National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 9) (PB 79 of 2019) (Cth)

Case

PB 79 of 2019

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 9)

National Health Act 1953

___________________________________________________________________________

I, BEN SLADIC, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under subsection 100(2) of the National Health Act 1953.

Dated                   30 September                 2019

BEN SLADIC

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

___________________________________________________________________________

  1. Name of Instrument

(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 9).

(2)This Instrument may also be cited as PB 79 of 2019.

  1. Commencement

This Instrument commences on 1 October 2019.

  1. Amendment of National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)

Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).

Schedule 1       Amendments

  1. Schedule 1, Part 1, entry for Atezolizumab

insert in numerical order in the column headed “Circumstances”: C9345 C9348 C9514 C9567

  1. Schedule 1, Part 1, entry for Bevacizumab in each of the forms: Solution for I.V. infusion 100 mg in 4 mL; and Solution for I.V. infusion 400 mg in 16 mL

insert in numerical order in the column headed “Circumstances”: C9346 C9347 C9454 C9566

  1. Schedule 1, Part 1, entry for Blinatumomab

omit from the column headed “Circumstances”: C8812 C8924 C8949 C8966         substitute: C9369 C9373 C9519 C9551

  1. Schedule 1, Part 1, entry for Inotuzumab ozogamicin

omit from the column headed “Circumstances”: C8768 C8857 C8858         substitute: C9470 C9600 C9601

  1. Schedule 1, Part 1, entry for Pertuzumab

omit from the column headed “Circumstances”: C4971 C5013 C5023         substitute: C9516 C9517 C9579

  1. Schedule 1, Part 1, entry for Rituximab

substitute:

Rituximab Solution for I.V. infusion 100 mg in 10 mL Injection Mabthera RO MP C7399 C7400 C9451 C9542 PB
Riximyo SZ MP C7399 C7400 C9451 C9542 PB
Solution for I.V. infusion 500 mg in 50 mL Injection Mabthera RO MP C7399 C7400 C9451 C9542 PB
Riximyo SZ MP C7399 C7400 C9451 C9542 PB

  1. Schedule 1, Part 1, entry for Trastuzumab in the form Powder for I.V. infusion 60 mg

(a)    omit from the column headed “Circumstances”: C4083 C4093 C4104 C4142 C4143 C4156 C5024 C5032 C5041 C5834 C5844 C7718 C7746

(b)    insert in numerical order in the column headed “Circumstances”: C9349 C9353 C9354 C9356 C9461 C9571 C9573 C9628

  1. Schedule 1, Part 1, entry for Trastuzumab in the form Powder for I.V. infusion 150 mg

(a)    omit from the column headed “Circumstances” (all instances): C4083 C4093 C4104 C4142 C4143 C4156 C5024 C5032 C5041 C5834 C5844 C7718 C7746

(b)    insert in numerical order in the column headed “Circumstances” (all instances): C9349 C9353 C9354 C9356 C9461 C9571 C9573 C9628

  1. Schedule 1, Part 1, entry for Trastuzumab emtansine in each of the forms: Powder for I.V. infusion 100 mg; and Powder for I.V. infusion 160 mg

omit from the column headed “Circumstances”: C4978 C4986 C6096 C6129        substitute: C9359 C9577 C9599

  1. Schedule 1, Part 2, entry for Atezolizumab [Maximum Amount: 1200; Number of Repeats: 5]

insert in numerical order in the column headed “Purposes”: P9348 P9514

  1. Schedule 1, Part 2, entry for Atezolizumab [Maximum Amount: 1200; Number of Repeats: 7]

insert in numerical order in the column headed “Purposes”: P9345 P9567

  1. Schedule 1, Part 2, entry for Bevacizumab [Maximum Amount: 1800; Number of Repeats: 5]

insert in numerical order in the column headed “Purposes”: P9346 P9347

  1. Schedule 1, Part 2, entry for Bevacizumab [Maximum Amount: 1800; Number of Repeats: 7]

insert in numerical order in the column headed “Purposes”: P9454 P9566

  1. Schedule 1, Part 2, entry for Blinatumomab

substitute:

Blinatumomab P9373 P9551 651 0
P9519 784 0
P9369 784 2

  1. Schedule 1, Part 2, entry for Inotuzumab ozogamicin

substitute:

Inotuzumab ozogamicin P9601 2820 4
P9600 3384 1
P9470 3384 2

  1. Schedule 1, Part 2, entry for Pertuzumab

substitute:

Pertuzumab P9579 420 3
P9516 840 0
P9517 840 1

  1. Schedule 1, Part 2, entry for Rituximab

substitute:

Rituximab P7399 800 5
P7400 P9542 800 7
P9451 800 11

  1. Schedule 1, Part 2, entry for Trastuzumab

substitute:

Trastuzumab P9628 250 9
P9356 500 0
P9349 P9461 P9571 750 3
P9353 P9354 P9573 1000 0

  1. Schedule 2

insert as first entry:

Aprepitant Capsule 165 mg Oral Aprepitant APOTEX TX MP C4216 C4223 C6383 C6464 1 5 C

  1. Schedule 2, entry for Ondansetron in each of the forms: I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL; and I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL

omit:

Onsetron ZP MP C5749 1 0 C

  1. Schedule 2, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)

omit:

Onsetron 4 ZP MP C5778 4 0 C

  1. Schedule 2, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate)

omit:

Onsetron 8 ZP MP C5778 4 0 C

  1. Schedule 2, entry for Trastuzumab [Maximum Quantity: 1; Number of Repeats: 0]

(a)    omit from the column headed “Circumstances”: C5024 C5032 C5041 C6060 C6061 C6062 C7717        substitute: C9351 C9353 C9462

(b)    omit from the column headed “Purposes”: P5032 P6060 P7717 substitute: P9353

  1. Schedule 2, entry for Trastuzumab [Maximum Quantity: 1; Number of Repeats: 3]

(a)    omit from the column headed “Circumstances”: C5024 C5032 C5041 C6060 C6061 C6062 C7717        substitute: C9351 C9353 C9462

(b)    omit from the column headed “Purposes”: P5024 P5041 P6061 P6062 substitute: P9351 P9462

  1. Schedule 3

omit:

ZP Medis Pharma Pty Ltd 67 109 225 747

  1. Schedule 4

insert as first entry:

Aprepitant

 C4216

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 a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND

Patient must be scheduled to be co-administered cyclophosphamide and an anthracycline.

No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 4216
C4223

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND

The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and 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 aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 4223
C6383

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND

The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND

Patient must be scheduled to be administered a chemotherapy regimen that includes either carboplatin or oxaliplatin.

No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.

Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.

 Compliance with Authority Required procedures - Streamlined Authority Code 6383
C6464

Nausea and vomiting

The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND

The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND

Patient must have had a prior episode of chemotherapy induced nausea or vomiting; AND

Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following intravenous chemotherapy agents: arsenic trioxide; azacitidine; cyclophosphamide at a dose of less than 1500 mg per square metre per day; cytarabine at a dose of greater than 1 g per square metre per day; dactinomycin; daunorubicin; doxorubicin; epirubicin; fotemustine; idarubicin; ifosfamide; irinotecan; melphalan; methotrexate at a dose of 250 mg to 1 g per square metre; raltitrexed.

No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.

Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.

 Compliance with Authority Required procedures - Streamlined Authority Code 6464

  1. Schedule 4, entry for Atezolizumab

insert in numerical order after existing text:

C9345 P9345

Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Grandfathering treatment

Patient must be undergoing combination treatment with bevacizumab and atezolizumab until disease progression, unless not tolerated.

The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND

Patient must have previously received treatment with these drugs for this condition prior to 1 October 2019; AND

Patient must have stable or responding disease; AND

Patient must have a WHO performance status of 0 or 1.

 Compliance with Authority Required procedures - Streamlined Authority Code 9345
C9348 P9348

Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Initial treatment 2

Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy.

The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND

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

Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material; AND

Patient must have progressive disease following treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) OR an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI); AND

Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 9348
C9514 P9514

Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Initial treatment 1

Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy.

The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND

Patient must not have previously been treated for this condition in the metastatic setting; AND

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

The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material.

