scholarly journals Higher Sustainability and Lower Opportunistic Behaviour in Healthcare: A New Framework for Performing Hospital-Based Health Technology Assessment

2018 ◽  
Vol 10 (10) ◽  
pp. 3550 ◽  
Author(s):  
Gabriele Palozzi ◽  
Sandro Brunelli ◽  
Camilla Falivena
Keyword(s):  
Public Health ◽  
Health Technology Assessment ◽  
Internal Control ◽  
Technology Assessment ◽  
New Technologies ◽  
National Health System ◽  
Health Technology ◽  
Management Control ◽  
The Impact

Innovative health technology deployment represents the primary challenge within the sustainability of public health systems. On one hand, new technologies may potentially improve access to care and the quality of services. On the other hand, their rapid evolution and broad implications on existing procedures increase the risk to adopt technologies that are not value for money. As a consequence, Health Technology Assessment (HTA) is a critical process at each level of the National Health System. Focusing on the organisational level, this paper explores the current practices of Hospital-Based HTA (HB-HTA) in terms of management, control and behaviours of various actors involved. Among several tasks, decision-makers are appointed at managing the conflict of interest around health technology development, that could pave the way for corruption or other misleading behaviours. Accordingly, the purpose of the study is proposing a new strategic framework, named Health Technology Balanced Assessment (HTBA), to foster hospital-based health technology management aimed to align strategy and actions. The conceptual model is developed on three perspectives (clinical, economic and organisational) to make the actors involved in the assessment (clinicians, health professionals, hospital managers and patients) aware of the impact of new technology on the value chain. Besides supporting the decision-making process, such a tool represents support for the internal control system as a whole. By promoting structured evaluation, it increases transparency and accountability of public health organisations. Moreover, in the long run, the framework proposed will be useful to reach selected United Nations Sustainable Development Goals (UN SDGs) to enhance the quality of healthcare in the future.

PP58 The Alliance Between Health Technology Assessment And Public Health In National Screening Policies

2019 ◽  
Vol 35 (S1) ◽  
pp. 48-48
Author(s):  
Leonor Varela-Lema ◽  
Janet Puñal-Riobóo ◽  
Paula Cantero-Muñoz ◽  
Maria José Faraldo-Vallés
Keyword(s):  
Public Health ◽  
Decision Making ◽  
Newborn Screening ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
National Health System ◽  
Health Technology ◽  
Screening Tests ◽  
Special Focus ◽  
Screening Programs

IntroductionDecision making regarding national population-based prenatal and newborn screening policies is recognized to be highly challenging. This paper aims to describe the formalized collaboration that has been established between the Spanish National Public Health Screening Advisory Committee (PHSAC) and the Spanish Network of Health Technology Assessment (HTA) agencies to support the development of evidence- and consensus-based recommendations to support this process.MethodsIn-depth description and analysis of the strategic and methodological processes that have been implemented within the Spanish National Health System prenatal and newborn screening frameworks, with special emphasis on the role, actions, and responsibilities of HTA agencies.ResultsThe role of HTA agencies is threefold: (i) support the PHSAC by providing evidence on safety, effectiveness and cost/effectiveness of the screening tests/strategies, as well as contextualized information regarding costs, organizational, social, legal and ethical issues; (ii) collaborate with the PHSAC in the development of formal evidence- and consensus-based recommendations for defining population screening programs, when required; (iii) analyze real-world data that is generated by piloted programs. This paper will provide real-life examples of how these processes were implemented in practice, with a special focus on the development of the non-invasive prenatal testing (NIPT) policy. Recommendations for NIPT were developed by a multidisciplinary group based on the European network for Health Technology Assessment (EUnetHTA) rapid assessment report and the predictive models that were built using national statistics and other contextualized data.ConclusionsThe current work represents an innovative approach for prenatal and newborn screening policymaking, which are commonly difficult to evaluate due to the low quality of evidence and the confounding public health issues. The paper raises awareness regarding the importance of joint collaborations in areas where evidence is commonly insufficient for decision making.

