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PB 67 of 2022 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme and related matters.
Administered by: Health and Aged Care
Registered 29 Jul 2022
Tabling HistoryDate
Tabled HR01-Aug-2022
Tabled Senate02-Aug-2022
To be repealed 23 Nov 2022
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

 

Commonwealth Coat of Arms of Australia

 

 

 

 

PB 67 of 2022

 

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022
(No. 8)

 

National Health Act 1953

________________________________________________________________________

 

I, NIKOLAI TSYGANOV, Assistant Secretary (Acting), Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, 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 July 2022

 

 

 

 

 

 

 

 

 

 

 

 

NIKOLAI TSYGANOV

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. 8).

(2)          This instrument may also be cited as PB 67 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 August 2022

1 August 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Note: This table relates only to the provisions of this instrument as originally made.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 Abemaciclib in each of the forms: Tablet 50 mg; Tablet 100 mg; and Tablet 150 mg 

                           omit from the column headed “Circumstances”: C12348 C12367 C12380       substitute: C13035 C13036 C13053

[2]             Schedule 1, Part 1, entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 25 mg

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

 

 

 

a

Amitriptyline Alphapharm 25

MQ

MP NP

 

 

50

2

50

 

 

[3]             Schedule 1, Part 1, entry for Bisacodyl in the form Enemas 10 mg in 5 mL, 25

                           omit from the column headed “Responsible Person”: AS                      substitute: OX

[4]             Schedule 1, Part 1, omit entry for Cromoglycic acid

[5]             Schedule 1, Part 1, after entry for Dipyridamole with aspirin

                           insert:

Diroximel fumarate

Capsule (enteric) 231 mg

Oral

 

Vumerity

BD

MP

C13034 C13072 C13090

 

120

5

120

 

 

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

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

 

 

 

a

NOUMED DONEPEZIL

VO

MP

C10099 C10100 C10107 C10108 C10110

P10107 P10110

28

1

28

 

 

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

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

 

 

 

a

NOUMED DONEPEZIL

VO

MP

C10099 C10100 C10107 C10108 C10110

P10099 P10100 P10108

28

5

28

 

 

 

 

 

 

 

 

NP

C10108

 

28

5

28

 

 

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

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

 

 

 

a

NOUMED DONEPEZIL

VO

MP

C10099 C10100 C10107 C10108 C10110

P10107 P10110

28

1

28

 

 

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

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

 

 

 

a

NOUMED DONEPEZIL

VO

MP

C10099 C10100 C10107 C10108 C10110

P10099 P10100 P10108

28

5

28

 

 

 

 

 

 

 

 

NP

C10108

 

28

5

28

 

 

[10]           Schedule 1, Part 1, entry for Dosulepin in the form Tablet containing dosulepin hydrochloride 75 mg

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

 

 

 

a

Dosulepin Mylan

MQ

MP NP

 

 

30

2

30

 

 

[11]           Schedule 1, Part 1, entry for Estradiol in the form Transdermal gel 1 mg (as hemihydrate) in 1 g sachet, 28

                           omit from the column headed “Responsible Person”: AS                      substitute: OX

[12]           Schedule 1, Part 1, entry for Ezetimibe

                   (a)        insert in numerical order in the column headed “Circumstances” for the brand “APO-Ezetimibe”: C7990

                   (b)        insert in numerical order in the column headed “Circumstances” for the brand “Blooms The Chemist Ezetimibe”: C7990

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

                   (a)        omit:

 

 

 

a

Lovan

AL

MP NP

C4755 C6277

 

28

5

28

 

 

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

 

 

 

a

NOUMED FLUOXETINE

VO

MP NP

C4755 C6277

 

28

5

28

 

 

[14]           Schedule 1, Part 1, entry for Fluoxetine in the form Tablet, dispersible, 20 mg (as hydrochloride)

                   (a)        omit:

 

 

 

a

Lovan 20 Tab

AL

MP NP

C4755 C6277

 

28

5

28

 

 

                   (b)        omit from the column headed “Schedule Equivalent” for the brand “Zactin Tablet”: a

[15]           Schedule 1, Part 1, omit entry for Fotemustine

[16]           Schedule 1, Part 1, entry for Glycomacropeptide and essential amino acids with vitamins and minerals

                           omit:

 

Sachets containing oral powder 51 g, 30 (PKU Bettermilk Lite)

Oral

 

PKU Bettermilk Lite

QH

MP NP

C4295

 

4

5

1

 

 

[17]           Schedule 1, Part 1, entry for Hydrocortisone in the form Tablet 20 mg

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

 

 

 

a

Hydrocortisone Mylan 20

MQ

MP NP

 

 

60

4

60

 

 

[18]           Schedule 1, Part 1, entry for Hydromorphone in the form Oral solution containing hydromorphone hydrochloride 1 mg per mL, 473 mL

                           substitute:

 

Oral solution containing hydromorphone hydrochloride
1 mg per mL, 1 mL

Oral

a

Hikma

LM

PDP

C10859

 

473

0

473

 

 

 

 

 

 

 

 

MP NP

C10764 C10770 C10777 C11697

P10764 P10770 P10777

473

0

473

 

 

 

 

 

a

Hydromorphone hydrochloride oral solution, USP (Medsurge)

DZ

PDP

C10859

 

473

0

473

 

 

 

 

 

 

 

 

MP NP

C10764 C10770 C10777 C11697

P10764 P10770 P10777

473

0

473

 

 

 

 

 

a

Hikma

LM

MP NP

C10764 C10770 C10777 C11697

P11697

473

1

473

 

 

 

 

 

a

Hydromorphone hydrochloride oral solution, USP (Medsurge)

