National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 6) (PB No. 56 of 2016) (Cth)
PB 56 of 2016
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 6)
National Health Act 1953
___________________________________________________________________________
I, Tony Wynd, Acting 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 27 June 2016
TONY WYND
Acting Assistant Secretary
Pharmaceutical Access Branch
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 2016 (No. 6).
(2)This Instrument may also be cited as PB 56 of 2016.
2 Commencement
This Instrument commences on 1 July 2016.
3 Amendments to PB 79 of 2011
Amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).
Amendments
Section 3, Definition for diluent fee
omit: $5.07 substitute: $5.14
Section 3, Definition for dispensing fee
omit: $6.93 substitute: $7.02
Section 3, Definition for distribution fee
omit: $25.59 substitute: $26.08
Section 3, Repeal the Definition for preparation fee
substitute: preparation fee means an amount of $83.22
Section 3, Definition for start date
omit: 2015 substitute: 2016
Schedule 1 Part 1 entry for Bleomycin in the form ‘Powder for injection containing bleomycin sulfate 15,000 I.U.’
omit from the column headed ‘Circumstances’ (all instances): C1139 C1198 substitute: C6224 C6275
Schedule 1 Part 1 entry for Cladribine in each of the forms ‘Injection 10 mg in 5 mL’ and ‘Solution for I.V. infusion 10 mg in 10 mL single use vial’
omit from the column headed ‘Circumstances’ (all instances): C3180 substitute: C6265
Schedule 1 Part 1 after entry for Epirubicin in the form ‘Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL’ and brand ‘Hospira Pty Limited’
insert:
Pharmorubicin PF MP D
Schedule 1 Part 1 after entry for Epirubicin in the form ‘Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL’ and brand ‘Epirubicin Kabi’
insert:
Pharmorubicin PF MP D
[10] Schedule 1 Part 1 after entry for Epirubicin in the form ‘Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL’ and brand ‘Hospira Pty Limited’
insert:
Pharmorubicin PF MP D
[11] Schedule 1 Part 1 entry for Fludarabine in each of the forms ‘Powder for I.V. injection containing fludarabine phosphate 50 mg’ and ‘Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL’
omit from the column headed ‘Circumstances’ (all instances): C3887 substitute: C6248
[12] Schedule 1 Part 1 entry for Fluorouracil in each of the forms ‘Injection 1000 mg in 20 mL’, ‘Injection 2500 mg in 50 mL’, ‘Injection 500 mg in 10 mL’, and ‘Injection 5000 mg in 100 mL’
omit from the column headed ‘Circumstances’ (all instances): C3923 C3924 substitute: C6266 C6297
[13] Schedule 1 Part 1 entry for Fotemustine in the form ‘Powder for injection 208 mg with solvent’
omit from the column headed ‘Circumstances’: C3181 substitute: C6288
[14] Schedule 1 Part 1 after entry for Gemcitabine in the form ‘Powder for I.V. infusion 1 g (as hydrochloride)’ and brand ‘Gemaccord’
omit:
Gemcitabine Actavis GN MP D
[15] Schedule 1 Part 1 entry for Idarubicin in each of the forms ‘Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL’ and ‘Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL’
omit from the column headed ‘Circumstances’ (all instances): C1006 substitute: C6247
[16] Schedule 1 Part 1 entry for Methotrexate
substitute:
Methotrexate Injection 5 mg in 2 mL vial Injection Hospira Pty Limited HH MP Pfizer Australia Pty Ltd PF MP Injection 50 mg in 2 mL vial Injection Hospira Pty Limited HH MP Methaccord EA MP Methotrexate MYX OC MP D Pfizer Australia Pty Ltd PF MP Solution concentrate for I.V. infusion 1000 mg in 10 mL vial Injection Hospira Pty Limited HH MP PB Methaccord EA MP PB Methotrexate MYX OC MP D Pfizer Australia Pty Ltd PF MP Solution concentrate for I.V. infusion 500 mg in 20 mL vial Injection Hospira Pty Limited HH MP PB Pfizer Australia Pty Ltd PF MP Solution concentrate for I.V. infusion 5000 mg in 50 mL vial Injection Methotrexate Ebewe SZ MP PB Pfizer Australia Pty Ltd PF MP
