Inotuzumab OzogamicinBesponsa

4.1 The PBAC provided advice regarding the sponsor’s request to terminate the Risk Sharing Arrangement (RSA) for inotuzumab ozogamicin for the treatment of acute lymphoblastic leukaemia (ALL). The PBAC advised that it is reasonable to reconsider the current arrangements of the RSA in the context of the divergence in PBS listings and utilisation patterns between inotuzumab ozogamicin and blinatumomab since the RSA was established.PSD · Mar 2026

4.2 The PBAC noted that inotuzumab ozogamicin has remained restricted to the relapsed or refractory setting and that utilisation and Commonwealth expenditure for inotuzumab ozogamicin has remained low and relatively stable over time. In contrast, the PBAC noted that blinatumomab has undergone additional PBS listing expansions, including newly diagnosed and MRD‑directed populations, with corresponding increases in utilisation and expenditure.PSD · Mar 2026

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