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PB 44 of 2012 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme and related matters.
Administered by: Health
Registered 25 Jul 2012
Tabling HistoryDate
Tabled HR14-Aug-2012
Tabled Senate14-Aug-2012
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

PB 44 of 2012

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012
(No.6)
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                                          19 July 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. 6).

            (2)        This Instrument may also be cited as PB 44 of 2012.

2          Commencement

            This Instrument commences on 1 August 2012.

3          Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010)

            Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).



Schedule 1     Amendments

 

[1]           Schedule 1, entry for Adalimumab in each of the forms: Injection 20 mg in 0.4 mL pre-filled syringe; Injection 40 mg in 0.8 mL pre-filled syringe; Injection 40 mg in 0.8 mL pre-filled pen; Injection 40 mg in 0.8 mL pre-filled syringe, 6; and Injection 40 mg in 0.8 mL pre-filled pen, 6

omit from the column headed “Responsible Person”: AB          substitute: VE

[2]           Schedule 1, entry for Alendronic Acid in the form Tablet 70 mg (as alendronate sodium)

omit from the column headed “Responsible Person” for the brand “Alendrobell 70mg”: BF          substitute: GQ

[3]           Schedule 1, entry for Amino acid formula with vitamins and minerals without lysine and low in tryptophan

(a) omit from the column headed “Form”: (GA express)         substitute: (GA express 15)

(b) omit from the column headed “Brand”: GA express          substitute: GA express 15

[4]           Schedule 1, entry for Amino acid formula with vitamins and minerals without methionine

(a) omit from the column headed “Form”: (HCU express)       substitute: (HCU express 15)

(b) omit from the column headed “Brand”: HCU express       substitute: HCU express 15

[5]           Schedule 1, entry for Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine

(a) omit from the column headed “Form”: (MMA/PA express)              substitute: (MMA/PA express 15)

(b) omit from the column headed “Brand”:   MMA/PA express             substitute: MMA/PA express 15

[6]           Schedule 1, after entry for Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine in the form Oral powder 500 g (XMTVI Maxamum)

insert in the columns in the order indicated:

 

Oral liquid 130 mL, 30 (MMA/PA cooler)

Oral

MMA/PA cooler

VF

MP NP

C1225 C1307

 

4

5

 

[7]           Schedule 1, entry for Amino acid formula with vitamins and minerals without phenylalanine

(a) omit from the column headed “Form”: (PKU Express)      substitute: (PKU express 15)

(b) omit from the column headed “Brand”:   PKU Express     substitute: PKU express 15

[8]           Schedule 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine in the form Sachets containing oral powder 29 g, 30 (PKU Anamix Junior)

insert in the columns in the order indicated:

 

Sachets containing oral powder 34 g, 30
(PKU express 20)

Oral

PKU express 20

VF

MP NP

C1286

 

4

5

 

[9]           Schedule 1, entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine

(a) omit from the column headed “Form”: (TYR Express)      substitute: (TYR express 15)

(b) omit from the column headed “Brand”:   TYR Express     substitute: TYR express 15

[10]         Schedule 1, entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine

(a) omit from the column headed “Form”: (MSUD Express)  substitute: (MSUD express 15)

(b) omit from the column headed “Brand”:   MSUD Express substitute: MSUD express 15

[11]         Schedule 1, after entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine in the form Sachets containing oral powder 29 g, 30 (MSUD Anamix Junior)

insert in the columns in the order indicated:

 

Sachets containing oral powder 34 g, 30 (MSUD express 20)

Oral

MSUD express 20

VF

MP NP

C1220

 

4

5

 

[12]         Schedule 1, entry for Aspirin in the form Tablet 100 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Spren 100

QA

MP NP

 

 

112

1

 


[13]         Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Max Quantity 30; Number of Repeats 5]

(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Atorvastatin SCP 10

RZ

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

STADA Atorvastatin

TD

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[14]         Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Max Quantity 30; Number of Repeats 11]

(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Atorvastatin SCP 10

RZ

MP

C1540 C3047

P3047

30

11

 

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

STADA Atorvastatin

TD

MP

C1540 C3047

P3047

30

11

 

[15]         Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Max Quantity 30; Number of Repeats 5]

(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Atorvastatin SCP 20

RZ

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

STADA Atorvastatin

TD

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 


[16]         Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Max Quantity 30; Number of Repeats 11]

(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Atorvastatin SCP 20

RZ

MP

C1540 C3047

P3047

30

11

 

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

STADA Atorvastatin

TD

MP

C1540 C3047

P3047

30

11

 

[17]         Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Max Quantity 30; Number of Repeats 5]

(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Atorvastatin SCP 40

RZ

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

STADA Atorvastatin

TD

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[18]         Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Max Quantity 30; Number of Repeats 11]

(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Atorvastatin SCP 40

RZ

MP

C1540 C3047

P3047

30

11

 

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

STADA Atorvastatin

TD

MP

C1540 C3047

P3047

30

11

 


[19]         Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Max Quantity 30; Number of Repeats 5]

(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Atorvastatin SCP 80

RZ

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

STADA Atorvastatin

TD

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[20]         Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Max Quantity 30; Number of Repeats 11]

(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Atorvastatin SCP 80

RZ

MP

C1540 C3047

P3047

30

11

 

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

STADA Atorvastatin

TD

MP

C1540 C3047

P3047

30

11

 

[21]         Schedule 1, after entry for Auranofin in the form Tablet 3 mg

insert in the columns in the order indicated:

