National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 8) (No. PB 93 of 2012)

Link to law: https://www.comlaw.gov.au/Details/F2012L02291

PB 93 of 2012
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012
(No. 8)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, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 26 November 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. 8).
            (2)        This Instrument may also be cited as PB 93 of 2012.
2          Commencement
This Instrument commences on 1 December 2012.
3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
            Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1     Amendments
 
[1]           Section 4, Definitions
(a)           omit full stop from the definition of Team Care Arrangements and substitute a semicolon
(b)           insert after definition of Team Care Arrangements and before Note:
TGA means Therapeutic Goods Administration;
WHO means World Health Organisation.
[2]           Schedule 1, entry for Aciclovir in the form Tablet 200 mg [GenRx Aciclovir; Max Quantity 50; Number of Repeats 0]
omit from the column headed “Pack Quantity”:          25           substitute:             50
[3]           Schedule 1, after entry for Adrenaline in the form I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector (Anapen)
insert:
Aflibercept
Solution for intravitreal injection 4 mg in 100 microlitres (40 mg per mL)
Injection
Eylea
BN
MP
C4153 C4154
 
1
2
1
 
[4]           Schedule 1, entry for Alendronic Acid in the form Tablet 70 mg (as alendronate sodium)
(a)      omit from the column headed “Circumstances” (all instances):
C2646
C3070

C3933
 

substitute:
C4122
C4123

C4133
 

(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Alendronate Pfizer
FZ
MP NP
C4122 C4123 C4133
 
4
5
4
 
 
[5]           Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol
omit from the column headed “Circumstances”:
C2646
C3070

C3933
 

substitute:
C4070
C4087

C4110
 

[6]           Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol
omit from the column headed “Circumstances” (twice occurring):
C2646
C3070

C3933
 

substitute:
C4122
C4123

C4133
 

[7]           Schedule 1, entry for Alendronic acid with colecalciferol and calcium
omit from the column headed “Circumstances” (twice occurring):
C2646
C3070

C3933
 

substitute:
C4122
C4123

C4133
 

[8]           Schedule 1, entry for Amlodipine with valsartan in the form Tablet 5 mg (as besylate)-80 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Valsartan/ Amlodipine Sandoz 80/5
NM
MP NP
C3307
 
28
5
28
 
 
[9]           Schedule 1, entry for Amlodipine with valsartan and hydrochlorothiazide in the form Tablet 5 mg (as besylate)-160 mg-12.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Valsartan/ Amlodipine/HCT Sandoz 160/5/12.5
NM
MP NP
C3539
 
28
5
28
 
 
[10]         Schedule 1, entry for Amoxycillin in the form Capsule 250 mg (as trihydrate)
(a)           omit:
 
 
 
GenRx Amoxycillin
GX
PDP
 
20
0
20
 
 
(b)           omit:
 
 
 
GenRx Amoxycillin
GX
MP NP MW
 
20
1
20
 
 
[11]         Schedule 1, entry for Amoxycillin in the form Capsule 500 mg (as trihydrate)
(a)           omit:
 
 
 
GenRx Amoxycillin
GX
PDP
 
20
0
20
 
 
(b)           omit:
 
 
 
GenRx Amoxycillin
GX
MP NP MW
 
20
1
20
 
 
[12]         Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 125 mg amoxycillin
(as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL [Max Quantity 1; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
GA-Amclav 125/31.25
GM
PDP
C1836 C1837
 
1
0
1
 
 
[13]         Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 125 mg amoxycillin
(as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL [Max Quantity 1; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
GA-Amclav 125/31.25
GM
MP NP
C1836 C1837
 
1
1
1
 
 
[14]         Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 400 mg amoxycillin
(as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL [Max Quantity 1; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
GA-Amclav Forte 400/57
GM
PDP
C1836 C1837
 
1
0
1
 
 
[15]         Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 400 mg amoxycillin
(as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL [Max Quantity 1; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
GA-Amclav Forte 400/57
GM
MP NP
C1836 C1837
 
1
1
1
 
 
[16]         Schedule 1, entry for Anastrozole
(a)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacy Choice Anastrozole
RI
MP NP
C2213
 
30
5
30
 
 
(b)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
STADA Anastrozole
TD
MP NP
C2213
 
30
5
30
 
 
[17]         Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride 20 mg in 2 mL
(a)           omit from the column headed “Max Quantity”:           5              substitute:             360
(b)           omit from the column headed “Number of Repeats”:  0              substitute:             5
[18]         Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride 50 mg in 5 mL
(a)           omit from the column headed “Max Quantity”:           5              substitute:             180
(b)           omit from the column headed “Number of Repeats”:  0              substitute:             5
[19]         Schedule 1, entry for Apomorphine in the form Solution for subcutaneous infusion containing apomorphine hydrochloride 50 mg in 10 mL pre-filled syringe
(a)           omit from the column headed “Max Quantity”:           5              substitute:             180
(b)           omit from the column headed “Number of Repeats”:  0              substitute:             5
[20]         Schedule 1, entry for Atenolol in the form Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Tenolten 50
DO
MP NP
 
30
5
30
 
 
[21]         Schedule 1, after entry for Atenolol in the form Tablet 50 mg [Terry White Chemists Atenolol]
insert in the columns in the order indicated:
 
Oral solution 50 mg in 10 mL, 300 mL
Oral
Atenolol-AFT
AE
MP NP
C4076
 
1
5
1
 
[22]         Schedule 1, entry for Auranofin in the form Capsule 3 mg
omit from the column headed “Responsible person”: BZ          substitute:             GH
[23]         Schedule 1, entry for Betamethasone
omit:
 
Ointment 200 micrograms (as valerate) per g, 100 g
Application
Antroquoril
FR
MP NP
C1422
 
2
0
1
 
 

 
 
 
Celestone-M
MK
MP NP
C1422
 
2
0
1
 
 

[24]         Schedule 1, entry for Bortezomib in the form Powder for injection 1 mg
omit all codes from the column headed “Circumstances” and substitute:
 
C4082
C4103

C4127
C4141

C4163
 

[25]         Schedule 1, entry for Bortezomib in the form Powder for injection 3.5 mg
omit all codes from the column headed “Circumstances” and substitute:
 
C4079
C4080

C4081
C4126

C4161
C4162

[26]         Schedule 1, entry for Cabazitaxel
omit all codes from the column headed “Circumstances” and substitute:
 
C4073
C4138
[27]         Schedule 1, entry for Carbomer with Triglyceride Lipids
omit from the column headed “Form”:
Eye gel 2 mg-10 mg per g, 10 g, single dose units 0.6 g, 30
substitute:
Eye gel 2 mg-10 mg per g, single dose units 0.6 g, 30
[28]         Schedule 1, entry for Carvedilol in the form Tablet 3.125 mg
omit:
 
 
 
GenRx Carvedilol
GX
MP NP
C1735 C3234
 
30
0
30
 
 
[29]         Schedule 1, entry for Carvedilol in the form Tablet 6.25 mg
omit:
 
 
 
GenRx Carvedilol
GX
MP NP
C1735 C3234
 
60
5
60
 
 
[30]         Schedule 1, entry for Carvedilol in the form Tablet 12.5 mg
omit:
 
 
 
GenRx Carvedilol
GX
MP NP
C1735 C3234
 
60
5
60
 
 
[31]         Schedule 1, entry for Cefaclor in the form Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL
(a)           omit:
 
 
 
Cefaclor Sandoz
SZ
PDP
 
1
0
1
 
 
(b)           omit:
 
 
 
Cefaclor Sandoz
SZ
MP
 
1
1
1
 
 
[32]         Schedule 1, entry for Cefaclor in the form Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL
(a)           omit:
 
 
 
Cefaclor Sandoz
SZ
PDP
 
1
0
1
 
 
(b)           omit:
 
 
 
Cefaclor Sandoz
SZ
MP
 
1
1
1
 
 
[33]         Schedule 1, entry for Cefepime in the form Powder for injection 2 g (as hydrochloride)
omit:
 
 
 
Maxipime
BQ
MP NP
C1427
 
10
0
1
 
 
[34]         Schedule 1, entry for Cephalexin in the form Granules for oral suspension 125 mg per 5 mL, 100 mL
(a)           omit:
 
 
 
GenRx Cephalexin
GX
PDP
 
1
0
1
 
 
(b)           omit:
 
 
 
GenRx Cephalexin
GX
MP NP
 
1
1
1
 
 
[35]         Schedule 1, entry for Cephalexin in the form Granules for oral suspension 250 mg per 5 mL, 100 mL
(a)           omit:
 
 
 
GenRx Cephalexin
GX
PDP
 
1
0
1
 
 
(b)           omit:
 
 
 
GenRx Cephalexin
GX
MP NP
 
1
1
1
 
 
[36]         Schedule 1, entry for Citalopram in each of the forms: Tablet 20 mg (as hydrobromide); and Tablet 40 mg (as hydrobromide)
omit:
 
 
 
GenRx Citalopram
GX
MP NP
C1211
 
28
5
28
 
 
[37]         Schedule 1, entry for Clarithromycin in the form Tablet 250 mg
omit:
 
 
 
GenRx Clarithromycin
GX
MP NP
 
14
1
14
 
[38]         Schedule 1, entry for Clopidogrel with aspirin in the form Tablet 75 mg (as hydrogen sulfate)-100 mg
(a)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Clopidogrel/ Aspirin 75/100
TX
MP NP
C1722 C3219 C3880
 
30
5
30
 
 
(b)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Chem mart Clopidogrel/ Aspirin 75/100
CH
MP NP
C1722 C3219 C3880
 
30
5
30
 
 
(c)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terry White Chemists  Clopidogrel/ Aspirin 75/100
TW
MP NP
C1722 C3219 C3880
 
30
5
30
 
 
[39]         Schedule 1, entry for Clozapine in each of the forms: Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg
omit from the column headed “Max Quantity” (all instances):                 100         substitute:             200
[40]         Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Max Quantity 20; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cyproterone-PS
FZ
MP
C1014 C1230 C1404
P1230
20
5
20
 
 
[41]         Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Max Quantity 100; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cyproterone-PS
FZ
MP
C1014 C1230 C1404
P1014 P1404
100
5
50
 
 
[42]         Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg
(a)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cyproterone-PS 100
FZ
MP
C1014 C1404
 
50
5
50
 
 
(b)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cyproterone Sandoz
HX
MP
C1014 C1404
 
50
5
50
 
 
 
 
[43]         Schedule 1, entry for Denosumab in the form Injection 60 mg in 1 mL pre-filled syringe
omit from the column headed “Circumstances”:
C3987  C4054
insert in numerical order:
C4094  C4145
[44]         Schedule 1, entry for Denosumab in the form Injection 120 mg in 1.7 mL
omit from the column headed “Circumstances”:
C1035  C4051
insert in numerical order:
C4150  C4158
[45]         Schedule 1, entry for Docetaxel
substitute:
Docetaxel
Solution concentrate for I.V. infusion 140 mg in 7 mL
Injection
Oncotaxel 140
TA
MP
C3888 C3892 C3916 C3956 C4078 C4140 C4155 C4160
 
