Health Technology Assessment System Research Articles

Right to Health Litigation in Brazil: The Problem and the Institutional Responses: Figure 1.

This article first analyses how courts, by applying the right to health as a trump against rationing decisions, have become a relevant healthcare policymaker in Brazil. Based on empirical findings, it argues that right to health litigation makes the Brazilian public health system less fair and efficient. It then discusses three responses to the negative impact of litigation on the health system: the public hearing held by the Supreme Federal Court and the test established thereafter; the recommendations by the National Council of Justice aimed at building courts’ institutional capacity; and Federal Law 12.401/11, which created a new health technology assessment system. Based on a comparative institutional analysis, it concludes that the latter response is the most adequate because it keeps the substantial decisions on the allocation of healthcare resources in the institution that has better capacity to make them and facilitates the judicial control of procedure.

Health technology assessment in Switzerland: a descriptive analysis of “Coverage with Evidence Development” decisions from 1996 to 2013

ObjectivesTo identify factors associated with the decisions of the Federal Department of Home Affairs concerning coverage with evidence development (CED) for contested novel medical technologies in Switzerland.DesignQuantitative, retrospective, descriptive analysis...

Health technology assessment in the Balkans: opportunities for a balanced drug assessment system

Countries in the Balkan region use pharmaco-economic data for decisions about the inclusion of new pharmaceuticals into their positive drug lists, but no predefined frameworks are used and resources for health technology assessment (HTA) are limited. The goal of this analysis is to investigate into possible development directions for the HTA system in the region, and provide some practical recommendations for a sustainable model. For this purpose, the main factors currently influencing HTA in Balkan countries are briefly presented, and possible development strategies are compared. A resource-saving balanced assessment approach is proposed. It is aligned with available resources and capabilities, and helps access to new pharmaceuticals while ensuring the transparency of decision-making processes and the stability of the pharmaceutical budget.

Economic Evaluation In Portugal – Establishment of The National Health Technology Assessment System (Sinats)

Economics is a social science that has a focus on allocating limited resources efficiently. In health care is essential to invest properly, assuring access to health technologies with the best cost-effective profile, ensuring the sustainability of National Health Systems. In Portugal, the INFARMED – National Authority of Medicines and Health Products I. P., has been making economic evaluations of medicines for 15 years, and is currently developing the National Health Technology Assessment System – SiNATS, of the utmost importance to the National Health System. Nowadays the assessment of the technologies (relative effectiveness assessment and cost-effectiveness) is focused on medicines, within the reimbursement process and the preliminary assessment to its acquisition by the National Health System’s Hospitals. Consequently, it is always done before the reimbursement decision, as a supporting tool to the decision itself. The purpose of this model is to guarantee a global system, and at the same time, extending it to new technologies besides medicines, e. g. medical devices. In these cases, the cost-effectiveness evaluation will be done through the whole life-cycle of that technology, affecting its price and use considering its real performance; instead of only its market entry. The INFARMED, by developing SiNATS, intends to contribute to minimize expenditures in health and the citizens' life quality, in order to assure the National Health System’s sustainability and efficient usage of public resources in health. Moreover, this system also aims to observe the technologies’ effectiveness and its usage, with the purpose of reducing wastes as well as to promote and award innovation and equal access to health technologies. This research intends to verify the applicability of the universal key principles of Health Technology Assessment Systems in SiNATS, in order to guarantee that the model achieves its proposing Objectives. The study will be focused on the structure of system.

