National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 12) (PB 124 of 2020) (Cth)

Case

PB 124 of 2020

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020
(No. 12)

National Health Act 1953

________________________________________________________________________

I, CAROLINE TURNOUR, Assistant Secretary (Acting), 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  21 December 2020

CAROLINE TURNOUR

Assistant Secretary (Acting)

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 2020 (No. 12).

(2)This Instrument may also be cited as PB 124 of 2020.

  1. Commencement

This Instrument commences on 1 January 2021.

  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, Part 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”: C8804 C8808 C8809 C8811

(b)omit from the column headed “Circumstances”: C8836 C8851 C8867

(c)insert in numerical order in the column headed “Circumstances”: C11089 C11096 C11107 C11113 C11122 C11138 C11154

  1. Schedule 1, Part 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”: C8804 C8808 C8809 C8811

(b)omit from the column headed “Circumstances”: C8836 C8851 C8867

(c)insert in numerical order in the column headed “Circumstances”: C11089 C11096 C11107 C11113 C11122 C11138 C11154

  1. Schedule 1, Part 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”: C8804 C8808 C8809 C8811

(b)omit from the column headed “Circumstances”: C8836 C8851 C8867

(c)insert in numerical order in the column headed “Circumstances”: C11089 C11096 C11107 C11113 C11122 C11138 C11154

  1. Schedule 1, Part 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”: C8804 C8808 C8809 C8811

(b)omit from the column headed “Circumstances”: C8836 C8851 C8867

(c)insert in numerical order in the column headed “Circumstances”: C11089 C11096 C11107 C11113 C11122 C11138 C11154

(d)omit from the column headed “Purposes”: P8804 P8808 P8809 P8811 P8836 P8851 P8867                 substitute: P11089 P11096 P11107 P11113 P11122 P11138 P11154

  1. Schedule 1, Part 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”: C8804 C8808 C8809 C8811

(b)omit from the column headed “Circumstances”: C8836 C8851 C8867

(c)insert in numerical order in the column headed “Circumstances”: C11089 C11096 C11107 C11113 C11122 C11138 C11154

  1. Schedule 1, Part 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”: C8804 C8808 C8809 C8811

(b)omit from the column headed “Circumstances”: C8836 C8851 C8867

(c)insert in numerical order in the column headed “Circumstances”: C11089 C11096 C11107 C11113 C11122 C11138 C11154

  1. Schedule 1, Part 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”: C8804 C8808 C8809 C8811

(b)omit from the column headed “Circumstances”: C8836 C8851 C8867

(c)insert in numerical order in the column headed “Circumstances”: C11089 C11096 C11107 C11113 C11122 C11138 C11154

  1. Schedule 1, Part 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”: C8804 C8808 C8809 C8811

(b)omit from the column headed “Circumstances”: C8836 C8851 C8867

(c)insert in numerical order in the column headed “Circumstances”: C11089 C11096 C11107 C11113 C11122 C11138 C11154

  1. Schedule 1, Part 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”: C8804 C8808 C8809 C8811

(b)omit from the column headed “Circumstances”: C8836 C8851 C8867

(c)insert in numerical order in the column headed “Circumstances”: C11089 C11096 C11107 C11113 C11122 C11138 C11154

(d)omit from the column headed “Purposes”: P8804 P8808 P8809 P8811 P8836 P8851 P8867          substitute: P11089 P11096 P11107 P11113 P11122 P11138 P11154

  1. Schedule 1, Part 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”: C8804 C8808 C8809 C8811

(b)omit from the column headed “Circumstances”: C8836 C8851 C8867

(c)insert in numerical order in the column headed “Circumstances”: C11089 C11096 C11107 C11113 C11122 C11138 C11154

  1. Schedule 1, Part 1, entry for Allopurinol in the form Tablet 100 mg

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

a NOUMED ALLOPURINOL VO MP NP 200 2 200

  1. Schedule 1, Part 1, entry for Allopurinol in the form Tablet 300 mg

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

a NOUMED ALLOPURINOL VO MP NP 60 2 60

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

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

a PULMORIS YC MP See Note 3 See Note 3 See Note 3 See Note 3 30 D(100)

