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PB 111 of 2020 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme and related matters.
Administered by: Health
Registered 27 Nov 2020
Tabling HistoryDate
Tabled HR30-Nov-2020
Tabled Senate01-Dec-2020
Date of repeal 24 Feb 2021
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

 

 

 

 

PB 111 of 2020

 

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020
(No. 11)

 

National Health Act 1953

________________________________________________________________________

 

I, THEA CONNOLLY, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

 

Dated  26th November 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

THEA CONNOLLY

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

 

1          Name of Instrument

(1)          This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 11).

(2)          This Instrument may also be cited as PB 111 of 2020.

2          Commencement

This Instrument commences on 1 December 2020.

3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).


 


Schedule 1           Amendments

[1]             Schedule 1, Part 1, entry for Ambrisentan in each of the forms: Tablet 5 mg; and Tablet 10 mg

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

 

 

 

a

Ambrisentan Mylan

AF

MP

See Note 3

See Note 3

See Note 3

See Note 3

30

 

D(100)

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

 

 

 

a

Cipla Ambrisentan

LR

MP

See Note 3

See Note 3

See Note 3

See Note 3

30

 

D(100)

                   (c)        insert in the column headed “Schedule Equivalent” for the brand “Volibris”:    a 

[2]             Schedule 1, Part 1, entry for Ampicillin in the form Powder for injection 1 g (as sodium)

                           substitute:

 

Powder for injection 1 g (as sodium)

Injection

a

Ampicyn

AF

PDP

 

 

5

0

5

 

 

 

 

 

 

 

 

MP NP

 

 

5

1

5

 

 

[3]             Schedule 1, Part 1, entry for Arsenic

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

 

 

 

 

Arsenic Trioxide Juno

JU

MP

C4793 C5997 C6018

 

See Note 3

See Note 3

10

 

D(100)

[4]             Schedule 1, Part 1, entry for Asenapine in each of the forms: Sublingual wafer 5 mg (as maleate); and Sublingual wafer 10 mg (as maleate)

                           omit from the column headed “Responsible Person”: LU             substitute: OQ

[5]             Schedule 1, Part 1, after entry for Beclometasone in the form Pressurised inhalation in breath actuated device containing beclometasone dipropionate 100 micrograms per dose, 200 doses (CFC-free formulation)

                           insert:

Beclometasone with formoterol

Pressurised inhalation containing beclometasone dipropionate 100 micrograms and formoterol fumarate dihydrate 6 micrograms per dose,120 dose

Inhalation by mouth

 

Fostair

EU

MP NP

C11057

 

1

5

1

 

 

[6]             Schedule 1, Part 1, entry for Betamethasone in the form Cream 200 micrograms (as valerate) per g, 100 g

                   (a)        omit from the column headed “Responsible Person” for the brand “Antroquoril”: FR                       substitute: OV

                   (b)        omit from the column headed “Responsible Person” for the brand “Celestone-M”: MK                     substitute: OQ

[7]             Schedule 1, Part 1, entry for Betamethasone in each of the forms: Cream 500 micrograms (as dipropionate) per g, 15 g; and Ointment
500 micrograms (as dipropionate) per g, 15 g

                   (a)        omit from the column headed “Responsible Person” for the brand “Diprosone” (all instances): MK                 substitute: OQ

                   (b)        omit from the column headed “Responsible Person” for the brand “Eleuphrat” (all instances): FR                   substitute: OV

[8]             Schedule 1, Part 1, entry for Betamethasone in the form Injection containing betamethasone acetate 3 mg with betamethasone sodium phosphate 3.9 mg in 1 mL

                           omit from the column headed “Responsible Person”: MK            substitute: OQ

[9]             Schedule 1, Part 1, entry for Bleomycin

                           omit:

 

Powder for injection containing bleomycin sulfate 15,000 I.U. in 1 vial

Injection

 

Bleomycin for Injection, USP

QY

MP

C6224 C6275

 

See Note 3

See Note 3

1

 

D(100)

[10]           Schedule 1, Part 1, entry for Cefalexin in the form Capsule 500 mg (as monohydrate) [Maximum Quantity: 20; Number of Repeats: 0]

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

 

 

 

a

NOUMED CEFALEXIN

VO

MP NP MW PDP

 

 

20

0

20

 

 

[11]           Schedule 1, Part 1, entry for Cefalexin in the form Capsule 500 mg (as monohydrate) [Maximum Quantity: 40; Number of Repeats: 0]

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

 

 

 

a

NOUMED CEFALEXIN

VO

MP NP MW

 

P10410

40
CN10410

0
CN10410

20

 

 

[12]           Schedule 1, Part 1, entry for Cefalexin in the form Capsule 500 mg (as monohydrate) [Maximum Quantity: 40; Number of Repeats: 1]

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

 

 

 

a

NOUMED CEFALEXIN

VO

MP

 

P6188

40
CN6188

1
CN6188

20

 

 

[13]           Schedule 1, Part 1, entry for Chorionic gonadotrophin in each of the forms: Injection set containing powder for injection 1,500 units, 3 and solvent 1 mL, 3; and Powder for injection 5,000 units with solvent

                           omit from the column headed “Responsible Person”: MK            substitute: OQ

[14]           Schedule 1, Part 1, entry for Clopidogrel with aspirin

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

 

 

 

a

APX-Clopidogrel/Aspirin 75/100

TY

MP NP

C5443 C5488 C5517

 

30

5

30

 

 

                   (b)        omit:

 

 

 

a

Clopidogrel/Aspirin Sandoz 75/100

SZ

MP NP

C5443 C5488 C5517

 

30

5

30

 

 

[15]           Schedule 1, Part 1, entry for Clostridium botulinum type A toxin - haemagglutinin complex in the form Lyophilised powder for I.M. injection
300 units [Maximum Quantity: 4; Number of Repeats: 0]