DZ

MP NP

C10764 C10770 C10777 C11697

P11697

473

1

473

 

 

[19]           Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled pen [Maximum Quantity: 1; Number of
Repeats: 0]

                   (a)        omit from the column headed “Circumstances”: C11825

                   (b)        omit from the column headed “Circumstances”: C11827

                   (c)        omit from the column headed “Circumstances”: C11869 C11871 C11873 C11874 C11909

                   (d)        omit from the column headed “Circumstances”: C11911 C11912 C11933 C11934 C11936

                   (e)        insert in numerical order in the column headed “Circumstances”: C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13095 C13096 C13097 C13104

                    (f)        omit from the column headed “Purposes”: P11869

                   (g)        insert in numerical order in the column headed “Purposes”: P13104

[20]           Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of
Repeats: 0]

                   (a)        omit from the column headed “Circumstances”: C11825

                   (b)        omit from the column headed “Circumstances”: C11827

                   (c)        omit from the column headed “Circumstances”: C11869 C11871 C11873 C11874 C11909

                   (d)        omit from the column headed “Circumstances”: C11911 C11912 C11933 C11934 C11936

                   (e)        insert in numerical order in the column headed “Circumstances”: C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13095 C13096 C13097 C13104

                    (f)        omit from the column headed “Purposes”: P11874 P11909                                     substitute: P13040 P13058 P13061 P13068 P13094 P13096

[21]           Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of
Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C11825

                   (b)        omit from the column headed “Circumstances”: C11827

                   (c)        omit from the column headed “Circumstances”: C11869 C11871 C11873 C11874 C11909

                   (d)        omit from the column headed “Circumstances”: C11911 C11912 C11933 C11934 C11936

                   (e)        insert in numerical order in the column headed “Circumstances”: C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13095 C13096 C13097 C13104

                    (f)        omit from the column headed “Purposes”: P11871 P11873 P11911 P11912 P11933 P11934 

                   (g)        insert in numerical order in the column headed “Purposes”: P13039 P13045 P13069 P13077 P13078 P13080 P13097

[22]           Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of
Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C11825

                   (b)        omit from the column headed “Circumstances”: C11827

                   (c)        omit from the column headed “Circumstances”: C11869 C11871 C11873 C11874 C11909

                   (d)        omit from the column headed “Circumstances”: C11911 C11912 C11933 C11934 C11936

                   (e)        insert in numerical order in the column headed “Circumstances”: C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13095 C13096 C13097 C13104

                    (f)        omit from the column headed “Purposes”: P11825

                   (g)        omit from the column headed “Purposes”: P11827

                   (h)        omit from the column headed “Purposes”: P11936

                    (i)        insert in numerical order in the column headed “Purposes”: P13043 P13056 P13079 P13095

[23]           Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 0]

                   (a)        omit from the column headed “Circumstances”: C11825

                   (b)        omit from the column headed “Circumstances”: C11827

                   (c)        omit from the column headed “Circumstances”: C11869 C11871 C11873 C11874 C11909

                   (d)        omit from the column headed “Circumstances”: C11911 C11912 C11933 C11934 C11936

                   (e)        insert in numerical order in the column headed “Circumstances”: C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13095 C13096 C13097 C13104

                    (f)        omit from the column headed “Purposes”: P11869

                   (g)        insert in numerical order in the column headed “Purposes”: P13104

[24]           Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 0]

                   (a)        omit from the column headed “Circumstances”: C11825

                   (b)        omit from the column headed “Circumstances”: C11827

                   (c)        omit from the column headed “Circumstances”: C11869 C11871 C11873 C11874 C11909

                   (d)        omit from the column headed “Circumstances”: C11911 C11912 C11933 C11934 C11936

                   (e)        insert in numerical order in the column headed “Circumstances”: C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13095 C13096 C13097 C13104

                    (f)        omit from the column headed “Purposes”: P11874 P11909                                     substitute: P13040 P13058 P13061 P13068 P13094 P13096

[25]           Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C11825

                   (b)        omit from the column headed “Circumstances”: C11827

                   (c)        omit from the column headed “Circumstances”: C11869 C11871 C11873 C11874 C11909

                   (d)        omit from the column headed “Circumstances”: C11911 C11912 C11933 C11934 C11936

                   (e)        insert in numerical order in the column headed “Circumstances”: C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13095 C13096 C13097 C13104

                    (f)        omit from the column headed “Purposes”: P11871 P11873 P11911 P11912 P11933 P11934

                   (g)        insert in numerical order in the column headed “Purposes”:  P13039 P13045 P13069 P13077 P13078 P13080 P13097

[26]           Schedule 1, Part 1, entry for Infliximab in the form Solution for injection 120 mg in 1 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C11825

                   (b)        omit from the column headed “Circumstances”: C11827

                   (c)        omit from the column headed “Circumstances”: C11869 C11871 C11873 C11874 C11909

                   (d)        omit from the column headed “Circumstances”: C11911 C11912 C11933 C11934 C11936

                   (e)        insert in numerical order in the column headed “Circumstances”: C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13095 C13096 C13097 C13104

                    (f)        omit from the column headed “Purposes”: P11825

                   (g)        omit from the column headed “Purposes”: P11827

                   (h)        omit from the column headed “Purposes”: P11936

                    (i)        insert in numerical order in the column headed “Purposes”: P13043 P13056 P13079 P13095

[27]           Schedule 1, Part 1, omit entry for Ledipasvir with sofosbuvir

[28]           Schedule 1, Part 1, entry for Nifedipine

                           omit:

 

Tablet 10 mg

Oral

 

Adefin 10

AF

MP NP

 

 

60

5

60

 

