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Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs
This study assessed whether five Health Technology Assessment (HTA) bodies in Europe were more negative about drugs with a Conditional Marketing Authorization (CMA) that are approved without controlled studies compared to CMA drugs that are approved based on controlled studies. The HTA recommendatio...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6587700/ https://www.ncbi.nlm.nih.gov/pubmed/30300938 http://dx.doi.org/10.1002/cpt.1251 |
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author | Vreman, Rick A. Bouvy, Jacoline C. Bloem, Lourens T. Hövels, Anke M. Mantel‐Teeuwisse, Aukje K. Leufkens, Hubert G.M. Goettsch, Wim G. |
author_facet | Vreman, Rick A. Bouvy, Jacoline C. Bloem, Lourens T. Hövels, Anke M. Mantel‐Teeuwisse, Aukje K. Leufkens, Hubert G.M. Goettsch, Wim G. |
author_sort | Vreman, Rick A. |
collection | PubMed |
description | This study assessed whether five Health Technology Assessment (HTA) bodies in Europe were more negative about drugs with a Conditional Marketing Authorization (CMA) that are approved without controlled studies compared to CMA drugs that are approved based on controlled studies. The HTA recommendations were categorized into positive, restricted, and negative. A total of 92 HTA recommendations were available for 27 drugs. Thirty of 62 (48%) and 17 of 30 (57%) of the recommendations were negative for drugs with and without controlled studies, respectively. Overall, only 12 (13%) recommendations were positive. In all jurisdictions, recommendations between drugs with and drugs without controlled data were comparable, which suggests that the presence of controlled data is not decisive in HTA evaluations. The small proportion of unrestricted positive recommendations highlights difficulties with recommending the drugs in this cohort, which may be caused by scientific uncertainty or other factors. Earlier collaboration between stakeholders is advised in order to improve patient access. |
format | Online Article Text |
id | pubmed-6587700 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-65877002019-07-08 Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs Vreman, Rick A. Bouvy, Jacoline C. Bloem, Lourens T. Hövels, Anke M. Mantel‐Teeuwisse, Aukje K. Leufkens, Hubert G.M. Goettsch, Wim G. Clin Pharmacol Ther Research This study assessed whether five Health Technology Assessment (HTA) bodies in Europe were more negative about drugs with a Conditional Marketing Authorization (CMA) that are approved without controlled studies compared to CMA drugs that are approved based on controlled studies. The HTA recommendations were categorized into positive, restricted, and negative. A total of 92 HTA recommendations were available for 27 drugs. Thirty of 62 (48%) and 17 of 30 (57%) of the recommendations were negative for drugs with and without controlled studies, respectively. Overall, only 12 (13%) recommendations were positive. In all jurisdictions, recommendations between drugs with and drugs without controlled data were comparable, which suggests that the presence of controlled data is not decisive in HTA evaluations. The small proportion of unrestricted positive recommendations highlights difficulties with recommending the drugs in this cohort, which may be caused by scientific uncertainty or other factors. Earlier collaboration between stakeholders is advised in order to improve patient access. John Wiley and Sons Inc. 2018-11-08 2019-03 /pmc/articles/PMC6587700/ /pubmed/30300938 http://dx.doi.org/10.1002/cpt.1251 Text en © 2018 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Research Vreman, Rick A. Bouvy, Jacoline C. Bloem, Lourens T. Hövels, Anke M. Mantel‐Teeuwisse, Aukje K. Leufkens, Hubert G.M. Goettsch, Wim G. Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs |
title | Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs |
title_full | Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs |
title_fullStr | Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs |
title_full_unstemmed | Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs |
title_short | Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs |
title_sort | weighing of evidence by health technology assessment bodies: retrospective study of reimbursement recommendations for conditionally approved drugs |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6587700/ https://www.ncbi.nlm.nih.gov/pubmed/30300938 http://dx.doi.org/10.1002/cpt.1251 |
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