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

Acute lymphoblastic leukaemia

Induction treatment of relapsed or refractory B-precursor cell ALL

The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND

The condition must not be present in the central nervous system or testis; AND

Patient must not have received more than 1 line of salvage therapy; AND

The condition must be one of the following: (i) untreated with this drug for Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL), (ii) treated with this drug for Pre-B-cell ALL, but the condition has not relapsed within 6 months of completing that course of treatment; AND

The condition must have more than 5% blasts in bone marrow; or

The condition must have measurable residual disease based on measurement in bone marrow following complete remission; AND

The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.

According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.

An amount of 651 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 1. An amount of 784 microgram, which may be obtained under Induction treatment - balance of supply restriction, will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.

Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed Acute Lymphoblastic Leukaemia in complete haematological remission PBS Authority Application - Supporting Information Form; and

(3) date of most recent chemotherapy (if applicable), and if this was the initial chemotherapy regimen or salvage therapy;

(4) for Philadelphia chromosome positive patients:

(i) the date of the most recent treatment with a TKI (in combination with chemotherapy); OR

(ii) if applicable the date of initial combined treatment with TKI and corticosteroids (if unable to tolerate chemotherapy).

(5) if applicable, the date of completion of blinatumomab treatment for Pre-B-cell ALL in CR and the date of the patient's subsequent relapse; and

(6) the percentage blasts in bone marrow count measured that is no more than 4 weeks old at the time of application.