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Global Health Econ Sustain Assessing budget impact estimates based on official data

eligible patients for each drug immediately initiate
therapy after drug registration at the local regulatory
agency (ANVISA, 2020) oversimplifies the real-world
scenario. At the time of approval, other standard-of-
care therapies already in use may be replaced by newly
approved therapies. Besides, among the 26 indications
listed by Borin et al. (2023), only one is incorporated
into the public health-care system (pembrolizumab for
advanced melanoma) despite 73.9% of the population
being covered exclusively by the public system.
Acknowledgments
Figure 1. Brazilian pharmaceutical market in 2022 (total billing and
individual drug categories [CMED, 2022]) and drug budgetary impact None.
projected by Borin et al. (2023). Abbreviation: CMED: Brazilian
Medicines Market Regulation Chamber. Funding
None.
to identify the proper sources for drug price and
other costs. Borin et al. (2023) relied on the CMED Conflict of interest
List Price, which sets the maximum price in Brazil. The authors declare that they have no competing interests.
However, this price may not represent the average
price charged to different payers across the country, Author contributions
and it does not consider mandatory discounts for
public payers (Coeficiente de Adequação de Preços Conceptualization: Bruno Salgado Riveros, Marina Gatto
[CAP]). In addition, the analysis did not include Cavalcanti
additional cost categories such as administration, Writing – original draft: Bruno Salgado Riveros, Marina
adverse events management, and terminal care costs. Gatto Cavalcanti, Letícia Paula Leonart
It is worth noting that new therapies may reduce these Writing – review and editing: Mariana Papaléo Rosim,
costs compared to current clinical practice. André Bergamim Almeida, Cristiane Aparecida
ii. Lack of time-on-treatment (ToT) adjustment: Several Licursi
indications for pembrolizumab have maximum
treatment durations described on the label, ranging Ethics approval and consent to participate
from 12 to 24 months (Keytruda Package Insert).
However, actual treatment durations are often Not applicable.
considerably shorter due to factors such as disease Consent for publication
progression, death, adverse events, and other reasons
necessitating therapy discontinuation. For example, Not applicable.
in the KEYNOTE-024 study (advanced lung cancer),
the median ToT for patients receiving pembrolizumab Availability of data
was 7 months (Reck et al., 2016), a factor overlooked Not applicable.
by Borin et al. (2023).
iii. Definition of eligible patients: Existing guidelines References
(Brazilian Ministry of Health, 2012; Sullivan et al., Borin, M.C., Barbosa, M.M., Pereira, C.O., Martins, C.R., Dos
2014) state the importance of clearly describing the Reis, D.P., Ribeiro, G.J., Tupinambás, J.T., et al. (2023).
rationale for estimating eligible patients to ensure Budgetary Impact of new label indications after initial drug
result consistency and transparency. However, Borin registration in Brazil: A case study of pembrolizumab and
et al. (2023) failed to provide details on their approach trastuzumab deruxtecan. GHES, 1(1):0994.
to estimating eligible patients, hindering thorough https://doi.org/10.36922/ghes.0994
assessment by other health economic specialists. Brazilian Ministry of Health. (2012). Diretrizes Metodológicas:
Although the authors appear to refer to all eligible Análise de Impacto Orçamentário. Manual para o
patients for each therapy, not all patients receive Sistema de SaúdedoBrasil.Brasília: Secretariat of Science,
treatment, and not all treated patients receive the Technology and Strategic Inputs, Department of Science
same therapy. In addition, assuming that 100% of and Technology.

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