National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 10) (PB 83 of 2018) (Cth)

Case

PB 83 of 2018

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 10)

National Health Act 1953

___________________________________________________________________________

I, LISA LA RANCE, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated 25 September 2018

LISA LA RANCE

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health


___________________________________________________________________________

  1. Name of Instrument

(1)This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 10).

(2)This Instrument may also be cited as PB 83 of 2018.

  1. Commencement

This Instrument commences on 1 October 2018.

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

Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Schedule 1       Amendments

  1. Section 4, Definitions

omit:

General Statement for Lipid Lowering Drugs means the statement set out in Part 2 of Schedule 4;

  1. Schedule 1, entry for Amino acids-synthetic, formula

omit:

Oral powder 400 g (Neocate Advance) Oral Neocate Advance SB MP NP C4305 C4312 C4323 C4330 C4337 C4338 C4339 C4345 C4352 C4415 8 5 1

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

omit:

a Ozlodip RA MP NP 30 5 30

  1. Schedule 1, entry for Amoxicillin in the form Capsule 250 mg (as trihydrate) [Maximum Quantity: 20; Number of Repeats: 0]

omit:

a Yomax 250 DO PDP 20 0 20

  1. Schedule 1, entry for Amoxicillin in the form Capsule 250 mg (as trihydrate) [Maximum Quantity: 20; Number of Repeats: 1]

omit:

a Yomax 250 DO MP NP MW 20 1 20

  1. Schedule 1, entry for Amoxicillin in the form Capsule 500 mg (as trihydrate) [Maximum Quantity: 20; Number of Repeats: 0]

omit:

a Yomax 500 DO PDP 20 0 20

  1. Schedule 1, entry for Amoxicillin in the form Capsule 500 mg (as trihydrate) [Maximum Quantity: 20; Number of Repeats: 1]

omit:

a Yomax 500 DO MP NP MW 20 1 20

  1. Schedule 1, entry for Anastrozole

omit:

a Azastrole ER MP NP C5464 30 5 30

  1. Schedule 1, entry for Bendamustine in the form Powder for injection containing bendamustine hydrochloride 25 mg

omit from the column headed "Circumstances": C6075 C6124            substitute: C7943 C7944 C7972

  1. Schedule 1, entry for Bendamustine in the form Powder for injection containing bendamustine hydrochloride 100 mg

omit from the column headed "Circumstances": C6075 C6124           substitute: C7943 C7944 C7972

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

omit from the column headed "Circumstances": C7376 C7377 C7389 C7390 C7402       

substitute: C7940 C7941 C7963 C7984 C7992

  1. Schedule 1, entry for Bortezomib in the form Powder for injection 3 mg

omit from the column headed "Circumstances": C4080 C4081 C4161 C4162 C7376 C7377 C7389 C7390 C7402 C7414 C7416

substitute: C7938 C7939 C7940 C7941 C7960 C7961 C7962 C7963 C7974 C7984 C7992

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

omit from the column headed "Circumstances": C4080 C4081 C4161 C4162 C7414 C7416       

substitute: C7938 C7939 C7960 C7961 C7962 C7974

  1. Schedule 1, entry for Bosentan in each of the forms: Tablet 62.5 mg (as monohydrate); and Tablet 125 mg (as monohydrate)

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

a BOSENTAN DR. REDDY'S RI MP See Note 3 See Note 3 See Note 3 See Note 3 60 D(100)

  1. Schedule 1, entry for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

(a)omit from the column headed "Circumstances" for the brand “DuoResp Spiromax”: C7527         substitute: C7970

(b)omit from the column headed "Circumstances" for the brand “Symbicort Turbuhaler 200/6”: C4380     substitute: C7970

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

(a)omit from the column headed "Circumstances" for the brand “DuoResp Spiromax”: C7527 C7574        substitute: C4689 C7979

(b)omit from the column headed "Circumstances" for the brand “Symbicort Turbuhaler 400/12”: C4394

(c)insert in numerical order in the column headed “Circumstances” for the brand “Symbicort Turbuhaler 400/12”: C7979

  1. Schedule 1, entry for Calcipotriol with betamethasone

omit:

Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g Application Daivobet 50/500 gel LO MP  NP C6809 1 1 1

  1. Schedule 1, entry for Calcipotriol with betamethasone in the form Gel containing calcipotriol 50 micrograms with betamethasone
    500 micrograms (as dipropionate) per g, 60 g 

omit from the column headed "Circumstances": C6873         substitute: C7947

  1. Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 4 mg

omit:

a Auro-Candesartan 4 DO MP NP 30 5 30

  1. Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 8 mg

omit:

a Auro-Candesartan 8 DO MP NP 30 5 30

  1. Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 16 mg

omit:

a Auro-Candesartan 16 DO MP NP 30 5 30

  1. Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 32 mg

omit:

a Auro-Candesartan 32 DO MP NP 30 5 30

  1. Schedule 1, entry for Capecitabine in the form Tablet 150 mg

omit:

a Xelabine QA MP 60 2 60

  1. Schedule 1, entry for Carbohydrate, fat, vitamins, minerals and trace elements and supplemented with arachidonic acid and docosahexaenoic acid 

omit: 

Sachets containing oral powder 21.5 g, 30 (basecal 100) Oral basecall 100 VF MP NP C4438 4 5 1

  1. Schedule 1, entry for Cefalexin in the form Capsule 250 mg (as monohydrate) [Maximum Quantity: 20; Number of Repeats: 0]

omit:

a Rancef RA PDP 20 0 20

  1. Schedule 1, entry for Cefalexin in the form Capsule 250 mg (as monohydrate) [Maximum Quantity: 20; Number of Repeats: 1]

omit:

a Rancef RA MP NP MW 20 1 20

  1. Schedule 1, entry for Cefalexin in the form Capsule 250 mg (as monohydrate) [Maximum Quantity: 40; Number of Repeats: 2]

omit:

a Rancef RA MP P4243 40
CN4243 		2
CN4243 		20

  1. Schedule 1, entry for Cisplatin in each of the forms: I.V. injection 50 mg in 50 mL; and I.V. injection 100 mg in 100 mL

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

Cisplatin Accord OC MP See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Citalopram in the form Tablet 20 mg (as hydrobromide) 

(a)omit:

a Auro-Citalopram 20 DO MP NP C4755 28 5 28

(b)omit:

a Celica RA MP NP C4755 28 5 28

  1. Schedule 1, entry for Citalopram in the form Tablet 40 mg (as hydrobromide)

omit:

a Auro-Citalopram 40 DO MP NP C4755 28 5 28

  1. Schedule 1, entry for Clindamycin

(a)omit:

a Cleocin FZ PDP C5487 24 0 24

(b)omit:

a Cleocin FZ MP NP MW C5470 48 1 24

  1. Schedule 1, entry for Clopidogrel with aspirin

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

a CLOPIDOGREL/ASPIRIN AN 75/100 ED MP NP C5443 C5488 C5517 30 5 30

  1. Schedule 1, entry for Cyclophosphamide

omit:

Tablet 50 mg (as monohydrate) Oral Endoxan BX MP 50 2 50

  1. Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg

omit:

a Cyrotone ER MP 100 5 50

  1. Schedule 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)

omit:

a Depreta 30 DO MP NP C5650 28 0 28

  1. Schedule 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)

omit:

a Depreta 60 DO MP NP C5650 28 5 28

  1. Schedule 1, omit entry for Emtricitabine

  1. Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)

omit:

a Escicor 10 RA MP NP C4755 28 5 28

  1. Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)

omit:

a Escicor 20 RA MP NP C4755 28 5 28

  1. Schedule 1, entry for Ezetimibe

substitute:

Ezetimibe Tablet 10 mg Oral a APO-Ezetimibe TX MP NP C7966 C7996 30 5 30
a Blooms The Chemist Ezetimibe IB MP NP C7966 C7996 30 5 30
a EZEMICHOL RW MP NP C7966 C7990 C7996 30 5 30
a Ezetimibe GH GQ MP NP C7966 C7996 30 5 30
a Ezetimibe Sandoz SZ MP NP C7966 C7996 30 5 30
a Ezetrol MK MP NP C7966 C7990 C7996 30 5 30
a Pharmacor Ezetimibe 10 CR MP NP C7966 C7990 C7996 30 5 30
a Zient 10mg AF MP NP C7966 C7990 C7996 30 5 30

  1. Schedule 1, entry for Ezetimibe and rosuvastatin

substitute:

Ezetimibe and rosuvastatin Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 5 mg (as calcium) Oral a Ezalo Composite Pack 10mg+5mg AF MP NP C7958 1 5 1
a Rosuzet Composite Pack MK MP NP C7958 1 5 1
Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 10 mg (as calcium) Oral a Ezalo Composite Pack 10mg+10mg AF MP NP C7957 1 5 1
a Rosuzet Composite Pack MK MP NP C7957 1 5 1
Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 20 mg (as calcium) Oral a Ezalo Composite Pack 10mg+20mg AF MP NP C7957 1 5 1
a Rosuzet Composite Pack MK MP NP C7957 1 5 1
Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 40 mg (as calcium) Oral a Ezalo Composite Pack 10mg+40mg AF MP NP C7957 1 5 1
a Rosuzet   Composite Pack MK MP NP C7957 1 5 1

  1. Schedule 1, entry for Ezetimibe with atorvastatin

substitute:

Ezetimibe with atorvastatin Tablet 10 mg-10 mg Oral Atozet MK MP NP C7958 30 5 30
Tablet 10 mg-20 mg Oral Atozet MK MP NP C7957 30 5 30
Tablet 10 mg-40 mg Oral Atozet MK MP NP C7957 30 5 30
Tablet 10 mg-80 mg Oral Atozet MK MP NP C7957 30 5 30

  1. Schedule 1, entry for Ezetimibe with simvastatin

substitute:

Ezetimibe with simvastatin Tablet 10 mg-10 mg                  Oral a APO-Ezetimibe/Simvastatin 10/10 TX MP NP C7958 30 5 30
a EZETIMIBE/SIMVASTATIN SANDOZ SZ MP NP C7958 30 5 30
a Vytorin MK MP NP C7958 30 5 30
a Zeklen 10/10 mg AF MP NP C7958 30 5 30
Tablet 10 mg-20 mg Oral a APO-Ezetimibe/Simvastatin 10/20 TX MP NP C7958 30 5 30
a EZETIMIBE/SIMVASTATIN SANDOZ SZ MP NP C7958 30 5 30
a Vytorin MK MP NP C7958 30 5 30
a Zeklen 10/20 mg AF MP NP C7958 30 5 30
Tablet 10 mg-40 mg Oral a APO-Ezetimibe/Simvastatin 10/40 TX MP NP C7957 30 5 30
a EZETIMIBE/SIMVASTATIN SANDOZ SZ MP NP C7957 30 5 30
a Vytorin MK MP NP C7957 30 5 30
a Zeklen 10/40 mg AF MP NP C7957 30 5 30
Tablet 10 mg-80 mg Oral a APO-Ezetimibe/Simvastatin 10/80 TX MP NP C7957 30 5 30
a EZETIMIBE/SIMVASTATIN SANDOZ SZ MP NP C7957 30 5 30
a Vytorin MK MP NP C7957 30 5 30
a Zeklen 10/80 mg AF MP NP C7957 30 5 30

  1. Schedule 1, entry for Flucloxacillin in the form Powder for injection 1 g (as sodium monohydrate) [Maximum Quantity: 5; Number of Repeats: 0]

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

a Flubiclox JU PDP 5 0 10

  1. Schedule 1, entry for Flucloxacillin in the form Powder for injection 1 g (as sodium monohydrate) [Maximum Quantity: 5; Number of Repeats: 1]

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

a Flubiclox JU MP NP 5 1 10

  1. Schedule 1, entry for Fluorouracil in the form Injection 500 mg in 10 mL

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

Fluorouracil Accord OC MP C6266 C6297 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Ganciclovir

substitute:

Ganciclovir Powder for I.V. infusion 500 mg (as sodium) Injection a Cymevene RO MP C4972 C4990 C4999 C5000 C5025 10 1 5 D(100)
a GANCICLOVIR SXP HN MP C4972 C4990 C4999 C5000 C5025 10 1 5 D(100)

  1. Schedule 1, omit entry for Indinavir

  1. Schedule 1, after entry for Insect allergen extract-paper wasp venom in the form Injection set containing 550 micrograms

insert:

Injection set containing 550 micrograms with diluent Injection Hymenoptera Paper Wasp Venom DE MP 1 0 1

  1. Schedule 1, after entry for Insect allergen extract-yellow jacket venom in the form Injection set containing 550 micrograms

insert:

Injection set containing 550 micrograms with diluent Injection Hymenoptera Yellow Jacket Venom DE MP 1 0 1

  1. Schedule 1, entry for Ivabradine in the form Tablet 5 mg (as hydrochloride)

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

a APO-Ivabradine TX MP NP C4979 56 5 56

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

  1. Schedule 1, entry for Ivabradine in the form Tablet 7.5 mg (as hydrochloride)

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

a APO-Ivabradine TX MP NP C4979 56 5 56

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

  1. Schedule 1, entry for Lercanidipine in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg; and Tablet containing lercanidipine hydrochloride 20 mg

omit:

a Ledip RA MP NP 28 5 28

  1. Schedule 1, entry for Lipegfilgrastim

substitute:

Lipegfilgrastim Injection 6 mg in 0.6 mL single use pre-filled syringe Injection Lonquex TB MP C7822 C7823 C7843 C7862 1 11 1 D(100)

  1. Schedule 1, after entry for Losartan in the form Tablet containing losartan potassium 50 mg

insert:

Lumacaftor with ivacaftor Tablet containing lumacaftor 100 mg with ivacaftor 125 mg Oral Orkambi VR MP See Note 3 See Note 3 See Note 3 112 D(100)
Tablet containing lumacaftor 200 mg with ivacaftor 125 mg Oral Orkambi VR MP See Note 3 See Note 3 See Note 3 112 D(100)

  1. Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg

omit:

a Metoprolol RBX RA MP NP 100 5 100

  1. Schedule 1, omit entry for Milk powder -- lactose free formula

  1. Schedule 1, entry for Mirtazapine in the form Tablet 30 mg

omit:

a Aurozapine 30 DO MP NP C5650 30 5 30

  1. Schedule 1, entry for Mirtazapine in the form Tablet 45 mg

omit:

a Aurozapine 45 DO MP NP C5650 30 5 30

  1. Schedule 1, entry for Naltrexone

omit:

a ReVia BQ MP NP C5364 30 1 30

  1. Schedule 1, omit entry for Nandrolone decanoate

  1. Schedule 1, entry for Obinutuzumab

insert in numerical order in the column headed “Circumstances”: C7935 C7936 C7950 C7959 C7968 C7981

