Estetrol With DrospirenoneNEXTSTELLIS
Recommended Women's healthNot applicableFirst-line line 💬 consumer voice
Oral contraceptive for women of reproductive age to prevent pregnancy.
1
Submissions
2025–25
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Mar 2025 Recommended Contraception
Access path
- TGA registered · NEXTSTELLIS
TGA label equal than the PBS population
- Mar 2025Recommended
vs combined oral contraceptives currently listed on the PBS…
- PBS listing · Not applicable
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
The PBAC recommended the listing of estetrol with drospirenone (E4/DRSP) as an Unrestricted Benefit. The PBAC’s recommendation for listing was based on its assessment that the cost-effectiveness of E4/DRSP would be acceptable if it were cost- minimised against newer combined oral contraceptives (COCs) such as ethinylestradiol with drospirenone (EE/DRSP)(Yaz and Yasmin).PSD · Mar 2025
The PBAC considered COCs listed on the PBS, including ethinylestradiol/drospirenone, 36PSD · Mar 2025
Economic analysis
The submission presented a cost-consequence analysis. The PBAC Guidelines (Version 5.0) state that cost-effectiveness should be estimated using a cost-effectiveness and/or a cost-utility analysis, and other economic evaluations such as a cost- 25PSD · Mar 2025
In the absence of trial based comparative data, the submission presented long-term safety benefits of E4/DRSP against other COCs, using surrogate biomarkers from the MIT-Es0001-C201 study and published literature, to support the proposed price premium for E4/DRSP. The MIT-Es0001-C201 was a 6-cycle study, and such study duration was insufficient to support a long-term safety claim.PSD · Mar 2025
Clinical claim
The submission described E4/DRSP as superior in terms of specific longer-term safety such as the risk of VTE and the risk of MI and stroke compared to EE/LNG and EE/DRSP. This claim was uncertain due to the following reasons:PSD · Mar 2025
• There were no head-to-head studies directly comparing the risk of VTE, MI and stroke with E4/DRSP compared to EE/LNG and EE/DRSP.PSD · Mar 2025
Consumer comments
The PBAC noted and welcomed input from individuals (1), health care professionals (4) and organisations (1) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with E4/DRSP, including providing effective contraception and menstrual management (such as providing regular periods and controlling irregular bleeding), and a lower risk of causing hormonal and mental health side effects, leading to …PSD · Mar 2025
The National Aboriginal Community Controlled Organisation (NACCHO) stated that where oral contraceptives are not listed on the PBS, for Aboriginal and Torres Strait 7PSD · Mar 2025
Cost-effectiveness
Cost-consequence analysis presented; no ICER calculated. PBAC Guidelines require cost-effectiveness or cost-utility analysis.
Economic model disputed
Decision context
PopulationWomen of reproductive age seeking oral contraception; the submission did not restrict to a narrower population within this group.
Why it was knocked back
- uncertain claim of superior safety (VTE/MI/stroke risk) based on surrogate biomarkers with no head-to-head trials; cost-consequence analysis does not meet PBAC guidelines requiring cost-effectiveness or cost-utility analysis; TGA considered association between surrogate biomarkers and VTE risk to be weak
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2025 | Recommended | combined oral contraceptives currently listed on the PBS (including ethinylestradiol with levonorgestrel and ethinylestr | — | Single-arm · Contraceptive efficacy (birth control); secondary endpoints included safety outcomes (VTE, MI/stroke risk). |
Consumer voice
Consumer input described benefits of E4/DRSP including effective contraception, menstrual management, lower risk of hormonal and mental health side effects, and better safety profile with improved tolerance and compliance. Input also highlighted access barriers due to prohibitive private pricing and called for more affordable contraceptive options.
The comments described a range of benefits of treatment with E4/DRSP, including providing effective contraception and menstrual management (such as providing regular periods and controlling irregular bleeding), and a lower risk of causing hormonal and mental health side effects, leading to better quality of life. Consumer comments · PSD
treatment efficacyside effectsquality of lifesafety profiletreatment burdenaccess barriers
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both TGA and PBAC describe oral contraception for women of reproductive potential/age to prevent pregnancy; no restriction applied.