1.  The whole of this instrument

1 March 2025

1 March 2025

C16292

P16292

Blinatumomab

Acute lymphoblastic leukaemia

Induction treatment

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 have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND

Patient must have received intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; 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; 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 PBS Authority Application - Supporting Information Form; and

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

(4) 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

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

Compliance with Written Authority Required procedures

C16308

P16308

Blinatumomab

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.

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

Patient must have achieved a complete remission; AND

The condition must be negative for measurable residual disease (MRD) using the same method used to establish initial MRD status; 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.

Compliance with Authority Required procedures

C16334

P16334

Blinatumomab

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

Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements for Pre-B-cell ALL in complete haematological remission (CR)

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

Patient must have commenced treatment with this medicine for this condition prior to 1 March 2025; AND

Patient must have had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, at initiation of non-PBS-subsidised treatment with this drug; 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 initial treatment of acute lymphoblastic leukaemia (ALL) at initiation of non-PBS-subsidised treatment with this drug; OR

Patient must have had at initiation of non-PBS-subsidised treatment with this drug: (i) achieved complete remission following intensive combination chemotherapy, (ii) measurable residual disease based on measurement in bone marrow, documented after the last course of systemic chemotherapy given as intensive combination chemotherapy treatment of ALL/as subsequent salvage therapy, whichever was the later, measured using flow cytometry/molecular methods; AND

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

Patient must have received at least 1 treatment cycle of non-PBS therapy under this restriction; AND

The treatment must not be more than 4 treatment cycles of therapy (non-PBS and PBS) 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.

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, and if this was the initial chemotherapy regimen or salvage therapy; and

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

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.

Compliance with Written Authority Required procedures

C16341

P16341

Blinatumomab

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

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

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

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 initial treatment of acute lymphoblastic leukaemia (ALL); OR

Patient must have: (i) achieved complete remission following intensive combination chemotherapy, (ii) measurable residual disease based on measurement in bone marrow, documented after the last course of systemic chemotherapy given as intensive combination chemotherapy treatment of ALL/as subsequent salvage therapy, whichever was the later, measured using flow cytometry/molecular methods; 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.

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, and if this was the initial chemotherapy regimen or salvage therapy; and

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

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.

Compliance with Written Authority Required procedures