Miriam Allein Zago Marcolino et al. Sérgio Renato da Rosa Decker Eduardo Gehling Bertoldi Carisi A. Polanczyk
Since the discovery, in 2003, that loss-of-function mutations in the gene that encodes proprotein convertase subtilisin/kexin type 9 (PCSK9) reduce LDL cholesterol levels, there has been growing interest in using PCSK9 pathways to treat patients with increased risk of cardiovascular disease and atherosclerosis., In multiple randomized clinical trials, PCSK9 inhibitors reduced LDL levels, with a significant reduction in cardiovascular events, although the effect on mortality has been less consistent. The FOURIER clinical trial was the largest randomized clinical trial with these medications, including 27,564 patients with high risks; it demonstrated a reduction in major cardiovascular events with the use of PCSK9 inhibitors, without any significant impact on cardiovascular mortality.
Nevertheless, the high cost of therapy, with continuous lifelong treatment, is an important obstacle to its use. Costs directly impact the prescription of these medications by physicians, as well as patient compliance, and large-scale adoption by health systems. This problem is not unique to low- and middle-income countries. Several international studies have indicated that, from an economic perspective, the prices of these drugs were not proportionate to the expected benefit., There has been massive appeal from the international community for a reduction in the price of PCSK9 inhibitors, which has been taking place over the years.,
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