FezolinetantVeoza
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.
Decisions on record
- Meeting Nov 2025 Recommended Moderate to severe menopause-related vasomotor symptoms in patients contraindicated to or intolerant of menopausal hormone therapy
- Meeting Mar 2025 Not recommended Moderate to severe menopause-related vasomotor symptoms (VMS) in patients unsuitable for MHT
Access path
- TGA registered · Veoza
TGA label narrower than the PBS population
- Mar 2025Not recommended
vs placebo (no treatment)
- ↻ resubmittedNov 2025Recommended
- PBS listing · Authority Required
From the public summary
Incremental cost/extra QALYs gained $&&&&2 $&&&&3 Step 4: Model-based analysis with 10-year time horizon, discounting of costs and outcomes Costs: drug acquisition + $&&&& $896 $&&&& $&&&& $896 $&&&& resource usePSD · Nov 2025
Incremental cost/extra QALY gained (base case) $&&&&4 $&&&&5 Source: Para 6.60, fezolinetant, PBAC MIN, March 2025 and Table 3.9.1, p96 of the resubmission. VMS=vasomotor symptoms, QALYs=quality-adjusted life-years.PSD · Nov 2025
6.34 Compared to the March 2025 submission, the cost-utility analysis in the resubmission was largely unchanged, and the model structure was retained.PSD · Nov 2025
6.35 A summary of the PBAC’s main concerns and key changes in the resubmission is presented in Table 8. 25PSD · Nov 2025
6.27 In patients with moderate to severe VMS associated with menopause and unsuitable for MHT (excluding MHT averse), the resubmission described fezolinetant 45 mg as superior in terms of effectiveness compared with no treatment (placebo) and manageable safety compared to no treatment (placebo). The clinical claim was unchanged from the March 2025 submission.PSD · Nov 2025
6.28 In March 2025, the PBAC considered that the claim of superior effectiveness over no treatment was likely supported by the evidence, however placebo was not the appropriate comparator for many patients who would be eligible for fezolinetant under the proposed restriction criteria.PSD · Nov 2025
6.3 Health professionals described VMS as debilitating and significantly impacting quality of life, and noted that currently non-hormonal treatments (clonidine, venlafaxine, oxybutynin, gabapentin, SSRIs/SNRIs) are being used off-label, with varying success and sometimes debilitating or intolerable side effects. Input noted MHT is effective, but not suitable for all women, especially those with contraindications (e.g., breast cancer survivors).PSD · Nov 2025
6.4 The PBAC noted the advice received from The Australian Menopause Society, WellFemme Telehealth Menopause Clinic, Royal Australian and New Zealand College of Obstetricians and Gynaecologists, and Inherited Cancers Australia clarifying the likely use of fezolinetant in clinical practice, expressing support for its use in patients contraindicated to MHT.PSD · Nov 2025
Cost-effectiveness
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.
Decision context
PopulationPost-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).
Risk sharingProposed RSA under a single arrangement with tiered subsidisation cap with rebates at three different expenditure thresholds (percentages and cap values redacted).
Why it was knocked back
- 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
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Recommended | placebo (no treatment) | — | RCT · Change from baseline in frequency and severity of moderate to severe VMS at Week 4, Week 12, and Week 24 |
| Mar 2025 | Not recommended | placebo (no treatment) | — | RCT · Other |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| DAYLIGHT | Ph 3 | 453 | Mean change in the frequency of moderate to severe VMS from baseline at week 24 | completed |
| SKYLIGHT 1 | Ph 3 | 527 | Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 4 | completed |
| SKYLIGHT 2 | Ph 3 | 501 | Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 4 | completed |
| SKYLIGHT 4 | Ph 3 | 1,831 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | completed |
Consumer voice
The PBAC received consumer input from 26 individuals, 45 health care professionals, and 4 organisations via the PBS website Consumer Comments facility on the resubmission.
The PBAC noted and welcomed the input on the resubmission from individuals (26), health care professionals (45) and organisations (4) via the Consumer Comments facility on the PBS website Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients unsuitable for MHT due to contraindication, cessation, or safety concerns; TGA label has no such restriction.