See Note 3
See Note 3
1
 
D(100)

 
Solution concentrate for I.V. infusion 160 mg in 16 mL
Injection
DBL Docetaxel Concentrated Injection
HH
MP
C3888 C3892 C3916 C3956 C4078 C4140 C4155 C4160
 
See Note 3
See Note 3
1
 
D(100)

 
Powder for I.V. infusion 20 mg with solvent
Injection
Docetaxel SUN
ZF
MP
C4078 C4140 C4155 C4160
 
See Note 3
See Note 3
1
 
D(100)

 
Powder for I.V. infusion 80 mg with solvent
Injection
Docetaxel SUN
ZF
MP
C4078 C4140 C4155 C4160
 
See Note 3
See Note 3
1
 
D(100)

 
Solution concentrate for I.V. infusion 20 mg in 1 mL
Injection
Oncotaxel 20
TA
MP
C3888 C3892 C3916 C3956 C4078 C4140 C4155 C4160
See Note 3
See Note 3
See Note 3
1
 
D(100)

 
 
 
Taxotere
SW
MP
C3888 C3892 C3916 C3956 C4078 C4140 C4155 C4160
See Note 3
See Note 3
See Note 3
1
 
D(100)

 
Solution concentrate for I.V. infusion 20 mg in 2 mL
Injection
DBL Docetaxel Concentrated Injection
HH
MP
C3888 C3892 C3916 C3956 C4078 C4140 C4155 C4160
See Note 3
See Note 3
See Note 3
1
 
D(100)

 
 
 
Docetaxel Ebewe
HX
MP
C3888 C3916 C4078 C4140 C4155 C4160
See Note 3
See Note 3
See Note 3
1
 
D(100)

 
 
 
Docetaxel Sandoz
SZ
MP
C3888 C3892 C3916 C3956 C4078 C4140 C4155 C4160
See Note 3
See Note 3
See Note 3
1
 
D(100)

 
Solution concentrate for I.V. infusion 80 mg in 4 mL
Injection
Oncotaxel 80
TA
MP
C3888 C3892 C3916 C3956 C4078 C4140 C4155 C4160
 
See Note 3
See Note 3
1
 
D(100)

 
 
 
Taxotere
SW
MP
C3888 C3892 C3916 C3956 C4078 C4140 C4155 C4160
 
See Note 3
See Note 3
1
 
D(100)

 
Solution concentrate for I.V. infusion 80 mg in 8 mL
Injection
DBL Docetaxel Concentrated Injection
HH
MP
C3888 C3892 C3916 C3956 C4078 C4140 C4155 C4160
 
See Note 3
See Note 3
1
 
D(100)

 
 
 
Docetaxel Ebewe
HX
MP
C3888 C3916 C4078 C4140 C4155 C4160
 
See Note 3
See Note 3
1
 
D(100)

 
 
 
Docetaxel Sandoz
SZ
MP
C3888 C3892 C3916 C3956 C4078 C4140 C4155 C4160
 
See Note 3
See Note 3
1
 
D(100)

 
Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent
Injection
Taxotere
SW
MP
C3888 C3892 C3916 C3956 C4078 C4140 C4155 C4160
 
See Note 3
See Note 3
1
 
D(100)

 
[46]         Schedule 1, entry for Etanercept
substitute:
 
Etanercept
Injection 50 mg in 1 mL single use auto-injector, 4
Injection
Enbrel
PF
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
1
 
C(100)

 
 
 
 
 
MP
See Note 1
C3273 C3275 C3489 C3510 C3524 C3708 C3770 C3771 C3772 C3773 C3774 C3775 C3776 C3777 C3778 C3779 C3780 C3781 C4088 C4114 C4115 C4116 C4125 C4136 C4137 C4151
P3273 P3275 P3489 P3510 P3524 P3708 P3770 P3772 P3774 P3776 P3778 P3779 P4088 P4114 P4115 P4116 P4125 P4136 P4137 P4151
1
3
1
 
 

 
 
 
 
 
MP
See Note 1
C3273 C3275 C3489 C3510 C3524 C3708 C3770 C3771 C3772 C3773 C3774 C3775 C3776 C3777 C3778 C3779 C3780 C3781 C4088 C4114 C4115 C4116 C4125 C4136 C4137 C4151
P3771 P3773 P3775 P3777 P3780 P3781
1
5
1
 
 

 
Injections 50 mg in 1 mL single use pre-filled syringes, 4
Injection
Enbrel
PF
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
1
 
C(100)

 
 
 
 
 
MP
See Note 1
C3273 C3275 C3489 C3510 C3524 C3708 C3770 C3771 C3772 C3773 C3774 C3775 C3776 C3777 C3778 C3779 C3780 C3781 C4088 C4114 C4115 C4116 C4125 C4136 C4137 C4151
P3273 P3275 P3489 P3510 P3524 P3708 P3770 P3772 P3774 P3776 P3778 P3779 P4088 P4114 P4115 P4116 P4125 P4136 P4137 P4151
1
3
1
 
 

 
 
 
 
 
 
C3273 C3275 C3489 C3510 C3524 C3708 C3770 C3771 C3772 C3773 C3774 C3775 C3776 C3777 C3778 C3779 C3780 C3781 C4088 C4114 C4115 C4116 C4125 C4136 C4137 C4151
P3771 P3773 P3775 P3777 P3780 P3781
1
5
1
 
 

 
Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL
Injection
Enbrel
PF
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
1
 
C(100)

 
 
 
 
 
MP
See Note 1
C3273 C3275 C3489 C3510 C3524 C3708 C3770 C3771 C3772 C3773 C3774 C3775 C3776 C3777 C3778 C3779 C3780 C3781 C4088 C4114 C4115 C4116 C4125 C4136 C4137 C4151
P3273 P3275 P3489 P3510 P3524 P3708 P3770 P3772 P3774 P3776 P3778 P3779 P4088 P4114 P4115 P4116 P4125 P4136 P4137 P4151
2
3
1
 
 

 
 
 
 
 
MP
See Note 1
C3273 C3275 C3489 C3510 C3524 C3708 C3770 C3771 C3772 C3773 C3774 C3775 C3776 C3777 C3778 C3779 C3780 C3781 C4088 C4114 C4115 C4116 C4125 C4136 C4137 C4151
P3771 P3773 P3775 P3777 P3780 P3781
2
5
1
 
 

[47]         Schedule 1, entry for Ezetimibe with Simvastatin in each of the forms: Tablet 10 mg-10 mg; and Tablet 10 mg-20 mg
omit all codes from the column headed “Circumstances” and substitute:
 
C4068
C4069

C4085
C4086

C4096
C4097

C4120
C4121

C4147
 

[48]         Schedule 1, entry for Ezetimibe with Simvastatin in each of the forms: Tablet 10 mg-40 mg; and Tablet 10 mg-80 mg
omit all codes from the column headed “Circumstances” and substitute:
 
C4068
C4069

C4085
C4086

C4096
C4097

C4120
C4121

[49]         Schedule 1, entry for Famciclovir in the form Tablet 125 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Famciclovir-GA
GM
MP NP
C3624
 
40
1
40
 
 
[50]         Schedule 1, entry for Famciclovir in the form Tablet 250 mg [Max Quantity 20; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Famciclovir-GA
GM
MP NP
C3622 C3623 C3624
P3624
20
1
20
 
 
[51]         Schedule 1, entry for Famciclovir in the form Tablet 250 mg [Max Quantity 21; Number of Repeats 0]
(a)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Famciclovir-GA
GM
MP NP
C3622 C3623 C3624
P3622
21
0
21
 
 
(b)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Famciclovir generichealth 250
GQ
MP NP
C3622 C3623
P3622
21
0
21
 
 
[52]         Schedule 1, entry for Famciclovir in the form Tablet 250 mg [Max Quantity 56; Number of Repeats 5]
(a)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Famciclovir-GA
GM
MP NP
C3622 C3623 C3624
P3623
56
5
56
 
 
(b)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Famciclovir generichealth 250
GQ
MP NP
C3622 C3623
P3623
56
5
56
 
 
[53]         Schedule 1, entry for Famciclovir in the form Tablet 500 mg [Max Quantity 56; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Famciclovir-GA
GM
MP NP
C3626 C3627 C3628 C3629
P3626 P3627 P3628 P3629
56
5
56
 
 
[54]         Schedule 1, entry for Gemfibrozil in the form Tablet 600 mg [Max Quantity 60; Number of Repeats 5]
(a)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Gemfibrozil-GA
GM
MP
C1540 C3047
P1540
60
5
60
 
 

 
 
 
 
 
NP
C1540
 
60
5
60
 
 

(b)           omit:
 
 
 
Lipazil 600 mg
GM
MP
C1540 C3047
P1540
60
5
60
 
 

 
 
 
 
 
NP
C1540
 
60
5
60
 
 

[55]         Schedule 1, entry for Gemfibrozil in the form Tablet 600 mg [Max Quantity 60; Number of Repeats 11]
(a)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Gemfibrozil-GA
GM
MP
C1540 C3047
P3047
60
11
60
 
 
(b)           omit:
 
 
 
Lipazil 600 mg
GM
MP
C1540 C3047
P3047
60
11
60
 
 
[56]         Schedule 1, entry for Glucose Indicator―Blood
(a)           insert in the columns indicated after “Test strips, 50 (Glucocard 01 Sensor)”:
 
Test strips, 50 (GlucoDr)
For external use
GlucoDr
OZ
MP NP
 
2
5
1
 
 

 
 
 
 
 
MP
 
P3035
2
11
1
 
 

(b)           omit:
 
Test strips, 50 (GlucoOz)
For external use
GlucoOz
OZ
MP NP
 
2
5
1
 
 

 
 
 
 
 
MP
 
P3035
2
11
1
 
 

[57]         Schedule 1, entry for Granisetron
substitute:
Granisetron
Tablet 2 mg (as hydrochloride)
Oral
Kytril
RO
MP NP
See Note 1
C4102 C4118 See Note 2
P4118
See Note 2
2
See Note 2
0
See Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C4102 C4118 See Note 2
P4102
See Note 2
5
See Note 2
1
See Note 2
5
 
 

 
Concentrated injection 3 mg (as hydrochloride) in 3 mL
Injection
Granisetron Kabi
PK
MP NP
See Note 1
C4077 C4092
See Note 2
 
1
See Note 2
0
See Note 2
1
 
 

 
 
