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 dasatinib 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

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; 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.

Conditions for PBS-subsidy beyond 24 months of treatment:

On the first occasion an authority application extends PBS-subsidy beyond 24 months, by annotating the prescription with the Streamlined Authority Required code, the prescriber is declaring 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 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.