PB 88 of 2013
National Health (Listing of Pharmaceutical
Benefits) Amendment Instrument 2013
(No. 14)
National Health Act 1953
I, FELICITY McNEILL, 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
18 December 2013
FELICITY McNEILL
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 2013 (No. 14).
(2)
2
This Instrument may also be cited as PB 88 of 2013.
Commencement
This Instrument commences on 1 January 2014.
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).
Instrument Number PB 88 of 2013
2
Schedule 1
[1]
Amendments
Schedule 1, entry for Alendronic Acid in the form Tablet 70 mg (as alendronate sodium)
omit:
[2]
Adronat
AF
MP NP
C4122 C4123
C4133
4
5
4
EleCare
AB
MP NP
C4305 C4312
C4323 C4330
C4337 C4338
C4339 C4345
C4352 C4368
C4414 C4415
8
5
1
MP NP
C4305 C4312 P4368 P4414
C4323 C4330
C4337 C4338
C4339 C4345
C4352 C4368
C4414 C4415
12
5
1
8
5
1
8
5
1
12
5
1
Schedule 1, entry for Amino acids—synthetic, formula
substitute:
Amino acids—synthetic, Oral powder 400 g (EleCare)
formula
Oral
P4305 P4312
P4323 P4330
P4337 P4338
P4339 P4345
P4352 P4415
Oral powder 400 g (Neocate Advance) Oral
Neocate Advance SB
MP NP
C4305 C4312
C4323 C4330
C4337 C4338
C4339 C4345
C4352 C4415
Oral powder 400 g (Neocate Advance Oral
Vanilla)
Neocate Advance SB
Vanilla
MP NP
C4305 C4312
C4323 C4330
C4337 C4338
C4339 C4345
C4352 C4368
C4414 C4415
MP NP
C4305 C4312 P4368 P4414
C4323 C4330
C4337 C4338
C4339 C4345
C4352 C4368
C4414 C4415
Instrument Number PB 88 of 2013
3
P4305 P4312
P4323 P4330
P4337 P4338
P4339 P4345
P4352 P4415
[3]
Schedule 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids
substitute:
Amino acid synthetic
formula supplemented
with long chain
polyunsaturated fatty
acids
[4]
Oral powder 400 g (EleCare LCP)
Oral
EleCare LCP
AB
MP NP
C4305 C4312
C4323 C4330
C4337 C4338
C4339 C4345
C4352 C4415
8
5
1
Oral powder 400 g (Neocate LCP)
Oral
Neocate LCP
SB
MP NP
C4305 C4312
C4323 C4330
C4337 C4338
C4339 C4345
C4352 C4415
8
5
1
8
5
1
8
5
1
12
5
1
Schedule 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and
medium chain triglycerides
substitute:
Amino acid synthetic
formula supplemented
with long chain
polyunsaturated fatty
acids and
medium chain
triglycerides
Oral powder 400 g (Alfamino)
Oral
Alfamino
NT
MP NP
C4305 C4312
C4323 C4330
C4337 C4338
C4339 C4345
C4352
Oral powder 400 g (Neocate Gold)
Oral
Neocate Gold
SB
MP NP
C4305 C4312
C4323 C4330
C4337 C4338
C4339 C4345
C4352 C4368
C4414 C4415
P4305 P4312
P4323 P4330
P4337 P4338
P4339 P4345
P4352 P4415
C4305 C4312 P4368 P4414
C4323 C4330
C4337 C4338
C4339 C4345
C4352 C4368
C4414 C4415
[5]
Schedule 1, entry for Amlodipine with valsartan in each of the forms: Tablet 5 mg (as besylate)-80 mg; Tablet 5 mg (as besylate)-160 mg;
Tablet 5 mg (as besylate)-320 mg; Tablet 10 mg (as besylate)-160 mg; and Tablet 10 mg (as besylate)-320 mg
omit from the column headed “Circumstances”:
[6]
C3307 substitute:
C4373
Schedule 1, entry for Amlodipine with valsartan and hydrochlorothiazide in each of the forms: Tablet 5 mg (as besylate)-160 mg-12.5 mg;
Tablet 5 mg (as besylate)-160 mg-25 mg; Tablet 10 mg (as besylate)-160 mg-12.5 mg; Tablet 10 mg (as besylate)-160 mg-25 mg; and
Tablet 10 mg (as besylate)-320 mg-25 mg
omit from the column headed “Circumstances”:
C3539 substitute:
C4311
Instrument Number PB 88 of 2013
4
[7]
Schedule 1, entry for Apixaban in the form Tablet 2.5 mg [Maximum Quantity 20; Number of Repeats 0]
(a)
omit from the column headed “Circumstances”:
C3957 C3991 C4043 C4044 C4046 C4269
substitute: C4269 C4359 C4381 C4382 C4402 C4409
(b)
[8]
omit from the column headed “Purposes”:
P3957 P4043 substitute:
P4359 P4381
Schedule 1, entry for Apixaban in the form Tablet 2.5 mg [Maximum Quantity 30; Number of Repeats 0]
(a)
omit from the column headed “Circumstances”:
C3957 C3991 C4043 C4044 C4046 C4269
substitute: C4269 C4359 C4381 C4382 C4402 C4409
(b)
[9]
omit from the column headed “Purposes”:
P3991 P4044 substitute:
P4382 P4409
Schedule 1, entry for Apixaban in the form Tablet 2.5 mg [Maximum Quantity 60; Number of Repeats 0]
(a)
omit from the column headed “Circumstances”:
C3957 C3991 C4043 C4044 C4046 C4269
substitute: C4269 C4359 C4381 C4382 C4402 C4409
(b)
[10]
omit from the column headed “Purposes”:
P4046 substitute:
Schedule 1, entry for Apixaban in the form Tablet 2.5 mg [Maximum Quantity 60; Number of Repeats 5]
omit from the column headed “Circumstances”:
substitute:
[11]
P4402
C3957 C3991 C4043 C4044 C4046 C4269
C4269 C4359 C4381 C4382 C4402 C4409
Schedule 1, entry for Aprepitant
omit:
Pack containing 1 capsule 125 mg
and 2 capsules 80 mg
[12]
Emend
MK
MP NP
See Note 1
C3619 C3620
C3621
1
5
1
10
0
10
60
5
60
Schedule 1, after entry for Benztropine in the form Injection containing benztropine mesylate 2 mg in 2 mL
insert in the columns in the order indicated:
Injection containing benztropine
mesylate 2 mg in 2 mL vial
[13]
Injection
Benztropine
Omega
FK
MP NP PDP
Oral
Kripton 5
AF
MP
Schedule 1, entry for Bromocriptine
omit:
Capsule 5 mg (as mesylate)
Instrument Number PB 88 of 2013
5
C1001 C1255
C1841 C1842
C1843 C1844
[14]
Schedule 1, entry for Budesonide with Eformoterol
substitute:
Budesonide with
eformoterol
[15]
Powder for oral inhalation in breath
actuated device containing
budesonide 100 micrograms with
eformoterol fumarate dihydrate 6
micrograms per dose, 120 doses
Inhalation by
mouth
Symbicort
Turbuhaler 100/6
AP
MP NP
C4380
1
5
1
Powder for oral inhalation in breath
actuated device containing
budesonide 200 micrograms with
eformoterol fumarate dihydrate 6
micrograms per dose, 120 doses
Inhalation by
mouth
Symbicort
Turbuhaler 200/6
AP
MP NP
C4380
1
5
1
Powder for oral inhalation in breath
actuated device containing
budesonide 400 micrograms with
eformoterol fumarate dihydrate 12
micrograms per dose, 60 doses, 2
Inhalation by
mouth
Symbicort
AP
Turbuhaler 400/12
MP NP
C4394 C4416
1
5
1
Pressurised inhalation containing
budesonide 50 micrograms with
eformoterol fumarate dihydrate 3
micrograms per dose, 120 doses
Inhalation by
mouth
Symbicort
Rapihaler 50/3
AP
MP NP
C4397
2
5
1
Pressurised inhalation containing
budesonide 100 micrograms with
eformoterol fumarate dihydrate 3
micrograms per dose, 120 doses
Inhalation by
mouth
Symbicort
Rapihaler 100/3
AP
MP NP
C4397
2
5
1
Pressurised inhalation containing
budesonide 200 micrograms with
eformoterol fumarate dihydrate 6
micrograms per dose, 120 doses
Inhalation by
mouth
Symbicort
Rapihaler 200/6
AP
MP NP
C4327 C4404
2
5
1
Schedule 1, entry for Calcitriol
omit from the column headed “Responsible Person” for the brand “Calciprox”:
[16]
substitute:
ER
Schedule 1, entry for Candesartan with Hydrochlorothiazide in each of the forms: Tablet containing candesartan cilexetil 16 mg with
hydrochlorothiazide 12.5 mg; Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg; and Tablet containing
candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg
omit from the column headed “Circumstances”:
[17]
GN
C3307 substitute:
C4374
Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 0]
(a)
(b)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Cephalex 250
CR
PDP
20
0
20
Pharmacor
Cephalexin 250
CR
PDP
20
0
20
omit:
Instrument Number PB 88 of 2013
6
[18]
Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 1]
(a)
(b)
[19]
(b)
CR
MP NP MW
20
1
20
Pharmacor
Cephalexin 250
CR
MP NP MW
20
1
20
omit:
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Cephalex 250
CR
MP
C4243
40
2
20
Pharmacor
Cephalexin 250
CR
MP
C4243
40
2
20
omit:
Schedule 1, entry for Clozapine in each of the forms: Tablet 25 mg: Tablet 50 mg; Tablet 100 mg; Tablet 200 mg; and
Oral liquid 50 mg per mL, 100 mL
omit from the column headed “Circumstances” (all instances):
[21]
Cephalex 250
Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Maximum Quantity: 40; Number of Repeats: 2]
(a)
[20]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
C1826 C1827 C3326 C3327 substitute
C4371 C4411
Schedule 1, after entry for Cyclophosphamide in the form Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Tablet 50 mg (as monohydrate)
[22]
[23]
[24]
[25]
Oral
Endoxan
BX
MP
50
2
50
Schedule 1, entry for Dabigatran etexilate in the form Capsule 75 mg (as mesilate) [Maximum Quantity 20; Number of Repeats 0]
(a)
omit from the column headed “Circumstances”:
(b)
omit from the column headed “Purposes”:
C3957 C4047 C4048 substitute:
P3957 substitute:
C4369 C4381 C4402
P4381
Schedule 1, entry for Dabigatran etexilate in the form Capsule 75 mg (as mesilate) [Maximum Quantity 20; Number of Repeats 1]
(a)
omit from the column headed “Circumstances”:
(b)
omit from the column headed “Purposes”:
C3957 C4047 C4048 substitute:
P4047 substitute:
C4369 C4381 C4402
P4369
Schedule 1, entry for Dabigatran etexilate in the form Capsule 75 mg (as mesilate) [Maximum Quantity 60; Number of Repeats 0]
(a)
omit from the column headed “Circumstances”:
(b)
omit from the column headed “Purposes”:
C3957 C4047 C4048 substitute:
P4048 substitute:
C4369 C4381 C4402
P4402
Schedule 1, entry for Dabigatran etexilate in the form Capsule 110 mg (as mesilate) [Maximum Quantity 20; Number of Repeats 0]
(a)
omit from the column headed “Circumstances”:
(b)
omit from the column headed “Purposes”:
C3957 C4047 C4048 C4269 substitute:
P3957 substitute:
P4381
Instrument Number PB 88 of 2013
7
C4269 C4369 C4381 C4402
[26]
[27]
[28]
Schedule 1, entry for Dabigatran etexilate in the form Capsule 110 mg (as mesilate) [Maximum Quantity 20; Number of Repeats 1]
(a)
omit from the column headed “Circumstances”:
(b)
omit from the column headed “Purposes”:
(a)
omit from the column headed “Circumstances”:
(b)
omit from the column headed “Purposes”:
C3957 C4047 C4048 C4269 substitute:
P4048 substitute:
C4269 C4369 C4381 C4402
P4402
C3957 C4047 C4048 C4269 substitute:
C4269 C4369 C4381 C4402
Schedule 1, entry for Dimethyl fumarate in the form Capsule (modified release) 120 mg
C4320 C4335 substitute
C4370 C4410
