PB 1 of 2011
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011
(No. 2)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 20 January 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. 2).
(2) This Instrument may also be cited as PB 1 of 2011.
2 Commencement
This Instrument commences on 1 February 2011.
3 Amendment of PB 108 of 2010
Schedule 1 amends PB 108 of 2010.
Schedule 1 Amendments
[1] Schedule 1, entry for Alprazolam in each of the forms: Tablet 1 mg (Alprazolam-GA); and Tablet 2 mg (Alprazolam-GA)
omit from the column headed “Responsible Person”: GM and insert: GN
[2] Schedule 1, entry for Alprazolam in each of the forms: Tablet 1 mg; and Tablet 2 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Ralozam
GM
MP NP
C1975
50
2
[3] Schedule 1, after entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids
insert in the columns in the order indicated:
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides
Oral powder 400 g (Neocate LCP + MCT)
Oral
Neocate LCP + MCT
SB
MP NP
C1687 C1688 C2805 C2806 C2807 C2808 C2809 C2810
8
5
[4] Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride 50 mg in 5 mL
omit from the column headed “Brand”: APO-go and insert: Apomine
[5] Schedule 1, entry for Aspirin in the form Tablet 100 mg (DBL Aspirin 100 mg)
omit from the column headed “Responsible Person”: YT and insert: GY
[6] Schedule 1, entry for Aspirin in the form Tablet 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Mayne Pharma Aspirin
YT
MP NP
112
1
[7] Schedule 1, after entry for Aurothiomalate
insert in the columns in the order indicated:
Azacitidine
Powder for injection 100 mg
Injection
Vidaza
CJ
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D
[8] Schedule 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate)
(a) insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “Zithromax”:
Zitrocin
GM
MP NP
C1405 C1838 C1839
P1838 P1839
2
0
(b) insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “Zithromax”:
Zitrocin
GM
MP NP
C1405 C1838 C1839
P1405
2
2
[9] Schedule 1, entry for Bethanechol
omit from the column headed “Responsible Person”: HA and insert: YN
[10] Schedule 1, entry for Cabergoline
omit:
Tablet 500 micrograms
Oral
Dostinex
PF
NP
C1289
2
0
MP
C1289 C2659 C2660 C2661 C2662
P1289
2
0
MP
C1289 C2659 C2660 C2661 C2662
P2659 P2660 P2661 P2662
8
5
Tinexa
SI
MP
C2659 C2660 C2661 C2662
P2659 P2660 P2661 P2662
8
5
substitute:
Tablet 500 micrograms
Oral
Dostan
GM
NP
C1289
2
0
MP
C1289 C2659 C2660 C2661 C2662
P1289
2
0
Dostinex
PF
NP
C1289
2
0
MP
C1289 C2659 C2660 C2661 C2662
P1289
2
0
Dostan
GM
MP
C1289 C2659 C2660 C2661 C2662
P2659 P2660 P2661 P2662
8
5
Dostinex
PF
MP
C1289 C2659 C2660 C2661 C2662
P2659 P2660 P2661 P2662
8
5
Tinexa
SI
MP
C2659 C2660 C2661 C2662
P2659 P2660 P2661 P2662
8
5
[11] Schedule 1, entry for Cabergoline in each of the forms: Tablet 1 mg; and Tablet 2 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Cobasol
GM
MP NP
C1255
30
5
[12] Schedule 1, entry for Cefepime in each of the forms: Powder for injection 1 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent); and Powder for injection 2 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
DBL Cefepime
HH
MP NP
C1427
10
0
[13] Schedule 1, entry for Doxorubicin ─ Pegylated Liposomal
omit from the column headed “Responsible Person”: SH and insert: JC (twice occurring)
[14] Schedule 1, after entry for Duloxetine
insert in the columns in the order indicated:
Dutasteride
Capsule 500 micrograms
Oral
Avodart
GK
MP
C3667
30
5
[15] 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
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Acetec
AL
MP NP
30
5
(b) omit:
Enahexal
HX
MP NP
30
5
[16] Schedule 1, entry for Famotidine
omit:
Famohexal
HX
MP NP
60
5
[17] Schedule 1, entry for Fluconazole in the form Solution for I.V. infusion 100 mg in 50 mL (Fluconazole Hexal)
omit from the column headed “Responsible Person”: SZ and insert: HX
[18] Schedule 1, entry for Fluconazole in the form Solution for I.V. infusion 100 mg in 50 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Fluconazole Sandoz
SZ
MP NP
C3613 C3614
C3615 C3616
C3617 C3618
7
0
[19] Schedule 1, entry for Fluvoxamine in each of the forms: Tablet containing fluvoxamine maleate 50 mg; and Tablet containing fluvoxamine maleate 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Fluvoxamine GA
GM
MP NP
C1211 C1241
30
5
[20] Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Gemplan
WQ
MP
See Note 1
C1193 C1194 C1740 C2069 C2141
4
2
[21] Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Gemplan
WQ
MP
See Note 1
C1193 C1194 C1740 C2069 C2141
2
2
[22] Schedule 1, entry for Hydrocortisone
omit:
Eye ointment containing hydrocortisone acetate 5 mg per g, 5 g
Application to the eye
Hycor
SI
AO MP NP
1
0
[23] Schedule 1, entry for Lercanidipine in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg; and Tablet containing lercanidipine hydrochloride 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Lercadip
GM
MP NP
28
5
[24] Schedule 1, entry for Lisinopril in the form Tablet 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Lisinopril Sandoz
SZ
MP NP
30
5
[25] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Metformin 1000
TX
MP NP
90
5
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Chem mart Metformin 1000
