PBAC's latest decision on Nintedanib: Noted (2024). Considered for Idiopathic Pulmonary Fibrosis (IPF) and Chronic Fibrosing Interstitial Lung Disease with a progressive phenotype (PF-ILD).
PBAC outcome
Noted
Restricted
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
7
first 2015
Submissions
7
2015 → 2024
Eligible population
Adults with Idiopathic Pulmonary Fibrosis (IPF) or Chronic Fibrosing Interstitial Lung Disease with a progressive phenotype (PF-ILD).
Therapy area
Respiratory
Line of therapy
Not applicable
Evidence base
Other
Comparator
pirfenidone
Economic model
Not modelled
ICER note
Category 3 submission (administrative revision of risk sharing arrangement caps); no economic evaluation undertaken. ICER values are not applicable as this is a subsidisation cap negotiation, not a clinical/economic assessment.
ICER (historical)
$75k/QALY–$105k/QALY across 2 submissions (2015–2016) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Risk sharing
Risk-sharing arrangement in place — Risk Sharing Arrangement (RSA) with subsidisation caps. Current IPF and PF-ILD listings have separate Deeds with separate caps. Submission proposes combining the subsidisation caps for IPF and PF-ILD for the remaining duration of the PF-ILD deed. A 100% rebate applies to Government expenditure beyond the financial cap.
Submission history
Mar 2015: Recommended with restriction · Authority Required
Mar 2015: Recommended with restriction · Authority Required
Nov 2015: Recommended with restriction · Authority Required — ICER $200k/QALY
Mar 2016: Not recommended · Restricted
Nov 2016: Deferred · Authority Required — ICER $105k/QALY
Mar 2021: Recommended with restriction · Authority Required