National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 5) (No. PB 37 of 2012)

Link to law: https://www.comlaw.gov.au/Details/F2012L01204

PB 37 of 2012
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012
(No.5)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 June 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. 5).
            (2)        This Instrument may also be cited as PB 37 of 2012.
2          Commencement
            This Instrument commences on 1 July 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, after entry for Amino acid formula with vitamins and minerals without methionine in the form Oral powder 500 g
(XMET Maxamum)
insert in the columns in the order indicated:
 
Oral liquid 125 mL, 30 (HCU Lophlex LQ 20)
Oral
HCU Lophlex LQ 20
SB
MP NP
C1314
 
3
5
 
[2]           Schedule 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine in the form Oral powder 500 g (XPhen, Tyr Maxamum)
insert in the columns in the order indicated:
 
Oral liquid 125 mL, 30 (TYR Lophlex LQ 20)
Oral
TYR Lophlex LQ 20
SB
MP NP
C1453
 
3
5
 
[3]           Schedule 1, after entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine in the form Oral powder 500 g (MSUD Maxamum)
insert in the columns in the order indicated:
 
Oral liquid 125 mL, 30 (MSUD Lophlex LQ 20)
Oral
MSUD Lophlex LQ 20
SB
MP NP
C1220
 
3
5
 
[4]           Schedule 1, entry for Amino acids—synthetic, formula
substitute:
Amino acids — synthetic, formula
Oral powder 400 g (EleCare)
Oral
EleCare
AB
MP NP
C1687 C1688 C2734 C2735 C4033 C4034 C4035 C4036 C4037 C4038 C4039
P1687 P1688 P4033 P4034 P4035 P4036 P4037 P4038 P4039
8
5
 

 
 
 
 
 
MP NP
C1687 C1688 C2734 C2735 C4033 C4034 C4035 C4036 C4037 C4038 C4039
P2734 P2735
12
5
 

 
Oral powder 400 g (Neocate Advance)
Oral
Neocate Advance
SB
MP NP
C1687 C1688 C4033 C4034 C4035 C4036 C4037 C4038 C4039
 
8
5
 

 
Oral powder 400 g (Neocate Advance Tropical Flavour)
Oral
Neocate Advance Tropical Flavour
SB
MP NP
C1687 C1688 C4033 C4034 C4035 C4036 C4037 C4038 C4039
 
8
5
 

 
Oral powder 400 g (Neocate Advance Vanilla)
Oral
Neocate Advance Vanilla
SB
MP NP
C1687 C1688 C2734 C2735 C4033 C4034 C4035 C4036 C4037 C4038 C4039
P1687 P1688 P4033 P4034 P4035 P4036 P4037 P4038 P4039
8
5
 

 
 
 
 
 
MP NP
C1687 C1688 C2734 C2735 C4033 C4034 C4035 C4036 C4037 C4038 C4039
P2734 P2735
12
5
 

[5]           Schedule 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids
substitute:
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids
Oral powder 400 g (Neocate LCP)
Oral
Neocate LCP
SB
MP NP
C1687 C1688 C4033 C4034 C4035 C4036 C4037 C4038 C4039
 
8
5
 

 
Oral powder 400 g (EleCare LCP)
Oral
EleCare LCP
AB
MP NP
C1687 C1688 C4033 C4034 C4035 C4036 C4037 C4038 C4039
 
8
5
 

[6]           Schedule 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and
medium chain triglycerides
substitute:
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides
Oral powder 400 g (Neocate Gold)
Oral
Neocate Gold
SB
MP NP
C1687 C1688 C2734 C2735 C4033 C4034 C4035 C4036 C4037 C4038 C4039
P1687 P1688 P4033 P4034 P4035 P4036 P4037 P4038 P4039
8
5
 

 
 
 
 
 
MP NP
C1687 C1688 C2734 C2735 C4033 C4034 C4035 C4036 C4037 C4038 C4039
P2734 P2735
12
5
 

[7]           Schedule 1, entry for Apixaban
substitute:
Apixaban
Tablet 2.5 mg
Oral
Eliquis
BQ
MP NP
C3957 C3991 C4043 C4044 C4046
P3957 P4043
20
0
 