CH
MP NP
90
5
(c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Terry White Chemists Metformin 1000
TW
MP NP
90
5
[26] Schedule 1, entry for Nicotine
substitute:
Nicotine
Transdermal patch 24.9 mg
Transdermal
Nicorette Patch
JT
MP NP
C3042 C3447 C3448
28
2
Transdermal patch 52.5 mg
Transdermal
Nicotinell Step 1
NC
MP NP
C3447 C3448
28
2
Transdermal patch 114 mg
Transdermal
Nicabate P
GC
MP NP
C3447 C3448
28
2
[27] Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)
(a) insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “APO-Ondansetron”:
Ondansetron-DRLA
RZ
MP NP
See Note 1
C3050 C3611
See Note 2
P3050
See Note 2
4
See Note 2
0
See Note 2
(b) insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “APO-Ondansetron”:
Ondansetron-DRLA
RZ
MP NP
C3050 C3611
P3611
10
1
[28] Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate)
(a) insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “APO-Ondansetron”:
Ondansetron-DRLA
RZ
MP NP
See Note 1
C3050 C3611
See Note 2
P3050
See Note 2
4
See Note 2
0
See Note 2
(b) insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “APO-Ondansetron”:
Ondansetron-DRLA
RZ
MP NP
C3050 C3611
P3611
10
1
[29] Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besylate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Reaptan 5/5
RX
MP NP
C3307 C3308
30
5
[30] Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besylate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Reaptan 5/10
RX
MP NP
C3307 C3308
30
5
[31] Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besylate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Reaptan 10/5
RX
MP NP
C3307 C3308
30
5
[32] Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besylate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Reaptan 10/10
RX
MP NP
C3307 C3308
30
5
[33] Schedule 1, entry for Risperidone in the form Tablet 0.5 mg
(a) insert in the columns in the order indicated, and in alphabetical after the first instance of the brand “Risperidone-GA”:
Risperidone Sandoz
SZ
MP NP
C1589 C2061 C3083
P2061 P3083
60
2
(b) insert in the columns in the order indicated, and in alphabetical after the second instance of the brand “Risperidone-GA”:
Risperidone Sandoz
SZ
MP NP
C1589 C2061 C3083
P1589
60
5
[34] Schedule 1, entry for Risperidone in the form Tablet 1 mg
(a) insert in the columns in the order indicated, and in alphabetical after the first instance of the brand “Risperidone generichealth”:
Risperidone Sandoz
SZ
MP NP
C1589 C2061 C2272 C3083
P2061 P3083
60
2
(b) insert in the columns in the order indicated, and in alphabetical after the second instance of the brand “Risperidone generichealth”:
Risperidone Sandoz
SZ
MP NP
C1589 C2061 C2272 C3083
P1589 P2272
60
5
[35] Schedule 1, entry for Risperidone in the form Tablet 2 mg
(a) insert in the columns in the order indicated, and in alphabetical after the first instance of the brand “Risperidone generichealth”:
Risperidone Sandoz
SZ
MP NP
C1589 C2272 C3083
P3083
60
2
(b) insert in the columns in the order indicated, and in alphabetical after the second instance of the brand “Risperidone generichealth”:
Risperidone Sandoz
SZ
MP NP
C1589 C2272 C3083
P1589 P2272
60
5
[36] Schedule 1, entry for Risperidone in the form Tablet 3 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Risperidone Sandoz
SZ
MP NP
C1589 C2272
60
5
[37] Schedule 1, entry for Risperidone in the form Tablet 4 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Risperidone Sandoz
SZ
MP NP
C1589 C2272
60
5
[38] Schedule 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Sertracor 50
MI
MP NP
C1211
30
5
[39] Schedule 1, entry for Sertraline in the form Tablet 100 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Sertracor 100
MI
MP NP
C1211
30
5
[40] Schedule 1, entry for Stavudine
omit:
Powder for oral solution 1 mg per mL, 200 mL
Oral
Zerit
BQ
MP
See Note 1
C3586 C3587 C3588 C3589
24
5
D
[41] Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Sumatriptan-GA
GM
MP NP
C3233
4
5
[42] Schedule 1, entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 200 mg
omit from the column headed “Brand”: Tramahexal SR and insert: Tramadol Sandoz SR
[43] Schedule 1, entry for Trastuzumab
insert as first entry in the columns in the order indicated:
Powder for I.V. infusion 60 mg
Injection
Herceptin
RO
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D
[44] Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride)
(a) insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “Valtrex”:
Zelitrex
RE
MP NP
C3622 C3631 C3632 C3633
P3632
20
0
(b) insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “Valtrex”:
Zelitrex
RE
MP NP
C3622 C3631 C3632 C3633
P3633
30
5
(c) insert in the columns in the order indicated, and in alphabetical order after the third instance of the brand “Valtrex”:
Zelitrex
RE
MP NP
C3622 C3631 C3632 C3633
P3622 P3631
42
0
[45] Schedule 1, entry for Vancomycin in the form Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)
(a) insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “Vancocin CP”:
Vancomycin Alphapharm
AF
MP
C1091 C1302 C1464
P1302
2
0
PDP
C1302
2
0
(b) insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “Vancocin CP”:
Vancomycin Alphapharm
AF
MP
C1091 C1302 C1464
P1091 P1464