                   (a)        insert in numerical order in the column headed “Circumstances”: C5178

                   (b)        insert in numerical order in the column headed “Circumstances”: C8929 

                   (c)        insert in numerical order in the column headed “Purposes”: P5178

                   (d)        insert in numerical order in the column headed “Purposes”: P8929 

[16]           Schedule 1, Part 1, entry for Clostridium botulinum type A toxin - haemagglutinin complex in the form Lyophilised powder for I.M. injection
300 units [Maximum Quantity: 5; Number of Repeats: 0]

                   (a)        insert in numerical order in the column headed “Circumstances”: C5178 

                   (b)        insert in numerical order in the column headed “Circumstances”: C8929

[17]           Schedule 1, Part 1, entry for Clostridium botulinum type A toxin - haemagglutinin complex in the form Lyophilised powder for I.M. injection
500 units [Maximum Quantity: 2; Number of Repeats: 0]

                   (a)        insert in numerical order in the column headed “Circumstances”: C5178

                   (b)        insert in numerical order in the column headed “Circumstances”: C8929 

                   (c)        insert in numerical order in the column headed “Purposes”: P5178

                   (d)        insert in numerical order in the column headed “Purposes”: P8929 

[18]           Schedule 1, Part 1, entry for Clostridium botulinum type A toxin - haemagglutinin complex in the form Lyophilised powder for I.M. injection
500 units [Maximum Quantity: 3; Number of Repeats: 0]

                   (a)        insert in numerical order in the column headed “Circumstances”: C5178 

                   (b)        insert in numerical order in the column headed “Circumstances”: C8929

[19]           Schedule 1, Part 1, entry for Corifollitropin alfa in each of the forms: Solution for injection 100 micrograms in 0.5 mL single dose pre-filled syringe; and Solution for injection 150 micrograms in 0.5 mL single dose pre-filled syringe

                           omit from the column headed “Responsible Person”: MK            substitute: OQ

[20]           Schedule 1, Part 1, entry for Dolutegravir with lamivudine

                   (a)        omit from the column headed “Circumstances”: C9909 C9934      

                   (b)        insert in numerical order in the column headed “Circumstances”: C11066 

[21]           Schedule 1, Part 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)

                           omit:

 

 

 

a

Esitalo

SZ

MP NP

C4755

 

28

5

28

 

 

[22]           Schedule 1, Part 1, entry for Etonogestrel

                           omit from the column headed “Responsible Person”: MK            substitute: OQ

[23]           Schedule 1, Part 1, entry for Follitropin beta in each of the forms: Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge; Solution for injection 600 I.U. in 0.72 mL multi-dose cartridge; and Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge

                           omit from the column headed “Responsible Person”: MK            substitute: OQ 

[24]           Schedule 1, Part 1, entry for Furosemide

                           substitute:

Furosemide

Injection 20 mg in 2 mL

Injection

 

Lasix

SW

MP NP

 

 

5

0

5

 

 

 

Oral solution 10 mg per mL,
30 mL

Oral

 

Lasix

SW

MP NP

 

 

1

3

1

 

 

 

Tablet 20 mg

Oral

a

Frusemix-M

TY

MP NP

 

 

100

1

50

 

 

 

 

 

a

Lasix-M

SW

MP NP

 

 

100

1

50

 

 

 

 

 

a

Urex-M

RW

MP NP

 

 

100

1

50

 

 

 

 

 

a

APO-Frusemide

TX

MP NP

 

 

100

1

100

 

 

 

 

 

a

Frusemix-M

TY

MP NP

 

 

100

1

100

 

 

 

 

 

a

FUROSEMIDE AN

EA

MP NP

 

 

100

1

100

 

 

 

Tablet 40 mg

Oral

a

APO-Frusemide

TX

MP NP

 

 

100

1

100

 

 

 

 

 

a

Frusax

ER

MP NP

 

 

100

1

100

 

 

 

 

 

a

Frusemix

TY

MP NP

 

 

100

1

100

 

 

 

 

 

a

FUROSEMIDE AN

EA

MP NP

 

 

100

1

100

 

 

 

 

 

a

Lasix

SW

MP NP

 

 

100

1

100

 

 

 

 

 

a

Uremide

AF

MP NP

 

 

100

1

100

 

 

 

 

 

 

Urex

RW

MP NP

 

 

100

1

100

 

 

 

Tablet 500 mg

Oral

 

Urex-Forte

RW

MP NP

 

 

50

3

50

 

 

[25]           Schedule 1, Part 1, entry for Ganirelix

                           omit from the column headed “Responsible Person”: MK            substitute: OQ

[26]           Schedule 1, Part 1, entry for Infliximab

                           omit from the column headed “Responsible Person” for the brand “Renflexis”: MK                 substitute: OQ 

[27]           Schedule 1, Part 1, entry for Ixekizumab

                           substitute:

Ixekizumab

Injection 80 mg in 1 mL single dose pre-filled pen

Injection

 

Taltz

LY

MP

C6696 C8804 C8830 C8837 C8851 C8867 C8892 C8954 C9116 C9118 C9141 C9164 C9172 C9184 C9194 C9429 C9431 C9901 C9983 C10997 C11030 C11054 C11061

P9429 P10997 P11054 P11061

2

1

2

 

 

 

 

 

 

 

 

MP

C6696 C8804 C8830 C8837 C8851 C8867 C8892 C8954 C9116 C9118 C9141 C9164 C9172 C9184 C9194 C9429 C9431 C9901 C9983 C10997 C11030 C11054 C11061

P6696 P8830 P8892 P9116 P9118 P9141 P9164 P9172 P9184 P9194 P9431 P11030

2

2

2

 

 

 

 

 

 

 

 

MP

C6696 C8804 C8830 C8837 C8851 C8867 C8892 C8954 C9116 C9118 C9141 C9164 C9172 C9184 C9194 C9429 C9431 C9901 C9983 C10997 C11030 C11054 C11061

P8804 P8837 P8851 P8867 P8954 P9901 P9983

2

3

2

 

 

[28]           Schedule 1, Part 1, entry for Labetalol in the form Tablet containing labetalol hydrochloride 200 mg

                           omit:

 

 

 

a

Presolol 200

AF

MP NP

 

 

100

5

100

 

 

[29]           Schedule 1, Part 1, entry for Lansoprazole in the form Capsule 30 mg [Maximum Quantity: 28; Number of Repeats: 1]

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

 

 

 

 

NOUMED LANSOPRAZOLE

VO

MP NP

C8774 C8775 C8776 C8780

P8774 P8775

28

1

28

 

 

[30]           Schedule 1, Part 1, entry for Lansoprazole in the form Capsule 30 mg [Maximum Quantity: 28; Number of Repeats: 5]

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

 

 

 

 

NOUMED LANSOPRAZOLE

VO

MP NP

C8774 C8775 C8776 C8780

P8776 P8780

28

5

28

 

 

[31]           Schedule 1, Part 1, entry for Levodopa with carbidopa in the form Tablet (prolonged release) 200 mg-50 mg

                           omit from the column headed “Responsible Person”: MK     substitute: OQ 


 

[32]           Schedule 1, Part 1, entry for Lurasidone in each of the forms: Tablet containing lurasidone hydrochloride 40 mg; and Tablet containing lurasidone hydrochloride 80 mg

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

 

 

 

a

Pharmacor Lurasidone

CR

MP NP

C4246

 

30

5

30

 

 

[33]           Schedule 1, Part 1, entry for Meloxicam in each of the forms: Tablet 7.5 mg; and Tablet 15 mg

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

 

 

 

 

APX-Meloxicam

TY

MP NP

C4907 C4962

 

30

3

30

 

 

[34]           Schedule 1, Part 1, entry for Mercaptopurine in the form Tablet containing mercaptopurine monohydrate 50 mg

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

 

 

 

a

MERCAPTOPURINE-LINK

LM

MP

 

 

100

2

25

 

 

                   (b)        insert in the column headed “Schedule Equivalent” for the brand “Purinethol”:  

[35]           Schedule 1, Part 1, entry for Mesalazine in the form Sachet containing prolonged release granules, 1 g per sachet

                   (a)        omit from the column headed “Maximum Quantity”: 120                  substitute: 100

                   (b)        omit from the column headed “Pack Quantity”: 120        substitute: 100

[36]           Schedule 1, Part 1, entry for Mesalazine in the form Suppository 1 g

                   (a)        omit from the column headed “Maximum Quantity”: 30                    substitute: 28

                   (b)        omit from the column headed “Pack Quantity”: 30          substitute: 28

[37]           Schedule 1, Part 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 500 mg

                   (a)        omit:

 

 

 

 

Diaformin XR

AF

MP NP

 

 

120

5

120

 

 

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

 

 

 

 

Pharmacor Metformin XR

CR

MP NP

 

 

120

5

120

 

 

[38]           Schedule 1, Part 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”:

 

 

 

a

APX-Metformin

TY

MP NP

 

 

100

5

100

 

 

[39]           Schedule 1, Part 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”:

 

 

 

a

APX-Metformin

TY

MP NP

 

 

60

5

60

 

 

[40]           Schedule 1, Part 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 1 g

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

 

 

 

a

Pharmacor Metformin XR

CR

MP NP

 

 

60

5

60

 

 

[41]           Schedule 1, Part 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”:

 

 

 

a

APX-Metformin

TY

MP NP

 

 

90

5

90

 

 

[42]           Schedule 1, Part 1, entry for Methyldopa

                           omit:

 

 

 

a

Hydopa

AF

MP NP

 

 

100

5

100

 

 

[43]           Schedule 1, Part 1, entry for Minocycline

                           omit:

 

 

 

a

Akamin 50

AF

MP NP

C5995

 

60

5

60

 

 

[44]           Schedule 1, Part 1, entry for Naproxen in the form Tablet 250 mg

                           substitute:

 

Tablet 250 mg

Oral

a

Naprosyn

IX

PDP

C6256 C6282

 

100

0

50

 

 

 

 

 

 

 

 

MP NP

C6149 C6214 C6283

 

100

3

50

 

 

[45]           Schedule 1, Part 1, entry for Naproxen in the form Tablet 500 mg

                           substitute:

 

Tablet 500 mg

Oral

a

Naprosyn

IX

PDP

C6256 C6282

 

50

0

50

 

 

 

 

 

 

 

 

MP NP

C6149 C6214 C6283

 

50

3

50

 

 

[46]           Schedule 1, Part 1, entry for Nitrazepam

                           substitute:

Nitrazepam

Tablet 5 mg

Oral

a

Mogadon

IL

MP NP PDP

 

 

25

0

25

 

 

 

 

 

 

 

 

MP NP

 

P6175

50

CN6175

3

CN6175

25

 

 

 

 

 

 

 

 

MP NP

 

P5661 P5771 P5941 P5950

50

CN5661 CN5771 CN5941 CN5950

5

CN5661 CN5771 CN5941 CN5950

25

 

 

[47]           Schedule 1, Part 1, entry for Norethisterone with ethinylestradiol in the form Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets

                   omit from the column headed “Schedule Equivalent” (all instances): a

[48]           Schedule 1, Part 1, after entry for Norethisterone with ethinylestradiol in the form Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets

                           insert:

 

Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets USP

Oral

 

Pirmella 1/35

DZ

MP NP

 

 

4

2

3

 

 

[49]           Schedule 1, Part 1, entry for Obinutuzumab

                   (a)        omit from the column headed “Circumstances”: C8184 

                   (b)        insert in numerical order in the column headed “Circumstances”: C11015 C11052 

[50]           Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg

                           omit from the column headed “Responsible Person” for the brand “Sevikar HCT 20/5/12.5”: MK                substitute: AF


 

[51]           Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg

                           omit from the column headed “Responsible Person” for the brand “Sevikar HCT 40/5/12.5”: MK                substitute: AF

[52]           Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 25 mg

                           omit from the column headed “Responsible Person” for the brand “Sevikar HCT 40/5/25”: MK                                      substitute: AF

