National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 3) (Cth)

Case

PB 23 of 2022

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022
(No. 3)

National Health Act 1953

________________________________________________________________________

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

Dated 29 March 2022

NIKOLAI TSYGANOV

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

________________________________________________________________________

  1. Name of Instrument

(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 3).

(2)This instrument may also be cited as PB 23 of 2022.

  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 April 2022 1 April 2022

Note: This table relates only to the provisions of this instrument as originally made.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

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

  1. Authority

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

  1. Schedule

Schedule 1 to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1 - Amendments

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

  1. Schedule 1, Part 1, omit entry for Alendronic acid with colecalciferol and calcium

  1. Schedule 1, Part 1, entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine

omit:

Sachets containing oral powder 34 g, 30 (TYR express 20) Oral TYR express 20 VF MP NP C5533 4 5 1

  1. Schedule 1, Part 1, entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine 

omit:

Sachets containing oral powder 34 g, 30 (MSUD express 20) Oral MSUD express 20 VF MP NP C5571 4 5 1

  1. Schedule 1, Part 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

a ATOMED DZ MP NP 30 5 30

  1. Schedule 1, Part 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

a ATOMED DZ MP P7598 30 11 30

  1. Schedule 1, Part 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

a ATOMED DZ MP NP 30 5 30

  1. Schedule 1, Part 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

a ATOMED DZ MP P7598 30 11 30

  1. Schedule 1, Part 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

a ATOMED DZ MP NP 30 5 30

  1. Schedule 1, Part 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

a ATOMED DZ MP P7598 30 11 30

  1. Schedule 1, Part 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

a ATOMED DZ MP NP 30 5 30

  1. Schedule 1, Part 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

a ATOMED DZ MP P7598 30 11 30

  1. Schedule 1, Part 1, entry for Azacitidine

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

a Azacitidine MSN JU MP See Note 3 See Note 3 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, Part 1, entry for Budesonide

insert as first entry:

Capsule (modified release) 3 mg Oral Entocort EU MP NP C12607 90 2 90

  1. Schedule 1, Part 1, after entry for Cabergoline in the form Tablet 2 mg

insert:

Cabotegravir Tablet 30 mg Oral Vocabria VI MP NP C12619 30 0 30 D(100)

  1. Schedule 1, Part 1, after entry for Cabotegravir

insert:

Cabotegravir and rilpivirine Pack containing 1 vial cabotegravir 600 mg in 3 mL and 1 vial rilpivirine 900 mg in 3mL Injection Cabenuva VI MP NP C12636 1 5 1 D(100)

  1. Schedule 1, Part 1, entry for Candesartan in each of the forms: Tablet containing candesartan cilexetil 4 mg; Tablet containing candesartan cilexetil 8 mg; Tablet containing candesartan cilexetil 16 mg; and Tablet containing candesartan cilexetil 32 mg

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

a NOUMED CANDESARTAN VO MP NP 30 5 30

  1. Schedule 1, Part 1, entry for Cromoglycic acid

omit:

Pressurised inhalation containing sodium cromoglycate 5 mg per dose, 112 doses (CFC-free formulation) Inhalation by mouth Intal Forte CFC-Free SW MP NP 1 5 1

  1. Schedule 1, Part 1, entry for Dasatinib in each of the forms: Tablet 20 mg; Tablet 50 mg; Tablet 70 mg; and Tablet 100 mg

omit from the column headed “Responsible Person” for the brand “TE-DASATINIB” (all instances): TI         substitute: AF

  1. Schedule 1, Part 1, omit entry for Docosahexaenoic acid with carbohydrate

  1. Schedule 1, Part 1, entry for Electrolyte replacement, oral

omit:

restore O.R.S. EA MP C6786 30 0 1

  1. Schedule 1, Part 1, after entry for Eletriptan in the form Tablet 80 mg (as hydrobromide)

insert:

Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor Pack containing 56 tablets elexacaftor 100 mg with tezacaftor 50 mg and with ivacaftor 75 mg and 28 tablets ivacaftor 150 mg Oral Trikafta VR MP See Note 3 See Note 3 See Note 3 See Note 3 1 D(100)

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

insert in numerical order in the column headed “Circumstances” (all instances): C12477

  1. Schedule 1, Part 1, omit entry for Etacrynic acid

  1. Schedule 1, Part 1, after entry for Fluticasone furoate with umeclidinium and vilanterol in the form Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms with umeclidinium 62.5 micrograms (as bromide) and vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

insert:

Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms with umeclidinium 62.5 micrograms (as bromide) and vilanterol 25 micrograms (as trifenatate) per dose, 30 doses Inhalation by mouth Trelegy Ellipta 200/62.5/25 GK MP NP C12603 1 5 1

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

omit:

a Lasix-M SW MP NP 100 1 50

  1. Schedule 1, Part 1, entry for Furosemide in the form Tablet 40 mg

omit:

a Lasix SW MP NP 100 1 100

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

omit:

a Dimirel AV MP NP 30 5 30

  1. Schedule 1, Part 1, after entry for Imatinib in the form Tablet 400 mg (as mesilate)

insert:

Tablet 600 mg (as mesilate) Oral Imatab JU MP C9203 C9207 C9208 C9209 C9240 C9319 C12525 C12527 C12536 C12541 C12542 C12543 P9203 P9207 P9208 P9319 P12525 P12527 P12542 P12543 30 2 30
MP C9203 C9207 C9208 C9209 C9240 C9319 C12525 C12527 C12536 C12541 C12542 C12543 P9209 P9240 P12536 P12541 30 5 30

  1. Schedule 1, Part 1, entry for Indacaterol with glycopyrronium and mometasone in each of the forms: Capsule containing powder for oral inhalation indacaterol 114 micrograms (as maleate) with glycopyrronium 46 micrograms (as bromide) and mometasone furoate 68 micrograms (for use in Breezhaler); and Capsule containing powder for oral inhalation indacaterol 114 micrograms (as maleate) with glycopyrronium
    46 micrograms (as bromide) and mometasone furoate 136 micrograms (for use in Breezhaler)

omit from the column headed “Circumstances”: C11470                      substitute: C12603

  1. Schedule 1, Part 1, entry for Ivermectin in the form Tablet 3 mg [Maximum Quantity: 4; Number of Repeats: 0]

insert in numerical order in the column headed “Circumstances”: C12604

  1. Schedule 1, Part 1, entry for Ivermectin in the form Tablet 3 mg [Maximum Quantity: 8; Number of Repeats: 2]

(a)insert in numerical order in the column headed “Circumstances”: C12604

(b)insert in numerical order in the column headed “Purposes”: P12604

  1. Schedule 1, Part 1, entry for Lacosamide

substitute:

Lacosamide Oral solution 10 mg per mL,
200 mL 		Oral Vimpat UC MP NP C8770 C8815 C12092 P12092 2 5 1
MP NP C8770 C8815 C12092 P8770 P8815 6 5 1
Tablet 50 mg Oral a Lacosam AF MP NP C8813 C8815 P8813 14 1 14
a Lacosamide ARX XT MP NP C8813 C8815 P8813 14 1 14
a Lacosamide Lupin GQ MP NP C8813 C8815 P8813 14 1 14
a Lacosamide Sandoz SZ MP NP C8813 C8815 C12092 P8813 14 1 14
a Vimcosa CR MP NP C8813 C8815 C12092 P8813 14 1 14
a Vimpat UC MP NP C8813 C8815 C12092 P8813 14 1 14
a Lacosam AF MP NP C8813 C8815 P8815 56 5 14
a Lacosamide ARX XT MP NP C8813 C8815 P8815 56 5 14
a Lacosamide Lupin GQ MP NP C8813 C8815 P8815 56 5 14
a Lacosamide Sandoz SZ MP NP C8813 C8815 C12092 P8815 P12092 56 5 14
a Vimcosa CR MP NP C8813 C8815 C12092 P8815 P12092 56 5 14
a Vimpat UC MP NP C8813 C8815 C12092 P8815 P12092 56 5 14
Tablet 100 mg Oral a Lacosamide Sandoz SZ MP C8770 C8813 C8815 C12092 C12225 P8813 P12225 14 1 14
NP C8770 C8813 C8815 C12092 P8813 14 1 14
a Vimcosa CR MP C8770 C8813 C8815 C12092 C12225 P8813 P12225 14 1 14
NP C8770 C8813 C8815 C12092 P8813 14 1 14
a Vimpat UC MP C8770 C8813 C8815 C12092 C12225 P8813 P12225 14 1 14
NP C8770 C8813 C8815 C12092 P8813 14 1 14
a Lacosam AF MP NP C8770 C8815 56 5 56
a Lacosamide ARX XT MP NP C8770 C8815 56 5 56
a Lacosamide Lupin GQ MP NP C8770 C8815 56 5 56
a Lacosamide Sandoz SZ MP C8770 C8813 C8815 C12092 C12225 P8770 P8815 P12092 56 5 56
NP C8770 C8813 C8815 C12092 P8770 P8815 P12092 56 5 56
a Vimcosa CR MP C8770 C8813 C8815 C12092 C12225 P8770 P8815 P12092 56 5 56
NP C8770 C8813 C8815 C12092 P8770 P8815 P12092 56 5 56
a Vimpat UC MP C8770 C8813 C8815 C12092 C12225 P8770 P8815 P12092 56 5 56
NP C8770 C8813 C8815 C12092 P8770 P8815 P12092 56 5 56
Tablet 150 mg Oral a Vimcosa CR MP C8770 C8813 C8815 C12092 C12225 P8813 P12225 14 1 14
NP C8770 C8813 C8815 C12092 P8813 14 1 14
a Vimpat UC MP C8770 C8813 C8815 C12092 C12225 P8813 P12225 14 1 14
NP C8770 C8813 C8815 C12092 P8813 14 1 14
a Lacosam AF MP NP C8770 C8815 56 5 56
a Lacosamide ARX XT MP NP C8770 C8815 56 5 56
a Lacosamide Lupin GQ MP NP C8770 C8815 56 5 56
a Lacosamide Sandoz SZ MP NP C8770 C8815 C12092 56 5 56
a Vimcosa CR MP C8770 C8813 C8815 C12092 C12225 P8770 P8815 P12092 56 5 56
NP C8770 C8813 C8815 C12092 P8770 P8815 P12092 56 5 56
a Vimpat UC MP C8770 C8813 C8815 C12092 C12225 P8770 P8815 P12092 56 5 56
NP C8770 C8813 C8815 C12092 P8770 P8815 P12092 56 5 56
Tablet 200 mg Oral a Lacosam AF MP NP C8770 C8815 56 5 56
a Lacosamide ARX XT MP NP C8770 C8815 56 5 56
a Lacosamide Lupin GQ MP NP C8770 C8815 56 5 56
a Lacosamide Sandoz SZ MP NP C8770 C8815 C12092 56 5 56
a Vimcosa CR MP NP C8770 C8815 C12092 56 5 56
a Vimpat UC MP NP C8770 C8815 C12092 56 5 56

  1. Schedule 1, Part 1, entry for Levonorgestrel with ethinylestradiol in the form Pack containing 21 tablets 150 micrograms-30 micrograms and
    7 inert tablets

substitute:

Pack containing 21 tablets 150 micrograms-30 micrograms and
7 inert tablets 		Oral a Eleanor 150/30 ED EA MP NP 4 2 4
a Evelyn 150/30 ED GQ MP NP 4 2 4
a Femme-Tab ED 30/150 AE MP NP 4 2 4
a Lenest 30 ED AF MP NP 4 2 4
a Levlen ED SY MP NP 4 2 4
a Micronelle 30 ED TX MP NP 4 2 4
Monofeme 28 FZ MP NP 4 2 4

  1. Schedule 1, Part 1, entry for Metronidazole in the form Tablet 400 mg

(a)omit:

a Metronide 400 AV PDP C5701 21 0 21

(b)omit:

a Metronide 400 AV MP NP C5702 21 1 21

  1. Schedule 1, Part 1, after entry for Mupirocin in the form Nasal ointment 20 mg (as calcium) per g, 5 g

insert:

Mycobacterium bovis (Bacillus Calmette and Guerin (BCG)) Danish 1331 strain Single dose pack containing powder for irrigation 30 mg,
4 vials 		Intravesical BCG Culture SSI LM MP C5540 3 1 1
MP C5597 3 1 1 C(100)

  1. Schedule 1, Part 1, entry for Nitrofurantoin in the form Capsule 50 mg

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

ARX-Nitrofurantoin XT MP NP MW 30 1 30

(b)omit:

Macrodantin PF MP NP MW 30 1 30

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

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

a ARX-Nitrofurantoin XT MP NP MW 30 1 30

(b)omit:

a Macrodantin  PF MP NP MW 30 1 30

  1. Schedule 1, Part 1, entry for Olaparib in the form Tablet 100 mg [Maximum Quantity: 112; Number of Repeats: 2]

(a)insert in numerical order in the column headed “Circumstances”: C12589 C12590 C12598

(b)insert in numerical order in the column headed “Purposes”: P12589 P12590

  1. Schedule 1, Part 1, entry for Olaparib in the form Tablet 100 mg [Maximum Quantity: 112; Number of Repeats: 5]

(a)insert in numerical order in the column headed “Circumstances”: C12589 C12590 C12598

(b)insert in numerical order in the column headed “Purposes”: P12598

  1. Schedule 1, Part 1, entry for Olaparib in the form Tablet 150 mg [Maximum Quantity: 112; Number of Repeats: 2]

(a)insert in numerical order in the column headed “Circumstances”: C12589 C12590 C12598

(b)insert in numerical order in the column headed “Purposes”: P12589 P12590

  1. Schedule 1, Part 1, entry for Olaparib in the form Tablet 150 mg [Maximum Quantity: 112; Number of Repeats: 5]

(a)insert in numerical order in the column headed “Circumstances”: C12589 C12590 C12598

(b)insert in numerical order in the column headed “Purposes”: P12598

  1. Schedule 1, Part 1, entry for Palonosetron

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

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

a Palonosetron Dr.Reddy's RZ MP NP C5686 1 0 1
MP C5805 1 0 1 C(100)

  1. Schedule 1, Part 1, entry for Pancreatic extract

omit:

Capsule (containing enteric coated minimicrospheres) providing not less than 40,000 BP units of lipase activity Oral Creon 40,000 GO MP NP 200 10 100
MP P5779 200 21 100

  1. Schedule 1, Part 1, after entry for Pancrelipase in the form Capsule (containing enteric coated microtablets) providing not less than 25,000 BP units of lipase activity

insert:

Capsule (containing enteric coated microtablets) providing not less than 25,000 BP units of lipase activity (s19A) Oral Panzytrat 25 000 (Allergan) DZ MP NP 200 10 100
MP P5779 200 21 100

  1. Schedule 1, Part 1, entry for Pegfilgrastim

(a)omit:

a Neulasta JU MP C7822 C7843 C9235 C9303 1 11 1 D(100)

(b)omit:

a Tezmota JX MP C7822 C7843 C9235 C9303 1 11 1 D(100)

  1. Schedule 1, Part 1, entry for Pembrolizumab

(a)omit from the column headed “Circumstances”: C10678

(b)omit from the column headed “Circumstances”: C10809 C10888

  1. Schedule 1, Part 1, entry for Progesterone in the form Pessary 200 mg

substitute:

Pessary 200 mg Vaginal Oripro ON MP C4997 45 0 15 C(100)
MP NP MW C11673 45 3 15

  1. Schedule 1, Part 1, entry for Raltitrexed

omit from the column headed “Circumstances”: C6228

  1. Schedule 1, Part 1, entry for Ramipril in the form Capsule 10 mg

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

APX-Ramipril TY MP NP 30 5 30

  1. Schedule 1, Part 1, after entry for Sildenafil

insert:

Siltuximab Powder for injection 100 mg Injection Sylvant EY MP C12585 C12594 2 4 1 D(100)
Powder for injection 400 mg Injection Sylvant EY MP C12585 C12594 2 4 1 D(100)

  1. Schedule 1, Part 1, entry for Siponimod in the form Tablet 250 micrograms (as hemifumarate)

omit from the column headed “Circumstances” (all instances): C10956

  1. Schedule 1, Part 1, entry for Siponimod in the form Tablet 2 mg (as hemifumerate)

omit from the column headed “Circumstances”: C10956

  1. Schedule 1, Part 1, after entry for Somatropin in the form Injection 18 i.u. (6 mg) cartridge with 3.15 mL diluent (with preservative)

insert:

Injection 36 i.u. (12 mg) cartridge with 3.15 mL diluent (with preservative) Injection Humatrope LY MP C5146 C5147 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8338 C8343 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8376 C8377 C8380 C8393 C8394 C8396 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8424 C8425 C8426 C8439 C8472 C8502 C9221 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, Part 1, entry for Somatropin in each of the forms: Powder for injection 5 mg (15 i.u.) with diluent in pre-filled pen (with preservative); and Powder for injection 12 mg (36 i.u.) with diluent in pre-filled pen (with preservative)

