Next Generation Health Technology Assessment to support patient-centred, societally oriented, real-time decision-making on access and reimbursement for health technologies throughout Europe

Informations projet

HTx

N° de convention de subvention: 825162

DOI

10.3030/825162

Projet clôturé

Date de signature de la CE 3 Decembre 2018

Date de début 1 Janvier 2019

Date de fin 30 Juin 2024

Financé au titre de

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Coût total

€ 9 640 775,00

Contribution de l’UE

€ 9 640 775,00

Coordonné par

UNIVERSITEIT UTRECHT
Netherlands

CORDIS fournit des liens vers les livrables publics et les publications des projets HORIZON.

Les liens vers les livrables et les publications des projets du 7e PC, ainsi que les liens vers certains types de résultats spécifiques tels que les jeux de données et les logiciels, sont récupérés dynamiquement sur OpenAIRE .

Livrables

Documents, reports (27)

Review on the current synergies with clinical guideline developers
A theoretical description of the suite of stratified and individualised cost-effectiveness analysis models that incorporate real-world data and open-access software code

A theoretical description of the suite of stratified and individualised costeffectiveness analysis models that incorporate realworld data and openaccess software code

. Reviews on applicable patients and models for proton therapy for patients with head and neck cancer

Reviews on applicable patients and models for proton therapy for patients with head and neck cancer

Report on real-word health outcomes (on population average and in subgroups) under different drug options for patients with relapsing-remitting MS

Report on realword health outcomes on population average and in subgroups under different drug options for patients with relapsingremitting MS

Report on Generalisation on the results of case studies
Overview of the development of the use of RWD including a review of international consensus methods currently developed
Report on the use of AI to predict treatment effect of orphan diseases. Experiments on how artificial data can be used to build better models when the available data set is small
Report on trade-off between treatment effectiveness and cost. Report and experiments how Pareto optimal results can be used to estimate the trade-off between treatment effectiveness and cost. (M60). These results also include a comparison to the results o

Report on trade-off between treatment effectiveness and cost. Report and experiments how Pareto optimal results can be used to estimate the trade-off between treatment effectiveness and cost. (M60). These results also include a comparison to the results of the health econometric analysis used in WP2

Dissemination plan, development of a corporate image and Project website

Dissemination plan development of a corporate image and Project website

Report on comparison of treatment models with real life in MDS patients using the EUMDS registry
Ontology on HTx Project

HTx Ontology

Systematic review

Systematic review on how cost effectiveness of combinations of health technologies individualisedpersonalised treatments and treatment pathways is currently being assessed by HTA bodies

Recommendations about the use of statistical modelling framework and the AI framework to make real-world prediction
Report on the comparative (cost-) effectiveness of proton therapy for patients with head and neck cancer

Report on the comparative (cost-) effectiveness of proton therapy for patients with head and neck cancer.

Reports outlining the acceptability and usefulness of the topics considered in the policy sandbox events, inclusive of recommendations on how project work can be translated into HTA policies and practices.
. Report on the relevant treatment combinations for the T1DM and T2DM patients

Report on the relevant treatment combinations for the T1DM and T2DM patients

Report on validation of AI models in DM1 and DM2 RW datasources

Report on validation AI models in DM T2 patient registries

Report of explanatory factors for treatment effectiveness based on the data from the case study. This includes experimental results using different machine learning methods showing which signals and factors are most important

Report of explanatory factors for treatment effectiveness based on the data from the case study This includes experimental results using different machine learning methods showing which signals and factors are most important

A theoretical description of the suite of network meta-analysis models for real-world effectiveness within patient subgroups and open-access software code

A theoretical description of the suite of network metaanalysis models for realworld effectiveness within patient subgroups and openaccess software code

Report describing the available data sources in MS

Report describing the available data sources in MS the parameters that they can estimate and an evaluation of their agreement and disagreement with respect to the evidence they provide on treatment effects

Review on the outcomes of synergies between regulatory agencies and HTA agencies
Policy paper on transferability of payment models throughout Europe (including low- and middle-income countries

Policy paper on transferability of payment models throughout Europe including low and middleincome countries

Review on treatment modalities for patients with myelodysplastic syndrome (MDS)

Review on treatment modalities for patients with myelodysplastic syndrome MDS

Review on suitable payment models for co-dependent technologies, combination technologies and advanced therapy medicinal products (ATMP's) and provide suggestions of alternative models

Review on suitable payment models for codependent technologies combination technologies and advanced therapy medicinal products ATMPs and provide suggestions of alternative models

Report on the prediction of treatment effectiveness. Experimental results using different machine learning methods showing how well explanatory factors can predict treatment effectiveness

Report on the prediction of treatment effectiveness Experimental results using different machine learning methods showing how well explanatory factors can predict treatment effectiveness

Review of change models methods for multi-lateral, multi-stakeholder initiatives

informed framework for realising change and commitment in the context of multilateral multistakeholder collaboration

Acceptability of pricing discussion during shared-decision making process between patients and physicians

understand how patients could be meaningfully and actively engaged in their care.