[53]           Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 12.5 mg

                           omit from the column headed “Responsible Person” for the brand ”Sevikar HCT 40/10/12.5”: MK              substitute: AF

[54]           Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 25 mg

                           omit from the column headed “Responsible Person” for the brand “Sevikar HCT 40/10/25”: MK                 substitute: AF

[55]           Schedule 1, Part 1, entry for Oxazepam

                           substitute:

Oxazepam

Tablet 15 mg

Oral

a

Serepax

AS

MP NP PDP

 

 

25

0

25

 

 

 

 

 

 

 

 

MP NP

 

P6176

50

CN6176

3

CN6176

25

 

 

 

 

 

 

 

 

MP NP

 

P6217 P6230 P6262

50

CN6217 CN6230 CN6262

5

CN6217 CN6230 CN6262

25

 

 

 

Tablet 30 mg

Oral

a

APO-Oxazepam

TX

MP NP PDP

 

 

25

0

25

 

 

 

 

 

a

Murelax

RW

MP NP PDP

 

 

25

0

25

 

 

 

 

 

a

Serepax

AS

MP NP PDP

 

 

25

0

25

 

 

 

 

 

a

APO-Oxazepam

TX

MP NP

 

P6176

50
CN6176

3
CN6176

25

 

 

 

 

 

a

Murelax

RW

MP NP

 

P6176

50
CN6176

3
CN6176

25

 

 

 

 

 

a

Serepax

AS

MP NP

 

P6176

50
CN6176

3
CN6176

25

 

 

 

 

 

a

APO-Oxazepam

TX

MP NP

 

P6217 P6230 P6262

50
CN6217 CN6230 CN6262

5
CN6217 CN6230 CN6262

25

 

 

 

 

 

a

Murelax

RW

MP NP

 

P6217 P6230 P6262

50
CN6217 CN6230 CN6262

5
CN6217 CN6230 CN6262

25

 

 

 

 

 

a

Serepax

AS

MP NP

 

P6217 P6230 P6262

50
CN6217 CN6230 CN6262

5
CN6217 CN6230 CN6262

25

 

 

[56]           Schedule 1, Part 1, entry for Paracetamol

                           omit: 

 

Suppositories 500 mg, 24

Rectal

 

Panadol

GC

MP NP

C6167

 

4

3

1

 

 

[57]           Schedule 1, Part 1, after entry for Paracetamol in the form Oral liquid 240 mg per 5 mL, 200 mL 

                           insert:

 

Suppositories 500 mg, 24

Rectal

 

Panadol

GC

MP NP

C6167

 

4

3

1

 

 

 

Suppository 500 mg

Rectal

 

Panadol

GC

MP NP

C6167

 

100

3

10

 

 

[58]           Schedule 1, Part 1, entry for Pioglitazone in the form Tablet 15 mg (as hydrochloride)

                           omit:

 

 

 

a

Pioglitazone Sandoz

SZ

MP NP

C4363 C4364 C4388

 

28

5

28

 

 

[59]           Schedule 1, Part 1, entry for Posaconazole

                           substitute:

Posaconazole

Tablet (modified release)
100 mg

Oral

 

Posaconazole Juno

JU

MP NP

C5169 C5395 C5396

 

24

0

24

 

 

[60]           Schedule 1, Part 1, after entry for Protein formula with carbohydrate, fat, vitamins and minerals

                           insert:

Protein formula with vitamins and minerals, and low in potassium, phosphorus, calcium, chloride and vitamin A

Oral liquid 125 mL, 24 (Renastep)

Oral

 

Renastep

VF

MP NP

C11070

 

8

5

1

 

 

[61]           Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 50 mg (as fumarate)

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

 

 

 

a

APX-Quetiapine XR

TY

MP NP

C4246 C5611 C5639

 

60

5

60

 

 

[62]           Schedule 1, Part 1, entry for Quetiapine in each of the forms: Tablet (modified release) 150 mg (as fumarate); and Tablet (modified release)
200 mg (as fumarate)

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

 

 

 

a

APX-Quetiapine XR

TY

MP NP

C4246 C5611 C5639

 

60

5

60

 

 

[63]           Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 300 mg (as fumarate)

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

 

 

 

a

APX-Quetiapine XR

TY

MP NP

C4246 C5611 C5639

 

60

5

60

 

 

[64]           Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 400 mg (as fumarate)

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

 

 

 

a

APX-Quetiapine XR

TY

MP NP

C4246 C5611 C5639

 

60

5

60

 

 

[65]           Schedule 1, Part 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 1]

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

 

 

 

a

Rabeprazole Mylan

AF

MP NP

C8774 C8775 C8776 C8780

P8774 P8775

30

1

30

 

 

[66]           Schedule 1, Part 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 5]

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

 

 

 

a

Rabeprazole Mylan

AF

MP NP

C8774 C8775 C8776 C8780

P8776 P8780

30

5

30

 

 

[67]           Schedule 1, Part 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)

                           omit:

 

 

 

a

Ranitidine Sandoz

SZ

MP NP MW

 

 

60

5

60

 

 

[68]           Schedule 1, Part 1, entry for Ranitidine in the form Tablet 300 mg (as hydrochloride)

                           omit:

 

 

 

a

Ranitidine Sandoz

SZ

MP NP

 

 

30

5

30

 

 

[69]           Schedule 1, Part 1, entry for Rifampicin

                           substitute:

Rifampicin

Capsule 150 mg

Oral

 

Rimycin 150

AF

MP NP

C5536 C5552 C5585 C11018

P5536 P5585

10

0

10

 

 

 

 

 

 

 

 

MP NP

C5536 C5552 C5585 C11018

P5552 P11018

100

0

100

 

 

 

 

 

 

 

 

MP NP

C5536 C5552 C5585 C11018

P11018

120

0

10

 

 

 

Capsule 300 mg

Oral

 

Rimycin 300

AF

MP NP

C5536 C5552 C5585 C11018

P5536 P5585

10

0

10

 

 

 

 

 

 

 

 