 

Capsule 3 mg

Oral

Ridaura

BZ

MP NP

 

 

60

5

 

[22]         Schedule 1, after entry for Busulfan

insert in the columns in the order indicated:

Cabazitaxel

Concentrated injection 60 mg (as acetone solvate) in 1.5 mL, with diluent

Injection

Jevtana

SW

MP

C7000 C7001

 

See Note 3

 

See Note 3

D


[23]         Schedule 1, entry for Cefepime in each of the forms: Powder for injection 1 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent); and Powder for injection 2 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Cefepime Sandoz

SZ

MP NP

C1427

 

10

0

 

[24]         Schedule 1, entry for Ceftriaxone in the form Powder for injection 1 g (as sodium) [Max Pharma Pty Ltd]

(a)        omit from the column headed “Brand”: Max Pharma Pty Ltd              substitute: Max Pharma Ceftriaxone

(b)           omit from the column headed “Responsible Person”: XF                          substitute: GQ

[25]         Schedule 1, after entry for Cefuroxime in the form Tablet 250 mg (as axetil)

insert in the columns in the order indicated:

 

Powder for oral suspension 125 mg (as axetil) per 5 mL, 70 mL

Oral

Zinnat

GK

PDP

 

 

1

0

 

 

 

 

 

 

MP

 

 

1

1

 

[26]         Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous)

(a) omit:

 

 

 

Cephabell

BF

PDP

 

 

20

0

 

 (b) omit:

 

 

 

Cephabell

BF

MP NP MW

 

 

20

1

 

[27]         Schedule 1, entry for Ciprofloxacin in each of the forms: Tablet 500 mg (as hydrochloride); and Tablet 750 mg (as hydrochloride)

omit from the column headed “Responsible Person” for the brand “Ciprofloxacin-BW”: BF          substitute: GQ

[28]         Schedule 1, entry for Citalopram in the form Tablet 20 mg (as hydrobromide)

omit:

 

 

 

Citalobell

BF

MP NP

C1211

 

28

5

 

[29]         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”:

 

 

 

Plavicor 75

MI

MP NP

C1719 C1720 C1721 C1722 C1723 C1724

 

28

5

 

[30]         Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

STADA Clopidogrel

TD

MP NP

C1719 C1720 C1721 C1722 C1723 C1724

 

28

5

 

[31]         Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Cyprocur 100

QA

MP

C1014 C1404

 

50

5

 

[32]         Schedule 1, entry for Denosumab in the form Injection 60 mg in 1 mL pre-filled syringe

omit from the column headed “Circumstances”:

C2758

insert in numerical order:

C4054

[33]         Schedule 1, entry for Diltiazem in the form Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg

(a) omit from the column headed “Responsible Person” for the brand “Diltahexal CD”: SZ          substitute: HX

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Diltiazem Sandoz CD

SZ

MP NP

 

 

30

5

 

[34]         Schedule 1, entry for Diltiazem in the form Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg

(a) omit from the column headed “Responsible Person” for the brand “Diltahexal CD”: SZ          substitute: HX

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Diltiazem Sandoz CD

SZ

MP NP

 

 

30

5

 

[35]         Schedule 1, entry for Docetaxel

omit from the column headed “Circumstances” (all instances):

C3884

insert in numerical order:

C7002

[36]         Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg;  Tablet containing enalapril maleate 10 mg;  and Tablet containing enalapril maleate 20 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Enalapril-PS

FZ

MP NP

 

 

30

5

 


[37]         Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes
solvent 1 mL

(a) insert in numerical order in the column headed “Circumstances” (twice occurring):

C4057 C4058 C4059 C4060

(b) insert in numerical order in the column headed “Purposes” where the Max Quantity is 2; Number of repeats 3:

P4057 P4058 P4059 P4060

[38]         Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4

(a) insert in numerical order in the column headed “Circumstances” (twice occurring):

C4057 C4058 C4059 C4060

(b) insert in numerical order in the column headed “Purposes” where the Max Quantity is 1; Number of repeats 3:

P4057 P4058 P4059 P4060

[39]         Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4

(a) insert in numerical order in the column headed “Circumstances” (twice occurring):

C4057 C4058 C4059 C4060

(b) insert in numerical order in the column headed “Purposes” where the Max Quantity is 1; Number of repeats 3:

P4057 P4058 P4059 P4060

[40]         Schedule 1, entry for Galantamine in each of the forms: Capsule (prolonged release) 8 mg (as hydrobromide); Capsule (prolonged release) 16 mg (as hydrobromide); and Capsule (prolonged release) 24 mg (as hydrobromide)

(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

APO-Galantamine MR

TX

MP NP

C2934 C2938 C3875 C3876

 

28

5

 

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Gamine XR

QA

MP NP

C2934 C2938 C3875 C3876

 

28

5

 

[41]         Schedule 1, entry for Gliclazide in the form Tablet 80 mg

omit:

 

 

 

Mellihexal

SZ

MP NP

 

 

100

5

 

[42]         Schedule 1, entry for Hydroxychloroquine

substitute:

Hydroxychloroquine

Tablet containing hydroxychloroquine sulfate 200 mg

Oral

APO-Hydroxychloroquine

TX

MP NP

 

 

100

1

 

 

 

 

Chem mart Hydroxychloroquine

CH

MP NP

 

 

100

1

 

 

 

 

Plaquenil

SW

MP NP

 

 

100

1

 

