Cargando…

Real World Data in Health Technology Assessment of Complex Health Technologies

The available evidence on relative effectiveness and risks of new health technologies is often limited at the time of health technology assessment (HTA). Additionally, a wide variety in real-world data (RWD) policies exist among HTA organizations. This study assessed which challenges, related to the...

Descripción completa

Detalles Bibliográficos
Autores principales: Hogervorst, Milou A., Pontén, Johan, Vreman, Rick A., Mantel-Teeuwisse, Aukje K., Goettsch, Wim G.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8866967/
https://www.ncbi.nlm.nih.gov/pubmed/35222045
http://dx.doi.org/10.3389/fphar.2022.837302
_version_ 1784655950539390976
author Hogervorst, Milou A.
Pontén, Johan
Vreman, Rick A.
Mantel-Teeuwisse, Aukje K.
Goettsch, Wim G.
author_facet Hogervorst, Milou A.
Pontén, Johan
Vreman, Rick A.
Mantel-Teeuwisse, Aukje K.
Goettsch, Wim G.
author_sort Hogervorst, Milou A.
collection PubMed
description The available evidence on relative effectiveness and risks of new health technologies is often limited at the time of health technology assessment (HTA). Additionally, a wide variety in real-world data (RWD) policies exist among HTA organizations. This study assessed which challenges, related to the increasingly complex nature of new health technologies, make the acceptance of RWD most likely. A questionnaire was disseminated among 33 EUnetHTA member HTA organizations. The questions focused on accepted data sources, circumstances that allowed for RWD acceptance and barriers to acceptance. The questionnaire was validated and tested for reliability by an expert panel, and pilot-tested before dissemination via LimeSurvey. Twenty-two HTA organizations completed the questionnaire (67%). All reported accepting randomized clinical trials. The most accepted RWD source were patient registries (19/22, 86%), the least accepted were editorials and expert opinions (8/22, 36%). With orphan treatments or companion diagnostics, organizations tended to be most likely to accept RWD sources, 4.3–3.2 on a 5-point Likert scale, respectively. Additional circumstances were reported to accept RWD (e.g., a high disease burden). The two most important barriers to accepting RWD were lacking necessary RWD sources and existing policy structures. European HTA organizations seem positive toward the (wider) use of RWD in HTA of complex therapies. Expanding the use of patient registries could be potentially useful, as a large share of the organizations already accepts this source. However, many barriers still exist to the widespread use of RWD. Our results can be used to prioritize circumstances in which RWD might be accepted.
format Online
Article
Text
id pubmed-8866967
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Frontiers Media S.A.
record_format MEDLINE/PubMed
spelling pubmed-88669672022-02-25 Real World Data in Health Technology Assessment of Complex Health Technologies Hogervorst, Milou A. Pontén, Johan Vreman, Rick A. Mantel-Teeuwisse, Aukje K. Goettsch, Wim G. Front Pharmacol Pharmacology The available evidence on relative effectiveness and risks of new health technologies is often limited at the time of health technology assessment (HTA). Additionally, a wide variety in real-world data (RWD) policies exist among HTA organizations. This study assessed which challenges, related to the increasingly complex nature of new health technologies, make the acceptance of RWD most likely. A questionnaire was disseminated among 33 EUnetHTA member HTA organizations. The questions focused on accepted data sources, circumstances that allowed for RWD acceptance and barriers to acceptance. The questionnaire was validated and tested for reliability by an expert panel, and pilot-tested before dissemination via LimeSurvey. Twenty-two HTA organizations completed the questionnaire (67%). All reported accepting randomized clinical trials. The most accepted RWD source were patient registries (19/22, 86%), the least accepted were editorials and expert opinions (8/22, 36%). With orphan treatments or companion diagnostics, organizations tended to be most likely to accept RWD sources, 4.3–3.2 on a 5-point Likert scale, respectively. Additional circumstances were reported to accept RWD (e.g., a high disease burden). The two most important barriers to accepting RWD were lacking necessary RWD sources and existing policy structures. European HTA organizations seem positive toward the (wider) use of RWD in HTA of complex therapies. Expanding the use of patient registries could be potentially useful, as a large share of the organizations already accepts this source. However, many barriers still exist to the widespread use of RWD. Our results can be used to prioritize circumstances in which RWD might be accepted. Frontiers Media S.A. 2022-02-10 /pmc/articles/PMC8866967/ /pubmed/35222045 http://dx.doi.org/10.3389/fphar.2022.837302 Text en Copyright © 2022 Hogervorst, Pontén, Vreman, Mantel-Teeuwisse and Goettsch. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Hogervorst, Milou A.
Pontén, Johan
Vreman, Rick A.
Mantel-Teeuwisse, Aukje K.
Goettsch, Wim G.
Real World Data in Health Technology Assessment of Complex Health Technologies
title Real World Data in Health Technology Assessment of Complex Health Technologies
title_full Real World Data in Health Technology Assessment of Complex Health Technologies
title_fullStr Real World Data in Health Technology Assessment of Complex Health Technologies
title_full_unstemmed Real World Data in Health Technology Assessment of Complex Health Technologies
title_short Real World Data in Health Technology Assessment of Complex Health Technologies
title_sort real world data in health technology assessment of complex health technologies
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8866967/
https://www.ncbi.nlm.nih.gov/pubmed/35222045
http://dx.doi.org/10.3389/fphar.2022.837302
work_keys_str_mv AT hogervorstmiloua realworlddatainhealthtechnologyassessmentofcomplexhealthtechnologies
AT pontenjohan realworlddatainhealthtechnologyassessmentofcomplexhealthtechnologies
AT vremanricka realworlddatainhealthtechnologyassessmentofcomplexhealthtechnologies
AT mantelteeuwisseaukjek realworlddatainhealthtechnologyassessmentofcomplexhealthtechnologies
AT goettschwimg realworlddatainhealthtechnologyassessmentofcomplexhealthtechnologies