Drospirenone With EthinylestradiolBella
Oral contraception. Yaz is also TGA-registered for treatment of moderate acne vulgaris and symptoms of premenstrual dysphoric disorder (PMDD) in women using oral contraception.
Decisions on record
- Meeting Nov 2024 Noted Contraception
- Meeting Jul 2024 Recommended Oral contraception, moderate acne vulgaris, premenstrual dysphoric disorder
Access path
- TGA registered · Bella
TGA label equal than the PBS population
- Nov 2024Recommended
Comparator changed: PBS-listed combined oral contraceptives (levonorgestrel-based…
- Nov 2024Recommended
Comparator changed: PBS-listed combined oral contraceptives (levonorgestrel-based…
- PBS listing
From the public summary
The Pharmaceutical Benefits Advisory Committee (PBAC) recommended the listing of drospirenone with ethinylestradiol as Unrestricted benefit listings in the following forms:PSD · Nov 2024
• Pack containing 24 tablets 3 mg drospirenone with 20 micrograms ethinylestradiol (as betadex clathrate) and 4 inert tablets (Yaz)PSD · Nov 2024
The PBAC noted the submission did not provide an economic analysis, therefore there was no basis for assessing cost-effectiveness.PSD · Nov 2024
The submission requested the following dispensed price for maximum quantity (DPMQ) and approved ex-manufacturer price (AEMP) for Yaz and Yasmin:PSD · Nov 2024
The submission described the effectiveness of Yaz as acceptable in terms of contraceptive efficacy. Yaz has acceptable safety, with similar AEs compared to Mercilon and were typical of those associated with use of a hormonal contraceptive.PSD · Nov 2024
The submission described Yasmin as effective in terms of contraceptive efficacy, cycle control and patient-reported outcomes of quality of life and wellbeing. Yasmin has similar safety and tolerability to other COCs (including Marvelon).PSD · Nov 2024
The PBAC noted and welcomed the input from individuals (1), health care professionals (1) and organisations (1) via the Consumer Comments facility on the PBS website. The comments described a range of benefits with the use of Yaz and Yasmin outside of its contraceptive effects, including reduced menstrual pain and improvements in acne and managing PMDD.PSD · Nov 2024
The National Aboriginal Community Controlled Health Organisation (NACCHO) stated that not having Yaz and Yasmin listed on the PBS can be a significant barrier to accessing these medicines for patients living in remote areas and obtaining medicines through the Remote Area Aboriginal Health Service S100 scheme.PSD · Nov 2024
Cost-effectiveness
No economic analysis was provided by the sponsor.
The PBAC noted the submission did not provide an economic analysis, therefore there was no basis for assessing cost-effectiveness. PBAC · 2024
Decision context
PopulationIndividuals requiring oral contraception (requested as Unrestricted benefit)
Why it was knocked back
- Lack of adequate comparative effectiveness data, lack of adequate comparative safety data, no economic analysis provided
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended | PBS-listed combined oral contraceptives (levonorgestrel-based formulations, norethisterone-based formulations) | — | Other · Contraception |
| Nov 2024 | Recommended | PBS-listed combined oral contraceptives (levonorgestrel-based COCs) | — | Other · Contraception |
Consumer voice
Consumer input highlighted benefits of Yaz and Yasmin beyond contraception, including reduced menstrual pain, acne improvement, and PMDD management. Comments emphasized the importance of contraceptive choice on the PBS and noted that current private market costs are prohibitive.
The comments described a range of benefits with the use of Yaz and Yasmin outside of its contraceptive effects, including reduced menstrual pain and improvements in acne and managing PMDD. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both TGA label and PBAC recommendation cover oral contraception as primary indication with unrestricted benefit population.