 

 

 

Terry White Chemist Hydroxychloroquine

TW

MP NP

 

 

100

1

 

[43]         Schedule 1, after entry for Ibuprofen

insert in the columns in the order indicated:

Icatibant

Injection 30 mg (as acetate) in 3 mL single use pre-filled syringe

Injection

Firazyr

ZI

MP

C4055 C4056

 

1

1

 

[44]         Schedule 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Indapamide-PS

FZ

MP NP

 

 

90

1

 

[45]         Schedule 1, entry for Lamivudine in the form Tablet 150 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Lamivudine RBX

RA

MP

See Note 1

C3586 C3587

C3588 C3589

 

120

5

D

[46]         Schedule 1, entry for Lamivudine in the form Tablet 300 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Lamivudine RBX

RA

MP

See Note 1

C3586 C3587

C3588 C3589

 

60

5

D

[47]         Schedule 1, entry for Latanoprost in the form Eye drops 50 micrograms per mL, 2.5 mL

substitute:

Latanoprost

Eye drops 50 micrograms per mL, 2.5 mL

Application to the eye

APO-Latanoprost

TX

MP AO

 

 

1

5

 

 

 

 

Chem mart Latanoprost

CH

MP AO

 

 

1

5

 

 

 

 

Latanoprost Pfizer

FZ

MP AO

 

 

1

5

 

 

 

 

Latanoprost Sandoz

SZ

MP AO

 

 

1

5

 

 

 

 

Terry White Chemists Latanoprost

TW

MP AO

 

 

1

5

 

 

 

 

Xalatan

PF

MP AO

 

 

1

5

 

[48]         Schedule 1, entry for Latanoprost with Timolol in the form Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Latanocom

FZ

MP AO

C3426 C3427

 

1

5

 

[49]         Schedule 1, entry for Letrozole in the form Tablet 2.5 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Lezole

WQ

MP NP

C1608 C2691 C2692

 

30

5

 

[50]         Schedule 1, entry for Leuprorelin in the form I.M. injection (modified release), powder for injection containing leuprorelin acetate 7.5 mg with diluent in pre-filled dual-chamber syringe

omit from the column headed “Responsible Person”: AB          substitute: VE

[51]         Schedule 1, entry for Leuprorelin in the form I.M. injection (modified release), powder for injection containing leuprorelin acetate 22.5 mg with diluent in pre-filled dual-chamber syringe

omit from the column headed “Responsible Person”: AB          substitute: VE

[52]         Schedule 1, entry for Leuprorelin in the form I.M. injection (modified release), powder for injection containing leuprorelin acetate 30 mg with diluent in pre-filled dual-chamber syringe

omit from the column headed “Responsible Person”: AB          substitute: VE

[53]         Schedule 1, entry for Levodopa with Carbidopa in the form Intestinal gel 20 mg-5 mg per mL, 100 mL

omit from the column headed “Responsible Person”: AB          substitute: VE

[54]         Schedule 1, entry for Lopinavir with Ritonavir in each of the forms: Tablet 100 mg-25 mg; Tablet 200 mg-50 mg; and Oral liquid 400 mg-100 mg per 5 mL, 60 mL

omit from the column headed “Responsible Person” for the brand “Kaletra” : AB            substitute: VE

[55]         Schedule 1, after entry for Magnesium

insert in the columns in the order indicated:

Mannitol

Pack containing 280 capsules containing powder for inhalation 40 mg and 2 inhalers

Inhalation by mouth

bronchitol

XA

MP
See Note 1

C4061 C4062 C4063 C4064

 

4

5

D

[56]         Schedule 1, entry for Meloxicam in the form Tablet 7.5 mg

(a)           omit from the column headed “Responsible Person” for the brand “Meloxibell”: BF        substitute: GQ

(b)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Meloxicam-PS

FZ

MP NP

C1547 C1848

 

30

3

 

[57]         Schedule 1, entry for Meloxicam in the form Tablet 15 mg

(a)           omit from the column headed “Responsible Person” for the brand “Meloxibell”: BF        substitute: GQ

(b)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Meloxicam-PS

FZ

MP NP

C1547 C1848

 

30

3

 

[58]         Schedule 1, entry for Meloxicam in the form Capsule 7.5 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Melox 7.5

GM

MP NP

C1547 C1848

 

30

3

 

[59]         Schedule 1, entry for Meloxicam in the form Capsule 15 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Melox 15

GM

MP NP

C1547 C1848

 

30

3

 

[60]         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”:

 

 

 

Formet Aspen 500

AS

MP NP

 

 

100

5

 

[61]         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”:

 

 

 

Formet Aspen 850

AS

MP NP

 

 

60

5

 

[62]         Schedule 1, entry for Mirtazapine in each of the forms: Tablet 15 mg (orally disintegrating); Tablet 30 mg (orally disintegrating); and Tablet 45 mg (orally disintegrating);

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Remeron SolTab

FR

MP NP

C1211

 

30

5

 

[63]         Schedule 1, entry for Morphine in each of the forms: Capsule containing morphine sulfate 10 mg (containing sustained release pellets); Capsule containing morphine sulfate 20 mg (containing sustained release pellets); Capsule containing morphine sulfate 50 mg (containing sustained release pellets); and Capsule containing morphine sulfate 100 mg (containing sustained release pellets)

omit from the column headed “Max Quantity”:           20           substitute:             28

[64]         Schedule 1, entry for Norfloxacin in the form Tablet 400 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Norfloxacin-PS

