NEMOLIZUMAB
Information current as at: 1 July 2026
Submission Details
- Brand name:
-
- Nemluvio®
- Form and strength:
-
Please search for and view the meeting agenda from the relevant meeting for more information
- Submission sponsor:
- GALDERMA AUSTRALIA PTY LTD
- Condition/indication:
(therapeutic use) -
- Atopic dermatitis
- Listing requested:
- Please see meeting agenda for more information
- Funding program:
- PBS General Schedule
- Request authority level:
- Please see meeting agenda for more information
- PBAC Submission type:
- New listing (Standard Re-entry Pathway)
- Comment:
- --
- Other PBAC consideration:
Progress Details
-
Submission received for: - March 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 19/11/2025 and close 21/01/2026 (see PBS Website)
-
PBAC meeting: - Held on 11/03/2026
-
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 recommend the listing of nemolizumab (NEMO) for the treatment of patients with severe atopic dermatitis (AD) affecting the whole body, face, and/or hands. The PBAC welcomed input from organisations and an individual which supported the resubmission. The PBAC recalled it previously did not recommend listing NEMO as it considered the previous submission’s claim that NEMO is similarly effective to dupilumab (DUPI) was not adequately supported by the clinical data comparing NEMO and DUPI. The PBAC noted that the resubmission presented additional information which included patients who underwent a longer period (to Week 24) of treatment with NEMO following an inadequate response after treatment with NEMO for 16 weeks. The PBAC considered that based on this new information, NEMO was likely as effective as DUPI. The PBAC’s recommendation was based on, among other matters, its assessment that the cost of NEMO should be no more than the least costly of either DUPI or upadacitinib. The PBAC advised that NEMO should join the current risk sharing arrangement for severe AD with no increase to the expenditure caps.