ASCIMINIB

Information current as at: 1 July 2026

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

Submission Details

Brand name:
  • Scemblix®
Form and strength:

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

Submission sponsor:
NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LIMITED
Condition/indication:
(therapeutic use)
  • Chronic myeloid leukaemia (CML)
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 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:
22/06/2026
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

PBAC Recommendation:

The PBAC recommended the addition of nurse practitioners (NPs) as authorised prescribers for asciminib on the Pharmaceutical Benefits Scheme (PBS), in the continuing treatment phase of all current indications.
Asciminib is currently listed on the PBS for patients with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) or accelerated phase (AP), who had been previously treated with two or more tyrosine kinase inhibitors (TKIs). This is in the third-line setting or beyond. It is also PBS-listed for patients with Ph+ CML in CP or AP, who had been previously treated with one or more TKIs and harbouring the T315I mutation. This is in the second-line setting or beyond. The PBAC noted and welcomed input from individuals. The PBAC acknowledged CML as an insidious disease that brings emotional and physical pain to both patients and families.
In its consideration, the PBAC recalled its July 2025 review of General Schedule oncology and haematology medicines, and whether these should be eligible for NP prescribing. Asciminib was not considered at this meeting as it had not been identified for review by stakeholders. For oncological or haematological conditions in general, the PBAC considered that the clinical work up required for a diagnosis and differential diagnosis may be complex and likely require that a patient’s care be overseen by an oncologist or haematologist. As such, the PBAC was of a view that limiting NP prescribing to continuing therapy with a specific medicine was more suitable, rather than allowing NP prescribing in both initiation and continuing settings. It considered that NPs sharing patient care with a medical practitioner would assist in mitigating potential risks. 
In its current decision, the PBAC advised that the listing for asciminib should follow precedent for other NP prescribing items for other drugs in this same class. The PBAC considered that its decision would result in no additional cost to the PBS. 

Public Summary Document:
Not yet available

Case ID
a1149
Page last updated
30 June 2026
v.9.19