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PB 42 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 (PBS) and related matters.
Administered by: Health
Registered 29 May 2020
Tabling HistoryDate
Tabled HR10-Jun-2020
Tabled Senate10-Jun-2020
Date of repeal 07 Oct 2020
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

 

 

 

 

PB 42 of 2020

 

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 5)

 

National Health Act 1953

________________________________________________________________________

 

I, THEA DANIEL, 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         29th May 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

THEA DANIEL

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. 5).

(2)          This Instrument may also be cited as PB 42 of 2020.

2          Commencement

This Instrument commences on 1 June 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, after entry for Amino acid formula with carbohydrate, vitamins, minerals and trace elements without phenylalanine

                             insert:

Amino acid formula with carbohydrate without phenylalanine

Tablets containing 0.92 g protein, 462 (PKU Easy Tablet)

Oral

 

PKU Easy Tablet

OH

MP NP

C4295

 

4

5

1

 

 

[2]              Schedule 1, after entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides in the form Oral powder 400 g (Neocate Junior)

                             insert:

Amino acid formula with fat, carbohydrate without methionine

Tablets containing 0.91 g protein, 462 (HCU Easy Tablet)

Oral

 

HCU Easy Tablet

OH

MP NP

C5534

 

5

5

1

 

 

[3]              Schedule 1, after entry for Amino acid formula with fat, carbohydrate without phenylalanine

                             insert:

Amino acid formula with fat, carbohydrate without phenylalanine and tyrosine

Tablets containing 0.91 g protein, 462 (TYR Easy Tablet)

Oral

 

TYR Easy Tablet

OH

MP NP

C5533

 

4

5

1

 

 

Amino acid formula with fat, carbohydrate without valine, leucine and isoleucine

Tablets containing 0.91 g protein, 462 (MSUD Easy Tablet)

Oral

 

MSUD Easy Tablet

OH

MP NP

C5571

 

5

5

1

 

 

[4]              Schedule 1, entry for Amitriptyline in each of the forms: Tablet containing amitriptyline hydrochloride 10 mg; Tablet containing amitriptyline hydrochloride 25 mg; and Tablet containing amitriptyline hydrochloride 50 mg

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

 

 

 

a

Amitriptyline Lupin

GQ

MP NP

 

 

50

2

50

 

 

[5]              Schedule 1, entry for Bortezomib in the form Powder for injection 1 mg

                   (a)        omit from the column headed “Circumstances”: C7963 C7984

                   (b)        insert in numerical order in the column headed “Circumstances”: C10426 C10454 C10455

[6]              Schedule 1, entry for Bortezomib in the form Powder for injection 3 mg

                   (a)        omit from the column headed “Circumstances”: C7963

                   (b)        omit from the column headed “Circumstances”: C7984

                   (c)        insert in numerical order in the column headed “Circumstances”: C10426 C10454 C10455

[7]              Schedule 1, entry for Budesonide with formoterol in the form Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

                             substitute:

 

Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

Inhalation by mouth

 

Symbicort Rapihaler 100/3

AP

MP NP

C4397 C10482

P10482

2

2

1

 

 

MP NP

C4397 C10482

P4397

2

5

1

 

 

[8]              Schedule 1, entry for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

                             substitute:

 

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

a

DuoResp Spiromax

TB

MP NP

C7970 C10464

P10464

1

2

1

 

 

a

Symbicort Turbuhaler 200/6

AP

MP NP

C7970 C10464

P10464

1

2

1

 

 

a

DuoResp Spiromax

TB

MP NP

C7970 C10464

P7970

1

5

1

 

 

a

Symbicort Turbuhaler 200/6

AP

MP NP

C7970 C10464

P7970

1

5

1

 

 

[9]              Schedule 1, entry for Buprenorphine in the form Transdermal patch 5 mg [Maximum Quantity: 2; Number of Repeats: 0]

(a)        omit from the column headed “Circumstances” (all instances): C4951

(b)        insert in numerical order in the column headed “Circumstances” (all instances): C10445

(c)        omit from the column headed “Purposes” (all instances): P4951                       substitute: P10445

[10]            Schedule 1, entry for Buprenorphine in the form Transdermal patch 5 mg [Maximum Quantity: 4; Number of Repeats: 2]

(a)        omit from the column headed “Circumstances” (all instances): C4951

(b)        insert in numerical order in the column headed “Circumstances” (all instances): C10445

[11]            Schedule 1, entry for Buprenorphine in the form Transdermal patch 10 mg [Maximum Quantity: 2; Number of Repeats: 0]

(a)        omit from the column headed “Circumstances” (all instances): C4951

(b)        insert in numerical order in the column headed “Circumstances” (all instances): C10445

(c)        omit from the column headed “Purposes” (all instances): P4951                      substitute: P10445

[12]            Schedule 1, entry for Buprenorphine in the form Transdermal patch 10 mg [Maximum Quantity: 4; Number of Repeats: 2]

(a)        omit from the column headed “Circumstances” (all instances): C4951

(b)        insert in numerical order in the column headed “Circumstances” (all instances): C10445

[13]            Schedule 1, entry for Buprenorphine in the form Transdermal patch 15 mg [Maximum Quantity: 2; Number of Repeats: 0]

(a)        omit from the column headed “Circumstances” (all instances): C4951

(b)        insert in numerical order in the column headed “Circumstances” (all instances): C10445

(c)        omit from the column headed “Purposes” (all instances): P4951                       substitute: P10445

[14]            Schedule 1, entry for Buprenorphine in the form Transdermal patch 15 mg [Maximum Quantity: 4; Number of Repeats: 2]

(a)        omit from the column headed “Circumstances” (all instances): C4951

(b)        insert in numerical order in the column headed “Circumstances” (all instances): C10445

[15]            Schedule 1, entry for Buprenorphine in the form Transdermal patch 20 mg [Maximum Quantity: 2; Number of Repeats: 0]

(a)        omit from the column headed “Circumstances” (all instances): C4951

(b)        insert in numerical order in the column headed “Circumstances” (all instances): C10445

(c)        omit from the column headed “Purposes” (all instances): P4951                       substitute: P10445

[16]            Schedule 1, entry for Buprenorphine in the form Transdermal patch 20 mg [Maximum Quantity: 4; Number of Repeats: 2]

(a)        omit from the column headed “Circumstances” (all instances): C4951

(b)        insert in numerical order in the column headed “Circumstances” (all instances): C10445

[17]            Schedule 1, entry for Buprenorphine in the form Transdermal patch 25 mg [Maximum Quantity: 2; Number of Repeats: 0]

(a)        omit from the column headed “Circumstances”: C4951

(b)        insert in numerical order in the column headed “Circumstances”: C10445

(c)        omit from the column headed “Purposes”: P4951            substitute: P10445

