National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 2) (No. PB 13 of 2012) (Cth)
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PB 13 of 2012
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012
(No.2)1
National Health Act 1953
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this Instrument under sections 84AF, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 23 March 2012
FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing
1 Name of Instrument
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 2).
(2) This Instrument may also be cited as PB 13 of 2012.
2 Commencement
This Instrument commences on 1 April 2012.
3 Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010)
Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).
Schedule 1 Amendments
[1]Schedule 1, entry for Abatacept
substitute:
Abatacept Injection 125 mg in 1 mL single dose pre-filled syringe Injection Orencia BQ MP C3996 C3997 C3998 P3996 C3997 4 3 MP C3996 C3997 C3998 P3998 4 5 Powder for I.V. infusion 250 mg Injection Orencia BQ MP
See Note 1See Note 3 See Note 3 See Note 3 See Note 3 PB [2]Schedule 1, entry for Amino acids—synthetic, formula
(a) omit:
Oral powder 400 g (Neocate) Oral Neocate SB MP NP C1687 C1688 C2805 C2806 C2807 C2808 C2809 C2810 8 5 (b) insert in the columns in the order indicated, after the entry for “Oral powder 400 g (Neocate Advance Tropical Flavour)”:
Oral powder 400 g (Neocate Advance Vanilla) Oral Neocate Advance Vanilla SB MP NP C1687 C1688 C2805 C2806 C2807 C2808 C2809 C2810 8 5 [3]Schedule 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and
medium chain triglycerides
(a) omit from the column headed “Form”: (Neocate LCP + MCT) substitute: (Neocate Gold)
(b) omit from the column headed “Brand”: Neocate LCP + MCT substitute: Neocate Gold
[4]Schedule 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besylate); and Tablet 10 mg (as besylate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Amlodipine Pfizer FZ MP NP 30 5 [5]Schedule 1, entry for Anastrozole
substitute:
Anastrozole Tablet 1 mg Oral Anastrol QA MP NP C2213 30 5 Anastrozole-DRLA RZ MP NP C2213 30 5 Anastrozole-GA GM MP NP C2213 30 5 Anastrozole GH GQ MP NP C2213 30 5 Anastrozole LW TA MP NP C2213 30 5 Anastrozole-PS FZ MP NP C2213 30 5 Anastrozole RBX RA MP NP C2213 30 5 Anastrozole Sandoz SZ MP NP C2213 30 5 Anzole WQ MP NP C2213 30 5 APO-Anastrozole TX MP NP C2213 30 5 Arimidex AP MP NP C2213 30 5 Chem mart Anastrozole CH MP NP C2213 30 5 Terry White Chemists Anastrozole TW MP NP C2213 30 5 [6]Schedule 1, entry for Apixaban
substitute:
Apixaban Tablet 2.5 mg Oral Eliquis BQ MP NP C3957 C3990 C3991 C3992 C3993 P3957 P3990 20 0 MP NP C3957 C3990 C3991 C3992 C3993 P3991 P3992 30 0 MP NP C3957 C3990 C3991 C3992 C3993 P3993 60 0 [7]Schedule 1, entry for Arsenic
omit from the column headed “Authorised Prescriber”: See Note 1
[8]Schedule 1, entry for Atorvastatin
substitute:
| Atorvastatin | Tablet 10 mg (as calcium) | Oral | Atorvastatin Pfizer | FZ | MP | C1540 C3047 | P1540 | 30 | 5 |
| NP | C1540 | 30 | 5 | ||||||
| Lipitor | PF | MP | C1540 C3047 | P1540 | 30 | 5 | |||
| NP | C1540 | 30 | 5 | ||||||
| Trovas | RA | MP | C1540 C3047 | P1540 | 30 | 5 | |||
| NP | C1540 | 30 | 5 | ||||||
| Atorvastatin Pfizer | FZ | MP | C1540 C3047 | P3047 | 30 | 11 | |||
| Lipitor | PF | MP | C1540 C3047 | P3047 | 30 | 11 | |||
| Trovas | RA | MP | C1540 C3047 | P3047 | 30 | 11 | |||
| Tablet 20 mg (as calcium) | Oral | Atorvastatin Pfizer | FZ | MP | C1540 C3047 | P1540 | 30 | 5 | |
| NP | C1540 | 30 | 5 | ||||||
| Lipitor | PF | MP | C1540 C3047 | P1540 | 30 | 5 | |||
| NP | C1540 | 30 | 5 | ||||||
| Trovas | RA | MP | C1540 C3047 | P1540 | 30 | 5 | |||
| NP | C1540 | 30 | 5 | ||||||
| Atorvastatin Pfizer | FZ | MP | C1540 C3047 | P3047 | 30 | 11 | |||
| Lipitor | PF | MP | C1540 C3047 | P3047 | 30 | 11 | |||
| Trovas | RA | MP | C1540 C3047 | P3047 | 30 | 11 | |||
| Tablet 40 mg (as calcium) | Oral | Atorvastatin Pfizer | FZ | MP | C1540 C3047 | P1540 | 30 | 5 | |
| NP | C1540 | 30 | 5 | ||||||
| Lipitor | PF | MP | C1540 C3047 | P1540 | 30 | 5 | |||
| NP | C1540 | 30 | 5 | ||||||
| Trovas | RA | MP | C1540 C3047 | P1540 | 30 | 5 | |||
| NP | C1540 | 30 | 5 | ||||||
| Atorvastatin Pfizer | FZ | MP | C1540 C3047 | P3047 | 30 | 11 | |||
| Lipitor | PF | MP | C1540 C3047 | P3047 | 30 | 11 | |||
| Trovas | RA | MP | C1540 C3047 | P3047 | 30 | 11 | |||
| Tablet 80 mg (as calcium) | Oral | Atorvastatin Pfizer | FZ | MP | C1540 C3047 | P1540 | 30 | 5 | |
| NP | C1540 | 30 | 5 | ||||||
| Lipitor | PF | MP | C1540 C3047 | P1540 | 30 | 5 | |||
| NP | C1540 | 30 | 5 | ||||||
| Trovas | RA | MP | C1540 C3047 | P1540 | 30 | 5 | |||
| NP | C1540 | 30 | 5 | ||||||
| Atorvastatin Pfizer | FZ | MP | C1540 C3047 | P3047 | 30 | 11 | |||
| Lipitor | PF | MP | C1540 C3047 | P3047 | 30 | 11 | |||
| Trovas | RA | MP | C1540 C3047 | P3047 | 30 | 11 |
[9]Schedule 1, entry for Azathioprine in each of the forms: Tablet 25 mg; and Tablet 50 mg
omit from the column headed “Number of Repeats” (all instances): 2 substitute: 5
[10]Schedule 1, entry for Bevacizumab
omit from the column headed “Authorised Prescriber” (all instances): See Note 1
[11]Schedule 1, entry for Bisoprolol in each of the forms: Tablet containing bisoprolol fumarate 2.5 mg; Tablet containing
bisoprolol fumarate 5 mg; and Tablet containing bisoprolol fumarate 10 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Bisoprolol TX MP NP C3234 28 5 (b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Chem mart Bisoprolol CH MP NP C3234 28 5 (c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Terry White Chemists Bisoprolol TW MP NP C3234 28 5 [12]Schedule 1, entry for Bleomycin
omit:
Bleomycin Powder for injection containing bleomycin sulfate 15,000 I.U. Injection Hospira Pty Limited HH MP
See Note 1C1139 C1198 See Note 3 See Note 3 D substitute:
Bleomycin Powder for injection containing bleomycin sulfate 15,000 I.U. Injection Bleo 15K WQ MP C1139 C1198 See Note 3 See Note 3 D Hospira Pty Limited HH MP C1139 C1198 See Note 3 See Note 3 D [13]Schedule 1, entry for Bortezomib
substitute:
Bortezomib Powder for injection 3.5 mg (with any determined brand of sodium chloride injection as the required solvent) Injection Velcade JC MP C3762 C3763 C3764 C3765 C3766 C3767 See Note 3 See Note 3 D [14]Schedule 1, entry for Carboplatin
omit from the column headed “Authorised Prescriber” (all instances): See Note 1
[15]Schedule 1, entry for Certolizumab pegol
omit from the column headed “Circumstances Code”:
C3476
[16]Schedule 1, entry for Cetuximab
omit from the column headed “Authorised Prescriber” (all instances): See Note 1
[17]Schedule 1, entry for Cisplatin
omit from the column headed “Authorised Prescriber” (all instances): See Note 1
[18]Schedule 1, entry for Cladribine
omit from the column headed “Authorised Prescriber” (twice occurring): See Note 1
[19]Schedule 1, entry for Clopidogrel
omit:
Tablet 75 mg (as besilate) Oral Clopidogrel Actavis GQ MP NP C1719 C1720 C1721 C1722 C1723 C1724 28 5 Clopidogrel-GA GM MP NP C1719 C1720 C1721 C1722 C1723 C1724 28 5 Clovix 75 QA MP NP C1719 C1720 C1721 C1722 C1723 C1724 28 5 substitute:
Tablet 75 mg (as besilate) Oral Clopidogrel Actavis TA MP NP C1719 C1720 C1721 C1722 C1723 C1724 28 5 Clopidogrel-GA GM MP NP C1719 C1720 C1721 C1722 C1723 C1724 28 5 Clopidogrel GH GQ MP NP C1719 C1720 C1721 C1722 C1723 C1724 28 5 Clopidogrel-PS FZ MP NP C1719 C1720 C1721 C1722 C1723 C1724 28 5 Clovix 75 QA MP NP C1719 C1720 C1721 C1722 C1723 C1724 28 5 [20]Schedule 1, entry for Clostridium Botulinum Type A Toxin—haemagglutinin Complex
substitute:
Clostridium Botulinum Type A Toxin—haemagglutinin Complex Lyophilised powder for I.M. injection 300 units Injection Dysport IS MP
See Note 1See Note 3 See Note 3 See Note 3 See Note 3 D Lyophilised powder for I.M. injection 500 units Injection Dysport IS MP
See Note 1See Note 3 See Note 3 See Note 3 See Note 3 D [21]Schedule 1, entry for Cyclophosphamide
omit from the column headed “Authorised Prescriber” (all instances): See Note 1
[22]Schedule 1, entry for Cytarabine
omit from the column headed “Authorised Prescriber”: See Note 1
[23]Schedule 1, entry for Dalteparin