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

omit:

Sachets containing oral powder 27.8 g, 30 (PKU Lophlex) Oral PKU Lophlex SB MP NP C4295 4 5 1

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

insert:

Apremilast Pack containing 4 tablets 10 mg, 4 tablets 20 mg and 19 tablets 30 mg Oral Otezla AN MP C11115 1 0 1
Tablet 30 mg Oral Otezla AN MP C11115 56 5 56

  1. Schedule 1, Part 1, entry for Arsenic

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

Arsenic Trioxide Accord OC MP C4793 C5997 C6018 See Note 3 See Note 3 10 D(100)

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

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

a Atorvachol RF MP NP 30 5 30

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

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

a Atorvachol RF MP P7598 30 11 30

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

omit from the column headed “Circumstances”: C7940 C7941 C10338 C10426 C10454 C10455   substitute: C11099

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

omit from the column headed “Circumstances”: C7938 C7939 C7940 C7941 C7960 C7961 C7962 C7974 C10338 C10426 C10454 C10455       
substitute: C11099

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

omit from the column headed “Circumstances”: C7938 C7939 C7960 C7961 C7962 C7974   substitute: C11099

  1. Schedule 1, Part 1, entry for Carbimazole

omit:

a NeoMercazole BZ MP NP 200 2 100

omit from the column headed “Schedule Equivalent” for the brand “Neo-Mercazole”: a

  1. Schedule 1, Part 1, entry for Carvedilol in the form Tablet 3.125 mg

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

a Carvidol RF MP NP C5324 C5394 30 0 30

  1. Schedule 1, Part 1, entry for Carvedilol in each of the forms: Tablet 6.25 mg; Tablet 12.5 mg; and Tablet 25 mg

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

a Carvidol RF MP NP C5324 C5394 60 5 60

  1. Schedule 1, Part 1, entry for Ciprofloxacin in each of the forms: Tablet 500 mg (as hydrochloride); and Tablet 750 mg (as hydrochloride)

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

a NOUMED CIPROFLOXACIN VO MP NP C5614 C5615 C5687 C5688 C5689 C5722 C5780 14 0 14

  1. Schedule 1, Part 1, after entry for Dapsone in the form Tablet 100 mg

insert:

Daratumumab Solution concentrate for I.V. infusion 100 mg in 5 mL Injection Darzalex JC MP C11075 C11076 C11131 C11142 See Note 3 See Note 3 1 D(100)
Solution concentrate for I.V. infusion 400 mg in 20 mL Injection Darzalex JC MP C11075 C11076 C11131 C11142 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, Part 1, entry for Diazepam in the form Tablet 5 mg [Maximum Quantity: 50; Number of Repeats: 0]

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

a NOUMED DIAZEPAM VO MP NP PDP 50 0 50

  1. Schedule 1, Part 1, entry for Diazepam in the form Tablet 5 mg [Maximum Quantity: 50 CN6176; Number of Repeats: 3 CN6176]

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

a NOUMED DIAZEPAM VO MP NP P6176 50
CN6176 		3
CN6176 		50

  1. Schedule 1, Part 1, entry for Disopyramide

omit from the column headed “Responsible Person”: PB            substitute: SW

  1. Schedule 1, Part 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 Safety-Lock AV MP NP 20 1 10
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 Safety-Lock AV MP NP 20 1 10
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 Safety-Lock AV MP NP 10 1 10
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 Safety-Lock AV MP NP 10 1 10
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 Safety-Lock AV MP NP 10 1 10
MP NP P4910 20 3 10

  1. Schedule 1, Part 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [Maximum Quantity: 30; Number of Repeats: 1]

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

NOUMED ESOMEPRAZOLE VO MP NP C8774 C8775 C8776 C8780 C8827 P8774 P8775 30 1 30

  1. Schedule 1, Part 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [Maximum Quantity: 30; Number of Repeats: 5]

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

NOUMED ESOMEPRAZOLE VO MP NP C8774 C8775 C8776 C8780 C8827 P8776 P8780 P8827 30 5 30

  1. Schedule 1, Part 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [Maximum Quantity: 30; Number of Repeats: 1]

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

NOUMED ESOMEPRAZOLE VO MP NP C8777 C8778 C8902 P8902 30 1 30

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

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

NOUMED ESOMEPRAZOLE VO MP NP C8777 C8778 C8902 P8777 P8778 30 5 30

  1. Schedule 1, Part 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL [Maximum Quantity: 2; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C8804

(b)omit from the column headed “Circumstances”: C8852

(c)omit from the column headed “Circumstances”: C9152

(d)insert in numerical order in the column headed “Circumstances”: C11083 C11084 C11107

(e)omit from the column headed “Purposes”: P8804

(f)omit from the column headed “Purposes”: P8852

(g)omit from the column headed “Purposes”: P9152

(h)insert in numerical order in the column headed “Purposes”: P11083 P11084 P11107

  1. Schedule 1, Part 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL [Maximum Quantity: 2; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C8804

(b)omit from the column headed “Circumstances”: C8852

(c)omit from the column headed “Circumstances”: C9152

(d)insert in numerical order in the column headed “Circumstances”: C11083 C11084 C11107

  1. Schedule 1, Part 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 3]

(a)omit from the column headed “Responsible Person”: MK                 substitute: RF

(b)omit from the column headed “Circumstances”: C8804

(c)omit from the column headed “Circumstances”: C8852

(d)omit from the column headed “Circumstances”: C9152

(e)insert in numerical order in the column headed “Circumstances”: C11083 C11084 C11107

(f)omit from the column headed “Purposes”: P8804

(g)omit from the column headed “Purposes”: P8852

(h)omit from the column headed “Purposes”: P9152

(i)insert in numerical order in the column headed “Purposes”: P11083 P11084 P11107

  1. Schedule 1, Part 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C8804

(b)omit from the column headed “Circumstances”: C8852

(c)omit from the column headed “Circumstances”: C9152

(d)insert in numerical order in the column headed “Circumstances”: C11083 C11084 C11107

(e)omit from the column headed “Purposes”: P8804

(f)omit from the column headed “Purposes”: P8852

(g)omit from the column headed “Purposes”: P9152

(h)insert in numerical order in the column headed “Purposes”: P11083 P11084 P11107

  1. Schedule 1, Part 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Responsible Person”: MK                 substitute: RF

(b)omit from the column headed “Circumstances”: C8804

(c)omit from the column headed “Circumstances”: C8852

(d)omit from the column headed “Circumstances”: C9152

(e)insert in numerical order in the column headed “Circumstances”: C11083 C11084 C11107

  1. Schedule 1, Part 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C8804

(b)omit from the column headed “Circumstances”: C8852

(c)omit from the column headed “Circumstances”: C9152

(d)insert in numerical order in the column headed “Circumstances”: C11083 C11084 C11107

  1. Schedule 1, Part 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 3]

(a)omit from the column headed “Responsible Person”: MK                 substitute: RF

(b)omit from the column headed “Circumstances”: C8804

(c)omit from the column headed “Circumstances”: C8852

(d)omit from the column headed “Circumstances”: C9152

(e)insert in numerical order in the column headed “Circumstances”: C11083 C11084 C11107

(f)omit from the column headed “Purposes”: P8804

(g)omit from the column headed “Purposes”: P8852

(h)omit from the column headed “Purposes”: P9152

(i)insert in numerical order in the column headed “Purposes”: P11083 P11084 P11107

  1. Schedule 1, Part 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C8804

(b)omit from the column headed “Circumstances”: C8852

(c)omit from the column headed “Circumstances”: C9152

(d)insert in numerical order in the column headed “Circumstances”: C11083 C11084 C11107

