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PCSK9 Inhibitors — Authority & Monitoring

Streamlined continuing authority since Jul 2024

Field: CardiovascularCode: CV-03BUpdated: June 2026Reference: pbs.gov.au / ESC-EAS 2025
Continuing PCSK9 inhibitor treatment now uses a streamlined authority (no phone call) once an adequate LDL-C response is documented, following the listing change effective 1 July 2024. No routine LFT or CK monitoring is needed — check LDL-C at 4–6 weeks after starting, then 3–6 monthly.

1Authority process

✓
Initial treatment — Apply via PBS Online (real-time) or telephone authority. Document the ASCVD/FH diagnosis, baseline LDL-C, statin dose and duration (or documented intolerance), ezetimibe use, and the specialist consultation details.
✓
Continuing treatment — A streamlined authority applies (no phone call) once an adequate LDL-C response is documented — confirm the exact current wording and response threshold at pbs.gov.au, as the listing was last revised effective 1 July 2024.

2Dosing across the class

AgentUsual dosingPractical notes
Evolocumab140mg SC fortnightly, or 420mg SC monthlySelf-administered; rotate injection sites; allow to reach room temperature before injecting
Alirocumab75mg or 150mg SC fortnightly, per responseSelf-administered; similar storage and site-rotation advice
Inclisiran284mg SC at baseline, 3 months, then 6-monthlyAdministered by a clinician — reduces the adherence burden of self-injection

3LDL targets & monitoring

Very-high-risk ASCVD: LDL-C<1.4mmol/L and ≥50% reduction from baseline (or <1.8mmol/L if a lower target isn't achievable), per the ESC/EAS 2025 focused update (numeric targets unchanged from 2019). HeFH without ASCVD: target <2.5mmol/L. Most patients on a PCSK9 inhibitor reach LDL-C<1.0mmol/L, with no lower safety threshold identified to date. Check LDL-C at 4–6 weeks to confirm an adequate response (needed for the continuing authority), then 3–6 monthly; no routine LFT or CK monitoring is required for any of the three agents.

Safety

  • Injection-site reactions are the most common side effect with evolocumab/alirocumab — usually mild redness, itching or swelling, not associated with serious allergy in trials.
  • No myopathy or hepatotoxicity signal with any PCSK9-pathway agent — a useful option in statin-intolerant patients.
  • Very low LDL-C appears safe in long-term follow-up, with no excess cognitive, neurological or adrenal effects identified to date.

Check / exclude

  • Inadequate response → confirm adherence and injection technique before assuming treatment failure.
  • Consider one-off Lp(a) testing when assessing residual cardiovascular risk, per the ESC/EAS 2025 update.
  • See CV-03A for eligibility pathways and the agent comparison.

CV-03B v1.0 · Reviewed Jun 2026 · Review Dec 2026

For health-professional use. Evidence: FOURIER (NEJM 2017), ODYSSEY OUTCOMES; ESC/EAS 2025 lipid guideline update. Companion sheet: CV-03A PCSK9 Inhibitors — PBS Eligibility.