TafasitamabMINJUVI
Recommended HaematologyAuthority RequiredLater-line line
Relapsed or refractory follicular lymphoma in patients who have had at least 1 prior systemic anti-CD20 therapy, treated in combination with lenalidomide and rituximab.
2
Submissions
2025–26
On the record
Redacted
ICER range
commercial-in-confidence
Redacted
Cost basis
Decisions on record
- Meeting Mar 2026 Recommended Relapsed and/or refractory follicular lymphoma (FL) no PSD
- Meeting Nov 2025 Deferred Relapsed and/or refractory follicular lymphoma – combination with lenalidomide and rituximab
Access path
- TGA registered · MINJUVI
TGA label narrower than the PBS population
- Nov 2025Deferred
vs rituximab-based chemotherapy (R-CHOP)
- Mar 2026Recommended · restricted
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
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 · Nov 2025
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 · Nov 2025
Economic analysis
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 · Nov 2025
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 · Nov 2025
Clinical claim
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 · Nov 2025
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 · Nov 2025
Financial management – risk sharing
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 · Nov 2025
For more detail on PBAC’s view, see section 7 PBAC outcome. 44 OFFICIALPSD · Nov 2025
Cost-effectiveness
ICER not stated in the public text; the economic model exists but values are redacted (marked as 'redacted content').
The PBAC considered that the claim of superior comparative effectiveness was highly uncertain but likely reasonable. PBAC · 2026
ICER uncertain
Decision context
PopulationAdults with relapsed or refractory follicular lymphoma who have had at least 1 prior systemic anti-CD20 therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | rituximab-based chemotherapy (R-CHOP) | — | RCT |
| Nov 2025 | Deferred | rituximab-based chemotherapy (R-CHOP) | — | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| inMIND | Ph 3 | 654 | FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugan… | active not recruiting |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to relapsed or refractory disease with ≥1 prior anti-CD20 therapy; TGA label includes all previously treated patients.