PBAC's latest decision on Irinotecan (nanoliposomal): Not recommended (2024). Considered for First-line treatment of metastatic pancreatic adenocarcinoma in previously untreated patients, administered as NALIRIFOX (nanoliposomal irinotecan in combination with oxaliplatin, 5-fluorouracil, and folinic acid/leucovorin).
PBAC outcome
Not recommended
Not applicable
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
4
first 2016
Submissions
4
2016 → 2024
Eligible population
Previously untreated adults with metastatic pancreatic adenocarcinoma with ECOG PS 0-1
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
OS
Key trials
NAPOLI-3, GENERATE
Comparator
Mixed comparator: gemcitabine plus nanoparticle albumin-bound paclitaxel (75%) and FOLFIRINOX (25%); PBAC considered FOLFIRINOX the appropriate main comparator
Economic model
CUA
ICER note
ICER not stated in the document. The PBAC did not consider the cost-utility analysis informative because FOLFIRINOX was considered the appropriate main comparator rather than Gem+NabP.
Why PBAC said no
Reasons cited in the latest PSD: Superiority of NALIRIFOX over FOLFIRINOX not adequately established by indirect evidence; concerns regarding reliability of indirect treatment comparisons due to transitivity violations and differences between GENERATE and NAPOLI-3 trials; uncertain clinical meaningfulness of OS improvement over Gem+NabP (1.9 months); higher rates of gastrointestinal toxicities and serious adverse events with NALIRIFOX versus Gem+NabP not adequately justified; inappropriate nominating of Gem+NabP as main comparator when FOLFIRINOX is the relevant clinical comparator; lack of robust evidence to support cost-utility analysis; uptake and financial estimates likely overestimated
Submission history
Nov 2016: Not recommended · Authority Required
Mar 2018: Noted · Restricted
Mar 2024: Recommended with restriction · Authority Required