FZ

MP NP

C1002 C1070

 

14

1

 

[65]         Schedule 1, entry for Octreotide in each of the forms: Injection 50 micrograms (as acetate) in 1 mL; Injection 100 micrograms (as acetate) in 1 mL; and Injection 500 micrograms (as acetate) in 1 mL

omit from the column headed “Responsible Person” for the brand “Octreotide MaxRx”: XF          substitute:             GQ

[66]         Schedule 1, entry for Oestradiol

omit:

 

Transdermal patches 2 mg, 8

Transdermal

Estraderm 25

NV

MP NP

 

 

1

5

 

[67]         Schedule 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg (as benzoate); Tablet 5 mg (as benzoate); Tablet 7.5 mg (as benzoate); and Tablet 10 mg (as benzoate)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

STADA Olanzapine

TD

MP NP

C1589 C2044

 

28

5

 

[68]         Schedule 1, entry for Omeprazole in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Omeprazole-PS

FZ

MP NP

C1177 C1337 C1476 C1533

P1337 P1476 P1533

30

5

 

[69]         Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 125 micrograms

omit:

 

 

 

Sifrol

BY

MP NP

C3088 C3216

P3216

30

0

 

 

 

 

 

 

MP NP

C3088 C3216

P3088

30

2

 

substitute:

 

 

 

Sifrol

BY

MP NP

C3088 C3216

P3216

30

0

 

 

 

 

Simipex 0.125

QA

MP NP

C3088 C3216

P3216

30

0

 

 

 

 

Sifrol

BY

MP NP

C3088 C3216

P3088

30

2

 

[70]         Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 250 micrograms [Max Quantity 100; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Simipex 0.25

QA

MP NP

C3088 C3216

P3216

100

5

 

[71]         Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 1 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Simipex 1

QA

MP NP

C3216

 

100

5

 

[72]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Max Quantity 30; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Pravastatin-PS

FZ

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[73]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Max Quantity 30; Number of Repeats 11]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Pravastatin-PS

FZ

MP

C1540 C3047

P3047

30

11

 

[74]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Pravastatin-PS

FZ

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[75]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 11]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Pravastatin-PS

FZ

MP

C1540 C3047

P3047

30

11

 

[76]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Pravastatin-PS

FZ

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[77]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 11]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Pravastatin-PS

FZ

MP

C1540 C3047

P3047

30

11

 

[78]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg [Max Quantity 30; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Pravastatin-PS

FZ

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[79]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg [Max Quantity 30; Number of Repeats 11]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Pravastatin-PS

FZ

MP

C1540 C3047

P3047

30

11

 

[80]         Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)

(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Quetiapine-Synthon

ZT

MP NP

C1589 C2044 C2765

 

60

5

 

(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

STADA Quetiapine

TD

MP NP

C1589 C2044 C2765

 

60

5

 

[81]         Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)

(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Quetiapine-Synthon

ZT

MP NP

C1589 C2044 C2765

 

90

5

 

(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

STADA Quetiapine

TD

MP NP

C1589 C2044 C2765

 

90

5

 

[82]         Schedule 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)

(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Quetiapine-Synthon

ZT

MP NP

C1589 C2044 C2765

 

60

5

 

(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

STADA Quetiapine

TD

MP NP

C1589 C2044 C2765

 

60

5

 

[83]         Schedule 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)

(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Quetiapine-Synthon

ZT

MP NP

C1589 C2044 C2765

 

60

5

 

(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

STADA Quetiapine

TD

MP NP

C1589 C2044 C2765

 

60

5

 

[84]         Schedule 1, entry for Ramipril in the form Capsule 1.25 mg

(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

APO-Ramipril

TX

MP NP

 

 

30

5

 

(b)       insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Chem mart Ramipril

CH

MP NP

 

 

30

5

 

(c)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Terry White Chemists Ramipril

TW

MP NP

 

 

30

5

 

[85]         Schedule 1, entry for Ramipril in the form Capsule 2.5 mg

(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

APO-Ramipril

TX

MP NP

 

 

30

5

 

(b)       insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Chem mart Ramipril

CH

MP NP

 

 

30

5

 

(c)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Terry White Chemists Ramipril

TW

MP NP

 

 

30

5

 

[86]         Schedule 1, entry for Ramipril in the form Capsule 5 mg

(a)       insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

APO-Ramipril

TX

MP NP

 

 

30

5

 

(b)       insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Chem mart Ramipril

CH

MP NP

 

 

30

5

 

(c)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Terry White Chemists Ramipril

TW

MP NP

 

 

30

5

 

[87]         Schedule 1, after entry for Ranitidine in the form Syrup 150 mg (as hydrochloride) per 10 mL, 300 mL

insert:

Rasagiline

Tablet 1 mg (as mesilate)

Oral

Azilect

LU

MP NP

C4053

 

30

5

 

[88]         Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 35 mg

omit:

 

 

 

Actonel Once-a-Week

SW

MP NP

C2645 C2646 C3070

 

4

5

 

[89]         Schedule 1, entry for Risedronic Acid and Calcium in the form Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate)

omit:

 

 

 

Actonel Combi

SW

MP NP

C2645 C2646 C3070

 

1

5

 

[90]         Schedule 1, entry for Ritonavir in each of the forms: Tablet 100 mg; and Oral solution 600 mg per 7.5 mL (80 mg per mL), 90 mL

omit from the column headed “Responsible Person” for the brand “Norvir”: AB               substitute: VE

