals function under fixed, prospective budgets with regulation of capital investments. Independent general practitioners serve a gatekeeper role for specialist and hospital services and are paid by capitation or fee for service. Specialists are paid by fee for service. All physicians' fees are controlled by the Ministry of Economic Affairs. Coverage of benefits is an important method of controlling the cost of services. There is increasing concern about health care quality. Health technology assessment (HTA) has become increasingly visible during the last 15 years. A special national fund for HTA, set up in 1988, has led to many formal and informal changes. HTA has evolved from a research activity into policy research for improving health care on the national level. In 1993 the government stated formally that enhancing effectiveness in health care was one of its prime targets and that HTA would be a prime tool for this purpose. The most important current issue is coordination of HTA activities, which is now undertaken by a new platform representing the important actors in health care and HTA.     

Health technology assessment in Switzerland

Switzerland has a mixed public and private healthcare system. All citizens are enrolled in compulsory basic health insurance. A 1996 law allows people to choose among different sickness funds and managed care plans. The federal government is empowered to act on important health issues, but the 26 cantons have prime responsibility in health care and social welfare. They have their own laws on health care, hygiene, hospitals, and social welfare. These laws are not harmonized. The system is complex, with a mix of public (mainly hospitals) and private (mainly doctors' offices) providers. The health services are decentralized. Ambulatory care was traditionally provided in doctors' offices, but the last decade has seen the development of centers for day surgery, group practices, and managed care plans. Decisions on placement, location, and extension of services are decentralized. The payment system is very complex. Current trends include global budgets, cost analyses, and prices related to patient categories. However, coverage policy is developed centrally and includes both traditionally established services and new technologies. New technologies are added to the list only after evaluation by the Federal Coverage Committee. The coverage process integrates health technology assessment (HTA). Coverage can be granted in stages, including limited coverage and temporary coverage. Technologies and coverage can be reevaluated on the basis of registries or assessment information. The structure of the Swiss healthcare system does not lend itself to the establishment of a national HTA program. However, recent moves include the development of a coordinating mechanism for HTA in Switzerland.     

Impact of health technology assessment implementation with a special focus on middle-income countries

ObjectivesBuilding an efficient health technology assessment (HTA) system requires significant effort and political commitment, in addition to human and financial resources. Expectations of what HTA can offer to middle-income countries (MICs) are continuously rising, which drives health policymakers to raise the question of whether HTA could help secure the financial sustainability needed to implement universal health coverage. In this study, we explored the impact HTA adoption may have on the countries and its impact on health system objectives, as well as transferability of benefits and drawbacks observed in higher-income to middle-income countries.MethodsWe utilized secondary data from a systematic literature review and primary data by disseminating a survey among local stakeholders in three MICs across three continents to capture their perspective on the impact of HTA implementation from a local context.ResultsIt was evident from the results of both the literature review and survey that the positive impacts of HTA implementation outweigh the negative impacts. Most of the reviewed literature discussed the impact of HTA on the intermediate objectives of the health finance policy in relation to the broad health system goals. According to the survey respondents, the most evident benefit of HTA implementation is improving the transparency and accountability of healthcare decisions.ConclusionsOverall, HTA implementation can introduce a myriad of benefits to healthcare systems in MICs as well. Our findings show that while HTA implementation may have the potential to generate cost savings in specific areas, there is no guarantee that HTA can generate savings at the macro level.Public Interest SummaryHealth technologies (medicines, devices, and interventions) are rapidly increasing in complexity and cost. Health Technology Assessment (HTA) guides healthcare decision-makers in choosing the most suitable, effective, affordable, and acceptable health technology to invest limited healthcare resources. However, healthcare decision-makers in middle-income countries (MICS) are still uncertain about whether adopting HTA would help them achieve the financial sustainability needed to achieve universal health coverage.Thereforewe sought to gather evidence on how HTA has affected the health systems of countries that have already adopted it by reviewing published research reports. In addition, healthcare decision-makers from three MICs were questioned about their perception of how HTA implementation will affect their country's health system.Wefound that the positive effects of HTA implementation outweigh the negative ones; specifically, the transparency and accountability of decisions are improved. However, although HTA implementation may generate cost savings in specific areas, it may not significantly contribute to overall financial sustainability.     

