PBAC's latest decision on Estetrol with drospirenone: Not recommended (2025). Considered for Oral contraceptive for women of reproductive age to prevent pregnancy.
PBAC outcome
Not recommended
Not applicable
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2025
Submissions
1
2025 → 2025
Eligible population
Women of reproductive age seeking oral contraception; the submission did not restrict to a narrower population within this group.
combined oral contraceptives currently listed on the PBS (including ethinylestradiol with levonorgestrel and ethinylestradiol with drospirenone)
Economic model
Cost-minimisation
ICER note
Cost-consequence analysis presented; no ICER calculated. PBAC Guidelines require cost-effectiveness or cost-utility analysis.
Why PBAC said no
Reasons cited in the latest PSD: uncertain claim of superior safety (VTE/MI/stroke risk) based on surrogate biomarkers with no head-to-head trials; cost-consequence analysis does not meet PBAC guidelines requiring cost-effectiveness or cost-utility analysis; TGA considered association between surrogate biomarkers and VTE risk to be weak