 
Kytril
RO
MP NP
See Note 1
C4077 C4092
See Note 2
 
1
See Note 2
0
See Note 2
1
 
 

[58]         Schedule 1, after entry for Human menopausal gonadotrophin
insert:
Hyaluronic Acid
Eye drops containing sodium hyaluronate 1 mg per mL, 10 mL
Application to the eye
Hylo-Fresh
AE
MP NP
C4105
 
1
5
1
 

 
 
 
 
 
AO
C4130
 
1
5
1
 
 

 
Eye drops containing sodium hyaluronate 2 mg per mL, 10 mL
Application to the eye
Hylo-Forte
AE
MP NP
C4105
 
1
5
1
 
 

 
 
 
 
 
AO
C4130
 
1
5
1
 
 

[59]         Schedule 1, entry for Hydroxocobalamin
substitute:
Hydroxocobalamin
Injection 1 mg (as acetate) in 1 mL
Injection
Vita-B12
GH
MP NP
C4111 C4134 C4135
 
3
0
3
 
 

 
Injection 1 mg (as chloride) in 1 mL
Injection
Hydroxo-B12
AS
MP NP
C4111 C4134 C4135
 
3
0
3
 
 

 
 
 
Neo-B12
HH
MP NP
C4111 C4134 C4135
 
3
0
3
 
 

[60]         Schedule 1, entry for Imiquimod
(a)      omit from the column headed “Pack Size” for the brand “Aldara”:             30         substitute:          1
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Imiquimod
TX
MP
C2816
 
1
1
1
 
 
[61]         Schedule 1, entry for Lamivudine in each of the forms: Tablet 150 mg; and Tablet 300 mg
omit from the column headed “Brand”:         Alphapharm Lamivudine             substitute:             Lamivudine Alphapharm
[62]         Schedule 1, entry for Lamotrigine in the form Tablet 25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Reedos 25
DO
MP NP
C1426
 
56
5
56
 
 
[63]         Schedule 1, entry for Lamotrigine in the form Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Reedos 50
DO
MP NP
C1426
 
56
5
56
 
 
[64]         Schedule 1, entry for Lamotrigine in the form Tablet 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Reedos 100
DO
MP NP
C1426
 
56
5
56
 
 
[65]         Schedule 1, entry for Lamotrigine in the form Tablet 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Reedos 200
DO
MP NP
C1426
 
56
5
56
 
 
[66]         Schedule 1, entry for Leflunomide in each of the forms: Tablet 10 mg; and Tablet 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Leflunomide-GA
GM
MP
C2644
 
30
5
30
 
 
[67]         Schedule 1, entry for Letrozole
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
STADA Letrozole
TD
MP NP
C1608 C2691 C2692
 
30
5
30
 
 
[68]         Schedule 1, entry for Lisinopril in each of the forms: Tablet 5 mg; Tablet 10 mg; and Tablet 20 mg
omit:
 
 
 
GenRx Lisinopril
GX
MP NP
 
30
5
30
 
 
[69]         Schedule 1, entry for Loperamide
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Gastrex
CR
MP NP
 
12
0
12
 
 
[70]         Schedule 1, entry for Meloxicam in each of the forms: Tablet 7.5 mg; and Tablet 15 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Meloxicam
TX
MP NP
C1547 C1848
 
30
3
30
 
[71]         Schedule 1, entry for Mirtazapine in the form Tablet 15 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Mirtazapine
TX
MP NP
C1211
 
30
5
30
 
[72]         Schedule 1, entry for Mycophenolic Acid
omit:
Mycophenolic Acid
Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid
Oral
Myfortic
NV
MP
C1763
 
120
3
120
 
 

 
 
 
 
 
MP
See Note 1
C1650 C3355
 
240
5
120
 
C(100)

 
Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid
Oral
Myfortic
NV
MP
C1763
 
120
3
120
 
 

 
 
 
 
 
MP
See Note 1
C1650 C3355
 
240
5
120
 
C(100)

substitute:
Mycophenolic Acid
Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid
Oral
Myfortic
NV
MP
C1763 C4131
P1763
120
3
120
 
 

 
 
 
 
 
MP
C1763 C4131
P4131
120
5
120
 
 

 
 
 
 
 
MP
See Note 1
C4084 C4095 C4108 C4146
 
240
5
120
 
C(100)

 
Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid
Oral
Myfortic
NV
MP
C1763 C4131
P1763
120
3
120
 
 

 
 
 
 
 
MP
C1763 C4131
P4131
120
5
120
 
 

 
 
 
 
 
MP
See Note 1
C4084 C4095 C4108 C4146
 
240
5
120
 
C(100)

[73]         Schedule 1, entry for Naloxone
insert as first item in the columns in the order indicated:
 
Injection containing naloxone hydrochloride 400 micrograms in 1 mL pre-filled syringe
Injection
Naloxone minijet
UC
MP NP PDP
 
5
0
1
 
 

 
 
 
 
 
MP NP
 
 
10
0
1
 
 

[74]         Schedule 1, after entry for Naproxen in the form Tablet 1 g (sustained release) [Proxen SR 1000] [Max Quantity 28; Number of Repeats 3]
insert in the columns in the order indicated:
 
Oral suspension 125 mg per mL, 474 mL
Oral
Phebra Naproxen Suspension
PL
MP NP
C4124 C4128 C4129 C4159
P4129
1
0
1
 
 

 
 
 
 
 
 
C4124 C4128 C4129 C4159
P4124 P4128 P4159
1
3
1
 
 

[75]         Schedule 1, omit entry for Neomycin with Bacitracin
[76]         Schedule 1, entry for Nevirapine in the form Tablet 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Nevirapine Alphapharm
AF
MP
See Note 1
C3586 C3587 C3588 C3589
 
120
5
60
 
D(100)
[77]         Schedule 1, entry for Octreotide in each of the forms: Injection 50 micrograms (as acetate) in 1 mL; Injection 100 micrograms (as acetate) in 1 mL; and Injection 500 micrograms (as acetate) in 1 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Octreotide (SUN)
ZF
MP
See Note 1
C2622 C2623 C3407 C3408
 
90
11
5
 
D(100)
[78]         Schedule 1, entry for Olanzapine in each of the forms: Wafer 15 mg; and Wafer 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Zypine ODT
AF
MP NP
C1589 C2044
 
28
5
28
 
 
[79]         Schedule 1, entry for Olmesartan with amlodipine in each of the forms: Tablet containing olmesartan medoxomil 20 mg with amlodipine
5 mg (as besylate); Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besylate); and Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besylate)
omit from the column headed “Authorised Prescriber”:            MP         substitute:             MP NP
[80]         Schedule 1, entry for Omeprazole
substitute:
Omeprazole
Tablet 20 mg (as magnesium)
Oral
Acimax Tablets
AL
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
Losec Tablets
AP
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
Omepral
PM
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
Omeprazole Sandoz
SZ
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
Acimax Tablets
AL
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
 
 
Losec Tablets
AP
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
 
 
Omepral
PM
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
 
 
Omeprazole Sandoz
SZ
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
Tablet 20 mg
Oral
APO-Omeprazole
TX
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
Chem mart Omeprazole
CH
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
Meprazol
SZ
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
Omeprazole-GA
GM
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
Omeprazole generichealth
GQ
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
Omeprazole-PS
FZ
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
Omeprazole RBX
RA
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
Omeprazole Winthrop
WA
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
Ozmep
ZP
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
Terry White Chemists Omeprazole
TW
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
APO-Omeprazole
TX
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
 
 
Chem mart Omeprazole
CH
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
 
 
Meprazol
SZ
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
 
 
Omeprazole-GA
GM
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
 
 
Omeprazole generichealth
GQ
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
 
 
Omeprazole-PS
FZ
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
 
 
Omeprazole RBX
RA
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
 
 
Omeprazole Winthrop
WA
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
 
 
Ozmep
ZP
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
 
 
Terry White Chemists Omeprazole
TW
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
Capsule 20 mg
Oral
APO-Omeprazole
TX
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
Maxor
AF
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
Omeprazole Sandoz
HX
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
Omepro-GA
GM
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
Pemzo
QA
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
Pharmacor Omeprazole 20
CR
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
Probitor
SZ
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 

 
 
 
APO-Omeprazole
TX
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
 
 
Maxor
AF
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
 
 
Omeprazole Sandoz
HX
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
 
 
Omepro-GA
GM
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
 
 
Pemzo
QA
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
 
 
Pharmacor Omeprazole 20
CR
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
 
 
Probitor
SZ
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 

 
Tablet 10 mg (as magnesium)
Oral
Losec Tablets
AP
MP NP
C1337 C1476 C1533
 
30
5
30
 
 

[81]          Schedule 1, after entry for Paraffin in the form Eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g
[Poly Visc] [Max Quantity 2; Number of Repeats 11]
insert in the columns in the order indicated:
 
Eye ointment, compound, containing liquid paraffin, light liquid paraffin, wool fat, white soft paraffin and retinyl palmitate, 5 g
Application to the eye
VitA-POS
AE
MP NP AO
 
2
5
1
 

 
 
 
 
 
MP
 
P4072
2
11
1
 
 

[82]         Schedule 1, entry for Pazopanib
substitute:
Pazopanib
Tablet 200 mg (as hydrochloride)
Oral
Votrient
GK
MP
C4067 C4109 C4112 C4148
P4112
30
5
30
 
 

 
 
 
 
 
 
C4067 C4109 C4112 C4148
P4148
90
2
90
 
 

 
 
 
 
 
 
C4067 C4109 C4112 C4148
P4067 P4109
90
5
90
 
 

 
Tablet 400 mg (as hydrochloride)
Oral
Votrient
GK
MP
C4067 C4109 C4112 C4148
P4112
30
5
30
 
 

 
 
 
 
 
 
C4067 C4109 C4112 C4148
P4148
60
2
60
 
 

 
 
 
 
 
 
C4067 C4109 C4112 C4148
P4067 P4109
60
5
60
 
 

[83]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg
(a)           omit:
 
 
 
GenRx Pravastatin
GX
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

(b)           omit:
 
 
 
GenRx Pravastatin
GX
MP
C1540 C3047
P3047
30
11
30
 
 
[84]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg
(a)           omit:
 
 
 
GenRx Pravastatin
GX
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

(b)           omit:
 
 
 
GenRx Pravastatin
GX
MP
C1540 C3047
P3047
30
11
30
 
 
[85]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg
(a)           omit:
 
 
 
GenRx Pravastatin
GX
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

(b)           omit:
 
 
 
GenRx Pravastatin
GX
MP
C1540 C3047
P3047
30
11
30
 
 
[86]         Schedule 1, entry for Rabeprazole
substitute:
Rabeprazole
Tablet containing rabeprazole sodium 10 mg (enteric coated)
Oral
APO-Rabeprazole
TX
MP NP
C1337 C1533
 
