scholarly journals THE ADDED VALUE OF INTEGRATE-HTA GUIDANCE IN THE WORK PROCESSES OF HEALTH TECHNOLOGY ASSESSMENT AGENCIES

2017 ◽  
Vol 33 (5) ◽  
pp. 597-598 ◽  
Author(s):  
Gert Jan van der Wilt ◽  
Wietske Kievit ◽  
Wija Oortwijn
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Added Value ◽  
Work Processes ◽  
Central Idea ◽  
Policy Relevance ◽  
Perverse Incentives ◽  
Potential Impact ◽  
The One

A central idea underlying the INTEGRATE-HTA project is that many of the interventions that are being used in health care are quite complex. By this, we mean that the relation between the delivery of the intervention on the one hand, and the onset of (desired and undesired) changes may be less straightforward than hoped for. There may be all sorts of reasons for this, varying from a lack of resources, lack of skills, perverse incentives, organizational problems, etc. Not identifying such factors and their potential impact may seriously compromise the policy relevance of a health technology assessment (HTA) (1). However, current approaches and methods in HTA do not seem to be adequately geared to deal with this complexity.

scholarly journals Development of a checklist to guide equity considerations in health technology assessment

2021 ◽  
Vol 37 ◽  
Author(s):  
Maria Benkhalti ◽  
Manuel Espinoza ◽  
Richard Cookson ◽  
Vivian Welch ◽  
Peter Tugwell ◽  
...  
Keyword(s):  
Knowledge Translation ◽  
Health Technology Assessment ◽  
Priority Setting ◽  
Technology Assessment ◽  
Literature Search ◽  
Health Inequities ◽  
Health Technology ◽  
Decision Makers ◽  
Added Value ◽  
Pilot Test

Abstract Objectives Health technology assessment (HTA) can impact health inequities by informing healthcare priority-setting decisions. This paper presents a novel checklist to guide HTA practitioners looking to include equity considerations in their work: the equity checklist for HTA (ECHTA). The list is pragmatically organized according to the generic HTA phases and can be consulted at each step. Methods A first set of items was based on the framework for equity in HTA developed by Culyer and Bombard. After rewording and reorganizing according to five HTA phases, they were complemented by elements emerging from a literature search. Consultations with method experts, decision makers, and stakeholders further refined the items. Further feedback was sought during a presentation of the tool at an international HTA conference. Lastly, the checklist was piloted through all five stages of an HTA. Results ECHTA proposes elements to be considered at each one of the five HTA phases: Scoping, Evaluation, Recommendations and Conclusions, Knowledge Translation and Implementation, and Reassessment. More than a simple checklist, the tool provides details and examples that guide the evaluators through an analysis in each phase. A pilot test is also presented, which demonstrates the ECHTA's usability and added value. Conclusions ECHTA provides guidance for HTA evaluators wishing to ensure that their conclusions do not contribute to inequalities in health. Several points to build upon the current checklist will be addressed by a working group of experts, and further feedback is welcome from evaluators who have used the tool.

scholarly journals Real-world evidence: perspectives on challenges, value, and alignment of regulatory and national health technology assessment data collection requirements

2021 ◽  
Vol 37 ◽  
Author(s):  
Hannah Sievers ◽  
Angelika Joos ◽  
Mickaël Hiligsmann
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Health Technology ◽  
Practical Experience ◽  
Added Value ◽  
Real World Data ◽  
Conflicting Demands ◽  
Real World Evidence ◽  
Semistructured Interviews

Abstract Objective This study aims to assess stakeholder perceptions on the challenges and value of real-world evidence (RWE) post approval, the differences in regulatory and health technology assessment (HTA) real-world data (RWD) collection requirements under the German regulation for more safety in drug supply (GSAV), and future alignment opportunities to create a complementary framework for postapproval RWE requirements. Methods Eleven semistructured interviews were conducted purposively with pharmaceutical industry experts, regulatory authorities, health technology assessment bodies (HTAbs), and academia. The interview questions focused on the role of RWE post approval, the added value and challenges of RWE, the most important requirements for RWD collection, experience with registries as a source of RWD, perceptions on the GSAV law, RWE requirements in other countries, and the differences between regulatory and HTA requirements and alignment opportunities. The interviews were recorded, transcribed, and translated for coding in Nvivo to summarize the findings. Results All experts agree that RWE could close evidence gaps by showing the actual value of medicines in patients under real-world conditions. However, experts acknowledged certain challenges such as: (i) heterogeneous perspectives and differences in outcome measures for RWE generation and (ii) missing practical experience with RWD collected through mandatory registries within the German benefit assessment due to an unclear implementation of the GSAV. Conclusions This study revealed that all stakeholder groups recognize the added value of RWE but experience conflicting demands for RWD collection. Harmonizing requirements can be achieved through common postlicensing evidence generation (PLEG) plans and joint scientific advice to address uncertainties regarding evidence needs and to optimize drug development.

