National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 3) (PB 23 of 2016) (Cth)

Case

PB 23 of 2016

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 3)

National Health Act 1953

___________________________________________________________________________

I, Julianne Quaine, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.

Dated 31 March 2016           

JULIANNE QUAINE

Assistant Secretary

Pharmaceutical Access Branch

Pharmaceutical Benefits Division

Department of Health

___________________________________________________________________

1              Name of Instrument

(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 3).

(2)This Instrument may also be cited as PB 23 of 2016.

2             Commencement

This Instrument commences on 1 April 2016.

3              Amendments to PB 79 of 2011

Amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).

Amendments

  1. Schedule 1 Part 1 entry for Arsenic in the form Injection concentrate containing arsenic trioxide 10 mg in 10 mL

insert in numerical order in the column headed “Circumstances”:           C5997  C6018

  1. Schedule 1 Part 1 after the entry for Bleomycin in the form Powder for injection containing bleomycin sulfate 15,000 I.U and the brand Bleo 15K

insert:

CIPLA BLEOMYCIN

LR

MP

 C1139 C1198 D

  1. Schedule 1 Part 1 after the entry for Irinotecan in the form I.V injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL and the brand Irinotecan MYX

insert:

MEDITAB IRINOTECAN LR MP D

  1. Schedule 1 Part 1 after the entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL and the brand Irinotecan Ebewe

insert:

MEDITAB IRINOTECAN LR MP D

  1. Schedule 1 Part 1 entry for Rituximab in the forms Solution for I.V. infusion 100 mg in 10 mL and Solution for I.V. infusion 500 mg in 50 mL

omit from the column headed ‘Circumstances’: C4674 C4677 C4678 C4686 C4701 C4706 C4726

substitute: C4706 C5980 C5998 C6001 C6009 C6034 C6039 C6040 C6058

  1. Schedule 1 Part 2 entry for Arsenic

substitute:

Arsenic P4793 18 89
Arsenic

P5997

P6018

18

140

  1. Schedule 1 Part 2 entry for Rituximab  

omit:

Rituximab

P4686

P4701 P4726

 800 7

P4677

P4678

 800 3
P4706 1100 5
P4674 800 11

substitute:

Rituximab P5980 P6009 P6034 P6040 800 7

P5998

P6039

 800 3
P4706 1100 5

P6001

P6058

 800 11

  1. Schedule 2 after the entry for Mesna

insert:

Netupitant with Palonosetron Capsule containing netupitant 300 mg with palonosetron 500 microgram (as hydrochloride) Oral Akynzeo ZD EMP C5991 C5994 1 5

  1. Schedule 2 entry for Palonosetron

omit from the column headed ‘Responsible Person’: TS      substitute: ZD

[10]  Schedule 2 after the entry for Palonosetron 

insert:

Rituximab

Solution for subcutaneous injection containing rituximab 1400 mg in

11.7 mL

 Injection Mabthera SC RO EMP

C5980

C5998

C6004

C6008

C6039

C6040

P5998

P6039

P5980

P6040

P6008

P6004

1

1

1

1

2

6

7

11

[11]      Schedule 2 after the entry for Rituximab

insert:

Trastuzumab Solution for subcutaneous injection containing trastuzumab 600 mg in 5 mL Injection Herceptin SC RO MP

C5024

C5032

C5041

C6059

C6060

C6061

C6062

P5032

P6059

P6060

P5024

P5041

P6061

P6062

1

1

0

3

[12]  Schedule 3 after entry for JU:

insert:

 LR Cipla Australia Pty Ltd 46 132 155 063

[13]  Schedule 3 after entry for YN:

insert:

 ZD Specialized Therapeutics Pty Ltd 89 601 114 087

[14]  Schedule 4 entry for Arsenic

substitute:

Arsenic C4793 P4793 Acute promyelocytic leukaemia
Induction and consolidation treatment
The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript; AND
The condition must be relapsed; AND
Patient must be arsenic naive at induction.

 Compliance with Authority Required procedures - Streamlined Authority Code 4793
C5997 P5997 Acute promyelocytic leukaemia
The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript.

