National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 13) (No. PB 74 of 2013)

Link to law: https://www.comlaw.gov.au/Details/F2013L02013

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PB 74 of 2013
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 13)
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 26 NOVEMBER 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. 13).
            (2)        This Instrument may also be cited as PB 74 of 2013.
2          Commencement
This Instrument commences on 1 December 2013.
3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
            Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1     Amendments
 
[1]           Schedule 1, after entry for Allopurinol in the form Tablet 300 mg [Zyloprim]
insert:
Alogliptin
Tablet 6.25 mg (as benzoate)
Oral
Nesina
TK
MP NP
C4349
 
28
5
28
 

 
Tablet 12.5 mg (as benzoate)
Oral
Nesina
TK
MP NP
C4349
 
28
5
28
 
 

 
Tablet 25 mg (as benzoate)
Oral
Nesina
TK
MP NP
C4349
 
28
5
28
 
 

[2]           Schedule 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides
insert as first item in the columns in the order indicated:
 
Oral powder 400 g (Alfamino)
Oral
Alfamino
NT
MP NP
C4305 C4312 C4323 C4330 C4337 C4338 C4339 C4345 C4352
 
8
5
1
 
 
[3]           Schedule 1, entry for Anastrozole
omit:
 
 
 
STADA Anastrozole
TD
MP NP
C2213
 
30
5
30
 
[4]           Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium)
(a)      omit:
 
 
 
STADA Atorvastatin
TD
MP
C1540 C3047
P1540
30
5
30
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

(b)      omit:
 
 
 
STADA Atorvastatin
TD
MP
C1540 C3047
P3047
30
11
30
 
[5]           Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium)
(a)      omit:
 
 
 
STADA Atorvastatin
TD
MP
C1540 C3047
P1540
30
5
30
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

 
(b)      omit:
 
 
 
STADA Atorvastatin
TD
MP
C1540 C3047
P3047
30
11
30
 
[6]           Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium)
(a)      omit:
 
 
 
STADA Atorvastatin
TD
MP
C1540 C3047
P1540
30
5
30
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

(b)      omit:
 
 
 
STADA Atorvastatin
TD
MP
C1540 C3047
P3047
30
11
30
 
[7]           Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium)
(a)      omit:
 
 
 
STADA Atorvastatin
TD
MP
C1540 C3047
P1540
30
5
30
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

(b)      omit:
 
 
 
STADA Atorvastatin
TD
MP
C1540 C3047
P3047
30
11
30
 
[8]           Schedule 1, after entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Brand: Trovas; Maximum Quantity: 30;
Number of Repeats: 11]
insert:
Atorvastatin and ezetimibe
Pack containing 30 tablets atorvastatin 10 mg (as calcium) and 30 tablets ezetemibe 10 mg
Oral
Atozet Composite Pack 10mg + 10mg
MK
MP NP
C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 C4353
 
1
5
1
 
 

 
Pack containing 30 tablets atorvastatin 20 mg (as calcium) and 30 tablets ezetemibe 10 mg
Oral
Atozet Composite Pack 10mg + 20mg
MK
MP NP
C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121
 
1
5
1
 
 

 
Pack containing 30 tablets atorvastatin 40 mg (as calcium) and 30 tablets ezetemibe 10 mg
Oral
Atozet Composite Pack 10mg + 40mg
MK
MP NP
C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121
 
1
5
1
 
 

 
 
Pack containing 30 tablets atorvastatin 80 mg (as calcium) and 30 tablets ezetemibe 10 mg
Oral
Atozet Composite Pack 10mg + 80mg
MK
MP NP
C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121
 
1
5
1
 
 
[9]           Schedule 1, entry for Bimatoprost with timolol
substitute:
Bimatoprost with timolol
Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, 3 mL
Application to the eye
Ganfort 0.3/5
AG
MP
C4343
 
1
5
1
 
 

 
 
 
 
 
AO
C4326
 
1
5
1
 
 

[10]         Schedule 1, entry for Brimonidine with Timolol
substitute:
Brimonidine with timolol
Eye drops containing brimonidine tartrate 2 mg with timolol 5 mg (as maleate) per mL, 5 mL
Application to the eye
Combigan
AG
MP
C4343
 
1
5
1
 
 

 
 
 
 
 
AO
C4326
 
1
5
1
 
 

[11]         Schedule 1, entry for Brinzolamide with timolol
substitute:
Brinzolamide with timolol
Eye drops 10 mg brinzolamide with timolol 5 mg (as maleate) per mL, 5 mL
Application to the eye
Azarga
AQ
MP
C4343
 
1
5
1
 
 

 
 
 
 
 
AO
C4326
 
1
5
1
 
 

[12]         Schedule 1, after entry for Budesonide with Eformoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2
insert in the columns in the order indicated:
 
Pressurised inhalation containing budesonide 50 micrograms with eformoterol fumarate dihydrate 3 micrograms per dose, 120 doses, 2
Inhalation by mouth
Symbicort Rapihaler 50/3
AP
MP NP
C4318
 
1
5
1
 
 

 
Pressurised inhalation containing budesonide 100 micrograms with eformoterol fumarate dihydrate 3 micrograms per dose, 120 doses, 2
Inhalation by mouth
Symbicort Rapihaler 100/3
AP
MP NP
C4318
 
1
5
1
 
 

 
Pressurised inhalation containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses, 2
Inhalation by mouth
Symbicort Rapihaler 200/6
AP
MP NP
C4327 C4333
 
1
5
1
 
 

 
[13]         Schedule 1, after entry for Calcium in the form Tablet 600 mg (as carbonate)
insert:
Canagliflozin
Tablet 100 mg (as hemihydrate)
Oral
Invokana
JC
MP NP
C4321
 
30
5
30
 

 
Tablet 300 mg (as hemihydrate)
Oral
Invokana
JC
MP NP
C4321
 
30
5
30
 
 

[14]         Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 4 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Auro-Candesartan 4
DO
MP NP
 
 
30
5
30
 
 
(b)      omit:
 
 
 
STADA Candesartan
TD
MP NP
 
 
30
5
30
 
 
[15]         Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 8 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Auro-Candesartan 8
DO
MP NP
 
 
30
5
30
 
 
(b)      omit:
 
 
 
