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

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 make sure 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 initial treatment with dasatinib or ponatinib?

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 by phone.

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 not sure.