SELPERCATINIB

Information current as at: 1 July 2026

Legend: Completed N In progress Not applicable N Yet to commence

Submission Details

Brand name:
  • Retevmo®
Form and strength:

Please search for and view the meeting agenda from the relevant meeting for more information

Submission sponsor:
ELI LILLY AUSTRALIA PTY LTD
Condition/indication:
(therapeutic use)
  • Medullary thyroid cancer (MTC)
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:
Change to existing listing (Category 1)
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:
Exception applied
Lodgement of required documentation:
07/05/2026
Acceptance of complete documentation:
Accepted
Agreement to listing arrangements:
Commenced on 14/05/2026
Status:
Finalised
7Government processes:
Commenced on 20/05/2026
8Medicine listed on the PBS:
Has not yet occurred

PBAC Outcome

PBAC Recommendation:

The PBAC recommended the listing of selpercatinib (Retevmo®) on the PBS, for the treatment of patients with locally advanced or metastatic medullary thyroid cancer (MTC), a rare type of thyroid cancer, that has a confirmed RET gene variant and cannot be surgically removed. The PBAC finalised its advice for selpercatinib out of session, following notification that, at its April 2026 meeting, the Medical Services Advisory Committee (MSAC) supported public funding of the related genetic testing to detect RET variants.

The PBAC welcomed input from individuals, health care professionals and organisations which described the debilitating impacts of progressive MTC, limited funded treatment options, and potential benefits associated with selpercatinib. The PBAC considered that because selpercatinib could be taken by mouth, it would help support access for rural and regional patients. The PBAC considered there was a high clinical need for patients with progressive MTC that cannot be surgically removed. However, the PBAC considered that the need for patients with indolent (slow growing) MTC was low and the benefits of treating these patients with selpercatinib was uncertain.

The PBAC noted there was evidence that selpercatinib delayed the time before cancer worsened compared with current treatments. While it appeared that selpercatinib may help people with MTC to live longer (overall survival), the size of this benefit was highly uncertain.  

The PBAC considered that the price proposed for selpercatinib was unacceptably high, and value for money was unclear because it was uncertain how long patients would stay on treatment and what the long-term benefits would be. The PBAC considered that the price for selpercatinib the treatment of MTC would be acceptable at the same price it is currently listed on the PBS for lung cancer. 

The PBAC considered changes to the estimated number of treated patients were required and noted there was likely to be an additional small population of patients diagnosed with locally advanced or metastatic MTC in the last few years who may be appropriate for treatment with selpercatinib once it is listed on the PBS. The PBAC recommended an arrangement should be in place to manage the financial risk to PBS associated with potential use of selpercatinib in patients with slow growing disease.

As part of its recommendation, the PBAC nominated selpercatinib to proceed through Pricing Pathway A, reflecting the clinical need and anticipated benefit. 

Public Summary Document:
Not yet available

Case ID
a1181
Page last updated
30 June 2026
v.9.19