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FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment

Accelerated approval (AA) by the FDA enables earlier access to promising new therapies. Health Canada has a similar process. Canada implemented a national health technology assessment (HTA) for reimbursement decisions in 2011. This study evaluated regulatory and funding timelines and decisions for F...

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Detalles Bibliográficos
Autores principales: Ho, Cheryl, Lim, Howard J., Regier, Dean A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8870743/
https://www.ncbi.nlm.nih.gov/pubmed/35200536
http://dx.doi.org/10.3390/curroncol29020036
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author Ho, Cheryl
Lim, Howard J.
Regier, Dean A.
author_facet Ho, Cheryl
Lim, Howard J.
Regier, Dean A.
author_sort Ho, Cheryl
collection PubMed
description Accelerated approval (AA) by the FDA enables earlier access to promising new therapies. Health Canada has a similar process. Canada implemented a national health technology assessment (HTA) for reimbursement decisions in 2011. This study evaluated regulatory and funding timelines and decisions for FDA AA cancer therapies in Canada. The FDA’s AA of malignant hematology and oncology from January 2000–December 2019 was reviewed. Dates from Health Canada, HTA decisions and provincial listings were collected. There were 94 FDA AAs, two of which were subsequently withdrawn. Of the 92 AAs, 70 received full (46)/conditional (24) Health Canada approval, and 22 were not filed. Since the introduction of HTA, 31 out of 45 of Health Canada’s approved indications underwent HTA review: 18 received a positive recommendation conditional on cost-effectiveness, 8 were not recommended and 5 were withdrawn/suspended. The median time from the AA to any Health Canada approval is 9.4 months, from any Health Canada approval to HTA decision is 5.8 months and from HTA decision to the first formulary listing is 12.0 months. The access and timeline for the first formulary listing differences were observed between the USA and Canada due to the decision of pharmaceutical companies to submit (or not) to regulatory/HTA bodies, national procedural delays with different healthcare delivery models and submission timelines. This study demonstrates that there is delayed access to promising new therapies in Canada.
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spelling pubmed-88707432022-02-25 FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment Ho, Cheryl Lim, Howard J. Regier, Dean A. Curr Oncol Article Accelerated approval (AA) by the FDA enables earlier access to promising new therapies. Health Canada has a similar process. Canada implemented a national health technology assessment (HTA) for reimbursement decisions in 2011. This study evaluated regulatory and funding timelines and decisions for FDA AA cancer therapies in Canada. The FDA’s AA of malignant hematology and oncology from January 2000–December 2019 was reviewed. Dates from Health Canada, HTA decisions and provincial listings were collected. There were 94 FDA AAs, two of which were subsequently withdrawn. Of the 92 AAs, 70 received full (46)/conditional (24) Health Canada approval, and 22 were not filed. Since the introduction of HTA, 31 out of 45 of Health Canada’s approved indications underwent HTA review: 18 received a positive recommendation conditional on cost-effectiveness, 8 were not recommended and 5 were withdrawn/suspended. The median time from the AA to any Health Canada approval is 9.4 months, from any Health Canada approval to HTA decision is 5.8 months and from HTA decision to the first formulary listing is 12.0 months. The access and timeline for the first formulary listing differences were observed between the USA and Canada due to the decision of pharmaceutical companies to submit (or not) to regulatory/HTA bodies, national procedural delays with different healthcare delivery models and submission timelines. This study demonstrates that there is delayed access to promising new therapies in Canada. MDPI 2022-01-18 /pmc/articles/PMC8870743/ /pubmed/35200536 http://dx.doi.org/10.3390/curroncol29020036 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Ho, Cheryl
Lim, Howard J.
Regier, Dean A.
FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment
title FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment
title_full FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment
title_fullStr FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment
title_full_unstemmed FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment
title_short FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment
title_sort fda accelerated approval for malignant hematology and oncology indications in the canadian environment
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8870743/
https://www.ncbi.nlm.nih.gov/pubmed/35200536
http://dx.doi.org/10.3390/curroncol29020036
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