[18]            Schedule 1, entry for Buprenorphine in the form Transdermal patch 25 mg [Maximum Quantity: 4; Number of Repeats: 2]

(a)        omit from the column headed “Circumstances”: C4951

(b)        insert in numerical order in the column headed “Circumstances”: C10445

[19]            Schedule 1, entry for Buprenorphine in the form Transdermal patch 30 mg [Maximum Quantity: 2; Number of Repeats: 0]

(a)        omit from the column headed “Circumstances”: C4951

(b)        insert in numerical order in the column headed “Circumstances”: C10445

(c)        omit from the column headed “Purposes”: P4951            substitute: P10445

[20]            Schedule 1, entry for Buprenorphine in the form Transdermal patch 30 mg [Maximum Quantity: 4; Number of Repeats: 2]

(a)        omit from the column headed “Circumstances”: C4951

(b)        insert in numerical order in the column headed “Circumstances”: C10445


 

[21]            Schedule 1, entry for Buprenorphine in the form Transdermal patch 40 mg [Maximum Quantity: 2; Number of Repeats: 0]

(a)        omit from the column headed “Circumstances”: C4951

(b)        insert in numerical order in the column headed “Circumstances”: C10445

(c)        omit from the column headed “Purposes”: P4951            substitute: P10445

[22]            Schedule 1, entry for Buprenorphine in the form Transdermal patch 40 mg [Maximum Quantity: 4; Number of Repeats: 2]

(a)        omit from the column headed “Circumstances”: C4951

(b)        insert in numerical order in the column headed “Circumstances”: C10445

[23]            Schedule 1, entry for Certolizumab pegol

                             substitute:

Certolizumab pegol

Injection 200 mg in 1 mL single use pre-filled syringe

Injection

 

Cimzia

UC

MP

C8626 C8627 C8679 C8705 C8706 C8753 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10456 C10458 C10459 C10468 C10480 C10489

P10458 P10459 P10489

2

0

2

 

 

MP

C8626 C8627 C8679 C8705 C8706 C8753 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10456 C10458 C10459 C10468 C10480 C10489

P8706 P9185 P9625

2

2

2

 

 

MP

C8626 C8627 C8679 C8705 C8706 C8753 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10456 C10458 C10459 C10468 C10480 C10489

P8627 P8679 P9063 P9105 P9430 P9431 P10431

2

5

2

 

 

MP

C8626 C8627 C8679 C8705 C8706 C8753 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10456 C10458 C10459 C10468 C10480 C10489

P8626 P8705 P8753 P9073 P9074 P9183 P9442 P9537 P9610 P10456 P10468 P10480

6

0

2

 

 

Solution for injection 200 mg in 1 mL pre-filled pen

Injection

 

Cimzia

UC

MP

C8626 C8627 C8679 C8705 C8706 C8753 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10456 C10458 C10459 C10468 C10480 C10489

P10458 P10459 P10489

2

0

2

 

 

MP

C8626 C8627 C8679 C8705 C8706 C8753 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10456 C10458 C10459 C10468 C10480 C10489

P8706 P9185 P9625

2

2

2

 

 

MP

C8626 C8627 C8679 C8705 C8706 C8753 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10456 C10458 C10459 C10468 C10480 C10489

P8627 P8679 P9063 P9105 P9430 P9431 P10431

2

5

2

 

 

MP

C8626 C8627 C8679 C8705 C8706 C8753 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10456 C10458 C10459 C10468 C10480 C10489

P8626 P8705 P8753 P9073 P9074 P9183 P9442 P9537 P9610 P10456 P10468 P10480

6

0

2

 

 

[24]            Schedule 1, entry for Ciprofloxacin in the form Tablet 500 mg (as hydrochloride)

                             omit:

 

 

 

a

Ciprofloxacin-BW

GQ

MP NP

C5614 C5615 C5687 C5688 C5689 C5722 C5780

 

14

0

14

 

 

[25]            Schedule 1, entry for Codeine

                             substitute:

Codeine

Tablet containing codeine phosphate hemihydrate 30 mg

Oral

 

Aspen Pharma Pty Ltd

AS

MP NP

C10442 C10444 C10479

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

MP NP

C10442 C10444 C10479

P10444 P10479

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

[26]            Schedule 1, entry for Codeine with paracetamol

                             substitute:

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

a

APO- Paracetamol/Codeine 500/30

TX

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

Codalgin Forte

AF

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

Codapane Forte 500/30

AL

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

Comfarol Forte

SZ

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

Panadeine Forte

SW

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

Paracetamol/Codeine GH 500/30

GQ

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

Prodeine Forte

AV

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

APO-Paracetamol/
Codeine 500/30

TX

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

a

Codalgin Forte

AF

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

a

Codapane Forte 500/30

AL

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

a

Comfarol Forte

SZ

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

a

Panadeine Forte

SW

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

a

Paracetamol/Codeine GH 500/30

GQ

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

a

Prodeine Forte

AV

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

[27]            Schedule 1, entry for Doxepin in each of the forms: Capsule 10 mg (as hydrochloride); and Capsule 25 mg (as hydrochloride)

                             omit:

 

 

 

 

Sinequan

PF

MP NP

 

 

50

2

50

 

 

[28]            Schedule 1, entry for Dutasteride with tamsulosin

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

 

 

 

a

Doubluts

GC

MP NP

C6189

 

30

5

30

 

 

(b)        insert in the column headed “Schedule Equivalent” for the brand “Duodart 500ug/400ug”: a

[29]            Schedule 1, entry for Fentanyl in the form Transdermal patch 1.28 mg

                   omit from the column headed “Circumstances”: C4952              substitute: C10441

[30]            Schedule 1, entry for Fentanyl in each of the forms: Transdermal patch 2.063 mg; and Transdermal patch 2.1 mg

                   omit from the column headed “Circumstances” (all instances): C4952       substitute: C10441

[31]            Schedule 1, entry for Fentanyl in the form Transdermal patch 2.55 mg

                   omit from the column headed “Circumstances”: C4952              substitute: C10441

[32]            Schedule 1, entry for Fentanyl in each of the forms: Transdermal patch 4.125 mg; and Transdermal patch 4.2 mg

                   omit from the column headed “Circumstances” (all instances): C4952       substitute: C10441

[33]            Schedule 1, entry for Fentanyl in each of the forms: Transdermal patch 5.10 mg; and Trandermal patch 7.65 mg

                   omit from the column headed “Circumstances”: C4952              substitute: C10441

[34]            Schedule 1, entry for Fentanyl in each of the forms: Transdermal patch 8.25 mg; and Transdermal patch 8.4 mg

                   omit from the column headed “Circumstances” (all instances): C4952       substitute: C10441

[35]            Schedule 1, entry for Fentanyl in the form Transdermal patch 10.20 mg

                   omit from the column headed “Circumstances”: C4952              substitute: C10441

