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Global Health Econ Sustain Impact of new drug indications in Brazil

medication by the Brazilian Health Regulatory Agency survival compared with chemotherapy (Marabelle et al.,
(Anvisa), fair pricing by CMED, and the effective 2020). In addition, pembrolizumab has received approval
incorporation of technology by the National Council for not only for melanoma and NSCLC but also for head-and-
Technological Development in Health (Conitec) (Ivama- neck cancer, classical Hodgkin’s lymphoma, and urothelial
Brummell et al., 2022). carcinoma. In many cases, pembrolizumab’s approval was

Cancer medications pose a significant challenge to the based on demonstrating improved outcomes compared to
sustainability of health-care systems in Brazil. The high existing treatments (Keytruda HCP, 2023).
cost of these drugs, especially innovative and targeted Trastuzumab deruxtecan (marketed as Enhertu )
®
therapies, creates financial burdens that strain public is a targeted cancer therapy designed to bind with cells
health-care budgets. The increasing prevalence of cancer that overexpress HER2 protein. This over-expression is
cases, coupled with the development of new and expensive commonly observed in certain types of cancer, such as
treatments, has led to a surge in spending on cancer breast and gastric cancer, and is believed to contribute to
medications (INCA, 2022). the development and growth of these tumors (MSD, 2023).
According to estimates from the National Cancer Based on the results from the Phase II study DESTINY-
Institute (INCA) for Brazil, it is projected that there will Breast 01 trial, trastuzumab deruxtecan has been approved
be 704,000 new cases of cancer in the period from 2023 for its first indication in the US for treating adult patients
to 2025, excluding non-melanoma skin cancer cases. Non- with HER2-positive unresectable or metastatic breast
melanoma skin cancer is estimated to be the most common, cancer who have received two or more prior anti-HER2-
with 220,000 new cases (31.3%), followed by breast based regimens in the metastatic setting (Marabelle et al.,
cancer, with 74,000 cases (10.5%); prostate cancer, with 2020). It has received label approval from the FDA for
72,000 cases (10.2%); colorectal cancer, with 46,000 cases HER2-positive, metastatic NSCLC, and locally advanced
(6.5%); lung cancer, with 32,000 cases (4.6%); and stomach or metastatic HER2-positive gastric cancer. The drug’s
cancer, with 21,000 cases (3.1%). The most frequent types indications continue to expand as the results of various
of cancer in men are expected to be non-melanoma skin ongoing clinical trials are published, including clinical
cancer, with 102,000 cases (29.9%); prostate cancer, with trials for HER2-expressing solid tumors and colorectal
72,000 cases (21.0%); colorectal cancer, with 22,000 cases cancer (Daiichi Sankyo, 2023; Destiny Clinical Trials,
(6.4%); lung cancer, with 18,000 cases (5.3%); stomach 2023; Keam, 2020; Modi et al., 2020).
cancer, with 13,000 cases (3.9%); and oral cavity cancer, Considering the inclusion impact of new indications for
with 11,000 cases (3.2%). In women, the most common drugs that are already registered in Brazil and recognizing
types of cancer are expected to be non-melanoma skin the need for the process of registering new drugs by
cancer, with 118,000 cases (32.7%); breast cancer, with regulatory agencies to evolve and keep pace with the new
74,000 cases (20.3%); colorectal cancer, with 24,000 cases market dynamic, this study aims to assess the budgetary
(6.5%); cervical cancer, with 17,000 cases (4.7%); lung impact resulting from the expansion of indications of
cancer, with 15,000 cases (4.0%); and thyroid cancer, with pembrolizumab and trastuzumab deruxtecan after their
14,000 cases (3.9%). The age-adjusted incidence rate, initial registration by Anvisa in Brazil.
excluding non-melanoma skin cancer, was 17% higher in
men (185.61) than in women (154.08), and it is considered 2. Methods
intermediate and compatible with rates observed in 2.1. Data sources
developing countries (INCA, 2022).
To determine the appropriate population for trastuzumab
Pembrolizumab (marketed as Keytruda ) is a
®
monoclonal antibody originally approved by the United deruxtecan and pembrolizumab, various data sources
States (US) Food and Drug Administration (FDA) in were utilized. Epidemiological data on cancer incidence
and mortality were sourced from INCA, which is part of
2014 for the treatment of advanced melanoma, a type the Brazilian Ministry of Health. INCA provides yearly
of skin cancer. Since its initial approval for metastatic statistics on cancer incidence derived from population-
melanoma, pembrolizumab has been studied for various
other indications and approved for several additional uses based cancer registries. These statistics were used to
(MSD, 2023). One of the most significant expansions of forecast the expected number of new cancer cases for the
indications for pembrolizumab came in 2017 when the upcoming years.
FDA approved it for treating non-small-cell lung cancer Additional data sources included clinical trial data,
(NSCLC). This approval was supported by data from reimbursement documents from Conitec, and the
clinical trials demonstrating an improvement in overall KEYNOTE studies for pembrolizumab. These sources

Volume 1 Issue 1 (2023) 3 https://doi.org/10.36922/ghes.0994