 
 
 
 
 
MP NP
C3957 C3991 C4043 C4044 C4046
P3991 P4044
30
0
 

 
 
 
 
 
MP NP
C3957 C3991 C4043 C4044 C4046
P4046
60
0
 

[8]           Schedule 1, entry for Bortezomib
omit from the column headed “Form”:           (with any determined brand of sodium chloride injection as the required solvent)
[9]           Schedule 1, entry for Carbomer in the form Eye gel 2 mg per g, 10 g
(a)        omit from the column headed “Responsible Person” for the brand “PAA” (twice occurring):          NM         substitute:                IQ
(b)           omit from the column headed “Responsible Person” for the brand “Viscotears” (twice occurring):               NV                substitute:             AQ
[10]         Schedule 1, entry for Carbomer in the form Eye gel 2 mg per g, single dose units 0.6 mL, 30
omit from the column headed “Responsible Person”:                 NV          substitute:             AQ
[11]         Schedule 1, entry for Cefepime in the form Powder for injection 1 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent)
omit:
 
 
 
Maxipime
BQ
MP NP
C1427
 
10
0
 
[12]         Schedule 1, entry for Ceftriaxone in each of the forms: Powder for injection 1 g (as sodium); and Powder for injection 2 g (as sodium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ceftriaxone-AFT
AE
MP NP
C1169 C1846 C1847
 
5
0
 
[13]         Schedule 1, entry for Ciprofloxacin in the form Tablet 500 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Loxip 500
DO
MP NP
C1431 C1432 C1572 C1573
 
14
0
 
[14]         Schedule 1, entry for Ciprofloxacin in the form Tablet 750 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Loxip 750
DO
MP NP
C1431 C1432 C1572 C1573
 
14
0
 
[15]         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”:
 
 
 
A-Citalopram
TA
MP NP
C1211
 
28
5
 
[16]         Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Clopidogrel 75
CR
MP NP
C1719 C1720 C1721 C1722 C1723 C1724
 
28
5
 
[17]         Schedule 1, entry for Dabigatran etexilate
substitute:
Dabigatran etexilate
Capsule 75 mg (as mesilate)
Oral
Pradaxa
BY
MP NP
C3957 C4047 C4048
P3957
20
0
 

 
 
 
 
 
MP NP
C3957 C4047 C4048
P4047
20
1
 

 
 
 
 
 
MP NP
C3957 C4047 C4048
P4048
60
0
 

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

 
 
 
 
 
MP NP
C3957 C4047 C4048
P4047
20
1
 

 
 
 
 
 
MP NP
C3957 C4047 C4048
P4048
60
0
 

[18]         Schedule 1, entry for Denosumab in the form Injection 120 mg in 1.7 mL
omit from the column headed “Circumstances”:
C3881
insert in numerical order:
C4051
[19]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 160 mg in 16 mL [DBL Docetaxel Concentrated Injection]
insert in numerical order in the column headed “Circumstances”:
C3892
[20]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL [DBL Docetaxel Concentrated Injection]
insert in numerical order in the column headed “Circumstances”:
C3892
 
[21]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL [DBL Docetaxel Concentrated Injection]
insert in numerical order in the column headed “Circumstances”:
C3892
[22]         Schedule 1, entry for Etonogestrel
omit from the column headed “Authorised Prescriber”:            MP NP                  substitute:             MP NP MW
[23]         Schedule 1, entry for Fentanyl
omit:
 