[17] Schedule 1 Part 1 after entry for Pemetrexed and the form ‘Powder for I.V. infusion 500 mg (as disodium heptahydrate)’
insert:
Powder for I.V. infusion 1 g (as disodium) Injection DBL Pemetrexed
HH MP C4789
C4792
D Pemetrexed MYX YN MP C4789
C4792
D
[18] Schedule 1 Part 1 entry for Raltitrexed in the form ‘Powder for I.V. infusion 2 mg in single use vial’
omit from the column headed ‘Circumstances’: C3185 substitute: C6228
[19] Schedule 1 Part 1 entry for Topotecan in the form ‘Powder for I.V. infusion 4 mg (as hydrochloride)’
omit from the column headed ‘Circumstances’ (all instances): C3186 substitute: C6238
[20] Schedule 1 Part 2 entry for Flourouracil
substitute:
Fluorouracil P6297 P6266 1000
550023
11
[21] Schedule 1 Part 2 entry for Methotrexate
omit from the column headed ‘Purposes’: P3925 substitute: P6276
[22] Schedule 2 entry for Trastuzumab
substitute:
Trastuzumab Solution for subcutaneous injection containing trastuzumab 600 mg in 5 mL Injection Herceptin SC RO MP C6059
C6060
C6061
C6062P6059
P60601
0
C6059
C6060
C6061C6062
P6061
P60621 3
[23] Schedule 4 entry for Bleomycin
substitute:
Bleomycin C6224 Germ cell neoplasms C6275 Lymphoma
[24] Schedule 4 entry for Cladribine
substitute:
| Cladribine | C6265 | Hairy cell leukaemia | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6265 |
[25] Schedule 4 entry for Fludarabine
substitute:
| Fludarabine | C6248 | B-cell chronic lymphocytic leukaemia Patient must have advanced disease (Binet Stage B or C); OR Patient must have evidence of progressive Stage A disease; AND The treatment must be in combination with cyclophosphamide. Stage A progressive disease is defined by at least one of the following: persistent rise in lymphocyte count with doubling time less than 12 months; a downward trend in haemoglobin or platelets, or both; more than 50% increase in the size of liver, spleen, or lymph nodes, or appearance of these signs if not previously present; constitutional symptoms attributable to disease. The diagnosis of chronic lymphocytic leukaemia (CLL) must have been established based on: (a) a lymphocytosis, with more than 5,000 million lymphocytes per L in the peripheral blood; and (b) a clonal population of B-cells (CD5/CD19) documented by flow cytometry. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6248 |
[26] Schedule 4 entry for Fluorouracil
substitute:
| Fluorouracil | C6266 | P6266 | Patients requiring administration of fluorouracil by intravenous infusion |
| C6297 | P6297 | Patients requiring administration of fluorouracil by intravenous injection |
[27] Schedule 4 entry for Fotemustine
substitute:
| Fotemustine | C6288 | P6288 | Metastatic malignant melanoma | Compliance with Authority Required procedures - Streamlined Authority Code 6288 |
[28] Schedule 4 entry for Idarubicin
substitute:
| Idarubicin | C6247 | Acute myelogenous leukaemia (AML) |
[29] Schedule 4 entry for Methotrexate
substitute:
| Methotrexate | P6276 | Patients receiving treatment with a high dose regimen |
[30] Schedule 4 entry for Raltitrexed
substitute:
| Raltitrexed | C6228 | Advanced colorectal cancer The treatment must only be used as a single agent in the treatment of this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 6228 |
[31] Schedule 4 entry for Topotecan
substitute:
| Topotecan | C6238 | Advanced metastatic ovarian cancer Patient must have failed prior therapy which included a platinum compound. | Compliance with Authority Required procedures - Streamlined Authority Code 6238 |
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