National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 1) (No. PB 101 of 2011) (Cth)
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
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 |
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
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
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
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
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
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
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
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.
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