script.reportAU
Oncology

Fulvestrant

Brand: Faslodex

PBAC's latest decision on Fulvestrant: Recommended with restriction (2020). Considered for First-line and second-line endocrine-based treatment of non-premenopausal patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer.

PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
—
ICER not stated
Submissions
1
first 2020
Submissions
1
2020 → 2020

Eligible population

Non-premenopausal patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) unresectable locally advanced or metastatic breast cancer.

Therapy area
Oncology
Line of therapy
First-line and Second-line
Evidence base
RCT
Primary endpoint
OS
Pivotal trial size
667 patients
Key trials
FALCON, FIRST
Comparator
anastrozole (first-line); everolimus + exemestane (second-line)
Economic model
CUA
ICER note
The submission presented a cost-effectiveness analysis for first-line treatment and a cost-minimisation analysis for second-line treatment. Specific ICER values are not stated in the PSD.

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