Human Menopausal Gonadotrophin
Treatment of infertility in anovulatory infertility (including polycystic ovarian disease) unresponsive to clomiphene citrate, and for controlled ovarian hyperstimulation to induce development of multiple follicles for assisted reproductive technologies (IVF/ET, GIFT, ICSI).
Decisions on record
- Meeting Mar 2026 Noted In vitro fertilisation no PSD
- Meeting Jul 2024 Noted Assisted reproductive technology no PSD
- Meeting Jul 2022 Recommended Assisted Reproductive Technology
- Meeting Mar 2012 Recommended Fertility drug
Access path
- Mar 2012Recommended · restricted
vs follitropin alfa
- Mar 2012Recommended · restricted
- Mar 2016Not recommended
non-inferior comparative effectiveness not adequately supported for ongoing pregnancy and live birth rate; claim of…
- ↻ resubmittedJul 2022Recommended · restricted
Comparator changed: follitropin alfa → human menopausal gonadotrophin powder for…
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of 600 I.U and 1200 I.U pre-filled multi-dose pen forms of human menopausal gonadotrophin (HMG) on the basis that it should be available under the Section 100 (In Vitro Fertilisation (IVF) Program) as Authority Required (STREAMLINED) benefits for Assisted Reproductive Technology.PSD · Jul 2022
6.2 The PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost-effectiveness for pen forms would be acceptable if it was cost-minimised against powder for injection (PFI) forms.PSD · Jul 2022
6.21 The equi-effective doses are estimated in the submission as 1 IU of HP-hMG andPSD · Mar 2016
1 IU of follitropin alfa over a treatment cycle based on CS002.PSD · Mar 2016
6.15 The submission described HP-hMG as non-inferior in terms of comparative effectiveness and non-inferior in terms of comparative safety over the primaryPSD · Mar 2016
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. PBAC assessed on cost-minimisation basis against existing PFI forms.
The PBAC considered that the claim of non-inferior comparative effectiveness was not adequately supported by the data. PBAC · 2016
Decision context
PopulationWomen receiving medical services for assisted reproductive technology (IVF/ET, GIFT, ICSI) under Medicare items 13200, 13201, 13202 or 13203, including those with anovulatory infertility unresponsive to clomiphene citrate.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2022 | Recommended · restricted | human menopausal gonadotrophin powder for injection (PFI) forms | — | Cost-minimisation · Cost-minimisation |
| Mar 2016 | Not recommended | follitropin alfa | — | RCT · Ovulation rate |
| Mar 2012 | Recommended · restricted | follitropin alfa | — | RCT · Ongoing pregnancy rate and live birth rate |
| Mar 2012 | Recommended · restricted | follitropin alfa | — | RCT |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to women receiving ART under specific Medicare items, narrowing the TGA's broader eligibility for ART candidates.