  1. Schedule 1, entry for Ocriplasmin

omit from the column headed "Responsible Person": NV            substitute: IJ

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

omit:

Ozin ODT 5 DO MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Olanzapine in the form Tablet 10 mg (orally disintegrating) 

omit:

Ozin ODT 10 DO MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Olanzapine in the form Tablet 15 mg (orally disintegrating)

omit:

Ozin ODT 15 DO MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Olanzapine in the form Tablet 20 mg (orally disintegrating)

omit:

Ozin ODT 20 DO MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)

omit:

a Zilfojim 4 DO MP NP C4102 10 1 10

  1. Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate)

omit:

a Zilfojim 8 DO MP NP C4102 10 1 10

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30; Number of Repeats: 2]

omit:

a Topra 40 DO MP NP C5444 C5445 C5512 C5529 P5445 30 2 30

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30; Number of Repeats: 5]

omit:

a Topra 40 DO MP NP C5444 C5445 C5512 C5529 P5444 P5512 P5529 30 5 30

  1. Schedule 1, entry for Pegfilgrastim

(a)omit from the column headed "Responsible Person" for the brand “Neulasta”: AN substitute: JU

(b)omit from the column headed "Responsible Person" for the brand “Ristempa”: GV substitute: JO

  1. Schedule 1, entry for Pioglitazone in the form Tablet 15 mg (as hydrochloride)

omit:

a Pizaccord RA MP NP C4363 C4364 C4388 28 5 28
a Prioten 15 DO MP NP C4363 C4364 C4388 28 5 28

  1. Schedule 1, entry for Pioglitazone in the form Tablet 30 mg (as hydrochloride)

omit:

a Prioten 30 DO MP NP C4363 C4364 C4388 28 5 28

  1. Schedule 1, entry for Pioglitazone in the form Tablet 45 mg (as hydrochloride)

omit:

a Pizaccord RA MP NP C4363 C4364 C4388 28 5 28
a Prioten 45 DO MP NP C4363 C4364 C4388 28 5 28

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Maximum Quantity: 30; Number of Repeats: 5]

omit:

a Auro-Pravastatin 10 DO MP NP 30 5 30

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit:

a Auro-Pravastatin 10 DO MP P7598 30 11 30

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Maximum Quantity: 30; Number of Repeats: 5]

omit:

a Auro-Pravastatin 20 DO MP NP 30 5 30

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit:

a Auro-Pravastatin 20 DO MP P7598 30 11 30

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Maximum Quantity: 30; Number of Repeats: 5]

omit:

a Auro-Pravastatin 40 DO MP NP 30 5 30

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit:

a Auro-Pravastatin 40 DO MP P7598 30 11 30

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg [Maximum Quantity: 30; Number of Repeats: 5]

omit:

a Auro-Pravastatin 80 DO MP NP 30 5 30

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit:

a Auro-Pravastatin 80 DO MP P7598 30 11 30

  1. Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)

omit:

a Delucon 25 DO MP NP C7893 C7916 C7927 60 0 60

  1. Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)

omit:

a Delucon 100 DO MP NP C4246 C5611 C5639 90 5 90

  1. Schedule 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)

omit:

a Delucon 200 DO MP NP C4246 C5611 C5639 60 5 60

  1. Schedule 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)

omit:

a Delucon 300 DO MP NP C4246 C5611 C5639 60 5 60

  1. Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 10 mg (enteric coated)

omit:

a Razit 10 DO MP NP C5444 C5512 28 5 28

  1. Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 2]

(a)omit:

a Rabeprazole generichealth GQ MP NP C5444 C5445 C5512 P5445 30 2 30

(b)omit:

a Razit 20 DO MP NP C5444 C5445 C5512 P5445 30 2 30

  1. Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit:

a Rabeprazole generichealth GQ MP NP C5444 C5445 C5512 P5444 P5512 30 5 30

(b)omit:

a Razit 20 DO MP NP C5444 C5445 C5512 P5444 P5512 30 5 30

  1. Schedule 1, entry for Ramipril in the form Capsule 1.25 mg

omit:

Vascalace Caps 1.25 DO MP NP 30 5 30

  1. Schedule 1, entry for Ramipril in the form Capsule 2.5 mg

omit:

Vascalace Caps 2.5 DO MP NP 30 5 30

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

omit:

Vascalace Caps 5 DO MP NP 30 5 30

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

omit:

Vascalace Caps 10 DO MP NP 30 5 30

  1. Schedule 1, entry for Ramipril in the form Tablet 1.25 mg 

omit:

Vascalace 1.25 DO MP NP 30 5 30

  1. Schedule 1, entry for Ramipril in the form Tablet 2.5 mg

omit:

Vascalace 2.5 DO MP NP 30 5 30

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

omit:

Vascalace 5 DO MP NP 30 5 30

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

omit: 

Vascalace 10 DO MP NP 30 5 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats: 5]

omit:

a Auro-Simvastatin 10 DO MP NP 30 5 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit:

a Auro-Simvastatin 10 DO MP P7598 30 11 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 5]

omit:

a Auro-Simvastatin 20 DO MP NP 30 5 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit:

a Auro-Simvastatin 20 DO MP P7598 30 11 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Maximum Quantity: 30; Number of Repeats: 5]

omit:

a Auro-Simvastatin 40 DO MP NP 30 5 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit:

a Auro-Simvastatin 40 DO MP P7598 30 11 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Maximum Quantity: 30; Number of Repeats: 5]

omit:

a Auro-Simvastatin 80 DO MP NP 30 5 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit:

a Auro-Simvastatin 80 DO MP P7598 30 11 30

  1. Schedule 1, entry for Sodium acid phosphate

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

a PHOSPHATE PHEBRA VU MP NP C5089 C5095 C5114 C5123 100 5 100

(b)insert in the column headed “Schedule Equivalent” for the brand “Phosphate Sandoz”: a

  1. Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate) 

omit:

Sumatriptan RBX RA MP NP C5259 4 5 4

  1. Schedule 1, entry for Tenofovir with emtricitabine

substitute:

Tenofovir with emtricitabine Tablet containing tenofovir disoproxil phosphate 291 mg with emtricitabine 200 mg Oral Tenofovir EMT GH GQ MP NP C7580 30 2 30
MP C6985 C6986 60 5 30 C(100)
Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg Oral Tenofovir/Emtricitabine 300/200 APOTEX TX MP NP C7580 30 2 30
Truvada GI MP NP C7580 30 2 30
Tenofovir/Emtricitabine 300/200 APOTEX TX MP C6985 C6986 60 5 30 C(100)
Truvada GI MP C6985 C6986 60 5 30 C(100)
Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg Oral Tenofovir Disoproxil Emtricitabine Mylan 300/200 AF MP NP C7580 30 2 30
Tenofovir EMT GH GQ MP NP C7580 30 2 30

  1. Schedule 1, entry for Timolol

omit:

Eye gel 1 mg (as maleate) per g, 5 g Application to the eye Nyogel AS AO MP 1 5 1

  1. Schedule 1, entry for Tramadol in each of the forms: Tablet (sustained release) containing tramadol hydrochloride 100 mg; Tablet (sustained release) containing tramadol hydrochloride 150 mg; and Tablet (sustained release) containing tramadol hydrochloride 200 mg

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

a Tramedo SR AL MP NP C5822 20 0 20

  1. Schedule 3

omit:

GV Amgen Australia Pty Limited 31 051 057 428

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

insert:

IJ I-Care Pharma Distributors Pty Ltd  60 139 207 882

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

insert:

VU The Trustee for Virgo Unit Trust (trading as Phebra)  77 695 661 635

  1. Schedule 4, entry for Atezolizumab

substitute:

Atezolizumab C6999 Locally advanced or metastatic non-small cell lung cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
Patient must have stable or responding disease. 		Compliance with Authority Required procedures - Streamlined Authority Code 6999
C7539 Locally advanced or metastatic non-small cell lung cancer
Initial treatment
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy. 		Compliance with Authority Required procedures - Streamlined Authority Code 7539
C7572 Locally advanced or metastatic non-small cell lung cancer
Grandfathering treatment
Patient must have received treatment with this drug for this condition prior to 1 April 2018; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
Patient must have stable or responding disease; AND
Patient must have had a WHO performance status of 0 or 1 at the time non PBS-subsidised treatment with this drug for this condition was initiated.
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 - Streamlined Authority Code 7572

  1. Schedule 4, entry for Bendamustine

substitute:

Bendamustine C7943 Previously untreated stage II bulky or stage III or IV indolent non-Hodgkin's lymphoma
Induction treatment
The condition must be CD20 positive; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
The treatment must be in combination with rituximab or obinutuzumab; AND
The treatment must not exceed 6 cycles (12 doses) with this drug under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 7943
C7944 Follicular lymphoma
Re-induction treatment
The condition must be CD20 positive; AND
The condition must be refractory to treatment with rituximab for this condition; AND
The condition must be symptomatic; AND
The treatment must be for re-induction treatment purposes only; AND
The treatment must be in combination with obinutuzumab; AND
The treatment must not exceed 6 cycles (12 doses) with this drug under this restriction.
The condition is considered rituximab-refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab-containing regimen. 		Compliance with Authority Required procedures - Streamlined Authority Code 7944
C7972 Previously untreated stage III or IV mantle cell lymphoma
Induction treatment
The condition must be CD20 positive; AND
The treatment must be in combination with rituximab; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than 6 cycles (12 doses) of treatment under this restriction; AND
Patient must not be eligible for stem cell transplantation. 		Compliance with Authority Required procedures - Streamlined Authority Code 7972

  1. Schedule 4, entry for Bortezomib

substitute:

Bortezomib C7938 P7938 Multiple myeloma
Retreatment of Progressive disease - Initial PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have progressive disease; AND
Patient must have previously been treated with PBS-subsidised bortezomib; AND
Patient must have experienced at least a partial response to the most recent course of PBS-subsidised bortezomib therapy; AND
Patient must not be receiving concomitant PBS-subsidised carfilzomib, thalidomide or its analogues; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of 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.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Details of the basis of the current diagnosis of progressive disease and nomination of which disease activity parameters that will be used to assess response, and diagnostic reports demonstrating the patient has achieved at least a partial response to the most recent course of PBS-subsidised bortezomib, if not previously documented 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) must be documented in the patient's medical records. 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. 		Compliance with Authority Required procedures - Streamlined Authority Code 7938
C7939 P7939 Multiple myeloma
Retreatment of Progressive disease - Continuing PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have previously received 4 treatment cycles of bortezomib in the current treatment course; AND
Patient must have demonstrated at the completion of cycle 4 at least a partial response to bortezomib; AND
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response; AND
Patient must not have a gap of more than 6 months between the initial PBS-subsidised treatment with this drug for this condition and continuing PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Diagnostic reports demonstrating the patient has achieved at least a partial response must be documented in the patient's medical records.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Diagnostic reports must be no more than one month old at the time of prescribing.
A response assessment prior to cycle 5 must be documented in the patient's medical records.
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart. 		Compliance with Authority Required procedures - Streamlined Authority Code 7939
C7940 P7940 Symptomatic multiple myeloma
Continuing PBS-subsidised treatment
Patient must have received an initial authority prescription for bortezomib for newly diagnosed symptomatic multiple myeloma and be ineligible for high dose chemotherapy; AND
Patient must not have developed disease progression while receiving PBS subsidised treatment with this drug for this condition; AND
Patient must not have achieved a best confirmed response to bortezomib at the time of prescribing; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
The treatment must be in combination with a corticosteroid and melphalan or cyclophosphamide; AND
Patient must not receive more than 5 cycles of treatment with bortezomib under this restriction.
Continuing PBS-subsidised supply requires that the gap between the initial PBS-subsidised treatment with this drug for this condition and this continuing treatment is no more than 6 months. 		Compliance with Authority Required procedures - Streamlined Authority Code 7940
C7941 P7941 Symptomatic multiple myeloma
Continuing PBS-subsidised treatment
Patient must have previously received PBS-subsidised treatment with this drug for newly diagnosed symptomatic multiple myeloma; AND
Patient must have severe acute renal failure; AND
Patient must have demonstrated at least a partial response at the completion of cycle 4; AND
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
Patient must not receive more than 5 cycles of treatment with bortezomib under this restriction.
A copy of the current pathology reports reporting Glomerular Filtration Rate from an Approved Pathology authority and diagnostic reports demonstrating the patient has achieved at least a partial response must be documented in the patient's medical records.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are not being used to monitor disease activity, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Continuing PBS-subsidised supply requires that the gap between the initial PBS-subsidised treatment with this drug for this condition and this continuing treatment is no more than 6 months. 		Compliance with Authority Required procedures - Streamlined Authority Code 7941
C7960 P7960 Multiple myeloma
Retreatment of Progressive disease - Continuing PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have previously received 8 treatment cycles of bortezomib in the current treatment course; AND
Patient must have demonstrated at the completion of cycle 8 at least a partial response to bortezomib; AND
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response; AND
Patient must not have a gap of more than 10 months between the initial PBS-subsidised treatment with this drug for this condition and continuing PBS-subsidised treatment with this drug for this condition following completion of 8 treatment cycles; AND
Patient must not receive more than 3 cycles of bortezomib under this restriction.
Diagnostic reports demonstrating the patient has achieved at least a partial response must be documented in the patient's medical records.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Diagnostic reports must be no more than one month old at the time of prescribing.
A response assessment prior to cycle 9 must be documented in the patient's medical records.
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart. 		Compliance with Authority Required procedures - Streamlined Authority Code 7960
C7961 P7961 Multiple myeloma
Treatment of Progressive disease - Initial PBS-subsidised treatment
The condition must be confirmed by a histological diagnosis; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must have undergone or be ineligible for a primary stem cell transplant; AND
Patient must not be receiving concomitant PBS-subsidised carfilzomib, thalidomide or its analogues; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of 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 and record of prior stem cell transplant or ineligibility for prior stem cell transplant; details of the basis of the diagnosis of progressive disease or failure to respond; and nomination of 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 provided 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. 		Compliance with Authority Required procedures - Streamlined Authority Code 7961
C7962 P7962 Multiple myeloma
Treatment of Progressive disease - Continuing PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have previously received 8 treatment cycles of bortezomib for progressive disease; AND
Patient must have demonstrated at the completion of cycle 8 at least a partial response to bortezomib; AND
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response; AND
Patient must not have a gap of more than 10 months between the initial PBS-subsidised treatment with this drug for this condition and continuing PBS-subsidised treatment with this drug for this condition following completion of 8 treatment cycles; AND
Patient must not receive more than 3 cycles of bortezomib under this restriction.
Diagnostic reports demonstrating the patient has achieved at least a partial response must be documented in the patient's medical records.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Diagnostic reports must be no more than one month old at the time of prescribing.
A response assessment prior to cycle 9 must be documented in the patient's medical records.
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart. 		Compliance with Authority Required procedures - Streamlined Authority Code 7962
C7963 P7963 Symptomatic multiple myeloma
Initial PBS-subsidised treatment
Patient must be newly diagnosed; AND
Patient must be ineligible for high dose chemotherapy; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
The treatment must be in combination with a corticosteroid and melphalan or cyclophosphamide; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 7963
C7974 P7974 Multiple myeloma
Treatment of Progressive disease - Continuing PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have previously received 4 treatment cycles of bortezomib for progressive disease; AND
Patient must have demonstrated at the completion of cycle 4 at least a partial response to bortezomib; AND
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response; AND
Patient must not have a gap of more than 6 months between the initial PBS-subsidised treatment with this drug for this condition and continuing PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Diagnostic reports demonstrating the patient has achieved at least a partial response must be documented in the patient's medical records.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Diagnostic reports must be no more than one month old at the time of prescribing.
A response assessment prior to cycle 5 must be documented in the patient's medical records.
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart. 		Compliance with Authority Required procedures - Streamlined Authority Code 7974
C7984 P7984 Symptomatic multiple myeloma
Initial PBS-subsidised treatment
Patient must be newly diagnosed; AND
Patient must have severe acute renal failure; AND
Patient must require dialysis; OR
Patient must be at high risk of requiring dialysis in the opinion of a nephrologist; AND
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Details of the histological diagnosis of multiple myeloma, the name of the nephrologist who has reviewed the patient and the date of review, a copy of the current pathology reports reporting Glomerular Filtration Rate from an Approved Pathology Authority, and nomination of the disease activity parameter(s) that will be used to assess response must be documented in the patient's medical records. Disease activity parameters include current diagnostic reports of at least one of the following:
(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) in oligo-secretory and non-secretory myeloma patients only, 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. Magnetic Resonance Imaging (MRI) or computed tomography (CT) scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be documented in the patient's medical records 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) should 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. 		Compliance with Authority Required procedures - Streamlined Authority Code 7984
C7992 P7992 Symptomatic multiple myeloma
Patient must be newly diagnosed; AND
Patient must be eligible for high dose chemotherapy and autologous stem cell transplantation; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
The treatment must be in combination with chemotherapy; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Details of the histological diagnosis of multiple myeloma must be documented in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 7992