Schedule 1, entry for Dimethyl fumarate in the form Capsule (modified release) 240 mg
omit from the column headed “Circumstances”:
[31]
P4369
Schedule 1, entry for Dabigatran etexilate in the form Capsule 110 mg (as mesilate) [Maximum Quantity 60; Number of Repeats 5]
omit from the column headed “Circumstances”:
[30]
P4047 substitute:
C4269 C4369 C4381 C4402
Schedule 1, entry for Dabigatran etexilate in the form Capsule 110 mg (as mesilate) [Maximum Quantity 60; Number of Repeats 0]
omit from the column headed “Circumstances”:
[29]
C3957 C4047 C4048 C4269 substitute:
C4356 substitute
C4417
Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; Tablet containing enalapril maleate 10 mg;
and Tablet containing enalapril maleate 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Enalapril
[32]
30
C3307 substitute:
C4389
C3307 substitute:
C4374
C2971 C2972 substitute:
C4362 C4386 C4387 C4403 C4406
Schedule 1, entry for Exenatide in each of the forms: Injection solution 5 micrograms per dose in pre-filled pen, 60 doses;
and Injection solution 10 micrograms per dose in pre-filled pen, 60 doses
omit from the column headed “Circumstances”:
[36]
5
Schedule 1, entry for Erlotinib in each of the forms: Tablet 25 mg (as hydrochloride); Tablet 100 mg (as hydrochloride); and
Tablet 150 mg (as hydrochloride)
omit from the column headed “Circumstances”:
[35]
30
Schedule 1, entry for Eprosartan with Hydrochlorothiazide
omit from the column headed “Circumstances”:
[34]
MP NP
Schedule 1, entry for Enalapril with Hydrochlorothiazide
omit from the column headed “Circumstances” (twice occurring):
[33]
TX
C3540 C3542 substitute:
C4392 C4405
Schedule 1, entry for Fluticasone with eformoterol in each of the forms: Pressurised inhalation containing fluticasone propionate 50
micrograms with eformoterol fumarate dihydrate 5 micrograms per dose, 120 doses; Pressurised inhalation containing fluticasone
propionate 125 micrograms with eformoterol fumarate dihydrate 5 micrograms per dose, 120 doses; and Pressurised inhalation
containing fluticasone propionate 250 micrograms with eformoterol fumarate dihydrate 10 micrograms per dose, 120 doses
omit from the column headed “Circumstances”:
C4315 substitute:
C4395
Instrument Number PB 88 of 2013
8
[37]
Schedule 1, entry for Fluticasone with Salmeterol in each of the forms: Pressurised inhalation containing fluticasone propionate 50
micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation); Pressurised inhalation containing
fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation); Powder
for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms with salmeterol 50 micrograms (as
xinafoate) per dose, 60 doses; and Powder for oral inhalation in breath actuated device containing fluticasone propionate 250
micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses
omit from the column headed “Circumstances”:
[38]
C4408
Schedule 1, entry for Fluticasone with Salmeterol in each of the forms: Pressurised inhalation containing fluticasone propionate 250
micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation); and Powder for oral inhalation in
breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60
doses
omit from the column headed “Circumstances”:
[39]
C1758 C1759 substitute:
C1758 C1759 C2680 substitute:
C4372 C4408
Schedule 1, entry for Fosinopril in each of the forms: Tablet containing fosinopril sodium 10 mg; and Tablet containing fosinopril
sodium 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Fosinopril
[40]
C3307 substitute:
5
30
C4389
(a)
omit from the column headed “Circumstances” (all instances):
(b)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
C3307 substitute:
UA
MP NP
C4389
C4389
30
5
30
1
0
1
Schedule 1, entry for Frusemide in the form Tablet 40 mg
omit from the column headed “Responsible Person” for the brand “Frusax”:
[43]
30
Schedule 1, entry for Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 20 mg with
hydrochlorothiazide 12.5 mg
Fosinopril/HCT
Actavis 20/12.5
[42]
MP NP
Schedule 1, entry for Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 10 mg with
hydrochlorothiazide 12.5 mg
omit from the column headed “Circumstances” (all instances):
[41]
TX
GN
substitute:
ER
Schedule 1, entry for Ganciclovir
omit:
Intravitreal implant 4.5 mg
[44]
Implantation
Vitrasert
BU
MP
See Note 1
C1612 C3379
Schedule 1, entry for Gefitinib
omit from the column headed “Circumstances”:
C4029 C4030 substitute:
Instrument Number PB 88 of 2013
9
C4384 C4387
D(100)
[45]
Schedule 1, entry for Glucose in the form I.V. infusion 69.5 mmol (anhydrous) per 250 mL, 250 mL
omit:
B. Braun Australia BR
Pty Ltd
[46]
(b)
1
1
omit:
B. Braun Australia BR
Pty Ltd
PDP
5
0
1
B. Braun Australia BR
Pty Ltd
MP NP
5
1
1
omit:
Schedule 1, entry for Glucose in the form I.V. infusion 139 mmol (anhydrous) per 500 mL, 500 mL
(a)
(b)
[48]
5
Schedule 1, entry for Glucose in the form I.V. infusion 278 mmol (anhydrous) per L, 1 L
(a)
[47]
MP NP
omit:
B. Braun Australia BR
Pty Ltd
PDP
5
0
1
B. Braun Australia BR
Pty Ltd
MP NP
5
1
1
1
1
1
omit:
Schedule 1, entry for Imiquimod in the form Cream 50 mg per g, 250 mg single use sachets, 12
omit:
Aldiq
[49]
MP
C4229
Schedule 1, entry for Irbesartan with Hydrochlorothiazide in each of the forms: Tablet 150 mg-12.5 mg; Tablet 300 mg-12.5 mg; and
Tablet 300 mg-25 mg
omit from the column headed “Circumstances” (all instances):
[50]
QA
C3307 substitute:
C4374
Schedule 1, entry for Lactulose
(a)
(b)
omit:
Duphalac
AB
MP NP
C1150 C1613 P3643
C3642 C3643
3
0
1
Duphalac
AB
MP NP
C1150 C1613 P3642
C3642 C3643
3
3
1
omit:
Instrument Number PB 88 of 2013
10
(c)
[51]
omit:
Duphalac
AB
MP NP
C1150 C1613 P1150 P1613
C3642 C3643
1
5
1
Arava
SW
MP
C2643 C2681
1
0
1
30
5
30
Schedule 1, entry for Leflunomide
omit:
Pack containing 3 tablets leflunomide
100 mg and 30 tablets leflunomide 20
mg
[52]
Oral
Schedule 1, entry for Leflunomide in each of the forms: Tablet 10 mg; and Tablet 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Leflunomide GH
[53]
MP
C2644
Schedule 1, entry for Lercanidipine with enalapril in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg with enalapril
maleate 10 mg; and Tablet containing lercanidipine hydrochloride 10 mg with enalapril maleate 20 mg
omit from the column headed “Circumstances” (all instances):
[54]
GQ
C3307 substitute:
C4398
Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30
insert as first item in the columns in the order indicated:
APOTX
MACROGOL plus
ELECTROLYTES
[55]
MP NP
See Note 1
C1263 C1613 P3643
C2693 C2823 See Note 2
C3642 C3643
See Note 2
2
See
Note 2
0
See
Note 2
1
MP NP
See Note 1
C1263 C1613 P3642
C2693 C2823 See Note 2
C3642 C3643
See Note 2
2
See
Note 2
3
See
Note 2
1
MP NP
See Note 1
C1263 C1613 P1263 P1613
C2693 C2823 P2693 P2823
C3642 C3643 See Note 2
See Note 2
1
See
Note 2
5
See
Note 2
1
Schedule 1, entry for Miconazole
(a)
(b)
omit:
Cream containing miconazole nitrate
20 mg per g, 15 g
Application
Daktarin
JT
MP NP
C2354
2
3
1
Lotion containing miconazole nitrate
20 mg per mL, 30 g
Application
Daktarin
JT
MP NP
C2354
1
2
1
omit:
Instrument Number PB 88 of 2013
11
[56]
Schedule 1, entry for Milk powder—lactose free formula
omit:
Oral powder 900 g (Karicare Aptamil
De-Lact)
[57]
Oral
Karicare Aptamil
De-Lact
NU
MP NP
C2760 C2762 P2762
5
0
1
MP NP
C2760 C2762 P2760
5
5
1
28
5
28
28
5
28
Schedule 1, entry for Olanzapine in the form Tablet 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Olanzapine GH
[58]
GQ
MP NP
C1589 C2044
Schedule 1, entry for Olanzapine in the form Tablet 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Olanzapine GH
[59]
C1589 C2044
C3307 substitute:
C4373
Schedule 1, entry for Olmesartan with Hydrochlorothiazide in each of the forms: Tablet containing olmesartan medoxomil 20 mg with
hydrochlorothiazide 12.5 mg; Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg; and Tablet containing
olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg
omit from the column headed “Circumstances”:
[61]
MP NP
Schedule 1, entry for Olmesartan with amlodipine in each of the forms: Tablet containing olmesartan medoxomil 20 mg with amlodipine
5 mg (as besylate); Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besylate); and Tablet containing olmesartan
medoxomil 40 mg with amlodipine 10 mg (as besylate)
omit from the column headed “Circumstances”:
[60]
GQ
C3307 substitute:
C4374
Schedule 1, entry for Pamidronic Acid
omit:
Injection set containing 4 vials powder Injection
for I.V. infusion containing disodium
pamidronate 15 mg and 4 ampoules
solvent 5 mL
[62]
Aredia 15 mg
NV
C3256
1
0
1
MP
See Note 1
C1500 C3341
1
2
1
Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
Number of Repeats: 2]
omit from the column headed “Responsible Person” for the brand “Panthron”: GN
[63]
MP NP
substitute:
ER
Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
Number of Repeats: 5]
omit from the column headed “Responsible Person” for the brand “Panthron”: GN
Instrument Number PB 88 of 2013
12
substitute:
ER
C(100)
[64]
Schedule 1, entry for Perindopril with amlodipine in each of the forms: Tablet containing 5 mg perindopril arginine with 5 mg amlodipine
(as besylate); Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besylate); Tablet containing 10 mg perindopril
arginine with 5 mg amlodipine (as besylate); and Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besylate)
omit from the column headed “Circumstances” (all instances):
C3307 C3308 substitute:
C4398 C4418
[65]
Schedule 1, entry for Perindopril with Indapamide in each of the forms: Tablet containing perindopril erbumine 4 mg
with indapamide hemihydrate 1.25 mg; and Tablet containing perindopril arginine 5 mg with indapamide hemihydrate 1.25 mg
omit from the column headed “Circumstances” (all instances):
C3307 substitute:
C4375
[66]
Schedule 1, entry for Pindolol in the form Tablet 15 mg
omit:
Barbloc 15
[67]
MP NP
50
5
50
Schedule 1, entry for Pioglitazone in each of the forms: Tablet 15 mg (as hydrochloride); Tablet 30 mg (as hydrochloride); and