(e)omit from the column headed “Purposes”: P8804

(f)omit from the column headed “Purposes”: P8852

(g)omit from the column headed “Purposes”: P9152

(h)insert in numerical order in the column headed “Purposes”: P11083 P11084 P11107

  1. Schedule 1, Part 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Responsible Person”: MK                 substitute: RF

(b)omit from the column headed “Circumstances”: C8804

(c)omit from the column headed “Circumstances”: C8852

(d)omit from the column headed “Circumstances”: C9152

(e)insert in numerical order in the column headed “Circumstances”: C11083 C11084 C11107

  1. Schedule 1, Part 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C8804

(b)omit from the column headed “Circumstances”: C8852

(c)omit from the column headed “Circumstances”: C9152

(d)insert in numerical order in the column headed “Circumstances”: C11083 C11084 C11107

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

omit:

DBL Fluorouracil Injection BP PF MP C6266 C6297 See Note 3 See Note 3 5 D(100)

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

omit:

a Prozac Tab LY MP NP C4755 C6277 28 5 28

  1. Schedule 1, Part 1, entry for Guselkumab

(a)omit from the column headed “Circumstances”: C10810 C10875

(b)omit from the column headed “Circumstances”: C10900

(c)insert in numerical order in the column headed “Circumstances”: C11097 C11114 C11130

  1. Schedule 1, Part 1, entry for Hyoscine

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

a HYOSCINE BUTYLBROMIDE MEDSURGE DZ MP NP C6207 30 3 5

  1. Schedule 1, Part 1, entry for Ixekizumab in the form Injection 80 mg in 1 mL single dose pre-filled pen [Maximum Quantity: 2; Number of Repeats: 1]

(a)omit from the column headed “Circumstances”: C8804

(b)omit from the column headed “Circumstances”: C8837 C8851 C8867

(c)omit from the column headed “Circumstances”: C8954

(d)omit from the column headed “Circumstances”: C9901 C9983

(e)insert in numerical order in the column headed “Circumstances”: C11089 C11096 C11107 C11113 C11122 C11138 C11154

  1. Schedule 1, Part 1, entry for Ixekizumab in the form Injection 80 mg in 1 mL single dose pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C8804

(b)omit from the column headed “Circumstances”: C8837 C8851 C8867

(c)omit from the column headed “Circumstances”: C8954

(d)omit from the column headed “Circumstances”: C9901 C9983

(e)insert in numerical order in the column headed “Circumstances”: C11089 C11096 C11107 C11113 C11122 C11138 C11154

  1. Schedule 1, Part 1, entry for Ixekizumab in the form Injection 80 mg in 1 mL single dose pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C8804

(b)omit from the column headed “Circumstances”: C8837 C8851 C8867

(c)omit from the column headed “Circumstances”: C8954

(d)omit from the column headed “Circumstances”: C9901 C9983

(e)insert in numerical order in the column headed “Circumstances”: C11089 C11096 C11107 C11113 C11122 C11138 C11154

(f)omit from the column headed “Purposes”: P8804 P8837 P8851 P8867 P8954 P9901 P9983          substitute: P11089 P11096 P11107 P11113 P11122 P11138 P11154

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

omit from the column headed “Circumstances” (all instances): C5138            substitute: C11081

  1. Schedule 1, Part 1, entry for Lamotrigine in the form Tablet 25 mg

(a)omit from the column headed “Circumstances” (all instances): C5138             substitute: C11081

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

a NOUMED LAMOTRIGINE VO MP NP C11081 56 5 56

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

(a)omit from the column headed “Circumstances” (all instances): C5138             substitute: C11081

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

a NOUMED LAMOTRIGINE VO MP NP C11081 56 5 56

  1. Schedule 1, Part 1, entry for Lamotrigine in the form Tablet 100 mg

(a)omit from the column headed “Circumstances” (all instances): C5138             substitute: C11081

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

a NOUMED LAMOTRIGINE VO MP NP C11081 56 5 56

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

(a)omit from the column headed “Circumstances” (all instances): C5138             substitute: C11081

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

a NOUMED LAMOTRIGINE VO MP NP C11081 56 5 56

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

(a)omit from the column headed “Circumstances”: C10991

(b)insert in numerical order in the column headed “Circumstances”: C11168

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

(a)omit from the column headed “Circumstances”: C10991

(b)insert in numerical order in the column headed “Circumstances”: C11168

(c)omit from the column headed “Purposes”: P10991

(d)insert in numerical order in the column headed “Purposes”: P11168

  1. Schedule 1, Part 1, entry for Levetiracetam in the form Oral solution 100 mg per mL, 300 mL

omit from the column headed “Circumstances” (all instances): C7620       substitute: C11077

  1. Schedule 1, Part 1, entry for Levetiracetam in each of the forms: Tablet 250 mg; Tablet 500 mg; and Tablet 1 g

omit from the column headed “Circumstances” (all instances): C7603       substitute: C11116

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

omit from the column headed “Circumstances”: C10666            substitute: C11176 C11181 C11183

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

omit from the column headed “Circumstances”: C10663 C10666               substitute: C11176 C11178 C11181 C11183 C11185

  1. Schedule 1, Part 1, entry for Paclitaxel in each of the forms: Solution concentrate for I.V. infusion 100 mg in 16.7 mL; Solution concentrate for I.V. infusion 150 mg in 25 mL; and Solution concentrate for I.V. infusion 300 mg in 50 mL

omit:

Anzatax PF MP See Note 3 See Note 3 1 D(100)

  1. Schedule 1, Part 1, entry for Pemetrexed in each of the forms: Powder for I.V. infusion 100 mg (as disodium); and Powder for I.V. infusion 500 mg (as disodium)

omit:

Alimta LY MP See Note 3 See Note 3 1 D(100)

  1. Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg

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

NOUMED PERINDOPRIL VO MP NP 30 5 30

  1. Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg

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

NOUMED PERINDOPRIL VO MP NP 30 5 30

  1. Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg

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

NOUMED PERINDOPRIL VO MP NP 30 5 30

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

insert:

Tablet 5 mg (USP) Oral APO-PINDOL DZ MP NP 100 5 100

  1. Schedule 1, Part 1, entry for Posaconazole

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

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

a Posaconazole Sandoz SZ MP NP C5169 C5395 C5396 24 0 24

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

(a)omit from the column headed “Circumstances”: C9932

(b)omit from the column headed “Circumstances”: C9952 C9953

(c)omit from the column headed “Circumstances”: C9970 C9978 C9979 C9980 C9984

(d)omit from the column headed “Circumstances”: C10001

(e)insert in numerical order in the column headed “Circumstances”: C10802 C10853 C11093 C11120 C11124 C11125 C11171

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

(a)omit from the column headed “Circumstances”: C9932

(b)omit from the column headed “Circumstances”: C9952 C9953

(c)omit from the column headed “Circumstances”: C9970 C9978 C9979 C9980 C9984

(d)omit from the column headed “Circumstances”: C10001

(e)insert in numerical order in the column headed “Circumstances”: C10802 C10853 C11093 C11120 C11124 C11125 C11171

(f)omit from the column headed “Purposes”: P9932 P9952 P9953 P9970 P9978 P9979 P9980 P9984 P10001     substitute: P10802 P10853 P11093 P11120 P11124 P11125 P11171

  1. Schedule 1, Part 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C8837 C8851 C8867

(b)omit from the column headed “Circumstances”: C8905

(c)omit from the column headed “Circumstances”: C9872 C9901

(d)insert in numerical order in the column headed “Circumstances”: C11089 C11096 C11113 C11122 C11138 C11154

  1. Schedule 1, Part 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C8837 C8851 C8867

(b)omit from the column headed “Circumstances”: C8905

(c)omit from the column headed “Circumstances”: C9872 C9901

(d)insert in numerical order in the column headed “Circumstances”: C11089 C11096 C11113 C11122 C11138 C11154

