National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 5) (No. PB 36 of 2014)

Link to law: https://www.comlaw.gov.au/Details/F2014L00588

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PB 36 of 2014
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 5)
National Health Act 1953
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 12 May 2014
 
 
 
 
 
 
 
 
 
 
 
FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health
 
1          Name of Instrument
            (1)        This Instrument is the National Health (Listing of Pharmaceutical                            Benefits) Amendment Instrument 2014 (No. 5).
            (2)        This Instrument may also be cited as PB 36 of 2014.
2          Commencement
This Instrument commences on 1 June 2014.
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 Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Fonat Plus
AF
MP NP
C4122 C4123 C4133
 
4
5
4
 
 
[2]           Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cadivast 5/10
AF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 
[3]           Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cadivast 5/20
AF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 
[4]           Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cadivast 5/40
AF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 
[5]           Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cadivast 5/80
AF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 
[6]           Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cadivast 10/10
AF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 
[7]           Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cadivast 10/20
AF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 
[8]           Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cadivast 10/40
AF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 
[9]           Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cadivast 10/80
AF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 
[10]         Schedule 1, entry for Arginine with carbohydrate in each of the forms: Sachets of oral powder 4 g containing 500 mg arginine, 30 (Arginine 500); and Sachets of oral powder 4 g containing 2 g arginine, 30 (Arginine 2000)
omit from the column headed “Circumstances”:          C1458   substitute:          C4555
[11]         Schedule 1, after entry for Arginine with carbohydrate in the form Sachets of oral powder 4 g containing 2 g arginine, 30 (Arginine 2000)
insert:
 
Sachets of oral powder 7.6 g containing 5 g arginine, 30 (Arginine 5000)
Oral
Arginine 5000
VF
MP NP
C4555
 
4
5
1
 
 
[12]         Schedule 1, entry for Candesartan in each of the forms: Tablet containing candesartan cilexetil 4 mg; Tablet containing candesartan cilexetil 8 mg; Tablet containing candesartan cilexetil 16 mg; and Tablet containing candesartan cilexetil 32 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Chem mart Candesartan
CH
MP NP
 
 
30
5
30
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terry White Chemists Candesartan
TW
MP NP
 
 
30
5
30
 
 
[13]         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”:
 
 
 
Chem mart Candesartan HCTZ 16/12.5
CH
MP NP
C4374
 
30
5
30
 
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terry White Chemists Candesartan HCTZ 16/12.5
TW
MP NP
C4374
 
30
5
30
 
 
[14]         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”:
 
 
 
Chem mart Candesartan HCTZ 32/12.5
CH
MP NP
C4374
 
30
5
30
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terry White Chemists Candesartan HCTZ 32/12.5
TW
MP NP
C4374
 
30
5
30
 
 
[15]         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”:
 
 
 
Chem mart Candesartan HCTZ 32/25
CH
MP NP
C4374
 
30
5
30
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terry White Chemists Candesartan HCTZ 32/25
TW
MP NP
C4374
 
30
5
30
 
 
[16]         Schedule 1, entry for Codeine with Paracetamol [Maximum Quantity: 20; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Paracetamol/ Codeine GH 500/30
GQ
MP NP PDP
 
 
20
0
20
 
 
 
[17]         Schedule 1, entry for Codeine with Paracetamol [Maximum Quantity: 60 CN2064; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Paracetamol/ Codeine GH 500/30
GQ
MP NP
 
P2064
60
CN2064
0
20
 
 
[18]         Schedule 1, entry for Diltiazem in the form Tablet containing diltiazem hydrochloride 60 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Diltiazem Actavis
UA
MP NP
 
 
90
5
90
 
 
[19]         Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; and Tablet containing enalapril maleate
10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Enalapril Actavis
UA
MP NP
 
 
30
5
30
 
 
[20]         Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL
(a)      omit from the column headed “Brand”:           Epirubicin Actavis 100             substitute:          Epirubicin ACT
(b)      omit from the column headed “Responsible Person”:     TA        substitute:          VN
[21]         Schedule 1, entry for Everolimus in each of the forms: Tablet 5 mg; and Tablet 10 mg
insert in numerical order in  the column headed “Circumstances”:        C4557
[22]         Schedule 1, entry for Exemestane
substitute:
Exemestane
Tablet 25 mg
Oral
APO‑Exemestane
TX
MP
C1541 C2457 C4552
 
