National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 4) (No. PB 25 of 2013) (Cth)

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PB 25 of 2013

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 4)

National Health Act 1953

___________________________________________________________________________

I, Kim Bessell, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.

Dated   23 April 2013

Mr KIM BESSELL

Assistant Secretary

Pharmaceutical Access Branch

Principal Pharmacy Advisor

Pharmaceutical Benefits Division

Department of Health and Ageing

___________________________________________________________________

1              Name of Instrument

(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No.4).

(2)This Instrument may also be cited as PB 25 of 2013.

2             Commencement

This Instrument commences on 1 May 2013.

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 Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL with manner of administration Injection:

omit:

Docetaxel Ebewe HX MP

C3888 C3916
C4078
C4140
C4155
C4160

 D

  1. Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL with manner of administration Injection:

omit:

Docetaxel Ebewe HX MP

C3888  C3916
C4078
C4140
C4155
C4160

 D

  1. Schedule 1 Part 1, after the entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial with manner of administration Injection/intravesical and brand Doxorubicin Ebewe:

insert:

Doxorubicin SZ HX MP D

  1. Schedule 1 Part 1, after the entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial with manner of administration Injection/intravesical and brand Doxorubicin Ebewe:

insert:

Doxorubicin SZ HX MP

D

  1. Schedule 1 Part 1, entry for Gemcitabine in the form Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL with manner of administration Injection:

substitute:

Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL Injection

Gemcitabine AS

Gemcitabine Ebewe

YA

SZ

MP

MP

D

D

  1. Schedule 1 Part 1, entry for Gemcitabine in the form Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL with manner of administration Injection:

substitute:

Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL Injection

Gemcitabine AS

Gemcitabine Ebewe

YA

SZ

MP

MP

D

D

[7]  Schedule 2, after the entry for Aprepitant in the form Pack containing 1 capsule 125mg and 2 capsules 80mg with manner of administration Oral and brand Emend:

insert:

Aprepitant Capsule 165 mg Oral Emend MK EMP C4216
C4217
C4223 		1 5

[8]  Schedule 4, entry for Aprepitant:

insert after C3621:

Aprepitant C4216

Management of Nausea and vomiting associated with cytotoxic chemotherapy being used to treat breast cancer, in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone where the patient is scheduled to be co-administered cyclophosphamide and an anthracycline; treatment is limited to 1 capsule of aprepitant 165 mg per cycle of cytotoxic chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 4216
C4217

Management of Nausea and vomiting associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy, in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle, where the patient has had a prior episode of chemotherapy induced nausea or vomiting, where any 1 of the following intravenous chemotherapy agents is to be administered:
(a) arsenic trioxide;
(b) azacitidine;
(c) carboplatin;
(d) cyclophosphamide at a dose of less than 1500 mg per square metre per day;
(d) cytarabine at a dose of greater than 1 g per square metre per day;
(e) dactinomycin;
(f) daunorubicin;
(g) doxorubicin;
(h) epirubicin;
(i) fotemustine;
(j) idarubicin;
(k) ifosfamide;
 (l) irinotecan;
(m) melphalan;
(n) methotrexate at a dose of 250 mg to 1 g per square metre;
(o) oxaliplatin;
(p) raltitrexed; and
where treatment is limited to1 capsule of aprepitant 165 mg per cycle of cytotoxic chemotherapy, and where concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.

 Compliance with Authority Required procedures - Streamlined Authority Code 4217
C4223

Management of Nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy, in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone, where any 1 of the following agents are to be administered:

(a)  altretamine;

(b) carmustine;
(c) cisplatin when a single dose constitutes a cycle of chemotherapy;
(d) cyclophosphamide at a dose of 1500 mg per square metre per day or greater;
(e) dacarbazine;
(f) procarbazine when a single dose constitutes a cycle of chemotherapy;
(g) streptozocin; and
where treatment is limited to 1 capsule of aprepitant 165 mg per cycle of cytotoxic chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 4223

Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.

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