National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 10) (No. PB 53 of 2013)

Link to law: https://www.comlaw.gov.au/Details/F2013L01580

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PB 53 of 2013
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 10)
National Health Act 1953
I, ADRIANA PLATONA, First Assistant Secretary (Acting), Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88, 99AEH and 101 of the National Health Act 1953.
Dated                                                  9 August 2013
 
 
 
 
 
 
 
 
 
 
 
ADRIANA PLATONA
First Assistant Secretary (Acting)
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 2013 (No. 10).
            (2)        This Instrument may also be cited as PB 53 of 2013.
2          Commencement
This Instrument commences on 1 September 2013.
3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
            Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1     Amendments
 
[1]           Schedule 1, entry for Apixaban
substitute:
Apixaban
Tablet 2.5 mg
Oral
Eliquis
BQ
MP NP
C3957 C3991 C4043 C4044 C4046 C4269
P3957 P4043
20
0
20
 
 

 
 
 
 
 
MP NP
C3957 C3991 C4043 C4044 C4046 C4269
P3991 P4044
30
0
30
 
 

 
 
 
 
 
MP NP
C3957 C3991 C4043 C4044 C4046 C4269
P4046
60
0
60
 
 

 
 
 
 
 
MP NP
C3957 C3991 C4043 C4044 C4046 C4269
P4269
60
5
60
 
 

 
Tablet 5 mg
Oral
Eliquis
BQ
MP NP
C4269
 
60
5
60
 
 

[2]           Schedule 1, entry for Buprenorphine with naloxone
omit:
 
Tablet (sublingual) 2 mg (as hydrochloride)-0.5 mg (as hydrochloride)
Sublingual
Suboxone
RC
MP NP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
28
D(100)

 
Tablet (sublingual) 8 mg (as hydrochloride)-2 mg (as hydrochloride)
Sublingual
Suboxone
RC
MP NP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
28
 
D(100)

[3]           Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Candesartan/ HCT Sandoz
SZ
MP NP
C3307
 
30
5
30
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Candesartan HCT 16/12.5
CR
MP NP
C3307
 
30
5
30
 
 
[4]           Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Candesartan/ HCT Sandoz
SZ
MP NP
C3307
 
30
5
30
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Candesartan HCT 32/12.5
CR
MP NP
C3307
 
30
5
30
 
 
[5]           Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Candesartan/ HCT Sandoz
SZ
MP NP
C3307
 
30
5
30
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Candesartan HCT 32/25
CR
MP NP
C3307
 
30
5
30
 
 
[6]           Schedule 1, entry for Cefepime in each of the forms: Powder for injection 1 g (as hydrochloride); and Powder for injection 2 g
(as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cefepime-AFT
AE
MP NP
C1427
 
10
0
1
 
 
[7]           Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg
(a)      omit:
 
 
 
Cyprohexal
SZ
MP
C1014 C1230 C1404
P1230
20
5
20
 
 
(b)      omit:
 
 
 
Cyprohexal
SZ
MP
C1014 C1230 C1404
P1014 P1404
100
5
50
 
 
[8]           Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg
omit:
 
 
 
Cyprohexal
SZ
MP
C1014 C1404
 
50
5
50
 
 
[9]           Schedule 1, entry for Dabigatran etexilate
omit:
 
Capsule 110 mg (as mesilate)
Oral
Pradaxa
BY
MP NP
C3957 C4047 C4048
P3957
20
0
10
 
 

 
 
 
 
 
MP NP
C3957 C4047 C4048
P4047
20
1
10
 
 

 
 
 
 
 
MP NP
C3957 C4047 C4048
P4048
60
0
60
 
 

substitute:
 
Capsule 110 mg (as mesilate)
Oral
Pradaxa
BY
MP NP
C3957 C4047 C4048 C4269
P3957
20
0
10
 
 

 
 
 
 
 
MP NP
C3957 C4047 C4048 C4269
P4047
20
1
10
 
 

 
 
 
 
 
MP NP
C3957 C4047 C4048 C4269
P4048
60
0
60
 
 

 
 
 
 
 
MP NP
C3957 C4047 C4048 C4269
C4269
60
5
60
 
 

 
Capsule 150 mg (as mesilate)
Oral
Pradaxa
BY
MP NP
C4269
 
60
5
60
 
 

[10]         Schedule 1, entry for Duloxetine in each of the forms Capsule 30 mg (as hydrochloride); and Capsule 60 mg (as hydrochloride)
[Manner of Administration Oral; Brand Duloxetine DR GH]
omit from “Duloxetine DR GH” in the column headed “Brand”:                      DR
[11]         Schedule 1, entry for Famciclovir in the form Tablet 250 mg [Maximum Quantity 21; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Auro-Famciclovir 250
DO
MP NP
C3622 C3623
P3622
21
0
21
 
