PB 68 of 2015
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015
(No. 7)
National Health Act 1953
I, KYLIE JONASSON, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, 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 27 July 2015
 
 
 
 
 
 
 
 
 
 
 
KYLIE JONASSON
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health
 
1          Name of Instrument
            (1)        This Instrument is the National Health (Listing of Pharmaceutical                            Benefits) Amendment Instrument 2015 (No. 7).
            (2)        This Instrument may also be cited as PB 68 of 2015.
2          Commencement
This Instrument commences on 1 August 2015.
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]           Schedule 1, entry for Aciclovir in the form Tablet 200 mg
omit:
 
 
 
Acihexal
SZ
MP NP
C3632
 
50
0
25
 
 
[2]           Schedule 1, entry for Aciclovir in the form Tablet 800 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Aciclovir Sandoz
HX
MP NP
C3622 C3631
 
35
0
35
 
 
[3]           Schedule 1, entry for Adalimumab in the form Injection 20 mg in 0.4 mL pre-filled syringe
omit from the column headed “Section 100/Prescriber Bag only”:         PB(100)            substitute:          C(100)
[4]           Schedule 1, after entry for Adalimumab in the form Injection 20 mg in 0.4 mL pre-filled syringe
insert in the columns in the order indicated:
 
 
 
 
 
MP
C5076 C5091 C5105 C5116 C5117
P5105
2
0
2
 
 

 
 
 
 
 
MP
C5076 C5091 C5105 C5116 C5117
P5076 P5117
2
3
2
 
 

 
 
 
 
 
MP
C5076 C5091 C5105 C5116 C5117
P5091 P5116
2
5
2
 
 

[5]           Schedule 1, after entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Circumstances: See Note 3]
insert in the columns in the order indicated:
 
 
 
 
 
MP
C3265 C3267 C3695 C3697 C3747 C3748 C3758 C3759 C3760 C3761 C4492 C4501 C4517 C4518 C4531 C4609 C4610 C4629 C4642 C4643 C4666 C4700 C4710 C4724 C4751 C4826 C4840 C4845 C4851 C4864 C5074 C5075 C5076 C5090 C5091 C5105 C5115 C5116 C5117
P5105
2
0
2
 
 
[6]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]
(a)      omit from the column headed “Circumstances”:            C2986  C2988  C2990  C2993  C2995
(b)      omit from the column headed “Circumstances”:            C3753  C3754  C3755  C3756  C3757
(c)      insert in numerical order:     C5074  C5075  C5076  C5090  C5091  C5105  C5115  C5116  C5117
(d)      omit from the column headed “Purposes”:       P2986  P2990  P2993
(e)      omit from the column headed “Purposes”:       P3753  P3754
(f)       insert in numerical order:     P5074  P5076  P5090  P5115  P5117
[7]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 3]
(a)      omit from the column headed “Circumstances”:            C2986  C2988  C2990  C2993  C2995
(b)      omit from the column headed “Circumstances”:            C3753  C3754  C3755  C3756  C3757
(c)      insert in numerical order:       C5074  C5075  C5076  C5090  C5091  C5105  C5115  C5116  C5117
[8]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 4]
(a)      omit from the column headed “Circumstances”:            C2986  C2988  C2990  C2993  C2995
(b)      omit from the column headed “Circumstances”:            C3753  C3754  C3755  C3756  C3757
(c)      insert in numerical order:       C5074  C5075  C5076  C5090  C5091  C5105  C5115  C5116  C5117
[9]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:            C2986  C2988  C2990  C2993  C2995
(b)      omit from the column headed “Circumstances”:            C3753  C3754  C3755  C3756  C3757
(c)      insert in numerical order:     C5074  C5075  C5076  C5090  C5091  C5105  C5115  C5116  C5117
(d)      omit from the column headed “Purposes”:       P2988  P2995
(e)      omit from the column headed “Purposes”:       P3755  P3756  C3757
(f)       insert in numerical order:     P5075  P5091  P5116
[10]         Schedule 1, after entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Circumstances: See Note 3]
insert in the columns in the order indicated:
 
 
 
 
 
MP
C3265 C3267 C3695 C3697 C3747 C3748 C3758 C3759 C3760 C3761 C4492 C4501 C4517 C4518 C4531 C4609 C4610 C4629 C4642 C4643 C4666 C4700 C4710 C4724 C4751 C4826 C4840 C4845 C4851 C4864 C5074 C5075 C5076 C5090 C5091 C5105 C5115 C5116 C5117
P5105
2
0
2
 
 
[11]         Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
(a)      omit from the column headed “Circumstances”:            C2986  C2988  C2990  C2993  C2995
(b)      omit from the column headed “Circumstances”:            C3753  C3754  C3755  C3756  C3757
(c)      insert in numerical order:     C5074  C5075  C5076  C5090  C5091  C5105  C5115  C5116  C5117
(d)      omit from the column headed “Purposes”:       P2986  P2990  P2993
(e)      omit from the column headed “Purposes”:       P3753  P3754
(f)       insert in numerical order:     P5074  P5076  P5090  P5115  P5117
[12]         Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]
(a)      omit from the column headed “Circumstances”:            C2986  C2988  C2990  C2993  C2995
(b)      omit from the column headed “Circumstances”:            C3753  C3754  C3755  C3756  C3757
(c)      insert in numerical order:       C5074  C5075  C5076  C5090  C5091  C5105  C5115  C5116  C5117
(d)      omit from the column headed “Purposes”:       C4751   substitute:         P4751
[13]         Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 4]
(a)      omit from the column headed “Circumstances”:            C2986  C2988  C2990  C2993  C2995
(b)      omit from the column headed “Circumstances”:            C3753  C3754  C3755  C3756  C3757
(c)      insert in numerical order:       C5074  C5075  C5076  C5090  C5091  C5105  C5115  C5116  C5117
[14]         Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:            C2986  C2988  C2990  C2993  C2995
(b)      omit from the column headed “Circumstances”:            C3753  C3754  C3755  C3756  C3757
(c)      insert in numerical order:     C5074  C5075  C5076  C5090  C5091  C5105  C5115  C5116  C5117
(d)      omit from the column headed “Purposes”:       P2988  P2995
(e)      omit from the column headed “Purposes”:       P3755  P3756  P3757
(f)       insert in numerical order:     P5075  P5091  P5116
[15]         Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe, 6
(a)      omit from the column headed “Circumstances”:            C2986  C2990  C2993
(b)      omit from the column headed “Circumstances”:            C3753  C3754
(c)      insert in numerical order:     C5074  C5076  C5090  C5115  C5117
 
[16]         Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen, 6
(a)      omit from the column headed “Circumstances”:            C2986  C2990  C2993
(b)      omit from the column headed “Circumstances”:            C3753  C3754
(c)      insert in numerical order:     C5074  C5076  C5090  C5115  C5117
[17]         Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Alendrobell plus D3
GQ
MP NP
C4070 C4087 C4110
 
4
5
4
 
 
[18]         Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Alendrobell plus D3
GQ
MP NP
C4122 C4123 C4133
 
4
5
4
 
 
(b)      omit from the column headed “Responsible Person” for the brand “Dronalen Plus”:          GN       substitute:          FR
[19]         Schedule 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine in the form Oral liquid 125 mL, 36
(PKU Anamix Junior LQ)
insert:
 
