National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 6) (PB 36 of 2018) (Cth)

Case

PB 36 of 2018

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 6)

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    29 May 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. 6).

(2)This Instrument may also be cited as PB 36 of 2018.

  1. Commencement

This Instrument commences on 1 June 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. Schedule 1, entry for Acamprosate in the form Tablet (enteric coated) containing acamprosate calcium 333 mg

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

a APO-Acamprosate TX MP NP C5366 180 1 180

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

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

omit:

a Zovirax 200 mg GK MP NP C5942 90 5 90

  1. Schedule 1, entry for Adalimumab in the form Injection 20 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C6916 C6917 C6918 C6921 C6931 C6932

(b)insert in numerical order in the column headed “Circumstances”: C7652 C7654 C7655 C7663 C7664

  1. Schedule 1, entry for Adalimumab in the form Injection 20 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C6916 C6917 C6918 C6921 C6931 C6932

(b)insert in numerical order in the column headed “Circumstances”: C7652 C7654 C7655 C7663 C7664

(c)omit from the column headed “Purposes”: P6918 P6931 P6932

(d)insert in numerical order in the column headed “Purposes”: P7652 P7655 P7664

  1. Schedule 1, entry for Adalimumab in the form Injection 20 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C6916 C6917 C6918 C6921 C6931 C6932

(b)insert in numerical order in the column headed “Circumstances”: C7652 C7654 C7655 C7663 C7664

(c)omit from the column headed “Purposes”: P6916 P6917 P6921

(d)insert in numerical order in the column headed “Purposes”: P7654 P7663

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C6916 C6917 C6918 C6921

(b)omit from the column headed “Circumstances”: C6931 C6932

(c)insert in numerical order in the column headed “Circumstances”: C7652 C7654 C7655 C7663 C7664

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C6916 C6917 C6918 C6921

(b)omit from the column headed “Circumstances”: C6931 C6932

(c)insert in numerical order in the column headed “Circumstances”: C7652 C7654 C7655 C7663 C7664

(d)omit from the column headed “Purposes”:          P6918 P6931 P6932

(e)insert in numerical order in the column headed “Purposes”: P7652 P7655 P7664

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C6916 C6917 C6918 C6921

(b)omit from the column headed “Circumstances”: C6931 C6932

(c)insert in numerical order in the column headed “Circumstances”: C7652 C7654 C7655 C7663 C7664

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 4]

(a)omit from the column headed “Circumstances”: C6916 C6917 C6918 C6921

(b)omit from the column headed “Circumstances”: C6931 C6932

(c)insert in numerical order in the column headed “Circumstances”: C7652 C7654 C7655 C7663 C7664

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C6916 C6917 C6918 C6921

(b)omit from the column headed “Circumstances”: C6931 C6932

(c)insert in numerical order in the column headed “Circumstances”: C7652 C7654 C7655 C7663 C7664

(d)omit from the column headed “Purposes”:          P6916 P6917 P6921

(e)insert in numerical order in the column headed “Purposes”: P7654 P7663

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre‑filled pen [Maximum Quantity: 2; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C6916 C6917 C6918 C6921

(b)omit from the column headed “Circumstances”: C6931 C6932

(c)insert in numerical order in the column headed “Circumstances”: C7652 C7654 C7655 C7663 C7664

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre‑filled pen [Maximum Quantity: 2; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C6916 C6917 C6918 C6921

(b)omit from the column headed “Circumstances”: C6931 C6932

(c)insert in numerical order in the column headed “Circumstances”: C7652 C7654 C7655 C7663 C7664

(d)omit from the column headed “Purposes”:          P6918 P6931 P6932

(e)insert in numerical order in the column headed “Purposes”: P7652 P7655 P7664

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre‑filled pen [Maximum Quantity: 2; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C6916 C6917 C6918 C6921

(b)omit from the column headed “Circumstances”: C6931 C6932

(c)insert in numerical order in the column headed “Circumstances”: C7652 C7654 C7655 C7663 C7664

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre‑filled pen [Maximum Quantity: 2; Number of Repeats: 4]

(a)omit from the column headed “Circumstances”: C6916 C6917 C6918 C6921

(b)omit from the column headed “Circumstances”: C6931 C6932

(c)insert in numerical order in the column headed “Circumstances”: C7652 C7654 C7655 C7663 C7664

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre‑filled pen [Maximum Quantity: 2; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C6916 C6917 C6918 C6921

(b)omit from the column headed “Circumstances”: C6931 C6932

(c)insert in numerical order in the column headed “Circumstances”: C7652 C7654 C7655 C7663 C7664

(d)omit from the column headed “Purposes”:          P6916 P6917 P6921

(e)insert in numerical order in the column headed “Purposes”: P7654 P7663

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre‑filled syringe, 6

(a)omit from the column headed “Circumstances”: C6918 C6931 C6932

(b)insert in numerical order in the column headed “Circumstances”: C7652 C7655 C7664

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre‑filled pen, 6

(a)omit from the column headed “Circumstances”: C6918 C6931 C6932

(b)insert in numerical order in the column headed “Circumstances”: C7652 C7655 C7664

  1. Schedule 1, entry for Adrenaline in the form I.M. injection 150 micrograms in 0.3 mL single dose syringe auto‑injector (EpiPen Jr.)

