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



This document outlines details of PBS-subsidised imatinib, dasatinib, nilotinib, ponatinib and asciminib for patients with chronic myeloid leukaemia (CML).

CML and listing dates

CML is a type of blood cancer.

Listing dates:

  • imatinib - 1 December 2001
  • dasatinib - 1 August 2007
  • nilotinib - 1 August 2008
  • ponatinib - 1 November 2015
  • asciminib – 1 May 2023

See Written Authority Required Drugs for more information.

Disease Phases

CML is categorised into chronic phase, accelerated phase and blast crisis.

The different phases of disease have different restrictions for PBS subsidy.

Chronic Phase is further split into lines of treatment:

  • A patient starts as first line treatment and can choose to commence on imatinib, dasatinib or nilotinib.
    • A patient who swaps treatment due to toxicity remains in 'first line' treatment
  • Second and third line treatment includes dasatinib and nilotinib.
  • Asciminib and ponatinib sits outside the lines of treatment and are available to patients after failure or toxicity to treatment

Untreated patients may commence imatinib in the accelerated phase or blast crisis. The patient's disease may improve with treatment and maybe reclassified into the chronic phase of treatment.

Enquiries

Transfer enquiries about prescription arrangements to the PBS Complex Drugs Programs team, and choose the option relevant to the conditions treated.

The Resources page contains links to application forms, contact details, item and restriction codes, the PBS schedule and the Services Australia website

Online Pharmaceutical Benefits Scheme (PBS) Authorities System (OPA System)

Process telephone Authority approval application

Processing and National Demand Allocation (PaNDA)

Processing Complex Authority Required Listings

Written Authority Required Drugs