STADA Candesartan
TD
MP NP
 
 
30
5
30
 
 
[16]         Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 16 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Auro-Candesartan 16
DO
MP NP
 
 
30
5
30
 
 
(b)      omit:
 
 
 
STADA Candesartan
TD
MP NP
 
 
30
5
30
 
 
[17]         Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 32 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Auro-Candesartan 32
DO
MP NP
 
 
30
5
30
 
 
(b)      omit:
 
 
 
STADA Candesartan
TD
MP NP
 
 
30
5
30
 
 
[18]         Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg
omit:
 
 
 
STADA Candesartan HCT 16/12.5
TD
MP NP
C3307
 
30
5
30
 
 
[19]         Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg
omit:
 
 
 
STADA Candesartan HCT 32/12.5
TD
MP NP
C3307
 
30
5
30
 
 
[20]         Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg
omit:
 
 
 
STADA Candesartan HCT 32/25
TD
MP NP
C3307
 
30
5
30
 
 
[21]         Schedule 1, entry for Carbamazepine in the form Tablet 200 mg [Maximum Quantity 200; Number of Repeats 0]
omit:
 
 
 
Carbamazepine Sandoz
SZ
PDP
 
 
200
0
200
 
 
substitute:
 
 
 
Carbamazepine Sandoz
SZ
PDP
 
 
200
0
100
 
 

 
 
 
 
 
PDP
 
 
200
0
200
 
 

[22]         Schedule 1, entry for Carbamazepine in the form Tablet 200 mg [Maximum Quantity 200; Number of Repeats 2]
omit:
 
 
 
Carbamazepine Sandoz
SZ
MP NP
 
 
200
2
200
 
 
substitute:
 
 
 
Carbamazepine Sandoz
SZ
MP NP
 
 
200
2
100
 
 

 
 
 
 
 
MP NP
 
 
200
2
200
 
 

[23]         Schedule 1, entry for Carbimazole in the form Tablet 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Carbimazol ARISTO
PQ
MP NP
 
 
200
2
100
 
 
[24]         Schedule 1, entry for Ceftriaxone in each of the forms: Powder for injection 1 g (as sodium); and Powder for injection 2 g (as sodium)
omit from the column headed “Brand”:          DBL Ceftriaxone               substitute:             Hospira Ceftriaxone
[25]         Schedule 1, entry for Clarithromycin in the form Tablet 250 mg
omit from the column headed “Brand”:          Clarihexal           substitute:             Clarithromycin Sandoz
[26]         Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)
omit:
 
 
 
STADA Clopidogrel
TD
MP NP
C1719 C1720 C1721 C1722 C1723 C1724
 
28
5
28
 
 
[27]         Schedule 1, after entry for Dabigatran etexilate in the form Capsule 150 mg (as mesilate)
insert:
Dabrafenib
Capsule 50 mg (as mesilate)
Oral
Tafinlar
GK
MP
C4317 C4340
P4317
120
3
120
 

 
 
 
 
 
MP
C4317 C4340
P4340
120
5
120
 
 

 
Capsule 75 mg (as mesilate)
Oral
Tafinlar
GK
MP
C4317 C4340
P4317
120
3
120
 
 

 
 
 
 
 
MP
C4317 C4340
P4340
120
5
120
 
 

[28]         Schedule 1, after entry for Dantrolene in the form Capsule containing dantrolene sodium 50 mg
insert:
Dapagliflozin
Tablet 10 mg (as propanediol monohydrate)
Oral
Forxiga
BQ
MP NP
C4331
 
28
5
28
 
[29]         Schedule 1, entry for Darunavir in the form Tablet 400 mg (as ethanolate)
omit from the column headed “Circumstances”:           C3940  C3941     substitute:             C4313  C4346
[30]         Schedule 1, after entry for Darunavir in the form Tablet 600 mg (as ethanolate)
insert in the columns in the order indicated:
 
Tablet 800 mg (as ethanolate)
Oral
Prezista
JC
MP
See Note 1
C4313 C4346
 
60
5
30
D(100)
[31]         Schedule 1, entry for Denosumab in the form Injection 60 mg in 1 mL pre-filled syringe
omit from the column headed “Circumstances”:           C4094  C4145     substitute:             C4314  C4347
 
[32]         Schedule 1, after entry for Diltiazem in the form Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg [Vasocardol CD]
insert in the columns in the order indicated:
Dimethyl fumarate
Capsule (modified release) 120 mg
Oral
Tecfidera
BD
MP
C4320 C4335
 
14
0
14
 
 

 
Capsule (modified release) 240 mg
Oral
Tecfidera
BD
MP
C4356
 
56
5
56
 
 

[33]         Schedule 1, entry for Donepezil in each of the forms: Tablet containing donepezil hydrochloride 5 mg; and Tablet containing
donepezil hydrochloride 10 mg
omit:
 
 
 
STADA Donepezil
TD
MP NP
C4219 C4220 C4224
 
28
5
28
 
 
[34]         Schedule 1, entry for Dorzolamide with Timolol
substitute:
Dorzolamide with timolol
Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL
Application to the eye
Cosopt
MK
MP
C4343
 
1
5
1
1
 

 
 
 
 
 
AO
C4326
 
1
5
1
1
 

[35]         Schedule 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Deotine 30
SZ
MP NP
C1211
 
28
0
28
 
 
[36]         Schedule 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Deotine 60
SZ
MP NP
C1211
 
28
5
28
 
 
[37]         Schedule 1, after entry for Everolimus in the form Tablet 1 mg
insert in the columns in the order indicated:
 
Tablet 2.5 mg
Oral
Afinitor
NV
MP
C4334 C4351
 
30
5
30
 
 

 
Tablet 5 mg
Oral
Afinitor
NV
MP
C4334 C4351
 
30
5
30
 
 

 
Tablet 10 mg
Oral
Afinitor
NV
MP
C4334 C4351
 
30
5
30
 
 

[38]         Schedule 1, after entry for Fluticasone in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms per dose, 60 doses
insert:
Fluticasone with eformoterol
Pressurised inhalation containing fluticasone propionate 50 micrograms with eformoterol fumarate dihydrate 5 micrograms per dose, 120 doses
Inhalation by mouth
flutiform 50/5
MF
MP NP
C4315
 
1
5
1
 
 

 
Pressurised inhalation containing fluticasone propionate 125 micrograms with eformoterol fumarate dihydrate 5 micrograms per dose, 120 doses
Inhalation by mouth
flutiform 125/5
MF
MP NP
C4315
 
1
5
1
 
 

 
Pressurised inhalation containing fluticasone propionate 250 micrograms with eformoterol fumarate dihydrate 10 micrograms per dose, 120 doses
Inhalation by mouth
flutiform 250/10
MF
MP NP
C4315
 
1
5
1
 
 

[39]         Schedule 1, entry for Ifosfamide in each of the forms: Powder for I.V. injection 1 g in single dose vial; and Powder for I.V. injection 2 g in single dose vial
(a)      omit from the column headed “Form”:                                in single dose vial
(b)      omit from the column headed “Circumstances”:               C1325  C1327
[40]         Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesylate) [Maximum Quantity 60; Number of Repeats 2]
(a)      omit from the column headed “Circumstances”:               C3847  C3848
(b)      insert in numerical order”:     C4342  C4355
[41]         Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesylate) [Maximum Quantity 60; Number of Repeats 5]
(a)      omit from the column headed “Circumstances”:               C3847  C3848
(b)      insert in numerical order”:     C4342  C4355
(c)      omit from the column headed “Purposes”:         P3847  P3848
(d)      insert in numerical order”:     P4342  P4355
[42]         Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesylate) [Maximum Quantity 30; Number of Repeats 2]
(a)      omit from the column headed “Circumstances”:               C3847  C3848
(b)      insert in numerical order”:     C4342  C4355
[43]         Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesylate) [Maximum Quantity 30; Number of Repeats 5]
(a)      omit from the column headed “Circumstances”:               C3847  C3848
(b)      insert in numerical order”:     C4342  C4355
(c)      omit from the column headed “Purposes”:         P3847  P3848
(d)      insert in numerical order”:     P4342  P4355
[44]         Schedule 1, entry for Insulin Isophane in the form Injection (bovine) 100 units per mL, 10 mL
insert in the column headed “Circumstances”:             C4332
 
[45]         Schedule 1, entry for Insulin Neutral in the form Injection (bovine) 100 units per mL, 10 mL
insert in the column headed “Circumstances”:             C4332
[46]         Schedule 1, entry for Irbesartan in each of the forms: Tablet 75 mg; Tablet 150 mg; and Tablet 300 mg
omit:
 
 
 
STADA Irbesartan
TD
MP NP
 
 
30
5
30
 
 
[47]         Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 150 mg-12.5 mg
omit:
 
 
 
STADA Irbesartan HCT 150/12.5
TD
MP NP
C3307
 
30
5
30
 
 
[48]         Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-12.5 mg
omit:
 
 
 
STADA Irbesartan HCT 300/12.5
TD
MP NP
C3307
 
30
5
30
 
 
[49]         Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-25 mg
omit:
 
 
 
STADA Irbesartan HCT 300/25
TD
MP NP
C3307
 
30
5
30
 
 
[50]         Schedule 1, after entry for Itraconazole
insert:
Ivabradine
Tablet 5 mg (as hydrochloride)
Oral
Coralan
SE
MP NP
C4310
 
56
5
56
 
 

 
Tablet 7.5 mg (as hydrochloride)
Oral
Coralan
SE
MP NP
C4310
 
56
5
56
 
 

[51]         Schedule 1, entry for Ivermectin
substitute:
Ivermectin
Tablet 3 mg
Oral
Stromectol
MK
MP NP
C4319 C4328
P4319
4
0
4
 
 

 
 
 
 
 
MP NP
C4319 C4328
P4328
8
2
4
 
 

[52]         Schedule 1, entry for Ketoconazole
omit:
 
Tablet 200 mg
Oral
Nizoral
JC
MP NP
C3604 C3605 C3606
P3606
10
0
10
 

 
 
 
 
 
MP NP
C3604 C3605 C3606
P3604 P3605
30
5
10
 
 

[53]         Schedule 1, entry for Latanoprost
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Latanoprost Actavis
GN
MP AO
 
 
1
5
1
 
 
[54]         Schedule 1, entry for Latanoprost with Timolol
substitute:
Latanoprost with timolol
Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL
Application to the eye
Latanocom
FZ
MP
C4343
 
1
5
1
 
 

 
 
 
 
 
AO
C4326
 
1
5
1
 
 

 
 
 
Xalacom
PF
MP
C4343
 
1
5
1
 
 

 
 
 
 
 
AO
C4326
 
1
5
1
 
 

[55]         Schedule 1, entry for Letrozole
omit:
 
 
 
STADA Letrozole
TD
MP NP
C1608 C2691 C2692
 
30
5
30
 
[56]         Schedule 1, entry for Linagliptin
omit from the column headed “Circumstances”:           C3540    substitute:             C4350
[57]         Schedule 1, entry for Macrogol 3350
omit:
Macrogol 3350
Sachets containing powder for oral solution 13.125 g with electrolytes, 30
Oral
LaxaCon
GN
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3643
See Note 2
2
See Note 2
0
See
Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3642
See Note 2
2
See Note 2
3
See
Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P1263 P1613 P2693 P2823
See Note 2
1
See Note 2
5
See
Note 2
1
 
 

 
 
 
Movicol
NE
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3643
See Note 2
2
See Note 2
0
See
Note 2
1
 
 

 
 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3642
See Note 2
2
See Note 2
3
See
Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P1263 P1613 P2693 P2823
See Note 2
1
See Note 2
5
See
Note 2
1
 
 

substitute:
Macrogol 3350
Sachets containing powder for oral solution 13.125 g with electrolytes, 30
Oral
LaxaCon
GN
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3643
See Note 2
2
See Note 2
0
See
Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3642
See Note 2
2
See Note 2
3
See
Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P1263 P1613 P2693 P2823
See Note 2
1
See Note 2
5
See
Note 2
1
 
 

 
 
 
lax-sachets
AE
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3643
See Note 2
2
See Note 2
0
See
Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3642
See Note 2
2
See Note 2
3
See
Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P1263 P1613 P2693 P2823
See Note 2
1
See Note 2
5
See
Note 2
1
 
 

 
 
 
Movicol
NE
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3643
See Note 2
2
See Note 2
0
See
Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3642
See Note 2
2
See Note 2
3
See
Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P1263 P1613 P2693 P2823
See Note 2
1
See Note 2
5
See
Note 2
1
 
