EVIDENCE REQUIRED BY HEALTH TECHNOLOGY ASSESSMENT AND REIMBURSEMENT BODIES EVALUATING DIAGNOSTIC OR PROGNOSTIC ALGORITHMS THAT INCLUDE OMICS DATA

2018 ◽  
Vol 34 (4) ◽  
pp. 368-377 ◽  
Author(s):  
Alexandre Barna ◽  
Teresita M Cruz-Sanchez ◽  
Karen Berg Brigham ◽  
Cong-Tri Thuong ◽  
Finn Boerlum Kristensen ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Clinical Utility ◽  
Real Life ◽  
Health Technology ◽  
Core Model ◽  
Social Aspects ◽  
Economic Evidence ◽  
Clinical Markers ◽  
Clinical Validity

Objectives:Multi-analyte assays with algorithmic analyses (MAAAs) use combinations of circulating and clinical markers including omics-based sources for diagnostic and/or prognostic purposes. Assessing MAAAs is challenging under existing health technology assessment (HTA) methods or practices. We undertook a scoping review to explore the HTA methods used for MAAAs to identify the criteria used for clinical research and reimbursement purposes.Methods:This review included only non-companion (stand-alone) tests that are actionable and that have been evaluated by leading HTA or insurer/reimbursement bodies up to September 2017.Results:Twenty-five reports and articles evaluating seventeen MAAAs were examined, most of which have been developed in oncology. The two main models used were the EUnetHTA Core model and the Evaluation of Genomic Applications in Practice and Prevention ACCE framework. Clinical validity and utility criteria were used, as were economic, ethical, legal, and social aspects. Economic evidence on MAAAs was scarce, and there is no consensus on whether the perspectives used are sufficiently broad to include all relevant stakeholders.Conclusions:Clinical utility and efficiency were the most used criteria, with stronger evidence needed linking the use of the algorithm with the clinical outcomes in real-life practice. HTA bodies must as well consider questions related to the analytical validity of MAAAs or with organizational aspects. The two main models, the EUnetHTA Core model and the ACCE framework, could be adapted to the assessment of MAAAs.

HEALTH TECHNOLOGY ASSESSMENT EVIDENCE ON E-HEALTH/M-HEALTH TECHNOLOGIES: EVALUATING THE TRANSPARENCY AND THOROUGHNESS

2018 ◽  
Vol 34 (1) ◽  
pp. 87-96 ◽  
Author(s):  
Vladimir Vukovic ◽  
Carlo Favaretti ◽  
Walter Ricciardi ◽  
Chiara de Waure
Keyword(s):  
Economic Evaluation ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Healthcare Systems ◽  
Core Model ◽  
Social Aspects ◽  
European Network ◽  
Health Technologies ◽  
Research Questions

Objectives:Evaluation is crucial for integration of e-Health/m-Health into healthcare systems and health technology assessment (HTA) could offer sound methodological basis for these evaluations. Aim of this study was to look for HTA reports on e-Health/m-Health technologies and to analyze their transparency, consistency and thoroughness, with the goal to detect areas that need improvement.Methods:PubMed, ISI-WOS, and University of York – Centre for Reviews and Dissemination–electronic databases were searched to identify reports on e-Health/m-Health technologies, published up until April 1, 2016. The International Network of Agencies for Health Technology Assessment (INAHTA) checklist was used to evaluate transparency and consistency of included reports. Thoroughness was assessed by checking the presence of domains suggested by the European network for Health Technology Assessment (EUnetHTA) HTA Core Model.Results:Twenty-eight reports published between 1999 and 2015 were included. Most were delivered by non-European countries (71.4 percent) and only 35.7 percent were classified as full reports. All the HTA reports defined the scope of research whereas more than 80 percent provided author details, summary, discussed findings, and conclusion. On the contrary, policy and research questions were clearly defined in around 30 percent and 50 percent of reports. With respect to the EUnetHTA Core Model, around 70 percent of reports dealt with effectiveness and economic evaluation, more than 50 percent described health problem and approximately 40 percent organizational and social aspects.Conclusions:E-Health/m-Health technologies are increasingly present in the field of HTA. Yet, our review identified several missing elements. Most of the reports failed to respond to relevant assessment components, especially ethical, social and organizational implications.

