script.reportAU
Oncology

Ribociclib

Brand: Kisqali

PBAC's latest decision on Ribociclib: Recommended with restriction (2025). Considered for Adjuvant treatment of hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), resected early breast cancer (eBC) at high risk of disease recurrence, in combination with endocrine therapy. Specifically for patients with Stage II or III disease with 1–3 positive axillary lymph nodes with grade ≤2 histology and tumour size <5 cm, or Stage IIB/III node-negative disease, or Stage IIA node-negative disease with grade 3 or grade 2 histology with positive molecular diagnostic outcome.

PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
—
ICER not stated
Submissions
7
first 2017
PBS spend
$95M
21,124 scripts · 2024

Eligible population

Adult patients with HR positive, HER2 negative early breast cancer with (a) stage II or III disease with 1–3 positive axillary lymph nodes with grade ≤2 histology and tumour size <5 cm, or (b) stage IIB or III node-negative disease, or (c) stage IIA node-negative disease with histological grade 3 or grade 2 with a positive molecular diagnostic outcome.

Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
iDFS
Key trials
NATALEE, postMONARCH
Comparator
adjuvant endocrine therapy alone
Economic model
CEA
ICER note
The submission was based on a cost-effectiveness analysis versus adjuvant ET alone, but no numeric ICER values are stated in the public text. The November 2024 PBAC consideration used a cost-minimisation analysis.
ICER (historical)
$75k/QALY across 3 submissions (2017–2020) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.

PBS expenditure

The Australian government paid $95M in PBS benefits for Ribociclib in 2024 across 21,124 scripts, at $4,493 per script.

Submission history

Similar precedents

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