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

Metastatic (Stage IV) HER2 positive breast cancer

Patient must have evidence of human epidermal growth factor (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) in either the primary tumour/a metastatic lesion - establish this finding once only with the first PBS prescription; AND

The condition must have progressed following treatment with at least one prior HER2 directed regimen for metastatic breast cancer; or

The condition must have, at the time of treatment initiation with this drug, progressed during/within 6 months following adjuvant treatment with a HER2 directed therapy; AND

Patient must have, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND

The treatment must not be prescribed where any of the following is present: (i) left ventricular ejection fraction of less than 50%, (ii) symptomatic heart failure; confirm cardiac function testing for the first PBS prescription only; AND

Patient must be undergoing initial treatment with this drug - the following are true: (i) this is the first prescription for this drug, (ii) this prescription seeks no more than 3 repeat prescriptions; or

Patient must be undergoing continuing treatment with drug - the following are true: (i) there has been an absence of further disease progression whilst on active treatment with this drug, (ii) this prescription does not seek to re-treat after disease progression, (iii) this prescription seeks no more than 8 repeat prescriptions.

Confirm that the following information is documented/retained in the patient's medical records once only with the first PBS prescription:

1) Evidence of HER2 gene amplification (evidence obtained in relation to past PBS treatment is acceptable).

2) Details of prior HER2 directed drug regimens prescribed for the patient.

3) Cardiac function test results (evidence obtained in relation to past PBS treatment is acceptable).

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2

Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg.