TECLISTAMAB
Information current as at: 1 July 2026
The pharmaceutical company has not advised whether they intend to proceed or not within 60 days of receiving the ratified PBAC minutes. The process for listing is considered inactive.
Submission Details
- Brand name:
-
- Tecvayli®
- Form and strength:
-
Please search for and view the meeting agenda from the relevant meeting for more information
- Submission sponsor:
- JANSSEN-CILAG PTY LTD
- Condition/indication:
(therapeutic use) -
- Relapsed or refractory multiple myeloma (RRMM)
- Listing requested:
- Please see meeting agenda for more information
- Funding program:
- PBS General Schedule, PBS Section 100 (Efficient Funding of Chemotherapy Program)
- Request authority level:
- Please see meeting agenda for more information
- PBAC Submission type:
- New PBS listing (Category 2)
- 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
-
PBAC outcome published: - Recommended (see PBAC Outcomes)
-
Notice of intent submitted:
- Awaiting lodgement from pharmaceutical company
-
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 that teclistamab be listed on the PBS for the treatment of patients with relapsed or refractory multiple myeloma (RRMM) who have received at least 3 prior lines of therapy. The PBAC considered that the use of teclistamab would result in similar outcomes (both in terms of efficacy and safety) as elranatamab, which is currently PBS listed for the treatment of RRMM in the same population requested for teclistamab. The PBAC welcomed the input from individuals, health care professionals and organisations. The PBAC noted that the input highlighted the continued need for new and effective therapies for patients with RRMM. The PBAC noted the positive responses to treatment for patients who have accessed teclistamab via clinical trials and the substantial improvements that treatment offered to their quality of life.
The PBAC considered that the requested restrictions, which aligned with the elranatamab restrictions, were appropriate. The PBAC advised that a flow on change to the elranatamab restrictions would be required to allow switching between teclistamab and elranatamab in the absence of disease progression (e.g. in case of intolerance to one drug). The PBAC also considered that the price of teclistamab should equal that of elranatamab and, as such, the listing of teclistamab on the PBS should have little to no impact on overall costs for the PBS. The PBAC advised that teclistamab should join the arrangement currently in place for elranatamab to manage financial risks with no increase in the existing spending limits.
