Squaring up the health economics of PCSK9 monoclonal antibodies ‘down under’

Abstract

Seminal data from population genetics have presaged the development of several novel lipid-regulating drugs and the prospect of more effectively addressing high residual risk of cardiovascular disease (CVD) in patients receiving secondary prevention therapies [1]. The most impressive development is the identification of proprotein convertase subtilisin/kexin type 9 (PCSK9), a regulator of the intracellular cycling of the low-density lipoprotein (LDL) receptor, as a target for lowering LDL-cholesterol (LDL-C) [2]. This journey most recently entered the phase of large scale CV outcome trials [2]. The most widely tested method for inhibiting PCSK9 entails the use of humanized monoclonal antibodies (mAbs) [2]. However, their high acquisition costs and budgeting impact on healthcare are concerning [3].

In this issue, Kumar et al. report an economic evaluation of PCSK9 inhibitors in Australia [4]. The secondary prevention population relates to the FOURIER trial [5]. Relative to placebo, they estimated an incremental cost-effectiveness ratio (ICER), reporting the cost per quality-adjusted life year (QALY) being higher than $300,000 [4]. The authors concluded that a significant reduction in cost is required to reach the point at which PCSK9 inhibitors can be recommended as cost-effective, an appropriate conclusion. There are a number of considerations, both clinical and economic, pointing to future research for demonstrating cost-effectiveness in specific populations.