 

 

Tablet 20 mg

Oral

 

Adefin 20

AF

MP NP

 

 

60

5

60

 

 

[29]           Schedule 1, Part 1, entry for Palbociclib in each of the forms: Tablet 75 mg; Tablet 100 mg; and Tablet 125 mg  

                           omit from the column headed “Circumstances”: C10015 C10735                        substitute: C13055 C13066 C13085

[30]           Schedule 1, Part 1, entry for Paliperidone in each of the forms: I.M. injection (modified release) 175 mg (as palmitate) in pre-filled syringe; 
I.M. injection (modified release) 263 mg (as palmitate) in pre-filled syringe; I.M. injection (modified release) 350 mg (as palmitate) in pre-filled syringe; and I.M. injection (modified release) 525 mg (as palmitate) in pre-filled syringe          

                           omit from the column headed “Circumstances”: C6832                        substitute: C13049

[31]           Schedule 1, Part 1, after entry for Paliperidone in the form I.M. injection (modified release) 525 mg (as palmitate) in pre-filled syringe

                           insert:

 

I.M. injection (modified release) 700 mg (as palmitate) in pre-filled syringe

Injection

 

Invega Hafyera

JC

MP NP

C13082

 

1

0

1

 

 

 

I.M. injection (modified release) 1000 mg (as palmitate) in pre-filled syringe

Injection

 

Invega Hafyera

JC

MP NP

C13082

 

1

0

1

 

 

[32]           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

Rasagiline Sandoz

SZ

MP NP

C5339

 

30

5

30

 

 

[33]           Schedule 1, Part 1, entry for Ribociclib in the form Tablet 200 mg [Maximum Quantity: 21; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C11471 C11498 C11499 C11500 C11507 C11508                substitute: C13037 C13074 C13084 C13093 C13099 C13105

                   (b)        omit from the column headed “Purposes”: P11471 P11498                    substitute: P13099 P13105

[34]           Schedule 1, Part 1, entry for Ribociclib in the form Tablet 200 mg [Maximum Quantity: 42; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C11471 C11498 C11499 C11500 C11507 C11508                substitute: C13037 C13074 C13084 C13093 C13099 C13105

                   (b)        omit from the column headed “Purposes”: P11500 P11508                   substitute: P13037 P13074

[35]           Schedule 1, Part 1, entry for Ribociclib in the form Tablet 200 mg [Maximum Quantity: 63; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C11471 C11498 C11499 C11500 C11507 C11508                substitute: C13037 C13074 C13084 C13093 C13099 C13105

                   (b)        omit from the column headed “Purposes”: P11499 P11507                   substitute: P13084 P13093

[36]           Schedule 1, Part 1, entry for Risankizumab in the form Injection 75 mg in 0.83 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 1]

                   (a)        insert in numerical order in the column headed “Circumstances”: C13063 C13070 C13098

                   (b)        insert in numerical order in the column headed “Purposes”: P13063 P13070 P13098

[37]           Schedule 1, Part 1, entry for Risankizumab in the form Injection 75 mg in 0.83 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]

                           insert in numerical order in the column headed “Circumstances”: C13063 C13070 C13098

[38]           Schedule 1, Part 1, entry for Risedronic acid in the form Tablet containing risedronate sodium 35 mg

                           omit:

 

 

 

a

Acris Once-a-Week

AF

MP NP

C6310 C6323 C6327

 

4

5

4

 

 

[39]           Schedule 1, Part 1, entry for Risedronic acid in the form Tablet containing risedronate sodium 150 mg

                           omit:

 

 

 

a

Acris Once-a-Month

AF

MP NP

C6310 C6323 C6327

 

1

5

1

 

 

[40]           Schedule 1, Part 1, entry for Rivaroxaban in the form Tablet 10 mg

                           substitute:

 

Tablet 10 mg

Oral

 

Xarelto

BN

MP NP

C4132 C4382 C4402

P4382

15

0

15

 

 

 

 

 

 

 

 

MP NP

C4132 C4382 C4402

P4402

15

1

15

 

 

 

 

 

 

 

 

MP NP

C4132 C4382 C4402

P4402

30

0

30

 

 

 

 

 

 

 

 

MP NP

C4132 C4382 C4402

P4132

30

5

30

 

 

[41]           Schedule 1, Part 1, entry for Roxithromycin

                           omit:

 

Tablet for oral suspension 50 mg

Oral

 

Rulide D

SW

PDP MP NP

 

 

10

0

10

 

 

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

                           omit from the column headed “Responsible Person”: AS                      substitute: OX

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

                           substitute:

Sitagliptin

Tablet 25 mg

Oral

a

Januvia

XW

MP

C6346 C6363 C6376 C7505 C7541

 

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505

 

28

5

28

 

 

 

 

 

a

Sitagliptin Lupin

GQ

MP NP

C6346 C6363 C6376 C7505

 

28

5

28

 

 

 

 

 

a

Sitagliptin Sandoz Pharma

SZ

MP

C6346 C6363 C6376 C7505 C7541

 

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505

 

28

5

28

 

 

 

 

 

a

Sitagliptin SUN

RA

MP

C6346 C6363 C6376 C7505 C7541

 

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505

 

28

5

28

 

 

 

 

 

a

Xelevia

XT

MP

C6346 C6363 C6376 C7505 C7541

 

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505

 

28

5

28

 

 

 

Tablet 50 mg

Oral

a

Januvia

XW

MP

C6346 C6363 C6376 C7505 C7541

 

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505

 

28

5

28

 

 

 

 

 

a

Sitagliptin Lupin

GQ

MP NP

C6346 C6363 C6376 C7505

 