Health technology assessment in Ireland

Ireland's health system is primarily funded from general taxation and is publicly provided, although private health care retains a considerable role. It is a unique structure, a mixture of universal health service free at the point of consumption and a fee-based private system where individuals subscribe to private health insurance that covers some of their medical expenses. The recent history of the Irish health services saw consolidation of existing services and an expansion into new areas to adapt to changing practices and needs. There has also been a drive to extract maximum efficiency so as to maintain the volume and quality of patient services at a time of very tight financial constraints. Introduction of new health technologies continued to accelerate. New technologies tended to spread rapidly before systematic appraisal of their costs and benefits. When the state is involved in funding the public hospital system, acceptance of new technology is a matter for discussion between agencies and the Department of Health and Children. Decisions about spending annual "development funding" have generally not been based on careful assessment of proposals for new technology. In 1995, a healthcare reform put new Public Health Departments in Health Boards in a prime position in Ireland's health services organization. These departments now emphasize evidence-based medicine. While Ireland does not have a national health technology assessment (HTA) program, there are plans to form an advisory group on HTA in 1998. HTA is seen as a significant element of future health policy in Ireland.     

Health technology assessment in Belgium

The Belgian healthcare system has a Bismarck-type compulsory health insurance, covering almost the entire population, combined with private provision of care. Providers are public health services, independent pharmacists, independent ambulatory care professionals, and hospitals and geriatric care facilities. Healthcare responsibilities are shared between the national Ministries of Public Health and Social Affairs, and the Dutch-, French-, and German-speaking Community Ministries of Health. The national ministries are responsible for sickness and disability insurance, financing, determination of accreditation criteria for hospitals and heavy medical care units, and construction of new hospitals. The six sickness and disability insurance funds are responsible for reimbursing health service benefits and paying disability benefits. The system's strength is that care is highly accessible and responsive to patients. However, the healthcare system's size remained relatively uncontrolled until recently, there is an excess supply of certain types of care, and there is a large number of small hospitals. The national government created a legal framework to modernize the insurance system to control budgetary deficits. Measures for reducing healthcare expenditures include regulating healthcare supply, healthcare evaluation, medical practice organization, and hospital budgets. The need to control healthcare facilities and quality of care in hospitals led to formal procedures for opening hospitals, acquiring expensive medical equipment, and developing highly specialized services. Reforms in payment and regulation are being considered. Health technology assessment (HTA) has played little part in the reforms so far. Belgium has no formal national program for HTA. The future of HTA in Belgium depends on a changing perception by providers and policy makers that health care needs a stronger scientific base.     

Challenges of Health Technology Assessment in Pluralistic Healthcare Systems: An ISPOR Council Report

Health technology assessment (HTA) has been growing in use over the past 40 years, especially in its impact on decisions regarding the reimbursement, adoption, and use of new drugs, devices, and procedures. In countries or jurisdictions with “pluralistic” healthcare systems, there are multiple payers or sectors, each of which could potentially benefit from HTA. Nevertheless, a single HTA, conducted centrally, may not meet the needs of these different actors, who may have different budgets, current standards of care, populations to serve, or decision-making processes.This article reports on the research conducted by an ISPOR Health Technology Assessment Council Working Group established to examine the specific challenges of conducting and using HTA in countries with pluralistic healthcare systems. The Group used its own knowledge and expertise, supplemented by a narrative literature review and survey of US payers, to identify existing challenges and any initiatives taken to address them. We recommend that countries with pluralistic healthcare systems establish a national focus for HTA, develop a uniform set of HTA methods guidelines, ensure that HTAs are produced in a timely fashion, facilitate the use of HTA in the local setting, and develop a framework to encourage transparency in HTA. These efforts can be enhanced by the development of good practice guidance from ISPOR or similar groups and increased training to facilitate local use of HTA.     

