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PB 37 of 2012 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (No. PB 108 of 2010) to provide for additions, deletions and changes to drugs, forms, brands, responsible person codes and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).
Administered by: Health
Registered 15 Jun 2012
Tabling HistoryDate
Tabled HR18-Jun-2012
Tabled Senate18-Jun-2012
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

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.