28

5

28

 

 

 

 

 

a

Sitagliptin Sandoz Pharma

SZ

MP

C6346 C6363 C6376 C7505 C7541

 

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505

 

28

5

28

 

 

 

 

 

a

Sitagliptin SUN

RA

MP

C6346 C6363 C6376 C7505 C7541

 

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505

 

28

5

28

 

 

 

 

 

a

Xelevia

XT

MP

C6346 C6363 C6376 C7505 C7541

 

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505

 

28

5

28

 

 

 

Tablet 100 mg

Oral

a

Januvia

XW

MP

C6346 C6363 C6376 C7505 C7541

 

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505

 

28

5

28

 

 

 

 

 

a

Sitagliptin Lupin

GQ

MP NP

C6346 C6363 C6376 C7505

 

28

5

28

 

 

 

 

 

a

Sitagliptin Sandoz Pharma

SZ

MP

C6346 C6363 C6376 C7505 C7541

 

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505

 

28

5

28

 

 

 

 

 

a

Sitagliptin SUN

RA

MP

C6346 C6363 C6376 C7505 C7541

 

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505

 

28

5

28

 

 

 

 

 

a

Xelevia

XT

MP

C6346 C6363 C6376 C7505 C7541

 

28

5

28

 

 

 

 

 

 

 

 

NP

C6346 C6363 C6376 C7505

 

28

5

28

 

 

[44]           Schedule 1, Part 1, entry for Sitagliptin with metformin

                           substitute:

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride

Oral

a

Janumet

XW

MP

C6333 C6334 C6344 C6443 C7507 C7530

 

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530

 

56

5

56

 

 

 

 

 

a

Velmetia

XT

MP

C6333 C6334 C6344 C6443 C7507 C7530

 

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530

 

56

5

56

 

 

 

Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride

Oral

a

Janumet

XW

MP

C6333 C6334 C6344 C6443 C7507 C7530

 

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530

 

56

5

56

 

 

 

 

 

a

Velmetia

XT

MP

C6333 C6334 C6344 C6443 C7507 C7530

 

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530

 

56

5

56

 

 

 

Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

 

Janumet XR

XW

MP

C6333 C6334 C6344 C6443 C7507 C7530

 

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530

 

56

5

56

 

 

 

Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

a

Janumet

XW

MP

C6333 C6334 C6344 C6443 C7507 C7530

 

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530

 

56

5

56

 

 

 

 

 

a

Velmetia

XT

MP

C6333 C6334 C6344 C6443 C7507 C7530

 

56

5

56

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530

 

56

5

56

 

 

 

Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

 

Janumet XR

XW

MP

C6333 C6334 C6344 C6443 C7507 C7530

 

28

5

28

 

 

 

 

 

 

 

 

NP

C6333 C6334 C6344 C6443 C7530

 

28

5

28

 

 

[45]           Schedule 1, Part 1, entry for Tamoxifen

                           omit from the column headed “Responsible Person” for the brand “Tamosin”: AS                             substitute: OX

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

                           omit from the column headed “Responsible Person”: AS                      substitute: OX

[47]           Schedule 1, Part 2, omit entry for Calcipotriol with betamethasone

[48]           Schedule 1, Part 2, entry for Cromoglycic acid

insert as first entry:

 

Pressurised inhalation containing sodium cromoglycate 1 mg per dose, 200 doses (CFC‑free formulation)

Inhalation by mouth

 

Intal CFC‑Free

SW

MP NP

 

 

1

5

1

 

 

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

insert:

Glycomacropeptide and essential amino acids with vitamins and minerals

Sachets containing oral powder 51 g, 30 (PKU Bettermilk Lite)

Oral

 

PKU Bettermilk Lite

QH

MP NP

C4295

 

4

5

1

 

 

Ledipasvir with sofosbuvir

Tablet containing 90 mg ledipasvir with 400 mg sofosbuvir

Oral

 

Harvoni

GI

MP NP

C5944 C5969 C5972

P5944

28

1

28

 

 

 

 

 

 

 

 

MP NP

C5944 C5969 C5972

P5969

28

2

28

 

 

 

 

 

 

 

 

MP NP

C5944 C5969 C5972

P5972

28

5

28

 

 

Nifedipine

Tablet 10 mg

Oral

 

Adefin 10

AF

MP NP

 

 

60

5

60

 

 

 

Tablet 20 mg

Oral

 

Adefin 20

AF

MP NP

 

 

60

5

60

 

 

[50]           Schedule 1, Part 2, after entry for Pancreatic extract

insert:

Rivaroxaban

Tablet 10 mg

Oral

 

Xarelto

BN

MP NP

C4369

P4369

10

1

10

 

 

Roxithromycin

Tablet for oral suspension 50 mg

Oral

 

Rulide D

SW

PDP MP NP

 

 

10

0

10

 

 

[51]           Schedule 3, after details relevant for Responsible Person code OW  

insert:

OX

Orion Pharma (Aus) Pty Limited

15 654 099 608


 

[52]           Schedule 3, after details relevant for Responsible Person code XT

insert:

XW

Arrotex Pharmaceuticals Pty Ltd

30 605 552 234

[53]           Schedule 4, Part 1, entry for Abemaciclib

                           substitute:

Abemaciclib

C13035

 

 

Locally advanced or metastatic breast cancer
Initial treatment
Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; OR
Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with one of (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant; OR
The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND
The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.
Patient must not be premenopausal.

Compliance with Authority Required procedures

 

C13036

 

 

Locally advanced or metastatic 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 in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND
The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.
Patient must not be premenopausal.