Tablet 45 mg (as hydrochloride)
omit from the column headed “Circumstances” (all instances):
[68]
AF
C3540 C3541 C3542 substitute:
C4363 C4364 C4388
Schedule 1, entry for Protein hydrolysate formula with medium chain triglycerides in the form Oral powder 400 g (Alfaré)
omit all codes from the column headed “Circumstances” and substitute:
C4357 C4358 C4365 C4366 C4376 C4377 C4378 C4379 C4393 C4399 C4400 C4401 C4412 C4413
[69]
Schedule 1, entry for Protein hydrolysate formula with medium chain triglycerides in the form Oral powder 450 g
(Karicare Aptamil Pepti-Junior Gold)
omit all codes from the column headed “Circumstances” and substitute:
C4357 C4358 C4365 C4366 C4376 C4377 C4378 C4393 C4399 C4400 C4401 C4412 C4413
[70]
Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
(a)
omit from the column headed “Circumstances” (all instances):
(b)
omit from the column headed “Number of Repeats” (all instances):
C1589 C2044 C2765 substitute:
5
substitute:
C4385 C4391 C4396
0
[71]
Schedule 1, entry for Quinapril with Hydrochlorothiazide in each of the forms: Tablet 10 mg quinapril (as hydrochloride) with 12.5 mg
hydrochlorothiazide; and Tablet 20 mg quinapril (as hydrochloride) with 12.5 mg hydrochlorothiazide
omit from the column headed “Circumstances”:
C3307 substitute:
C4389
[72]
Schedule 1, entry for Ramipril with Felodipine in each of the forms: Tablet 2.5 mg-2.5 mg (modified release); and Tablet 5 mg-5 mg
(modified release)
omit from the column headed “Circumstances” (all instances):
C3307 substitute:
C4398
[73]
Schedule 1, entry for Rivaroxaban in the form Tablet 10 mg [Maximum Quantity: 10; Number of Repeats: 0]
(a)
omit from the column headed “Circumstances”:
(b)
omit from the column headed “Purposes”:
C3957 C3993 C4047 C4048 C4050
P3957 substitute:
P4381
Instrument Number PB 88 of 2013
13
substitute:
C4369 C4381 C4382 C4402
[74]
[75]
[76]
[77]
[78]
Schedule 1, entry for Rivaroxaban in the form Tablet 10 mg [Maximum Quantity: 10; Number of Repeats: 1]
(a)
omit from the column headed “Circumstances”:
(b)
omit from the column headed “Purposes”:
(a)
omit from the column headed “Circumstances”:
(b)
omit from the column headed “Purposes”:
C4369 C4381 C4382 C4402
P4369
C3957 C3993 C4047 C4048 C4050
P4050 substitute:
substitute:
C4369 C4381 C4382 C4402
P4382
Schedule 1, entry for Rivaroxaban in the form Tablet 10 mg [Maximum Quantity: 15; Number of Repeats: 1]
(a)
omit from the column headed “Circumstances”:
(b)
omit from the column headed “Purposes”:
C3957 C3993 C4047 C4048 C4050
P4048 substitute:
substitute:
C4369 C4381 C4382 C4402
P4402
Schedule 1, entry for Rivaroxaban in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats: 0]
(a)
omit from the column headed “Circumstances”:
(b)
omit from the column headed “Purposes”:
C3957 C3993 C4047 C4048 C4050
P3993 substitute:
substitute:
C4369 C4381 C4382 C4402
P4402
Schedule 1, entry for Rosiglitazone in each of the forms: Tablet 4 mg (as maleate); and Tablet 8 mg (as maleate)
C3722 substitute:
C4367
Schedule 1, entry for Rosiglitazone with Metformin in each of the forms: Tablet containing 2 mg rosiglitazone (as maleate) with 500 mg
metformin hydrochloride; Tablet containing 2 mg rosiglitazone (as maleate) with 1 g metformin hydrochloride; Tablet containing 4 mg
rosiglitazone (as maleate) with 500 mg metformin hydrochloride; and Tablet containing 4 mg rosiglitazone (as maleate) with 1 g
metformin hydrochloride
omit from the column headed “Circumstances”:
[80]
P4047 substitute:
substitute:
Schedule 1, entry for Rivaroxaban in the form Tablet 10 mg [Maximum Quantity: 15; Number of Repeats: 0]
omit from the column headed “Circumstances”:
[79]
C3957 C3993 C4047 C4048 C4050
C3723 substitute:
C4383
Schedule 1, entry for Sertraline in each of the forms: Tablet 50 mg (as hydrochloride); and Tablet 100 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Sertraline
[81]
TX
MP NP
C1211
30
5
30
5
1
1
5
0
1
Schedule 1, entry for Sodium Chloride in the form I.V. infusion 38.5 mmol per 250 mL, 250 mL
omit:
B. Braun Australia BR
Pty Ltd
[82]
MP NP
Schedule 1, entry for Sodium Chloride in the form I.V. infusion 77 mmol per 500 mL, 500 mL
(a)
omit:
B. Braun Australia BR
Pty Ltd
Instrument Number PB 88 of 2013
14
PDP
(b)
omit:
B. Braun Australia BR
Pty Ltd
[83]
5
1
1
Schedule 1, entry for Sodium Chloride in the form I.V. infusion 154 mmol per L, 1 L
(a)
(b)
[84]
MP NP
omit:
B. Braun Australia BR
Pty Ltd
PDP
5
0
1
B. Braun Australia BR
Pty Ltd
MP NP
5
1
1
omit:
Schedule 1, entry for Sodium Lactate Compound in each of the forms: I.V. infusion containing approximately 65 mmol sodium (as lactate
and chloride), 2.7 mmol potassium (as chloride), 0.9 mmol calcium (as chloride), 14 mmol bicarbonate (as lactate) and 56 mmol chloride
per 500 mL, 500 mL; and I.V. infusion containing approximately 131 mmol sodium (as lactate and chloride), 5 mmol potassium (as
chloride), 2 mmol calcium (as chloride), 29 mmol bicarbonate (as lactate) and 111 mmol chloride per L, 1 L
omit:
B. Braun Australia BR
Pty Ltd
MP NP
5
1
1
[85]
Schedule 1, entry for Telmisartan with amlodipine in each of the forms: Tablet 40 mg-5 mg (as besylate); Tablet 40 mg-10 mg
(as besylate); Tablet 80 mg-5 mg (as besylate); and Tablet 80 mg-10 mg (as besylate)
omit from the column headed “Circumstances”:
C3307 substitute:
C4373
[86]
Schedule 1, entry for Telmisartan with Hydrochlorothiazide in each of the forms: Tablet 40 mg-12.5 mg; Tablet 80 mg-12.5 mg; and
Tablet 80 mg-25 mg
omit from the column headed “Circumstances” (all instances):
C3307 substitute:
C4374
[87]
Schedule 1, entry for Teriparatide
(a)
omit from the column headed “Circumstances”:
(b)
insert in numerical order:
C4101
C4407
[88]
Schedule 1, entry for Trandolapril with Verapamil in each of the forms: Tablet containing trandolapril 2 mg with verapamil hydrochloride
180 mg (sustained release); and Tablet containing trandolapril 4 mg with verapamil hydrochloride 240 mg (sustained release)
omit from the column headed “Circumstances”:
C3307 substitute:
C4390
[89]
Schedule 1, entry for Triglycerides—medium chain, formula
omit:
Oral powder 420 g (Caprilon)
Oral
Caprilon
SB
Instrument Number PB 88 of 2013
15
MP NP
C1068 C1670
C1671
8
5
1
[90]
Schedule 1, entry for Valsartan with hydrochlorothiazide in each of the forms: Tablet 80 mg-12.5 mg; Tablet 160 mg-12.5 mg; and
Tablet 160 mg-25 mg
omit from the column headed “Circumstances”:
C3307 substitute:
C4374
[91]
Schedule 1, entry for Valsartan with hydrochlorothiazide in each of the forms: Tablet 320 mg-12.5 mg; and Tablet 320 mg-25 mg
omit from the column headed “Circumstances”:
C3307 substitute:
C4361
[92]
Schedule 3, after details relevant to Responsible Person Code EO
insert:
ER
[93]
Eris Pharmaceuticals (Australia) Pty Ltd
64 139 968 139
Schedule 4, Part 1, entry for Amino acids—synthetic, formula
substitute:
Amino acids―synthetic,
formula
C4305
P4305
Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist;
The condition must not be isolated infant colic or reflux;
Patient must be older than 24 months of age
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4312
P4312
Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in
consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist;
Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides);
Patient must be up to the age of 24 months
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4323
P4323
Cows' milk protein enteropathy
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in
consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist;
The condition must not be isolated infant colic or reflux;
Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond
to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides)
as the principal formula;
Patient must be up to the age of 24 months
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4330
P4330
Cows' milk anaphylaxis
Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist;
Patient must be up to the age of 24 months
Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction
The name of the specialist and the date of birth of the patient must be included in the authority application
Instrument Number PB 88 of 2013
16
Compliance with
Authority Required
procedures
C4337
P4337
Cows' milk protein enteropathy
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have an
appointment to be assessed by one of these specialists;
The condition must not be isolated infant colic or reflux;
Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond
to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides)
as the principal formula;
Patient must be up to the age of 24 months
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4338
P4338
Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist at intervals
not greater than 12 months;
The condition must not be isolated infant colic or reflux;
Patient must be older than 24 months of age
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4339
P4339
Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist;
Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides) prior to commencement
with initial treatment;
Patient must be up to the age of 24 months
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4345
P4345
Severe cows' milk protein enteropathy with failure to thrive
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have
been assessed at least once or have an appointment to be assessed by one of these specialists;
The condition must not be isolated infant colic or reflux;
Patient must have had failure to thrive prior to commencement with initial treatment;
Patient must be up to the age of 24 months
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4352
P4352
Severe cows' milk protein enteropathy with failure to thrive
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in
consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist;