Oral liquid 130 mL, 30 (PKU Air 15)
Oral
PKU Air 15
VF
MP NP
C4295
 
4
5
1
 
 
[20]         Schedule 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine in the form Oral liquid 130 mL, 30
(PKU Cooler 15)
insert:
 
Oral liquid 174 mL, 30 (PKU Air 20)
Oral
PKU Air 20
VF
MP NP
C4295
 
4
5
1
 
 
[21]         Schedule 1, entry for Apixaban
substitute:
Apixaban
Tablet 2.5 mg
Oral
Eliquis
BQ
MP NP
C4132 C4269 C4359 C4381 C4382 C4402 C4409
P4359 P4381
20
0
20
 
 

 
 
 
 
 
MP NP
C4132 C4269 C4359 C4381 C4382 C4402 C4409
P4382 P4409
30
0
30
 
 

 
 
 
 
 
MP NP
C4132 C4269 C4359 C4381 C4382 C4402 C4409
P4402
60
0
60
 
 

 
 
 
 
 
MP NP
C4132 C4269 C4359 C4381 C4382 C4402 C4409
P4132 P4269
60
5
60
 
 

 
Tablet 5 mg
Oral
Eliquis
BQ
MP NP
C4098 C4099 C4269 C5083 C5098
P4098 P5098
28
0
28
 
 

 
 
 
 
 
MP NP
C4098 C4099 C4269 C5083 C5098
P4099 P4269 P5083
60
5
60
 
 

[22]         Schedule 1, entry for Aripiprazole in each of the forms: Tablet 10 mg; Tablet 15 mg; Tablet 20 mg; and Tablet 30 mg
omit from the column headed “Responsible Person”:                 BQ          substitute:             OS
[23]         Schedule 1, entry for Azathioprine in each of the forms: Tablet 25 mg; and Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Azran
FM
MP NP
 
 
100
5
100
 
 
[24]         Schedule 1, entry for Bisoprolol in each of the forms: Tablet containing bisoprolol fumarate 2.5 mg; Tablet containing bisoprolol fumarate 5 mg; and Tablet containing bisoprolol fumarate 10 mg
omit from the column headed “Brand”:         Bisoprolol GH   substitute:             Bisoprolol generichealth
[25]         Schedule 1, omit entry for Canagliflozin
[26]         Schedule 1, omit entry for Cinacalcet
[27]         Schedule 1, entry for Clindamycin
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Calindamin
QA
MP NP MW PDP
C1145
 
24
0
24
 
 
[28]         Schedule 1, entry for Dabrafenib in the form Capsule 50 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats:3]
(a)      omit from the column headed “Circumstances”:            C4317  C4340    substitute:          C5082  C5125
(b)      omit from the column headed “Purposes”:       P4317   substitute:          P5082
[29]         Schedule 1, entry for Dabrafenib in the form Capsule 50 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats:5]
(a)      omit from the column headed “Circumstances”:            C4317  C4340    substitute:          C5082  C5125
(b)      omit from the column headed “Purposes”:       P4340   substitute:          P5125
[30]         Schedule 1, entry for Dabrafenib in the form Capsule 75 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats:3]
(a)      omit from the column headed “Circumstances”:            C4317  C4340    substitute:          C5082  C5125
(b)      omit from the column headed “Purposes”:       P4317   substitute:          P5082
 
[31]         Schedule 1, entry for Dabrafenib in the form Capsule 75 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats:5]
(a)      omit from the column headed “Circumstances”:            C4317  C4340    substitute:          C5082  C5125
(b)      omit from the column headed “Purposes”:       P4340   substitute:          P5125
[32]         Schedule 1, entry for Darunavir in each of the forms: Tablet 150 mg (as ethanolate); Tablet 600 mg (as ethanolate)
omit from the column headed “Circumstances”:        C4313   substitute:             C5094
[33]         Schedule 1, entry for Desferrioxamine in the form Powder for injection containing desferrioxamine mesylate 2 g
omit:
 
 
 
Desferal 2 g
NV
MP
C1085 C3340
 
60
5
1
 
D(100)
[34]         Schedule 1, after entry for Ezetimibe and rosuvastatin in the form Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 40 mg (as calcium)
insert:
Ezetimibe with atorvastatin
Tablet 10 mg-10 mg
Oral
Atozet
MK
MP NP
C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 C4353
 
30
5
30
 
 

 
Tablet 10 mg-20 mg
Oral
Atozet
MK
MP NP
C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121
 
30
5
30
 
 

 
Tablet 10 mg-40 mg
Oral
Atozet
MK
MP NP
C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121
 
30
5
30
 
 

 
Tablet 10 mg-80 mg
Oral
Atozet
MK
MP NP
C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121
 
30
5
30
 
 

[35]         Schedule 1, after entry for Glatiramer in the form Injection containing glatiramer acetate 20 mg in 1 mL single dose pre‑filled syringe
insert in the columns in the order indicated:
 
Injection containing glatiramer acetate 40 mg in 1 mL single dose pre‑filled syringe
Injection
Copaxone
TB
MP
C4881 C4887
 
12
5
12
 
 
[36]         Schedule 1, entry for Glucose and Ketone Indicator—Urine in each of the forms: Test strips, 50 (Keto-Diabur-Test 5000); and
Test strips, 50 (Keto-Diastix)
omit from the column headed “Purposes”:   P3035   substitute:             P5086
 
[37]         Schedule 1, entry for Glucose Indicator—Blood
omit:
 
Test strips, 100 (Accu-Chek Mobile)
For external use
Accu-Chek Mobile
RD
MP
C3552 C3553
P3552
1
5
1
 
 

 
 
 
 
 
NP
C3552
 
1
5
1
 
 

 
 
 
 
 
MP
C3552 C3553
P3553
1
11
1
 
 

substitute:
 
Test strips, 100 (Accu-Chek Mobile)
For external use
Accu-Chek Mobile
RD
MP
C5088 C5100
P5088
1
5
1
 
 

 
 
 
 
 
NP
C5088
 
1
5
1
 
 

 
 
 
 
 
MP
C5088 C5100
P5100
1
11
1
 
 

[38]         Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 100 (Accu-Chek Performa)
insert in the columns in the order indicated:
 
Test strips, 100 (Betachek C50)
For external use
Betachek C50
NA
MP NP
 
 
1
5
1
 
 

 
 
 
 
 
MP
 
P4241
1
11
1
 
 

[39]         Schedule 1, entry for Glucose Indicator—Urine
omit from the column headed “Purposes”:   P3035   substitute:             P5080
[40]         Schedule 1, entry for Hydroxychloroquine
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Hydroxychloroquine GH
GQ
MP NP
 
 
100
1
100
 
 
[41]         Schedule 1, entry for Lactulose
(a)      omit:
 
 
 
Genlac
QA
MP NP
C1150 C1613 C3642 C3643
P3643
3
0
1
 
 
(b)      omit:
 
 
 
Genlac
QA
MP NP
C1150 C1613 C3642 C3643
P3642
3
3
1
 
 
(c)      omit:
 
 
 
Genlac
QA
MP NP
C1150 C1613 C3642 C3643
P1150 P1613
1
5
1
 
 
 
[42]         Schedule 1, entry for Lansoprazole in the form Tablet 30 mg (orally disintegrating) [Maximum Quantity: 28; Number of Repeats: 1]
(a)      insert in numerical order in the column headed “Circumstances” for the brand “Lansoprazole ODT GH”:       C1337 C1533
(b)      insert in the column headed “Purposes”:            P1177
[43]         Schedule 1, entry for Lansoprazole in the form Tablet 30 mg (orally disintegrating) [Maximum Quantity: 28; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Lansoprazole ODT GH
GQ
MP NP
C1177 C1337 C1533
P1337 P1533
28
5
28
 