(a)omit from the column headed “Form”: (EpiPen Jr.)

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

a Adrenaline Jr Mylan AF

MP NP

 C4909 C4946 C4947 1 0 1

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

  1. Schedule 1, entry for Adrenaline in the form I.M. injection 300 micrograms in 0.3 mL single dose syringe auto‑injector (EpiPen)

(a)omit from the column headed “Form”: (EpiPen)

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

a Adrenaline Mylan AF MP NP C4909 C4946 C4947 1 0 1

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

  1. Schedule 1, entry for Alprazolam

substitute:

Alprazolam Tablet 250 micrograms Oral a Kalma 0.25 AF MP NP C6773 10 0 10
MP NP C6773 10 0 50
Tablet 500 micrograms Oral a Alprax 0.5 QA MP NP C6773 10 0 10
a Kalma 0.5 AF MP NP C6773 10 0 10
MP NP C6773 10 0 50
Tablet 1 mg Oral a Alprax 1 QA MP NP C6773 10 0 10
a Kalma 1 AF MP NP C6773 10 0 10
MP NP C6773 10 0 50

  1. Schedule 1, entry for Amino acids-synthetic, formula in the form Oral powder 400 g (Neocate Advance Vanilla)

(a)omit from the column headed “Form”: Advance              substitute:             Junior

(b)omit from the column headed “Brand”:                Neocate Advance Vanilla           substitute:             Neocate Junior Vanilla

  1. Schedule 1, entry for Amlodipine with Atorvastatin in all forms

omit all codes from the column headed “Circumstances”

  1. Schedule 1, entry for Buprenorphine

substitute:

Buprenorphine Tablet (sublingual) 400 micrograms (as hydrochloride) Sublingual Subutex IR MP NP C6451 See Note 3 See Note 3 7 PB(100)
Tablet (sublingual) 2 mg (as hydrochloride) Sublingual Subutex IR MP NP C6451 See Note 3 See Note 3 7 PB(100)
Tablet (sublingual) 8 mg (as hydrochloride) Sublingual Subutex IR MP NP C6451 See Note 3 See Note 3 7 PB(100)
Transdermal patch 5 mg Transdermal a Bupredermal TX MP NP C4951 C6151 P4951 2 0 2
a Norspan MF MP NP C4951 C6151 P4951 2 0 2
a Bupredermal TX MP NP C4951 C6151 P6151 4 2 2
a Norspan MF MP NP C4951 C6151 P6151 4 2 2
Transdermal patch 10 mg Transdermal a Bupredermal TX MP NP C4951 C6151 P4951 2 0 2
a Norspan MF MP NP C4951 C6151 P4951 2 0 2
a Bupredermal TX MP NP C4951 C6151 P6151 4 2 2
a Norspan MF MP NP C4951 C6151 P6151 4 2 2
Transdermal patch 15 mg Transdermal Norspan MF MP NP C4951 C6151 P4951 2 0 2
MP NP C4951 C6151 P6151 4 2 2
Transdermal patch 20 mg Transdermal a Bupredermal TX MP NP C4951 C6151 P4951 2 0 2
a Norspan MF MP NP C4951 C6151 P4951 2 0 2
a Bupredermal TX MP NP C4951 C6151 P6151 4 2 2
a Norspan MF MP NP C4951 C6151 P6151 4 2 2
Transdermal patch 25 mg Transdermal Norspan MF MP NP C4951 C6151 P4951 2 0 2
MP NP C4951 C6151 P6151 4 2 2
Transdermal patch 30 mg Transdermal Norspan MF MP NP C4951 C6151 P4951 2 0 2
MP NP C4951 C6151 P6151 4 2 2
Transdermal patch 40 mg Transdermal Norspan MF MP NP C4951 C6151 P4951 2 0 2
MP NP C4951 C6151 P6151 4 2 2

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

insert:

Cabozantinib Tablet 20 mg Oral Cabometyx IS MP C7631 C7639 P7639 30 2 30
MP C7631 C7639 P7631 30 5 30
Tablet 40 mg Oral Cabometyx IS MP C7631 C7639 P7639 30 2 30
MP C7631 C7639 P7631 30 5 30
Tablet 60 mg Oral Cabometyx IS MP C7631 C7639 P7639 30 2 30
MP C7631 C7639 P7631 30 5 30

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

omit:

Celecoxib RBX RA MP NP C4907 C4962 60 3 60

  1. Schedule 1, entry for Celecoxib in the form Capsule 200 mg

omit:

Celecoxib RBX RA MP NP C4907 C4962 30 3 30

  1. Schedule 1, entry for Cyclophosphamide in the form Tablet 50 mg

omit from the column headed “Brand”:            Cycloblastin      substitute:             Cyclonex

  1. Schedule 1, omit entry for Daclizumab

  1. Schedule 1, entry for Dicloxacillin

substitute:

Dicloxacillin Capsule 250 mg (as sodium) Oral a Dicloxacillin Mylan 250 AL MP NP MW C5415 24 0 24
PDP C5268 24 0 24
a Distaph 250 AF MP NP MW C5415 24 0 24
PDP C5268 24 0 24
Capsule 500 mg (as sodium) Oral a Dicloxacillin Mylan 500 AL MP C5415 C6188 P5415 24 0 24
PDP C5268 24 0 24
NP MW C5415 24 0 24
a Distaph 500 AF MP C5415 C6188 P5415 24 0 24
PDP C5268 24 0 24
NP MW C5415 24 0 24
a Dicloxacillin Mylan 500 AL MP C5415 C6188 P6188 48 1 24
a Distaph 500 AF MP C5415 C6188 P6188 48 1 24

  1. Schedule 1, omit entry for Didanosine

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

omit:

a Donepezil generichealth GQ MP NP C4219 C4220 C4224 28 5 28

  1. Schedule 1, after entry for Dorzolamide with timolol in the form Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL

insert:

Dosulepin Capsule containing dosulepin hydrochloride 25 mg Oral a Dosulepin Mylan AL MP NP 50 2 50
a Dothep 25 AF MP NP 50 2 50
Tablet containing dosulepin hydrochloride 75 mg Oral a Dosulepin Mylan AL MP NP 30 2 30
a Dothep 75 AF MP NP 30 2 30

  1. Schedule 1, omit entry for Dothiepin

  1. Schedule 1, after entry for Doxycycline in the form Capsule 100 mg (as hydrochloride) (containing enteric coated pellets)

insert:

Dulaglutide Injection 1.5 mg in 0.5 mL single dose pre-filled pen Injection Trulicity LY MP NP C5478 C7645 4 5 4

  1. Schedule 1, entry for Enoxaparin

substitute:

Enoxaparin Injection containing enoxaparin sodium 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre-filled syringe Injection a Clexane SW MP NP 20 0 10
a Enoxaparin Winthrop WA MP NP 20 0 10
a Clexane SW MP NP P4910 20 3 10
a Enoxaparin Winthrop WA MP NP P4910 20 3 10
Injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in 0.4 mL pre-filled syringe Injection a Clexane SW MP NP 20 0 10
a Enoxaparin Winthrop WA MP NP 20 0 10
a Clexane SW MP NP P4910 20 3 10
a Enoxaparin Winthrop WA MP NP P4910 20 3 10
Injection containing enoxaparin sodium 60 mg (6,000 I.U. anti-Xa) in 0.6 mL pre-filled syringe Injection a Clexane SW MP NP 10 1 10
a Enoxaparin Winthrop WA MP NP 10 1 10
a Clexane SW MP NP P4910 20 3 10
a Enoxaparin Winthrop WA MP NP P4910 20 3 10
Injection containing enoxaparin sodium 80 mg (8,000 I.U. anti-Xa) in 0.8 mL pre-filled syringe Injection a Clexane SW MP NP 10 1 10
a Enoxaparin Winthrop WA MP NP 10 1 10
a Clexane SW MP NP P4910 20 3 10
a Enoxaparin Winthrop WA MP NP P4910 20 3 10
Injection containing enoxaparin sodium 100 mg (10,000 I.U. anti-Xa) in 1 mL pre-filled syringe Injection a Clexane SW MP NP 10 1 10
a Enoxaparin Winthrop WA MP NP 10 1 10
a Clexane SW MP NP P4910 20 3 10
a Enoxaparin Winthrop WA MP NP P4910 20 3 10

  1. Schedule 1, entry for Everolimus

substitute:

Everolimus Tablet 0.25 mg Oral Certican NV MP 60 3 60
MP P5554 P5555 P5794 P5795 120
CN5554 CN5555 CN5794 CN5795 		5
CN5554 CN5555 CN5794 CN5795 		60 C(100)
Tablet 0.5 mg Oral Certican NV MP 60 3 60
MP P5554 P5555 P5794 P5795 120
CN5554 CN5555 CN5794 CN5795 		5
CN5554 CN5555 CN5794 CN5795 		60 C(100)
Tablet 0.75 mg Oral Certican NV MP 120 3 60
MP P5554 P5555 P5794 P5795 240
CN5554 CN5555 CN5794 CN5795 		5
CN5554 CN5555 CN5794 CN5795 		60 C(100)
Tablet 1 mg Oral Certican NV MP 120 3 60
MP P5554 P5555 P5794 P5795 240
CN5554 CN5555 CN5794 CN5795 		5
CN5554 CN5555 CN5794 CN5795 		60 C(100)
Tablet 2.5 mg Oral Afinitor NV MP C4351 C7431 30 5 30
Tablet 5 mg Oral Afinitor NV MP C4351 C4604 C4812 C4837 C4861 C7431 C7432 P4604 P4861 30 2 30
Everolimus Sandoz SZ MP C4837 C4861 P4861 30 2 30
Afinitor NV MP C4351 C4604 C4812 C4837 C4861 C7431 C7432 P4351 P4812 P4837 P7431 P7432 30 5 30
Everolimus Sandoz SZ MP C4837 C4861 P4837 30 5 30
Tablet 10 mg Oral Afinitor NV MP C4351 C4604 C4812 C4837 C4861 C7431 C7432 P4604 P4861 30 2 30
Everolimus Sandoz SZ MP C4837 C4861 P4861 30 2 30
Afinitor NV MP C4351 C4604 C4812 C4837 C4861 C7431 C7432 P4351 P4812 P4837 P7431 P7432 30 5 30
Everolimus Sandoz SZ MP C4837 C4861 P4837 30 5 30

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

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

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

a Zient 10mg AF MP NP C5537 C5538 C5543 C5544 C5562 C5563 C5575 C5576 C5577 C5586 C5594 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 C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 C4147 1 5 1
a Rosuzet Composite Pack MK MP NP C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 C4147 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 C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 1 5 1
a Rosuzet Composite Pack MK MP NP C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 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 C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 1 5 1
a Rosuzet Composite Pack MK MP NP C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 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 C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 1 5 1
a Rosuzet Composite Pack MK MP NP C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 1 5 1

  1. Schedule 1, entry for Ezetimibe with Simvastatin

substitute:

Ezetimibe with simvastatin Tablet 10 mg‑10 mg Oral a Vytorin MK MP NP C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 C4147 30 5 30
a Zeklen 10/10mg AF MP NP C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 C4147 30 5 30
Tablet 10 mg‑20 mg Oral a Vytorin MK MP NP C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 C4147 30 5 30
a Zeklen 10/20mg AF MP NP C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 C4147 30 5 30
Tablet 10 mg‑40 mg Oral a Vytorin MK MP NP C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 30 5 30
a Zeklen 10/40mg AF MP NP C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 30 5 30
Tablet 10 mg‑80 mg Oral a Vytorin MK MP NP C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 30 5 30
a Zeklen 10/80mg AF MP NP C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 30 5 30

  1. Schedule 1, entry for Fenofibrate

substitute:

Fenofibrate Tablet 48 mg Oral Lipidil GO MP NP 60 5 60
MP P7640 60 11 60
Tablet 145 mg Oral Lipidil GO MP NP 30 5 30
MP P7640 30 11 30

  1. Schedule 1, after entry for Fluticasone in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms per dose, 60 doses

insert:

Fluticasone furoate with umeclidinium and vilanterol Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms with umeclidinium 62.5 micrograms (as bromide) and vilanterol 25 micrograms (as trifenatate) per dose, 30 doses Inhalation by mouth Trelegy Ellipta 100/62.5/25 GK MP NP C7651 1 5 1

  1. Schedule 1, entry for Gemfibrozil

substitute:

Gemfibrozil Tablet 600 mg Oral a Ausgem RW MP NP 60 5 60
a Lipigem AF MP NP 60 5 60
a Ausgem RW MP P7640 60 11 60
a Lipigem AF MP P7640 60 11 60

  1. Schedule 1, after entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre‑filled pen

insert:

Injection 100 mg in 1 mL single use pre-filled pen Injection Simponi JC MP C7662 C7666 C7671 C7675 C7684 C7685 P7662 P7675 P7684 1 1 1
MP C7662 C7666 C7671 C7675 C7684 C7685 P7666 P7671 P7685 1 5 1

  1. Schedule 1, entry for Hydrocortisone in the form Tablet 4 mg

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

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

a Hydrortisone Mylan 4 AL MP NP 50 4 50

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

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

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

a Hydrortisone Mylan 20 AL MP NP 60 4 60

  1. Schedule 1, entry for Hydroxychloroquine

omit:

a Hydroxychloroquine RBX RA MP NP 100 1 100

  1. Schedule 1, omit entry for Interferon alfa-2b

  1. Schedule 1, entry for Irbesartan in each of the forms: Tablet 75 mg; Tablet 150 mg; and Tablet 300 mg

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

a AVSARTAN RF MP NP 30 5 30

  1. Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 150 mg-12.5 mg

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

a AVSARTAN HCT 150/12.5 RF MP NP C4374 30 5 30

  1. Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-12.5 mg

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

a AVSARTAN HCT 300/12.5 RF MP NP C4374 30 5 30

  1. Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-25 mg

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

a AVSARTAN HCT 300/25 RF MP NP C4374 30 5 30

  1. Schedule 1, entry for Lamivudine

omit:

Oral solution 5 mg per mL, 240 mL Oral Zeffix RW MP C4993 C5036 5 5 1 D(100)

  1. Schedule 1, entry for Lincomycin

(a)omit from the column headed “Form”:             Injection 600 mg (as hydrochloride) in 2 mL

substitute:   Injection 600 mg (as hydrochloride monohydrate) in 2 mL

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

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

a LINCOMYCIN SXP XC PDP
MP NP MW 		5 0 5

  1. Schedule 1, entry for Metoclopramide in the form Tablet containing metoclopramide hydrochloride 10 mg

omit:

a Metoclopramide RBX RA MP NP MW PDP 25 0 25

  1. Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg

omit:

Metoprolol RBX RA MP NP 60 5 60

  1. Schedule 1, entry for Moxonidine each of the forms: Tablet 200 micrograms; and Tablet 400 micrograms

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

a Moxonidine MYL AF MP NP C4944 30 5 30

(b)insert in the column headed “Schedule Equivalent” for all brands:              a

  1. Schedule 1, after entry for Nortriptyline in the form Tablet 25 mg (as hydrochloride)

insert:

Nusinersen Solution for injection 12 mg in 5 mL Injection Spinraza BD MP See Note 3 See Note 3 See Note 3 See Note 3 1 D(100)

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

insert in the column headed “Schedule Equivalent” for all brands:          a

  1. Schedule 1, entry for Olanzapine

omit:

Tablet 2.5 mg (as benzoate) Oral Olanzapine generichealth 2.5 GQ MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Paritaprevir with ritonavir with ombitasvir and dasabuvir

omit from column headed “Brand”:   Veikira Pak         substitute:             Viekira Pak

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium)

omit from the column headed “Responsible Person” for the brand “Crosuva 5” (twice occurring): ZP            substitute: RW

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium)

omit from the column headed “Responsible Person” for the brand “Crosuva 10” (twice occurring): ZP         substitute: RW

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium)

omit from the column headed “Responsible Person” for the brand “Crosuva 20” (twice occurring): ZP         substitute: RW

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium)

omit from the column headed “Responsible Person” for the brand “Crosuva 40” (twice occurring):  ZP        substitute: RW

  1. Schedule 1, omit entry for Stavudine

  1. Schedule 1, entry for Tobramycin in the form Solution for inhalation 300 mg in 5 mL

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

a Tobramycin WKT LI MP C5520 56 2 56

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

omit:

a Venla RBX RA MP NP C5650 28 5 28

  1. Schedule 3, details relevant to Responsible Person code FX

omit from the column headed “Responsible Person”:    Finox Biotech Australia            substitute:          Gedeon Richter Australia Pty Ltd

  1. Schedule 4, Part 1, entry for Adalimumab

(a)omit:

C6916 P6916 Moderate to severe ulcerative colitis
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.
Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction. 		Compliance with Authority Required procedures
C6917 P6917 Moderate to severe ulcerative colitis
Initial 3 (Grandfathered patient)
Patient must have a documented history of moderate to severe ulcerative colitis; AND
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2016; AND
Patient must be receiving treatment with this drug at the time of application; AND
Patient must have a Mayo score greater than or equal to 6 prior to commencing treatment with this drug; OR
Patient must have a partial Mayo score is greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo score) prior to commencing treatment with this drug; OR
Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 prior to commencing treatment with this drug, if aged 6 to 17 years; OR
Patient must have a documented history of moderate to severe refractory ulcerative colitis prior to having commenced treatment with this drug where a Mayo clinic, partial Mayo clinic or PUCAI baseline assessment is not available, if aged 6 to 17 years; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Applications for authorisation of initial treatment must be in writing and must include: (a) a completed authority prescription form; and (b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current and baseline Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheets including the dates of assessment of the patient's condition; and (ii) the date of commencement of this drug; and (iii) the signed patient or guardian acknowledgement
The current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment must be no more than 1 month old at the time of application. The baseline assessment must be from immediately prior to commencing treatment with this drug. Where a baseline assessment is not available the prescriber must contact the Department of Human Services to discuss.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
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 Written Authority Required procedures
C6918 P6918 Moderate to severe ulcerative colitis
Balance of supply for Initial 1 and Initial 2
Patient must have received insufficient treatment with this drug under the Initial 1 (new patient or recommencement of treatment after more than 5 years break in therapy) restriction to complete 16 weeks of treatment; OR
Patient must have received insufficient treatment with this drug under the Initial 2 (Change or Re-commencing of treatment after less than 5 years break in therapy) to complete 16 weeks of treatment.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Authority approval for sufficient therapy to complete a maximum of 16 weeks of treatment may be requested by telephone by contacting the Department of Human Services. 		Compliance with Authority Required procedures
C6921 P6921 Moderate to severe ulcerative colitis
Balance of supply for Continuing treatment and Initial 3 (Grandfathered patients)
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; OR
Patient must have received insufficient treatment with this drug to complete 24 weeks of treatment under the Initial 3 (Grandfathered patients).
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Authority approval for sufficient therapy to complete a maximum of 24 weeks of treatment may be requested by telephone by contacting the Department of Human Services. 		Compliance with Authority Required procedures