The role of health technology assessment on pharmaceutical reimbursement in selected middle-income countries

ObjectiveMiddle-income countries are often referred to as developing or emerging economies and face multiple challenges of severe financial stresses in their health care sectors, and high disease burden. The objective of this study is to provide an overview of how health technology assessment (HTA) is used and organized in selected middle-income countries and its role in the process of pharmaceutical coverage.MethodsWe selected middle-income countries where HTA activities are evident: Argentina, Brazil, China, Colombia, Israel, Mexico, Philippines, Korea, Taiwan, Thailand, and Turkey. We collected and reviewed relevant information to describe the health care and reimbursement systems and how HTA relates to coverage decision-making of pharmaceuticals. This was supplemented by information from a structured survey among professionals working in public and private health insurance, industry, regulatory authorities, ministries of health, academic units or HTA.ResultsAll countries require market authorization for pharmaceuticals to be sold and most countries have a national plan defining which pharmaceuticals can be reimbursed. However, the use of HTA in reimbursement decisions is still in its early stages with varying levels of HTA guidance implementation.ConclusionsThe study provides evidence of the development of HTA in coverage decision-making in middle-income countries. Increased health care spending and the resulting access to modern technology give a strong impetus to HTA. However, HTA is developing with uneven speed in middle-income countries and many countries are building on the organisational and methodological experience from established HTA agencies.     

Assessing the impact of health technology assessment in The Netherlands

OBJECTIVES: Investments in health research should lead to improvements in health and health care. This is also the remit of the main HTA program in the Netherlands. The aims of this study were to assess whether the results of this program have led to such improvements and to analyze how best to assess the impact from health research. METHODS: We assessed the impact of individual HTA projects by adapting the "payback framework" developed in the United Kingdom. We conducted dossier reviews and sent a survey to principal investigators of forty-three projects awarded between 2000 and 2003. We then provided an overview of documented output and outcome that was assessed by ten HTA experts using a scoring method. Finally, we conducted five case studies using information from additional dossier review and semistructured key informant interviews. RESULTS: The findings confirm that the payback framework is a useful approach to assess the impact of HTA projects. We identified over 101 peer reviewed papers, more than twenty-five PhDs, citations of research in guidelines (six projects), and implementation of new treatment strategies (eleven projects). The case studies provided greater depth and understanding about the levels of impact that arise and why and how they have been achieved. CONCLUSIONS: It is generally too early to determine whether the HTA program led to actual changes in healthcare policy and practice. However, the results can be used as a baseline measurement for future evaluation and can help funding organizations or HTA agencies consider how to assess impact, possibly routinely. This, in turn, could help inform research strategies and justify expenditure for health research.     

Reported Challenges in Health Technology Assessment of Complex Health Technologies

ObjectivesWith complex health technologies entering the market, methods for health technology assessment (HTA) may require changes. This study aimed to identify challenges in HTA of complex health technologies.MethodsA survey was sent to European HTA organizations participating in European Network for HTA (EUnetHTA). The survey contained open questions and used predefined potentially complex health technologies and 7 case studies to identify types of complex health technologies and challenges faced during HTA. The survey was validated, tested for reliability by an expert panel, and pilot tested before dissemination.ResultsA total of 22 HTA organizations completed the survey (67%). Advanced therapeutic medicinal products (ATMPs) and histology-independent therapies were considered most challenging based on the predefined complex health technologies and case studies. For the case studies, more than half of the reported challenges were “methodological,” equal in relative effectiveness assessments as in cost-effectiveness assessments. Through the open questions, we found that most of these challenges actually rooted in data unavailability. Data were reported as “absent,” “insufficient,” “immature,” or “low quality” by 18 of 20 organizations (90%), in particular data on quality of life. Policy and organizational challenges and challenges because of societal or political pressure were reported by 8 (40%) and 4 organizations (20%), respectively. Modeling issues were reported least often (n = 2, 4%).ConclusionsMost challenges in HTA of complex health technologies root in data insufficiencies rather than in the complexity of health technologies itself. As the number of complex technologies grows, the urgency for new methods and policies to guide HTA decision making increases.     