 
[44]         Schedule 1, entry for Levetiracetam in the form Oral solution 100 mg per mL, 300 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Levetiracetam-AFT
AE
MP NP
C3291
 
1
5
1
 
 
[45]         Schedule 1, entry for Mesna in each of the forms: Solution for I.V. injection 400 mg in 4 mL ampoule; and Solution for I.V. injection 1 g
in 10 mL ampoule
omit from the column headed “Circumstances”:        C1618   substitute:             C5106  C5130
[46]         Schedule 1, after entry for Nystatin in the form Cream 100,000 units per g, 15 g
insert:
Obinutuzumab
Solution for I.V. infusion 1000 mg in 40 mL
Injection
Gazyva
RO
MP
C5126
 
See Note 3
See Note 3
1
 
D(100)
[47]         Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Oxycodone Aspen
FM
MP NP PDP
C4926 C4959
 
20
0
20
 
 
[48]         Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APOTEX-Pantoprazole
GX
MP NP
C1337 C1476 C1533
 
30
5
30
 
 
[49]         Schedule 1, entry for Poly-l-lactic acid in the form Powder for injection 150 mg [Maximum Quantity: 2; Number of Repeats: 0]
(a)      omit from the column headed “Circumstances”:            C3182  C3183    substitute:          C5087  C5122
(b)      omit from the column headed “Purposes”:       P3183   substitute:          P5122 
[50]         Schedule 1, entry for Poly-l-lactic acid in the form Powder for injection 150 mg [Maximum Quantity: 2; Number of Repeats: 4]
(a)      omit from the column headed “Circumstances”:            C3182  C3183    substitute:          C5087  C5122
(b)      omit from the column headed “Purposes”:       P3182   substitute:          P5087 
 
[51]         Schedule 1, after entry for Polyvinyl Alcohol in the form Eye drops 30 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative)
insert:
Pomalidomide
Capsule 3 mg
Oral
Pomalyst
CJ
MP
See Note 3
 
See Note 3
See Note 3
21
 
D(100)

 
Capsule 4 mg
Oral
Pomalyst
CJ
MP
See Note 3
 
See Note 3
See Note 3
21
 
D(100)

[52]         Schedule 1, entry for Propranolol in each of the forms: Tablet containing propranolol hydrochloride 10 mg; and Tablet containing propranolol hydrochloride 40 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Propranolol
TX
MP NP
 
 
100
5
100
 
 
[53]         Schedule 1, entry for Sodium Acid Phosphate
omit from the column headed “Circumstances”:        C1099  C1157  C1167  C1467     substitute:             C5089  C5095  C5114  C5123 
[54]         Schedule 1, after entry for Testosterone in the form I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL
insert in the columns in the order indicated:
 
Transdermal cream 50 mg per mL, 50 mL
Transdermal
AndroForte 5
LX
MP
C4866 C4867 C4868 C4869 C4870
 
1
6
1
 
 
[55]         Schedule 1, after entry for Testosterone in the form Transdermal gel 50 mg in 5 g sachet, 30
insert in the columns in the order indicated:
 
Transdermal gel (pump pack) 12.5 mg per 1.25 g dose, 60 doses, 2
Transdermal
Testogel
HB
MP
C4866 C4867 C4868 C4869 C4870
 
1
4
1
 
 
[56]         Schedule 1, entry for Tetracosactrin
omit from the column headed “Responsible Person”:                 NV          substitute:             LM
[57]         Schedule 1, after entry for Tramadol in the form Injection containing tramadol hydrochloride 100 mg in 2 mL [Brand: Tramal 100]
insert:
Trametinib
Tablet 500 micrograms
Oral
Mekinist
NV
MP
C5081 C5108
P5108
90
3
30
 
 

 
 
 
 
 
MP
C5081 C5108
P5081
90
5
30
 
 

 
Tablet 2 mg
Oral
Mekinist
NV
MP
C5081 C5108
P5108
30
3
30
 
 

 
 
 
 
 
MP
C5081 C5108
P5081
30
5
30
 
 

 
 
[58]         Schedule 1, after entry for Triglycerides—medium chain, formula in the form Oral powder 400 g (Peptamen Junior)
insert:
 
Oral liquid 500 mL, 8 (Nutrini Peptisorb)
Oral
Nutrini Peptisorb
SB
MP NP
C4660
 
8
5
1
 
 
[59]         Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 20; Number of Repeats: 0]
omit from the column headed “Responsible Person” for the brand “Zelitrex”:    UA          substitute:             FM
[60]         Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]
omit from the column headed “Responsible Person” for the brand “Zelitrex”:    UA          substitute:             FM
[61]         Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 42; Number of Repeats: 0]
omit from the column headed “Responsible Person” for the brand “Zelitrex”:    UA          substitute:             FM
[62]         Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 500; Number of Repeats: 2]
omit from the column headed “Responsible Person” for the brand “Zelitrex”:    UA          substitute:             FM
[63]         Schedule 1, after entry for Varenicline in the form Tablet 1 mg (as tartrate)
insert:
Vedolizumab
Powder for injection 300 mg
Injection
Entyvio
TK
MP
See Note 3
 
See Note 3
See Note 3
1
 
D(100)
[64]         Schedule 2, Part 1, entry for Aqueous Cream APF
omit from the column headed “Circumstances”:          For use only as a base combined with active ingredients
[65]         Schedule 2, Part 1, entry for Ascorbic Acid BP
omit from the column headed “Circumstances”:          For use only as an ingredient of ferrous sulfate mixtures
[66]         Schedule 2, Part 1, entry for Cetomacrogol Cream, Aqueous APF
omit from the column headed “Circumstances”:          For use only as a base combined with active ingredients
[67]         Schedule 2, Part 1, entry for Cetrimide Cream, Aqueous APF
omit from the column headed “Circumstances”:          For use only as a base combined with active ingredients
[68]         Schedule 2, Part 1, entry for Chlorhexidine Cream, Aqueous APF
omit from the column headed “Circumstances”:          For use only as a base combined with active ingredients
[69]         Schedule 2, Part 1, entry for Codeine Phosphate BP
omit from the column headed “Circumstances”:          May only be prescribed in linctuses, mixtures and mixtures for children
[70]         Schedule 2, Part 1, entry for Emulsifying Ointment BP
omit from the column headed “Circumstances”:          For use only as a base combined with active ingredients
 