omit:
Injection containing dalteparin sodium 10,000 I.U. (anti-Xa) in 1 mL single dose pre-filled syringe Injection Fragmin PF MP NP 10 1 P3688 30 5 Injection containing dalteparin sodium 12,500 I.U. (anti-Xa) in 0.5 mL single dose pre-filled syringe Injection Fragmin PF MP NP 10 1 P3688 30 5 substitute:
Injection containing dalteparin sodium 10,000 I.U. (anti-Xa) in 1 mL single dose pre-filled syringe Injection Fragmin PF MP NP 10 1 MP NP P1148 20 3 MP NP P3688 30 5 Injection containing dalteparin sodium 12,500 I.U. (anti-Xa) in 0.5 mL single dose pre-filled syringe Injection Fragmin PF MP NP 10 1 MP NP P1148 20 3 MP NP P3688 30 5 [24]Schedule 1, entry for Dasatinib
substitute:
Dasatinib Tablet 20 mg Oral Sprycel BQ MP C2769 C2770 C2771 C3999 C4000 C4003 C4004 P2769 P2770 P2771 60 2 MP C2769 C2770 C2771 C3999 C4000 C4003 C4004 P3999 P4000 P4003 P4004 60 5 Tablet 50 mg Oral Sprycel BQ MP C2769 C2770 C2771 C3999 C4000 C4003 C4004 P2769 P2770 P2771 60 2 MP C2769 C2770 C2771 C3999 C4000 C4003 C4004 P3999 P4000 P4003 P4004 60 5 Tablet 70 mg Oral Sprycel BQ MP C2769 C2770 C2771 C3999 C4000 C4003 C4004 P2769 P2770 P2771 60 2 MP C2769 C2770 C2771 C3999 C4000 C4003 C4004 P3999 P4000 P4003 P4004 60 5 Tablet 100 mg Oral Sprycel BQ MP C2769 C2770 C2771 C3999 C4000 C4003 C4004 P2769 P2770 P2771 30 2 MP C2769 C2770 C2771 C3999 C4000 C4003 C4004 P3999 P4000 P4003 P4004 30 5 [25]Schedule 1, entry for Docetaxel
omit from the column headed “Authorised Prescriber” (all instances): See Note 1
[26]Schedule 1, entry for Doxorubicin
omit from the column headed “Authorised Prescriber” (all instances): See Note 1
[27]Schedule 1, entry for Doxorubicin in each of the forms: Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial; and Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Accord Doxorubicin WQ MP See Note 3 See Note 3 D [28]Schedule 1, entry for Doxorubicin—Pegylated Liposomal
substitute:
Doxorubicin – Pegylated Liposomal Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL Injection Caelyx JC MP
C1568 C1795 C1796 C3905 C3910 C3911 See Note 3 See Note 3 D MP
See Note 1C1828 C1829 C3348 C3349 4 5 D Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL Injection Caelyx JC MP
C1568 C1795 C1796 C3905 C3910 C3911 See Note 3 See Note 3 D [29]Schedule 1, entry for Epirubicin
substitute:
| Epirubicin | Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL | Injection/ intravesical | Epiccord | WQ | MP | See Note 3 | See Note 3 | D |
| Epirubicin Actavis 10 | TA | MP | See Note 3 | See Note 3 | D | |||
| Epirubicin Ebewe | SZ | MP | See Note 3 | See Note 3 | D | |||
| Pharmorubicin Solution | PF | MP | See Note 3 | See Note 3 | D |
| Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL | Injection/ intravesical | Epiccord | WQ | MP | See Note 3 | See Note 3 | D |
| Epirubicin Actavis 20 | TA | MP | See Note 3 | See Note 3 | D | ||
| Pharmorubicin Solution | PF | MP | See Note 3 | See Note 3 | D | ||
| Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL | Injection/ intravesical | Epiccord | WQ | MP | See Note 3 | See Note 3 | D |
| Epirubicin Actavis 50 | TA | MP | See Note 3 | See Note 3 | D | ||
| Epirubicin Ebewe | SZ | MP | See Note 3 | See Note 3 | D | ||
| Epirubicin Kabi | PK | MP | See Note 3 | See Note 3 | D | ||
| Hospira Pty Limited | HH | MP | See Note 3 | See Note 3 | D | ||
| Pharmorubicin Solution | PF | MP | See Note 3 | See Note 3 | D | ||
| Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL | Injection/ intravesical | Epirubicin Actavis 100 | TA | MP | See Note 3 | See Note 3 | D |
| Epirubicin Ebewe | SZ | MP | See Note 3 | See Note 3 | D | ||
| Hospira Pty Limited | HH | MP | See Note 3 | See Note 3 | D | ||
| Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL | Injection/ intravesical | DBL Epirubicin Hydrochloride Injection | HH | MP | See Note 3 | See Note 3 | D |
| Epiccord | WQ | MP | See Note 3 | See Note 3 | D | ||
| Epirubicin Actavis 200 | TA | MP | See Note 3 | See Note 3 | D | ||
| Epirubicin Ebewe | SZ | MP | See Note 3 | See Note 3 | D | ||
| Epirubicin Kabi | PK | MP | See Note 3 | See Note 3 | D |
[30]Schedule 1, entry for Epoprostenol
(a) omit:
Powder for I.V. infusion 500 micrograms (as sodium) with diluent Injection Flolan GK MP
See Note 1See Note 3 See Note 3 See Note 3 See Note 3 D (b) omit:
Powder for I.V. infusion 1.5 mg (as sodium) with diluent Injection Flolan GK MP
See Note 1See Note 3 See Note 3 See Note 3 See Note 3 D [31]Schedule 1, entry for Etoposide
omit from the column headed “Authorised Prescriber” (all instances): See Note 1
[32]Schedule 1, entry for Fluconazole in each of the forms: Capsule 50 mg; Capsule 100 mg; and Capsule 200 mg
omit:
DBL Fluconazole HH MP NP C3613 C3614 C3615 C3616 C3617 C3618 28 5 [33]Schedule 1, entry for Fludarabine
omit from the column headed “Authorised Prescriber” (all instances): See Note 1
[34]Schedule 1, entry for Fluorouracil
omit from the column headed “Authorised Prescriber” (all instances): See Note 1
[35]Schedule 1, entry for Fluoxetine in the form Tablet, dispersible, 20 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Zactin Tablet AF MP NP C1211 C1241 28 5 [36]Schedule 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)
omit:
Fluohexal HX MP NP C1211 C1241 28 5 [37]Schedule 1, entry for Fotemustine
omit from the column headed “Authorised Prescriber”: See Note 1
[38]Schedule 1, entry for Frusemide in the form Tablet 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Frusemide-PS FZ MP NP 100 1 [39]Schedule 1, entry for Frusemide in the form Tablet 40 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Frusax GN MP NP 100 1 (b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Frusemide-PS FZ MP NP 100 1 [40]Schedule 1, entry for Gabapentin in each of the forms: Tablet 600 mg; and Tablet 800 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Nupentin Tabs AF MP NP C2664 100 5 [41]Schedule 1, entry for Gemcitabine
omit from the column headed “Authorised Prescriber” (all instances): See Note 1
[42]Schedule 1, entry for Gentamicin in the form Injection 80 mg (as sulfate) in 2 mL
omit:
Hospira Pty Limited HH MP NP 10 1 [43]Schedule 1, entry for Glatiramer
omit from the column headed “Responsible Person”: SW substitute: CS
[44]Schedule 1, entry for Glucose Indicator—Blood
omit:
Test strips, 50 (Freestyle Papillon) For external use Freestyle Papillon MS MP NP 2 5 MP P3035 2 11 [45]Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe
(a) omit from the column headed “Circumstances Code” (twice occurring):
C3484
(b) omit from the column headed “Purposes Code”:
P3484
[46]Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen
(a) omit from the column headed “Circumstances Code” (twice occurring):
C3484
(b) omit from the column headed “Purposes Code”:
P3484
[47]Schedule 1, entry for Idarubicin
omit from the column headed “Authorised Prescriber” (all instances): See Note 1
[48]Schedule 1, entry for Ifosfamide
omit from the column headed “Authorised Prescriber” (twice occurring): See Note 1
[49]Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesylate)
(a) omit from the column headed “Circumstances Code” (twice occurring):
C2210 C2488
(b) insert in each instance in numerical order:
C4007 C4008
[50]Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesylate) [Max Quantity 60; Number of Repeats 5]
(a) omit from the column headed “Purposes Code”:
P2210 P2488
(b) insert in numerical order:
P4007 P4008
[51]Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesylate)
(a) omit from the column headed “Circumstances Code” (twice occurring):
C2210 C2488
(b) insert in each instance in numerical order:
C4007 C4008
[52]Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesylate) [Max Quantity 30; Number of Repeats 5]
(a) omit from the column headed “Purposes Code”:
P2210 P2488
(b) insert in numerical order:
P4007 P4008
[53]Schedule 1, entry for Irinotecan
omit from the column headed “Authorised Prescriber” (all instances): See Note 1
[54]Schedule 1, entry for Isotretinoin in each of the forms: Capsule 10 mg; and Capsule 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Isotretinoin TX MP C1354 60 3 [55]Schedule 1, entry for Letrozole
substitute:
Letrozole Tablet 2.5 mg Oral APO-Letrozole TX MP NP C1608 C2691 C2692 30 5 Chem mart Letrozole CH MP NP C1608 C2691 C2692 30 5 Femara 2.5 mg NV MP NP C1608 C2691 C2692 30 5 Femolet AF MP NP C1608 C2691 C2692 30 5 Fera QA MP NP C1608 C2691 C2692 30 5 Letara FZ MP NP C1608 C2691 C2692 30 5 Letrozole Actavis TA MP NP C1608 C2691 C2692 30 5 Letrozole-DRLA RZ MP NP C1608 C2691 C2692 30 5 Letrozole-GA GM MP NP C1608 C2691 C2692 30 5 Letrozole generichealth GQ MP NP C1608 C2691 C2692 30 5 Letrozole RBX RA MP NP C1608 C2691 C2692 30 5 Letrozole Sandoz SZ MP NP C1608 C2691 C2692 30 5 Terry White Chemists Letrozole TW MP NP C1608 C2691 C2692 30 5 [56]Schedule 1, entry for Methotrexate
omit:
Injection 5 mg in 2 mL vial Injection Hospira Pty Limited HH MP
See Note 1See Note 2 5
See Note 20
See Note 2Injection 50 mg in 2 mL vial Injection Hospira Pty Limited HH MP
See Note 1See Note 2 5
See Note 25
See Note 2Pfizer Australia Pty Ltd PF MP
See Note 1See Note 2 5
See Note 25
See Note 2Solution concentrate for I.V. infusion 500 mg in 20 mL vial Injection Hospira Pty Limited HH MP
See Note 1See Note 3 See Note 3 See Note 3 PB Solution concentrate for I.V. infusion 1000 mg in 10 mL vial Injection Hospira Pty Limited HH MP
See Note 1See Note 3 See Note 3 See Note 3 PB Methotrexate Ebewe SZ MP
See Note 1See Note 3 See Note 3 See Note 3 PB Solution concentrate for I.V. infusion 5000 mg in 50 mL vial Injection Methotrexate Ebewe SZ MP
See Note 1See Note 3 See Note 3 See Note 3 PB substitute:
Injection 5 mg in 2 mL vial Injection Hospira Pty Limited HH MP See Note 2 5
See Note 20
See Note 2Injection 50 mg in 2 mL vial Injection Hospira Pty Limited HH MP See Note 2 5
See Note 25
See Note 2Methaccord WQ MP
See Note 2 5
See Note 25
See Note 2Pfizer Australia Pty Ltd PF MP See Note 2 5
See Note 25
See Note 2Solution concentrate for I.V. infusion 500 mg in 20 mL vial Injection Hospira Pty Limited HH MP See Note 3 See Note 3 See Note 3 PB Solution concentrate for I.V. infusion 1000 mg in 10 mL vial Injection Hospira Pty Limited HH MP See Note 3 See Note 3 See Note 3 PB Methaccord WQ MP See Note 3 See Note 3 See Note 3 PB Methotrexate Ebewe SZ MP See Note 3 See Note 3 See Note 3 PB Solution concentrate for I.V. infusion 5000 mg in 50 mL vial Injection Methotrexate Ebewe SZ MP See Note 3 See Note 3 See Note 3 PB [57]Schedule 1, entry for Mitozantrone
omit from the column headed “Authorised Prescriber” (all instances): See Note 1
[58]Schedule 1, entry for Mycophenolic Acid
omit:
Capsule containing mycophenolate mofetil 250 mg Oral CellCept RO MP C1765 C1766 300 3 MP
See Note 1C1650 C1651 C3355 C3356 600 5 C Tablet containing mycophenolate mofetil 500 mg Oral CellCept RO MP C1765 C1766 150 3 MP
See Note 1C1650 C1651 C3355 C3356 300 5 C substitute:
Capsule containing mycophenolate mofetil 250 mg Oral APO-Mycophenolate TX MP C1765 C1766 300 3 CellCept RO MP C1765 C1766 300 3 Ceptolate AF MP C1765 C1766 300 3 Imulate QA MP C1765 C1766 300 3 Mycophenolate Sandoz SZ MP C1765 C1766 300 3 APO-Mycophenolate TX MP
See Note 1C1650 C1651 C3355 C3356 600 5 C CellCept RO MP
See Note 1C1650 C1651 C3355 C3356 600 5 C Ceptolate AF MP
See Note 1C1650 C1651 C3355 C3356 600 5 C Imulate QA MP
See Note 1C1650 C1651 C3355 C3356 600 5 C Mycophenolate Sandoz SZ MP
See Note 1C1650 C1651 C3355 C3356 600 5 C
Tablet containing mycophenolate mofetil 500 mg Oral APO-Mycophenolate TX MP C1765 C1766 150 3 CellCept RO MP C1765 C1766 150 3 Ceptolate AF MP C1765 C1766 150 3 Imulate QA MP C1765 C1766 150 3 Mycophenolate Sandoz SZ MP C1765 C1766 150 3 APO-Mycophenolate TX MP
See Note 1C1650 C1651 C3355 C3356 300 5 C CellCept RO MP
See Note 1C1650 C1651 C3355 C3356 300 5 C Ceptolate AF MP
See Note 1C1650 C1651 C3355 C3356 300 5 C Imulate QA MP
See Note 1C1650 C1651 C3355 C3356 300 5 C Mycophenolate Sandoz SZ MP
See Note 1C1650 C1651 C3355 C3356 300 5 C [59]Schedule 1, after entry for Nevirapine in the form Tablet 200 mg
insert in the columns in the order indicated:
Tablet 400 mg (extended release) Oral Viramune XR BY MP
See Note 1C3587 C3589 C3994 C3995 60 5 D [60]Schedule 1, entry for Nilotinib
substitute:
Nilotinib Capsule 150 mg (as hydrochloride monohydrate) Oral Tasigna NV MP C4005 C4006 120 5 Capsule 200 mg (as hydrochloride monohydrate) Oral Tasigna NV MP C4001 C4002 120 5 [61]Schedule 1, entry for Oestradiol
omit:
Transdermal patches 8 mg, 8 Transdermal Estraderm 100 NV MP NP 1 5 [62]Schedule 1, entry for Olanzapine
omit:
Olanzapine Tablet 2.5 mg Oral Zyprexa LY MP NP C1589 C2044 28 5 Tablet 5 mg Oral Zyprexa LY MP NP C1589 C2044 28 5 Tablet 7.5 mg Oral Zyprexa LY MP NP C1589 C2044 28 5 Tablet 10 mg Oral Zyprexa LY MP NP C1589 C2044 28 5 Wafer 5 mg Oral Zyprexa Zydis LY MP NP C1589 C2044 28 5 Wafer 10 mg Oral Zyprexa Zydis LY MP NP C1589 C2044 28 5 substitute:
| Olanzapine | Tablet 2.5 mg | Oral | APO-Olanzapine | TX | MP NP | C1589 C2044 | 28 | 5 |
| Chem mart Olanzapine | CH | MP NP | C1589 C2044 | 28 | 5 | |||
| Lanzek | EL | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine-DRLA | RZ | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine-GA | GM | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine-PS | FZ | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine RBX | RA | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine Sandoz | SZ | MP NP | C1589 C2044 | 28 | 5 | |||
| Ozin 2.5 | DO | MP NP | C1589 C2044 | 28 | 5 | |||
| Terry White Chemists Olanzapine | TW | MP NP | C1589 C2044 | 28 | 5 | |||
| Zylap 2.5 | QA | MP NP | C1589 C2044 | 28 | 5 | |||
| Zypine | AF | MP NP | C1589 C2044 | 28 | 5 | |||
| Zyprexa | LY | MP NP | C1589 C2044 | 28 | 5 | |||
| Tablet 5 mg | Oral | APO-Olanzapine | TX | MP NP | C1589 C2044 | 28 | 5 | |
| Chem mart Olanzapine | CH | MP NP | C1589 C2044 | 28 | 5 | |||
| Lanzek | EL | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine-DRLA | RZ | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine-GA | GM | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine-PS | FZ | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine RBX | RA | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine Sandoz | SZ | MP NP | C1589 C2044 | 28 | 5 | |||
| Ozin 5 | DO | MP NP | C1589 C2044 | 28 | 5 | |||
| Terry White Chemists Olanzapine | TW | MP NP | C1589 C2044 | 28 | 5 | |||
| Zylap 5 | QA | MP NP | C1589 C2044 | 28 | 5 | |||
| Zypine | AF | MP NP | C1589 C2044 | 28 | 5 | |||
| Zyprexa | LY | MP NP | C1589 C2044 | 28 | 5 | |||
| Tablet 7.5 mg | Oral | APO-Olanzapine | TX | MP NP | C1589 C2044 | 28 | 5 | |
| Chem mart Olanzapine | CH | MP NP | C1589 C2044 | 28 | 5 | |||
| Lanzek | EL | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine-DRLA | RZ | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine-GA | GM | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine-PS | FZ | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine RBX | RA | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine Sandoz | SZ | MP NP | C1589 C2044 | 28 | 5 | |||
| Ozin 7.5 | DO | MP NP | C1589 C2044 | 28 | 5 | |||
| Terry White Chemists Olanzapine | TW | MP NP | C1589 C2044 | 28 | 5 | |||
| Zylap 7.5 | QA | MP NP | C1589 C2044 | 28 | 5 | |||
| Zypine | AF | MP NP | C1589 C2044 | 28 | 5 | |||
| Zyprexa | LY | MP NP | C1589 C2044 | 28 | 5 | |||
| Tablet 10 mg | Oral | APO-Olanzapine | TX | MP NP | C1589 C2044 | 28 | 5 | |
| Chem mart Olanzapine | CH | MP NP | C1589 C2044 | 28 | 5 | |||
| Lanzek | EL | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine-DRLA | RZ | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine-GA | GM | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine-PS | FZ | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine RBX | RA | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine Sandoz | SZ | MP NP | C1589 C2044 | 28 | 5 | |||
| Ozin 10 | DO | MP NP | C1589 C2044 | 28 | 5 | |||
| Terry White Chemists Olanzapine | TW | MP NP | C1589 C2044 | 28 | 5 | |||
| Zylap 10 | QA | MP NP | C1589 C2044 | 28 | 5 | |||
| Zypine | AF | MP NP | C1589 C2044 | 28 | 5 | |||
| Zyprexa | LY | MP NP | C1589 C2044 | 28 | 5 | |||
| Tablet 2.5 mg (as benzoate) | Oral | Olanzapine generichealth 2.5 | GQ | MP NP | C1589 C2044 | 28 | 5 | |
