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

Acute lymphoblastic leukaemia

Initial treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must be expressing the T315I mutation; AND

Patient must have failed treatment with chemotherapy, with or without another tyrosine kinase inhibitor; AND

Patient must have failed allogeneic haemopoietic stem cell transplantation (where appropriate); AND

Must be treated by a medical practitioner.

Failure of treatment is defined as either:

1. Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with intensive chemotherapy, with or without another tyrosine kinase inhibitor;

2. Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by chemotherapy, with or without another tyrosine kinase inhibitor;

3. Morphological or cytogenetic relapse or persistence of leukaemia after allogeneic haemopoietic stem cell transplantation.

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.

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 Initial PBS authority application form; and

3. a signed patient acknowledgement; and

4. a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript; and evidence of the T315I mutation. The date of the relevant pathology report(s), which should be within the previous 6 months, need(s) to be provided.

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

Acute lymphoblastic leukaemia

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must not have progressive disease; 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.