Federal Register of Legislation - Australian Government

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PB 74 of 2021 Other as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme and related matters.
Administered by: Health
Registered 31 Jul 2021
Tabling HistoryDate
Tabled HR03-Aug-2021
Tabled Senate03-Aug-2021
Date of repeal 19 Oct 2021
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

 

 

 

 

 

PB 74 of 2021

 

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021
(No. 7)

 

National Health Act 1953

________________________________________________________________________

 

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

 

Dated           27 July 2021

 

 

 

 

 

 

 

 

 

 

 

 

NIKOLAI TSYGANOV

Assistant Secretary (Acting)

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 2021 (No. 7).

(2)          This instrument may also be cited as PB 74 of 2021.

2          Commencement

(1)          Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  Sections 1 to 4 and anything in this instrument not elsewhere covered by this table

1 August 2021

1 August 2021

2.  Schedule 1

1 November 2020

1 November 2020

3. Schedule 2

1 August 2021

1 August 2021

Note:    This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)          Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3          Authority

This instrument is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

4          Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.


Schedule 1          Authorised Prescriber Amendments

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

[1]             Section 4 (definition of authorised prescriber)

                           repeal the definition, substitute:

authorised prescriber, for a pharmaceutical benefit, means a PBS prescriber (within the meaning of Part VII of the Act) authorised under section 9 or 9A to write a prescription for the supply of the benefit;

[2]             After section 9

                           insert:

9A  Authorised prescriber—Schedule 2

For the purposes of subsection 88(1) of the Act, a medical practitioner is authorised to write a prescription for the supply of an extemporaneously‑prepared pharmaceutical benefit.


 


Schedule 2           Other Amendments

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

[1]             Schedule 1, Part 1, entry for Acarbose in the form Tablet 100 mg

                           omit:

 

 

 

a

Glucobay 100

BN

MP NP

 

 

90

5

90

 

 

[2]             Schedule 1, Part 1, entry for Aciclovir in the form Eye ointment 30 mg per g, 4.5 g

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

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

 

 

 

a

XOROX

IX

MP NP

C5965

 

1

0

1

 

 

 

 

 

 

 

 

AO

C5964

 

1

0

1

 

 

[3]             Schedule 1, Part 1, entry for Adrenaline (epinephrine) in the form Injection 1 mg (as acid tartrate) in 1 mL (1 in 1,000) [Maximum Quantity: 5; Number of Repeats: 0]

omit from the column headed “Authorised Prescriber”: PDP      substitute: PDP MP NP

[4]             Schedule 1, Part 1, after entry for Adrenaline (epinephrine) in the form Injection 1 mg (as acid tartrate) in 1 mL (1 in 1,000)

                           insert:

 

Solution for injection 1 mg (as tartrate) in 1 mL (1 in 1,000)

Injection

 

ADRENALINE RENAUDIN

LM

PDP MP NP

 

 

5

0

10

 

 

 

 

 

 

 

 

MP NP

 

 

5

1

10

 

 

[5]             Schedule 1, Part 1, after entry for Alendronic acid with colecalciferol and calcium

                           insert:

Alirocumab

Injection 75 mg in 1 mL single use pre-filled pen

Injection

 

Praluent

SW

MP

C12008 C12010 C12011 C12054 C12055

 

2

5

2

 

 

 

Injection 150 mg in 1 mL single use pre-filled pen

Injection

 

Praluent

SW

MP

C12008 C12010 C12011 C12054 C12055

 

2

5

2

 

 


 

[6]             Schedule 1, Part 1, entry for Atenolol in the form Tablet 50 mg

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

 

 

 

a

APX-Atenolol

TY

MP NP

 

 

30

5

30

 

 

[7]             Schedule 1, Part 1, entry for Atezolizumab in the form Solution concentrate for I.V. infusion 1200 mg in 20 mL

                           omit from the column headed “Circumstances”: C9345

[8]             Schedule 1, Part 1, entry for Azathioprine in each of the forms: Tablet 25 mg; and Tablet 50 mg

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

 

 

 

a

NOUMED AZATHIOPRINE

VO

MP NP

 

 

100

5

100

 

 

[9]             Schedule 1, Part 1, entry for Bisoprolol in each of the forms: Tablet containing bisoprolol fumarate 2.5 mg; Tablet containing bisoprolol fumarate 5 mg; and Tablet containing bisoprolol fumarate 10 mg

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

 

 

 

a

Bisoprolol Dr.Reddy's

RI

MP NP

C5324

 

28

5

28

 

 

[10]           Schedule 1, Part 1, entry for Blinatumomab

                           omit from the column headed “Circumstances”: C9878

[11]           Schedule 1, Part 1, entry for Botulinum toxin type A purified neurotoxin complex

                           omit from the column headed “Circumstances”: C9271

[12]           Schedule 1, Part 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 [Maximum Quantity: 1; Number of Repeats: 2]

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

 

 

 

a

BiResp Spiromax

TB

MP

C7970 C10464 C10538

P10464

1

2

1

 

 

 

 

 

 

 

 

NP

C7970 C10464

P10464

1

2

1

 

 

[13]           Schedule 1, Part 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 [Maximum Quantity: 1; Number of Repeats: 5]

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

 

 

 

a

BiResp Spiromax

TB

MP

C7970 C10464 C10538

P7970 P10538

1

5

1

 

 

 

 

 

 

 

 

NP

C7970 C10464

P7970

1

5

1

 

 

[14]           Schedule 1, Part 1, entry for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2

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

 

 

 

a

BiResp Spiromax

TB

MP NP

C7979 C10121

 

1

5

1

 

 

[15]           Schedule 1, Part 1, entry for Cetuximab in each of the forms: Solution for I.V. infusion 100 mg in 20 mL; and Solution for I.V. infusion 500 mg in 100 mL

                   (a)        omit from the column headed “Circumstances”: C4945 C4965

                   (b)        insert in numerical order in the column headed “Circumstances”: C12016 C12045

