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PB 33 of 2022 Lists 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 29 Apr 2022

 

Commonwealth Coat of Arms of Australia

 

 

 

 

PB 33 of 2022

 

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022
(No. 4)

 

National Health Act 1953

________________________________________________________________________

 

I, CAROLINE TURNOUR, 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                 28 April 2022

 

 

 

 

 

 

 

 

 

 

 

 

CAROLINE TURNOUR

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

________________________________________________________________________

 


 

1          Name of Instrument

(1)          This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 4).

(2)          This instrument may also be cited as PB 33 of 2022.

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. The whole of this instrument

1 May 2022

1 May 2022

Note: This table relates only to the provisions of this instrument as originally made.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          Schedule

Schedule 1 to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 - Amendments

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

[1]             Schedule 1, Part 1, entry for Abiraterone in each of the forms: Tablet containing abiraterone acetate 250 mg; and Tablet containing abiraterone acetate 500 mg

                           omit from the column headed “Circumstances”: C12352                      substitute: C12700

[2]             Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 0]

                   (a)        insert in numerical order in the column headed “Circumstances”: C11715 C11716

                   (b)        omit from the column headed “Circumstances”: C11758       

                   (c)        omit from the column headed “Circumstances”: C11789

[3]             Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]

                   (a)        insert in numerical order in the column headed “Circumstances”: C11715 C11716

                   (b)        omit from the column headed “Circumstances”: C11758

                   (c)        omit from the column headed “Circumstances”: C11789       

[4]             Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]

                   (a)        insert in numerical order in the column headed “Circumstances”: C11715 C11716

                   (b)        omit from the column headed “Circumstances”: C11758

                   (c)        omit from the column headed “Circumstances”: C11789       

[5]             Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled pen [Maximum Quantity: 3; Number of Repeats: 0]

                   (a)        insert in numerical order in the column headed “Circumstances”: C11715 C11716

                   (b)        omit from the column headed “Circumstances”: C11758

                   (c)        omit from the column headed “Circumstances”: C11789       

                   (d)        insert in numerical order in the column headed “Purposes”: P11715 P11716

                   (e)        omit from the column headed “Purposes”: P11758                 

                    (f)        omit from the column headed “Purposes”: P11789                 

[6]             Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 0]

                   (a)        insert in numerical order in the column headed “Circumstances”: C11715 C11716

                   (b)        omit from the column headed “Circumstances”: C11758

                   (c)        omit from the column headed “Circumstances”: C11789       

[7]             Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]

                   (a)        insert in numerical order in the column headed “Circumstances”: C11715 C11716

                   (b)        omit from the column headed “Circumstances”: C11758

                   (c)        omit from the column headed “Circumstances”: C11789       

[8]             Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]

                   (a)        insert in numerical order in the column headed “Circumstances”: C11715 C11716

                   (b)        omit from the column headed “Circumstances”: C11758

                   (c)        omit from the column headed “Circumstances”: C11789       

[9]             Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 3; Number of Repeats: 0]

                   (a)        insert in numerical order in the column headed “Circumstances”: C11715 C11716

                   (b)        omit from the column headed “Circumstances”: C11758

                   (c)        omit from the column headed “Circumstances”: C11789       

                   (d)        insert in numerical order in the column headed “Purposes”: P11715 P11716

                   (e)        omit from the column headed “Purposes”: P11758

                    (f)        omit from the column headed “Purposes”: P11789                 

[10]           Schedule 1, Part 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [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-Amoxicillin/Clavulanic Acid

XT

MP NP

C5832 C5893 C10405

P5832 P5893

10

0

10

 

 

 

 

 

 

 

 

MW

C5832 C5893

 

10

0

10

 

 

 

 

 

 

 

 

PDP

C5833 C5894

 

10

0

10

 

 

[11]           Schedule 1, Part 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [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-Amoxicillin/Clavulanic Acid

XT

MP NP

C5832 C5893 C10405

P10405

20

0

10

 

 

[12]           Schedule 1, Part 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [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-Amoxicillin/Clavulanic Acid

XT

MP NP

C5832 C5893 C10413

P5832 P5893

10

0

10

 

 

 

 

 

 

 

 

PDP

C5833 C5894

 

10

0

10

 

 

[13]           Schedule 1, Part 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [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-Amoxicillin/Clavulanic Acid

XT

MP NP

C5832 C5893 C10413

P10413

20

0

10

 

 

[14]           Schedule 1, Part 1, after entry for Anastrozole

                           insert:

Apalutamide

Tablet 60 mg

Oral

 

Eryland

JC

MP

C12895

 

120

5

120

 

 

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

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

 

 

 

 

DBL Bortezomib

PF

MP

C11099

 

See Note 3

See Note 3

1

 

D(100)

[16]           Schedule 1, Part 1, after entry for Budesonide in the form Powder for oral inhalation in breath actuated device 400 micrograms per dose, 200 doses

                           insert:

 

Tablet 500 micrograms (orally disintegrating)

Oral

 

Jorveza

FD

MP

C12836 C12837 C12909

 

60

5

60

 

 

 

Tablet 1 mg (orally disintegrating)

Oral

 

Jorveza

FD

MP

C12836 C12837 C12909 C12938

P12836 P12837 P12909

60

5

60

 

 

 

 

 

 

 

 

MP

C12836 C12837 C12909 C12938

P12938

90

1

90

 

 


 

[17]           Schedule 1, Part 1, entry for Buprenorphine in each of the forms: Injection (modified release) 8 mg in 0.16 mL pre-filled syringe; Injection (modified release) 16 mg in 0.32 mL pre-filled syringe; Injection (modified release) 24 mg in 0.48 mL pre-filled syringe; and Injection (modified release) 32 mg in 0.64 mL pre-filled syringe

                           omit from the column headed “Circumstances”: C9212      substitute: C12701

[18]           Schedule 1, Part 1, entry for Buprenorphine in each of the forms: Injection (modified release) 64 mg in 0.18 mL pre-filled syringe; and Injection (modified release) 96 mg in 0.27 mL pre-filled syringe

                           omit from the column headed “Circumstances”: C9212      substitute: C12915

[19]           Schedule 1, Part 1, entry for Buprenorphine in the form Injection (modified release) 128 mg in 0.36 mL pre-filled syringe

                           omit from the column headed “Circumstances”: C9212      substitute: C12915

[20]           Schedule 1, Part 1, after entry for Buprenorphine in the form Injection (modified release) 128 mg in 0.36 mL pre-filled syringe

                           insert:

 

Injection (modified release)
160 mg in 0.45 mL pre-filled syringe

Injection

 

Buvidal Monthly

UR

MP NP

C12915

 

See Note 3

See Note 3

1

 

PB(100)

[21]           Schedule 1, Part 1, entry for Cabotegravir and rilpivirine

                  omit from the column headed “Form”: Pack containing 1 vial cabotegravir 600 mg in 3 mL and 1 vial rilpivirine 900 mg in 3mL            
substitute:
Pack containing 1 vial cabotegravir 600 mg in 3 mL and 1 vial rilpivirine 900 mg in 3 mL

[22]           Schedule 1, Part 1, entry for Carfilzomib in each of the forms: Powder for injection 10 mg; Powder for injection 30 mg; and Powder for injection 60 mg

                           omit from the column headed “Circumstances”: C11196 C11197 C11198 C11291         substitute: C12694 C12849 C12930 C12934

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

                           substitute:

Clopidogrel

Tablet 75 mg (as besilate)

Oral

 

BTC Clopidogrel

JB

MP NP

 

 

28

5

28

 

 

 

 

 

 

Clopidogrel APOTEX

GX

MP NP

 

 

28

5

28

 

 

 

 

 

 

Clopidogrel GH

GQ

MP NP

 

 

28

5

28

 

 

 

 

 

 

Clovix 75

RW

MP NP

 

 

28

5

28

 

 

 

 

 

 

Plidogrel

RF

MP NP

 

 

28

5

28

 

 

 

Tablet 75 mg (as hydrogen sulfate)

Oral

 

Blooms the Chemist Clopidogrel

IB

MP NP

 

 

28

5

28

 

 

 

 

 

 

Clopidogrel Sandoz Pharma

HX

MP NP

 

 

28

5

28

 

 

 

 

 

 

Clopidogrel Winthrop

WA

MP NP

 

 

28

5

28

 

 

 

 

 

 

Iscover

AV

MP NP

 

 

28

5

28

 

 

 

 

 

 

Piax

AF

MP NP

 

 

28

5

28

 

 

 

 

 

 

Plavicor 75

CR

MP NP

 

 

28

5

28

 

 

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

                           omit from the column headed “Circumstances” (all instances): C5443 C5488 C5517

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

                           omit from the column headed “Circumstances”: C11075 C11076 C11131 C12350         substitute: C12691 C12692 C12844 C12845

[26]           Schedule 1, Part 1, entry for Daratumumab in the form Solution for subcutaneous injection containing daratumumab 1800 mg in
15 mL [Maximum Quantity: 1; Number of Repeats: 4]

                   (a)        omit from the column headed “Circumstances”: C11075 C11076 C12350 C12369             substitute: C12691 C12692 C12842 C12845

                   (b)        omit from the column headed “Purposes”: P11076                  substitute: P12845

[27]           Schedule 1, Part 1, entry for Daratumumab in the form Solution for subcutaneous injection containing daratumumab 1800 mg in
15 mL [Maximum Quantity: 1; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C11075 C11076 C12350 C12369             substitute: C12691 C12692 C12842 C12845

                   (b)        omit from the column headed “Purposes”: P11075                  substitute: P12691

[28]           Schedule 1, Part 1, entry for Daratumumab in the form Solution for subcutaneous injection containing daratumumab 1800 mg in
15 mL [Maximum Quantity: 1; Number of Repeats: 7]

                   (a)        omit from the column headed “Circumstances”: C11075 C11076 C12350 C12369             substitute: C12691 C12692 C12842 C12845

                   (b)        omit from the column headed “Purposes”: P12369                  substitute: P12842

[29]           Schedule 1, Part 1, entry for Daratumumab in the form Solution for subcutaneous injection containing daratumumab 1800 mg in
15 mL [Maximum Quantity: 1; Number of Repeats: 8]

                   (a)        omit from the column headed “Circumstances”: C11075 C11076 C12350 C12369             substitute: C12691 C12692 C12842 C12845

                   (b)        omit from the column headed “Purposes”: P12350                  substitute: P12692

[30]           Schedule 1, Part 1, entry for Darolutamide

                           omit from the column headed “Circumstances”: C12398                      substitute: C12895

[31]           Schedule 1, Part 1, entry for Desmopressin

                           omit:

 

Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 50 actuations, 5 mL

Nasal

 

Desmopressin Acetate (Medsurge)

DZ

MP

C5266 C5267 C5342

P5267 P5342

1

5

1

 

 

 

 

 

 

 

 

NP

C5267 C5342

 

1

5

1

 

 

 

 

 

 

 

 