[36]            Schedule 1, entry for Fentanyl in each of the forms: Transdermal patch 12.375 mg; Transdermal patch 12.6 mg; Transdermal patch 16.5 mg; and Transdermal patch 16.8 mg

                   omit from the column headed “Circumstances” (all instances): C4952       substitute: C10441

[37]            Schedule 1, entry for Ferric derisomaltose

                             substitute:

Ferric derisomaltose

Injection 500 mg (iron) in 5 mL

Injection

 

Monofer

PF

MP NP

 

 

3

0

1

 

 

Injection 1000 mg (iron) in 10 mL

Injection

 

Monofer

PF

MP NP

 

 

1

1

1

 

 

[38]            Schedule 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)

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

 

 

 

a

BTC Fluoxetine

JB

MP NP

C4755 C6277

 

28

5

28

 

 

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

 

 

 

a

Fluoxetine APOTEX

TY

MP NP

C4755 C6277

 

28

5

28

 

 

[39]            Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1; Number of Repeats: 3]

(a)        omit from the column headed “Circumstances”: C8155 C8201 C8223 C8224 C8225 C8229

(b)        insert in numerical order in the column headed “Circumstances”: C10434 C10435 C10436 C10461 C10490 C10491

(c)        omit from the column headed “Purposes”: P8201 P8223 P8229

(d)        insert in numerical order in the column headed “Purposes”: P10435 P10436 P10490 P10491

[40]            Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1; Number of Repeats: 5]

(a)        omit from the column headed “Circumstances”: C8155 C8201 C8223 C8224 C8225 C8229

(b)        insert in numerical order in the column headed “Circumstances”: C10434 C10435 C10436 C10461 C10490 C10491

(c)        omit from the column headed “Purposes”: P8155 P8224 P8225

(d)        insert in numerical order in the column headed “Purposes”: P10434 P10461

[41]            Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 3]

(a)        omit from the column headed “Circumstances”: C8155 C8201 C8223 C8224 C8225 C8229

(b)        insert in numerical order in the column headed “Circumstances”: C10434 C10435 C10436 C10461 C10490 C10491

(c)        omit from the column headed “Purposes”: P8201 P8223 P8229

(d)        insert in numerical order in the column headed “Purposes”: P10435 P10436 P10490 P10491

[42]            Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 5]

(a)        omit from the column headed “Circumstances”: C8155 C8201 C8223 C8224 C8225 C8229

(b)        insert in numerical order in the column headed “Circumstances”: C10434 C10435 C10436 C10461 C10490 C10491

(c)        omit from the column headed “Purposes”: P8155 P8224 P8225

(d)        insert in numerical order in the column headed “Purposes”: P10434 P10461

[43]            Schedule 1, entry for Hydromorphone

                             substitute:

Hydromorphone

Injection containing hydromorphone hydrochloride 2 mg in 1 mL

Injection

a

Dilaudid

MF

MP NP

C10439

 

5

0

5

 

 

a

HYDROMORPHONE JUNO

JU

MP NP

C10439

 

5

0

5

 

 

a

MEDSURGE HYDROMORPHONE 2 mg/1 mL

DZ

MP NP

C10439

 

5

0

5

 

 

Injection containing hydromorphone hydrochloride 10 mg in 1 mL

Injection

a

Dilaudid-HP

MF

MP NP

C10439

 

5

0

5

 

 

a

HYDROMORPHONE JUNO-HP

JU

MP NP

C10439

 

5

0

5

 

 

a

MEDSURGE HYDROMORPHONE HP 10 mg/1 mL

DZ

MP NP

C10439

 

5

0

5

 

 

Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 200 mL

Oral

 

Dilaudid

MF

MP NP

C10439

 

1

0

1

 

 

PDP

C10440

 

1

0

1

 

 

Tablet containing hydromorphone hydrochloride 2 mg

Oral

 

Dilaudid

MF

MP NP

C10439 C10451

P10451

10

0

20

 

 

PDP

C10440 C10451

P10451

10

0

20

 

 

MP NP

C10439 C10451

P10439

20

0

20

 

 

PDP

C10440 C10451

P10440

20

0

20

 

 

Tablet (modified release) containing hydromorphone hydrochloride 4 mg

Oral

 

Jurnista

JC

MP NP

C10448

 

14

0

14

 

 

Tablet containing hydromorphone hydrochloride 4 mg

Oral

 

Dilaudid

MF

MP NP

C10439 C10451

P10451

10

0

20

 

 

PDP

C10440 C10451

P10451

10

0

20

 

 

MP NP

C10439 C10451

P10439

20

0

20

 

 

PDP

C10440 C10451

P10440

20

0

20

 

 

Tablet (modified release) containing hydromorphone hydrochloride 8 mg

Oral

 

Jurnista

JC

MP NP

C10448

 

14

0

14

 

 

Tablet containing hydromorphone hydrochloride 8 mg

Oral

 

Dilaudid

MF

MP NP

C10439 C10451

P10451

10

0

20

 

 

PDP

C10440 C10451

P10451

10

0

20

 

 

MP NP

C10439 C10451

P10439

20

0

20

 

 

PDP

C10440 C10451

P10440

20

0

20

 

 

Tablet (modified release) containing hydromorphone hydrochloride 16 mg

Oral

 

Jurnista

JC

MP NP

C10448

 

14

0

14

 

 

Tablet (modified release) containing hydromorphone hydrochloride 32 mg

Oral

 

Jurnista

JC

MP NP

C10448

 

14

0

14

 

 

Tablet (modified release) containing hydromorphone hydrochloride 64 mg

Oral

 

Jurnista

JC

MP NP

C10448

 

14

0

14

 

 

[44]            Schedule 1, entry for Isotretinoin in each of the forms: Capsule 10 mg; and Capsule 20 mg

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

 

 

 

a

Isotretinoin Lupin

GQ

MP

C5224

 

60

3

60

 

 

[45]            Schedule 1, entry for Lenalidomide in each of the forms: Capsule 5 mg; Capsule 10 mg; Capsule 15 mg; and Capsule 25 mg

                             insert as first entry:

 

 

 

 

 

 

MP

See Note 3

See Note 3

See Note 3

See Note 3

14

 

D(100)

[46]            Schedule 1, entry for Levodopa with carbidopa

                             omit:

 

Tablet (modified release) 200 mg-50 mg

Oral

 

Carbidopa and Levodopa Extended-release Tablets

DZ

MP NP

C5253

 

100

5

100

 

 

[47]            Schedule 1, entry for Mepolizumab

                             insert as first entry:

 

Injection 100 mg in 1 mL single dose pre-filled pen

Injection

 

Nucala

GK

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

D(100)

[48]            Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g

                             omit:

 

 

 

a

Metformin generichealth 1000

GQ

MP NP

 

 

90

5

90

 

 