MP NP

C5536 C5552 C5585 C11018

P5552 P11018

100

0

100

 

 

 

 

 

 

 

 

MP NP

C5536 C5552 C5585 C11018

P11018

120

0

10

 

 

 

Syrup 100 mg per 5 mL, 60 mL

Oral

 

Rifadin

SW

MP NP

C5536 C5585

 

1

0

1

 

 

[70]           Schedule 1, Part 1, entry for Rivaroxaban

                           insert as first entry:

 

Tablet 2.5 mg

Oral

 

Xarelto

BN

MP

C10992 C11013

 

60

5

60

 

 

 

 

 

 

 

 

NP

C10992

 

60

5

60

 

 

[71]           Schedule 1, Part 1, entry for Tadalafil

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

 

 

 

a

TADALIS 20

LR

MP

See Note 3

See Note 3

See Note 3

See Note 3

56

 

D(100)

[72]           Schedule 1, Part 1, entry for Trastuzumab in the form Powder for I.V. infusion 150 mg

                           omit from the column headed “Responsible Person” for the brand “Ontruzant”: MK                    substitute: OQ

[73]           Schedule 1, Part 1, entry for Trimethoprim in the form Tablet 300 mg [Maximum Quantity: 7; Number of Repeats: 1]

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

 

 

 

a

Trimethoprim Mylan

AL

MP NP

 

 

7

1

7

 

 

[74]           Schedule 1, Part 1, entry for Trimethoprim in the form Tablet 300 mg [Maximum Quantity: 14; Number of Repeats: 2]

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

 

 

 

a

Trimethoprim Mylan

AL

MP

 

P4243

14
CN4243

2
CN4243

7

 

 

[75]           Schedule 1, Part 1, entry for Trimethoprim in the form Tablet 300 mg [Maximum Quantity: 28; Number of Repeats: 0]

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

 

 

 

a

Trimethoprim Mylan

AL

MP

 

P6163

28

0

7

 

 

[76]           Schedule 1, Part 1, entry for Venetoclax

                           substitute:

Venetoclax

Pack containing 14 tablets venetoclax 10 mg and 7 tablets venetoclax 50 mg and 7 tablets venetoclax 100 mg and 14 tablets venetoclax 100 mg

Oral

 

Venclexta

VE

MP

C8607 C11053

 

1

0

1

 

 

 

Tablet 10 mg

Oral

 

Venclexta

VE

MP

C10995

 

14

0

14

 

 

 

Tablet 50 mg

Oral

 

Venclexta

VE

MP

C10995

 

7

0

7

 

 

 

Tablet 100 mg

Oral

 

Venclexta

VE

MP

C11017 C11069 C11073

P11017

120

4

120

 

 

 

 

 

 

 

 

MP

C11017 C11069 C11073

P11069 P11073

120

5

120

 

 

[77]           Schedule 1, Part 1, entry for Venlafaxine in each of the forms: Capsule (modified release) 75 mg (as hydrochloride); and Capsule (modified release) 150 mg (as hydrochloride)

                           omit:

 

 

 

a

Venlafaxine Sandoz XR

SZ

MP NP

C5650

 

28

5

28

 

 

[78]           Schedule 1, Part 2, omit entry for Aciclovir

[79]           Schedule 1, Part 2, after entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

                           insert:

Ampicillin

Powder for injection 1 g (as sodium)

Injection

a

Austrapen

AL

PDP

 

 

5

0

5

 

 

 

 

 

 

 

 

MP NP

 

 

5

1

5

 

 

[80]           Schedule 1, Part 2, after entry for Ampicillin

                           insert:

Bleomycin

Powder for injection containing bleomycin sulfate 15,000 I.U. in 1 vial

Injection

 

Bleomycin for Injection, USP

QY

MP

C6224 C6275

 

See Note 3

See Note 3

1

 

D(100)

[81]           Schedule 1, Part 2, entry for Cefazolin

omit from the column headed “Manner of Administration”: Oral                  substitute: Injection

[82]           Schedule 1, Part 2, after entry for Cefazolin

                           insert:

Clopidogrel with aspirin

Tablet 75 mg (as hydrogen sulfate)-100 mg

Oral

a

Clopidogrel/Aspirin Sandoz 75/100

SZ

MP NP

C5443 C5488 C5517

 

30

5

30

 

 

[83]           Schedule 1, Part 2, entry for Donepezil in the form Tablet containing donepezil hydrochloride 10 mg [Maximum Quantity: 28; Number of Repeats: 1]

omit from the column headed “Authorised Prescriber”: NP

[84]           Schedule 1, Part 2, entry for Donepezil in the form Tablet containing donepezil hydrochloride 10 mg [Purposes: P10099 P10100 P10108; Maximum Quantity: 28; Number of Repeats: 5]

                           omit from the column headed “Authorised Prescriber”: NP

[85]           Schedule 1, Part 2, entry for Donepezil in the form Tablet containing donepezil hydrochloride 10 mg [Circumstances: C10108: Maximum Quantity: 28; Number of Repeats: 5]

                           omit from the column headed “Authorised Prescriber”: MP

[86]           Schedule 1, Part 2, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)

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

 

 

 

a

Esitalo

SZ

MP NP

C4755

 

28

5

28

 

 

[87]           Schedule 1, Part 2, omit entry for Fluconazole

[88]           Schedule 1, Part 2, after entry for Ketoconazole

                           insert:

Labetalol

Tablet containing labetalol hydrochloride 200 mg

Oral

a

Presolol 200

AF

MP NP

 

 

100

5

100

 

 

[89]           Schedule 1, Part 2, after entry for Levodopa with carbidopa

                           insert:

Mesalazine

Sachet containing prolonged release granules, 1 g per sachet

Oral

 

Pentasa

FP

MP NP

C9443 C9444

 

120

5

120

 

 

 

Suppository 1 g

Rectal

 

Pentasa

FP

MP NP

C4878

 

28

1

28

 

 

[90]           Schedule 1, Part 2, after entry for Mesalazine in the form Suppository 1 g