5
0
[46] Schedule 1, entry for Vancomycin in the form Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)
(a) insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “Hospira Pty Limited”:
Vancomycin Alphapharm
AF
MP
C1091 C1302 C1464
P1302
1
0
PDP
C1302
1
0
(b) insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “Hospira Pty Limited”:
Vancomycin Alphapharm
AF
MP
C1091 C1302 C1464
P1091 P1464
3
0
[47] Schedule 1, entry for Varenicline
omit:
Tablet 1 mg (as tartrate)
Oral
Champix
PF
MP NP
C2776
112
0
substitute:
Tablet 1 mg (as tartrate)
Oral
Champix
PF
MP NP
C3670 C3671
P3671
56
2
MP NP
C3670 C3671
P3670
112
0
[48] Schedule 3, after details relevant to Responsible person code GX
insert:
GY
Mayne Pharma International Pty Ltd
88 007 870 984
[49] Schedule 3, details relevant to Responsible person code PL
omit:
Virgo Unit Trust
insert:
The Trustee for Virgo Unit Trust (trading as Phebra)
[50] Schedule 3, after details relevant to Responsible person code RD
insert:
RE
GlaxoSmithKline Australia Pty Ltd
47 100 162 481
[51] Schedule 3, after details relevant to Responsible person code RO
insert:
RX
Servier Laboratories (Aust.) Pty Ltd
54 004 838 500
[52] Schedule 4, Part 1, after entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids
insert in the columns in the order indicated:
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides
C1687
Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed
Compliance with Authority Required procedures
C1688
Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition
Compliance with Authority Required procedures
C2805
Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where combined intolerance is 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, and where the date of birth of the patient is included in the authority application
Compliance with Authority Required procedures
C2806
Initial treatment, in consultation with a paediatric gastroenterologist or specialist allergist, for up to 3 months, of a child up to the age of 2 years with severe intolerance (not infant colic) to cows' milk protein, and where the date of birth of the patient is included in the authority application
Compliance with Authority Required procedures
C2807
Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
Compliance with Authority Required procedures
C2808
Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
Compliance with Authority Required procedures
C2809
Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application
Compliance with Authority Required procedures
C2810
Treatment for severe intolerance (not infant colic) to cows' milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
Compliance with Authority Required procedures
[53] Schedule 4, Part 1, after entry for Duloxetine
insert in the columns in the order indicated:
Dutasteride
C3667
Treatment, in combination with an alpha-antagonist, of lower urinary tract symptoms due to benign prostatic hyperplasia where treatment is initiated by a urologist
Compliance with Authority Required procedures - Streamlined Authority Code 3667
[54] Schedule 4, Part 1, entry for Nicotine
substitute:
Nicotine
C3042
Nicotine dependence in an Aboriginal or a Torres Strait Islander person as the sole PBS-subsidised therapy
Compliance with Authority Required procedures
C3447
Short-term sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who has entered a comprehensive support and counselling program, and where details of the program are specified in the initial authority application
Compliance with Authority Required procedures
C3448
Short-term sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who is entering a comprehensive support and counselling program during the same consultation at which the authority application is made, and where details of the program are specified in the initial authority application
Compliance with Authority Required procedures
[55] Schedule 4, Part 1, entry for Varenicline
substitute:
Varenicline
C2774
Commencement of short-term, sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who has entered a comprehensive support and counselling program, and where details of the program are specified in the authority application
Compliance with Authority Required procedures
C2775
Commencement of short-term, sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who is entering a comprehensive support and counselling program during the same consultation at which the authority application is made, and where details of the program are specified in the authority application
Compliance with Authority Required procedures
C3670
P3670
Continuation of short-term sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has previously been issued with an authority prescription for this drug and who is enrolled in a comprehensive support and counselling program
Compliance with Authority Required procedures
C3671
P3671
Completion of short-term sole PBS-subsidised therapy as an aid to achieving long-term abstinence after completion of an initial 12-week PBS-subsidised course in a patient who has ceased smoking, and who is enrolled in a comprehensive support and counselling program
Compliance with Authority Required procedures
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
