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

Acute Myeloid Leukaemia

Maintenance therapy - Initial treatment

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

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

Patient must have demonstrated complete remission after induction and consolidation chemotherapy in combination with midostaurin confirmed through a bone marrow biopsy pathology report; AND

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

The condition must be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition confirmed through a pathology report from an Approved Pathology Authority.

A maximum of 3 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.

The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:

(a) confirmation that the patient is not undergoing or has not undergone a stem cell transplant; and

(b) confirmation that the patient does not have progressive disease; and

(c) details (date, unique identifying number/code or provider number) of a recent bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient is in complete remission; and

(d) details (date, unique identifying number/code or provider number) of the pathology test demonstrating that the condition was FMS tyrosine kinase 3 (FLT3) (ITD or TKD) mutation positive prior to commencing midostaurin.

All reports must be documented in the patient's medical records.

If the application is submitted through HPOS upload or mail, it must include:

(a) a completed authority prescription form; and

(b) a completed authority form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).