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

Acute Myeloid Leukaemia

Induction therapy

Patient must not have received prior chemotherapy as induction therapy for this condition; AND

The condition must be either: (i) newly diagnosed therapy-related acute myeloid leukaemia (AML), (ii) newly diagnosed AML with myelodysplasia-related changes (MRC) (prior myelodysplastic syndromes (MDS) or MDS-related cytogenetic or molecular abnormality); AND

The condition must not be either: (i) internal tandem duplication (ITD); (ii) tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3), mutation positive; AND

Patient must not have favourable cytogenetic risk acute myeloid leukaemia (AML); AND

Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND

The treatment must not exceed two cycles of induction therapy under this restriction.

This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.

The prescriber must confirm whether the patient has newly diagnosed therapy-related AML or AML-MRC. The test result and date of testing must be provided at the time of application and documented in the patient's file.

The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information.

Each prescription must include the amount of daunorubicin with cytarabine (Vyxeos) that is appropriate to be prescribed for the patient. For the purposes of the authority application, the maximum amount requested is based on the daunorubicin dose only. The prescribed amount of daunorubicin must be expressed in milligrams.