[16]           Schedule 1, Part 1, entry for Clarithromycin in the form Tablet 250 mg

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

 

 

 

a

NOUMED CLARITHROMYCIN

VO

MP NP

 

 

14

1

14

 

 

[17]           Schedule 1, Part 1, entry for Clonazepam in each of the forms: Injection 1 mg in 2 mL (set containing solution 1 mg in 1 mL and 1 mL diluent); and Oral liquid 2.5 mg per mL, 10 mL

                           omit from the column headed “Responsible Person”: RO             substitute: PB

[18]           Schedule 1, Part 1, entry for Clonazepam in the form Tablet 500 micrograms

                           omit from the column headed “Responsible Person” for the brand “Rivotril” (all instances): RO                 substitute: PB

[19]           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)        omit from the column headed “Circumstances”: C9463

                   (b)        omit from the column headed “Circumstances”: C9871

                   (c)        omit from the column headed “Purposes”: P9463

[20]           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)        omit from the column headed “Circumstances”: C9463

                   (b)        omit from the column headed “Circumstances”: C9871

                   (c)        omit from the column headed “Purposes”: P9871


 

[21]           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)        omit from the column headed “Circumstances”: C9463

                   (b)        omit from the column headed “Circumstances”: C9871

                   (c)        omit from the column headed “Purposes”: P9463

[22]           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)        omit from the column headed “Circumstances”: C9463

                   (b)        omit from the column headed “Circumstances”: C9871

                   (c)        omit from the column headed “Purposes”: P9871

[23]           Schedule 1, Part 1, entry for Colchicine

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

 

 

 

a

Colcine

CR

MP NP

 

 

30

5

30

 

 

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

                           substitute:

Deferasirox

Tablet 90 mg

Oral

a

CIPLA DEFERASIROX

LR

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

30

 

D(100)

 

 

 

a

Eferas

AF

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

30

 

D(100)

 

 

 

a

Jadenu

NM

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

30

 

D(100)

 

 

 

a

Pharmacor Deferasirox FC

CR

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

30

 

D(100)

 

 

 

a

CIPLA DEFERASIROX

LR

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

30

 

D(100)

 

 

 

a

Eferas

AF

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

30

 

D(100)

 

 

 

a

Jadenu

NM

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

30

 

D(100)

 

 

 

a

Pharmacor Deferasirox FC

CR

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

30

 

D(100)

 

Tablet 180 mg

Oral

a

CIPLA DEFERASIROX

LR

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

30

 

D(100)

 

 

 

a

Eferas

AF

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

30

 

D(100)

 

 

 

a

Jadenu

NM

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

30

 

D(100)

 

 

 

a

Pharmacor Deferasirox FC

CR

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

30

 

D(100)

 

 

 

a

CIPLA DEFERASIROX

LR

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

30

 

D(100)

 

 

 

a

Eferas

AF

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

30

 

D(100)

 

 

 

a

Jadenu

NM

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

30

 

D(100)

 

 

 

a

Pharmacor Deferasirox FC

CR

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

30

 

D(100)

 

Tablet 360 mg

Oral

a

CIPLA DEFERASIROX

LR

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

30

 

D(100)

 

 

 

a

Eferas

AF

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

30

 

D(100)

 

 

 

a

Jadenu

NM

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

30

 

D(100)

 

 

 

a

Pharmacor Deferasirox FC

CR

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

30

 

D(100)

 

 

 

a

CIPLA DEFERASIROX

LR

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

30

 

D(100)

 

 

 

a

Eferas

AF

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

30

 

D(100)

 

 

 

a

Jadenu

NM

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

30

 

D(100)

 

 

 

a

Pharmacor Deferasirox FC

CR

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

30

 

D(100)

[25]           Schedule 1, Part 1, entry for Diazepam in the form Tablet 5 mg

                           omit from the column headed “Responsible Person” for the brand “Valium” (all instances): RO                  substitute: IX

[26]           Schedule 1, Part 1, entry for Evolocumab in the form Injection 140 mg in 1 mL single use pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C10343

                   (b)        omit from the column headed “Circumstances”: C10377 C10379

                   (c)        omit from the column headed “Circumstances”  C10385

                   (d)        insert in numerical order in the column headed “Circumstances”: C12008 C12010 C12011 C12012

                   (e)        omit from the column headed “Purposes”: P10343

                    (f)        omit from the column headed “Purposes”: P10377 P10379 P10385

                   (g)        insert in numerical order in the column headed “Purposes”: P12008 P12010 P12011 P12012

[27]           Schedule 1, Part 1, entry for Evolocumab in the form Injection 140 mg in 1 mL single use pre-filled pen [Maximum Quantity: 3; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C10343

                   (b)        omit from the column headed “Circumstances”: C10377 C10379

                   (c)        omit from the column headed “Circumstances”: C10385

                   (d)        insert in numerical order in the column headed “Circumstances”: C12008 C12010 C12011 C12012

[28]           Schedule 1, Part 1, entry for Evolocumab in the form Injection 420 mg in 3.5 mL single use pre-filled cartridge

                   (a)        omit from the column headed “Circumstances”: C10343

                   (b)        omit from the column headed “Circumstances”: C10377 C10379

                   (c)        omit from the column headed “Circumstances”: C10385

                   (d)        insert in numerical order in the column headed “Circumstances”: C12008 C12010 C12011 C12012

[29]           Schedule 1, Part 1, entry for Exenatide

                           omit:

 

Injection (modified release) 2 mg single dose pre-filled pen

Injection

 

Bydureon

AP

MP NP

C6505 C6519

 

4

5

4

 

 

[30]           Schedule 1, Part 1, after entry for Framycetin

                           insert:

Fremanezumab

Solution for injection 225 mg in 1.5 mL single dose pre-filled syringe

Injection

 

Ajovy

TB

MP

C12029 C12064

P12064

1

2

1

 

 

 

 

 

 

 

 

MP

C12029 C12064

P12029

1

5

1

 

 

