National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2010 (No. 1) (No. PB 123 of 2010) (Cth)
PB 123 of 2010
National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2010 (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 15 December 2010
FELICITY MCNEILL
Acting First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing
___________________________________________________________________
1 Name of Amendment Instrument
(1)This Amendment Instrument is the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2010 (No.1).
(2)This instrument may also be cited as PB 123 of 2010.
2 Commencement
This Amendment Instrument commences on 1 January 2011.
3 Amendments to PB 117 of 2010
Schedule 1 amends PB 117 of 2010.
Schedule 1 Amendments
section 4, definition of manufacturer’s pack
omit:
subsection 6 (2) of the Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2010
and insert:
the determination made under paragraph 98B(1)(a) of the Act
[2] after subsection 11(e)
substitute:
(f)the letters ‘PBS’ or ‘RPBS’, as appropriate;
(g)the name of the chemotherapy pharmaceutical benefit;
(h)the strength of the chemotherapy pharmaceutical benefit;
(i)the quantity or dosage of the chemotherapy pharmaceutical benefit or both the quantity and dosage of the chemotherapy pharmaceutical benefit;
(j)if the dosage of the chemotherapy pharmaceutical benefit is provided under paragraph (i) – how often the chemotherapy pharmaceutical benefit is to be taken by the patient and the period that the chemotherapy pharmaceutical benefit is prescribed;
(k)the date the medication chart is prepared.
[3] paragraph 28(2)(b)
omit:
under Schedules 1, 2 or 3 of the National Health Act 1953 Pharmaceutical Benefits Rules under Subsection 99AAA(8)
and insert:
in accordance with the rules determined by the Minister under subsection 99AAA(8)
[4] Schedule 1, entry for Aprepitant
omit from the column headed “Circumstances”:
C2071 C2330 C3446
and insert:
C3619 C3620 C3621
[5] Schedule 1, after 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
insert in the columns in the order indicated:
| Solution concentrate for I.V. infusion 20 mg in 1 mL | Injection | Taxotere | SW | EMP | C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428 | P3051 | 1 | 0 |
| Taxotere | SW | EMP | C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428 | P1194 P1742 P2416 P2439 P2732 P3292 P3428 | 2 | 0 | ||
| Solution concentrate for I.V. infusion 80 mg in 4 mL | Injection | Taxotere | SW | EMP | C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428 | 1 | 0 |
[6] Schedule 1, entry for Gemcitabine the form Powder for I.V. infusion 200 mg (as hydrochloride)
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
| Gemcitabine Kabi | PK | EMP | C1193 C1194 C1740 C2069 C2141 | 4 | 2 |
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
| Gemcitabine Sun | ZF | EMP | C1193 C1194 C1740 C2069 C2141 | 4 | 2 |
[7] Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride)
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
| Gemcitabine Kabi | PK | EMP | C1193 C1194 C1740 C2069 C2141 | 2 | 2 |
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
| Gemcitabine Sun | ZF | EMP | C1193 C1194 C1740 C2069 C2141 | 2 | 2 |
[8] Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 2 g (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
| Gemcitabine Kabi | PK | EMP | C1193 C1194 C1740 C2069 C2141 | 1 | 2 |
[9] Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 50 mg in 10 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
| Oxaliplatin Kabi | PK | EMP | C2717 C3449 C3450 | 1 | 2 |
[10] Schedule 1, entry for Oxaliplatin in the forms Powder for I.V. infusion 50 mg; and Powder for I.V. infusion 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
| Xalox | WQ | EMP | C2717 C3449 C3450 | 1 | 2 |
[11] Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 30 mg in 5 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
| Paclitaxel Kabi | PK | EMP | C1194 C1293 C1742 C2417 C2439 C3428 | 5 | 0 |
[12] Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 100 mg in 16.7 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
| Paclitaxel Kabi | PK | EMP | C1194 C1293 C1742 C2417 C2439 C3428 | 2 | 0 |
[13] Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed ‘Brand’:
| Paclitaxel Kabi | PK | EMP | C1194 C1293 C1742 C2417 C2439 C3428 | 1 | 0 |
[14] Schedule 2, after
| WQ | Willow Pharmaceuticals Pty Ltd | 80 118 534 704 |
insert in the columns in the order indicated:
| ZF | Sun Pharmaceutical Industries Pty Ltd | 64 130 119 603 |
[15] Schedule 3, entry for Aprepitant
substitute:
| Aprepitant | C3619 | Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy, in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where any 1 of the following chemotherapy agents are to be administered: (a) altretamine; (b) carmustine; (c) cisplatin, when a single dose constitutes a cycle of chemotherapy; (d) cyclophosphamide, at a dose of 1500 mg per square metre per day or greater; (e) dacarbazine; (f) procarbazine, when a single dose constitutes a cycle of chemotherapy; (g) streptozocin; and where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy | Compliance with Authority Required procedures – Streamlined Authority Code 3619 |
| C3620 | Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat breast cancer, in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where cyclophosphamide and an anthracycline are to be co-administered, and where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy | Compliance with Authority Required procedures – Streamlined Authority Code 3620 | |
| C3621 | Management of nausea and vomiting associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy, in combination with a 5-hydroxytryptamine type 3 receptor (5HT3) antagonist and dexamethasone on day 1, where the patient has had a prior episode of chemotherapy induced nausea or vomiting where any 1 of the following intravenous chemotherapy agents is to be administered: (a) arsenic trioxide; (b) azacitidine; (c) carboplatin; (d) cyclophosphamide, at a dose of less than 1500 mg per square metre per day; (e) cytarabine, at a dose of greater than 1 g per square metre per day; (f) dactinomycin; (g) daunorubicin; (h) doxorubicin; (i) epirubicin; (j) fotemustine; (k) idarubicin; (l) ifosfamide; (m) irinotecan; (n) melphalan; (o) methotrexate, at a dose of 250 mg to 1 g per square metre; (p) oxaliplatin; (q) raltitrexed; and where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy, and where concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle | Compliance with Authority Required procedures - Streamlined Authority Code 3621 |
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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