AccScience Publishing / GHES / Volume 2 / Issue 1 / DOI: 10.36922/ghes.1889
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LETTER TO EDITOR

Budgetary impact of new label indications after initial drug registration in Brazil: A case study of pembrolizumab and trastuzumab deruxtecan

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/ )
Funding
None.
References

Borin, M.C., Barbosa, M.M., Pereira, C.O., Martins, C.R., Dos Reis, D.P., Ribeiro, G.J., Tupinambás, J.T., et al. (2023). Budgetary Impact of new label indications after initial drug registration in Brazil: A case study of pembrolizumab and trastuzumab deruxtecan. GHES, 1(1):0994. https://doi.org/10.36922/ghes.0994

 

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].

 

Executive Secretariat of the Drug Market Regulation Chamber (SCMED). (2023). Anuário Estatístico do Mercado Farmacêutico 2022. Available from: https://www. gov.br/anvisa/ptbr/centraisdeconteudo/publicacoes/ medicamentos/cmed/anuario-estatistico-2022-tabelas.xlsx/ view [Last accessed on 2023 Sep 02].

 

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

Conflict of interest
The authors declare that they have no competing interests.
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Global Health Economics and Sustainability, Electronic ISSN: 2972-4570 Published by AccScience Publishing