Demonstrators, pilots, prototypes (11)

Report on the synthesis of data from RCT and RWD of MDS patients with myelodysplastic syndrome

Report on the synthesis of data from RCT and RWD of MDS patients with myelodysplastic syndrome (MDS)

Policy sandbox events used to test shared decision-making (SDM) methods and payment models
Web application enabling users to select PROMs
Report of workshops to identify activities to increase the synergies with guideline developers

Report of Workshops to identify activities to increase the synergies with guideline developers

A theoretical description of the suite of network meta-analysis models for real-world effectiveness and open-access software code

A theoretical description of the suite of network metaanalysis models for realworld effectiveness and openaccess software code

A series of statistical / micro-econometrics models to estimate key input parameters (e.g. treatment effects, risks, costs and benefits) from RWD for use in cost-effectiveness analysis
Report of workshops alignment with other H2020 and IMI projects
Report on the assessment of transferability study cases
A theoretical description of the statistical prediction model that predicts health outcomes and costs for treatments and treatment pathways in real world, the associated open-access software code
Report of workshop on how clinicians and patients can use RWE to explore expectations regarding the outcome(s) of treatment and to make shared decisions

Report of workshop on how clinicians and patients can use RWE to explore expectations regarding the outcomes of treatment and to make shared decisions

Report on how AI can help patients and healthcare professionals in decision-making on optimal treatment strategy. Report on how and what results should be visualised and presented to healthcare professionals. This report will also include a comparison wit

Report on how AI can help patients and healthcare professionals in decision-making on optimal treatment strategy. Report on how and what results should be visualised and presented to healthcare professionals. This report will also include a comparison with the toolkit that is developed in WP2

Websites, patent fillings, videos etc. (1)

Training materials for patients (toolbox) presented on the project website

Publications

Peer reviewed articles (32)

A Systematic Review of Collective Evidences Investigating the Effect of Diabetes Monitoring Systems and Their Application in Health Care

Auteurs: Maria Kamusheva, Konstantin Tachkov, Maria Dimitrova, Zornitsa Mitkova, Gema García-Sáez, M. Elena Hernando, Wim Goettsch, Guenka Petrova
Publié dans: Frontiers in endocrinology, 2020, ISSN 1664-2392
Éditeur: Frontiers Media
DOI: 10.3389/fendo.2021.636959

Real World Data in Health Technology Assessment of Complex Health Technologies. Frontiers in Pharmacology.  

Auteurs: Hogervorst, M. A., Pontén, J., Vreman, R. A., Mantel-Teeuwisse, A. K., Goettsch W. G
Publié dans: Frontiers in Pharmacology, 2022, ISSN 1663-9812
Éditeur: Frontiers Media S.A.
DOI: 10.3389/fphar.2022.837302

Potential Barriers of Patient Involvement in Health Technology Assessment in Central and Eastern European Countries. Frontiers in Public Health.  

Auteurs: Dimitrova, M., Jakab, I., Mitkova, Z., Kamusheva, M., Tachkov, K., Németh, B., Zemplényi, A., Dawoud, D., Delnoij, D. M. J., Houýez, F., Kaló, Z
Publié dans: Frontiers in Public Health, 2023, ISSN 1471-6348
Éditeur: Frontiers Media S.A
DOI: 10.3389/fpubh.2022.922708

ClinFlow–An Interactive Application for Clinical Data Mining

Auteurs: Oana Stoicescu, Eija Ferreira, Satu Tamminen, Pekka Siirtola, Gunjan Chandra, Riitta Veijola, Juha Röning
Publié dans: Public Health and Informatics, 2021, ISSN 1947-2579
Éditeur: Chicago IL
DOI: 10.3233/shti210162

The relation between prediction model performance measures and patient selection outcomes for proton therapy in head and neck cancer.

