PB 24 of 2011
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011
(No. 4)1
National Health Act 1953
I, FELICITY McNEILL, Acting First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this Instrument under sections 84AF, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 18 March 2011
FELICITY McNEILL
Acting First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing
1 Name of Instrument
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 4).
(2) This Instrument may also be cited as PB 24 of 2011.
2 Commencement
This Instrument commences on 1 April 2011.
3 Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010)
Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).
Schedule 1 Amendments
[1] Schedule 1, entry for Adalimumab
substitute:
Adalimumab
Injection 20 mg in 0.4 mL pre-filled syringe
Injection
Humira
AB
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
PB
Injection 40 mg in 0.8 mL pre-filled syringe
Injection
Humira
AB
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
C
MP
C2986 C2987 C2988 C2989 C2990 C2991 C2992 C2993 C2994 C2995 C3265 C3266 C3267 C3268 C3270 C3272 C3486 C3487 C3488 C3502 C3503 C3504 C3520 C3521 C3522 C3523 C3568 C3569 C3570 C3695 C3696 C3697 C3698
P2986 P2987 P2990 P2991 P2993 P3695 P3696
2
2
MP
C2986 C2987 C2988 C2989 C2990 C2991 C2992 C2993 C2994 C2995 C3265 C3266 C3267 C3268 C3270 C3272 C3486 C3487 C3488 C3502 C3503 C3504 C3520 C3521 C3522 C3523 C3568 C3569 C3570 C3695 C3696 C3697 C3698
P3486 P3487 P3502 P3503 P3520 P3521 P3568 P3569
2
3
MP
C2986 C2987 C2988 C2989 C2990 C2991 C2992 C2993 C2994 C2995 C3265 C3266 C3267 C3268 C3270 C3272 C3486 C3487 C3488 C3502 C3503 C3504 C3520 C3521 C3522 C3523 C3568 C3569 C3570 C3695 C3696 C3697 C3698
P3265 P3266 P3267 P3268
2
4
MP
C2986 C2987 C2988 C2989 C2990 C2991 C2992 C2993 C2994 C2995 C3265 C3266 C3267 C3268 C3270 C3272 C3486 C3487 C3488 C3502 C3503 C3504 C3520 C3521 C3522 C3523 C3568 C3569 C3570 C3695 C3696 C3697 C3698
P2988 P2989 P2992 P2994 P2995 P3270 P3272 P3488 P3504 P3522 P3523 P3570 P3697 P3698
2
5
Injection 40 mg in 0.8 mL pre-filled pen
Injection
Humira
AB
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
C
MP
C2986 C2987 C2988 C2989 C2990 C2991 C2992 C2993 C2994 C2995 C3265 C3266 C3267 C3268 C3270 C3272 C3486 C3487 C3488 C3502 C3503 C3504 C3520 C3521 C3522 C3523 C3568 C3569 C3570 C3695 C3696 C3697 C3698
P2986 P2987 P2990 P2991 P2993 P3695 P3696
2
2
MP
C2986 C2987 C2988 C2989 C2990 C2991 C2992 C2993 C2994 C2995 C3265 C3266 C3267 C3268 C3270 C3272 C3486 C3487 C3488 C3502 C3503 C3504 C3520 C3521 C3522 C3523 C3568 C3569 C3570 C3695 C3696 C3697 C3698
P3486 P3487 P3502 P3503 P3520 P3521 P3568 P3569
2
3
MP
C2986 C2987 C2988 C2989 C2990 C2991 C2992 C2993 C2994 C2995 C3265 C3266 C3267 C3268 C3270 C3272 C3486 C3487 C3488 C3502 C3503 C3504 C3520 C3521 C3522 C3523 C3568 C3569 C3570 C3695 C3696 C3697 C3698
P3265 P3266 P3267 P3268
2
4
MP
C2986 C2987 C2988 C2989 C2990 C2991 C2992 C2993 C2994 C2995 C3265 C3266 C3267 C3268 C3270 C3272 C3486 C3487 C3488 C3502 C3503 C3504 C3520 C3521 C3522 C3523 C3568 C3569 C3570 C3695 C3696 C3697 C3698
P2988 P2989 P2992 P2994 P2995 P3270 P3272 P3488 P3504 P3522 P3523 P3570 P3697 P3698
2
5
Injection 40 mg in 0.8 mL pre-filled syringe, 6
Injection
Humira
AB
MP
C2986 C2987 C2990 C2991 C2993 C3695 C3696
1
0
Injection 40 mg in 0.8 mL pre-filled pen, 6
Injection
Humira
AB
MP
C2986 C2987 C2990 C2991 C2993 C3695 C3696
1
0
[2] Schedule 1, after entry for Adalimumab
insert in the columns in the order indicated:
Adapalene with benzoyl peroxide
Gel 1 mg-25 mg per g, 30 g
Application
Epiduo
GA
MP
C3689 C3690
P3689
1
1
MP
C3689 C3690
P3690
1
3
NP
C3690
1
3
[3] Schedule 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besylate); and Tablet 10 mg (as besylate)
omit:
Perivasc
AL
MP NP
30
5
[4] Schedule 1, entry for Atenolol in the form Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Atenolol generichealth
