AccScience Publishing / GHES / Online First / DOI: 10.36922/ghes.1889
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LETTER TO EDITOR

Inadequate analysis of the budgetary impact of new label indications after initial drug registration in Brazil: A response to a published case study

Bruno Salgado Riveros1* Marina Gatto Cavalcanti1 Letícia Paula Leonart1 Mariana Papaléo Rosim1 André Bergamim Almeida1 Cristiane Aparecida Licursi1
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1 MSD Brazil, São Paulo, São Paulo, Brazil
Submitted: 20 September 2023 | Accepted: 15 December 2023 | Published: 29 February 2024
© 2024 by the Author (s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/ )
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Funding
None.
Conflict of interest
The authors declare that they have no competing interests.
References

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Brazilian Ministry of Health. (2012). Diretrizes Metodológicas: Análise de Impacto Orçamentário. Manual para o Sistema de SaúdedoBrasil.Brasília: Secretariat of Science, Technology and Strategic Inputs, Department of Science and Technology.

 

Brazilian Health Regulatory Agency (ANVISA). (2020). Conceitosand Definições.Available from: https://www.gov. br/anvisa/pt-br/acessoainformacao/perguntasfrequentes/ medicamentos/conceitos-e-definicoes/conceitos-e-definicoes [Last accessed on 2023 Sep 02].

 

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Keytruda. Package Insert. Merck Sharp DohmeFarmacêutica LTDA. Available from: https://consultas.anvisa.gov.br/#/ bulario/q/?nomeproduto=keytruda [Last accessed on 2023 Sep 02].

 

Reck, M., Rodríguez-Abreu, D., Robinson, A.G., Hui, R., Csőszi, T., Fülöp, A., et al. (2016). Pembrolizumab versus chemotherapy for PD-L1 positive non-small-cell lung cancer.The New England Journal of Medicine, 375(19):1823-1833. https://doi.org/10.1056/NEJMoa1606774

 

Sullivan, S.D., Mauskopf, J.A., Augustovski, F., Jaime Caro, J., Lee, K.M., Minchin, M., et al. (2014). Budget impact analysis-principles of good practice: Report of the ISPOR 2012 budget impact analysis good practice II task force. Value in Health, 2014;17(1):5-14. https://doi.org/10.1016/j.jval.2013.08.2291

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Global Health Economics and Sustainability, Electronic ISSN: 2972-4570 Published by AccScience Publishing