Lozenges 200 micrograms (as citrate), 3
Buccal
Actiq
OA
MP NP
C3663
 
3
0
 

 
Lozenges 400 micrograms (as citrate), 3
Buccal
Actiq
OA
MP NP
C3663
 
3
0
 

 
Lozenges 600 micrograms (as citrate), 3
Buccal
Actiq
OA
MP NP
C3663
 
3
0
 

 
Lozenges 800 micrograms (as citrate), 3
Buccal
Actiq
OA
MP NP
C3663
 
3
0
 

 
Lozenges 1200 micrograms (as citrate), 3
Buccal
Actiq
OA
MP NP
C3663
 
3
0
 

 
Lozenges 1600 micrograms (as citrate), 3
Buccal
Actiq
OA
MP NP
C3663
 
3
0
 

 
Lozenges 200 micrograms (as citrate), 30
Buccal
Actiq
OA
MP NP
C3664
 
2
0
 

 
Lozenges 400 micrograms (as citrate), 30
Buccal
Actiq
OA
MP NP
C3664
 
2
0
 

 
Lozenges 600 micrograms (as citrate), 30
Buccal
Actiq
OA
MP NP
C3664
 
2
0
 

 
Lozenges 800 micrograms (as citrate), 30
Buccal
Actiq
OA
MP NP
C3664
 
2
0
 

 
Lozenges 1200 micrograms (as citrate), 30
Buccal
Actiq
OA
MP NP
C3664
 
2
0
 

 
Lozenges 1600 micrograms (as citrate), 30
Buccal
Actiq
OA
MP NP
C3664
 
2
0
 

 
substitute:
 
Lozenge 200 micrograms (as citrate)
Buccal
Actiq
OA
MP NP
C3663 C3664
P3663
9
0
 

 
 
 
 
 
MP NP
C3663 C3664
P3664
60
0
 

 
Lozenge 400 micrograms (as citrate)
Buccal
Actiq
OA
MP NP
C3663 C3664
P3663
9
0
 

 
 
 
 
 
MP NP
C3663 C3664
P3664
60
0
 

 
Lozenge 600 micrograms (as citrate)
Buccal
Actiq
OA
MP NP
C3663 C3664
P3663
9
0
 

 
 
 
 
 
MP NP
C3663 C3664
P3664
60
0
 

 
Lozenge 800 micrograms (as citrate)
Buccal
Actiq
OA
MP NP
C3663 C3664
P3663
9
0
 

 
 
 
 
 
MP NP
C3663 C3664
P3664
60
0
 

 
Lozenge 1200 micrograms (as citrate)
Buccal
Actiq
OA
MP NP
C3663 C3664
P3663
9
0
 

 
 
 
 
 
MP NP
C3663 C3664
P3664
60
0
 

 
Lozenge 1600 micrograms (as citrate)
Buccal
Actiq
OA
MP NP
C3663 C3664
P3663
9
0
 

 
 
 
 
 
MP NP
C3663 C3664
P3664
60
0
 

[24]         Schedule 1, entry for Gefitinib
substitute:
Gefitinib
Tablet 250 mg
Oral
Iressa
AP
MP
C4029 C4030
 
30
3
 
[25]         Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 100 (Accu-Chek Performa)
insert in the columns in the order indicated:
 
Test strips, 100 (BGStar)
For external use
BGStar
SW
MP NP
 
 
1
5
 

 
 
 
 
 
MP
 
P3035
1
11
 

[26]         Schedule 1, entry for Hypromellose in the form Eye drops 3 mg per mL, 15 mL
(a)        omit from the column headed “Responsible Person” for the brand “Genteal” (twice occurring):   NV          substitute:                AQ
(b)           omit from the column headed “Responsible Person” for the brand “In a Wink Moisturising” (twice occurring):        NM                substitute:             IQ
[27]         Schedule 1, entry for Hypromellose with Carbomer 980 in the form Ocular lubricating gel 3 mg-2 mg per g, 10 g
(a)        omit from the column headed “Responsible Person” for the brand “Genteal gel” (twice occurring):             NV                substitute:             AQ
(b)           omit from the column headed “Responsible Person” for the brand “HPMC PAA” (twice occurring):            NM                substitute:             IQ
[28]         Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irinotecan Alphapharm
AF
MP
C3184
 
See Note 3
See Note 3
D
[29]         Schedule 1, entry for Levetiracetam in the form Tablet 250 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Kerron 250
DO
MP NP
C2664
 
60
5
 
[30]         Schedule 1, entry for Levetiracetam in the form Tablet 500 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Kerron 500
DO
MP NP
C2664
 