MP

C5266 C5267 C5342

P5266

2

5

1

 

 

[32]           Schedule 1, Part 1, entry for Dupilumab in the form Injection 200 mg in 1.14 mL single dose pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]

                           omit from the column headed “Circumstances”: C11425 C11479

[33]           Schedule 1, Part 1, entry for Dupilumab in the form Injection 300 mg in 2 mL single dose pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]

                           omit from the column headed “Circumstances”: C11425 C11479

[34]           Schedule 1, Part 1, after entry for Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor

                           insert:

Elotuzumab

Powder for injection 300 mg

Injection

 

Empliciti

BQ

MP

C12847 C12891

 

See Note 3

See Note 3

1

 

D(100)

 

Powder for injection 400 mg

Injection

 

Empliciti

BQ

MP

C12847 C12891

 

See Note 3

See Note 3

1

 

D(100)

[35]           Schedule 1, Part 1, entry for Enzalutamide

                           omit from the column headed “Circumstances”: C12371                      substitute: C12937

[36]           Schedule 1, Part 1, entry for Glimepiride in the form Tablet 1 mg

                           omit:

 

 

 

a

Diapride 1

RW

MP NP

 

 

30

5

30

 

 

[37]           Schedule 1, Part 1, entry for Glimepiride in the form Tablet 2 mg

                           omit:

 

 

 

a

Diapride 2

RW

MP NP

 

 

30

5

30

 

 

[38]           Schedule 1, Part 1, entry for Glimepiride in the form Tablet 3 mg

                           omit:

 

 

 

a

Diapride 3

RW

MP NP

 

 

30

5

30

 

 

[39]           Schedule 1, Part 1, entry for Glimepiride in the form Tablet 4 mg

                           omit:

 

 

 

a

Diapride 4

RW

MP NP

 

 

30

5

30

 

 

[40]           Schedule 1, Part 1, entry for Hydroxychloroquine

                           substitute:

Hydroxychloroquine

Tablet containing hydroxychloroquine sulfate
200 mg

Oral

a

APO- Hydroxychloroquine

TX

MP NP

 

 

100

1

100

 

 

 

 

 

a

Hequinel

RW

MP NP

 

 

100

1

100

 

 

 

 

 

a

Hydroxychloroquine GH

GQ

MP NP

 

 

100

1

100

 

 

 

 

 

a

Plaquenil

SW

MP NP

 

 

100

1

100

 

 

[41]           Schedule 1, Part 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Brand: Imatinib GH; Maximum Quantity: 60; Number of
Repeats: 2]

                   (a)        insert in numerical order in the column headed “Circumstances”: C9208

                   (b)        insert in numerical order in the column headed “Circumstances”: C9238

                   (c)        insert in numerical order in the column headed “Circumstances”: C9278

                   (d)        insert in numerical order in the column headed “Circumstances”: C9319

                   (e)        insert in numerical order in the column headed “Purposes”: P9208 P9319

[42]           Schedule 1, Part 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Brand: Imatinib GH; Maximum Quantity: 60; Number of
Repeats: 5]

                   (a)        insert in numerical order in the column headed “Circumstances”: C9208

                   (b)        insert in numerical order in the column headed “Circumstances”: C9238

                   (c)        insert in numerical order in the column headed “Circumstances”: C9278

                   (d)        insert in numerical order in the column headed “Circumstances”: C9319

                   (e)        insert in numerical order in the column headed “Purposes”: P9238

                    (f)        insert in numerical order in the column headed “Purposes”: P9278

[43]           Schedule 1, Part 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Brand: Imatinib GH; Maximum Quantity: 30; Number of
Repeats: 2]

                   (a)        insert in numerical order in the column headed “Circumstances”: C9208

                   (b)        insert in numerical order in the column headed “Circumstances”: C9238

                   (c)        insert in numerical order in the column headed “Circumstances”: C9278

                   (d)        insert in numerical order in the column headed “Circumstances”: C9319

                   (e)        insert in numerical order in the column headed “Purposes”: P9208 P9319

[44]           Schedule 1, Part 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Brand: Imatinib GH; Maximum Quantity: 30; Number of
Repeats: 5]

                   (a)        insert in numerical order in the column headed “Circumstances”: C9208

                   (b)        insert in numerical order in the column headed “Circumstances”: C9238

                   (c)        insert in numerical order in the column headed “Circumstances”: C9278

                   (d)        insert in numerical order in the column headed “Circumstances”: C9319

                   (e)        insert in numerical order in the column headed “Purposes”: P9238

                    (f)        insert in numerical order in the column headed “Purposes”: P9278

[45]           Schedule 1, Part 1, entry for Imatinib in the form Tablet 600 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C9319

                   (b)        insert in numerical order in the column headed “Circumstances”: C12685 

                   (c)        omit from the column headed “Purposes”: P9319

                   (d)        insert in numerical order in the column headed “Purposes”: P12685 

[46]            Schedule 1, Part 1, entry for Imatinib in the form Tablet 600 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C9319

                   (b)        insert in numerical order in the column headed “Circumstances”: C12685 

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

                           substitute:

Metoprolol

Tablet containing metoprolol tartrate 50 mg

Oral

a

APO-Metoprolol

TX

MP NP

 

 

100

5

100

 

 

 

 

 

a

Betaloc

AP

MP NP

 

 

100

5

100

 

 

 

 

 

a

Metoprolol Sandoz

SZ

MP NP

 

 

100

5

100

 

 

 

 

 

a

Metrol 50

RW

MP NP

 

 

100

5

100

 

 

 

 

 

a

Minax 50

AF

MP NP

 

 

100

5

100

 

 

 

 

 

 

Mistrom

ZS

MP NP

 

 

100

5

100

 

 

 

 

 

a

NOUMED METOPROLOL

VO

MP NP

 

 

100

5

100

 

 

 

Tablet containing metoprolol tartrate 100 mg

Oral

a

APO-Metoprolol

TX

MP NP

 

 

60

5

60

 

 

 

 

 

a

Betaloc

AP

MP NP

 

 

60

5

60

 

 

 

 

 

a

Metoprolol Sandoz

SZ

MP NP

 

 

60

5

60

 

 

 

 

 

a

Metrol 100

RW

MP NP

 

 

60

5

60

 

 

 

 

 

a

Minax 100

AF

MP NP

 

 

60

5

60

 

 

 

 

 

 

Mistrom

ZS

MP NP

 

 

60

5

60

 

 

 

 

 

a

NOUMED METOPROLOL

VO

MP NP

 

 

60

5

60

 

 

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

substitute:

Molnupiravir

Capsule 200 mg

Oral

 

Lagevrio

MK

MP NP

C12839 C12923 C12936

 

40

0

40

 

 

[49]           Schedule 1, Part 1, entry for Morphine in the form Tablet containing morphine sulfate pentahydrate 10 mg (controlled release)

                   (a)        omit:

 

 

 

a

Momex SR 10

RW

MP NP

C10748 C10752 C10755 C11753

P10748 P10752 P10755

28

0

28

 

 

                   (b)        omit:

 

 

 

a

Momex SR 10

RW

MP NP

C10748 C10752 C10755 C11753

P11753

56

0

28

 

 

[50]           Schedule 1, Part 1, entry for Morphine in the form Tablet containing morphine sulfate pentahydrate 30 mg (controlled release)

                   (a)        omit:

 

 

 

a

Momex SR 30

RW

MP NP

C10748 C10752 C10755 C11753

P10748 P10752 P10755

28

0

28

 

 

                   (b)        omit:

 

 

 

a

Momex SR 30

RW

MP NP

C10748 C10752 C10755 C11753

P11753

56

0

28

 

 

[51]           Schedule 1, Part 1, entry for Morphine in the form Tablet containing morphine sulfate pentahydrate 60 mg (controlled release)

                   (a)        omit:

 

 

 

a

Momex SR 60

RW

MP NP

C10748 C10752 C10755 C11753

P10748 P10752 P10755

28

0

28

 

 

                   (b)        omit:

 

 

 

a

Momex SR 60

RW

MP NP

C10748 C10752 C10755 C11753

P11753

56

0

28

 

 

[52]           Schedule 1, Part 1, entry for Morphine in the form Tablet containing morphine sulfate pentahydrate 100 mg (controlled release)

                   (a)        omit:

 

 

 

a

Momex SR 100

RW

MP NP

C10748 C10752 C10755 C11753

P10748 P10752 P10755

28

0

28

 

 

                   (b)        omit:

 

 

 

a

Momex SR 100

RW

MP NP

C10748 C10752 C10755 C11753

P11753

56

0

28

 

 

[53]           Schedule 1, Part 1, entry for Netupitant with Palonosetron

                           omit from the column headed “Responsible Person”: MF   substitute: JZ

[54]           Schedule 1, Part 1, entry for Nintedanib in each of the forms: Capsule 100 mg; and Capsule 150 mg

                           omit from the column headed “Circumstances”: C6950 C6961 C6975              substitute: C12650 C12651 C12653 C12654 C12655 C12661

[55]           Schedule 1, Part 1, after entry for Nintedanib in the form Capsule 150 mg

                           insert:

Nirmatrelvir and ritonavir

Pack containing 4 tablets nirmatrelvir 150 mg and 2 tablets ritonavir 100 mg, 5

Oral

 

Paxlovid

HD

MP NP

C12839 C12923 C12936

 

1

0

1

 

 

[56]           Schedule 1, Part 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg; and Tablet 5 mg

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

 

 

 

a

NOUMED OLANZAPINE

VO

MP NP

C5856 C5869

 

28

5

28

 

 

[57]           Schedule 1, Part 1, entry for Olanzapine in each of the forms: Tablet 7.5 mg; and Tablet 10 mg

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

 

 

 

a

NOUMED OLANZAPINE

VO

MP NP

C5856 C5869

 

28

5

28

 

 

[58]           Schedule 1, Part 1, after entry for Omeprazole in the form Tablet 20 mg (as magnesium)

                           insert:

Onasemnogene abeparvovec

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

D(100)

 

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3 

See Note 3 

1

 

D(100)

 

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3 

See Note 3 

1

 

D(100)

 

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3 

See Note 3 

1

 

D(100)

 

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3 

See Note 3 

1

 

D(100)

 

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3 

See Note 3 

1

 

D(100)

 

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 8 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3 

See Note 3 

1

 

D(100)

 

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3 

See Note 3 

1

 

D(100)

 

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3 

See Note 3 

1

 

D(100)

 

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3 

See Note 3 

1

 

D(100)

 

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3 

See Note 3 

1

 

D(100)

 

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3 

See Note 3 

1

 

D(100)

 

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3 

See Note 3 

1

 

D(100)

 

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3 

See Note 3 

1

 

D(100)

 

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

D(100)

 

Pack containing 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

D(100)

 

Pack containing 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

D(100)

 

Pack containing 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

D(100)

 

Pack containing 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

D(100)

 

Pack containing 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

D(100)

 

Pack containing 8 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

D(100)