[71]         Schedule 2, Part 1, entry for Ephedrine Hydrochloride BP
omit from the column headed “Circumstances”:          May only be prescribed in nasal instillations
[72]         Schedule 2, Part 1, entry for Magnesium Sulfate BP
omit from the column headed “Circumstances”:          May only be prescribed for other than oral use
[73]         Schedule 2, Part 1, entry for Paraffin, Liquid BP
omit from the column headed “Circumstances”:          May only be prescribed for other than oral use
[74]         Schedule 2, Part 1, entry for Phenobarbitone Sodium BP
omit from the column headed “Circumstances”:          May only be prescribed for the treatment of epilepsy
[75]         Schedule 2, Part 1, entry for Phenol, Liquefied BP
omit from the column headed “Circumstances”:          Not available for ear drops
[76]         Schedule 2, Part 1, entry for Simple Ointment (white) BP
omit from the column headed “Circumstances”:          For use only as a base combined with active ingredients
[77]         Schedule 2, Part 1, entry for Simple Ointment (yellow) BP
omit from the column headed “Circumstances”:          For use only as a base combined with active ingredients
[78]         Schedule 2, Part 1, entry for Water For Injections, sterilised BP
omit from the column headed “Circumstances”:          May only be prescribed in eye drops and eye lotions
[79]         Schedule 2, Part 1, entry for Wool Alcohols Ointment (white) BP
omit from the column headed “Circumstances”:          For use only as a base combined with active ingredients
[80]         Schedule 2, Part 1, entry for Wool Alcohols Ointment (yellow) BP
omit from the column headed “Circumstances”:          For use only as a base combined with active ingredients
[81]         Schedule 2, Part 1, entry for Zinc Cream BP
omit from the column headed “Circumstances”:          For use only as a base combined with active ingredients
[82]         Schedule 3, after details relevant to Responsible Person code LU
insert:
LX
Lawley Pharmaceuticals Pty Ltd
 12 095 973 523
[83]         Schedule 3, after details relevant to Responsible Person code ON
insert:
OS
Otsuka Australia Pharmaceutical Pty Ltd
 20 601 768 754
[84]         Schedule 4, Part 1, entry for Adalimumab
(a)      omit:

 
C2986
P2986
 
Crohn disease — initial treatment 1
(patient assessed by CDAI)
Initial treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with severe refractory Crohn disease who satisfies the following criteria:
(a) has confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and
(b) has not received any prior PBS‑subsidised treatment with adalimumab or infliximab for Crohn disease, or, where the patient has previously received PBS‑subsidised treatment with adalimumab or infliximab for this condition, has received no such treatment for a period of 5 years or more starting from the date the last application for PBS‑subsidised treatment with adalimumab or infliximab for this condition was approved; and
(c) has signed a patient acknowledgement indicating they understand and acknowledge that PBS‑subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS‑subsidised treatment, as outlined in the restriction for continuing treatment; and
(d) has failed to achieve an adequate response to prior systemic therapy including:
(i) a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; and
(ii) immunosuppressive therapy including:
— azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or
— 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or
— methotrexate at a dose of at least 15 mg weekly for 3 or more months; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration‑approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens mentioned at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
failure to achieve an adequate response is indicated by a severity of disease activity which results in a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as assessed, and is demonstrated in the patient at the time of the authority application;
all tests and assessments are performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
the most recent CDAI assessment is no more than 1 month old at the time of application;
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient’s condition; and
(ii) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy); and
(iii) the signed patient acknowledgement;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of initial treatment in a treatment cycle, by a gastroenterologist or a consultant physician, of a patient with severe refractory Crohn disease who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C2988
P2988
 
Crohn disease — initial treatment 3
(patient assessed by CDAI)
Commencement of a treatment cycle with an initial PBS‑subsidised course of adalimumab for continuing treatment, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of severe refractory Crohn disease and was receiving treatment with adalimumab prior to 9 November 2007; and
(b) had a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 prior to commencing treatment with adalimumab; and
(c) has signed a patient acknowledgement indicating that they understand and acknowledge that PBS‑subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS‑subsidised treatment, as outlined in the restriction for continuing treatment; and
(d) has demonstrated or sustained an adequate response to treatment with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as a reduction in Crohn Disease Activity Index (CDAI) Score to no greater than 150;
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current and baseline Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient’s condition; and
(ii) the signed patient acknowledgment;
the current CDAI assessment is no more than 1 month old at the time of application;
the baseline CDAI assessment is from immediately prior to commencing treatment with adalimumab;
the course of treatment is limited to a maximum of 24 weeks of treatment;
a patient may qualify for PBS‑subsidised treatment under this restriction once only
Compliance with Written Authority Required procedures
 

 
 
 
 
Continuation of a course of initial PBS‑subsidised treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS‑subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C2990
P2990
 
Crohn disease — initial treatment 1
(patient with short gut syndrome or an ostomy patient)
Initial treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with severe refractory Crohn disease who satisfies the following criteria:
(a) has confirmed Crohn disease defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and
(b) has diagnostic imaging or surgical evidence of short gut syndrome or has an ileostomy or colostomy; and
(c) has evidence of intestinal inflammation; and
(d) has not received any prior PBS‑subsidised treatment with adalimumab or infliximab for Crohn disease, or, where the patient has previously received PBS‑subsidised treatment with adalimumab or infliximab for this condition, has received no such treatment for a period of 5 years or more starting from the date the last application for PBS‑subsidised treatment with adalimumab or infliximab for this condition was approved; and
(e) has signed a patient acknowledgement indicating they understand and acknowledge that PBS‑subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS‑subsidised treatment, as outlined in the restriction for continuing treatment; and
(f) has failed to achieve an adequate response to prior systemic drug therapy including:
(i) a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; and
(ii) immunosuppressive therapy including:
— azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or
— 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or
— methotrexate at a dose of at least 15 mg weekly for 3 or more months; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
if treatment with any of the drugs mentioned at (f) above is contraindicated according to the relevant Therapeutic Goods Administration‑approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens mentioned at (f) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
failure to achieve an adequate response is indicated by the following and is demonstrated in the patient at the time of the authority application:
(a) have evidence of intestinal inflammation, including:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C‑reactive protein (CRP) level greater than 15 mg per L; and/or
(ii) faeces: higher than normal lactoferrin or calprotectin level; and/or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery; and/or
(b) be assessed clinically as being in a high faecal output state; and/or
(c) be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of adalimumab;
all tests and assessments are performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy); and
(ii) reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iii) date of the most recent clinical assessment; and
(iv) the signed patient acknowledgement;
all assessments, pathology tests and diagnostic imaging studies are made within 1 month of the date of application;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of initial treatment in a treatment cycle, by a gastroenterologist or a consultant physician, of a patient with severe refractory Crohn disease who has short gut syndrome or an ileostomy or colostomy and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C2993
P2993
 
Crohn disease — initial treatment 1
(patient with extensive small intestine disease)
Initial treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with severe refractory Crohn disease who satisfies the following criteria:
(a) has confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and
(b) has extensive small intestinal disease with radiological evidence of intestinal inflammation affecting more than 50 cm of the small intestine; and
(c) has not received any prior PBS‑subsidised treatment with adalimumab or infliximab for Crohn disease, or, where the patient has previously received PBS‑subsidised treatment with adalimumab or infliximab for this condition, has received no such treatment for a period of 5 years or more starting from the date the last application for PBS‑subsidised treatment with adalimumab or infliximab for this condition was approved; and
(d) has signed a patient acknowledgement indicating they understand and acknowledge that PBS‑subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS‑subsidised treatment, as outlined in the restriction for continuing treatment; and
(e) has failed to achieve an adequate response to prior systemic therapy including:
(i) a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; and
(ii) immunosuppressive therapy including:
— azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or
— 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or
— methotrexate at a dose of at least 15 mg weekly for 3 or more months; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
if treatment with any of the drugs mentioned at (e) above is contraindicated according to the relevant Therapeutic Goods Administration‑approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens mentioned at (e) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
failure to achieve an adequate response is indicated by the following and is demonstrated in the patient at the time of the authority application:
(a) have severity of disease activity which results in a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and/or
(b) have evidence of active intestinal inflammation, including:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C‑reactive protein (CRP) level greater than 15 mg per L; and/or
(ii) faeces: higher than normal lactoferrin or calprotectin level; and/or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery; and/or
(c) be assessed clinically as being in a high faecal output state; and/or
(d) be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of adalimumab;
all tests and assessments are performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy); and
(ii) (1) reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; or
(2) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the dates of assessment of the patient’s condition, if relevant; and
(iii) date of the most recent clinical assessment; and
(iv) the signed patient acknowledgement;
all assessments, pathology tests and diagnostic imaging studies are made within 1 month of the date of application;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of initial treatment in a treatment cycle, by a gastroenterologist or a consultant physician, of a patient with severe refractory Crohn disease who has extensive small intestine disease, and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C2995
P2995
 