The condition must not be isolated infant colic or reflux;
Patient must be up to the age of 24 months
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4368
P4368
Eosinophilic oesophagitis
Initial treatment for up to 3 months
Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist;
Patient must require an amino acid based formula as a component of a dietary elimination program;
Patient must be 18 years of age or less
Treatment with oral steroids should not be commenced during the period of initial treatment
Instrument Number PB 88 of 2013
17
Compliance with
Authority Required
procedures
Eosinophilic oesophagitis is demonstrated by the following criteria:
(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and
(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis;
and
(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where
the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal
antral and duodenal biopsies
The date of birth of the patient must be included in the authority application
C4414
P4414
Eosinophilic oesophagitis
Continuing treatment
Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist;
Patient must have responded to an initial course of PBS-subsidised treatment;
Patient must be 18 years of age or less
Compliance with
Authority Required
procedures
Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely
involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal
biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment
C4415
P4415
Severe intestinal malabsorption including short bowel syndrome
Patient must have failed to respond to protein hydrolysate formulae; OR
Patient must have been receiving parenteral nutrition
[94]
Compliance with
Authority Required
procedures
Schedule 4, Part 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids
substitute:
Amino acid synthetic
C4305
formula supplemented with
long chain polyunsaturated
fatty acids
Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist;
The condition must not be isolated infant colic or reflux;
Patient must be older than 24 months of age
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4312
Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in
consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist;
Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides);
Patient must be up to the age of 24 months
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4323
Cows' milk protein enteropathy
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in
consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist;
The condition must not be isolated infant colic or reflux;
Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond
to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides)
as the principal formula;
Patient must be up to the age of 24 months
The name of the specialist and the date of birth of the patient must be included in the authority application
Instrument Number PB 88 of 2013
18
Compliance with
Authority Required
procedures
C4330
Cows' milk anaphylaxis
Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist;
Patient must be up to the age of 24 months
Compliance with
Authority Required
procedures
Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction
The name of the specialist and the date of birth of the patient must be included in the authority application
C4337
Cows' milk protein enteropathy
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have an
appointment to be assessed by one of these specialists;
The condition must not be isolated infant colic or reflux;
Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond
to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides)
as the principal formula;
Patient must be up to the age of 24 months
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4338
Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist at intervals
not greater than 12 months;
The condition must not be isolated infant colic or reflux;
Patient must be older than 24 months of age
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4339
Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist;
Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides) prior to commencement
with initial treatment;
Patient must be up to the age of 24 months
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4345
Severe cows' milk protein enteropathy with failure to thrive
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have
been assessed at least once or have an appointment to be assessed by one of these specialists;
The condition must not be isolated infant colic or reflux;
Patient must have had failure to thrive prior to commencement with initial treatment;
Patient must be up to the age of 24 months
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4352
Severe cows' milk protein enteropathy with failure to thrive
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in
consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist;
The condition must not be isolated infant colic or reflux;
Patient must be up to the age of 24 months
The name of the specialist and the date of birth of the patient must be included in the authority application
Instrument Number PB 88 of 2013
19
Compliance with
Authority Required
procedures
C4415
Severe intestinal malabsorption including short bowel syndrome
Patient must have failed to respond to protein hydrolysate formulae; OR
Patient must have been receiving parenteral nutrition
[95]
Compliance with
Authority Required
procedures
Schedule 4, Part 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and
medium chain triglycerides
substitute:
Amino acid synthetic
C4305
formula supplemented with
long chain polyunsaturated
fatty acids and
medium chain triglycerides
P4305
Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist;
The condition must not be isolated infant colic or reflux;
Patient must be older than 24 months of age
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4312
P4312
Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in
consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist;
Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides);
Patient must be up to the age of 24 months
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4323
P4323
Cows' milk protein enteropathy
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in
consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist;
The condition must not be isolated infant colic or reflux;
Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond
to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides)
as the principal formula;
Patient must be up to the age of 24 months
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4330
P4330
Cows' milk anaphylaxis
Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist;
Patient must be up to the age of 24 months
Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction
The name of the specialist and the date of birth of the patient must be included in the authority application
Instrument Number PB 88 of 2013
20
Compliance with
Authority Required
procedures
C4337
P4337
Cows' milk protein enteropathy
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have an
appointment to be assessed by one of these specialists;
The condition must not be isolated infant colic or reflux;
Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond
to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides)
as the principal formula;
Patient must be up to the age of 24 months
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4338
P4338
Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist at intervals
not greater than 12 months;
The condition must not be isolated infant colic or reflux;
Patient must be older than 24 months of age
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4339
P4339
Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist;
Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides) prior to commencement
with initial treatment;
Patient must be up to the age of 24 months
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4345
P4345
Severe cows' milk protein enteropathy with failure to thrive
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have
been assessed at least once or have an appointment to be assessed by one of these specialists;
The condition must not be isolated infant colic or reflux;
Patient must have had failure to thrive prior to commencement with initial treatment;
Patient must be up to the age of 24 months
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4352
P4352
Severe cows' milk protein enteropathy with failure to thrive
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in
consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist;
The condition must not be isolated infant colic or reflux;
Patient must be up to the age of 24 months
The name of the specialist and the date of birth of the patient must be included in the authority application
Instrument Number PB 88 of 2013
21
Compliance with
Authority Required
procedures
C4368
P4368
Eosinophilic oesophagitis
Initial treatment for up to 3 months
Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist;
Patient must require an amino acid based formula as a component of a dietary elimination program;
Patient must be 18 years of age or less
Compliance with
Authority Required
procedures
Treatment with oral steroids should not be commenced during the period of initial treatment
Eosinophilic oesophagitis is demonstrated by the following criteria:
(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and
(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis;
and
(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where
the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal
antral and duodenal biopsies
The date of birth of the patient must be included in the authority application
C4414
P4414
Eosinophilic oesophagitis
Continuing treatment
Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist;
Patient must have responded to an initial course of PBS-subsidised treatment;
Patient must be 18 years of age or less
Compliance with
Authority Required
procedures
Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely
involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal
biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment
C4415
P4415
Severe intestinal malabsorption including short bowel syndrome
Patient must have failed to respond to protein hydrolysate formulae; OR
Patient must have been receiving parenteral nutrition
[96]
Schedule 4, Part 1, entry for Amlodipine with valsartan
substitute:
Amlodipine with valsartan
C4373
Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy;
The condition must be inadequately controlled with an angiotensin II antagonist; OR
The condition must be inadequately controlled with a dihydropyridine calcium channel blocker
[97]
Schedule 4, Part 1, entry for Amlodipine with valsartan and hydrochlorothiazide
substitute:
Amlodipine with valsartan
and hydrochlorothiazide
C4311
Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy;
The condition must be inadequately controlled with concomitant treatment with two of the following: an angiotensin II antagonist, a
dihydropyridine calcium channel blocker or a thiazide diuretic
Instrument Number PB 88 of 2013
22
Compliance with
Authority Required
procedures
[98]
Schedule 4, Part 1, entry for Apixaban
(a)
(b)
omit:
C3957
P3957
Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 10 days of therapy
Compliance with
Authority Required
procedures
C3991
P3991
Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 15 days of therapy
Compliance with
Authority Required
procedures
C4043
P4043
Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 10 days supply to complete Compliance with
a course of treatment
Authority Required
procedures
C4044
P4044
Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 15 days supply to complete Compliance with
a course of treatment
Authority Required
procedures
C4046
P4046
Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 30 days supply to complete Compliance with
a course of treatment
Authority Required
procedures
insert in numerical order following existing text:
C4359
P4359
Prevention of venous thromboembolism
Patient must be undergoing total hip replacement;
Patient must require up to 10 days supply to complete a course of treatment
C4381
P4381
Prevention of venous thromboembolism
Patient must be undergoing total knee replacement;
Patient must require up to 10 days of therapy
C4382
P4382
Prevention of venous thromboembolism
Patient must be undergoing total knee replacement;
Patient must require up to 15 days of therapy
C4402
P4402
Prevention of venous thromboembolism
Patient must be undergoing total hip replacement
Patient must require up to 30 days supply to complete a course of treatment
C4409
P4409
Prevention of venous thromboembolism
Patient must be undergoing total hip replacement;
Patient must require up to 15 days supply to complete a course of treatment
Instrument Number PB 88 of 2013
23
Compliance with
Authority Required
procedures Streamlined Authority
Code 4359
Compliance with
Authority Required
procedures Streamlined Authority
Code 4381
Compliance with
Authority Required
procedures Streamlined Authority
Code 4382
Compliance with
Authority Required
procedures Streamlined Authority
Code 4402
Compliance with
Authority Required
procedures Streamlined Authority
Code 4409
[99]
Schedule 4, Part 1, entry for Aprepitant
omit:
C3619
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy, in combination with a
5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where any 1 of the following chemotherapy agents are to be
administered:
(a) altretamine;
(b) carmustine;
(c) cisplatin, when a single dose constitutes a cycle of chemotherapy;
(d) cyclophosphamide, at a dose of 1500 mg per square metre per day or greater;
(e) dacarbazine;
(f) procarbazine, when a single dose constitutes a cycle of chemotherapy;
(g) streptozocin; and
where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic
chemotherapy
Compliance with
Authority Required
procedures Streamlined Authority
Code 3619
C3620
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat breast cancer, in combination with
a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where cyclophosphamide and an anthracycline are to be coadministered, and where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle
of cytotoxic chemotherapy
Compliance with
Authority Required
procedures Streamlined Authority
Code 3620
C3621
Management of nausea and vomiting associated with moderately emetogenic cytotoxic chemotherapy being used to treat
malignancy, in combination with a 5-hydroxytryptamine type 3 receptor (5HT3) antagonist and dexamethasone on day 1, where the
patient has had a prior episode of chemotherapy induced nausea or vomiting where any 1 of the following intravenous chemotherapy
agents is to be administered:
(a) arsenic trioxide;
(b) azacitidine;
(c) carboplatin;
(d) cyclophosphamide, at a dose of less than 1500 mg per square metre per day;
(e) cytarabine, at a dose of greater than 1 g per square metre per day;
(f) dactinomycin;
(g) daunorubicin;
(h) doxorubicin;
(i) epirubicin;
(j) fotemustine;
(k) idarubicin;
(l) ifosfamide;
(m) irinotecan;
(n) melphalan;
(o) methotrexate, at a dose of 250 mg to 1 g per square metre;
(p) oxaliplatin;
(q) raltitrexed; and
where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic
chemotherapy, and where concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any
chemotherapy cycle
Compliance with
Authority Required
procedures Streamlined Authority
Code 3621
Instrument Number PB 88 of 2013
24
[100]
Schedule 4, Part 1, entry for Budesonide with Eformoterol
substitute:
Budesonide with
eformoterol
C4327
Chronic obstructive pulmonary disease (COPD)
Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy;
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta-2 agonist bronchodilator
therapy
C4380
Asthma
Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of
inhaled corticosteroids; OR
Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require
single maintenance and reliever therapy; OR
Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid
and long acting beta-2 agonist and require single maintenance and reliever therapy;
Patient must be aged 12 years or over
C4394
Asthma
Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of
inhaled corticosteroids;
Patient must be aged 12 years or over
C4397
Asthma
Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of
inhaled corticosteroids; OR
Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require
single maintenance and reliever therapy; OR
Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid
and long acting beta-2 agonist;
Patient must be aged 12 years or over
C4404
Asthma
Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of
inhaled corticosteroids;
Patient must be aged 12 years or over
C4416
Chronic obstructive pulmonary disease (COPD)
Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy;
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta-2 agonist bronchodilator
therapy;
The treatment must be for symptomatic treatment
[101]
Schedule 4, Part 1, entry for Candesartan with Hydrochlorothiazide
substitute:
Candesartan with
hydrochlorothiazide
C4374
Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy;
The condition must be inadequately controlled with an an angiotensin II antagonist; OR
The condition must be inadequately controlled with a thiazide diuretic
Instrument Number PB 88 of 2013
25
[102]
Schedule 4, Part 1, entry for Clozapine
substitute:
Clozapine
C4371
Where the patient is receiving treatment at/from a private hospital
Schizophrenia
Patient must be non-responsive to other neuroleptic agents; OR
Patient must be intolerant of other neuroleptic agents
Compliance with
Written or Telephone
Authority Required
procedures
A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised
C4411
Where the patient is receiving treatment at/from a public hospital
Schizophrenia
Patient must be non-responsive to other neuroleptic agents; OR
Patient must be intolerant of other neuroleptic agents
A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised
[103]
Compliance with
Written or Telephone
Authority Required
procedures Streamlined Authority
Code 4411
Schedule 4, Part 1, entry for Dabigatran etexilate
(a)
(b)
omit:
C3957
P3957
Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 10 days of therapy
Compliance with
Authority Required
procedures
C4047
P4047
Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 20 days supply to complete Compliance with
a course of treatment
Authority Required
procedures
C4048
P4048
Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 30 days supply to complete Compliance with
a course of treatment
Authority Required
procedures
insert in numerical order following existing text:
C4369
P4369
Prevention of venous thromboembolism
Patient must be undergoing total hip replacement;
Patient must require up to 20 days supply to complete a course of treatment
C4381
P4381
Prevention of venous thromboembolism
Patient must be undergoing total knee replacement;
Patient must require up to 10 days of therapy
C4402
P4402
Prevention of venous thromboembolism
Patient must be undergoing total hip replacement;
Patient must require up to 30 days supply to complete a course of treatment
Instrument Number PB 88 of 2013
26
Compliance with
Authority Required
procedures Streamlined Authority
Code 4369
Compliance with
Authority Required
procedures Streamlined Authority
Code 4381
Compliance with
Authority Required
procedures Streamlined Authority
Code 4402
[104]
Schedule 4, Part 1, entry for Dimethyl fumarate
substitute:
Dimethyl fumarate
C4370
Multiple sclerosis
Continuing treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the
brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification
provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not
psychological) injury to the patient;
The treatment must be as monotherapy;
Patient must have previously been issued with an authority prescription for this drug; OR
Patient must have been receiving treatment with this drug prior to 1 December 2013;
Patient must not show continuing progression of disability while on treatment with this drug
Compliance with
Authority Required
procedures
Where applicable, the date of the magnetic resonance imaging scan must be provided with the authority application
C4410
Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the
brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification
provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not
psychological) injury to the patient;
The treatment must be as monotherapy;
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple
sclerosis, in the preceding 2 years;
Patient must be ambulatory (without assistance or support)
Compliance with
Authority Required
procedures
Where applicable, the date of the magnetic resonance imaging scan must be provided with the authority application
C4417
Multiple sclerosis
Continuing treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the
brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification
provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not
psychological) injury to the patient;
The treatment must be as monotherapy;
Patient must have previously been issued with an authority prescription for this drug; OR
Patient must have been receiving treatment with this drug prior to 1 December 2013;
Patient must not show continuing progression of disability while on treatment with this drug
Where applicable, the date of the magnetic resonance imaging scan must be provided with the authority application
[105]
Schedule 4, Part 1, entry for Enalapril with Hydrochlorothiazide
substitute:
Enalapril with
Hydrochlorothazide
C4389
Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy;
The condition must be inadequately controlled with an ACE inhibitor; OR
The condition must be inadequately controlled with a thiazide diuretic
Instrument Number PB 88 of 2013
27
Compliance with
Authority Required
procedures
[106]
Schedule 4, Part 1, entry for Eprosartan with Hydrochlorothiazide
substitute:
Eprosartan with
Hydrochlorothiazide
[107]
C4374
Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy;
The condition must be inadequately controlled with an an angiotensin II antagonist; OR
The condition must be inadequately controlled with a thiazide diuretic
Schedule 4, Part 1, entry for Erlotinib
substitute:
Erlotinib
C4362
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy;
Patient must not have received previous PBS-subsidised treatment with another epidermal growth factor receptor (EGFR) tyrosine
kinase inhibitor (TKI); OR
Patient must have developed intolerance to another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) of a
severity necessitating permanent treatment withdrawal;
Patient must have failed prior therapy which included a platinum compound;
Patient must have a WHO performance status of 3 or less;
The condition must have progressed following treatment with docetaxel or pemetrexed; OR
Patient must have a contraindication or intolerance to treatment with docetaxel and pemetrexed;
Patient must not be able to receive further chemotherapy subsidised by the PBS or from other sources following treatment with
erlotinib;
Patient must have a wild type epidermal growth factor receptor (EGFR) gene; OR
Patient must have an epidermal growth factor receptor (EGFR) gene of unknown type
Compliance with
Written Authority
Required procedures
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Non-Small Cell Lung Cancer Erlotinib Authority Application - Supporting Information Form, which includes:
(i) evidence that the patient has been treated with platinum-based chemotherapy; AND
(ii) evidence that disease progression has occurred following treatment with docetaxel or pemetrexed. In patients in whom docetaxel
or pemetrexed is contraindicated or cannot be tolerated the prescriber must state the reasons for intolerance or the contraindication;
AND
(iii) a declaration from the prescriber that the patient has exhausted all opportunities for treatment with chemotherapy either on the
PBS, through special access schemes or in a clinical trial; and
(3) a signed patient acknowledgement
C4386
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be as monotherapy;
Patient must have previously been issued with an authority prescription for this drug prior to 1 January 2014;
Patient must not have progressive disease;
Patient must have a wild type epidermal growth factor receptor (EGFR) gene; OR
Patient must have an epidermal growth factor receptor (EGFR) gene of unknown type
C4387
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy;
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC;
Patient must not have received previous PBS-subsidised treatment with another epidermal growth factor receptor (EGFR) tyrosine
kinase inhibitor (TKI); OR
Instrument Number PB 88 of 2013
28
Compliance with
Authority Required
procedures
Compliance with
Authority Required
procedures
Patient must have developed intolerance to another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) of a
severity necessitating permanent treatment withdrawal;
Patient must have a WHO performance status of 2 or less;
Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to
treatment with EGFR tyrosine kinase inhibitors in tumour material
C4403
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be as monotherapy;
Patient must have previously been issued with an authority prescription for this drug;
Patient must not have progressive disease;
Patient must have a wild type epidermal growth factor receptor (EGFR) gene; OR
Patient must have an epidermal growth factor receptor (EGFR) gene of unknown type
Compliance with
Written Authority
Required procedures
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Non-Small Cell Lung Cancer Erlotinib Authority Application - Supporting Information Form, which includes:
(i) evidence that the patient has been treated with platinum-based chemotherapy; AND
(ii) evidence that disease progression has occurred following treatment with docetaxel or pemetrexed. In patients in whom docetaxel
or pemetrexed is contraindicated or cannot be tolerated the prescriber must state the reasons for intolerance or the contraindication;
AND
(iii) a declaration from the prescriber that the patient has exhausted all opportunities for treatment with chemotherapy either on the
PBS, through special access schemes or in a clinical trial; and
(3) a signed patient acknowledgement
C4406
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be as monotherapy;
Patient must have previously been issued with an authority prescription for this drug;
Patient must not have progressive disease;
Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to
treatment with EGFR tyrosine kinase inhibitors in tumour material
[108]
Compliance with
Authority Required
procedures
Schedule 4, Part 1, entry for Exenatide
substitute:
Exenatide
C4392
Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea;
Patient must have a contraindication to a combination of metformin and a sulfonylurea; OR
Patient must not have tolerated a combination of metformin and a sulfonylurea;
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor
(gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite
treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per
L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2
inhibitor despite treatment with either metformin or a sulfonylurea
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records
at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an
SGLT2 inhibitor was initiated
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
Instrument Number PB 88 of 2013
29
Compliance with
Authority Required
procedures Streamlined Authority
Code 4392
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a
gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records
C4405
Diabetes mellitus type 2
The treatment must be in combination with metformin;
The treatment must be in combination with a sulfonylurea;
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor
(gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite
treatment with maximally tolerated doses of metformin and a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per
L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2
inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records
at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an
SGLT2 inhibitor was initiated
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a
gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records
[109]
Schedule 4, Part 1, entry for Fluticasone with eformoterol
substitute:
Fluticasone with
eformoterol
[110]
C4395
Asthma
Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of
inhaled corticosteroids;
Patient must be aged 12 years or over
Schedule 4, Part 1, entry for Fluticasone with Salmeterol
substitute:
Fluticasone with salmeterol C4372
Chronic obstructive pulmonary disease (COPD)
Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy;
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta-2 agonist bronchodilator
therapy;
The treatment must be for symptomatic treatment
C4408
Asthma
Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of
inhaled corticosteroids;
Patient must have been stabilised on concomitant inhaled salmeterol xinafoate and fluticasone propionate if aged less than 12 years
Instrument Number PB 88 of 2013
30
Compliance with
Authority Required
procedures Streamlined Authority
Code 4405
[111]
Schedule 4, Part 1, entry for Fosinopril with Hydrochlorothiazide
substitute:
Fosinopril with
hydrochlorothiazide
[112]
C4389
Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy;
The condition must be inadequately controlled with an ACE inhibitor; OR
The condition must be inadequately controlled with a thiazide diuretic
Schedule 4, Part 1, entry for Gefitinib
substitute:
Gefitinib
C4384
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be as monotherapy;
Patient must have previously been issued with an authority prescription for this drug;
Patient must not have progressive disease
C4387
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy;
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC;
Patient must not have received previous PBS-subsidised treatment with another epidermal growth factor receptor (EGFR) tyrosine
kinase inhibitor (TKI); OR
Patient must have developed intolerance to another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) of a
severity necessitating permanent treatment withdrawal;
Patient must have a WHO performance status of 2 or less;
Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to
treatment with EGFR tyrosine kinase inhibitors in tumour material
[113]
Compliance with
Authority Required
procedures
Compliance with
Authority Required
procedures
Schedule 4, Part 1, entry for Irbesartan with Hydrochlorothiazide
substitute:
Irbesartan with
Hydrochlorothiazide
[114]
C4374
Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy;
The condition must be inadequately controlled with an an angiotensin II antagonist; OR
The condition must be inadequately controlled with a thiazide diuretic
Schedule 4, Part 1, entry for Leflunomide
(a)
omit:
C2643
Initial treatment of severe active rheumatoid arthritis where other disease modifying anti-rheumatic drugs (including methotrexate) are Compliance with
ineffective and/or inappropriate and where treatment is initiated by a physician
Authority Required
procedures Streamlined Authority
Code 2643
Instrument Number PB 88 of 2013
31
(b)
omit:
C2681
[115]
Initial treatment of severe active psoriatic arthritis where other disease modifying anti-rheumatic drugs (including methotrexate) are
ineffective and/or inappropriate and where treatment is initiated by a physician
Schedule 4, Part 1, entry for Lercanidipine with enalapril
substitute:
Lercanidipine with enalapril C4398
Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy;
The condition must be inadequately controlled with an ACE inhibitor; OR
The condition must be inadequately controlled with a dihydropyridine calcium channel blocker
[116]
Schedule 4, Part 1, entry for Olmesartan with amlodipine
substitute:
Olmesartan with
amlodipine
[117]
C4373
Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy;
The condition must be inadequately controlled with an angiotensin II antagonist; OR
The condition must be inadequately controlled with a dihydropyridine calcium channel blocker
Schedule 4, Part 1, entry for Olmesartan with Hydrochlorothiazide
substitute:
Olmesartan with
hydrochlorothiazide
[118]
C4374
Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy;
The condition must be inadequately controlled with an an angiotensin II antagonist; OR
The condition must be inadequately controlled with a thiazide diuretic
Schedule 4, Part 1, entry for Perindopril with amlodipine
substitute:
Perinopril with amlodipine
C4398
Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy;
The condition must be inadequately controlled with an ACE inhibitor; OR
The condition must be inadequately controlled with a dihydropyridine calcium channel blocker
C4418
Stable coronary heart disease
The treatment must not be for the initiation of therapy for coronary heart disease;
The condition must be stabilised by treatment with perindopril and amlodipine at the same doses
Instrument Number PB 88 of 2013
32
Compliance with
Authority Required
procedures Streamlined Authority
Code 2681
[119]
Schedule 4, Part 1, entry for Perindopril with Indapamide
substitute:
Perinopril with indapamide C4375
Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy;
The condition must be inadequately controlled with a thiazide-like diuretic; OR
The condition must be inadequately controlled with an ACE inhibitor
[120]
Pioglitazone
Schedule 4, Part 1, entry for Pioglitazone
substitute:
C4363
Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea;
Patient must have a contraindication to a combination of metformin and a sulfonylurea; OR
Patient must not have tolerated a combination of metformin and a sulfonylurea;
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor
(gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite
treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per
L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2
inhibitor despite treatment with either metformin or a sulfonylurea
Compliance with
Authority Required
procedures Streamlined Authority
Code 4363
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records
at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an
SGLT2 inhibitor was initiated
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a
gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records
C4364
Diabetes mellitus type 2
The treatment must be in combination with metformin;
The treatment must be in combination with a sulfonylurea;
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor
(gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite
treatment with maximally tolerated doses of metformin and a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per
L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2
inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records
at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an
SGLT2 inhibitor was initiated
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a
gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records
Instrument Number PB 88 of 2013
33
Compliance with
Authority Required
procedures Streamlined Authority
Code 4364
C4388
Diabetes mellitus type 2
The treatment must be in combination with insulin;
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor
(gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite
treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per
L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2
inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated
Compliance with
Authority Required
procedures Streamlined Authority
Code 4388
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records
at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an
SGLT2 inhibitor was initiated
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a
gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records
[121]
Schedule 4, Part 1, entry for Protein hydrolysate formula with medium chain triglycerides
substitute:
Protein hydrolysate formula C4357
with medium chain
triglycerides
Cows' milk protein enteropathy and intolerance to soy protein
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and
hepatologist, or in consultation with a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric
gastroenterologist and hepatologist;
The condition must not be isolated infant colic or reflux;
Patient must have demonstrated a clinical improvement with the protein hydrolysate formula with medium chain triglycerides;
Patient must be up to the age of 24 months
Compliance with
Authority Required
procedures
The date of birth of the patient must be included in the authority application
C4358
Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist;
Patient must be up to the age of 24 months
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4365
Cows' milk protein enteropathy and intolerance to soy protein
Must be treated by a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and
hepatologist;
The condition must not be isolated infant colic or reflux;
Patient must have failed to respond to a strict soy-based cows' milk protein free diet;
Patient must be older than 24 months of age
Compliance with
Authority Required
procedures
The name of the specialist and the date of birth of the patient must be included in the authority application
C4366
Cystic fibrosis
Compliance with
Authority Required
procedures
Instrument Number PB 88 of 2013
34
C4376
Cows' milk protein enteropathy and intolerance to soy protein
Initial treatment
Must be treated by a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and
hepatologist, or in consultation with a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric
gastroenterologist and hepatologist;
The condition must not be isolated infant colic or reflux;
Patient must have failed to respond to a strict soy-based cows' milk protein free diet;
Patient must be up to the age of 24 months
Compliance with
Authority Required
procedures
The date of birth of the patient must be included in the authority application
C4377
Enterokinase deficiency
Compliance with
Authority Required
procedures
C4378
Proven fat malabsorption
Compliance with
Authority Required
procedures
C4379
Chylothorax
Compliance with
Authority Required
procedures
C4393
Chylous ascites
Compliance with
Authority Required
procedures
C4399
Chronic liver failure with fat malabsorption
Compliance with
Authority Required
procedures
C4400
Severe diarrhoea of greater than 2 weeks duration
Compliance with
Authority Required
procedures
Patient must be aged less than 4 months
The date of birth of the patient must be included in the authority application
C4401
Severe intestinal malabsorption including short bowel syndrome
Compliance with
Authority Required
procedures
C4412
Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein
Compliance with
Authority Required
procedures
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in
consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist;
Patient must be up to the age of 24 months
The name of the specialist and the date of birth of the patient must be included in the authority application
C4413
[122]