 

Pack containing 9 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

 

Zolgensma

NV

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

D(100)

[59]           Schedule 1, Part 1, entry for Osimertinib in each of the forms: Tablet 40 mg; and Tablet 80 mg

                           omit from the column headed “Circumstances”: C11176


 

[60]           Schedule 1, Part 1, entry for Palonosetron

                           omit from the column headed “Responsible Person” for the brand “Aloxi”: MF                substitute: JZ

[61]           Schedule 1, Part 1, entry for Peginterferon alfa-2a in each of the forms: Injection 135 micrograms in 0.5 mL single use pre-filled syringe: and Injection 180 micrograms in 0.5 mL single use pre-filled syringe

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

[62]           Schedule 1, Part 1, entry for Pirfenidone in each of the forms: Capsule 267 mg; and Tablet 267 mg

                           omit from the column headed “Circumstances”: C6950 C6961 C6975              substitute: C12650 C12651 C12661

[63]           Schedule 1, Part 1, entry for Pirfenidone in the form Tablet 801mg

                           omit from the column headed “Circumstances”: C6961                        substitute: C12661

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

                           omit:

 

 

 

a

QUEPINE XR

RF

MP NP

C4246 C5611 C5639

 

60

5

60

 

 

[65]           Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 150 mg (as fumarate)

                           omit:

 

 

 

a

QUEPINE XR

RW

MP NP

C4246 C5611 C5639

 

60

5

60

 

 

[66]           Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 200 mg (as fumarate)

                           omit:

 

 

 

a

QUEPINE XR

RF

MP NP

C4246 C5611 C5639

 

60

5

60

 

 

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

                           omit:

 

 

 

a

Quetiapine GH 200

GQ

MP NP

C4246 C5611 C5639

 

60

5

60

 

 

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

                           omit:

 

 

 

a

QUEPINE XR

RF

MP NP

C4246 C5611 C5639

 

60

5

60

 

 

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

                           omit:

 

 

 

a

QUEPINE XR

RF

MP NP

C4246 C5611 C5639

 

60

5

60

 

 

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

                           omit:

 

 

 

a

Ausran

RW

MP NP MW

 

 

60

5

60

 

 

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

                           omit:

 

 

 

a

Ausran

RW

MP NP

 

 

30

5

30

 

 

[72]           Schedule 1, Part 1, entry for Rasagiline

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

 

 

 

a

Alziras

RW

MP NP

C5339

 

30

5

30

 

 

[73]           Schedule 1, Part 1, entry for Risdiplam

                  omit from the column headed “Pack Quantity”: See Note 3    substitute: 1

[74]           Schedule 1, Part 1, after entry for Ruxolitinib in the form Tablet 20 mg

                           insert:

Sacituzumab govitecan

Powder for injection 180 mg

Injection

 

Trodelvy

GI

MP

C12656 C12669 C12670

 

See Note 3

See Note 3

1

 

D(100)

[75]           Schedule 1, Part 1, entry for Selexipag in the form Tablet 200 micrograms [Maximum Quantity: 60; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C11241

                   (b)        omit from the column headed “Purposes”: P11241

[76]           Schedule 1, Part 1, entry for Selexipag in the form Tablet 200 micrograms [Maximum Quantity: 140; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C11241

                   (b)        omit from the column headed “Purposes”: P11241

[77]           Schedule 1, Part 1, entry for Selexipag in each of the forms: Tablet 400 micrograms; and Tablet 600 micrograms

                           omit from the column headed “Circumstances”: C11241


 

[78]           Schedule 1, Part 1, entry for Selexipag in the form Tablet 800 micrograms [Maximum Quantity: 60; Number of Repeats: 3]

                           omit from the column headed “Circumstances”: C11241

[79]           Schedule 1, Part 1, entry for Selexipag in the form Tablet 800 micrograms [Maximum Quantity: 60; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C11241

                   (b)        omit from the column headed “Purposes”: P11241

[80]           Schedule 1, Part 1, entry for Selexipag in each of the forms: Tablet 1 mg; Tablet 1.2 mg; Tablet 1.4 mg; and Tablet 1.6 mg

                           omit from the column headed “Circumstances”: C11241

[81]           Schedule 1, Part 1, entry for Simvastatin in the form Tablet 10 mg

                   (a)        omit:

 

 

 

a

Lipex 10

AL

MP NP

 

 

30

5

30

 

 

                   (b)        omit:

 

 

 

a

Simvastatin generichealth

GQ

MP NP

 

 

30

5

30

 

 

                   (c)        omit:

 

 

 

a

Zocor

MQ

MP NP

 

 

30

5

30

 

 

                   (d)        omit:

 

 

 

a

Lipex 10

AL

MP

 

P7598

30

11

30

 

 

                   (e)        omit:

 

 

 

a

Simvastatin generichealth

GQ

MP

 

P7598

30

11

30

 

 

                    (f)        omit:

 

 

 

a

Zocor

MQ

MP

 

P7598

30

11

30

 

 

[82]           Schedule 1, Part 1, entry for Simvastatin in the form Tablet 20 mg

                   (a)        omit:

 

 

 

a

Simvastatin generichealth

GQ

MP NP

 

 

30

5

30

 

 


 

                   (b)        omit:

 

 

 

a

Simvastatin generichealth

GQ

MP

 

P7598

30

11

30

 

 

[83]           Schedule 1, Part 1, entry for Simvastatin in the form Tablet 40 mg

                   (a)        omit:

 

 

 

a

Simvastatin generichealth

GQ

MP NP

 

 

30

5

30

 

 

                   (b)        omit:

 

 

 

a

Simvastatin generichealth

GQ

MP

 

P7598

30

11

30

 

 

[84]           Schedule 1, Part 1, entry for Somatropin

                           substitute:

Somatropin

Injection 0.4 mg (1.2 i.u.) with diluent in single use syringe (without preservative)

Injection

 

Genotropin MiniQuick

PF

MP

C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887

 

See Note 3

See Note 3

7

 

D(100)

 

Injection 0.6 mg (1.8 i.u.) with diluent in single use syringe (without preservative)

Injection

 

Genotropin MiniQuick

PF

MP

C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887

 

See Note 3

See Note 3

7

 

D(100)

 

Injection 0.8 mg (2.4 i.u.) with diluent in single use syringe (without preservative)

Injection

 

Genotropin MiniQuick

PF

MP

C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887

 

See Note 3

See Note 3

7

 

D(100)

 

Injection 1 mg (3 i.u.) with diluent in single use syringe (without preservative)

Injection

 

Genotropin MiniQuick

PF

MP

C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887

 

See Note 3

See Note 3

7

 

D(100)

 

Injection 1.2 mg (3.6 i.u.) with diluent in single use syringe (without preservative)

Injection

 

Genotropin MiniQuick

PF

MP

C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887

 

See Note 3

See Note 3

7

 

D(100)

 

Injection 1.4 mg (4.2 i.u.) with diluent in single use syringe (without preservative)

Injection

 

Genotropin MiniQuick

PF

MP

C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887

 

See Note 3

See Note 3

7

 

D(100)

 

Injection 1.6 mg (4.8 i.u.) with diluent in single use syringe (without preservative)

Injection

 

Genotropin MiniQuick

PF

MP

C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887

 

See Note 3

See Note 3

7

 

D(100)

 

Injection 1.8 mg (5.4 i.u.) with diluent in single use syringe (without preservative)

Injection

 

Genotropin MiniQuick

PF

MP

C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887

 

See Note 3

See Note 3

7

 

D(100)

 

Injection 2 mg (6 i.u.) with diluent in single use syringe (without preservative)

Injection

 

Genotropin MiniQuick

PF

MP

C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887

 

See Note 3

See Note 3

7

 

D(100)

 

Injection 18 i.u. (6 mg) cartridge with 3.15 mL diluent (with preservative)

Injection

 

Humatrope

LY

MP

C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12734 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12797 C12799 C12803 C12831 C12832 C12834 C12835 C12858 C12860 C12866 C12884 C12906 C12907 C12922

 

See Note 3

See Note 3

1

 

D(100)

 

Injection 36 i.u. (12 mg) cartridge with 3.15 mL diluent (with preservative)

Injection

 

Humatrope

LY

MP

C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12734 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12797 C12799 C12803 C12831 C12832 C12834 C12835 C12858 C12860 C12866 C12884 C12906 C12907 C12922

 

See Note 3

See Note 3

1

 

D(100)

 

Injection 72 i.u. (24 mg) cartridge with 3.15 mL diluent (with preservative)

Injection

 

Humatrope

LY

MP

C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12734 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12797 C12799 C12803 C12831 C12832 C12834 C12835 C12858 C12860 C12866 C12884 C12906 C12907 C12922

 

See Note 3

See Note 3

1

 

D(100)

 

Powder for injection 5 mg (15 i.u.) with diluent in pre-filled pen (with preservative)

Injection

 

Genotropin GoQuick

PF

MP

C11102 C11104 C12588 C12601 C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887

 

See Note 3

See Note 3

1

 

D(100)

 

Powder for injection 12 mg (36 i.u.) with diluent in pre-filled pen (with preservative)

Injection

 

Genotropin GoQuick

PF

MP

C11102 C11104 C12588 C12601 C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12768 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12791 C12793 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887

 

See Note 3

See Note 3

1

 

D(100)

 

Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen

Injection

 

Norditropin FlexPro

NO

MP

C11102 C11104 C12588 C12601 C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12884 C12929

 

See Note 3

See Note 3

1

 

D(100)

 

Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative)

Injection

 

Omnitrope Surepal 5

SZ

MP

C12713 C12719 C12720 C12721 C12749 C12752 C12754 C12755 C12787 C12788 C12789 C12790 C12805 C12806 C12807 C12809 C12810 C12817 C12820 C12821 C12824 C12826 C12855 C12857 C12861 C12871 C12872 C12873 C12876 C12877 C12879 C12880 C12882 C12886 C12899 C12901 C12916 C12918 C12926 C12927 C12928 C12932

 

See Note 3

See Note 3

1

 

D(100)

 

 

 

 

Scitropin A

SA

MP

C12713 C12719 C12720 C12721 C12749 C12752 C12754 C12755 C12787 C12788 C12789 C12790 C12805 C12806 C12807 C12809 C12810 C12817 C12820 C12821 C12824 C12826 C12855 C12857 C12861 C12871 C12872 C12873 C12876 C12877 C12879 C12880 C12882 C12886 C12899 C12901 C12916 C12918 C12926 C12927 C12928 C12932

 

See Note 3

See Note 3

1

 

D(100)

 

Solution for injection 6 mg (18 i.u.) in 1.03 mL cartridge (with preservative)

Injection

 

Saizen

SG

MP

C12703 C12704 C12711 C12712 C12721 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12749 C12752 C12758 C12760 C12761 C12764 C12765 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12797 C12799 C12803 C12806 C12831 C12832 C12834 C12858 C12860 C12861 C12866 C12884

