Medroxyprogesterone AcetateDepo-Provera
Contraception in women, particularly in remote communities where it is a preferred form among Aboriginal and Torres Strait Islander women.
Decision on record
- Meeting Nov 2023 Recommended Unrestricted benefit contraception
Access path
- TGA registered · Depo-Provera
TGA label equal than the PBS population
- Nov 2023Recommended
vs medroxyprogesterone acetate 150 mg/mL injection, vial form
- PBS listing · Unrestricted
From the public summary
6.1 The PBAC recommended the listing of medroxyprogesterone PFS (Depo-Provera®) on the General Schedule (Unrestricted Benefit) under the same circumstances as the PBS- listed medroxyprogesterone vial (Depo-Provera®, Depo-Ralovera®).PSD · Nov 2023
6.2 The PBAC considered that the nomination of medroxyprogesterone vial as the comparator was appropriate. The PBAC noted that a bioequivalence study was not required by the TGA, and that the TGA approval letter confirmed that medroxyprogesterone PFS and medroxyprogesterone vial are the same except for the container type (with consequential changes to manufacturing processes), shelf-life and storage conditions.PSD · Nov 2023
Cost-effectiveness
No economic analysis submitted; cost-minimisation basis assessment only.
The PBAC noted that this submission is not eligible for an Independent Review because it received a positive recommendation. PBAC · 2023
Decision context
PopulationWomen requiring contraception, particularly Aboriginal and Torres Strait Islander women in remote communities.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2023 | Recommended | medroxyprogesterone acetate 150 mg/mL injection, vial form | — | Cost-minimisation · Cost-minimisation |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — TGA label references same indications as existing vial form; PBAC recommends contraception in women, the established indication for medroxyprogesterone acetate.
Listed in law
PBS listings commencing 1 Jun 2024 were made by these 5 determinations under the National Health Act 1953. A determination covers every listing that commenced that day, so this is the legal instrument in force for the date — not a document naming this medicine. Open it and check.
| Determination | Made | Status | |
|---|---|---|---|
| PB 52 of 2024 | 30 May 2024 | Repealed | PDF ↗ |
| PB 53 of 2024 | 30 May 2024 | Repealed | PDF ↗ |
| PB 53 of 2024 | 30 May 2024 | Repealed | PDF ↗ |
| PB 54 of 2024 | 30 May 2024 | Repealed | PDF ↗ |
| PB 54 of 2024 | 30 May 2024 | Repealed | PDF ↗ |