  1. Schedule 1, Part 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C8837 C8851 C8867

(b)omit from the column headed “Circumstances”: C8905

(c)omit from the column headed “Circumstances”: C9872 C9901

(d)insert in numerical order in the column headed “Circumstances”: C11089 C11096 C11113 C11122 C11138 C11154

  1. Schedule 1, Part 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C8837 C8851 C8867

(b)omit from the column headed “Circumstances”: C8905

(c)omit from the column headed “Circumstances”: C9872 C9901

(d)insert in numerical order in the column headed “Circumstances”: C11089 C11096 C11113 C11122 C11138 C11154

  1. Schedule 1, Part 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 4; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C8837 C8851 C8867

(b)omit from the column headed “Circumstances”: C8905

(c)omit from the column headed “Circumstances”: C9872 C9901

(d)insert in numerical order in the column headed “Circumstances”: C11089 C11096 C11113 C11122 C11138 C11154

  1. Schedule 1, Part 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 8; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C8837 C8851 C8867

(b)omit from the column headed “Circumstances”: C8905

(c)omit from the column headed “Circumstances”: C9872 C9901

(d)insert in numerical order in the column headed “Circumstances”: C11089 C11096 C11113 C11122 C11138 C11154

(e)omit from the column headed “Purposes”: P8837 P8851 P8867 P8905

(f)omit from the column headed “Purposes”: P9872 P9901

(g)insert in numerical order in the column headed “Purposes”: P11089 P11096 P11113 P11122 P11138 P11154

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

(a)omit from the column headed “Circumstances”: C10042 C10113 C10132 C10133

(b)insert in numerical order in the column headed “Circumstances”: C11102 C11104 C11117 C11151

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

(a)omit from the column headed “Circumstances”: C10042 C10113 C10132 C10133

(b)insert in numerical order in the column headed “Circumstances”: C11102 C11104 C11117 C11151

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

(a)omit from the column headed “Circumstances”: C10042 C10113 C10132 C10133

(b)insert in numerical order in the column headed “Circumstances”: C11102 C11104 C11117 C11151

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

(a)omit from the column headed “Circumstances”: C10042 C10113 C10132 C10133

(b)insert in numerical order in the column headed “Circumstances”: C11102 C11104 C11117 C11151

  1. Schedule 1, Part 1, entry for Sorafenib in the form Tablet 200 mg (as tosilate) [Maximum Quantity: 120; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C10960

(b)insert in numerical order in the column headed “Circumstances”: C11160

(c)omit from the column headed “Purposes”: P10960

(d)insert in numerical order in the column headed “Purposes”: P11160

  1. Schedule 1, Part 1, entry for Sorafenib in the form Tablet 200 mg (as tosilate) [Maximum Quantity: 120; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C10960

(b)insert in numerical order in the column headed “Circumstances”: C11160

  1. Schedule 1, Part 1, entry for Tenofovir with emtricitabine in the form Tablet containing tenofovir disoproxil phosphate 291 mg with emtricitabine 200 mg [Maximum Quantity: 30; Number of Repeats: 2]

omit from the column headed “Circumstances”: C7580              substitute: C11143

  1. Schedule 1, Part 1, entry for Tenofovir with emtricitabine in the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg [Maximum Quantity: 30; Number of Repeats: 2]

omit from the column headed “Circumstances”: C7580              substitute: C11143

  1. Schedule 1, Part 1, entry for Tenofovir with emtricitabine in the form Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg [Maximum Quantity: 30; Number of Repeats: 2]

omit from the column headed “Circumstances”: C7580              substitute: C11143

  1. Schedule 1, Part 1, entry for Tildrakizumab in the form Injection 100 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 1]

(a)omit from the column headed “Circumstances”: C10832 C10833 C10852

(b)omit from the column headed “Circumstances”: C10854 C10873

(c)insert in numerical order in the column headed “Circumstances”: C11090 C11091 C11120 C11123 C11147

  1. Schedule 1, Part 1, entry for Tildrakizumab in the form Injection 100 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C10832 C10833 C10852