60
5
 
[31]         Schedule 1, entry for Levetiracetam in the form Tablet 1 g
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Kerron 1000
DO
MP NP
C2664
 
60
5
 
[32]         Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metformin Pfizer
FZ
MP NP
 
 
100
5
 
[33]         Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metformin Pfizer
FZ
MP NP
 
 
60
5
 
[34]         Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metformin Pfizer
FZ
MP NP
 
 
90
5
 
[35]         Schedule 1, entry for Mirtazapine in each of the forms: Tablet 30 mg; and Tablet 45 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Mirtazapine GH
GQ
MP NP
C1211
 
30
5
 
[36]         Schedule 1, entry for Moclobemide in each of the forms: Tablet 150 mg; and Tablet 300 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Moclobemide-PS
FZ
MP NP
C1211
 
60
5
 
[37]         Schedule 1, entry for Olanzapine in the form Tablet 2.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Olanzapine 2.5
CR
MP NP
C1589 C2044
 
28
5
 
[38]         Schedule 1, entry for Olanzapine in the form Tablet 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Olanzapine 5
CR
MP NP
C1589 C2044
 
28
5
 
[39]         Schedule 1, entry for Olanzapine in the form Tablet 7.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Olanzapine 7.5
CR
MP NP
C1589 C2044
 
28
5
 
[40]         Schedule 1, entry for Olanzapine in the form Tablet 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Olanzapine 10
CR
MP NP
C1589 C2044
 
28
5
 
[41]         Schedule 1, entry for Omeprazole in the form Tablet 20 mg (as magnesium) [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 Sandoz
SZ
MP NP
C1177 C1337 C1476 C1533
P1177
30
1
 
[42]         Schedule 1, entry for Omeprazole in the form Tablet 20 mg (as magnesium) [Max Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Omeprazole Sandoz
SZ
MP NP
C1177 C1337 C1476 C1533
P1337 P1476 P1533
30
5
 
[43]         Schedule 1, entry for Ondansetron
omit:
Ondansetron
Tablet (orally disintegrating) 4 mg
Oral
Ondansetron ODT-DRLA
RZ
MP NP
See Note 1
C3050 C3611 See Note 2
P3050
See Note 2
4
See Note 2
0
See Note 2
 

 
 
 
 
 
MP NP
C3050 C3611
P3611
10
1
 

 
Tablet (orally disintegrating) 8 mg
Oral
Ondansetron ODT-DRLA
RZ
MP NP
See Note 1
C3050 C3611 See Note 2
P3050
See Note 2
4
See Note 2
0
See Note 2
 

 
 
 
 
 
MP NP
C3050 C3611
P3611
10
1
 

substitute:
Ondansetron
Tablet (orally disintegrating) 4 mg
Oral
Ondansetron ODT-DRLA
RZ
MP NP
See Note 1
C3050 C3611 See Note 2
P3050
See Note 2
4
See Note 2
0
See Note 2
 

 
 
 
Onsetron ODT 4
WQ
MP NP
See Note 1
C3050 C3611 See Note 2
P3050
See Note 2
4
See Note 2
0
See Note 2
 

 
 
 
Ondansetron ODT-DRLA
RZ
MP NP
C3050 C3611
P3611
10
1
 

 
 
 
Onsetron ODT 4
WQ
MP NP
C3050 C3611
P3611
10
1
 

 
Tablet (orally disintegrating) 8 mg
Oral
Ondansetron ODT-DRLA
RZ
MP NP
See Note 1
C3050 C3611 See Note 2
P3050
See Note 2
4
See Note 2
0
See Note 2
 

 
 
 
Onsetron ODT 8
WQ
MP NP
See Note 1
C3050 C3611 See Note 2
P3050
See Note 2
4
See Note 2
0
See Note 2
 

 
 
 
Ondansetron ODT-DRLA
RZ
MP NP
C3050 C3611
P3611
10
1
 

 
 
 
Onsetron ODT 8
WQ
MP NP
C3050 C3611
P3611
10
1
 

[44]         Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Max Quantity 4; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Zondan
GM
MP NP
See Note 1
C3050 C3611
See Note 2
P3050
See Note 2
4
See Note 2
0
See Note 2
 
[45]         Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Max Quantity 10; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Zondan
GM
MP NP
C3050 C3611
P3611
10
1
 
[46]         Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Max Quantity 4; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Zondan
GM
MP NP
See Note 1
C3050 C3611
See Note 2
P3050
See Note 2
4
See Note 2
0
See Note 2
 
[47]         Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Max Quantity 10; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Zondan
GM
MP NP
C3050 C3611
P3611
10
1
 
[48]         Schedule 1, omit entry for Polygeline
[49]         Schedule 1, entry for Protein hydrolysate formula with medium chain triglycerides
substitute:
Protein hydrolysate formula with medium chain triglycerides
Oral powder 400 g (Alfaré)
Oral
Alfaré
NT
MP NP
C1034 C1059 C1068 C1080 C1092 C1310 C1364 C1670 C2567 C4040 C4041 C4042
 
8
5
 

 
Oral powder 450 g (Karicare Aptamil Pepti-Junior Gold)
Oral
Karicare Aptamil Pepti-Junior Gold
NU
MP NP
C1034 C1059 C1080 C1092 C1310 C1364 C1670 C2567 C4040 C4041 C4042
 
8
5
 

[50]         Schedule 1, entry for Rivaroxaban
substitute:
Rivaroxaban
Tablet 10 mg
Oral
Xarelto
BN
MP NP
C3957 C3993 C4047 C4048 C4050
P3957
10
0
 

 
 
 
 
 
MP NP
C3957 C3993 C4047 C4048 C4050
P4047
10
1
 

 
 
 
 
 
MP NP
C3957 C3993 C4047 C4048 C4050
P4050
15
0
 

 
 
 
 
 
MP NP
C3957 C3993 C4047 C4048 C4050
P4048
15
1
 

 
 
 
 
 
MP NP
C3957 C3993 C4047 C4048 C4050
P3993
30
0
 

[51]         Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Max Quantity 42; Number of Repeats 0]
(a)        omit from the column headed “Responsible Person” for the brand “Terbihexal”:                              SZ          substitute:                HX
(b)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terbinafine Sandoz
SZ
MP NP
C2191 C2865 C3244
P2865 P3244
42
0
 
[52]         Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Max Quantity 42; Number of Repeats 1]
(a)        omit from the column headed “Responsible Person” for the brand “Terbihexal”:                              SZ          substitute:                HX
(b)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terbinafine Sandoz
SZ
MP NP
C2191 C2865 C3244
P2191
42
1
 
[53]         Schedule 1, entry for Teriparatide
omit all codes from the column headed “Circumstances” and substitute:
C4031  C4032
[54]         Schedule 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL
omit from the column headed “Circumstances”:
C3881  C3882
insert in numerical order:
C4051  C4052
[55]         Schedule 3, details relevant to Responsible person code GH
omit:
Goldshield Healthcare (Australia) Pty Limited
substitute:
Mercury Pharma (Australia) Pty Limited
 
[56]         Schedule 4, Part 1, entry for Amino acids—synthetic, formula
(a)           omit:
 
C2805
P2805
Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application
Compliance with Authority Required procedures

 
C2806
P2806
Initial treatment, in consultation with a paediatric gastroenterologist or specialist allergist, for up to 3 months, of a child up to the age of 2 years with severe intolerance (not infant colic) to cows' milk protein, and where the date of birth of the patient is included in the authority application
Compliance with Authority Required procedures

 
C2807
P2807
Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
Compliance with Authority Required procedures

 
C2808
P2808
Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
Compliance with Authority Required procedures

 
C2809
P2809
Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application
Compliance with Authority Required procedures

 
C2810
P2810
Treatment for severe intolerance (not infant colic) to cows' milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
Compliance with Authority Required procedures

(b)           insert in numerical order after existing text:
 
C4033
P4033
Initial treatment, in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist, for up to 6 months, for cows' milk protein enteropathy with combined intolerance to both soy protein and protein hydrolysate formulae (not isolated colic or reflux) in a child up to the age of 24 months. Combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula. The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