[49]            Schedule 1, entry for Methadone in the form Injection containing methadone hydrochloride 10 mg in 1 mL

                             omit from the column headed “Circumstances”: C4953              substitute: C10441

[50]            Schedule 1, entry for Methadone in the form Tablet containing methadone hydrochloride 10 mg

                             omit from the column headed “Circumstances”: C4953              substitute: C10441

[51]            Schedule 1, entry for Montelukast in the form Tablet, chewable, 4 mg (as sodium)

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

 

 

 

a

Montelukast Lupin

HQ

MP NP

C6666

 

28

5

28

 

 

[52]            Schedule 1, entry for Montelukast in the form Tablet, chewable, 5 mg (as sodium)

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

 

 

 

a

Montelukast Lupin

HQ

MP NP

C6674 C7781

 

28

5

28

 

 

[53]            Schedule 1, entry for Morphine

                             substitute:

Morphine

Capsule containing morphine sulfate pentahydrate 10 mg (containing sustained release pellets)

Oral

 

Kapanol

YN

MP NP

C9248 C10445

 

28

0

28

 

 

Capsule containing morphine sulfate pentahydrate 20 mg (containing sustained release pellets)

Oral

 

Kapanol

YN

MP NP

C9248 C10445

 

28

0

28

 

 

Capsule containing morphine sulfate pentahydrate 30 mg (controlled release)

Oral

 

MS Mono

MF

MP NP

C10445

 

14

0

14

 

 

Capsule containing morphine sulfate pentahydrate 50 mg (containing sustained release pellets)

Oral

 

Kapanol

YN

MP NP

C10445

 

28

0

28

 

 

Capsule containing morphine sulfate pentahydrate 60 mg (controlled release)

Oral

 

MS Mono

MF

MP NP

C10445

 

14

0

14

 

 

Capsule containing morphine sulfate pentahydrate 90 mg (controlled release)

Oral

 

MS Mono

MF

MP NP

C10445

 

14

0

14

 

 

Capsule containing morphine sulfate pentahydrate 100 mg (containing sustained release pellets)

Oral

 

Kapanol

YN

MP NP

C10445

 

28

0

28

 

 

Capsule containing morphine sulfate pentahydrate 120 mg (controlled release)

Oral

 

MS Mono

MF

MP NP

C10445

 

14

0

14

 

 

Injection containing morphine hydrochloride trihydrate 10 mg in 1 mL

Injection

 

Morphine Juno

JU

MP NP MW

C10472

 

5

0

5

 

 

PDP

C10478

 

5

0

5

 

 

Injection containing morphine sulfate pentahydrate 10 mg in 1 mL

Injection

 

Hospira Pty Limited

PF

MP NP MW

C10472

 

5

0

5

 

 

PDP

C10478

 

5

0

5

 

 

 

MORPHINE SULFATE 10 mg/1 mL MEDSURGE

DZ

MP NP MW

C10472

 

5

0

5

 

 

PDP

C10478

 

5

0

5

 

 

Injection containing morphine sulfate pentahydrate 15 mg in 1 mL

Injection

a

Hospira Pty Limited

PF

MP NP MW

C10472

 

5

0

5

 

 

PDP

C10478

 

5

0

5

 

 

a

MORPHINE SULFATE 15 mg/1 mL MEDSURGE

DZ

MP NP MW

C10472

 

5

0

5

 

 

PDP

C10478

 

5

0

5

 

 

Injection containing morphine hydrochloride trihydrate 20 mg in 1 mL

Injection

 

Morphine Juno

JU

MP NP

C10472

 

5

0

5

 

 

PDP

C10478

 

5

0

5

 

 

Injection containing morphine sulfate pentahydrate 30 mg in 1 mL

Injection

a

Hospira Pty Limited

PF

MP NP

C10472

 

5

0

5

 

 

PDP

C10478

 

5

0

5

 

 

a

MORPHINE SULFATE 30 mg/1 mL MEDSURGE

DZ

MP NP

C10472

 

5

0

5

 

 

PDP

C10478

 

5

0

5

 

 

Injection containing morphine hydrochloride trihydrate 50 mg in 5 mL

Injection

 

Morphine Juno

JU

MP NP

C10472

 

5

0

5

 

 

Injection containing morphine hydrochloride trihydrate 100 mg in 5 mL

Injection

 

Morphine Juno

JU

MP NP

C10472

 

5

0

5

 

 

Oral solution containing morphine hydrochloride trihydrate 2 mg per mL, 200 mL

Oral

 

Ordine 2

MF

MP NP

C10439

 

1

0

1

 

 

PDP

C10440

 

1

0

1

 

 

Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 200 mL

Oral

 

Ordine 5

MF

MP NP

C10439

 

1

0

1

 

 

PDP

C10440

 

1

0

1

 

 

Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 200 mL

Oral

 

Ordine 10

MF

MP NP

C10439

 

1

0

1

 

 

PDP

C10440

 

1

0

1

 

 

Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 20 mg per sachet

Oral

 

MS Contin Suspension 20 mg

MF

MP NP

C10445

 

28

0

28

 

 

Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 30 mg per sachet

Oral

 

MS Contin Suspension 30 mg

MF

MP NP

C10445

 

28

0

28

 

 

Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 60 mg per sachet

Oral

 

MS Contin Suspension 60 mg

MF

MP NP

C10445

 

28

0

28

 

 

Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 100 mg per sachet

Oral

 

MS Contin Suspension 100 mg

MF

MP NP

C10445

 

28

0

28

 

 

Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 200 mg per sachet

Oral

 

MS Contin Suspension 200 mg

MF

MP NP

C10466 C10487

 

28

0

28

 

 

Tablet containing morphine sulfate pentahydrate 5 mg (controlled release)

Oral

 

MS Contin

MF

MP NP

C10445

 

28

0

28

 

 

Tablet containing morphine sulfate pentahydrate 10 mg

Oral

 

Sevredol

MF

MP NP

C6168 C10486

P10486

20

0

20

 

 

MP NP

C6168 C10486

P6168

20

2

20

 

 

Tablet containing morphine sulfate pentahydrate 10 mg (controlled release)

Oral

a

Momex SR 10

RW

MP NP

C10445

 

28

0

28

 

 

a

Morphine MR AN

EA

MP NP

C10445

 

28

0

28

 

 

a

MORPHINE MR APOTEX

TX

MP NP

C10445

 

28

0

28

 

 

a

Morphine MR Mylan

AF

MP NP

C10445

 

28

0

28

 

 

a

MS Contin

MF

MP NP

C10445

 

28

0

28

 

 

Tablet containing morphine sulfate pentahydrate 15 mg (controlled release)

Oral

 

MS Contin

MF

MP NP

C10445

 

28

0

28

 

 

Tablet containing morphine sulfate pentahydrate 20 mg

Oral

 

