National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 10) (No. PB 86 of 2014) (Cth)
PB 86 of 2014
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 10)
National Health Act 1953
___________________________________________________________________________
I, Kim Bessell, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.
Dated TWENTY FOURTH October 2014
KIM BESSELL
Assistant Secretary
Pharmaceutical Access Branch
Principal Pharmacy Advisor
Pharmaceutical Benefits Division
Department of Health
___________________________________________________________________
1 Name of Instrument
(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No.10).
(2)This Instrument may also be cited as PB 86 of 2014.
2 Commencement
This Instrument commences on 1 November 2014.
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
Schedule 1 Part 1, entry for ‘Cabazitaxel’ in the form ‘Concentrated injection 60 mg (as acetone solvate) in 1.5 mL, with diluent’ with the manner of administration Injection:
omit from the column headed ‘Circumstances’ (all instances):
C4237 C4262
substitute:
C4661 C4662
Schedule 1 Part 1 entry for ‘Carboplatin’ in the form ‘Solution for I.V. injection 450 mg in 45 mL’ with manner of administration Injection:
omit :
Pfizer Australia Pty Ltd PF MP D
Schedule 1 Part 1, entry for ‘Docetaxel’ in the forms ‘Powder for I.V. infusion 20 mg with solvent’; and ‘Powder for I.V. infusion 80 mg with solvent’ with manner of administration Injection:
omit from the column headed ‘Circumstances’ (all instances):
C4078 C4140 C4160 C4239
Schedule 1 Part 1, entry for ‘Docetaxel’ in the forms ‘Solution concentrate for I.V. infusion 140 mg in 7 mL’; ‘Solution concentrate for I.V. infusion 160 mg in 16 mL’; ‘Solution concentrate for I.V. infusion 20 mg in 1 mL’; ‘Solution concentrate for I.V. infusion 20 mg in 2 mL’; ‘Solution concentrate for I.V. infusion 80 mg in 4 mL’; and ‘Solution concentrate for I.V. infusion 80 mg in 8 mL’ with manner of administration Injection:
omit from the column headed ‘Circumstances’ (all instances):
C3888 C3892 C3916 C3956 C4078 C4140 C4160 C4239
Schedule 1 Part 1 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:
omit :
Adriamycin PF MP
D
Schedule 1 Part 1 entry for ‘Doxorubicin’ in the form ‘Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial’ with manner of administration Injection/ intravesical:
omit :
Adriamycin Solution PF MP D
Schedule 1 Part 1 entry for ‘Epirubicin’ in the form ‘Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL’ with manner of administration Injection/ intravesical:
omit :
Pharmorubicin Solution PF MP D
Schedule 1 Part 1 entry for ‘Irinotecan’ in the form ‘I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL’ with manner of administration Injection:
omit :
Camptosar PF MP D
Schedule 1 Part 1 entry for ‘Methotrexate’ in the form ‘Injection 50 mg in 2 mL vial’ with manner of administration Injection:
omit :
Pfizer Australia Pty Ltd PF MP D
[10] Schedule 1 Part 1, entry for ‘Paclitaxel’ in the forms ‘Solution concentrate for I.V. infusion 100 mg in 16.7 mL’; ‘Solution concentrate for I.V. infusion 150 mg in 25 mL’; ‘Solution concentrate for I.V. infusion 30 mg in 5 mL’; and ‘Solution concentrate for I.V. infusion 300 mg in 50 mL’ with manner of administration Injection:
omit from the column headed ‘Circumstances’ (all instances):
C3186 C3890 C3902 C3917 C3955 C3956
[11] Schedule 4, after the entry for Bortezomib;
omit:
Cabazitaxel
C4237 Castration resistant metastatic carcinoma of the prostate
The treatment must be in combination with prednisone or prednisolone,
The treatment must not be used in combination with abiraterone,
Patient must have failed treatment with docetaxel due to resistance or intolerance,
Patient must have a WHO performance status of 2 or less,
Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel.Compliance with Authority Required procedures
C4262 Castration resistant metastatic carcinoma of the prostate:
The treatment must be in combination with prednisone or prednisolone,
The treatment must not be used in combination with abiraterone,
Patient must have failed treatment with docetaxel due to resistance or intolerance,
Patient must have a WHO performance status of 2 or less,
Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel.Compliance with Authority Required procedures - Streamlined Authority Code 4262
Insert:
Cabazitaxel
C4661 Castration resistant metastatic carcinoma of the prostate
The treatment must be in combination with prednisone or prednisolone,
The treatment must not be used in combination with abiraterone,
Patient must have failed treatment with docetaxel due to resistance or intolerance,
Patient must have a WHO performance status of 2 or less,
Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel.Compliance with Authority Required procedures
C4662 Castration resistant metastatic carcinoma of the prostate:
The treatment must be in combination with prednisone or prednisolone,
The treatment must not be used in combination with abiraterone,
Patient must have failed treatment with docetaxel due to resistance or intolerance,
Patient must have a WHO performance status of 2 or less,
Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel.Compliance with Authority Required procedures - Streamlined Authority Code 4662
[12] Schedule 4, after the entry for Cladribine;
omit:
Docetaxel
C3888 P3888 Neoadjuvant treatment of a patient with a World Health Organisation performance status of 1 or less, with inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx, in combination with cisplatin and fluorouracil Compliance with Authority Required procedures – Streamlined Authority Code 3888 C3892 P3892 Adjuvant treatment of operable breast cancer in combination with cyclophosphamide Compliance with Authority Required procedures – Streamlined Authority Code 3892 C3916 P3916 Adjuvant treatment of node‑positive breast cancer in combination with an anthracycline and cyclophosphamide Compliance with Authority Required procedures – Streamlined Authority Code 3916 C3956 P3956 Treatment of HER2 positive breast cancer in combination with trastuzumab Compliance with Authority Required procedures – Streamlined Authority Code 3956 C4078 Locally advanced or metastatic non‑small cell lung cancer
Compliance with Authority Required procedures ‑ Streamlined Authority Code 4078 C4140 Advanced metastatic ovarian cancer
Patient must have failed prior therapy which included a platinum compound.
Compliance with Authority Required procedures ‑ Streamlined Authority Code 4140 C4160 Metastatic breast cancer Compliance with Authority Required procedures ‑ Streamlined Authority Code 4160 C4239 Androgen independent (castration resistant) metastatic carcinoma of the prostate
Patient must have a Karnofsky performance status score of at least 60%,
The treatment must be used as first‑line chemotherapy,
The treatment must be administered in three weekly cycles,
Patient must not receive more than 10 cycles of treatment with docetaxel under this restriction.Compliance with Authority Required procedures ‑ Streamlined Authority Code 4239
[13] Schedule 4, after the entry for Ondansetron;
omit:
Paclitaxel
C3186 Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound Compliance with Authority Required procedures ‑ Streamlined Authority Code 3186 C3890 Locally advanced or metastatic non‑small cell lung cancer Compliance with Authority Required procedures ‑ Streamlined Authority Code 3890 C3902 Primary treatment of ovarian cancer in combination with a platinum compound Compliance with Authority Required procedures ‑ Streamlined Authority Code 3902 C3917 Adjuvant treatment of node‑positive breast cancer administered sequentially to an anthracycline and cyclophosphamide Compliance with Authority Required procedures ‑ Streamlined Authority Code 3917 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
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