Estradiol; progesterone; estradiol and progesterone combination
Brand: Estrogel; Prometrium; Estrogel Pro
PBAC's latest decision on Estradiol; progesterone; estradiol and progesterone combination: Recommended with restriction (2024). Considered for Estrogel: treatment of troublesome menopausal vasomotor symptoms in women and prevention of osteoporosis in postmenopausal women at high risk of future fractures. Prometrium: hormone replacement therapy – adjunctive use with estrogen in postmenopausal women with an intact uterus. Estrogel Pro: hormone replacement therapy for estrogen deficiency symptoms in postmenopausal women with an intact uterus.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2024
Submissions
1
2024 → 2024
Eligible population
Estrogel: women with symptoms of estrogen deficiency seeking MHT. Prometrium: women with an intact uterus receiving treatment with estrogen for the symptoms of menopause. Estrogel Pro: women with an intact uterus with symptoms of estrogen deficiency seeking MHT.
Therapy area
Women's health
Line of therapy
Not applicable
Evidence base
Other
Primary endpoint
Estrogel: reduction in the frequency of moderate to severe hot flushes; Prometrium: endometrial hyperplasia; Estrogel Pro: reduction in the frequency of moderate to severe hot flushes and endometrial hyperplasia
Comparator
Estrogel: estradiol gel sachets 1 mg/g (Sandrena); Prometrium: medroxyprogesterone acetate (MPA) 5 mg or 10 mg; Estrogel Pro: individual components (Estrogel and Prometrium) dispensed separately
Economic model
Cost-minimisation; CEA
ICER note
Estrogel evaluation was based on cost-minimisation analysis; Prometrium evaluation was based on cost-effectiveness analysis; Estrogel Pro evaluation was based on cost-minimisation analysis. Specific ICER values are not stated in the public summary document.