PP141 Legal Governance: How Does Law Circumscribe The Social Role Of Health Technology Assessment?

2017 ◽  
Vol 33 (S1) ◽  
pp. 136-137
Author(s):  
Louise Bernier ◽  
Georges-Auguste Legault ◽  
Charles-Etienne Daniel ◽  
Suzanne Kocsis Bédard ◽  
Jean-Pierre Béland ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Social Role ◽  
Health Technology ◽  
Legal Framework ◽  
Soft Law ◽  
List Type ◽  
Hard Law ◽  
The Social

INTRODUCTION:One of the barriers of integrating ethics in Health Technology Assessment (HTA) relates to the social role of HTA (1). The aim of this study is to provide a better understanding of the way by which law circumscribes the social role of HTA. Our hypothesis: HTA's social role is embedded within a mixed governance based on hard law and soft law.METHODS:Three HTA agencies were conveniently selected for our study: Haute Autorité de santé (HAS) (France), National Institute for Health and Care Excellence (NICE) (United Kingdom) and Institut national d'excellence en santé et en services sociaux (INESSS) (Québec, Canada). Our analysis of the legal, administrative and procedural documents relating to the existence and assessment processes of these three agencies is guided by the following criteria: 1.The normative strength of the documents (categories of hard law or soft law) (2)2.The definition of the agencies’ social role (1)3.The integration of ethics in the agencies’ mandate.RESULTS:Hard law contributes to establish a general mandate and some legal legitimacy for these agencies. Soft law, grounded in the HTA producers' practices, plays a major role in the legal governance of HTA. Our results demonstrate that these agencies existing practices seem to circumscribe their social role further than their constitutive laws. In this context, social actors become responsible to define, structure and operationalize the implementation of HTA.In addition, the legal framework (hard law) through which HTA unfolds does not clearly support its structural and social role. Despite existing legal frameworks, the normative legitimacy of HTA is not entirely established, as it depends on soft law. Taken altogether, this maintains a persisting conceptual vagueness in HTA governance.CONCLUSIONS:The social role of HTA should be defined either through modifying existing legislations (hard law) or through harmonization of the agencies internal policies and regulations (soft law). Such legal initiatives would help clarify the aims of HTA evaluations: assessments (scientific) or appraisal (value-laden), and therefore give a clearer indication on how best to integrate ethics in HTA.

OP75 Facts And Values In Health Technology Assessment: The Case Of Non-Invasive Prenatal Testing

2019 ◽  
Vol 35 (S1) ◽  
pp. 19-19
Author(s):  
Bart Bloemen ◽  
Maarten Jansen ◽  
Wouter Rijke ◽  
Wija Oortwijn ◽  
Gert Vanderwilt
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Prenatal Testing ◽  
Health Technology ◽  
Non Invasive ◽  
Relevant Evidence ◽  
Healthcare Technologies ◽  
General Abstract ◽  
Structured Questionnaire

IntroductionHealth Technology Assessment (HTA) is where facts and values meet: the evidence that is considered relevant to the assessment of a technology depends on the value framework used. In the context of the European project VALIDATE (Values in doing assessments of healthcare technologies), we assessed to what extent this interplay between facts and values is acknowledged in HTA reports on non-invasive prenatal testing (NIPT). Our aim is to gain a better understanding of this fact-value relationship, and to contribute to the development of capacity for ethical analyses in HTA.MethodsFive reviewers independently analyzed HTA reports on NIPT, obtained from the National Institute for Health Research (NIHR) HTA database, by answering a structured questionnaire on: (i) arguments, values, and conclusions; (ii) relations between values and collected evidence; (iii) operationalizations of the values involved. Ethical argumentation was analyzed using the method of specifying norms. This method holds that for general, abstract ethical principles to reach concrete cases, principles need to be specified in such a way as to achieve maximal coherence between different value commitments and practice. The results of the analysis were discussed in joint meetings to arrive at a consensus on interpretation.ResultsOur results show that the pivotal role of values in defining what counts as relevant evidence and why, is rarely acknowledged. The same holds for the importance of specifying values as a means to achieve greater coherence between the use of healthcare technologies and a range of values.ConclusionsThere is ample room for improvement in clarifying the role of values in HTA: they can serve to explain and justify what evidence is considered relevant to the assessment of a healthcare technology. Recognizing that abstract values need specification in order to reach concrete cases opens up new opportunities for exploring in what way values are affected by healthcare technologies.

