EstradiolESTRADOT
Short-term treatment of climacteric symptoms after natural or surgical menopause. A lower strength formulation (500 microgram) to allow greater flexibility in dosing and reduce product wastage.
Decisions on record
- Meeting Nov 2024 Recommended Menopausal hormone therapy
- Meeting Jul 2024 Recommended Climacteric symptoms after natural or surgical menopause
- Meeting Mar 2014 Recommended Femoston Conti® Abbott Australasia Pty Ltd Hormone Replacement Therapy (HRT) Resubmission to request a General Schedule unrestricted benefit for the treatment of menopause related symptoms. no PSD
- Meeting Mar 2014 Recommended Vagifem Low ® Novo Nordisk Pharmaceuticals Pty Ltd Atrophic vaginitis To request a General Schedule unrestricted benefit listing for the treatment of atrophic vaginitis due to oestrogen deficiency. no PSD
- Meeting Jul 2009 Recommended Post-menopausal symptoms - hormone replacement therapy no PSD
- Meeting Mar 2003 Recommended Hormone replacement therapy for women no PSD
Access path
- TGA registered · ESTRADOT
TGA label narrower than the PBS population
- Jul 2024Recommended · restricted
vs estradiol 1 mg in 1 gram gel sachet (Sandrena 1 mg)
- PBS listing · Unrestricted
From the public summary
6.1 The PBAC recommended the listing of estradiol 500 microgram in 0.5 gram gel sachet (Sandrena) as a General Schedule (Unrestricted Benefit) listing and a corresponding 60-day MDQ General Schedule (Restricted Benefit) listing, consistent with the PBS listings for Sandrena 1 mg in 1 gram gel sachet.PSD · Jul 2024
6.2 The PBAC considered that the option to prescribe a lower strength estradiol gel sachet would allow greater flexibility in dosing, improve ability to titrate doses to individual requirements and reduce product wastage.PSD · Jul 2024
5.3 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of Sandrena 500 microgram in 0.5 gram gel sachets compared with Sandrena 1 mg in 1 gram gel sachets. 3PSD · Jul 2024
5.4 The submission claimed that Sandrena 500 microgram in 0.5 gram gel sachet is bioequivalent to Sandrena 1 mg in 1 gram gel sachet on a 1 mg to 1 mg basis, with the only difference being the volume of gel in the sachet.PSD · Jul 2024
Cost-effectiveness
Not modelled. This is a minor submission for a new strength of an already-listed drug, presented as a cost-minimisation comparison (substitution from 1 mg to 500 microgram strength).
The PBAC considered that the option to prescribe a lower strength estradiol gel sachet would allow greater flexibility in dosing, improve ability to titrate doses to individual requirements and reduce product wastage. PBAC · 2024
Decision context
PopulationWomen requiring 500 microgram estradiol daily for short-term treatment of climacteric symptoms after natural or surgical menopause.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2024 | Recommended · restricted | estradiol 1 mg in 1 gram gel sachet (Sandrena 1 mg) | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to women requiring specifically 500 microgram daily dose; TGA label does not specify dose.