Page 189 - GHES-2-4

Global Health Economics and
Sustainability
Addressing response to new drug indications

understanding the regulatory and market environment in Finally, it is important to highlight the broader context of
which our study was conducted (Cruz et al., 2022; Sullivan our findings. Not all Brazilians have access to these innovative
et al., 2014). drugs despite their proven beneficial outcomes. A primary
Our assumption of a median treatment time of barrier is the significant financial burden associated with
1 year was based on a balanced estimate, recognizing the use of such drugs. If all eligible patients in Brazil were
that treatment duration can vary. We aimed to provide a to benefit from these drugs, the healthcare system would
reasonable average for our analysis, acknowledging the need to spend an amount comparable to its entire budget
inherent variability in treatment durations. for therapies treating widespread chronic conditions, such
as diabetes and hypertension, which serve a much larger
To determine the appropriate patient population for portion of the population. This disparity highlights the
the drugs, we utilized a combination of epidemiological unsustainable nature of current drug pricing strategies,
data from INCA, clinical trial data, reimbursement where high-cost treatments for smaller populations strain
documents from Conitec, and the KEYNOTE studies for the system disproportionately. This stark reality underscores
pembrolizumab. These sources provided comprehensive the challenges faced by countries with low GDPs, especially
insights into the specific inclusion criteria for the drugs when their drug pricing techniques mirror those of
and helped determine patient populations for different developed nations. Thus, while the authors have highlighted
indications. The epidemiological funnel used in our study certain limitations in our study, we believe that these
to enhance clarity and reproducibility can be shared upon limitations underscore the critical need for a comprehensive
request (INCA, 2022; Marabelle et al., 2020). evaluation of drug pricing strategies. Addressing these
A recent decision by the National Institute for Health issues is essential to ensure broader accessibility and equity
and Care Excellence (NICE) in the UK highlights a in healthcare, particularly in countries with low GDPs.
similar issue. NICE expressed disappointment in being
unable to recommend Enhertu (trastuzumab deruxtecan) Conflict of interest
for HER2-low advanced breast cancer for use within The authors declare that they have no competing interests.
the National Health Service due to the company’s
pricing decisions. This scenario underscores the critical References
challenge of balancing innovation with affordability, a ANS Realiza a 30 Reunião Técnica da Cosaúde. (n.d.). Agência
a
dilemma not unique to the UK and highly relevant in Nacional de Saúde Suplementar. Available from: https://
the Brazilian context. The inability of health-care systems www.gov.br/ans/pt-br/assuntos/noticias/sociedade/ans-
to access innovative therapies because of prohibitive realiza-a-30a-reuniao-tecnica-da-cosaude [Last accessed on
costs reinforces the urgency of reevaluating drug pricing 2024 Jul 30].
strategies globally. This decision by NICE serves as Bero, L. (2017). Addressing Bias and conflict of interest among
a reminder that even in more affluent countries, the biomedical researchers. JAMA, 317(17):1723-1724.
tension between drug pricing and accessibility remains a
significant barrier. For countries such as Brazil, with a low https://doi.org/10.1001/jama.2017.3854
gross domestic product (GDP) and limited health-care Cruz, J.A.W., da Cunha, M.A.V.C., de Moraes, T.P., Marques, S.,
resources, these challenges are even more pronounced. Tuon, F.F., Gomide, A.L., et al. (2022). Brazilian private
This further supports our argument for a comprehensive health system: History, scenarios, and trends. BMC Health
evaluation of drug pricing strategies to ensure that life- Services Research, 22(1):49.
saving treatments are accessible to all who need them, https://doi.org/10.1186/s12913-021-07376-2
regardless of the economic constraints of the healthcare INCA. (2022). INCA Estima 704 Mil Casos de Câncer Por Ano
system (NICE, 2024). No Brasil Até 2025. Instituto Nacional de Câncer - INCA.
It is crucial to address a significant oversight in the Available from: https://www.gov.br/inca/pt-br/assuntos/
response by Riveros et al. (2024): the authors did not declare noticias/2022/inca-estima-704-mil-casos-de-cancer-por-
their conflict of interest. This omission is concerning and ano-no-brasil-ate-2025 [Last accessed on 2024 Jul 30].
should have been addressed as it directly pertains to the Marabelle, A., Le, D.T., Ascierto, P.A., Di Giacomo, A.M.,
objectivity of their critique. Transparency regarding De Jesus-Acosta, A., Delord, J.P., et al. (2020). Efficacy
potential conflicts of interest is essential to maintain the of pembrolizumab in patients with noncolorectal high
integrity and trustworthiness of scientific discourse. Failure microsatellite instability/mismatch repair-deficient cancer:
to disclose such conflicts can undermine the credibility of Results from the phase II KEYNOTE-158 study. Journal of
the feedback provided and the overall scientific discussion Clinical Oncology, 38(1):1-10.
(Bero, 2017). https://doi.org/10.1200/JCO.19.02105

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