1.  The whole of this instrument

1 July 2022

1 July 2022

Reladdin

AF

MP

D

C10275

P10275

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; AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must not have received prior anti‑HER2 therapy for this condition; AND
Patient must not have received prior chemotherapy for this condition; AND
The treatment must be in combination with trastuzumab and a taxane; AND
The treatment must not be in combination with nab‑paclitaxel; 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.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes details 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).
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval.

Compliance with Written Authority Required procedures

C13018

P13018

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
Patient must have a WHO performance status of 0 or 1; AND
Patient must not have received prior anti-HER2 therapy for this condition; AND
Patient must not have received prior chemotherapy for this condition; AND
The treatment must be in combination with trastuzumab and a taxane; AND
The treatment must not be in combination with nab-paclitaxel; 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.
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) must be provided at the time of application.
The pathology report 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.

Compliance with Authority Required procedures

C10214

P10214

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 as monotherapy; 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.

Compliance with Authority Required procedures

C10255

P10255

Early HER2 positive breast cancer
Initial adjuvant treatment
The treatment must be prescribed within 12 weeks after surgery; AND
Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND
Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane‑based chemotherapy prior to surgery; 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; AND
The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Early Breast Cancer ‑ PBS Supporting Information Form which includes details from the pathology report from an approved pathology authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery.

Compliance with Written Authority Required procedures

C10510

P10510

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; 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 as monotherapy; 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.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes:
(i) details 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) and tick a box to state the person has Stage IV disease;
(ii) dates of treatment with trastuzumab and pertuzumab; and
(iii) date of demonstration of progression following treatment with trastuzumab and pertuzumab; or
(iv) 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.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval.

Compliance with Written Authority Required procedures

C12989

P12989

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.

Compliance with Authority Required procedures

C13004

P13004

Early HER2 positive breast cancer
Initial adjuvant treatment
The treatment must be prescribed within 12 weeks after surgery; AND
Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND
Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy prior to surgery; 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; AND
The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined.
Authority applications for initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery.
The pathology report must be documented in the patient's medical records.
If the application is submitted through HPOS upload or mail, it must include:
(i) a completed authority prescription form; and
(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice)

Compliance with Written Authority Required procedures

C13017

P13017

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.

Compliance with Authority Required procedures