scholarly journals A Systematic Review of the Value Assessment Frameworks Used within Health Technology Assessment of Omics Technologies and Their Actual Adoption from HTA Agencies

2020 ◽  
Vol 17 (21) ◽  
pp. 8001
Author(s):  
Ilda Hoxhaj ◽  
Laurenz Govaerts ◽  
Steven Simoens ◽  
Walter Van Dyck ◽  
Isabelle Huys ◽  
...  
Keyword(s):  
Systematic Review ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Clinical Utility ◽  
Clinical Effectiveness ◽  
Health Technology ◽  
Value Assessment ◽  
Economic Aspects ◽  
Clinical Validity ◽  
Omics Technologies

Background: Omics technologies, enabling the measurements of genes (genomics), mRNA (transcriptomics), proteins (proteomics) and metabolites (metabolomics), are valuable tools for personalized decision-making. We aimed to identify the existing value assessment frameworks used by health technology assessment (HTA) doers for the evaluation of omics technologies through a systematic review. Methods: PubMed, Scopus, Embase and Web of Science databases were searched to retrieve potential eligible articles published until 31 May 2020 in English. Additionally, through a desk research in HTA agencies’ repositories, we retrieved the published reports on the practical use of these frameworks. Results: Twenty-three articles were included in the systematic review. Twenty-two frameworks, which addressed genetic and/or genomic technologies, were described. Most of them derived from the ACCE framework and evaluated the domains of analytical validity, clinical validity and clinical utility. We retrieved forty-five reports, which mainly addressed the commercial transcriptomic prognostics and next generation sequencing, and evaluated clinical effectiveness, economic aspects, and description and technical characteristics. Conclusions: A value assessment framework for the HTA evaluation of omics technologies is not standardized and accepted, yet. Our work reports that the most evaluated domains are analytical validity, clinical validity and clinical utility and economic aspects.

OP43 Robotic Or Conventional Gait Training Rehabilitation? A Health Technology Assessment Study

2018 ◽  
Vol 34 (S1) ◽  
pp. 16-17
Author(s):  
Martina Andellini ◽  
Francesco Faggiano ◽  
Roxana di Mauro ◽  
Pietro Derrico ◽  
Matteo Ritrovato
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Conventional Therapy ◽  
Health Technology ◽  
Gait Training ◽  
Core Model ◽  
Gait Rehabilitation ◽  
Alternative Technologies ◽  
Movement Trajectories ◽  
Robotic Gait

Introduction:The purpose of this study is to gather evidence on safety and overall effectiveness of three alternative technologies for gait rehabilitation in diplegic children with Cerebral Palsy: robotic, conventional and joint conventional and robotic gait training.Methods:A new methodology, decision-oriented health technology assessment (DoHTA), was applied to assess the technology on clinical, technical, organizational, economic, social and ethical, legal and safety domains. This method, conceived as a hospital-based HTA tool for supporting the introduction of innovative technologies, has been implemented merging the EUnetHTA Core Model® with the Multi-Criteria Decision Analysis. In particular, the general items of the EUnetHTA Core Model® are re-formulated as performance indicators and re-placed along a decision tree structure that, from the one hand, respects the original top-down design of the EUnetHTA model (growing level of detail from domains to issues) and, from the other hand, allows obtaining a quantitative evaluation of each identified performance indicator.Results:The multiple indicators, which have been identified for the seven domains, play important and different roles in the alternative technologies evaluation. DoHTA results showed that robotic system offers the possibility to control more accurately the exerted forces and movement trajectories than the traditional therapy. It gives the possibility to measure the task performances parameters and to receive the patient feedback simultaneously. To carry out robotic gait rehabilitation fewer therapists are required compared with the conventional therapy, resulting in lower therapists’ physical workload.Conclusions:Despite the great perspectives that robotics offer to motor rehabilitation, it seems that robotic gait training could not provide greater benefits in terms of motor and functional recovery compared to the conventional therapy. Preliminary results, supported by most recent literature evidence, lead to the hypothesis that joint use of robotic and conventional therapy can produce better clinical outcomes than the separate use of the two rehabilitation techniques.