 

See Note 3

See Note 3

1

 

D(100)

 

Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative)

Injection

 

Omnitrope Surepal 10

SZ

MP

C12713 C12719 C12720 C12721 C12749 C12752 C12754 C12755 C12787 C12788 C12789 C12790 C12805 C12806 C12807 C12809 C12810 C12817 C12820 C12821 C12824 C12826 C12855 C12857 C12861 C12871 C12872 C12873 C12876 C12877 C12879 C12880 C12882 C12886 C12899 C12901 C12916 C12918 C12926 C12927 C12928 C12932

 

See Note 3

See Note 3

1

 

D(100)

 

 

 

 

SciTropin A

SA

MP

C12713 C12719 C12720 C12721 C12749 C12752 C12754 C12755 C12787 C12788 C12789 C12790 C12805 C12806 C12807 C12809 C12810 C12817 C12820 C12821 C12824 C12826 C12855 C12857 C12861 C12871 C12872 C12873 C12876 C12877 C12879 C12880 C12882 C12886 C12899 C12901 C12916 C12918 C12926 C12927 C12928 C12932

 

See Note 3

See Note 3

1

 

D(100)

 

Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen

Injection

 

Norditropin FlexPro

NO

MP

C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12884 C12929

 

See Note 3

See Note 3

1

 

D(100)

 

Solution for injection 10 mg (30 i.u.) in 2 mL cartridge (with preservative)

Injection

 

NutropinAq

IS

MP

C11102 C11104 C12588 C12601 C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12884 C12929

 

See Note 3

See Note 3

1

 

D(100)

 

Solution for injection 12 mg (36 i.u.) in 1.5 mL cartridge (with preservative)

Injection

 

Saizen

SG

MP

C12703 C12704 C12711 C12712 C12721 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12749 C12752 C12758 C12760 C12761 C12764 C12765 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12797 C12799 C12803 C12806 C12831 C12832 C12834 C12858 C12860 C12861 C12866 C12884

 

See Note 3

See Note 3

1

 

D(100)

 

Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative)

Injection

 

Omnitrope Surepal 15

SZ

MP

C12713 C12719 C12720 C12721 C12749 C12752 C12754 C12755 C12787 C12788 C12789 C12790 C12805 C12806 C12807 C12809 C12810 C12817 C12820 C12821 C12824 C12826 C12855 C12857 C12861 C12871 C12872 C12873 C12876 C12877 C12879 C12880 C12882 C12886 C12899 C12901 C12916 C12918 C12926 C12927 C12928 C12932

 

See Note 3

See Note 3

1

 

D(100)

 

Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen

Injection

 

Norditropin FlexPro

NO

MP

C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12758 C12760 C12761 C12764 C12765 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12797 C12798 C12799 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12884 C12929

 

See Note 3

See Note 3

1

 

D(100)

 

Solution for injection 20 mg (60 i.u.) in 2.5 mL cartridge (with preservative)

Injection

 

Saizen

SG

MP

C12703 C12704 C12711 C12712 C12721 C12722 C12723 C12725 C12726 C12730 C12731 C12733 C12737 C12738 C12743 C12749 C12752 C12758 C12760 C12761 C12764 C12765 C12769 C12770 C12771 C12773 C12774 C12775 C12779 C12780 C12781 C12784 C12785 C12797 C12799 C12803 C12806 C12831 C12832 C12834 C12858 C12860 C12861 C12866 C12884

 

See Note 3

See Note 3

1

 

D(100)

[85]           Schedule 1, Part 1, after entry for Triglycerides - medium chain, formula in the form Oral liquid 500 mL, 8 (Nutrini Peptisorb)

                           insert:

 

Oral liquid 500 mL, 12 (Nutrini Peptisorb)

Oral

 

Nutrini Peptisorb

SB

MP NP

C4660

 

12

5

1

 

 

[86]           Schedule 1, Part 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]

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

 

 

 

a

NOUMED VALACICLOVIR

VO

MP NP

C5940 C5961

 

30

5

30

 

 

[87]           Schedule 1, Part 1, after entry for Varenicline in the form Tablet 1 mg (as tartrate)

                           insert:

 

Tablet 1 mg (as tartrate) (s19A)

Oral

 

APO-Varenicline (Canada)

XT

MP NP

C6885 C7483

P6885

56

2

56

 

 

 

 

 

 

 

 

MP NP

C6885 C7483

P7483

112

0

56

 

 

[88]         Schedule 1, Part 2, after entry for Calcipotriol with betamethasone

insert:

Clopidogrel

Tablet 75 mg (as besilate)

Oral

 

BTC Clopidogrel

JB

MP NP

C4165 C4166

 

28

5

28

 

 

 

 

 

 

Clopidogrel APOTEX

GX

MP NP

C4165 C4166

 

28

5

28

 

 

 

 

 

 

Clopidogrel GH

GQ

MP NP

C4165 C4166

 

28

5

28

 

 

 

 

 

 

Clovix 75

RW

MP NP

C4165 C4166

 

28

5

28

 

 

 

 

 

 

Plidogrel

RF

MP NP

C4165 C4166

 

28

5

28

 

 

 

Tablet 75 mg (as hydrogen sulfate)

Oral

 

Blooms the Chemist Clopidogrel

IB

MP NP

C4165 C4166

 

28

5

28

 

 

 

 

 

 

Clopidogrel Sandoz Pharma

HX

MP NP

C4165 C4166

 

28

5

28

 

 

 

 

 

 

Clopidogrel Winthrop

WA

MP NP

C4165 C4166

 

28

5

28

 

 

 

 

 

 

Iscover

AV

MP NP

C4165 C4166

 

28

5

28

 

 

 

 

 

 

Piax

AF

MP NP

C4165 C4166

 

28

5

28

 

 

[89]         Schedule 1, Part 2, after entry for Enfuvirtide

insert:

Hydroxychloroquine

Tablet containing hydroxychloroquine sulfate 200mg

Oral

a

APO- Hydroxychloroquine

TX

MP

C10417 C10418

 

100

1

100

 

 

 

 

 

a

Hequinel

RW

MP

C10417 C10418

 

100

1

100

 

 

 

 

 

a

Hydroxychloroquine GH

GQ

MP

C10417 C10418

 

100

1

100

 

 

 

 

 

a

Plaquenil

SW

MP

C10417 C10418

 

100

1

100

 

 

[90]           Schedule 3, after details relevant for Responsible Person code HB

                           insert:

HD

Department of Health

83 605 426 759

[91]           Schedule 3, after details relevant for Responsible Person code JX

                           insert:

JZ

Juniper Biologics Pty Ltd

 97 655 479 897

[92]           Schedule 3, after details relevant for Responsible Person code XN

                           insert:

XO

Echo Therapeutics Pty Ltd

 92 628 298 699

[93]           Schedule 4, Part 1, entry for Abiraterone

                           substitute:

Abiraterone

C12700

 

 

Castration resistant metastatic carcinoma of the prostate
The treatment must be used in combination with a corticosteroid; AND
The treatment must not be used in combination with chemotherapy; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); OR
Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation.

Compliance with Authority Required procedures

[94]           Schedule 4, Part 1, entry for Adalimumab

                   (a)        omit:

 

C11758

P11758

 

Severe Crohn disease
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist, consultant physician, paediatrician or specialist paediatric gastroenterologist; AND
Patient must have, at the time of application, disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 6 to 17 years inclusive.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
The authority application must be made in writing and must include:
(1) two completed authority prescription forms; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The PCDAI assessment must be no more than 4 weeks old at the time of application.
A PCDAI assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks therapy so that there is adequate time for a response to be demonstrated.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

Compliance with Written Authority Required procedures

                   (b)        omit:

 

C11789

P11789

 

Severe Crohn disease
Initial treatment - Initial 1 (new patient)
Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND
Patient must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; OR
Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra-indication to each of prednisolone (or equivalent), azathioprine, 6-mercaptopurine and methotrexate; AND
Patient must have, at the time of application, disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40 preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment and which is no more than 4 weeks old at the time of application; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 6 to 17 years inclusive.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
The authority application must be made in writing and must include:
(1) two completed authority prescription forms; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application. Details of the accepted toxicities including severity can be found on the Services Australia website (www.servicesaustralia.gov.au).
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

Compliance with Written Authority Required procedures

[95]           Schedule 4, Part 1, after entry for Anastrozole

                           insert:

Apalutamide

C12895

 

 

Castration resistant non-metastatic carcinoma of the prostate
The condition must have evidence of an absence of distant metastases on the most recently performed conventional medical imaging used to evaluate the condition; AND
The condition must be associated with a prostate-specific antigen level that was observed to have at least doubled in value in a time period of within 10 months anytime prior to first commencing treatment with this drug; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); OR
Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation.
Patient must be undergoing concurrent treatment with androgen deprivation therapy.
Prescribing instructions:
Retain the results of all investigative imaging and prostate-specific antigen (PSA) level measurements on the patient's medical records - do not submit copies of these with this authority application.
The PSA level doubling time must be based on at least three PSA levels obtained within a time period of 10 months any time prior to first commencing a novel hormonal drug for this condition. The third reading is to demonstrate that the doubling was durable and must be at least 1 week apart from the second reading.

Compliance with Authority Required procedures

[96]           Schedule 4, Part 1, entry for Budesonide

                           insert in numerical order after existing text:

 

C12836

P12836

 

Eosinophilic oesophagitis
First continuing treatment - Confirmation of remission
Patient must have previously received PBS-subsidised initial treatment with this drug for this condition; AND
Patient must have documented evidence of having achieved histologic remission while receiving initial PBS-subsidised treatment with this drug for this condition, defined as a peak eosinophil count of less than 5 eosinophils per high power field (hpf), corresponding to less than 16 eosinophils per mm2hpf on oesophageal biopsy; AND
Patient must not receive more than 26 weeks of treatment under this restriction.
Must be treated by a gastroenterologist.
Histologic assessment should be based on the peak eosinophils count derived from the evaluation of at least eight oesophageal biopsies (minimum of four collected from each of the mid and distal segments, with the distal segment biopsies taken at least 5 cm above the gastroesophageal junction).
The histologic assessment should, where possible, be performed by the same physician who confirmed the diagnosis of eosinophilic oesophagitis in the patient. This assessment, which will be used to determine eligibility for continuing treatment, should be conducted and submitted after the patient has completed 8 weeks of the initial treatment course and no later than 2 weeks prior to the patient completing the PBS-subsidised initial treatment course, to avoid an interruption to supply. Where a histologic assessment is not undertaken and the results submitted, the patient will be not be eligible for ongoing treatment.

Compliance with Authority Required procedures

 

C12837

P12837

 

Eosinophilic oesophagitis
Subsequent continuing treatment - Maintenance of remission
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; OR
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the - Transitioning from non-PBS to PBS-subsided treatment - Grandfather treatment restriction; AND
The condition must not have progressed while being treated with this drug.
Must be treated by a gastroenterologist or in consultation with a gastroenterologist.