Auteurs: Leeuwenberg AM, Reitsma JB, Van den Bosch LGLJ, Hoogland J, van der Schaaf A , Hoebers FJP, Wijers OB, Langendijk JA, Moons KGM, Schuit E
Publié dans: Journal of the European Society for Therapeutic Radiology and Oncology, 2022, ISSN 0167-8140
Éditeur: Elsevier BV
DOI: 10.1016/j.radonc.2022.109449

A Review of Economic Models Submitted to NICE’s Technology Appraisal Programme, for Treatments of T1DM & T2DM. Frontiers in Pharmacology.  

Auteurs: Daly, M-J., Elvidge, J., Chantler, T., Dawoud, D
Publié dans: Frontiers in Pharmacology, 2022, ISSN 1663-9812
Éditeur: Frontiers Media S.A.
DOI: 10.3389/fphar.2022.887298

Using real-world evidence in healthcare from Western to Central and Eastern Europe: a review of existing barriers. Journal of Comparative Effectiveness Research.  

Auteurs: Kamusheva, M., Németh, B., Zemplényi, A., Kaló, Z., Elvidge, J., Dimitrova, M., Pontén, J., Tachkov, K., Mitkova, Z.
Publié dans: Journal of Comparative Effectiveness Research, 2022, ISSN 2042-6305
Éditeur: Future Medicine Ltd.
DOI: 10.2217/cer-2022-0065

Comparing methods addressing multi-collinearity when developing prediction models

Auteurs: Leeuwenberg, Artuur M.; van Smeden, Maarten; Langendijk, Johannes A.; van der Schaaf, Arjen; Mauer, Murielle E.; Moons, Karel G. M.; Reitsma, Johannes B.; Schuit, Ewoud
Publié dans: Diagnostic and Prognostic Research, Numéro 5, 2022, ISSN 2397-7523
Éditeur: BioMed Central
DOI: 10.1186/s41512-021-00115-5

Decision Curve Analysis for Personalized Treatment Choice between Multiple Options. Medical Decision Making.  

Auteurs: Chalkou, K., Vickers, A.J., Pellegrini, F., Manca, A., Salanti, G
Publié dans: Society for Medical Decision Making, 2023, ISSN 0272-989X
Éditeur: Sage Science Press
DOI: 10.1177/0272989x221143058

Impacts of Data Synthesis: A Metric for Quantifiable Data Standards and Performances. Data

Auteurs: Chandra, G., Siirtola, P., Tamminen, S., Knip, M.J., Veijola, R., Röning, J
Publié dans: Data, 2022, ISSN 2306-5729
Éditeur: MDPI
DOI: 10.3390/data7120178

Understanding innovation of health technology assessment methods: the IHTAM framework

Auteurs: Li Jiu, Milou A. Hogervorst, Rick A. Vreman, Rick A. Vreman, Aukje K. Mantel-Teeuwisse, Wim G. Goettsch
Publié dans: Technology Assessment in Health Care, 2022, ISSN 0266-4623
Éditeur: Cambridge University Press
DOI: 10.1017/s0266462322000010

Health technology assessment of tests for SARS-CoV-2 and treatments for COVID-19: A proposed approach and best-practice recommendations. International Journal of Technology Assessment in Health Care.  

Auteurs: Elvidge, J., Summerfield, A., Knies, S., Németh, B., Kaló, Z., Goettsch, W., Dawoud, D. (2023).
Publié dans: International Journal of Technology Assessment in Health Care, 2023, ISSN 1471-6348
Éditeur: Cambridge University Press
DOI: 10.1017/s0266462323000223

Reimbursement and payment models in Central and Eastern European as well as Middle Eastern countries: A survey of their current use and future outlook. Drug Discovery Today.  

Auteurs: Callenbach, M.H. E., Ádám, I., Vreman, R. A., Németh, B., Kaló, Z., Goettsch, W. G
Publié dans: Drug Discovery Today, 2023, ISSN 1359-6446
Éditeur: Elsevier BV
DOI: 10.1016/j.drudis.2022.103433

Recommendations to overcome barriers to the use of artificial intelligence-driven evidence in health technology assessment. Frontiers in Public Health.  

Auteurs: Zemplényi, A., Tachkov, K., Balkanyi, L., Németh, B., Petykó, Zs. I., Petrova, G., Czech, M., Dawoud, D., Goettsch, W., Gutierrez, I. I., Hren, R., Knies, S., Lorenzovici, L., Maravic, Z., Piniazhko, O., Savova, A., Manova, M., Tesar, T., Zerovnik, S., Kaló, Z
Publié dans: Frontiers in Public Health, 2023, ISSN 1664-8714
Éditeur: Frontiers Media S.A
DOI: 10.3389/fpubh.2023.1088121

Synergy between health technology assessments and clinical guidelines for multiple sclerosis. Clinical and Translational Science.  