| Tablet 5 mg (as benzoate) | Oral | Olanzapine generichealth 5 | GQ | MP NP | C1589 C2044 | 28 | 5 | |
| Tablet 7.5 mg (as benzoate) | Oral | Olanzapine generichealth 7.5 | GQ | MP NP | C1589 C2044 | 28 | 5 | |
| Tablet 10 mg (as benzoate) | Oral | Olanzapine generichealth 10 | GQ | MP NP | C1589 C2044 | 28 | 5 | |
| Tablet 5 mg (orally disintegrating) | Oral | APO-Olanzapine ODT | TX | MP NP | C1589 C2044 | 28 | 5 | |
| Chem mart Olanzapine ODT | CH | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine-GA ODT | GM | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine ODT-DRLA | RZ | MP NP | C1589 C2044 | 28 | 5 | |||
| PS Olanzapine ODT | FZ | MP NP | C1589 C2044 | 28 | 5 | |||
| Terry White Chemists Olanzapine ODT | TW | MP NP | C1589 C2044 | 28 | 5 | |||
| Zylap ODT 5 | QA | MP NP | C1589 C2044 | 28 | 5 | |||
| Tablet 10 mg (orally disintegrating) | Oral | APO-Olanzapine ODT | TX | MP NP | C1589 C2044 | 28 | 5 | |
| Chem mart Olanzapine ODT | CH | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine-GA ODT | GM | MP NP | C1589 C2044 | 28 | 5 | |||
| Olanzapine ODT-DRLA | RZ | MP NP | C1589 C2044 | 28 | 5 | |||
| PS Olanzapine ODT | FZ | MP NP | C1589 C2044 | 28 | 5 | |||
| Terry White Chemists Olanzapine ODT | TW | MP NP | C1589 C2044 | 28 | 5 | |||
| Zylap ODT 10 | QA | MP NP | C1589 C2044 | 28 | 5 | |||
| Tablet 15 mg (orally disintegrating) | Oral | APO-Olanzapine ODT | TX | MP NP | C1589 C2044 | 28 | 5 | |
| Chem mart Olanzapine ODT | CH | MP NP | C1589 C2044 | 28 | 5 | |||
| Terry White Chemists Olanzapine ODT | TW | MP NP | C1589 C2044 | 28 | 5 | |||
| Tablet 20 mg (orally disintegrating) | Oral | APO-Olanzapine ODT | TX | MP NP | C1589 C2044 | 28 | 5 | |
| Chem mart Olanzapine ODT | CH | MP NP | C1589 C2044 | 28 | 5 | |||
| Terry White Chemists Olanzapine ODT | TW | MP NP | C1589 C2044 | 28 | 5 | |||
| Wafer 5 mg | Oral | Lanzek Zydis | EL | MP NP | C1589 C2044 | 28 | 5 | |
| Zypine ODT | AF | MP NP | C1589 C2044 | 28 | 5 | |||
| Zyprexa Zydis | LY | MP NP | C1589 C2044 | 28 | 5 | |||
| Wafer 10 mg | Oral | Lanzek Zydis | EL | MP NP | C1589 C2044 | 28 | 5 | |
| Zypine ODT | AF | MP NP | C1589 C2044 | 28 | 5 | |||
| Zyprexa Zydis | LY | MP NP | C1589 C2044 | 28 | 5 |
[63]Schedule 1, entry for Ondansetron in each of the forms: Tablet 4 mg (as hydrochloride dihydrate) [Max Quantity 10;
Number of Repeats 1]; and Tablet 8 mg (as hydrochloride dihydrate) [Max Quantity 10; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Ondasetron Tabs Pfizer FZ MP NP C3611 P3611 10 1 [64]Schedule 1, entry for Oxaliplatin
omit from the column headed “Authorised Prescriber” (all instances): See Note 1
[65]Schedule 1, entry for Paclitaxel
omit from the column headed “Authorised Prescriber” (all instances): See Note 1
[66]Schedule 1, entry for Paclitaxel, nanoparticle albumin-bound
omit from the column headed “Authorised Prescriber”: See Note 1
[67]Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)
omit from the column headed “Circumstances Code” (all instances):
C1533
substitute:
C1337 C1476 C1533
[68]Schedule 1, entry for Pemetrexed
omit from the column headed “Authorised Prescriber” (twice occurring): See Note 1
[69]Schedule 1, entry for Perindopril with Indapamide in the form Tablet containing perindopril erbumine 4 mg with
indapamide hemihydrate 1.25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Indopril Combi 4/1.25 QA MP NP C3307 30 5 [70]Schedule 1, entry for Prazosin
substitute:
Prazosin Tablet 1 mg (as hydrochloride) Oral APO-Prazosin TX MP NP 100 5 Chem mart Prazosin CH MP NP 100 5 Minipress PF MP NP 100 5 Terry White Chemists Prazosin TW MP NP 100 5 Tablet 2 mg (as hydrochloride) Oral APO-Prazosin TX MP NP 100 5 Chem mart Prazosin CH MP NP 100 5 Minipress PF MP NP 100 5 Terry White Chemists Prazosin TW MP NP 100 5 Tablet 5 mg (as hydrochloride) Oral APO-Prazosin TX MP NP 100 5 Chem mart Prazosin CH MP NP 100 5 Minipress PF MP NP 100 5 Terry White Chemists Prazosin TW MP NP 100 5 [71]Schedule 1, entry for Quetiapine
omit:
Quetiapine Tablet 25 mg (as fumarate) Oral Seroquel AP MP NP C1589 C2044 C2765 60 5 Tablet 100 mg (as fumarate) Oral Seroquel AP MP NP C1589 C2044 C2765 90 5 Tablet 200 mg (as fumarate) Oral Seroquel AP MP NP C1589 C2044 C2765 60 5 Tablet 300 mg (as fumarate) Oral Seroquel AP MP NP C1589 C2044 C2765 60 5 substitute:
| Quetiapine | Tablet 25 mg (as fumarate) | Oral | APO-Quetiapine | TX | MP NP | C1589 C2044 C2765 | 60 | 5 |
| Chem mart Quetiapine | CH | MP NP | C1589 C2044 C2765 | 60 | 5 | |||
| Delucon 25 | DO | MP NP | C1589 C2044 C2765 | 60 | 5 | |||
| Quetiaccord | WQ | MP NP | C1589 C2044 C2765 | 60 | 5 | |||
| Quetiapine Actavis 25 | TA | MP NP | C1589 C2044 C2765 | 60 | 5 | |||
| Quetiapine-DRLA | RZ | MP NP | C1589 C2044 C2765 | 60 | 5 | |||
| Quetiapine GH 25 | GQ | MP NP | C1589 C2044 C2765 | 60 | 5 | |||
| Quetiapine Pfizer | FZ | MP NP | C1589 C2044 C2765 | 60 | 5 | |||
| Quetiapine RBX | RA | MP NP | C1589 C2044 C2765 | 60 | 5 | |||
| Quetiapine Sandoz | SZ | MP NP | C1589 C2044 C2765 | 60 | 5 | |||
| Quipine | GM | MP NP | C1589 C2044 C2765 | 60 | 5 | |||
| Sequase | PM | MP NP | C1589 C2044 C2765 | 60 | 5 | |||
| Seroquel | AP | MP NP | C1589 C2044 C2765 | 60 | 5 | |||
| Terry White Chemists Quetiapine | TW | MP NP | C1589 C2044 C2765 | 60 | 5 |
| Tablet 100 mg (as fumarate) | Oral | APO-Quetiapine | TX | MP NP | C1589 C2044 C2765 | 90 | 5 |
| Chem mart Quetiapine | CH | MP NP | C1589 C2044 C2765 | 90 | 5 | ||
| Delucon 100 | DO | MP NP | C1589 C2044 C2765 | 90 | 5 | ||
| Quetiaccord | WQ | MP NP | C1589 C2044 C2765 | 90 | 5 | ||
| Quetiapine Actavis 100 | TA | MP NP | C1589 C2044 C2765 | 90 | 5 | ||
| Quetiapine-DRLA | RZ | MP NP | C1589 C2044 C2765 | 90 | 5 | ||
| Quetiapine GH 100 | GQ | MP NP | C1589 C2044 C2765 | 90 | 5 | ||
| Quetiapine Pfizer | FZ | MP NP | C1589 C2044 C2765 | 90 | 5 | ||
| Quetiapine RBX | RA | MP NP | C1589 C2044 C2765 | 90 | 5 | ||
| Quetiapine Sandoz | SZ | MP NP | C1589 C2044 C2765 | 90 | 5 | ||
| Quipine | GM | MP NP | C1589 C2044 C2765 | 90 | 5 | ||
| Sequase | PM | MP NP | C1589 C2044 C2765 | 90 | 5 | ||
| Seroquel | AP | MP NP | C1589 C2044 C2765 | 90 | 5 | ||
| Terry White Chemists Quetiapine | TW | MP NP | C1589 C2044 C2765 | 90 | 5 | ||
| Tablet 200 mg (as fumarate) | Oral | APO-Quetiapine | TX | MP NP | C1589 C2044 C2765 | 60 | 5 |
| Chem mart Quetiapine | CH | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Delucon 200 | DO | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Quetiaccord | WQ | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Quetiapine Actavis 200 | TA | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Quetiapine-DRLA | RZ | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Quetiapine GH 200 | GQ | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Quetiapine Pfizer | FZ | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Quetiapine RBX | RA | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Quetiapine Sandoz | SZ | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Quipine | GM | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Sequase | PM | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Seroquel | AP | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Terry White Chemists Quetiapine | TW | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Tablet 300 mg (as fumarate) | Oral | APO-Quetiapine | TX | MP NP | C1589 C2044 C2765 | 60 | 5 |
| Chem mart Quetiapine | CH | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Delucon 300 | DO | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Quetiaccord | WQ | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Quetiapine Actavis 300 | TA | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Quetiapine-DRLA | RZ | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Quetiapine GH 300 | GQ | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Quetiapine Pfizer | FZ | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Quetiapine RBX | RA | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Quetiapine Sandoz | SZ | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Quipine | GM | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Sequase | PM | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Seroquel | AP | MP NP | C1589 C2044 C2765 | 60 | 5 | ||
