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).

For information on how to process a PBS Authority, see Processing Complex Authority Required Listings. Contact a Local Peer Support (LPS) if unsure on how to action an application.

Restrictions	Authority level and section	PA assessment	Processing system	Prescriber type	Prescriber self-serve
Chronic phase First line Initial and repeat initial	Telephone Electronic S85	No	OPA	Not specified	Yes
Chronic phase First line Continuing	Streamlined S85	No	N/A	Not specified	N/A
Chronic phase First line Change from dasatinib or nilotinib for toxicities or intolerances within the initial phase	Telephone Electronic S85	No	OPA	Not specified	Yes
Chronic phase First line Change from dasatinib or nilotinib for toxicities or intolerances within the continuing phase	Streamlined S85	No	N/A	Not specified	N/A
Accelerated phase or blast phase First line Initial	Telephone Electronic S85	No	OPA	Not specified	Yes
Accelerated phase or blast phase First line Continuing	Streamlined S85	No	N/A	Not specified	N/A

Dasatinib quick reference

Table 2

Restrictions	Authority level and section	PA assessment	Processing system	Prescriber type	Prescriber self-serve
Chronic phase First line Initial and repeat initial	Telephone Electronic S85	No	OPA	Not specified	Yes
Chronic phase First line Continuing	Streamlined S85	No	N/A	Not specified	N/A
Chronic phase First line Change from imatinib or nilotinib for toxicities or intolerances within the initial phase	Telephone Electronic S85	No	OPA	Not specified	Yes
Chronic phase First line Change from imatinib or nilotinib for toxicities or intolerances within the continuing phase	Streamlined S85	No	N/A	Not specified	N/A
Chronic, accelerated or blast phase Second or third line Initial and repeat initial	Telephone Electronic S85	No	OPA	Not specified	Yes
Chronic, accelerated or blast phase Second or third line Continuing	Streamlined S85	No	N/A	Not specified	N/A
Chronic or accelerated phase Second line Change from nilotinib for toxicities or intolerances Initial	Telephone Electronic S85	No	OPA	Not specified	Yes
Chronic phase Second line Change from nilotinib for toxicities or intolerances Continuing	Streamlined S85	No	N/A	Not specified	N/A

Nilotinib quick reference

Table 3

Restrictions	Authority level and section	PA assessment	Processing system	Prescriber type	Prescriber self-serve
Chronic phase First line Initial and repeat initial 150mg only	Telephone Electronic S85	No	OPA	Not specified	Yes
Chronic phase First line Continuing 150mg only	Streamlined S85	No	N/A	Not specified	N/A
Chronic phase First line Change from imatinib or dasatinib for toxicities or intolerances within the initial phase 150mg only	Telephone Electronic S85	No	OPA	Not specified	Yes
Chronic phase First line Change from imatinib or dasatinib for toxicities or intolerances within the continuing phase 150mg only	Streamlined S85	No	N/A	Not specified	N/A
Chronic Phase First line Continuing 150 mg only	Streamlined S85	No	N/A	Not specified	N/A
Chronic Phase First line Grandfather 200 mg only	Streamlined S85	No	N/A	Not specified	N/A
Chronic or accelerated phase Second or third line Initial and repeat initial 200mg only	Telephone Electronic S85	No	OPA	Not specified	Yes
Chronic phase Second or third line Continuing 200mg only	Streamlined S85	No	N/A	Not specified	N/A
Chronic or accelerated phase Second line Change from dasatinib for toxicities or intolerances within the initial phase 200 mg only	Telephone Electronic S85	No	OPA	Not specified	Yes
Chronic Phase Second line Change from dasatinib for toxicities or intolerances within the continuing phase 200 mg only	Streamlined S85	No	N/A	Not specified	N/A

Ponatinib quick reference

Table 4

Restrictions	Authority level and section	PA assessment	Processing system	Prescriber type	Prescriber self-serve
Initial and repeat initial PB171 form	Written Electronic S85	No	OPA	Must be treated by a: medical practitioner	Yes
First continuing PB084 form	Written Electronic S85	No	OPA	Must be treated by a: medical practitioner nurse practitioner where patient care is being shared with a medical practitioner and the prescription continues existing therapy with this medicine	Yes
Subsequent continuing	Telephone Electronic S85	No	OPA	Must be treated by a: medical practitioner nurse practitioner where patient care is being shared with a medical practitioner and the prescription continues existing therapy with this medicine	Yes

Asciminib quick reference

Table 5

Restrictions	Authority level and section	PA assessment	Processing system	Prescriber type	Prescriber self-serve
Initial for patients with T315I PB171 form	Written Electronic S85	No	OPA	Not specified	Yes
Continuing for patients with T315I PB084 form	Written Electronic S85	No	OPA	Not specified	Yes
Initial for patients without T315I	Telephone Electronic S85	No	OPA	Not specified	Yes
Continuing for patients without T315I	Streamlined	No	OPA	Not specified	Yes

Operational Information

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

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