PBAC's latest decision on Trifluridine with tipiracil: Recommended with restriction (2019). Considered for Extension to current listing for treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have been previously treated with, or are not candidates for treatment with, fluoropyrimidine, platinum and either a taxane- or irinotecan-based chemotherapy and, if appropriate, HER2/neu-targeted therapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
—
ICER not stated
Submissions
7
first 2016
Submissions
7
2016 → 2019
Eligible population
Adults with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have received at least two prior chemotherapy regimens including a fluoropyrimidine, platinum, and either a taxane or irinotecan, with ECOG performance status 0–1, and who are refractory to or intolerant of their most recent prior therapy.
Therapy area
Oncology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
OS
Pivotal trial size
507 patients
Key trials
TAGS
Comparator
placebo plus best supportive care (BSC)
Economic model
CUA
ICER note
ICER value(s) not stated in the public summary document; economic evaluation section incomplete in provided text.
ICER (historical)
$15k/QALY–$45k/QALY across 5 submissions (2017–2018) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
Nov 2016: Recommended with restriction · Authority Required
Mar 2017: Recommended with restriction · Authority Required — ICER $75k/QALY
Jul 2017: Not recommended · Authority Required — ICER $75k/QALY
Nov 2017: Not recommended · Restricted — ICER $75k/QALY
Mar 2018: Not recommended · Authority Required — ICER $75k/QALY
Jul 2018: Not recommended · Authority Required — ICER $45k/QALY
Nov 2019: Recommended with restriction · Authority Required