Auteurs: Hogervorst, M. A., Vreman, R. A., Zawada, A., Zielińska, M., Dawoud, D. M., de Jong, B. A., Mantel- Teeuwisse, A. K., Goettsch, W. G. (2023).
Publié dans: Clinical and Translational Science, 2023, ISSN 1752-8062
Éditeur: Wiley-Blackwell
DOI: 10.1111/cts.13492

Delayed payment schemes in Central-Eastern Europe and Middle-East.

Auteurs: Ádám, I., Callenbach, M., Németh, B., Vreman, R. A., Pontén, J., Strbad, T., Dawoud, D., Kostyuk, A., Seyam, A., Nagy, L., Goettsch, W. G., Kaló, Z.
Publié dans: Frontiers in Medicine, 2022, ISSN 2296-858X
Éditeur: Frontiers Media S.A
DOI: 10.3389/fmed.2022.940371

Reported Challenges in Health Technology Assessment of Complex Health Technologies

Auteurs: Milou A. Hogervorst; Rick A. Vreman; Aukje K. Mantel-Teeuwisse; Wim G. Goettsch
Publié dans: Value in Health, Numéro 1, 2021, ISSN 1098-3015
Éditeur: Blackwell Publishing Inc.
DOI: 10.1016/j.jval.2021.11.1356

The sandbox approach and its potential for use in health technology assessment: A literature review

Auteurs: Emily Leckenby, Dalia Dawoud, Jacoline Bouvy, Páll Jónsson
Publié dans: Applied health economics and health policy, 2021, ISSN 1175-5652
Éditeur: Open Mind Journals
DOI: 10.1007/s40258-021-00665-1

Development, validation and clinical usefulness of a prognostic model for relapse in relapsing-remitting multiple sclerosis

Auteurs: Chalkou, Konstantina; Steyerberg, Ewout; Bossuyt, Patrick; Subramanian, Suvitha; Benkert, Pascal; Kuhle, Jens; Disanto, Giulio; Kappos, Ludwig; Egger, Matthias; Salanti, Georgia
Publié dans: Diagnostic and Prognostic Research, Numéro 3, 2021, ISSN 2397-7523
Éditeur: BioMed Central
DOI: 10.1186/s41512-021-00106-6

Data-Driven Identification of Long-Term Glycemia Clusters and Their Individualized Predictors in Finnish Patients with Type 2 Diabetes. Clinical Epidemiology.  

Auteurs: Lavikainen, P., Chandra, G., Siirtola, P., Tamminen, S., Ihalapathirana, A.T., Röning, J., Laatikainen, T., Martikainen, J
Publié dans: Journal of Clinical Epidemiology, 2023, ISSN 1878-5921
Éditeur: Elsevier
DOI: 10.2147/clep.s380828

Synthesizing cross-design evidence and cross-format data using network meta-regression. Research Synthesis Methods.  

Auteurs: Hamza, T., Chalkou, K., Pellegrini, F., Kuhle, J., Benkert, P., Lorscheider, J., Zecca, C., Iglesias-Urrutia, C. P., Manca, A., Furukawa, T. A., Cipriani, A., Salanti, G. (2023).
Publié dans: Research Synthesis Methods, 2023, ISSN 1759-2887
Éditeur: Wiley
DOI: 10.1002/jrsm.1619

Assessing Technologies for COVID-19: What are the Challenges for Health Technology Assessment Agencies? Findings From a Survey and Roundtable Workshop.

Auteurs: Jamie Elvidge; Dalia Dawoud; Dalia Dawoud
Publié dans: Pharmacoeconomics, Numéro 1, 2021, ISSN 1170-7690
Éditeur: Adis International Ltd.
DOI: 10.1007/s40273-021-01097-4

Recommendations for patient involvement in health technology assessment in Central and Eastern European countries. Frontiers in Public Health. 

