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 treatment with chemotherapy; AND

Patient must have failed treatment with imatinib; AND

Patient must have failed an allogeneic haemopoietic stem cell transplantation if applicable; AND

Must be treated by a medical practitioner.

Failure of treatment is defined as either:

(i) Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with intensive chemotherapy and imatinib;

(ii) Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by chemotherapy and imatinib;

(iii) 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 expressing 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:

(a) details of the proposed prescription; and

(b) a completed Acute Lymphoblastic Leukaemia Dasatinib PBS Authority Application - Supporting Information Form; and

(c) 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. 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

The condition must be expressing the Philadelphia chromosome; or

The condition must have the transcript BCR-ABL; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition as second-line therapy following treatment with imatinib; AND

The condition must not have progressed; 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.

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

Acute lymphoblastic leukaemia

Induction and Consolidation therapy

Patient must be newly diagnosed; AND

The condition must be expressing the Philadelphia chromosome; or

The condition must have the transcript BCR-ABL; AND

The treatment must be in combination with chemotherapy or corticosteroids; AND

Patient must not have previously experienced a failure to respond to the PBS-subsidised first line treatment with this drug for this condition; or

Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first-line therapy for this condition; AND

Must be treated by a medical practitioner.

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

(a) details of the proposed prescription; and

(b) a completed Acute Lymphoblastic Leukaemia Dasatinib PBS Authority Application - Supporting Information Form; and

(c) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow. (The date of the relevant pathology report needs to be provided).

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

Acute lymphoblastic leukaemia

Maintenance of first complete remission

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

Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised treatment with imatinib as a first-line therapy for this condition; AND

The condition must be expressing the Philadelphia chromosome; or

The condition must have the transcript BCR-ABL; AND

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

Patient must be undergoing treatment with this drug that is occurring within the first 24 months from the first administered dose; or

Patient must be undergoing treatment with this drug that is occurring beyond the first 24 months from the first administered dose - the patient meets the conditions as outlined below; 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.

Conditions for PBS-subsidy beyond 24 months of treatment:

On the first occasion an authority application extends PBS-subsidy beyond 24 months, confirm that:

1) The condition is expressing the Philadelphia chromosome,

2) Measurable residual disease (MRD) is present,

3) MRD has been confirmed in at least one of: (i) marrow, (ii) peripheral blood,

4) MRD has been confirmed within the preceding 6 months of this authority application,

5) MRD has been ascertained by at least one of: (i) a molecular method, (ii) flow cytometry,

6) Allogenic stem cell transplantation is considered by the prescriber to be unsuitable for the patient.

For any subsequent authority application beyond the 24 month time mark, confirm that MRD has been detected within the preceding 12 months of this subsequent authority application. Where MRD has since become undetectable, confirm that PBS-subsidy has not exceeded a further 12 months duration from the date that MRD became undetectable.