INOTUZUMAB OZOGAMICIN
Information current as at: 1 July 2026
Submission Details
- Brand name:
-
- Besponsa®
- Form and strength:
-
Please search for and view the meeting agenda from the relevant meeting for more information
- Submission sponsor:
- PFIZER AUSTRALIA PTY LTD
- Condition/indication:
(therapeutic use) -
- Acute lymphoblastic leukaemia (ALL)
- Listing requested:
- Please see meeting agenda for more information
- Funding program:
- PBS Section 100 (Efficient Funding of Chemotherapy Program)
- Request authority level:
- Please see meeting agenda for more information
- PBAC Submission type:
- Other business (Category 3)
- Comment:
- --
- Other PBAC consideration:
- --
Progress Details
-
Submission received for: - March 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 19/11/2025 and close 21/01/2026 (see PBS Website)
-
PBAC meeting: - Held on 11/03/2026
-
PBAC outcome published: - Advice Provided (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
The PBAC advised that the Risk Sharing Arrangement (RSA) for inotuzumab ozogamicin for the treatment of acute lymphoblastic leukaemia can be removed. In forming this view, the PBAC noted that utilisation of inotuzumab ozogamicin has remained low and relatively stable over time and that no new clinical uncertainties or changes to the PBS restriction had been identified for inotuzumab ozogamicin since listing. The PBAC considered that the original rationale for including inotuzumab ozogamicin in a shared RSA with blinatumomab, which was to manage uncertain financial estimates and a high incremental cost-effectiveness ratio, had diminished over time.