EVOLOCUMAB
Information current as at: 1 September 2026
Submission Details
- Brand name:
-
- Repatha®
- Form and strength:
-
- Injection 140 mg in 1 mL single use pre-filled pen
- Submission sponsor:
- AMGEN AUSTRALIA PTY LIMITED
- Condition/indication:
(therapeutic use) -
- Non-familial hypercholesterolaemia; Familial heterozygous hypercholesterolaemia; Familial homozygous hypercholesterolaemia
- Listing requested:
- To request new listings for evolocumab with increased maximum dispensed quantities for all currently listed indications to allow for 60-day prescriptions.
- Funding program:
- PBS General Schedule
- Request authority level:
- Authority Required
- PBAC Submission type:
- New PBS listing (Category 4)
- 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
-
5Lodgement of required documentation:
- 18/08/2026
-
Acceptance of complete documentation:
- Under consideration
-
6Agreement to listing arrangements:
- Has not yet commenced
-
7Government processes:
- Has not yet commenced
-
8Medicine listed on the PBS:
- Has not yet occurred
PBAC Outcome
The PBAC recommended listing of evolocumab with increased maximum dispensed quantities (MDQs) consistent with the Government’s 60-day prescription initiative for the treatment of homozygous familial hypercholesterolaemia (HoFH), heterozygous familial hypercholesterolaemia (HeFH) and non-familial hypercholesterolaemia (non-FH). The PBAC considered that evolocumab meets the criteria for an increased MDQ based on the exclusion criteria established at the December 2022 PBAC meeting when the PBAC considered a list of PBS medicines indicated for the treatment of chronic conditions for their suitability for listing with increased MDQs per dispensing.