(b)omit:

C6931 P6931 Moderate to severe ulcerative colitis
Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)
Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg (for a child, 1 to 2 mg/kg up to 40 mg) prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); OR
Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Applications for authorisation of initial treatment must be in writing and must include:(a) two completed authority prescription forms; and(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and(iii) the signed patient acknowledgement or guardian acknowledgement.
For patients weighing 40 kg or greater, a maximum quantity and number of repeats to provide for an initial 16 weeks course of this drug consisting of a 160 mg dose at week 0, 80 mg dose at week 2 and 40 mg dose at weeks 4, 6, 8, 10, 12 and 14 will be authorised.
For patients weighing less than 40 kg, a maximum quantity and number of repeats to provide for an initial 16 weeks of this drug consisting of a 80 mg dose at week 0, 40 mg dose at week 2 and a 20 mg dose at weeks 4, 6, 8, 10, 12 and 14 will be authorised.
Two completed authority prescriptions must be submitted with every initial application for this drug.For patients weighing 40 kg or greater, one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription must be written for 2 doses of 40 mg and 2 repeats.
For patients weighing less than 40 kg, one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 1 month old at the time of application.
Patients who fail to achieve a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 within the first 12 weeks of receiving this drug for ulcerative colitis, or have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or have failed to maintain a PUCAI score less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated.
The patient or guardian (required if patient is aged 6 to 17 years) must have signed a patient acknowledgement indicating that he or she understands and acknowledges that the PBS-subsidised treatment will cease if he or she does not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website. 		Compliance with Written Authority Required procedures
C6932 P6932 Moderate to severe ulcerative colitis
Change or Re-commencement of treatment after a break of less than 5 years in therapy (Initial 2)
Patient must have previously received PBS-subsidised treatment with adalimumab, infliximab or vedolizumab for this condition in this treatment cycle; OR
Patient must have previously received PBS-subsidised treatment with adalimumab or infliximab for this condition in this treatment cycle if aged 6 to 17 years; AND
Patient must not have failed PBS-subsidised treatment with adalimumab for this condition in the current treatment cycle; OR
Patient must not have failed PBS-subsidised treatment with adalimumab for this condition in the current treatment cycle more than once if aged 6 to 17 years.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of this drug within the timelines specified in the relevant restriction. If the response assessment to the previous course of this drug is not submitted as detailed in the relevant restriction, the patient will be deemed to have failed therapy with this drug.
Applications for authorisation of initial treatment must be in writing and must include:
(a) two completed authority prescription forms; and(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].
Two completed authority prescriptions must be submitted with every initial application for this drug.For patients weighing 40 kg or greater, one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription must be written for 2 doses of 40 mg and 2 repeats.
For patients weighing less than 40 kg, one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats. 		Compliance with Written Authority Required procedures

(c)insert in numerical order after existing text:

C7652 P7652

Moderate to severe ulcerative colitis

Change or Re-commencement of treatment after a break in therapy of less than 5 years (Initial 2)

Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have previously received PBS-subsidised treatment with adalimumab, golimumab, infliximab or vedolizumab for this condition in this treatment cycle; OR
Patient must have previously received PBS-subsidised treatment with adalimumab or infliximab for this condition in this treatment cycle if aged 6 to 17 years; AND
Patient must not have failed PBS-subsidised treatment with adalimumab for this condition in the current treatment cycle; OR
Patient must not have failed PBS-subsidised treatment with adalimumab for this condition in the current treatment cycle more than once if aged 6 to 17 years.
Patient must be 6 years of age or older.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of this drug within the timelines specified in the relevant restriction. If the response assessment to the previous course of this drug is not submitted as detailed in the relevant restriction, the patient will be deemed to have failed therapy with this drug.
Applications for authorisation of change or recommencement treatment must be in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].
Two completed authority prescriptions must be submitted with every initial application for this drug. For patients weighing 40 kg or greater, one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription must be written for 2 doses of 40 mg and 2 repeats.
For patients weighing less than 40 kg, one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.

 Compliance with Written Authority Required procedures
C7654 P7654

Moderate to severe ulcerative colitis

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.

