National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 2) (No. PB 13 of 2012)

Link to law: https://www.comlaw.gov.au/Details/F2012L00730

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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 1
See 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 1
C1139 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 1
See 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 1
See 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 1
C1828 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 1
See 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 1
See 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 1
 
See Note 2
5
See Note 2
0
See Note 2
 

 
Injection 50 mg in 2 mL vial
Injection
Hospira Pty Limited
HH
MP
See Note 1
 
See Note 2
5
See Note 2
5
See Note 2
 

 
 
 
Pfizer Australia Pty Ltd
PF
MP
See Note 1
 
See Note 2
5
See Note 2
5
See Note 2
 

 
Solution concentrate for I.V. infusion 500 mg in 20 mL vial
Injection
Hospira Pty Limited
HH
MP
See Note 1
 
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 1
 
See Note 3
See Note 3
See Note 3
PB

 
 
 
Methotrexate Ebewe
SZ
MP
See Note 1
 
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 1
 
See 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 2
0
See Note 2
 

 
Injection 50 mg in 2 mL vial
Injection
Hospira Pty Limited
HH
MP
 
See Note 2
5
See Note 2
5
See Note 2
 

 
 
 
Methaccord
WQ
MP

 
See Note 2
5
See Note 2
5
See Note 2
 

 
 
 
Pfizer Australia Pty Ltd
PF
MP
 
See Note 2
5
See Note 2
5
See Note 2
 

 
Solution 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 1
C1650 C1651 C3355 C3356
 
600
5
C

 
Tablet containing mycophenolate mofetil 500 mg
Oral
CellCept
RO
MP
C1765 C1766
 
150
3
 

 
 
 
 
 
MP
See Note 1
C1650 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 1
C1650 C1651 C3355 C3356
 
600
5
C

 
 
 
CellCept
RO
MP
See Note 1
C1650 C1651 C3355 C3356
 
600
5
C

 
 
 
Ceptolate
AF
MP
See Note 1
C1650 C1651 C3355 C3356
 
600
5
C

 
 
 
Imulate
QA
MP
See Note 1
C1650 C1651 C3355 C3356
 
600
5
C

 
 
 
Mycophenolate Sandoz
SZ
MP
See Note 1
C1650 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 1
C1650 C1651 C3355 C3356
 
300
5
C

 
 
 
CellCept
RO
MP
See Note 1
C1650 C1651 C3355 C3356
 
300
5
C

 
 
 
Ceptolate
AF
MP
See Note 1
C1650 C1651 C3355 C3356
 
300
5
C

 
 
 
Imulate
QA
MP
See Note 1
C1650 C1651 C3355 C3356
 
300
5
C

 
 
 
Mycophenolate Sandoz
SZ
MP
See Note 1
C1650 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 1
C3587 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 1
C3586 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 1
See 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 treatment
Compliance 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 treatment
Compliance 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 treatment
Compliance 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 only
Compliance 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-treatment
Compliance 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 demonstrated
Compliance 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 involvement
Compliance 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 response
Compliance 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 form
Compliance 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 response
Compliance 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 only
Compliance 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 therapy
Compliance 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-treatment
Compliance 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 form
Compliance 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 response
Compliance 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 disease
Compliance 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 disease
Compliance 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 involvement
Compliance 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 response
Compliance 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 form
Compliance 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 response
Compliance 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 disease
Compliance 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 infection
Compliance 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 disease
Compliance 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 infection
Compliance 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. 
See http://www.frli.gov.au.