REFLECTIONS AND PERSPECTIVES ON BIOSIMILARS IN BRAZIL

Objective: Biological agents are among the medicines with the highest revenue in the world market. Biosimilars are copies of biological products introduced into the market to offer clinical efficacy like the originator or reference product at lower prices. This study aimed to verify the characteristics and price differences between biological medicines registered and marketed in Brazil until the end of 2019. Methods: All records were collected by November 2019 on the website of the National Health Surveillance Agency (Anvisa). The list of the Chamber of Regulation of the Medicines Market (CMED) consulted for the price analysis, has an economic classificatory criterion with eight ranges. Categorization, according to the date/period of authorization for marketing, was also made. Results: At Anvisa site, there are 144 drugs present in 277 products distributed in three regulatory categories: new, biological, and similar. Approximately 73% of drugs have been approved in the past five years. Three classes represent 77.9% of all drugs-antineoplastics and immunomodulatory agents (38.6%), blood and blood organ forming (20.7%), and alimentary tract and metabolism (18.6%). Of the 178 products listed in the CMED, 26 (14.6%) have prices above 10,000 reais. Conclusion: The prices of original products, for most of the inputs, are lower than those of biosimilars, reversing the international logic

COST-EFFECTIVENESS ANALYSIS OF TRASTUZUMAB IN THE TREATMENT OF METASTATIC BREAST CANCER

Objective: To perform a cost-effectiveness analysis of pharmacological treatments for MBC in the context of the Brazilian Unified Health System (Sistema Único de Saúde - SUS) by comparing the drugs docetaxel and paclitaxel in isolation and in combination with trastuzumab. Methods: The results for each treatment were simulated using a Markov model and a hypothetical cohort of 1000 women aged 50 years diagnosed with MBC with overexpression of HER2. The progression of MBC was simulated for 48 months and the transitions between health states occurred monthly. A sensitivity analysis was performed. The discount rate considered was 5% per year. Results: The addition of trastuzumab allowed a gain of eight to ten months in the average lifespan after a four-year treatment. The increased threshold allows the increased use of trastuzumab combined with paclitaxel in the treatment of MBC. The combination of trastuzumabwith docetaxel and paclitaxel achieved an effective gain in the survival of patients with MBC, and the average survival time doubled compared with monotherapy. Conclusion: Considering that the costs per quality-adjusted life year (QALY) of these treatment strategies were below the threshold of 3 times the per capita GDP recommended by WHO, both strategies can be considered cost-effective