Mifepristone And MisoprostolARZESTRA
Termination of an intrauterine pregnancy of up to 63 days of gestation.
Decision on record
- Meeting Mar 2023 Recommended Termination of an intrauterine pregnancy
Access path
- TGA registered · ARZESTRA
TGA label equal than the PBS population
- Mar 2013Recommended · restricted
vs surgical termination of pregnancy (STOP) by vacuum…
- Jul 2014Recommended
Comparator changed: surgical termination of pregnancy (STOP) by vacuum aspiration →…
- Mar 2023Recommended · restricted
Evidence: Registry → Cost-minimisation
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended a change to the restriction level of mifepristone and misoprostol from Authority Required to Authority Required (STREAMLINED) for the termination of intrauterine pregnancy.PSD · Mar 2023
5.2 The PBAC noted that regardless of the authority level, prescribers are required to prescribe in accordance with the PBS restriction and agreed with the view presented in the sponsor’s pre-PBAC response that the prescriber’s obligation to acquire the knowledge and skill to prescribe a drug safely is a fundamental aspect of prescribing practice.PSD · Mar 2023
4.4 The submission further claimed that the requested change in authority level would not increase use of MS-2 Step, given the maturity of the market, the year-to-year consistency of script numbers, and the familiarity of prescribers with the use of MS-2 Step. It is unclear if this assumption is reasonable. In addition, the submission claimed that the current expenditure on MS-2 Step is modest by comparison with other PBS-listed medicines.PSD · Mar 2023
4.5 The submission stated that the treatment criteria would remain the same, including no change to the requirements for prescribers to be registered with the MS-2 Step Prescribing Program.PSD · Mar 2023
Cost-effectiveness
This is a Category 3 minor submission requesting a change in authority type from Authority Required (Telephone) to Authority Required (STREAMLINED). No economic evaluation was conducted; no ICER calculated. The submission is not eligible for cost-effectiveness assessment.
The PBAC also recalled from its March 2013 consideration that MTOP was less costly than STOP under all the realistic sensitivity analyses presented. PBAC · 2023
Decision context
PopulationFemales of childbearing age with an intrauterine pregnancy of up to 63 days of gestation.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2023 | Recommended · restricted | surgical termination of pregnancy (STOP) | — | Cost-minimisation · Cost-minimisation |
| Jul 2014 | Recommended | surgical termination of pregnancy (STOP) | — | Registry · Comparative effectiveness and safety |
| Mar 2013 | Recommended · restricted | surgical termination of pregnancy (STOP) by vacuum aspiration | — | RCT · Proportion of women reporting failure of termination of pregnancy requiring surgical intervention |
Consumer voice
Five consumer organisations highlighted that PBS listing of the composite pack would remove cost barriers to early medical termination of pregnancy and improve access for women in rural or remote areas, ensuring equitable care across the population.
Comments noted the benefits of the composite pack for up to 63 days' gestation in terms of opportunity for women in rural or remote areas to access MTOP Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify termination of intrauterine pregnancy ≤63 days gestation in females of childbearing age; no population restriction applied.