TafasitamabMINJUVI

7.1 The PBAC deferred making a recommendation for tafasitamab for use in combination with lenalidomide and rituximab for the treatment of patients with relapsed or refractory (R/R) follicular lymphoma (FL) as the TGA Delegate’s Overview was not available at the time of PBAC consideration.PSD · Mar 2026

The PBAC noted that the economic analysis used as the basis of its advice included amendments to the extent of benefit estimated beyond the period of follow-up in the trial. The PBAC considered the financial estimates to be overestimated and advised that adjustments to the financial model were required.PSD · Mar 2026

6.41 The submission presented a stepped economic evaluation of tafasitamab plus R2 versus R-CHEMO, based on the inMIND trial, and implementing a modelled evaluation.PSD · Mar 2026

R-CHOP was used as a proxy for all R-CHEMO. Table 11 summarises the key aspects of the model presented in the submission.PSD · Mar 2026

6.36 The submission described tafasitamab plus lenalidomide and rituximab as superior in terms of effectiveness compared with rituximab-based chemotherapy and inferior in terms of safety compared to rituximab-based chemotherapy, but with an acceptable safety profile.PSD · Mar 2026

6.37 The evaluation considered the therapeutic conclusion was adequately supported by the clinical evidence presented; however, uncertainty remained regarding the magnitude of the benefit in the Australian setting due to the following:PSD · Mar 2026

6.75 No specific risk-sharing arrangement (RSA) was proposed by the submission; however, the submission indicated that the sponsor was willing to enter into an RSA should it help to ensure early access for patients via a timely PBS listing.PSD · Mar 2026

For more detail on PBAC’s view, see section 7 PBAC outcome. 45 OFFICIALPSD · Mar 2026