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Chronic myeloid leukaemia (CML) Program in Pharmaceutical Benefits Scheme (PBS) 012-18051108




CML restriction and item codes

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A linked attachment is available for staff only (i.e. under IPS/FOI)PBS CML restriction and item codes

Contact details

PBS Complex Drugs Programs

Forms

Chronic myeloid leukaemia - asciminib or ponatinib - initial authority application (PB171)

Chronic myeloid leukaemia - asciminib - continuing authority application form (PB084)

Services Australia website

Chronic myeloid leukaemia

FAQs from service officers

Table 1: see Table 2 in Processing Complex Authority Required Listings for FAQs about all Complex programs.

Item

Description

1

What changes are implemented on 1 October 2026 for imatinib, dasatinib and nilotinib?

From 1 October 2026, the restrictions for imatinib, dasatinib and nilotinib are simplified. Each medicine now only has initial and continuing treatment restrictions.

Reference to treatment lines (first, second or third) and treatment phases (accelerated or blast) are removed. In addition, nilotinib is no longer limited to a specific strength for any stage of therapy.

2

Can patients receive more than one initial authority approval for ponatinib or asciminib?

Yes. Multiple initial approvals can be provided for ponatinib or asciminib, up to a maximum of 18 months in total. After this, patients must meet the requirements for continuing treatment.