BEMPEDOIC ACID BEMPEDOIC ACID WITH EZETIMIBE
Information current as at: 1 September 2026
Submission Details
- Brand name:
-
- Nexletol®
- Nexlizet®
- Form and strength:
-
- Tablet 180mg
- Tablet 180mg bempedoic acid with 10 mg ezetimibe
- Submission sponsor:
- SEQIRUS (AUSTRALIA) PTY LTD
- Condition/indication:
(therapeutic use) -
- Hypercholesterolaemia
- Listing requested:
- To request listing of bempedoic acid, as monotherapy and in combination with ezetimibe, for the treatment of adult patients with hypercholesterolaemia (heterozygous familial and non-familial) at high risk of a first cardiovascular event or with established symptomatic atherosclerotic cardiovascular disease who have statin intolerance or are on maximally tolerated statin therapy, and despite treatment with ezetimibe, continue to have low-density lipoprotein cholesterol (LDL-C) levels greater than 1.8 mmol/L.
- Funding program:
- PBS General Schedule
- Request authority level:
- Authority Required (STREAMLINED)
- PBAC Submission type:
- New PBS listing (Category 2)
- Comment:
- --
- Other PBAC consideration:
- --
Progress Details
-
Submission received for: - July 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 25/03/2026 and close 20/05/2026 (see PBS Website)
-
PBAC meeting: - Held on 08/07/2026
-
PBAC outcome published: - Not Recommended (see PBAC Outcomes)
-
Lodgement of required documentation: - Not applicable
-
Agreement to listing arrangements: - Not applicable
-
Government processes: - Not applicable
-
Medicine listed on the PBS: - Not applicable
PBAC Outcome
The PBAC did not recommend bempedoic acid and bempedoic acid with ezetimibe for the treatment of adult patients with hypercholesterolaemia (heterozygous familial (HeFH) and non-familial) at high risk of a first cardiovascular (CV) event or with established symptomatic atherosclerotic cardiovascular disease (ASCVD). The proposed listing included patients who cannot tolerate statins or are on maximally tolerated statin therapy, and despite treatment with ezetimibe, continue to have low-density lipoprotein cholesterol (LDL) levels above 1.8 mmol/L.
The PBAC welcomed the comments from health professionals and organisations supporting the PBS listing of bempedoic acid. The input noted the benefits of bempedoic acid included its oral administration, favourable tolerability, and evidence from the CLEAR OUTCOMES trial demonstrating fewer cardiovascular events with bempedoic acid compared with placebo in patients who could not tolerate statin therapy. The PBAC acknowledged that there remains a clinical need for additional treatment options, particularly for patients who are statin-intolerant or who are not adequately managed with statins or ezetimibe but are not eligible for PCSK9 inhibitors.
The PBAC noted that the trial evidence suggested bempedoic acid reduced major adverse cardiovascular events and reduced LDL cholesterol compared with placebo. However, the PBAC considered that it was uncertain whether the benefits shown in the main clinical trial would be seen in the Australian population as the trial population did not adequately reflect the target population of the proposed listing. As a result, the PBAC noted that the expected size of benefit in the proposed population would also be uncertain. The PBAC considered that the economic model was subject to substantial uncertainty and required further revision, particularly in relation to the modelling of costs over time. The PBAC considered that a price reduction together with a risk sharing arrangement was likely required to achieve a listing that would be value for money.
Sponsor’s Comment:
The sponsor had no comment.