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
[1] 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
[2] 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
[3] 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
[4] 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
[5] 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
[6] 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
[7] 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
[8] 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
[9] 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