Compliance with Authority Required procedures

 

C12909

P12909

 

Eosinophilic oesophagitis
Transitioning from non-PBS to PBS-subsidised treatment - Grandfather treatment
Patient must have previously received non-PBS-subsidised treatment with a corticosteroid for this condition prior to 1 May 2022; AND
Patient must be receiving non-PBS treatment with a corticosteroid for this condition at the time of application; AND
Patient must have had, prior to commencement of non-PBS-subsidised treatment with a corticosteroid, a history of symptoms of oesophageal dysfunction; AND
Patient must have had, prior to commencement of non-PBS-subsidised treatment with a corticosteroid, eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy confirming the presence of at least 15 eosinophils in at least one high power field (hpf); corresponding to approximately 60 eosinophils per mm2hpf; AND
Patient must have documented evidence that they are currently in histologic remission, where remission is defined as a peak eosinophil count of less than 5 eosinophils per high power field (hpf); corresponding to less than 16 eosinophils per mm2hpf on oesophageal biopsy.
Must be treated by a gastroenterologist.
A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the subsequent continuing treatment criteria.
Symptoms of oesophageal dysfunction include at least one of the following: dysphasia, odynophagia, transient or self-cleared food impaction, chest pain, epigastric discomfort, vomiting/regurgitation.
Histologic assessment should be based on the peak eosinophils count derived from the evaluation of at least eight oesophageal biopsies (minimum of four collected from each of the mid and distal segments, with the distal segment biopsies taken at least 5 cm above the gastroesophageal junction).
The histologic assessment should, where possible, be performed by the same physician who confirmed the diagnosis of eosinophilic oesophagitis in the patient. This assessment, which will be used to determine eligibility for continuing treatment, should have been conducted after the patient has completed 8 weeks of the initial treatment course and no later than 2 weeks prior to the patient completing the initial treatment course, to avoid an interruption to supply. Where a histologic assessment is not undertaken and the results submitted, the patient will not be eligible for ongoing treatment.

Compliance with Authority Required procedures

 

C12938

P12938

 

Eosinophilic oesophagitis
Initial treatment - Induction of remission
Patient must have a history of symptoms of oesophageal dysfunction; AND
Patient must have eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy confirming the presence of at least 15 eosinophils in at least one high power field (hpf); corresponding to approximately 60 eosinophils per mm2hpf; AND
Patient must not receive more than 90 days of treatment under this restriction.
Must be treated by a gastroenterologist.
Applications for treatment of this condition must be received within 12 weeks of biopsy.
Symptoms of oesophageal dysfunction include at least one of the following: dysphasia, odynophagia, transient or self-cleared food impaction, chest pain, epigastric discomfort, vomiting/regurgitation.
Diagnostic sensitivity increases with the number of biopsies and is optimised after taking at least eight biopsies (minimum of four collected from each of the mid and distal segments, with the distal segment biopsies taken at least 5 cm above the gastroesophageal junction).
A histologic assessment of the oesophageal biopsy should be planned for approximately 8 weeks after the initiation of the first PBS-subsidised treatment with this drug under this restriction, and no later than 2 weeks prior to the patient completing the PBS-subsidised initial treatment course, to determine the patient's eligibility for continuing therapy and to avoid an interruption to supply.

Compliance with Authority Required procedures

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

                           insert in numerical order after existing text:

 

C12701

 

 

Opiate dependence
Must be treated by a health care professional.
The treatment must be within a framework of medical, social and psychological treatment.

 

 

C12915

 

 

Opiate dependence
Must be treated by a health care professional.
The treatment must be within a framework of medical, social and psychological treatment; AND
Patient must be stabilised on one of the following prior to commencing treatment with this drug for this condition: (i) weekly prolonged release buprenorphine (Buvidal Weekly) (ii) sublingual buprenorphine (iii) buprenorphine/naloxone.

 

[98]           Schedule 4, Part 1, entry for Carfilzomib

                           substitute:

Carfilzomib

C12694

 

 

Multiple myeloma
Initial treatment - once weekly treatment regimen
The condition must be confirmed by a histological diagnosis; AND
The treatment must be in combination with dexamethasone; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must have undergone or be ineligible for a stem cell transplant; AND
Patient must not have previously received this drug for this condition; AND
Patient must not receive more than three cycles of treatment under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.

Compliance with Authority Required procedures - Streamlined Authority Code 12694

 

C12849

 

 

Multiple myeloma
Continuing treatment - once weekly treatment regimen
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be in combination with dexamethasone; AND
Patient must not develop disease progression while receiving treatment with this drug for this condition; AND
Patient must not receive more than 3 cycles of treatment per continuing treatment course authorised under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.

Compliance with Authority Required procedures - Streamlined Authority Code 12849

 

C12930

 

 

Multiple myeloma
Continuing treatment - twice weekly treatment regimen
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be in combination with dexamethasone; AND
Patient must not develop disease progression while receiving treatment with this drug for this condition; AND
Patient must not receive more than 3 cycles of treatment per continuing treatment course authorised under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.

Compliance with Authority Required procedures - Streamlined Authority Code 12930

 

C12934

 

 

Multiple myeloma
Initial treatment - twice weekly treatment regimen
The condition must be confirmed by a histological diagnosis; AND
The treatment must be in combination with dexamethasone; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must have undergone or be ineligible for a stem cell transplant; AND
Patient must not have previously received this drug for this condition; AND
Patient must not receive more than three cycles of treatment under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.

Compliance with Authority Required procedures - Streamlined Authority Code 12934

[99]           Schedule 4, Part 1, entry for Clopidogrel

                           omit:

 

C5436

 

 

Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events
Patient must be in one whom low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding.

Compliance with Authority Required procedures - Streamlined Authority Code 5436

 

C5459

 

 

Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events
Patient must have a history of symptomatic cerebrovascular ischaemic episodes while on therapy with low-dose aspirin.

Compliance with Authority Required procedures - Streamlined Authority Code 5459

 

C5508

 

 

Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events
Patient must have a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs (NSAIDs).

Compliance with Authority Required procedures - Streamlined Authority Code 5508

 

C5517

 

 

Prevention of recurrence of myocardial infarction or unstable angina
Patient must have a history of symptomatic cardiac ischaemic events while on therapy with low-dose aspirin.

Compliance with Authority Required procedures - Streamlined Authority Code 5517

 

C5524

 

 

Prevention of recurrence of myocardial infarction or unstable angina
Patient must be in one whom low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding.

Compliance with Authority Required procedures - Streamlined Authority Code 5524

 

C5525

 

 

Prevention of recurrence of myocardial infarction or unstable angina
Patient must have a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs (NSAIDs).

Compliance with Authority Required procedures - Streamlined Authority Code 5525

[100]        Schedule 4, 1, omit entry for Clopidogrel with aspirin

[101]        Schedule 4, Part 1, entry for Daratumumab

                           substitute:

Daratumumab

C12691

P12691

 

Relapsed and/or refractory multiple myeloma
Continuing treatment of second-line drug therapy from week 25 until disease progression (administered every 4 weeks)
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.

Compliance with Authority Required procedures

 

C12692

P12692

 

Relapsed and/or refractory multiple myeloma
Initial treatment as second-line drug therapy for weeks 1 to 9 (administered once weekly)
The condition must be confirmed by a histological diagnosis; AND
The treatment must be in combination with bortezomib and dexamethasone; AND
Patient must have progressive disease after only one prior therapy (i.e. use must be as second-line drug therapy; use as third-line drug therapy or beyond is not PBS-subsidised).
Patient must be undergoing treatment with this drug in one of the following situations: (i) for the first time, (ii) changing the drug's form (intravenous/subcutaneous) within the first 9 weeks of treatment.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient's medical records.
Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.
A line of therapy is defined as 1 or more cycles of a planned treatment program. This may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner.
A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse, or toxicity, with the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease.

Compliance with Authority Required procedures

 

C12842

P12842

 

Relapsed and/or refractory multiple myeloma
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Patient must have been on treatment with this drug in the subcutaneous form for this condition prior to 1 November 2021; AND
Patient must have met all initial treatment PBS-eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are: (i) the condition was confirmed by histological diagnosis, (ii) the treatment is/was being used as part of triple combination therapy with bortezomib and dexamethasone, (iii) the condition progressed (see definition of progressive disease below) after one prior therapy, but not after more than two prior lines of therapies (i.e. this drug was commenced as second-line treatment), (iv) the treatment was/is not to be used in combination with another PBS-subsidised drug indicated for this condition outside of the intended combination where stated, and (v) the patient had never been treated with this drug; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient's medical records.
Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.
A line of therapy is defined as 1 or more cycles of a planned treatment program. This may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner.
A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse, or toxicity, with the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease.

Compliance with Authority Required procedures

 

C12844

 

 

Relapsed and/or refractory multiple myeloma
Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply
Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 January 2021; AND
Patient must have met all initial treatment PBS-eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are: (i) the condition was confirmed by histological diagnosis, (ii) the treatment is/was being used as part of triple combination therapy with bortezomib and dexamethasone, (iii) the condition progressed (see definition of progressive disease below) after one prior therapy, but not after more than two prior lines of therapies (i.e. this drug was commenced as second-line treatment), (iv) the treatment was/is not to be used in combination with another PBS-subsidised drug indicated for this condition outside of the intended combination where stated, and (v) the patient had never been treated with this drug; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient's medical records.
Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.
A line of therapy is defined as 1 or more cycles of a planned treatment program. This may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner.
A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse, or toxicity, with the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease.

Compliance with Authority Required procedures

 

C12845

P12845

 

Relapsed and/or refractory multiple myeloma
Continuing treatment of second-line drug therapy for weeks 10 to 24 (administered every 3 weeks)
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be in combination with bortezomib and dexamethasone; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.

Compliance with Authority Required procedures

[102]        Schedule 4, Part 1, entry for Darolutamide

                           substitute:

Darolutamide

C12895

 

 

Castration resistant non-metastatic carcinoma of the prostate
The condition must have evidence of an absence of distant metastases on the most recently performed conventional medical imaging used to evaluate the condition; AND
The condition must be associated with a prostate-specific antigen level that was observed to have at least doubled in value in a time period of within 10 months anytime prior to first commencing treatment with this drug; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); OR
Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation.
Patient must be undergoing concurrent treatment with androgen deprivation therapy.
Prescribing instructions:
Retain the results of all investigative imaging and prostate-specific antigen (PSA) level measurements on the patient's medical records - do not submit copies of these with this authority application.
The PSA level doubling time must be based on at least three PSA levels obtained within a time period of 10 months any time prior to first commencing a novel hormonal drug for this condition. The third reading is to demonstrate that the doubling was durable and must be at least 1 week apart from the second reading.

