ELEXACAFTOR WITH TEZACAFTOR AND WITH IVACAFTOR, AND IVACAFTOR
Information current as at: 1 June 2026
PBAC meeting date: July 2026
Submission Details
- Brand name:
-
- Trikafta®
- Form and strength:
-
- Pack containing 28 sachets containing granules elexacaftor 100 mg with tezacaftor 50 mg and with ivacaftor 75 mg and 28 sachets containing granules ivacaftor 75 mg
- Submission sponsor:
- VERTEX PHARMACEUTICALS (AUSTRALIA) PTY. LTD.
- Condition/indication:
(therapeutic use) -
- Cystic fibrosis
- Listing requested:
- To request a change to the existing listing for Trikafta (granules formulation) for the treatment of cystic fibrosis to allow patients aged 6-11 years weighing less than 30 kg to use either the granule or tablet formulation of the same dose.
- Funding program:
- PBS Section 100 (Highly Specialised Drugs Program)
- Request authority level:
- Authority Required (Written)
- PBAC Submission type:
- Change to existing listing (–)
- 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)
-
3PBAC meeting:
- Has not yet occurred
-
4PBAC outcome published:
- Pending PBAC outcome (see PBAC Outcomes)
-
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
Case ID
1226
Page last updated
31 May 2026
v.9.19