28
5
28
 
 

 
 
 
Chem mart Rabeprazole
CH
MP NP
C1337 C1533
 
28
5
28
 
 

 
 
 
Pariet
JC
MP NP
C1337 C1533
 
28
5
28
 
 

 
 
 
Parzole 10
ZP
MP NP
C1337 C1533
 
28
5
28
 
 

 
 
 
Prabez
AF
MP NP
C1337 C1533
 
28
5
28
 
 

 
 
 
Rabeprazole-GA
GM
MP NP
C1337 C1533
 
28
5
28
 
 

 
 
 
Rabeprazole generichealth
GQ
MP NP
C1337 C1533
 
28
5
28
 
 

 
 
 
Rabeprazole Pfizer
FZ
MP NP
C1337 C1533
 
28
5
28
 
 

 
 
 
Rabeprazole Sandoz
SZ
MP NP
C1337 C1533
 
28
5
28
 
 

 
 
 
Rabzole
JS
MP NP
C1337 C1533
 
28
5
28
 
 

 
 
 
Terry White Chemists Rabeprazole
TW
MP NP
C1337 C1533
 
28
5
28
 
 

 
Tablet containing rabeprazole sodium 20 mg (enteric coated)
Oral
APO-Rabeprazole
TX
MP NP
C1177 C1337 C1533
P1177
30
2
30
 
 

 
 
 
Chem mart Rabeprazole
CH
MP NP
C1177 C1337 C1533
P1177
30
2
30
 
 

 
 
 
Pariet
JC
MP NP
C1177 C1337 C1533
P1177
30
2
30
 
 

 
 
 
Parzole 20
ZP
MP NP
C1177 C1337 C1533
P1177
30
2
30
 
 

 
 
 
Prabez
AF
MP NP
C1177 C1337 C1533
P1177
30
2
30
 
 

 
 
 
Rabeprazole-GA
GM
MP NP
C1177 C1337 C1533
P1177
30
2
30
 
 

 
 
 
Rabeprazole generichealth
GQ
MP NP
C1177 C1337 C1533
P1177
30
2
30
 
 

 
 
 
Rabeprazole Pfizer
FZ
MP NP
C1177 C1337 C1533
P1177
30
2
30
 
 

 
 
 
Rabeprazole Sandoz
SZ
MP NP
C1177 C1337 C1533
P1177
30
2
30
 
 

 
 
 
Rabzole
JS
MP NP
C1177 C1337 C1533
P1177
30
2
30
 
 

 
 
 
Terry White Chemists Rabeprazole
TW
MP NP
C1177 C1337 C1533
P1177
30
2
30
 
 

 
 
 
APO-Rabeprazole
TX
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
 
 

 
 
 
Chem mart Rabeprazole
CH
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
 
 

 
 
 
Pariet
JC
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
 
 

 
 
 
Parzole 20
ZP
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
 
 

 
 
 
Prabez
AF
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
 
 

 
 
 
Rabeprazole-GA
GM
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
 
 

 
 
 
Rabeprazole generichealth
GQ
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
 
 

 
 
 
Rabeprazole Pfizer
FZ
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
 
 

 
 
 
Rabeprazole Sandoz
SZ
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
 
 

 
 
 
Rabzole
JS
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
 
 

 
 
 
Terry White Chemists Rabeprazole
TW
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
 
 

[87]         Schedule 1, entry for Raloxifene
omit from the column headed “Circumstances”:          C2647   substitute:          C4071
[88]         Schedule 1, entry for Ranitidine in the form Tablet 300 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ranoxyl
GM
MP NP
 
30
5
30
 
[89]         Schedule 1, entry for Riluzole
substitute:
Riluzole
Tablet 50 mg
Oral
APO-Riluzole
TX
MP NP
C1762 C2718
 
56
5
56
 
 

 
 
 
Rilutek
SW
MP NP
C1762 C2718
 
56
5
56
 
 

 
 
 
Riluzole Sandoz
SZ
MP NP
C1762 C2718
 
56
5
56
 
 

[90]         Schedule 1, entry for Risedronic Acid in each of the forms: Tablet containing risedronate sodium 5 mg; Tablet containing risedronate sodium 35 mg; Tablet (enteric coated) containing risedronate sodium 35 mg; and Tablet containing risedronate sodium 150 mg
omit from the column headed “Circumstances” (all instances):
C2645
C2646

C3070
 

substitute:
C4117
C4122

C4123
 

[91]         Schedule 1, entry for Risedronic Acid and Calcium
substitute”:
Risedronic Acid and Calcium
Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate)
Oral
Acris Combi
AF
MP NP
C4117 C4122 C4123
 
1
5
1
 
 

 
 
 
Actonel Combi
SW
MP NP
C4117 C4122 C4123
 
1
5
1
 
 

 
Pack containing 4 enteric coated tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate)
Oral
Actonel EC Combi
SW
MP NP
C4117 C4122 C4123
 
1
5
1
 
 

 
 
 
Risedronate Winthrop  EC Combi
WA
MP NP
C4117 C4122 C4123
 
1
5
1
 
 

[92]         Schedule 1, entry for Risedronic acid and calcium with colecalciferol
omit from the column headed “Circumstances” (all instances):
C2645
C2646

C3070
 

substitute:
C4117
C4122

C4123
 

[93]         Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [APO-Risperidone; Max Quantiy 60; Number of Repeats 2]
omit from the column headed “Pack Quantity”:                          60           substitute:             20
[94]         Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Risperdal; Max Quantiy 60; Number of Repeats 2]
omit from the column headed “Pack Quantity”:                          60           substitute:             20
[95]         Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [APO-Risperidone; Max Quantiy 60; Number of Repeats 5]
omit from the column headed “Pack Quantity”:                          60           substitute:             20
[96]         Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Risperdal; Max Quantiy 60; Number of Repeats 5]
omit from the column headed “Pack Quantity”:                          60           substitute:             20
[97]         Schedule 1, after entry for Rivaroxaban in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 0]
insert in the columns in the order indicated:
 
Tablet 15 mg
Oral
Xarelto
BN
MP NP
C4098
 
42
0
42
 

 
Tablet 20 mg
Oral
Xarelto
BN
MP NP
C4099 C4132
 
28
5
28
 
 

[98]         Schedule 1, entry for Simvastatin in the form Tablet 20 mg
(a)           omit:
 
 
 
GenRx Simvastatin
GX
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

(b)           omit:
 
 
 
GenRx Simvastatin
GX
MP
C1540 C3047
P3047
30
11
30
 
 
[99]         Schedule 1, entry for Simvastatin in the form Tablet 40 mg
(a)           omit:
 
 
 
GenRx Simvastatin
GX
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

(b)           omit:
 
 
 
GenRx Simvastatin
GX
MP
C1540 C3047
P3047
30
11
30
 
 
 
[100]       Schedule 1, entry for Simvastatin in the form Tablet 80 mg
(a)           omit:
 
 
 
GenRx Simvastatin
GX
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

(b)           omit:
 
 
 
GenRx Simvastatin
GX
MP
C1540 C3047
P3047
30
11
30
 
 
[101]       Schedule 1, entry for Strontium
omit from the column headed “Circumstances”:
C2647
C2758
substitute:
C4071
C4107
[102]       Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Sumatriptan RBX
RA
MP NP
C3233
 
4
5
4
 
 
[103]       Schedule 1, entry for Sunitinib
substitute:
 
Sunitinib
Capsule 12.5 mg (as malate)
Oral
Sutent
PF
MP
C3206 C3207 C4106 C4119
P3206 P3207 P4119
28
1
28
 
 

 
 
 
 
 
MP
C3206 C3207 C4106 C4119
P4106
28
3
28
 
 

 
Capsule 25 mg (as malate)
Oral
Sutent
PF
MP
C3206 C3207 C4106 C4119
P3206 P3207 P4119
28
1
28
 
 

 
 
 
 
 
MP
C3206 C3207 C4106 C4119
P4106
28
3
28
 
 

 
Capsule 50 mg (as malate)
Oral
Sutent
PF
MP
C3206 C3207 C4106 C4119
P3206 P3207 P4119
28
1
28
 
 

 
 
 
 
 
MP
C3206 C3207 C4106 C4119
P4106
28
3
28
 
 

[104]       Schedule 1, entry for Terbinafine in the form Tablet 250 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”:
 
 
 
Pharmacy Choice Terbinafine
RI
MP NP
C2191 C2865 C3244
P2865 P3244
42
0
42
 
 
[105]       Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Max Quantity 42; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacy Choice Terbinafine
RI
MP NP
C2191 C2865 C3244
P2191
42
1
42
 
 
[106]       Schedule 1, entry for Teriparatide
omit from the column headed “Circumstances”:
C4031
C4032
substitute:
C4101
C4113
[107]       Schedule 1, entry for Venlafaxine in each of the forms: Capsule (modified release) 75 mg (as hydrochloride); and Capsule (modified release) 150 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
STADA Venlafaxine SR
TD
MP NP
C1211
 
28
5
28
 
[108]       Schedule 1, entry for Zoledronic acid in the form Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL
omit from the column headed “Circumstances”:
C3290
C3945

C3946
C3947

substitute:
C3290
C4100

C4149
C4157

 
[109]       Schedule 3
omit:
HA
Hamilton Pharmaceutical Pty Ltd
 93 008 204 635
[110]       Schedule 3, after details relevant to Responsible person code JJ
insert:
JS
Janssen-Cilag Pty Ltd
 47 000 129 975
[111]       Schedule 3, after details relevant to Responsible person code RD
insert:
RI
Dr Reddy's Laboratories (Australia) Pty Ltd
 16 120 092 408
[112]       Schedule 4, Part 1, after entry for Adrenaline
insert:

Aflibercept
C4153
 
 
Subfoveal choroidal neovascularisation (CNV)
Initial treatment
Must be treated by a ophthalmologist;
The condition must be due to age-related macular degeneration (AMD);
The condition must be diagnosed by fluorescein angiography;
The treatment must be the sole PBS-subsidised therapy for this condition
Authority approval for initial treatment of each eye must be sought
The first authority application for each eye must be made in writing or by telephone
A written application must include:
(a) a completed authority prescription form;
(b) a completed Subfoveal Choroidal Neovascularisation (CNV) PBS Supporting Information Form; and
(c) a copy of the fluorescein angiogram
A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised
Where a fluorescein angiogram cannot be performed due to a contraindication as listed in the TGA-approved product information, details of the contraindication must be provided. A copy of the report of an alternative method of diagnosis must be included in the application, for example, optical coherence tomography (OCT) or red free photography
Compliance with Written or Telephone Authority Required procedures