Compliance with Authority Required procedures

[103]        Schedule 4, Part 1, entry for Dupilumab

                           omit:

 

C11425

 

 

Chronic severe atopic dermatitis
Transitioning from non-PBS to PBS-subsidised supply - treatment of the whole body (Grandfather listing)
Patient must have been receiving treatment with this biological medicine for this PBS indication prior to 1 March 2021; AND
Patient must have had a Physicians Global Assessment (PGA) baseline score of at least 4 as evidence of severe disease despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days prior to commencing non-PBS-subsidised therapy with this biological medicine; AND
Patient must have had an Eczema Area and Severity Index (EASI) baseline score of at least 20 despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days prior to commencing non-PBS-subsidised therapy with this biological medicine; AND
Patient must have an age appropriate Dermatology Life Quality Index (DLQI) baseline score (of any value) measured following treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days, prior to having commenced non-PBS-subsidised therapy with this biological medicine; OR
Patient must have, where the above baseline DLQI was not recorded in the patient's medical records, a current age-appropriate DLQI score (of any value) measured; AND
The condition must have had lesions for at least 6 months from the time of the initial diagnosis of chronic severe atopic dermatitis affecting either of: (i) the whole body, (ii) face/hands, prior to commencing non-PBS-subsidised therapy with this biological medicine; AND
Patient must not be experiencing an inadequate response to current non-PBS-subsidised therapy with this biological medicine; AND
The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND
Patient must not have experienced an inadequate response to this biological medicine in this indication, prior to commencing non-PBS-subsidised therapy with this biological medicine.
Must be treated by a dermatologist; OR
Must be treated by a clinical immunologist.
Patient must be 12 years of age or older.
State each of the qualifying PGA, EASI and DLQI scores in the authority application. The name/s of the medium to high potency topical corticosteroids trialled prior to commencing treatment with this biological medicine must be documented in the patient's medical records.
The EASI and DLQI baseline measurements are to form the basis of determining if an adequate response to treatment has been achieved under the Continuing treatment restriction.
A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Authority Required procedures

 

C11479

 

 

Chronic severe atopic dermatitis
Transitioning from non-PBS to PBS-subsidised supply - treatment of the face and/or hands (Grandfather listing)
Patient must have been receiving treatment with this biological medicine for this PBS indication prior to 1 March 2021; AND
The condition must have had at least 2 of the following Eczema Area and Severity Index (EASI) symptom sub-scores for erythema, oedema/papulation, excoriation, lichenification rated as severe despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days, prior to commencing non-PBS-subsidised therapy with this biological medicine; OR
The condition must have affected at least 30% of the face/hands surface area despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days, prior to commencing non-PBS-subsidised therapy with this biological medicine; AND
Patient must have an age appropriate Dermatology Life Quality Index (DLQI) baseline score (of any value) measured following treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days, prior to having commenced non-PBS-subsidised therapy with this biological medicine; OR
Patient must have, where the above baseline DLQI was not recorded in the patient's medical records, a current age-appropriate DLQI score (of any value) measured; AND
The condition must have had lesions for at least 6 months from the time of the initial diagnosis of chronic severe atopic dermatitis affecting either of: (i) the whole body, (ii) face/hands, prior to commencing non-PBS-subsidised therapy with this biological medicine; AND
Patient must not be experiencing an inadequate response to current non-PBS-subsidised therapy with this biological medicine; AND
The treatment must be the sole PBS-subsidised biological medicine for this condition; AND
Patient must not have experienced an inadequate response to this biological medicine in this indication, prior to commencing non-PBS-subsidised therapy with this biological medicine.
Must be treated by a dermatologist; OR
Must be treated by a clinical immunologist.
Patient must be 12 years of age or older.
State each of the 4 Eczema Area and Severity Index (EASI) symptom sub-score ratings for erythema, oedema/papulation, excoriation, lichenification that were present prior to having commenced non-PBS-subsidised therapy, in the authority application. The name/s of the medium to high potency topical corticosteroids trialled prior to commencing treatment with this biological medicine is/are to be documented in the patient's medical records.
A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Authority Required procedures

[104]        Schedule 4, Part 1, after entry for Eletriptan

                           insert:

Elotuzumab

C12847

 

 

Relapsed and/or refractory multiple myeloma
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be in combination with lenalidomide and dexamethasone; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.

Compliance with Authority Required procedures

 

C12891

 

 

Relapsed and/or refractory multiple myeloma
Initial treatment
The condition must be confirmed by a histological diagnosis; AND
The treatment must be in combination with lenalidomide and dexamethasone; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must have undergone or be ineligible for a stem cell transplant; AND
Patient must not have previously received this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.

Compliance with Authority Required procedures

[105]        Schedule 4, Part 1, entry for Enzalutamide

                           substitute:

Enzalutamide

C12937

 

 

Castration resistant metastatic carcinoma of the prostate
The treatment must not be used in combination with chemotherapy; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); OR
Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation.

Compliance with Authority Required procedures

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

                           omit:

 

C10419

 

 

Autoimmune disorder
Continuing treatment
Patient must have previously been treated with PBS-subsidised therapy with this drug for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 10419

 

C10420

 

 

Malaria
Continuing treatment
Patient must have previously been treated with PBS-subsidised therapy with this drug for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 10420

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

                           insert in numerical order after existing text:

 

C12685

P12685

 

Malignant gastrointestinal stromal tumour
Initial treatment
The condition must be metastatic; OR
The condition must be unresectable; AND
The condition must be histologically confirmed by the detection of CD117 on immunohistochemical staining; AND
The condition must have not achieved a response with this drug at a dose of 400 mg per day; AND
The treatment must not exceed 3 months under this restriction.
Authority prescriptions for a higher dose will not be approved during this initial 3 month treatment period.
Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved.
A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347: 472-80.)
A pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining must be documented in the patient's medical records.
Details of the most recent (within 2 months of the application) computed tomography (CT) scan, magnetic resonance imaging (MRI) or ultrasound assessment of the tumour(s), including whether or not there is evidence of metastatic disease must be documented in the patient's medical records.
Where the application for authority to prescribe is being sought on the basis of an unresectable tumour, written evidence must be documented in the patient's medical records.

Compliance with Authority Required procedures

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

                           substitute:

Molnupiravir

C12839

 

 

SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result verified by a medical practitioner or nurse practitioner; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation at the time of prescribing; AND
Patient must be moderately to severely immunocompromised; AND
Patient must be at risk of progression to severe disease due to immunocompromised status; AND
The treatment must be initiated within 5 days of symptom onset.
Patient must be at least 18 years of age.
For the purpose of administering this restriction, "moderately to severely immunocompromised" patients are those with:
1. any primary or acquired immunodeficiency including:
a. Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders,
b. Post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months),
c. Immunocompromised due to primary or acquired (HIV/AIDS) immunodeficiency OR
2. any significantly immunocompromising condition(s) where, in the last 3 months the patient has received:
a. Chemotherapy or whole body radiotherapy,
b. High-dose corticosteroids (greater than or equal to 20 mg of prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy,
c. Biological agents and other treatments that deplete or inhibit B cell or T cell function (anti-CD20 antibodies, BTK inhibitors, JAK inhibitors, sphingosine 1-phosphate receptor modulators, anti-CD52 antibodies, anti-complement antibodies, anti-thymocyte globulin),
d. Selected conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) including mycophenolate, methotrexate (more than 0.4mg/kg/week), leflunomide, azathioprine (at least 3mg/kg/day), 6-mercaptopurine (at least 1.5mg/kg/day), alkylating agents (e.g. cyclophosphamide, chlorambucil), and systemic calcineurin inhibitors (e.g. cyclosporin, tacrolimus) OR
3. any significantly immunocompromising condition(s) where, in the last 12 months the patient has received rituximab,
4. Others with very high risk conditions including Down Syndrome, cerebral palsy, congenital heart disease, thalassemia, sickle cell disease and other haemoglobinopathies OR
5. People with severe intellectual or physical disabilities requiring residential care
Details of the patients' medical condition necessitating use of this drug must be recorded in the patients' medical records.
For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
Access to this drug through this restriction is permitted irrespective of vaccination status.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, the test must be verified by a medical practitioner or nurse practitioner. The test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.

Compliance with Authority Required procedures - Streamlined Authority Code 12839

 

C12923

 

 

SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result verified by a medical practitioner or nurse practitioner; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation at the time of prescribing; AND
Patient must be aged 65 years or over and at high risk; AND
The treatment must be initiated within 5 days of symptom onset.
For the purpose of administering this restriction, high risk is defined as the presence of at least two of the following conditions:
The patient has received less than 2 doses of SARS-CoV-2 vaccine,
The patient is aged 75 years or over,
The patient is in residential aged care or residential disability care,
Neurological conditions, including stroke and dementia,
Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis,
Congestive heart failure (NYHA Class II or greater),
Obesity (BMI greater than 30 kg/m 2 ),
Diabetes Types I and II, requiring medication for glycaemic control,
Renal failure (eGFR less than 60mL/min),
Cirrhosis, or
The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above.
Details of the patients' medical condition necessitating use of this drug must be recorded in the patients' medical records.
For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, the test must be verified by a medical practitioner or nurse practitioner. The test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.

Compliance with Authority Required procedures - Streamlined Authority Code 12923

 

C12936

 

 

SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result verified by a medical practitioner or nurse practitioner; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation at the time of prescribing.
Patient must identify as Aboriginal or Torres Strait Islander.
Patient must be aged 50 or over and at high risk; AND
The treatment must be initiated within 5 days of symptom onset.
For the purpose of administering this restriction, high risk is defined as the presence of at least two of the following conditions:
The patient has received less than 2 doses of SARS-CoV-2 vaccine,
The patient is in residential aged care or residential disability care,
Neurological conditions, including stroke and dementia,
Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis,
Congestive heart failure (NYHA Class II or greater),
Obesity (BMI greater than 30kg/m 2 ),
Diabetes Types I and II, requiring medication for glycaemic control,
Renal failure (eGFR less than 60mL/min),
Cirrhosis, or
The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above.
Details of the patients' medical condition necessitating use of this drug must be recorded in the patients' medical records.
For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, the test must be verified by a medical practitioner or nurse practitioner. The test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.

Compliance with Authority Required procedures - Streamlined Authority Code 12936

[109]        Schedule 4, Part 1, entry for Nintedanib

                           substitute:

Nintedanib

C12650

 

 

Idiopathic pulmonary fibrosis
Initial treatment 1 - new patient
The condition must be diagnosed through a multidisciplinary team; AND
Patient must have chest high resolution computed tomography (HRCT) consistent with diagnosis of idiopathic pulmonary fibrosis within the previous 12 months; AND
Patient must have a forced vital capacity (FVC) greater than or equal to 50% predicted for age, gender and height; AND
Patient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7; AND
Patient must not have had an acute respiratory infection at the time of FVC measurement; AND
Patient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin equal to or greater than 30%; AND
Patient must not have interstitial lung disease due to other known causes including domestic and occupational environmental exposures, connective tissue disease, or drug toxicity; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician; AND
Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial disease, (ii) idiopathic pulmonary fibrosis; AND
Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial disease, (ii) idiopathic pulmonary fibrosis; AND
Patient must be undergoing treatment with this pharmaceutical benefit only where the prescriber has explained to the patient/patient's guardian the following: (i) that certain diagnostic criteria must be met to be eligible to initiate treatment, (ii) continuing treatment is not based on quantified improvements in diagnostic measurements, but will be determined by clinician judgement.
A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Document in the patient's medical records the qualifying FVC, FEV1/FVC ratio and DLCO measurements. Retain medical imaging in the patient's medical records.