INTRODUCTION: HEALTH TECHNOLOGY ASSESSMENT AND THE EUROPEAN UNION

2000 ◽  
Vol 16 (2) ◽  
pp. 299-302 ◽  
Author(s):  
David Banta ◽  
Wija Oortwijn
Keyword(s):  
Public Health ◽  
Decision Making ◽  
European Union ◽  
Health Technology Assessment ◽  
European Commission ◽  
Technology Assessment ◽  
Health Technology ◽  
The European Union ◽  
European Level

Health technology assessment (HTA) has become increasingly important in the European Union as an aid to decision making. As agencies and programs have been established, there is increasing attention to coordination of HTA at the European level, especially considering the growing role of the European Union in public health in Europe. This series of papers describes and analyzes the situation with regard to HTA in the 15 members of the European Union, plus Switzerland. The final paper draws some conclusions, especially concerning the future involvement of the European Commission in HTA.

scholarly journals HTA AND ITS LEGAL ISSUES: A FRAMEWORK FOR IDENTIFYING LEGAL ISSUES IN HEALTH TECHNOLOGY ASSESSMENT

2014 ◽  
Vol 30 (6) ◽  
pp. 587-594 ◽  
Author(s):  
Daniel Widrig ◽  
Brigitte Tag
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Legal Issues ◽  
Extensive Literature ◽  
Legal Analysis ◽  
Swiss Health ◽  
Extensive Literature Search ◽  
Legal Technology

Objectives: Legal analysis can highlight important issues that are relevant when deciding whether a medical technology should be implemented or reimbursed. Literature and studies show that even though the law is an acknowledged part of health technology assessment (HTA), legal issues are rarely considered in practice. One reason for this may be the lack of knowledge about the diversity of legal issues that are relevant for HTA. Therefore, this contribution aims primarily to identify and then explain the relevant legal issues in HTA. This study offers a framework for identifying the legal issues in HTAs in different jurisdictions and provides a basis for further research.Methods: After extensive literature search, the authors review Swiss health law to identify legal issues that are relevant to HTA. The authors then categorize these legal issues using a framework with an inside and outside perspective. Finally, they explain a selection of these legal issues with several examples.Results: This study reveals numerous legal issues that are relevant for HTA and underlines the necessity of incorporating legal analysis in HTAs. The suggested perspectival framework in this study provides a basis to structure the legal analysis. The identified legal issues are relevant in other countries and the perspectival framework is transferable to other jurisdictions.Conclusions: The article underlines the importance of in-depth discussion about the role of law in HTA. It provides a structured overview of the legal issues in HTA and suggests a development of more concrete instruments toward a standardized legal technology assessment.

OP73 Using Visualization In Scoping The Literature For A Prognostic Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 33-34
Author(s):  
Mark Clowes
Keyword(s):  
Rheumatoid Arthritis ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Large Scale ◽  
Health Technology ◽  
Processing Power ◽  
Literature Searches ◽  
Alternative Means ◽  
Prognostic And Predictive Markers

INTRODUCTION:One of the challenges of large scale Health Technology Assessment (HTA) projects is managing the large volume of studies retrieved by the requisite comprehensive literature searches. At the scoping stage of the project, a pragmatic judgement needs to be made as to how sensitive the search strategy should be in order to find all the relevant papers without returning an overwhelming volume of irrelevant studies.METHODS:For this HTA (evaluating prognostic and predictive markers in rheumatoid arthritis), the research team already had prior knowledge of several key markers of interest, but wanted to ensure that no others had been missed. Advice from practising clinicians was obtained, but for additional validation, a broad scoping search was conducted for ‘rheumatoid arthritis’ using the sensitive Haynes filters for prognostic (1) and clinical prediction (2) studies. Unsurprisingly, this initial search retrieved too many studies for them all to be admitted to the full review; but once those dealing with known markers had been removed, a sample of the remaining records was loaded into a software visualization tool (3) to display “heat maps” of frequently occurring terms and phrases.RESULTS:On this occasion, no additional markers were identified, however this provided reassurance that the advice obtained from clinicians was comprehensive, enabling the HTA team to proceed confidently with its evaluation of the selected markers.CONCLUSIONS:Visualization offers an alternative means of exploring and interrogating large text archives, and has the potential to complement the role of traditional search methods in identifying literature for systematic reviews and health technology assessments. As processing power increases and more and more full-text papers become available open access, it may provide a solution to some of the limitations associated with comprehensive searching.

