InclisiranLeqvio
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).
Decisions on record
- Meeting Nov 2024 Recommended Familial heterozygous hypercholesterolaemia and non-familial hypercholesterolaemia
- Meeting Nov 2024 Recommended Familial heterozygous hypercholesterolaemia and non-familial hypercholesterolaemia
- Meeting May 2023 Recommended Hypercholesterolaemia and atherosclerotic cardiovascular disease no PSD
- Meeting Mar 2023 Not recommended Hypercholesterolaemia; atherosclerotic cardiovascular disease (ASCVD)
- Meeting Jul 2021 Withdrawn Hypercholesterolaemia no PSD
Access path
- TGA registered · Leqvio
TGA label narrower than the PBS population
- May 2023Recommended
vs ezetimibe (second-line); evolocumab and alirocumab…
- Nov 2024Recommended
Evidence: RCT → Other
- Nov 2024Recommended · restricted
Evidence: RCT → Other
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended the amendment to the PBS listings of inclisiran to allow nurse practitioners (NPs) to initiate and continue treatment of inclisiran, in consultation with a specialist physician for the treatment of familial heterozygous hypercholesterolaemia (HeFH) and non-familial hypercholesterolaemia (non-FH).PSD · Nov 2024
5.2 The PBAC noted the submission did not propose any changes to the price of inclisiran and anticipated the proposed prescriber change will not lead to an increase in prescribing of inclisiran because HeFH and non-FH with atherosclerotic cardiovascular disease (ASCVD) are well understood diseases with strict PBS and diagnostic criteria.PSD · Nov 2024
6.36 The submission presented both a modelled economic evaluation of inclisiran compared to ezetimibe for the second-line treatment of hypercholesterolemia in patients with atherosclerotic cardiovascular disease and a CMA between inclisiran and PCSK9 inhibitor therapies in the subsequent line setting.PSD · Mar 2023
Cost effectiveness analysis of inclisiran compared to ezetimibe (followed by PCSK9 inhibitor therapies, if required)PSD · Mar 2023
Inclisiran is non-inferior in terms of efficacy and safety compared to evolocumab and alirocumab Source: Table 1; Attachment 4; Attachment 11 of the submission Abbreviations: LDL-C, low density lipoprotein cholesterolPSD · Mar 2023
1.4 The ESC considered the proposed positioning of inclisiran as a second-line alternative to ezetimibe was not justified for multiple reasons:PSD · Mar 2023
4.2 The PBAC noted and welcomed input from four health care professionals and two organisations via the Consumer Comments facility on the PBS website. The comments from health care professionals including NPs and an interventional cardiologist stated that there was little downside to allowing NPs to prescribe inclisiran given the need for patient access, noting that the indications are clearly outlined in the PBS restrictions, there are minimal …PSD · Nov 2024
4.3 The submission stated the proposed amendment to the listing of inclisiran would streamline patient’s journey with hypercholesterolaemia, reduce health care utilisation costs and time commitment for patients, reduce cardiologist and GP appointments and administration, and provide continuity of care for patients with their NP.PSD · Nov 2024
Cost-effectiveness
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.
The PBAC therefore considered the change was likely to result in a nil financial impact to the PBS and RPBS. PBAC · 2024
Decision context
PopulationAdults 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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended | — | — | Other |
| Nov 2024 | Recommended · restricted | evolocumab | — | Other |
| May 2023 | Recommended | ezetimibe (second-line); evolocumab and alirocumab (subsequent-line) | — | RCT · LDL-C reduction |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| ORION-9 | Ph 3 | 482 | Percent Change in LDL-C From Baseline To Day 510 | completed |
Consumer voice
A health care professional and two patient organisations (Hearts4heart and Heart Support Australia) supported streamlining the authority level for inclisiran, citing reduced administrative delays, improved patient outcomes, better access particularly for rural and regional patients, and decreased healthcare costs.
streamlining the authority level for inclisiran would increase access to patients, improve outcomes and decrease health care costs for the community Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients who have inadequately responded to or are intolerant of statin therapy; TGA label includes broader combinations and monotherapy scenarios.