National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 12) (PB 122 of 2015) (Cth)

PB 122 of 2015

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 12)

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     22 December 2015           

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 2015 (No. 12).

(2)This Instrument may also be cited as PB 122 of 2015.

2             Commencement

This Instrument commences on 1 January 2016.

3              Amendments to PB 79 of 2011

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

Amendments

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

   omit:

Hospira Pty Limited HH MP    D

1. Schedule 1 Part 1 after entry for Pemetrexed in the form Powder for I.V. infusion 100 mg (as disodium heptahydrate) and brand Alimta:

   insert:

Pemetrexed MYX YN MP C4789 C4792 D

1. Schedule 1 Part 1 after entry for Pemetrexed in the form Powder for I.V. infusion 500 mg (as disodium heptahydrate) and brand Alimta:

   insert:

Pemetrexed MYX	YN	MP	C4789 C4792	D
Pemetrexed Sandoz	SZ	MP	C4789 C4792	D

1. Schedule 1 Part 1 entry for Trastuzumab in each of the forms Powder for I.V. infusion 150 mg and Powder for I.V. infusion 60 mg:

   insert in the column headed ‘Circumstances’ (in numerical order): C5825, C5834, C5844

2. Schedule 1 Part 2 entry for Trastuzumab:

   substitute:

Trastuzumab	P4104	250	9
P4156
P4142	500	0
P4164
P4083	750	3
P4093
P5024
P5825
P5834
P4143	1000	0
P4144
P5032
P5844
P5041	1000	3

1. Schedule 4 entry for Trastuzumab: 

   insert after C5041 (in numerical order):

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