PBAC's latest decision on Durvalumab: Recommended with restriction (2025). Considered for Perioperative treatment (neoadjuvant and adjuvant) of patients with muscle-invasive bladder cancer (MIBC) who are planning to undergo radical cystectomy and are eligible for cisplatin-based neoadjuvant chemotherapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
10
first 2018
PBS spend
$227M
21,504 scripts · 2024
Eligible population
Adult patients with muscle-invasive bladder cancer (clinical stage T2-T4a, N0-N1, M0) who are eligible for cisplatin-based neoadjuvant chemotherapy and planning to undergo radical cystectomy, with ECOG performance status ≤1
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
EFS
Key trials
NIAGARA, CM274
Comparator
Standard of care (gemcitabine plus cisplatin neoadjuvant chemotherapy followed by active surveillance); adjuvant nivolumab for high-risk patients
Economic model
CUA
ICER note
ICER values appear to be redacted (marked as '@@@@ ' in the pricing section); the public summary does not contain explicit ICER figures
ICER (historical)
$55k/QALY–$75k/QALY across 2 submissions (2019–2023) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
PBS expenditure
The Australian government paid $227M in PBS benefits for Durvalumab in 2024 across 21,504 scripts, at $10,551 per script.
Submission history
Nov 2018: Recommended with restriction · Restricted
Jul 2019: Recommended with restriction · Authority Required
Jul 2019: Recommended with restriction · Restricted
Nov 2019: Recommended with restriction · Authority Required — ICER $75k/QALY
Nov 2020: Recommended with restriction · Restricted
Mar 2022: Recommended · Authority Required
Mar 2023: Recommended with restriction · Authority Required