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Patient Access, Unmet Medical Need, Expected Benefits, and Concerns Related to the Utilisation of Biosimilars in Eastern European Countries: A Survey of Experts

This policy research aims to map patient access barriers to biologic treatments, to explore how increased uptake of biosimilars may lower these hurdles and to identify factors limiting the increased utilisation of biosimilars. A policy survey was developed to review these questions in 10 Central and...

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Autores principales: Inotai, Andras, Csanadi, Marcell, Petrova, Guenka, Dimitrova, Maria, Bochenek, Tomasz, Tesar, Tomas, York, Kristina, Fuksa, Leos, Kostyuk, Alexander, Lorenzovici, Laszlo, Omelyanovskiy, Vitaly, Egyed, Katalin, Kalo, Zoltan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5818964/
https://www.ncbi.nlm.nih.gov/pubmed/29546072
http://dx.doi.org/10.1155/2018/9597362
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author Inotai, Andras
Csanadi, Marcell
Petrova, Guenka
Dimitrova, Maria
Bochenek, Tomasz
Tesar, Tomas
York, Kristina
Fuksa, Leos
Kostyuk, Alexander
Lorenzovici, Laszlo
Omelyanovskiy, Vitaly
Egyed, Katalin
Kalo, Zoltan
author_facet Inotai, Andras
Csanadi, Marcell
Petrova, Guenka
Dimitrova, Maria
Bochenek, Tomasz
Tesar, Tomas
York, Kristina
Fuksa, Leos
Kostyuk, Alexander
Lorenzovici, Laszlo
Omelyanovskiy, Vitaly
Egyed, Katalin
Kalo, Zoltan
author_sort Inotai, Andras
collection PubMed
description This policy research aims to map patient access barriers to biologic treatments, to explore how increased uptake of biosimilars may lower these hurdles and to identify factors limiting the increased utilisation of biosimilars. A policy survey was developed to review these questions in 10 Central and Eastern European (CEE) and Commonwealth of Independent States (CIS) countries. Two experts (one public and one private sector representative) from each country completed the survey. Questions were related to patient access, purchasing, clinical practice, and real-world data collection on both original biologics and biosimilars. Restrictions on the number of patients that can be treated and related waiting lists were reported as key patient access barriers. According to respondents, for both clinicians and payers the primary benefit of switching patients to biosimilars would be to treat more patients. However, concerns with therapeutic equivalence and fear of immunogenicity may reduce utilisation of biosimilars. Similar limitations in patient access to both original biologics and biosimilars raise concerns about the appropriateness and success of current biosimilar policies in CEE and CIS countries. The conceptual framework for additional real-world data collection exists in all countries which may provide a basis for future risk-management activities including vigorous pharmacovigilance data collection.
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spelling pubmed-58189642018-03-15 Patient Access, Unmet Medical Need, Expected Benefits, and Concerns Related to the Utilisation of Biosimilars in Eastern European Countries: A Survey of Experts Inotai, Andras Csanadi, Marcell Petrova, Guenka Dimitrova, Maria Bochenek, Tomasz Tesar, Tomas York, Kristina Fuksa, Leos Kostyuk, Alexander Lorenzovici, Laszlo Omelyanovskiy, Vitaly Egyed, Katalin Kalo, Zoltan Biomed Res Int Research Article This policy research aims to map patient access barriers to biologic treatments, to explore how increased uptake of biosimilars may lower these hurdles and to identify factors limiting the increased utilisation of biosimilars. A policy survey was developed to review these questions in 10 Central and Eastern European (CEE) and Commonwealth of Independent States (CIS) countries. Two experts (one public and one private sector representative) from each country completed the survey. Questions were related to patient access, purchasing, clinical practice, and real-world data collection on both original biologics and biosimilars. Restrictions on the number of patients that can be treated and related waiting lists were reported as key patient access barriers. According to respondents, for both clinicians and payers the primary benefit of switching patients to biosimilars would be to treat more patients. However, concerns with therapeutic equivalence and fear of immunogenicity may reduce utilisation of biosimilars. Similar limitations in patient access to both original biologics and biosimilars raise concerns about the appropriateness and success of current biosimilar policies in CEE and CIS countries. The conceptual framework for additional real-world data collection exists in all countries which may provide a basis for future risk-management activities including vigorous pharmacovigilance data collection. Hindawi 2018-01-10 /pmc/articles/PMC5818964/ /pubmed/29546072 http://dx.doi.org/10.1155/2018/9597362 Text en Copyright © 2018 Andras Inotai et al. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Inotai, Andras
Csanadi, Marcell
Petrova, Guenka
Dimitrova, Maria
Bochenek, Tomasz
Tesar, Tomas
York, Kristina
Fuksa, Leos
Kostyuk, Alexander
Lorenzovici, Laszlo
Omelyanovskiy, Vitaly
Egyed, Katalin
Kalo, Zoltan
Patient Access, Unmet Medical Need, Expected Benefits, and Concerns Related to the Utilisation of Biosimilars in Eastern European Countries: A Survey of Experts
title Patient Access, Unmet Medical Need, Expected Benefits, and Concerns Related to the Utilisation of Biosimilars in Eastern European Countries: A Survey of Experts
title_full Patient Access, Unmet Medical Need, Expected Benefits, and Concerns Related to the Utilisation of Biosimilars in Eastern European Countries: A Survey of Experts
title_fullStr Patient Access, Unmet Medical Need, Expected Benefits, and Concerns Related to the Utilisation of Biosimilars in Eastern European Countries: A Survey of Experts
title_full_unstemmed Patient Access, Unmet Medical Need, Expected Benefits, and Concerns Related to the Utilisation of Biosimilars in Eastern European Countries: A Survey of Experts
title_short Patient Access, Unmet Medical Need, Expected Benefits, and Concerns Related to the Utilisation of Biosimilars in Eastern European Countries: A Survey of Experts
title_sort patient access, unmet medical need, expected benefits, and concerns related to the utilisation of biosimilars in eastern european countries: a survey of experts
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5818964/
https://www.ncbi.nlm.nih.gov/pubmed/29546072
http://dx.doi.org/10.1155/2018/9597362
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