GQ
MP NP
30
5
[5] Schedule 1, entry for Carmellose
omit from the column headed “Responsible Person” (twice occurring): HA substitute: VT
[6] Schedule 1, entry for Ciprofloxacin in each of the forms: Tablet 250 mg (as hydrochloride); Tablet 500 mg (as hydrochloride); and Tablet 750 mg (as hydrochloride)
omit from the column headed “Circumstances” (all instances):
C3680
[7] Schedule 1, entry for Clindamycin
omit from the column headed “Responsible Person”: KR substitute: FZ
[8] Schedule 1, omit entry for Dydrogesterone
[9] Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; Tablet containing enalapril maleate
10 mg; and Tablet containing enalapril maleate 20 mg
omit:
Alphapril
AF
MP NP
30
5
[10] Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
DBL Epirubicin Hydrochloride Injection
HH
MP
See Note 1
1
0
[11] Schedule 1, entry for Filgrastim
omit from the column headed “Form”:
Injection 300 micrograms in 0.5 mL single use pre-filled syringe
substitute:
Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Neupogen)
[12] Schedule 1, after entry for Filgrastim in the form Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Neupogen)
insert in the columns in the order indicated:
Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Nivestim)
Injection
Nivestim
HH
MP
See Note 1
C2912 C2913 C2914 C2915 C2916 C2917 C2918 C2919 C2920 C2921 C2922 C2923 C2924 C2925 C2926 C2927 C2928 C2929 C2930 C3087 C3187 C3357 C3358 C3359 C3360 C3361 C3362 C3363 C3364 C3365 C3366 C3367 C3368 C3369 C3370 C3371 C3372 C3373 C3374 C3375 C3376 C3377
20
11
D
[13] Schedule 1, entry for Filgrastim
omit from the column headed “Form”:
Injection 480 micrograms in 0.5 mL single use pre-filled syringe
substitute:
Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Neupogen)
[14] Schedule 1, after entry for Filgrastim in the form Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Neupogen)
insert in the columns in the order indicated:
Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Nivestim)
Injection
Nivestim
HH
MP
See Note 1
C2912 C2913 C2914 C2915 C2916 C2917 C2918 C2919 C2920 C2921 C2922 C2923 C2924 C2925 C2926 C2927 C2928 C2929 C2930 C3087 C3187 C3357 C3358 C3359 C3360 C3361 C3362 C3363 C3364 C3365 C3366 C3367 C3368 C3369 C3370 C3371 C3372 C3373 C3374 C3375 C3376 C3377
20
11
D
[15] Schedule 1, entry for Flupenthixol Decanoate
omit:
Oily I.M. injection 20 mg in 1 mL ampoule
Injection
Fluanxol Depot
LU
MP NP
5
0
Oily I.M. injection 40 mg in 2 mL ampoule
Injection
Fluanxol Depot
LU
MP NP
5
0
[16] Schedule 1, entry for Gabapentin in the form Capsule 300 mg
omit from the column headed “Responsible Person”: AW substitute: GN
[17] Schedule 1, entry for Gabapentin in the form Capsule 400 mg
(a) omit:
Douglas Gabapentin 400 mg
GN
MP NP
C2664
100
5
(b) omit from the column headed “Responsible Person”: AW substitute: GN
[18] Schedule 1, entry for Gabapentin in the form Tablet 600 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pharmacor Gabapentin 600
CR
MP NP
C2664
100
5
[19] Schedule 1, entry for Gabapentin in the form Tablet 800 mg
(a) omit from the column headed “Responsible Person”: AW substitute: GN
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pharmacor Gabapentin 800
CR
MP NP
C2664
100
5
[20] Schedule 1, entry for Glucose Indicator—Blood
omit:
Test strips, 50 (Glucostix)
For external use
Glucostix
BN
MP NP
2
5
MP
P3035
2
11
[21] Schedule 1, entry for Hydrocortisone in the form Cream containing hydrocortisone acetate 10 mg per g, 50 g
(a) omit:
Cortef
VT
PDP
C1422
1
0
(b) omit:
Cortef
VT
MP NP
C1422
1
1
[22] Schedule 1, entry for Idarubicin
omit:
Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL single use vial
Injection
Zavedos Solution
PF
MP
See Note 1
C1006
3
0
Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL single use vial
Injection
Zavedos Solution
PF
MP
See Note 1
C1006
6
0
substitute:
Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL
Injection
Idarubicin Ebewe
IT
MP
See Note 1
C1006
3
0
Zavedos Solution
PF
MP
See Note 1
C1006
3
0
Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL
Injection
Idarubicin Ebewe
IT
MP
See Note 1
C1006
6
0
Zavedos Solution
PF
MP
See Note 1
C1006
6
0
[23] Schedule 1, entry for Insulin Isophane
omit:
Protaphane NovoLet
3 mL
NL
MP NP
5
1
[24] Schedule 1, entry for Isotretinoin in the form Capsule 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Rocta 10
SI
MP
C1354
60
3
[25] Schedule 1, entry for Isotretinoin in the form Capsule 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Rocta 20
SI
MP
C1354
60
3
[26] Schedule 1, entry for Medroxyprogesterone in each of the forms: Tablet containing medroxyprogesterone acetate 5 mg; Tablet containing medroxyprogesterone acetate 10 mg; and Injection containing medroxyprogesterone acetate 150 mg in 1 mL
omit from the column headed “Responsible Person” (all instances): KR substitute: FZ
[27] Schedule 1, entry for Methylprednisolone in the form Injection containing methylprednisolone acetate 40 mg in 1 mL
omit from the column headed “Responsible Person”: KR substitute: FZ
[28] Schedule 1, entry for Moclobemide
omit from the column headed “Responsible Person” (twice occurring): RO substitute: VP
[29] Schedule 1, entry for Norethisterone in the form Tablets 350 micrograms, 28
omit from the column headed “Responsible Person”: KR substitute: FZ
[30] Schedule 1, entry for Norethisterone with Ethinyloestradiol
(a) omit from the column headed “Responsible Person” (all instances): KR substitute: FZ
(b) omit:
Tablets 500 micrograms-35 micrograms, 21
Oral
Brevinor
PF
MP NP
4
2
(c) omit:
Tablets 1 mg-35 micrograms, 21
Oral
Brevinor-1
PF
MP NP
4
2
[31] Schedule 1, entry for Norfloxacin in the form Tablet 400 mg (Norflohexal)
omit from the column headed “Responsible Person”: SZ substitute: HX
[32] Schedule 1, entry for Norfloxacin in the form Tablet 400 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Norfloxacin Sandoz
SZ
MP NP
C1002 C1070
14
1
[33] Schedule 1, after entry for Olanzapine in the form Wafer 10 mg
insert in the columns in the order indicated:
Wafer 15 mg
Oral
Zyprexa Zydis
LY
MP NP
C1589 C2044
28
5
Wafer 20 mg
Oral
Zyprexa Zydis
LY
MP NP
C1589 C2044
28
5
[34] Schedule 1, entry for Oxycodone in each of the forms: Tablet containing oxycodone hydrochloride 5 mg (controlled release); Tablet containing oxycodone hydrochloride 10 mg (controlled release); Tablet containing oxycodone hydrochloride 15 mg (controlled release); Tablet containing oxycodone hydrochloride 20 mg (controlled release); Tablet containing oxycodone hydrochloride 30 mg (controlled release); Tablet containing oxycodone hydrochloride 40 mg (controlled release); and Tablet containing oxycodone hydrochloride 80 mg (controlled release)
omit from the column headed “Max Quantity”: 20 substitute: 28
[35] Schedule 1, entry for Pancreatic Extract
omit:
Capsule (containing enteric coated minimicrospheres) providing not less than 5,000 BP units of lipase activity
Oral
Creon 5000
SM
MP NP
500
10
MP
P3046
500
21
[36] Schedule 1, entry for Pioglitazone
substitute:
Pioglitazone
Tablet 15 mg (as hydrochloride)
Oral
Acpio 15
SI
MP NP
C3540 C3541 C3542
28
5
Actos
LY
MP NP
C3540 C3541 C3542
28
5
APOTEX-Pioglitazone
TX
MP NP
C3540 C3541 C3542
28
5
Chem mart Pioglitazone
CH
MP NP
C3540 C3541 C3542
28
5
Pharmacor Pioglitazone 15
CR
MP NP
C3540 C3541 C3542
28
5
Pioglitazone generichealth 15
GQ
MP NP
C3540 C3541 C3542
28
5
Pizaccord
MI
MP NP
C3540 C3541 C3542
28
5
Terry White Chemists Pioglitazone
TW
MP NP
C3540 C3541 C3542
28
5
Tablet 30 mg (as hydrochloride)
Oral
Acpio 30
SI
MP NP
C3540 C3541 C3542
28
5
Actos
LY
MP NP
C3540 C3541 C3542
28
5
APOTEX-Pioglitazone
TX
MP NP
C3540 C3541 C3542
