Estradiol With Progesterone
Treatment of moderate to severe vasomotor symptoms in postmenopausal women with an intact uterus.
Decisions on record
- Meeting Nov 2025 Recommended Moderate to severe vasomotor symptoms in postmenopausal women
- Meeting Nov 2024 Recommended Menopausal hormone therapy
Access path
- Nov 2025Recommended · restricted
vs Estrogel Pro (estradiol transdermal gel 0.06% with…
- PBS listing · Unrestricted
From the public summary
7.1 The PBAC recommended the listing of estradiol with progesterone (Bijuva) as a General Schedule unrestricted benefit listing, and a corresponding General Schedule restricted benefit listing for 60-day maximum dispensed quantity.PSD · Nov 2025
7.2 The PBAC noted this product is currently available on the private market, however cost is a barrier to access. The PBAC noted consumer input stated that it was important to have a range of MHT options available on the PBS, particularly in the context of shortages of other MHT products.PSD · Nov 2025
6.61 The submission presented a cost-minimisation approach (CMA) of Bijuva versus Estrogel Pro, based on the assumption that Estrogel Pro is the product that will most likely be displaced in clinical practice. As stated in paragraph 5.2, estradiol gel may not be an appropriate comparator for estradiol oral tablets.PSD · Nov 2025
6.62 For the requested population, i.e., postmenopausal women with an intact uterus experiencing estrogen deficiency symptoms, the following PBS-listed medicines may be considered alternative therapies because they could be replaced in practice: oral combination MHT, such as concomitant PBS-listed oral estradiol tablets and MP capsules.PSD · Nov 2025
6.54 The submission described Bijuva as non-inferior to Estrogel Pro in terms of effectiveness at improving estrogen-deficiency menopause symptoms and that both products provided comparable protection against endometrial hyperplasia. This claim was uncertain for the following reasons:PSD · Nov 2025
• The comparison was based on an unadjusted anchored ITC of Bijuva versus Estrogel (for VMS), using placebo as a common comparator, and an unadjusted unanchored ITC of Bijuva versus Estrogel Pro (for endometrial hyperplasia).PSD · Nov 2025
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as the submission assumed equi-effectiveness between Bijuva and Estrogel Pro.
The submission presented a cost-minimisation approach (CMA) of Bijuva versus Estrogel Pro, based on the assumption that Estrogel Pro is the product that will most likely be displaced in clinical practice. PSD · 2025
Decision context
PopulationPostmenopausal women with an intact uterus experiencing moderate to severe vasomotor symptoms and estrogen deficiency symptoms.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Recommended · restricted | Estrogel Pro (estradiol transdermal gel 0.06% with micronised progesterone capsules 100 mg) | — | Meta-analysis |
Consumer voice
Multiple healthcare organizations and colleges commented on the benefits of estradiol with progesterone as an additional treatment option for menopause, noting improved access through PBS listing, symptom relief, better adherence with a single capsule formulation, and the need for equitable prescriber access.
listing of MP on the PBS has decreased the financial barrier to this medication, however currently individuals who want to use MP but do not or cannot use a transdermal estrogen are unable to access this medication in a combined preparation, limiting access and choice. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to moderate-to-severe vasomotor symptoms; TGA label covers all estrogen deficiency symptoms without severity threshold.