Auteurs: Jakab, I., Dimitrova, M., Houÿez, F., Bereczky, T., Fövényes, M., Maravic, Z., Belina, I., Andriciuc, C., Tóth, K., Piniazhko, O., Hren, R., Gutierrez-Ibarluzea, I., Czech, M., Tesar, T., Niewada, M., Lorenzovici, L., Kamusheva, M., Manova, M., Savova, A., Mitkova, Z., Tachkov, K., Németh, B., Petykó, Zs. I., Dawoud, D., Delnoij, D., Knies, S., Goettsch, W., Kaló, Z. (2023).
Publié dans: Frontiers in Public Health, 2023, ISSN 1664-8714
Éditeur: Frontiers Media S.A
DOI: 10.3389/fpubh.2023.1176200

A Bayesian dose-response meta-analysis model: A simulations study and application

Auteurs: Tasnim Hamza; Andrea Cipriani; Toshi A. Furukawa; Matthias Egger; Nicola Orsini; Georgia Salanti
Publié dans: Statistical Methods in Medical Research, Numéro 3, 2021, ISSN 0962-2802
Éditeur: SAGE Publications
DOI: 10.1177/0962280220982643

Barriers to Use Artificial Intelligence Methodologies in Health Technology Assessment in Central and East European Countries. Frontiers in Public Health.  

Auteurs: Tachkov, K., Zemplenyi, A., Kamusheva, M., Dimitrova, M., Siirtola, P., Pontén, J., Németh, B., Kaló, Z., Petrova, G
Publié dans: Frontiers in Public Health, 2022, ISSN 1471-6348
Éditeur: Frontiers Media S.A
DOI: 10.3389/fpubh.2022.921226

Diagnostics and Treatments of COVID-19: A Living Systematic Review of Economic Evaluations

Auteurs: Jamie Elvidge, Ashley Summerfield, David Nicholls, Dalia Dawoud
Publié dans: Value in Health, 2022, ISSN 1098-3015
Éditeur: Blackwell Publishing Inc.
DOI: 10.1016/j.jval.2022.01.001

The Potential Value of Identifying Type 2 Diabetes Subgroups in the CPRD Cohort for Guiding Intensive Treatment: A HTx Study Comparing Novel Data-Driven Clustering to Traditional Risk-Driven Subgroups

Auteurs: Xinyu Li, Junfeng Wang, James Altunkaya, Francisco Javier Somolinos-Simón, Anoukh van Giessen, Li Jiu et al
Publié dans: Diabetes care journal, 2023, ISSN 0149-5992
Éditeur: American Diabetes Association
DOI: 10.2337/dc22-2170

Improving interactions between health technology assessment bodies and regulatory agencies: a systematic review and cross-sectional survey on processes, progress, outcomes, and challenges

Auteurs: Richard Ofori-Asenso, Christine E. Hallgreen, Marie Louise De Bruin
Publié dans: Frontiers in Medicine, 2020, ISSN 2296-858X
Éditeur: Frontiers Media S.A.
DOI: 10.3389/fmed.2020.582634

Guidance on using real-world evidence from Western Europe in Central and Eastern European health policy decision making. Journal of Comparative Effectiveness Research. 

Auteurs: Németh, B., Kamusheva, M., Mitkova, Z., Petykó, Zs. I., Zemplényi, A., Dimitrova, M., Tachkov, K., Balkányi, L., Czech, M., Dawoud, D., Goettsch, W., Hren, R., Knies, S., Lorenzovici, L., Maravic, Z., Piniazhko, O., Zerovnik, S., Kaló, Z
Publié dans: Journal of Comparative Effectiveness Research, 2023, ISSN 2042-6305
Éditeur: Future Medicine Ltd.
DOI: 10.57264/cer-2022-0157

A two‐stage prediction model for heterogeneous effects of treatments

Auteurs: Konstantina Chalkou, Ewout Steyerberg, Matthias Egger, Andrea Manca, Fabio Pellegrini, Georgia Salanti
Publié dans: Statistics in Medicine, 2021, ISSN 0277-6715
Éditeur: John Wiley & Sons Inc.
DOI: 10.1002/sim.9034

Outcome-based reimbursement in Central-Eastern Europe and Middle-East. Frontiers in Medicine.  

Auteurs: Ádám, I., Callenbach, M., Németh, B., Vreman, R.A., Tollin, C., Pontén, J., Dawoud, D., Elvidge, J., Crabb, N., van Waalwijk van Doorn-Khosrovani, S.B., Pisters-van Roy, A., Vincziczki, Á., Almomani, E., Vajagic, M., Oner, Z.G., Matni, M., Fürst, J., Kahveci, R., Goettsch, W.G., Kaló, Z
Publié dans: Frontiers in Medicine, 2022, ISSN 2296-858X
Éditeur: Frontiers Media S.A
DOI: 10.3389/fmed.2022.940886

OP96 Patient Reported Outcome Measure-Select App. International Journal of Technology Assessment in Health Care.  

Auteurs: Quik, E
Publié dans: International Journal of Technology Assessment in Health Care, 2022, ISSN 1471-6348
Éditeur: Cambridge University Pres
DOI: 10.1017/s0266462322001428