script.reportAU
Women's health

Lutropin alfa

Brand: Luveris

PBAC's latest decision on Lutropin alfa: Recommended with restriction (2015). Considered for Stimulation of follicular development in women with severe luteinising hormone deficiency undergoing assisted reproductive technology.

PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
1
first 2015
Submissions
1
2015 → 2015

Eligible population

Women with severe LH deficiency, particularly poor responders to rFSH-only treatment, undergoing controlled ovarian stimulation in assisted reproductive technology (IVF/GIFT).

Therapy area
Women's health
Line of therapy
Not applicable
Evidence base
Meta-analysis
Primary endpoint
Live births
Pivotal trial size
6,443 patients
Key trials
Lehert 2014, Study 21008, Study 6253
Comparator
rFSH alone (recombinant follicle stimulating hormone)
Economic model
CEA
ICER note
Economic evaluation results are redacted (marked with ''' in the document). Step 2 base-case modelled evaluation for clinical pregnancy showed the intervention 'Dominates', but actual ICER values are commercially sensitive and not published in the PSD.

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