PBAC's latest decision on Abemaciclib: Recommended with restriction (2023). Considered for Adjuvant treatment of hormone receptor positive, HER2-negative, lymph node positive, invasive, resected early breast cancer at high risk of disease recurrence, in combination with standard endocrine therapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
5
first 2019
PBS spend
$46M
11,002 scripts · 2024
Eligible population
Adult patients with hormone receptor positive (HR+), HER2-negative, lymph node positive, invasive, resected early breast cancer (stages 1-3) at high risk of recurrence, defined as either ≥4 positive axillary lymph nodes or 1-3 positive axillary lymph nodes plus either tumour size ≥5 cm or grade 3 tumour histology.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
IDFS
Key trials
monarchE
Comparator
standard adjuvant endocrine therapy (ET) alone
Economic model
CUA
ICER note
ICER value is redacted (commercially sensitive); document indicates PBAC previously considered an ICER of up to $30,000/QALY gained would account for uncertainty regarding modelled OS.
Risk sharing
Risk-sharing arrangement in place — Risk sharing arrangement (RSA) with annual subsidisation caps and rebate for use exceeding financial caps.
PBS expenditure
The Australian government paid $46M in PBS benefits for Abemaciclib in 2024 across 11,002 scripts, at $4,209 per script.
Submission history
Mar 2019: Recommended with restriction · Authority Required
Mar 2021: Recommended with restriction · Authority Required
Mar 2022: Recommended with restriction · Authority Required
Mar 2023: Not recommended · Authority Required
Nov 2023: Recommended with restriction · Authority Required