 Compliance with Authority Required procedures - Streamlined Authority Code 5997
C6018 P6018 Acute promyelocytic leukaemia
Induction and consolidation treatment
The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript. 		Compliance with Authority Required procedures - Streamlined Authority Code 6018

[15]  Schedule 4 after the entry for Mitozantrone

insert:

Netupitant with Palonosetron C5991 Nausea and vomiting
The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with dexamethasone; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following agents: altretamine; carmustine; cisplatin when a single dose constitutes a cycle of chemotherapy; cyclophosphamide at a dose of 1500 mg per square metre per day or greater; dacarbazine; procarbazine when a single dose constitutes a cycle of chemotherapy; streptozocin.
No more than 1 capsule of 300 mg netupitant/0.5 mg palonosetron fixed dose combination will be authorised per cycle of cytotoxic chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 5991
C5994 Nausea and vomiting
The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer; AND
The treatment must be in combination with dexamethasone; AND
Patient must be scheduled to be co-administered cyclophosphamide and an anthracycline.
No more than 1 capsule of 300 mg netupitant/0.5 mg palonosetron fixed dose combination will be authorised per cycle of cytotoxic chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 5994

[16]  Schedule 4 entry for Rituximab

omit:

Rituximab C4674 P4674 Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma. Treatment Phase: Maintenance therapy. Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application, and must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction. Treatment must be maintenance therapy. Compliance with Authority Required procedures - Streamlined Authority Code 4674
C4677 P4677 Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma. Treatment Phase: Re-induction treatment. Treatment must be for re-induction treatment purposes only, and the condition must have relapsed or be refractory to treatment. Patient must not receive more than 4 doses under this restriction. Compliance with Authority Required procedures - Streamlined Authority Code 4677
C4678 P4678 Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma. Treatment Phase: Re-induction treatment
The treatment must be for re-induction treatment purposes only, and the condition must have relapsed or be refractory to treatment. Patient must not receive more than 4 doses under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 4678
C4686 P4686 Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma. Treatment Phase: Maintenance therapy. Treatment must be maintenance therapy.  Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application, andmust not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction. Compliance with Authority Required procedures - Streamlined Authority Code 4686
C4701 P4701 Previously untreated CD20 positive diffuse large B-cell non-Hodgkin's lymphoma. Treatment Phase: Induction treatment. Treatment must be in combination with chemotherapy.The condition must be previously untreated, must be symptomatic, and must be for induction treatment purposes only. Patient must not receive more than 8 doses under this restriction. Compliance with Authority Required procedures - Streamlined Authority Code 4701
C4706 P4706 Chronic lymphocytic leukaemia (CLL). The condition must be CD20 positive chronic lymphocytic leukaemia (CLL), and treatment must be in combination with chemotherapy. Compliance with Authority Required procedures - Streamlined Authority Code 4706
C4726 P4726 Previously untreated Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma. Treatment Phase: Induction treatment. Treatment must be in combination with chemotherapy. The condition must be previously untreated, must be symptomatic, and must be for induction treatment purposes only. Patient must not receive more than 8 doses under this restriction. Compliance with Authority Required procedures - Streamlined Authority Code 4726

substitute:

Rituximab C4706 P4706 Chronic lymphocytic leukaemia (CLL)
The condition must be CD20 positive chronic lymphocytic leukaemia (CLL); AND
The treatment must be in combination with chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 4706
C5980 P5980 Previously untreated CD20 positive diffuse large B-cell non-Hodgkin's lymphoma
Induction treatment
The treatment must be in combination with chemotherapy; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than 8 doses of rituximab in total, including intravenous and subcutaneous injections, and no more than 7 doses of subcutaneous rituximab under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.

 Compliance with Authority Required procedures - Streamlined Authority Code 5980
C5998 P5998 Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma
Re-induction treatment
The treatment must be for re-induction treatment purposes only; AND
The condition must have relapsed or be refractory to treatment; AND
Patient must not receive more than 4 doses of rituximab in total, including intravenous and subcutaneous injections, and no more than 3 doses of subcutaneous rituximab under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 4 doses in total.