  1. Schedule 4, entry for Budesonide with formoterol

(a)omit:

C4394 Asthma
Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.
Patient must be aged 12 years or over. 		Compliance with Authority Required procedures - Streamlined Authority Code 4394

(b)omit:

C7527 Asthma
Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; OR
Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; OR
Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy.
Patient must be aged 18 years or older. 		Compliance with Authority Required procedures - Streamlined Authority Code 7527
C7574 Chronic obstructive pulmonary disease (COPD)
Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy; AND
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND
The treatment must be for symptomatic treatment.
Patient must be aged 18 years or older. 		Compliance with Authority Required procedures - Streamlined Authority Code 7574

(c)insert in numerical order after existing text:

C7970 Asthma
Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; OR
Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; OR
Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy. 		Compliance with Authority Required procedures - Streamlined Authority Code 7970
C7979 Asthma
Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids. 		Compliance with Authority Required procedures - Streamlined Authority Code 7979

  1. Schedule 4, entry for Calcipotriol with betamethasone

(a)omit:

C6873 Chronic stable plaque type psoriasis vulgaris
The condition must be inadequately controlled by potent topical corticosteroid monotherapy; AND
Patient must require more than 30 grams of product per month. 		Compliance with Authority Required procedures - Streamlined Authority Code 6873

(b)insert in numerical order after existing text:

C7947 Chronic stable plaque type psoriasis vulgaris
The condition must be inadequately controlled by potent topical corticosteroid monotherapy. 		Compliance with Authority Required procedures - Streamlined Authority Code 7947

  1. Schedule 4, omit entry for Emtricitabine

  1. Schedule 4, entry for Ezetimibe

substitute:

Ezetimibe C7966 Hypercholesterolaemia
Patient must have developed a clinically important product-related adverse event during treatment with an HMG CoA reductase inhibitor (statin) necessitating a reduction in the statin dose; OR
Patient must have developed a clinically important product-related adverse event during treatment with an HMG CoA reductase inhibitor (statin) necessitating a withdrawal of the statin treatment; OR
Patient must be one in whom treatment with an HMG CoA reductase inhibitor (statin) is contraindicated; AND
Patient must have coronary heart disease; OR
Patient must have cerebrovascular disease; OR
Patient must have peripheral vascular disease; OR
Patient must have diabetes mellitus with microalbuminuria; OR
Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; OR
Patient must have diabetes mellitus and be aged 60 years or more; OR
Patient must have a family history of coronary heart disease in two or more first degree relatives before the age of 55 years; OR
Patient must have a family history of coronary heart disease in one or more first degree relatives before the age of 45 years; OR
Patient must have heterozygous familial hypercholesterolaemia; OR
Patient must have homozygous familial hypercholesterolaemia; OR
Patient must have a level of absolute risk of a cardiovascular event greater than 15% over 5 years as calculated using the Australian Absolute Cardiovascular Disease Risk Calculator (National Vascular Disease Prevention Alliance), as in force on
1 April 2018.
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.
Microalbuminuria is defined as urinary albumin excretion rate of greater than 20mcg/min or urinary albumin to creatinine ratio of greater than 2.5 for males, or greater than 3.5 for females.
The type and severity of the adverse event or contraindication must be documented in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 7966
C7990 Hypercholesterolaemia
Patient must have homozygous sitosterolaemia. 		Compliance with Authority Required procedures - Streamlined Authority Code 7990
C7996 Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise; AND
The treatment must be co-administered with an HMG CoA reductase inhibitor (statin); AND
Patient must have cholesterol concentrations that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have coronary heart disease; OR
Patient must have cerebrovascular disease; OR
Patient must have peripheral vascular disease; OR
Patient must have diabetes mellitus with microalbuminuria; OR
Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; OR
Patient must have diabetes mellitus and be aged 60 years or more; OR
Patient must have a family history of coronary heart disease in two or more first degree relatives before the age of 55 years; OR
Patient must have a family history of coronary heart disease in one or more first degree relatives before the age of 45 years; OR
Patient must have heterozygous familial hypercholesterolaemia; OR
Patient must have homozygous familial hypercholesterolaemia; OR
Patient must have a level of absolute risk of a cardiovascular event greater than 15% over 5 years as calculated using the Australian Absolute Cardiovascular Disease Risk Calculator (National Vascular Disease Prevention Alliance), as in force on
1 April 2018.
Inadequate control with a statin is defined as a LDL cholesterol concentration in excess of current target lipid levels for primary and secondary prevention after at least 3 months of treatment at a maximum tolerated dose of a statin.
The dose and duration of statin treatment and the cholesterol concentration which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated.
The cholesterol concentration which shows inadequate control must be no more than 2 months old when ezetimibe is initiated.
Microalbuminuria is defined as urinary albumin excretion rate of greater than 20mcg/min or urinary albumin to creatinine ratio of greater than 2.5 for males, or greater than 3.5 for females. 		Compliance with Authority Required procedures - Streamlined Authority Code 7996

  1. Schedule 4, entry for Ezetimibe and rosuvastatin

substitute:

Ezetimibe and rosuvastatin C7957 Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must have cholesterol concentrations that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have coronary heart disease; OR
Patient must have cerebrovascular disease; OR
Patient must have peripheral vascular disease; OR
Patient must have diabetes mellitus with microalbuminuria; OR
Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; OR
Patient must have diabetes mellitus and be aged 60 years or more; OR
Patient must have a family history of coronary heart disease in two or more first degree relatives before the age of 55 years; OR
Patient must have a family history of coronary heart disease in one or more first degree relatives before the age of 45 years; OR
Patient must have heterozygous familial hypercholesterolaemia; OR
Patient must have homozygous familial hypercholesterolaemia; OR
Patient must have a level of absolute risk of a cardiovascular event greater than 15% over 5 years as calculated using the Australian Absolute Cardiovascular Disease Risk Calculator (National Vascular Disease Prevention Alliance), as in force on
1 April 2018.
Inadequate control with a statin is defined as a LDL cholesterol concentration in excess of current target lipid levels for primary and secondary prevention after at least 3 months of treatment at a maximum tolerated dose of a statin.
The dose and duration of statin treatment and the cholesterol concentration which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated.
The cholesterol concentration which shows inadequate control must be no more than 2 months old when ezetimibe is initiated.
Microalbuminuria is defined as urinary albumin excretion rate of greater than 20mcg/min or urinary albumin to creatinine ratio of greater than 2.5 for males, or greater than 3.5 for females. 		Compliance with Authority Required procedures - Streamlined Authority Code 7957
C7958 Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must have cholesterol concentrations that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have developed a clinically important product-related adverse event during treatment with an HMG CoA reductase inhibitor (statin) necessitating a reduction in the statin dose; AND
Patient must have coronary heart disease; OR
Patient must have cerebrovascular disease; OR
Patient must have peripheral vascular disease; OR
Patient must have diabetes mellitus with microalbuminuria; OR
Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; OR
Patient must have diabetes mellitus and be aged 60 years or more; OR
Patient must have a family history of coronary heart disease in two or more first degree relatives before the age of 55 years; OR
Patient must have a family history of coronary heart disease in one or more first degree relatives before the age of 45 years; OR
Patient must have heterozygous familial hypercholesterolaemia; OR
Patient must have homozygous familial hypercholesterolaemia; OR
Patient must have a level of absolute risk of a cardiovascular event greater than 15% over 5 years as calculated using the Australian Absolute Cardiovascular Disease Risk Calculator (National Vascular Disease Prevention Alliance), as in force on
1 April 2018.
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.
Microalbuminuria is defined as urinary albumin excretion rate of greater than 20mcg/min or urinary albumin to creatinine ratio of greater than 2.5 for males, or greater than 3.5 for females.
The type and severity of the adverse event or contraindication must be documented in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 7958

  1. Schedule 4, entry for Ezetimibe with atorvastatin

substitute:

Ezetimibe with atorvastatin C7957 Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must have cholesterol concentrations that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have coronary heart disease; OR
Patient must have cerebrovascular disease; OR
Patient must have peripheral vascular disease; OR
Patient must have diabetes mellitus with microalbuminuria; OR
Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; OR
Patient must have diabetes mellitus and be aged 60 years or more; OR
Patient must have a family history of coronary heart disease in two or more first degree relatives before the age of 55 years; OR
Patient must have a family history of coronary heart disease in one or more first degree relatives before the age of 45 years; OR
Patient must have heterozygous familial hypercholesterolaemia; OR
Patient must have homozygous familial hypercholesterolaemia; OR
Patient must have a level of absolute risk of a cardiovascular event greater than 15% over 5 years as calculated using the Australian Absolute Cardiovascular Disease Risk Calculator (National Vascular Disease Prevention Alliance), as in force on
1 April 2018.
Inadequate control with a statin is defined as a LDL cholesterol concentration in excess of current target lipid levels for primary and secondary prevention after at least 3 months of treatment at a maximum tolerated dose of a statin.
The dose and duration of statin treatment and the cholesterol concentration which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated.
The cholesterol concentration which shows inadequate control must be no more than 2 months old when ezetimibe is initiated.
Microalbuminuria is defined as urinary albumin excretion rate of greater than 20mcg/min or urinary albumin to creatinine ratio of greater than 2.5 for males, or greater than 3.5 for females. 		Compliance with Authority Required procedures - Streamlined Authority Code 7957
C7958 Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must have cholesterol concentrations that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have developed a clinically important product-related adverse event during treatment with an HMG CoA reductase inhibitor (statin) necessitating a reduction in the statin dose; AND
Patient must have coronary heart disease; OR
Patient must have cerebrovascular disease; OR
Patient must have peripheral vascular disease; OR
Patient must have diabetes mellitus with microalbuminuria; OR
Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; OR
Patient must have diabetes mellitus and be aged 60 years or more; OR
Patient must have a family history of coronary heart disease in two or more first degree relatives before the age of 55 years; OR
Patient must have a family history of coronary heart disease in one or more first degree relatives before the age of 45 years; OR
Patient must have heterozygous familial hypercholesterolaemia; OR
Patient must have homozygous familial hypercholesterolaemia; OR
Patient must have a level of absolute risk of a cardiovascular event greater than 15% over 5 years as calculated using the Australian Absolute Cardiovascular Disease Risk Calculator (National Vascular Disease Prevention Alliance), as in force on
1 April 2018.
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.
Microalbuminuria is defined as urinary albumin excretion rate of greater than 20mcg/min or urinary albumin to creatinine ratio of greater than 2.5 for males, or greater than 3.5 for females.
The type and severity of the adverse event or contraindication must be documented in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 7958

  1. Schedule 4, entry for Ezetimibe with simvastatin

substitute:

Ezetimibe with simvastatin C7957 Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must have cholesterol concentrations that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have coronary heart disease; OR
Patient must have cerebrovascular disease; OR
Patient must have peripheral vascular disease; OR
Patient must have diabetes mellitus with microalbuminuria; OR
Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; OR
Patient must have diabetes mellitus and be aged 60 years or more; OR
Patient must have a family history of coronary heart disease in two or more first degree relatives before the age of 55 years; OR
Patient must have a family history of coronary heart disease in one or more first degree relatives before the age of 45 years; OR
Patient must have heterozygous familial hypercholesterolaemia; OR
Patient must have homozygous familial hypercholesterolaemia; OR
Patient must have a level of absolute risk of a cardiovascular event greater than 15% over 5 years as calculated using the Australian Absolute Cardiovascular Disease Risk Calculator (National Vascular Disease Prevention Alliance), as in force on
1 April 2018.
Inadequate control with a statin is defined as a LDL cholesterol concentration in excess of current target lipid levels for primary and secondary prevention after at least 3 months of treatment at a maximum tolerated dose of a statin.
The dose and duration of statin treatment and the cholesterol concentration which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated.
The cholesterol concentration which shows inadequate control must be no more than 2 months old when ezetimibe is initiated.
Microalbuminuria is defined as urinary albumin excretion rate of greater than 20mcg/min or urinary albumin to creatinine ratio of greater than 2.5 for males, or greater than 3.5 for females. 		Compliance with Authority Required procedures - Streamlined Authority Code 7957
C7958 Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must have cholesterol concentrations that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have developed a clinically important product-related adverse event during treatment with an HMG CoA reductase inhibitor (statin) necessitating a reduction in the statin dose; AND
Patient must have coronary heart disease; OR
Patient must have cerebrovascular disease; OR
Patient must have peripheral vascular disease; OR
Patient must have diabetes mellitus with microalbuminuria; OR
Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; OR
Patient must have diabetes mellitus and be aged 60 years or more; OR
Patient must have a family history of coronary heart disease in two or more first degree relatives before the age of 55 years; OR
Patient must have a family history of coronary heart disease in one or more first degree relatives before the age of 45 years; OR
Patient must have heterozygous familial hypercholesterolaemia; OR
Patient must have homozygous familial hypercholesterolaemia; OR
Patient must have a level of absolute risk of a cardiovascular event greater than 15% over 5 years as calculated using the Australian Absolute Cardiovascular Disease Risk Calculator (National Vascular Disease Prevention Alliance), as in force on
1 April 2018.
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.
Microalbuminuria is defined as urinary albumin excretion rate of greater than 20mcg/min or urinary albumin to creatinine ratio of greater than 2.5 for males, or greater than 3.5 for females.
The type and severity of the adverse event or contraindication must be documented in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 7958