Sevredol

MF

MP NP

C6168 C10486

P10486

20

0

20

 

 

MP NP

C6168 C10486

P6168

20

2

20

 

 

Tablet containing morphine sulfate pentahydrate 30 mg

Oral

 

Anamorph

RW

MP NP

C10439 C10451

P10451

10

0

20

 

 

PDP

C10440 C10451

P10451

10

0

20

 

 

MP NP

C10439 C10451

P10439

20

0

20

 

 

PDP

C10440 C10451

P10440

20

0

20

 

 

Tablet containing morphine sulfate pentahydrate 30 mg (controlled release)

Oral

a

Momex SR 30

RW

MP NP

C10445

 

28

0

28

 

 

a

Morphine MR AN

EA

MP NP

C10445

 

28

0

28

 

 

a

MORPHINE MR APOTEX

TX

MP NP

C10445

 

28

0

28

 

 

a

Morphine MR Mylan

AF

MP NP

C10445

 

28

0

28

 

 

a

MS Contin

MF

MP NP

C10445

 

28

0

28

 

 

Tablet containing morphine sulfate pentahydrate 60 mg (controlled release)

Oral

a

Momex SR 60

RW

MP NP

C10445

 

28

0

28

 

 

a

Morphine MR AN

EA

MP NP

C10445

 

28

0

28

 

 

a

MORPHINE MR APOTEX

TX

MP NP

C10445

 

28

0

28

 

 

a

Morphine MR Mylan

AF

MP NP

C10445

 

28

0

28

 

 

a

MS Contin

MF

MP NP

C10445

 

28

0

28

 

 

Tablet containing morphine sulfate pentahydrate 100 mg (controlled release)

Oral

a

Momex SR 100

RW

MP NP

C10445

 

28

0

28

 

 

a

Morphine MR AN

EA

MP NP

C10445

 

28

0

28

 

 

a

MORPHINE MR APOTEX

TX

MP NP

C10445

 

28

0

28

 

 

a

Morphine MR Mylan

AF

MP NP

C10445

 

28

0

28

 

 

a

MS Contin

MF

MP NP

C10445

 

28

0

28

 

 

Tablet containing morphine sulfate pentahydrate 200 mg (controlled release)

Oral

 

MS Contin

MF

MP NP

C6151 C10466 C10487

P10466 P10487

28

0

28

 

 

MP NP

C6151 C10466 C10487

P6151

28

2

28

 

 

[54]            Schedule 1, entry for Oxycodone

                             substitute:

Oxycodone

Capsule containing oxycodone hydrochloride 5 mg

Oral

a

Oxycodone BNM

LI

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

OxyNorm

MF

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

Oxycodone BNM

LI

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

a

OxyNorm

MF

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

Capsule containing oxycodone hydrochloride 10 mg

Oral

a

Oxycodone BNM

LI

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

OxyNorm

MF

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

Oxycodone BNM

LI

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

a

OxyNorm

MF

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

Capsule containing oxycodone hydrochloride 20 mg

Oral

a

Oxycodone BNM

LI

MP NP

C10444

 

20

0

20

 

 

a

OxyNorm

MF

MP NP

C10444

 

20

0

20

 

 

Oral solution containing oxycodone hydrochloride 1 mg per mL, 250 mL

Oral

 

OxyNorm Liquid 1mg/mL

MF

MP NP

C10444

 

1

0

1

 

 

PDP

C10446

 

1

0

1

 

 

Suppository 30 mg (as pectinate)

Rectal

 

Proladone

FF

MP NP

C10477

 

12

0

12

 

 

PDP

C10485

 

12

0

12

 

 

Tablet containing oxycodone hydrochloride 5 mg

Oral

a

Endone

AF

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

Mayne Pharma Oxycodone IR

YN

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

Oxycodone Aspen

AL

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

Endone

AF

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

a

Mayne Pharma Oxycodone IR

YN

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

a

Oxycodone Aspen

AL

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

Tablet containing oxycodone hydrochloride 10 mg (controlled release)

Oral

a

Novacodone

HX

MP NP

C10445

 

28

0

28

 

 

a

Oxycodone Sandoz

SZ

MP NP

C10445

 

28

0

28

 

 

a

OxyContin

MF

MP NP

C10445

 

28

0

28

 

 

Tablet containing oxycodone hydrochloride 15 mg (controlled release)

Oral

 

OxyContin

MF

MP NP

C10445

 

28

0

28

 

 

Tablet containing oxycodone hydrochloride 20 mg (controlled release)

Oral

a

Novacodone

HX

MP NP

C10445

 

28

0

28

 

 

a

Oxycodone Sandoz

SZ

MP NP

C10445

 

28

0

28

 

 

a

OxyContin

MF

MP NP

C10445

 

28

0

28

 

 

Tablet containing oxycodone hydrochloride 30 mg (controlled release)

Oral

 

OxyContin

MF

MP NP

C10445

 

28

0

28

 

 

Tablet containing oxycodone hydrochloride 40 mg (controlled release)

Oral

a

Novacodone

HX

MP NP

C10445

 

28

0

28

 

 

a

Oxycodone Sandoz

SZ

MP NP

C10445

 

28

0

28

 

 

a

OxyContin

MF

MP NP

C10445

 

28

0

28

 

 

Tablet containing oxycodone hydrochloride 80 mg (controlled release)

Oral

a

Novacodone

HX

MP NP

C10445

 

28

0

28

 

 

a

Oxycodone Sandoz

SZ

MP NP

C10445

 

28

0

28

 

 

a

OxyContin

MF

MP NP

C10445

 

28

0

28

 

 

[55]            Schedule 1, entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 2.5 mg with naloxone hydrochloride 1.25 mg

                             omit from the column headed “Circumstances”: C4951              substitute: C10445

[56]            Schedule 1, entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 5 mg with naloxone hydrochloride 2.5 mg

                             omit from the column headed “Circumstances”: C4951              substitute: C10445

[57]            Schedule 1, entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 10 mg with naloxone hydrochloride 5 mg

                             omit from the column headed “Circumstances”: C4951              substitute: C10445

[58]            Schedule 1, entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 15 mg with naloxone hydrochloride 7.5 mg

                             omit from the column headed “Circumstances”: C4951              substitute: C10445

[59]            Schedule 1, entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 20 mg with naloxone hydrochloride 10 mg

                             omit from the column headed “Circumstances”: C4951              substitute: C10445

[60]            Schedule 1, entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 30 mg with naloxone hydrochloride 15 mg

                             omit from the column headed “Circumstances”: C4951              substitute: C10445

[61]            Schedule 1, entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 40 mg with naloxone hydrochloride 20 mg

                             omit from the column headed “Circumstances”: C4951              substitute: C10445

[62]            Schedule 1, entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 60 mg with naloxone hydrochloride 30 mg