Crohn disease — initial treatment 3
(patient with short gut syndrome or extensive small intestine disease, or an ostomy patient)
Commencement of a treatment cycle with an initial PBS‑subsidised course of adalimumab for continuing treatment, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of severe refractory Crohn disease and was receiving treatment with adalimumab prior to 9 November 2007; and
(b) (1) has a history of extensive small intestinal disease with radiological evidence of intestinal inflammation affecting more than 50 cm of the small intestine; or
(2) has diagnostic imaging or surgical evidence of short gut syndrome or has an ileostomy or colostomy with a documented history of intestinal inflammation; and
(c) has signed a patient acknowledgement indicating that they understand and acknowledge that PBS‑subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS‑subsidised treatment, as outlined in the restriction for continuing treatment; and
(d) has demonstrated or sustained an adequate response to treatment with adalimumab according to the criteria included in the relevant continuation restriction; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as:
(a) a reduction in Crohn Disease Activity Index (CDAI) Score to no greater than 150; or
(b) improvement of intestinal inflammation as demonstrated by:
(i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a
C‑reactive protein (CRP) level no greater than 15 mg per L; and/or
(ii) faeces: normalisation of lactoferrin or calprotectin level; and/or
(iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or
(c) reversal of high faecal output state; or
(d) avoidance of the need for surgery or total parenteral nutrition (TPN);
the same criteria used to determine an inadequate response to prior treatment at baseline are used to determine response to treatment and eligibility for continuing therapy, according to the criteria included in the continuing treatment restriction;
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) (1) the completed current and baseline Crohn Disease Activity Index (CDAI) Score calculation sheet, where relevant, including the date of the assessment of the patient’s condition; or
(2) the reports and dates of the current and baseline pathology or diagnostic imaging test(s) in order to assess response to therapy; or
(3) the date of clinical assessment(s); and
(ii) the signed patient acknowledgement;
the patient’s assessment is no more than 1 month old at the time of application;
the baseline assessment is from immediately prior to commencing treatment with adalimumab;
the course of treatment is limited to a maximum of 24 weeks of treatment;
a patient may qualify for PBS‑subsidised treatment under this restriction once only
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of initial PBS‑subsidised treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease with extensive small intestine disease, short gut syndrome or an ileostomy or colostomy, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS‑subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

(b)      omit:

 
C3753
P3753
 
Crohn disease — initial treatment 2
(patient assessed by CDAI)
Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient who:
(a) has a documented history of severe refractory Crohn disease; and
(b) in this treatment cycle, has received prior PBS‑subsidised treatment with infliximab or adalimumab for this condition; and
(c) has not failed PBS‑subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient’s condition; and
(ii) details of prior adalimumab and infliximab treatment including details of date and duration of treatment; and
to demonstrate a response to treatment the application is accompanied by the results of the patient’s most recent course of adalimumab or infliximab therapy where:
(a) the response assessment is provided to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased; and
(b) (i) if the course of therapy is a 16‑week initial course (in the case of adalimumab), the assessment of response is made following a minimum of 12 weeks of treatment; or
(ii) if the course of therapy is a 3 dose initial course (in the case of infliximab), the assessment of response is made up to 12 weeks after the first dose (6 weeks following the third dose);
if the response assessment to the previous course of adalimumab or infliximab treatment is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a gastroenterologist or a consultant physician, of a patient who has a documented history of severe refractory Crohn disease, and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment or recommencement of treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C3754
P3754
 
Crohn disease — initial treatment 2
(patient with short gut syndrome or extensive small intestine disease, or an ostomy patient)
Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient who:
(a) has a documented history of severe refractory Crohn disease and has short gut syndrome, an ileostomy or colostomy, or extensive small intestine disease; and
(b) in this treatment cycle, has received prior PBS‑subsidised treatment with infliximab or adalimumab for this condition; and
(c) has not failed PBS‑subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following: (i) reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criteria, if relevant; and (ii) details of prior adalimumab and infliximab treatment including details of date and duration of treatment;
to demonstrate a response to treatment the application is accompanied by the results of the patient’s most recent course of adalimumab or infliximab therapy where:
(a) the response assessment is provided to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased; and
(b) (i) if the course of therapy is a 16‑week initial course (in the case of adalimumab), the assessment of response is made following a minimum of 12 weeks of treatment; or
(ii) if the course of therapy is a 3 dose initial course (in the case of infliximab), the assessment of response is made up to 12 weeks after the first dose (6 weeks following the third dose);
if the response assessment to the previous course of adalimumab or infliximab treatment is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;
the same baseline criterion used to determine response to an initial course of adalimumab treatment is used to determine response, and thus eligibility for continued PBS‑subsidised therapy, to subsequent courses of treatment;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a gastroenterologist or a consultant physician, of a patient who has a documented history of severe refractory Crohn disease and has short gut syndrome, an ileostomy or colostomy, or extensive small intestine disease, and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment or recommencement of treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C3755
P3755
 
Crohn disease — continuing treatment
(patient assessed by CDAI)
Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of severe refractory Crohn disease; and
(b) has demonstrated or sustained an adequate response to treatment with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150;
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient’s condition;
the CDAI assessment is no more than 1 month old at the time of application;
the CDAI assessment of the patient’s response to a course of treatment is provided to the Chief Executive Medicare no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 16‑week initial course, the assessment is made following a minimum of 12 weeks of therapy;
where an assessment is not submitted to the Chief Executive Medicare as detailed above the patient is deemed to have failed to respond, or to have failed to sustain a response, to treatment with adalimumab, despite demonstrating a response as defined above;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;
patients are eligible to receive continuing adalimumab treatment in courses of up to 24 weeks providing they continue to sustain the response
Compliance with Written Authority Required procedures

 
 
 
 
Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C3756
P3756
 
Crohn disease — continuing treatment
(patient with short gut syndrome or an ostomy patient)
Continuing treatment in an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of severe refractory Crohn disease with intestinal inflammation and with short gut syndrome or with an ileostomy or colostomy; and
(b) has demonstrated or sustained an adequate response to treatment with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as:
(a) improvement of intestinal inflammation as demonstrated by:
(i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a
C‑reactive protein (CRP) level no greater than 15 mg per L; and/or
(ii) faeces: normalisation of lactoferrin or calprotectin level; and/or
(iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or
(b) reversal of high faecal output state; or
(c) avoidance of the need for surgery or total parenteral nutrition (TPN);
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy or the date of clinical assessment;
the patient’s assessment is no more than 1 month old at the time of application;
the assessment of the patient’s response to a course of treatment is provided to the Chief Executive Medicare no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 16‑week initial course, the assessment is made following a minimum of 12 weeks of therapy;
where an assessment is not submitted to the Chief Executive Medicare as detailed above the patient is deemed to have failed to respond, or to have failed to sustain a response, to treatment with adalimumab, despite demonstrating a response as defined above;
the same baseline criterion used to determine response to an initial course of adalimumab treatment is used to determine response, and thus eligibility for continued PBS‑subsidised therapy, to subsequent courses of treatment;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;
patients are eligible to receive continuing adalimumab treatment in courses of up to 24 weeks providing they continue to sustain the response 3757
Compliance with Written Authority Required procedures

