Alirocumab
Treatment of familial heterozygous hypercholesterolaemia (he-FH) and non-familial hypercholesterolaemia (non-FH), and prevention of cardiovascular events.
Decisions on record
- Meeting Mar 2025 Noted Familial and non-familial hypercholesterolaemia no PSD
- Meeting Mar 2023 Recommended Familial heterozygous hypercholesterolaemia (he-FH) and non-familial hypercholesterolaemia (non-FH)
- Meeting Nov 2022 Withdrawn Hypercholesterolaemia no PSD
- Meeting Mar 2020 Recommended Hypercholesterolaemia
- Meeting Mar 2019 Recommended Hypercholesterolaemia
- Meeting Nov 2017 Not recommended Familial hypercholesterolaemia and clinical atherosclerotic cardiovascular disease
Access path
- Nov 2017Not recommended
Inadequate clinical evidence of cardiovascular outcomes (primary endpoints are LDL-c reduction only; ODYSSEY OUTCOMES…
- ↻ resubmittedMar 2019Recommended · restricted
Comparator changed: ezetimibe and placebo → evolocumab (for he-FH); placebo (for non-FH…
- Mar 2020Recommended · restricted
Comparator changed: evolocumab (for he-FH); placebo (for non-FH and diabetes mellitus…
- Mar 2023Recommended
Comparator changed: evolocumab → alirocumab 150 mg in 1 mL pre-filled pen
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of alirocumab AI under the same circumstances as alirocumab PFP. 5PSD · Mar 2023
6.2 The PBAC noted the sponsor’s view that the appropriate main comparator for alirocumab is two pens of alirocumab 150 mg in 1 mL PFP devices. The PBAC agreed that alirocumab PFP was an appropriate comparator and also considered that evolocumab was also a relevant comparator.PSD · Mar 2023
5.7 The submission presented a cost-minimisation analysis of alirocumab AI compared with alirocumab PFP for the respective indications at the published dispensed price per maximum quantity (DPMQ) (Table 3). It was assumed that there would be no differences in setting of care, utilisation adherence, persistence, effectiveness, safety or use of other healthcare resources between these strengths or devices of alirocumab.PSD · Mar 2023
Table 3: Cost-minimisation analysis presented by the submission Treatment regimen Published DPMQ (23 October 2022) (Initial and continuing 1 x 300 mg/2 mL device (proposed) 2 x 150 mg/1 mL devices (current) treatment) 300 mg SC Q4W $498.31 $498.31PSD · Mar 2023
5.3 The submission claimed non-inferior comparative effectiveness and safety of alirocumab AI compared with alirocumab PFP.PSD · Mar 2023
5.4 The TGA Delegate confirmed that alirocumab AI is bioequivalent to the registered alirocumab PFP. The Delegate noted that alirocumab AI may provide a benefit for the patient by providing an option to administer a single injection for a monthly dose of 300 mg of alirocumab. The Delegate noted the human factor data suggests a comparable useability between the two devices.PSD · Mar 2023
5.2 The PBAC noted and welcomed input from health care professionals (5) via the Consumer Comments facility on the PBS website. The comments described a range of benefits associated with alirocumab AI, including fewer side effects due to decreased injection frequency and easier and more convenient administration compared to alirocumab PFP. 3PSD · Mar 2023
6.96 The resubmission stated that the sponsor was willing to undertake a risk sharing arrangement, but did not provide any details regarding the arrangement. For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Mar 2019
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as submission demonstrated equi-effectiveness at the same cost.
Decision context
PopulationPatients with familial heterozygous hypercholesterolaemia (he-FH) and non-familial hypercholesterolaemia (non-FH) with high or very high cardiovascular risk and hypercholesterolaemia not adequately controlled with their lipid-modifying therapy.
Risk sharingExisting Deed of Agreement in place for alirocumab; AI form will be subject to the same Deed arrangements.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2023 | Recommended | alirocumab 150 mg in 1 mL pre-filled pen | — | Single-arm · Bioequivalence |
| Mar 2020 | Recommended · restricted | evolocumab | — | Cost-minimisation · Cost-minimisation |
| Mar 2019 | Recommended · restricted | evolocumab (for he-FH); placebo (for non-FH and diabetes mellitus, post ACS) | — | RCT · LDL reduction; cardiovascular outcomes (ODYSSEY OUTCOMES) |
| Nov 2017 | Not recommended | ezetimibe and placebo | — | Meta-analysis · LDL-C |
Consumer voice
Healthcare professionals provided input describing benefits of alirocumab AI including fewer side effects due to decreased injection frequency and easier, more convenient administration compared to alirocumab PFP.
The comments described a range of benefits associated with alirocumab AI, including fewer side effects due to decreased injection frequency and easier and more convenient administration compared to alirocumab PFP. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with high/very high cardiovascular risk and inadequate control despite current lipid-modifying therapy.