(a)omit from the column headed “Circumstances”: C11117 C11151

(b)insert in numerical order in the column headed “Circumstances”: C12588 C12601

  1. Schedule 1, Part 1, after entry for Somatropin in the form Powder for injection 12 mg (36 i.u.) with diluent in pre-filled pen (with preservative)

omit:

Injection 36 i.u. (12 mg) cartridge with 3.15 mL diluent (with preservative) Injection Humatrope LY MP C5146 C5147 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8338 C8343 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8376 C8377 C8380 C8393 C8394 C8396 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8424 C8425 C8426 C8439 C8472 C8502 C9221 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, Part 1, entry for Somatropin in the form Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen

(a)omit from the column headed “Circumstances”: C11117 C11151

(b)insert in numerical order in the column headed “Circumstances”: C12588 C12601

  1. Schedule 1, Part 1, entry for Somatropin in the form Solution for injection 10 mg (30 i.u.) in 2 mL cartridge (with preservative)

(a)omit from the column headed “Circumstances”: C11117 C11151        

(b)insert in numerical order in the column headed “Circumstances”: C12588 C12601

  1. Schedule 1, Part 1, entry for Tiotropium in the form Solution for oral inhalation 2.5 micrograms (as bromide monohydrate) per actuation
    (60 actuations)

(a)omit from the column headed “Circumstances”: C8605

(b)insert in numerical order in the column headed “Circumstances”: C12599

  1. Schedule 1, Part 1, after entry for Trastuzumab in the form Powder for I.V. infusion 420 mg

insert:

Powder for I.V. infusion 440 mg with diluent Injection Herzuma EW MP C9349 C9353 C9571 C9573 C10213 C10293 C10294 C10296 See Note 3 See Note 3 1 PB(100)

  1. Schedule 1, Part 2,

insert as first entry:

Alendronic acid with colecalciferol and calcium Pack containing 4 tablets containing alendronic acid 70 mg (as alendronate sodium) with
140 micrograms colecalciferol and 48 tablets calcium 500 mg (as carbonate) 		Oral ReddyMax Plus D‑Cal RZ MP NP C6306 C6319 C6325 1 5 1

  1. Schedule 1, Part 2, after entry for Alendronic acid with colecalciferol and calcium

insert:

Amino acid formula with vitamins and minerals without phenylalanine and tyrosine Sachets containing oral powder 34 g, 30 (TYR express 20) Oral TYR express 20 VF MP NP C5533 4 5 1

  1. Schedule 1, Part 2, after entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine

insert:

Amino acid formula with vitamins and minerals without valine, leucine and isoleucine Sachets containing oral powder 34 g, 30 (MSUD express 20) Oral MSUD express 20 VF MP NP C5571 4 5 1

  1. Schedule 1, Part 2, after entry for Calcipotriol with betamethasone

insert:

Cromoglycic acid Pressurised inhalation containing sodium cromoglycate 5 mg per dose, 112 doses (CFC‑free formulation) Inhalation by mouth Intal Forte CFC‑Free SW MP NP 1 5 1

  1. Schedule 1, Part 2, after entry for Desmopressin

insert:

Electrolyte replacement, oral Oral rehydration salts containing glucose monohydrate 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10 Oral restore O.R.S. EA MP C6786 30 0 1

  1. Schedule 1, Part 2, after entry for Palbociclib in the form Capsule 125 mg

insert:

Pancreatic extract Capsule (containing enteric coated minimicrospheres) providing not less than 40,000 BP units of lipase activity Oral Creon 40,000 GO MP NP 200 10 100
MP P5779 200 21 100

  1. Schedule 3, after details relevant for Responsible Person code EW

insert:

EY EUSA Pharma (Australia) Pty Ltd 14 646 058 728

  1. Schedule 4, Part 1, entry for Budesonide

insert in numerical order after existing text:

C12607 Mild to moderate Crohn disease
The condition must affect the ileum; OR
The condition must affect the ascending colon; OR
The condition must affect the ileum and ascending colon.
The total duration of therapy should be no more than 12 weeks in any single course. 		Compliance with Authority Required procedures - Streamlined Authority Code 12607

  1. Schedule 4, Part 1, after entry for Cabergoline

insert:

Cabotegravir C12619 HIV infection
Patient must be virologically suppressed on a stable antiretroviral regimen for at least 6 months; AND
The treatment must be in combination with rilpivirine tablets; AND
Patient must intend to proceed to treatment with intramuscular administration of cabotegravir and rilpivirine. 		Compliance with Authority Required procedures - Streamlined Authority Code 12619

  1. Schedule 4, Part 1, after entry for Cabotegravir

insert:

Cabotegravir and rilpivirine C12636 HIV infection
Patient must have previously received PBS-subsidised therapy for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition. 		Compliance with Authority Required procedures - Streamlined Authority Code 12636

  1. Schedule 4, Part 1, omit entry for Docosahexaenoic acid with carbohydrate

  1. Schedule 4, Part 1, entry for Empagliflozin

insert in numerical order after existing text:

C12477 Chronic heart failure
Patient must be symptomatic with NYHA classes II, III or IV; AND
Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor. 		Compliance with Authority Required procedures - Streamlined Authority Code 12477

  1. Schedule 4, Part 1, omit entry for Etacrynic acid

  1. Schedule 4, Part 1, entry for Fluticasone furoate with umeclidinium and vilanterol

insert in numerical order after existing text:

C12603 Severe asthma
Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of: (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique.
Patient must be at least 18 years of age.
Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist. 		Compliance with Authority Required procedures - Streamlined Authority Code 12603

  1. Schedule 4, Part 1, entry for Indacaterol with glycopyrronium and mometasone

substitute:

Indacaterol with glycopyrronium and mometasone C12603 Severe asthma
Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of: (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique.
Patient must be at least 18 years of age.
Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist. 		Compliance with Authority Required procedures - Streamlined Authority Code 12603

  1. Schedule 4, Part 1, entry for Ivermectin

insert in numerical order after existing text:

C12604 P12604 Human sarcoptic scabies
The condition must be established by clinical and/or parasitological examination.
Patient must identify as Aboriginal or Torres Strait Islander; AND
Patient must weigh 15 kg or over; AND
Patient must be 5 years of age or older. 		Compliance with Authority Required procedures - Streamlined Authority Code 12604

  1. Schedule 4, Part 1, after entry for Mupirocin

insert:

Mycobacterium bovis (Bacillus Calmette and Guerin (BCG)) Danish 1331 strain C5540 Primary and relapsing superficial urothelial carcinoma of the bladder
C5597 Primary and relapsing superficial urothelial carcinoma of the bladder

  1. Schedule 4, Part 1, entry for Olaparib

insert in numerical order after existing text:

C12589 P12589 Castration resistant metastatic carcinoma of the prostate
Transitioning from non-PBS to PBS-subsided treatment - Grandfather arrangements
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 April 2022; AND
The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation; AND
The treatment must not be subsidised in combination with: (i) chemotherapy, (ii) a novel hormonal drug; AND
The condition must have progressed following prior treatment that included a novel hormonal drug for this condition (metastatic/non-metastatic disease), prior to initiating non-PBS-subsidised treatment with this drug; AND
Patient must have had a WHO performance status of 2 or less prior to initiating non-PBS-subsidised treatment.
Patient must be undergoing continuing treatment with this drug where non-PBS-subsidised treatment was for untreated (with this drug) disease which also has not progressed on non-PBS-subsidised treatment. 		Compliance with Authority Required procedures
C12590 P12590 Castration resistant metastatic carcinoma of the prostate
Initial treatment
The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation; AND
The treatment must not be subsidised in combination with: (i) chemotherapy, (ii) a novel hormonal drug; AND
The condition must have progressed following prior treatment that included a novel hormonal drug for this condition (metastatic/non-metastatic disease); AND
Patient must have a WHO performance status of 2 or less.
Patient must be undergoing treatment with this drug for the first time. 		Compliance with Authority Required procedures
C12598 P12598 Castration resistant metastatic carcinoma of the prostate
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 treatment with this drug for this condition; AND
The treatment must not be subsidised in combination with: (i) chemotherapy, (ii) a novel hormonal drug. 		Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Pembrolizumab

(a)omit:

C10678 Relapsed or refractory primary mediastinal B-cell lymphoma
Grandfather treatment (initial treatment of a patient commenced on non-PBS-subsidised treatment)
Patient must have received treatment with this drug for this condition prior to 1 September 2020; AND
The condition must be diagnosed as primary mediastinal B-cell lymphoma through histological investigation combined with at least one of: (i) positron emission tomography - computed tomography (PET-CT) scan, (ii) PET scan, (iii) CT scan, with the results retained in the patient's medical records; AND
Patient must have been treated with rituximab-based chemotherapy prior to initiating treatment with this drug for this condition; AND
Patient must have been experiencing relapsed/refractory disease prior to initiating treatment with this drug for this condition; AND
Patient must have been autologous stem cell transplant (ASCT) ineligible following a single line of treatment prior to initiating treatment with this drug for this condition; OR
Patient must have undergone an autologous stem cell transplant (ASCT) prior to initiating treatment with this drug for this condition; OR
Patient must have been treated with at least 2 chemotherapy treatment lines for this condition, one of which must have included rituximab-based chemotherapy, prior to initiating treatment with this drug for this condition; AND
Patient must not have received treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must not exceed a total of 35 cycles in a lifetime; AND
The treatment must not exceed a total of 7 doses under this restriction.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form;
(b) a completed primary mediastinal B-cell lymphoma pembrolizumab PBS Authority Application for Grandfathered patients, which includes:
(i) confirmation that histology results and PET/CT scans support a diagnosis of primary mediastinal B-cell lymphoma and are retained on the patient's medical records;
(ii) details of prior treatments for this condition 		Compliance with Written Authority Required procedures

(b)omit:

C10809 Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Grandfather treatment - 6 weekly treatment regimen
Patient must have previously received non-PBS-subsidised drug for adjuvant treatment following complete surgical resection prior to 1 September 2020; AND
Patient must have a WHO performance status of 1 or less prior to starting non-PBS treatment with this drug; AND
Patient must not have evidence of recurrence; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
Patient must have commenced non-PBS-subsidised treatment within 12 weeks of complete surgical resection; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. 		Compliance with Authority Required procedures
C10888 Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Grandfather treatment - 3 weekly treatment regimen
Patient must have previously received non-PBS-subsidised drug for adjuvant treatment following complete surgical resection prior to 1 September 2020; AND
Patient must have a WHO performance status of 1 or less prior to starting non-PBS treatment with this drug; AND
Patient must not have evidence of recurrence; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
Patient must have commenced non-PBS-subsidised treatment within 12 weeks of complete surgical resection; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. 		Compliance with Authority Required procedures

  1. Schedule 4, Part 1, omit entry for Raltitrexed

  1. Schedule 4, Part 1, after entry for Sevelamer

insert:

Siltuximab C12585 Idiopathic multicentric Castleman disease (iMCD)
Initial treatment
Patient must have a diagnosis of iMCD consistent with the latest international, evidence-based consensus diagnostic criteria for this condition with the relevant diagnostic findings documented in the patient's medical records; AND
The condition must not be, to the prescriber's best knowledge, any of the following diseases that can mimic iMCD: (i) human herpes virus-8 infection, (ii) an Epstein-Barr virus-lymphoproliferative disorder, (iii) an acute/uncontrolled infection (e.g. cytomegalovirus, toxoplasmosis, human immunodeficiency virus, tuberculosis) leading to inflammation with adenopathy, (iv) an autoimmune/autoinflammatory disease, (v) a malignant/lymphoproliferative disorder.
Must be treated by a haematologist; OR
Must be treated by a medical physician working under the supervision of a haematologist; AND
Patient must be undergoing treatment through this treatment phase once only in a lifetime, where the full number of repeats are prescribed; OR
Patient must be undergoing treatment through this treatment phase for up to the first 5 doses in a lifetime, where the full number of repeats was not prescribed with the first prescription.
Prescribe the most efficient combination of vials/strengths based on the patient's body weight to keep any amount of unused drug to a minimum. 		Compliance with Authority Required procedures
C12594 Idiopathic multicentric Castleman disease (iMCD)
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 treatment with this drug for this condition.
Must be treated by a haematologist; OR
Must be treated by a medical physician working under the supervision of a haematologist.
Prescribe the most efficient combination of vials/strengths based on the patient's body weight to keep any amount of unused drug to a minimum. 		Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Siponimod

omit:

C10956 Multiple sclerosis
Grandfather treatment (transition from non-PBS-subsidised to PBS-subsidised treatment)
Patient must have commenced non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 November 2020; AND
The condition must have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of at least one of the brain/spinal cord prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR
The condition must have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis supported by written certification, which is documented in the patient's medical records, from a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have mild disability in at least 3 functional systems prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR
Patient must have moderate disability in at least 1 functional system prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must be ambulatory, with/without assistance/support; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Functional systems referred to in this restriction are the: visual, brain stem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral/cognitive systems.
A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. 		Compliance with Authority Required procedures - Streamlined Authority Code 10956

  1. Schedule 4, Part 1, entry for Somatropin

(a)omit:

C11117 Severe growth hormone deficiency
Initial treatment of adult onset growth hormone deficiency
Must be treated by an endocrinologist.
Patient must have adult onset growth hormone deficiency secondary to organic hypothalamic or pituitary disease; AND
Patient must have an insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; OR
Patient must have an arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; OR
Patient must have a glucagon provocation test with maximum serum GH less than 3 micrograms per litre.
Patient must be aged 18 years or older.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender. 		Compliance with Written Authority Required procedures
C11151 Severe growth hormone deficiency
Continuing treatment in a person with a mature skeleton or aged 18 years or older
Must be treated by an endocrinologist.
Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause in a patient with a mature skeleton, or, in a patient with Prader-Willi syndrome and aged 18 years or older; OR
Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to adult onset growth hormone deficiency secondary to organic hypothalamic or pituitary disease in a patient aged 18 years or older. 		Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C12588 Severe growth hormone deficiency
Initial treatment of late onset growth hormone deficiency
Must be treated by an endocrinologist.
Patient must have onset of growth hormone deficiency secondary to organic hypothalamic or pituitary disease diagnosed at chronological age of 18 years or older; OR
Patient must have onset of growth hormone deficiency diagnosed after skeletal maturity (bone age greater than or equal to 15.5 years in males or 13.5 years in females) and before chronological age of 18 years; AND
Patient must have a diagnostic insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; OR
Patient must have a diagnostic arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; OR
Patient must have a diagnostic glucagon provocation test with maximum serum GH less than 3 micrograms per litre.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender. 		Compliance with Written Authority Required procedures
C12601 Severe growth hormone deficiency
Continuing treatment in a person with a mature skeleton or aged 18 years or older
Must be treated by an endocrinologist.
Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause in a patient with a mature skeleton, or, in a patient with Prader-Willi syndrome and chronological age of 18 years or older; OR
Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to late onset of growth hormone deficiency secondary to organic hypothalamic or pituitary disease in a patient with chronological age of 18 years or older; OR
Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to late onset of growth hormone deficiency diagnosed after skeletal maturity (bone age greater than or equal to 15.5 years in males or 13.5 years in females) and before chronological age of 18 years. 		Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Tiotropium

(a)omit:

C8605 Severe asthma
Patient must have experienced at least one severe exacerbation, which has required documented use of systemic corticosteroids, in the previous 12 months while receiving optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta-2 agonist (LABA) unless a LABA is contraindicated.
Patient must be aged 18 years or older.
Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.

(b)insert in numerical order after existing text:

C12599 Severe asthma
Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of: (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique; AND
The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta-2 agonist (LABA) unless a LABA is contraindicated.
Patient must be at least 18 years of age.
Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.

  1. Schedule 5, after entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [GRP-26052]

insert:

GRP-26183 Injection 50 mg in 1 mL single use auto-injector, 4 Injection Brenzys
Injections 50 mg in 1 mL single use pre-filled syringes, 4 Injection Brenzys

  1. Schedule 5, entry for Nitrofurantoin in the form Capsule 50 mg

(a)insert in alphabetical order in the column headed “Brand”: ARX-Nitrofurantoin

(b)omit from the column headed “Brand”: Macrodantin

  1. Schedule 5, after entry for Ondansetron in the form Wafter 8 mg [GRP-17042]

insert:

Pancrelipase GRP-26177 Capsule (containing enteric coated microtablets) providing not less than 25,000 BP units of lipase activity Oral Panzytrat 25000
Capsule (containing enteric coated microtablets) providing not less than 25,000 BP units of lipase activity (s19A) Oral Panzytrat 25 000 (Allergan)

  1. Schedule 5, entry for Ramipril in the form Capsule 10 mg [GRP-15431]

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

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