 
 
 
 
Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease with short gut syndrome or an ileostomy or colostomy, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C3757
P3757
 
Crohn disease — continuing treatment
(patient with extensive small intestine disease)
Continuing treatment in an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of severe refractory Crohn disease with extensive intestinal inflammation affecting more than 50 cm of the small intestine; and
(b) has demonstrated or sustained an adequate response to treatment with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as:
(a) a reduction in Crohn Disease Activity Index (CDAI) Score to no greater than 150; or
(b) improvement of intestinal inflammation as demonstrated by:
(i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour, or a
C‑reactive protein (CRP) level no greater than 15 mg per L; and/or
(ii) faeces: normalisation of lactoferrin or calprotectin level; and/or
(iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or
(c) reversal of high faecal output state; or
(d) avoidance of the need for surgery or total parenteral nutrition (TPN);
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient’s condition; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy; or
(iii) the date of clinical assessment;
all assessments are no more than 1 month old at the time of application;
the assessment of the patient’s response to a course of treatment is provided to the Chief Executive Medicare no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 16‑week initial course, the assessment is made following a minimum of 12 weeks of therapy;
where an assessment is not submitted to the Chief Executive Medicare as detailed above the patient is deemed to have failed to respond, or to have failed to sustain a response, to treatment with adalimumab, despite demonstrating a response as defined above;
the same baseline criterion used to determine response to an initial course of adalimumab treatment is used to determine response, and thus eligibility for continued PBS‑subsidised therapy, to subsequent courses of treatment;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;
patients are eligible to receive continuing adalimumab treatment in courses of up to 24 weeks providing they continue to sustain the response
Compliance with Written Authority Required procedures

 
 
 
 
Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of severe refractory Crohn disease with extensive small intestine disease, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

(c)      insert in numerical order after existing text:

 
C5074
P5074
 
Severe Crohn disease
Initial treatment (new patient - initial 1)
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; OR
Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contraindication to steroids; AND
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more months or have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contraindication to this drug; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months or have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contraindication to this drug; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more months or have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contraindication to this drug; AND
Patient must have severity of disease activity which results in a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 if affected by extensive small intestine disease; OR
Patient must have severity of disease activity which results in a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 if not affected by extensive small intestine disease, short gut syndrome or is an ostomy patient; AND
Patient must have evidence of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR
Patient must have radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine; OR
Patient must (a) have evidence of intestinal inflammation, including: (i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or (ii) faeces: higher than normal lactoferrin or calprotectin level; or (iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery; or (b) be assessed clinically as being in a high faecal output state; or (c) be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient
Patient must be aged 18 years or older
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iv) the date of the most recent clinical assessment; and
(v) the signed patient acknowledgement indicating they understand and acknowledge that the PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment
Two completed authority prescriptions must be submitted with every initial application for adalimumab. One prescription must be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats. The second prescription must be written for 2 doses of 40 mg and 2 repeats
Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested by telephone by contacting the Department of Human Services
Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period
All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application
Details of the accepted toxicities including severity can be found on the Department of Human Services website
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy
A maximum quantity and number of repeats to provide for an initial 16 week course of this drug will be authorised
If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase
The assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of therapy so that there is adequate time for a response to be demonstrated
This assessment, which will be used to determine eligibility for further continuing treatment, must be submitted to the Department of Human Services 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 Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
Compliance with Written Authority Required procedures

 
C5075
P5075
 
Severe Crohn disease
Continuing treatment
Patient must have a documented history of severe Crohn disease; AND
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment with this drug; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient
Patient must be aged 18 years or older
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment
All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.
If the application is the first application for continuing treatment with this drug, an assessment of the patient's response to the initial course of treatment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response
At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient dose. Up to a maximum of 5 repeats will be authorised
If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase
Compliance with Written or Telephone Authority Required procedures

 
C5076
P5076
 
Severe Crohn disease
Initial treatment (new paediatric patient) of Crohn disease in a paediatric patient assessed by PCDAI (Initial 1)
Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist, consultant physician, paediatrician or specialist paediatric gastroenterologist; AND
Patient must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; OR
Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra-indication to each of prednisolone (or equivalent), azathioprine, 6-mercaptopurine and methotrexate; AND
Patient must have, at the time of application, disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40 preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment and which is no more than 1 month old at the time of application
Patient must be aged 6 to 17 years inclusive
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist
Applications for authorisation of initial treatment must be in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed paediatric Crohn Disease PBS Authority Application -Supporting Information Form [may be downloaded from the Department of Human Services website (www.humanservices.gov.au)] which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) details of previous systemic drug therapy [dosage, date of commencement and duration of therapy] or dates of enteral nutrition; and
(iii) the signed patient or guardian acknowledgement indicating they understand and acknowledge that the PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application. Details of the accepted toxicities including severity can be found on the Human Services website (www.humanservices.gov.au)
A maximum quantity and number of repeats to provide for an initial 16 week course of this drug consisting of a 160 mg dose at week 0, 80 mg dose at week 2 and 40 mg dose at weeks 4, 6, 8, 10, 12 and 14 for patients 40 kg or greater (for patients 40 kg or less, the course is a 80 mg dose at week 0, 40 mg dose at week 2 and a 20 mg dose at weeks 4, 6, 8, 10, 12 and 14) will be authorised
Two completed authority prescriptions should be submitted with every initial application for this drug. For patients weighing 40 kg or greater: one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription should be written for 2 doses of 40 mg and 2 repeats. For patients weighing less than 40 kg: one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats
If fewer than 2 repeats (for patients 40 kg or greater) or 3 repeats (for patients less than 40 kg) are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with this drug may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period
A PCDAI assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks therapy so that there is adequate time for a response to be demonstrated
This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services 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 Department of Human Services within these time-frames, the patient will be deemed to have failed to respond to treatment with this drug
It is recommended that an application for continuing treatment is posted to the Department of Human Services at the time of the 12 week assessment, to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug
Compliance with Written Authority Required procedures

 
C5090
P5090
 
Severe Crohn disease
Balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete the initial dose (i.e. the initial infusion regimen at weeks 0 and 2); OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 2 doses (new patients) or 5 repeats (Continuing treatment
Patient must be aged 18 years or older
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]
Authority approval for sufficient therapy to complete a maximum of 2 initial doses or 5 repeats may be requested by telephone by contacting the Department of Human Services
Compliance with Written or Telephone Authority Required procedures