 
[12]         Schedule 1, entry for Famciclovir in the form Tablet 250 mg [Maximum Quantity 56; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Auro-Famciclovir 250
DO
MP NP
C3622 C3623
P3623
56
5
56
 
 
[13]         Schedule 1, after entry for Filgrastim in the form Injection 300 micrograms in 0.5 mL single use pre-filled syringe (TevaGrastim)
insert in the columns in the order indicated:
 
Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Zarzio)
Injection
Zarzio
SZ
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
5
 
D(100)
[14]         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 0.5 mL single use pre-filled syringe (Zarzio)
Injection
Zarzio
SZ
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
5
 
D(100)
[15]         Schedule 1, after entry for Flutamide in the form Tablet 250 mg
insert:
 
Tablet 250 mg, 30
Oral
Flutamide MYLAN
AF
MP NP
C3674
 
3
5
1
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 

[16]         Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride)
omit:
 
 
 
Gemzar
LY
MP
 
 
See Note 3
See Note 3
1
 
D(100)
[17]         Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride)
omit:
 
 
 
Gemzar
LY
MP
 
 
See Note 3
See Note 3
1
 
D(100)
[18]         Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 2 g (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Gemcitabine Actavis 2000
WQ
MP
 
See Note 3
See Note 3
1
D(100)
[19]         Schedule 1, entry for Granisetron in the form Concentrated injection 3 mg (as hydrochloride) in 3 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Granisetron-AFT
AE
MP NP
See Note 1
C4077 C4092
See Note 2
 
1
See Note 2
0
See Note 2
1
 
[20]         Schedule 1, entry for Hydroxychloroquine
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Hydroxychloro
quine Actavis
GM
MP NP
 
100
1
100
 
[21]         Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
omit:
 
 
 
Formet 500
QA
MP NP
 
 
100
5
100
 
 
[22]         Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg
omit:
 
 
 
Formet 850
QA
MP NP
 
 
60
5
60
 
 
[23]         Schedule 1, entry for Misoprostol
omit:
 
 
 
Cytotec
PF
MP
C2630 C2631 C2632
 
120
2
120
 
 
[24]         Schedule 1, entry for Montelukast in the form Tablet, chewable, 4 mg (as sodium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Montelukast 4
CR
MP NP
C2617
 
28
5
28
 
 
[25]         Schedule 1, entry for Montelukast in the form Tablet, chewable, 5 mg (as sodium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Montelukast 5
CR
MP NP
C2618 C3217
 
28
5
28
 
 
[26]         Schedule 1, entry for Norfloxacin
omit:
 
 
 
Noroxin
MK
MP NP
C1002 C1070
 
14
1
14
 
 
[27]         Schedule 1, entry for Ondansetron in each of the forms: I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL; and I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL
omit:
 
 
 
Zofran
AS
MP NP
See Note 1
C3050 C3611
See Note 2
See Note 2
1
See Note 2
0
See
Note 2
1
 
[28]         Schedule 1, entry for Paclitaxel in each of the forms: Solution concentrate for I.V. infusion 30 mg in 5 mL; and Solution concentrate for I.V. infusion 100 mg in 16.7 mL
omit:
 
 
 
Paclitaxel Pfizer
PF
MP
C3186 C3890 C3902 C3917 C3955 C3956
 
See Note 3
See Note 3
1
 
D(100)
[29]         Schedule 1, entry for Quinapril in the form Tablet 5 mg (as hydrochloride)
omit:
 
 
 
Acquin 5
QA
MP NP
 
 
30
5
30
 
 
[30]         Schedule 1, entry for Quinapril in the form Tablet 10 mg (as hydrochloride)
omit:
 
 
 
Acquin 10
QA
MP NP
 
 
30
5
30
 
 
[31]         Schedule 1, entry for Quinapril in the form Tablet 20 mg (as hydrochloride)
omit:
 
 
 
Acquin 20
QA
MP NP
 
 
30
5
30
 
 
[32]         Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated)
(a)      omit:
 
 
 
Rabeprazole Actavis 20
TA
MP NP
C1177 C1337 C1533
P1177
30
2
30
 
 
(b)      omit:
 
 
 
Rabeprazole Actavis 20
TA
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
 
 
[33]         Schedule 1, entry for Raltegravir
substitute:
Raltegravir
Tablet 25 mg (as potassium)
Oral
Isentress
MK
MP
See Note 1
C4273 C4274 C4275 C4276
 
360
5
60
 
D(100)

 
Tablet 100 mg (as potassium)
Oral
Isentress
MK
MP
See Note 1
C4273 C4274 C4275 C4276
 