 
C4154
 
 
Subfoveal choroidal neovascularisation (CNV)
Continuing treatment
Must be treated by a ophthalmologist;
The condition must be due to age-related macular degeneration (AMD);
The treatment must be the sole PBS-subsidised therapy for this condition;
Patient must have previously been granted an authority prescription for the same eye
Compliance with Written or Telephone Authority Required procedures


[113]       Schedule 4, Part 1, entry for Alendronic Acid
substitute:

Alendronic Acid
C3256
 
 
Symptomatic Paget disease of bone
Compliance with Authority Required procedures - Streamlined Authority Code 3256

 
C4122
 
 
Corticosteroid-induced osteoporosis
Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy;
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4122

 
C4123
 
 
Established osteoporosis
Patient must have fracture due to minimal trauma;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Compliance with Authority Required procedures - Streamlined Authority Code 4123

 
C4133
 
 
Osteoporosis
Patient must be aged 70 years or older;
Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4133

[114]       Schedule 4, Part 1, entry for Alendronic acid with colecalciferol
substitute:

Alendronic acid with colecalciferol
C4070
 
 
Corticosteroid-induced osteoporosis
Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy;
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4070

 
C4087
 
 
Established osteoporosis
Patient must have fracture due to minimal trauma;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Compliance with Authority Required procedures - Streamlined Authority Code 4087

 
C4110
 
 
Osteoporosis
Patient must be aged 70 years or older;
Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4110

 
C4122
 
 
Corticosteroid-induced osteoporosis
Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy;
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4122

 
C4123
 
 
Established osteoporosis
Patient must have fracture due to minimal trauma;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Compliance with Authority Required procedures - Streamlined Authority Code 4123

 
C4133
 
 
Osteoporosis
Patient must be aged 70 years or older;
Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4133

[115]       Schedule 4, Part 1, entry for Alendronic acid with colecalciferol and calcium
substitute:

Alendronic acid with colecalciferol and calcium
C4122
 
 
Corticosteroid-induced osteoporosis
Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy;
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4122

 
C4123
 
 
Established osteoporosis
Patient must have fracture due to minimal trauma;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Compliance with Authority Required procedures - Streamlined Authority Code 4123

 
C4133
 
 
Osteoporosis
Patient must be aged 70 years or older;
Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4133

[116]       Schedule 4, Part 1, after entry for Atazanavir
insert:
Atenolol
C4076
 
 
For a patient who is unable to take a solid dose form of atenolol

 
[117]       Schedule 4, Part 1, entry for Bevacizumab [Circumstances Code C3894]
omit from the column headed “Circumstances and Purposes”:                performace       substitute:          performance
[118]       Schedule 4, Part 1, entry for Bortezomib
substitute:

Bortezomib
C4079
 
 
Multiple myeloma
Retreatment of Progressive disease - Initial PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide;
Patient must have progressive disease;
Patient must have previously been treated with PBS-subsidised bortezomib;
Patient must have experienced at least a partial response to the most recent course of PBS-subsidised bortezomib therapy;
Patient must not be receiving concomitant PBS-subsidised lenalidomide;
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause)
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein)
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma bortezomib Authority Application - Supporting Information Form which includes details of the basis of the current diagnosis of progressive disease and nomination of which disease activity parameters will be used to assess response; and
(3) diagnostic reports demonstrating the patient has achieved at least a partial response to the most recent course of PBS-subsidised bortezomib, if not previously provided; and
(4) a signed patient acknowledgment
To enable confirmation of eligibility for treatment current diagnostic reports of at least one of the following must be provided:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided
Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided
Compliance with Written Authority Required procedures

 
C4080
 
 
Multiple myeloma
Retreatment of Progressive disease - Continuing PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide;
Patient must have previously received 8 treatment cycles of bortezomib in the current treatment course;
Patient must have demonstrated at the completion of cycle 8 at least a partial response to bortezomib;
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response;
Patient must not have a gap of more than 10 months between the initial application and an application following completion of 8 treatment cycles;
Patient must not receive more than 3 cycles of bortezomib under this restriction
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information form; and
(3) diagnostic reports demonstrating the patient has achieved at least a partial response
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein)
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L
Diagnostic reports must be no more than one month old at the time of application
Where a response assessment is not submitted prior to cycle 9, patients will be deemed to have failed to respond to treatment with bortezomib
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart
Compliance with Written Authority Required procedures

 
C4081
 
 
Multiple myeloma
Treatment of Progressive disease - Continuing PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide;
Patient must have previously received 8 treatment cycles of bortezomib for progressive disease;
Patient must have demonstrated at the completion of cycle 8 at least a partial response to bortezomib;
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response;
Patient must not have a gap of more than 10 months between the initial application and an application following completion of 8 treatment cycles;
Patient must not receive more than 3 cycles of bortezomib under this restriction
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information form; and
(3) diagnostic reports demonstrating the patient has achieved at least a partial response
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein)
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L
Diagnostic reports must be no more than one month old at the time of application
Where a response assessment is not submitted prior to cycle 9, patients will be deemed to have failed to respond to treatment with bortezomib
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart
Compliance with Written Authority Required procedures

 
C4082
 
 
Symptomatic multiple myeloma
Continuing PBS-subsidised treatment
Patient must have received an initial authority prescription for bortezomib for newly diagnosed symptomatic multiple myeloma and be ineligible for high dose chemotherapy;
Patient must not have demonstrated progressive disease at the time of application;
Patient must not have achieved a best confirmed response to bortezomib at the time of application;
Patient must not be receiving PBS-subsidised thalidomide or lenalidomide;
The treatment must be in combination with a corticosteroid and melphalan or cyclophosphamide;
Patient must not receive more than 5 cycles of treatment with bortezomib under this restriction
Continuing PBS-subsidised supply will not be approved if there is a gap of more than 6 months between the initial application and this application
Compliance with Written or Telephone Authority Required procedures

 
C4103
 
 
Symptomatic multiple myeloma
Patient must be newly diagnosed;
Patient must be eligible for high dose chemotherapy and autologous stem cell transplantation;
Patient must not be receiving PBS-subsidised thalidomide or lenalidomide;
The treatment must be in combination with chemotherapy;
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma; and
(3) a signed patient acknowledgement
Compliance with Written Authority Required procedures

 
C4126
 
 
Multiple myeloma
Treatment of Progressive disease - Initial PBS-subsidised treatment
The condition must be confirmed by a histological diagnosis;
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide;
Patient must have progressive disease after at least one prior therapy;
Patient must have undergone or be ineligible for a primary stem cell transplant;
Patient must have experienced treatment failure after a trial of at least four (4) weeks of thalidomide at a dose of at least 100 mg daily or have failed to achieve at least a minimal response after eight (8) or more weeks of thalidomide-based therapy for progressive disease;
Patient must not be receiving concomitant PBS-subsidised lenalidomide;
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause)
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein
Thalidomide treatment failure is defined as:
(1) confirmed disease progression during thalidomide treatment or within 6 months of discontinuing thalidomide treatment; or
(2) severe intolerance or toxicity unresponsive to clinically appropriate dose adjustment
Severe intolerance due to thalidomide is defined as unacceptable somnolence or sedation interfering with activities of daily living
Toxicity from thalidomide is defined as peripheral neuropathy (Grade 2 or greater, interfering with function), drug-related seizures, serious Grade 3 or 4 drug-related dermatological reactions, such as Stevens-Johnson Syndrome, or other Grade 3 or 4 toxicity
Failure to achieve at least a minimal response after 8 or more weeks of thalidomide-based therapy for progressive disease is defined as:
(1) less than a 25% reduction in serum or urine M protein; or
(2) in oligo-secretory and non-secretory myeloma patients only, less than a 25% reduction in the difference between involved and uninvolved serum free light chain levels
If the dosing requirement for thalidomide cannot be met, the application must state the reasons why this criterion cannot be satisfied
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma bortezomib Authority Application - Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; details of thalidomide treatment failure; details of the basis of the diagnosis of progressive disease or failure to respond; and nomination of which disease activity parameters will be used to assess response; and
(3) duration of thalidomide and daily dose prescribed; and
(4) a signed patient acknowledgment
To enable confirmation of eligibility for treatment, current diagnostic reports of at least one of the following must be provided:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided
Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided
Compliance with Written Authority Required procedures

 
C4127
 
 
Symptomatic multiple myeloma
Initial PBS-subsidised treatment
Patient must be newly diagnosed;
Patient must have severe acute renal failure;
Patient must require dialysis; OR
Patient must be at high risk of requiring dialysis in the opinion of a nephrologist;
The treatment must be in combination with a corticosteroid and/or cyclophosphamide;
Patient must not be receiving PBS-subsidised thalidomide or lenalidomide;
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, the name of the nephrologist who has reviewed the patient and the date of review, a copy of the current pathology reports reporting Glomerular Filtration Rate from an Approved Pathology Authority, and nomination of the disease activity parameter(s) that will be used to assess response; and
(3) a signed patient acknowledgement
Disease activity parameters include current diagnostic reports of at least one of the following:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) in oligo-secretory and non-secretory myeloma patients only, the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. Magnetic Resonance Imaging (MRI) or computed tomography (CT) scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients
Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided
Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided
Compliance with Written Authority Required procedures

 
C4141
 
 
Symptomatic multiple myeloma
Continuing PBS-subsidised treatment
Patient must have received an initial authority prescription for bortezomib for newly diagnosed symptomatic multiple myeloma and have severe acute renal failure;
Patient must have demonstrated at least a partial response at the completion of cycle 4 at the time of application;
The treatment must be in combination with a corticosteroid and/or cyclophosphamide;
Patient must not be receiving PBS-subsidised thalidomide or lenalidomide;
Patient must not receive more than 5 cycles of treatment with bortezomib under this restriction
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information form, which includes a copy of the current pathology reports reporting Glomerular Filtration Rate from an Approved Pathology authority; and
(3) diagnostic reports demonstrating the patient has achieved at least a partial response
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein)
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels
If serum M protein and urine Bence-Jones protein and serum FLC are not being used to monitor disease activity, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L
Continuing PBS-subsidised supply will not be approved if there is a gap of more than 6 months between the initial application and this application
Compliance with Written or Telephone Authority Required procedures

 
C4161
 
 
Multiple myeloma
Retreatment of Progressive disease - Continuing PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide;
Patient must have previously received 4 treatment cycles of bortezomib in the current treatment course;
Patient must have demonstrated at the completion of cycle 4 at least a partial response to bortezomib;
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response;
Patient must not have a gap of more than 6 months between the initial application and subsequent applications;
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information form; and
(3) diagnostic reports demonstrating the patient has achieved at least a partial response
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein)
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L
Diagnostic reports must be no more than one month old at the time of application
Where a response assessment is not submitted prior to cycle 5, patients will be deemed to have failed to respond to treatment with bortezomib
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart
Compliance with Written Authority Required procedures