                           insert:

Metformin

Tablet (extended release) containing metformin hydrochloride 500 mg

Oral

 

Diaformin XR

AF

MP NP

 

 

120

5

120

 

 

[91]           Schedule 1, Part 2, after entry for Metformin

                           insert:

Methyldopa

Tablet 250 mg (as sesquihydrate)

Oral

a

Hydopa

AF

MP NP

 

 

100

5

100

 

 

[92]           Schedule 1, Part 2, after entry for Methyldopa

                           insert:

Minocycline

Tablet 50 mg (as hydrochloride)

Oral

a

Akamin 50

AF

MP NP

C5995

 

60

5

60

 

 

[93]           Schedule 1, Part 2, after entry for Minocycline

                           insert:

Naproxen

Tablet 250 mg

Oral

a

Inza 250

AF

PDP

C6256 C6282

 

100

0

50

 

 

 

 

 

 

 

 

MP NP

C6149 C6214 C6283

 

100

3

50

 

 

 

Tablet 500 mg

Oral

a

Inza 500

AF

PDP

C6256 C6282

 

50

0

50

 

 

 

 

 

 

 

 

MP NP

C6149 C6214 C6283

 

50

3

50

 

 

[94]           Schedule 1, Part 2, after entry for Nifedipine

                           insert: 

Nitrazepam

Tablet 5 mg

Oral

a

Alodorm

AF

MP NP PDP

 

 

25

0

25

 

 

 

 

 

 

 

 

MP NP

 

P6175

50
CN6175

3
CN6175

25

 

 

 

 

 

 

 

 

MP NP

 

P5661 P5771 P5941 P5950

50
CN5661 CN5771 CN5941 CN5950

5
CN5661 CN5771 CN5941 CN5950

25

 

 

[95]           Schedule 1, Part 2, omit entry for Olanzapine

[96]           Schedule 1, Part 2, after entry for Oxaliplatin

                           insert: 

Oxazepam

Tablet 15 mg

Oral

a

Alepam 15

AF

MP NP PDP

 

 

25

0

25

 

 

 

 

 

 

 

 

MP NP

 

P6176

50
CN6176

3
CN6176

25

 

 

 

 

 

 

 

 

MP NP

 

P6217 P6230 P6262

50
CN6217 CN6230 CN6262

5
CN6217 CN6230 CN6262

25

 

 

 

Tablet 30 mg

Oral

a

Alepam 30

AF

MP NP PDP

 

 

25

0

25

 

 

 

 

 

 

 

 

MP NP

 

P6176

50
CN6176

3
CN6176

25

 

 

 

 

 

 

 

 

MP NP

 

P6217 P6230 P6262

50
CN6217 CN6230 CN6262

5
CN6217 CN6230 CN6262

25

 

 

[97]           Schedule 1, Part 2, after entry for Phenoxybenzamine

                           insert:

Pioglitazone

Tablet 15 mg (as hydrochloride)

Oral

a

Pioglitazone Sandoz

SZ

MP NP

C4363 C4364 C4388

 

28

5

28

 

 

[98]           Schedule 1, Part 2, after entry for Ranitidine in the form Tablet, effervescent, 150 mg (as hydrochloride)

                           insert:

 

Tablet 150 mg (as hydrochloride)

Oral

a

Ranitidine Sandoz

SZ

MP NP MW

 

 

60

5

60

 

 

 

Tablet 300 mg (as hydrochloride)

Oral

a

Ranitidine Sandoz

SZ

MP NP

 

 

30

5

30

 

 

[99]           Schedule 1, Part 2, after entry for Tramadol

                           insert:

Venlafaxine

Capsule (modified release)
75 mg (as hydrochloride)

Oral

a

Venlafaxine Sandoz XR

SZ

MP NP

C5650

 

28

5

28

 

 

 

Capsule (modified release)
150 mg (as hydrochloride)

Oral

a

Venlafaxine Sandoz XR

SZ

MP NP

C5650

 

28

5

28

 

 

[100]        Schedule 3

                           omit:

FR

Merck Sharp & Dohme (Australia) Pty Ltd

 14 000 173 508

[101]        Schedule 3, after details relevant to Responsible Person code ON

                           insert:

OQ

Organon Pharma Pty Ltd

54 637 107 512

[102]        Schedule 3, after details relevant to Responsible Person code OU

                           insert:

OV

Organon Pharma Pty Ltd

54 637 107 512

[103]        Schedule 4, Part 1, after entry for Beclometasone

                           insert:

Beclometasone with formoterol

C11057

 

 

Asthma
Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.
Patient must be aged 18 years or older.

Compliance with Authority Required procedures - Streamlined Authority Code 11057

[104]        Schedule 4, Part 1, entry for Clostridium botulinum type A toxin - haemagglutinin complex

                   (a)        insert as first entry:

 

C5178

P5178

 

Moderate to severe spasticity of the upper limb
Patient must have cerebral palsy.
Patient must be aged from 2 to 17 years inclusive.
Must be treated by a neurologist; OR
Must be treated by an orthopaedic surgeon; OR
Must be treated by a paediatrician; OR
Must be treated by a rehabilitation specialist; OR
Must be treated by a plastic surgeon.

Compliance with Authority Required procedures - Streamlined Authority Code 5178

 


 

                   (b)        insert after entry for Circumstances Code “C8822”:

 

C8929

P8929

 

Moderate to severe spasticity of the upper limb
Patient must have cerebral palsy.
Patient must be aged 18 years or older.
Must be treated by a neurologist; OR
Must be treated by an orthopaedic surgeon; OR
Must be treated by a paediatrician; OR
Must be treated by a rehabilitation specialist; OR
Must be treated by a plastic surgeon.

