PBAC's latest decision on Follitropin alfa: Not recommended (2021). Considered for Treatment of women undergoing assisted reproductive technology (ART) requiring controlled ovarian stimulation. Also approved for anovulatory infertility in women unresponsive to clomiphene citrate and for stimulation of spermatogenesis in gonadotrophin-deficient men.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
4
first 2016
Submissions
4
2016 → 2021
Eligible population
Women undergoing assisted reproductive technology requiring controlled ovarian stimulation; receiving medical services as described in Medicare Benefits Schedule items 13200, 13201, 13202 or 13203
Biosimilar preparations of follitropin alfa (Bemfola used as proxy in economic evaluation)
Economic model
Cost-minimisation
ICER note
Requested prices are redacted; no explicit ICER calculation was presented or discussed in the document
Why PBAC said no
Reasons cited in the latest PSD: PBAC considered the submission's claim of superior effectiveness contradictory to TGA's biosimilar regulatory framework; lack of in-vitro characterisation data; claimed superiority not biologically or clinically plausible given the mechanism of action relates to oocyte retrieval, not live birth; trials not powered to detect differences in live birth rates; inadequate patient population details; average trial participant age (32.3 years) significantly younger than Australian ART population
Submission history
Mar 2016: Recommended with restriction · Restricted
Mar 2018: Recommended with restriction · Authority Required
Jul 2021: Recommended with restriction · Restricted