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Scenario drafting for early technology assessment of next generation sequencing in clinical oncology

BACKGROUND: Next Generation Sequencing (NGS) is expected to lift molecular diagnostics in clinical oncology to the next level. It enables simultaneous identification of mutations in a patient tumor, after which targeted therapy may be assigned. This approach could improve patient survival and/or ass...

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Autores principales: Joosten, S.E.P., Retèl, V.P., Coupé, V.M.H., van den Heuvel, M.M., van Harten, W.H.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4744630/
https://www.ncbi.nlm.nih.gov/pubmed/26851938
http://dx.doi.org/10.1186/s12885-016-2100-0
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author Joosten, S.E.P.
Retèl, V.P.
Coupé, V.M.H.
van den Heuvel, M.M.
van Harten, W.H.
author_facet Joosten, S.E.P.
Retèl, V.P.
Coupé, V.M.H.
van den Heuvel, M.M.
van Harten, W.H.
author_sort Joosten, S.E.P.
collection PubMed
description BACKGROUND: Next Generation Sequencing (NGS) is expected to lift molecular diagnostics in clinical oncology to the next level. It enables simultaneous identification of mutations in a patient tumor, after which targeted therapy may be assigned. This approach could improve patient survival and/or assist in controlling healthcare costs by offering expensive treatment to only those likely to benefit. However, NGS has yet to make its way into the clinic. Health Technology Assessment can support the adoption and implementation of a novel technology, but at this early stage many of the required variables are still unknown. METHODS: Scenario drafting and expert elicitation via a questionnaire were used to identify factors that may act as a barrier or facilitate adoption of NGS-based molecular diagnostics. Attention was paid to predominantly elicit quantitative answers, allowing their use in future modelling of cost-effectiveness. RESULTS: Adequately informing patients and physicians, the latters’ opinion on clinical utility and underlying evidence as well as presenting sequencing results within a relevant timeframe may act as pivotal facilitators. Reimbursement for NGS-based testing and accompanying therapies (both general and in case of off-label prescription) was found to be a potential barrier. Competition on the market and demonstrating clinical utility may also be challenging. Importantly, numerous quantitative values for variables related to each of these potential barriers/facilitators, such as such as desired panel characteristics, willingness to pay or the expected number of targets identified per person, were also elicited. CONCLUSIONS: We have identified several factors that may either pose a barrier or facilitate the adoption of NGS in the clinic. We believe acting upon these findings, for instance by organizing educational events, advocating new ways of evidence generation and steering towards the most cost-effective solution, will accelerate the route from bench-to-bedside. Moreover, due to the methodology of expert elicitation, this study provides parameters that can be incorporated in future cost-effectiveness modeling to steer the development of NGS gene panels towards the most optimal direction. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12885-016-2100-0) contains supplementary material, which is available to authorized users.
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spelling pubmed-47446302016-02-08 Scenario drafting for early technology assessment of next generation sequencing in clinical oncology Joosten, S.E.P. Retèl, V.P. Coupé, V.M.H. van den Heuvel, M.M. van Harten, W.H. BMC Cancer Research Article BACKGROUND: Next Generation Sequencing (NGS) is expected to lift molecular diagnostics in clinical oncology to the next level. It enables simultaneous identification of mutations in a patient tumor, after which targeted therapy may be assigned. This approach could improve patient survival and/or assist in controlling healthcare costs by offering expensive treatment to only those likely to benefit. However, NGS has yet to make its way into the clinic. Health Technology Assessment can support the adoption and implementation of a novel technology, but at this early stage many of the required variables are still unknown. METHODS: Scenario drafting and expert elicitation via a questionnaire were used to identify factors that may act as a barrier or facilitate adoption of NGS-based molecular diagnostics. Attention was paid to predominantly elicit quantitative answers, allowing their use in future modelling of cost-effectiveness. RESULTS: Adequately informing patients and physicians, the latters’ opinion on clinical utility and underlying evidence as well as presenting sequencing results within a relevant timeframe may act as pivotal facilitators. Reimbursement for NGS-based testing and accompanying therapies (both general and in case of off-label prescription) was found to be a potential barrier. Competition on the market and demonstrating clinical utility may also be challenging. Importantly, numerous quantitative values for variables related to each of these potential barriers/facilitators, such as such as desired panel characteristics, willingness to pay or the expected number of targets identified per person, were also elicited. CONCLUSIONS: We have identified several factors that may either pose a barrier or facilitate the adoption of NGS in the clinic. We believe acting upon these findings, for instance by organizing educational events, advocating new ways of evidence generation and steering towards the most cost-effective solution, will accelerate the route from bench-to-bedside. Moreover, due to the methodology of expert elicitation, this study provides parameters that can be incorporated in future cost-effectiveness modeling to steer the development of NGS gene panels towards the most optimal direction. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12885-016-2100-0) contains supplementary material, which is available to authorized users. BioMed Central 2016-02-06 /pmc/articles/PMC4744630/ /pubmed/26851938 http://dx.doi.org/10.1186/s12885-016-2100-0 Text en © Joosten et al. 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Joosten, S.E.P.
Retèl, V.P.
Coupé, V.M.H.
van den Heuvel, M.M.
van Harten, W.H.
Scenario drafting for early technology assessment of next generation sequencing in clinical oncology
title Scenario drafting for early technology assessment of next generation sequencing in clinical oncology
title_full Scenario drafting for early technology assessment of next generation sequencing in clinical oncology
title_fullStr Scenario drafting for early technology assessment of next generation sequencing in clinical oncology
title_full_unstemmed Scenario drafting for early technology assessment of next generation sequencing in clinical oncology
title_short Scenario drafting for early technology assessment of next generation sequencing in clinical oncology
title_sort scenario drafting for early technology assessment of next generation sequencing in clinical oncology
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4744630/
https://www.ncbi.nlm.nih.gov/pubmed/26851938
http://dx.doi.org/10.1186/s12885-016-2100-0
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