VP60 The Importance Of Patient Organizations Involvement In Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 176-176
Author(s):  
Kathi Apostolidis ◽  
Lydia Makaroff ◽  
Francesco De Lorenzo ◽  
Francesco Florindi
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Patient Preferences ◽  
Health Technology ◽  
White Paper ◽  
Public Consultation ◽  
Policy Position ◽  
List Type ◽  
Patient Organizations ◽  
The Impact

INTRODUCTION:In Europe, the work done by the European Commission and the European Network for Health Technology Assessment (EUnetHTA) has consolidated the role of Health Technology Assessment (HTA), and promises to better harmonize its impact across European Union (EU) countries. However, more work is needed to improve patient involvement in assessing new health technology, and in developing research priorities.METHODS:The European Cancer Patient Coalition (ECPC) developed a model for engagement of patients in HTA based on the experience from: •ECPC's ‘Value of Innovation in Oncology’ White Paper, which includes input from ECPC's membership•ECPC's leading role in the Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER) study, funded by the Innovative Medicines Initiative, to develop guidelines on how patient-preference studies should be performed throughout the development of new medical treatments.RESULTS:The ECPC ‘Value of Innovation in Oncology’ White Paper was launched in 2017. The paper provides ECPC's policy position on key obstacles to equitable access to meaningful innovation. The paper recommends the establishment of an EU-wide HTA body to reduce delays and variations in access and to avoid duplication of effort by individual Member States. The paper also recommends that patients should be formally and routinely included in HTA policy and operations at EU and at national levels. These recommendations were also submitted to the European Commission's public consultation on strengthening EU cooperation on HTA.Through its work in PREFER, ECPC is helping to improve how patient preferences are measured and valued to capture the impact of health technology on patients daily life. Patient preferences are concerned with measuring how patients value components such as treatment end points, route of administration, treatment duration, treatment frequency, frequency of side-effects, price, and quality of life.CONCLUSIONS:Patient organization involvement in HTA is vital. Patient organizations offer unique insights, experiences, identify unmet needs, and can help to produce practical recommendations

OP51 Thrombectomy In France: A National Use Of European Network for Health Technology Assessment (EUnetHTA) Joint Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 24-24
Author(s):  
Huguette Lhuillier-Nkandjeu ◽  
Michèle Morin-Surroca
Keyword(s):  
Health Insurance ◽  
Ischaemic Stroke ◽  
Health Technology Assessment ◽  
National Health Insurance ◽  
National Health ◽  
Technology Assessment ◽  
Acute Ischaemic Stroke ◽  
Health Technology ◽  
List Type ◽  
European Network

INTRODUCTION:Mechanical thrombectomy (MT) is used in patients with acute ischaemic stroke due to occlusion of a proximal cerebral artery. Over the years endovascular techniques have been used to re-canalise blocked vessels, but are not currently reimbursed by National Health Insurance in France.The aim was to assess the efficacy and safety of MT in combination with intravenous tissue plasminogen activator (IV t-PA), or as an alternative to it, in adults with an acute ischaemic stroke who are not eligible for thrombolysis or in whom thrombolysis has failed; to support the reimbursement decision by National Health Insurance.METHODS:Within the scope of The European Network for Health Technology Assessment (EUnetHTA), a rapid assessment of “Endovascular therapy using devices for acute ischaemic stroke” was jointly produced with Haute Autorité de santé (HAS) as a reviewer.RESULTS:The EUnetHTA report provided a systematic review based on eight randomized controlled trials (RCT) for effectiveness and all available published data for safety.To produce its assessment, HAS has adapted the EUnetHTA report by: 1.Updating the systematic literature review including the latest published trials2.Retaining the subgroup analysis of the five most recent trials considered more relevant in the EUnetHTA report for the assessment of effectiveness3.Analysing specifically the different endovascular interventions studied in the five RCTs4.Taking into account contributions from stakeholders.CONCLUSIONS:This horizontal collaboration among European HTA doers has facilitated and shortened the assessment of the clinical benefit of this technology, confirming the relevance of EUnetHTA cooperation.This clinical assessment of thrombectomy is to be completed by the evaluation of its organizational impact in the management of acute ischemic stroke.

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