| Terry White Chemists Quetiapine | TW | MP NP | C1589 C2044 C2765 | 60 | 5 |
[72]Schedule 1, entry for Quinapril in the form Tablet 5 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Acquin Aspen 5 AS MP NP 30 5 [73]Schedule 1, entry for Quinapril in the form Tablet 10 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Acquin Aspen 10 AS MP NP 30 5 [74]Schedule 1, entry for Quinapril in the form Tablet 20 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Acquin Aspen 20 AS MP NP 30 5 [75]Schedule 1, entry for Raltitrexed
omit from the column headed “Authorised Prescriber”: See Note 1
[76]Schedule 1, entry for Ramipril in the form Capsule 10 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Ramipril TX MP NP 30 5 (b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Chem mart Ramipril CH MP NP 30 5 (c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Terry White Chemists Ramipril TW MP NP 30 5 [77]Schedule 1, after entry for Rifampicin in the form Syrup 100 mg per 5 mL, 60 mL
insert in the columns in the order indicated:
Rilpivirine Tablet 25 mg (as hydrochloride) Oral Edurant JC MP
See Note 1C3586 C3587 C3588 C3589 60 5 D [78]Schedule 1, entry for Rituximab
substitute:
Rituximab Solution for I.V. infusion 100 mg in 10 mL Injection Mabthera RO MP
C1744 C1745 C2068 C2386 C3908 C3909 C3912 C3915 C3931 C3932 See Note 3 See Note 3 See note 3 D Solution for I.V. infusion 500 mg in 50 mL Injection Mabthera RO MP
See Note 1
See Note 3 See Note 3 See Note 3 See note 3 D RO MP
C1744 C1745 C2068 C2386 C3908 C3909 C3912 C3915 C3931 C3932 See Note 3 See Note 3 See note 3 D [79]Schedule 1, entry for Sertraline in each of the forms: Tablet 50 mg (as hydrochloride); and Tablet 100 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Sertraline Pfizer FZ MP NP C1211 C1241 C1975 30 5 [80]Schedule 1, entry for Simvastatin in the form Tablet 80 mg
(a) omit:
Simvahexal HX MP C1540 C3047 P1540 30 5 NP C1540 30 5 (b) omit:
Simvahexal HX MP C1540 C3047 P3047 30 11 [81]Schedule 1, after entry for Tacrolimus in the form Capsule 5 mg (once daily prolonged release) [Prograf XL]
insert in the columns in the order indicated:
Tadalafil Tablet 20 mg Oral Adcirca LY MP
See Note 1See Note 3 See Note 3 See Note 3 See Note 3 D [82]Schedule 1, entry for Topotecan
omit from the column headed “Authorised Prescriber”: See Note 1
[83]Schedule 1, entry for Trastuzumab
omit from the column headed “Authorised Prescriber” (twice occurring): See Note 1
[84]Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Max Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Valaclovir Actavis 500 TA MP NP C3622 C3623 C3624 C3631 P3623 P3624 30 5 [85]Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Max Quantity 42; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Valaciclovir Actavis 500 TA MP NP C3622 C3623 C3624 C3631 P3622 P3631 42 0 [86]Schedule 1, entry for Venlafaxine
substitute:
| Venlafaxine | Capsule (modified release) 37.5 mg (as hydrochloride) | Oral | Efexor-XR | PF | MP NP | C1211 | 28 | 0 |
| Elaxine SR 37.5 | ZP | MP NP | C1211 | 28 | 0 | |||
| Venla RBX | RA | MP NP | C1211 | 28 | 0 | |||
| Capsule (modified release) 75 mg (as hydrochloride) | Oral | APO-Venlafaxine XR | TX | MP NP | C1211 | 28 | 5 | |
| Chem mart Venlafaxine XR | CH | MP NP | C1211 | 28 | 5 | |||
| Efexor-XR | PF | MP NP | C1211 | 28 | 5 | |||
| Elaxine SR 75 | ZP | MP NP | C1211 | 28 | 5 | |||
| Enlafax-XR | AF | MP NP | C1211 | 28 | 5 | |||
| Terry White Chemists Venlafaxine XR | TW | MP NP | C1211 | 28 | 5 | |||
| Venlafaxine generichealth XR | GQ | MP NP | C1211 | 28 | 5 | |||
| Venlafaxine Sandoz XR | SZ | MP NP | C1211 | 28 | 5 | |||
| Venla RBX | RA | MP NP | C1211 | 28 | 5 | |||
| Venlexor XR | GM | MP NP | C1211 | 28 | 5 | |||
| Capsule (modified release) 150 mg (as hydrochloride) | Oral | APO-Venlafaxine XR | TX | MP NP | C1211 | 28 | 5 | |
| Chem mart Venlafaxine XR | CH | MP NP | C1211 | 28 | 5 | |||
| Efexor-XR | PF | MP NP | C1211 | 28 | 5 | |||
| Elaxine SR 150 | ZP | MP NP | C1211 | 28 | 5 | |||
| Enlafax-XR | AF | MP NP | C1211 | 28 | 5 | |||
| Terry White Chemists Venlafaxine XR | TW | MP NP | C1211 | 28 | 5 | |||
| Venlafaxine generichealth XR | GQ | MP NP | C1211 | 28 | 5 | |||
| Venlafaxine Sandoz XR | SZ | MP NP | C1211 | 28 | 5 | |||
| Venla RBX | RA | MP NP | C1211 | 28 | 5 | |||
| Venlexor XR | GM | MP NP | C1211 | 28 | 5 |
[87]Schedule 1, entry for Vinblastine
omit from the column headed “Authorised Prescriber”: See Note 1
[88]Schedule 1, entry for Vincristine
omit from the column headed “Authorised Prescriber” (twice occurring): See Note 1
[89]Schedule 1, entry for Vinorelbine
omit from the column headed “Authorised Prescriber” (all instances): See Note 1
[90] Schedule 3, after details relevant to Responsible person code EH
insert:
EL Eli Lilly Australia Pty Ltd 39 000 233 992 [91] Schedule 4, Part 1, after entry for Abacavir with Lamivudine and Zidovudine
insert:
Abatacept C3996 P3996 Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 24 months)
Initial PBS-subsidised treatment with abatacept, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; and
(c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with abatacept for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 16 weeks of treatmentCompliance with Written Authority Required procedures
Continuation of a course of initial treatment with abatacept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total Compliance with Written or Telephone Authority Required procedures C3997 P3997 Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS-subsidised treatment with abatacept, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS-subsidised treatment with abatacept for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with abatacept are not eligible to commence treatment with abatacept until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with abatacept and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised abatacept treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised abatacept treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 16 weeks of treatmentCompliance with Written Authority Required procedures
Continuation of a course of initial treatment with abatacept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total Compliance with Written or Telephone Authority Required procedures C3998 P3998 Rheumatoid arthritis — continuing treatment
Continuing PBS-subsidised treatment with abatacept, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with abatacept; and
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with abatacept; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with abatacept;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of abatacept therapy is a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment is limited to a maximum of 24 weeks of treatmentCompliance with Written Authority Required procedures
Continuation of a course of continuing treatment with abatacept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total Compliance with Written or Telephone Authority Required procedures [92] Schedule 4, Part 1, entry for Apixaban
substitute:
Apixaban C3957 P3957 Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 10 days of therapy
Compliance with Authority Required procedures C3990 P3990 Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 10 days of therapy
Compliance with Authority Required procedures C3991 P3991 Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 15 days of therapy
Compliance with Authority Required procedures C3992 P3992 Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 15 days of therapy
Compliance with Authority Required procedures C3993 P3993 Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 30 days of therapy
Compliance with Authority Required procedures [93] Schedule 4, Part 1, entry for Certolizumab pegol
omit:
C3476 Rheumatoid arthritis — initial treatment 3
Initial PBS-subsidised supply for continuing treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of an adult who:
(a) has a documented history of severe active rheumatoid arthritis; and
(b) was receiving treatment with certolizumab pegol prior to 1 March 2010; and