  1. Schedule 4, entry for Idelalisib

substitute:

Idelalisib C7052 Refractory follicular B-cell non-Hodgkin's lymphoma
Initial treatment
The condition must be refractory to a prior therapy with rituximab; AND
The condition must be refractory to a prior therapy with an alkylating agent; AND
The treatment must be the sole PBS subsidised treatment for this condition.
The condition is considered refractory to a prior therapy when the patient experiences less than a partial response or progression of disease within 6 months after completion of the prior therapy.
The condition is considered refractory to both rituximab and an alkylating agent if the agents were administered together or in successive treatment regimens.
The authority application must be made in writing and must include:
a) A completed authority prescription form; and
b) A completed Refractory follicular B-cell non-Hodgkin's lymphoma PBS Authority Application - Supporting information form which must include date of completion of prior therapies with rituximab and an alkylating agent. 		Compliance with Written Authority Required procedures
C7053 Refractory follicular B-cell non-Hodgkin's lymphoma
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition. 		Compliance with Authority Required procedures
C7387 Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
Initial treatment
Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be in combination with rituximab for up to a maximum of 8 doses, followed by monotherapy; AND
The condition must have relapsed or be refractory to at least one prior therapy; AND
The condition must be CD20 positive; AND
Patient must have a total cumulative illness rating scale (CIRS) score of greater than 6 (excluding CLL-induced illness or organ damage); AND
Patient must be inappropriate for chemo-immunotherapy.
A patient can be considered inappropriate for chemo-immunotherapy when one or more of the following are experienced:
1. Severe neutropenia defined as absolute neutrophil count of less than or equal to 1.0 x 109/L; or
2. Severe thrombocytopenia defined as platelet count of less than or equal to 50 x 109/L; or
3. Evidence of one or more 17p chromosomal deletions demonstrated by fluorescence in situ hybridisation (FISH).
Full blood count results must be no more than 1 month old at the time of application.
The authority application must be made in writing and must include:
a) A completed authority prescription form;
b) A completed CLL/SLL PBS Authority Application - Supporting information form; and
c) Pathology report indicating that the patient can be considered inappropriate for chemo-immunotherapy due to one or more of the following:
1) Recent severe neutropenia; or
2) Recent severe thrombocytopenia; or
3) Presence of 17p chromosomal deletion using fluorescence in situ hybridisation (FISH).
A Grandfathered patient who has previously received non-PBS subsidised treatment with this drug for this condition prior to
1 September 2017 must have met all the initial restriction criteria prior to initiating non-PBS subsidised treatment. A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. 		Compliance with Written Authority Required procedures
C7388 Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition. 		Compliance with Authority Required procedures

  1. Schedule 4, omit entry for Indinavir

  1. Schedule 4, entry for Lipegfilgrastim

substitute:

Lipegfilgrastim C7822 Chemotherapy-induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must be at greater than 20% risk of developing febrile neutropenia; OR
Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days. 		Compliance with Authority Required procedures - Streamlined Authority Code 7822
C7823 Chemotherapy-induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must be at greater than 20% risk of developing febrile neutropenia; OR
Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days. 		Compliance with Authority Required procedures
C7843 Chemotherapy-induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days. 		Compliance with Authority Required procedures - Streamlined Authority Code 7843
C7862 Chemotherapy-induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days. 		Compliance with Authority Required procedures

  1. Schedule 4, omit entry for Milk powder -- lactose free formula

  1. Schedule 4, omit entry for Nandrolone decanoate

  1. Schedule 4, entry for Nintedanib

substitute:

Nintedanib C6950 Idiopathic pulmonary fibrosis
Initial treatment 1 - new patient
The condition must be diagnosed through a multidisciplinary team; AND
Patient must have chest high resolution computed tomography (HRCT) consistent with diagnosis of idiopathic pulmonary fibrosis within the previous 12 months; AND
Patient must have a forced vital capacity (FVC) greater than or equal to 50% predicted for age, gender and height; AND
Patient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7; AND
Patient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin equal to or greater than 30%; AND
Patient must not have interstitial lung disease due to other known causes including domestic and occupational environmental exposures, connective tissue disease, or drug toxicity; AND
The treatment must be the sole PBS subsidised treatment for this condition.
Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician.
A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis.
Patient must not have an acute respiratory infection at the time of FVC testing.
Application for authorisation of initial treatment must be in writing and must include:
a) a completed authority prescription form; and
b) a completed IPF Authority Application Supporting Information Form; and
c) a signed patient acknowledgement. 		Compliance with Authority Required procedures
C6961 Idiopathic pulmonary fibrosis
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS subsidised treatment for this condition.
Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician. 		Compliance with Authority Required procedures
C6975 Idiopathic pulmonary fibrosis
Initial treatment 2 - change or re-commencement of treatment
Patient must have previously received PBS-subsidised treatment with nintedanib or pirfenidone for this condition; AND
The treatment must be the sole PBS subsidised treatment for this condition.
Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician. 		Compliance with Authority Required procedures

  1. Schedule 4, entry for Nivolumab

(a)omit entry for circumstances code C6997 and substitute:

C6997 Locally advanced or metastatic non-small cell lung cancer
Grandfathering treatment
Patient must have received treatment with this drug for this condition prior to 1 August 2017; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
Patient must have stable or responding disease; AND
Patient must have a WHO performance status of 0 or 1.
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 - Streamlined Authority Code 6997

(b)omit entry for circumstances code C7567 and substitute:

C7567 Locally advanced or metastatic non-small cell lung cancer
Initial treatment
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. 		Compliance with Authority Required procedures - Streamlined Authority Code 7567

  1. Schedule 4, entry for Obinutuzumab

insert in numerical order after existing text:

C7935 Stage II bulky or Stage III/IV follicular lymphoma
Maintenance therapy
Patient must have previously received PBS subsidised treatment with this drug under the previously untreated initial restriction; OR
Patient must have previously received PBS subsidised treatment with this drug under the previously untreated grandfather restriction; AND
The condition must be CD20 positive; AND
Patient must have demonstrated a partial or complete response to PBS subsidised induction treatment with this drug for this condition; AND
The treatment must be maintenance therapy; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND
Patient must not have developed disease progression while receiving PBS subsidised treatment with this drug for this condition. 		Compliance with Authority Required procedures
C7936 Stage II bulky or Stage III/IV follicular lymphoma
Grandfather treatment - previously untreated setting
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 October 2018; AND
The condition must be CD20 positive; AND
The condition must have been untreated 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 be in combination with chemotherapy for induction treatment; AND
The treatment must not exceed 10 doses for induction treatment with this drug for this condition; OR
Patient must have demonstrated a partial or complete response to induction treatment with this drug for this condition for maintenance treatment; AND
The treatment must be the sole PBS subsidised treatment for maintenance treatment; AND
The treatment must not exceed 12 doses or 2 years duration of maintenance treatment, whichever comes first.
A patient may only qualify for PBS subsidised initiation treatment once in a lifetime under:
i) the previously untreated induction treatment restriction; or
ii) the rituximab-refractory re-induction restriction; or
iii) the previously untreated grandfather restriction; or
iv) the rituximab-refractory grandfather restriction. 		Compliance with Authority Required procedures
C7950 Follicular lymphoma
Maintenance therapy
Patient must have previously received PBS subsidised treatment with this drug under the rituximab refractory initial restriction; OR
Patient must have previously received PBS subsidised treatment with this drug under the rituximab refractory grandfather restriction; AND
The condition must be CD20 positive; AND
The condition must have been refractory to treatment with rituximab; AND
Patient must have demonstrated a partial or complete response to PBS subsidised re-induction treatment with this drug for this condition; AND
The treatment must be maintenance therapy; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND
Patient must not have developed disease progression while receiving PBS subsidised treatment with this drug for this condition. 		Compliance with Authority Required procedures
C7959 Follicular lymphoma
Re-induction treatment
Patient must not have previously received PBS subsidised obinutuzumab; AND
The condition must be CD20 positive; AND
The condition must be refractory to treatment with rituximab for this condition; AND
The condition must be symptomatic; AND
The treatment must be for re-induction treatment purposes only; AND
The treatment must be in combination with bendamustine; AND
The treatment must not exceed 8 doses for re-induction treatment with this drug for this condition.
The condition is considered rituximab-refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab-containing regimen.
A patient may only qualify for PBS subsidised initiation treatment once in a lifetime under:
i) the previously untreated induction treatment restriction; or
ii) the rituximab-refractory re-induction restriction; or
iii) the previously untreated grandfather restriction; or
iv) the rituximab-refractory grandfather restriction. 		Compliance with Authority Required procedures
C7968 Follicular lymphoma
Grandfather treatment - rituximab refractory
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 October 2018; AND
The condition must be CD20 positive; AND
The condition must have been refractory to treatment with rituximab prior to initiating non-PBS treatment 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 be in combination with bendamustine for re-induction treatment; AND
The treatment must not exceed 8 doses for re-induction treatment with this drug for this condition; OR
Patient must have demonstrated a partial or complete response to re-induction treatment with this drug for this condition; AND
The treatment must be the sole PBS subsidised treatment for maintenance treatment; AND
The treatment must not exceed 12 doses or 2 years duration of maintenance treatment, whichever comes first.
The condition is considered rituximab-refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab-containing regimen.
A patient may only qualify for PBS subsidised initiation treatment once in a lifetime under:
i) the previously untreated induction treatment restriction; or
ii) the rituximab-refractory re-induction restriction; or
iii) the previously untreated grandfather restriction; or
iv) the rituximab-refractory grandfather restriction. 		Compliance with Authority Required procedures
C7981 Stage II bulky or Stage III/IV follicular lymphoma
Induction treatment
The condition must be CD20 positive; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
The treatment must be in combination with chemotherapy; AND
The treatment must not exceed 10 doses for induction treatment with this drug for this condition.
A patient may only qualify for PBS subsidised initiation treatment once in a lifetime under:
i) the previously untreated induction treatment restriction; or
ii) the rituximab-refractory re-induction restriction; or
iii) the previously untreated grandfather restriction; or
iv) the rituximab-refractory grandfather restriction. 		Compliance with Authority Required procedures

  1. Schedule 4, entry for Pirfenidone

substitute:

Pirfenidone C6950 Idiopathic pulmonary fibrosis
Initial treatment 1 - new patient
The condition must be diagnosed through a multidisciplinary team; AND
Patient must have chest high resolution computed tomography (HRCT) consistent with diagnosis of idiopathic pulmonary fibrosis within the previous 12 months; AND
Patient must have a forced vital capacity (FVC) greater than or equal to 50% predicted for age, gender and height; AND
Patient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7; AND
Patient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin equal to or greater than 30%; AND
Patient must not have interstitial lung disease due to other known causes including domestic and occupational environmental exposures, connective tissue disease, or drug toxicity; AND
The treatment must be the sole PBS subsidised treatment for this condition.
Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician.
A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis.
Patient must not have an acute respiratory infection at the time of FVC testing.
Application for authorisation of initial treatment must be in writing and must include:
a) a completed authority prescription form; and
b) a completed IPF Authority Application Supporting Information Form; and
c) a signed patient acknowledgement. 		Compliance with Authority Required procedures
C6961 Idiopathic pulmonary fibrosis
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS subsidised treatment for this condition.
Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician. 		Compliance with Authority Required procedures
C6975 Idiopathic pulmonary fibrosis
Initial treatment 2 - change or re-commencement of treatment
Patient must have previously received PBS-subsidised treatment with nintedanib or pirfenidone for this condition; AND
The treatment must be the sole PBS subsidised treatment for this condition.
Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician. 		Compliance with Authority Required procedures

  1. Schedule 4, omit Part 2 – General statement for lipid-lowering drugs (in entirety)

  1. Schedule 5, omit entry for Ganciclovir

  1. Schedule 5, entry for Olanzapine in the form Tablet 20 mg (orally disintegrating) [GRP-15643]

omit from the column headed “Brand”:     Ozin ODT 20

  1. Schedule 5, entry for Olanzapine in the form Tablet 10 mg (orally disintegrating) [GRP-15723]

omit from the column headed “Brand”:    Ozin ODT 10

  1. Schedule 5, entry for Olanzapine in the form Tablet 5 mg (orally disintegrating) [GRP-15797]

omit from the column headed “Brand”:    Ozin ODT 5

  1. Schedule 5, entry for Olanzapine in the form Tablet 15 mg (orally disintegrating) [GRP-15953]

omit from the column headed “Brand”:    Ozin ODT 15

  1. Schedule 5, entry for Ramipril in the form Capsule 5 mg [GRP-15424]

omit from the column headed “Brand”: Vascalace Caps 5

  1. Schedule 5, entry for Ramipril in the form Tablet 5 mg [GRP-15424]

omit from the column headed “Brand”: Vascalace 5

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

omit from the column headed “Brand”: Vascalace Caps 10

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

omit from the column headed “Brand”: Vascalace 10

  1. Schedule 5, entry for Ramipril in the form Capsule 1.25 mg [GRP-15640]

omit from the column headed “Brand”: Vascalace Caps 1.25

  1. Schedule 5, entry for Ramipril in the form Tablet 1.25 mg [GRP-15640]

omit from the column headed “Brand”: Vascalace 1.25

  1. Schedule 5, entry for Ramipril in the form Capsule 2.5 mg [GRP-15769]

omit from the column headed “Brand”: Vascalace Caps 2.5

  1. Schedule 5, entry for Ramipril in the form Tablet 2.5 mg [GRP-15769]

omit from the column headed “Brand”: Vascalace 2.5

  1. Schedule 5, entry for Sumatriptan in the form Tablet 50 mg (as succinate) [GRP-15928]

omit from the column headed “Brand”: Sumatriptan RBX

  1. Schedule 5, entry for Tenofovir with emtricitabine in the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg [GRP-21638]

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

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