[31]           Schedule 1, Part 1, entry for Galcanezumab in the form Injection 120 mg in 1 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C11821 C11823                     substitute: C12029 C12064

                   (b)        omit from the column headed “Purposes”: P11821         substitute: P12029

[32]           Schedule 1, Part 1, entry for Galcanezumab in the form Injection 120 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 1]

                   (a)        omit from the column headed “Circumstances”: C11821 C11823                     substitute: C12029 C12064

                   (b)        omit from the column headed “Purposes”: P11823         substitute: P12064

[33]           Schedule 1, Part 1, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [Maximum Quantity: 4; Number of Repeats: 0]

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

 

 

 

 

APX-Ondansetron ODT

TY

MP NP

C5618 C10498

P5618

4

0

4

 

 

 

 

 

 

 

 

MP

C5743

 

4

0

4

 

C(100)

[34]           Schedule 1, Part 1, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [Maximum Quantity: 10; Number of Repeats: 1]

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

 

 

 

 

APX-Ondansetron ODT

TY

MP NP

C5618 C10498

P10498

10

1

10

 

 


 

[35]           Schedule 1, Part 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Maximum Quantity: 4; Number of Repeats: 0]

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

 

 

 

a

APX-Ondansetron

TY

MP NP

C4118 C10498

P4118

4

0

4

 

 

 

 

 

 

 

 

MP

C5778

 

4

0

4

 

C(100)

[36]           Schedule 1, Part 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Maximum Quantity: 10; Number of Repeats: 1]

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

 

 

 

a

APX-Ondansetron

TY

MP NP

C4118 C10498

P10498

10

1

10

 

 

[37]           Schedule 1, Part 1, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [Maximum Quantity: 4; Number of Repeats: 0]

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

 

 

 

 

APX-Ondansetron ODT

TY

MP NP

C5618 C10498

P5618

4

0

4

 

 

 

 

 

 

 

 

MP

C5743

 

4

0

4

 

C(100)

[38]           Schedule 1, Part 1, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [Maximum Quantity: 10; Number of Repeats: 1]

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

 

 

 

 

APX-Ondansetron ODT

TY

MP NP

C5618 C10498

P10498

10

1

10

 

 

[39]           Schedule 1, Part 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Maximum Quantity: 4; Number of Repeats: 0]

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

 

 

 

a

APX-Ondansetron

TY

MP NP

C4118 C10498

P4118

4

0

4

 

 

 

 

 

 

 

 

MP

C5778

 

4

0

4

 

C(100)

[40]           Schedule 1, Part 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Maximum Quantity: 10; Number of Repeats: 1]

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

 

 

 

a

APX-Ondansetron

TY

MP NP

C4118 C10498

P10498

10

1

10

 

 

[41]           Schedule 1, Part 1, entry for Panitumumab in each of the forms: Solution concentrate for I.V. infusion 100 mg in 5 mL; and Solution concentrate for I.V. infusion 400 mg in 20 mL

                   (a)        omit from the column headed “Circumstances”: C5439 C5447

                   (b)        insert in numerical order in the column headed “Circumstances”: C12035 C12066

[42]           Schedule 1, Part 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 100; Number of Repeats: 0]

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

 

 

 

a

Paracetamol Sandoz Pharma

QS

PDP

C5846 C5885

P5846

100

0

100

 

 

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

 

 

 

a

Wagner Health Paracetamol

BG

PDP

C5846 C5885

P5846

100

0

100

 

 

[43]           Schedule 1, Part 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 100; Number of Repeats: 1]

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

 

 

 

a

Paracetamol Sandoz Pharma

QS

MP NP

C5835 C5865

P5835

100

1

100

 

 

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

 

 

 

a

Wagner Health Paracetamol

BG

MP NP

C5835 C5865

P5835

100

1

100

 

 

[44]           Schedule 1, Part 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 300; Number of Repeats: 0]

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

 

 

 

a

Paracetamol Sandoz Pharma

QS

PDP

C5846 C5885

P5885

300

0

100

 

 

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

 

 

 

a

Wagner Health Paracetamol

BG

PDP

C5846 C5885

P5885

300

0

100

 

 

[45]           Schedule 1, Part 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 300; Number of Repeats: 4]

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

 

 

 

a

Paracetamol Sandoz Pharma

QS

MP NP

C5835 C5865

P5865

300

4

100

 

 

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

 

 

 

a

Wagner Health Paracetamol

BG

MP NP

C5835 C5865

P5865

300

4

100

 

 


 

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

                           insert as first entry:

Paraffin

Eye drops containing liquid paraffin, glycerol, tyloxapol, poloxamer-188, trometamol hydrochloride, trometamol, cetalkonium chloride, 10 mL (preservative free)

Application to the eye

 

Cationorm

CS

MP NP AO

C6172

 

1

5

1

 

 

[47]           Schedule 1, Part 1, entry for Paroxetine

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

 

 

 

a

APX-Paroxetine

TY

MP NP

C4755 C6277 C6636

 

30

5

30

 

 

[48]           Schedule 1, Part 1, entry for Pembrolizumab

                           insert in numerical order in the column headed “Circumstances”: C11993 C12033 C12065

[49]           Schedule 1, Part 1, entry for Ramipril in the form Capsule 10 mg

                           omit:

 

 

 

 

Ramace 10 mg

AV

MP NP

 

 

30

5

30

 

 

[50]           Schedule 1, Part 1, entry for Ramipril in the form Tablet 1.25 mg

                           omit:

 

 

 

 

Ramace 1.25 mg

AV

MP NP

 

 

30

5

30

 

 

[51]           Schedule 1, Part 1, entry for Ramipril in the form Tablet 2.5 mg

                           omit:

 

 

 

 

Ramace 2.5 mg

AV

MP NP

 

 

30

5

30

 

 

[52]           Schedule 1, Part 1, entry for Ramipril in the form Tablet 5 mg

                           omit:

 

 

 

 

Ramace 5 mg

AV

MP NP

 

