VUTRISIRAN
Information current as at: 1 September 2026
Submission Details
- Brand name:
-
- Amvuttra®
- Form and strength:
-
- Injection 25 mg (as sodium) in 0.5 mL pre-filled syringe
- Submission sponsor:
- MEDISON PHARMA AUSTRALIA PTY LIMITED
- Condition/indication:
(therapeutic use) -
- Transthyretin amyloid cardiomyopathy (ATTR-CM)
- Listing requested:
- To request listing of vutrisiran for the treatment of adult patients with wild-type or hereditary ATTR-CM with documented evidence of the transthyretin precursor protein present who have experienced at least one episode of hospitalisation that was a direct result of heart failure or have clinical evidence of heart failure without hospitalisation that required treatment with a diuretic for improvement.
- Funding program:
- PBS General Schedule
- Request authority level:
- Authority Required (Written) for initial treatment Authority Required (Telephone/Online) for continuing treatment
- PBAC Submission type:
- Change to existing 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: - Recommended (see PBAC Outcomes)
-
Notice of intent submitted:
- Awaiting lodgement from pharmaceutical company
-
5Lodgement of required documentation:
-
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 vutrisiran (Amvuttra®) on the PBS for the treatment of transthyretin amyloidosis with cardiomyopathy (ATTR-CM) in patients with New York Heart Association (NYHA) Class I or II disease. The PBAC did not recommend listing in patients with NYHA Class III disease as the comparator, tafamidis, is not PBS listed for this group and the submission did not provide an economic analysis to justify the proposed price.
The PBAC welcomed input from individuals and organisations supporting the listing. The input highlighted the severe impact of ATTR-CM on quality of life and the importance of additional treatment options, especially for patients who do not adequately respond to or cannot tolerate tafamidis.
The PBAC considered the main clinical comparison of vutrisiran and tafamidis in the submission to be uncertain, however based on the totality of the available evidence, was satisfied that vutrisiran is likely to be similarly effective to tafamidis at reducing mortality and recurrent cardiovascular events. The PBAC also considered vutrisiran likely has similar safety to tafamidis.
The PBAC advised the cost of vutrisiran would be acceptable if the annual cost of treatment was not higher than that of tafamidis. The PBAC considered that vutrisiran given as one 25 mg injection every 12 weeks was equivalent to once daily oral tafamidis 61 mg.
The PBAC considered the vutrisiran restriction should ensure combination use with tafamidis is not permitted (but switching between agents is acceptable) and this should flow on to the existing tafamidis listings.