Belantamab MafodotinBlenrep

7.1 The PBAC did not recommend belantamab mafodotin, in combination with bortezomib and dexamethasone (BmBd), for the treatment of relapsed and/or refractory multiple myeloma (RRMM) after one prior line of therapy. The PBAC considered that a broader listing for use in the wider RRMM setting, rather than just the second-line setting would be more appropriate.PSD · Nov 2025

7.2 The PBAC considered that the primary reason for this outcome was the proposed place in therapy. The PBAC noted that restricting BmBd to the second line setting did not align with the clinical trial or with how clinicians would like to use MM therapies.PSD · Nov 2025

6.49 The submission presented a modelled economic evaluation comparing BmBd with DBd for the treatment of patients with multiple myeloma after one prior line of therapy. The economic evaluation was based on the results of the DREAMM-7 trial (lenalidomide-exposed subgroup), with additional modelled data. The economic evaluation was presented as a stepped cost-effectiveness/cost-utility analysis.PSD · Nov 2025

Table 9: Summary of model structure, key inputs and rationale Component Summary Belantamab in combination with bortezomib and dexamethasone (BmBd) versus daratumumab in Treatments combination with bortezomib and dexamethasone (DBd) 20 years in the model base case versus a median follow-up of 39.4 months in the DREAMM-7 ITT Time horizon population and 37.5 months in the lenalidomide-exposed subgroup13.PSD · Nov 2025

terms of efficacy, but inferior in terms of safety, compared to DBd. Source: Table 1-1, p21 of the submission.PSD · Nov 2025

Abbreviations: BmBd, belantamab in combination with bortezomib and dexamethasone; DBd, daratumumab in combination with bortezomib and dexamethasone; MRD, minimal residual disease. a Daratumumab is also available as a subcutaneous formulation. While the recommended treatment frequency is the same as the intravenous formulation, the recommended dose is 1,800 mg.PSD · Nov 2025

6.79 The submission noted that a risk-sharing arrangement based on agreed budget impact estimates would be required for the PBS listing of belantamab mafodotin. The submission stated that utilisation beyond the expenditure cap would be associated with an alternative rebate level that is yet to be determined. For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Nov 2025