Acute lymphoblastic leukaemia (ALL) Program in Pharmaceutical Benefits Scheme (PBS) 012-18051101

This document outlines details of PBS-subsidised blinatumomab, dasatinib, imatinib, inotuzumab and ponatinib for patients with acute lymphoblastic leukaemia (ALL).

For information on how to process a PBS Authority, see Processing Complex Authority Required Listings.

Step	Action
1	Dasatinib and imatinib and ‘first-line’ applications The patient may switch between ‘first line’ dasatinib or imatinib treatment due to toxicity or intolerance.
2	Blinatumomab only applications Induction treatment is limited to a maximum of 2 treatment cycles in a patient’s lifetime Consolidation treatment is limited to a maximum of 3 treatment cycles in a patient’s lifetime for relapsed or refractory B-precursor cell ALL, or 2 treatment cycles in a patient's lifetime for Pre-B-cell ALL in complete haematological remission The Online PBS Authorities system will reject applications for treatment beyond the maximum allowed. If the prescriber needs a top up or replacement, the assessment may need to be overridden
3	Inotuzumab applications Induction treatment is limited to a maximum of 3 treatment cycles in a patient’s lifetime Consolidation treatment is limited to a maximum of 5 treatment cycles in a patient’s lifetime Patients are limited to a maximum of 6 total treatment cycles in a lifetime across the induction and consolidation treatment restrictions

Blinatumomab quick reference

Table 2

Restrictions	Authority level and section	PA assessment	Processing system	Prescriber type	Prescriber self-serve
Initial (Induction) PB210 form	Written S100: blinatumomab	No	OPA	N/A	No
Grandfather PB381 form	Written S100: blinatumomab	No	OPA	N/A	No
Continuing (Consolidation)	Telephone Electronic S100: blinatumomab	No	OPA	N/A	Yes
Induction - Balance of Supply	Telephone Electronic S100: blinatumomab	No	OPA	N/A	Yes

Dasatinib quick reference

Table 3

Restrictions	Authority level and section	PA assessment	Processing system	Prescriber type	Prescriber self-serve
Initial (induction/consolidation) - first line PB271 form	Written S85: dasatinib	Yes	OPA	N/A	No
Continuing (maintenance of first complete remission) - first line	Telephone Electronic S85: dasatinib	No	OPA	N/A	Yes
Initial - second line PB077 form	Written S85: dasatinib	Yes	OPA	N/A	No
Continuing - second line	Telephone Electronic S85: dasatinib	No	OPA	N/A	Yes
Change - whilst in first line initial phase (due to toxicity) PB271 form	Written S85: dasatinib	Yes	OPA	N/A	No
Change - whilst in first line continuing phase (due to toxicity)	Telephone Electronic S85: dasatinib	No	OPA	N/A	Yes

Imatinib quick reference

Table 4

Restrictions	Authority level and section	PA assessment	Processing system	Prescriber type	Prescriber self-serve
Initial (induction/consolidation)	Telephone S85: imatinib	No	OPA	N/A	No
Continuing (maintenance of first complete remission)	Streamlined S85: imatinib	No	N/A	N/A	N/A
Change - whilst in first line initial phase (due to toxicity)	Telephone Electronic S85: imatinib	No	OPA	N/A	Yes
Change - whilst in first line continuing phase (due to toxicity)	Streamlined S85: imatinib	No	N/A	N/A	N/A

Inotuzumab ozogamicin quick reference

Table 5

Restrictions

Authority level and section

PA assessment

Processing system

Prescriber type

Prescriber self-serve

Initial (induction)

PB269 form

Written

S100 EFC:

inotuzumab

Yes

OPA

N/A

Continuing (consolidation)

Telephone

Electronic

S100 EFC:

inotuzumab

OPA

N/A

Yes

Ponatinib quick reference

Table 6:

Restrictions

Authority level and section

PA assessment

Processing system

Prescriber type

Prescriber self-serve

Initial

PB169 form

Written

S85:

ponatinib

Yes

OPA

N/A

Continuing