Cetrorelix
Prevention of premature luteinisation and ovulation in patients undergoing controlled ovarian stimulation followed by oocyte pick up and assisted reproductive techniques.
Decisions on record
- Meeting Nov 2025 Recommended Assisted reproductive technology (ART) – prevention of premature luteinisation and ovulation
- Meeting Jul 2010 Recommended Fertility drug no PSD
Access path
- Nov 2025Recommended
vs cetrorelix (Cetrotide)
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of cetrorelix, solution for injection 250 micrograms (as acetate) in 1 mL single use pre-filled syringe, on the basis that it should be available only under the same special arrangements as the currently listed cetrorelix (Cetrotide®) 250 microgram powder for reconstitution injection and inert substance diluent (1 mL syringe) for use in assisted reproductive technology to prevent premature luteinisation and ovulation …PSD · Nov 2025
6.2 The PBAC advised that the restriction should be the same as that for the currently listed brand of cetrorelix. The PBAC advised that an administrative note on dispensing be added to the listings of both brands of cetrorelix regarding the different presentations of the SC injection, and that prescribers and dispensers should be aware of this if substituting one item for the other.PSD · Nov 2025
5.6 The submission presented a cost-minimisation analysis (CMA) vs Cetrotide, with equi-effective doses: Femvi 250 microgram SC = Cetrotide 250 microgram SC. Pricing considerationsPSD · Nov 2025
5.7 The submission proposed an AEMP of $29.55 which assumed application of the 25% First New Brand (FNB) statutory price reduction (SPR) to the current AEMP of Femvi.PSD · Nov 2025
5.3 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of Femvi compared with Cetrotide. 5.4 This claim was made on the basis of:PSD · Nov 2025
• Same active (cetrorelix), same strength (250 microgram/mL), same route (subcutaneous); both aqueous solutions at the point of injection (Femvi prefilled syringe; Cetrotide powder + diluent). 3 OFFICIALPSD · Nov 2025
5.2 The PBAC noted and welcomed the input from medical organisations (1) via the Consumer Comments facility on the PBS website. The PBAC noted the advice received from the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) providing support for increasing “availability, accessibility and affordability of medications for women and girls in Australia”. RANZCOG did not provide a specific comment regarding Femvi.PSD · Nov 2025
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as equi-effective doses assumed
The PBAC advised that the utilisation estimates of nil financial impact were reasonable, where Femvi would be listed under the same price and circumstances as Cetrotide. PBAC · 2025
Decision context
PopulationPatients undergoing controlled ovarian stimulation for assisted reproductive technology, receiving medical services as described in MBS items 13200, 13201, 13202 or 13203
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Recommended | cetrorelix (Cetrotide) | — | Cost-minimisation · Cost-minimisation |
Consumer voice
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) provided input supporting increased availability, accessibility and affordability of medications for women and girls in Australia, but did not provide a specific comment regarding Femvi.
availability, accessibility and affordability of medications for women and girls in Australia Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients receiving specific MBS items (13200–13203), narrowing the TGA's broader assisted reproductive techniques population.