OBJECTIVES Eculizumab is a high-cost monoclonal antibody used for complications in patients with Paroxysmal Nocturnal Hemoglobinuria and Atypical Haemolytic Uremic Syndrome, two rare diseases. Approved by the FDA and the EMA in 2007, the market approval in Brazil was only granted in March 2017, by Anvisa. Before eculizumab incorporation into the Unified Health System (SUS) in December 2018, judicial demands to access the drug headed public spending with litigated medicines for several years. The study examined purchases of eculizumab by the Brazilian federal government from 2007 to 2018, in terms of quantities, expenditures and prices.

METHODS We extracted eculizumab purchases data between January 2007 and December 2018, from the Integrated General Services Administration System (SIASG). We examined number of purchases, quantities purchased, annual expenses and prices. Prices were restated by the IPCA for December 2018 and values converted to US dollars (1R$ = USD 0.2580778). Trend analyses were performed using the least square method.

RESULTS Beginning in 2009, the Brazilian Ministry of Health carried out all purchases through a bidding waiver for the provision of litigated medicines. There was a growing trend in number of purchases and in quantities purchased over time. There were 283 purchases during the period, totaling 116,792 vials, being 28.2% purchased in 2018. Total corrected expenses amounted to more than R$ 2.44 billion (USD 630.73 million). After market approval, the weighted average price (PMP) fell approximately 35%, to values below regulated prices established by the Drug Market Regulation Chamber (CMED)

CONCLUSIONS Eculizumab represented extremely significant expenses for the SUS during the period. All purchases were made to address litigation, outside the competitive environment. After Anvisa’s market approval, prices dropped significantly, which may show further reduction, since there is no active patent in place anymore in Brazil, and the drug was incorporated by SUS in December 2018.