Compliance with Written Authority Required procedures

 

C12651

 

 

Idiopathic pulmonary fibrosis
Initial treatment 2 - change or recommencement of treatment
Patient must have previously received PBS-subsidised treatment with nintedanib or pirfenidone for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician; AND
Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial disease, (ii) idiopathic pulmonary fibrosis; AND
Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial disease, (ii) idiopathic pulmonary fibrosis.

Compliance with Authority Required procedures

 

C12653

 

 

Progressive fibrosing Interstitial lung disease
Initial treatment
The condition must be diagnosed through a multidisciplinary team; AND
The condition must have chest imaging through high resolution computed tomography (HRCT) that is no older than 12 months, to support the diagnosis of the PBS indication; AND
The condition must display, through HRCT, an affected area of no less than 10% (after rounding to the nearest multiple of 5); AND
Patient must have a current (no older than 2 years) forced vital capacity (FVC) measurement of no less than 45% predicted, adjusted for each of: (i) age, (ii) gender, (iii) height; AND
The condition must be of a progressive nature, observed by, in the 2 years leading up to this authority application, any of: (i) a worsening in relative FVC% predicted measurement of no less than 10%, (ii) a worsening in relative FVC% predicted measurement in the range 5-10%, combined with worsening of respiratory symptoms, (iii) a worsening in relative FVC% predicted measurement in the range 5-10%, combined with increases in fibrosis observed on HRCT; document at least one of (i) to (iii) in the patient's medical records; AND
Patient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7; AND
Patient must not have had an acute respiratory infection at the time of FVC measurement; AND
Patient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin that is both: (i) at least 30% predicted, (ii) no greater than 80% predicted; AND
The condition must not be interstitial lung disease due to idiopathic pulmonary fibrosis (apply under the correct PBS listing if it is); AND
The condition must not be due to reversible causes (e.g. drug toxicity).
Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician; AND
Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial disease, (ii) idiopathic pulmonary fibrosis; AND
Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial disease, (ii) idiopathic pulmonary fibrosis; AND
Patient must be undergoing treatment with this pharmaceutical benefit only where the prescriber has explained to the patient/patient's guardian the following: (i) that certain diagnostic criteria must be met to be eligible to initiate treatment, (ii) continuing treatment is not based on quantified improvements in diagnostic measurements, but will be determined by clinician judgement.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis.
Document in the patient's medical records the qualifying FVC, FEV1/FVC ratio and DLCO measurements. Retain medical imaging in the patient's medical records.

Compliance with Written Authority Required procedures

 

C12654

 

 

Progressive fibrosing Interstitial lung disease
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition.
Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician; AND
Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial disease, (ii) idiopathic pulmonary fibrosis; AND
Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial disease, (ii) idiopathic pulmonary fibrosis.

Compliance with Authority Required procedures

 

C12655

 

 

Progressive fibrosing Interstitial lung disease
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Patient must have received non-PBS-subsidised treatment with this drug for this indication of 'progressive fibrosing interstitial lung disease' (not 'idiopathic pulmonary fibrosis') prior to 1 May 2022; AND
The condition must be diagnosed through a multidisciplinary team; AND
The condition must have chest imaging through high resolution computed tomography (HRCT) that was no older than 12 months at the time non-PBS supply was initiated, to support the diagnosis of the PBS indication; AND
The condition must have displayed, through HRCT, an affected area of no less than 10% (after rounding to the nearest multiple of 5) at the time non-PBS supply was initiated; AND
Patient must have had a forced vital capacity (FVC) measurement no less than 45% predicted, prior to initiating non-PBS supply treatment with this drug for this indication, that was no older than 2 years at the time of non-PBS subsidised treatment initiation, in addition to being adjusted for each of: (i) age, (ii) gender, (iii) height; AND
The condition must have been of a progressive nature prior to initiating non-PBS-subsidised treatment, observed by, in any time period leading up to the initiation of non-PBS-subsidised supply, any of: (i) a worsening in relative FVC% predicted measurement of no less than 10%, (ii) a worsening in relative FVC% predicted measurement in the range 5-10%, combined with worsening of respiratory symptoms, (iii) a worsening in relative FVC% predicted measurement in the range 5-10%, combined with increases in fibrosis observed on HRCT; document at least one of (i) to (iii) in the patient's medical records; AND
Patient must have had a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7 at the time of initiating non-PBS-subsidised supply; AND
Patient must not have had an acute respiratory infection at the time of FVC measurement; AND
Patient must have had, prior to initiating non-PBS-subsidised supply, a diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin that was both: (i) at least 30% predicted, (ii) no greater than 80% predicted; AND
The condition must not be interstitial lung disease due to idiopathic pulmonary fibrosis (apply under the correct PBS listing if it is); AND
The condition must not be due to reversible causes (e.g. drug toxicity).
Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician; AND
Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial disease, (ii) idiopathic pulmonary fibrosis; AND
Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial disease, (ii) idiopathic pulmonary fibrosis; AND
Patient must be undergoing treatment with this pharmaceutical benefit only where the prescriber has explained to the patient/patient's guardian the following: (i) that certain diagnostic criteria must be met to be eligible to initiate treatment, (ii) continuing treatment is not based on quantified improvements in diagnostic measurements, but will be determined by clinician judgement.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis.
Document in the patient's medical records the qualifying FVC, FEV1/FVC ratio and DLCO measurements. Retain medical imaging in the patient's medical records.

Compliance with Written Authority Required procedures

 

C12661

 

 

Idiopathic pulmonary fibrosis
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician; AND
Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial disease, (ii) idiopathic pulmonary fibrosis; AND
Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial disease, (ii) idiopathic pulmonary fibrosis.

Compliance with Authority Required procedures

[110]        Schedule 4, Part 1, after entry for Nintedanib

                           insert:

Nirmatrelvir and ritonavir

C12839

 

 

SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result verified by a medical practitioner or nurse practitioner; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation at the time of prescribing; AND
Patient must be moderately to severely immunocompromised; AND
Patient must be at risk of progression to severe disease due to immunocompromised status; AND
The treatment must be initiated within 5 days of symptom onset.
Patient must be at least 18 years of age.
For the purpose of administering this restriction, "moderately to severely immunocompromised" patients are those with:
1. any primary or acquired immunodeficiency including:
a. Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders,
b. Post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months),
c. Immunocompromised due to primary or acquired (HIV/AIDS) immunodeficiency OR
2. any significantly immunocompromising condition(s) where, in the last 3 months the patient has received:
a. Chemotherapy or whole body radiotherapy,
b. High-dose corticosteroids (greater than or equal to 20 mg of prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy,
c. Biological agents and other treatments that deplete or inhibit B cell or T cell function (anti-CD20 antibodies, BTK inhibitors, JAK inhibitors, sphingosine 1-phosphate receptor modulators, anti-CD52 antibodies, anti-complement antibodies, anti-thymocyte globulin),
d. Selected conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) including mycophenolate, methotrexate (more than 0.4mg/kg/week), leflunomide, azathioprine (at least 3mg/kg/day), 6-mercaptopurine (at least 1.5mg/kg/day), alkylating agents (e.g. cyclophosphamide, chlorambucil), and systemic calcineurin inhibitors (e.g. cyclosporin, tacrolimus) OR
3. any significantly immunocompromising condition(s) where, in the last 12 months the patient has received rituximab,
4. Others with very high risk conditions including Down Syndrome, cerebral palsy, congenital heart disease, thalassemia, sickle cell disease and other haemoglobinopathies OR
5. People with severe intellectual or physical disabilities requiring residential care
Details of the patients' medical condition necessitating use of this drug must be recorded in the patients' medical records.
For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
Access to this drug through this restriction is permitted irrespective of vaccination status.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, the test must be verified by a medical practitioner or nurse practitioner. The test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.

Compliance with Authority Required procedures - Streamlined Authority Code 12839

 

C12923

 

 

SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result verified by a medical practitioner or nurse practitioner; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation at the time of prescribing; AND
Patient must be aged 65 years or over and at high risk; AND
The treatment must be initiated within 5 days of symptom onset.
For the purpose of administering this restriction, high risk is defined as the presence of at least two of the following conditions:
The patient has received less than 2 doses of SARS-CoV-2 vaccine,
The patient is aged 75 years or over,
The patient is in residential aged care or residential disability care,
Neurological conditions, including stroke and dementia,
Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis,
Congestive heart failure (NYHA Class II or greater),
Obesity (BMI greater than 30 kg/m 2 ),
Diabetes Types I and II, requiring medication for glycaemic control,
Renal failure (eGFR less than 60mL/min),
Cirrhosis, or
The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above.
Details of the patients' medical condition necessitating use of this drug must be recorded in the patients' medical records.
For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, the test must be verified by a medical practitioner or nurse practitioner. The test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.

Compliance with Authority Required procedures - Streamlined Authority Code 12923

 

C12936

 

 

SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result verified by a medical practitioner or nurse practitioner; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation at the time of prescribing.
Patient must identify as Aboriginal or Torres Strait Islander.
Patient must be aged 50 or over and at high risk; AND
The treatment must be initiated within 5 days of symptom onset.
For the purpose of administering this restriction, high risk is defined as the presence of at least two of the following conditions:
The patient has received less than 2 doses of SARS-CoV-2 vaccine,
The patient is in residential aged care or residential disability care,
Neurological conditions, including stroke and dementia,
Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis,
Congestive heart failure (NYHA Class II or greater),
Obesity (BMI greater than 30kg/m 2 ),
Diabetes Types I and II, requiring medication for glycaemic control,
Renal failure (eGFR less than 60mL/min),
Cirrhosis, or
The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above.
Details of the patients' medical condition necessitating use of this drug must be recorded in the patients' medical records.
For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
Where a RAT is used to confirm diagnosis, the test must be verified by a medical practitioner or nurse practitioner. The test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.

Compliance with Authority Required procedures - Streamlined Authority Code 12936

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

                           omit:

 

C11176

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Transitioning from non-PBS to PBS-subsidised supply as first-line EGFR tyrosine kinase inhibitor therapy - 'Grandfather' treatment
Patient must have received non-PBS subsidised treatment with this drug as first-line EGFR tyrosine kinase inhibitor therapy for this PBS indication prior to 1 January 2021; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have had a WHO performance status of 2 or less prior to initiating non-PBS-subsidised treatment; AND
Patient must not have developed disease progression while receiving non-PBS-subsidised treatment with this drug for this condition.
Patient must have evidence in tumour material of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors that was obtained prior to initiating non-PBS subsidised treatment.
A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria.

