1.  The whole of this instrument

1 September 2024

1 September 2024

C10125 C10206 C10216 C10297 C10521 C10917 C10939 C13443 C13448 C15455

P10917

1

8

Granisetron Kabi

C4139

1

0

V4139

ONDANSETRON ODT-WGR

C5743

4

0

V5743

ONDANSETRON-WGR

C5778

4

0

V5778

ONDANSETRON ODT-WGR

C5743

4

0

V5743

ONDANSETRON-WGR

C5778

4

0

V5778

C15818

P15818

Trastuzumab emtansine

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 form upload or mail, it must include:

(i) details of the proposed prescription; 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).

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

Compliance with Written Authority Required procedures

C15819

P15819

Trastuzumab emtansine

Early HER2 positive breast cancer

Continuing adjuvant treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have developed disease progression while being treated with this drug 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; AND

The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined.

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

Compliance with Authority Required procedures

C15820

P15820

Trastuzumab

Early HER2 positive breast cancer

Initial treatment (3 weekly regimen)

Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); 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

Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; OR

Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.

HER2 positivity must be demonstrated by in situ hybridisation (ISH).

Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.

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

Compliance with Authority Required procedures - Streamlined Authority Code 15820

C15826

Trastuzumab deruxtecan

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.

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).

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

Compliance with Authority Required procedures

C15827

P15827

Trastuzumab emtansine

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.

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

Compliance with Authority Required procedures

C15828

P15828

Trastuzumab emtansine

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.

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

Compliance with Authority Required procedures

C15831

P15831

Trastuzumab

Early HER2 positive breast cancer

Initial treatment (weekly regimen)

Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); 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

Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; OR

Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.

HER2 positivity must be demonstrated by in situ hybridisation (ISH).

Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.

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

Compliance with Authority Required procedures - Streamlined Authority Code 15831

C15832

Trastuzumab deruxtecan

Unresectable and/or metastatic HER2-low breast cancer

Patient must have evidence of human epidermal growth factor receptor 2 (HER2)-low disease; AND

Patient must have received prior chemotherapy in the metastatic setting; OR

Patient must have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy; AND

Patient must have received or be ineligible for endocrine therapy in the metastatic setting, if hormone receptor positive; 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.

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.

HER2-low is defined as an immunohistochemical (IHC) score of 1+ or an IHC score of 2+ and a negative result on in situ hybridization (ISH).

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-low status

2) Details of prior drug regimens prescribed for the patient

3) Cardiac function test results

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

Compliance with Authority Required procedures