National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 4) (PB 31 of 2017) (Cth)

PB 31 of 2017

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 4)

National Health Act 1953

I, JULIANNE QUAINE, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health and Minister for Sport, make this Instrument under subsection 100(2) of the National Health Act 1953.

Dated            28      APRIL 2017

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 2017 (No. 4).

(2)  This Instrument may also be cited as PB 31 of 2017.

2  Commencement

(1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1.  Sections 1 to 4 and anything in this instrument not elsewhere covered by this table	1 May 2017.	1 May 2017
2.  Schedule 1	1 May 2017.	1 May 2017
3.  Schedule 2	1 April 2017.	1 April 2017

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3Amendment of PB 79 of 2011

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

4  Schedules

  The National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1— Amendments commencing on 1 May 2017

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

1. Schedule 1, Part 1 (after table item dealing with Bleomycin)

insert:

Blinatumomab Powder for I.V. infusion 38.5 micrograms Injection Blincyto AN MP C6892
C6893
C6894
C6895 D

1. Schedule 1, Part 1 (table item dealing with Fludarabine, in the form ‘Powder for I.V. injection containing fludarabine phosphate 50 mg’)

omit from the column headed ‘Circumstances’:   C6248

1. Schedule 1, Part 1 (table item dealing with Fludarabine, in the form ‘Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL’)

omit from the column headed ‘Circumstances’:   C6248

1. Schedule 1, Part 2 (after table item dealing with Bleomycin)

insert:

Blinatumomab		P6892	784	2
P6893	784	0
P6894	784	0
P6895	651	0

1. Schedule 2 (table item dealing with Bacillus Calmette and Guerin, Connaught strain)

omit:

Bacillus Calmette and Guerin, Connaught strain Powder for intravesical administration containing 6.6 to 19.2 x 10 ⁸ CFU Intravesical ImmuCyst SW EMP C5598 3 1

1. Schedule 2 (after table item dealing with Folinic acid)

insert:

Fosaprepitant Powder for I.V. infusion 150 mg Injection Emend IV MK EMP C6852 C6886 C6887 C6891 1 5

1. Schedule 2 (table item dealing with Granisetron, in the form ‘Concentrated injection 3 mg (as hydrochloride) in 3 mL’)

omit:

Granisetron APOTEX TX EMP C4139 1 0

1. Schedule 2 (table item dealing with Interferon Alfa-2a)

omit:

Injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe’

Injection

Roferon-A

RO

EMP

C6661 C6678

P6678

5

4

C

C6661

P6661

5

5

C6678

1. Schedule 2 (table item dealing with Netupitant with Palonosetron, in the form ‘Capsule containing netupitant 300 mg with palonosetron 500 microgram (as hydrochloride)’)

insert in the column headed ‘Circumstances’ (in numerical order):    C6879

10  Schedule 4 (table item dealing with Bacillus Calmette and Guerin, Connaught strain)

omit:

Bacillus Calmette and Guerin, Connaught strain C5598 Carcinoma in situ of the urinary bladder

11  Schedule 4 (after table item dealing with Bleomycin)

insert:

Blinatumomab	C6892	P6892	Acute lymphoblastic leukaemia (ALL) 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.	Compliance with Authority Required procedures
C6893	P6893	Acute lymphoblastic leukaemia (ALL) 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 less than 2; AND The condition must not be present in the central nervous system or testis; AND The condition must be Philadelphia chromosome negative; 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 bllinatumomab 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 Authority Required procedures
C6894	P6894	Acute lymphoblastic leukaemia (ALL) Grandfathering 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 less than 2; AND The condition must not be present in the central nervous system or testis; AND The condition must be Philadelphia chromosome negative; 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 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 2017. 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. 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 blinatumomab for ALL must not exceed 2 treatment cycles for induction therapy, and 3 treatment cycles for consolidation therapy in a lifetime. Patients who have received two treatment cycles as induction therapy with this drug for this condition prior to 1 May 2017 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 2017 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. A complete remission is defined as bone marrow blasts of less than or equal to 5%, no evidence of disease and a full recovery of peripheral blood counts with platelets of greater than 100,000 per microliter, and absolute neutrophil count (ANC) of greater than 1,000 per microliter. A complete remission with partial haematological recovery is defined as bone marrow blasts of less than or equal to 5%, no evidence of disease and a partial recovery of peripheral blood counts with platelets of greater than 50,000 per microliter, and absolute neutrophil count (ANC) of greater than 500 per microliter. Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy 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) a signed patient acknowledgement. (4) date of most recent blinatumomab dose, and if this was for induction or consolidation therapy. If for consolidation therapy, how many treatment cycle(s) of PBS-subsidised blinatumomab will be required for completion of consolidation therapy; and (5) date of latest chemotherapy prior to receiving non-PBS subsidised blinatumomab, and if it was the initial chemotherapy regimen or for salvage therapy; and (6) a copy of bone marrow biopsy report prior to receiving non-PBS subsidised blinatumomab.	Compliance with Written Authority Required procedures
C6895	P6895	Acute lymphoblastic leukaemia (ALL) Induction treatment The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of less than 2; AND The condition must not be present in the central nervous system or testis; AND The condition must be Philadelphia chromosome negative; AND Patient must have received intensive combination chemotherapy for initial treatment of ALL or for subsequent 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) a signed patient acknowledgement. (4) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy; and (5) 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

12  Schedule 4 (table item dealing with Fludarabine)

omit:

Fludarabine C6248 B‑cell chronic lymphocytic leukaemia
Patient must have advanced disease (Binet Stage B or C); OR
Patient must have evidence of progressive Stage A disease; AND
The treatment must be in combination with cyclophosphamide.
Stage A progressive disease is defined by at least one of the following: persistent rise in lymphocyte count with doubling time less than 12 months; a downward trend in haemoglobin or platelets, or both; more than 50% increase in the size of liver, spleen, or lymph nodes, or appearance of these signs if not previously present; constitutional symptoms attributable to disease.
The diagnosis of chronic lymphocytic leukaemia (CLL) must have been established based on:
(a) a lymphocytosis, with more than 5,000 million lymphocytes per L in the peripheral blood; and
(b) a clonal population of B‑cells (CD5/CD19) documented by flow cytometry. Compliance with Authority Required procedures ‑ Streamlined Authority Code 6248

13  Schedule 4 (after table item dealing with Folinic acid)

insert:

Fosaprepitant	C6852	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 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy. Concomitant use of a 5HT3 antagonist should not occur with fosaprepitant on days 2 and 3 of any chemotherapy cycle.	Compliance with Authority Required procedures - Streamlined Authority Code 6852
C6886	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 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy.	Compliance with Authority Required procedures - Streamlined Authority Code 6886
C6887	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 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy. Concomitant use of a 5HT3 antagonist should not occur with fosaprepitant on days 2 and 3 of any chemotherapy cycle.	Compliance with Authority Required procedures - Streamlined Authority Code 6887
C6891	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 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy.	Compliance with Authority Required procedures - Streamlined Authority Code 6891

14  Schedule 4 (table item dealing with Netupitant with Palonosetron)

substitute:

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
C6879	Nausea and vomiting The condition must must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND The treatment must be in combination with 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 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 6879

Schedule 2— Amendments commencing on 1 April 2017

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

1. Schedule 1, Part 1 (table item dealing with Epirubicin, in the form ‘Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL’, and after brand DBL Epirubicin Hydrochloride Injection)

insert:

Epirubicin Accord OC MP D

1. Schedule 1, Part 1 (table item dealing with Pembrolizumab)

substitute:

Pembrolizumab Powder for injection 50 mg Injection Keytruda MK MP C6801
C6806
C6817
C6828
C6829 D