The current status and future direction of Korean health technology assessment system

원회의 의견으로 확인하였다. 당시에는 의료기술을 과학적 Health technology assessment was first introduced to the Republic of Korea in 2006 by amending the Medical Services Act. The Committee of New Health Technology Assessment (CNHTA) is the ministerial committee that has the responsibility of reviewing the safety and effectiveness of new health technology. CNHTA review plays a gatekeeping role for new health technology in Korea, which can increase the burden on patients in Korea, either by out-of pocket payments or co-pays for National Health Insurance covered service. This kind of gatekeeping is a function of the healthcare system in many countries where no financial cap such as a fixed budget or diagnosis-related group payment is applied. However, it has been argued that gatekeeping works against industrial promotion policy. The one-stop service introduced in 2014 is a system similar to US parallel review between the US Food and Drug Administration and Centers for Medicare and Medicaid Services. This service provides a simultaneous process of regulatory review by the Ministry of Food and Drug Safety, identification of existing technology by the Health Insurance Review and Assessment Services, and new health technology assessment by the National Evidence-based Healthcare Collaborating Agency and the Ministry of Health and Welfare. This service is expected to reduce the total review process by 3 to12 months. A limited health technology appointment service was introduced in April 2014. This service designates orphan health technologies and health technologies for rare and incurable diseases and supports evidence development at designated hospitals. Several countries have similar systems: US Coverage with Evidence Development, Canadian Conditionally Funded Field Evaluation, UK Only in Research, and many others. The future direction of Health technology assessment should focus on the life cycle management of health technology. A consistent, continuous, and transformative mechanism to manage from the research and development of health technology to delisting obsolete technology to make room for new innovative technology is warranted.

KEY ASPECTS REGARDING THE INTRODUCTION OF HEALTH TECHNOLOGY ASSESSMENT IN ROMANIA

Regarding Health Technology Assessment (HTA) represents a form of policy research which considers the short and long term consequences of health technologies. The first steps towards HTA were taken in Romania more than 15 years ago, but the effects seem insignificant even though they have never been measured. After 2011 HTA re-entered on the Romanian health care reforms’ agenda and it started the design of the legal framework in order to develop the HTA system. The scope of this article is to briefly present some key principles and aspects which could represent the fundamentals of a quick development of HTA in the following years. This article is not meant to present an evaluation of the HTA steps which have been done so far. In order to develop a HTA system there is a need for the involvement of key policy making stakeholders who have to express their willingness and demand for the usage of data generated by the HTA system for the decision-making process. Also, there is a need of resources (human, financial, organisational) and for capacity-building of institutions who will offer the ground to develop the HTA. In Romania, the willingness to develop the HTA system is expressed in the health policies (specifically in the Government Program for 2013-2016), but there is still a lot to do in terms of designing the legal framework and the development of required institutions for an HTA system. In this context, there are four key aspects which could facilitate the introduction and functioning of the HTA in Romania, grouped under the „Four P” (Partnership, Pragmatism, Predictability and Praise), aspects detailed in the context of Romanian health care system. The application of these „Four P” has to be coupled with the health policies in order to integrate the HTA system with the continuous reform of the health services: public financing, basic package, evaluation of quality etc. And to all these aspects there is a need to associate change champions, leaders who believe in HTA and who could become pioneers and development catalysts of HTA in Romania if they get support from the political environment. Keywords: HTA - Health Technology Assessment, health policy, health reform, resources allocation.

Courts as Healthcare Policy-Makers: The Problem, the Responses to the Problem and Problems in the Responses

This article starts by analysing healthcare litigation in Brazil by means of a literature review of articles that contribute with empirical findings on this phenomenon. Based on this review, I argue that health care litigation in Brazil makes the public health system less fair and rational. In the second part of this article, I discuss the three most overarching responses to control the level of litigation and its impact on the public health system: (i) the public hearing held by the Supreme Federal Court and the criteria the court established thereafter; (ii) the recommendations by the National Council of Justice aimed at building courts’ institutional capacity; and (iii) the enactment of the Federal Law 12.401/11, which created a new health technology assessment system. I argue that latter is the best response because it keeps the substantive decisions on the allocation of healthcare resources in the institution that is in the best position to make them. Moreover, this legislation will make the decisions about provision of health treatments more explicit, making easier for courts to control the procedure and the reasons for these decisions.

