National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023 (No. 5) (Cth)

Case

PB 43 of 2023

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023
(No. 5)

National Health Act 1953

I, NIKOLAI TSYGANOV, Assistant Secretary, 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               30 May            2023

NIKOLAI TSYGANOV

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Contents

1......... Name............................................................................................................................... 1

2......... Commencement............................................................................................................... 1

3......... Authority......................................................................................................................... 1

4......... Schedules......................................................................................................................... 1

Schedule 1—Amendments  2

National Health (Listing of Pharmaceutical Benefits) Instrument 2012
(PB 71 of 2012).   2

  1. Name

(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023 (No. 5).

(2)This Instrument may also be cited as PB 43 of 2023.

  1. 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 June 2023 1 June 2023

Note:          This table relates only to the provisions of this instrument as originally made.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

  1. Authority

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

4       Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

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

  1. Schedule 1, Part 1, entry for Ambrisentan in the form Tablet 5 mg

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

a Ambrisentan Viatris AL MP See Note 3 See Note 3 See Note 3 See Note 3 30 D(100)

  1. Schedule 1, Part 1, entry for Amisulpride in the form Tablet 200 mg 

omit:

a Amisulpride 200 Winthrop WA MP NP C4246 60 5 60

  1. Schedule 1, Part 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besilate); and Tablet 10 mg (as besilate)

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

a Blooms Amlodipine BG MP NP 30 5 30

  1. Schedule 1, Part 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (s19A)

substitute:

Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (s19A) Oral Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Aurobindo - Medsurge) DZ MP NP C5832 C5893 C10413 P5832 P5893 10 0 20
PDP C5833 C5894 10 0 20
Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Aurobindo – Pro Pharmaceuticals) QY MP NP C5832 C5893 C10413 P5832 P5893 10 0 20
PDP C5833 C5894 10 0 20
Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Micro Labs) QZ MP NP C5832 C5893 C10413 P5832 P5893 10 0 20
PDP C5833 C5894 10 0 20
Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Aurobindo - Medsurge) DZ MP NP C5832 C5893 C10413 P10413 20 0 20
Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Aurobindo – Pro Pharmaceuticals) QY MP NP C5832 C5893 C10413 P10413 20 0 20
Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Micro Labs) QZ MP NP C5832 C5893 C10413 P10413 20 0 20

  1. Schedule 1, Part 1, entry for Apalutamide

insert in numerical order in the column headed “Circumstances”: C14034

  1. Schedule 1, Part 1, entry for Azacitidine

(a)omit:

a AZACITIDINE DR.REDDY'S RI MP See Note 3 See Note 3 See Note 3 See Note 3 1 D(100)

(b)omit:

a Azadine RZ MP See Note 3 See Note 3 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, Part 1, entry for Baricitinib in the form Tablet 2 mg [Maximum Quantity: 28; Number of Repeats: 5]

omit from the column headed “Pack Quantity”: 3     substitute: 28

  1. Schedule 1, Part 1, entry for Bimatoprost in the form Eye drops 300 micrograms per mL, single dose units 0.4 mL, 30

omit from the column headed “Responsible Person”: AG       substitute: VE

  1. Schedule 1, Part 1, entry for Bimatoprost in the form Eye drops 300 micrograms per mL, 3 mL

omit from the column headed “Responsible Person” for the brand “Lumigan”: AG        substitute: VE

  1. Schedule 1, Part 1, entry for Bimatoprost with timolol in each of the forms: Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, single dose units 0.4 mL, 30; and Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, 3 mL

omit from the column headed “Responsible Person”: AG       substitute: VE

  1. Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 3.5 mg

omit:

Bortezomib-Dr.Reddy's RI MP C11099 C13745 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, Part 1, entry for Botulinum toxin type A purified neurotoxin complex

omit from the column headed “Responsible Person”: AG       substitute: VE

  1. Schedule 1, Part 1, entry for Brimonidine in the form Eye drops containing brimonidine tartrate 1.5 mg per mL, 5 mL

omit from the column headed “Responsible Person”: AG       substitute: VE

  1. Schedule 1, Part 1, entry for Brimonidine in the form Eye drops containing brimonidine tartrate 2 mg per mL, 5 mL

(a)omit from the column headed “Responsible Person” for the brand “Alphagan”: AG      substitute: VE

(b)omit from the column headed “Responsible Person” for the brand “Enidin”: PE  substitute: VB

  1. Schedule 1, Part 1, entry for Brimonidine with timolol

omit from the column headed “Responsible Person”: AG       substitute: VE

  1. Schedule 1, Part 1, entry for Cannabidiol

insert in numerical order in the column headed “Circumstances”: C14047

  1. Schedule 1, Part 1, entry for Carmellose

substitute:

Carmellose Eye drops containing carmellose sodium 5 mg per mL, single dose units 0.4 mL, 30 Application to the eye a Cellufresh VE MP NP AO C6172 3 5 1
a Optifresh Tears PP MP NP AO C6172 3 5 1
Eye drops containing carmellose sodium 5 mg per mL, 10 mL Application to the eye Evolve Carmellose CX MP NP AO C6172 1 5 1
Eye drops containing carmellose sodium 5 mg per mL, 15 mL Application to the eye Refresh Tears Plus VE AO C6120 1 5 1
MP C6073 C6098 P6073 1 5 1
NP C6073 1 5 1
MP C6073 C6098 P6098 1 11 1
Eye drops containing carmellose sodium 10 mg per mL, single dose units 0.4 mL, 30 Application to the eye a Celluvisc VE MP NP AO C6172 3 5 1
a Optifresh Plus PP MP NP AO C6172 3 5 1
Eye drops containing carmellose sodium 10 mg per mL, 15 mL Application to the eye Refresh Liquigel VE AO C6120 1 5 1
MP C6073 C6098 P6073 1 5 1
NP C6073 1 5 1
MP C6073 C6098 P6098 1 11 1

  1. Schedule 1, Part 1, entry for Carmellose with glycerin

omit from the column headed “Responsible Person”: AG       substitute: VE

  1. Schedule 1, Part 1, entry for Cefalexin in the form Granules for oral suspension 250 mg (as monohydrate) per 5 mL, 100 mL

