PBAC's latest decision on Follitropin alfa and lutropin alfa: Recommended (2015). Considered for Stimulation of follicular development in women with severe LH and FSH deficiency for assisted reproductive technology (IVF/GIFT) treatment.
PBAC outcome
Recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2014
Submissions
2
2014 → 2015
Eligible population
Women requiring both rFSH and rLH supplementation with severe LH deficiency for whom treatment with the fixed dose combination is appropriate after titration to the FSH and LH doses in the combination product after at least one cycle of treatment, undergoing assisted reproductive technology (IVF/GIFT).
Therapy area
Women's health
Line of therapy
Not applicable
Evidence base
Meta-analysis
Primary endpoint
Clinical pregnancy rate
Pivotal trial size
5,214 patients
Key trials
Lehert 2014 meta-analysis
Comparator
follitropin alfa (Gonal-f) and lutropin alfa (Luveris) as individual components
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated. Submission proposed pricing as sum of individual components with no additional PBS cost.