A Delphi study on valuing DNA sequencing in oncology: a European stakeholder developed framework for assessing next generation sequencing and comprehensive genomic profiling diagno...

Autores
Augustovski, Federico Ariel; Danitza, Chavez; Madeleine, Haig; Caitlin, Main; Argento, Fernando; Colaci, Carla; Mackenzie, Mills; Alfie, Verónica; Pichón-Riviere, Andres; Alcaraz, Andrea; Panos, Kanavos
Año de publicación
2025
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Background: Advanced genomic technologies like Next Generation Sequencing and Comprehensive Genomic Profiling are pivotal for the prevention, management and treatment of cancer by identifying crucial genetic markers. However, their adoption in Europe is inconsistent, partly due to the lack of a validated approach to assessing their value.Methods: A multi-phase mixed-methods approach was implemented, integrating a systematic review and multi-stakeholder consensus-generating Delphi exercise to derive a comprehensive set of value criteria and arrive at a value assessment framework. This value assessment framework adapted an existing Latin American-focused diagnostic framework to the European context. The Delphi included representatives from the broader stakeholder community (patient advocacy, industry, decision-makers, health technology assessment, regulators, academia, and physicians). Over four rounds, participants refined and rated the significance of these criteria in the context of the assessment of the specified technologies in oncology, particularly for reimbursement decisions. Responses were analysed in terms of stability and level of consensus in order to generate a final value assessment framework.Findings: 34 individuals participated in all rounds of the Delphi exercise. The final value assessment framework includes 8 distinct value criteria, including: clinical impact; test performance and quality; quality of scientific evidence; non-clinical impact; impact on health system integration, organisation and delivery of care; economic aspects; ethical and governance concerns; and health system priorities. Within these criteria, a total of 27 distinct sub-criteria were identified, 23 of which had consensus as ´important´ or ´very important´ in assessing value.Interpretation: The resultant value assessment framework is validated by a wide range of key European stakeholders and enables systematic assessment of Next Generation Sequencing and Comprehensive Genomic Profiling technologies used in oncology diagnostics within the European setting. The framework includes aspects that are not adequately considered in current health technology assessment and goes beyond existing value assessment frameworks through the inclusion of newer criteria such as data governance concerns.Funding: Funding was provided by the Precision Cancer Consortium with an unrestricted educational grant.
Fil: Augustovski, Federico Ariel. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Danitza, Chavez. The London School of Economics and Political Science; Reino Unido
Fil: Madeleine, Haig. The London School of Economics and Political Science; Reino Unido
Fil: Caitlin, Main. The London School of Economics and Political Science; Reino Unido
Fil: Argento, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Colaci, Carla. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Mackenzie, Mills. The London School of Economics and Political Science; Reino Unido
Fil: Alfie, Verónica. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Pichón-Riviere, Andres. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Alcaraz, Andrea. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Panos, Kanavos. The London School of Economics and Political Science; Reino Unido
Materia
Decision-making
Delphi panel
Health technology assessment
NGS/CGP diagnostics
Next generation sequencing
Precision medicine
Value framework
Comprehensive genomic profiling
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/291106
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/291106
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling A Delphi study on valuing DNA sequencing in oncology: a European stakeholder developed framework for assessing next generation sequencing and comprehensive genomic profiling diagnosticsAugustovski, Federico ArielDanitza, ChavezMadeleine, HaigCaitlin, MainArgento, FernandoColaci, CarlaMackenzie, MillsAlfie, VerónicaPichón-Riviere, AndresAlcaraz, AndreaPanos, KanavosDecision-makingDelphi panelHealth technology assessmentNGS/CGP diagnosticsNext generation sequencingPrecision medicineValue frameworkComprehensive genomic profilinghttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Background: Advanced genomic technologies like Next Generation Sequencing and Comprehensive Genomic Profiling are pivotal for the prevention, management and treatment of cancer by identifying crucial genetic markers. However, their adoption in Europe is inconsistent, partly due to the lack of a validated approach to assessing their value.Methods: A multi-phase mixed-methods approach was implemented, integrating a systematic review and multi-stakeholder consensus-generating Delphi exercise to derive a comprehensive set of value criteria and arrive at a value assessment framework. This value assessment framework adapted an existing Latin American-focused diagnostic framework to the European context. The Delphi included representatives from the broader stakeholder community (patient advocacy, industry, decision-makers, health technology assessment, regulators, academia, and physicians). Over four rounds, participants refined and rated the significance of these criteria in the context of the assessment of the specified technologies in oncology, particularly for reimbursement decisions. Responses were analysed in terms of stability and level of consensus in order to generate a final value assessment framework.Findings: 34 individuals participated in all rounds of the Delphi exercise. The final value assessment framework includes 8 distinct value criteria, including: clinical impact; test performance and quality; quality of scientific evidence; non-clinical impact; impact on health system integration, organisation and delivery of care; economic aspects; ethical and governance concerns; and health system priorities. Within these criteria, a total of 27 distinct sub-criteria were identified, 23 of which had consensus as ´important´ or ´very important´ in assessing value.Interpretation: The resultant value assessment framework is validated by a wide range of key European stakeholders and enables systematic assessment of Next Generation Sequencing and Comprehensive Genomic Profiling technologies used in oncology diagnostics within the European setting. The framework includes aspects that are not adequately considered in current health technology assessment and goes beyond existing value assessment frameworks through the inclusion of newer criteria such as data governance concerns.Funding: Funding was provided by the Precision Cancer Consortium with an unrestricted educational grant.Fil: Augustovski, Federico Ariel. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Danitza, Chavez. The London School of Economics and Political Science; Reino UnidoFil: Madeleine, Haig. The London School of Economics and Political Science; Reino UnidoFil: Caitlin, Main. The London School of Economics and Political Science; Reino UnidoFil: Argento, Fernando. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Colaci, Carla. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Mackenzie, Mills. The London School of Economics and Political Science; Reino UnidoFil: Alfie, Verónica. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Pichón-Riviere, Andres. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Alcaraz, Andrea. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Panos, Kanavos. The London School of Economics and Political Science; Reino UnidoElsevier2025-11info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/291106Augustovski, Federico Ariel; Danitza, Chavez; Madeleine, Haig; Caitlin, Main; Argento, Fernando; et al.; A Delphi study on valuing DNA sequencing in oncology: a European stakeholder developed framework for assessing next generation sequencing and comprehensive genomic profiling diagnostics; Elsevier; eBioMedicine; 121; 11-2025; 1-102352-3964CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://linkinghub.elsevier.com/retrieve/pii/S2352396425003913info:eu-repo/semantics/altIdentifier/doi/10.1016/j.ebiom.2025.105947info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2026-08-25T15:33:08Zoai:ri.conicet.gov.ar:11336/291106instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982026-08-25 15:33:09.408CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv A Delphi study on valuing DNA sequencing in oncology: a European stakeholder developed framework for assessing next generation sequencing and comprehensive genomic profiling diagnostics
title A Delphi study on valuing DNA sequencing in oncology: a European stakeholder developed framework for assessing next generation sequencing and comprehensive genomic profiling diagnostics
spellingShingle A Delphi study on valuing DNA sequencing in oncology: a European stakeholder developed framework for assessing next generation sequencing and comprehensive genomic profiling diagnostics
Augustovski, Federico Ariel
Decision-making
Delphi panel
Health technology assessment
NGS/CGP diagnostics
Next generation sequencing
Precision medicine
Value framework
Comprehensive genomic profiling
title_short A Delphi study on valuing DNA sequencing in oncology: a European stakeholder developed framework for assessing next generation sequencing and comprehensive genomic profiling diagnostics
title_full A Delphi study on valuing DNA sequencing in oncology: a European stakeholder developed framework for assessing next generation sequencing and comprehensive genomic profiling diagnostics
title_fullStr A Delphi study on valuing DNA sequencing in oncology: a European stakeholder developed framework for assessing next generation sequencing and comprehensive genomic profiling diagnostics
title_full_unstemmed A Delphi study on valuing DNA sequencing in oncology: a European stakeholder developed framework for assessing next generation sequencing and comprehensive genomic profiling diagnostics
title_sort A Delphi study on valuing DNA sequencing in oncology: a European stakeholder developed framework for assessing next generation sequencing and comprehensive genomic profiling diagnostics
dc.creator.none.fl_str_mv Augustovski, Federico Ariel
Danitza, Chavez
Madeleine, Haig
Caitlin, Main
Argento, Fernando
Colaci, Carla
Mackenzie, Mills
Alfie, Verónica
Pichón-Riviere, Andres
Alcaraz, Andrea
Panos, Kanavos
author Augustovski, Federico Ariel
author_facet Augustovski, Federico Ariel
Danitza, Chavez
Madeleine, Haig
Caitlin, Main
Argento, Fernando
Colaci, Carla
Mackenzie, Mills
Alfie, Verónica
Pichón-Riviere, Andres
Alcaraz, Andrea
Panos, Kanavos
author_role author
author2 Danitza, Chavez
Madeleine, Haig
Caitlin, Main
Argento, Fernando
Colaci, Carla
Mackenzie, Mills
Alfie, Verónica
Pichón-Riviere, Andres
Alcaraz, Andrea
Panos, Kanavos
author2_role author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Decision-making
Delphi panel
Health technology assessment
NGS/CGP diagnostics
Next generation sequencing
Precision medicine
Value framework
Comprehensive genomic profiling
topic Decision-making
Delphi panel
Health technology assessment
NGS/CGP diagnostics
Next generation sequencing
Precision medicine
Value framework
Comprehensive genomic profiling
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Background: Advanced genomic technologies like Next Generation Sequencing and Comprehensive Genomic Profiling are pivotal for the prevention, management and treatment of cancer by identifying crucial genetic markers. However, their adoption in Europe is inconsistent, partly due to the lack of a validated approach to assessing their value.Methods: A multi-phase mixed-methods approach was implemented, integrating a systematic review and multi-stakeholder consensus-generating Delphi exercise to derive a comprehensive set of value criteria and arrive at a value assessment framework. This value assessment framework adapted an existing Latin American-focused diagnostic framework to the European context. The Delphi included representatives from the broader stakeholder community (patient advocacy, industry, decision-makers, health technology assessment, regulators, academia, and physicians). Over four rounds, participants refined and rated the significance of these criteria in the context of the assessment of the specified technologies in oncology, particularly for reimbursement decisions. Responses were analysed in terms of stability and level of consensus in order to generate a final value assessment framework.Findings: 34 individuals participated in all rounds of the Delphi exercise. The final value assessment framework includes 8 distinct value criteria, including: clinical impact; test performance and quality; quality of scientific evidence; non-clinical impact; impact on health system integration, organisation and delivery of care; economic aspects; ethical and governance concerns; and health system priorities. Within these criteria, a total of 27 distinct sub-criteria were identified, 23 of which had consensus as ´important´ or ´very important´ in assessing value.Interpretation: The resultant value assessment framework is validated by a wide range of key European stakeholders and enables systematic assessment of Next Generation Sequencing and Comprehensive Genomic Profiling technologies used in oncology diagnostics within the European setting. The framework includes aspects that are not adequately considered in current health technology assessment and goes beyond existing value assessment frameworks through the inclusion of newer criteria such as data governance concerns.Funding: Funding was provided by the Precision Cancer Consortium with an unrestricted educational grant.