 

30

5

30

 

 

[53]           Schedule 1, Part 1, after entry for Risankizumab

                           insert:

Risdiplam

Powder for oral solution
750 micrograms per mL, 80 mL

Oral

 

Evrysdi

RO

MP

See Note 3

See Note 3

See Note 3

See Note 3

See Note 3

 

D(100)

[54]           Schedule 1, Part 1, entry for Roxithromycin in the form Tablet 150 mg [Maximum Quantity: 10; Number of Repeats: 0]

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

 

 

 

a

APX-Roxithromycin

TY

MP NP PDP

 

 

10

0

10

 

 

[55]           Schedule 1, Part 1, entry for Roxithromycin in the form Tablet 150 mg [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

APX-Roxithromycin

TY

MP NP

 

P10404

20
CN10404

0
CN10404

10

 

 

[56]           Schedule 1, Part 1, entry for Roxithromycin in the form Tablet 300 mg [Maximum Quantity: 5; Number of Repeats: 0]

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

 

 

 

a

APX-Roxithromycin

TY

MP NP PDP

 

 

5

0

5

 

 

[57]           Schedule 1, Part 1, entry for Roxithromycin in the form Tablet 300 mg [Maximum Quantity: 10; Number of Repeats: 0]

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

 

 

 

a

APX-Roxithromycin

TY

MP NP

 

P10404

10
CN10404

0
CN10404

5

 

 

[58]           Schedule 1, Part 1, entry for Valganciclovir in the form Tablet 450 mg (as hydrochloride)

                   (a)        omit:

 

 

 

a

Valcyte

RO

MP

C4980 C4989 C9316

 

120

5

60

 

D(100)

 

 

 

 

 

 

NP

C4980

 

120

5

60

 

D(100)

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

 

 

 

a

VALGANCICLOVIR HETERO

GG

MP

C4980 C4989 C9316

 

120

5

60

 

D(100)

 

 

 

 

 

 

NP

C4980

 

120

5

60

 

D(100)

[59]           Schedule 1, Part 1, entry for Vancomycin in the form Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)

omit from the column headed “Schedule Equivalent”: a


 

[60]           Schedule 1, Part 2

insert as first entry:

Acarbose

Tablet 100 mg

Oral

a

Glucobay 100

BN

MP NP

 

 

90

5

90

 

 

[61]           Schedule 1, Part 2, after entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate)

insert:

Exenatide

Injection (modified release) 2 mg single dose pre-filled pen

Injection

 

Bydureon

AP

MP NP

C6505 C6519

 

4

5

4

 

 

[62]           Schedule 1, Part 2, entry for Folinic acid

omit:

 

Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL

Injection

a

Leucovorin Calcium (Hospira Pty Limited)

PF

MP

 

 

10

2

1

 

 

[63]           Schedule 1, Part 2, after entry for Raloxifene

insert:

Ramipril

Capsule 10 mg

Oral

 

Ramace 10 mg

AV

MP NP

 

 

30

5

30

 

 

 

Tablet 1.25 mg

Oral

 

Ramace 1.25 mg

AV

MP NP

 

 

30

5

30

 

 

 

Tablet 2.5 mg

Oral

 

Ramace 2.5 mg

AV

MP NP

 

 

30

5

30

 

 

 

Tablet 5 mg

Oral

 

Ramace 5 mg

AV

MP NP

 

 

30

5

30

 

 

[64]           Schedule 1, Part 2, after entry for Tramadol in the form Injection containing tramadol hydrochloride 100 mg in 2 mL

insert:

Valganciclovir

Tablet 450 mg (as hydrochloride)

Oral

a

Valcyte

RO

MP

C4980 C4989 C9316

 

120

5

60

 

D(100)

 

 

 

 

 

 

NP

C4980

 

120

5

60

 

D(100)

[65]           Schedule 1, Part 2, omit entry for Vancomycin

[66]           Schedule 2, Part 1, omit entry for Paraffin, Soft Yellow BP

[67]           Schedule 2, Part 1, omit entry for Red Syrup APF 15

[68]           Schedule 3, after details relevant to Responsible Person code GC

                           insert:

GG

Gem Pharma Pty Ltd

45 641 456 868

[69]           Schedule 3, after details relevant to Responsible Person code QH

                           insert:

QS

Sandoz Pty Ltd

 60 075 449 553

[70]           Schedule 4, Part 1, after entry for Alendronic acid with colecalciferol and calcium

                           insert:

Alirocumab

C12008

 

 

Familial heterozygous hypercholesterolaemia
Initial treatment
The treatment must be in conjunction with dietary therapy and exercise; AND
The condition must have been confirmed by genetic testing; OR
The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 6; AND
Patient must have an LDL cholesterol level in excess of 2.6 millimoles per litre in the presence of symptomatic atherosclerotic cardiovascular disease; OR
Patient must have an LDL cholesterol level in excess of 5 millimoles per litre; AND
Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; OR
Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; OR
Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND
Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise; AND
Patient must not be receiving concomitant PBS-subsidised treatment with another drug that belongs to the same pharmacological class as this drug, for this PBS indication.
Must be treated by a specialist physician.
Symptomatic atherosclerotic cardiovascular disease is defined as:
(i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or
(ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or
(iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)).
The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be stated at the time of application, documented in the patient's medical records and must be no more than 8 weeks old.
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.
If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal.
In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved.
The following must be stated at the time of application and documented in the patient's medical records:
(i) the qualifying Dutch Lipid Clinic Network Score; or
(ii) the result of genetic testing confirming a diagnosis of familial heterozygous hypercholesterolaemia
One of the following must be stated at the time of application and documented in the patient's medical records regarding prior statin treatment:
(i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or
(ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or
(iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information.