[91]         Schedule 1, entry for Roxithromycin in the form Tablet 150 mg [Max Quantity 10; Number of Repeats 0]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Roxithromycin-PS

FZ

PDP

 

 

10

0

 

[92]         Schedule 1, entry for Roxithromycin in the form Tablet 150 mg [Max Quantity 10; Number of Repeats 1]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Roxithromycin-PS

FZ

MP NP

 

 

10

1

 

[93]         Schedule 1, entry for Roxithromycin in the form Tablet 300 mg [Max Quantity 5; Number of Repeats 0]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Roxithromycin-PS

FZ

PDP

 

 

5

0

 

[94]         Schedule 1, entry for Roxithromycin in the form Tablet 300 mg [Max Quantity 5; Number of Repeats 1]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Roxithromycin-PS

FZ

MP NP

 

 

5

1

 

[95]         Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Simvastatin-DRLA

RZ

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[96]         Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 11]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Simvastatin-DRLA

RZ

MP

C1540 C3047

P3047

30

11

 

[97]         Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Simvastatin-DRLA

RZ

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[98]         Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 11]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Simvastatin-DRLA

RZ

MP

C1540 C3047

P3047

30

11

 


[99]         Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 5]

(a) omit:

 

 

 

Simvahexal

HX

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Simvastatin-DRLA

RZ

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[100]       Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 11]

(a) omit:

 

 

 

Simvahexal

HX

MP

C1540 C3047

P3047

30

11

 

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Simvastatin-DRLA

RZ

MP

C1540 C3047

P3407

30

11

 

[101]       Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Simvastatin-DRLA

RZ

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[102]       Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 11]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Simvastatin-DRLA

RZ

MP

C1540 C3047

P3047

30

11

 


[103]       Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Sumagran Aspen 50

AS

MP NP

C3233

 

4

5

 

[104]       Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Max Quantity 5; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Orion Temozolomide

ON

MP

C1736 C1737 C2100 C2101

P1736 P1737 P2101

5

5

 

[105]       Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Max Quantity 15; Number of Repeats 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Orion Temozolomide

ON

MP

C1736 C1737 C2100 C2101

P2100

15

2

 

[106]       Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Max Quantity 5; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Orion Temozolomide

ON

MP

C1736 C1737 C2100 C2101

P1736 P1737 P2101

5

5

 

[107]       Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Max Quantity 15; Number of Repeats 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Orion Temozolomide

ON

MP

C1736 C1737 C2100 C2101

P2100

15

2

 

[108]       Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Max Quantity 5; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Orion Temozolomide

ON

MP

C1736 C1737 C2100 C2101

P1736 P1737 P2101

5

5

 

[109]       Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Max Quantity 15; Number of Repeats 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Orion Temozolomide

ON

MP

C1736 C1737 C2100 C2101

P2100

15

2

 

[110]       Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Max Quantity 5; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Orion Temozolomide

ON

MP

C1736 C1737 C2100 C2101

P1736 P1737 P2101

5

5

 

[111]       Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Max Quantity 15; Number of Repeats 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Orion Temozolomide

ON

MP

C1736 C1737 C2100 C2101

P2100

15

2

 

[112]       Schedule 1, entry for Temozolomide in the form Capsule 250 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Orion Temozolomide

ON

MP

C1736 C1737 C2101

 

5

5

 

[113]       Schedule 1, after entry for Tiaprofenic Acid

insert:

Ticagrelor

Tablet 90 mg

Oral

Brilinta

AP

MP NP

C3879

 

56

5

 

[114]       Schedule 1, entry for Tipranavir

omit:

 

Oral liquid 100 mg per mL, 95 mL

Oral

Aptivus

BY

MP

See Note 1

C3602 C3603

 

7

5

D

[115]       Schedule 1, entry for Topotecan

insert in the columns in the order indicated:

 

 

 

Topotecan

PK

MP

C3186

 

See Note 3

See Note 3

D

[116]       Schedule 1, after entry for Triglycerides – medium chain, formula in the form Sachets containing oral powder 16 g, 30 (MCT Pro-Cal)

insert in the columns in the order indicated:

 

Oral powder 400 g (Lipistart)

Oral

Lipistart

VF

MP NP

C1068 C1511 C1513 C1670 C1671

 

8

5

 

[117]       Schedule 3

omit:

BF

Bellwether Pharma Ltd

15 109 403 287

[118]       Schedule 3, after details relevant to Responsible person code TA

insert:

TD

STADA Pharmaceuticals Australia Pty Limited

73 154 966 944

[119]       Schedule 3, after details relevant to Responsible person code UC

insert:

VE

AbbVie Pty Ltd

48 156 384 262

[120]       Schedule 3, after details relevant to Responsible person code WQ

insert:

XA

Pharmaxis Ltd

75 082 811 630

[121]       Schedule 3

omit:

XF

Max Pharma Pty Ltd

93 121 857 878

[122]       Schedule 4, Part 1, after entry for Bupropion

insert:

Cabazitaxel

C7000

 

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Treatment, in combination with prednisone or prednisolone, of castration resistant metastatic carcinoma of the prostate in a patient who has failed treatment with docetaxel due to resistance or intolerance and has a World Health Organisation performance status of 2 or less

Compliance with Authority Required procedures

 

C7001

 

