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Access to novel cancer medicines in four countries in Central and Eastern Europe in relation to clinical benefit

BACKGROUND: Almost 100 novel cancer medicines have been approved in Europe over the last decade. Limited public health care resources in countries in Central and Eastern Europe (CEE) call for a prioritization of access to effective medicines. We investigated how both reimbursement status and waiting...

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Autores principales: Hofmarcher, T., Szilagyiova, P., Gustafsson, A., Dolezal, T., Rutkowski, P., Baxter, C., Karamousouli, E.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10485399/
https://www.ncbi.nlm.nih.gov/pubmed/37413761
http://dx.doi.org/10.1016/j.esmoop.2023.101593
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author Hofmarcher, T.
Szilagyiova, P.
Gustafsson, A.
Dolezal, T.
Rutkowski, P.
Baxter, C.
Karamousouli, E.
author_facet Hofmarcher, T.
Szilagyiova, P.
Gustafsson, A.
Dolezal, T.
Rutkowski, P.
Baxter, C.
Karamousouli, E.
author_sort Hofmarcher, T.
collection PubMed
description BACKGROUND: Almost 100 novel cancer medicines have been approved in Europe over the last decade. Limited public health care resources in countries in Central and Eastern Europe (CEE) call for a prioritization of access to effective medicines. We investigated how both reimbursement status and waiting time to reimbursement correlate with the magnitude of clinical benefit provided by novel medicines in four selected countries (Czechia, Hungary, Poland, and Slovakia). MATERIALS AND METHODS: A total of 124 indications of 51 cancer medicines with marketing authorization by the European Medicines Agency in 2011-2020 were included and followed up until 2022. Data on reimbursement status and waiting time to reimbursement (i.e. time from marketing authorization to national reimbursement approval) were collected for each country. Data were analyzed in relation to clinical benefit status (i.e. substantial versus nonsubstantial clinical benefit) of indications according to the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). RESULTS: The degree of reimbursement differed between countries with 64% of indications with reimbursement in Czechia, 40% in Hungary, 51% in Poland, and 19% in Slovakia. In all countries, a significantly greater proportion of indications with a substantial clinical benefit was reimbursed (P < 0.05). The median waiting time to reimbursement ranged from 27 months in Poland to 37 months in Hungary. No significant differences in waiting time in relation to clinical benefit were observed in any country (P = 0.25-0.84). CONCLUSIONS: Cancer medicines with a substantial clinical benefit are more likely to be reimbursed in all four CEE countries. Waiting times to reimbursement are equally long for medicines with or without a substantial clinical benefit, indicating a lack of prioritization of fast access to medicines delivering a substantial benefit. Incorporation of the ESMO-MCBS in reimbursement assessments and decisions could aid in better utilization of limited resources to deliver more effective cancer care.
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spelling pubmed-104853992023-09-09 Access to novel cancer medicines in four countries in Central and Eastern Europe in relation to clinical benefit Hofmarcher, T. Szilagyiova, P. Gustafsson, A. Dolezal, T. Rutkowski, P. Baxter, C. Karamousouli, E. ESMO Open Original Research BACKGROUND: Almost 100 novel cancer medicines have been approved in Europe over the last decade. Limited public health care resources in countries in Central and Eastern Europe (CEE) call for a prioritization of access to effective medicines. We investigated how both reimbursement status and waiting time to reimbursement correlate with the magnitude of clinical benefit provided by novel medicines in four selected countries (Czechia, Hungary, Poland, and Slovakia). MATERIALS AND METHODS: A total of 124 indications of 51 cancer medicines with marketing authorization by the European Medicines Agency in 2011-2020 were included and followed up until 2022. Data on reimbursement status and waiting time to reimbursement (i.e. time from marketing authorization to national reimbursement approval) were collected for each country. Data were analyzed in relation to clinical benefit status (i.e. substantial versus nonsubstantial clinical benefit) of indications according to the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). RESULTS: The degree of reimbursement differed between countries with 64% of indications with reimbursement in Czechia, 40% in Hungary, 51% in Poland, and 19% in Slovakia. In all countries, a significantly greater proportion of indications with a substantial clinical benefit was reimbursed (P < 0.05). The median waiting time to reimbursement ranged from 27 months in Poland to 37 months in Hungary. No significant differences in waiting time in relation to clinical benefit were observed in any country (P = 0.25-0.84). CONCLUSIONS: Cancer medicines with a substantial clinical benefit are more likely to be reimbursed in all four CEE countries. Waiting times to reimbursement are equally long for medicines with or without a substantial clinical benefit, indicating a lack of prioritization of fast access to medicines delivering a substantial benefit. Incorporation of the ESMO-MCBS in reimbursement assessments and decisions could aid in better utilization of limited resources to deliver more effective cancer care. Elsevier 2023-07-04 /pmc/articles/PMC10485399/ /pubmed/37413761 http://dx.doi.org/10.1016/j.esmoop.2023.101593 Text en © 2023 The Authors https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Original Research
Hofmarcher, T.
Szilagyiova, P.
Gustafsson, A.
Dolezal, T.
Rutkowski, P.
Baxter, C.
Karamousouli, E.
Access to novel cancer medicines in four countries in Central and Eastern Europe in relation to clinical benefit
title Access to novel cancer medicines in four countries in Central and Eastern Europe in relation to clinical benefit
title_full Access to novel cancer medicines in four countries in Central and Eastern Europe in relation to clinical benefit
title_fullStr Access to novel cancer medicines in four countries in Central and Eastern Europe in relation to clinical benefit
title_full_unstemmed Access to novel cancer medicines in four countries in Central and Eastern Europe in relation to clinical benefit
title_short Access to novel cancer medicines in four countries in Central and Eastern Europe in relation to clinical benefit
title_sort access to novel cancer medicines in four countries in central and eastern europe in relation to clinical benefit
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10485399/
https://www.ncbi.nlm.nih.gov/pubmed/37413761
http://dx.doi.org/10.1016/j.esmoop.2023.101593
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