                             omit from the column headed “Circumstances”: C4951              substitute: C10445

[63]            Schedule 1, entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 80 mg with naloxone hydrochloride 40 mg

                             omit from the column headed “Circumstances”: C4951              substitute: C10445

[64]            Schedule 1, omit entry for Oxytocin

[65]            Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg

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

 

 

 

 

BTC Perindopril

JB

MP NP

 

 

30

5

30

 

 

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

 

 

 

 

Perindopril APOTEX

TY

MP NP

 

 

30

5

30

 

 

[66]            Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg

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

 

 

 

 

BTC Perindopril

JB

MP NP

 

 

30

5

30

 

 

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

 

 

 

 

Perindopril APOTEX

TY

MP NP

 

 

30

5

30

 

 

[67]            Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg

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

 

 

 

 

BTC Perindopril

JB

MP NP

 

 

30

5

30

 

 

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

 

 

 

 

Perindopril APOTEX

TY

MP NP

 

 

30

5

30

 

 

[68]            Schedule 1, entry for Protein formula with carbohydrate, fat, vitamins and minerals

                             omit:

 

Oral liquid 500 mL, 8 (Nutrini Peptisorb Energy)

Oral

 

Nutrini Peptisorb Energy

NU

MP NP

C6890

 

10

5

1

 

 

[69]            Schedule 1, entry for Risperidone in the form Oral solution 1 mg per mL, 100 mL

                             substitute:

 

Oral solution 1 mg per mL, 100 mL

Oral

a

Risperdal

JC

MP NP

C4246 C5907 C6898 C6899 C10020 C10021 C10052

P6898 P6899 P10020 P10021 P10052

1

2

1

 

 

a

Rixadone

AF

MP NP

C4246 C5907 C6898 C6899 C10020 C10021 C10052

P6898 P6899 P10020 P10021 P10052

1

2

1

 

 

a

Risperdal

JC

MP NP

C4246 C5907 C6898 C6899 C10020 C10021 C10052

P4246 P5907

1

5

1

 

 

a

Rixadone

AF

MP NP

C4246 C5907 C6898 C6899 C10020 C10021 C10052

P4246 P5907

1

5

1

 

 

[70]            Schedule 1, entry for Sevelamer

                             substitute:

Sevelamer

Tablet containing sevelamer carbonate 800 mg

Oral

 

Sevelamer Apotex

TX

MP NP

C5491

 

180

5

180

 

 

 

Sevelamer Lupin

GQ

MP NP

C5491

 

180

5

180

 

 

 

Sevelamer Apotex

TX

MP

C5530 C9762

 

360

5

180

 

C(100)

 

Sevelamer Lupin

GQ

MP

C5530 C9762

 

360

5

180

 

C(100)

Tablet containing sevelamer hydrochloride 800 mg

Oral

 

Renagel

GZ

MP NP

C5491

 

180

5

180

 

 

MP

C5530 C9762

 

360

5

180

 

C(100)

[71]            Schedule 1, entry for Tapentadol in each of the forms: Tablet (modified release) 50 mg (as hydrochloride); and Tablet (modified release) 100 mg (as hydrochloride)

                             omit from the column headed “Circumstances”: C4556              substitute: C10445

[72]            Schedule 1, entry for Tapentadol in each of the forms: Tablet (modified release) 150 mg (as hydrochloride); and Tablet (modified release) 200 mg (as hydrochloride)

                             omit from the column headed “Circumstances”: C4556              substitute: C10445

[73]            Schedule 1, entry for Tapentadol in the form Tablet (modified release) 250 mg (as hydrochloride)

                             omit from the column headed “Circumstances”: C4556              substitute: C10445

[74]            Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride)

(a)        omit:

 

 

 

a

Terbinafine GH

GQ

MP NP

C6395 C6404 C6453

P6404 P6453

42

0

42

 

 

(b)        omit:

 

 

 

a

Terbinafine GH

GQ

MP NP

C6395 C6404 C6453

P6395

42

1

42

 

 

[75]            Schedule 1, entry for Tramadol

                             substitute:

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

a

APO-Tramadol

TX

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

Chem mart Tramadol

CH

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

Terry White Chemists Tramadol

TW

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

Tramadol AMNEAL

EF

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

Tramadol AN

EA

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

Tramadol Sandoz

SZ

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

Tramadol SCP

CR

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

Tramal

CS

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

Tramedo

AF

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

Zydol

RW

MP NP

C10442 C10444

P10442

10

0

20

 

 

PDP

C10442 C10446

P10442

10

0

20

 

 

a

APO-Tramadol

TX

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

a

Chem mart Tramadol

CH

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

a

Terry White Chemists Tramadol

TW

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

a

Tramadol AMNEAL

EF

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

a

Tramadol AN

EA

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

a

Tramadol Sandoz

SZ

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

a

Tramadol SCP

CR

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

a

Tramal

CS

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

a

Tramedo

AF

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

a

Zydol

RW

MP NP

C10442 C10444

P10444

20

0

20

 

 

PDP

C10442 C10446

P10446

20

0

20

 

 

Injection containing tramadol hydrochloride 100 mg in 2 mL

Injection

a

Tramadol ACT

JO

MP NP

C10444

 

5

0

5

 

 

PDP

C10446

 

5

0

5

 

 

a

Tramadol AN

JU

MP NP

C10444

 

5

0

5

 

 

PDP

C10446

 

5

0

5

 

 

a

Tramadol Sandoz

SZ

MP NP

C10444

 

5

0

5

 

 

PDP

C10446

 

5

0

5

 

 

a

Tramal 100

CS

MP NP

C10444

 

5

0

5

 

 

PDP

C10446

 

5

0

5

 

 

Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL

Oral

 

Tramal

CS

MP NP

C10444

 

1

0

1

 

 

PDP

C10446

 

1

0

1

 

 

Tablet (sustained release) containing tramadol hydrochloride 50 mg

Oral

 

Tramal SR 50

CS

MP NP

C10445

 

20

0

20

 

 

Tablet (sustained release) containing tramadol hydrochloride 100 mg

Oral

a

APO-Tramadol SR

TX

MP NP

C10445

 

20

0

20

 

 

a

Chem mart Tramadol SR

CH

MP NP

C10445

 

20

0

20

 

 

a

Terry White Chemists Tramadol SR

TW

MP NP

C10445

 

20

0

20

 

 

a

Tramadol AN SR

EA

MP NP

C10445

 

20

0

20

 

 

a

Tramadol Sandoz SR

SZ

MP NP

C10445

 

20

0

20

 

 

a

Tramadol SR generichealth

GQ

MP NP

C10445

 

20

0

20

 

 

a

Tramal SR 100

CS

MP NP

C10445

 

20

0

20

 

 

a

Tramedo SR

AL

MP NP

C10445

 

20

0

20

 

