National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 11) (PB 112 of 2015) (Cth)

PB 112 of 2015

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 11)

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   26 November 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. 11).

(2)This Instrument may also be cited as PB 112 of 2015.

2             Commencement

This Instrument commences on 1 December 2015.

3              Amendments to 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 Epirubicin:

   omit:

Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL Injection/ intravesical Epirubicin Actavis 10 UA MP D

1. Schedule 1 Part 1 entry for Epirubicin:

   omit:

Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL Injection/ intravesical Epirubicin Actavis 20 UA MP D

1. Schedule 1 Part 1, after entry for Paclitaxel in each of the forms: Solution concentrate for I.V infusion 100 mg in 16.7 mL; Solution concentrate for I.V infusion 150 mg in 25 mL; Solution concentrate for I.V infusion 30 mg in 5 mL and Solution concentrate for I.V infusion 300 mg in 50 mL and brand Anzatax:

   insert:

Paclitaxel ACT EF MP D

1. Schedule 2, after entry for Granisetron in the form Concentrated injection 3 mg (as hydrochloride) in 3 mL and brand Granisetron-AFT:

   insert:

Granisetron APOTEX TX EMP C4139 1 0

1. Schedule 2, entry for Ondansetron in each of the forms: Tablet 4 mg (as hydrochloride dihydrate); Tablet 8 mg (as hydrochloride dihydrate); and Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL:

   omit from the column headed ‘Circumstances’ (all instances): C3050

   insert in the column headed ‘Circumstances’ (all instances): C5778

2. Schedule 2, entry for Ondansetron in each of the forms: Tablet (orally disintegrating) 4 mg; Tablet (orally disintegrating) 8 mg; Wafer 4 mg; and Wafer 8 mg:

   omit from the column headed ‘Circumstances’ (all instances): C3050

   insert in the column headed ‘Circumstances’ (all instances): C5743

3. 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 from the column headed ‘Circumstances’ (all instances): C3050

   insert in the column headed ‘Circumstances’ (all instances): C5749

4. Schedule 2, entry for Palonosetron in the form Injection 250 micrograms (as hydrochloride) in 5 mL

   omit from the column headed ‘Circumstances’: C3545

   insert in the column headed ‘Circumstances’ : C5805

5. Schedule 2, entry for Tropisetron in the form I.V. injection 5 mg (as hydrochloride) in 5 mL

   omit from the column headed ‘Circumstances’: C3050

   insert in the column headed ‘Circumstances’:  C5749

[10] Schedule 3, entry for Amneal Pharmaceuticals Pty Ltd, Responsible Person code, EA:

omit from the column headed ‘ABN’: 21 147 854 484

insert in the column headed “ABN”: 11 163 167 851

[11]Schedule 3, after the entry for Amneal Pharmaceuticals Pty Ltd, Responsible Person code, ED:

insert:

EF Amneal Pharmaceuticals Pty Ltd 11 163 167 851

[12]Schedule 4, entry for Ondansetron:

substitute:

Ondansetron	C5743	Nausea and vomiting The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration. Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.
	C5749	Nausea and vomiting The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration. Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.
	C5778	Nausea and vomiting The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration. Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.

[13]Schedule 4, entry for Palonosetron:

substitute:

Palonosetron C5805 Nausea and vomiting
The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.

[14]Schedule 4, entry for Tropisetron:

substitute:

Tropisetron C5749 Nausea and vomiting
The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.
Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle