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

Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL)

Initial treatment of newly-diagnosed Pre-B-cell ALL in the consolidation phase

Must be treated by a physician experienced in the treatment of haematological malignancies; AND

Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND

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

Patient must have achieved complete remission following intensive combination chemotherapy for acute lymphoblastic leukaemia (ALL); or

Patient must have Philadelphia chromosome positive ALL, and both (i) have achieved complete remission following combination therapy with a tyrosine kinase inhibitor and corticosteroids (ii) be unable to tolerate chemotherapy; 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 3 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 four or more hours), supervision by a health care professional or hospitalisation is recommended.

An amount of 784 mcg will be sufficient for a continuous infusion of blinatumomab over 28 days in each cycle.

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

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.

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

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

(5) the date of the course of combination therapy with a tyrosine kinase inhibitor and corticosteroid for Philadelphia chromosome positive patients.

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

Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL)

Continuing treatment of Pre-B-cell ALL in complete haematological remission (CR)

Must be treated by a physician experienced in the treatment of haematological malignancies; AND

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

Patient must have achieved a complete remission; AND

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

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

For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for four or more hours), supervision by a health care professional or hospitalisation is recommended.

An amount of 784 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in each cycle.

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

Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.