PP136 How To Apply Health Technology Assessment To Large Scale e-Health Processes

2019 ◽  
Vol 35 (S1) ◽  
pp. 63-64
Author(s):  
Gro-Hilde Severinsen ◽  
Line Silsand ◽  
Anne Ekeland
Keyword(s):  
Health Technology Assessment ◽  
Information And Communication Technologies ◽  
Clinical Data ◽  
Technology Assessment ◽  
Large Scale ◽  
New Technologies ◽  
Health Technology ◽  
Added Value ◽  
Health Region ◽  
Wide Range

IntroductionThere are enormous expectations for e-health solutions to support high quality healthcare services, with accessibility, and effectiveness as key goals. E-health encompasses a wide range of information and communication technologies applied to health care, and focuses on combining clinical activity, technical development, and political requirements. Hence, e-health solutions must be evaluated in relation to the desired goals, to justify the high costs of such solutions.MethodsHealth technology assessment (HTA) aims to produce rational decisions for purchasing new technologies and evaluating healthcare investments, like drugs and medical equipment, by measuring added value in relation to clinical effectiveness, safety, and cost effectiveness. It is desired to also apply HTA assessment on large scale e-health solutions, but traditional quantitative HTA methodology may not be applicable to complex e-health systems developed and implemented as ongoing processes over years. Systematic reviews and meta-analyses of these processes risk being outdated when published, therefore action research designed to work with complex, large scale programs may be a more suitable approach.ResultsIn the project, we followed the development of a new process-oriented electronic patient record system (EPR) in northern Norway. Part of the process was structuring clinical data to be used in electronic forms within the system. This was the first time a health region structured the clinical data and designed the forms; receiving feedback alongside the process was very important. The goal was to use structured forms as a basis for reusing EPR data within and between systems, and to enable clinical decision support.DiscussionAfter designing a prototype of a structured form, we wrote an assessment report focusing on designing a methodology for such development, which stakeholders to include, and how to divide the work between the health region and the system vendor. The answers to such questions will have both practical and economic consequences for designing the next phase of the process.

COMPREHENSIVE ASSESSMENT OF COMPLEX TECHNOLOGIES: INTEGRATING VARIOUS ASPECTS IN HEALTH TECHNOLOGY ASSESSMENT

2017 ◽  
Vol 33 (5) ◽  
pp. 570-576 ◽  
Author(s):  
Kristin Bakke Lysdahl ◽  
Kati Mozygemba ◽  
Jacob Burns ◽  
Jan Benedikt Brönneke ◽  
James B. Chilcott ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Stakeholder Involvement ◽  
Complex Interventions ◽  
Health Technology ◽  
Legal Aspects ◽  
Added Value ◽  
Health Technologies ◽  
Stakeholder Perspectives ◽  
Wide Range

Objectives: Despite recent development of health technology assessment (HTA) methods, there are still methodological gaps for the assessment of complex health technologies. The INTEGRATE-HTA guidance for effectiveness, economic, ethical, socio-cultural, and legal aspects, deals with challenges when assessing complex technologies, such as heterogeneous study designs, multiple stakeholder perspectives, and unpredictable outcomes. The objective of this article is to outline this guidance and describe the added value of integrating these assessment aspects.Methods: Different methods were used to develop the various parts of the guidance, but all draw on existing, published knowledge and were supported by stakeholder involvement. The guidance was modified after application in a case study and in response to feedback from internal and external reviewers.Results: The guidance consists of five parts, addressing five core aspects of HTA, all presenting stepwise approaches based on the assessment of complexity, context, and stakeholder involvement. The guidance on effectiveness, health economics and ethics aspects focus on helping users choose appropriate, or further develop, existing methods. The recommendations are based on existing methods’ applicability for dealing with problems arising with complex interventions. The guidance offers new frameworks to identify socio-cultural and legal issues, along with overviews of relevant methods and sources.Conclusions: The INTEGRATE-HTA guidance outlines a wide range of methods and facilitates appropriate choices among them. The guidance enables understanding of how complexity matters for HTA and brings together assessments from disciplines, such as epidemiology, economics, ethics, law, and social theory. This indicates relevance for a broad range of technologies.

