PBAC's latest decision on Romidepsin: Deferred (2017). Considered for Treatment of relapsed or chemotherapy-refractory peripheral T-cell lymphoma (PTCL) following at least first-line chemotherapy.
PBAC outcome
Deferred
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2016
Submissions
2
2016 → 2017
Eligible population
Adults with relapsed or refractory peripheral T-cell lymphoma who have received at least one prior systemic therapy.
Therapy area
Haematology
Line of therapy
Later-line
Evidence base
Single-arm
Primary endpoint
OS
Pivotal trial size
130 patients
Key trials
Study GPI-06-0002 (Study 0002), Piekarz et al (2011)
Comparator
no active therapy
Economic model
CUA
ICER note
ICER values are redacted (marked with '''). The document states DPMAs were recalculated but specific ICER figures are not publicly disclosed.
Submission history
Nov 2016: Recommended with restriction · Authority Required