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



ALL restriction and item codes

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\\INTERNAL.DEPT.LOCAL\Shared\NAT\SERDELEXCEL\WORKPRODIMP\Operation Blueprint Migration\RDT Release Icons\32w\icon-hidden-attachment.pngPBS ALL blinatumomab/inotuzumab restriction and item codes

\\INTERNAL.DEPT.LOCAL\Shared\NAT\SERDELEXCEL\WORKPRODIMP\Operation Blueprint Migration\RDT Release Icons\32w\icon-hidden-attachment.pngPBS ALL imatinib/dasatinib/ponatinib restriction and item codes

Contact details

PBS Complex Drugs Programs

Services Australia website

External websites

FAQs from Service Officers

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

Item

Description

1

When processing a blinatumomab initial request, what is the correct process to follow if the Q&As in OPA do not align with the application form?

Check to ensure that the correct item and restriction code are selected as multiple indications are on the same application form.

2

What is the procedure when a prescriber calls requesting a dose reduction for inotuzumab ozogamicin?

If the dose change is more than 10% (increase or decrease):

  • a replacement script must be approved under the same item and restriction code as the previous approval. Answers to questions of the previous approval can be used to complete the Q&As, and
  • override the rejection and add an authority comment 'dose change'.

3

What is the procedure when a prescriber or pharmacist calls stating that the quantity approved for inotuzumab ozogamicin is not sufficient to provide the 3 doses required for each cycle of treatment?

Escalate to a Pharmaceutical Adviser (PA).

4

What is the procedure for handling a delayed assessment application when a prescriber uses the Online PBS Authorities (OPA) system to request dasatinib for first-line or second-line initial treatment, or for a switch during the first-line initial phase due to toxicity?

Start by confirming that a relevant pathology report is attached and that it matches the correct patient. Once this is verified, escalate the application to a PA.

5

What is the procedure if an incorrect/unrelated report is uploaded for a delayed dasatinib application submitted via the OPA system?

Reject the application if an incorrect or unrelated report (such as a random image) is attached. Authority requests for first-line or second-line initial treatment, or for a switch during the first-line initial phase due to toxicity, must include a valid pathology report. Escalate to a PA if unsure.

6

How to answer the prescriber type question that is not on the form?

For written applications received via HPOS or mail, use the prescriber type displayed in OPA to complete the prescriber type question.