Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Relapsed or refractory Acute Myeloid Leukaemia

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must not have developed disease progression while being treated with this drug for this condition; AND

The treatment must not be for maintenance therapy post-transplant; AND

Must be treated by a medical practitioner; or

Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.

Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.

If abnormal blood counts suggest the potential for relapsed AML, following a response to gilteritinib, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.

Progressive disease is defined as the presence of any of the following:

(a) Leukaemic cells in the CSF; or

(b) Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy; or

(c) Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause; or

(d) Extramedullary leukaemia.