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