Page 188 - GHES-2-4

Global Health Economics and
Sustainability

LETTER TO EDITOR
Authors’ reply: Inadequate analysis of the

budgetary impact of new label indications after
initial drug registration in Brazil: A response to a

published case study

1,2
Marcus Carvalho Borin * , Mariana Michel Barbosa 1,2 ,
Camila Oliveira Pereira 1,2 , Carina Rejane Martins 1 ,
Daniel Pitchon dos Reis 1 , Geraldo José Coelho Ribeiro 1,3 ,
Júlia Teixeira Tupinambás 1 , Karina de Castro Zocrato 1 ,
Lélia Maria de Almeida Carvalho 1 , Marcela Pinto de Freitas 1 ,
Maria da Glória Cruvinel Horta 1 , Mariza Cristina Torres Talim 1 ,
Ernesto Gomes de Azevedo 1 , Sergio Adriano Loureiro Bersan 1 , and
Silvana Marcia Bruschi Kelles 1,3

1 Unimed-BH, Health Technology Assessment Group, Belo Horizonte, Minas Gerais, Brazil
2 Department of Social Pharmacy, Federal University of Minas Gerais (UFMG), Faculty of Pharmacy,
Belo Horizonte, Minas Gerais, Brazil
3 Department of Medicine, Pontifical Catholic University of Minas Gerais, Institute of Biological and
Health Sciences, Betim, Minas Gerais, Brazil
Academic editor:
Mihajlo Jakovljevic M.D. Ph.D. MAE
*Corresponding author:
Marcus Carvalho Borin We appreciate the detailed feedback provided by Riveros et al. (2024) on our paper
(marcusborin@ufmg.br)
“Budgetary impact of new label indications after initial drug registration in Brazil: A case
Citation: Borin, M.C., study of pembrolizumab and trastuzumab deruxtecan.” We welcome this opportunity
Barbosa, M.M., Pereira, C.O.,
Martins, C.R., dos Reis, D.P., to clarify and expand upon the methodology, findings, and inherent limitations of our
Ribeiro, G.J.C., et al. (2024). study.
Authors’ reply: Inadequate analysis
of the budgetary impact of new Rather than actual sales of the two drugs in question, our study aimed to describe
label indications after initial drug a hypothetical scenario based on all label indications for these drugs. Thus, regarding
registration in Brazil: A response
to a published case study. Global the comparison of our estimates with real-world sales data, it is important to clarify
Health Econ Sustain, 2(4):4439. that our objective was to explore the potential impact of expanding label indications
https://doi.org/10.36922/ghes.4439 while maintaining the initial price for specific patient niches. This hypothetical scenario
Received: August 5, 2024 was designed to underscore the financial implications of broader drug usage under
Accepted: August 14, 2024 existing pricing structures. By doing so, we aimed to provide insights into how expanded
indications could influence overall healthcare expenditures.
Published Online: September 23,
2024 The scenario we presented envisages a situation in which all potentially eligible
Copyright: © 2024 Author(s). patients can access the drugs. Our intention was not to conduct a budgetary impact
This is an Open-Access article analysis for drug incorporation into the health-care system but to illustrate the potential
distributed under the terms of the
Creative Commons Attribution financial impact of expanded label indications at current price points. This approach
License, permitting distribution, helps highlight the broader economic consequences of such expansions and underscores
and reproduction in any medium, the need for strategic planning in health-care budgeting.
provided the original work is
properly cited. While we acknowledge the ISPOR Good Practice guidelines, it is crucial to consider
Publisher’s Note: AccScience the specific context of Brazil’s supplementary health system, wherein prices often align
Publishing remains neutral with with the maximum price listed by CMED (ANS realiza a 30 reunião técnica da Cosaúde,
a
regard to jurisdictional claims in
published maps and institutional n.d.). Our analysis focused on the current pricing scenario for eligible patients within
affiliations. each niche instead of on prices in the public health system. This distinction is vital for

Volume 2 Issue 4 (2024) 1 https://doi.org/10.36922/ghes.4439