Inclisiran on the PBS

Inclisiran was recently added to the Pharmaceutical Benefits Scheme (PBS) as a third-line option for non-familial hypercholesterolaemia and familial heterozygous hypercholesterolaemia.

Inclisiran is a first-in-class therapy known as a small interfering ribonucleic acid (siRNA). This medication reduces hepatic production of proprotein convertase subtilisin/kexin type 9 (PCSK9), an enzyme involved in LDL receptor regulation. The reduced level of circulating PCSK9 leads to increased LDL receptor recycling and expression on the surface of hepatocytes, increasing the uptake of LDL. Studies demonstrate that inclisiran lowers LDL levels by around 50% compared to placebo.

A potential advantage of inclisiran is the favourable dosing schedule. The first two doses are given three months apart, and maintenance doses are every six months. This may be particularly advantageous for patients with poor adherence to regular therapy. Inclisiran is administered as a subcutaneous injection, with each dose intended to be given by a healthcare professional. Inclisiran appears to be well-tolerated, with clinical trials generally reporting similar adverse events between placebo and inclisiran groups. The exception was injection site reactions, which occurred in 8.2% of inclisiran-treated patients and 1.8% of the placebo group in pivotal trials.