Az egészségügyi technológiaértékelés múltja, jelene és jövője – nemzetközi perspektívából

2021 ◽  
Vol 20 (2) ◽  
pp. 38-41
Author(s):  
Péter Szegner
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Core Model ◽  
European Network

Az egészségügy finanszírozása és fenntarthatósága kapcsán kiemelt fontosságú a bizonyítékokon alapuló döntéshozatal. Napjaink diszruptív trendjei – például a digitalizáció, az adatvezérelt rendszerek, és természetesen a COVID-19 járvány – illetve az egészségügyi rendszerek átalakulása következtében kiemelt szerep juthat a multidiszciplináris egészségügyi technológiaértékelés (Health Technology Assessment, HTA) területének. Magyar országon 2004 óta működik a HTA-val kapcsolatos feladatokat ellátó, társadalombiztosítási befogadási folyamatban döntéstámogató szereppel bíró Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet Technológia-értékelő Főosztálya (TÉF). Európai szinten a European Network for Health Technology Assessment (EUnetHTA) tekinthető az egyik legnagyobb volumenű nemzetközi kezdeményezésnek a területen, mely 2021-ben 29 országból 81 szervezetet ölelt fel. Az EUnetHTA számos eszköze és közös értékelése segíti a tagállamokat, ennek keretében jött létre a HTA Core Model, a gyártókkal folytatott korai tudományos konzultációk, vagy a befogadást követő tudományos bizonyítékok előállítását célzó pilotok. A jövőt illetően kiemelendő, hogy 2021 második felét követően jelentős átalakulás veszi kezdetét az európai technológiaértékelésben – így az EUnetHTA hálózat évtizedes együttműködése nem folytatódik tovább jelen formájában. Az átalakulás egyik fő hajtóereje az Európai Parlament és az Európai Unió Tanácsa által 2021 júniusában elfogadott HTA szabályozás. Az EUnetHTA által kidolgozott jövőbeli HTA együttműködés modellje (FMC) és az elmúlt 15 év nemzetközi tapasztalatai alapján állítható, hogy az ellátórendszerben megjelenő számos lehetőségre és kihívásra megfelelő választ tud majd adni az európai HTA közösség. A végső cél pedig továbbra is a betegek számára hozzáférhető és fenntartható egészségügyi szolgáltatások biztosítása, illetve a társadalom egészségi állapotának javítása lesz.

Community engagement in Health Technology Assessment and beyond: from guests in the process to hosts

2020 ◽  
pp. 1-3
Author(s):  
Catherine M. Holliday
Keyword(s):  
Health Technology Assessment ◽  
Community Engagement ◽  
Technology Assessment ◽  
Nonprofit Organization ◽  
Health Technology ◽  
Health Conditions ◽  
Significant Shift ◽  
Economic Evidence ◽  
Supportive Environments ◽  
Community Input

Abstract In Health Technology Assessment (HTA), clinical and economic evidence are assessed in the regulatory and reimbursement environments, with community input considered as complementary to this. Stakeholders are calling for more meaningful community engagement, but this will not be reached without a significant shift. The Centre for Community-Driven Research (CCDR) is a nonprofit organization bringing much needed change to the way we think about community engagement in health. This article is based on CCDR's experience and outlines three system changes needed to advance community engagement in decisions about health and HTA. This paper comes from the perspective of engaging everyday people in the process as opposed to representation on panels and committees. The three key areas of change that are discussed include building holistic evidence, creating supportive environments, and infrastructure for community engagement, with the term community referring to people affected by disease or health conditions and their carers/families.

scholarly journals Description of the use of multicriteria to support pricing and reimbursement decisions by European health technology assessment bodies

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
David Elvira ◽  
Mercè Obach ◽  
Caridad Pontes
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Assessment Tools ◽  
Assessment Model ◽  
Core Model ◽  
Specific Advice ◽  
European Health ◽  
Pricing And Reimbursement ◽  
Assessment Strategies