 
C4162
 
 
Multiple myeloma
Treatment of Progressive disease - Continuing PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide;
Patient must have previously received 4 treatment cycles of bortezomib for progressive disease;
Patient must have demonstrated at the completion of cycle 4 at least a partial response to bortezomib;
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response;
Patient must not have a gap of more than 6 months between the initial application and subsequent applications;
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information form; and
(3) diagnostic reports demonstrating the patient has achieved at least a partial response
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein)
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L
Diagnostic reports must be no more than one month old at the time of application
Where a response assessment is not submitted prior to cycle 5, patients will be deemed to have failed to respond to treatment with bortezomib
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart
Compliance with Written Authority Required procedures

 
C4163
 
 
Symptomatic multiple myeloma
Initial PBS-subsidised treatment
Patient must be newly diagnosed;
Patient must be ineligible for high dose chemotherapy;
Patient must not be receiving PBS-subsidised thalidomide or lenalidomide;
The treatment must be in combination with a corticosteroid and melphalan or cyclophosphamide;
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma and ineligibility for high dose chemotherapy; and
(3) a signed patient acknowledgement
Compliance with Written Authority Required procedures

[119]       Schedule 4, Part 1, entry for Cabazitaxel
substitute:

 
C4073
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Castration resistant metastatic carcinoma of the prostate
The treatment must be in combination with prednisone or prednisolone;
Patient must have failed treatment with docetaxel due to resistance or intolerance;
Patient must have a WHO performance status of 2 or less
Compliance with Authority Required procedures

 
C4138
 
 
Where the patient is receiving treatment at/from a Public Hospital
Castration resistant metastatic carcinoma of the prostate
The treatment must be in combination with prednisone or prednisolone;
Patient must have failed treatment with docetaxel due to resistance or intolerance;
Patient must have a WHO performance status of 2 or less
Compliance with Authority Required procedures - Streamlined Authority Code 4138

[120]       Schedule 4, Part 1, entry for Denosumab
substitute:

Denosumab
C4094
 
 
Osteoporosis
Patient must be female;
Patient must be aged 70 years or older;
Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4094

 
C4145
 
 
Established post-menopausal osteoporosis
Patient must have fracture due to minimal trauma;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Compliance with Authority Required procedures - Streamlined Authority Code 4145

 
C4150
 
 
Bone metastases
The condition must be due to castration-resistant prostate cancer
Compliance with Authority Required procedures - Streamlined Authority Code 4150

 
C4158
 
 
Bone metastases
The condition must be due to breast cancer
Compliance with Authority Required procedures - Streamlined Authority Code 4158

[121]       Schedule 4, Part 1, entry for Docetaxel
substitute:

Docetaxel
C3888
 
 
Neoadjuvant treatment of a patient with a World Health Organisation performance status of 1 or less, with inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx, in combination with cisplatin and fluorouracil
Compliance with Authority Required procedures - Streamlined Authority Code 3888

 
C3892
 
 
Adjuvant treatment of operable breast cancer in combination with cyclophosphamide
Compliance with Authority Required procedures - Streamlined Authority Code 3892

 
C3916
 
 
Adjuvant treatment of node-positive breast cancer in combination with an anthracycline and cyclophosphamide
Compliance with Authority Required procedures - Streamlined Authority Code 3916

 
C3956
 
 
Treatment of HER2 positive breast cancer in combination with trastuzumab
Compliance with Authority Required procedures - Streamlined Authority Code 3956

 
C4078
 
 
Locally advanced or metastatic non-small cell lung cancer
 
Compliance with Authority Required procedures - Streamlined Authority Code 4078


 
C4140
 
 
Advanced metastatic ovarian cancer
Patient must have failed prior therapy which included a platinum compound
Compliance with Authority Required procedures - Streamlined Authority Code 4140


 
C4155
 
 
Androgen independent (castration resistant) metastatic carcinoma of the prostate
Patient must have a Karnofsky performance status score of at least 60%;
The treatment must be used as first-line chemotherapy;
The treatment must be administered in three weekly cycles;
Patient must not receive more than 10 cycles of treatment with docetaxel under this restriction
Compliance with Authority Required procedures - Streamlined Authority Code 4155


 
C4160
 
 
Metastatic breast cancer
Compliance with Authority Required procedures - Streamlined Authority Code 4160


[122]       Schedule 4, Part 1, entry for Etanercept
(a)      omit:

 
C4057
P4057
 
Chronic plaque psoriasis (Whole body) [Initial treatment — No prior biological agent]
Initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who:
(a) has severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and
(b) has not received any prior PBS-subsidised treatment with etanercept for this condition; and
(c) whose parent or authorised guardian has signed a patient acknowledgement; and
(d) has failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 3 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; and/or
(iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or where phototherapy is contraindicated, please provide details at the time of application
If intolerance to treatment with phototherapy, methotrexate or acitretin develops during the relevant period of use, which is of a severity to necessitate permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application
The following initiation criterion indicates failure to achieve an adequate response and must be demonstrated in all patients at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment
(c) The most recent PASI assessment must be no more than 1 month old at the time of application
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and
(iii) the parent or authorised guardian signed patient and prescriber acknowledgements
A maximum of 24 weeks of treatment with etanercept will be authorised under this restriction. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance of treatment, a further 8 weeks treatment, will be authorised if the submitted PASI assessment shows an adequate demonstrated response to treatment
A PASI assessment of the patient's response to the initial 16 week course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment under this restriction, must be submitted to the Chief Executive Medicare no later than 1 month from the date of completion of this initial course of treatment.  Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept
An adequate response to treatment is defined as:
Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, when compared with the pre-etanercept treatment baseline value
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who has severe chronic plaque psoriasis and who, although qualifying for an initial 16 week course of treatment with etanercept under the criteria specified above, has previously been issued with an authority prescription for less than 16 weeks of etanercept treatment, and where approval of the application would enable the patient to complete the initial 16 week treatment course
Compliance with Written or Telephone Authority Required procedures

 
C4058
P4058
 
Chronic plaque psoriasis (Whole body) [Re-Treatment — Received prior etanercept under PBS]
Treatment as systemic monotherapy (other than methotrexate) by a dermatologist for a patient under 18 years who has:
(a) a documented history of severe chronic plaque psoriasis; and
(b) received prior PBS-subsidised treatment with etanercept for this condition; and
(c) not failed PBS-subsidised therapy with etanercept for the treatment of this condition more than once in the current Treatment Cycle
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior etanercept treatment, including date
A total maximum of 24 weeks of treatment with etanercept will be authorised under this restriction. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance of treatment, a further 8 weeks treatment, will be authorised if the submitted PASI assessment shows an adequate demonstrated response to treatment
A PASI assessment of the patient's response to the initial 16 week course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment under this restriction, must be submitted to the Chief Executive Medicare no later than 1 month from the date of completion of this course of treatment. Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who has a documented history of severe chronic plaque psoriasis, who has previously received PBS-subsidised treatment with etanercept for this condition, and who, although qualifying for an initial 16 week course of treatment with etanercept under the criteria specified above, has previously been issued with an authority prescription for less than 16 weeks of etanercept treatment, and where approval of the application would enable the patient to complete the initial 16 week treatment course
Compliance with Written or Telephone Authority Required procedures

 
C4059
P4059
 
Chronic plaque psoriasis (Face, hand, foot) [Initial treatment — No prior biological agent]
Initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who:
(a) has severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and
(b) has not received any prior PBS-subsidised treatment with etanercept for this condition; and
(c) whose parent or authorised guardian has signed a patient acknowledgement; and
(d) has failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 3 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; and/or
(iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or where phototherapy is contraindicated, please provide details at the time of application
If intolerance to treatment with phototherapy, methotrexate or acitretin develops during the relevant period of use, which is of a severity to necessitate permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application
The following initiation criterion indicates failure to achieve an adequate response and must be demonstrated in all patients at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment
(c) The most recent PASI assessment must be no more than 1 month old at the time of application
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and
(iii) the parent or authorised guardian signed patient and prescriber acknowledgements
A maximum of 24 weeks of treatment with etanercept will be authorised under this restriction. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance of treatment, a further 8 weeks treatment, will be authorised if the submitted PASI assessment shows an adequate demonstrated response to treatment
A PASI assessment of the patient's response to the initial 16 week course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated.  This assessment, which will be used to determine eligibility for a further 8 weeks of treatment under this restriction, must be submitted to the Chief Executive Medicare no later than 1 month from the date of completion of this initial course of treatment.  Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, when compared with the pre-etanercept treatment baseline value
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who has severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot and who, although qualifying for an initial 16 week course of treatment with etanercept under the criteria specified above, has previously been issued with an authority prescription for less than 16 weeks of etanercept treatment, and where approval of the application would enable the patient to complete the initial 16 week treatment course
Compliance with Written or Telephone Authority Required procedures

 
C4060
P4060
 
Chronic plaque psoriasis (Face, hand, foot) [Re-Treatment — Received prior etanercept under PBS]
Treatment as systemic monotherapy (other than methotrexate) by a dermatologist for a patient under 18 years who has:
(a) a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
(b) received prior PBS-subsidised treatment with etanercept for this condition; and
(c) not failed PBS-subsidised therapy with etanercept for the treatment of this condition more than once in the current Treatment Cycle
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior etanercept treatment, including date
A total maximum of 24 weeks of treatment with etanercept will be authorised under this restriction. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance of treatment, a further 8 weeks treatment, will be authorised if the submitted PASI assessment shows an adequate demonstrated response to treatment
A PASI assessment of the patient's response to the initial 16 week course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment under this restriction, must be submitted to the Chief Executive Medicare no later than 1 month from the date of completion of this course of treatment. Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who has a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, who has previously received PBS-subsidised treatment with etanercept for this condition, and who, although qualifying for an initial 16 week course of treatment with etanercept under the criteria specified above, has previously been issued with an authority prescription for less than 16 weeks of etanercept treatment, and where approval of the application would enable the patient to complete the initial 16 week treatment course
Compliance with Written or Telephone Authority Required procedures

(b)      insert in numerical order following existing text:

 
C4088
P4088
 
Severe chronic plaque psoriasis
Initial treatment or Re-treatment (Whole body) - completion of course
Must be treated by a dermatologist;
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate;
Patient must have received 16 weeks treatment under the Initial treatment (whole body) restriction for severe chronic plaque psoriasis; OR
Patient must have received 16 weeks treatment under the Re-treatment (whole body) restriction for severe chronic plaque psoriasis;
Patient must have demonstrated an adequate response to treatment;
Patient must not receive more than 8 weeks of treatment with etanercept under this restriction
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, when compared with the pre-etanercept treatment baseline value
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of assessment of the patient's condition
The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment
A PASI assessment of the patient's response to the initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept
 
