PB 1 of 2012
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012
(No.1)1
National Health Act 1953
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this Instrument under sections 84AF, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 7 February 2012
FELICITY McNEILL
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 2012 (No. 1).
(2) This Instrument may also be cited as PB 1 of 2012.
2 Commencement
This Instrument commences on 1 March 2012.
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 Abacavir with Lamivudine and Zidovudine
omit from the column headed “Circumstances”:
C3590
C3591
C3592
C3593
substitute:
C3979
C3980
C3981
C3982
[2] Schedule 1, entry for Adefovir
omit from the column headed “Circumstances”:
C3863
C3864
substitute:
C3971
C3972
C3973
C3974
[3] Schedule 1, entry for Amlodipine in the form Tablet 5 mg (as besylate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Auro-Amlodipine 5
DO
MP NP
30
5
[4] Schedule 1, entry for Amlodipine in the form Tablet 10 mg (as besylate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Auro-Amlodipine 10
DO
MP NP
30
5
[5] Schedule 1, entry for Amlodipine with valsartan and hydrochlorothiazide
omit from the column headed “Authorised Prescriber” (all instances): MP substitute: MP NP
[6] 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-PS
FZ
MP NP
30
5
[7] Schedule 1, entry for Bisoprolol in each of the forms: Tablet containing bisoprolol fumarate 2.5 mg; Tablet containing bisoprolol fumarate 5 mg; and Tablet containing bisoprolol fumarate 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Bisoprolol Pfizer
FZ
MP NP
C3234
28
5
[8] Schedule 1, entry for Calcitriol in the form Capsule 0.25 microgram
(a) omit from the column headed “Brand”: Calcitriol-DP substitute: Calciprox
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Calcitriol-PS
FZ
MP NP
C1165 C1166 C1167 C1467 C2636
100
3
[9] Schedule 1, entry for Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate)
(a) omit:
Douglas Cefaclor-CD
GM
PDP
10
0
(b) omit:
Douglas Cefaclor-CD
GM
MP
10
1
[10] Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Max Quantity 20; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Cephalexin-PS
FZ
PDP
20
0
[11] Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Max Quantity 20; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Cephalexin-PS
FZ
MP NP MW
20
1
[12] Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Max Quantity 20; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Cephalexin-PS
FZ
PDP
20
0
[13] Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Max Quantity 20; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Cephalexin-PS
FZ
MP NP MW
20
1
[14] Schedule 1, after entry for Choriogonadotropin alfa in the form Solution for injection 250 micrograms in 0.5 mL pre-filled syringe
insert in the columns in the order indicated:
Solution for injection 250 micrograms in 0.5 mL pre-filled pen
Injection
Ovidrel
SG
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D
[15] Schedule 1, entry for Ciprofloxacin in each of the forms: Tablet 500 mg (as hydrochloride); and Tablet 750 mg (as hydrochloride)
(a) omit:
Ascent Pharmaceuticals Limited
GN
MP NP
C1431 C1432 C1572 C1573
14
0
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Ciprofloxacin-PS
FZ
MP NP
C1431 C1432 C1572 C1573
14
0
[16] Schedule 1, entry for Citalopram in the form Tablet 20 mg (as hydrobromide)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Auro-Citalopram 20
DO
MP NP
C1211
28
5
[17] Schedule 1, entry for Citalopram in the form Tablet 40 mg (as hydrobromide)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Auro-Citalopram 40
DO
MP NP
C1211
28
5
[18] Schedule 1, after entry for Darunavir in the form Tablet 400 mg (as ethanolate)
insert in the columns in the order indicated:
Tablet 600 mg (as ethanolate)
Oral
Prezista
JC
MP
See Note 1
C3594 C3595
120
5
D
[19] Schedule 1, entry for Denosumab in the form Injection 60 mg in 1 mL in pre-filled syringe
(a) omit from the column headed “Authorised Prescriber”: MP substitute: MP NP
(b) omit from the column headed “Circumstances”:
C3579
C3580
substitute:
C2758
C3987
[20] Schedule 1, entry for Enalapril in the form Tablet containing enalapril maleate 5 mg
omit:
Enalapril-DP 5mg
GN
MP NP
30
5
[21] Schedule 1, entry for Enalapril in the form Tablet containing enalapril maleate 10 mg
omit:
Enalapril-DP 10mg
GN
MP NP
30
5
[22] Schedule 1, entry for Enalapril in the form Tablet containing enalapril maleate 20 mg
omit:
Enalapril-DP 20mg
GN
MP NP
30
5
[23] Schedule 1, entry for Entecavir in the form Tablet containing entecavir monohydrate 0.5 mg
omit from the column headed “Circumstances”:
C3871
C3872
substitute:
C3959
C3960
C3961
C3962
[24] Schedule 1, entry for Entecavir in the form Tablet containing entecavir monohydrate 1 mg
omit from the column headed “Circumstances”:
C3873
C3874
substitute:
C3963
C3964
C3965
C3966
[25] Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Epirubicin Actavis 10
TA
MP
See Note 1
See Note 3
See Note 3
D
[26] Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Epirubicin Actavis 20
TA
MP
See Note 1
See Note 3
See Note 3
D
[27] Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Epirubicin Actavis 50
TA
MP
See Note 1
See Note 3
See Note 3
D
[28] Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Epirubicin Actavis 100
TA
MP
See Note 1
See Note 3
See Note 3
D
[29] 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”:
Epirubicin Actavis 200
TA
MP
See Note 1
See Note 3
See Note 3
D
[30] Schedule 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Escitalopram GA
GN
MP NP
C1211
28
5
[31] Schedule 1, entry for Essential Amino Acids Formula
(a) omit from the column headed “Form”: Oral powder 200 g, 2 substitute: Oral powder 200 g
(b) omit from the column headed “Max Quantity”: 3 substitute: 6
[32] Schedule 1, entry for Exemestane in the form Tablet 25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Exemestane Sandoz
SZ
MP NP
C1541 C2457
30
5
[33] Schedule 1, entry for Exenatide in each of the forms: Injection solution 5 micrograms per dose in pre-filled pen, 60 doses; and Injection solution 10 micrograms per dose in pre-filled pen, 60 doses
omit from the column headed “Circumstances”:
C3536
C3538
C3676
C3677
substitute:
C3540
C3542
[34] Schedule 1, entry for Famotidine in the form Tablet 20 mg
omit:
Pepcidine M
MK
MP NP
60
5
[35] Schedule 1, after entry for Filgrastim in the form Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Nivestim)
insert in the columns in the order indicated:
Injection 300 micrograms in 0.5 mL single use pre-filled syringe (TevaGrastim)
Injection
TevaGrastim
AS
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 C3833 C3834
20
11
D
[36] Schedule 1, after entry for Filgrastim in the form Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Nivestim)
insert in the columns in the order indicated:
Injection 480 micrograms in 0.8 mL single use pre-filled syringe (TevaGrastim)
Injection
TevaGrastim
AS
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 C3833 C3834
20
11
D
[37] Schedule 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Fluoxetine-PS
FZ
MP NP
C1211 C1241
28
5
[38] Schedule 1, entry for Foscarnet in the form I.V. infusion containing foscarnet sodium 24 mg per mL, 250 mL
omit from the column headed “Responsible Person”: AP substitute: IX
[39] Schedule 1, entry for Gemcitabine in all forms
omit from the column headed “Circumstances” (leave column blank in all instances):
C1193
C1194
C1740
C2069
C2141
C3889
C3890
C3906
C3913
C3914
[40] Schedule 1, after entry for Gemcitabine in the form Powder for I.V. infusion 2 g (as hydrochloride) [Gemcitabine Kabi]
insert in the columns in the order indicated:
Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 5 mL
Injection
Gemcitabine Ebewe
SZ
MP
See Note 1
See Note 3
See Note 3
D
Solution concentrate for I.V. infusion 1 g (as hydrochloride) in 25 mL
Injection
Gemcitabine Ebewe
SZ
MP
See Note 1
See Note 3
See Note 3
D
Solution concentrate for I.V. infusion 2 g (as hydrochloride) in 50 mL
Injection
Gemcitabine Ebewe
SZ
MP
See Note 1
See Note 3
See Note 3
D
[41] Schedule 1, entry for Interferon Alfa-2a in the form Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe [Max Quantity 30; Number of Repeats 5]
omit from the column headed “Circumstances”:
C3869
C3870
substitute:
C3959
C3960
C3961
C3962
[42] Schedule 1, entry for Interferon Alfa-2a in the form Injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe [Max Quantity 30; Number of Repeats 5]
omit from the column headed “Circumstances”:
C3869
C3870
substitute:
C3959
C3960
C3961
C3962
[43] Schedule 1, entry for Interferon Alfa-2a in the form Injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe [Max Quantity 30; Number of Repeats 5]
omit from the column headed “Circumstances”:
C3869 C3870
substitute:
C3959
C3960
C3961
C3962
[44] Schedule 1, entry for Interferon Alfa-2a in the form Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe [Max Quantity 30; Number of Repeats 5]
omit from the column headed “Circumstances”:
C3869
C3870
substitute:
C3959
C3960
C3961
C3962
[45] Schedule 1, entry for Interferon Alfa-2b in each of the forms: Solution for injection 10,000,000 I.U. in 1 mL single dose vial; and Solution for injection 18,000,000 I.U. in 3 mL single dose vial
omit from the column headed “Circumstances”:
C3869
C3870
substitute:
C3959
C3960
C3961
C3962
[46] Schedule 1, entry for Interferon Alfa-2b in the form Solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen
[Max Quantity 2; Number of Repeats 5]
omit from the column headed “Circumstances”:
C3869
C3870
substitute:
C3959
C3960
C3961
C3962
[47] Schedule 1, entry for Interferon Alfa-2b in the form Solution for injection 25,000,000 I.U. in 2.5 mL single dose vial
omit from the column headed “Circumstances”:
C3869
C3870
substitute:
C3959
C3960
C3961
C3962
[48] Schedule 1, entry for Interferon Alfa-2b in the form Solution for injection 60,000,000 I.U. in 1.2 mL multi-dose injection pen
omit from the column headed “Circumstances”:
C3869
C3870
substitute:
C3959
C3960
C3961
C3962
[49] Schedule 1, entry for Interferon Alfa-2b in the form Solution for injection 30,000,000 I.U. in 1.2 mL multi-dose injection pen [Max Quantity 2; Number of Repeats 5]
omit from the column headed “Circumstances”:
C3869
C3870
substitute:
C3959
C3960
C3961
C3962
[50] Schedule 1, entry for Lamivudine in each of the forms: Tablet 100 mg; and Oral solution 5 mg per mL, 240 mL
omit from the column headed “Circumstances”:
C3871
C3872
substitute:
C3959
C3960
C3961
C3962
[51] Schedule 1, entry for Lamotrigine in each of the forms: Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg
(a) omit:
Lamotrigine-DP
GM
MP NP
C1426
56
5
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Lamotrigine-PS
FZ
MP NP
C1426
56
5
[52] Schedule 1, after entry for Lignocaine in the form Infusion containing lignocaine hydrochloride 500 mg in 5 mL
insert in the columns in the order indicated:
Linagliptin
Tablet 5 mg
Oral
Trajenta
BY
MP NP
C3540
30
5
[53] Schedule 1, entry for Lisinopril in each of the forms: Tablet 5 mg; Tablet 10 mg; and Tablet 20 mg
(a) omit:
Liprace
GM
MP NP
30
5
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Lisinopril-PS
FZ
MP NP
30
5
[54] Schedule 1, entry for Medroxyprogesterone in the form Tablet containing medroxyprogesterone acetate 10 mg
omit:
Medroxyhexal
HX
MP NP
30
2
[55] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
omit:
Ascent Pharmaceuticals Limited
GN
MP NP
100
5
[56] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg
omit:
Ascent Pharmaceuticals Limited
GN
MP NP
60
5
[57] Schedule 1, entry for Milk powder — lactose free formula
omit:
Oral powder 900 g (Karicare De-Lact)
Oral
Karicare De-Lact
SB
MP NP
C2760 C2762
P2762
5
0
MP NP
C2760 C2762
P2760
5
5
[58] Schedule 1, entry for Oestradiol in the form Transdermal gel 1 mg (as hemihydrate) in 1 g sachet, 28
omit from the column headed “Responsible Person”: MK substitute: AS
[59] Schedule 1, entry for Omeprazole in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Omeprazole-PS
FZ
MP NP
C1177 C1337 C1476 C1533
P1177
30
1
[60] Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Max Quantity 30; Number of Repeats 2]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Panthron
GN
MP NP
C1177 C1337 C1476 C1533
P1177
30
2
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pantoprazole-PS
FZ
MP NP
C1177 C1337 C1476 C1533
P1177
30
2
[61] Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Max Quantity 30; Number of Repeats 5]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Panthron
GN
MP NP
C1177 C1337 C1476 C1533
P1337 P1476 P1533
30
5
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pantoprazole-PS
FZ
MP NP
C1177 C1337 C1476 C1533
P1337 P1476 P1533
30
5
[62] Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pantoprazole-PS
FZ
MP NP
C1533
30
5
[63] Schedule 1, entry for Paroxetine in the form Tablet 20 mg (as hydrochloride)
omit:
Paroxetine-DP
GM
MP NP
C1211 C1241 C1862
30
5
[64] Schedule 1, entry for Peginterferon Alfa-2a in each of the forms: Injection 135 micrograms in 0.5 mL single use pre-filled syringe; and Injection 180 micrograms in 0.5 mL single use pre-filled syringe
omit from the column headed “Circumstances”:
C3867
C3868
substitute:
C3975
C3976
C3977
C3978
[65] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg
(a) omit:
Pravastatin 10
MI
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
(b) omit:
Pravastatin 10
MI
MP
C1540 C3047
P3047
30
11
[66] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg
(a) omit:
Pravastatin 20
MI
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
(b) omit:
Pravastatin 20
MI
MP
C1540 C3047
P3047
30
11
[67] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg
(a) omit:
Pravastatin 40
MI
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
(b) omit:
Pravastatin 40
MI
MP
C1540 C3047
P3047
30
11
[68] Schedule 1, entry for Prochlorperazine in the form Tablet containing prochlorperazine maleate 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Prochlorperazine-PS
FZ
PDP MP NP
25
0
[69] Schedule 1, entry for Protein hydrolysate formula with medium chain triglycerides
omit:
Oral powder 450 g (Pepti-Junior Gold)
Oral
Pepti-Junior Gold
SB
MP NP
C1034 C1059 C1080 C1092 C1310 C1364 C1670 C2567 C2806 C2811 C2812 C2813 C2814 C2815
8
5
[70] Schedule 1, entry for Ramipril in each of the forms: Capsule 1.25 mg; Capsule 2.5 mg; and Capsule 5 mg
omit:
Ramipril-DP
GN
MP NP
30
5
[71] Schedule 1, entry for Ramipril in the form Capsule 10 mg
(a) omit:
Ramipril-DP
GN
MP NP
30
5
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Ramipril-PS
FZ
MP NP
30
5
[72] Schedule 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Ranitidine-PS
FZ
MP NP MW
60
5
[73] Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Max Quantity 60; Number of Repeats 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Risperidone Pfizer
FZ
MP NP
C1589 C2061 C3083
P2061 P3083
60
2
[74] Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Max Quantity 60; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Risperidone Pfizer
FZ
MP NP
C1589 C2061 C3083
P1589
60
5
[75] Schedule 1, entry for Risperidone in the form Tablet 1 mg [Max Quantity 60; Number of Repeats 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Risperidone Pfizer
FZ
MP NP
C1589 C2061 C2272 C3083
P2061 P3083
60
2
[76] Schedule 1, entry for Risperidone in the form Tablet 1 mg [Max Quantity 60; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Risperidone Pfizer
FZ
MP NP
C1589 C2061 C2272 C3083
P1589 P2272
60
5
[77] Schedule 1, entry for Risperidone in the form Tablet 2 mg [Max Quantity 60; Number of Repeats 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Risperidone Pfizer
FZ
MP NP
C1589 C2272 C3083
P3083
60
2
[78] Schedule 1, entry for Risperidone in the form Tablet 2 mg [Max Quantity 60; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Risperidone Pfizer
FZ
MP NP
C1589 C2272 C3083
P1589 P2272
60
5
[79] Schedule 1, entry for Risperidone in each of the forms: Tablet 3 mg; and Tablet 4 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Risperidone Pfizer
FZ
MP NP
C1589 C2272
60
5
[80] Schedule 1, entry for Roxithromycin in the form Tablet 150 mg
(a) omit:
Roxide
HX
PDP
10
0
(b) omit:
Roxide
HX
MP NP
10
1
[81] Schedule 1, entry for Roxithromycin in the form Tablet 300 mg
(a) omit:
Roxide
HX
PDP
5
0
(b) omit:
Roxide
HX
MP NP
5
1
[82] Schedule 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Auro-Sertraline 50
DO
MP NP
C1211 C1241 C1975
30
5
(b) omit:
Concorz
HX
MP NP
C1211
30
5
[83] Schedule 1, entry for Sertraline in the form Tablet 100 mg (as hydrochloride)
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Auro-Sertraline 100
DO
MP NP
C1211 C1241 C1975
30
5
(b) omit:
Concorz
HX
MP NP
C1211
30
5
[84] Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Auro-Simvastatin 10
DO
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[85] Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Auro-Simvastatin 10
DO
MP
C1540 C3047
P3047
30
11
[86] Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Auro-Simvastatin 20
DO
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[87] Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Auro-Simvastatin 20
DO
MP
C1540 C3047
P3047
30
11
[88] Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Auro-Simvastatin 40
DO
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[89] Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Auro-Simvastatin 40
DO
MP
C1540 C3047
P3047
30
11
[90] Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Auro-Simvastatin 80
DO
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[91] Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 11]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Auro-Simvastatin 80
DO
MP
C1540 C3047
P3047
30
11
(b) omit from the column headed “Responsible Person” for the brand “Simvastatin Sandoz”: CR substitute: SZ
[92] Schedule 1, after entry for Somatropin in the form Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) [Norditropin SimpleXx]
insert in the columns in the order indicated:
Solution for injection 6 mg (18 i.u.) in 1.03 mL cartridge (with preservative)
Injection
Saizen
SG
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D
Solution for injection 12 mg (36 i.u.) in 1.5 mL cartridge (with preservative)
Injection
Saizen
SG
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D
Solution for injection 20 mg (60 i.u.) in 2.5 mL cartridge (with preservative)
Injection
Saizen
SG
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D
[93] Schedule 1, entry for Telbivudine
omit from the column headed “Circumstances”:
C3865
C3866
substitute:
C3967
C3968
C3969
C3970
[94] Schedule 1, entry for Tenofovir
omit from the column headed “Circumstances”:
C3863
C3864
C3865
C3866
substitute:
C3967
C3968
C3969
C3970
C3971
C3972
C3973
C3974
[95] Schedule 1, entry for Tenofovir with emtricitabine and efavirenz
omit from the column headed “Circumstances”:
C3586
C3587
C3588
C3589
substitute:
C3983
C3984
C3985
C3986
[96] Schedule 3, after details relevant to Responsible person code CX
insert:
DO
Aurobindo Pharma (Australia) Pty Limited
45 118 452 369
[97] Schedule 3, after details relevant to Responsible person code IS
insert:
IX
Clinect Pty Ltd
76 150 558 473
[98] Schedule 3, details relevant to Responsible person code VP
insert in the column headed “ABN”: 61 140 839 658
[99] Schedule 4, Part 1, entry for Abacavir with Lamivudine and Zidovudine
substitute:
Abacavir with Lamivudine and Zidovudine
C3979
Where the patient is receiving treatment at/from a private hospital
Initial treatment of human immunodeficiency virus (HIV) infection in a patient over 12 years of age, weighing 40 kg or more, with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease
Compliance with Written or Telephone Authority Required procedures
C3980
Where the patient is receiving treatment at/from a private hospital
Continuing treatment of human immunodeficiency virus (HIV) infection where the patient over 12 years of age, weighing 40 kg or more, has previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures
C3981
Where the patient is receiving treatment at/from a public hospital
Initial treatment of human immunodeficiency virus (HIV) infection in a patient over 12 years of age, weighing 40 kg or more, with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3981
C3982
Where the patient is receiving treatment at/from a public hospital
Continuing treatment of human immunodeficiency virus (HIV) infection where the patient over 12 years of age, weighing 40 kg or more, has previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3982
[100] Schedule 4, Part 1, entry for Adalimumab [Circumstances Code 3743]
omit all text from the column headed “Authority Requirements – Part of Circumstances” and substitute:
Compliance with
Written Authority
Required procedures
[101] Schedule 4, Part 1, entry for Adalimumab [part of Circumstances Code 3743—line commencing “Continuation of a course of
initial treatment, …….”]
insert in the column headed “Authority Requirements – Part of Circumstances” (currently having no corresponding text):
Compliance with
Written or Telephone Authority Required procedures
[102] Schedule 4, Part 1, entry for Adefovir
substitute:
Adefovir
C3971
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient without cirrhosis who has failed antihepadnaviral therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance
Compliance with Written or Telephone Authority Required procedures
C3972
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient with cirrhosis who has failed antihepadnaviral therapy and who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures
C3973
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient without cirrhosis who has failed antihepadnaviral therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3973
C3974
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient with cirrhosis who has failed antihepadnaviral therapy and who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3974
[103] Schedule 4, Part 1, entry for Denosumab
substitute:
Denosumab
C1035
Bone metastases from breast cancer
Compliance with Authority Required procedures
C2758
Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a woman aged 70 years or older with a bone mineral density T-score of -3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 2758
C3881
Bone metastases from hormone-resistant prostate cancer
Compliance with Authority Required procedures
C3987
Treatment as the sole PBS-subsidised anti-resorptive agent for established post-menopausal osteoporosis in a woman with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected 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 3987
[104] Schedule 4, Part 1, entry for Entecavir
substitute:
Entecavir
C3959
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures
C3960
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy
Compliance with Written or Telephone Authority Required procedures
C3961
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3961
C3962
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3962
C3963
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient without cirrhosis who has failed lamivudine and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance
Compliance with Written or Telephone Authority Required procedures
C3964
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B
Chronic hepatitis B in a patient without cirrhosis who has failed lamivudine and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3964
C3965
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient with cirrhosis who has failed lamivudine and who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures
C3966
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient with cirrhosis who has failed lamivudine and who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3966
[105] Schedule 4, Part 1, entry for Exenatide
substitute:
Exenatide
C3540
Treatment of type 2 diabetes, in combination with either metformin or a sulfonylurea, 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 either metformin or a sulfonylurea; 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 either metformin or a sulfonylurea; 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 3540
C3542
Treatment of type 2 diabetes, in combination with metformin and a sulfonylurea, in a patient:
(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 maximally tolerated doses of metformin and a sulfonylurea; 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 maximally tolerated doses of metformin and a sulfonylurea; 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 3542
[106] Schedule 4, Part 1, omit entry for Gemcitabine
[107] Schedule 4, Part 1, entry for Interferon Alfa-2a
(a) omit:
C3869
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Is not a person with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L)
Compliance with Written or Telephone Authority Required procedures
C3870
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Is not a person with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L)
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3870
(b) insert after existing text in the columns in the order indicated:
C3959
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures
C3960
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy
Compliance with Written or Telephone Authority Required procedures
C3961
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3961
C3962
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3962
[108] Schedule 4, Part 1, entry for Interferon Alfa-2b
(a) omit:
C3869
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Is not a person with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L)
Compliance with Written or Telephone Authority Required procedures
C3870
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Is not a person with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L)
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3870
(b) insert after existing text in the columns in the order indicated:
C3959
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures
C3960
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy
Compliance with Written or Telephone Authority Required procedures
C3961
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3961
C3962
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3962
[109] Schedule 4, Part 1, entry for Lamivudine
omit:
C3871
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures
C3872
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3872
substitute:
C3959
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures
C3960
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy
Compliance with Written or Telephone Authority Required procedures
C3961
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3961
C3962
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3962
[110] Schedule 4, Part 1, after entry for Levonorgestrel
insert:
Linagliptin
C3540
Treatment of type 2 diabetes, in combination with either metformin or a sulfonylurea, 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 either metformin or a sulfonylurea; 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 either metformin or a sulfonylurea; 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 3540
[111] Schedule 4, Part 1, entry for Peginterferon Alfa-2a
omit:
C3867
Where the patient is receiving treatment at/from a private hospital
Monotherapy in a patient with chronic hepatitis B and compensated liver disease who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Have received no prior peginterferon alfa therapy for the treatment of hepatitis B;
(4) Is not a person with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L).