360
5
60
 
D(100)

 
Tablet 400 mg (as potassium)
Oral
Isentress
MK
MP
See Note 1
C3586 C3587 C3588 C3589
 
120
5
60
 
D(100)

[34]         Schedule 1, entry for Risedronic Acid and Calcium in the form Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate)
omit:
 
 
 
Actonel Combi
SW
MP NP
C4122 C4123 C4133
 
1
5
1
 
 
[35]         Schedule 1, entry for Salbutamol
omit:
 
Nebuliser solution 5 mg (as sulfate) per mL, 30 mL
Inhalation
Pfizer Australia Pty Ltd
PF
MP NP
C1754 C1755
 
2
2
1
 
 
[36]         Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate)
omit:
 
 
 
Sumagran 50
QA
MP NP
C3233
 
4
5
2
 
 
[37]         Schedule 1, after entry for Tadalafil
insert:
Tafluprost
Eye drops 15 micrograms per mL, single dose units 0.3 mL, 30
Application to the eye
Saflutan
MK
MP AO
 
 
1
5
1
 
[38]         Schedule 4, Part 1, entry for Apixaban
insert in numerical order following existing text:
 
C4269
P4269
 
Prevention of stroke or systemic embolism
Patient must have non-valvular atrial fibrillation
Patient must have one or more risk factors for developing stroke or systemic embolism
Risk factors for developing stroke or systemic ischaemic embolism are:
(i) Prior stroke (ischaemic or unknown type), transient ischaemic attack or non-central nervous system (CNS) systemic embolism;
(ii) age 75 years or older;
(iii) hypertension;
(iv) diabetes mellitus;
(v) heart failure and/or left ventricular ejection fraction 35% or less
Compliance with Authority Required procedures - Streamlined Authority Code 4269
[39]         Schedule 4, Part 1, entry for Dabigatran etexilate
insert in numerical order following existing text:
 
C4269
P4269
 
Prevention of stroke or systemic embolism
Patient must have non-valvular atrial fibrillation
Patient must have one or more risk factors for developing stroke or systemic embolism
Risk factors for developing stroke or systemic ischaemic embolism are:
(i) Prior stroke (ischaemic or unknown type), transient ischaemic attack or non-central nervous system (CNS) systemic embolism;
(ii) age 75 years or older;
(iii) hypertension;
(iv) diabetes mellitus;
(v) heart failure and/or left ventricular ejection fraction 35% or less
Compliance with Authority Required procedures - Streamlined Authority Code 4269
[40]         Schedule 4, Part 1, entry for Misoprostol
omit:

 
C2630
 
 
Reduction in the incidence of gastrointestinal complications in patients who have a history of peptic ulcer disease and where non-steroidal anti-inflammatory drug therapy is essential
Compliance with Authority Required procedures - Streamlined Authority Code 2630

 
C2631
 
 
Duodenal ulcer (including pyloric and stomal ulcers), proven by current or prior x-ray, endoscopy or surgery, where the date on which, and the method by which, the ulcer was proven are documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 2631

 
C2632
 
 
Gastric ulcer, proven by x-ray, endoscopy or surgery within the previous 2 years, where the date on which, and the method by which, the ulcer was proven are documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 2632

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

 
C4273
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
The treatment must be in combination with other antiretroviral agents,
Patient must be antiretroviral experienced with at least 6 months therapy with 2 alternate classes of anti-retroviral therapy,
Patient must have previously received PBS-subsidised therapy for HIV infection,
Patient must be aged 2 years or older
Compliance with Written and Telephone Authority Required procedures

 
 
C4274
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
The treatment must be in combination with other antiretroviral agents,
Patient must be antiretroviral experienced with at least 6 months therapy with 2 alternate classes of anti-retroviral therapy,
Patient must have previously received PBS-subsidised therapy for HIV infection,
Patient must be aged 2 years or older
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4274

 
C4275
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
The treatment must be in combination with other antiretroviral agents,
Patient must be antiretroviral experienced with at least 6 months therapy with 2 alternate classes of anti-retroviral therapy,
Patient must have a CD4 count of less than 500 per cubic millimetre; OR
Patient must have symptomatic HIV disease,
Patient must be aged 2 years or older
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4275

 
C4276
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
The treatment must be in combination with other antiretroviral agents,
Patient must be antiretroviral experienced with at least 6 months therapy with 2 alternate classes of anti-retroviral therapy,
Patient must have a CD4 count of less than 500 per cubic millimetre; OR
Patient must have symptomatic HIV disease,
Patient must be aged 2 years or older
Compliance with Written and Telephone Authority Required procedures