Where the patient is receiving treatment at/from a Public Hospital

Treatment, in combination with prednisone or prednisolone, of castration resistant metastatic carcinoma of the prostate in a patient who has failed treatment with docetaxel due to resistance or intolerance and has a World Health Organisation performance status of 2 or less

Compliance with Authority Required procedures – Streamlined Authority Code 7001

[123]       Schedule 4, Part 1, entry for Denosumab

(a)           omit:

 

C2758

 

Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a woman aged 70 years or older with a bone mineral density T-score of -3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated

Compliance with Authority Required procedures – Streamlined Authority Code 2758

(b)           insert in numerical order after existing text:

 

C4054

 

Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a woman aged 70 years of age or older with a bone mineral density T-score of -2.5 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated

Compliance with Authority Required procedures – Streamlined Authority Code 4054

[124]       Schedule 4, Part 1, entry for Docetaxel

(a)           omit:

 

C3884

 

Treatment of androgen independent (hormone refractory) metastatic carcinoma of the prostate in a patient with a Karnofsky performance-status score of at least 60%, where docetaxel is used as first-line chemotherapy and administered in three weekly cycles

Compliance with Authority Required procedures – Streamlined Authority Code 3884

(b)           insert in numerical order after existing text:

 

C7002

 

Treatment of androgen independent (castration resistant) metastatic carcinoma of the prostate in a patient with a Karnofsky performance-status score of at least 60%, where docetaxel is used as first-line chemotherapy and administered in three weekly cycles

Compliance with Authority Required procedures – Streamlined Authority Code 7002

[125]       Schedule 4, Part 1, entry for Etanercept

insert in numerical order after existing text:

 

C4057

P4057

Chronic plaque psoriasis (Whole body) [Initial treatment — No prior biological agent]

Initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who:

(a) has severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and

(b) has not received any prior PBS-subsidised treatment with etanercept for this condition; and

(c) whose parent or authorised guardian has signed a patient acknowledgement; and

(d) has failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 3 treatments:

(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or

(ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; and/or

(iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks

If treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or where phototherapy is contraindicated, please provide details at the time of application

If intolerance to treatment with phototherapy, methotrexate or acitretin develops during the relevant period of use, which is of a severity to necessitate permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application

The following initiation criterion indicates failure to achieve an adequate response and must be demonstrated in all patients at the time of the application:

(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment

(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment

(c) The most recent PASI assessment must be no more than 1 month old at the time of application

Applications for authorisation must be made in writing and must include:

(a) a completed authority prescription form; and

(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following:

(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and

(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and

(iii) the parent or authorised guardian signed patient and prescriber acknowledgements

A maximum of 24 weeks of treatment with etanercept will be authorised under this restriction. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance of treatment, a further 8 weeks treatment, will be authorised if the submitted PASI assessment shows an adequate demonstrated response to treatment

A PASI assessment of the patient's response to the initial 16 week course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment under this restriction, must be submitted to the Chief Executive Medicare no later than 1 month from the date of completion of this initial course of treatment.  Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept

An adequate response to treatment is defined as:

Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, when compared with the pre-etanercept treatment baseline value

Compliance with Written Authority Required procedures

 

 

 

Continuation of initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who has severe chronic plaque psoriasis and who, although qualifying for an initial 16 week course of treatment with etanercept under the criteria specified above, has previously been issued with an authority prescription for less than 16 weeks of etanercept treatment, and where approval of the application would enable the patient to complete the initial 16 week treatment course

Compliance with Written or Telephone Authority Required procedures

 

C4058

P4058

Chronic plaque psoriasis (Whole body) [Re-Treatment — Received prior etanercept under PBS]

Treatment as systemic monotherapy (other than methotrexate) by a dermatologist for a patient under 18 years who has:

(a) a documented history of severe chronic plaque psoriasis; and

(b) received prior PBS-subsidised treatment with etanercept for this condition; and

(c) not failed PBS-subsidised therapy with etanercept for the treatment of this condition more than once in the current Treatment Cycle

Applications for authorisation must be made in writing and must include:

(a) a completed authority prescription form; and

(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following:

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and

(ii) details of prior etanercept treatment, including date

A total maximum of 24 weeks of treatment with etanercept will be authorised under this restriction. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance of treatment, a further 8 weeks treatment, will be authorised if the submitted PASI assessment shows an adequate demonstrated response to treatment

A PASI assessment of the patient's response to the initial 16 week course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment under this restriction, must be submitted to the Chief Executive Medicare no later than 1 month from the date of completion of this course of treatment. Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept

Compliance with Written Authority Required procedures

 

 

 

Continuation of initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who has a documented history of severe chronic plaque psoriasis, who has previously received PBS-subsidised treatment with etanercept for this condition, and who, although qualifying for an initial 16 week course of treatment with etanercept under the criteria specified above, has previously been issued with an authority prescription for less than 16 weeks of etanercept treatment, and where approval of the application would enable the patient to complete the initial 16 week treatment course

Compliance with Written or Telephone Authority Required procedures

 

C4059

P4059

Chronic plaque psoriasis (Face, hand, foot) [Initial treatment — No prior biological agent]

Initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who:

(a) has severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and

(b) has not received any prior PBS-subsidised treatment with etanercept for this condition; and

(c) whose parent or authorised guardian has signed a patient acknowledgement; and

(d) has failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 3 treatments:

(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or

(ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; and/or

(iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks

If treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or where phototherapy is contraindicated, please provide details at the time of application

