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

Acute Myeloid Leukaemia

Maintenance therapy - Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the initial maintenance treatment restriction; AND

Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND

Patient must not be undergoing or have undergone a stem cell transplant.

A maximum of 9 cycles will be authorised under this restriction in a lifetime.

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, 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:

• Leukaemic cells in the CSF;
• Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;
• Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;
• Extramedullary leukaemia.

A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.