Page 88 - GHES-1-1

Global Health Econ Sustain

ORIGINAL RESEARCH ARTICLE
Budgetary impact of new label indications after

initial drug registration in Brazil: A case study of
pembrolizumab and trastuzumab deruxtecan

1,2
1,2
Marcus Carvalho Borin *, Mariana Michel Barbosa , Camila Oliveira Pereira ,
1,2
1
1
Carina Rejane Martins , Daniel Pitchon dos Reis , Geraldo José Coelho Ribeiro ,
1,3
1
1
Júlia Teixeira Tupinambás , Karina de Castro Zocrato , Lélia Maria de Almeida
Carvalho , Marcela Pinto de Freitas , Maria da Glória Cruvinel Horta ,
1
1
1
Mariza Cristina Torres Talim , Ernesto Gomes de Azevedo ,
1
1
Sergio Adriano Loureiro Bersan , and Silvana Marcia Bruschi Kelles 1,3
1
1 Health Technology Assessment Group, Unimed-BH, Belo Horizonte, MG, Brazil
2 Faculty of Pharmacy, Federal University of Minas Gerais (UFMG). Belo Horizonte, MG, Brazil
3 Department of Medicine, Pontifical Catholic University of Minas Gerais, Betim, MG, Brazil
Abstract
Academic editor:
Mihajlo Jakovljevic M.D. Ph.D. MAE The pharmaceutical landscape has undergone a transformative shift due to
*Corresponding author: emerging technologies, leading to a projected value of USD 405.52 billion for
Marcus Carvalho Borin the global pharmaceutical manufacturing market in 2020. Brazil, representing
(marcusborin@gmail.com) 2% of the global pharmaceutical market, boasts a comprehensive public health
Citation: Borin, M.C., system called Sistema Único de Saúde (SUS), ensuring universal health coverage.
Barbosa, M.M., Pereira, C.O., However, the public and private health sectors in Brazil operate independently,
Martins, C.R., dos Reis, D.P.,
Ribeiro, G.J.C., et al. 2023. with 23% of Brazilians possessing private health insurance plans. Regulated by
Budgetary impact of new label the Brazilian Drug Market Regulation Chamber (CMED), which controls drug
indications after initial drug prices based on international retail prices and other factors, the pharmaceutical
registration in Brazil: A case study
of pembrolizumab and trastuzumab market in Brazil faces significant challenges in maintaining the sustainability
deruxtecan. Global Health Econ of the Brazilian health-care system, particularly due to the high costs of cancer
Sustai, 1(1): 0994. medications, such as pembrolizumab and trastuzumab deruxtecan. This study
https://doi.org/10.36922/ghes.0994
aims to assess the budgetary impact of expanding indications for pembrolizumab
Received: May 25, 2023 and trastuzumab deruxtecan in Brazil after their initial registration by the
Accepted: July 18, 2023 Brazilian Health Regulatory Agency. Utilizing epidemiological data from the
National Cancer Institute (INCA) and clinical trial data, we estimated the eligible
Published Online: August 16, 2023
patient populations and associated costs for these medications. Trastuzumab
Copyright: © 2023 Author(s). deruxtecan’s eligible patient population increased from 383 to 23,000 across
This is an Open Access article
distributed under the terms of the various indications, resulting in a total cost increase from USD 90.6 million to
Creative Commons Attribution USD 5.0 billion. Similarly, pembrolizumab’s eligible patient population expanded
License, permitting distribution, from 1796 to 99,544 for multiple indications, causing the total cost increase
and reproduction in any medium,
provided the original work is from USD 121.1 million to USD 6.7 billion. The study highlights the substantial
properly cited. expansions in indications and patient eligibility for trastuzumab deruxtecan and
Publisher’s Note: AccScience pembrolizumab in Brazil, with significant budgetary implications potentially
Publishing remains neutral with jeopardizing the health-care system’s sustainability. To ensure the long-term
regard to jurisdictional claims in
published maps and institutional sustainability of health-care systems and to provide equitable access to optimal
affiliations. treatments, it is crucial for policymakers to monitor and adjust drug prices

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