If intolerance to treatment with phototherapy, methotrexate or acitretin develops during the relevant period of use, which is of a severity to necessitate permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application

The following initiation criterion indicates failure to achieve an adequate response and must be demonstrated in all patients at the time of the application:

(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:

(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; or

(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment

(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment

(c) The most recent PASI assessment must be no more than 1 month old at the time of application

Applications for authorisation must be made in writing and must include:

(a) a completed authority prescription form; and

(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following:

(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and

(iii) the parent or authorised guardian signed patient and prescriber acknowledgements

A maximum of 24 weeks of treatment with etanercept will be authorised under this restriction. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance of treatment, a further 8 weeks treatment, will be authorised if the submitted PASI assessment shows an adequate demonstrated response to treatment

A PASI assessment of the patient's response to the initial 16 week course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated.  This assessment, which will be used to determine eligibility for a further 8 weeks of treatment under this restriction, must be submitted to the Chief Executive Medicare no later than 1 month from the date of completion of this initial course of treatment.  Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept

An adequate response to treatment is defined as:

A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, when compared with the pre-etanercept treatment baseline value

Compliance with Written Authority Required procedures

 

 

 

Continuation of initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who has severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot and who, although qualifying for an initial 16 week course of treatment with etanercept under the criteria specified above, has previously been issued with an authority prescription for less than 16 weeks of etanercept treatment, and where approval of the application would enable the patient to complete the initial 16 week treatment course

Compliance with Written or Telephone Authority Required procedures

 

C4060

P4060

Chronic plaque psoriasis (Face, hand, foot) [Re-Treatment — Received prior etanercept under PBS]

Treatment as systemic monotherapy (other than methotrexate) by a dermatologist for a patient under 18 years who has:

(a) a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and

(b) received prior PBS-subsidised treatment with etanercept for this condition; and

(c) not failed PBS-subsidised therapy with etanercept for the treatment of this condition more than once in the current Treatment Cycle

Applications for authorisation must be made in writing and must include:

(a) a completed authority prescription form; and

(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following:

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

(ii) details of prior etanercept treatment, including date

A total maximum of 24 weeks of treatment with etanercept will be authorised under this restriction. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance of treatment, a further 8 weeks treatment, will be authorised if the submitted PASI assessment shows an adequate demonstrated response to treatment

A PASI assessment of the patient's response to the initial 16 week course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment under this restriction, must be submitted to the Chief Executive Medicare no later than 1 month from the date of completion of this course of treatment. Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept

Compliance with Written Authority Required procedures

 

 

 

Continuation of initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who has a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, who has previously received PBS-subsidised treatment with etanercept for this condition, and who, although qualifying for an initial 16 week course of treatment with etanercept under the criteria specified above, has previously been issued with an authority prescription for less than 16 weeks of etanercept treatment, and where approval of the application would enable the patient to complete the initial 16 week treatment course

Compliance with Written or Telephone Authority Required procedures

[126]       Schedule 4, Part 1, after entry for Ibuprofen

insert:

Icatibant

C4055

 

Initial supply for anticipated emergency treatment of an acute attack of hereditary angioedema in a patient with confirmed diagnosis of C1-esterase inhibitor deficiency who has been assessed to be at significant risk of an acute attack of hereditary angioedema by or in consultation with a clinical immunologist, respiratory physician, specialist allergist or general physician experienced in the management of patients with hereditary angioedema

The name of the specialist consulted must be provided at the time of application for initial supply

The name of the Approved Pathology Authority and date of the diagnosing pathology test must be included in the authority application

Compliance with Authority Required procedures

 

C4056

 

Continuing supply for anticipated emergency treatment of an acute attack of hereditary angioedema, where the patient has previously been issued with an authority prescription for this drug

Compliance with Authority Required procedures

[127]       Schedule 4, Part 1, after entry for Magnesium

insert:

Mannitol

C4061

 

Where the patient is receiving treatment at/from a private hospital

Treatment of cystic fibrosis in a patient who satisfies all of the following criteria:

(1) Prior to mannitol therapy, the patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved PI mannitol initiation dose assessment. If the patient has a negative hyperresponsiveness test they may be eligible for PBS subsidised treatment with mannitol;

(2) Is 6 years of age or older;

(3) Has a FEV1 greater than 30% predicted for age, gender and height;

(4) Is intolerant or inadequately responsive to dornase alfa;

(5) Has evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease);

(6) Is participating in a 4 week trial, as detailed below, or has achieved a 10% or greater improvement in FEV1 (compared to baseline established prior to mannitol treatment) after a 4 week trial

In order for patients to be eligible for participation in the HSD program, the following conditions must be met:

(1) Patients must be assessed at cystic fibrosis clinics/centres which are under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis and the prescribing of mannitol therapy under the HSD program is limited to such physicians. If attendance at such units is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit;

(2) The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at established lung function testing laboratories, unless this is not possible because of geographical isolation;

(3) Prior to mannitol therapy, a baseline measurement of FEV1 must be undertaken during a stable period of the disease;

(4) Initial therapy is limited to 4 weeks' treatment with mannitol at a dose of 400 mg twice daily;

(5) At or towards the end of the initial 4 weeks' trial, patients must be reassessed and a further FEV1 measurement be undertaken (single test under conditions as above). Patients who achieve a 10% or greater improvement in FEV1 (compared to baseline established prior to mannitol treatment) are eligible for continued subsidy under the HSD program at a dose of 400mg twice daily;