 

 
[58]         Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg
(a)      omit:
 
 
 
APO-Metoprolol
TX
MP NP
 
 
100
5
100
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metatar
FM
MP NP
 
 
100
5
100
 
 
[59]         Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg
(a)      omit:
 
 
 
APO-Metoprolol
TX
MP NP
 
 
60
5
60
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metatar
FM
MP NP
 
 
60
5
60
 
 
[60]         Schedule 1, entry for Miconazole in the form Tincture 20 mg per mL, 30 mL
omit from the column headed “Brand”:          Daktarin               substitute:             Daktarin Tincture
[61]         Schedule 1, after entry for Milk powder—lactose free formula in the form Oral powder 900 g (Karicare Aptamil De‑Lact)
insert in the columns in the order indicated:
 
Oral powder 900 g (Karicare Aptamil Gold De‑Lact)
Oral
Karicare Aptamil Gold De‑Lact
NU
MP NP
C4324 C4336
P4324
5
0
1
 
 

 
 
 
 
 
MP NP
C4324 C4336
P4336
5
5
1
 
 

[62]         Schedule 1, entry for Nicotine in the form Transdermal patch 17.5 mg
(a)      omit from the column headed “Circumstances”:               C3447  C3448     substitute:             C4307  C4348
(b)      omit from the column headed “Number of Repeats”:        0          substitute:             2
[63]         Schedule 1, entry for Nicotine in the form Transdermal patch 24.9 mg
omit from the column headed “Circumstances”:           C4231  C4232  C4233      substitute:             C4307  C4344  C4348
[64]         Schedule 1, entry for Nicotine in the form Transdermal patch 35 mg
(a)      omit from the column headed “Circumstances”:               C3447  C3448     substitute:             C4307  C4348
(b)      omit from the column headed “Number of Repeats”:        0          substitute:             2
 
[65]         Schedule 1, entry for Nicotine
omit:
 
Transdermal patch 52.5 mg
Transdermal
Nicotinell Step 1
NC
MP NP
C3042 C3447 C3448
P3447 P3448
28
0
28
 
 

 
 
 
 
 
MP NP
C3042 C3447 C3448
P3042
28
2
28
 
 

substitute:
 
Transdermal patch 52.5 mg
Transdermal
Nicotinell Step 1
NC
MP NP
C4307 C4344 C4348
 
28
2
28
 
 
[66]         Schedule 1, entry for Nicotine in the form Transdermal patch 114 mg
omit from the column headed “Circumstances”:           C4231  C4232  C4233      substitute:             C4307  C4344  C4348
[67]         Schedule 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg (as benzoate); Tablet 5 mg (as benzoate); Tablet 7.5 mg
(as benzoate); and Tablet 10 mg (as benzoate)
omit:
 
 
 
STADA Olanzapine
TD
MP NP
C1589 C2044
 
28
5
28
 
 
[68]         Schedule 1, entry for Olanzapine in each of the forms: Tablet 5 mg (orally disintegrating); and Tablet 10 mg (orally disintegrating)
omit:
 
 
 
STADA Olanzapine ODT
TD
MP NP
C1589 C2044
 
28
5
28
 
 
[69]         Schedule 1, after entry for Olmesartan with amlodipine in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine
10 mg (as besylate)
insert:
Olmesartan with amlodipine and hydrochlorothiazide
Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg
Oral
Sevikar HCT 20/5/12.5
MK
MP NP
C4311
 
30
5
30
 
 

 
Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg
Oral
Sevikar HCT 40/5/12.5
MK
MP NP
C4311
 
30
5
30
 
 

 
Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 25 mg
Oral
Sevikar HCT 40/5/25
MK
MP NP
C4311
 
30
5
30
 
 

 
 
Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 12.5 mg
Oral
Sevikar HCT 40/10/12.5
MK
MP NP
C4311
 
30
5
30
 
 

 
Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 25 mg
Oral
Sevikar HCT 40/10/25
MK
MP NP
C4311
 
30
5
30
 
 

[70]         Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate)
(a)      omit:
 
 
 
STADA Pantoprazole
TD
MP NP
C1177 C1337 C1476 C1533
P1177
30
2
30
 
(b)      omit:
 
 
 
STADA Pantoprazole
TD
MP NP
C1177 C1337 C1476 C1533
P1337 P1476 P1533
30
5
30
 
[71]         Schedule 1, entry for Perindopril in the form Tablet containing perindopril arginine 2.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
PREXUM 2.5
RX
MP NP
 
 
30
5
30
 
 
[72]         Schedule 1, entry for Perindopril in the form Tablet containing perindopril arginine 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
PREXUM 5
RX
MP NP
 
 
30
5
30
 
 
[73]         Schedule 1, entry for Perindopril in the form Tablet containing perindopril arginine 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
PREXUM 10
RX
MP NP
 
 
30
5
30
 
 
[74]         Schedule 1, entry for Perindopril with Indapamide in the form Tablet containing perindopril arginine 5 mg with indapamide
hemihydrate 1.25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Prexum Combi 5/1.25
RX
MP NP
C3307
 
30
5
30
 
 
[75]         Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
omit:
 
 
 
STADA Quetiapine
TD
MP NP
C1589 C2044 C2765
 
60
5
60
 
 
[76]         Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
omit:
 
 
 
STADA Quetiapine
TD
MP NP
C1589 C2044 C2765
 
90
5
90
 
 
[77]         Schedule 1, entry for Quetiapine in each of the forms: Tablet 200 mg (as fumarate); and Tablet 300 mg (as fumarate)
omit:
 
 
 
STADA Quetiapine
TD
MP NP
C1589 C2044 C2765
 
60
5
60
 
 
[78]         Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated)
(a)      omit:
 
 
 
STADA Rabeprazole
TD
MP NP
C1177 C1337 C1533
P1177
30
2
30
 
(b)      omit:
 
 
 
STADA Rabeprazole
TD
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
 
[79]         Schedule 1, after entry for Rifampicin in the form Syrup 100 mg per 5 mL, 60 mL
insert:
Rifaximin
Tablet 550 mg
Oral
Xifaxan
NE
MP
C4306
 
56
5
56
 
 
[80]         Schedule 1, entry for Roxithromycin in the form Tablet 150 mg [Maximum Quantity 10; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Roxithromycin GH
GQ
PDP
 
