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

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

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

Restrictions

Authority level and section

PA assessment

Processing system

Prescriber type

Prescriber self-serve

Initial (induction/consolidation) -

first line

PB271 form

Written

Electronic

S85:

dasatinib

Yes

OPA

N/A

Yes - delayed assessment (due to pathology report attachment)

Continuing

(maintenance of first complete remission) -

first line

Telephone

Electronic

S85:

dasatinib

No

OPA

N/A

Yes

Initial -

second line

PB077 form

Written

Electronic

S85:

dasatinib

Yes

OPA

N/A

Yes - delayed assessment (due to pathology report attachment)

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

Electronic

S85:

dasatinib

Yes

OPA

N/A

Yes - delayed assessment (due to pathology report attachment)

Change - whilst in first line continuing phase

(due to toxicity)

Telephone

Electronic

S85:

dasatinib

No

OPA

N/A

Yes

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

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

No

Continuing (consolidation)

Telephone

Electronic

S100 EFC:

inotuzumab

No

OPA

N/A

Yes

Restrictions

Authority level and section

PA assessment

Processing system

Prescriber type

Prescriber self-serve

Initial

PB169 form

Written

S85:

ponatinib

Yes

OPA

N/A

No

Continuing

Telephone

Electronic

S85:

ponatinib

No

OPA

N/A

Yes

Delayed assessment check for

Examples

Outcome

Uploaded pathology report

It is for the correct patient on the application

Escalate to PA

It is for the incorrect patient on the application

Reject

Unrelated document(s) attached

Reject