PBAC's latest decision on Trabectedin: Recommended with restriction (2021). Considered for Advanced (unresectable and/or metastatic) leiomyosarcoma in patients who have received prior chemotherapy treatment including an anthracycline.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2021
Submissions
1
2021 → 2021
Eligible population
Adults aged 18 years or older with advanced (unresectable and/or metastatic) leiomyosarcoma who have received prior chemotherapy treatment including an anthracycline, with ECOG performance status of 2 or less.
Therapy area
Oncology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
577 patients
Key trials
Study 3007, PALETTE, TSAR
Comparator
pazopanib
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design.
Risk sharing
Risk-sharing arrangement in place — Special Pricing Arrangement (SPA) discussed; sponsor indicated willingness to negotiate an SPA for trabectedin based on the SPA for pazopanib.