Etonogestrel With EthinylestradiolNuvaring
Contraception for women seeking a non-oral contraceptive preparation who have difficulty swallowing tablets, gastrointestinal disturbances (e.g. malabsorption), or undesirable side effects with oral contraceptives.
Decision on record
- Meeting May 2025 Recommended Contraception
Access path
- TGA registered · Nuvaring
TGA label narrower than the PBS population
- May 2025Recommended
vs depot medroxyprogesterone acetate injection (DMPA)
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended the listing of etonogestrel with ethinylestradiol (ENG/EE) contraceptive vaginal ring (CVR) as a General Schedule Unrestricted Benefit. The PBAC’s recommendation for listing was based on its assessment that the cost- effectiveness of ENG/EE CVR would be acceptable if it were cost-minimised against the PBS-listed combined oral contraceptives (COCs) drospirenone with ethinylestradiol (EE/DRSP).PSD · May 2025
7.2 The PBAC noted that the submission nominated depo-medroxyprogesterone acetate (DMPA) injection as the main comparator and COCs as alternative comparators. The PBAC considered that there were a number of appropriate comparators, including recently PBS-listed COCs containing EE/DRSP.PSD · May 2025
6.75 The submission presented a cost minimisation approach to the economic analysis. The key inputs into the cost minimisation approach are listed in Table 8.PSD · May 2025
Table 8: Key components and assumptions of the cost-minimisation approach Component Claim or assumption Based on evidence presented in the submission, the effectiveness of the CVR is Therapeutic claim: effectiveness demonstrated to be non-inferior to DMPA with respect to unintended pregnancies at 5.5 – 24 months.PSD · May 2025
6.71 The submission described CVR as non-inferior for the prevention of pregnancy compared to DMPA. This claim was not adequately supported; the evidence presented was of poor quality and unsuitable for the indirect treatment comparison on which the claim depended.PSD · May 2025
6.72 The submission described CVR as non-inferior in terms of safety compared to DMPA.PSD · May 2025
6.5 No evidence was presented to support the efficacy and safety of CVR in the population proposed for PBS-subsidised use. For example, breast tenderness may be less common with CVR than with COCs, but it does occur,8 and no evidence was presented to show that women with troublesome breast tenderness with COCs do not have troublesome breast tenderness with CVR.PSD · May 2025
6.6 As well as the formal claims of non-inferiority in contraceptive efficacy and safety, the submission made a number of claims of superiority of CVR to COCs or DMPA. These were not well-supported by evidence.PSD · May 2025
Cost-effectiveness
Cost-minimisation analysis approach used; no ICER calculated as per cost-minimisation methodology.
In the context of the cost-minimisation approach taken by the submission, a further consideration for the PBAC is that, under Section 101(3B) of the National Health Act 1953, when the proposed medicine is substantially more costly than an alternative therapy, the committee cannot make a positive recommendation unless it is satisfied that, for some patients, the proposed medicine provides a significant improvement in efficacy and/or reduction of toxicity over the alternative therapy. PBAC · 2025
Decision context
PopulationWomen seeking contraception who meet at least one of the following criteria: difficulty swallowing tablets, gastrointestinal disturbances (e.g. malabsorption), or undesirable side effects with oral contraceptives.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| May 2025 | Recommended | depot medroxyprogesterone acetate injection (DMPA) | — | Cost-minimisation · Cost-minimisation |
Consumer voice
Healthcare professionals and organisations supported CVR as a unique contraceptive option providing choice and discretion, particularly for women with medication routine challenges. Consumer input highlighted cost as a barrier to access and emphasised that PBS listing would improve affordability and equity, especially for Aboriginal and Torres Strait Islander peoples.
CVR is a unique contraceptive and provides another contraceptive option for individuals (including, but not limited to, the groups of women specified in the submission), providing choice. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to women with specific contraceptive barriers: difficulty swallowing tablets, gastrointestinal disturbances, or oral contraceptive side effects.