Gonadotrophin-menopausal human (highly purified human menopausal gonadotrophin, hp-hmg)
Brand: Menopur®
PBAC's latest decision on Gonadotrophin-menopausal human (highly purified human menopausal gonadotrophin, hp-hmg): Not recommended (2016). Considered for Anovulatory infertility in women who have failed to ovulate or conceive on clomiphene citrate and/or gonadorelin, or controlled ovarian hyperstimulation as part of an Assisted Reproductive Technology (ART) treatment program.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2016
Submissions
1
2016 → 2016
Eligible population
Women with WHO Group II anovulatory infertility who have failed to ovulate or conceive on clomiphene citrate and/or gonadorelin, excluding those with primary ovarian failure, hyperpituitarism, or primary amenorrhoea
Therapy area
Women's health
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
ORR
Pivotal trial size
184 patients
Key trials
CS002
Comparator
follitropin alfa
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated. Economic evaluation based on cost per dose comparison.
Why PBAC said no
Reasons cited in the latest PSD: No new clinical data provided to address PBAC's previous concerns; claim of non-inferior comparative effectiveness not adequately supported; lower confidence interval for live births and ongoing pregnancy exceeded the 10% non-inferiority margin previously accepted by PBAC; considerable uncertainty regarding equi-effective doses