 Compliance with Authority Required procedures - Streamlined Authority Code 5998
C6001 P6001 Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
Maintenance therapy
Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND
The treatment must be maintenance therapy; AND
Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction.

 Compliance with Authority Required procedures - Streamlined Authority Code 6001
C6004 P6004 Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
Maintenance therapy
Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND
The treatment must be maintenance therapy; AND
Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction.

 Compliance with Authority Required procedures - Streamlined Authority Code 6004
C6008 P6008 Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
Maintenance therapy
The treatment must be maintenance therapy; AND
Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND
Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.

 Compliance with Authority Required procedures - Streamlined Authority Code 6008
C6009 P6009 Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
Maintenance therapy
The treatment must be maintenance therapy; AND
Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND
Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.

 Compliance with Authority Required procedures - Streamlined Authority Code 6009
C6034 P6034 Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
Maintenance therapy
The treatment must be maintenance therapy; AND
Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND
Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.

 Compliance with Authority Required procedures - Streamlined Authority Code 6034
C6039 P6039 Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma
Re-induction treatment
The treatment must be for re-induction treatment purposes only; AND
The condition must have relapsed or be refractory to treatment; AND
Patient must not receive more than 4 doses of rituximab in total, including intravenous and subcutaneous injections, and no more than 3 doses of subcutaneous rituximab under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 4 doses in total.

 Compliance with Authority Required procedures - Streamlined Authority Code 6039
C6040 P6040 Previously untreated Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
Induction treatment
The treatment must be in combination with chemotherapy; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than 8 doses of rituximab in total, including intravenous and subcutaneous injections, and no more than 7 doses of subcutaneous rituximab under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.

 Compliance with Authority Required procedures - Streamlined Authority Code 6040
C6058 P6058 Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
Maintenance therapy
Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND
The treatment must be maintenance therapy; AND
Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction.

 Compliance with Authority Required procedures - Streamlined Authority Code 6058

[17]  Schedule 4 entry for Trastuzumab

substitute:

Trastuzumab C4083 P4083 Locally advanced HER2 positive breast cancer
Continuing treatment (3 weekly regimen)
Patient must have previously received treatment with PBS-subsidised trastuzumab; 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.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment.
For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 6 mg per kg.
Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose.

 Compliance with Written or Telephone Authority Required procedures
C4093 P4093 Early HER2 positive breast cancer
Continuing treatment (3 weekly regimen)
Patient must have previously received treatment with PBS-subsidised trastuzumab; 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.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment.
For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 6 mg per kg.
Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose.

 Compliance with Written or Telephone Authority Required procedures
C4104 P4104 Locally advanced HER2 positive breast cancer
Continuing treatment (weekly regimen)
Patient must have previously received treatment with PBS-subsidised trastuzumab; 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.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment.
For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 2 mg per kg.
Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose.

 Compliance with Written or Telephone Authority Required procedures
C4142 P4142 Locally advanced HER2 positive breast cancer
Initial treatment (weekly regimen)
Patient must commence treatment concurrently with neoadjuvant chemotherapy; 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.
HER2 positivity must be demonstrated by in situ hybridisation (ISH).
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:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.
For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 4 mg per kg.

 Compliance with Written Authority Required procedures
C4143 P4143 Locally advanced HER2 positive breast cancer
Initial treatment (3 weekly regimen)
Patient must commence treatment concurrently with neoadjuvant chemotherapy; 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.
HER2 positivity must be demonstrated by in situ hybridisation (ISH).
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:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.
For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 8 mg per kg.

 Compliance with Written Authority Required procedures
C4144 P4144 Early HER2 positive breast cancer
Initial treatment (3 weekly regimen)
Patient must commence treatment concurrently with adjuvant chemotherapy; AND
Patient must have undergone 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
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.
HER2 positivity must be demonstrated by in situ hybridisation (ISH).
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:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.
For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 8 mg per kg.

 Compliance with Written Authority Required procedures
C4156 P4156 Early HER2 positive breast cancer
Continuing treatment (weekly regimen)
Patient must have previously received treatment with PBS-subsidised trastuzumab; 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.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment.
For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 2 mg per kg.
Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose.