Treatment is limited to 1 course of treatment for a duration of up to 48 weeks
Compliance with Written or Telephone Authority Required procedures
C3868
Where the patient is receiving treatment at/from a public hospital
Monotherapy in a patient with chronic hepatitis B who and compensated liver disease who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Have received no prior peginterferon alfa therapy for the treatment of hepatitis B;
(4) Is not a person with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L.
Treatment is limited to 1 course of treatment for a duration of up to 48 weeks
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3868
substitute:
C3975
Where the patient is receiving treatment at/from a private hospital
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Has received no prior peginterferon alfa therapy for the treatment of hepatitis B
Compliance with Written or Telephone Authority Required procedures
C3976
Where the patient is receiving treatment at/from a private hospital
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Treatment is limited to 1 course of treatment for a duration of up to 48 weeks
Compliance with Written or Telephone Authority Required procedures
C3977
Where the patient is receiving treatment at/from a public hospital
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Has received no prior peginterferon alfa therapy for the treatment of hepatitis B
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3977
C3978
Where the patient is receiving treatment at/from a public hospital
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who has detectable HBV DNA.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.
Treatment is limited to 1 course of treatment for a duration of up to 48 weeks
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3978
[112] Schedule 4, Part 1, entry for Telbivudine
substitute:
Telbivudine
C3967
Where the patient is receiving treatment at/from a private hospital
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis who is nucleoside analogue naive and satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy
Compliance with Written or Telephone Authority Required procedures
C3968
Where the patient is receiving treatment at/from a private hospital
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who is nucleoside analogue naive and who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures
C3969
Where the patient is receiving treatment at/from a public hospital
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis who is nucleoside analogue naive and satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3969
C3970
Where the patient is receiving treatment at/from a public hospital
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who is nucleoside analogue naive and who has detectable HBV DNA.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3970
[113] Schedule 4, Part 1, entry for Tenofovir
omit:
C3863
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient who has failed antihepadnaviral therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures
C3864
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B
Chronic hepatitis B in a patient who has failed antihepadnaviral therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3864
C3865
Where the patient is receiving treatment at/from a private hospital
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B who is nucleoside analogue naive and satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures
C3866
Where the patient is receiving treatment at/from a public hospital
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B who is nucleoside analogue naive and satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative - in conjunction with documented hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3866
substitute:
C3967
Where the patient is receiving treatment at/from a private hospital
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis who is nucleoside analogue naive and satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy
Compliance with Written or Telephone Authority Required procedures
C3968
Where the patient is receiving treatment at/from a private hospital
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who is nucleoside analogue naive and who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures
C3969
Where the patient is receiving treatment at/from a public hospital
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis who is nucleoside analogue naive and satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3969
C3970
Where the patient is receiving treatment at/from a public hospital
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who is nucleoside analogue naive and who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3970
C3971
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient without cirrhosis who has failed antihepadnaviral therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance
Compliance with Written or Telephone Authority Required procedures
C3972
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient with cirrhosis who has failed antihepadnaviral therapy and who has detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures
C3973
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient without cirrhosis who has failed antihepadnaviral therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3973
C3974
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient with cirrhosis who has failed antihepadnaviral therapy and who has detectable HBV DNA.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3974
[114] Schedule 4, Part 1, entry for Tenofovir with emtricitabine and efavirenz
substitute:
Tenofovir with emtricitabine and efavirenz
C3983
Where the patient is receiving treatment at/from a private hospital
Initial treatment of human immunodeficiency virus (HIV) infection in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease
Compliance with Written or Telephone Authority Required procedures
C3984
Where the patient is receiving treatment at/from a private hospital
Continuing treatment of human immunodeficiency virus (HIV) infection where the patient has previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures
C3985
Where the patient is receiving treatment at/from a public hospital
Initial treatment of human immunodeficiency virus (HIV) infection in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3985
C3986
Where the patient is receiving treatment at/from a public hospital
Continuing treatment of human immunodeficiency virus (HIV) infection where the patient has previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3986
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.
