National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 6) (PB 55 of 2018) (Cth)
PB 55 of 2018
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 6)
National Health Act 1953
___________________________________________________________________________
I, JULIANNE QUAINE, Assistant Secretary, Private Health Insurance and 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 27 June 2018
JULIANNE QUAINE
Assistant Secretary
Private Health Insurance and Pharmacy Branch
Technology Assessment and Access Division
Department of Health
___________________________________________________________________________
Name of Instrument
(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 6).
(2)This Instrument may also be cited as PB 55 of 2018.
Commencement
This Instrument commences on 1 July 2018.
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
Part 1, Section 3, Definition for diluent fee
omit: $5.21 substitute: $5.28
Part 1, Section 3, Definition for dispensing fee
omit: $7.15 substitute: $7.29
Part 1, Section 3, Definition for distribution fee
omit: $26.28 substitute: $26.65
Part 1, Section 3, Definition for preparation fee
omit: $83.83 substitute:$84.44
Schedule 1, Part 1, entry for Trastuzumab in each of the forms: Powder for I.V. infusion 60 mg and Powder for I.V. infusion 150 mg
(a)omit from the column headed “Circumstances”: C4144
(b)omit from the column headed “Circumstances”: C4164
(c)omit from the column headed “Circumstances”: C5825
(d)insert in numerical order in the column headed “Circumstances” C7718 C7746
Schedule 1, Part 2, entry for Trastuzumab [Maximum Amount: 500; Number of Repeats: 0]
omit from the column headed “Purposes”: P4164 substitute: P7746
Schedule 1, Part 2, entry for Trastuzumab [Maximum Amount: 750; Number of Repeats: 3]
omit from the column headed “Purposes”: P5825
Schedule 1, Part 2, entry for Trastuzumab [Maximum Amount: 1000; Number of Repeats: 0]
(a)omit from the column headed “Purposes”: P4144
(b)insert in numerical order in the column headed “Purposes”: P7718
Schedule 2, omit entry for Bacillus Calmette and Guerin, Tice strain
Schedule 2, after entry for Mesna in the form Solution for I.V. injection 1 g in 10 mL ampoule
insert:
Mycobacterium bovis (Bacillus Calmette and Guerin), Tice strain Vial containing powder for intravesical administration approximately 5 x 108 CFU Intravesical OncoTICE MK MP C5597 3 1 C
Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
Ondansetron Mylan ODT AF MP C5743 4 0 C
Schedule 2, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
Ondansetron Mylan Tablets AF MP C5778 4 0 C
Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
Ondansetron Mylan ODT AF MP C5743 4 0 C
Schedule 2, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate)
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
Ondansetron Mylan Tablets AF MP C5778 4 0 C
Schedule 2, entry for Trastuzumab [Maximum Quantity: 1; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C6059
(b)insert in numerical order in the column headed “Circumstances”: C7717
(c)omit from the column headed “Purposes”: P6059
(d)insert in numerical order in the column headed “Purposes”: P7717
Schedule 2, entry for Trastuzumab [Maximum Quantity: 1; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C6059
(b)insert in numerical order in the column headed “Circumstances”: C7717
Schedule 4, omit entry for Bacillus Calmette and Guerin, Tice strain
Schedule 4, after entry for Methotrexate
insert:
Mycobacterium bovis (Bacillus Calmette and Guerin), Tice strain C5597 Primary and relapsing superficial urothelial carcinoma of the bladder
Schedule 4, entry for Trastuzumab
(a)omit:
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
(b)omit:
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
(c)omit:
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
(d)omit:
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
(e)insert in numerical order after existing text:
C7717 P7717 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).
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 Authority Required procedures C7718 P7718 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).
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 Authority Required procedures C7746 P7746 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).
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 Authority Required procedures
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