Fil: Augustovski, Federico Ariel. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Danitza, Chavez. The London School of Economics and Political Science; Reino Unido
Fil: Madeleine, Haig. The London School of Economics and Political Science; Reino Unido
Fil: Caitlin, Main. The London School of Economics and Political Science; Reino Unido
Fil: Argento, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Colaci, Carla. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Mackenzie, Mills. The London School of Economics and Political Science; Reino Unido
Fil: Alfie, Verónica. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Pichón-Riviere, Andres. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Alcaraz, Andrea. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Panos, Kanavos. The London School of Economics and Political Science; Reino Unido
description Background: Advanced genomic technologies like Next Generation Sequencing and Comprehensive Genomic Profiling are pivotal for the prevention, management and treatment of cancer by identifying crucial genetic markers. However, their adoption in Europe is inconsistent, partly due to the lack of a validated approach to assessing their value.Methods: A multi-phase mixed-methods approach was implemented, integrating a systematic review and multi-stakeholder consensus-generating Delphi exercise to derive a comprehensive set of value criteria and arrive at a value assessment framework. This value assessment framework adapted an existing Latin American-focused diagnostic framework to the European context. The Delphi included representatives from the broader stakeholder community (patient advocacy, industry, decision-makers, health technology assessment, regulators, academia, and physicians). Over four rounds, participants refined and rated the significance of these criteria in the context of the assessment of the specified technologies in oncology, particularly for reimbursement decisions. Responses were analysed in terms of stability and level of consensus in order to generate a final value assessment framework.Findings: 34 individuals participated in all rounds of the Delphi exercise. The final value assessment framework includes 8 distinct value criteria, including: clinical impact; test performance and quality; quality of scientific evidence; non-clinical impact; impact on health system integration, organisation and delivery of care; economic aspects; ethical and governance concerns; and health system priorities. Within these criteria, a total of 27 distinct sub-criteria were identified, 23 of which had consensus as ´important´ or ´very important´ in assessing value.Interpretation: The resultant value assessment framework is validated by a wide range of key European stakeholders and enables systematic assessment of Next Generation Sequencing and Comprehensive Genomic Profiling technologies used in oncology diagnostics within the European setting. The framework includes aspects that are not adequately considered in current health technology assessment and goes beyond existing value assessment frameworks through the inclusion of newer criteria such as data governance concerns.Funding: Funding was provided by the Precision Cancer Consortium with an unrestricted educational grant.
publishDate 2025
dc.date.none.fl_str_mv 2025-11
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/291106
Augustovski, Federico Ariel; Danitza, Chavez; Madeleine, Haig; Caitlin, Main; Argento, Fernando; et al.; A Delphi study on valuing DNA sequencing in oncology: a European stakeholder developed framework for assessing next generation sequencing and comprehensive genomic profiling diagnostics; Elsevier; eBioMedicine; 121; 11-2025; 1-10
2352-3964
CONICET Digital
CONICET
url http://hdl.handle.net/11336/291106
identifier_str_mv Augustovski, Federico Ariel; Danitza, Chavez; Madeleine, Haig; Caitlin, Main; Argento, Fernando; et al.; A Delphi study on valuing DNA sequencing in oncology: a European stakeholder developed framework for assessing next generation sequencing and comprehensive genomic profiling diagnostics; Elsevier; eBioMedicine; 121; 11-2025; 1-10
2352-3964
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/https://linkinghub.elsevier.com/retrieve/pii/S2352396425003913
info:eu-repo/semantics/altIdentifier/doi/10.1016/j.ebiom.2025.105947
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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