Biliary atresia
Compliance with
Authority Required
procedures
Schedule 4, Part 1, entry for Quetiapine
insert in numerical order following existing text:
C4385
Bipolar I disorder
Compliance with
Authority Required
The treatment must be maintenance therapy;
Instrument Number PB 88 of 2013
35
C4391
The treatment must be for dose titration purposes
procedures Streamlined Authority
Code 4385
Schizophrenia
Compliance with
Authority Required
procedures Streamlined Authority
Code 4391
The treatment must be for dose titration purposes
C4396
Acute mania
The condition must be associated with bipolar I disorder;
The treatment must be as monotherapy;
The treatment must be for dose titration purposes
[123]
Compliance with
Authority Required
procedures Streamlined Authority
Code 4396
Schedule 4, Part 1, entry for Quinapril with Hydrochlorothiazide
substitute:
Quinapril with
hydrochlorothiazide
[124]
C4389
Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy;
The condition must be inadequately controlled with an ACE inhibitor; OR
The condition must be inadequately controlled with a thiazide diuretic
Schedule 4, Part 1, entry for Ramipril with Felodipine
substitute:
Ramipril with felodipine
C4398
Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy;
The condition must be inadequately controlled with an ACE inhibitor; OR
The condition must be inadequately controlled with a dihydropyridine calcium channel blocker
[125]
Schedule 4, Part 1, entry for Rivaroxaban
(a)
omit:
C3957
P3957
Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 10 days of therapy
Compliance with
Authority Required
procedures
C3993
P3993
Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 30 days of therarpy
Compliance with
Authority Required
procedures
C4047
P4047
Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 20 days supply to complete Compliance with
a course of treatment
Authority Required
procedures
C4048
P4048
Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 30 days supply to complete Compliance with
a course of treatment
Authority Required
procedures
C4050
P4050
Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 15 days of therapy
Instrument Number PB 88 of 2013
36
Compliance with
Authority Required
procedures
(b)
insert in numerical order following existing text:
C4369
P4369
Prevention of venous thromboembolism
Patient must be undergoing total hip replacement;
Patient must require up to 20 days supply to complete a course of treatment
C4381
P4381
Prevention of venous thromboembolism
Patient must be undergoing total knee replacement;
Patient must require up to 10 days of therapy
C4382
P4382
Prevention of venous thromboembolism
Patient must be undergoing total knee replacement;
Patient must require up to 15 days of therapy
C4402
P4402
Prevention of venous thromboembolism
Patient must be undergoing total hip replacement;
Patient must require up to 30 days supply to complete a course of treatment
[126]
Compliance with
Authority Required
procedures Streamlined Authority
Code 4369
Compliance with
Authority Required
procedures Streamlined Authority
Code 4381
Compliance with
Authority Required
procedures Streamlined Authority
Code 4382
Compliance with
Authority Required
procedures Streamlined Authority
Code 4402
Schedule 4, Part 1, entry for Rosiglitazone
substitute:
Rosiglitazone
C4367
Diabetes mellitus type 2
Compliance with
Authority Required
The treatment must be in combination with metformin; OR
procedures
The treatment must be in combination with a sulfonylurea;
Patient must have a contraindication to a combination of metformin and a sulfonylurea; OR
Patient must not have tolerated a combination of metformin and a sulfonylurea;
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor
(gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite
treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per
L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2
inhibitor despite treatment with either metformin or a sulfonylurea
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records
at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an
SGLT2 inhibitor was initiated
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a
gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records
Instrument Number PB 88 of 2013
37
[127]
Schedule 4, Part 1, entry for Rosiglitazone with Metformin
substitute:
Rosiglitazone with
metformin
C4383
Diabetes mellitus type 2
Compliance with
Authority Required
Patient must have a contraindication to a sulfonylurea; OR
procedures
Patient must not have tolerated a sulfonylurea;
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor
(gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite
treatment with metformin; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per
L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2
inhibitor despite treatment with metformin
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records
at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an
SGLT2 inhibitor was initiated
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a
gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records
[128]
Schedule 4, Part 1, entry for Telmisartan with amlodipine
substitute:
Telmisartan with
amlodipine
[129]
C4373
Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy;
The condition must be inadequately controlled with an angiotensin II antagonist; OR
The condition must be inadequately controlled with a dihydropyridine calcium channel blocker
Schedule 4, Part 1, entry for Telmisartan with Hydrochlorothiazide
substitute:
Telmisartan with
Hydrochlorothiazide
[130]
C4374
Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy;
The condition must be inadequately controlled with an an angiotensin II antagonist; OR
The condition must be inadequately controlled with a thiazide diuretic
Schedule 4, Part 1, entry for Teriparatide
(a)
omit:
C4101
Severe established osteoporosis
Compliance with
Authority Required
procedures
Initial treatment
Must be treated by a specialist; OR
Must be treated by a consultant physician;
Patient must be at very high risk of fracture;
Patient must have a bone mineral density (BMD) T-score of -3.0 or less;
Instrument Number PB 88 of 2013
38
Patient must have had 2 or more fractures due to minimal trauma;
Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an antiresorptive agent at adequate doses;
The treatment must be the sole PBS-subsidised agent;
The treatment must not exceed a lifetime maximum of 18 months therapy
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the
posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below
the affected vertebral body
If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the
contraindication must be provided at the time of application
If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one antiresorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months
continuous therapy. Details must be provided at the time of application
Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this
restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or
150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months, strontium
ranelate 2 g per day and zoledronic acid 5 mg per annum
Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s)
which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must
be provided at the time of application
(b)
insert in numerical order following existing text:
C4407
Severe established osteoporosis
Initial treatment
Must be treated by a specialist; OR
Must be treated by a consultant physician;
Patient must be at very high risk of fracture;
Patient must have a bone mineral density (BMD) T-score of -3.0 or less;
Patient must have had 2 or more fractures due to minimal trauma;
Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an antiresorptive agent at adequate doses;
The treatment must be the sole PBS-subsidised agent;
The treatment must not exceed a lifetime maximum of 18 months therapy
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the
posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below
the affected vertebral body
If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the
contraindication must be documented in the patient's medical record at the time treatment with teriparatide is initiated
If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one antiresorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months
continuous therapy. Details must be documented in the patient's medical record at the time treatment with teriparatide is initiated
Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this
restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or
150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months, strontium
ranelate 2 g per day and zoledronic acid 5 mg per annum
Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s)
which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must
be provided at the time of application
Instrument Number PB 88 of 2013
39
Compliance with
Authority Required
procedures
[131]
Schedule 4, Part 1, entry for Trandolapril with Verapamil
substitute:
Trandolapril with Verapamil C4390
Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy;
The condition must be inadequately controlled with an ACE inhibitor; OR
The condition must be inadequately controlled with verapamil
[132]
Schedule 4, Part 1, entry for Valsartan with hydrochlorothiazide
substitute:
Valsartan with
hydrochlorothiazide
C4361
Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy;
The condition must be inadequately controlled with an an angiotensin II antagonist; OR
The condition must be inadequately controlled with a thiazide diuretic
C4374
Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy;
The condition must be inadequately controlled with an an angiotensin II antagonist; OR
The condition must be inadequately controlled with a thiazide diuretic
Instrument Number PB 88 of 2013
40