Compliance with Authority Required procedures

 

C13053

 

 

Locally advanced or metastatic breast cancer
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Patient must have received treatment with this drug for this PBS indication prior to 1 November 2021; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
Patient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS supply was initiated; OR
Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have had a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 2 at the time non-PBS supply was initiated; AND
The treatment must be in combination with one of: (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant, where the patient has never been treated with endocrine therapy for advanced/metastatic disease at the time non-PBS supply was initiated; OR
The treatment must be in combination with fulvestrant only, where at the time non-PBS supply was initiated, the patient had recurrent/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease; AND
The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.
Patient must not be premenopausal.

Compliance with Authority Required procedures

[54]           Schedule 4, Part 1, entry for Calcipotriol with betamethasone

                           omit:

 

C7947

 

 

Chronic stable plaque type psoriasis vulgaris
The condition must be inadequately controlled by potent topical corticosteroid monotherapy.

Compliance with Authority Required procedures - Streamlined Authority Code 7947

[55]           Schedule 4, Part 1, after entry for Dipyridamole with aspirin

                           insert:

Diroximel fumarate

C13034

 

 

Multiple sclerosis
Continuing treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 13034

 

C13072

 

 

Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 13072

 

C13090

 

 

Multiple sclerosis
Grandfather treatment
Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 August 2022; AND
The condition must be/have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of at least one of the brain/spinal cord; OR
The condition must be/have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis supported by written certification, which is documented in the patient's medical records, from a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support); AND
Patient must not show continuing progression of disability while on treatment with this drug.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 13090

[56]           Schedule 4, Part 1, omit entry for Fotemustine

[57]           Schedule 4, Part 1, entry for Infliximab

                   (a)        omit:

 

C11825

P11825

 

Severe Crohn disease
Initial PBS-subsidised treatment (Grandfather patient) - subcutaneous form
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)].
Patient must have a documented history of severe Crohn disease; AND
Patient must have previously received non-PBS-subsidised treatment with this drug with the subcutaneous form for this condition prior to 1 July 2021; AND
Patient must have previously received induction treatment consisting of 2 doses with this drug for this condition in the intravenous form; AND
Patient must be receiving treatment with this drug for this condition at the time of application; AND
Patient must have had a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 prior to commencing treatment with this drug; OR
Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR
Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; OR
Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of the most recent clinical assessment.
An application for the continuing treatment must be accompanied with the assessment of response conducted up to 12 weeks after the first dose of infliximab and no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where a response assessment is not conducted within 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.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
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

                   (b)        omit:

 

C11827

P11827

 

Severe active rheumatoid arthritis
Initial PBS-subsidised treatment (Grandfather patient) - subcutaneous form
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have previously received non-PBS-subsidised treatment with this drug with the subcutaneous form for this condition prior to 1 July 2021; AND
Patient must have previously received induction treatment consisting of 2 doses with this drug for this condition in the intravenous form; AND
Patient must be receiving treatment with this drug for this condition at the time of application; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; OR
Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
Patient must have demonstrated an adequate response to treatment with this drug; OR
Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
All applications for treatment with this drug for this condition under this restriction must include baseline joint count and ESR and/or CRP as determined at the completion of a 6 month intensive DMARD trial but prior to ceasing DMARD therapy, and measurement of response to the prior course of non-PBS-subsidised therapy with this drug. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.
If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) 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 patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.
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.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.

Compliance with Written Authority Required procedures

                   (c)        omit:

 

C11869

P11869

 

Severe active rheumatoid arthritis
Balance of supply for Initial treatment, Continuing treatment or Grandfather patient - subcutaneous form
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the Initial treatment with subcutaneous form restriction to complete 22 weeks initial treatment (intravenous and subcutaneous inclusive); OR
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment with subcutaneous form restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Grandfather restriction to complete 24 weeks of treatment; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND
The treatment must provide no more than the balance of up to 22 weeks treatment available under the Initial treatment - subcutaneous form; OR
The treatment must provide no more than the balance of up to 24 weeks treatment available under the Continuing treatment - subcutaneous form; OR
The treatment must provide no more than the balance of up to 24 weeks therapy under Initial PBS-subsidised treatment (Grandfather patient) - subcutaneous form.
Patient must be aged 18 years or older.

Compliance with Authority Required procedures

 

C11871

P11871

 

Moderate to severe ulcerative colitis
Re-initiation with subcutaneous form
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)].
Patient must have previously received maintenance treatment with the subcutaneous form of this drug under continuing treatment and have had a treatment break; AND
Patient must have received 1 intravenous infusion with this drug for this condition at week 0 under Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years); OR
Patient must have received 1 intravenous infusion with this drug for this condition at week 0 under Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); OR
Patient must have a concurrent authority application for 1 dose of the intravenous infusion for this condition under either Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); AND
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition.
Patient must be aged 18 years or older.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) 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).
An assessment of a patient's response to this initial course of treatment must be conducted up to 12 weeks after the first dose of infliximab and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
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.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C11873

P11873

 

Severe Crohn disease
Re-initiation with subcutaneous form
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)].
Patient must have previously received maintenance treatment with the subcutaneous form of this drug under continuing treatment and have had a treatment break; AND
Patient must have received 1 intravenous infusion with this drug for this condition at week 0 under Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years); OR
Patient must have received 1 intravenous infusion with this drug for this condition at week 0 under Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); OR
Patient must have a concurrent authority application for 1 dose of the intravenous infusion for this condition under either Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); AND
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition.
Patient must be aged 18 years or older.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) 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).
An assessment of a patient's response to this initial course of treatment must be conducted up to 12 weeks after the first dose of infliximab and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
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.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C11874

P11874

 

Severe Crohn disease
Balance of supply for Initial treatment, Continuing treatment or Grandfather patient - subcutaneous form
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)].
Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks initial treatment (intravenous and subcutaneous inclusive); OR
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment with subcutaneous form restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Grandfather restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment - subcutaneous form; OR
The treatment must provide no more than the balance of up to 24 weeks treatment available under the Continuing treatment - subcutaneous form; OR
The treatment must provide no more than the balance of up to 24 weeks therapy under Initial PBS-subsidised treatment (Grandfather patient) - subcutaneous form.
Patient must be aged 18 years or older.

