MIFEPRISTONE AND MISOPROSTOL
Information current as at: 1 September 2026
Submission Details
- Brand name:
-
- MS-2 Step®
- Form and strength:
-
- Pack containing 1 tablet mifepristone 200 mg and 4 tablets misoprostol 200 micrograms
- Submission sponsor:
- MS HEALTH PTY LTD
- Condition/indication:
(therapeutic use) -
- Termination of an intra-uterine pregnancy
- Listing requested:
- To request a change to the existing listing of mifepristone and misoprostol for the termination of an intra-uterine pregnancy, such that the condition must be an intra-uterine pregnancy of up to 70 days of gestation (compared to 63 days of gestation with the existing listing).
- Funding program:
- PBS General Schedule
- Request authority level:
- Authority Required (STREAMLINED)
- PBAC Submission type:
- Change to existing listing (Category 2)
- Comment:
- --
- Other PBAC consideration:
- --
Progress Details
-
Submission received for: - July 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 25/03/2026 and close 20/05/2026 (see PBS Website)
-
PBAC meeting: - Held on 08/07/2026
-
5Lodgement of required documentation:
-
6Agreement to listing arrangements:
- Has not yet commenced
-
7Government processes:
- Has not yet commenced
-
8Medicine listed on the PBS:
- Has not yet occurred
PBAC Outcome
The PBAC recommended extending the PBS listing of mifepristone and misoprostol (MS-2 Step®) for the medical termination of intra-uterine pregnancy from up to 63 days of gestation to up to 70 days of gestation. The PBAC also recommended the inclusion of a prescribing instruction requiring patients to undertake a follow-up pregnancy test to confirm that the medical termination of the intra-uterine pregnancy is completed. The PBAC acknowledged the consumer comments received strongly supported the submission. The PBAC considered that medical termination of pregnancy (MTOP) using MS-2 Step® at a gestation age of 64 to 70 days is an effective option, noting that a small number of patients would require a follow-up procedure following MTOP to complete the medical termination of the intra-uterine pregnancy. The PBAC also considered that the cost comparison of MTOP and STOP was appropriate, and that MTOP with MS-2 Step® was cost saving. The PBAC considered that the estimated financial impact of extending the restriction for MS-2 Step® for use up to 70 days of gestation was reasonable.