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Access to Novel Drugs for Non‐Small Cell Lung Cancer in Central and Southeastern Europe: A Central European Cooperative Oncology Group Analysis

BACKGROUND: Treatment of non‐small cell lung cancer (NSCLC) improved substantially in the last decades. Novel targeted and immune‐oncologic drugs were introduced into routine treatment. Despite accelerated development and subsequent drug registrations by the European Medicinal Agency (EMA), novel dr...

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Autores principales: Cufer, Tanja, Ciuleanu, Tudor E., Berzinec, Peter, Galffy, Gabriela, Jakopovic, Marko, Jassem, Jacek, Jovanovic, Dragana, Mihaylova, Zhasmina, Ostoros, Gyula, Thallinger, Christiane, Zemanova, Milada, Zielinski, Christoph
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7066717/
https://www.ncbi.nlm.nih.gov/pubmed/32162818
http://dx.doi.org/10.1634/theoncologist.2019-0523
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author Cufer, Tanja
Ciuleanu, Tudor E.
Berzinec, Peter
Galffy, Gabriela
Jakopovic, Marko
Jassem, Jacek
Jovanovic, Dragana
Mihaylova, Zhasmina
Ostoros, Gyula
Thallinger, Christiane
Zemanova, Milada
Zielinski, Christoph
author_facet Cufer, Tanja
Ciuleanu, Tudor E.
Berzinec, Peter
Galffy, Gabriela
Jakopovic, Marko
Jassem, Jacek
Jovanovic, Dragana
Mihaylova, Zhasmina
Ostoros, Gyula
Thallinger, Christiane
Zemanova, Milada
Zielinski, Christoph
author_sort Cufer, Tanja
collection PubMed
description BACKGROUND: Treatment of non‐small cell lung cancer (NSCLC) improved substantially in the last decades. Novel targeted and immune‐oncologic drugs were introduced into routine treatment. Despite accelerated development and subsequent drug registrations by the European Medicinal Agency (EMA), novel drugs for NSCLC are poorly accessible in Central and Eastern European (CEE) countries. MATERIAL AND METHODS: The Central European Cooperative Oncology Group conducted a survey among experts from 10 CEE countries to provide an overview on the availability of novel drugs for NSCLC and time from registration to reimbursement decision in their countries. RESULTS: Although first‐generation epidermal growth factor receptor tyrosine kinase inhibitors were reimbursed and available in all countries, for other registered therapies—even for ALK inhibitors and checkpoint inhibitors in first‐line—there were apparent gaps in availability and/or reimbursement. There was a trend for better availability of drugs with longer time from EMA marketing authorization. Substantial differences in access to novel drugs among CEE countries were observed. In general, the availability of drugs is not in accordance with the Magnitude of Clinical Benefit Scale (MCBS), as defined by the European Society for Medical Oncology (ESMO). Time spans between drug registrations and national decisions on reimbursement vary greatly, from less than 3 months in one country to more than 1 year in the majority of countries. CONCLUSION: The access to novel drugs for NSCLC in CEE countries is suboptimal. To enable access to the most effective compounds within the shortest possible time, reimbursement decisions should be faster and ESMO MCBS should be incorporated into decision making.
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spelling pubmed-70667172020-04-06 Access to Novel Drugs for Non‐Small Cell Lung Cancer in Central and Southeastern Europe: A Central European Cooperative Oncology Group Analysis Cufer, Tanja Ciuleanu, Tudor E. Berzinec, Peter Galffy, Gabriela Jakopovic, Marko Jassem, Jacek Jovanovic, Dragana Mihaylova, Zhasmina Ostoros, Gyula Thallinger, Christiane Zemanova, Milada Zielinski, Christoph Oncologist Brief Communications BACKGROUND: Treatment of non‐small cell lung cancer (NSCLC) improved substantially in the last decades. Novel targeted and immune‐oncologic drugs were introduced into routine treatment. Despite accelerated development and subsequent drug registrations by the European Medicinal Agency (EMA), novel drugs for NSCLC are poorly accessible in Central and Eastern European (CEE) countries. MATERIAL AND METHODS: The Central European Cooperative Oncology Group conducted a survey among experts from 10 CEE countries to provide an overview on the availability of novel drugs for NSCLC and time from registration to reimbursement decision in their countries. RESULTS: Although first‐generation epidermal growth factor receptor tyrosine kinase inhibitors were reimbursed and available in all countries, for other registered therapies—even for ALK inhibitors and checkpoint inhibitors in first‐line—there were apparent gaps in availability and/or reimbursement. There was a trend for better availability of drugs with longer time from EMA marketing authorization. Substantial differences in access to novel drugs among CEE countries were observed. In general, the availability of drugs is not in accordance with the Magnitude of Clinical Benefit Scale (MCBS), as defined by the European Society for Medical Oncology (ESMO). Time spans between drug registrations and national decisions on reimbursement vary greatly, from less than 3 months in one country to more than 1 year in the majority of countries. CONCLUSION: The access to novel drugs for NSCLC in CEE countries is suboptimal. To enable access to the most effective compounds within the shortest possible time, reimbursement decisions should be faster and ESMO MCBS should be incorporated into decision making. John Wiley & Sons, Inc. 2019-11-29 2020-03 /pmc/articles/PMC7066717/ /pubmed/32162818 http://dx.doi.org/10.1634/theoncologist.2019-0523 Text en © 2019 The Authors. The Oncologist published by Wiley Periodicals, Inc. on behalf of AlphaMed Press. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Brief Communications
Cufer, Tanja
Ciuleanu, Tudor E.
Berzinec, Peter
Galffy, Gabriela
Jakopovic, Marko
Jassem, Jacek
Jovanovic, Dragana
Mihaylova, Zhasmina
Ostoros, Gyula
Thallinger, Christiane
Zemanova, Milada
Zielinski, Christoph
Access to Novel Drugs for Non‐Small Cell Lung Cancer in Central and Southeastern Europe: A Central European Cooperative Oncology Group Analysis
title Access to Novel Drugs for Non‐Small Cell Lung Cancer in Central and Southeastern Europe: A Central European Cooperative Oncology Group Analysis
title_full Access to Novel Drugs for Non‐Small Cell Lung Cancer in Central and Southeastern Europe: A Central European Cooperative Oncology Group Analysis
title_fullStr Access to Novel Drugs for Non‐Small Cell Lung Cancer in Central and Southeastern Europe: A Central European Cooperative Oncology Group Analysis
title_full_unstemmed Access to Novel Drugs for Non‐Small Cell Lung Cancer in Central and Southeastern Europe: A Central European Cooperative Oncology Group Analysis
title_short Access to Novel Drugs for Non‐Small Cell Lung Cancer in Central and Southeastern Europe: A Central European Cooperative Oncology Group Analysis
title_sort access to novel drugs for non‐small cell lung cancer in central and southeastern europe: a central european cooperative oncology group analysis
topic Brief Communications
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7066717/
https://www.ncbi.nlm.nih.gov/pubmed/32162818
http://dx.doi.org/10.1634/theoncologist.2019-0523
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