Compliance with Authority Required procedures

 

C11909

P11909

 

Moderate to severe ulcerative colitis
Balance of supply for Initial treatment, Continuing treatment or Grandfather patient - subcutaneous form
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)].
Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks initial treatment (intravenous and subcutaneous inclusive); OR
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment with subcutaneous form restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Grandfather restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment - subcutaneous form; OR
The treatment must provide no more than the balance of up to 24 weeks treatment available under the Continuing treatment - subcutaneous form; OR
The treatment must provide no more than the balance of up to 24 weeks therapy under Initial PBS-subsidised treatment (Grandfather patient) - subcutaneous form.
Patient must be aged 18 years or older.

Compliance with Authority Required procedures

                   (d)        omit:

 

C11911

P11911

 

Severe active rheumatoid arthritis
Initial treatment with subcutaneous form at weeks 6, 8, 10, 12, 14 and 16
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received 2 intravenous infusions with this drug for this condition at weeks 0 and 2 under Initial 1 (new patient); OR
Patient must have received 2 intravenous infusions with this drug for this condition at weeks 0 and 2 under Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) if changing treatment from another biological medicine to infliximab; OR
Patient must have a concurrent authority application for 2 doses of the intravenous infusion for this condition under either Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months); AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) 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).
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment.
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.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.

Compliance with Written Authority Required procedures

 

C11912

P11912

 

Severe active rheumatoid arthritis
Re-initiation with subcutaneous form
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have previously received maintenance treatment with the subcutaneous form of this drug under continuing treatment and have had a treatment break; AND
Patient must have received 1 intravenous infusion with this drug for this condition at week 0 under Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months); OR
Patient must have received 1 intravenous infusion with this drug for this condition at week 0 under Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months); OR
Patient must have a concurrent authority application for 1 dose of the intravenous infusion for this condition under either Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months); AND
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) 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).
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment.
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.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.

Compliance with Written Authority Required procedures

 

C11933

P11933

 

Severe Crohn disease
Initial treatment with subcutaneous form at weeks 6, 8, 10, 12, 14 and 16
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)].
Patient must have received 2 intravenous infusions with this drug for this condition at weeks 0 and 2 under Initial 1 (new patient); OR
Patient must have received 2 intravenous infusions with this drug for this condition at weeks 0 and 2 under Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) if changing treatment from another biological medicine to infliximab; OR
Patient must have a concurrent authority application for the intravenous infusion for this condition under either Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years).
Patient must be aged 18 years or older.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) 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).
An assessment of a patient's response to this initial course of treatment must be conducted up to 12 weeks after the first dose of infliximab and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
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.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C11934

P11934

 

Moderate to severe ulcerative colitis
Initial treatment with subcutaneous form at weeks 6, 8, 10, 12, 14 and 16
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)].
Patient must have received 2 intravenous infusions with this drug for this condition at weeks 0 and 2 under Initial 1 (new patient); OR
Patient must have received 2 intravenous infusions with this drug for this condition at weeks 0 and 2 under Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) if changing treatment from another biological medicine to infliximab; OR
Patient must have a concurrent authority application for the intravenous infusion for this condition under either Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years).
Patient must be aged 18 years or older.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) 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).
An assessment of a patient's response to this initial course of treatment must be conducted up to 12 weeks after the first dose of infliximab and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
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.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C11936

P11936

 

Moderate to severe ulcerative colitis
Initial PBS-subsidised treatment (Grandfather patient) - subcutaneous form
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)].
Patient must have previously received non-PBS-subsidised treatment with this drug with the subcutaneous form for this condition prior to 1 July 2021; AND
Patient must have previously received induction treatment consisting of 2 doses with this drug for this condition in the intravenous form; AND
Patient must have had a Mayo clinic score greater than or equal to 6 prior to commencing treatment with this drug; OR
Patient must have had a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores were both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo score) prior to commencing treatment with this drug; OR
Patient must have a documented history of moderate to severe refractory ulcerative colitis prior to having commenced treatment with this drug where a Mayo clinic or partial Mayo clinic baseline assessment is not available; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application Form which includes the following:
(i) the completed baseline Mayo clinic or partial Mayo clinic calculation sheet prior to initiating treatment (if available) and current Mayo clinic or partial Mayo clinic calculation sheet to demonstrate response, including the date of assessment;
(ii) If the baseline Mayo or partial Mayo clinic calculation is not available, reason must be provided; and
(iii) the date of commencement of this drug.
The current Mayo clinic or partial Mayo clinic assessment must be no more than 4 weeks old at the time of application. The baseline assessment must be from immediately prior to commencing treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
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 Written Authority Required procedures

                   (e)        insert in numerical order after existing text:

 

C13039

P13039

 

Complex refractory Fistulising Crohn disease
Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made
Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND
Patient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved.
Patient must be at least 18 years of age.
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).
The PBS administrator will confirm that:
(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;
(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.

Compliance with Written Authority Required procedures

 

C13040

P13040

 

Severe psoriatic arthritis
Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND
Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; OR
Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions.
Patient must be at least 18 years of age.
Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as 'Cancelled'.

