ESTRADIOL WITH PROGESTERONE
Information current as at: 1 September 2026
Submission Details
- Brand name:
-
- Bijuva®
- Form and strength:
-
- Capsule containing estradiol 1mg (as hemihydrate) with progesterone 100mg
- Submission sponsor:
- THERAMEX AUSTRALIA PTY LTD
- Condition/indication:
(therapeutic use) -
- Vasomotor symptoms in post-menopausal women
- Listing requested:
- To consider the sponsor's revised proposal for listing estradiol with progesterone for the treatment of moderate to severe vasomotor symptoms in post-menopausal women. This item was previously recommended by the PBAC at its November 2025 meeting.
- Funding program:
- PBS General Schedule
- Request authority level:
- Unrestricted Benefit for 30-day listing Restricted Benefit for 60-day listing
- PBAC Submission type:
- New PBS listing (Category 3)
- Comment:
- --
- Other PBAC consideration:
- --
Progress Details
-
Submission received for: - July 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 25/03/2026 and close 20/05/2026 (see PBS Website)
-
PBAC meeting: - Held on 08/07/2026
-
5Lodgement of required documentation:
-
6Agreement to listing arrangements:
- Has not yet commenced
-
7Government processes:
- Has not yet commenced
-
8Medicine listed on the PBS:
- Has not yet occurred
PBAC Outcome
The Pharmaceutical Benefits Advisory Committee provided further consideration of its November 2025 recommendation to list oral estradiol with progesterone (Bijuva) as a General Schedule unrestricted benefit listing, and corresponding General Schedule restricted benefit listings for 60-day maximum dispensed quantity.
The PBAC considered that the risk of venous thromboembolism (VTE) associated with Bijuva may be acceptable to women without risk factors for VTE who cannot tolerate topical MHT or where topical MHT is not suitable. The PBAC advised that a claim of non-inferior safety for the risk of endometrial hyperplasia would be reasonable for Bijuva compared to oral estradiol and progesterone prescribed separately and Estrogel Pro.
The PBAC reiterated its previous advice that there is a need to maintain a diverse range of MHT options on the PBS. The PBAC noted that there is currently no oral fixed dose combination product containing estradiol and progesterone (or a progestogen) for continuous MHT listed on the PBS. Overall, the PBAC was satisfied that inclusion of Bijuva, as a combined oral capsule, would offer additional options to women requiring MHT and facilitate individualised treatment choices, and that it may offer a meaningful difference to some patients compared to MHT options currently PBS-listed.
The PBAC noted that the price requested for Bijuva was at a modest monthly premium over the individual components, but advised that listing at the requested price was acceptable, given the need to maintain diverse treatment options for women requiring MHT.