 Compliance with Authority Required procedures
C7655 P7655

Moderate to severe ulcerative colitis

Balance of supply for Initial 1 and Initial 2

Patient must have received insufficient treatment with this drug under the Initial 1 (new patient or recommencement of treatment after more than 5 years break in therapy) restriction to complete 16 weeks of treatment; OR
Patient must have received insufficient treatment with this drug under the Initial 2 (Change or Re-commencing of treatment after less than 5 years break in therapy) to complete 16 weeks of treatment.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.

 Compliance with Authority Required procedures
C7663 P7663

Moderate to severe ulcerative colitis

Balance of supply for Continuing treatment

Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.

 Compliance with Authority Required procedures
C7664 P7664

Moderate to severe ulcerative colitis

Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)

Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg (for a child, 1 to 2 mg/kg up to 40 mg) prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); OR
Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Applications for authorisation of initial treatment must be in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the signed patient acknowledgement or guardian acknowledgement.
For patients weighing 40 kg or greater, a maximum quantity and number of repeats to provide for an initial 16 weeks course of this drug consisting of a 160 mg dose at week 0, 80 mg dose at week 2 and 40 mg dose at weeks 4, 6, 8, 10, 12 and 14 will be authorised.
For patients weighing less than 40 kg, a maximum quantity and number of repeats to provide for an initial 16 weeks of this drug consisting of a 80 mg dose at week 0, 40 mg dose at week 2 and a 20 mg dose at weeks 4, 6, 8, 10, 12 and 14 will be authorised.
Two completed authority prescriptions must be submitted with every initial application for this drug.  For patients weighing 40 kg or greater, one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription must be written for 2 doses of 40 mg and 2 repeats.
For patients weighing less than 40 kg, one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 1 month old at the time of application.
Patients who fail to achieve a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 within the first 12 weeks of receiving this drug for ulcerative colitis, or have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or have failed to maintain a PUCAI score less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated.
The patient or guardian (required if patient is aged 6 to 17 years) must have signed a patient acknowledgement indicating that he or she understands and acknowledges that the PBS-subsidised treatment will cease if he or she does not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, omit entry for Amlodipine with atorvastatin

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

insert:

Cabozantinib C7631 P7631

Stage IV clear cell variant renal cell carcinoma (RCC)

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.

 Compliance with Authority Required procedures - Streamlined Authority Code 7631
C7639 P7639

Stage IV clear cell variant renal cell carcinoma (RCC)

Initial treatment

Patient must have progressive disease according to the Response Evaluation Criteria In Solid Tumours (RECIST) following first-line treatment with a tyrosine kinase inhibitor; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS-subsidised therapy for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 7639

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

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

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

insert:

Dulaglutide C5478

Diabetes mellitus type 2

The treatment must be in combination with metformin; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

 Compliance with Authority Required procedures - Streamlined Authority Code 5478
C7645

Diabetes mellitus type 2

The treatment must be in combination with metformin; AND
Patient must have a contraindication to a combination of metformin and a sulfonylurea; OR
Patient must not have tolerated a combination of metformin and a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with metformin; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with metformin.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

 Compliance with Authority Required procedures - Streamlined Authority Code 7645

  1. Schedule 4, Part 1, entry for Fenofibrate

substitute:

Fenofibrate P7640 For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements.

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

insert:

Fluticasone furoate with umeclidinium and vilanterol C7651

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 bronchodilator therapy with a long acting muscarinic antagonist (LAMA) and a long acting beta-2 agonist (LABA), or an inhaled corticosteroid (ICS) and a LABA; OR
Patient must have been stabilised on a combination of a LAMA, LABA and an ICS for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 7651

  1. Schedule 4, Part 1, entry for Gemfibrozil

substitute:

Gemfibrozil P7640 For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements.

  1. Schedule 4, Part 1, entry for Golimumab

insert in numerical order after existing text:

C7662 P7662

Moderate to severe ulcerative colitis

Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)

Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score).
Patient must be aged 18 years or older.
Applications for authorisation of initial treatment must be in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the signed patient acknowledgement.
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written providing for a loading dose of 200 mg at week 0 and a dose of 100 mg at week 2. This prescription should specify a quantity of 3 injections of 100 mg and no repeats. The second prescription should be for the subsequent doses at weeks 6 and 10. This prescription should specify a quantity of 1 injection of 100 mg and one repeat. All tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 1 month old at the time of application.
Patients who fail to achieve a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 or have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose for patients administered doses at weeks 0, 2, 6 and 10 so that there is adequate time for a response to be demonstrated.
Patients must have signed a patient acknowledgement indicating they understand and acknowledge that the PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.

 Compliance with Written Authority Required procedures
C7666 P7666

Moderate to severe ulcerative colitis

Balance of supply for Continuing treatment and Initial 3 (Grandfathered patients)

Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; OR
Patient must have received insufficient treatment with this drug to complete 24 weeks of treatment under the Initial 3 (Grandfathered patients).
Patient must be aged 18 years or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].