30
5
30
 

 
 
 
 
 
NP
C1541 C2457
 
30
5
30
 
 

 
 
 
Aromasin
PF
MP
C1541 C2457 C4552
 
30
5
30
 
 

 
 
 
 
 
NP
C1541 C2457
 
30
5
30
 
 

 
 
 
Exaccord
RA
MP
C1541 C2457 C4552
 
30
5
30
 
 

 
 
 
 
 
NP
C1541 C2457
 
30
5
30
 
 

 
 
 
Exemestane‑GA
GN
MP
C1541 C2457 C4552
 
30
5
30
 
 

 
 
 
 
 
NP
C1541 C2457
 
30
5
30
 
 

 
 
 
Exemestane GH
GQ
MP
C1541 C2457 C4552
 
30
5
30
 
 

 
 
 
 
 
NP
C1541 C2457
 
30
5
30
 
 

 
 
 
Exemestane Pfizer
FZ
MP
C1541 C2457 C4552
 
30
5
30
 
 

 
 
 
 
 
NP
C1541 C2457
 
30
5
30
 
 

 
 
 
Exemestane Sandoz
SZ
MP
C1541 C2457 C4552
 
30
5
30
 
 

 
 
 
 
 
NP
C1541 C2457
 
30
5
30
 
 

[23]         Schedule 1, after entry for Fentanyl in the form Transdermal patch 16.8 mg [Brand: Fentanyl Sandoz]
insert:
Ferric carboxymaltose
Injection 500 mg (iron) in 10 mL
Injection
ferinject
VL
MP NP
 
 
2
1
1
 
 
[24]         Schedule 1, entry for Gemfibrozil
(a)      omit:
 
 
 
Lopid
PF
MP
C1540 C3047
P1540
60
5
60
 

 
 
 
 
 
NP
C1540
 
60
5
60
 
 

(b)      omit:
 
 
 
Lopid
PF
MP
C1540 C3047
P3047
60
11
60
 
[25]         Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 100 (FreeStyle Optium)
insert in the columns in the order indicated:
 
Test strips, 100 (GoodLife)
For external use
GoodLife
JN
MP NP
 
 
1
5
1
 
 

 
 
 
 
 
MP
 
P4241
1
11
1
 
 

[26]         Schedule 1, entry for Lactulose
(a)      omit:
 
 
 
Lac‑Dol
GN
MP NP
C1150 C1613 C3642 C3643
P3643
3
0
1
 
(b)      omit:
 
 
 
Lac‑Dol
GN
MP NP
C1150 C1613 C3642 C3643
P3642
3
3
1
 
(c)      omit:
 
 
 
Lac‑Dol
GN
MP NP
C1150 C1613 C3642 C3643
P1150 P1613
1
5
1
 
[27]         Schedule 1, entry for Lamotrigine in the form Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Lamotrigine Aspen 50
FM
MP NP
C1426
 
56
5
56
 
 
[28]         Schedule 1, entry for Mycophenolic Acid in the form Capsule containing mycophenolate mofetil 250 mg
(a)      omit:
 
 
 
Imulate
QA
MP
C1765 C1766
 
300
3
100
 
(b)      omit:
 
 
 
Imulate
QA
MP
See Note 1
C1650 C1651 C3355 C3356
 
600
5
100
C(100)
[29]         Schedule 1, entry for Mycophenolic Acid in the form Tablet containing mycophenolate mofetil 500 mg
(a)      omit:
 
 
 
Imulate
QA
MP
C1765 C1766
 
150
3
50
 
(b)      omit:
 
 
 
Imulate
QA
MP
See Note 1
C1650 C1651 C3355 C3356
 
300
5
50
C(100)
[30]         Schedule 1, entry for Nandrolone Decanoate
omit from the column headed “Responsible Person”:                 MK       substitute:          AS
[31]         Schedule 1, entry for Oestriol in each of the forms: Pessaries 500 micrograms, 15; and Vaginal cream 1 mg per g, 15 g
omit from the column headed “Responsible Person”:                 MK       substitute:          AS
[32]         Schedule 1, after entry for Phenoxybenzamine in the form Capsule containing phenoxybenzamine hydrochloride 10 mg
insert in the columns in the order indicated:
 