(6) Patients who fail to meet a 10% or greater improvement in FEV1 after the initial 4 weeks' treatment at a dose of 400 mg twice daily, may have 1 further trial in the next 12 months but not before 3 months after the initial trial;

(7) Following an initial 6 months' therapy, a global assessment must be undertaken involving the patient, the patient's family (in the case of paediatric patients) and the treating physician(s) to establish that all agree that mannitol powder for inhalation treatment is continuing to produce worthwhile benefits. (Mannitol therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.) Further reassessments are to be undertaken at six-monthly intervals;

(8) Other aspects of treatment, such as physiotherapy, must be continued;

(9) Where there is documented evidence that a patient already receiving mannitol therapy would have met the criteria for subsidy (i.e. satisfied the criteria for the 4 week trial and achieved a 10% or greater improvement in FEV1) then the patient is eligible to continue treatment under the HSD program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period)

Compliance with Written or Telephone Authority Required procedures

 

C4062

 

Where the patient is receiving treatment at/from a private hospital

Grandfather — for patients who initiated mannitol treatment prior to 1 August 2012

Continuation of treatment of cystic fibrosis in a patient 6 years of age or older, who initiated treatment with mannitol prior to 1 August 2012 and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis team, documents agreement that mannitol treatment is continuing to produce worthwhile benefit. Further reassessments are to be undertaken and documented yearly. Treatment with mannitol should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use

Compliance with Written or Telephone Authority Required procedures

 

C4063

 

Where the patient is receiving treatment at/from a public hospital

Treatment of cystic fibrosis in a patient who satisfies all of the following criteria:

(1) Prior to mannitol therapy, the patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved PI mannitol initiation dose assessment. If the patient has a negative hyperresponsiveness test they may be eligible for PBS subsidised treatment with mannitol;

(2) Is 6 years of age or older;

(3) Has a FEV1 greater than 30% predicted for age, gender and height;

(4) Is intolerant or inadequately responsive to dornase alfa;

(5) Has evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease);

(6) Is participating in a 4 week trial, as detailed below, or has achieved a 10% or greater improvement in FEV1 (compared to baseline established prior to mannitol treatment) after a 4 week trial

In order for patients to be eligible for participation in the HSD program, the following conditions must be met:

(1) Patients must be assessed at cystic fibrosis clinics/centres which are under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis and the prescribing of mannitol therapy under the HSD program is limited to such physicians. If attendance at such units is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit;

(2) The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at established lung function testing laboratories, unless this is not possible because of geographical isolation;

(3) Prior to mannitol therapy, a baseline measurement of FEV1 must be undertaken during a stable period of the disease;

(4) Initial therapy is limited to 4 weeks' treatment with mannitol at a dose of 400 mg twice daily;

(5) At or towards the end of the initial 4 weeks' trial, patients must be reassessed and a further FEV1 measurement be undertaken (single test under conditions as above). Patients who achieve a 10% or greater improvement in FEV1 (compared to baseline established prior to mannitol treatment) are eligible for continued subsidy under the HSD program at a dose of 400mg twice daily;

(6) Patients who fail to meet a 10% or greater improvement in FEV1 after the initial 4 weeks' treatment at a dose of 400 mg twice daily, may have 1 further trial in the next 12 months but not before 3 months after the initial trial;

(7) Following an initial 6 months' therapy, a global assessment must be undertaken involving the patient, the patient's family (in the case of paediatric patients) and the treating physician(s) to establish that all agree that mannitol powder for inhalation treatment is continuing to produce worthwhile benefits. (Mannitol therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.) Further reassessments are to be undertaken at six-monthly intervals;

(8) Other aspects of treatment, such as physiotherapy, must be continued;

(9) Where there is documented evidence that a patient already receiving mannitol therapy would have met the criteria for subsidy (i.e. satisfied the criteria for the 4 week trial and achieved a 10% or greater improvement in FEV1) then the patient is eligible to continue treatment under the HSD program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period)

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4063

 

C4064

 

Where the patient is receiving treatment at/from a public hospital

Grandfather — for patients who initiated mannitol treatment prior to 1 August 2012

Continuation of treatment of cystic fibrosis in a patient 6 years of age or older, who initiated treatment with mannitol prior to 1 August 2012 and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis team, documents agreement that mannitol treatment is continuing to produce worthwhile benefit. Further reassessments are to be undertaken and documented yearly. Treatment with mannitol should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4064

[128]       Schedule 4, Part 1, after entry for Ranitidine

insert:

Rasagiline

C4053

 

Parkinson disease

Compliance with Authority Required procedures – Streamlined Authority Code 4053

[129]       Schedule 4, Part 1, after entry for Tiaprofenic acid

insert:

Ticagrelor

C3879

 

Treatment of acute coronary syndrome (myocardial infarction or unstable angina) in combination with aspirin

Compliance with Authority Required procedures – Streamlined Authority Code 3879

[130]       Schedule 4, Part 1, entry for Tipranavir

omit:

 

C3602

 

Where the patient is receiving treatment at/from a private hospital

Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with ritonavir in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance.

Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity

Compliance with Written or Telephone Authority Authority Required procedures

 

C3603

 

Where the patient is receiving treatment at/from a public hospital

Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with ritonavir in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance.

Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity

Compliance with Written or Telephone Authority Authority Required procedures - Streamlined Authority Code 3603

 

 

 

 

 

 

 

 

 

 

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.