Follitropin Alfa + Lutropin Alfa; Lutropin AlfaPergoveris solution for injection
Recommended Women's healthRestrictedNot applicable line
Stimulation of follicular development in assisted reproductive technology (IVF) under the Section 100 program.
1
Submissions
1 resub
2016–16
On the record
—
ICER range
Not modelled
Cost basis
Access path
- TGA registered · Pergoveris solution for injection
TGA label narrower than the PBS population
- Mar 2016Recommended
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended amending the maximum PBS quantities for the current Section 100 listings of follitropin alfa + lutropin alfa and lutropin alfa from seven to 14, consistent with the maximum PBS quantities available for other drugs used for ovarian stimulation.PSD · Mar 2016
6.2 The PBAC noted that the maximum PBS quantity for other Section 100 IVF drugs, including follitropin alfa, follitropin beta and human menopausal gonadotrophin, provide for at least 11 to 15 days of treatment, while the current maximum quantities (7) for follitropin alfa + lutropin alfa and lutropin alfa only provide for seven days of treatment.PSD · Mar 2016
Cost-effectiveness
Not modelled — minor submission requesting increase to maximum quantities only; no economic evaluation conducted.
Decision context
PopulationPatients undergoing ovarian stimulation for assisted reproductive technology (IVF) under the Section 100 program.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2016 | Recommended | — | — | Meta-analysis |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted subsidy to patients meeting Section 100 program criteria, a specific administrative subset of the broader TGA-registered IVF population.