National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2011 (No. 1) (No. PB 100 of 2011) (Cth)

Case

PB 100 of 2011

National Health (Efficient Funding of Chemotherapy) 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 (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2011 (No. 1).

(2)This Instrument may also be cited as PB 100 of 2011.

2             Commencement

This Instrument commences on 1 January 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. Schedule 1 Part 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 MP D
  1. 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’

(a) omit:

C3893

(b) omit:

C3918

(c) insert in numerical order:

C3955

C3956

  1. 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’

(a) omit:

C3893

(b) omit:

C3918

(c) insert in numerical order:

C3955

C3956

  1. Schedule 1 Part 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

  1. Schedule 1 Part 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

  1. Schedule 1 Part 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

  1. 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’

(a) omit:

C3893

(b) omit:

C3918

(c) insert in numerical order:

C3955

C3956

  1. Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 1 mL, in the column headed ‘Circumstances’

(a) omit (all instances):

C3893

(b) omit (all instances):

C3918

(c) insert after C3916 (all instances):

C3955

C3956

  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 and brand DBL Docetaxel Concentrated Injection, in the column headed ‘Circumstances’

(a) omit:

C3893

(b) omit:

C3918

(c) insert in numerical order:

C3955

C3956

[10]  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’

(a) omit:

C3893

(b) insert in numerical order:

C3955

[11]  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’

(a) omit:

C3893

(b) omit:

C3918

(c) insert in numerical order:

C3955

C3956

[12]  Schedule 1 Part 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

[13]  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’

(a) omit:

C3893

(b) omit:

C3918

(c) insert in numerical order:

C3955

C3956

[14]  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’

(a) omit:

C3893

(b) insert in numerical order:

C3955

[15]  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’

(a) omit:

C3893

(b) omit:

C3918

(c) insert in numerical order:

C3955

C3956

[16]  Schedule 1 Part 1, after entry for Gemcitabine in the form Solution concentrate for I.V. infusion 500 mg (as hydrochloride) in 50 mL

insert in the columns in the order indicated:

Solution for injection 1 g (as hydrochloride) in 26.3 mL Injection DBL Gemcitabine Injection HH MP C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914 D
Solution for injection 2 g (as hydrochloride) in 52.6 mL Injection DBL Gemcitabine Injection HH MP C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914 D
Solution for injection 200 mg (as hydrochloride) in 5.3 mL Injection DBL Gemcitabine Injection HH MP C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914 D

[17]  Schedule 1 Part 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 MP C3184 D

[18]  Schedule 1 Part 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

[19]  Schedule 1 Part 1, after 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 MP C3186 C3890  C3902 C3917
C3955
C3956
D

[20]  Schedule 1 Part 1, after 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 MP C3186 C3890  C3902 C3917
C3955
C3956
D

[21]  Schedule 1 Part 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 MP C3186 C3890  C3902 C3917
C3955
C3956
D

[22]  Schedule 1 Part 1, entry for Paclitaxel, nanoparticle albumin-bound in the column headed ‘Circumstances’

omit:

C3897

insert:

C3955

C3956

[23]  Schedule 4, 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

[24]  Schedule 4, 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

[25]  Schedule 4, 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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