Compliance with Authority Required procedures

 

C13043

P13043

 

Severe psoriatic arthritis
Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
The treatment must have both: (i) provided the patient with an adequate response with the preceding supply, (ii) been assessed for response after at least 12 weeks of therapy; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
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).
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.

Compliance with Written Authority Required procedures

 

C13045

P13045

 

Moderate to severe ulcerative colitis
Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made
Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND
Patient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved.
Patient must be at least 18 years of age.
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).
The PBS administrator will confirm that:
(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;
(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.

Compliance with Written Authority Required procedures

 

C13056

P13056

 

Complex refractory Fistulising Crohn disease
Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug.
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)].
Patient must be at least 18 years of age.
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).
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
The most recent fistula assessment must be no more than 1 month old at the time of application.

Compliance with Written Authority Required procedures

 

C13058

P13058

 

Severe chronic plaque psoriasis
Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription
Must be treated by a dermatologist; AND
Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; OR
Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions.
Patient must be at least 18 years of age.
Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as 'Cancelled'.

Compliance with Authority Required procedures

 

C13061

P13061

 

Moderate to severe ulcerative colitis
Balance of supply for Initial treatment, Continuing treatment - subcutaneous form
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)].
Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks initial treatment (intravenous and subcutaneous inclusive); OR
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment with subcutaneous form restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment - subcutaneous form; OR
The treatment must provide no more than the balance of up to 24 weeks treatment available under the Continuing treatment - subcutaneous form.
Patient must be at least 18 years of age.

Compliance with Authority Required procedures

 

C13068

P13068

 

Severe Crohn disease
Balance of supply for Initial treatment, Continuing treatment - subcutaneous form
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)].
Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks initial treatment (intravenous and subcutaneous inclusive); OR
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment with subcutaneous form restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment - subcutaneous form; OR
The treatment must provide no more than the balance of up to 24 weeks treatment available under the Continuing treatment - subcutaneous form.
Patient must be at least 18 years of age.

Compliance with Authority Required procedures

 

C13069

P13069

 

Severe active rheumatoid arthritis
Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made
Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND
Patient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved.
Patient must be at least 18 years of age.
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).
The PBS administrator will confirm that:
(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;
(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.

Compliance with Written Authority Required procedures

 

C13077

P13077

 

Ankylosing spondylitis
Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made
Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND
Patient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved.
Patient must be at least 18 years of age.
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).
The PBS administrator will confirm that:
(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;
(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.

Compliance with Written Authority Required procedures

 

C13078

P13078

 

Severe chronic plaque psoriasis
Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made
Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND
Patient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved.
Patient must be at least 18 years of age.
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).
The PBS administrator will confirm that:
(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;
(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.

Compliance with Written Authority Required procedures

 

C13079

P13079

 

Severe chronic plaque psoriasis
Continuing treatment (whole body, or, face/hand/foot) with subcutaneous form or switching from intravenous form to subcutaneous form
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
The treatment must have both: (i) provided the patient with an adequate response with the preceding supply, (ii) been assessed for response after at least 12 weeks of therapy; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a dermatologist.
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).
Where the condition is affecting the whole body, an adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by at least 75%, or, is sustained at this level, when compared with the baseline value for this treatment cycle. State the qualifying PASI score in the authority application.
Where the condition is affecting the face/hand/foot, an adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) A reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or, sustained at this level, as compared to the baseline values. Indicate the rating (0=none, 1=slight) for each of these 3 observations in the authority application for each affected area; or
(ii) A reduction by at least 75% in the skin area affected, or, sustained at this level, as compared to the baseline value for this treatment cycle. State the qualifying numerical percentage figure in the authority application for each affected area.
All assessment findings must be no more than 1 month old at the time of application. Response assessments must be performed on the same affected area assessed at baseline.

Compliance with Written Authority Required procedures

 

C13080

P13080

 

Severe Crohn disease
Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made
Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND
Patient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved.
Patient must be at least 18 years of age.
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).
The PBS administrator will confirm that:
(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;
(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.

Compliance with Written Authority Required procedures

 

C13094

P13094

 

Complex refractory Fistulising Crohn disease
Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription
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)]; AND
Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; OR
Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions.
Patient must be at least 18 years of age.
Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as 'Cancelled'.

Compliance with Authority Required procedures

 

C13095

P13095

 

Ankylosing spondylitis
Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
The treatment must have both: (i) provided the patient with an adequate response with the preceding supply, (ii) been assessed for response after at least 12 weeks of therapy; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(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).
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
All measurements provided must be no more than 1 month old at the time of application.

Compliance with Written Authority Required procedures

 

C13096

P13096

 

Ankylosing spondylitis
Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis; AND
Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; OR
Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions.
Patient must be at least 18 years of age.
Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as 'Cancelled'.

Compliance with Authority Required procedures

 

C13097

P13097

 

Severe psoriatic arthritis
Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made
Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND
Patient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved.
Patient must be at least 18 years of age.
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).
The PBS administrator will confirm that:
(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;
(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.

Compliance with Written Authority Required procedures

 

C13104

P13104

 

Severe active rheumatoid arthritis
Balance of supply for Initial treatment, Continuing treatment - subcutaneous form
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the Initial treatment with subcutaneous form restriction to complete 22 weeks initial treatment (intravenous and subcutaneous inclusive); OR
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment with subcutaneous form restriction to complete 24 weeks treatment; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND
The treatment must provide no more than the balance of up to 22 weeks treatment available under the Initial treatment - subcutaneous form; OR
The treatment must provide no more than the balance of up to 24 weeks treatment available under the Continuing treatment - subcutaneous form.
Patient must be at least 18 years of age.

