DrospirenoneLUCINDA
Contraception in women. Drospirenone is a progestogen-only pill (POP) indicated for women requesting contraception, particularly those with contraindications to estrogen-containing combined oral contraceptives.
Decision on record
- Meeting Nov 2024 Recommended Contraception
Access path
- TGA registered · LUCINDA
TGA label narrower than the PBS population
- Nov 2024Recommended
vs levonorgestrel 30 microgram tablets (Microlut) and…
- PBS listing · Unrestricted
From the public summary
7.1 The PBAC recommended the listing of drospirenone 4 mg tablets (Slinda) as an Unrestricted Benefit.PSD · Nov 2024
7.2 The PBAC noted comments from clinicians at the oral contraceptives stakeholder meeting and the sponsor hearing, and comments from health professionals and individuals in the consumer comments, highlighting the importance of having a range of contraceptive options available on the PBS so that cost is not a barrier to accessing the most appropriate option, noting that contraceptive requirements may change throughout life.PSD · Nov 2024
6.42 The submission presented a modified economic evaluation by estimating the number of unintended pregnancies needed for cost neutrality (break-even) from a health care system perspective. The purpose of this approach was to translate the superior efficacy of drospirenone (avoidance of unintended pregnancies) into cost savings and compare these savings to the incremental cost of drospirenone.PSD · Nov 2024
6.43 As stated in paragraph 5.2, while the submission nominated levonorgestrel as the main comparator, norethisterone was used in the economic evaluation due to its lower price. The ESC agreed that norethisterone was an appropriate comparator for the economic analysis. Although this approach was conservative, the incremental 16PSD · Nov 2024
6.32 The submission claimed that drospirenone was superior in terms of effectiveness (pregnancy rate) and safety (bleeding patterns), compared to levonorgestrel, for women requesting contraception.PSD · Nov 2024
6.33 Given the mechanism of action on ovulation suppression, drospirenone may be superior to levonorgestrel, but the magnitude of its relative effectiveness was uncertain because:PSD · Nov 2024
6.2 The PBAC noted and welcomed the input from individuals (17), health care professionals (8) and organisations (3) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with drospirenone.PSD · Nov 2024
Health professionals commented that drospirenone has a range of clinical benefits in addition to effective contraception, including benefits for heavy menstrual bleeding, dysmenorrhoea, endometriosis, menstrual-related migraine, and for women who experience adverse effects or have contraindications to estrogen-containing contraceptives.PSD · Nov 2024
Cost-effectiveness
Cost-effectiveness analysis conducted on a break-even basis (cost neutrality); no specific ICER range stated as numeric values.
Decision context
PopulationHealthy women at risk of pregnancy who are sexually active and requesting contraception, particularly those with contraindications to estrogen-containing combined oral contraceptives. Excludes breastfeeding women and those under 18 years of age (as per trial exclusion criteria).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended | levonorgestrel 30 microgram tablets (Microlut) and norethisterone 350 microgram tablets (Noriday) | — | RCT · Pregnancy rate (Pearl Index) |
Consumer voice
Consumer input from 17 individuals, 8 health professionals, and 3 organisations described clinical benefits of drospirenone including effective contraception, management of heavy menstrual bleeding, dysmenorrhoea, endometriosis, and menstrual-related migraine. However, high cost was identified as a significant access barrier, while improved quality of life and work productivity were noted as advan
Health professionals and organisations noted the higher cost of drospirenone compared to other POPs was a barrier to patients accessing this medicine, and individuals also highlighted that the high cost of drospirenone was a disadvantage. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to women aged ≥18, excludes breastfeeding women, and prioritises those with estrogen contraindications.