Compliance with Authority Required procedures

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

                           substitute:

Pirfenidone

C12650

 

 

Idiopathic pulmonary fibrosis
Initial treatment 1 - new patient
The condition must be diagnosed through a multidisciplinary team; AND
Patient must have chest high resolution computed tomography (HRCT) consistent with diagnosis of idiopathic pulmonary fibrosis within the previous 12 months; AND
Patient must have a forced vital capacity (FVC) greater than or equal to 50% predicted for age, gender and height; AND
Patient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7; AND
Patient must not have had an acute respiratory infection at the time of FVC measurement; AND
Patient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin equal to or greater than 30%; AND
Patient must not have interstitial lung disease due to other known causes including domestic and occupational environmental exposures, connective tissue disease, or drug toxicity; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician; AND
Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial disease, (ii) idiopathic pulmonary fibrosis; AND
Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial disease, (ii) idiopathic pulmonary fibrosis; AND
Patient must be undergoing treatment with this pharmaceutical benefit only where the prescriber has explained to the patient/patient's guardian the following: (i) that certain diagnostic criteria must be met to be eligible to initiate treatment, (ii) continuing treatment is not based on quantified improvements in diagnostic measurements, but will be determined by clinician judgement.
A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Document in the patient's medical records the qualifying FVC, FEV1/FVC ratio and DLCO measurements. Retain medical imaging in the patient's medical records.

Compliance with Written Authority Required procedures

 

C12651

 

 

Idiopathic pulmonary fibrosis
Initial treatment 2 - change or recommencement of treatment
Patient must have previously received PBS-subsidised treatment with nintedanib or pirfenidone for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician; AND
Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial disease, (ii) idiopathic pulmonary fibrosis; AND
Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial disease, (ii) idiopathic pulmonary fibrosis.

Compliance with Authority Required procedures

 

C12661

 

 

Idiopathic pulmonary fibrosis
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician; AND
Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial disease, (ii) idiopathic pulmonary fibrosis; AND
Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial disease, (ii) idiopathic pulmonary fibrosis.

Compliance with Authority Required procedures

[113]        Schedule 4, Part 1, after entry for Ruxolitinib

                           insert:

Sacituzumab govitecan

C12656

P12656

 

Unresectable locally advanced or metastatic triple-negative breast cancer
Initial treatment
Patient must have progressive disease following two or more prior systemic therapies, at least one of them in the locally advanced or metastatic setting; AND
The condition must be inoperable; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND
The treatment must be the sole PBS-subsidised therapy for this PBS indication.

Compliance with Authority Required procedures - Streamlined Authority Code 12656

 

C12669

P12669

 

Unresectable locally advanced or metastatic triple-negative breast cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this PBS indication.

Compliance with Authority Required procedures - Streamlined Authority Code 12669

 

C12670

P12670

 

Unresectable locally advanced or metastatic triple-negative breast cancer
Transitioning from non-PBS to PBS-subsidised supply - Grandfather treatment
Patient must must have received treatment with this drug for this PBS indication prior to 1 May 2022; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 1 prior to treatment initiation of non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this PBS indication.

Compliance with Authority Required procedures - Streamlined Authority Code 12670

[114]        Schedule 4, Part 1, entry for Selexipag

                           omit:

 

C11241

P11241

 

Pulmonary arterial hypertension (PAH)
Transitioning from non-PBS subsidised to PBS-subsidised supply - 'Grandfather' treatment
Patient must have received non-PBS subsidised treatment with this drug prior to 1 February 2021; AND
Patient must have failed to achieve/maintain a WHO Functional Class II status with PAH agents (other than this agent) given as dual therapy, prior to treatment initiation with this drug; AND
Patient must have had WHO Functional Class III PAH at treatment initiation with this drug; OR
Patient must have had WHO Functional Class IV PAH at treatment initiation with this drug; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND
The treatment must not be as monotherapy.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
For the purposes of administering this restriction, disease progression has developed if at least one of the following has occurred:
(i) Hospitalisation due to worsening PAH;
(ii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with worsening of WHO functional class status;
(iii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with the need for additional PAH-specific therapy;
(iv) Initiation of parenteral prostanoid therapy or long-term oxygen therapy for worsening of PAH;
(v) Need for lung transplantation or balloon atrial septostomy for worsening of PAH.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.

Compliance with Authority Required procedures

[115]        Schedule 4, Part 1, entry for Somatropin

                           substitute:

Somatropin

C11102

 

 

Severe growth hormone deficiency
Initial treatment of childhood onset growth hormone deficiency in a patient who has received non-PBS subsidised treatment as a child
Must be treated by an endocrinologist.
Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND
Patient must have previously received non-PBS subsidised treatment with this drug for this condition as a child; AND
Patient must have current or historical evidence of an insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; OR
Patient must have current or historical evidence of an arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; OR
Patient must have current or historical evidence of a glucagon provocation test with maximum serum GH less than 3 micrograms per litre.
Patient must have a mature skeleton; OR
Patient must have a diagnosis of Prader-Willi syndrome and be aged 18 years or older.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender.

Compliance with Written Authority Required procedures

 

C11104

 

 

Severe growth hormone deficiency
Initial treatment of childhood onset growth hormone deficiency in a patient who has received PBS-subsidised treatment as a child
Must be treated by an endocrinologist.
Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition as a child.
Patient must have a mature skeleton; OR
Patient must have a diagnosis of Prader-Willi syndrome and be aged 18 years or older.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form.

Compliance with Written Authority Required procedures

 

C12588

 

 

Severe growth hormone deficiency
Initial treatment of late onset growth hormone deficiency
Must be treated by an endocrinologist.
Patient must have onset of growth hormone deficiency secondary to organic hypothalamic or pituitary disease diagnosed at chronological age of 18 years or older; OR
Patient must have onset of growth hormone deficiency diagnosed after skeletal maturity (bone age greater than or equal to 15.5 years in males or 13.5 years in females) and before chronological age of 18 years; AND
Patient must have a diagnostic insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; OR
Patient must have a diagnostic arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; OR
Patient must have a diagnostic glucagon provocation test with maximum serum GH less than 3 micrograms per litre.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender.

Compliance with Written Authority Required procedures

 

C12601

 

 

Severe growth hormone deficiency
Continuing treatment in a person with a mature skeleton or aged 18 years or older
Must be treated by an endocrinologist.
Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause in a patient with a mature skeleton, or, in a patient with Prader-Willi syndrome and chronological age of 18 years or older; OR
Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to late onset of growth hormone deficiency secondary to organic hypothalamic or pituitary disease in a patient with chronological age of 18 years or older; OR
Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to late onset of growth hormone deficiency diagnosed after skeletal maturity (bone age greater than or equal to 15.5 years in males or 13.5 years in females) and before chronological age of 18 years.

Compliance with Authority Required procedures

 

C12703

 

 

Growth retardation secondary to an intracranial lesion, or cranial irradiation
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.

Compliance with Written Authority Required procedures

 

C12704

 

 

Short stature due to short stature homeobox (SHOX) gene disorders
Initial treatment
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND
Patient must have a current height at or below the 1stpercentile for age and sex; AND
Patient must have a growth velocity below the 25thpercentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; OR
Patient must have an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND
6. If the patient's condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient's increased risk of gonadoblastoma is in place; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.

Compliance with Written Authority Required procedures

 

C12705

 

 

Short stature and poor body composition due to Prader-Willi syndrome
Initial treatment
Patient must have diagnostic results consistent with Prader-Willi syndrome (the condition must be genetically proven); OR
Patient must have a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist; AND
Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with no sleep disorders identified; OR
Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified which are not of sufficient severity to require treatment; OR
Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified for which the patient is currently receiving ameliorative treatment; AND
Patient must not have uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient's current height; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must not have a chronological age of 18 years or greater.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. A minimum of 6 months of recent growth data (height, weight and waist circumference). The most recent data must not be older than three months; AND
4. The date at which skeletal maturity was achieved (if applicable) [Note: In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity]; AND
5. (a) Confirmation that the patient has diagnostic results consistent with Prader-Willi syndrome; OR
(b) Confirmation that the patient has a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist
6. Confirmation that the patient has been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months and any sleep disorders identified via polysomnography that required treatment have been addressed; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with 1 repeat allowed)
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.

Compliance with Written Authority Required procedures

 

C12711

 

 

Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a chronological age of 5 years or greater.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.

Compliance with Written Authority Required procedures

 

C12712

 

 

Short stature associated with Turner syndrome
Recommencement of treatment as a reclassified patient
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature associated with Turner syndrome; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a height greater than or equal to 155.0 cm; AND
Patient must not have a bone age of 13.5 years or greater.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. A height measurement from immediately prior to commencement of growth hormone treatment; AND
4. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND
5. Recent growth data (height and weight, not older than three months); AND
6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.

Compliance with Written Authority Required procedures

 

C12713

 

 

Biochemical growth hormone deficiency and precocious puberty
Initial treatment
Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; OR
Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; OR
Patient must be female and menarche occurred before the chronological age of 10 years; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight) at intervals no greater than six months. The most recent data must not be older than three months; OR
(b) A minimum of 6 months of recent growth data (height and weight) for older children (males chronological age 12 and over or bone age 10 and over, females chronological age 10 and over or bone age 8 and over). The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. Confirmation that the patient has precocious puberty; AND
7. Confirmation that the patient is undergoing Gonadotropin Releasing Hormone agonist therapy, for pubertal suppression; AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.

Compliance with Written Authority Required procedures

 

C12719

 

 

Short stature associated with biochemical growth hormone deficiency
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
Patient must be aged 3 years or older.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.

Compliance with Written Authority Required procedures

 

C12720

 

 

Short stature and slow growth
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature and slow growth; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have previously received treatment under the indication short stature associated with chronic renal insufficiency, have undergone a renal transplant and a 12 month period of observation following the transplant, and have an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; OR
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment; OR
(b) Confirmation that the patient has previously received treatment under the indication short stature associated with chronic renal insufficiency, has undergone a renal transplant and a 12 month period of observation following the transplant, and has an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; AND
4. Recent growth data (height and weight, not older than three months); AND
5. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.

Compliance with Written Authority Required procedures

 

C12721

 

 

Short stature associated with chronic renal insufficiency
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with chronic renal insufficiency; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and a growth velocity less than or equal to the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; OR
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND
4. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2; AND
5. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
6. Recent growth data (height and weight, not older than three months); AND
7. A bone age result performed within the last 12 months; AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.

Compliance with Written Authority Required procedures

 

C12722

 

 

Growth retardation secondary to an intracranial lesion, or cranial irradiation
Initial treatment
Patient must have had an intracranial lesion which is under appropriate observation and management; OR
Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arg