script.reportAU
Oncology

Pembrolizumab

Brand: Keytruda

PBAC's latest decision on Pembrolizumab: Not recommended (2025). Considered for Treatment of unresectable advanced and metastatic cancers, excluding adjuvant, neoadjuvant, or perioperative settings, and excluding tumours known to be unresponsive to PD-1 inhibitors.

PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
49
first 2015
PBS spend
$1.13B
133,120 scripts · 2024

Eligible population

Adults with unresectable advanced or metastatic cancers (across multiple cancer types including NSCLC, melanoma, urothelial cancer, colorectal cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, Hodgkin lymphoma, and others), excluding adjuvant, neoadjuvant, or perioperative settings and tumours known to be unresponsive to PD-1 inhibitors.

Therapy area
Oncology
Line of therapy
Any
Evidence base
Cost-minimisation
Economic model
BIA only
ICER note
No ICER calculated; this is a broad multi-indication listing proposal with risk-sharing arrangement rather than a traditional cost-effectiveness analysis.
ICER (historical)
$35k/QALY–$45k/QALY across 3 submissions (2016–2023) — 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 — Two-tier risk-sharing arrangement (RSA) with tiered subsidisation caps. Tier 1 covers current PBS-listed indications and two PBAC-recommended but not yet implemented indications at effective price. Tier 2 applies a consolidated rebate for expanded use including future indications, retreatment, use beyond 2 years, and rare cancers.

Why PBAC said no

Reasons cited in the latest PSD: Not recommended at July 2025 meeting; proposal did not establish reliable basis for financial estimates. The PBAC considered the financial model lacked sufficient clarity on inputs and underlying assumptions, and outputs could not be adequately verified. Model did not include required elements such as offset medicines, patient copayments, Services Australia impacts, and MBS administration costs impacts.

PBS expenditure

The Australian government paid $1.13B in PBS benefits for Pembrolizumab in 2024 across 133,120 scripts, at $8,518 per script.

Submission history

Similar precedents

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