 
10
0
10
 
 
[81]         Schedule 1, entry for Roxithromycin in the form Tablet 150 mg [Maximum Quantity 10; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Roxithromycin GH
GQ
MP NP
 
 
10
1
10
 
 
[82]         Schedule 1, entry for Roxithromycin in the form Tablet 300 mg [Maximum Quantity 5; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Roxithromycin GH
GQ
PDP
 
 
5
0
5
 
 
[83]         Schedule 1, entry for Roxithromycin in the form Tablet 300 mg [Maximum Quantity 5; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Roxithromycin GH
GQ
MP NP
 
 
5
1
5
 
 
[84]         Schedule 1, entry for Saxagliptin
omit from the column headed “Circumstances”:           C3540    substitute:             C4350
[85]         Schedule 1, entry for Sitagliptin in each of the forms: Tablet 25 mg (as phosphate monohydrate); Tablet 50 mg (as phosphate monohydrate); and Tablet 100 mg (as phosphate monohydrate)
omit from the column headed “Circumstances”:           C3540    substitute:             C4350
[86]         Schedule 1, entry for Sitagliptin with metformin in each of the forms: Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 500 mg metformin hydrochloride; Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 850 mg metformin hydrochloride; and Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride
omit from the column headed “Circumstances”:           C3149  C3543     substitute:             C4309  C4325
[87]         Schedule 1, entry for Sunitinib
substitute:
Sunitinib
Capsule 12.5 mg (as malate)
Oral
Sutent
PF
MP
C3206 C3207 C4106 C4119 C4341 C4354
P3206 P3207 P4119
28
1
28
 
 

 
 
 
 
 
MP
C3206 C3207 C4106 C4119 C4341 C4354
P4354
28
2
28
 
 

 
 
 
 
 
MP
C3206 C3207 C4106 C4119 C4341 C4354
P4106
28
3
28
 
 

 
 
 
 
 
MP
C3206 C3207 C4106 C4119 C4341 C4354
P4341
28
5
28
 
 

 
Capsule 25 mg (as malate)
Oral
Sutent
PF
MP
C3206 C3207 C4106 C4119 C4341 C4354
P3206 P3207 P4119
28
1
28
 
 

 
 
 
 
 
MP
C3206 C3207 C4106 C4119 C4341 C4354
P4354
28
2
28
 
 

 
 
 
 
 
MP
C3206 C3207 C4106 C4119 C4341 C4354
P4106
28
3
28
 
 

 
 
 
 
 
MP
C3206 C3207 C4106 C4119 C4341 C4354
P4341
28
5
28
 
 

 
Capsule 50 mg (as malate)
Oral
Sutent
PF
MP
C3206 C3207 C4106 C4119 C4341 C4354
P3206 P3207 P4119
28
1
28
 
 

 
 
 
 
 
MP
C3206 C3207 C4106 C4119 C4341 C4354
P4354
28
2
28
 
 

 
 
 
 
 
 
MP
C3206 C3207 C4106 C4119 C4341 C4354
P4106
28
3
28
 
 

 
 
 
 
 
MP
C3206 C3207 C4106 C4119 C4341 C4354
P4341
28
5
28
 
 

[88]         Schedule 1, after entry for Terbutaline in the form Injection containing terbutaline sulfate 500 micrograms in 1 mL
insert in the columns in the order indicated:
 
Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 100 doses
Inhalation by mouth
Bricanyl Turbuhaler
AP
MP NP
 
 
2
5
1
 
 
[89]         Schedule 1, after entry for Terbutaline in the form Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 200 doses
insert:
Teriflunomide
Tablet 14 mg
Oral
Aubagio
GZ
MP
C4316 C4329
 
28
5
28
 
 
[90]         Schedule 1, entry for Travoprost with Timolol
substitute:
Travoprost with timolol
Eye drops 40 micrograms travoprost with timolol 5 mg (as maleate) per mL, 2.5 mL
Application to the eye
Duotrav
AQ
MP
C4343
 
1
5
1
 
 

 
 
 
 
 
AO
C4326
 
1
5
1
 
 

[91]         Schedule 1, entry for Venlafaxine in each of the forms: Capsule (modified release) 75 mg (as hydrochloride); and Capsule (modified release) 150 mg (as hydrochloride)
omit:
 
 
 
STADA Venlafaxine‑SR
TD
MP NP
C1211
 
28
5
28
 
 
[92]         Schedule 1, entry for Vildagliptin
omit from the column headed “Circumstances”:           C3540    substitute:             C4350
[93]         Schedule 1, entry for Vildagliptin with metformin in each of the forms: Tablet containing 50 mg vildagliptin with 500 mg metformin hydrochloride; Tablet containing 50 mg vildagliptin with 850 mg metformin hydrochloride; and Tablet containing 50 mg vildagliptin with 1000 mg metformin hydrochloride
omit from the column headed “Circumstances”:           C3543  C3686     substitute:             C4308  C4325
 
[94]         Schedule 1, entry for Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose in the form Sachets containing oral powder 100 g, 10 (RenaStart)
omit from the column headed “Circumstances”:           C1596    substitute:             C4322
[95]         Schedule 1, after entry for Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose in the form Sachets containing oral powder 100 g, 10 (RenaStart)
insert in the columns in the order indicated:
 
Oral powder 400 g, 6 (Renastart)
Oral
Renastart
VF
MP NP
C4322
 
4
5
1
 
 
[96]         Schedule 1, entry for Ziprasidone in each of the forms: Capsule 20 mg (as hydrochloride); Capsule 40 mg (as hydrochloride);
Capsule 60 mg (as hydrochloride); and Capsule 80 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Ziprasidone
TX
MP NP
C1589 C3084
 
60
5
60
 
 
[97]         Schedule 3
omit:
TD
STADA Pharmaceuticals Australia Pty Limited
 73 154 966 944
[98]         Schedule 4, Part 1, after entry for Alendronic acid with colecalciferol and calcium
insert:
Alogliptin
C4349
 
 
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, 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 despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, a HbA1c measurement greater than 7% 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 dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (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
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with alogliptin
Compliance with Authority Required procedures - Streamlined Authority Code 4349

 
[99]         Schedule 4, Part 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides
insert in numerical order following existing text:

 
C4305
 
 
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
The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures


 
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
The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures


 
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
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
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
Compliance with Authority Required procedures


 
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
The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures


 

 
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
The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures


 
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
The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures


 
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
The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures


 
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
Compliance with Authority Required procedures


[100]       Schedule 4, Part 1, after entry for Atorvastatin
insert:

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


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


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


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


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


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

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


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


 
C4353
 
 
Hypercholesterolaemia
Patient must be eligible for PBS-subsidised lipid-lowering medication (according to the criteria set out in the General Statement for Lipid-Lowering Drugs);
Patient must have developed a clinically important product-related adverse event during treatment with an HMG CoA reductase inhibitor (statin) necessitating a reduction in the atorvastatin dose
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin
Compliance with Authority Required procedures - Streamlined Authority Code 4353


[101]       Schedule 4, Part 1, entry for Bimatoprost with timolol
substitute:

Bimatoprost with timolol
C4326
 
 
Elevated intra-ocular pressure
The condition must have been inadequately controlled with monotherapy;
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension
 

 
C4343
 
 
Elevated intra-ocular pressure
The condition must have been inadequately controlled with monotherapy;
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension
 

[102]       Schedule 4, Part 1, entry for Brimonidine with Timolol
substitute:

Brimonidine with timolol
C4326
 
 
Elevated intra-ocular pressure
The condition must have been inadequately controlled with monotherapy;
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension
 

 
C4343
 
 
Elevated intra-ocular pressure
The condition must have been inadequately controlled with monotherapy;
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension
 

[103]       Schedule 4, Part 1, entry for Brinzolamide with timolol
substitute:

Brinzolamide with timolol
C4326
 
 
Elevated intra-ocular pressure
The condition must have been inadequately controlled with monotherapy;
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension
 

 
C4343
 
 
Elevated intra-ocular pressure
The condition must have been inadequately controlled with monotherapy;
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension
 

[104]       Schedule 4, Part 1, entry for Budesonide with Eformoterol
insert in numerical order following existing text:

 
C4318
 
 
Asthma
Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids and have been stabilised on concomitant inhaled eformoterol fumarate and budesonide; 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
 

 
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
 

 
C4333
 
 
Asthma
Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids and have been stabilised on concomitant inhaled eformoterol fumarate and budesonide
 

[105]       Schedule 4, Part 1, after entry for Calcium
insert:
Canagliflozin
C4321
 
 
Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea;
The condition must not be able to be adequately controlled by treatment with 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; 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
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
Compliance with Authority Required procedures

[106]       Schedule 4, Part 1, after entry for Dabigatran etexilate
insert:

Dabrafenib
C4317
P4317
 
Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
The treatment must be the sole PBS-subsidised therapy for this condition;
The condition must be positive for a BRAF V600 mutation;
The condition must not have been treated previously with PBS subsidised therapy; OR
Patient must have developed intolerance to another BRAF inhibitor of a severity necessitating permanent treatment withdrawal,
Patient must have a WHO performance status of 2 or less
Compliance with Authority Required procedures


 
C4340
P4340
 
Unresectable Stage III or Stage IV malignant melanoma
Continuing treatment
The treatment must be the sole PBS-subsidised therapy for this condition;
Patient must have previously been issued with an authority prescription for this drug;
Patient must have stable or responding disease
Compliance with Authority Required procedures


[107]       Schedule 4, Part 1, after entry for Dantrolene
insert:
Dapagliflozin
C4331
 
 
Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea;
The condition must not be able to be adequately controlled by treatment with 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; 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
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
Compliance with Authority Required procedures

 
[108]       Schedule 4, Part 1, entry for Darunavir
(a)      omit:

 
C3940
 
 
Where the patient is receiving treatment at/from a Private Hospital
Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 100 mg ritonavir in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance, and who has not demonstrated darunavir resistance associated mutations detected on resistance testing
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity
Compliance with Written or Telephone Authority Required procedures

 
C3941
 
 
Where the patient is receiving treatment at/from a Public Hospital
Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 100 mg ritonavir in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance, and who has not demonstrated darunavir resistance associated mutations detected on resistance testing
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity
Compliance with  Written or Telephone Authority Required procedures - Streamlined Authority Code 3941

(b)      insert in numerical order following existing text:

 
C4313
 
 
Human immunodeficiency virus (HIV) infection
The treatment must be in addition to optimised background therapy;
The treatment must be in combination with other antiretroviral agents;
The treatment must be co-administered with 100 mg ritonavir;
Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen;
Patient must not have demonstrated darunavir resistance associated mutations detected on resistance testing
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4313


 
C4346
 
 
Human immunodeficiency virus (HIV) infection
The treatment must be in addition to optimised background therapy;
The treatment must be in combination with other antiretroviral agents;
The treatment must be co-administered with 100 mg ritonavir;
Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen;
Patient must not have demonstrated darunavir resistance associated mutations detected on resistance testing
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity
Compliance with Written and Telephone Authority Required procedures


[109]       Schedule 4, Part 1, entry for Denosumab
(a)      omit:

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

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

(b)      insert in numerical order following existing text:

 
C4314
 
 
Osteoporosis
Patient must be aged 70 years or older;
Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4314


 
C4347
 
 
Established osteoporosis
Patient must have fracture due to minimal trauma;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Compliance with Authority Required procedures - Streamlined Authority Code 4347


[110]       Schedule 4, Part 1, after entry for Didanosine
insert:

Dimethyl fumarate
C4320
 
 
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; OR
Patient must have been receiving treatment with this drug prior to 1 December 2013;
Patient must be ambulatory (without assistance or support)
Where applicable, the date of the magnetic resonance imaging scan must be provided with the authority application
Compliance with Authority Required procedures


 
C4335
 
 
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;
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
Compliance with Authority Required procedures


 
C4356
 
 
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;
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
Compliance with Authority Required procedures


[111]       Schedule 4, Part 1, entry for Dorzolamide with Timolol
substitute:

Dorzolamide with timolol
C4326
 
 
Elevated intra-ocular pressure
The condition must have been inadequately controlled with monotherapy;
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension
 

 
C4343
 
 
Elevated intra-ocular pressure
The condition must have been inadequately controlled with monotherapy;
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension
 