Compliance with Written Authority Required procedures


 
C4114
P4114
 
Severe chronic plaque psoriasis
Initial treatment or Re-treatment (Whole body) - balance of first supply
Must be treated by a dermatologist;
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate;
Patient must have received insufficient therapy under the Initial treatment (whole body) restriction for severe chronic plaque psoriasis to complete 16 weeks treatment; OR
Patient must have received insufficient therapy under the Re-treatment (whole body) restriction for severe chronic plaque psoriasis to complete 16 weeks treatment;
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions
Compliance with Written or Telephone Authority Required procedures


 
C4115
P4115
 
Severe chronic plaque psoriasis
Initial treatment (Face, hand, foot)
Must be treated by a dermatologist;
Patient must be under 18 years of age and a parent or authorised guardian must have signed a patient acknowledgement;
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate;
Patient must have the plaque or plaques of the face, or palm of hand or sole of foot present for at least 6 months from the time of initial diagnosis;
Patient must not have received any prior PBS-subsidised treatment with etanercept for this condition; OR
Patient must not have received any PBS-subsidised treatment with etanercept for this condition for at least 12 months;
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; and/or (iii)acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;
Patient must not receive more than 16 weeks of treatment with etanercept under this restriction
Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application
Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in a patient at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment
(c) The most recent PASI assessment must be no more than 1 month old at the time of application
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and face, hand, foot area diagrams including the dates of assessment of the patient's condition
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and
(iii) the parent or authorised guardian signed patient and prescriber acknowledgements
Where a patient has had a 12 month treatment break, the length of the break is measured from the date the most recent treatment was stopped to the date of the application to re-commence treatment
Compliance with Written Authority Required procedures


 
C4116
P4116
 
Severe chronic plaque psoriasis
Initial treatment or Re-treatment (Face, hand, foot) - completion of course
Must be treated by a dermatologist;
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate;
Patient must have received 16 weeks treatment under the Initial treatment (Face, hand, foot) restriction for severe chronic plaque psoriasis; OR
Patient must have received 16 weeks treatment under the Re-treatment (Face, hand, foot) restriction for severe chronic plaque psoriasis;
Patient must have demonstrated an adequate response to treatment;
Patient must not receive more than 8 weeks of treatment with etanercept under this restriction
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the PASI symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of assessment of the patient's condition
The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment
A PASI assessment of the patient's response to the initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept
Compliance with Written Authority Required procedures


 
C4125
P4125
 
Severe chronic plaque psoriasis
Re-treatment (Whole body)
Must be treated by a dermatologist;
Patient must be under 18 years of age;
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate;
Patient must have a documented history of severe chronic plaque psoriasis of the whole body;
Patient must have received prior PBS-subsidised treatment with etanercept for this condition in the past 12 months;
Patient must have demonstrated a response to etanercept and experienced a disease flare; OR
Patient must not have failed more than once to achieve an adequate response with etanercept;
Patient must not receive more than 16 weeks of treatment with etanercept under this restriction
A patient is eligible for re-treatment due to disease flare if there is a 50% or greater change in the patients PASI score or the patient has a current PASI score of greater than 15, compared to the most recent response assessment following cessation of the most recent 24 weeks of PBS-subsidised etanercept
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior etanercept treatment, including date ceased
Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment
Compliance with Written Authority Required procedures


 
C4136
P4136
 
Severe chronic plaque psoriasis
Initial treatment of Re-treatment (Face, hand, foot) - balance of first supply
Must be treated by a dermatologist;
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate;
Patient must have received insufficient therapy under the Initial treatment (Face, hand, foot) restriction for severe chronic plaque psoriasis to complete 16 weeks treatment; OR
Patient must have received insufficient therapy under the Re-treatment (Face, hand, foot) restriction for severe chronic plaque psoriasis to complete 16 weeks treatment;
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions
Compliance with Written or Telephone Authority Required procedures


 
C4137
P4137
 
Severe chronic plaque psoriasis
Re-treatment (Face, hand, foot)
Must be treated by a dermatologist;
Patient must be under 18 years of age;
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate;
Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot;
Patient must have received prior PBS-subsidised treatment with etanercept for this condition in the past 12 months
Patient must have demonstrated a response to etanercept and experienced a disease flare; OR
Patient must not have failed more than once to achieve an adequate response with etanercept;
Patient must not receive more than 16 weeks of treatment with etanercept under this restriction
A patient is eligible for re-treatment due to disease flare if:
(i) all subscores are rated moderate to severe or 2 of the 3 subscores are rated severe to very severe; or
(ii) the skin area affected is a 50% or greater change or the area affected is 30% or more of the face, palm of a hand or sole of a foot, compared to the most recent response assessment following cessation of the most recent 24 weeks of PBS-subsidised etanercept
The authority application must be made in writing and must include :
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area digrams including the dates of assessment of the patient's condition; and
(ii) details of prior etanercept treatment, including date ceased
Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment
Compliance with Written Authority Required procedures


 
C4151
P4151
 
Severe chronic plaque psoriasis
Initial treatment (whole body)
Must be treated by a dermatologist;
Patient must be under 18 years of age and a parent or authorised guardian must have signed a patient acknowledgement;
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate;
Patient must have lesions present for at least 6 months from the time of initial diagnosis;
Patient must not have received any prior PBS-subsidised treatment with etanercept for this condition; OR
Patient must not have received any PBS-subsidised treatment with etanercept for this condition for at least 12 months;
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; and/or (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;
Patient must not receive more than 16 weeks of treatment with etanercept under this restriction
Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application
Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in a patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment
(c) The most recent PASI assessment must be no more than 1 month old at the time of application
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and
(iii) the parent or authorised guardian signed patient and prescriber acknowledgements
Where a patient has had a 12 month treatment break, the length of the break is measured from the date the most recent treatment was stopped to the date of the application to re-commence treatment
Compliance with Written Authority Required procedures


[123]       Schedule 4, Part 1, entry for Ezetimibe with Simvastatin
substitute:

Ezetimibe with Simvastatin
C4068
 
 
Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise;
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin);
Patient must have coronary heart disease
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4068

 
C4069
 
 
Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise;
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin);
Patient must have heterozygous familial hypercholesterolaemia
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4069

 
C4085
 
 
Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise;
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin);
Patient must have diabetes mellitus
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4085

 
C4086
 
 
Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise;
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin);
Patient must have peripheral vascular disease
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4086

 
C4096
 
 
Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise;
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin);
Patient must have symptomatic cerebrovascular disease
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4096

 
C4097
 
 
Hypercholesterolaemia
Patient must have homozygous familial hypercholesterolaemia;
Patient must be eligible for PBS-subsidised lipid-lowering medication (according to the criteria set out in the General Statement for Lipid-Lowering Drugs)
Compliance with Authority Required procedures - Streamlined Authority Code 4097

 
C4120
 
 
Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise;
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin);
Patient must have a family history of coronary heart disease;
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4120

 
C4121
 
 
Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise;
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin);
Patient must have hypertension
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4121

 
C4147
 
 
Hypercholesterolaemia
Patient must be eligible for PBS-subsidised lipid-lowering medication (according to the criteria set out in the General Statement for Lipid-Lowering Drugs);
Patient must have developed a clinically important product-related adverse event during treatment with an HMG CoA reductase inhibitor (statin) necessitating a reduction in the statin dose
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin
Compliance with Authority Required procedures - Streamlined Authority Code 4147

[124]       Schedule 4, Part 1, entry for Granisetron
substitute:

Granisetron
C4077
P4077
 
Nausea and vomiting
The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration
 

 
C4092
P4092
 
Nausea and vomiting
The condition must be associated with radiotherapy being used to treat malignancy
Compliance with Authority Required procedures - Streamlined Authority Code 4092
 

 
C4102
P4102
 
Nausea and vomiting
The condition must be associated with radiotherapy being used to treat malignancy.

Compliance with Authority Required procedures - Streamlined Authority Code 4102

 
C4118
P4118
 
Nausea and vomiting
The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration
 

[125]       Schedule 4, Part 1, after entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate
insert:

Hyaluronic Acid
C4105
 
 
Severe dry eye syndrome
Patient must be sensitive to preservatives in multi-dose eye drops.

Compliance with Authority Required procedures - Streamlined Authority Code 4105

 
C4130
 
 
Severe dry eye syndrome
Patient must be sensitive to preservatives in multi-dose eye drops.

Compliance with Authority Required procedures


[126]       Schedule 4, Part 1, entry for Hydroxocobalamin
substitute:

Hydroxocobalamin
C4111
 
 
Pernicious anaemia
 

 
C4134
 
 
Proven vitamin B12 deficiencies other than pernicious anaemia
 

 
C4135
 
 
Anaemias associated with vitamin B12 deficiency
Patient must have had a gastrectomy;
The treatment must be for prophylaxis
 

[127]       Schedule 4, Part 1, entry for Mycophenolic Acid
insert in numerical order following existing text:

 
C4084
 
 
Prophylaxis of renal allograft rejection
Management
The treatment must be under the supervision and direction of a transplant unit
Compliance with Authority Required procedures - Streamlined Authority Code 4084


 
C4095
 
 
WHO Class III, IV or V lupus nephritis
Management
The condition must be proven by biopsy;
Must be treated by a nephrologist or in consultation with a nephrologist
The name of the consulting nephrologist must be included in the patient medical records
Compliance with Authority Required procedures - Streamlined Authority Code 4095


 
C4108
 
 
Prophylaxis of renal allograft rejection
Management
The treatment must be under the supervision and direction of a transplant unit
 
Compliance with Written or Telephone Authority Required procedures


 
C4131
P4131
 
WHO Class III, IV or V lupus nephritis
Maintenance
The condition must be proven by biopsy;
Patient must have received initiation treatment;
The treatment must be under the supervision and direction of a nephrologist reviewing the patient
The name of the nephrologist reviewing treatment and the date of the latest review, which must be within the last 12 months, must be included in the authority application
 
Compliance with Written or Telephone Authority Required procedures


 
C4146
 
 
WHO Class III, IV or V lupus nephritis
Management
The condition must be proven by biopsy;
Must be treated by a nephrologist or in consultation with a nephrologist
The name of the consulting nephrologist must be included in the patient medical records
Compliance with Written or Telephone Authority Required procedures


[128]       Schedule 4, Part 1, entry for Naproxen
(a)      omit:

 
C3647
P3647
 
Initial supply, for up to 4 months, for a palliative care patient where severe pain is a problem in patients unable to take a solid dose form of a non-steroidal anti-inflammatory agent
Compliance with Authority Required procedures - Streamlined Authority Code 3647

