ELEXACAFTOR WITH TEZACAFTOR AND WITH IVACAFTOR, AND IVACAFTOR

Brand name:

• Trikafta®

Form and strength:

Please search for and view the medicine's Public Summary Document (PSD) for more information

Submission sponsor:

Vertex Pharmaceuticals (Australia) Pty, Ltd

Condition/indication:
(therapeutic use)

• Cystic fibrosis

Listing requested:

Please see PSD for more information

Funding program:

Please see PSD for more information

Request authority level:

Please see PSD for more information

PBAC Submission type:

New listing (Category 2)

Comment:

--

Other PBAC consideration:

• ELEXACAFTOR WITH TEZACAFTOR AND WITH IVACAFTOR, AND IVACAFTOR

Submission received for:

March 2023 PBAC meeting

Opportunity for consumer comment:

--

PBAC meeting:

Held on 08/03/2023

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

22/12/2022

Lodgement of required documentation:

20/01/2023

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 17/03/2023

Status:

Finalised

Government processes:

Commenced on 17/03/2023

Medicine listed on the PBS:

01/05/2023 (see PBS schedule)