A NEW HEALTH TECHNOLOGY ASSESSMENT SYSTEM FOR JAPAN? SIMULATING THE POTENTIAL IMPACT ON THE PRICE OF SIMEPREVIR

2017 ◽  
Vol 33 (1) ◽  
pp. 121-127 ◽  
Author(s):  
Jörg Mahlich ◽  
Isao Kamae ◽  
Bruno Rossi
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Cost Utility ◽  
Assessment System ◽  
Unit Price ◽  
Public Healthcare ◽  
Pricing Scheme ◽  
Potential Impact ◽  
Japanese Yen

Objectives:Japanese authorities have announced a plan to introduce a health technology assessment (HTA) system in 2016. This study assessed the potential impact of such a policy on the price of the antivirologic drug simeprevir.Methods:Taking the antivirologic drug simeprevir as an example, we compared the current Japanese price with hypothetical prices that might result if a U.K. (cost-utility) or German (efficiency frontier) style HTA assessment was in place.Results:The simeprevir unit price under the current Japanese pricing scheme is 13,122 Japanese yen (equivalent to 109.35 U.S. dollars as of April 2015). Depending on the selection of comparators and the pricing method, and assuming that HTA will be used as a basis for price setting, the estimated prices of simeprevir vary up to four times higher than under the current Japanese pricing scheme.Conclusions:Although the analysis is based on only one drug, it cannot be taken for granted that a new HTA system would reduce public healthcare expenditure in Japan.

Austria: History of health technology assessment during the past 20 years

2009 ◽  
Vol 25 (S1) ◽  
pp. 74-81 ◽  
Author(s):  
Claudia Wild
Keyword(s):  
Decision Support ◽  
Health Technology Assessment ◽  
Healthcare System ◽  
Technology Assessment ◽  
System Analysis ◽  
High Volume ◽  
Health Technology ◽  
Public Understanding ◽  
Added Value ◽  
Research Activities

Objectives: The aim of this article is to describe and analyze the stages toward recognition and implementation of health technology assessment (HTA).Methods: System analysis of structures and institutions and their use of HTA.Results: Austria is a latecomer in implementing evaluations/HTA as decision support. It can to a certain degree absorb the increasing international knowledge. Austria had a long time to observe the successes and failures of HTA in other countries and to learn from other countries. The implementation of HTA within the Austrian healthcare system ran through stages of uptake: starting 1989 with a systematic review on international activities, first international networking and collaboration since 1991, proposed assessments until the late 1990s, followed by reactive assessments on demand mostly on high volume and costly technologies since then. Since 2000, HTA is used on a regular basis for investment and reimbursement decisions by several players, namely the Ministry of Health, the Social Insurance and hospital cooperations. In 2006, the Austrian HTA-institute was founded.Conclusions: It took approximately 15 years from first research activities in HTA to an institutionalization. HTA in Austria is not only product- but also process-oriented: The actual production of assessments for decision support is as important as the structuring and accompanying of the process of decisions making. In addition, shaping the public understanding of science (characterized by the intrinsic belief that all new medical interventions provide added value to the healthcare system) is part of Austrian HTA.

scholarly journals Health Technology Assessment of Advanced Therapy Medicinal Products: Comparison Among 3 European Countries

2021 ◽  
Vol 12 ◽  
Author(s):  
Lucia Gozzo ◽  
Giovanni Luca Romano ◽  
Francesca Romano ◽  
Serena Brancati ◽  
Laura Longo ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
National Level ◽  
Health Technology ◽  
European Countries ◽  
Added Value ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Products ◽  
Therapeutic Value ◽  
Advanced Therapy

Even for centrally approved products, each European country is responsible for the effective national market access. This step can result in inequalities in terms of access, due to different opinions about the therapeutic value assessed by health technology assessment (HTA) bodies. Advanced therapy medicinal products (ATMPs) represent a major issue with regard to the HTA in order to make them available at a national level. These products are based on genes, tissues, or cells, commonly developed as one-shot treatment for rare or ultrarare diseases and mandatorily authorized by the EMA with a central procedure. This study aims to provide a comparative analysis of HTA recommendations issued by European countries (France, Germany, and Italy) following EMA approval of ATMPs. We found a low rate of agreement on the therapeutic value (in particular the “added value” compared to the standard of care) of ATMPs. Despite the differences in terms of clinical assessment, the access has been usually guaranteed, even with different timing and limitations. In view of the importance of ATMPs as innovative therapies for unmet needs, it is crucial to understand and act on the causes of disagreement among the HTA. In addition, the adoption of the new EU regulation on HTA would be useful to reduce disparities of medicine’s assessment among European countries.

scholarly journals Rival perspectives in health technology assessment and other economic evaluations for investing in global and national health. Who decides? Who pays?

