Estradiol; Progesterone; Estradiol And Progesterone Combination
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.
Access path
- Nov 2024Recommended · restricted
vs Estrogel: estradiol gel sachets 1 mg/g (Sandrena)…
- PBS listing · Restricted
From the public summary
The PBAC recommended the listing of estradiol (Estrogel), progesterone (Prometrium) and estradiol and progesterone (Estrogel Pro) as General Schedule unrestricted benefit listings, and corresponding General Schedule restricted benefit listings for 60- day maximum dispensed quantities.PSD · Nov 2024
The PBAC noted these products are currently available on the private market, however cost is a barrier to access. The PBAC noted consumer comments stated it was important to have a range of MHT options available on the PBS, particularly in the context of shortages of other MHT products. Consumer comments also stated these products were effective in managing symptoms of menopause and provided benefits compared to other MHT products currently PBS-listed.PSD · Nov 2024
Estradiol The submission presented a cost-minimisation and a revealed preference approach for Estrogel versus Sandrena based on the claim of non-inferior efficacy and safety.PSD · Nov 2024
The submission proposed an approved ex-manufacturer price (AEMP) of $ per pack of Estrogel based on two key steps:PSD · Nov 2024
The submission described Estrogel as non-inferior in terms of effectiveness (reducing the frequency of moderate to severe hot flushes) compared to Sandrena. This claim was adequately supported; however, the submission did not provide any evidence supporting the claim that Estrogel provides additional benefit of preventing osteoporosis in postmenopausal women at high risk of future fractures.PSD · Nov 2024
The submission described Estrogel as non-inferior in terms of safety compared to Sandrena. This claim was adequately supported. No evidence was presented regarding differences in itching or skin reactions. The pre-PBAC response stated that reduction in skin irritation could be included in the clinical claim as an additional benefit of Estrogel compared to Sandrena, due to reasons cited in paragraph 6.30.PSD · Nov 2024
• while an estradiol gel product is available on the PBS, it is harder to use and adjust dosage compared to the Estrogel pump pack where the dose can be easily adjusted and individualised for the patient.PSD · Nov 2024
Consumers stated benefits of using Estrogel, including improvements in hot flushes, mood, brain fog, migraine, anxiety, insomnia, aches and pains, hair loss, balancing hormonal fluctuations, and protection against heart conditions and bone density loss.PSD · Nov 2024
Cost-effectiveness
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.
Decision context
PopulationEstrogel: 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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended · restricted | Estrogel: estradiol gel sachets 1 mg/g (Sandrena); Prometrium: medroxyprogesterone acetate (MPA) 5 mg or 10 mg; Estrogel | — | Other · 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 |
Consumer voice
Consumer input indicated that Estrogel is a preferred first-line treatment with fewer adverse effects than oral forms, easier dosage adjustment than alternative gel products, and provides benefits for menopausal symptoms and quality of life, though cost remains a significant access barrier. Health professionals and research organisations highlighted that topical estrogen is safer than oral prepara
MHT patches are often not available due to shortages and have disadvantages such as falling off, and Estrogel is an alternative Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to postmenopausal women with intact uterus; TGA label includes all postmenopausal women regardless of uterine status.