PHP78 Similar HTA, Different Access Outcome? Comparison of Orphan Oncology Drug Assessment in South Korea, Australia and the UK

In general, demonstrating cost-effectiveness for orphan drugs including orphan oncology agents is challenging. Reasons include high incremental cost per QALY and insufficient clinical evidence. Even in an established Health Technology Assessment (HTA) system such as the UK, orphan oncology agents are often rejected as they are not cost-effective. In Asia-Pacific, South Korea and Australia employ a similar HTA system. HTA recommendations between the countries, however, are not always comparable. This research aims to understand the drivers for positive recommendations and implications for improved patient access to oncology treatments. Review HTA recommendations in UK, Australia and South Korea for sunitinib, dasatinib, lenalidomide, imatinib and rituximab. Compare and contrast prices, level of clinical evidence and reimbursed patient populations in the context of the specific assessment criteria in each country. Identify drivers for positive recommendations. Of the selected drugs, more have received positive recommendations in South Korea and Australia than UK. A drug that receives a positive recommendation is usually priced lower in South Korea than Australia or the UK. Between Australia and UK, Australia tends to reimburse at a lower price. The level of clinical evidence has less impact on evaluations in South Korea. In the UK, if NICE recommends an orphan oncology drug, usually a patient access scheme is included. While pricing is not dictated by NICE in the UK, access remains highly regulated. Manufacturers often need to set up patient access schemes in order to prove their orphan oncology drugs cost-effective and optimize patient access. On the other hand, in South Korea, the HTA process is less defined and more driven by minimizing costs. While cost-effectiveness is the main driver for a positive recommendation, formal price negotiation processes in South Korea and Australia lead to access more consistently.

Interview: Health technology assessment in Asia: an emerging trend

Bong-min Yang, PhD (in economics), is Professor and former Dean of the School of Public Health at the Seoul National University, South Korea. Professor Yang has led research and written many papers in health economics and healthcare systems in Korea and Asia. His recent research and publications focus on the field of economic evaluation and outcomes research. He played a key role in the introduction of a formal health technology assessment system within Korean healthcare. He is currently serving as Executive Director, Institute of Health and Environment, Seoul National University. In addition to his research and publications, Professor Yang is Associate Editor for Journal of Comparative Effectiveness Research, is co-editor-in-chief for Value in Health Regional Issues, and is currently chair of the Management Advisory Board of Value in Health and a member of the editorial board of the Journal of Medical Economics. He has been a policy consultant to China, Japan, Indonesia, Hong Kong, Malaysia, Taiwan, Thailand and India. He has also worked as a short-term consultant at the WHO, ADB, UNDP and the World Bank. For the Korean government, he served as Chairperson of the Health Insurance Reform Committee, and Chairperson of the Drug Pricing and Reimbursement Committee. He is currently serving as Chair of the International Society of Pharmacoeconomics and Outcomes Research-Asia Consortium, and a member of the Board of Directors of the International Society of Pharmacoeconomics and Outcomes Research.

Systematic review for new health technology assessment

We used a systematic review to evaluate the safety and effectiveness of a new health technology in Korea. The results of the systematic review are being used by the Health Insurance Review and Assessment Service when the Ministry of Health and Welfare introduces new medical technology. The purpose of this study is to introduce this systematic review, which is the main methodology for evaluating the safety and effectiveness of new medical technology, and to share our experience of performing a systematic review to guide the reader in performing a systematic literature review accurately and easily. This paper presents the process of new health technology evaluation using a systematic review. A systematic review involves collecting current available evidence of health technology systematically. According to the evaluation process, in the first meeting of sub-committee, we develop a systematic review protocol including PICO and criteria for inclusion/exclusion. In the second meeting of sub-committee, we search comprehensively for appropriate literature according to the clinical question and to select in a clear and reproducible method. We also assess study quality, considering the internal validity and external validity of the selected literature, and make a table of extracted data. In the third meeting of sub-committee, we extract general information, study characteristics information, and study outcome information, and synthesize the outcomes. In the forth meeting of sub-committee, we finalize the conclusions based on synthesizing the studies. After the subcommittees' assessments, the results are presented to the Committee for New Health Technology. Finally, we report this result to the Ministry of Health and Welfare. The systematic review is useful for helping policymakers make decisions about the introduction of new health technology based on evidence. It enables people to minimize confusion due to weak evidence for health technology. In case of domestically developed technology and technology for rare disease, it is difficult assess health technology due to a lack of evidence, so assessing raw data (charts, results of clinical trials) is needed in addition to a systematic review. Furthermore, the government should support clinical studies to develop evidence on new health technologies with potential benefit, and the introduction of a conditional coverage decision in the new health technology assessment system is necessary to deal with uncertainty.