 
C5091
P5091
 
Severe Crohn disease
Continuing treatment of Crohn disease in a paediatric patient assessed by PCDAI
Patient must have a documented history of severe Crohn disease; AND
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug as defined as a reduction in PCDAI Score by at least 15 points as compared to baseline and a total of PCDAI score of 40 points or less with the PCDAI assessment being no more than 1 month old at the time of application
Patient must be aged 6 to 17 years inclusive
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form [may be downloaded from the Department of Human Services website (www.humanservices.gov.au)] which includes the following:
(i) the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient's condition
The PCDAI assessment must be no more than 1 month old at the time of application
If the application is the first application for continuing treatment with adalimumab, a PCDAI assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of therapy so that there is adequate time for a response to be demonstrated
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response
A maximum of 24 weeks treatment will be authorised under this criterion
Where fewer than 5 repeats are requested at the time of application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment may be requested by telephone by contacting Medicare Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) and authorised through the Balance of Supply treatment phase PBS restriction
Compliance with Written Authority Required procedures

 
C5105
P5105
 
Severe Crohn disease
Balance of supply for paediatric patient
Patient must received insufficient therapy with this drug under Initial 1 (new patient or patient recommencing treatment after break of more than 5 years) or Initial 2 (change or recommencement of treatment after a break of less than 5 years) or Initial 3 (grandfathered patients) or Continuing treatment to complete the maximum duration of treatment specified in the relevant treatment phase; AND
The treatment must provide no more than the balance of up to 16 weeks of therapy (new patients or change/re-commencement patients; Initial 1 or Initial 2) or 24 weeks of therapy (Continuing patients or Grandfathered patients)
Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician or a specialist paediatric gastroenterologist
Compliance with Authority Required procedures

 
C5115
P5115
 
Severe Crohn disease
Change or Re-commencement of treatment (initial 2)
Patient must have a documented history of severe Crohn disease; AND
Patient must have received prior PBS-subsidised treatment with a biological disease modifying drug for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle
Patient must be aged 18 years or older
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form, which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment; and
(iv) the details of prior biological disease modifying drug treatment including the details of date and duration of treatment
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological disease modifying drug (bDMD) therapy within the timeframes specified in the relevant restriction
Where the most recent course of PBS-subsidised bDMD treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased
If the response assessment to the previous course of bDMD treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of bDMD
A maximum quantity and number of repeats to provide for an initial 16 week course of this drug will be authorised
If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase
The assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of therapy so that there is adequate time for a response to be demonstrated
This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services 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 Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
It is recommended that an application for continuing treatment is posted to the Department of Human Services at the time of the 12 week assessment, to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug
Compliance with Written Authority Required procedures

 
C5116
P5116
 
Severe Crohn disease
Initial PBS-subsidised treatment of Crohn disease in a paediatric patient who has previously received non-PBS-subsidised therapy with this drug (Initial 3 - Grandfather)
Patient must have been receiving treatment with this drug prior to 1 August 2015; AND
Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist, consultant physician, paediatrician or specialist paediatric gastroenterologist; AND
Patient must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; OR
Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra-indication to each of prednisolone (or equivalent), azathioprine, 6-mercaptopurine and methotrexate; AND
Patient must have had disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40 preferably whilst still on prior conventional treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment; AND
Patient must have demonstrated an adequate response to treatment with this drug as defined as a reduction in PCDAI Score by at least 15 points as compared to baseline and a total of PCDAI score of 40 points or less with the PCDAI assessment being no more than 1 month old at the time of application
Patient must be aged 6 to 17 years inclusive
Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician or a specialist paediatric gastroenterologist
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed paediatric Crohn Disease PBS Authority Application -Supporting Information Form [may be downloaded from the Department of Human Services website (www.humanservices.gov.au)] which includes the following:
(i) the completed current and baseline Paediatric Crohn Disease Activity Index (PCDAI) Score calculation sheet;
(ii) the date of commencement of this drug; and
(iii) the signed patient or guardian acknowledgement indicating they understand and acknowledge that the PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment
The patient's current PCDAI assessment must be no more than 1 month old at the time of application. The baseline PCDAI assessment must be from immediately prior to commencing treatment with this drug
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug
A maximum of 24 weeks treatment will be approved under this criterion
Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) and authorised through the Balance of Supply treatment phase PBS restriction
Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria
Compliance with Written Authority Required procedures

 
C5117
P5117
 
Severe Crohn disease
Change or re-commencement of treatment of Crohn disease in a paediatric patient assessed by PCDAI (Initial 2)
Patient must have a documented history of severe Crohn disease; AND
Patient must in this treatment cycle, have received prior PBS-subsidised treatment with this drug for this condition; OR
Patient must in this treatment cycle, have received prior PBS-subsidised treatment with infliximab for this condition and have a current PCDAI score of 40 or greater; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle
Patient must be aged 6 to 17 years inclusive
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of TNF-alfa antagonist therapy within the timeframes specified in the relevant restriction
Where the most recent course of PBS-subsidised TNF-alfa antagonist treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased
If the response assessment to the previous course of TNF-alfa antagonist treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of TNF-alfa antagonist
Applications for authorisation of initial treatment must be in writing and must include:
(a) two completed authority prescription form; and
(b) a completed paediatric Crohn Disease PBS Authority Application -Supporting Information Form [may be downloaded from the Department of Human Services website (www.humanservices.gov.au)] which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) Score calculation sheet; and
(ii) details of prior TNF-alfa antagonist treatment including details of date and duration of treatment
Two completed authority prescriptions should be submitted with every initial application for this drug. For patients weighing 40 kg or greater: one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription should be written for 2 doses of 40 mg and 2 repeats. For patients weighing less than 40 kg: one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats
If fewer than 2 repeats (for patients 40 kg or greater) or 3 repeats (for patients less than 40 kg) are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with this drug may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period
A PCDAI assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks therapy so that there is adequate time for a response to be demonstrated
This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services 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 Department of Human Services within these time-frames, the patient will be deemed to have failed to respond to treatment with this drug
It is recommended that an application for continuing treatment is posted to the Department of Human Services at the time of the 12 week assessment, to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug
Compliance with Written Authority Required procedures

 
[85]         Schedule 4, Part 1, entry for Adefovir [Circumstances Code C4510]
omit from the column headed “Circumstances and Purposes”:               
Persons with Child's class B or C cirrhosis
substitute:            
Patients with Child's class B or C cirrhosis
[86]         Schedule 4, Part 1, entry for Apixaban
(a)      insert in numerical order:

 
C4098
P4098
 
Deep vein thrombosis
Initial treatment
Patient must have confirmed acute symptomatic deep vein thrombosis; AND
Patient must not have symptomatic pulmonary embolism
Compliance with Authority Required procedures - Streamlined Authority Code 4098

 
C4099
P4099
 
Deep vein thrombosis
Continuing treatment
Patient must have confirmed acute symptomatic deep vein thrombosis; AND
Patient must not have symptomatic pulmonary embolism
Compliance with Authority Required procedures - Streamlined Authority Code 4099

 
C4132
P4132
 
Prevention of recurrent venous thromboembolism
Continuing treatment
Patient must have a history of venous thromboembolism
Compliance with Authority Required procedures - Streamlined Authority Code 4132

(b)      insert in numerical order after existing text:

 
C5083
P5083
 
Pulmonary embolism
Continuing treatment
Patient must have confirmed acute symptomatic pulmonary embolism
Compliance with Authority Required procedures - Streamlined Authority Code 5083

 
C5098
P5098
 
Pulmonary embolism
Initial treatment
Patient must have confirmed acute symptomatic pulmonary embolism
Compliance with Authority Required procedures - Streamlined Authority Code 5098

