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Global Health Econ Sustain Impact of new drug indications in Brazil

Table 1. Incremental indications for trastuzumab deruxtecan
Indications Estimate eligible patients Annual treatment cost per patient (USD) Total cost (USD)
HER2+in 3 line of treatment 383 236,610.35 90,621,763.50
rd
HER2+in 2 line of treatment 581 219,312.92* 127,420,806.64
nd
HER2-low-expressing 23,000 219,312.92* 5,044,197,164.99
(IHC 1+or IHC 2+/ISH-) in 2 line of treatment
nd
Note: *The price of trastuzumab deruxtecan decreased due to the lower new international price.
cancer in the second line of treatment, with an estimated
23,000 eligible patients and the same annual treatment cost
per patient. This expansion led to a substantial increase in
the total cost, amounting to USD 5,044,197,164.99.
3.2. Pembrolizumab
The first registration for the pembrolizumab drug was
granted in Brazil by Anvisa in 2016, initially restricted
to patients with advanced melanoma. Over time, the
label indications for pembrolizumab were expanded,
encompassing 20 new diseases or stages of cancer. Table 2 Figure 1. Estimated eligible population for pembrolizumab in Brazil
provides an overview of the incremental indications for by year.
pembrolizumab, including the year of inclusion and the
respective indications. Each year, new indications were
added, expanding the therapeutic options for patients
across a wide range of cancers, including melanoma,
NSCLC, urothelial carcinoma, head-and-neck squamous
cell carcinoma, Hodgkin’s lymphoma, renal cell carcinoma,
colorectal cancer, endometrial carcinoma, bladder cancer,
esophageal or gastroesophageal junction cancer, and
triple-negative breast cancer.
The expansion of indications for pembrolizumab
resulted in a significant increase in the estimated number Figure 2. Estimated total cost for pembrolizumab in Brazil
of eligible patients. In 2016, the estimated eligible (in billion USD).
population for pembrolizumab in Brazil was 1796 patients. pembrolizumab in Brazil. The indications for trastuzumab
This number gradually increased over subsequent years, deruxtecan were extended multiple times, leading to an
reaching 99,544 patients in 2022 (Figure 1).
increase in eligible patients from 383 to 23,000 and a rise
The expansion of indications also had a substantial in total costs from USD 90.6 million to USD 5.0 billion.
impact on the total cost of treatment with pembrolizumab. Similarly, the indications for pembrolizumab expanded to
In 2016, the total cost was approximately USD 121.1 encompass 20 new diseases or stages of cancer, resulting
million. As the eligible patient population increased in an increase in eligible patients from 1796 to 99,544
and new indications were added, the total cost of and a rise in total costs from USD 121.1 million to USD
pembrolizumab escalated to USD 6.7 billion in 2022 6.7 billion.
(Figure 2). This substantial increase underscores the According to data from the Ministry of Health’s
budgetary implications associated with the expanded use Information System on Public Health Budgets (SIOPS), it is
of pembrolizumab and the challenges faced by health- estimated that Public Health Actions and Services (ASPS)
care systems in managing the costs of innovative cancer accounted for approximately 4.83% of GDP in 2020. In
therapies. terms of actual figures, health spending in 2020 amounted
4. Discussion to BRL 358 billion, marking a significant increase of 44.3%
of compared to the total expenditure of BRL 241 billion
This study revealed significant expansions in indications in 2011 (adjusted for inflation as of December 2020)
and patient eligibility for trastuzumab deruxtecan and (Ministério da Saúde, 2023).

Volume 1 Issue 1 (2023) 5 https://doi.org/10.36922/ghes.0994