Compliance with Authority Required procedures

 

C12010

 

 

Non-familial hypercholesterolaemia
Continuing treatment with this drug or switching treatment from another drug within the same pharmacological class
Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR
Patient must have received PBS-subsidised treatment with a drug from the same pharmacological class as this drug for this PBS indication; AND
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must not be receiving concomitant PBS-subsidised treatment with another drug that belongs to the same pharmacological class as this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 12010

 

C12011

 

 

Familial heterozygous hypercholesterolaemia
Continuing treatment with this drug or switching treatment from another drug within the same pharmacological class
Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR
Patient must have received PBS-subsidised treatment with a drug from the same pharmacological class as this drug for this PBS indication; AND
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must not be receiving concomitant PBS-subsidised treatment with another drug that belongs to the same pharmacological class as this drug, for this PBS indication.

Compliance with Authority Required procedures - Streamlined Authority Code 12011

 

C12054

 

 

Non-familial hypercholesterolaemia
Initial treatment
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must not be receiving concomitant PBS-subsidised treatment with another drug that belongs to the same pharmacological class as this drug; AND
Patient must have symptomatic atherosclerotic cardiovascular disease; AND
Patient must have an LDL cholesterol level in excess of 2.6 millimoles per litre prior to commencing treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9); AND
Patient must have atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); OR
Patient must have severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; OR
Patient must have had at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; OR
Patient must have diabetes mellitus with microalbuminuria; OR
Patient must have diabetes mellitus and be aged 60 years or more; OR
Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; OR
Patient must have a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher; AND
Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; OR
Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; OR
Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND
Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise.
Must be treated by a specialist physician.
Symptomatic atherosclerotic cardiovascular disease is defined as:
(i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or
(ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or
(iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)).
The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be stated at the time of application, documented in the patient's medical records and must be no more than 8 weeks old.
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.
If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal.
In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved.
One of the following must be stated at the time of application and documented in the patient's medical records regarding prior statin treatment:
(i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or
(ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or
(iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information.
One or more of the following must be stated at the time of application and documented in the patient's medical records regarding the presence of cardiovascular disease or high risk of experiencing a cardiovascular event:
(i) atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); or
(ii) severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; or
(iii) history of at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; or
(iv) diabetes mellitus with microalbuminuria; or
(v) diabetes mellitus and age 60 years of more; or
(vi) Aboriginal or Torres Strait Islander with diabetes mellitus; or
(vii) a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher

Compliance with Authority Required procedures

 

C12055

 

 

Familial heterozygous hypercholesterolaemia
Grandfather treatment
Patient must have received non-PBS subsidised treatment with this drug for this PBS indication prior to 1 August 2021; AND
The treatment must be in conjunction with dietary therapy and exercise; AND
The condition must have been confirmed by genetic testing prior to starting non-PBS-subsidised treatment with this drug for this condition; OR
The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 6 prior to starting non-PBS-subsidised treatment with this drug for this condition; AND
Patient must have had an LDL cholesterol level in excess of 2.6 millimoles per litre in the presence of symptomatic atherosclerotic cardiovascular disease at the time non-PBS-subsidised treatment with this drug for this condition was initiated; OR
Patient must have had an LDL cholesterol level in excess of 5 millimoles per litre at the time non-PBS-subsidised treatment with this drug for this condition was initiated; AND
Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR
Patient must have developed a clinically important product-related adverse event necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR
Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND
Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not be receiving concomitant PBS-subsidised treatment with another drug that belongs to the same pharmacological class as this drug, for this PBS indication.
Must be treated by a specialist physician.
Symptomatic atherosclerotic cardiovascular disease is defined as:
(i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or
(ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or
(iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)).
The qualifying LDL cholesterol level must have been measured following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events), must be stated at the time of application, documented in the patient's medical records and must have been no more than 8 weeks old at the time non-PBS-subsidised treatment with this drug for this condition was initiated.
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.
If treatment with atorvastatin or rosuvastatin resulted in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must have been treated with the alternative statin (atorvastatin or rosuvastatin) unless there was a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should have occurred after a washout period of at least 4 weeks, or if the creatine kinase (CK) level was elevated, the retrial should not have occurred until CK had returned to normal.
In the event of a trial of the alternative statin, the dose of the alternative statin should have been increased not more often than every 4 weeks until the maximum tolerated dose was reached or target LDL-c had been achieved.
The following must be stated at the time of application and documented in the patient's medical records:
(i) the qualifying Dutch Lipid Clinic Network Score; or
(ii) the result of genetic testing confirming a diagnosis of familial heterozygous hypercholesterolaemia
One of the following must be stated at the time of application and documented in the patient's medical records regarding prior statin treatment:
(i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or
(ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or
(iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information.
A 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.

Compliance with Authority Required procedures

[71]           Schedule 4, Part 1, entry for Atezolizumab

                           omit:

 

C9345

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfathering treatment
Patient must be undergoing combination treatment with bevacizumab and atezolizumab until disease progression, unless not tolerated.
The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND
Patient must have previously received treatment with these drugs for this condition prior to 1 October 2019; AND
Patient must have stable or responding disease; AND
Patient must have a WHO performance status of 0 or 1.

Compliance with Authority Required procedures - Streamlined Authority Code 9345

[72]           Schedule 4, Part 1, entry for Blinatumomab

                           omit:

 

C9878

 

 

Acute lymphoblastic leukaemia
Grandfather treatment
Patient must have a documented history of relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND
Patient must have a documented history of receiving intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND
Patient must not have received more than 1 line of salvage therapy; AND
Patient must have a documented history of more than 5% blasts in bone marrow; AND
Patient must have received treatment with this drug for this condition prior to 1 October 2019; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.
An amount of 651 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 1. An amount of 784 microgram, which may be obtained through a request for an increased maximum amount, will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.
Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
Treatment with this drug for this condition must not exceed 5 treatment cycles in a lifetime.
Patients who have received up to 2 treatment cycles as induction therapy with this drug for this condition prior to 1 October 2019 must have achieved a complete remission or a complete remission with partial haematological recovery in order to continue with PBS-subsidised treatment with this drug.
Patients who have received at least 1 treatment cycle as consolidation therapy with this drug for this condition prior to 1 October 2019 must have achieved a complete remission or a complete remission with partial haematological recovery in order to continue with PBS-subsidised treatment with this drug.
Patients who fail to demonstrate a complete remission (CR) or complete remission with incomplete haematological recovery (CRi) after 2 cycles of PBS-subsidised treatment with this agent must cease PBS-subsidised treatment with this agent.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and
(3) date of the most recent blinatumomab dose, if this was for induction or consolidation therapy, and how many treatment cycle(s) of PBS-subsidised blinatumomab will be required for completion of induction or consolidation therapy; and
(4) date of most recent chemotherapy prior to receiving non-PBS subsidised blinatumomab, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and
(5) a copy of the most recent bone marrow biopsy report prior to receiving non-PBS subsidised blinatumomab.

Compliance with Written Authority Required procedures

[73]           Schedule 4, Part 1, entry for Botulinum toxin type A purified neurotoxin complex

omit:

 

C9271

 

 

Moderate to severe spasticity of the lower limb following an acute event
Grandfathered treatment
Must be treated by a neurologist; OR
Must be treated by an orthopaedic surgeon; OR
Must be treated by a rehabilitation specialist; OR
Must be treated by a plastic surgeon; OR
Must be treated by a geriatrician.
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 September 2019; AND
The condition must have been moderate to severe spasticity of the lower limb/s following an acute event, defined as a Modified Ashworth Scale rating of 3 or more prior to commencing non-PBS subsidised treatment; AND
The treatment must only be used as second line therapy when standard management has failed; OR
The treatment must only be used as an adjunct to physical therapy; AND
The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating of at least 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND
Patient must not have established severe contracture in the limb to be treated; AND
The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per lower limb in the the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per lower limb each year thereafter.
Patient must be aged 18 years or older.
Standard management includes physiotherapy and/or oral spasticity agents.

Compliance with Authority Required procedures - Streamlined Authority Code 9271

[74]           Schedule 4, Part 1, entry for Cetuximab

                   (a)        omit:

 

C4945

 

 

Metastatic colorectal cancer
Continuing treatment
Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND
Patient must not have progressive disease; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab.
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.

Compliance with Authority Required procedures - Streamlined Authority Code 4945

 

C4965

 

 

Metastatic colorectal cancer
Initial treatment
Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have failed to respond to first-line chemotherapy; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab.
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.

Compliance with Authority Required procedures - Streamlined Authority Code 4965

                   (b)        insert in numerical order after existing text:

 

C12016

 

 

Metastatic colorectal cancer
Continuing treatment
Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; OR
Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of treatment with first-line pembrolizumab for dMMR mCRC; AND
Patient must not have progressive disease; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab.
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.

Compliance with Authority Required procedures - Streamlined Authority Code 12016

 

C12045

 

 

Metastatic colorectal cancer
Initial treatment
Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have failed to respond to first-line chemotherapy; OR
The condition must have progressed following first-line treatment with pembrolizumab for dMMR mCRC; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab.
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.

Compliance with Authority Required procedures - Streamlined Authority Code 12045

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

                   (a)        omit:

 

C9463

P9463

 

Moderate to severe spasticity of the upper limb following an acute event
Grandfathered treatment
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 October 2019; AND
The condition must have been moderate to severe spasticity of the upper limb/s following an acute event, defined as a Modified Ashworth Scale rating of 3 or more prior to commencing non-PBS subsidised treatment; AND
The treatment must only be used as second line therapy when standard management has failed; OR
The treatment must only be used as an adjunct to physical therapy; AND
The treatment must not continue if the patient did not respond (defined as not having had a decrease in spasticity rating greater than 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND
The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per upper limb in the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per upper limb each year thereafter; AND
Patient must not have established severe contracture in the limb to be treated.
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 rehabilitation specialist; OR
Must be treated by a plastic surgeon; OR
Must be treated by a geriatrician.
Standard management includes physiotherapy and/or oral spasticity agents.

Compliance with Authority Required procedures - Streamlined Authority Code 9463

                   (b)        omit:

 

C9871

P9871

 

Moderate to severe spasticity of the lower limb following an acute event
Grandfather treatment
Must be treated by a neurologist; OR
Must be treated by an orthopaedic surgeon; OR
Must be treated by a rehabilitation specialist; OR
Must be treated by a plastic surgeon; OR
Must be treated by a geriatrician.
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2019; AND
The condition must have been moderate to severe spasticity of the lower limb/s following stroke, or other acute neurological event, defined as a Modified Ashworth Scale rating of 3 or more prior to commencing non-PBS subsidised treatment; AND
The treatment must only be used as second line therapy when standard management has failed; OR
The treatment must only be used as an adjunct to physical therapy; AND
The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating of at least 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND
Patient must not have established severe contracture in the limb to be treated; AND
The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per lower limb in the the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per lower limb each year thereafter.
Patient must be aged 18 years or older.
Standard management includes physiotherapy and/or oral spasticity agents.

Compliance with Authority Required procedures - Streamlined Authority Code 9871

[76]           Schedule 4, Part 1, entry for Evolocumab

                   (a)        omit:

 

C10343

P10343

 

Non-familial hypercholesterolaemia
Initial treatment
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must have symptomatic atherosclerotic cardiovascular disease; AND
Patient must have an LDL cholesterol level in excess of 2.6 millimoles per litre; AND
Patient must have atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); OR
Patient must have severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; OR
Patient must have had at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; OR
Patient must have diabetes mellitus with microalbuminuria; OR
Patient must have diabetes mellitus and be aged 60 years or more; OR
Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; OR
Patient must have a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher; AND
Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; OR
Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; OR
Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND
Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise.
Must be treated by a specialist physician.
Symptomatic atherosclerotic cardiovascular disease is defined as:
(i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or
(ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or
(iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)).
The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be stated at the time of application, documented in the patient's medical records and must be no more than 8 weeks old.
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.
If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal.
In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved.
One of the following must be stated at the time of application and documented in the patient's medical records regarding prior statin treatment:
(i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or
(ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or
(iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information.
One or more of the following must be stated at the time of application and documented in the patient's medical records regarding the presence of cardiovascular disease or high risk of experiencing a cardiovascular event:
(i) atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); or
(ii) severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; or
(iii) history of at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; or
(iv) diabetes mellitus with microalbuminuria; or
(v) diabetes mellitus and age 60 years of more; or
(vi) Aboriginal or Torres Strait Islander with diabetes mellitus; or
(vii) a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher

Compliance with Authority Required procedures

                   (b)        omit:

 

C10377

P10377

 

Familial heterozygous hypercholesterolaemia
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be in conjunction with dietary therapy and exercise.

