PBAC's latest decision on Follitropin delta: Recommended with restriction (2017). Considered for 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.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2017
Submissions
1
2017 → 2017
Eligible population
Women aged 18–40 years undergoing their first controlled ovarian stimulation cycle for IVF/ICSI.
Therapy area
Women's health
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Other
Pivotal trial size
1,329 patients
Key trials
ESTHER-1, ESTHER-2
Comparator
follitropin alfa (Gonal F)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design.