Three PCSK9-pathway agents are now PBS-listed. Evolocumab and alirocumab are monoclonal antibodies dosed fortnightly or monthly; inclisiran is an siRNA dosed twice-yearly after an initial booster. A GP can initiate in consultation with a specialist across three pathways — ASCVD, heterozygous FH, or homozygous FH. Eligibility thresholds have changed more than once since 2021 — confirm the exact current wording at pbs.gov.au before applying.
1Eligibility — the three pathways
✓Pathway 1 — ASCVD — Established atherosclerotic cardiovascular disease (prior myocardial infarction, ischaemic stroke, coronary revascularisation, or symptomatic peripheral arterial disease) with LDL-C above the current PBS threshold despite maximally tolerated statin ± ezetimibe (or documented statin intolerance).
✓Pathway 2 — HeFH — Confirmed heterozygous familial hypercholesterolaemia (Dutch Lipid Clinic Network Score, Simon Broome criteria, or a pathogenic LDLR/APOB/PCSK9 mutation). The LDL-C threshold differs depending on whether ASCVD is also present — the exact current figures for each are not reproduced here; confirm at pbs.gov.au.
✓Pathway 3 — HoFH — Confirmed homozygous familial hypercholesterolaemia (genetic testing, or a high Dutch Lipid Clinic Network Score with consistent clinical features). No LDL-C threshold applies — managed with specialist input.
✓GP initiation — A GP can initiate evolocumab or alirocumab in consultation with a specialist (cardiologist, endocrinologist or lipidologist); inclisiran follows a similar model, with specialist consultation required for the first prescription. Document the consultation in the notes.
Safety
- Confirm the patient doesn't have a secondary or reversible cause of hypercholesterolaemia (hypothyroidism, nephrotic syndrome, cholestasis) before committing to long-term PCSK9 inhibitor therapy.
- Document specialist consultation and baseline LDL-C clearly — required for the PBS authority application.
- PBS thresholds and restriction wording for this drug class have changed multiple times since 2021.
Check / exclude
- Confirm current LDL-C thresholds and HeFH scoring requirements at pbs.gov.au — exact figures for each pathway are not reproduced on this sheet.
- Confirm adequate statin trial (or documented intolerance to ≥2 statins) is recorded.
- See CV-03B for the authority process, dosing and monitoring.
CV-03A v1.0 · Reviewed Jun 2026 · Review Dec 2026
For health-professional use. Eligibility thresholds summarised from public reporting; always confirm exact figures at pbs.gov.au. Companion sheet: CV-03B PCSK9 Inhibitors — Authority & Monitoring.
