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The Importance of and Challenges with Adopting Life-Cycle Regulation and Reimbursement in Canada

Regulatory and reimbursement decisions for drugs and vaccines are increasingly based on limited safety and efficacy evidence. In this environment, life-cycle approaches to evaluation are needed. A life-cycle approach grants market approval and/or positive reimbursement decisions based on an undertak...

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Autores principales: McPhail, Melanie, McCabe, Christopher, Regier, Dean A., Bubela, Tania
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Longwoods Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8935925/
https://www.ncbi.nlm.nih.gov/pubmed/35319446
http://dx.doi.org/10.12927/hcpol.2022.26726
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author McPhail, Melanie
McCabe, Christopher
Regier, Dean A.
Bubela, Tania
author_facet McPhail, Melanie
McCabe, Christopher
Regier, Dean A.
Bubela, Tania
author_sort McPhail, Melanie
collection PubMed
description Regulatory and reimbursement decisions for drugs and vaccines are increasingly based on limited safety and efficacy evidence. In this environment, life-cycle approaches to evaluation are needed. A life-cycle approach grants market approval and/or positive reimbursement decisions based on an undertaking to conduct post-market clinical trials that address evidentiary uncertainties, relying on the collection and analysis of post-market data. In practice, however, both conditional regulatory and reimbursement decisions have proven problematic. Here we discuss some of the regulatory implications and unsettled ethical and pragmatic issues, taking lessons from the recent experiences of Israel in rapidly approving the Pfizer-BioNTech COVID-19 vaccine.
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spelling pubmed-89359252022-03-29 The Importance of and Challenges with Adopting Life-Cycle Regulation and Reimbursement in Canada McPhail, Melanie McCabe, Christopher Regier, Dean A. Bubela, Tania Healthc Policy Research Paper Regulatory and reimbursement decisions for drugs and vaccines are increasingly based on limited safety and efficacy evidence. In this environment, life-cycle approaches to evaluation are needed. A life-cycle approach grants market approval and/or positive reimbursement decisions based on an undertaking to conduct post-market clinical trials that address evidentiary uncertainties, relying on the collection and analysis of post-market data. In practice, however, both conditional regulatory and reimbursement decisions have proven problematic. Here we discuss some of the regulatory implications and unsettled ethical and pragmatic issues, taking lessons from the recent experiences of Israel in rapidly approving the Pfizer-BioNTech COVID-19 vaccine. Longwoods Publishing 2022-02 /pmc/articles/PMC8935925/ /pubmed/35319446 http://dx.doi.org/10.12927/hcpol.2022.26726 Text en Copyright © 2022 Longwoods Publishing https://creativecommons.org/licenses/by-nc/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial 4.0 License, which permits rights to copy and redistribute the work for non-commercial purposes only, provided the original work is given proper attribution.
spellingShingle Research Paper
McPhail, Melanie
McCabe, Christopher
Regier, Dean A.
Bubela, Tania
The Importance of and Challenges with Adopting Life-Cycle Regulation and Reimbursement in Canada
title The Importance of and Challenges with Adopting Life-Cycle Regulation and Reimbursement in Canada
title_full The Importance of and Challenges with Adopting Life-Cycle Regulation and Reimbursement in Canada
title_fullStr The Importance of and Challenges with Adopting Life-Cycle Regulation and Reimbursement in Canada
title_full_unstemmed The Importance of and Challenges with Adopting Life-Cycle Regulation and Reimbursement in Canada
title_short The Importance of and Challenges with Adopting Life-Cycle Regulation and Reimbursement in Canada
title_sort importance of and challenges with adopting life-cycle regulation and reimbursement in canada
topic Research Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8935925/
https://www.ncbi.nlm.nih.gov/pubmed/35319446
http://dx.doi.org/10.12927/hcpol.2022.26726
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