Follitropin DeltaRekovelle
Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycles.
Decision on record
- Meeting Nov 2017 Recommended Assisted reproductive technology (ART)
Access path
- TGA registered · Rekovelle
TGA label narrower than the PBS population
- Nov 2017Recommended
vs follitropin alfa (Gonal F)
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing, under a S100 special arrangement of follitropin delta for controlled ovarian stimulation (COS) in patients undergoing assisted reproductive technologies (ART), on a cost-minimisation basis against follitropin alfa, with an equi-effective dose of 1,896 IU follitropin alfa to 93.6 mcg follitropin delta. 11PSD · Nov 2017
7.2 The PBAC accepted the nominated comparator, follitropin alfa, as it is the most commonly used form of follitropin on the PBS, and noted that the other follitropin products available on the PBS were all listed on a cost-minimisation basis to follitropin alfa and none of the other follitropin products have subsequently undergone price reductions.PSD · Nov 2017
6.16 Table 7 presents the key assumptions and components of the cost-minimisation approach presented by the submission.PSD · Nov 2017
Table 7: Key assumptions and components of the cost-minimisation approach Component Claim or assumption Therapeutic Based on evidence presented in Section 2 of the submission, effectiveness is assumed to be non-inferior.PSD · Nov 2017
6.2 PBAC noted and welcomed the input from health care professionals (3) and organisations (1) via the Consumer Comments facility on the PBS website. Input indicated that follitropin delta has a unique dose finding algorithm, and because it can deliver an individualised dose to patients it may minimise wastage and potentially lower costs to patients and the PBS.PSD · Nov 2017
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
Decision context
PopulationWomen aged 18–40 years undergoing their first controlled ovarian stimulation cycle for IVF/ICSI.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2017 | Recommended | follitropin alfa (Gonal F) | — | RCT · Other |
Clinical evidence
Consumer voice
Healthcare professionals and organisations noted that follitropin delta has a unique dose-finding algorithm enabling individualised dosing, which may minimise wastage and lower costs. ACCESS Australia indicated it could reduce the risk of Ovarian Hyperstimulation Syndrome compared with other gonadotropins.
follitropin delta has a unique dose finding algorithm, and because it can deliver an individualised dose to patients it may minimise wastage and potentially lower costs to patients and the PBS Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to women aged 18–40 years in their first controlled ovarian stimulation cycle; TGA label has no age or cycle-number restrictions.