script.reportAU
Oncology

Osimertinib

Brand: Tagrisso

PBAC's latest decision on Osimertinib: Recommended with restriction (2025). Considered for First-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to EGFR tyrosine kinase inhibitors, as either osimertinib monotherapy or in combination with platinum-based chemotherapy plus pemetrexed.

PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
$75k/QALY
Range: $55k/QALY–$75k/QALY
Submissions
9
first 2017
PBS spend
$163M
20,842 scripts · 2024

Eligible population

Patients with locally advanced (Stage IIIB/C) or metastatic (Stage IV) NSCLC with evidence of activating EGFR mutations (exon 19 deletions or exon 21 L858R substitutions) known to confer sensitivity to EGFR tyrosine kinase inhibitors, receiving first-line treatment as either monotherapy or in combination with platinum-based chemotherapy plus pemetrexed.

Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
557 patients
Key trials
FLAURA2
Comparator
osimertinib monotherapy
Economic model
CUA
Risk sharing
Risk-sharing arrangement in place — A revised risk-sharing arrangement for osimertinib indications was proposed, with increased caps to account for additional net expenditure on osimertinib associated with the extended listing (O+C joining the existing risk sharing agreement for osimertinib).

PBS expenditure

The Australian government paid $163M in PBS benefits for Osimertinib in 2024 across 20,842 scripts, at $7,843 per script.

Submission history

Similar precedents

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