 Compliance with Authority Required procedures
C7671 P7671

Moderate to severe ulcerative colitis

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must be 18 years or older.
Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1  with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.

 Compliance with Authority Required procedures
C7675 P7675

Moderate to severe ulcerative colitis

Change or Re-commencement of treatment after a break in therapy of less than 5 years (Initial 2)

Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS-subsidised treatment with adalimumab, golimumab, infliximab or vedolizumab for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with golimumab for this condition in the current treatment cycle.
Patient must be aged 18 years or older.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of this drug within the timelines specified in the relevant restriction. If the response assessment to the previous course of this drug is not submitted as detailed in the relevant restriction, the patient will be deemed to have failed therapy with this drug.
Applications for authorisation of change or recommencement treatment must be in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) Mayo clinical assessment (to demonstrate response to prior treatment).
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written providing for a loading dose of 200 mg at week 0 and a dose of 100 mg at week 2. This prescription should specify a quantity of 3 injections of 100 mg and no repeats. The second prescription should be for the subsequent doses at weeks 6 and 10. This prescription should specify a quantity of 1 injection of 100 mg and one repeat.

 Compliance with Written Authority Required procedures
C7684 P7684

Moderate to severe ulcerative colitis

Balance of supply for Initial 1 and Initial 2

Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug under the Initial 1 restriction to complete 14 weeks of treatment (weeks 0, 2, 6 and 10); OR
Patient must have received insufficient therapy with this drug under the Initial 2 restriction to complete 14 weeks of treatment (weeks 0, 2, 6 and 10).
Patient must be aged 18 years or older.

 Compliance with Authority Required procedures
C7685 P7685

Moderate to severe ulcerative colitis

Initial 3 (Grandfathered patients)

Patient must have previously received non-PBS-subsidised therapy with this drug for this condition prior to 1 June 2018; AND
Patient must have had a Mayo clinic score greater than or equal to 6 prior to commencing treatment with this drug; OR
Patient must have had a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores were both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo score) prior to commencing treatment with this drug; OR
Patient must have a documented history of moderate to severe refractory ulcerative colitis prior to having commenced treatment with this drug where a Mayo clinic, partial Mayo clinic baseline assessment is not available; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 after receiving doses of this drug at weeks 0, 2, 6 and 10 for this condition.
Patient must be aged 18 years or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed baseline Mayo clinic or partial Mayo clinic calculation sheet prior to initiating treatment (if available) and current Mayo clinic or partial Mayo clinic calculation sheet to demonstrate response, including the date of assessment;
(ii) If the baseline Mayo or partial Mayo clinic calculation is not available, reason must be provided;
(iii) the date of commencement of this drug; and
(iv) the signed patient acknowledgement.
The current Mayo clinic or partial Mayo clinic assessment must be no more than 1 month old at the time of application. The baseline assessment must be from immediately prior to commencing treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
Where a grandfather patient has received all four doses at weeks, 0, 2, 6 and 10 by 1 June 2018, one completed authority prescription should be submitted with the application for this drug, specifying a quantity of 1 injection of 100 mg and up to 5 repeats.
Where a grandfather patient has not received doses at weeks 2, 6 and 10 by 1 June 2018, one completed authority prescription should be submitted with the application for this drug specifying a quantity of 1 injection of 100 mg and 2 repeats.
Where a grandfather patient has not received doses at weeks 6 and 10 by 1 June 2018, one completed authority prescription should be submitted with the application for this drug specifying a quantity of 1 injection of 100 mg and 1 repeat.
Where a grandfather patient has not received the dose at week 10 by 1 June 2018, one completed authority prescription should be submitted with the application for this drug specifying a quantity of 1 injection of 100 mg and 0 repeats.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, omit entry for Interferon Alfa‑2b

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

  1. Schedule 5, after entry for Etanercept [GRP-21359]

insert:

Everolimus GRP-22362 Tablet 5 mg Oral Afinitor
Everolimus Sandoz
GRP-22363 Tablet 10 mg Oral Afinitor
Everolimus Sandoz

  1. Schedule 5, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate)

(a)omit from the column headed “Brand”:                        NexazoleNexium

(b)substitute:               Nexazole
   Nexium

  1. Schedule 5, entry for Olanzapine

omit:

GRP-15492 Tablet 2.5 mg Oral APO-Olanzapine
Chem mart Olanzapine
Olanzacor 2.5
Olanzapine AN
Olanzapine RBX
Olanzapine Sandoz
Olanzapine-DRLA
Ozin 2.5
PRYZEX
Terry White Chemists Olanzapine
Zypine
Zyprexa
Tablet 2.5 mg (as benzoate) Oral Olanzapine generichealth 2.5
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