PBAC's latest decision on Mogamulizumab: Noted (2025). Considered for Treatment of relapsed or refractory cutaneous T-cell lymphoma (mycosis fungoides or Sezary syndrome) previously treated with at least one prior systemic therapy.
PBAC outcome
Noted
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
3
first 2020
Submissions
3
2020 → 2025
Eligible population
Adults with histologically confirmed relapsed or refractory cutaneous T-cell lymphoma (mycosis fungoides or Sezary syndrome) who have received at least one prior systemic therapy.
Therapy area
Oncology
Line of therapy
Later-line
Evidence base
Single-arm
Primary endpoint
OS
Pivotal trial size
372 patients
Key trials
MAVORIC, ANCLD
Comparator
vorinostat
Economic model
Cost-minimisation
ICER note
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).
Risk sharing
Risk-sharing arrangement in place — Special Pricing Arrangements apply.
Submission history
Jul 2020: Recommended with restriction · Authority Required
Nov 2020: Recommended with restriction · Authority Required