Estimation of Premature Deaths From Lack of Access to Anti-HER2 Therapy for Advanced Breast Cancer in the Brazilian Public Health System

Abstract

PurposePatients with human epidermal growth factor receptor 2 (HER2) -positive metastatic tumors treated in the public health system in Brazil do not have access to trastuzumab. This study aimed to estimate the impact of the lack of access to anti-HER2 therapies on the mortality of these patients.MethodsOn the basis of published data, the number of patients with HER2-positive advanced breast cancer in 2016 who should receive anti-HER2 targeted therapy was estimated. Three different treatment groups were considered for this hypothetical cohort: chemotherapy alone, chemotherapy plus trastuzumab, and chemotherapy plus trastuzumab and pertuzumab. The number of patients alive after 2 years of follow-up was estimated on the basis of the efficacy results of the pivotal trials considering these interventions.ResultsIt was calculated that 2,008 women will be diagnosed with advanced HER2-positive breast cancer in Brazil in 2016. It was estimated that only 808 women would be alive in 2018 if they receive only chemotherapy (which is the treatment offered by the public health system). On the other hand, the bar rises to 1,408 women alive in 2018 if they receive chemotherapy plus trastuzumab and 1,576 women alive in 2018 if they receive the gold standard of chemotherapy plus trastuzumab and pertuzumab.ConclusionTrastuzumab is included in the WHO’s list of essential medications, but the Brazilian public health system does not yet provide this treatment to its population with advanced disease. The introduction of trastuzumab and pertuzumab would have a positive effect, preventing premature deaths in women with metastatic HER2-positive breast cancer in Brazil.

Obesity as a prognostic factor in breast cancer women

“…To this day, it is still not available in metastatic diseases. This impact is reflected in worse survival and estimation of premature deaths in Brazil in patients with HER2 expression due to the lack of access to anti-HER2 therapies, as shown in the study by Debiase et al 41 In the present study, lymph node positive, tumor size greater than 2.0 cm and triple negative histologic subtype were independent factors of worse prognosis for death. Age under 50 years, positive lymph node, tumor size greater than 2.0 cm and negative Hormonal Receptor were independent factors of worse prognosis for progression, and these findings are in agreement with established knowledge.…”

Characteristics and prognosis of stage I-III breast cancer subtypes in Brazil: The AMAZONA retrospective cohort study

“…Almost 81% of patients were insured by public health system where there are several limitations in drug access. For instance, trastuzumab was approved as adjuvant or neoadjuvant treatment for early BC only in 2013 [30]. In our study, only 13.4% of HER-2 positive patients received adjuvant trastuzumab, which certainly impacted our estimates of survival in these subjects; therefore, we need to consider that the estimated survival rates do not translate to current status in Brazil, as BC treatment has improved in the past ten years.…”

Development of New Formulations of Biologics: Expectations, Immunogenicity, and Safety for Subcutaneous Trastuzumab

“…Despite being considered a breakthrough in HER2+ breast cancer treatment, the high cost of trastuzumab makes access to this drug a challenge, mainly in undeveloped countries, resulting in a worse prognosis for breast cancer patients [ 10 , 11 ]. Since 2017, after patent expiration, some trastuzumab biosimilars have been approved in several countries [ 12 – 17 ] (Table 1 ), and their use has been strongly supported by the European Society of Medical Oncology [ 18 ].…”