Australia reviews its health technology assessment system, changes recommended

Australia reviews its health technology assessment system, changes recommended

Comparison of 3 systems for assigning priority to patients on waiting lists for cataract extraction

Objective: As the demand for cataract surgery grows, patients in some health care systems are assigned to a waiting list. Several explicit priority tools have been developed. We compared 3 of these: the IRYSS-Cataract Priority Score (ICPS), Catalan Agency for Health Technology Assessment and Research cataract priority system (CCPS), and Western Canada Waiting List project for cataract surgery (WCWL). Design: Prospective cohort study. Participants: A total of 1723 consecutive patients awaiting cataract surgery at 5 hospitals. Methods: The ICPS, CCPS, and WCWL were applied to these patients after the collection of data. The 3 prioritization systems were compared using correlation methods, 95% limits of agreement, and the kappa coefficient. Results: Means and standard deviations for the different prioritization systems were 60.9 (22.2) for the ICPS, 35.7 (20.4) forthe CCPS, and 25.7 (21.5) forthe WCWL. Pearson's correlation coefficients were 0.56 between the ICPS and the CCPS, 0.62 between the WCWL and CCPS, and 0.71 between the ICPS and WCWL. The kappa value among them ranged from 0.13 to 0.40, and the intraclass correlation coefficients ranged from 0.31 to 0.55. Conclusions: These 3 prioritization tools showed acceptable correlations but assigned significantly different point scores to similar scenarios. This may have consequences when using these tools for managing a waiting list for cataract extraction.

Potential for 2 priority systems to be used as appropriateness of indication tools for cataract surgery

Objective: To test 2 systems developed to prioritize patients on waiting lists for cataract surgery, the Western Canadian Waiting List (WCWL), and the Catalan Agency for Health Technology Assessment and Research Cataract Priority System (CCPS), as tools for judging the appropriateness of the intervention. Design: Cross-sectional study with follow-up. Participants: A total of 1723 prospective patients awaiting cataract extraction in 5 hospitals were included in the study. Methods: Priority scores using the WCWL and the CCPS systems were calculated and compared with visual acuity (VA) and visual function, measured by the Visual Function-14 index, before and after surgery. The sensitivity of each priority system to different groups was evaluated using a validated appropriateness of indications tool for cataract extraction. One-way analysis of variance and the Jonckheere-Terpstra test were used to detect differences in group scores. Spearman correlation coefficients were also examined. Results: The WCWL and CCPS systems produced different mean values according to the preoperative levels of VA and visual function ( p < 0.0001). Neither system showed a significant difference in mean scores based on gains in VA and visual function. Both systems produced different mean scores according to the different groups of appropriateness set by the appropriateness of indications tool for cataract ( p < 0.0001). Conclusions: Given that appropriateness tools should correlate with outcomes, we recommend using neither the WCWL nor the CCPS for appropriateness purposes. Incorporating new criteria into these systems may improve the correlation with important outcomes and their adequacy for use as appropriateness tools.