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 72 ◽  
Author(s):  
Anthony Culyer ◽  
Kalipso Chalkidou ◽  
Yot Teerawattananon ◽  
Benjarin Santatiwongchai
Keyword(s):  
Health Technology Assessment ◽  
Societal Perspective ◽  
Technology Assessment ◽  
Health Technology ◽  
Economic Evaluations ◽  
First Principle ◽  
Explicit Statement ◽  
The One ◽  
Selection Of ◽  
The Ideal

There seems to be a general agreement amongst practitioners of economic evaluations, including Health Technology Assessment, that the explicit statement of a perspective is a necessary element in designing and reporting research. Moreover, there seems also to be a general presumption that the ideal perspective is “societal”. In this paper we endorse the first principle but dissent from the second. A review of recommended perspectives is presented. The societal perspective is frequently not the one recommended. The societal perspective is shown to be less comprehensive than is commonly supposed, is inappropriate in many contexts and, in any case, is in general not a perspective to be determined independently of the context of a decision problem. Moreover, the selection of a perspective, societal or otherwise, is not the prerogative of analysts.

OP72 Added Value Of Using Individual Patient Data Meta-analysis

2018 ◽  
Vol 34 (S1) ◽  
pp. 26-26
Author(s):  
Bing Guo ◽  
Carmen Moga
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Health Technology ◽  
Patient Data ◽  
Added Value ◽  
Decision Making Process ◽  
Subgroup Analyses

Introduction:Although individual patient data meta-analysis (IPD MA) is considered the gold standard of systematic reviews (SRs), a recent International Network of Agencies for Health Technology Assessment survey indicates that IPD MA is not frequently included in a health technology assessment (HTA), or conducted by HTA researchers. The objective of this presentation is to describe our first experience with including an IPD MA in a HTA report, discuss the added value for an evidence-based decision-making process, and advocate for expanding work in this field.Methods:An overview of SRs on endovascular therapy for acute ischemic stroke included one IPD MA and six study-level SRs/MAs. Methodological quality was appraised by two reviewers independently using the tool recommended by the Cochrane IPD MA working group for the IPD MA, and the AMSTAR (A MeaSurement Tool to Assess systematic Reviews) for the study-level reviews. Pooled results from subgroup analyses based on access to primary patient data were compared to those reported in SRs that conducted subgroup analyses based on the published data to identify patients or clinical factors that would impact clinical outcomes.Results:The overall findings were similar between the IPD MA and other SRs/MAs. However, when compared to aggregated data used in study-level SRs/MAs, subgroup analyses based on patient data allowed for adjustment of confounders, multiple categories within a subgroup, standardization of outcomes across trials, and detailed data checking. Larger sample sizes of each pre-defined subgroup permitted for more precise estimates of treatment effects. A number of methodological issues in the IPD MA were identified; particularly, no assessment of risk of bias of included trials was conducted.Conclusions:Access to original patient data is demanding and conducting IPD MA requires extensive resources. The advantages of having an improved quality analysis, an appropriate quantification of the effects in the analyzed subgroups, and precision of results may justify additional efforts, and may increase confidence in the decision-making process.

Health Technology Assessment in Health Economics

2011 ◽  
pp. 69-86
Author(s):  
Steven Simoens
Keyword(s):  
Health Economics ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Expenditure ◽  
Health Technology ◽  
Decision Makers ◽  
Added Value ◽  
Healthcare Sector ◽  
Scarce Resources ◽  
Health Technologies

This chapter introduces health technology assessment and health economics as tools for decision makers to allocate scarce resources in the healthcare sector. It argues that information about the safety, efficacy and effectiveness, organizational implications, social and ethical consequences, legal considerations, and health economic aspects of the application of a health technology needs to be taken into account with a view to informing decisions about the registration and reimbursement of a health technology. Also, the author hopes that understanding the methodology and use of health technology assessment and health economics will persuade the reader of the added value of such studies and promote the application of health technologies that support further health improvements, whilst containing health expenditure.

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