Compliance with Authority Required procedures - Streamlined Authority Code 8929

[105]        Schedule 4, Part 1, entry for Dolutegravir with lamivudine

                   (a)        omit:

 

C9909

 

 

HIV infection
Grandfathered treatment
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2019; AND
Patient must have been antiretroviral treatment naive prior to initiating this drug for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9909

 

C9934

 

 

HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy with this drug for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9934

                   (b)        insert in numerical order after existing text:

 

C11066

 

 

HIV infection
Continuing or change of treatment
Patient must have previously received PBS-subsidised therapy for HIV infection.

Compliance with Authority Required procedures - Streamlined Authority Code 11066

[106]        Schedule 4, Part 1, entry for Ixekizumab

                   (a)        insert after entry for Circumstances Code “C9194”:

 

C9429

P9429

 

Ankylosing spondylitis
Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.

Compliance with Authority Required procedures

 

C9431

P9431

 

Ankylosing spondylitis
Continuing treatment - balance of supply
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C10997

P10997

 

Ankylosing spondylitis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application Form.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
All measurements provided must be no more than 4 weeks old at the time of application.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C11030

P11030

 

Ankylosing spondylitis
Continuing treatment
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application Form.
An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
All measurements provided must be no more than 4 weeks old at the time of application.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C11054

P11054

 

Ankylosing spondylitis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND
Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; OR
Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; OR
Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application Form which includes the following:
(i) details of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a BASDAI score.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C11061

P11061

 

Ankylosing spondylitis
Initial treatment - Initial 1 (new patient)
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.
The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application Form which includes the following:
(i) details of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a baseline BASDAI score; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
(iv) baseline ESR and/or CRP level
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

[107]        Schedule 4, Part 1, entry for Obinutuzumab

                   (a)        omit:

 

C8184

 

 

Chronic lymphocytic leukaemia (CLL)
The condition must be CD20 positive; AND
The condition must be previously untreated; AND
Patient must be inappropriate for fludarabine based chemo-immunotherapy; AND
The treatment must be in combination with chlorambucil; AND
Patient must have a creatinine clearance 30 mL/min or greater; AND
Patient must have a total cumulative illness rating scale (CIRS) score of greater than 6 (excluding CLL-induced illness or organ damage); OR
Patient must have a creatinine clearance less than 70 mL/min.
Treatment must be discontinued in patients who experience disease progression whilst on this treatment.

Compliance with Authority Required procedures - Streamlined Authority Code 8184

                   (b)        insert in numerical order after existing text:

 

C11015

 

 

Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
For combination use with venetoclax treatment cycles 1 to 6 inclusive in first-line therapy
The condition must be untreated; AND
The treatment must be in combination with PBS-subsidised venetoclax.

Compliance with Authority Required procedures - Streamlined Authority Code 11015

 

C11052

 

 

Chronic lymphocytic leukaemia (CLL)
Combination use with chlorambucil only
The condition must be CD20 positive; AND
The condition must be previously untreated; AND
Patient must be inappropriate for fludarabine based chemo-immunotherapy; AND
The treatment must be in combination with chlorambucil; AND
Patient must have a creatinine clearance 30 mL/min or greater; AND
Patient must have a total cumulative illness rating scale (CIRS) score of greater than 6 (excluding CLL-induced illness or organ damage); OR
Patient must have a creatinine clearance less than 70 mL/min.
Treatment must be discontinued in patients who experience disease progression whilst on this treatment.

Compliance with Authority Required procedures - Streamlined Authority Code 11052

[108]        Schedule 4, Part 1, entry for Posaconazole

                           omit:

 

C5617

 

 

Fungal infection
The condition must be fusariosis; OR
The condition must be zygomycosis; OR
The condition must be coccidioidomycosis; OR
The condition must be chromoblastomycosis; OR
The condition must be mycetoma; AND
Patient must be unable to tolerate alternative therapy; OR
Patient must have disease refractory to alternative therapy.

Compliance with Authority Required procedures

 

C5724

 

 

Prophylaxis of invasive fungal infections including both yeasts and moulds
Patient must be considered at high risk of developing an invasive fungal infection due to anticipated neutropenia (an absolute neutrophil count less than 500 cells per cubic millimetre), for at least 10 days whilst receiving chemotherapy for acute myeloid leukaemia or myelodysplastic syndrome; OR
Patient must be considered at high risk of developing an invasive fungal infection due to having acute graft versus host disease (GVHD) grade II, III or IV, or extensive chronic GVHD, and receiving intensive immunosuppressive therapy after allogeneic haematopoietic stem cell transplant.
No more than 6 months therapy per episode will be PBS-subsidised

Compliance with Authority Required procedures

 

C5747

 

 

Invasive aspergillosis
Patient must be unable to tolerate alternative therapy; OR
Patient must have disease refractory to alternative therapy.

Compliance with Authority Required procedures

[109]        Schedule 4, Part 1, after entry for Protein formula with carbohydrate, fat, vitamins and minerals

                           insert:

Protein formula with vitamins and minerals, and low in potassium, phosphorus, calcium, chloride and vitamin A

C11070

 

 

Chronic renal failure
Patient must be a child aged 3 years or older.
Patient must require treatment with a low protein and a low phosphorus diet; OR
Patient must require treatment with a low protein, low phosphorus and low potassium diet.

Compliance with Authority Required procedures - Streamlined Authority Code 11070

[110]        Schedule 4, Part 1, entry for Rifampicin

                           insert in numerical order after existing text:

 

C11018

P11018

 

Mycobacterium ulcerans infection (Buruli ulcer)
The treatment must be used in combination with another antibiotic for the treatment of Buruli ulcer.