Role of health technology assessment in shaping the benefits package in The Netherlands

In many countries of the Western world, the role of health technology assessment (HTA) in funding decisions of medical technologies is increasing. HTAs are expected to support decision-makers in delineating the collectively funded benefits package. To maximize their potential, it is essential that assessments are valid, reliable and timely, and that it is transparent how information provided in assessments is used in decision-making. Against this background, this article aims to review the current state of affairs regarding the use of HTA in the area of medical specialist care in The Netherlands and to evaluate strengths and weaknesses of the HTA-based system for priority setting. The reason to do so was the introduction of a new hospital financing system in The Netherlands, which allowed for expansion of the HTA system that already existed for pharmaceuticals to medical specialist care. A comprehensive account of the HTA system for medical specialist care was created using the so-called Hutton framework, followed by an exploration of its strengths and weaknesses. An important lesson to be learned from the early Dutch experiences with HTA in the area of medical specialist care is that the nature and complexity of health technologies in this area create practical problems regarding the amount and quality of available data needed to make the HTA-based system work. This hampers an unambiguous interpretation of assessment data and thus calls for stronger requirements regarding transparency and stakeholder participation. Future work focusing on the role of HTA in funding decisions is needed to provide insights in best practices for HTA systems in circumstances where a delicate balance needs to be achieved between promoting innovation, supporting effective and timely decision-making and preventing the coverage of technologies that represent a waste of resources.

The Design of a Health Technology Assessment System in Telepathology

Up to a few years ago, the management of the information on the slides (virtual slides) in telepathology applications was principally based on the design and construction of a few identical and expensive platforms with microscope units and software tools for the display and for electronic control (zooming, moving, and cutting of images). The development of information technology tools allows the diffusion of new visualization strategies and the availability of low cost or free visualization proprietary tools. New competitive systems such as client-server architectures are available in telepathology today. The investigation of the new technologies for telepathology is a basic and core aspect in telemedicine technology assessment. A new interactive environment to investigate the health technology assessment of a telepathology system has been studied. In particular, in consideration of previous experience the methodology focused both on the senior pathologist and younger student pathologist. Two interactive forms were created by a working group: a feedback form and a diagnostic form. The first was designed to investigate the technology characteristics and acceptance of the telepathology systems. The second tool was designed to investigate the diagnostic accuracy on a significant sample of virtual slides by two different groups of pathologists (senior and younger students). The acceptance of the methodology was very high.

Health technology assessment in England and Wales.

In this study, we describe the current state of the Health Technology Assessment (HTA) system in England and Wales. This system rests on a distinction between assessment and appraisal and has three main strands: researcher-led HTA, the research and development program, and the HTA-NICE (National Institute for Clinical Excellence) process. We outline the pressures for HTA and how it has evolved in the British National Health Service. We discuss how HTA priorities are chosen, how HTA information is collected and assessed, how HTA evidence is used, and we make some observations about its impact. In our discussion, we consider some limitations of the HTA system, its possible divergence from evidence-based health care, its centralization, and some of the key challenges for managing HTA-driven policy. But we remain hopeful that HTA can contribute to better and more explicit decision-making within England and Wales.

Pharmaceutical industry's perspective on health technology assessment.

This article presents the pharmaceutical industry's perspective on health technology assessment (HTA) with specific comments on the HTA systems in England and Wales, France, The Netherlands, and Sweden. The comments are focused on the following main themes: (i) The contributions of the HTA system to overall efficiency in the health-care system, (ii) HTA as a cost-driver for industry, patients, government, and society, and (iii) The various implementation barriers that currently exist for a successful implementation of HTA results.

Health technology assessment in Europe. Improving clarity and performance.

This paper discusses the challenges facing health technology assessment (HTA) in Europe, based on an explicit analysis of the characteristics of an "optimal" HTA system. It has three objectives: a) to elaborate an explicit system of policy goals and the characteristics of an optimal HTA system that facilitates the achievement of these goals; b) to identify the general institutional incentive barriers (government and market failures) that prevent the attainment of an optimal HTA system in Europe; and c) to argue that evaluation of the implications of health technologies for equity and inequality in health is an essential part of this optimal system and a considerable challenge for HTA decision makers, especially as national governments realign policy toward equity goals.