PB 48 of 2012
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2012 (No. 6)
 
National Health Act 1953
___________________________________________________________________________
 
I, FELICITY McNEILL, First Assistant Secretary, 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  24 July 2012
 
 
 
 
 
 
 
 
 
 
 
FELICITY McNEILL
First Assistant Secretary
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 2012 (No. 6).
 
(2)                This Instrument may also be cited as PB 48 of 2012.
 
2             Commencement
                This Instrument commences on 1 August 2012.
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]    Section 3, after definition for infusion prescription
insert:
National Health Reform Agreement has the meaning given in the Federal Financial Relations Act 2009.
[2]    Section 3, definition of participating hospital authority
substitute:
participating hospital authority means an approved hospital authority for a public hospital that is participating in a Pharmaceutical Reform Arrangement within the meaning of the National Health Reform Agreement.
[3]    Schedule 1 Part 1, after entry for Bortezomib
insert in the columns in the order indicated:
 
        Cabazitaxel
Concentrated injection 60mg (as acetone solvate) in 1.5 mL, with diluent
Injection
Jevtana
SW
MP
C7000
C7001
D
 
[4]    Schedule 1 Part 1, entry for Docetaxel in the form Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL with solvent, in the column headed ‘Circumstances’
omit:
C3884
 insert after C3956:
C7002
[5]    Schedule 1 Part 1, entry for Docetaxel in the form Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent, in the column headed ‘Circumstances’
omit:
C3884
 insert after C3956:
C7002
[6]    Schedule 1 Part 1, entry for Docetaxel in the form Powder for I.V. infusion 20 mg with solvent, in the column headed ‘Circumstances’
omit:
C3884
 insert after C3955:
C7002
[7]    Schedule 1 Part 1, entry for Docetaxel in the form Powder for I.V. infusion 80 mg with solvent, in the column headed ‘Circumstances’
omit:
C3884
insert after C3955:
C7002
[8]    Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 140 mg in 7 mL, in the column headed ‘Circumstances’
omit:
C3884
insert after C3956:
C7002
[9]    Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 160 mg in 16 mL, in the column headed ‘Circumstances’
omit:
C3884
insert after C3956:
C7002
[10]  Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 1 mL with manner of administration Injection and brand Oncotaxel 20, in the column headed ‘Circumstances’
omit:
C3884
insert after C3956:
C7002
[11]  Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 1 mL with manner of administration Injection and brand Taxotere, in the column headed ‘Circumstances’
omit:
C3884
insert after C3956:
C7002
[12]  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 and brand DBL Docetaxel Concentrated Injection, in the column headed ‘Circumstances’
omit:
C3884
insert after C3956:
C7002
[13]  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 and brand Docetaxel Ebewe, in the column headed ‘Circumstances’
omit:
C3884
insert after C3955:
C7002
[14]  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 and brand Docetaxel Sandoz, in the column headed ‘Circumstances’
omit:
C3884
insert after C3956:
C7002
[15]  Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 4 mL with manner of administration Injection and brand Oncotaxel 80, in the column headed ‘Circumstances’
omit:
C3884
insert after C3956:
C7002
[16]  Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 4 mL with manner of administration Injection and brand Taxotere, in the column headed ‘Circumstances’
omit:
C3884
insert after C3956:
C7002
[17]  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 and brand DBL Docetaxel Concentrated Injection, in the column headed ‘Circumstances’
omit:
C3884
insert after C3956:
C7002
[18]  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 and brand Docetaxel Ebewe, in the column headed ‘Circumstances’
omit:
C3884
insert after C3955:
C7002
[19]  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 and brand Docetaxel Sandoz, in the column headed ‘Circumstances’
omit:
C3884
insert after C3956:
C7002
[20]  Schedule 1 Part 1, after entry for Topotecan in the form Powder for I.V. infusion 4 mg (as hydrochloride) with manner of administration Injection and brand Hycamtin
insert in the columns in the order indicated:
 
 
 
Topotecan Kabi
PK
MP
C3186
D

 
 
 
 
 
 
 
 
 

[21]  Schedule 1 Part 2, after entry for Bortezomib
insert in the columns in the order indicated:
 
        Cabazitaxel
 
55
5
 
 
 
 
 
 
 
 
 


 
 
 
 
 
[22]  Schedule 4, after entry for Bortezomib
insert in the columns in the order indicated:
 
Cabazitaxel
C7000
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital, treatment, in combination with prednisone or prednisolone, of castration resistant metastatic carcinoma of the prostate in a patient who has failed treatment with docetaxel due to resistance or intolerance and has a WHO performance status of 2 or less.
Compliance with Authority Required procedures

 
C7001
 
Where the patient is receiving treatment at/from a Public Hospital, treatment, in combination with prednisone or prednisolone, of castration resistant metastatic carcinoma of the prostate in a patient who has failed treatment with docetaxel due to resistance or intolerance and has a WHO performance status of 2 or less.
Compliance with Authority Required procedures - Streamlined Authority Code 7001

 
[23]  Schedule 4, entry for Docetaxel
omit:
 
C3884
P3884
Treatment of androgen independent (hormone refractory) metastatic carcinoma of the prostate in a patient with a Karnofsky performance-status score of at least 60%, where docetaxel is used as first-line chemotherapy and administered in three weekly cycles
Compliance with Authority Required procedures – Streamlined Authority Code 3884
insert after C3956:
 
C7002
P7002
Treatment of androgen independent (castration resistant) metastatic carcinoma of the prostate in a patient with a Karnofsky performance-status score of at least 60%, where docetaxel is used as first-line chemotherapy and administered in three weekly cycles
Compliance with Authority Required procedures – Streamlined Authority Code 7002
 
 
Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. 
See http://www.frli.gov.au.