PBAC's latest decision on Pirfenidone: Recommended with restriction (2018). Considered for Treatment of idiopathic pulmonary fibrosis (IPF). This submission was for new tablet forms (267 mg and 801 mg) as formulation changes to the previously listed pirfenidone capsule.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
4
first 2015
Submissions
4
2015 → 2018
Eligible population
Patients with idiopathic pulmonary fibrosis meeting specified clinical criteria including FVC ≥50% predicted, FEV1/FVC >0.7, and DLCO ≥30% corrected for haemoglobin, diagnosed through a multidisciplinary team.
Therapy area
Respiratory
Line of therapy
Any
Evidence base
Cost-minimisation
Primary endpoint
Cost-minimisation
Comparator
pirfenidone 267 mg capsule
Economic model
Cost-minimisation
ICER note
Minor submission with cost-minimisation analysis; no new ICER calculated as submission involved formulation change only.
ICER (historical)
$45k/QALY–$75k/QALY across 2 submissions (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 — The new presentations would join the current Risk Sharing Arrangement for pirfenidone and nintedanib.
Submission history
Nov 2015: Recommended with restriction · Authority Required
Mar 2016: Recommended with restriction · Authority Required — ICER $75k/QALY
Nov 2016: Recommended with restriction · Authority Required — ICER $75k/QALY
Mar 2018: Recommended with restriction · Authority Required