28
5
Chem mart Pioglitazone
CH
MP NP
C3540 C3541 C3542
28
5
Pharmacor Pioglitazone 30
CR
MP NP
C3540 C3541 C3542
28
5
Pioglitazone generichealth 30
GQ
MP NP
C3540 C3541 C3542
28
5
Pizaccord
MI
MP NP
C3540 C3541 C3542
28
5
Terry White Chemists Pioglitazone
TW
MP NP
C3540 C3541 C3542
28
5
Tablet 45 mg (as hydrochloride)
Oral
Acpio 45
SI
MP NP
C3540 C3541 C3542
28
5
Actos
LY
MP NP
C3540 C3541 C3542
28
5
APOTEX-Pioglitazone
TX
MP NP
C3540 C3541 C3542
28
5
Chem mart Pioglitazone
CH
MP NP
C3540 C3541 C3542
28
5
Pharmacor Pioglitazone 45
CR
MP NP
C3540 C3541 C3542
28
5
Pioglitazone generichealth 45
GQ
MP NP
C3540 C3541 C3542
28
5
Pizaccord
MI
MP NP
C3540 C3541 C3542
28
5
Terry White Chemists Pioglitazone
TW
MP NP
C3540 C3541 C3542
28
5
[37] Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 35 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Risedronate
TX
MP NP
C2645 C2646 C3070
4
5
Chem mart Risedronate
CH
MP NP
C2645 C2646 C3070
4
5
Terry White Chemists Risedronate
TW
MP NP
C2645 C2646 C3070
4
5
[38] Schedule 1, after entry for Rizatriptan
insert in the columns in the order indicated:
Romiplostin
Powder for injection 375 micrograms
Injection
Nplate
AN
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D
Powder for injection 625 micrograms
Injection
Nplate
AN
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D
[39] Schedule 1, entry for Sertraline in each of the forms: Tablet 50 mg (as hydrochloride); and Tablet 100 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Sertraline-DRLA
RZ
MP NP
C1211
30
5
[40] Schedule 1, omit entry for Sitaxentan
[41] Schedule 1, entry for Sulfasalazine in the form Tablet 500 mg (enteric coated)
omit from the column headed “Responsible Person” (twice occurring): KR substitute: FZ
[42] Schedule 1, entry for Tinidazole
omit from the column headed “Responsible Person”: GP substitute: FZ
[43] Schedule 1, entry for Valaciclovir
substitute:
Valaciclovir
Tablet 500 mg (as hydrochloride)
Oral
APO-Valaciclovir
TX
MP NP
C3622 C3623 C3624 C3631 C3632
P3632
20
0
Chem mart Valaciclovir
CH
MP NP
C3622 C3623 C3624 C3631 C3632
P3632
20
0
Terry White Chemists Valaciclovir
TW
MP NP
C3622 C3623 C3624 C3631 C3632
P3632
20
0
Vaclovir
AF
MP NP
C3622 C3623 C3624 C3631 C3632
P3632
20
0
Valaciclovir GA
GM
MP NP
C3622 C3623 C3624 C3631 C3632
P3632
20
0
Valaciclovir Sandoz
SZ
MP NP
C3622 C3624 C3631 C3632
P3632
20
0
Valnir
SI
MP NP
C3622 C3623 C3624 C3631 C3632
P3632
20
0
Valtrex
GK
MP NP
C3622 C3623 C3624 C3631 C3632
P3632
20
0
Zelitrex
RE
MP NP
C3622 C3623 C3624 C3631 C3632
P3632
20
0
APO-Valaciclovir
TX
MP NP
C3622 C3623 C3624 C3631 C3632
P3623 P3624
30
5
Chem mart Valaciclovir
CH
MP NP
C3622 C3623 C3624 C3631 C3632
P3623 P3624
30
5
Terry White Chemists Valaciclovir
TW
MP NP
C3622 C3623 C3624 C3631 C3632
P3623 P3624
30
5
Vaclovir
AF
MP NP
C3622 C3623 C3624 C3631 C3632
P3623 P3624
30
5
Valaciclovir GA
GM
MP NP
C3622 C3623 C3624 C3631 C3632
P3623 P3624
30
5
Valaciclovir RBX
RA
MP NP
C3622 C3623 C3624 C3631
P3623 P3624
30
5
Valaciclovir Sandoz
SZ
MP NP
C3622 C3624 C3631 C3632
P3624
30
5
Valaciclovir SZ
HX
MP NP
C3623 C3624
P3623 P3624
30
5
Valnir
SI
MP NP
C3622 C3623 C3624 C3631 C3632
P3623 P3624
30
5
Valtrex
GK
MP NP
C3622 C3623 C3624 C3631 C3632
P3623 P3624
30
5
Zelitrex
RE
MP NP
C3622 C3623 C3624 C3631 C3632
P3623 P3624
30
5
APO-Valaciclovir
TX
MP NP
C3622 C3623 C3624 C3631 C3632
P3622 P3631
42
0
Chem mart Valaciclovir
CH
MP NP
C3622 C3623 C3624 C3631 C3632
P3622 P3631
42
0
Terry White Chemists Valaciclovir
TW
MP NP
C3622 C3623 C3624 C3631 C3632
P3622 P3631
42
0
Vaclovir
AF
MP NP
C3622 C3623 C3624 C3631 C3632
P3622 P3631
42
0
Valaciclovir GA
GM
MP NP
C3622 C3623 C3624 C3631 C3632
P3622 P3631
42
0
Valaciclovir RBX
RA
MP NP
C3622 C3623 C3624 C3631
P3622 P3631
42
0
Valaciclovir Sandoz
SZ
MP NP
C3622 C3624 C3631 C3632
P3622 P3631
42
0
Valnir
SI
MP NP
C3622 C3623 C3624 C3631 C3632
P3622 P3631
42
0
Valtrex
GK
MP NP
C3622 C3623 C3624 C3631 C3632
P3622 P3631
42
0
Zelitrex
RE
MP NP
C3622 C3623 C3624 C3631 C3632
P3622 P3631
42
0
APO-Valaciclovir
TX
MP
See Note 1
C1494 C3419
500
2
C
Valtrex
GK
MP
See Note 1
C1494 C3419
500
2
C
[44] Schedule 1, after entry for Vildagliptin
insert in the columns in the order indicated:
Vildagliptin with metformin
Tablet containing 50 mg vildagliptin with 500 mg metformin hydrochloride
Oral
Galvumet 50/500
NV
MP NP
C3543 C3686
60
5
Tablet containing 50 mg vildagliptin with 850 mg metformin hydrochloride
Oral
Galvumet 50/850
NV
MP NP
C3543 C3686
60
5
Tablet containing 50 mg vildagliptin with 1000 mg metformin hydrochloride
Oral
Galvumet 50/1000
NV
MP NP
C3543 C3686
60
5
[45] Schedule 1, after entry for Zolmitriptan
insert in the columns in the order indicated:
Zonisamide
Capsule 25 mg
Oral
Zonegran
SA
MP
C2664
56
5
Capsule 50 mg
Oral
Zonegran
SA
MP
C2664
56
5
Capsule 100 mg
Oral
Zonegran
SA
MP
C2664
112
5
[46] Schedule 1, omit entry for Zuclopenthixol Decanoate
[47] Schedule 3, after details relevant to Responsible person code FR
insert:
FZ
Pfizer Australia Pty Ltd
50 008 422 348
[48] Schedule 3
omit:
GP
Pfizer Australia Pty Ltd
50 008 422 348
[49] Schedule 3
omit:
KR
Pfizer Australia Pty Ltd
50 008 422 348
[50] Schedule 3
omit:
NL
Novo Nordisk Pharmaceuticals Pty Limited
40 002 879 996
[51] Schedule 3, after details relevant to Responsible person code RZ
insert:
SA
SciGen (Australia) Pty Limited
76 055 016 969
[52] Schedule 3, after details relevant to Responsible person code VI
insert:
VP
Meda Valeant Pharma Australia Pty Ltd
[53] Schedule 4, Part 1, entry for Adalimumab
insert after existing text in the columns in the order indicated:
C3695
P3695
Fistulising Crohn disease — initial treatment 1
Initial treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with complex refractory fistulising Crohn disease who:
(a) has confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and
(b) has an externally draining enterocutaneous or rectovaginal fistula; and
(c) has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) a signed patient acknowledgement;
the most recent fistula assessment is no more than 1 month old at the time of application;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatment
Compliance with Written Authority Required procedures
Continuation of initial treatment in a treatment cycle, by a gastroenterologist or a consultant physician as specified above, of a patient with complex refractory fistulising Crohn disease who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures
C3696
P3696
Fistulising Crohn disease — initial treatment 2
(change or recommencement of PBS-subsidised treatment)
Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology or a consultant physician in general medicine specialising in gastroenterology, of a patient with complex refractory fistulising Crohn disease who:
(a) has a documented history of complex refractory fistulising Crohn disease; and
(b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or infliximab for a draining enterocutaneous or rectovaginal fistula; and
(c) has not failed PBS-subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where TNF-alfa antagonist means adalimumab or infliximab; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) details of prior TNF-alfa antagonist treatment including details of date and duration of treatment;
the most recent fistula assessment is no more than 1 month old at the time of application;
to demonstrate a response to treatment the application must be accompanied by the results of the patient's most recent course of TNF-alfa antagonist therapy;
the assessment of response to the most recent course of TNF-alfa antagonist therapy must:
(a) be provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and
(b) have been made following a minimum of 12 weeks of treatment if the course of therapy was a 16-week initial course of adalimumab, and up to 12 weeks after the first dose (6 weeks following the third dose) if the course of therapy was a 3 dose initial course of infliximab;
if the response assessment to the previous course of TNF-alfa antagonist treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of TNF-alfa antagonist;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment;
the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatment
Compliance with Written Authority Required procedures
Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a gastroenterologist or a consultant physician as specified above, of a patient who has a documented history of complex refractory fistulising Crohn disease, and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment or recommencement of treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures
C3697
P3697
Fistulising Crohn disease — initial treatment 3
(previous adalimumab treatment non-PBS-subsidised)
Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology, or other consultant physician in consultation with a gastroenterologist, of a patient who satisfies the following criteria:
(a) has a documented history of complex refractory fistulising Crohn disease and was receiving treatment with adalimumab prior to 4 November 2010; and
(b) had a draining enterocutaneous or rectovaginal fistula(e) prior to commencing treatment with adalimumab; and
(c) has signed a patient acknowledgement indicating that they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criteria for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(d) is receiving treatment with adalimumab at the time of application; and
(e) has demonstrated or sustained an adequate response to treatment with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to adalimumab treatment is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient;
the application for authorisation is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current and baseline Fistula Assessment form including the date of assessment of the patient's condition; and
(ii) a signed patient acknowledgement;
the current fistula assessment is no more than 1 month old at the time of application;
the baseline fistula assessment is from immediately prior to commencing treatment with adalimumab;
the course of treatment is limited to a maximum of 24 weeks of treatment;
a patient is eligible for PBS-subsidised treatment under this restriction once only
Compliance with Written Authority Required procedures
Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of complex refractory fistulising Crohn disease and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures
C3698
P3698
Fistulising Crohn disease — continuing treatment
Continuing PBS-subsidised treatment with adalimumab within an ongoing treatment cycle, by a gastroenterologist, a consultant physician in internal medicine specialising in gastroenterology, a consultant physician in general medicine specialising in gastroenterology, or other consultant physician in consultation with a gastroenterologist, of a patient who:
(a) has a documented history of complex refractory fistulising Crohn disease; and
(b) has demonstrated or sustained an adequate response to treatment with adalimumab; and
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for fistulising Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient;
the authority application is made in writing and includes a completed copy of the appropriate Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition;
the fistula assessment is no more than 1 month old at the time of application;