OP135 Confirmatory Versus Explorative Endpoints In Drug Approval Versus Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 63-64
Author(s):  
Ines Niehaus ◽  
Charalabos-Markos Dintsios
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Drug Approval ◽  
Health Technology ◽  
Benefit Assessment ◽  
Benefit Ratio ◽  
Early Benefit Assessment ◽  
The Impact ◽  
Early Benefit

INTRODUCTION:The early benefit assessment of drugs in Germany and their preceded market authorization pursue different objectives, resulting in divergent decision-making strategies. This is reflected inter alia by the diverse inclusion of confirmatory endpoints within the assessments of oncological drugs. The pharmaceutical manufacturers are facing the challenge of meeting the requirements for both evaluation processes by the available evidence and avoiding hereby negative early benefit assessments. This is mainly due to the concept of mutually relevant clinical trials.METHODS:Identification and gathering of the endpoints is based on a specifically developed guide. The extracted data from the documents of completed assessments up to July 2015 are used to estimate both separately and together the impact of explorative in relation to confirmatory endpoints on the drug approval and early benefit assessment, by contrasting the European Medicines Agency's risk-benefit-ratio and the benefit-harm-balancing of the national Health Technology Assessment (HTA) jurisdiction.RESULTS:Twenty-one of fourty-one studies’ oncological assessments could be included in the endpoint analysis. From a procedural point of view both the drug approval and the early benefit assessment seem to be not confirmatory since they include explorative endpoints as well. Yet, drug approval is in terms of quality of endpoints more confirmatory than early benefit assessment since it contains a higher proportion of primary endpoints. The latter implies only in 67 percent of the assessments a primary endpoint to be relevant for the benefit-harm-balancing. Moreover, explorative mortality endpoints reached the highest agreement and explorative endpoints capturing health-related quality of life no agreement, referring to the mutual relevance of endpoints for the risk-benefit-ratio and the benefit-harm-balancing.CONCLUSIONS:The missing information transparency of the assessment reports compared to the information offered within the early benefit assessment makes an assignment of endpoints with respect to the mutually relevant clinical trial sometimes troublesome. To warrant, in the long run, a broader confirmatory basis for decisions in health care supported by HTA, a closer inter-institutional cooperation of approval authorities and German HTA jurisdictions seems favorable.

THE USE AND IMPACT OF RAPID HEALTH TECHNOLOGY ASSESSMENTS

2000 ◽  
Vol 16 (2) ◽  
pp. 651-656 ◽  
Author(s):  
David Hailey ◽  
Paula Corabian ◽  
Christa Harstall ◽  
Wendy Schneider
Keyword(s):  
Health Technology Assessment ◽  
Healthcare System ◽  
Technology Assessment ◽  
Rapid Assessment ◽  
Health Technology ◽  
Decision Makers ◽  
Assessment Program ◽  
Detailed Evaluation ◽  
The Impact

Objectives: To consider the impact of rapid health technology assessments undertaken as part of a program in a provincial healthcare system in response to urgent requests for advice.Methods: Review of the development and preparation of 20 rapid assessment reports, communication with decision makers within the healthcare system, and appraisal of data subsequent to preparation of the reports.Results: Fourteen of the assessments were judged to have had an influence on policy and other decisions, as judged by responses from those who had requested advice. Another four were considered to have provided guidance, while having less immediate influence on decisions, and two others had no apparent impact. Quality of the assessments was considered acceptable, on the basis of literature that subsequently became available and from comments received.Conclusions: These brief reports are considered to be a useful component of a health technology assessment program. However, they should be regarded as provisional appraisals and followed up with more detailed evaluation where possible.

scholarly journals Health technology assessment to optimize health technology utilization: Using implementation initiatives and monitoring processes

2010 ◽  
Vol 26 (3) ◽  
pp. 309-316 ◽  
Author(s):  
Katrine B. Frønsdal ◽  
Karen Facey ◽  
Marianne Klemp ◽  
Inger Natvig Norderhaug ◽  
Berit Mørland ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Health System ◽  
Technology Assessment ◽  
Health Technology ◽  
Evidence Based ◽  
Use Of Technology ◽  
Monitoring Activities ◽  
The Impact ◽  
Policy Forum

Background: The way in which a health technology is used in any particular health system depends on the decisions and actions of a variety of stakeholders, the local culture, and context. In 2009, the HTAi Policy Forum considered how health technology assessment (HTA) could be improved to optimize the use of technologies (in terms of uptake, change in use, or disinvestment) in such complex systems.Methods: In scoping, it was agreed to focus on initiatives to implement evidence-based guidance and monitoring activities. A review identified systematic reviews of implementation initiatives and monitoring activities. A two-day deliberative workshop was held to discuss key papers, members’ experiences, and collectively address key questions. This consensus paper was developed by email and finalized at a postworkshop meeting.Results: Evidence suggests that the impact and use of HTA could be increased by ensuring timely delivery of relevant reports to clearly determined policy receptor (decision-making) points. To achieve this, the breadth of assessment, implementation initiatives such as incentives and targeted, intelligent dissemination of HTA result, needs to be considered. HTA stakeholders undertake a variety of monitoring activities, which could inform optimal use of a technology. However, the quality of these data varies and is often not submitted to an HTA.Conclusions: Monitoring data should be sufficiently robust so that they can be used in HTA to inform optimal use of technology. Evidence-based implementation initiatives should be developed for HTA, to better inform decision makers at all levels in a health system about the optimal use of technology.

scholarly journals Expectations for the Development of Health Technology Assessment in Brazil

2021 ◽  
Vol 18 (22) ◽  
pp. 11912
Author(s):  
Julia Simões Corrêa Galendi ◽  
Carlos Antonio Caramori ◽  
Clarissa Lemmen ◽  
Dirk Müller ◽  
Stephanie Stock
Keyword(s):  
Public Health ◽  
Health Care ◽  
Health Technology Assessment ◽  
Capacity Building ◽  
Technology Assessment ◽  
Public Involvement ◽  
Population Data ◽  
Health Technology ◽  
Public Health Care ◽  
The Impact

The implementation of health technology assessment (HTA) in emerging countries depends on the characteristics of the health care system and the needs of public health care. The objective of this survey was to investigate experts’ expectations for the development of HTA in Brazil and to derive measures to strengthen the impact of HTA in Brazil on health care decisions. Based on a scoping literature review, a questionnaire was developed proposing eight theses for seven domains of HTA: (i) capacity building, (ii) public involvement, (iii) role of cost-effectiveness analysis (CEA), (iv) institutional framework, (v) scope of HTA studies, (vi) methodology of HTA, and (vii) HTA as the basis for jurisdiction. Thirty experts responded in full to the survey and agreed to five of the eight theses proposed. Experts suggested several measures to promote HTA within the scope of each domain, thus addressing capacity building related to HTA, availability, and reliability of population data, and legal endowment of the HTA system. Finally, HTA processes in Brazil should also address public health issues (e.g., appraisal of interventions directed at chronic diseases).

scholarly journals Health technology assessment in Switzerland

2009 ◽  
Vol 25 (S1) ◽  
pp. 174-177 ◽  
Author(s):  
Pedro Koch ◽  
Julian Schilling ◽  
Marlène Läubli ◽  
Florian Mitscherlich ◽  
Dieter Melchart ◽  
...  
Keyword(s):  
Public Health ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
New Technologies ◽  
Health Technology ◽  
Federal Law ◽  
Public And Private ◽  
Health Technologies ◽  
For Profit ◽  
The One

Objectives and Methods: To review Switzerland's mixed public and private healthcare system with regard to health technology assessment (HTA).Results: In the past, remarkable work in HTA was done. Accomplishments include the following: (i) Switzerland became an early member of the International Network of Agencies for Health Technology Assessment. (ii) HTA has its legal bases in terms of effectiveness, appropriateness, and efficiency. (iii) The federal law allows the introduction of new technologies for a limited time for evaluation. (iv) A Swiss Network for Health Technology Assessment was established. In 2004, federal HTA activities moved from the Swiss Federal Office “of Social Security” to the one for “Public Health.” The Office mainly mandates, manages, and coordinates evaluations attached to its prevention and intervention sections in the fields of AIDS, illegal drugs, and legal drugs.Conclusions: Because of the absence of a governmental institution assessing and reporting on new health technologies, private and for profit organizations became more important for the decision-making processes. In a regulated market, the implications may be crucial for the public health.

scholarly journals HEALTH TECHNOLOGY ASSESSMENT IN EVALUATION OF PHARMACEUTICALS IN THE CZECH REPUBLIC

2017 ◽  
Vol 33 (3) ◽  
pp. 339-344 ◽  
Author(s):  
Lenka Vostalová ◽  
Jana Mazelová ◽  
Jiří Samek ◽  
Milan Vocelka
Keyword(s):  
Czech Republic ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
New Technologies ◽  
Health Technology ◽  
Medicinal Products ◽  
State Institute ◽  
The Czech Republic ◽  
Administrative Proceedings ◽  
The Impact

Objectives: In the Czech Republic, the health technology assessment (HTA) approaches have been implemented in evaluation of medicinal products since 2008.The aim of this study was to provide an overview of the implementation of HTA and different levels thereof in the evaluation process conducted by the State Institute for Drug Control (SUKL) and to describe the impact of HTA on the entrance of new medicinal entities into out-patient healthcare system including highly innovative and orphan drugs.Methods: Materials supporting this overview were collected using the records in the database of administrative proceedings of SUKL, in-house standard operating procedures, and the legislation in force. Based on these sources as well as the hands-on knowledge of the current practice, a brief description of the general rules of administrative proceedings involving HTA of varying complexity was elaborated. Characteristic features of the individual types of proceedings, basic differences in the complexity of HTA employed, and its most important challenges were summarized.Results: In Czech Republic, HTA in the formal administrative proceedings ensures a transparent process of introduction of new medicinal products into clinical practice and leaves space for restriction of reimbursement conditions to minimize budget impact.Conclusions: As a robust as well as pragmatic HTA methodology has been implemented by SUKL, relevant stakeholders (marketing authorization holders, Health Care Funds, clinical expert groups) are now able to influence reimbursement of new technologies.

scholarly journals Validity of Surrogate Endpoints and Their Impact on Coverage Recommendations: A Retrospective Analysis across International Health Technology Assessment Agencies

2021 ◽  
pp. 0272989X2199455
Author(s):  
Oriana Ciani ◽  
Bogdan Grigore ◽  
Hedwig Blommestein ◽  
Saskia de Groot ◽  
Meilin Möllenkamp ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
International Health ◽  
Surrogate Endpoint ◽  
Health Technology ◽  
Surrogate Endpoints ◽  
Patient Centered ◽  
Statistical Validation ◽  
Level Of Evidence ◽  
The Impact

Background Surrogate endpoints (i.e., intermediate endpoints intended to predict for patient-centered outcomes) are increasingly common. However, little is known about how surrogate evidence is handled in the context of health technology assessment (HTA). Objectives 1) To map methodologies for the validation of surrogate endpoints and 2) to determine their impact on acceptability of surrogates and coverage decisions made by HTA agencies. Methods We sought HTA reports where evaluation relied on a surrogate from 8 HTA agencies. We extracted data on the methods applied for surrogate validation. We assessed the level of agreement between agencies and fitted mixed-effects logistic regression models to test the impact of validation approaches on the agency’s acceptability of the surrogate endpoint and their coverage recommendation. Results Of the 124 included reports, 61 (49%) discussed the level of evidence to support the relationship between the surrogate and the patient-centered endpoint, 27 (22%) reported a correlation coefficient/association measure, and 40 (32%) quantified the expected effect on the patient-centered outcome. Overall, the surrogate endpoint was deemed acceptable in 49 (40%) reports ( k-coefficient 0.10, P = 0.004). Any consideration of the level of evidence was associated with accepting the surrogate endpoint as valid (odds ratio [OR], 4.60; 95% confidence interval [CI], 1.60–13.18, P = 0.005). However, we did not find strong evidence of an association between accepting the surrogate endpoint and agency coverage recommendation (OR, 0.71; 95% CI, 0.23–2.20; P = 0.55). Conclusions Handling of surrogate endpoint evidence in reports varied greatly across HTA agencies, with inconsistent consideration of the level of evidence and statistical validation. Our findings call for careful reconsideration of the issue of surrogacy and the need for harmonization of practices across international HTA agencies.

CAPACITY BUILDING IN AGENCIES FOR EFFICIENT AND EFFECTIVE HEALTH TECHNOLOGY ASSESSMENT

2016 ◽  
Vol 32 (4) ◽  
pp. 292-299 ◽  
Author(s):  
Debjani Mueller ◽  
Iñaki Gutiérrez-Ibarluzea ◽  
Tara Schuller ◽  
Marco Chiumente ◽  
Jeonghoon Ahn ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Capacity Building ◽  
Technology Assessment ◽  
Health Technology ◽  
Group Discussions ◽  
Middle Income ◽  
Working Together ◽  
Effective Decision ◽  
Effective Decision Making ◽  
The Impact

Objectives: Health technology assessment (HTA) yields information that can be ideally used to address deficiencies in health systems and to create a wider understanding of the impact of different policy considerations around technology reimbursement and use. The structure of HTA programs varies across different jurisdictions according to decision-maker needs. Moreover, conducting HTA requires specialized skills. Effective decision making should include multiple criteria (medical, economic, technical, ethical, social, legal, and cultural) and requires multi-disciplinary teams of experts working together to produce these assessments. A workshop explored the multi-disciplinary skills and competencies required to build an effective and efficient HTA team, with a focus on low- and middle-income settings.Methods: This proceeding summarizes main points from a workshop on capacity building, drawing on presentations and group discussions among attendees including different points of view.Results and Conclusions: The workshop and thus this study would have benefited from a larger variety of stakeholders. Therefore, the conclusions arising from the workshop are not the opinion of a representative sample of HTA professionals. Nonetheless, organizations and speakers were carefully selected to provide a valuable approach to this theme. Thus, these proceedings highlight some of the gaps and needs in the education and training programs offered worldwide and calls for further investigation.

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.

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