 Compliance with Written or Telephone Authority Required procedures
C4164 P4164 Early HER2 positive breast cancer
Initial treatment (weekly regimen)
Patient must commence treatment concurrently with adjuvant chemotherapy; AND
Patient must have undergone 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
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.
HER2 positivity must be demonstrated by in situ hybridisation (ISH).
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:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.
For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 4 mg per kg.

 Compliance with Written Authority Required procedures
C5024 P5024 Metastatic (Stage IV) HER2 positive breast cancer
Continuing treatment
Patient must have previously been issued with an authority prescription for 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.
Where a patient has a break in trastuzumab therapy of more than 1 week from when the last dose was due, authority approval will be granted for a new loading dose.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.

 Compliance with Written or Telephone Authority Required procedures
C5032 P5032 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 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 a copy 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 patient has Stage IV disease.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.

 Compliance with Written Authority Required procedures
C5041 P5041 HER2 positive breast cancer
Grandfathering treatment
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition before 1 July 2015; 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.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.

 Compliance with Written or Telephone Authority Required procedures
C5825 P5825 Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction
Initial PBS-subsidised treatment (Grandfather patient)
Patient must have evidence of human epidermal growth factor receptor 2 (HER2) positivity; AND
Patient must have been treated with this drug for this condition prior to 1 January 2016; 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.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Metastatic (Stage IV) HER2 positive adenocarcinoma of stomach or gastro-oesophageal junction authority application form which includes confirmation that the patient has Stage IV disease and a copy of the pathology report from an Approved Pathology Authority confirming evidence of human epidermal growth factor receptor 2 (HER2) positivity.

 Compliance with Written Authority Required procedures
C5834 P5834 Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must not have progressive disease; 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.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.

 Compliance with Written or Telephone Authority Required procedures
C5844 P5844 Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction
Initial treatment
Patient must have evidence of human epidermal growth factor receptor 2 (HER2) positivity as demonstrated by immunohistochemistry 2+ or more in tumour material; AND
Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on more than 6 copies of HER2 in the same tumour tissue sample; AND
Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on the ratio of HER2 to chromosome 17 being more than 2 in the same tumour tissue sample; AND
Patient must commence treatment in combination with cisplatin and capecitabine; OR
Patient must commence treatment in combination with cisplatin and 5 fluorouracil; AND
Patient must not have previously received this drug for this condition; AND
Patient must not have received prior chemotherapy for this condition; AND
Patient must have a WHO performance status of 2 or less; 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 Metastatic (Stage IV) HER2 positive adenocarcinoma of stomach or gastro-oesophageal junction authority application form which includes confirmation that the patient has Stage IV disease and a copy of the pathology report from an Approved Pathology Authority confirming evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated in tumour material by both (i) immunohistochemistry (IHC) 2+ or IHC 3+ AND (ii) in situ hybridisation (ISH) results based on both more than 6 copies of HER2 AND the ratio of HER2: chromosome 17 being more than 2 in the same tumour tissue sample
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment

 Compliance with Written Authority Required procedures
C6059 P6059 Early HER2 positive breast cancer
Initial treatment (3 weekly regimen)
Patient must commence treatment concurrently with adjuvant chemotherapy; AND
Patient must have undergone 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
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.
HER2 positivity must be demonstrated by in situ hybridisation (ISH).
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:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.

 Compliance with Written Authority Required procedures
C6060 P6060 Locally advanced HER2 positive breast cancer
Initial treatment (3 weekly regimen)
Patient must commence treatment concurrently with neoadjuvant chemotherapy; 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.
HER2 positivity must be demonstrated by in situ hybridisation (ISH).
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:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.

 Compliance with Written Authority Required procedures
C6061 P6061 Early HER2 positive breast cancer
Continuing treatment (3 weekly regimen)
Patient must have previously received treatment with PBS-subsidised trastuzumab; 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.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment.
Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose.

 Compliance with Written or Telephone Authority Required procedures
C6062 P6062 Locally advanced HER2 positive breast cancer
Continuing treatment (3 weekly regimen)
Patient must have previously received treatment with PBS-subsidised trastuzumab; 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.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment.
Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose. 		Compliance with Written or Telephone Authority Required procedures
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