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Global Health Econ Sustain                                            Impact of new drug indications in Brazil



            expanded indications. Such an assessment could provide   Project administration: Silvana Marcia Bruschi Kelles
            valuable insights into the value of these treatments in   Supervision: Ernesto Gomes de Azevedo, Sergio Adriano
            different patient populations, informing decision-making   Loureiro Bersan, Silvana Marcia Bruschi Kelles
            processes and resource allocation strategies.      Visualization:  Daniel Pitchon dos Reis, Geraldo José
              The economic impact of expanded indications for     Coelho Ribeiro, Júlia Teixeira Tupinambás, Karina
            drugs, particularly in oncology and rare diseases, will   de Castro Zocrato, Lélia Maria de Almeida Carvalho,
            depend on several factors, including the size of the eligible   Marcela Pinto de Freitas, Maria da Glória Cruvinel
            patient population for treatment with the drug, the cost   Horta
            of the drug itself, and the potential benefits of treatment   Writing – original draft: Marcus Carvalho Borin, Mariana
            in  terms  of  improved  patient  outcomes  and  reduced   Michel Barbosa, Silvana Marcia Bruschi Kelles
            healthcare costs.                                  Writing –  review &  editing:  Marcus Carvalho Borin,
                                                                  Mariana Michel Barbosa, Silvana Marcia Bruschi
            5. Conclusion                                         Kelles
            Pharmaceutics has brought clinical benefits in many   Ethics approval and consent to participate
            areas. However, the costs of these benefits are becoming
            unsustainable for many countries and health systems.   Not applicable.
            Expanding the range of uses for drugs such as trastuzumab
            deruxtecan and pembrolizumab can have a significant   Consent for publication
            impact on healthcare budgets and jeopardize the    Not applicable.
            sustainability of health-care systems. In Brazil, where drug
            prices are not closely monitored after initial registration,   Availability of data
            the only changes in prices occur due to the annual inflation-  Data can be obtained from the corresponding author
            regulated adjustment. Monitoring drug prices after their   following a formal request.
            initial pricing is crucial to assess the need for adjustments,
            particularly when new therapeutic options for the same   References
            condition become available or when a drug becomes
            obsolete. It is essential to revise and adjust drug prices after   Bach, P.B., & Saltz, L.B. (2017). Raising the dose and raising
            their initial pricing to ensure that health systems remain   the cost: The case of Pembrolizumab in lung cancer. JNCI:
                                                                  Journal of the National Cancer Institute, 109:djx125.
            sustainable and can provide the best possible treatment
            for patients. Policymakers must be aware of this unique      https://doi.org/10.1093/jnci/djx125
            challenge.                                         Brewer, G.J. (2006). Article commentary: Fundamental problems
                                                                  lie ahead in the drug discovery and commercialization
            Acknowledgments                                       process: Restructuring of the pharmaceutical industry
            None.                                                 and an improved partnership with academia are required.
                                                                  Journal of Investigative Medicine, 54(6):291-302.
            Funding                                               https://doi.org/10.2310/6650.2006.05030
            This study was fully supported by Unimed-BH.       CMED.  (2004).  Resolução CMED  No  2,  De  5 De Março  De
                                                                  2004-Português (Brasil). Available from: https://www.
            Conflict of interest                                  gov.br/anvisa/pt-br/assuntos/medicamentos/cmed/
            The authors declare that they have no competing interests.  air/arquivos/5517json-file-1/view  [Last  accessed  on
                                                                  2023 Jan 20].
            Author contributions                               Columbia University Mailman School of Public Health. (2020).
            Conceptualization:  Marcus Carvalho Borin, Mariana    Brazil Summary. Columbia University Mailman School of
               Michel Barbosa, Camila Oliveira Pereira, Silvana   Public Health. Available from: https://www.publichealth.
               Marcia Bruschi Kelles.                             columbia.edu/research/others/comparative-health-policy-
            Investigation:  Marcus  Carvalho  Borin,  Mariana  Michel   library/brazil-summary [Last accessed on 2023 Nov 07].
               Barbosa, Camila Oliveira Pereira, Silvana Marcia   Cruz, J.A.W., da Cunha, M.A.V.C., de Moraes, T.P., Marques, S.,
               Bruschi Kelles                                     Tuon, F.F., Gomide, A.L.,  et al. (2022). Brazilian private
            Methodology:  Marcus  Carvalho  Borin,  Mariana Michel   health system: History, scenarios, and trends. BMC Health
               Barbosa,  Carina  Rejane  Martins,  Mariza  Cristina   Services Research, 22:49.
               Torres Talim                                       https://doi.org/10.1186/s12913-021-07376-2


            Volume 1 Issue 1 (2023)                         8                        https://doi.org/10.36922/ghes.0994
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