(c) has demonstrated a response to certolizumab pegol treatment, as specified in the criteria for continuing PBS-subsidised treatment with certolizumab pegol; and (d) is receiving treatment with certolizumab pegol at the time of application; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
the course of treatment is limited to a maximum of 24 weeks of treatment;
a patient is eligible for PBS-subsidised treatment under the above criteria once onlyCompliance with Written Authority Required procedures Continuation of a course of initial PBS-subsidised treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of an adult with a documented history of severe active rheumatoid arthritis who was receiving non-PBS-subsidised treatment with certolizumab pegol prior to 1 March 2010 and at the time of the initial application for PBS-subsidised therapy and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total Compliance with Written or Telephone Authority Required procedures
[94] Schedule 4, Part 1, entry for Dasatinib
(a) omit:
C3039 P3039 Chronic myeloid leukaemia
Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial treatment with dasatinib as a pharmaceutical benefit for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response to dasatinib, or less than 1% BCR-ABL level in the blood, within 18 months of the commencement of treatment and at 12 monthly intervals thereafter; and
where the following conditions apply:
a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells;
a bone marrow or peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response;
response to PBS-subsidised treatment with dasatinib is assessed by:
(1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe; or
(2) quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale;
the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows:
(i) between 10 and 18 months of the commencement of treatment with dasatinib, at which time patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and
(ii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been sustained;
the authority application includes:
(1) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib Authority Application Form for continuing treatment; and
(2) demonstration of continued response to treatment as evidenced by:
(a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; or
(b) a copy of the quantitative PCR analysis showing a peripheral blood level of BCR-ABL of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; and
(3) if the cytogenetic analysis submitted with the application was conducted using FISH with BCR-ABL specific probe because standard karyotyping was not informative, a copy of the non-informative standard karyotype analysis;
a patient who has previously received PBS-subsidised treatment with dasatinib and has at any time failed to meet the criteria for continuing treatment, is not eligible for PBS-subsidised re-treatmentCompliance with Written Authority Required procedures
C3078 P3078 Chronic myeloid leukaemia
Initial treatment, as the sole PBS-subsidised therapy, of a patient with chronic myeloid leukaemia in any disease phase bearing the Philadelphia chromosome or expressing the transcript BCR-ABL, and who:
(a) has active leukaemia (as defined by the presence on current pathology assessments of either the Philadelphia chromosome on cytogenetic or fluorescence in situ hybridisation (FISH) analysis, or the presence of the transcript BCR-ABL greater than 1% on the international scale); and
(b) has failed an adequate trial of imatinib, where failure of an adequate trial of imatinib is defined as:
(i) lack of response to initial imatinib therapy, defined as either:
— failure to achieve a haematological response after a minimum of 3 months of therapy with imatinib, for patients initially treated in chronic phase; or
— failure to achieve any cytogenetic response after a minimum of 6 months of therapy with imatinib, for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or
— failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months of therapy with imatinib; or
(ii) loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Philadelphia positive cells on bone marrow biopsy), during ongoing imatinib therapy; or
(iii) loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing in value by at least 5 fold to a level of greater than 1% confirmed on a subsequent test), during ongoing imatinib therapy; or
(iv) development of accelerated phase or blast crisis in a patient previously prescribed imatinib for any phase of chronic myeloid leukaemia, where:
(1) accelerated phase is defined by the presence of 1 or more of the following:
— percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or
— percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or
— peripheral basophils greater than or equal to 20%; or
— progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or
— karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); and
(2) blast crisis is defined as either:
— percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or
— extramedullary involvement other than spleen and liver; or
(v) disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia; or
(vi) grade 3 or 4 non-haematological toxicity that is imatinib related and necessitates permanent cessation of imatinib; and
where the authority application includes:
(a) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib PBS Authority Application - Supporting Information Form; and
(b) a signed patient acknowledgement; and
(c) a bone marrow biopsy pathology report demonstrating that the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 1% on the international scale, and the date of the relevant pathology report; and
(d)(1) where there has been a loss of response to imatinib, a copy of the current confirming pathology report, or reports, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement; or
(2) details of Grade 3 or 4 non-haematological imatinib related toxicity;
for patients with imatinib related toxicities, leukaemia activity does not need to be demonstratedCompliance with Written Authority Required procedures
(b) insert after existing text:
C3999 P3999 Initial treatment, as the sole PBS-subsidised therapy, of a patient with chronic myeloid leukaemia in any disease phase who has failed an adequate trial of imatinib or nilotinib as first-line treatment
Failure of an adequate trial of imatinib or nilotinib is defined as:
(i) Lack of response to initial imatinib or nilotinib therapy, defined as either:
— failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or nilotinib for patients initially treated in chronic phase; or
— failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or nilotinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or
— failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or nilotinib; OR
(ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or nilotinib therapy; OR
(iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or nilotinib therapy; OR
(iv) Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or nilotinib for any phase of chronic myeloid leukaemia
Accelerated phase is defined by the presence of 1 or more of the following:
(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or
(2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or
(3) Peripheral basophils greater than or equal to 20%; or
(4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or
(5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); OR
Blast crisis is defined as either:
(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or
(2) Extramedullary involvement other than spleen and liver; OR
(v) Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia
Patients should be commenced on a dose of dasatinib of at least 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to dasatinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals
Applications for authorisation must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Chronic Myeloid Leukaemia - Second and Third Line - Supporting Information Form; and
(c) a signed patient acknowledgement; and
(d) a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale. (The date of the relevant pathology report needs to be provided); and
