The PCSK9i revolution: important changes to PBS eligibility

These next-generation lipid therapies may see more patients benefit, say experts
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Clinical studies on the PCSK9 inhibitor class show they dramatically lower LDL-C levels – by an average of up to 60% – when combined with other lipid lowering therapies such as statins and cholesterol absorption inhibitors.

Data from the FOURIER and ODYSSEY cardiovascular outcomes trials show PCSK9 inhibitors can lower the risk of serious CV events such as myocardial infarction, strokes, and revascularisations, as well as reducing mortality in high-risk patients. 

While the evidence suggests these biologics may have revolutionised the landscape of lipid management, they were previously out of reach for many patients as government subsidies narrowly concentrated on those with familial hypercholesterolemia.

However, recent changes to the availability of these next-generation lipid therapies may see more patients benefit. In May 2020 the government announced the extended PBS listing of Amgen’s evolocumab (Repatha), one of two PCSK9 inhibitors on the Australian market, to include patients with atherosclerotic cardiovascular disease (ASCVD) and additional risk factors.