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

 
C4334
 
 
Tuberous sclerosis complex (TSC)
Continuing treatment
The condition must be subependymal giant cell astrocytomas (SEGAs) associated with TSC; OR
The condition must be visceral tumours associated with TSC;
The treatment must be the sole PBS-subsidised therapy for this condition;
Patient must have previously been treated with PBS-subsidised everolimus for this condition;
Patient must have demonstrated a response to prior treatment
Compliance with Authority Required procedures


 
C4351
 
 
Tuberous sclerosis complex (TSC)
Initial treatment
The condition must be subependymal giant cell astrocytomas (SEGAs) associated with TSC; OR
The condition must be visceral tumours associated with TSC;
The treatment must be the sole PBS-subsidised therapy for this condition;
Patient must not be a candidate for curative surgical resection
Compliance with Authority Required procedures


 
[113]       Schedule 4, Part 1, after entry for Flutamide
insert:
Fluticasone with eformoterol
C4315
 
 
Asthma
Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids
 
[114]       Schedule 4, Part 1, entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate
[Circumstances Code C4253]
omit from the column headed “Circumstances and Purposes”:
KetoCal 3:1 should only be used under strict supervision of a dietician, together with a metabolic physician and/or neurologist
substitute:
KetoCal 3:1 should only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist
[115]       Schedule 4, Part 1, entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate
[Circumstances Code C4289]
omit from the column headed “Circumstances and Purposes”:
KetoCal 4:1 should only be used under strict supervision of a dietician, together with a metabolic physician and/or neurologist
substitute:
KetoCal 4:1 should only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist
[116]       Schedule 4, Part 1, omit entry for Ifosfamide
[117]       Schedule 4, Part 1, entry for Imatinib
(a)      omit:

 
C3847
P3847
 
Resectable gastrointestinal stromal tumour
Adjuvant treatment of a patient at high risk of recurrence following complete resection of primary gastrointestinal stromal tumour (GIST) which has been histologically confirmed by the detection of CD117 on immunohistochemical staining, at a dose not exceeding 400 mg per day for a period of 12 months.
High risk of recurrence is defined as:
Primary GIST greater than 5 cm with a mitotic count of greater than 5/50 high power fields (HPF); or
Primary GIST greater than 10 cm with any mitotic rate; or
Primary GIST with a mitotic count of greater than 10/50 HPF.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Imatinib Mesylate (Glivec) PBS Authority Application for Use in Adjuvant Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following:
(i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and
(ii) a copy of the pathology report must include the size and mitotic rate of the tumour, and the date of tumour resection must be documented, which must not be more than 3 months prior to the date of this application
Compliance with Written Authority Required procedures

 
C3848
P3848
 
Resectable gastrointestinal stromal tumour
Initial treatment of a patient who was receiving adjuvant imatinib mesylate for gastrointestinal stromal tumour (GIST) prior to 1 September 2011 and who meets the PBS eligibility criteria for adjuvant treatment with imatinib mesylate of a patient at high risk of recurrence following complete resection of primary GIST. The patient is eligible to receive sufficient imatinib at a dose of 400 mg per day to complete 12 months of combined PBS-subsidised and non-PBS-subsidised therapy.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Imatinib Mesylate (Glivec) PBS Authority Application for Use in Adjuvant Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following:
(i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and
(ii) a copy of the pathology report must include the size and mitotic rate of the tumour, and the date of tumour resection must be documented
Compliance with Written Authority Required procedures

(b)      insert in numerical order following existing text:

 
C4342
P4342
 
Gastrointestinal stromal tumour
Continuing treatment
The treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST);
Patient must be at high risk of recurrence following complete surgical resection of primary GIST;
The treatment must not exceed a dose of 400 mg per day for a period of 36 months in total (initial plus continuing therapy);
Patient must have previously been issued with an authority prescription for imatinib for adjuvant treatment following complete resection of primary GIST
Applications for continuing therapy may be made by telephone
Compliance with Written or Telephone Authority Required procedures


 
C4355
P4355
 
Gastrointestinal stromal tumour
Initial treatment
The treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST);
Patient must be at high risk of recurrence following complete surgical resection of primary GIST;
The condition must be histologically confirmed by the detection of CD117 on immunohistochemical staining;
The treatment must not exceed a dose of 400 mg per day for a period of 36 months in total (initial plus continuing therapy)
Applications for authorisation of initial treatment must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Imatinib Mesylate (Glivec) PBS Authority Application for Use in Adjuvant Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following:
(i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and
(ii) a copy of the pathology report must include the size and mitotic rate of the tumour, and the date of tumour resection must be documented, which must not be more than 3 months prior to the date of this application
High risk of recurrence is defined as:
Primary GIST greater than 5 cm with a mitotic count of greater than 5/50 high power fields (HPF); or
Primary GIST greater than 10 cm with any mitotic rate; or
Primary GIST with a mitotic count of greater than 10/50 HPF
Compliance with Written Authority Required procedures


[118]       Schedule 4, Part 1, after entry for Insulin Detemir
insert:

Insulin Isophane
C4332
 
 
Diabetes mellitus
Patient must be intolerant to human insulin
Compliance with Authority Required procedures

Insulin Neutral
C4332
 
 
Diabetes mellitus
Patient must be intolerant to human insulin
Compliance with Authority Required procedures

 
[119]       Schedule 4, Part 1, after entry for Itraconazole
insert:
Ivabradine
C4310
 
 
Chronic heart failure
Patient must be symptomatic with NYHA classes II or III;
Patient must be in sinus rhythm;
Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 35%;
Patient must have a resting heart rate at or above 77 bpm at the time ivabradine treatment is initiated;
Patient must receive concomitant optimal standard chronic heart failure treatment, which must include the maximum tolerated dose of a beta-blocker, unless contraindicated or not tolerated
Resting heart rate should be measured by ECG after 5 minutes rest
The ECG result must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures

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

Ivermectin
C4319
P4319
 
Onchocerciasis
Compliance with Authority Required procedures - Streamlined Authority Code 4319

 
C4328
P4328
 
Strongyloidiasis
Compliance with Authority Required procedures - Streamlined Authority Code 4328

[121]       Schedule 4, Part 1, entry for Ketoconazole
omit:

 
C3604
P3604
 
Oral candidiasis in severely immunocompromised persons where topical therapy has failed
Compliance with Authority Required procedures - Streamlined Authority Code 3604

 
C3605
P3605
 
Systemic or deep mycoses where other forms of therapy have failed
Compliance with Authority Required procedures - Streamlined Authority Code 3605

 
C3606
P3606
 
Symptomatic genital candidiasis recurring after treatment of at least 2 episodes with topical therapy
Compliance with Authority Required procedures - Streamlined Authority Code 3606

 
[122]       Schedule 4, Part 1, entry for Latanoprost with Timolol
substitute:

Latanoprost with timolol
C4326
 
 
Elevated intra-ocular pressure
The condition must have been inadequately controlled with monotherapy;
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension
 

 
C4343
 
 
Elevated intra-ocular pressure
The condition must have been inadequately controlled with monotherapy;
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension
 

[123]       Schedule 4, Part 1, entry for Linagliptin
substitute:
Linagliptin
C4350
 
 
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:
(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
Compliance with Authority Required procedures - Streamlined Authority Code 4350

[124]       Schedule 4, Part 1, entry for Milk powder—lactose free formula
insert in numerical order following existing text:

 
C4324
P4324
 
Acute lactose intolerance
Patient must be up to the age of 12 months
The date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures


 
C4336
P4336
 
Chronic lactose intolerance
Patient must be up to the age of 12 months;
The condition must be proven to be lactose intolerance;
Lactose intolerance must have been proven by either:
(a) relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food; or
(b) not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet; or
(c) hydrogen breath test
The date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures


[125]       Schedule 4, Part 1, entry for Nicotine
substitute:

Nicotine
C4307
 
 
Nicotine dependence
The treatment must be the sole PBS-subsidised therapy for this condition;
Patient must have indicated they are ready to cease smoking;
Patient must be entering a comprehensive support and counselling program during the consultation at which this prescription is written;
Patient must not receive more than 12 weeks of PBS-subsidised nicotine replacement therapy per 12-month period
Details of the support and counselling program must be documented in the patient's medical records at the time treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4307


 
C4344
 
 
Nicotine dependence
Patient must be an Aboriginal or a Torres Strait Islander person;
The treatment must be the sole PBS-subsidised therapy for this condition
Compliance with Authority Required procedures - Streamlined Authority Code 4344

 
C4348
 
 
Nicotine dependence
The treatment must be the sole PBS-subsidised therapy for this condition;
Patient must have indicated they are ready to cease smoking;
Patient must have entered a comprehensive support and counselling program;
Patient must not receive more than 12 weeks of PBS-subsidised nicotine replacement therapy per 12-month period
Details of the support and counselling program must be documented in the patient's medical records at the time treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4348


[126]       Schedule 4, Part 1, after entry for Olmesartan with amlodipine
insert:
Olmesartan with amlodipine 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
 
[127]       Schedule 4, Part 1, after entry for Rifampicin
insert:
Rifaximin
C4306
 
 
Prevention of hepatic encephalopathy
Must be treated by a gastroenterologist or hepatologist or in consultation with a gastroenterologist or hepatologist;
The treatment must be in combination with lactulose, if lactulose is tolerated;
Patient must have had prior episodes of hepatic encephalopathy
Compliance with Authority Required procedures

[128]       Schedule 4, Part 1, entry for Saxagliptin
substitute:
Saxagliptin
C4350
 
 
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:
(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
Compliance with Authority Required procedures - Streamlined Authority Code 4350

[129]       Schedule 4, Part 1, entry for Sitagliptin
substitute:
Sitagliptin
C4350
 
 
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:
(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
Compliance with Authority Required procedures - Streamlined Authority Code 4350

[130]       Schedule 4, Part 1, entry for Sitagliptin with metformin
substitute:

Sitagliptin with metformin
C4309
 
 
Diabetes mellitus type 2
Continuing treatment
Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and sitagliptin
Compliance with Authority Required procedures - Streamlined Authority Code 4309

 
C4325
 
 
Diabetes mellitus type 2
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 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
Compliance with Authority Required procedures - Streamlined Authority Code 4325


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

 
C4341
P4341
 
Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)
Continuing treatment
Patient must have previously been issued with an authority prescription for sunitinib;
Patient must not have progressive disease;
The treatment must be as monotherapy
Compliance with Authority Required procedures


 
C4354
P4354
 
Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)
Initial treatment
Patient must be symptomatic (despite somatostatin analogues); OR
Patient must have disease progression;
The treatment must be as monotherapy
Disease progression must be documented in the patient's medical records
Compliance with Authority Required procedures


[132]       Schedule 4, Part 1, after entry for Terbinafine
insert:

Teriflunomide
C4316
 
 
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;
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
Compliance with Authority Required procedures


 
C4329
 
 
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; OR
Patient must have been receiving treatment with this drug prior to 1 December 2013;
Patient must be ambulatory (without assistance or support)
Where applicable, the date of the magnetic resonance imaging scan must be provided with the authority application
Compliance with Authority Required procedures


[133]       Schedule 4, Part 1, entry for Travoprost with Timolol
substitute:

Travoprost with timolol
C4326
 
 
Elevated intra-ocular pressure
The condition must have been inadequately controlled with monotherapy;
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension
 

 
C4343
 
 
Elevated intra-ocular pressure
The condition must have been inadequately controlled with monotherapy;
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension
 

[134]       Schedule 4, Part 1, entry for Vildagliptin
substitute:
Vildagliptin
C4350
 
 
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:
(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
Compliance with Authority Required procedures - Streamlined Authority Code 4350

[135]       Schedule 4, Part 1, entry for Vildagliptin with metformin
substitute:

Vildagliptin with metformin
C4308
 
 
Diabetes mellitus type 2
Continuing treatment
Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and vildagliptin
Compliance with Authority Required procedures - Streamlined Authority Code 4308

 
C4325
 
 
Diabetes mellitus type 2
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 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
Compliance with Authority Required procedures - Streamlined Authority Code 4325


[136]       Schedule 4, Part 1, entry for Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose
substitute:
Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose
C4322
 
 
Chronic renal failure
Patient must be an infant or a young child;
Patient must require treatment with a low protein, low phosphorus and low potassium diet; OR
Patient must require treatment with a low protein and a low phosphorus diet
Compliance with Authority Required procedures