PB 101 of 2011
National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 1)
 
National Health Act 1953
___________________________________________________________________________
 
I, FELICITY McNEILL, Acting First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.
Dated 13 December 2011
 
 
 
 
 
 
 
 
 
 
 
FELICITY McNEILL
Acting First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing
___________________________________________________________________
 
 
 
 
 
1              Name of Instrument
 
(1)                This Instrument is the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No.1).
 
(2)                This Instrument may also be cited as PB 101 of 2011.
 
2             Commencement
                This Instrument commences on 1 January 2012.
3              Amendments to PB 87 of 2011
                      Schedule 1 amends the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2011 (PB 87 of 2011).
 
 
Schedule 1                   Amendments
 
[1]    Schedule 1, after entry for Carboplatin in the form Solution for I.V. injection 450 mg in 45 mL with manner of administration Injection and brand Carboplatin Ebewe
insert:
 
 
 
Carboplatin Kabi
PK
EMP
 
 
2
0
D
 
[2]    Schedule 1, entry for Docetaxel in the form ‘Solution concentrate for I.V. infusion 140 mg in 7mL, in the column headed ‘Circumstances’
(a) omit:
C3893
(b) omit:
C3918
(c) insert in numerical order:
C3955
C3956
[3]    Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 160 mg in 16 mL, in the column headed ‘Circumstances’
(a) omit:
C3893
(b) omit:
C3918
(c) insert in numerical order:
C3955
C3956
[4]    Schedule 1, entry for Docetaxel in the form Powder for I.V. infusion 20 mg with solvent, in the column headed ‘Circumstances’
(a) omit:
C3893
 (b) substitute:
C3955
 
 
[5]    Schedule 1, entry for Docetaxel in the form Powder for I.V. infusion 80 mg with solvent, in the column headed ‘Circumstances’
(a) omit:
C3893
(b) substitute:
C3955
[6]    Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 1 mL with maximum quantity 1, in the column headed ‘Circumstances’
(a) omit (all instances):
C3893
(b) omit (all instances):
C3918
(c) insert after C3916 (all instances):
C3955
C3956
[7]    Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 1 mL with maximum quantity 2, in the column headed ‘Circumstances’
(a) omit (all instances):
C3893
(b) omit (all instances):
C3918
(c) insert after C3916 (all instances):
C3955
C3956
[8]    Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 1 mL with maximum quantity 2, in the column headed ‘Purposes’
(a) omit (all instances):
P3893
(b) omit (all instances):
P3918
 
(c) insert after P3916 (all instances):
P3955
P3956
[9]    Schedule 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, with maximum quantity 1, in the column headed ‘Circumstances’
(a) omit:
C3893
(b) omit:
C3918
(c) insert in numerical order:
C3955
C3956
[10]  Schedule 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, with maximum quantity 1, in the column headed ‘Circumstances’
(a) omit:
C3893
(b) insert in numerical order:
C3955
[11]  Schedule 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, with maximum quantity 1, in the column headed ‘Circumstances’
(a) omit:
C3893
(b) omit:
C3918
(c) insert in numerical order:
C3955
C3956
 
 
 
[12]  Schedule 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, with maximum quantity 2, in the column headed ‘Circumstances’
(a) omit:
C3893
(b) omit:
C3918
(c) insert in numerical order:
C3955
C3956
[13]  Schedule 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, with maximum quantity 2, in the column headed ‘Purposes’
(a) omit:
P3893
(b) omit:
P3918
(c) insert in numerical order:
P3955
P3956
[14]  Schedule 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, with maximum quantity 2, in the column headed ‘Circumstances’
(a) omit:
C3893
(b) insert in numerical order:
C3955
[15]  Schedule 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, with maximum quantity 2, in the column headed ‘Purposes’
(a) omit:
P3893
(b) insert in numerical order:
P3955
[16]  Schedule 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, with maximum quantity 2, in the column headed ‘Circumstances’
(a) omit:
C3893
(b) omit:
C3918
(c) insert in numerical order:
C3955
C3956
[17]  Schedule 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, with maximum quantity 2, in the column headed ‘Purposes’
(a) omit:
P3893
(b) omit:
P3918
(c) insert in numerical order:
P3955
P3956
[18]  Schedule 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 with maximum quantity 1, in the column headed ‘Circumstances’
(a) omit:
C3893
(b) omit:
C3918
(c) insert in numerical order:
C3955
C3956
 
 
 
[19]  Schedule 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 with maximum quantity 2, in the column headed ‘Circumstances’
(a) omit:
C3893
(b) omit:
C3918
(c) insert in numerical order:
C3955
C3956
[20]  Schedule 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 with maximum quantity 2, in the column headed ‘Purposes’
(a) omit:
P3893
(b) omit:
P3918
(c) insert in numerical order:
P3955
P3956
[21]  Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 4 mL, in the column headed ‘Circumstances’
(a) omit (all instances):
C3893
(b) omit (all instances):
C3918
(c) insert after C3916 (all instances):
C3955
C3956
[22]  Schedule 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’
(a) omit:
C3893
(b) omit:
C3918
(c) insert in numerical order:
C3955
C3956
[23]  Schedule 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’
(a) omit:
C3893
(b) insert in numerical order:
C3955
[24]  Schedule 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’
(a) omit:
C3893
(b) omit:
C3918
(c) insert in numerical order:
C3955
C3956
[25]  Schedule 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’
(a) omit:
C3893
(b) omit:
C3918
(c) insert in numerical order:
C3955
C3956
[26]  Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride) with manner of administration Injection and brand DBL Gemcitabine for Injection
omit:
Gemcitabine
Powder for I.V. infusion 200 mg (as hydrochloride)
Injection
DBL Gemcitabine for Injection
HH
EMP
C3889 C3890 C3906 C3913 C3914
 
4
2
D
 
substitute:
 

Gemcitabine
Solution for injection 200 mg (as hydrochloride) in 5.3 mL
Injection
DBL Gemcitabine Injection
HH
EMP
C3889 C3890 C3906 C3913 C3914
 
4
2
D

 
Powder for I.V. infusion 200 mg (as hydrochloride)
Injection
DBL Gemcitabine for Injection
HH
EMP
C3889 C3890 C3906 C3913 C3914
 
4
2
D

 
[27]  Schedule 1, after entry for Gemcitabine in the form Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL
insert:
 
 
Solution for injection 1 g (as hydrochloride) in 26.3 mL
Injection
DBL Gemcitabine Injection
HH
EMP
C3889 C3890 C3906 C3913 C3914
 
2
2
D
 
[28]  Schedule 1, after entry for Gemcitabine in the form Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL
insert:
 
 
Solution for injection 2 g (as hydrochloride) in 52.6 mL
Injection
DBL Gemcitabine Injection
HH
EMP
C3889 C3890 C3906 C3913 C3914
 
1
2
D
 
[29]  Schedule 1, after entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL with manner of administration Injection and brand Irinotecan Ebewe
insert:
 
 
 
Tecan
WQ
EMP
C3184
 
1
3
D
 
[30]  Schedule 1, entry for Paclitaxel, in the column headed ‘Circumstances’
(a) omit (all instances):
C3893
(b) omit (all instances):
C3918
(c) insert after C3917 (all instances):
C3955
C3956
[31]  Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 30 mg in 5 mL with manner of administration Injection and brand Paclitaxel Kabi
insert:
 
 
 
Paclitaxel Pfizer
PF
EMP
C3186 C3890 C3902 C3917 C3955 C3956
 
5
0
D
 
[32]  Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 100 mg in 16.7 mL with manner of administration Injection and brand Paclitaxel Kabi
insert:
 
 
 
Paclitaxel Pfizer
PF
EMP
C3186 C3890 C3902 C3917 C3955 C3956
 
2
0
D
 
[33]  Schedule 1, after entry for Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL with manner of administration Injection and brand Paclitaxel Kabi
insert:
 
 
 
Paclitaxel Pfizer
PF
EMP
C3186 C3890 C3902 C3917 C3955 C3956
 
1
0
D
 
[34]  Schedule 1, entry for Paclitaxel, nanoparticle albumin-bound in the column headed ‘Circumstances’
omit:
C3897
 
insert in numerical order:
C3955
C3956
[35]  Schedule 3, entry for Docetaxel
(a) omit:
 
C3893
P3893
Advanced breast cancer after failure of prior therapy
Compliance with Authority Required procedures – Streamlined Authority Code 3893
(b) omit:
 
C3918
P3918
Treatment of HER2 positive early breast cancer in combination with trastuzumab
Compliance with Authority Required procedures – Streamlined Authority Code 3918
(c) insert in numerical order:
 
C3955
P3955
Metastatic breast cancer
Compliance with Authority Required procedures – Streamlined Authority Code 3955

 
C3956
P3956
Treatment of HER2 positive breast cancer in combination with trastuzumab
Compliance with Authority Required procedures – Streamlined Authority Code 3956

 
[36]  Schedule 3, entry for Paclitaxel
(a) omit:
 
C3893
 
Advanced breast cancer after failure of prior therapy
Compliance with Authority Required procedures – Streamlined Authority Code 3893
(b) omit:
 
C3918
 
Treatment of HER2 positive early breast cancer in combination with trastuzumab
Compliance with Authority Required procedures – Streamlined Authority Code 3918
(c) insert in numerical order:
 
C3955
 
Metastatic breast cancer
Compliance with Authority Required procedures – Streamlined Authority Code 3955

 
C3956
 
Treatment of HER2 positive breast cancer in combination with trastuzumab
Compliance with Authority Required procedures – Streamlined Authority Code 3956

 
[37]  Schedule 3, entry for Paclitaxel, nanoparticle albumin-bound
omit:
Paclitaxel, nanoparticle albumin-bound
C3897
 
Metastatic breast cancer after failure of prior therapy
Compliance with Authority Required procedures - Streamlined Authority Code 3897
substitute:
Paclitaxel, nanoparticle albumin-bound
C3955
 
Metastatic breast cancer
Compliance with Authority Required procedures – Streamlined Authority Code 3955

 
C3956
 
Treatment of HER2 positive breast cancer in combination with trastuzumab
Compliance with Authority Required procedures – Streamlined Authority Code 3956

 
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.