 
C4034
P4034
Initial treatment, in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist, for up to 6 months, for severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux) in a child up to the age of 24 months. The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

 
C4035
P4035
Initial treatment for combined intolerance (not isolated infant colic or reflux) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

 
C4036
P4036
Treatment, in consultation with a specialist allergist or clinical immunologist, for a child with cows' milk anaphylaxis, up to the age of 24 months. Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction. The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

 
C4037
P4037
Continuing treatment for cows' milk protein enteropathy with combined intolerance to both soy protein and protein hydrolysate formulae (not isolated infant colic or reflux) in a child up to the age of 24 months. The child must have been assessed or have an appointment to be assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

 
C4038
P4038
Continuing treatment for severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux) in a child up to the age of 24 months. The child must have been assessed at least once or have an appointment to be assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. Then name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

 
C4039
P4039
Continuing treatment for combined intolerance (not isolated infant colic or reflux) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist at intervals not greater than 12 months. The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

[57]         Schedule 4, Part 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids
substitute:
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids
C1687
 
Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed
Compliance with Authority Required procedures

 
C1688
 
Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition
Compliance with Authority Required procedures

 
C4033
 
Initial treatment, in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist, for up to 6 months, for cows' milk protein enteropathy with combined intolerance to both soy protein and protein hydrolysate formulae (not isolated colic or reflux) in a child up to the age of 24 months. Combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula. The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

 
C4034
 
Initial treatment, in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist, for up to 6 months, for severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux) in a child up to the age of 24 months. The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

 
C4035
 
Initial treatment for combined intolerance (not isolated infant colic or reflux) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

 
C4036
 
Treatment, in consultation with a specialist allergist or clinical immunologist, for a child with cows' milk anaphylaxis, up to the age of 24 months. Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction. The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

 
 
C4037
 
Continuing treatment for cows' milk protein enteropathy with combined intolerance to both soy protein and protein hydrolysate formulae (not isolated infant colic or reflux) in a child up to the age of 24 months. The child must have been assessed or have an appointment to be assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

 
C4038
 
Continuing treatment for severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux) in a child up to the age of 24 months. The child must have been assessed at least once or have an appointment to be assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. Then name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

 
C4039
 
Continuing treatment for combined intolerance (not isolated infant colic or reflux) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist at intervals not greater than 12 months. The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

[58]         Schedule 4, Part 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and
medium chain triglycerides
substitute:
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides
C1687
P1687
Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed
Compliance with Authority Required procedures

 
C1688
P1688
Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition
Compliance with Authority Required procedures

 
C2734
P2734
Initial treatment for up to 3 months, by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who requires an amino acid based formula as a component of a dietary elimination programme, and where:
eosinophilic oesophagitis is demonstrated by the following criteria:
(i) chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and
(ii) a lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and
(iii) eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy specimen had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies;
the date of birth of the patient is included in the authority application;
treatment with oral steroids is not commenced during the period of initial treatment
Compliance with Authority Required procedures

 
C2735
P2735
Continuing treatment by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who has responded to an initial course of PBS-subsidised treatment, and where:
response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy specimen has 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies;
the response criteria will be deemed to have been not met if the patient commenced oral steroids during initial treatment
Compliance with Authority Required procedures

 
C4033
P4033
Initial treatment, in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist, for up to 6 months, for cows' milk protein enteropathy with combined intolerance to both soy protein and protein hydrolysate formulae (not isolated colic or reflux) in a child up to the age of 24 months. Combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula. The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

 
C4034
P4034
Initial treatment, in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist, for up to 6 months, for severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux) in a child up to the age of 24 months. The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

 
C4035
P4035
Initial treatment for combined intolerance (not isolated infant colic or reflux) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

 
C4036
P4036
Treatment, in consultation with a specialist allergist or clinical immunologist, for a child with cows' milk anaphylaxis, up to the age of 24 months. Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction. The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

 
 