Compliance with Authority Required procedures

[111]        Schedule 4, Part 1, entry for Rivaroxaban

                           insert in numerical order after existing text:

 

C10992

 

 

Chronic stable atherosclerotic disease
Continuing treatment
Patient must have received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be in combination with aspirin, but not with any other anti-platelet therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 10992

 

C11013

 

 

Chronic stable atherosclerotic disease
Initial treatment
The treatment must be in combination with aspirin, but not with any other anti-platelet therapy; AND
Patient must have a diagnosis of coronary artery disease in addition to at least one of the following risk factors: (i) diagnosed heart failure (left ventricular ejection fraction of at least 30% but less than 50%) (ii) diagnosed kidney disease classified by an eGFR in the range of 15-60 mL/min (iii) diabetes mellitus combined with at least one of the following: (a) age at least 60 years (b) concomitant microalbuminuria (c) Aboriginal/Torres Strait Islander descent; OR
Patient must have a diagnosis of peripheral artery disease in addition to at least one of the following risk factors: (i) concomitant coronary artery disease (ii) diagnosed heart failure (left ventricular ejection fraction of at least 30% but less than 50%) (iii) diagnosed kidney disease classified by an eGFR in the range of 15-60 mL/min (iv) diabetes mellitus combined with at least one of the following: (a) age at least 60 years (b) concomitant microalbuminuria (c) Aboriginal/Torres Strait Islander descent; AND
Patient must have at least one of the following if coronary artery disease is present: (i) a previous multi-vessel coronary revascularisation procedure (ii) significant stenosis in at least 2 coronary arteries (iii) a previous single vessel coronary revascularisation procedure with significant stenosis in more than 1 coronary artery; OR
Patient must have at least one of the following if peripheral arterial disease is present: (i) a previous peripheral/carotid artery revascularisation intervention (ii) intermittent claudication with an ankle-brachial index less than 0.9 (iii) asymptomatic carotid artery stenosis greater than 50%; AND
The condition must be diagnosed by at least one of: (i) invasive (selective) angiography (ii) non-invasive imaging (i.e. CT scan, ultrasound) (iii) ankle-brachial index measurement in the case of peripheral arterial disease with intermittent claudication; AND
Patient must have clinical findings/observations by the treating physician that exclude each of the following: (i) high risk of bleeding (ii) prior stroke within one month of treatment initiation (iii) prior haemorrhagic / lacunar stroke (iv) severe heart failure with a known ejection fraction less than 30% (v) New York Heart Association class III to IV heart failure symptoms (i.e. symptoms corresponding to moderate to severe limitation on physical activity, whereby any of fatigue/palpitations/dyspnoea occur upon zero to minimal activity) (vi) an estimated glomerular filtration rate less than 15 mL/minute (vii) a requirement for dual antiplatelet therapy (viii) a requirement for non-acetylsalicylic acid antiplatelet therapy (ix) a requirement for a higher dose of oral anticoagulant therapy.
Must be treated by a specialist physician; OR
Must be treated by a physician who has consulted a specialist physician.

Compliance with Authority Required procedures - Streamlined Authority Code 11013

[112]        Schedule 4, Part 1, entry for Venetoclax

                   (a)        omit:

 

C8586

 

 

Chronic lymphocytic leukaemia (CLL)
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be in combination with rituximab for up to a maximum of 6 cycles, followed by monotherapy; AND
The treatment must be ceased on disease progression or on completion of 24 months of PBS-subsidised treatment with this drug for this condition, whichever comes first.

Compliance with Authority Required procedures

 


 

                   (b)        omit:

 

C8699

 

 

Chronic lymphocytic leukaemia (CLL)
Initial treatment - Extension of dose titration
Patient must have experienced a treatment interruption during the PBS-subsidised dose titration with this drug for this condition; AND
Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must be used as monotherapy for this condition under this restriction.

Compliance with Authority Required procedures

                   (c)        insert in numerical order after existing text:

 

C10995

 

 

Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
Dose modification
The treatment must be for dose titration purposes.

Compliance with Authority Required procedures

 

C11017

P11017

 

Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
First continuing treatment (treatment cycles 2 to 6 inclusive) of first-line therapy
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses); AND
The treatment must cease upon disease progression.

Compliance with Authority Required procedures

 

C11053

 

 

Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
Initial treatment in first-line therapy - Dose titration (weeks 1 to 4 of a 5-week ramp-up schedule)
The condition must be untreated; AND
Patient must be inappropriate for fludarabine based chemo-immunotherapy; AND
The treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses); AND
Patient must have a creatinine clearance 30 mL/min or greater; AND
Patient must have a total cumulative illness rating scale (CIRS) score of greater than 6 (excluding CLL-induced illness or organ damage); OR
Patient must have a creatinine clearance less than 70 mL/min.

Compliance with Authority Required procedures

 

C11069

P11069

 

Chronic lymphocytic leukaemia (CLL)
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be in combination with rituximab for up to a maximum of 6 cycles, followed by monotherapy; AND
The treatment must be ceased on disease progression or on completion of 24 months of PBS-subsidised treatment under this restriction with this drug for this condition, whichever comes first.

Compliance with Authority Required procedures

 

C11073

P11073

 

Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
Second and final continuing treatment prescription (treatment cycles 7 to 12 inclusive) of first-line therapy
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must cease upon disease progression; OR
The treatment must cease upon completion of 12 cycles of treatment with this drug for this condition, whichever comes first.

Compliance with Authority Required procedures

[113]        Schedule 5, entry for Lansoprazole in the form Capsule 30 mg [GRP-14641]

                           insert in alphabetical order in the column headed “Brand”: NOUMED LANSOPRAZOLE

[114]        Schedule 5, entry for Meloxicam in the form Tablet 15 mg [GRP-15468]

                           insert in alphabetical order in the column headed “Brand”: APX-Meloxicam

[115]        Schedule 5, entry for Meloxicam in the form Tablet 7.5 mg [GRP-15658]

                           insert in alphabetical order in the column headed “Brand”: APX-Meloxicam

[116]        Schedule 5, entry for Metforminin the form Tablet (extended release) containing metformin hydrochloride 500 mg [GRP-24200]

                           insert in alphabetical order in the column headed “Brand”: Pharmacor Metformin XR

[117]        Schedule 5, after entry for Morphine in the form Injection containing morphine sulfate pentahydrate 10 mg in 1 mL [GRP-20890] 

                           insert:

Norethisterone with ethinylestradiol

GRP-24444

Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets

Oral

Brevinor-1
Norimin-1 28 Day

 

 

Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets USP

Oral

Pirmella 1/35