SOTATERCEPT
Information current as at: 1 July 2026
PBAC meeting date: November 2026
Submission Details
- Brand name:
-
- Winrevair®
- Form and strength:
-
- Powder for subcutaneous injection 45 mg (50 mg per mL)
- Powder for subcutaneous injection 60 mg (50 mg per mL)
- Submission sponsor:
- MERCK SHARP & DOHME (AUSTRALIA) PTY LTD
- Condition/indication:
(therapeutic use) -
- Pulmonary arterial hypertension (PAH)
- Listing requested:
- Resubmission to request listing of sotatercept as add-on therapy for the treatment of adult patients with PAH who have not achieved low risk status according to a validated PAH risk score calculator and have been on stable doses of dual or triple therapy for at least 90 days. The treatment must form part of triple combination therapy consisting of an endothelin receptor antagonist and phosphodiesterase-5 inhibitor, or part of quadruple combination therapy consisting of an endothelin receptor antagonist, phosphodiesterase-5 inhibitor, and selexipag or a prostanoid.
- Funding program:
- PBS Section 100 (Highly Specialised Drugs Program)
- Request authority level:
- Authority Required (Telephone/Online)
- PBAC Submission type:
- New PBS listing (–)
- Comment:
- --
- Other PBAC consideration:
Progress Details
-
Submission received for: - November 2026 PBAC meeting
-
2Opportunity for consumer comment:
- Open 22/07/2026 and close 16/09/2026 (see PBS Website)
-
3PBAC meeting:
- Has not yet occurred
-
4PBAC outcome published:
- Pending PBAC outcome (see PBAC Outcomes)
-
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
Case ID
a1308
Page last updated
23 July 2026
v.9.19