 Compliance with Authority Required procedures - Streamlined Authority Code 9514
C9567 P9567

Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Continuing treatment

Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated.

Patient must have previously received PBS-subsidised treatment with this drug in this line of treatment; AND

Patient must have stable or responding disease.

 Compliance with Authority Required procedures - Streamlined Authority Code 9567

  1. Schedule 4, entry for Bevacizumab

insert in numerical order after existing text:

C9346 P9346

Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Initial treatment 1

Patient must be undergoing combination treatment with atezolizumab and platinum-doublet chemotherapy.

The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND

Patient must not have previously been treated for this condition in the metastatic setting; AND

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

The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material.

 Compliance with Authority Required procedures - Streamlined Authority Code 9346
C9347 P9347

Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Initial treatment 2

Patient must be undergoing combination treatment with atezolizumab and platinum-doublet chemotherapy.

The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND

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

Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material; AND

Patient must have progressive disease following treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) OR an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI); AND

Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 9347
C9454 P9454

Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Grandfathering treatment

Patient must be undergoing combination treatment with bevacizumab and atezolizumab until disease progression, unless not tolerated.

The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND

Patient must have previously received treatment with these drugs for this condition prior to 1 October 2019; AND

Patient must have stable or responding disease; AND

Patient must have a WHO performance status of 0 or 1.

 Compliance with Authority Required procedures - Streamlined Authority Code 9454
C9566 P9566

Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Continuing treatment

Patient must be undergoing combination treatment with atezolizumab until disease progression, unless not tolerated.

The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND

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

Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 9566

  1. Schedule 4, entry for Blinatumomab

substitute:

C9369 P9369

Acute lymphoblastic leukaemia

Consolidation treatment

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

Patient must have achieved a complete remission; OR

Patient must have achieved a complete remission with partial haematological recovery; AND

The treatment must not be more than 3 treatment cycles under this restriction in a lifetime; AND

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

 Compliance with Written Authority Required procedures
C9373 P9373

Acute lymphoblastic leukaemia

Grandfather treatment

Patient must have a documented history of relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND

Patient must have a documented history of receiving intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND

Patient must not have received more than 1 line of salvage therapy; AND

Patient must have a documented history of more than 5% blasts in bone marrow; AND

Patient must have received treatment with this drug for this condition prior to 1 October 2019; AND

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

An amount of 651 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 1. An amount of 784 microgram, which may be obtained under Induction treatment - balance of supply restriction, will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.

Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.

A patient may qualify for PBS-subsidised treatment under this restriction once only.

Treatment with this drug for this condition must not exceed 5 treatment cycles in a lifetime.

Patients who have received up to 2 treatment cycles as induction therapy with this drug for this condition prior to 1 October 2019 must have achieved a complete remission or a complete remission with partial haematological recovery in order to continue with PBS-subsidised treatment with this drug.

Patients who have received at least 1 treatment cycle as consolidation therapy with this drug for this condition prior to 1 October 2019 must have achieved a complete remission or a complete remission with partial haematological recovery in order to continue with PBS-subsidised treatment with this drug.

Patients who fail to demonstrate a complete remission (CR) or complete remission with incomplete haematological recovery (CRi) after 2 cycles of PBS-subsidised treatment with this agent must cease PBS-subsidised treatment with this agent.

The authority application must be made in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and

(3) date of the most recent blinatumomab dose, if this was for induction or consolidation therapy, and how many treatment cycle(s) of PBS-subsidised blinatumomab will be required for completion of induction or consolidation therapy; and

(4) date of most recent chemotherapy prior to receiving non-PBS subsidised blinatumomab, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and

(5) a copy of the most recent bone marrow biopsy report prior to receiving non-PBS subsidised blinatumomab.

 Compliance with Written Authority Required procedures
C9519 P9519

Acute lymphoblastic leukaemia

Induction treatment - balance of supply

The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND

The condition must not be present in the central nervous system or testis; AND

Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND

Patient must have received insufficient therapy with this agent for this condition under the Induction treatment restriction to complete a maximum of 2 treatment cycles in a lifetime.

According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.

An amount of 784 mcg will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.

Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.