Compliance with Authority Required procedures - Streamlined Authority Code 10377

 

C10379

P10379

 

Familial heterozygous hypercholesterolaemia
Initial treatment
The treatment must be in conjunction with dietary therapy and exercise; AND
The condition must have been confirmed by genetic testing; OR
The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 6; AND
Patient must have an LDL cholesterol level in excess of 2.6 millimoles per litre in the presence of symptomatic atherosclerotic cardiovascular disease; OR
Patient must have an LDL cholesterol level in excess of 5 millimoles per litre; AND
Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; OR
Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; OR
Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND
Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise.
Must be treated by a specialist physician.
Symptomatic atherosclerotic cardiovascular disease is defined as:
(i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or
(ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or
(iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)).
The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be stated at the time of application, documented in the patient's medical records and must be no more than 8 weeks old.
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.
If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal.
In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved.
The following must be stated at the time of application and documented in the patient's medical records:
(i) the qualifying Dutch Lipid Clinic Network Score; or
(ii) the result of genetic testing confirming a diagnosis of familial heterozygous hypercholesterolaemia
One of the following must be stated at the time of application and documented in the patient's medical records regarding prior statin treatment:
(i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or
(ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or
(iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information.

Compliance with Authority Required procedures

                   (c)        omit:

 

C10385

P10385

 

Non-familial hypercholesterolaemia
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be in conjunction with dietary therapy and exercise.

Compliance with Authority Required procedures - Streamlined Authority Code 10385

                   (d)        insert in numerical order after existing text:

 

C12008

P12008

 

Familial heterozygous hypercholesterolaemia
Initial treatment
The treatment must be in conjunction with dietary therapy and exercise; AND
The condition must have been confirmed by genetic testing; OR
The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 6; AND
Patient must have an LDL cholesterol level in excess of 2.6 millimoles per litre in the presence of symptomatic atherosclerotic cardiovascular disease; OR
Patient must have an LDL cholesterol level in excess of 5 millimoles per litre; AND
Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; OR
Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; OR
Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND
Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise; AND
Patient must not be receiving concomitant PBS-subsidised treatment with another drug that belongs to the same pharmacological class as this drug, for this PBS indication.
Must be treated by a specialist physician.
Symptomatic atherosclerotic cardiovascular disease is defined as:
(i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or
(ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or
(iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)).
The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be stated at the time of application, documented in the patient's medical records and must be no more than 8 weeks old.
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.
If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal.
In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved.
The following must be stated at the time of application and documented in the patient's medical records:
(i) the qualifying Dutch Lipid Clinic Network Score; or
(ii) the result of genetic testing confirming a diagnosis of familial heterozygous hypercholesterolaemia
One of the following must be stated at the time of application and documented in the patient's medical records regarding prior statin treatment:
(i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or
(ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or
(iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information.

Compliance with Authority Required procedures

 

C12010

P12010

 

Non-familial hypercholesterolaemia
Continuing treatment with this drug or switching treatment from another drug within the same pharmacological class
Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR
Patient must have received PBS-subsidised treatment with a drug from the same pharmacological class as this drug for this PBS indication; AND
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must not be receiving concomitant PBS-subsidised treatment with another drug that belongs to the same pharmacological class as this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 12010

 

C12011

P12011

 

Familial heterozygous hypercholesterolaemia
Continuing treatment with this drug or switching treatment from another drug within the same pharmacological class
Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR
Patient must have received PBS-subsidised treatment with a drug from the same pharmacological class as this drug for this PBS indication; AND
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must not be receiving concomitant PBS-subsidised treatment with another drug that belongs to the same pharmacological class as this drug, for this PBS indication.

Compliance with Authority Required procedures - Streamlined Authority Code 12011

 

C12012

P12012

 

Non-familial hypercholesterolaemia
Initial treatment
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must not be receiving concomitant PBS-subsidised treatment with another drug that belongs to the same pharmacological class as this drug; AND
Patient must have symptomatic atherosclerotic cardiovascular disease; AND
Patient must have an LDL cholesterol level in excess of 2.6 millimoles per litre; AND
Patient must have atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); OR
Patient must have severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; OR
Patient must have had at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; OR
Patient must have diabetes mellitus with microalbuminuria; OR
Patient must have diabetes mellitus and be aged 60 years or more; OR
Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; OR
Patient must have a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher; AND
Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; OR
Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; OR
Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND
Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise.
Must be treated by a specialist physician.
Symptomatic atherosclerotic cardiovascular disease is defined as:
(i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or
(ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or
(iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)).
The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be stated at the time of application, documented in the patient's medical records and must be no more than 8 weeks old.
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.
If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal.
In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved.
One of the following must be stated at the time of application and documented in the patient's medical records regarding prior statin treatment:
(i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or
(ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or
(iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information.
One or more of the following must be stated at the time of application and documented in the patient's medical records regarding the presence of cardiovascular disease or high risk of experiencing a cardiovascular event:
(i) atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); or
(ii) severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; or
(iii) history of at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; or
(iv) diabetes mellitus with microalbuminuria; or
(v) diabetes mellitus and age 60 years of more; or
(vi) Aboriginal or Torres Strait Islander with diabetes mellitus; or
(vii) a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher

Compliance with Authority Required procedures

[77]           Schedule 4, Part 1, after entry for Fotemustine

                           insert:

Fremanezumab

C12029

P12029

 

Chronic migraine
Continuing treatment
Must be treated by a specialist neurologist or in consultation with a specialist neurologist; AND
Patient must not be undergoing concurrent treatment with the following PBS benefits: (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have achieved and maintained a 50% or greater reduction from baseline in the number of migraine days per month; AND
Patient must continue to be appropriately managed for medication overuse headache.
Patient must have the number of migraine days per month documented in their medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 12029

 

C12064

P12064

 

Chronic migraine
Initial treatment
Must be treated by a neurologist; AND
Patient must not be undergoing concurrent treatment with the following PBS benefits: (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication.
Patient must have experienced an average of 15 or more headache days per month, with at least 8 days of migraine, over a period of at least 6 months, prior to commencement of treatment with this medicine for this condition; AND
Patient must have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications prior to commencement of treatment with this drug for this condition; AND
Patient must be appropriately managed by his or her practitioner for medication overuse headache, prior to initiation of treatment with this drug.
Patient must be aged 18 years or older.
Prophylactic migraine medications are propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate or topiramate.
Patient must have the number of migraine days per month documented in their medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 12064

[78]           Schedule 4, Part 1, entry for Galcanezumab

                           substitute:

Galcanezumab

C12029

P12029

 

Chronic migraine
Continuing treatment
Must be treated by a specialist neurologist or in consultation with a specialist neurologist; AND
Patient must not be undergoing concurrent treatment with the following PBS benefits: (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have achieved and maintained a 50% or greater reduction from baseline in the number of migraine days per month; AND
Patient must continue to be appropriately managed for medication overuse headache.
Patient must have the number of migraine days per month documented in their medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 12029

 

C12064

P12064

 

Chronic migraine
Initial treatment
Must be treated by a neurologist; AND
Patient must not be undergoing concurrent treatment with the following PBS benefits: (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication.
Patient must have experienced an average of 15 or more headache days per month, with at least 8 days of migraine, over a period of at least 6 months, prior to commencement of treatment with this medicine for this condition; AND
Patient must have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications prior to commencement of treatment with this drug for this condition; AND
Patient must be appropriately managed by his or her practitioner for medication overuse headache, prior to initiation of treatment with this drug.
Patient must be aged 18 years or older.
Prophylactic migraine medications are propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate or topiramate.
Patient must have the number of migraine days per month documented in their medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 12064

[79]           Schedule 4, Part 1, entry for Panitumumab

                   (a)        omit:

 

C5439

 

 

Metastatic colorectal cancer
Initial treatment
Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have failed to respond to first-line chemotherapy; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.

Compliance with Authority Required procedures - Streamlined Authority Code 5439

 

C5447

 

 

Metastatic colorectal cancer
Continuing treatment
Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND
Patient must not have progressive disease; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.

Compliance with Authority Required procedures - Streamlined Authority Code 5447


 

                   (b)        insert in numerical order after existing text:

 

C12035

 

 

Metastatic colorectal cancer
Continuing treatment
Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; OR
Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of treatment with first-line pembrolizumab for dMMR mCRC; AND
Patient must not have progressive disease; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.

Compliance with Authority Required procedures - Streamlined Authority Code 12035

 

C12066

 

 

Metastatic colorectal cancer
Initial treatment
Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have failed to respond to first-line chemotherapy; OR
The condition must have progressed following first-line treatment with pembrolizumab for dMMR mCRC; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.

Compliance with Authority Required procedures - Streamlined Authority Code 12066

[80]           Schedule 4, Part 1, entry for Paraffin

                           insert in numerical order after existing text:

 

C6172

 

 

Severe dry eye syndrome
Patient must be sensitive to preservatives in multi-dose eye drops.

Compliance with Authority Required procedures - Streamlined Authority Code 6172

[81]           Schedule 4, Part 1, entry for Pembrolizumab

                           insert in numerical order after existing text:

 

C11993

 

 

Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer
Transitioning from non-PBS to PBS subsided treatment - Grandfather treatment
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 August 2021; AND
Patient must not have received prior PBS funded treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for colorectal cancer; AND
Patient must have been untreated for this indication (i.e untreated for each of: (i) unresectable disease, (ii) metastatic disease), prior to initiating treatment with this drug; AND
Patient must have stable or responding disease; AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must have deficient mismatch repair (dMMR) colorectal cancer, as determined by immunohistochemistry test; AND
The treatment must not exceed a total of 35 cycles or up to 24 months of treatment in a lifetime for this condition.
A 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.

Compliance with Authority Required procedures

 

C12033

 

 

Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer
Initial treatment
Patient must be untreated for this PBS indication (i.e untreated for each of: (i) unresectable disease, (ii) metastatic disease); AND
Patient must not have received prior treatment for colorectal cancer with each of: (i) a programmed cell death-1 (PD-1) inhibitor, (ii) a programmed cell death ligand-1 (PD-L1) inhibitor; AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must have deficient mismatch repair (dMMR) colorectal cancer, as determined by immunohistochemistry test; AND
The treatment must not exceed a total of 7 doses under this restriction.

Compliance with Authority Required procedures

 

C12065

 

 

Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must not exceed a total of 35 cycles or up to 24 months of treatment in a lifetime for this condition.

Compliance with Authority Required procedures

[82]           Schedule 5, after entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen

                           insert:

Adrenaline (epinephrine)

GRP-25410

Injection 1 mg (as acid tartrate) in 1 mL (1 in 1,000)

Injection

Link Medical Products Pty Ltd

 

 

Solution for injection 1 mg (as tartrate) in 1 mL (1 in 1,000)

Injection

ADRENALINE RENAUDIN

[83]           Schedule 5, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [GRP-15402]

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

[84]           Schedule 5, entry for Ondansetronin the form Tablet (orally disintegrating) 4 mg [GRP-15983]

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

[85]           Schedule 5, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [GRP-16933]

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

[86]           Schedule 5, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [GRP-17042]

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