ASCIMINIB
Information current as at: 1 July 2026
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
-
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 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.