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

  1. Schedule 1, Part 1, after entry for Cefalexin in the form Granules for oral suspension 250 mg (as monohydrate) per 5 mL, 100 mL [Maximum Quantity: 1; Number of Repeats: 1]

insert:

Granules for oral suspension 250 mg (as monohydrate) per 5 mL, 100 mL (s19A) Oral Keforal QY PDP 1 0 1
MP NP 1 1 1

  1. Schedule 1, Part 1, entry for Ceftriaxone in the form Powder for injection 1 g (as sodium)

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

a Ceftriaxone Viatris AL MP NP C5830 C5862 C5868 5 0 5
MP NP C5830 C5862 C5868 5 0 10

  1. Schedule 1, Part 1, entry for Ceftriaxone in the form Powder for injection 2 g (as sodium)

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

a Ceftriaxone Viatris AL MP NP C5826 C5881 C5890 5 0 5
MP NP C5826 C5881 C5890 5 0 10

  1. Schedule 1, Part 1, after entry for Ciclosporin in the form Capsule 100 mg [Maximum Quantity: 120; Number of Repeats: 5]

insert:

Eye drops 900 micrograms per mL, single dose units 0.25 mL, 60 Application to the eye Cequa RA MP AO C14026 C14032 1 5 1

  1. Schedule 1, Part 1, entry for Ciclosporin in the form Eye drops 1 mg per mL, single dose units 0.3 mL, 30

omit from the column headed “Circumstances”: C12284 C12346       substitute: C14026 C14032

  1. Schedule 1, Part 1, entry for Ciprofloxacin in the form Tablet 500 mg (as hydrochloride)

omit:

a Ciprofloxacin GH HQ MP NP C5614 C5615 C5687 C5688 C5689 C5722 C5780 14 0 14

  1. Schedule 1, Part 1, entry for Dexamethasone in the form Intravitreal injection 700 micrograms

omit from the column headed “Responsible Person”: AG       substitute: VE

  1. Schedule 1, Part 1, after entry for Disopyramide in the form Capsule 100 mg

insert:

Capsule 100 mg (s19A) Oral Rythmodan (Canada) OJ MP NP 100 5 84

  1. Schedule 1, Part 1, entry for Donepezil in each of the forms: Tablet containing donepezil hydrochloride 5 mg; and Tablet containing donepezil hydrochloride 10 mg            

omit:

a Donepezil-DRLA RZ MP C13938 C13940 C13941 28 5 28
NP C13938 28 5 28

  1. Schedule 1, Part 1, entry for Dosulepin in the form Capsule containing dosulepin hydrochloride 25 mg

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

a Dosulepin Viatris MQ MP NP 50 2 50

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

omit from the column headed “Circumstances”: C4755        substitute: C4690 C4703 C4755 C4756 C4757

  1. Schedule 1, Part 1, entry for Ezetimibe

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

a BTC Ezetimibe BG MP NP C7966 C7990 C7996 30 5 30

  1. Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 2.063 mg

omit from the column headed “Responsible Person”: ZP       substitute: RW

  1. Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 4.125 mg

omit from the column headed “Responsible Person”: ZP       substitute: RW

  1. Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 8.25 mg

omit from the column headed “Responsible Person”: ZP       substitute: RW

  1. Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 12.375 mg

omit from the column headed “Responsible Person”: ZP       substitute: RW

  1. Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 16.5 mg

omit from the column headed “Responsible Person”: ZP       substitute: RW

  1. Schedule 1, Part 1, entry for Fingolimod in the form Capsule 500 micrograms (as hydrochloride)

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

a Fingolimod-Teva TB MP C10162 C10172 28 5 28

  1. Schedule 1, Part 1, entry for Fluorometholone in the form Eye drops 1 mg per mL, 5 mL

omit from the column headed “Responsible Person”: AG       substitute: VE

  1. Schedule 1, Part 1, entry for Fluticasone propionate with salmeterol in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

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

a Fluticasone Salmeterol Ciphaler 500/50 LR MP NP C4930 C10121 1 5 1

  1. Schedule 1, Part 1, entry for Fosaprepitant

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

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

a FOSAPREPITANT-AFT AE MP NP C6852 C6886 C6887 C6891 1 5 1

  1. Schedule 1, Part 1, entry for Gentamicin in the form Eye drops 3 mg (as sulfate) per mL, 5 mL

omit from the column headed “Responsible Person”: AG       substitute: VE

  1. Schedule 1, Part 1, entry for Gliclazide in the form Tablet 60 mg (modified release)

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

a Gliclazide Lupin MR GQ MP NP 60 5 60

  1. Schedule 1, Part 1, entry for Labetalol

omit:

Tablet containing labetalol hydrochloride 200 mg Oral a Trandate AS MP NP 100 5 100

  1. Schedule 1, Part 1, after entry for Larotrectinib in the form Capsule 100 mg (as sulfate) [Maximum Quantity: 56; Number of Repeats: 5]

insert:

Oral solution 20 mg per mL (as sulfate), 50 mL, 2 Oral VITRAKVI BN MP C12980 C12981 C12982 P12981 P12982 1 2 1
MP C12980 C12981 C12982 P12980 1 5 1

  1. Schedule 1, Part 1, entry for Leflunomide in the form Tablet 10 mg

omit from the column headed “Responsible Person” for the brand “Lunava 10”: ZP     substitute: RW

  1. Schedule 1, Part 1, entry for Leflunomide in the form Tablet 20 mg

omit from the column headed “Responsible Person” for the brand “Lunava 20”: ZP     substitute: RW

  1. Schedule 1, Part 1, entry for Lenalidomide

substitute:

Lenalidomide Capsule 5 mg Oral Cipla Lenalidomide LR MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 28 D(100)
Lenalide JU MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 28 D(100)
Lenalidomide Dr.Reddy's RI MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 28 D(100)
Lenalidomide Sandoz SZ MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 28 D(100)
Lenalidomide-Teva TB MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 28 D(100)
Lenalidomide Viatris AF MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
Revlimid CJ MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 28 D(100)
Capsule 10 mg Oral Cipla Lenalidomide LR MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 28 D(100)
Lenalide JU MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 28 D(100)
Lenalidomide Dr.Reddy's RI MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 28 D(100)
Lenalidomide Sandoz SZ MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 28 D(100)
Lenalidomide-Teva TB MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 28 D(100)
Lenalidomide Viatris AF MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
Revlimid CJ MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 28 D(100)
Capsule 15 mg Oral Cipla Lenalidomide LR MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 28 D(100)
Lenalide JU MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 28 D(100)
Lenalidomide Dr.Reddy's RI MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 28 D(100)
Lenalidomide Sandoz SZ MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 28 D(100)
Lenalidomide-Teva TB MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 28 D(100)
Lenalidomide Viatris AF MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
Revlimid CJ MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 28 D(100)
Capsule 25 mg Oral Cipla Lenalidomide LR MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
Lenalide JU MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
Lenalidomide Dr.Reddy's RI MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
Lenalidomide Sandoz SZ MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
Lenalidomide-Teva TB MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
Lenalidomide Viatris AF MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)
Revlimid CJ MP See Note 3 See Note 3 See Note 3 See Note 3 14 D(100)
MP See Note 3 See Note 3 See Note 3 See Note 3 21 D(100)

  1. Schedule 1, Part 1, entry for Lenvatinib in the form Capsule 4 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 2]

insert in numerical order in the column headed “Circumstances”: C14041 C14042 C14043

  1. Schedule 1, Part 1, entry for Lenvatinib in the form Capsule 4 mg (as mesilate) [Maximum Quantity: 60; Number of Repeats: 2]

(a)insert in numerical order in the column headed “Circumstances”: C14041 C14042 C14043

(b)insert in numerical order in the column headed “Purposes”: P14041 P14042 P14043

  1. Schedule 1, Part 1, entry for Lenvatinib in the form Capsule 4 mg (as mesilate) [Maximum Quantity: 90; Number of Repeats: 2]

insert in numerical order in the column headed “Circumstances”: C14041 C14042 C14043

  1. Schedule 1, Part 1, entry for Lenvatinib in the form Capsule 10 mg (as mesilate)

insert in numerical order in the column headed “Circumstances”: C14041 C14042 C14043

  1. Schedule 1, Part 1, entry for Levonorgestrel with ethinylestradiol in the form Pack containing 6 tablets 50 micrograms-30 micrograms, 5 tablets 75 micrograms-40 micrograms, 10 tablets 125 micrograms-30 micrograms and 7 inert tablets

(a)omit from the column headed “Schedule Equivalent” for the brand “Logynon ED”: b    substitute: a

(b)omit from the column headed “Schedule Equivalent” for the brand “Trifeme 28”: a

(c)omit:

a Triphasil 28 PF MP NP 4 2 4

(d)omit from the column headed “Schedule Equivalent” for the brand “Triquilar ED”: b    substitute: a

  1. Schedule 1, Part 1, entry for Levothyroxine

substitute:

Levothyroxine Tablet containing 50 micrograms anhydrous levothyroxine sodium Oral b Eltroxin LT MP NP 200 1 200
a Eutroxsig LN MP NP 200 1 200
b Levothox AF MP NP 200 1 200
a LEVOXINE RA MP NP 200 1 200
a Oroxine AS MP NP 200 1 200
Tablet containing 75 micrograms anhydrous levothyroxine sodium Oral b Eltroxin LT MP NP 200 1 200
a Eutroxsig LN MP NP 200 1 200
b Levothox AF MP NP 200 1 200
a LEVOXINE RA MP NP 200 1 200
a Oroxine AS MP NP 200 1 200
Tablet containing 100 micrograms anhydrous levothyroxine sodium Oral b Eltroxin LT MP NP 200 1 200
a Eutroxsig LN MP NP 200 1 200
b Levothox AF MP NP 200 1 200
a LEVOXINE RA MP NP 200 1 200
a Oroxine AS MP NP 200 1 200
Tablet containing 125 micrograms anhydrous levothyroxine sodium Oral a Eltroxin LT MP NP 200 1 200
a Levothox AF MP NP 200 1 200
Tablet containing 200 micrograms anhydrous levothyroxine sodium Oral b Eltroxin LT MP NP 200 1 200
a Eutroxsig LN MP NP 200 1 200
b Levothox AF MP NP 200 1 200
a LEVOXINE RA MP NP 200 1 200
a Oroxine AS MP NP 200 1 200

  1. Schedule 1, Part 1, entry for Lisinopril in each of the forms: Tablet 5 mg; and Tablet 10 mg

omit:

a Lisinopril generichealth GQ MP NP 30 5 30

  1. Schedule 1, Part 1, after entry for Minoxidil in the form Tablet 10 mg

insert:

Tablet 10 mg (s19A) Oral Minoxidil 10 mg (Roma Pharmaceuticals) OJ MP NP C5177 100 5 60

  1. Schedule 1, Part 1, entry for Mometasone in the form Lotion containing mometasone furoate 1 mg per g, 30 mL

(a)omit:

a Momasone AS MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 0 1

(b)omit:

a Momasone AS MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1

(c)omit:

a Momasone AS MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 3 5 1

(d)omit:

a Momasone AS MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 P6263 4 5 1

(e)omit:

a Momasone AS MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 5 5 1

  1. Schedule 1, Part 1, entry for Naltrexone

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

  1. Schedule 1, Part 1, entry for Nicotine

substitute:

Nicotine Transdermal patch 17.5 mg Transdermal Nicotinell Step 3 ON MP NP C14040 28 2 28
Transdermal patch 35 mg Transdermal Nicotinell Step 2 ON MP NP C14040 28 2 28
Transdermal patch 39.4 mg Transdermal nicorette 16hr Invisipatch JT MP NP C14040 28 2 28
Transdermal patch 52.5 mg Transdermal Nicotinell Step 1 ON MP NP C5140 C14040 28 2 28
Transdermal patch 114 mg Transdermal Nicabate P GJ MP NP C14040 28 2 28

  1. Schedule 1, Part 1, entry for Ofloxacin

omit from the column headed “Responsible Person”: AG       substitute: VE

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

omit:

a Olanzapine-DRLA RZ MP NP C5856 C5869 28 5 28

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

omit:

a Olanzapine-DRLA RZ MP NP C5856 C5869 28 5 28

  1. Schedule 1, Part 1, entry for Olmesartan in each of the forms: Tablet containing olmesartan medoxomil 20 mg; and Tablet containing olmesartan medoxomil 40 mg

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

a Olsetan MQ MP NP 30 5 30

  1. Schedule 1, Part 1, entry for Omeprazole in the form Tablet 20 mg

omit from the column headed “Responsible Person” for the brand “Ozmep” (all instances): ZP                 substitute (all instances): RW

  1. Schedule 1, Part 1, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg

(a)omit:

Ondansetron ODT GH GQ MP NP C5618 C10498 P5618 4 0 4
MP C5743 4 0 4 C(100)

(b)omit:

Ondansetron ODT GH GQ MP NP C5618 C10498 P10498 10 1 10

  1. Schedule 1, Part 1, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg

(a)omit:

Ondansetron ODT GH GQ MP NP C5618 C10498 P5618 4 0 4
MP C5743 4 0 4 C(100)

(b)omit:

Ondansetron ODT GH GQ MP NP C5618 C10498 P10498 10 1 10

  1. Schedule 1, Part 1, entry for Paracetamol in the form Tablet 665 mg (modified release) [Maximum Quantity: 192; Number of Repeats: 3]

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

a Parapane OSTEO AF MP NP C6225 C6280 P6225 192 3 96

  1. Schedule 1, Part 1, entry for Paracetamol in the form Tablet 665 mg (modified release) [Maximum Quantity: 192; Number of Repeats: 5]

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

a Parapane OSTEO AF MP NP C6225 C6280 P6280 192 5 96

  1. Schedule 1, Part 1, entry for Paraffin in the form Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g

omit from the column headed “Responsible Person” for the brand “Refresh Night Time” (all instances): AG           substitute (all instances): VE

  1. Schedule 1, Part 1, entry for Paroxetine

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

a Blooms The Chemist Paroxetine BG MP NP C4755 C6277 C6636 30 5 30

  1. Schedule 1, Part 1, entry for Pembrolizumab

insert in numerical order in the column headed “Circumstances”: C14027 C14028 C14044

  1. Schedule 1, Part 1, after entry for Phenoxymethylpenicillin in the form Powder for oral liquid 250 mg (as potassium) per 5 mL, 100 mL [Maximum Quantity: 2; Number of Repeats: 1]

insert:

Powder for oral liquid 250 mg (as potassium) per 5 mL, 100 mL (s19A) Oral Penopen QY PDP 2 0 1
MP NP 2 1 1

  1. Schedule 1, Part 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg

(a)omit:

a Pravastatin generichealth GQ MP NP 30 5 30

(b)omit:

a Pravastatin generichealth GQ MP P7598 30 11 30

  1. Schedule 1, Part 1, entry for Prednisolone with phenylephrine

omit from the column headed “Responsible Person”: AG       substitute: VE

  1. Schedule 1, Part 1, entry for Pregabalin in the form Capsule 25 mg

omit:

a Pregabalin GH GQ MP NP C4172 56 5 56

  1. Schedule 1, Part 1, entry for Quinapril in the form Tablet 20 mg (as hydrochloride)

omit:

a Quinapril generichealth GQ MP NP 30 5 30

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

(a)omit from the column headed “Schedule Equivalent” for the brand “APO-Ranitidine”: a

(b)omit:

a Zantac AS MP NP MW 60 5 60

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

(a)omit from the column headed “Schedule Equivalent” for the brand “APO-Ranitidine”: a

(b)omit:

a Zantac AS MP NP 30 5 30

  1. Schedule 1, Part 1, entry for Rasagiline

omit:

a Rasazil GQ MP NP C5339 30 5 30

  1. Schedule 1, Part 1, entry for Selinexor

substitute:

Selinexor Tablet 20 mg Oral Xpovio TG MP C13161 C14021 C14022 C14023 C14024 C14031 C14037 C14039 C14045 P14021 P14022 P14045 16 2 16 D(100)
MP C13161 C14021 C14022 C14023 C14024 C14031 C14037 C14039 C14045 P14023 P14024 P14037 20 2 20 D(100)
MP C13161 C14021 C14022 C14023 C14024 C14031 C14037 C14039 C14045 P13161 P14031 P14039 32 2 32 D(100)

  1. Schedule 1, Part 1, entry for Telmisartan in the form Tablet 80 mg

omit:

a Telmisartan GH GQ MP NP 28 5 28

  1. Schedule 1, Part 1, entry for Telmisartan with hydrochlorothiazide in the form Tablet 40 mg-12.5 mg

omit:

a Telmisartan HCT GH 40/12.5 GQ MP NP C4374 28 5 28

  1. Schedule 1, Part 1, entry for Telmisartan with hydrochlorothiazide in the form Tablet 80 mg-12.5 mg

omit:

a Telmisartan HCT GH 80/12.5 GQ MP NP C4374 28 5 28

  1. Schedule 1, Part 1, entry for Tenofovir with emtricitabine in the form Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg

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

Tenofovir Disoproxil Emtricitabine Viatris 300/200 AL MP NP C11143 30 2 30
MP NP C6985 C6986 60 5 30 C(100)

  1. Schedule 1, Part 1, entry for Venlafaxine in the form Capsule (modified release) 37.5 mg (as hydrochloride)

omit from the column headed “Responsible Person” for the brand “Elaxine SR 37.5”: ZP            substitute: RW

  1. Schedule 1, Part 1, entry for Venlafaxine in the form Capsule (modified release) 75 mg (as hydrochloride)

omit from the column headed “Responsible Person” for the brand “Elaxine SR 75”: ZP                           substitute: RW

  1. Schedule 1, Part 1, entry for Venlafaxine in the form Capsule (modified release) 150 mg (as hydrochloride)

omit from the column headed “Responsible Person” for the brand “Elaxine SR 150”: ZP             substitute: RW

