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

Metastatic (Stage IV) HER2 positive breast cancer

Initial treatment

Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority; AND

The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; or

The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab; AND

Patient must have a WHO performance status of 0 or 1; AND

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

The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.

The following information must be provided by the prescriber at the time of application:

(a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH).

(b) dates of treatment with trastuzumab and pertuzumab;

(c) date of demonstration of progression following treatment with trastuzumab and pertuzumab; or

(d) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment.

If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application.

All reports must be documented in the patient's medical records.

Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval.

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.

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

Metastatic (Stage IV) HER2 positive breast cancer

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for metastatic (Stage IV) HER2 positive breast cancer; AND

Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND

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

The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.

A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.

The treatment must not exceed a lifetime total of one continuous course for this PBS indication.

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.