BLINATUMOMAB
Information current as at: 1 September 2026
Submission Details
- Brand name:
-
- Blincyto®
- Form and strength:
-
- Powder for I.V. infusion 38.5 micrograms
- Submission sponsor:
- AMGEN AUSTRALIA PTY LIMITED
- Condition/indication:
(therapeutic use) -
- Acute lymphoblastic leukaemia (ALL) Precursor B-cell ALL (Pre-B-cell ALL)
- Listing requested:
- To request revision of the current combined blinatumomab/inotuzumab ozogamicin Risk Sharing Arrangement (RSA) for ALL and Pre-B-cell ALL.
- Funding program:
- PBS Section 100 (Efficient Funding of Chemotherapy)
- Request authority level:
- Authority Required
- PBAC Submission type:
- Change to existing listing (Category 3)
- 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: - 10/08/2026
-
Acceptance of complete documentation:
- Accepted
-
6Agreement to listing arrangements:
- Commenced on 18/08/2026
-
Status:
- Under consideration
-
7Government processes:
- Has not yet commenced
-
8Medicine listed on the PBS:
- Has not yet occurred
PBAC Outcome
The PBAC advised that it would be appropriate to increase the subsidisation caps under the existing blinatumomab Risk Sharing Arrangement (RSA) to account for additional utilisation of blinatumomab to treat minimum residual disease (MRD)‑negative paediatric B-precursor acute lymphoblastic leukaemia (B‑ALL).
Case ID
1215
Page last updated
31 August 2026
v.9.19