Capsule containing 10 mg phenoxybenzamine hydrochloride
Oral
Dibenzyline
BZ
MP NP
C1239 C1285
 
100
5
100
 
[33]         Schedule 1, entry for Phenoxybenzamine
omit:
 
Capsules containing phenoxybenzamine hydrochloride 10 mg, 100
Oral
Dibenzyline
BZ
MP NP
C1239 C1285
 
1
5
1
 
[34]         Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rabeprazole RBX
RA
MP NP
C1177 C1337 C1533
P1177
30
2
30
 
 
[35]         Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rabeprazole RBX
RA
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
 
 
[36]         Schedule 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Risperidone Actavis 2
UA
MP NP
C1589 C2272 C3083
P3083
60
2
60
 
 
[37]         Schedule 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Risperidone Actavis 2
UA
MP NP
C1589 C2272 C3083
P1589 P2272
60
5
60
 
 
[38]         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 Actavis 3
UA
MP NP
C1589 C2272
 
60
5
60
 
 
[39]         Schedule 1, after entry for Tamoxifen in the form Tablet 20 mg (as citrate) [Brand: Tamoxifen Sandoz]
insert:
Tapentadol
Tablet (modified release) 50 mg (as hydrochloride)
Oral
Palexia SR
CS
MP NP
C4556
 
28
0
28
 
 

 
Tablet (modified release) 100 mg (as hydrochloride)
Oral
Palexia SR
CS
MP NP
C4556
 
28
0
28
 
 

 
Tablet (modified release) 150 mg (as hydrochloride)
Oral
Palexia SR
CS
MP NP
C4556
 
28
0
28
 
 

 
Tablet (modified release) 200 mg (as hydrochloride)
Oral
Palexia SR
CS
MP NP
C4556
 
28
0
28
 
 

 
Tablet (modified release) 250 mg (as hydrochloride)
Oral
Palexia SR
CS
MP NP
C4556
 
28
0
28
 
 

[40]         Schedule 3, after details relevant to Responsible Person code JJ
insert:
JN
JNS Biomedical Pty Ltd
 79 163 593 833
[41]         Schedule 3, after details relevant to Responsible Person code VI
insert:
VL
Vifor Pharma Pty Limited
 87 086 114 043
[42]         Schedule 4, Part 1, entry for Arginine with carbohydrate
substitute:
Arginine with carbohydrate
C4555
 
 
Urea cycle disorders
 
[43]         Schedule 4, Part 1, entry for Everolimus
insert in numerical order following existing text:
 
C4557
 
 
Metastatic (Stage IV) breast cancer
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must have acquired endocrine resistance as demonstrated by initial response and then recurrence or progression of disease after treatment with letrozole or anastrozole; AND
The treatment must be in combination with exemestane
Patient must be female; AND
Patient must be post-menopausal
Compliance with Authority Required procedures

[44]         Schedule 4, Part 1, entry for Exemestane
insert in numerical order following existing text:
 
C4552
 
 
Metastatic (Stage IV) breast cancer
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
Patient must be receiving PBS-subsidised everolimus concomitantly for this condition
Patient must be female; AND
Patient must be post-menopausal
 
[45]         Schedule 4, Part 1, entry for Plerixafor [Circumstances Code: 4549]
omit from the column headed “Circumstances and Purposes”:
Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per microlitre on the day of planned collection; OR
substitute:
Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per millilitre or less than 10 million per litre on the day of planned collection; OR
[46]         Schedule 4, Part 1, entry for Plerixafor [Circumstances Code: 4550]
omit from the column headed “Circumstances and Purposes”:
Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per microlitre on the day of planned collection; OR
substitute:
Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per millilitre or less than 10 million per litre on the day of planned collection; OR
[47]         Schedule 4, Part 1, after entry for Tamoxifen
insert:
Tapentadol
 
C4556
 
 
Chronic severe disabling pain
The condition must be unresponsive to non-narcotic analgesics