 
C3648
P3648
 
Continuing supply for a palliative care patient where severe pain is a problem in patients unable to take a solid dose form of a non-steroidal anti-inflammatory agent
Compliance with Authority Required procedures - Streamlined Authority Code 3648

(b)      insert in numerical order following existing text:

 
C4124
P4124
 
Bone pain
The condition must be due to malignant disease;
Patient must be unable to take a solid dose form of a non-steroidal anti-inflammatory agent
 
Compliance with Authority Required procedures - Streamlined Authority Code 4124

 
C4128
P4128
 
Severe pain
Initial treatment
Patient must be undergoing palliative care;
Patient must be unable to take a solid dose form of a non-steroidal anti-inflammatory agent;
Patient must not receive more than 4 months treatment under this restriction
 
Compliance with Authority Required procedures - Streamlined Authority Code 4128

 
C4129
P4129
 
Severe pain
Continuing treatment
Patient must be undergoing palliative care;
Patient must be unable to take a solid dose form of a non-steroidal anti-inflammatory agent
Compliance with Authority Required procedures - Streamlined Authority Code 4129

 
C4159
P4159
 
Chronic arthropathies (including osteoarthritis)
The condition must have an inflammatory component;
Patient must be unable to take a solid dose form of a non-steroidal anti-inflammatory agent
Compliance with Authority Required procedures - Streamlined Authority Code 4159

[129]       Schedule 4, Part 1, entry for Omeprazole
substitute:

Omeprazole
C1337
 
 
Scleroderma oesophagus
 

 
C1476
 
 
Zollinger-Ellison syndrome
 

 
C1533
 
 
Gastro-oesophageal reflux disease
 

 
C4074
P4074
 
Peptic ulcer
Initial treatment
 

 
C4075
P4075
 
Zollinger-Ellison syndrome
 

 
C4089
P4089
 
Gastro-oesophageal reflux disease
 

 
C4152
P4152
 
Scleroderma oesophagus
 

[130]       Schedule 4, Part 1, entry for Paraffin
insert in numerical order following existing text:
 
 
P4072
 
For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements
 
 
[131]       Schedule 4, Part 1, entry for Pazopanib
substitute:

Pazopanib
C4067
P4067
 
Stage IV clear cell variant renal cell carcinoma (RCC)
Initial treatment
Patient must have been receiving treatment with pazopanib prior to 1 October 2012;
The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition
Compliance with Authority Required procedures


 
C4109
P4109
 
Stage IV clear cell variant renal cell carcinoma (RCC)
Continuing treatment beyond 3 months
Patient must have previously been issued with an authority prescription for pazopanib;
Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST);
The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition
Compliance with Authority Required procedures


 
C4112
P4112
 
Stage IV clear cell variant renal cell carcinoma (RCC)
Continuing treatment beyond 3 months
Patient must have previously been issued with an authority prescription for pazopanib;
Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST);
Patient must require dose adjustment;
The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition
Compliance with Authority Required procedures


 
C4148
P4148
 
Stage IV clear cell variant renal cell carcinoma (RCC)
Initial treatment
Patient must meet the Memorial Sloan Kettering Cancer Centre (MSKCC) low to intermediate risk group criteria;
Patient must have a WHO performance status of 2 or less;
The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition
Patients who have progressive disease on sunitinib are not eligible to receive PBS-subsidised pazopanib
Compliance with Authority Required procedures


[132]       Schedule 4, Part 1, entry for Raloxifene
substitute:
Raloxifene
C4071
 
 
Established post-menopausal osteoporosis
Patient must have fracture due to minimal trauma;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Compliance with Authority Required procedures - Streamlined Authority Code 4071

[133]       Schedule 4, Part 1, entry for Risedronic Acid
substitute:

Risedronic Acid
C3256
 
 
Symptomatic Paget disease of bone
 
Compliance with Authority Required procedures - Streamlined Authority Code 3256


 
C4117
 
 
Osteoporosis
Patient must be aged 70 years or older;
Patient must have a Bone Mineral Density (BMD) T-score of -3.0 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4117


 
C4122
 
 
Corticosteroid-induced osteoporosis
Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy;
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4122


 
C4123
 
 
Established osteoporosis
Patient must have fracture due to minimal trauma;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Compliance with Authority Required procedures - Streamlined Authority Code 4123


[134]       Schedule 4, Part 1, entry for Risedronic Acid and Calcium
substitute:

Risedronic Acid and Calcium
C4117
 
 
Osteoporosis
Patient must be aged 70 years or older;
Patient must have a Bone Mineral Density (BMD) T-score of -3.0 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4117


 
C4122
 
 
Corticosteroid-induced osteoporosis
Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy;
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4122


 
C4123
 
 
Established osteoporosis
Patient must have fracture due to minimal trauma;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Compliance with Authority Required procedures - Streamlined Authority Code 4123


[135]       Schedule 4, Part 1, entry for Risedronic acid and calcium with colecalciferol
substitute:

Risedronic acid and calcium with colecalciferol
C4117
 
 
Osteoporosis
Patient must be aged 70 years or older;
Patient must have a Bone Mineral Density (BMD) T-score of -3.0 or less
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4117


 
C4122
 
 
Corticosteroid-induced osteoporosis
Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy;
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4122


 
C4123
 
 
Established osteoporosis
Patient must have fracture due to minimal trauma;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Compliance with Authority Required procedures - Streamlined Authority Code 4123


[136]       Schedule 4, Part 1, entry for Rivaroxaban
insert in numerical order following existing text:

 
C4098
 
 
 
Deep vein thrombosis
Initial treatment
Patient must have confirmed acute symptomatic deep vein thrombosis;
Patient must not have symptomatic pulmonary embolism
Compliance with Authority Required procedures - Streamlined Authority Code 4098


 
C4099
 
 
Deep vein thrombosis
Continuing treatment
Patient must have confirmed acute symptomatic deep vein thrombosis;
Patient must not have symptomatic pulmonary embolism
Compliance with Authority Required procedures - Streamlined Authority Code 4099


 
C4132
 
 
Prevention of recurrent venous thromboembolism
Continuing treatment
Patient must have a history of venous thromboembolism
 
Compliance with Authority Required procedures - Streamlined Authority Code 4132


[137]       Schedule 4, Part 1, entry for Strontium
substitute:

Strontium
C4071
 
 
Established post-menopausal osteoporosis
Patient must have fracture due to minimal trauma;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Compliance with Authority Required procedures - Streamlined Authority Code 4071


 
C4107
 
 
Osteoporosis
Patient must be female;
Patient must be aged 70 years or older;
Patient must have a Bone Mineral Density (BMD) T-score of -3.0 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4107


[138]       Schedule 4, Part 1, entry for Sunitinib
substitute:

Sunitinib
C3206
P3206
 
Initial PBS-subsidised treatment as monotherapy of a patient with World Health Organisation performance status of 2 or less with a metastatic or unresectable malignant gastrointestinal stromal tumour after failure of imatinib mesylate treatment due to resistance or intolerance, and where the application for authorisation includes:
(1) a completed copy of the appropriate Sunitinib Malate (Sutent) PBS Authority Application for Use in the Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form; and
(2) a signed patient acknowledgement
 
Compliance with Written Authority Required procedures

 
C3207
P3207
 
Continuing PBS-subsidised treatment as monotherapy of a patient with World Health Organisation performance status of 2 or less with a metastatic or unresectable malignant gastrointestinal stromal tumour who has previously been issued with an authority prescription for sunitinib and who does not have progressive disease on sunitinib

Compliance with Written or Telephone Authority Required procedures


 
C4106
P4106
 
Stage IV clear cell variant renal cell carcinoma (RCC)
Continuing treatment beyond 3 months
Patient must have previously been issued with an authority prescription for sunitinib;
Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST);
The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition
Compliance with Authority Required procedures


 
C4119
P4119
 
Stage IV clear cell variant renal cell carcinoma (RCC)
Initial treatment
Patient must meet the Memorial Sloan Kettering Cancer Centre (MSKCC) low to intermediate risk group criteria;
Patient must have a WHO performance status of 2 or less;
The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition
Patients who have developed progressive disease on pazopanib are not eligible to receive PBS-subsidised sunitinib
Compliance with Authority Required procedures


[139]       Schedule 4, Part 1, entry for Teriparatide
substitute:

Teriparatide
C4101
 
 
Severe established osteoporosis
Initial treatment
Must be treated by a specialist; OR
Must be treated by a consultant physician;
Patient must be at very high risk of fracture;
Patient must have a bone mineral density (BMD) T-score of -3.0 or less;
Patient must have had 2 or more fractures due to minimal trauma;
Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses;
The treatment must be the sole PBS-subsidised agent;
The treatment must not exceed a lifetime maximum of 18 months therapy
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be provided at the time of application
If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be provided at the time of application
Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months, strontium ranelate 2 g per day and zoledronic acid 5 mg per annum
Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be provided at the time of application
 
Compliance with Authority Required procedures


 
4113
 
 
Severe established osteoporosis
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug;
The treatment must not exceed a lifetime maximum of 18 months therapy
Compliance with Authority Required procedures


[140]       Schedule 4, Part 1, entry for Zoledronic acid
(a)      omit:

 
C3945
 
 
Treatment as the sole PBS-subsidised anti-resorptive agent for corticosteroid-induced osteoporosis in a patient currently on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy with a bone mineral density T-score of -1.5 or less, and where the duration and dose of corticosteroid therapy, and the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement, are documented in the patient's medical records when treatment is initiated, and where PBS-subsidised treatment is limited to 1 dose per patient each year
Compliance with Authority Required procedures - Streamlined Authority Code 3945

 
C3946
 
 
Treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in a patient with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body, and where PBS-subsidised treatment is limited to 1 dose per patient per year
Compliance with Authority Required procedures - Streamlined Authority Code 3946


 
C3947
 
 
Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -3.0 or less, where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated, and where PBS-subsidised treatment is limited to 1 dose per patient each year
Compliance with Authority Required procedures - Streamlined Authority Code 3947

(b)      insert in numerical order following existing text:

 
C4100
 
 
Corticosteroid-induced osteoporosis
Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy;
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition;
Patient must not receive more than one PBS-subsidised treatment per year
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4100


 
C4149
 
 
Osteoporosis
Patient must be aged 70 years or older;
Patient must have a Bone Mineral Density (BMD) T-score of -3.0 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition;
Patient must not receive more than one PBS-subsidised treatment per year
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4149


 
C4157
 
 
Established osteoporosis
Patient must have fracture due to minimal trauma;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition;
Patient must not receive more than one PBS-subsidised treatment per year
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Compliance with Authority Required procedures - Streamlined Authority Code 4157


 
 
 
 
 
 
]
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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.
 
Read Entire Law on www.comlaw.gov.au