价值重塑下的我国卫生技术评估发展与展望

基于价值的医疗服务供给是世界范围内的热点议题。通过系统梳理价值医疗内涵,分析价值重塑下我国卫生技术评估面临的挑战,提出建立科学的HTA运作机制,加强HTA筹资及服务购买机制建设,制定HTA方法指南、加强HTA相关数据库建设等建议,旨在为我国卫生事业高质量发展提供参考。     

Health Technology Assessment (HTA), evidenzbasierte Medizin (EbM) Alter Wein in neuen Schläuchen?

Health Technology Assessment (HTA) defines the systematic analysis of short and long-term consequences of the application of medical technologies with the aim of supporting decisions in policy-making and practice. The aim of directly supporting decision-making at a political level is the major difference to evidence-based medicine and guideline development. In Germany, HTA is being established only since the nineties. In this period, however, important steps for a permanent establishment of HTA in the German health service have been undertaken. One of these steps was the German HTA project, which was funded from 1995 to 2001 by the Federal Ministry of Health. Beginning in 2001, this initiative will be relaunched by the German Institute for Medical Documentation and Information (DIMDI) as a regular HTA program. The bodies managing the German health care system rely increasingly on HTA reports when deciding on coverage of health technologies. HTA thus proves to be an instrument, which could be of benefit in the optimisation of the health care system.     

Advancing primary care to promote equitable health: implications for China

China is a country with vast regional differences and uneven economic development, which have led to widening gaps between the rich and poor in terms of access to healthcare, quality of care, and health outcomes. China's healthcare reform efforts must be tailored to the needs and resources of each region and community. Building and strengthening primary care within the Chinese health care system is one way to effectively address health challenges. This paper begins by outlining the concept of primary care, including key definitions and measurements. Next, results from a number of studies will demonstrate that primary care characteristics are associated with savings in medical costs, improvements in health outcomes and reductions in health disparities. This paper concludes with recommendations for China on successfully incorporating a primary care model into its national health policy, including bolstering the primary care workforce, addressing medical financing structures, recognizing the importance of evidence-based medicine, and looking to case studies from countries that have successfully implemented health reform.     

Health technology assessment in its local contexts: studies of telehealthcare

Health technology assessment (HTA) is one of the major research enterprises of late modernity, reaching into fields of previously autonomous professional practice, and critically interrogating the organisation and delivery of health care. The 'evaluation' of new health technologies within the field of HTA is increasingly a normative political expectation, as discourses of 'evidence-based' practice run through health policy in the UK and elsewhere. Despite its importance in governing the direction of innovation in health care delivery, there are hardly any empirical studies of HTA in practice. In this paper, we draw on two ethnographic studies of telehealthcare implementation and evaluation in the UK to explore the practical conduct of HTA, and we focus specifically on the social organisation and conduct of randomised controlled trials of these new technologies. The paper examines how evaluation forms a mediating set of practices that make the embedding or normalisation of a new technology possible; and present a simple model of the social and technical contingencies within the evaluation process.     

Evaluation of new medicines in Spain and comparison with other European countries

ObjectiveTo compare the use of health technology assessment (HTA) as a tool to support pricing and reimbursement (P&R) of new medicines in Spain with England, Sweden, France and Germany.MethodFor each country, the literature is used to identify the purpose and timing of the P&R decision, the HTA and decision-making procedures used to generate evidence, and the criteria used to make decisions.ResultsResults are presented as a summary of the HTA landscape for P&R of new medicines in each country. Comparisons are made between Spain and other countries regarding the procedure and implementation of HTA.ConclusionsBased on these assessments, we made recommendations for how HTA might develop in Spain with the aim of improving governance and efficiency. Spain has made considerable progress in recent years, but still falls short of international standards in terms of independence of the HTA agencies and decision-making committees from political influence and industrial policy, the setting of prices of medicines in relation to health gain, improve the transparency of the process and results of the evaluation, and promote the participation of stakeholders. In common with other countries, Spain needs to clarify the role of cost-effectiveness criteria. Further progress needs to be made to coordinate effort across the various agencies, strengthen technical staff, and ensure equitable access to medicines between regions.