ELEXACAFTOR WITH TEZACAFTOR AND WITH IVACAFTOR, AND IVACAFTOR
Information current as at: 1 September 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 (Committee Secretariat)
- 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
-
Lodgement of required documentation: - 17/08/2026
-
Acceptance of complete documentation:
- Accepted
-
Agreement to listing arrangements: - Commenced on 24/08/2026
-
Status:
- Finalised
-
7Government processes:
- Commenced on 24/08/2026
-
8Medicine listed on the PBS:
- Has not yet occurred
PBAC Outcome
The PBAC recommended a change to the restriction criteria for elexacaftor 100 mg + tezacaftor 50 mg + ivacaftor 75 mg granules to allow prescribing for patients aged between 6 years to 11 years. This would allow young patients (who weigh less than 30 kg) to access a granule formulation.
Case ID
1226
Page last updated
31 August 2026
v.9.19