 

a

Zydol SR 100

RW

MP NP

C10445

 

20

0

20

 

 

Tablet (sustained release) containing tramadol hydrochloride 150 mg

Oral

a

APO-Tramadol SR

TX

MP NP

C10445

 

20

0

20

 

 

a

Chem mart Tramadol SR

CH

MP NP

C10445

 

20

0

20

 

 

a

Terry White Chemists Tramadol SR

TW

MP NP

C10445

 

20

0

20

 

 

a

Tramadol AN SR

EA

MP NP

C10445

 

20

0

20

 

 

a

Tramadol Sandoz SR

SZ

MP NP

C10445

 

20

0

20

 

 

a

Tramadol SR generichealth

GQ

MP NP

C10445

 

20

0

20

 

 

a

Tramal SR 150

CS

MP NP

C10445

 

20

0

20

 

 

a

Tramedo SR

AL

MP NP

C10445

 

20

0

20

 

 

a

Zydol SR 150

RW

MP NP

C10445

 

20

0

20

 

 

Tablet (sustained release) containing tramadol hydrochloride 200 mg

Oral

a

APO-Tramadol SR

TX

MP NP

C10445

 

20

0

20

 

 

a

Chem mart Tramadol SR

CH

MP NP

C10445

 

20

0

20

 

 

a

Terry White Chemists Tramadol SR

TW

MP NP

C10445

 

20

0

20

 

 

a

Tramadol AN SR

EA

MP NP

C10445

 

20

0

20

 

 

a

Tramadol Sandoz SR

SZ

MP NP

C10445

 

20

0

20

 

 

a

Tramadol SR generichealth

GQ

MP NP

C10445

 

20

0

20

 

 

a

Tramal SR 200

CS

MP NP

C10445

 

20

0

20

 

 

a

Tramedo SR

AL

MP NP

C10445

 

20

0

20

 

 

a

Zydol SR 200

RW

MP NP

C10445

 

20

0

20

 

 

[76]            Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 80 mg-12.5 mg

(a)        insert in the column headed “Schedule Equivalent” for the existing brand “Co-Diovan 80/12.5”: a

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

 

 

 

a

Dilart HCT 80/12.5

AF

MP NP

C4374

 

28

5

28

 

 

[77]            Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 160 mg-12.5 mg

(a)        insert in the column headed “Schedule Equivalent” for the existing brand “Co-Diovan 160/12.5”: a

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

 

 

 

a

Dilart HCT 160/12.5

AF

MP NP

C4374

 

28

5

28

 

 

[78]            Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 160 mg-25 mg

(a)        insert in the column headed “Schedule Equivalent” for the existing brand “Co-Diovan 160/25”: a

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

 

 

 

a

Dilart HCT 160/25

AF

MP NP

C4374

 

28

5

28

 

 

[79]            Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 320 mg-12.5 mg

(a)        insert in the column headed “Schedule Equivalent” for the existing brand “Co-Diovan 320/12.5”: a

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

 

 

 

a

Dilart HCT 320/12.5

AF

MP NP

C4361

 

28

5

28

 

 

[80]            Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 320 mg-25 mg

(a)        insert in the column headed “Schedule Equivalent” for the existing brand “Co-Diovan 320/25”: a

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

 

 

 

a

Dilart HCT 320/25

AF

MP NP

C4361

 

28

5

28

 

 

[81]            Schedule 4, Part 1, after entry for Amino acid formula with carbohydrate, vitamins, minerals and trace elements without phenylalanine

                             insert:

Amino acid formula with carbohydrate without phenylalanine

C4295

 

 

Phenylketonuria

 

[82]            Schedule 4, Part 1, after entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides

                             insert:

Amino acid formula with fat, carbohydrate without methionine

C5534

 

 

Pyridoxine non-responsive homocystinuria

 

[83]            Schedule 4, Part 1, after entry for Amino acid formula with fat, carbohydrate without phenylalanine

                             insert:

Amino acid formula with fat, carbohydrate without phenylalanine and tyrosine

C5533

 

 

Tyrosinaemia

 

Amino acid formula with fat, carbohydrate without valine, leucine and isoleucine

C5571

 

 

Maple syrup urine disease

 

[84]            Schedule 4, Part 1, entry for Bortezomib

(a)        omit:

 

C7963

 

 

Symptomatic multiple myeloma
Initial PBS-subsidised treatment
Patient must be newly diagnosed; AND
Patient must be ineligible for high dose chemotherapy; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
The treatment must be in combination with a corticosteroid and melphalan or cyclophosphamide; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 7963

(b)        omit:

 

C7984

 

 

Symptomatic multiple myeloma
Initial PBS-subsidised treatment
Patient must be newly diagnosed; AND
Patient must have severe acute renal failure; AND
Patient must require dialysis; OR
Patient must be at high risk of requiring dialysis in the opinion of a nephrologist; AND
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Details of the histological diagnosis of multiple myeloma, the name of the nephrologist who has reviewed the patient and the date of review, a copy of the current pathology reports reporting Glomerular Filtration Rate from an Approved Pathology Authority, and nomination of the disease activity parameter(s) that will be used to assess response must be documented in the patient's medical records. Disease activity parameters include current diagnostic reports of at least one of the following:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) in oligo-secretory and non-secretory myeloma patients only, the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. Magnetic Resonance Imaging (MRI) or computed tomography (CT) scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be documented in the patient's medical records for all patients.
Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be documented in the patient's medical records.
Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 7984

(c)        insert in numerical order after existing text:

 

C10426

 

 

Symptomatic multiple myeloma
Initial PBS-subsidised treatment
The condition must be newly diagnosed; AND
Patient must have severe acute renal failure; AND
Patient must require dialysis; OR
Patient must be at high risk of requiring dialysis in the opinion of a nephrologist; AND
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Details of the histological diagnosis of multiple myeloma, the name of the nephrologist who has reviewed the patient and the date of review, a copy of the current pathology reports reporting Glomerular Filtration Rate from an Approved Pathology Authority, and nomination of the disease activity parameter(s) that will be used to assess response must be documented in the patient's medical records. Disease activity parameters include current diagnostic reports of at least one of the following:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) in oligo-secretory and non-secretory myeloma patients only, the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. Magnetic Resonance Imaging (MRI) or computed tomography (CT) scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be documented in the patient's medical records for all patients.
Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be documented in the patient's medical records.
Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 10426

 

C10454

 

 

Multiple myeloma
Triple combination therapy (bortezomib, lenalidomide and dexamethasone)
The condition must be newly diagnosed; AND
The treatment must be in combination with lenalidomide and dexamethasone; AND
The treatment must not be in combination with PBS-subsidised thalidomide, pomalidomide or carfilzomib; AND
The treatment must not be changing from dual combination therapy with lenalidomide and dexamethasone for symptomatic multiple myeloma to triple therapy with lenalidomide, bortezomib and dexamethasone; AND
Patient must not receive more than 8 cycles of treatment with bortezomib under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 10454

 

C10455

 

 

Symptomatic multiple myeloma
Initial PBS-subsidised treatment
The condition must be newly diagnosed; AND
Patient must be ineligible for high dose chemotherapy; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
The treatment must be in combination with a corticosteroid and melphalan or cyclophosphamide; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 10455

[85]            Schedule 4, Part 1, entry for Budesonide with formoterol

(a)        insert in the column headed “Purposes Code” for the circumstance code “C4397”: P4397

(b)        insert in the column headed “Purposes Code” for the circumstance code “C7970”: P7970

(c)        insert in numerical order after existing text:

 

C10464

P10464

 

Mild asthma
Patient must have asthma and require an anti-inflammatory reliever therapy; AND
Patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA).
Device (inhaler) technique should be reviewed at each clinical visit and before initiating treatment with this medicine.

