MogamulizumabPOTELIGEO
Treatment of relapsed or refractory cutaneous T-cell lymphoma (mycosis fungoides or Sezary syndrome) previously treated with at least one prior systemic therapy.
Decisions on record
- Meeting Sep 2025 Noted Cutaneous T-cell lymphoma (relapsed or refractory) no PSD
- Meeting Mar 2025 Recommended Cutaneous T-cell lymphoma (CTCL), relapsed or refractory, after ≥1 prior systemic therapy
- Meeting Nov 2020 Not recommended The proposed TGA indication is the treatment of adult patients with mycosis fungoides (MF) or Sezary syndrome (SS) who have received at least one prior systemic therapy.
- Meeting Jul 2020 Not recommended Cutaneous T-Cell Lymphoma (CTCL)
Access path
- TGA registered · POTELIGEO
TGA label equal than the PBS population
- Jul 2020Not recommended
vs vorinostat
- Nov 2020Not recommended
- ↻ resubmittedSep 2025Noted
Evidence: RCT → Single-arm
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the Authority Required listing of mogamulizumab for the treatment of patients with relapsed or refractory cutaneous T cell lymphoma (CTCL), on the basis that it should be available only under special arrangements under Section 100 (Efficient Funding of Chemotherapy Program).PSD · Mar 2025
7.2 The PBAC welcomed the input from individuals who described the impact of relapsed or refractory CTCL on their quality of life, and from health care professionals who highlighted that durable remissions are not attained with one line of treatment. The PBAC noted the input from clinicians in the sponsor hearing regarding the limitations of treatment options currently available.PSD · Mar 2025
Time horizon The model horizon of 20 years was considered The time horizon was reduced to 10 long (para 6.56, mogamulizumab PSD, July 2020 years. PBAC Meeting) 2 OFFICIALPSD · Mar 2025
OFFICIAL Public Summary Document – March 2025 PBAC Meeting with September 2025 Addendum Component Matter of concern How the resubmission addresses it Clinical benefit The PBAC considered the extent of benefit for The additional evidence presented by mogamulizumab versus vorinostat could not be the resubmission did not adequately determined from the available evidence in support the claim of superior MAVORIC (para 7.7, mogamulizumab PSD, July effectiveness …PSD · Mar 2025
6.23 The resubmission described mogamulizumab as non-inferior in terms of safety compared to vorinostat. This claim was previously accepted (see paragraph 6.20).PSD · Mar 2025
6.24 No formal claim was made for mogamulizumab against ECP and brentuximab. The comparative effectiveness of mogamulizumab versus ECP and brentuximab remains unknown.PSD · Mar 2025
6.2 The PBAC noted and welcomed the input from individuals (15), health care professionals (7) and organisations (2) via the Consumer Comments facility on the PBS website. The comments from health care professionals described the high symptom burden often faced by patients with relapsed or refractory CTCL and highlighted that durable remissions are not attained with one line of treatment.PSD · Mar 2025
6.46 No risk-sharing arrangement (RSA) was proposed. A RSA was not considered during the July 2020 and November 2020 PBAC Meetings.PSD · Mar 2025
Cost-effectiveness
A cost-minimisation approach (CMA) was proposed in the Pre-Sub-Committee Response; no numeric ICER is stated in the public text. Previous submissions had ICERs of $55,000–$75,000/QALY (July 2020) and $255,000–$355,000/responder (November 2020).
Decision context
PopulationAdults with histologically confirmed relapsed or refractory cutaneous T-cell lymphoma (mycosis fungoides or Sezary syndrome) who have received at least one prior systemic therapy.
Risk sharingSpecial Pricing Arrangements apply.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Sep 2025 | Noted | vorinostat | — | Single-arm · OS |
| Nov 2020 | Not recommended | vorinostat | — | RCT · PFS |
| Jul 2020 | Not recommended | vorinostat | — | RCT · PFS |
Consumer voice
Healthcare professionals highlighted the high symptom burden in relapsed/refractory CTCL and the importance of improved disease control and quality of life. Individuals with the condition and carers described the debilitating nature including fatigue, skin symptoms causing discomfort and anxiety, social isolation, side effects from current treatments, and barriers to access including cost and geog
The comments from health care professionals described the high symptom burden often faced by patients with relapsed or refractory CTCL and highlighted that durable remissions are not attained with one line of treatment. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify adults with MF/SS after ≥1 prior systemic therapy; PBAC adds 'histologically confirmed' and 'relapsed/refractory' which restate the TGA label's clinical intent.