  1. Schedule 1, Part 1, entry for Vinorelbine in the form Capsule 20 mg (as tartrate)

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

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

a Velabine LI MP C4242 C4272 20 2 1

  1. Schedule 1, Part 1, entry for Vinorelbine in the form Capsule 30 mg (as tartrate)

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

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

a Velabine LI MP C4242 C4272 16 2 1

  1. Schedule 1, Part 2, omit entry for Abatacept

  1. Schedule 1, Part 2, omit entry for Adalimumab

  1. Schedule 1, Part 2, omit entry for Ampicillin

  1. Schedule 1, Part 2, omit entry for Baricitinib

  1. Schedule 1, Part 2, omit entry for Certolizumab pegol

  1. Schedule 1, Part 2, omit entry for Dipyridamole with aspirin

  1. Schedule 1, Part 2, entry for Donepezil in each of the forms: Tablet containing donepezil hydrochloride 5 mg; and Tablet containing donepezil hydrochloride 10 mg

omit:

a Donepezil-DRLA RZ MP C10099 C10100 28 5 28

  1. Schedule 1, Part 2, omit entry for Doxepin

  1. Schedule 1, Part 2, omit entry for Etanercept

  1. Schedule 1, Part 2, omit entry for Golimumab

  1. Schedule 1, Part 2, omit entry for Infliximab

  1. Schedule 1, Part 2, after entry for Insulin aspart in the form Injections (human analogue) (fast acting), pre-filled pen, 100 units per mL,
    3 mL, 5

insert:

Labetalol Tablet containing labetalol hydrochloride 200 mg Oral a Trandate AS MP NP 100 5 100

  1. Schedule 1, Part 2, omit entry for Pindolol

  1. Schedule 1, Part 2, entry for Polyvinyl alcohol

(a)omit from the column headed “Responsible Person” for the brand “Liquifilm Tears” (all instances): AG             substitute (all instances): VE

(b)omit from the column headed “Responsible Person” for the brand “PVA Tears” (all instances): PE  substitute (all instances): VB

  1. Schedule 1, Part 2, omit entry for Risedronic acid and calcium

  1. Schedule 1, Part 2, omit entry for Tofacitinib

  1. Schedule 1, Part 2, omit entry for Upadacitinib

  1. Schedule 3,

omit:

AG Allergan Australia Pty Limited  85 000 612 831

  1. Schedule 3,

omit:

PE Allergan Australia Pty Limited  85 000 612 831

  1. Schedule 3, after details relevant to Responsible Person code QY

insert:

QZ Pro Pharmaceuticals Group Pty. Ltd. 20 605 457 430

  1. Schedule 3, after details relevant to Responsible Person code UR

insert:

VB AbbVie Pty Ltd 48 156 384 262

  1. Schedule 4, Part 1, entry for Abatacept

omit:

C12378 P12378 Severe active rheumatoid arthritis
First continuing treatment - Critical shortage of tocilizumab - Temporary listing
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 this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab); AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
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.
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 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 application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of 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 has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.
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.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. 		Compliance with Written Authority Required procedures
C12385 P12385 Severe active rheumatoid arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab)
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 been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
The treatment must be in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; 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.
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 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).
If a patient has received 12 weeks or more of therapy with tocilizumab as their most recent treatment, evidence of a response must be provided.
If a patient has not received a minimum of 12 weeks therapy with tocilizumab, evidence of a response is not required to be provided under this restriction. This switch in therapy from tocilizumab will not be counted as treatment failure to tocilizumab.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
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.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
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.
Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 5 repeats.
Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 5 repeats. 		Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Adalimumab

omit:

C12354 P12354 Severe active rheumatoid arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab)
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 been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
The treatment must be in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times.
Patient must be aged 18 years or older.
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).
If a patient has received 12 weeks or more of therapy with tocilizumab as their most recent treatment, evidence of a response must be provided.
If a patient has not received a minimum of 12 weeks therapy with tocilizumab, evidence of a response is not required to be provided under this restriction. This switch in therapy from tocilizumab will not be counted as treatment failure to tocilizumab.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
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.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
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
C12364 P12364 Severe active juvenile idiopathic arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab)
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 been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
The treatment must be in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle.
Patient must be aged 18 years or older.
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).
If a patient has received 12 weeks or more of therapy with tocilizumab as their most recent treatment, evidence of a response must be provided.
If a patient has not received a minimum of 12 weeks therapy with tocilizumab, evidence of a response is not required to be provided under this restriction. This switch in therapy from tocilizumab will not be counted as treatment failure to tocilizumab.
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) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) 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, cervical spine 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).
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. 		Compliance with Written Authority Required procedures
C12366 P12366 Severe active rheumatoid arthritis
First continuing treatment - Critical shortage of tocilizumab - Temporary listing
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 this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab); AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
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.
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 application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of 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 has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.
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.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. 		Compliance with Written Authority Required procedures
C12391 P12391 Severe active juvenile idiopathic arthritis
First continuing treatment - Critical shortage of tocilizumab - Temporary listing
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 this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab); AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
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) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) 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, cervical spine 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.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where a response assessment is not conducted within 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.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. 		Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Apalutamide

insert in numerical order after existing text:

C14034 Metastatic castration sensitive carcinoma of the prostate
The treatment must be/have been initiated within 6 months of treatment initiation with androgen deprivation therapy; AND
Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); OR
Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.
Patient must be undergoing concurrent androgen deprivation therapy. 		Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Baricitinib

omit:

C12354 P12354 Severe active rheumatoid arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab)
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 been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
The treatment must be in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times.
Patient must be aged 18 years or older.
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).
If a patient has received 12 weeks or more of therapy with tocilizumab as their most recent treatment, evidence of a response must be provided.
If a patient has not received a minimum of 12 weeks therapy with tocilizumab, evidence of a response is not required to be provided under this restriction. This switch in therapy from tocilizumab will not be counted as treatment failure to tocilizumab.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
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.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
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
C12366 P12366 Severe active rheumatoid arthritis
First continuing treatment - Critical shortage of tocilizumab - Temporary listing
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 this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab); AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
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.
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 application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of 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 has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.
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.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. 		Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Cannabidiol

insert in numerical order after existing text:

C14047 Seizures of the Lennox-Gastaut syndrome
Patient must have a diagnosis of Lennox-Gastaut syndrome confirmed by an electroencephalogram (EEG) that showed a pattern of slow (less than 3.0 hertz) spike-and-wave discharges with generalised paroxysmal fast activity (sleep recording should be obtained where it is possible); AND
Patient must have (as an initiating patient)/have had (as a continuing patient) more than one type of generalised seizures; AND
Patient must have had at least two drop seizures (atonic, tonic or tonic-clonic) per week that are not adequately controlled with at least two other anti-epileptic drugs prior to initiating treatment with this medicine; AND
The treatment must be as adjunctive therapy to at least two other anti-epileptic drugs.
Must be treated by a neurologist if treatment is being initiated; OR
Must be treated by a neurologist if treatment is being continued or re-initiated; OR
Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued; OR
Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued.
Tonic seizures must have been recorded on video-EEG or have been clearly observed and reported by a witness.
Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records. 		Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Certolizumab pegol

(a)omit:

C12354 P12354 Severe active rheumatoid arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab)
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 been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
The treatment must be in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times.
Patient must be aged 18 years or older.
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).
If a patient has received 12 weeks or more of therapy with tocilizumab as their most recent treatment, evidence of a response must be provided.
If a patient has not received a minimum of 12 weeks therapy with tocilizumab, evidence of a response is not required to be provided under this restriction. This switch in therapy from tocilizumab will not be counted as treatment failure to tocilizumab.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
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.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
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
C12366 P12366 Severe active rheumatoid arthritis
First continuing treatment - Critical shortage of tocilizumab - Temporary listing
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 this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab); AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
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.
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 application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of 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 has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.
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.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. 		Compliance with Written Authority Required procedures

(b)omit:

C12393 P12393 Severe active rheumatoid arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab) - Balance of Supply
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 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab) restriction to complete 24 weeks treatment, depending on the dosage regimen; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. 		Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Ciclosporin

(a)omit:

C12284 Chronic severe dry eye disease with keratitis
Continuing treatment
Patient must have received PBS-subsidised treatment with this drug for this condition; AND
The condition must have improved to an extent that corneal fluorescein staining, using the same scale used at the time of the first authority application, shows an improvement (reduction) by at least 3 grades from baseline (the grade stated in the first authority application) - the improvement need only be demonstrated by staining once only with the first Continuing treatment authority application; AND
The condition must have improved to an extent that the patient's ocular surface disease index score at the time of this authority application, has improved (reduced) by at least 30% compared to the value stated in the first authority application (i.e. baseline).
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; OR
Must be treated by an optometrist in accordance with Optometry Board of Australia guidelines.
Prescribing instructions:
State in the first continuing treatment authority application for this drug:
(i) an improved corneal fluorescein staining grade (a numerical value that has improved by 3 grades from that provided in the first Initial 1 treatment authority application).
State in all continuing treatment authority applications:
(ii) the ocular surface disease index score at the time of this authority application (a numerical value that is at least 30% lower than that stated in the first Initial 1 treatment authority application). 		Compliance with Authority Required procedures
C12346 Chronic severe dry eye disease with keratitis
Initial treatment for up to the first 180 days of treatment
Patient must have a corneal fluorescein staining (CFS) grade of 4 at treatment initiation, using at least one of: (i) the Oxford scale, (ii) the modified Oxford scale, (iii) an equivalent scale to the Oxford scale as determined by the prescriber; AND
Patient must have an ocular surface disease index (OSDI) score of at least 23 at treatment initiation; AND
The condition must be inadequately controlled by monotherapy with a preservative free artificial tears substitute.
Patient must be undergoing simultaneous treatment with a preservative free artificial tears substitute; AND
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; OR
Must be treated by an optometrist in accordance with Optometry Board of Australia guidelines; AND
Patient must not be undergoing treatment with this drug under this treatment phase beyond day 180 of treatment.
Patient must be at least 18 years of age.
Prescribing instruction:
State in the first authority application for this drug, for the purpose of having a baseline measurement to assess response to treatment under the Continuing treatment listing, each of: (i) the qualifying corneal fluorescein staining grade (a numerical value no less than 4), (ii) the qualifying ocular surface disease index score (a numerical value no less than 23). 		Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C14026 Chronic severe dry eye disease with keratitis
Initial treatment for up to the first 180 days of treatment
Patient must have a corneal fluorescein staining (CFS) grade of 4 at treatment initiation, using at least one of: (i) the Oxford scale, (ii) the modified Oxford scale, (iii) an equivalent scale to the Oxford scale as determined by the prescriber; AND
Patient must have an ocular surface disease index (OSDI) score of at least 23 at treatment initiation; AND
The condition must be inadequately controlled by monotherapy with a preservative free artificial tears substitute; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be undergoing simultaneous treatment with a preservative free artificial tears substitute; AND
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; OR
Must be treated by an optometrist in accordance with Optometry Board of Australia guidelines; AND
Patient must not be undergoing treatment with this drug under this treatment phase beyond day 180 of treatment.
Patient must be at least 18 years of age.
Prescribing instruction:
State in the first authority application for this drug, for the purpose of having a baseline measurement to assess response to treatment under the Continuing treatment listing, each of: (i) the qualifying corneal fluorescein staining grade (a numerical value no less than 4), (ii) the qualifying ocular surface disease index score (a numerical value no less than 23). 		Compliance with Authority Required procedures
C14032 Chronic severe dry eye disease with keratitis
Continuing treatment
Patient must have received PBS-subsidised treatment with this drug for this condition; AND
The condition must have improved to an extent that corneal fluorescein staining, using the same scale used at the time of the first authority application, shows an improvement (reduction) by at least 3 grades from baseline (the grade stated in the first authority application) - the improvement need only be demonstrated by staining once only with the first Continuing treatment authority application; AND
The condition must have improved to an extent that the patient's ocular surface disease index score at the time of this authority application, has improved (reduced) by at least 30% compared to the value stated in the first authority application (i.e. baseline); AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; OR
Must be treated by an optometrist in accordance with Optometry Board of Australia guidelines.
Prescribing instructions:
State in the first continuing treatment authority application for this drug:
(i) an improved corneal fluorescein staining grade (a numerical value that has improved by 3 grades from that provided in the first Initial 1 treatment authority application).
State in all continuing treatment authority applications:
(ii) the ocular surface disease index score at the time of this authority application (a numerical value that is at least 30% lower than that stated in the first Initial 1 treatment authority application). 		Compliance with Authority Required procedures