Compliance with Authority Required procedures - Streamlined Authority Code 10464

 

C10482

P10482

 

Mild asthma
Patient must have asthma and require an anti-inflammatory reliever therapy; AND
Patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA).
Patient must be aged 12 years or over.
Device (inhaler) technique should be reviewed at each clinical visit and before initiating treatment with this medicine.

Compliance with Authority Required procedures - Streamlined Authority Code 10482

[86]            Schedule 4, Part 1, entry for Buprenorphine

(a)        omit:

 

C4951

P4951

 

Chronic severe disabling pain
The condition must be unresponsive to non-opioid analgesics.

 

(b)        insert in numerical order after existing text:

 

C10445

P10445

 

Chronic severe pain
The condition must require daily, continuous, long term therapy with this treatment; AND
Patient must have pain directly attributable to cancer; OR
Patient must have previously experienced inadequate management of pain relief following maximum tolerated doses of non-opioid or other opioid analgesics; OR
The condition must be such that maximum tolerated doses of non-opioid or other opioid analgesics would provide inadequate management of pain relief; OR
Patient must be unable to use non-opioid or other opioid analgesics due to contraindications, adverse effects or intolerance.
Authorities for increased maximum quantities and/or repeats must only be considered for:
(i) chronic severe disabling pain where the total duration of non-PBS and PBS-subsidised opioid analgesic treatment is less than 12 months; or
(ii) chronic severe disabling pain where the total duration of non-PBS and PBS-subsidised opioid analgesic treatment will or has exceeded 12 months and the patient's pain management has been reviewed through consultation with the patient by another medical practitioner, and the clinical need for continuing opioid analgesic treatment has been confirmed immediately prior to the first application or at least once in the past 12 months for subsequent applications. The full name of the medical practitioner consulted and the date of the most recent consultation are to be provided at the time of each application; or
(iii) chronic severe disabling pain where the total duration of non-PBS and PBS-subsidised opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's pain management has not been reviewed through consultation with the patient by another medical practitioner to confirm the clinical need for continuing opioid analgesic treatment. A review must have been planned to take place within 3 months from the date of this application. The full name of the medical practitioner consulted and the date of the consultation are to be provided at the time of the application.
Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and up to 2 repeats).

Compliance with Authority Required procedures - Streamlined Authority Code 10445

[87]            Schedule 4, Part 1, entry for Certolizumab pegol

                             insert in numerical order after existing text:

 

C10431

P10431

 

Non-radiographic axial spondyloarthritis
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 for this condition; AND
The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.
An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:
(a) a CRP measurement no greater than 10 mg per L; or
(b) a CRP measurement reduced by at least 20% from baseline.
If the requirement to demonstrate an elevated CRP level could not be met under an initial treatment restriction, a reduction in the BASDAI score from baseline will suffice for the purposes of administering this continuing treatment restriction.
The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.

Compliance with Written Authority Required procedures

 

C10456

P10456

 

Non-radiographic axial spondyloarthritis
Initial treatment - Initial 2 (Change or re-commencement 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 failed, or ceased to respond to, PBS-subsidised treatment with biological medicines more than three times for this PBS-indication during the current treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS-indication twice or more in the current treatment cycle; AND
Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, 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 non-radiographic axial spondyloarthritis.
An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment.
A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application.
An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:
(a) a CRP measurement no greater than 10 mg per L; or
(b) a CRP measurement reduced by at least 20% from baseline.
The assessment of the patient's response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment.
BASDAI scores and CRP levels must be documented in the patient's medical records.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
If the application is not made through the online system, the authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Non-radiographic axial spondyloarthritis change or recommencement of treatment PBS Authority Application - Supporting Information Form which seeks:
(i) the BASDAI score confirming a reduction of 2 or more units from baseline and the C-reactive protein (CPR) level if the patient has had an adequate response to the most recent course of biological medicine; or
(ii) confirmation that the patient has failed to achieve an adequate response with the most recent supply of biological medicine; or
(iii) confirmation that an intolerance to the most recent supply of biological medicine had occurred; and
(iv) an updated BASDAI score and CRP level if new baseline measurements are to be used for future assessments of response

Compliance with Written Authority Required procedures

 

C10458

P10458

 

Non-radiographic axial spondyloarthritis
Grandfather treatment
Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 June 2020; AND
Patient must have had chronic lower back pain and stiffness for 3 or more months that was relieved by exercise but not rest, prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have had 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, prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must have had one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis prior to commencing non-PBS subsidised treatment with this biological medicine; AND
The condition must have been diagnosed as non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria, prior to having commenced non-PBS subsidised treatment with this biological medicine; AND
The condition must have been sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI) prior to commencing non-PBS subsidised treatment with this biological medicine; AND
The condition must have had presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent) prior to commencing non-PBS subsidised treatment with this biological medicine; AND
The condition must have had BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium) prior to commencing non-PBS subsidised treatment with this biological medicine; AND
The treatment must not exceed a maximum of 24 weeks with this drug 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 non-radiographic axial spondyloarthritis.
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 to NSAIDs and must have been demonstrated prior to initiation of non-PBS subsidised treatment with this biological medicine for this condition:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and
(b) C-reactive protein (CRP) level greater than 10 mg per L.
The BASDAI score and CRP level must have been determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must have been no more than 1 month old at the time of initiating non-PBS subsidised treatment with this biological medicine for this condition.
If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Non-radiographic axial spondyloarthritis Grandfathered PBS Authority Application - Supporting Information Form which seeks details of:
(i) a copy of the radiological report confirming the absence of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; and
(ii) a BASDAI score and CRP level that substantiates failure to achieve an adequate response to NSAIDs prior to initiating non-PBS subsidised treatment with this biological medicine for this condition; and
(iii) the MRI report; and
(iv) the NSAIDs trialled, their doses and duration of treatment. If applicable, th