PBAC's latest decision on Fezolinetant: Not recommended (2025). Considered for Moderate to severe vasomotor symptoms (VMS) associated with menopause in patients unsuitable for menopausal hormone therapy (MHT) due to contraindication, treatment cessation, or risk versus benefit safety concerns.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2025
Submissions
2
2025 → 2025
Eligible population
Post-menopausal women experiencing moderate to severe VMS who are unsuitable for MHT due to contraindications, treatment cessation, or underlying conditions requiring special caution (excluding those unwilling to take MHT in the current resubmission).
Therapy area
Women's health
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
Change from baseline in frequency and severity of moderate to severe VMS at Week 4, Week 12, and Week 24
Key trials
DAYLIGHT, SKYLIGHT 1, SKYLIGHT 2, SKYLIGHT 4
Comparator
placebo (no treatment)
Economic model
CUA
ICER note
ICER values are redacted in the public document; the March 2025 submission reported an ICER of approximately $35,000–<$45,000/QALY (redacted as '$$$$1'), and the resubmission estimated an ICER in the range $25,000–<$35,000/QALY (redacted as '$$$$3'). The PSD footnote states redacted values correspond to ranges but does not publish the exact figures.
Risk sharing
Risk-sharing arrangement in place — Proposed RSA under a single arrangement with tiered subsidisation cap with rebates at three different expenditure thresholds (percentages and cap values redacted).
Why PBAC said no
Reasons cited in the latest PSD: Clinical place not well-defined; proposed population broader than clinically appropriate; increasing safety concern of drug-induced liver disease inadequately addressed; unacceptably high ICER and financial impact; symptomatic hepatotoxicity concern with limited safety data beyond 52 weeks; onerous liver function monitoring requirements; uncertain and potentially overestimated patient population and uptake rates; uncertain comparator choice (no treatment not appropriate for all requested subpopulations).
Submission history
Mar 2025: Recommended with restriction · Authority Required