Terapia antiangiogênica para edema macular diabético: impacto orçamentário no sus e influência dos acordos mercadológicos

Abstract

Budget Impact Analysis (BIA) are very often the last studies before the of health technologies incorporation in a health system, and the litigation of health rights profile might expose therapeutic vacuums and guide the path of studies, as well as BIA. Using this assumption, BIA was performed by the deterministic planning method to evaluate the incorporation of anti-angiogenic therapy of intravitreal application for the second-line treatment of Diabetic Macular Edema in the Unified Health System (SUS) of the State of Minas Gerais, a current inexistent alternative and often target of lawsuits. We included in the analysis the medicines Bevacizumab, Ranibizumab and Alfibercept, all of them with known evidences of effectiveness and safety, however being the first used off-label in Brazil. The incremental budgetary impact of the medicines represents, over a five-year horizon, R$ 473,226,278.78 for Bevacizumab; R$ 2,378,732,103.09 for Ranibizumab and R$ 3,703,524,490.16 for Aflibercept, according to the epidemiological approach. According to measured demand estimate, the amounts are R$ 69,493,906.95 for Bevacizumab, R$ 349,319,965.60 for Ranibizumab and R$ 543,867,485.47 for Aflibercept, so that Bevacizumabe proved to be the more viable alternative as it has lower costs. A Bevacizumab incorporation would generate an increase of around 3% of the State of Minas Gerais budget for procurement of medicines, according to measured demand estimate. It is considered that it is feasible within the Minas Gerais State SUS, depending on the careful evaluation and opinion of the manager's priorities. The price discrepancy between products demonstrates the performance of forces and market agreements. For the present case we realize that in addition to a commercial agreement that involves not registering an effective drug for a given condition, the courts were even used in order to modulate a kind of public policy not only based by the health needs of the population. This especific procedure seems to be executed worldwide, proof of this is that there is an novel European judicial agreement arising from a procedure originated in italian court, which imposed a fine on Roche and Novartis of EUR 90.6 million and EUR 92 million respectively. This fine was justified by the fact that the two companies entered into an agreement, for the period evaluated between June 1, 2011 and February 27, 2014, which "aimed at obtaining an artificial differentiation between Avastin (Bevacizumab) and Lucentis (Ranibizumab), manipulating the perception of the risks of using Avastin in ophthalmology ". At the core of this struggle, we can exemplify this as a case in which SUS, is being hampered by the interests dictated by the capitalist exploitation of health, that in a context of neoliberal agenda. This whole plot leads us to a very important discussion about health innovation, the current patent system, the financing of health systems and profits when health is placed under the market's perspective.