C4037
P4037
Continuing treatment for cows' milk protein enteropathy with combined intolerance to both soy protein and protein hydrolysate formulae (not isolated infant colic or reflux) in a child up to the age of 24 months. The child must have been assessed or have an appointment to be assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

 
C4038
P4038
Continuing treatment for severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux) in a child up to the age of 24 months. The child must have been assessed at least once or have an appointment to be assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. Then name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

 
C4039
P4039
Continuing treatment for combined intolerance (not isolated infant colic or reflux) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist at intervals not greater than 12 months. The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

[59]         Schedule 4, Part 1, entry for Apixaban
substitute:
Apixaban
C3957
P3957
Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 10 days of therapy;
Compliance with Authority Required procedures

 
C3991
P3991
Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 15 days of therapy;
Compliance with Authority Required procedures

 
C4043
P4043
Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 10 days supply to complete a course of treatment
Compliance with Authority Required procedures

 
C4044
P4044
Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 15 days supply to complete a course of treatment
Compliance with Authority Required procedures

 
C4046
P4046
Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 30 days supply to complete a course of treatment
Compliance with Authority Required procedures

[60]         Schedule 4, Part 1, entry for Dabigatran etexilate
substitute:
 
C3957
P3957
Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 10 days of therapy
Compliance with Authority Required procedures

 
C4047
P4047
Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 20 days supply to complete a course of treatment
Compliance with Authority Required procedures

 
C4048
P4048
Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 30 days supply to complete a course of treatment
Compliance with Authority Required procedures

[61]         Schedule 4, Part 1, entry for Denosumab
(a)           omit:
 
C3881
 
Bone metastases from hormone-resistant prostate cancer
Compliance with Authority Required procedures
(b)           insert in numerical order after existing text:
 
C4051
 
Bone metastases from castration-resistant prostate cancer
Compliance with Authority Required procedures
[62]         Schedule 4, Part 1, entry for Gefitinib
substitute:
Gefitinib
C4029
 
Initial PBS-subsidised treatment, as monotherapy, of locally advanced or metastatic non-small cell lung cancer in patients with a WHO performance status of 2 or less, where:
(1) disease progression has occurred following treatment with at least 1 chemotherapy agent; and
(2) there is evidence that the patient has an activating mutation(s) of the epidermal growth factor receptor (EGFR) gene in tumour material
Compliance with Authority Required procedures

 
C4030
 
Continuing PBS-subsidised treatment, as monotherapy, of locally advanced or metastatic non-small cell lung cancer in patients with a WHO performance status of 2 or less, where the patient has previously been issued with an authority prescription for gefitinib
Compliance with Authority Required procedures

[63]         Schedule 4, Part 1, entry for Protein hydrolysate formula with medium chain triglycerides
(a)           omit:
 
C2806
 
Initial treatment, in consultation with a paediatric gastroenterologist or specialist allergist, for up to 3 months, of a child up to the age of 2 years with severe intolerance (not infant colic) to cows' milk protein, and where the date of birth of the patient is included in the authority application
Compliance with Authority Required procedures

 
C2811
 
Initial treatment, for up to 3 months, for intolerance (not infant colic) to both cows' milk protein and soy protein in a child up to the age of 2 years, where intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free diet with a soy protein as the principal formula, and where the date of birth of the patient is included in the authority application
Compliance with Authority Required procedures

 
C2812
 
Continuing treatment for intolerance (not infant colic) to both cows' milk protein and soy protein in a child up to the age of 2 years, where clinical improvement has been demonstrated with the protein hydrolysate formula with medium chain triglycerides, and where the date of birth of the patient is included in the authority application
Compliance with Authority Required procedures

 
C2813
 
Continuing treatment for intolerance (not infant colic) to both cows' milk protein and soy protein in a child aged 2 years and over, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
Compliance with Authority Required procedures

 
C2814
 
Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child up to the age of 2 years, where clinical improvement has been demonstrated with the protein hydrolysate formula with medium chain triglycerides and soy protein is not tolerated or is likely not to be tolerated, and where the date of birth of the patient is included in the authority application
Compliance with Authority Required procedures

