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

Acute lymphoblastic leukaemia

Initial treatment

The condition must be expressing the Philadelphia chromosome; or

The condition must have the transcript BCR-ABL; AND

Patient must have failed prior treatment with PBS-subsidised dasatinib for this condition; or

Patient must have developed intolerance to PBS-subsidised dasatinib of a severity requiring treatment withdrawal; AND

Must be treated by a medical practitioner.

Failure of treatment with dasatinib is defined as either:

1. Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with PBS-subsidised dasatinib for this condition; or

2. Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by PBS-subsidised dasatinib for this condition; or

3. Rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition.

Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; OR the presence of cells bearing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission; OR rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition.

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

1. details of the proposed prescription; and

2. a completed Acute Lymphoblastic Leukaemia ponatinib PBS Authority Application - Supporting Information Form; and

3. a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript. The date of the relevant pathology report(s) need(s) to be provided; or

4. pathology reports documenting rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition. The date of the relevant pathology report(s) need(s) to be provided.

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

Acute lymphoblastic leukaemia

Continuing treatment

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

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

Must be treated by a medical practitioner; or

Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.