  1. Schedule 4, Part 1, omit entry for Dipyridamole with aspirin

  1. Schedule 4, Part 1, entry for Etanercept

omit:

C12354 P12354 Severe active rheumatoid arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab)
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 been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
The treatment must be in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times.
Patient must be aged 18 years or older.
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).
If a patient has received 12 weeks or more of therapy with tocilizumab as their most recent treatment, evidence of a response must be provided.
If a patient has not received a minimum of 12 weeks therapy with tocilizumab, evidence of a response is not required to be provided under this restriction. This switch in therapy from tocilizumab will not be counted as treatment failure to tocilizumab.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
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.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
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
C12359 P12359 Severe active juvenile idiopathic arthritis
First continuing treatment - Critical shortage of tocilizumab - Temporary listing
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 this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab); AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
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) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) 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, cervical spine 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.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where a response assessment is not conducted within 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. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. 		Compliance with Written Authority Required procedures
C12366 P12366 Severe active rheumatoid arthritis
First continuing treatment - Critical shortage of tocilizumab - Temporary listing
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 this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab); AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
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.
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 application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of 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 has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.
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.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. 		Compliance with Written Authority Required procedures
C12389 P12389 Severe active juvenile idiopathic arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab)
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 been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
The treatment must be in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle.
Patient must be aged 18 years or older.
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).
If a patient has received 12 weeks or more of therapy with tocilizumab as their most recent treatment, evidence of a response must be provided.
If a patient has not received a minimum of 12 weeks therapy with tocilizumab, evidence of a response is not required to be provided under this restriction. This switch in therapy from tocilizumab will not be counted as treatment failure to tocilizumab.
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) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) 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, cervical spine 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).
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
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. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. 		Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Nicotine

substitute:

Nicotine C5140 Nicotine dependence
Patient must be an Aboriginal or a Torres Strait Islander person.
The treatment must be the sole PBS-subsidised therapy for this condition.
C14040 Nicotine dependence
The treatment must be as an aid to achieving abstinence from smoking; AND
The treatment must not be a PBS-benefit with other non-nicotine drugs that are PBS indicated for smoking cessation; AND
Patient must have indicated they are ready to cease smoking; AND
Patient must not receive more than 2 x 12-week PBS-subsidised treatment courses per 12 month period.
Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program or is about to enter such a program at the time PBS-subsidised treatment is initiated.
Details of the support and counselling program must be documented in the patient's medical records at the time treatment is initiated.

  1. Schedule 4, Part 1, entry for Pembrolizumab

insert in numerical order after existing text:

C14027 Advanced, metastatic or recurrent endometrial carcinoma
Initial treatment
Patient must have received prior treatment with platinum-based chemotherapy; AND
The condition must be untreated with each of: (i) programmed cell death-1/ligand-1 (PD-1/PDL-1) inhibitor therapy, (ii) tyrosine kinase inhibitor therapy; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation.
Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; OR
Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records; AND
Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR
Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions. 		Compliance with Authority Required procedures - Streamlined Authority Code 14027
C14028 Advanced, metastatic or recurrent endometrial carcinoma
Transitioning from non-PBS to PBS-subsided supply - Grandfather arrangements
Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 June 2023; AND
The treatment must be occurring in a patient where each of the following is true: (i) the patient had received prior treatment with platinum-based chemotherapy, (ii) the patient was untreated at treatment initiation with each of: (a) programmed cell death-1/ligand-1 (PD-1/PDL-1) inhibitor therapy, (b) tyrosine kinase inhibitor therapy, (iii) the patient's WHO performance status was no higher than 1 at treatment initiation, (iv) this drug is being prescribed in either: (a) a combination of pembrolizumab plus lenvatinib only, (b) as monotherapy where there was a contraindication/intolerance to the other drug in the combination - document the details in the patient's medical records, (v) disease progression has not occurred whilst on treatment, (vi) this prescription does not extend treatment beyond 24 months from the first administered dose.
Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR
Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions. 		Compliance with Authority Required procedures - Streamlined Authority Code 14028
C14044 Advanced, metastatic or recurrent endometrial carcinoma
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 receiving PBS-subsidised treatment with this drug for this condition.
Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; OR
Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records; AND
Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR
Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND
Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime. 		Compliance with Authority Required procedures - Streamlined Authority Code 14044

  1. Schedule 4, Part 1, omit entry for Risedronic acid and calcium

  1. Schedule 4, Part 1, entry for Selinexor

substitute:

Selinexor C13161 P13161 Relapsed and/or refractory multiple myeloma
Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply - Dose requirement of 160 mg per week
Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 September 2022; AND
The treatment must be in combination with dexamethasone; AND
Patient must have progressive disease after at least four prior lines of therapy, prior to initiating non-PBS-subsidised therapy with this drug for this condition; AND
Patient must have demonstrated refractory disease to prior treatments, prior to initiating non-PBS-subsidised therapy with this drug for this condition, which must include: (i) a minimum of two proteasome inhibitors; and (ii) a minimum of two immunomodulators; and (iii) an anti-CD38 monoclonal antibody; AND
Patient must not be receiving concomitant PBS-subsidised treatment with any of the following: (i) proteasome inhibitors, (ii) Immunomodulators, (iii) anti-CD38 monoclonal antibody.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. 		Compliance with Authority Required procedures
C14021 P14021 Relapsed and/or refractory multiple myeloma
Initial treatment - Dose requirement of 80 mg, 60 mg or 40 mg per week
The condition must be confirmed by a histological diagnosis; AND
Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; OR
Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must not have previously received this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient's medical records.
Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.
Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy 		Compliance with Authority Required procedures
C14022 P14022 Relapsed and/or refractory multiple myeloma
Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply - Dose requirement of 80 mg, 60 mg or 40 mg per week
Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 June 2023; AND
Patient must have met all initial treatment PBS eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are: (a) the condition was confirmed by histological diagnosis, (b) the treatment is/was being used as part of combination therapy limited to this drug in combination with either: (i) dexamethasone, (ii) dexamethasone plus bortezomib, (c) the condition progressed (see definition of progressive disease below) after at least one prior therapy, (d) the patient had never been treated with this drug; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. 		Compliance with Authority Required procedures
C14023 P14023 Relapsed and/or refractory multiple myeloma
Continuing treatment - Dose requirement of 100 mg per week
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; OR
Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. 		Compliance with Authority Required procedures
C14024 P14024 Relapsed and/or refractory multiple myeloma
Initial treatment - Dose requirement of 100 mg per week
The condition must be confirmed by a histological diagnosis; AND
Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; OR
Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must not have previously received this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy 		Compliance with Authority Required procedures
C14031 P14031 Relapsed and/or refractory multiple myeloma
Continuing treatment - Dose requirement of 160 mg per week
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. 		Compliance with Authority Required procedures
C14037 P14037 Relapsed and/or refractory multiple myeloma
Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply - Dose requirement of 100 mg per week
Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 June 2023; AND
Patient must have met all initial treatment PBS eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are: (a) the condition was confirmed by histological diagnosis, (b) the treatment is/was being used as part of combination therapy limited to this drug in combination with either: (i) dexamethasone, (ii) dexamethasone plus bortezomib, (c) the condition progressed (see definition of progressive disease below) after at least one prior therapy, (d) the patient had never been treated with this drug; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. 		Compliance with Authority Required procedures
C14039 P14039 Relapsed and/or refractory multiple myeloma
Initial treatment - Dose requirement of 160 mg per week
The condition must be confirmed by a histological diagnosis; AND
Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must not have previously received this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy 		Compliance with Authority Required procedures
C14045 P14045 Relapsed and/or refractory multiple myeloma
Continuing treatment - Dose requirement of 80 mg, 60 mg or 40 mg per week
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; OR
Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. 		Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Tofacitinib

omit:

C12354 P12354 Severe active rheumatoid arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab)
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 been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
The treatment must be in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times.
Patient must be aged 18 years or older.
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).
If a patient has received 12 weeks or more of therapy with tocilizumab as their most recent treatment, evidence of a response must be provided.
If a patient has not received a minimum of 12 weeks therapy with tocilizumab, evidence of a response is not required to be provided under this restriction. This switch in therapy from tocilizumab will not be counted as treatment failure to tocilizumab.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
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.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
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
C12366 P12366 Severe active rheumatoid arthritis
First continuing treatment - Critical shortage of tocilizumab - Temporary listing
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 this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab); AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
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.
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 application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of 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 has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.
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.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. 		Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Upadacitinib

omit:

C12354 P12354 Severe active rheumatoid arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab)
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 been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
The treatment must be in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times.
Patient must be aged 18 years or older.
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).
If a patient has received 12 weeks or more of therapy with tocilizumab as their most recent treatment, evidence of a response must be provided.
If a patient has not received a minimum of 12 weeks therapy with tocilizumab, evidence of a response is not required to be provided under this restriction. This switch in therapy from tocilizumab will not be counted as treatment failure to tocilizumab.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
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.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
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
C12366 P12366 Severe active rheumatoid arthritis
First continuing treatment - Critical shortage of tocilizumab - Temporary listing
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 this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab); AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
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.
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 application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of 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 has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.
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.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. 		Compliance with Written Authority Required procedures

  1. Schedule 5, entry for Amoxicillin with clavulanic acid

substitute:

Amoxicillin with clavulanic acid GRP-26768 Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) Oral AMCLAVOX DUO FORTE 875/125
APO-AMOXY/CLAV 875/125
APO-Amoxycillin and Clavulanic Acid
APX-Amoxicillin/Clavulanic Acid
AlphaClav Duo Forte
AmoxyClav generichealth 875/125
Amoxyclav AN 875/125
Augmentin Duo forte
Curam Duo Forte 875/125
Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (s19A) Oral Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Aurobindo - Medsurge)
Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Aurobindo – Pro Pharmaceuticals)
Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Micro Labs)

  1. Schedule 5, after entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (s19A)

insert:

Cefalexin GRP-27406 Granules for oral suspension 250 mg (as monohydrate) per 5 mL, 100 mL Oral Cefalexin Sandoz
Ibilex 250
Keflex
Granules for oral suspension 250 mg (as monohydrate) per 5 mL, 100 mL (s19A) Oral Keforal

  1. Schedule 5, after entry for Desvenlafaxine in the form Tablet (modified release) 50 mg (as benzoate) [GRP-16220]

insert:

Disopyramide GRP-27397 Capsule 100 mg Oral Rythmodan
Capsule 100 mg (s19A) Oral Rythmodan (Canada)

  1. Schedule 5, after entry for Lansoprazole in the form Tablet 30 mg (orally disintegrating)

insert:

Larotrectinib GRP-27403 Oral solution 20 mg per mL (as sulfate), 50 mL, 2 Oral VITRAKVI
Oral solution 20 mg per mL (as sulfate), 100 mL Oral Vitrakvi

  1. Schedule 5, after entry for Methylprednisolone in the form Powder for injection 40 mg (as sodium succinate) with diluent

insert:

Minoxidil GRP-27410 Tablet 10 mg Oral Loniten
Tablet 10 mg (s19A) Oral Minoxidil 10 mg (Roma Pharmaceuticals)

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

omit from the column headed “Brand”: ODT Ondansetron GH

  1. Schedule 5, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [GRP-15983]

omit from the column headed “Brand”: ODT Ondansetron GH

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

omit from the column headed “Brand”: ODT Ondansetron GH

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

omit from the column headed “Brand”: ODT Ondansetron GH

  1. Schedule 5, after entry for Perindopril with indapamide in the form Tablet containing perindopril arginine 5 mg with indapamide hemihydrate 1.25 mg

insert:

Phenoxymethylpenicillin GRP-27408 Powder for oral liquid 250 mg (as potassium) per 5 mL, 100 mL Oral Phenoxymethylpenicillin-AFT
Powder for oral liquid 250 mg (as potassium) per 5 mL, 100 mL (s19A) Oral Penopen

  1. Schedule 5, entry for Tenofovir with emtricitabine in the form Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg

insert in alphabetical order in the column headed “Brand”: Tenofovir Disoproxil Emtricitabine Viatris 300/200

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