Page 199 - GHES-2-1

Global Health Econ Sustain

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 Riveros*, Marina Gatto Cavalcanti, Letícia Paula Leonart,
Mariana Papaléo Rosim, André Bergamim Almeida,
and Cristiane Aparecida Licursi
MSD Brazil, São Paulo, São Paulo, Brazil

Health technology assessment (HTA) has gained increasing recognition as a tool
for informing decision-making in health management. In this sense, it is imperative
to compare the findings from Borin et al. (2023) with the guidelines established by the
Brazilian Ministry of Health (2012) and to ensure the adoption of the good practices of
BIA (Sullivan et al., 2014). This adoption is crucial for strengthening HTA within the
Brazilian health system.
The Brazilian Medicines Market Regulation Chamber (CMED), an inter-ministerial
body responsible for the economic regulation of the pharmaceutical market in Brazil,
through its executive secretariat (SCMED), annually publishes statistics and indicators
Academic editor:
Mihajlo Jakovljevic M.D. Ph.D. MAE on the Brazilian pharmaceutical market. In its most recent publication (SCMED, 2023)
it is estimated that the total billing of the Brazilian industrial pharmaceutical market to
*Corresponding author:
Bruno Salgado Riveros be US$ 25.4 billion (exchange rate: 5.164 BRL = 1 USD, consistent with the rate used by
(bruno.riveros@merck.com) Borin et al., 2023).
Citation: Riveros, B.S., In Figure 1, we present the total pharmaceutical market value as reported by SCMED,
Cavalcanti, M.G., Leonart, L.P., alongside the billing values corresponding to each medicine category for the year 2022.
Rosim, M.P., Almeida, A.B., &
Licursi, C.A. (2024). Budgetary In addition, Figure 1 presents the total values for pembrolizumab and trastuzumab
impact of new label indications after deruxtecan calculated by Borin et al. (2023) for the same year. Notably, these drugs are
initial drug registration in Brazil: classified as “biological medicines” according to the Brazilian Health Regulatory Agency
A case study of pembrolizumab and
trastuzumab deruxtecan. Global (ANVISA, 2020).
Health Econ Sustain, 2(1): 1889.
https://doi.org/10.36922/ghes.1889 Borin et al. (2023) presented estimates of USD 5.2 billion for trastuzumab deruxtecan
and USD 6.7 billion for pembrolizumab. However, these estimates lack support from
Received: September 20, 2023
official data, as the combined sum of both projections (USD 11.9 billion) nearly doubles
Accepted: December 15, 2023 the whole market size of biological medicines sales in the country (USD 6.6 billion)
Published Online: February 29, 2024 (Figure 1).
Copyright: © 2024 Author(s). The substantial overestimation of Borin et al. (2023) can be explained by several
This is an Open-Access article reasons. First, while the authors claim to address budgetary impact, their analysis
distributed under the terms of the presents an increase in costs over time under an unrealistic scenario where all eligible
Creative Commons Attribution
License, permitting distribution, patients receive identical treatment. A proper comparison to estimate budget impact
and reproduction in any medium, should be made against current clinical practice (Brazilian Ministry of Health, 2012;
provided the original work is Sullivan et al., 2014), a crucial aspect overlooked by the authors. In addition, three other
properly cited.
critical aspects were not addressed:
Publisher’s Note: AccScience
Publishing remains neutral with i. Perspective (definition of payer): The National Guideline for Budget Impact Analysis
regard to jurisdictional claims in (BIA) (Brazilian Ministry of Health, 2012) and the Principles of Good Practice for
published maps and institutional
affiliations. BIA from ISPOR (Sullivan et al., 2014) emphasize the need for a clear perspective

Volume 2 Issue 1 (2024) 1 https://doi.org/10.36922/ghes.1889