National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 5) (PB 40 of 2017) (Cth)
PB 40 of 2017
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 5)
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 30 MAY 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. 5).
(2) This Instrument may also be cited as PB 40 of 2017.
2 Commencement
This Instrument commences on 1 June 2017.
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The National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 June 2017
National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)
Schedule 1, Part 1 (table item dealing with Brentuximab Vedotin)
substitute:
Brentuximab Vedotin
Powder for I.V. Infusion 50 mg
Injection
Adcetris
TK
MP
C4675
C4719
C6903
C6904
C6936
C6941
D
Schedule 1, Part 1 (table item dealing with Carboplatin, in the form ‘Solution for I.V. injection 450 mg in 45 mL’, manner of administration ‘Injection’)
insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
Carboplatin Accord
OC
MP
D
Schedule 1, Part 1 (table item dealing with Docetaxel, in the form ‘Solution concentrate for I.V. infusion 80 mg in 4 mL’, manner of administration ‘Injection’)
insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
Docetaxel Accord
OC
MP
D
Schedule 1, Part 1 (table item dealing with Epirubicin, in the form ‘Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL’, manner of administration ‘Injection/intravesical’)
insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
Epirube
TB
MP
D
Schedule 1, Part 1 (table item dealing with Epirubicin, in the form ‘Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL’, manner of administration ‘Injection/intravesical’)
insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
Epirube
TB
MP
D
Schedule 1, Part 1 (table item dealing with Oxaliplatin, in the form ‘Solution concentrate for I.V. infusion 100 mg in 20 mL’, manner of administration ‘Injection’)
insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
Oxaliplatin Accord
OC
MP
D
Schedule 1, Part 1 (table item dealing with Paclitaxel, in the form ‘Solution concentrate for I.V. infusion 100 mg in 16.7 mL’, manner of administration ‘Injection’)
insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
Paclitaxin
TB
MP
D
Schedule 1, Part 1 (table item dealing with Paclitaxel, in the form ‘Solution concentrate for I.V. infusion 150 mg in 25 mL’, manner of administration ‘Injection’)
insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
Paclitaxin
TB
MP
D
Schedule 1, Part 1 (table item dealing with Paclitaxel, in the form ‘Solution concentrate for I.V. infusion 30 mg in 5 mL’, manner of administration ‘Injection’)
insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
Paclitaxin
TB
MP
D
10 Schedule 1, Part 1 (table item dealing with Paclitaxel, in the form ‘Solution concentrate for I.V. infusion 300 mg in 50 mL’, manner of administration ‘Injection’)
insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
Paclitaxin
TB
MP
D
11 Schedule 1, Part 1 (table item dealing with Paclitaxel, in the form ‘Solution concentrate for I.V. infusion 300 mg in 50 mL’, manner of administration ‘Injection’)
insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
Paclitaxel Accord
OC
MP
D
12 Schedule 1, Part 2 (table item dealing with Brentuximab Vedotin)
substitute:
Brentuximab Vedotin P4675 200 11 P6904 P6941 P4719 200 3 P6903 P6936
13 Schedule 2 (table item dealing with Netupitant with Palonosetron)
substitute:
| Netupitant with Palonosetron | Capsule containing netupitant 300 mg with palonosetron 500 microgram (as hydrochloride) | Oral | Akynzeo | MF | EMP | C5991 C5994 C6879 C6937 | 1 | 5 |
14 Schedule 3, after details relevant to Responsible Person code LY
insert:
| MF | Mundipharma Pty Limited | 87 081 322 509 |
15 Schedule 4 (table item dealing with Brentuximab Vedotin)
substitute:
Brentuximab Vedotin
C4675
P4675
CD30 positive systemic anaplastic large cell lymphoma
Continuing treatment
Patient must not have progressive disease; AND
Patient must have previously been issued with an authority prescription for this drug.
The treatment must not exceed a lifetime total of 16 cycles.Compliance with Authority Required procedures
C4719
P4719
CD30 positive systemic anaplastic large cell lymphoma
Initial treatment
The treatment must be for curative intent; AND
Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND
Patient must demonstrate relapsed or chemotherapy-refractory disease.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Systemic anaplastic large cell lymphoma Brentuximab PBS Authority Application - Supporting Information Form which includes the following:
(i) a histology report including evidence of the tumour's CD30 positivity from a biopsy subsequent to the most recently delivered prior treatment with radiation, chemotherapy, biologics, immunotherapy or other agents;
(ii) The date of initial diagnosis of systemic anaplastic large cell lymphoma;
(iii) Dates of commencement and completion of front-line curative intent chemotherapy;
(iv) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory;
(v) a declaration of whether the patient has had, or is planned to have, a transplant
A maximum quantity and number of repeats to provide for an initial course of brentuximab vedotin of 4 cycles will be authorised as part of the initiating restriction.Compliance with Written Authority Required procedures
C6903 P6903 Relapsed or Refractory Hodgkin lymphoma
Initial treatment
Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND
Patient must not be suitable for ASCT for this condition; OR
Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND
Patient must have experienced a relapsed CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; OR
Patient must have experienced a refractory CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; AND
Patient must not receive more than 4 cycles of treatment under this restriction.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form;
(b) a completed Hodgkin lymphoma brentuximab PBS Authority Application; and
(c) a signed patient acknowledgement.Compliance with Written Authority Required procedures C6904
P6904
Relapsed or Refractory Hodgkin lymphoma
Continuing treatment
Patient must have undergone a primary autologous stem cell transplant (ASCT) for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 12 cycles of treatment under this restriction.
Authority applications for continuing treatment may be made by telephone to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday)
The treatment must not exceed a total of 16 cycles in a lifetimeCompliance with Authority Required procedures
C6936
P6936
Relapsed or Refractory Hodgkin lymphoma
Initial treatment
Patient must have undergone a primary autologous stem cell transplant (ASCT); AND
Patient must have experienced a relapsed CD30+ Hodgkin lymphoma post ASCT; OR
Patient must have experienced a refractory CD30+ Hodgkin lymphoma post ASCT; AND
Patient must not receive more than 4 cycles of treatment under this restriction.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form;
(b) a completed Hodgkin lymphoma brentuximab PBS Authority Application; and
(c) a signed patient acknowledgement.Compliance with Written Authority Required procedures
C6941
P6941
Relapsed or Refractory Hodgkin lymphoma
Continuing treatment
Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND
Patient must not be suitable for ASCT for this condition; OR
Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 12 cycles of treatment under this restriction.
Authority applications for continuing treatment may be made by telephone to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday)
The treatment must not exceed a total of 16 cycles in a lifetimeCompliance with Authority Required procedures
16 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
C6937 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 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 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 6937
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