(e) where there has been a loss of response to imatinib or nilotinib, a copy of the current confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvementCompliance with Written Authority Required procedures
C4000 P4000 Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial PBS-subsidised treatment with dasatinib for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response, or less than 1% BCR-ABL level in the blood, to dasatinib in the preceding 18 months and thereafter at 12 monthly intervals
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Chronic Myeloid Leukaemia - Second and Third Line - Application Form for continuing treatment; and
(3) demonstration of continued response to treatment as evidenced by either:
(a) major cytogenetic response. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report needs to be provided; or
(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report needs to be provided
Definitions of response
A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells
A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic responseCompliance with Written Authority Required procedures
C4003 P4003 Initial treatment, as the sole PBS-subsidised therapy, of a patient in the chronic phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, BCR-ABL tyrosine kinase, and who has a primary diagnosis of chronic myeloid leukaemia
Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved
Patients should be commenced on a dose of dasatinib of at least 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to dasatinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and
(3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow; and
(4) a signed patient acknowledgement formCompliance with Written Authority Required procedures
C4004 P4004 Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial PBS-subsidised treatment with dasatinib for the chronic phase of chronic myeloid leukaemia and who has demonstrated either a major cytogenetic response or less than 1% BCR-ABL level in the blood
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) demonstration of continued response to treatment as evidenced by either:
(a) major cytogenetic response. Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided; or
(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale. Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided
Definitions of response
A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells
A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic responseCompliance with Written Authority Required procedures
[95] Schedule 4, Part 1, entry for Golimumab
omit:
C3484 P3484 Rheumatoid arthritis — initial treatment 3
Initial PBS-subsidised supply for continuing treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of an adult who:
(a) has a documented history of severe active rheumatoid arthritis; and
(b) was receiving treatment with golimumab prior to 1 March 2010; and
(c) has demonstrated a response to golimumab treatment, as specified in the criteria for continuing PBS-subsidised treatment with golimumab; and (d) is receiving treatment with golimumab at the time of application; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
the course of treatment is limited to a maximum of 24 weeks of treatment;
a patient is eligible for PBS-subsidised treatment under the above criteria once onlyCompliance with Written Authority Required procedures Continuation of a course of initial PBS-subsidised treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of an adult with a documented history of severe active rheumatoid arthritis who was receiving non-PBS-subsidised treatment with golimumab prior to 1 March 2010 and at the time of the initial application for PBS-subsidised therapy and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total Compliance with Written or Telephone Authority Required procedures [96] Schedule 4, Part 1, entry for Imatinib
(a) omit:
C2210 P2210 Chronic myeloid leukaemia (chronic phase)
Initial treatment of patients in the chronic phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia; and
where the following conditions apply:
treatment under this restriction is limited to a maximum of 18 months of therapy from the date the first application for initial treatment is approved;
the application for authorisation includes:
(1) a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia - Supporting Information form; and
(2) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the bcr-abl transcript in either peripheral blood or bone marrow; and
(3) a copy of a signed patient acknowledgement form indicating that the patient understands and acknowledges that PBS-subsidised treatment with imatinib mesylate for the chronic phase of chronic myeloid leukaemia will cease if subsequent testing demonstrates that:
(i) the patient has failed to achieve a major cytogenetic response within the initial 18 months of treatment; or
(ii) the patient has failed to sustain a major cytogenetic response for 12 months from the date of the last pathology report that indicated that a major cytogenetic response had been achieved;
the patient is not receiving concomitant PBS-subsidised interferon alfa therapyCompliance with Written Authority Required procedures C2488 P2488 Chronic myeloid leukaemia (chronic phase)
Continuing treatment of patients who have received initial treatment with imatinib mesylate as a pharmaceutical benefit for the chronic phase of chronic myeloid leukaemia and who have demonstrated either a major cytogenetic response or less than 1% bcr-abl level in the blood in the preceding 12 months; and
where the following conditions apply:
a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells;
a peripheral blood bcr-abl level of less than 1% on the international scale (Blood 108: 28-37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response;
response to PBS-subsidised treatment with imatinib mesylate is assessed by:
(1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with bcr-abl specific probe; or
(2) quantitative PCR indicating the relative level of bcr-abl transcript in the peripheral blood using the international scale;
the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows:
(i) between 10 and 12 months of the commencement of treatment with imatinib mesylate, at which time patients in whom a major cytogenetic response or peripheral blood bcr-abl level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and
(ii) within 18 months of the commencement of treatment with imatinib mesylate, in patients who have failed to demonstrate a major cytogenetic response or peripheral blood bcr-abl level of less than 1% at between 10 and 12 months (at which time patients in whom a major cytogenetic response or peripheral blood bcr-abl level of less than 1% is demonstrable by 18 months are eligible for a further 12 months of treatment); and
(iii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood bcr-abl level of less than 1% has been sustained;
the authority application includes:
(1) demonstration of continued response to treatment as evidenced by:
(a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months, in which case only the date of this report need be provided; or
(b) a copy of the quantitative PCR analysis showing a peripheral blood level of bcr-abl of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months, in which case only the date of this report need be provided; and
(2) if the cytogenetic analysis submitted with the application was conducted using FISH with bcr-abl specific probe because standard karyotyping was not informative, a copy of the non-informative standard karyotype analysis;
a patient who has previously received PBS-subsidised treatment with imatinib mesylate and has at any time failed to meet the criteria for continuing treatment of chronic myeloid leukaemia in the chronic phase, is not eligible for PBS-subsidised re-treatmentCompliance with Written Authority Required procedures
(b) insert after existing text:
C4007 P4007 Chronic myeloid leukaemia (chronic phase)