Abstract Background Heterogeneity in drug access throughout Europe may be influenced by differences in drug-assessment strategies. The EUnetHTA’s assessment core model (EUnetHTA-core) and the EVIDEM’s multicriteria framework are reference methodologies in this context, the latter including a wider compromise between non-contextual and contextual criteria. Compliance of 37 European Health Technology Assessment bodies (HTAb) with EUnetHTA-core has been reported, but the use of EVIDEM by this HTAb is still unknown. Methods To describe the uptake and use of multicriteria approaches to evaluate drug value by European HTAb using EVIDEM as reference framework, a multicriteria framework was obtained based on EVIDEM model. The criteria used for drug appraisal by HTAb was extracted from the EUnetHTA report, and completed through search of websites, publications and HTAb reports. Use of EVIDEM assessment model in 37 European HTAb has been described semi-quantitatively and summarized using an alignment heatmap. Results Aligned, medium or misaligned profiles were seen for 24,3%, 51,4% and 24,3% of HTAb when matching to EVIDEM dimensions and criteria was considered. HTAb with explicit responsibilities in providing specific advice on reimbursement showed more aligned profiles on contextual and non-contextual dimensions. Conclusions EUnetHTA’s core model is limited in assessing medicines while EVIDEM’s framework provides contextual dimension used by some HTAb in Europe that can be escalated to other agencies. Most of the 37 European HTAb have room to broaden their contextual assessment tools, especially when social and medical perception of need requires to be explicit to support payer’s decision on reimbursement.

scholarly journals Testing the HTA Core Model: Experiences from two pilot projects

2009 ◽  
Vol 25 (S2) ◽  
pp. 21-27 ◽  
Author(s):  
Iris Pasternack ◽  
Heidi Anttila ◽  
Marjukka Mäkelä ◽  
Tuija Ikonen ◽  
Pirjo Räsänen ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Core Model ◽  
Pilot Projects ◽  
Common Pool ◽  
Team Meetings ◽  
Maximum Utilization

Objectives: The aim of this study was to analyze and describe process and outcomes of two pilot assessments based on the HTA Core Model, discuss the applicability of the model, and explore areas of development.Methods: Data were gathered from HTA Core Model and pilot Core HTA documents, their validation feedback, questionnaires to investigators, meeting minutes, emails, and discussions in the coordinating team meetings in the Finnish Office for Health Technology Assessment (FINOHTA).Results: The elementary structure of the HTA Core Model proved useful in preparing HTAs. Clear scoping and good coordination in timing and distribution of work would probably help improve applicability and avoid duplication of work.Conclusions: The HTA Core Model can be developed into a platform that enables and encourages true HTA collaboration in terms of distribution of work and maximum utilization of a common pool of structured HTA information for national HTA reports.

scholarly journals PHP116 Clincal and Economic Evidence Bases for Health Technology Assessment: A Comparison of Three Jurisdictions

2011 ◽  
Vol 14 (7) ◽  
pp. A354
Author(s):  
J.W. Walter ◽  
D.S. Spinner ◽  
J. Birt ◽  
L. Bowman ◽  
J. Mauskopf ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Economic Evidence

scholarly journals Evaluation of Ethical Analyses in Seven Reports from the European Network for Health Technology Assessment

2019 ◽  
Vol 35 (4) ◽  
pp. 273-279
Author(s):  
Perihan Elif Ekmekci ◽  
Müberra Devrim Güner
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Analysis Data ◽  
Health Technology ◽  
Ethical Analysis ◽  
Core Model ◽  
European Network ◽  
Ethical Perspective ◽  
Existing Problems ◽  
Ethical Appropriateness

AbstractObjectivesEthics has been considered among the core domains of health technology assessment (HTA), but there are still disputes regarding ethical analysis. This study aimed to examine full final reports of the European Network for Health Technology Assessment (EUnetHTA) in terms of their compliance with the ethical methodology and ethical perspective of the HTA Core Model®.MethodsThe study examines seven full final HTA reports of EUnetHTA written based on the methodology proposed in the HTA Core Model®. The reports were analyzed using the following parameters: competency of the person/group who conducted ethical analysis, assessment elements, and the methodology of ethical analysis.ResultsThe results show that, although the HTA Core Model® helped to standardize the final reports of the assessment, there are still concerns regarding the competency of the ethical analysis team, the perspectives on the purpose of ethical analysis, data sources and viewpoints of various stakeholders, use of ethical analysis methodology, and the evaluation of the ethical appropriateness of the entire HTA process.ConclusionsThe HTA Core Model® helped to standardize the final reports on the HTA; however, not all issues with the content and outcomes were solved. The lack of expertise in ethics and insufficiency of the teams regarding ethical analysis are other existing problems. This study also demonstrated that stakeholder viewpoints in general and patient perspectives, in particular, have been overlooked in the HTA process.

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