Compliance with Authority Required procedures

[58]           Schedule 4, Part 1, entry for Palbociclib

                           substitute:

Palbociclib

C13055

 

 

Locally advanced or metastatic breast cancer
Initial treatment
Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; OR
Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with a non-steroidal aromatase inhibitor; OR
The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND
The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.
Patient must not be premenopausal.

Compliance with Authority Required procedures

 

C13066

 

 

Locally advanced or metastatic 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 in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND
The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.
Patient must not be premenopausal.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.

Compliance with Authority Required procedures

 

C13085

 

 

Locally advanced or metastatic breast cancer
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 August 2022; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
Patient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS supply was initiated; OR
Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have had a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 2 at the time non-PBS supply was initiated; AND
The treatment must be in combination with fulvestrant only, where at the time non-PBS supply was initiated, the patient had recurrent/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease; AND
The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.
Patient must not be premenopausal.

Compliance with Authority Required procedures

[59]           Schedule 4, Part 1, entry for Paliperidone

                   (a)        omit:

 

C6832

 

 

Schizophrenia
Patient must have previously received and be stabilised on PBS-subsidised paliperidone once-monthly injection for at least 4 consecutive months.

Compliance with Authority Required procedures - Streamlined Authority Code 6832

                   (b)        insert in numerical order after existing text:

 

C13049

 

 

Schizophrenia
Patient must have previously received and be stabilised on PBS-subsidised paliperidone once-monthly injection for at least 4 consecutive months; OR
Patient must have previously received and be stabilised on PBS-subsidised paliperidone six-monthly injection for at least one cycle.

Compliance with Authority Required procedures - Streamlined Authority Code 13049

 

C13082

 

 

Schizophrenia
Patient must have previously received and be stabilised on PBS-subsidised paliperidone three-monthly injection for at least one cycle; OR
Patient must have previously received and be stabilised on PBS-subsidised paliperidone once-monthly injection for at least 4 consecutive months.

Compliance with Authority Required procedures - Streamlined Authority Code 13082

[60]           Schedule 4, Part 1, entry for Ribociclib

                           substitute:

Ribociclib

C13037

P13037

 

Locally advanced or metastatic 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 in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND
The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND
Patient must require dosage reduction requiring a pack of 42 tablets.
Patient must not be premenopausal.

Compliance with Authority Required procedures

 

C13074

P13074

 

Locally advanced or metastatic breast cancer
Initial treatment
Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; OR
Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with one of (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant; OR
The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND
The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND
Patient must require dosage reduction requiring a pack of 42 tablets.
Patient must not be premenopausal.

Compliance with Authority Required procedures

 

C13084

P13084

 

Locally advanced or metastatic breast cancer
Initial treatment
Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; OR
Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with one of (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant; OR
The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND
The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.
Patient must not be premenopausal.

Compliance with Authority Required procedures

 

C13093

P13093

 

Locally advanced or metastatic 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 in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND
The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.
Patient must not be premenopausal.

Compliance with Authority Required procedures

 

C13099

P13099

 

Locally advanced or metastatic 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 in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND
Patient must require dosage reduction requiring a pack of 21 tablets; AND
The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.
Patient must not be premenopausal.

Compliance with Authority Required procedures

 

C13105

P13105

 

Locally advanced or metastatic breast cancer
Initial treatment
Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; OR
Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with one of (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant; OR
The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND
The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND
Patient must require dosage reduction requiring a pack of 21 tablets.
Patient must not be premenopausal.

Compliance with Authority Required procedures

[61]           Schedule 4, Part 1, entry for Risankizumab

                           insert in numerical order after existing text:

 

C13063

P13063

 

Severe chronic plaque psoriasis
'Grandfathered' patient - Whole body (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy)
Must be treated by a dermatologist.
Patient must have severe chronic plaque psoriasis where lesions had been present for at least 6 months from the time of initial diagnosis prior to initiating non-PBS-subsidised treatment; AND
Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 August 2022; AND
Patient must have had a Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing treatment with this drug for this condition; AND
Patient must have demonstrated a response to treatment following at least 12 weeks of non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheets including the date of the assessment of the patient's condition at baseline (prior to initiation of therapy with this drug); and
(c) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
The most recent PASI assessment must be no more than 4 weeks old at the time of application.

Compliance with Written Authority Required procedures

 

C13070

P13070

 

Severe chronic plaque psoriasis
Grandfathered patient - Face, hand, foot or Whole body - Balance of Supply
Must be treated by a dermatologist.
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must have received insufficient therapy with this drug for this condition under the Grandfathered patient - Whole body restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Grandfathered patient - Face, hand, foot restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.

Compliance with Authority Required procedures

 

C13098

P13098

 

Severe chronic plaque psoriasis
'Grandfathered' patient - Face, hand, foot (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy)
Must be treated by a dermatologist.
Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, where lesions have been present for at least 6 months from the time of initial diagnosis prior to initiating non-PBS-subsidised treatment; AND
Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 August 2022; AND
Patient must have had disease, prior to treatment with this drug for this condition, classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling were rated as severe or very severe; or (ii) the skin area affected was 30% or more of the face, palm of a hand or sole of a foot; AND
Patient must have demonstrated a response to treatment following at least 12 weeks of non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
The PASI assessment must be performed on the same affected area as assessed at baseline or prior to initiation of treatment with this drug.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheets demonstrating response and face, hand, foot area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of therapy with this drug); and
(c) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Written Authority Required procedures

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

                           omit:

 

C4381

P4381

 

Prevention of venous thromboembolism
Patient must be undergoing total knee replacement.
Patient must require up to 10 days of therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 4381