PBAC's latest decision on Inclisiran: Noted (2024). Considered for Amendment to restriction level for treatment of familial heterozygous hypercholesterolaemia (FHeH) and non-familial hypercholesterolaemia (non-FH) from Authority Required (Telephone/Online) to Authority Required (STREAMLINED).
PBAC outcome
Noted
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
3
first 2023
Submissions
3
2023 → 2024
Eligible population
Adults with familial heterozygous hypercholesterolaemia or non-familial hypercholesterolaemia with atherosclerotic cardiovascular disease or at high risk of cardiovascular events, who have inadequately responded to or are intolerant of statin therapy.
Therapy area
Cardiovascular
Line of therapy
Any
Evidence base
Other
Comparator
evolocumab
Economic model
not-modelled
ICER note
This is a Category 3 submission requesting an amendment to restriction level only; no new economic evaluation was conducted. The previous economic evaluation (March 2023 PBAC Meeting) was based on a cost-minimisation analysis to evolocumab.
Submission history
Mar 2023: Not recommended · Authority Required
Nov 2024: Recommended with restriction · Authority Required