 Compliance with Written Authority Required procedures
C9551 P9551

Acute lymphoblastic leukaemia

Induction treatment

The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND

The condition must not be present in the central nervous system or testis; AND

Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND

Patient must have received intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND

Patient must not have received more than 1 line of salvage therapy; AND

The condition must have more than 5% blasts in bone marrow; AND

The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.

According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.

An amount of 651 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 1. An amount of 784 microgram, which may be obtained under Induction treatment - balance of supply restriction, will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.

Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.

The authority application must be made in writing and must include:

(1) a completed authority prescription form;

(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and

(3) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and

(4) a copy of the most recent bone marrow biopsy report of no more than one month old at the time of application.

 Compliance with Written Authority Required procedures

  1. Schedule 4, entry for Inotuzumab ozogamicin

substitute:

C9470 P9470

Acute lymphoblastic leukaemia

Induction treatment

The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND

Patient must have received intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND

Patient must not have received more than 1 line of salvage therapy; AND

Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND

The condition must be CD22-positive; AND

The condition must have more than 5% blasts in bone marrow; AND

The treatment must not be more than 3 treatment cycles under this restriction in a lifetime.

This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.

The authority application must be made in writing and must include:

(1) two completed authority prescription forms;

(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and

(3) evidence that the condition is CD22-positive; and

(4) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and

(5) a copy of the most recent bone marrow biopsy report of no more than one month old at the time of application.

The treatment must not exceed 0.8mg per m2for the first dose of a treatment cycle (Day 1), and 0.5mg per m2for subsequent doses (Days 8 and 15) within a treatment cycle.

Treatment with this drug for this condition must not exceed 6 treatment cycles in a lifetime.

 Compliance with Written Authority Required procedures
C9600 P9600

Acute lymphoblastic leukaemia

Grandfather treatment

Patient must have a documented history of relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND

Patient must have a documented history of receiving intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND

Patient must not have received more than 2 lines of salvage therapy; AND

The condition must be Philadelphia chromosome negative; AND

The condition must be CD22-positive; AND

Patient must have a documented history of more than 5% blasts in bone marrow; AND

Patient must have received treatment with this drug for this condition prior to 1 May 2019; AND

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

This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.

A patient may qualify for PBS-subsidised treatment under this restriction once only.

Treatment with this drug for this condition must not exceed 6 treatment cycles in a lifetime.

Patients who have received up to three treatment cycles as induction therapy with this drug for this condition prior to 1 May 2019 must have achieved a complete remission or a complete remission with partial haematological recovery in order to continue with PBS-subsidised treatment with this drug.

Patients who have received at least one treatment cycle as consolidation therapy with this drug for this condition prior to 1 May 2019 must have achieved a complete remission or a complete remission with partial haematological recovery in order to continue with PBS-subsidised treatment with this drug.

Patients who fail to demonstrate a complete remission (CR) or complete remission with incomplete haematological recovery (CRi) after 3 cycles of PBS-subsidised treatment with this agent must cease PBS-subsidised treatment with this agent.

The authority application must be made in writing and must include:

(1) a completed authority prescription form;

(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and

(3) evidence that the condition is CD22-positive; and

(4) date of most recent inotuzumab ozogamicin dose, if this was for induction or consolidation therapy, and how many treatment cycle(s) of PBS-subsidised inotuzumab ozogamicin will be required for completion of induction or consolidation therapy; and

(5) date of latest chemotherapy prior to receiving non-PBS subsidised inotuzumab ozogamicin, and if it was the initial chemotherapy regimen or for salvage therapy and what line of salvage; and

(6) a copy of bone marrow biopsy report prior to receiving non-PBS subsidised inotuzumab ozogamicin.

 Compliance with Written Authority Required procedures
C9601 P9601

Acute lymphoblastic leukaemia

Consolidation treatment

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

Patient must have achieved a complete remission; OR

Patient must have achieved a complete remission with partial haematological recovery; AND

The treatment must not be more than 5 treatment cycles under this restriction in a lifetime; AND

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

This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.

The treatment must not exceed 0.5mg per m2for all doses within a treatment cycle

Treatment with this drug for this condition must not exceed 6 treatment cycles in a lifetime.

