Inotuzumab OzogamicinBesponsa
Relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (B-ALL), including Philadelphia chromosome-positive disease.
Decisions on record
- Meeting Mar 2026 Advice provided Acute lymphoblastic leukaemia (ALL)
- Meeting Nov 2018 Recommended Acute lymphoblastic leukaemia (ALL)
Access path
- TGA registered · Besponsa
TGA label narrower than the PBS population
- Nov 2018Recommended · restricted
vs blinatumomab
- May 2019Deferred
Comparator changed: blinatumomab → blinatumomab; tyrosine kinase inhibitors (TKIs) for…
- Mar 2026Noted
Comparator changed: blinatumomab; tyrosine kinase inhibitors (TKIs) for Ph+ disease →…
- PBS listing · Restricted
From the public summary
4.1 The PBAC deferred making a decision to extend the recommended listing of inotuzumab, which was for the treatment of relapsed or refractory (R/R) Ph- B- precursor acute lymphocytic leukaemia (B-ALL), to include patients with Ph+ disease.PSD · May 2019
The PBAC deferred making a recommendation to enable further work on the restriction and financial estimates.PSD · May 2019
6.66 The submission presented a cost-minimisation analysis of inotuzumab versus blinatumomab, based on the claim of non-inferior effectiveness and different but non- inferior safety.PSD · Nov 2018
6.67 The submission estimated the equi-effective doses as: inotuzumab 9 x 1 mg vials overPSD · Nov 2018
6.60 The submission described inotuzumab as non-inferior in terms of effectiveness compared with blinatumomab and different but non-inferior in terms of safety compared to blinatumomab in the treatment of relapsed/refractory, Philadelphia chromosome negative, CD22-positive, B-cell precursor acute lymphoblastic leukaemia.PSD · Nov 2018
6.61 The evaluation considered that the clinical claim presented in the submission was not adequately supported. The results of the formal indirect comparison may not be reliable given the lack of exchangeability between the INO-VATE ALL and TOWER trials in terms of baseline patient characteristics, eligibility criteria, outcome definitions, disease progression criteria and standard of care chemotherapy regimens.PSD · Nov 2018
6.4 The PBAC noted and welcomed the input from a health professional via the Consumer Comments facility on the PBS website. The comments described the benefits of inotuzumab for patients with very high risk childhood ALL primarily as a bridge to HSCT. 11PSD · Nov 2018
6.90 The submission noted that blinatumomab is subject to a special pricing arrangement and may also be subject to an expenditure capped risk-sharing arrangement. The submission suggested that a special pricing arrangement and risk-sharing arrangement would be required for inotuzumab. The sponsor stated that it is willing to work with the Department of Health to finalise the details of suitable arrangements.PSD · Nov 2018
Cost-effectiveness
This is a Category 3 submission requesting advice on termination of a Risk Sharing Arrangement. The original listing was on a cost-minimisation basis; no new ICER was calculated in this submission.
The PBAC recalled that inotuzumab ozogamicin was originally recommended for PBS listing on a cost‑minimisation basis against blinatumomab and that the RSA expenditure caps had been increased to include inotuzumab ozogamicin and sequential use of blinatumomab and inotuzumab ozogamicin. PBAC · 2026
Decision context
PopulationAdults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia, including Philadelphia chromosome-positive disease.
Risk sharingShared Risk Sharing Arrangement (RSA) with blinatumomab established at listing in May 2019. The PBAC advised that termination of the RSA for inotuzumab ozogamicin would be reasonable due to divergence in PBS listings and utilisation patterns.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Noted | blinatumomab | — | Cost-minimisation |
| May 2019 | Deferred | blinatumomab; tyrosine kinase inhibitors (TKIs) for Ph+ disease | — | RCT · ORR |
| Nov 2018 | Recommended · restricted | blinatumomab | — | RCT · Complete remission |
Consumer voice
A health professional provided input via the Consumer Comments facility describing the benefits of inotuzumab for patients with very high risk childhood ALL primarily as a bridge to HSCT.
The comments described the benefits of inotuzumab for patients with very high risk childhood ALL primarily as a bridge to HSCT. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to second-line, specific performance status, prior treatment history, and blast percentage criteria absent from TGA label.