[87]         Schedule 4, Part 1, omit entry for Canagliflozin
[88]         Schedule 4, Part 1, omit entry for Cinacalcet
[89]         Schedule 4, Part 1, entry for Dabrafenib
substitute:

Dabrafenib
C5082
P5082
 
Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
The condition must be positive for a BRAF V600 mutation; AND
The condition must not have been treated previously with PBS subsidised therapy; OR
Patient must have developed intolerance to another BRAF inhibitor of a severity necessitating permanent treatment withdrawal; AND
Patient must have a WHO performance status of 2 or less
Compliance with Authority Required procedures

 
C5125
P5125
 
Unresectable Stage III or Stage IV malignant melanoma
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must have stable or responding disease
Compliance with Authority Required procedures

[90]         Schedule 4, Part 1, entry for Darunavir
insert in numerical order:
 
C5094
 
 
Human immunodeficiency virus (HIV) infection
The treatment must be in addition to optimised background therapy; AND
The treatment must be in combination with other antiretroviral agents; AND
The treatment must be co-administered with 100 mg ritonavir twice daily; AND
Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5094

[91]         Schedule 4, Part 1, after entry for Ezetimibe and rosuvastatin
insert:

Ezetimibe with atorvastatin
C4068
 
 
Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
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; AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
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; AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
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; AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
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; AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
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; AND
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; AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
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; AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
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

 
C4353
 
 
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); AND
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 atorvastatin 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 4353

[92]         Schedule 4, Part 1, entry for Glucose and Ketone Indicator—Urine
substitute:
Glucose and Ketone Indicator—Urine
 
P5086
 
Urine glucose and ketone monitoring
Patient must be 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
 
[93]         Schedule 4, Part 1, entry for Glucose Indicator—Blood
(a)      omit:

 
C3552
P3552
 
For use in patients on insulin therapy
 

 
 
C3553
P3553
 
For use in patients on insulin therapy 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
 

(b)      insert in numerical order after existing text:

 
C5088
P5088
 
Blood glucose monitoring
Patient must be on insulin therapy
 

 
C5100
P5100
 
Blood glucose monitoring
Patient must be on insulin therapy; AND
Patient must be 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
 

[94]         Schedule 4, Part 1, entry for Glucose Indicator—Urine
substitute:
Glucose Indicator—Urine
 
P5080
 
Urine glucose monitoring
Patient must be 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
 
[95]         Schedule 4, Part 1, entry for Mesna
substitute:

Mesna
C5106
 
 
Urothelial toxicity
Prophylaxis or reduction of toxicity
The treatment must be adjunctive therapy to ifosfamide or high dose cyclophosphamide
 

 
C5130
 
 
Urothelial toxicity
Prophylaxis or reduction of toxicity
The treatment must be adjunctive therapy to ifosfamide or high dose cyclophosphamide
 

[96]         Schedule 4, Part 1, after entry for Nystatin
insert:
Obinutuzumab
C5126
 
 
Chronic lymphocytic leukaemia (CLL)
Patient must require treatment for CD20 positive chronic lymphocytic leukaemia (CLL); AND
The condition must be previously untreated; AND
Patient must be inappropriate for fludarabine based chemo-immunotherapy; AND
The treatment must be in combination with chlorambucil; AND
Patient must have a creatinine clearance 30 mL/min or greater; AND
Patient must have a total cumulative illness rating scale (CIRS) score of greater than 6 (excluding CLL-induced illness or organ damage); OR
Patient must have a creatinine clearance less than 70 mL/min
Treatment must be discontinued in patients who experience disease progression while on treatment
Applications for authorisation must be in writing and must include:
(a) a completed authority prescription form; AND
(b) a completed CD20 positive Chronic Lymphocytic Leukaemia PBS Authority Application - Supporting Information Form which includes:
i) documentation that the patient has CD20 positive CLL (flow cytometry pathology report from blood or bone marrow, noting that this may be from some time earlier); AND
ii) a statement that the patient is previously untreated, is inappropriate for fludarabine based chemo immunotherapy, that treatment will be in combination with chlorambucil; AND
iii) documentation that the patient has a creatinine clearance 30 mL/min or greater; AND
iv) One of the following, either:
A completed cumulative illness rating scale (CIRS) score form demonstrating that the patient has a score of greater than 6 (excluding CLL-induced illness or organ damage) OR
Documentation that the patient has a creatinine clearance less than 70 mL/min
Compliance with Written Authority Required procedures

[97]         Schedule 4, Part 1, entry for Poly-l-lactic acid
substitute:

Poly-l-lactic acid
C5087
P5087
 
Severe facial lipoatrophy
Initial PBS-subsidised treatment
The treatment must be for facial administration only; AND
The condition must be caused by therapy for HIV infection
Accreditation following completion of injection administration training with Galderma is required to prescribe poly-l-lactic acid under the PBS. Patients must be referred from the HIV physician to the accredited injector
Compliance with Written or Telephone Authority Required procedures


 
C5122
P5122
 
Severe facial lipoatrophy
Maintenance PBS-subsidised treatment
The treatment must be for facial administration only; AND
The condition must be caused by therapy for HIV infection
Accreditation following completion of injection administration training with Galderma is required to prescribe poly-l-lactic acid under the PBS. Patients must be referred from the HIV physician to the accredited injector
Compliance with Written or Telephone Authority Required procedures


 
[98]         Schedule 4, Part 1, entry for Sodium Acid Phosphate
substitute:

Sodium Acid Phosphate
C5089
 
 
Hypophosphataemic rickets
Compliance with Authority Required procedures - Streamlined Authority Code 5089

 
C5095
 
 
Familial hypophosphataemia
Compliance with Authority Required procedures - Streamlined Authority Code 5095

 
C5114
 
 
Vitamin D-resistant rickets
Compliance with Authority Required procedures - Streamlined Authority Code 5114

 
C5123
 
 
Hypercalcaemia
Compliance with Authority Required procedures - Streamlined Authority Code 5123

[99]         Schedule 4, Part 1, entry for Tenofovir [Circumstances Code C4476]
(a)      omit from the column headed “Circumstances and Purposes”:     
Chronic hepatitis B
substitute:  
Chronic hepatitis B infection
(b)      omit from the column headed “Circumstances and Purposes”:     
Persons with Child's class B or C cirrhosis
substitute:  
Patients with Child's class B or C cirrhosis
[100]       Schedule 4, Part 1, entry for Tenofovir [Circumstances Codes C4489 and C4490]
omit from the column headed “Circumstances and Purposes”:               
Chronic hepatitis B
substitute:            
Chronic hepatitis B infection
 
[101]       Schedule 4, Part 1, entry for Tenofovir [Circumstances Code C4510]
(a)      omit from the column headed “Circumstances and Purposes”:     
Chronic hepatitis B
substitute:  
Chronic hepatitis B infection
(b)      omit from the column headed “Circumstances and Purposes”:     
Persons with Child's class B or C cirrhosis
substitute:  
Patients with Child's class B or C cirrhosis
[102]       Schedule 4, Part 1, after entry for Tramadol
insert:

Trametinib
C5081
P5081
 
Unresectable Stage III or Stage IV malignant melanoma
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must be receiving PBS-subsidised dabrafenib concomitantly for this condition; AND
Patient must have stable or responding disease
Compliance with Authority Required procedures

 
C5108
P5108
 
Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
Patient must be receiving PBS-subsidised dabrafenib concomitantly for this condition; AND
Patient must not have had progressive disease when treated with a BRAF inhibitor
Compliance with Authority Required procedures