Initial treatment, as the sole PBS-subsidised therapy, of a patient in the chronic phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, BCR-ABL tyrosine kinase, and who has a primary diagnosis of chronic myeloid leukaemia
Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved
Patients should be commenced on a dose of imatinib mesylate of 400 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to imatinib mesylate therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and
(3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow; and
(4) a signed patient acknowledgement formCompliance with Written Authority Required procedures C4008 P4008 Chronic myeloid leukaemia (chronic phase)
Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial PBS-subsidised treatment with imatinib mesylate for the chronic phase of chronic myeloid leukaemia and who has demonstrated either a major cytogenetic response or less than 1% BCR-ABL level in the blood
First continuing applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) demonstration of a response to treatment as evidenced by either:
(a) major cytogenetic response; or
(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale
Definitions of response
A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells
A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic responseCompliance with Written Authority Required procedures Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has previously been issued with an authority prescription for continuing treatment with imatinib mesylate for the chronic phase of chronic myeloid leukaemia. Patients must maintain a major cytogenetic response or have a peripheral blood BCR-ABL of less than 1% to receive continuing therapy Compliance with Written or Telephone Authority Required procedures [97] Schedule 4, Part 1, entry for Nevirapine
insert after existing text:
C3994 Where the patient is receiving treatment at/from a private hospital
Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient who has been stabilised on nevirapine immediate release with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV diseaseCompliance with Written or Telephone Authority Required procedures C3995 Where the patient is receiving treatment at/from a public hospital
Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient who has been stabilised on nevirapine immediate release with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV diseaseCompliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3995 [98] Schedule 4, Part 1, entry for Nilotinib
substitute:
Nilotinib C4001 Initial treatment, as the sole PBS-subsidised therapy, of a patient with chronic myeloid leukaemia in chronic or accelerated phase who has failed an adequate trial of imatinib or dasatinib as first-line treatment
Failure of an adequate trial of imatinib or dasatinib is defined as:
(i) Lack of response to initial imatinib or dasatinib therapy, defined as either:
— failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or dasatinib for patients initially treated in chronic phase; or
— failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or dasatinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or
— failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or dasatinib; OR
(ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or dasatinib therapy; OR
(iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or dasatinib therapy; OR
(iv) Development of accelerated phase in a patient previously prescribed imatinib or dasatinib for the chronic phase of chronic myeloid leukaemia
Accelerated phase is defined by the presence of 1 or more of the following:
(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or
(2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or
(3) Peripheral basophils greater than or equal to 20%; or
(4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or
(5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); OR
(v) Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib or dasatinib therapy in patients with accelerated phase chronic myeloid leukaemia, provided that blast crisis has been excluded on bone marrow biopsy
Patients should be commenced on a dose of nilotinib of 400 mg twice daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to nilotinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals
Applications for authorisation must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Chronic Myeloid Leukaemia - Second and Third Line - Supporting Information Form; and
(c) a signed patient acknowledgement; and
(d) a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale. (The date of the relevant pathology report needs to be provided); and
(e) where there has been a loss of response to imatinib or dasatinib, a copy of the current confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvementCompliance with Written Authority Required procedures
C4002 Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial PBS-subsidised treatment with nilotinib for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response, or less than 1% BCR-ABL level in the blood, to dasatinib in the preceding 18 months and thereafter at 12 monthly intervals
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Chronic Myeloid Leukaemia - Second and Third Line - Application Form for continuing treatment; and
(3) demonstration of continued response to treatment as evidenced by either:
(a) major cytogenetic response. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report needs to be provided; or
(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report needs to be provided
Definitions of response
A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells
A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic responseCompliance with Written Authority Required procedures
C4005 Initial treatment, as the sole PBS-subsidised therapy, of a patient in the chronic phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, BCR-ABL tyrosine kinase, and who has a primary diagnosis of chronic myeloid leukaemia
Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved
Patients should be commenced on a dose of nilotinib of 300 mg twice daily. Continuing therapy is dependent on patients demonstrating a response to nilotinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and
(3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow; and
(4) a signed patient acknowledgement formCompliance with Written Authority Required procedures
C4006 Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial PBS-subsidised treatment with nilotinib for the chronic phase of chronic myeloid leukaemia and who has demonstrated either a major cytogenetic response or less than 1% BCR-ABL level in the blood
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) demonstration of continued response to treatment as evidenced by either:
(a) major cytogenetic response. Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided; or
(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale. Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided
Definitions of response
A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells
A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic responseCompliance with Written Authority Required procedures
[99] Schedule 4, Part 1, after entry for Rifampicin
insert:
Rilpivirine C3586 Where the patient is receiving treatment at/from a private hospital
Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV diseaseCompliance with Written or Telephone Authority Required procedures C3587 Where the patient is receiving treatment at/from a private hospital
Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infectionCompliance with Written or Telephone Authority Required procedures C3588 Where the patient is receiving treatment at/from a public hospital
Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV diseaseCompliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588 C3589 Where the patient is receiving treatment at/from a public hospital
Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infectionCompliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589 1Note
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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