 Compliance with Written Authority Required procedures

  1. Schedule 4, entry for Pertuzumab

substitute:

C9516 P9516

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 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 person has Stage IV disease.

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
C9517 P9517

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; OR

Patient must have received non-PBS-subsidised trastuzumab for this condition before 1 July 2015; AND

Patient must not have received non-PBS-subsidised treatment with trastuzumab for this condition before 1 July 2014; AND

Patient must not have received prior therapy with trastuzumab emtansine or lapatinib for this condition; AND

The treatment must be in combination with 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.

Authority applications for treatment must be made in writing and must include a completed authority prescription form.

Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA) during treatment.

 Compliance with Written Authority Required procedures
C9579 P9579

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

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

The treatment must be in combination with 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.

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. However, short treatment breaks are permitted. A patient who has a treatment break of less than 6 weeks in PBS-subsidised treatment with this drug for reasons other than disease progression is eligible to continue to receive PBS-subsidised treatment with this drug. A patient who has a treatment break of more than 6 weeks in PBS-subsidised treatment with this drug is not eligible to receive PBS-subsidised treatment with this drug.

Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment.

 Compliance with Authority Required procedures

  1. Schedule 4, entry for Rituximab

insert in numerical order after existing text:

C9451 P9451

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 induction treatment with either R-CHOP or R-CVP regimens for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current treatment with this drug for this condition; AND

Patient must not have received bendamustine induction therapy; 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 9451
C9542 P9542

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 treatment with this drug for this condition; 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 9542

  1. Schedule 4, entry for Trastuzumab

substitute:

C9349 P9349

Metastatic (Stage IV) HER2 positive breast cancer

Continuing treatment

Patient must have previously received PBS-subsidised treatment 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.

Where a patient has a break in trastuzumab therapy of more than 1 week from when the last dose was due, a new loading dose may be required.

 Compliance with Authority Required procedures - Streamlined Authority Code 9349
C9351 P9351

Early HER2 positive breast cancer

3 weekly treatment 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.

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

 Compliance with Authority Required procedures - Streamlined Authority Code 9351
C9353 P9353

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.

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

 Compliance with Authority Required procedures - Streamlined Authority Code 9353
C9354 P9354

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.

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.

 Compliance with Authority Required procedures - Streamlined Authority Code 9354
C9356 P9356

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.

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.

 Compliance with Authority Required procedures - Streamlined Authority Code 9356
C9461 P9461

Early HER2 positive breast cancer

Continuing treatment (3 weekly regimen)

Patient must have previously received PBS-subsidised treatment 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

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

 Compliance with Authority Required procedures - Streamlined Authority Code 9461
C9462 P9462

Metastatic (Stage IV) HER2 positive breast cancer

Continuing treatment

Patient must have previously received PBS-subsidised treatment 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.

 Compliance with Authority Required procedures - Streamlined Authority Code 9462
C9571 P9571

Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction

Continuing treatment

Patient must have previously received PBS-subsidised treatment with 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.

 Compliance with Authority Required procedures - Streamlined Authority Code 9571
C9573 P9573

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 platinum based chemotherapy and capecitabine; OR

Patient must commence treatment in combination with platinum based chemotherapy 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.

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

 Compliance with Authority Required procedures - Streamlined Authority Code 9573
C9628 P9628

Early HER2 positive breast cancer

Continuing treatment (weekly regimen)

Patient must have previously received PBS-subsidised treatment 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

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

 Compliance with Authority Required procedures - Streamlined Authority Code 9628

  1. Schedule 4, entry for Trastuzumab emtansine

substitute:

C9359

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

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.

 Compliance with Authority Required procedures
C9577

Metastatic (Stage IV) 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; OR

Patient must have received non-PBS-subsidised trastuzumab for this condition before 1 July 2015; OR

Patient must have received PBS-subsidised lapatinib for this condition before 1 July 2015; 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.

Authority applications for treatment must be made in writing and must include a completed authority prescription form.

Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA) during treatment.

 Compliance with Written Authority Required procedures
C9599

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) 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 person has Stage IV disease;

(ii) dates of treatment with trastuzumab and pertuzumab; and

(iii) date of demonstration of progression whilst on 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
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