 
C2815
 
Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child aged 2 years and over, where the child has been assessed by a paediatric gastroenterologist or specialist allergist, and where the date of birth of the patient is included in the authority application
Compliance with Authority Required procedures

(b)           insert in numerical order after existing text:
 
C4040
 
Initial treatment by, or in consultation with, a specialist allergist, clinical immunologist, paediatrician or specialist paediatric gastroenterologist for both cows' milk protein enteropathy and intolerance to soy protein (not isolated infant colic or reflux) in a child up to the age of 24 months. The child should have failed to respond to a strict soy-based cows' milk protein free diet. The date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

 
C4041
 
Continuing treatment by, or in consultation with, a specialist allergist, clinical immunologist, paediatrician or specialist paediatric gastroenterologist for both cows' milk protein enteropathy and intolerance to soy protein (not isolated infant colic or reflux) in a child up to the age of 24 months, where clinical improvement has been demonstrated with the protein hydrolysate formula with medium chain triglycerides. The date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

 
C4042
 
Treatment by a specialist allergist, clinical immunologist, paediatrician or specialist paediatric gastroenterologist for both cows' milk protein enteropathy and intolerance to soy protein (not isolated infant colic or reflux) in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application
Compliance with Authority Required procedures

[64]         Schedule 4, Part 1, entry for Rivaroxaban
substitute:
Rivaroxaban
C3957
P3957
Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 10 days of therapy
Compliance with Authority Required procedures

 
C3993
P3993
Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 30 days of therarpy
Compliance with Authority Required procedures

 
C4047
P4047
Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 20 days supply to complete a course of treatment
Compliance with Authority Required procedures

 
C4048
P4048
Prevention of venous thromboembolism in a patient undergoing total hip replacement who requires up to 30 days supply to complete a course of treatment
Compliance with Authority Required procedures

 
C4050
P4050
Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 15 days of therapy
Compliance with Authority Required procedures

[65]         Schedule 4, Part 1, entry for Teriparatide
substitute:
Teriparatide
C4031
 
Initial treatment, as the sole PBS-subsidised agent, by a specialist or consultant physician, for severe, established osteoporosis in a patient with a very high risk of fracture who:
(a) has a bone mineral density (BMD) T-score of -3.0 or less; and
(b) has had 2 or more fractures due to minimal trauma; and
(c) has experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a 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
If treatment with anti-resorptive therapy is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, details of the contraindication must be provided at the time of application
If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of 1 anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details of toxicities including severity must be provided at the time of application
Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months, disodium etidronate 200 mg with calcium carbonate 1.25 g per day, strontium ranelate 2 g per day and zoledronic acid 5 mg per annum
Details of prior anti-resorptive therapy, fracture history including the date(s) and site(s), the symptoms associated with the fracture(s) which developed during the course of anti-resorptive therapy, and the score of the qualifying BMD measurement must be provided to Medicare Australia at the time of application
Compliance with Authority Required procedures

 
C4032
 
Continuing treatment for severe established osteoporosis where the patient has previously been issued with an authority prescription for this drug
Teriparatide must only be used for a lifetime maximum of 18 months therapy (18 pens). Up to a maximum of 18 pens will be reimbursed through the PBS
Compliance with Authority Required procedures

[66]         Schedule 4, Part 1, entry for Zoledronic acid
(a)           omit:
 
C3881
 
Where the patient is receiving treatment at/from a private hospital
Bone metastases from hormone-resistant prostate cancer
Compliance with Written or Telephone Authority Required procedures

 
C3882
 
Where the patient is receiving treatment at/from a public hospital
Bone metastases from hormone-resistant prostate cancer
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3882

(b)           insert in numerical order after existing text:
 
C4051
 
Where the patient is receiving treatment at/from a private hospital
Bone metastases from castration-resistant prostate cancer
Compliance with Written or Telephone Authority Required procedures

 
C4052
 
Where the patient is receiving treatment at/from a public hospital
Bone metastases from castration-resistant prostate cancer
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4052

 
 
 
 
 
 
 
 
 
 
 
 
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.
 
Read Entire Law on www.comlaw.gov.au