the assessment of the patient's response to a course of treatment is provided to the Medicare Australia CEO no later than 4 weeks from the date of completion of the course, and, if the course of treatment is a 16-week initial course, the assessment is made following a minimum of 12 weeks of therapy;
where an assessment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with adalimumab;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment;
patients are eligible to receive continuing adalimumab treatment in courses of up to 24 weeks providing they continue to sustain the response
Compliance with Written Authority Required procedures
Continuing treatment within an ongoing treatment cycle, by a gastroenterologist, a consultant physician as specified above, or other consultant physician in consultation with a gastroenterologist, of a patient who has a documented history of complex refractory fistulising Crohn disease and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures
[54] Schedule 4, Part 1, after entry for Adalimumab
insert in the columns in the order indicated:
Adapalene with benzoyl peroxide
C3689
P3689
Acute treatment, in combination with an oral antibiotic, of severe acne vulgaris.
C3690
P3690
Maintenance treatment of severe acne vulgaris.
[55] Schedule 4, Part 1, entry for Ciprofloxacin
omit:
C3680
For use in skin or soft tissue infections (wound management) where other antimicrobial agents are ineffective or inappropriate.
Compliance with Authority Required procedures
[56] Schedule 4, Part 1, entry for Valaciclovir
substitute:
Valaciclovir
C1494
Where the patient is receiving treatment at/from a private hospital
Prophylaxis of cytomegalovirus infection and disease following renal transplantation in patients at risk of cytomegalovirus disease
Compliance with Written or Telephone Authority Required procedures
C3419
Where the patient is receiving treatment at/from a public hospital
Prophylaxis of cytomegalovirus infection and disease following renal transplantation in patients at risk of cytomegalovirus disease
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3419
C3622
P3622
Treatment of patients with herpes zoster within 72 hours of the onset of the rash
Compliance with Authority Required procedures - Streamlined Authority Code 3622
C3623
P3623
Suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis
Compliance with Authority Required procedures - Streamlined Authority Code 3623
C3624
P3624
Episodic treatment of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis
Compliance with Authority Required procedures - Streamlined Authority Code 3624
C3631
P3631
Herpes zoster ophthalmicus
Compliance with Authority Required procedures - Streamlined Authority Code 3631
C3632
P3632
Moderate to severe initial genital herpes
Compliance with Authority Required procedures - Streamlined Authority Code 3632
[57] Schedule 4, Part 1, after entry for Vildagliptin
insert in the columns in the order indicated:
Vildagliptin with metformin
C3543
Treatment of type 2 diabetes in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and:
(a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 is greater than 7%, despite treatment with metformin; or
(b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a gliptin, a glitazone or a glucagon-like peptide-1 shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with metformin; and
where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and
where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 3543
C3686
Continuation of therapy in type 2 diabetes mellitus in a patient who has 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 3686
[58] Schedule 4, Part 1, after entry for Zolmitriptan
insert in the columns in the order indicated:
Zonisamide
C2664
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs
Compliance with Authority Required procedures - Streamlined Authority Code 2664
1Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.
See http://www.frli.gov.au.