(b)omit from the column headed “Circumstances”: C10854 C10873

(c)insert in numerical order in the column headed “Circumstances”: C11090 C11091 C11120 C11123 C11147

(d)omit from the column headed “Purposes”: P10832 P10833 P10852

(e)omit from the column headed “Purposes”: P10854 P10873

(f)insert in numerical order in the column headed “Purposes”: P11090 P11091 P11120 P11123 P11147

  1. Schedule 1, Part 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Maximum Quantity: 1; Number of Repeats: 1]

(a)omit from the column headed “Circumstances”: C8918 C8919 C8963 C8964 C8986

(b)omit from the column headed “Circumstances”: C9875 C9930

(c)insert in numerical order in the column headed “Circumstances”: C11086 C11119 C11120 C11137 C11145 C11153 C11161

  1. Schedule 1, Part 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Maximum Quantity: 1; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C8918 C8919 C8963 C8964 C8986

(b)omit from the column headed “Circumstances”: C9875 C9930

(c)insert in numerical order in the column headed “Circumstances”: C11086 C11119 C11120 C11137 C11145 C11153 C11161

(d)omit from the column headed “Purposes”: P8918 P8919 P8963 P8964 P8986

(e)omit from the column headed “Purposes”: P9875 P9930

(f)insert in numerical order in the column headed “Purposes”: P11086 P11119 P11120 P11137 P11145 P11153 P11161

  1. Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Maximum Quantity: 2; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C8918 C8919 C8963 C8964 C8986

(b)omit from the column headed “Circumstances”: C9875 C9930

(c)insert in numerical order in the column headed “Circumstances”: C11086 C11119 C11120 C11137 C11145 C11153 C11161

  1. Schedule 1, Part 1, entry for Vancomycin in the form Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)

substitute:

Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride) Injection a Vancomycin Alphapharm AF MP C5716 C5717 C5769 P5717 1 0 1
PDP C5801 1 0 1
MP C5716 C5717 C5769 P5716 P5769 3 0 1

  1. Schedule 1, Part 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

omit from the column headed “Responsible Person” for the brand “Zometa”: NV      substitute: SA

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

insert:

Bortezomib Powder for injection 1 mg Injection Velcade JC MP C7940 C7941 C10338 C10426 C10454 C10455 See Note 3 See Note 3 1 D(100)
Powder for injection 3 mg Injection Velcade JC MP C7938 C7939 C7940 C7941 C7960 C7961 C7962 C7974 C10338 C10426 C10454 C10455 See Note 3 See Note 3 1 D(100)
Powder for injection 3.5 mg Injection Velcade JC MP C7938 C7939 C7960 C7961 C7962 C7974 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, Part 2, after entry for Donepezil in the form Tablet containing donepezil hydrochloride 10 mg [Authorised Prescriber: NP; Maximum Quantity: 28; Number of Repeats: 5]

insert:

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 1 10
a Enoxaparin Winthrop WA MP NP 20 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 40 mg (4,000 I.U. anti-Xa) in 0.4 mL pre-filled syringe Injection a Clexane SW MP NP 20 1 10
a Enoxaparin Winthrop WA MP NP 20 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 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, Part 2, after entry for Flucloxacillin in the form Capsule 500 mg (as sodium) [Maximum Quantity: 48; Number of Repeats: 1]

insert:

Fluoxetine Tablet, dispersible, 20 mg (as hydrochloride) Oral a Prozac Tab LY MP NP C4755 C6277 28 5 28

  1. Schedule 1, Part 2, entry for Mesalazine in the form Suppository 1 g

(a)omit from the column headed “Maximum Quantity”: 28               substitute: 30

(b)omit from the column headed “Pack Quantity”: 28            substitute: 30

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

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

  1. Schedule 1, Part 2, after entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg [Authorised Prescriber: PDP; Maximum Quantity: 20; Number of Repeats: 0]

insert:

Vancomycin Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride) Injection a DBL Vancomycin Hydrochloride PF MP C5716 C5717 C5769 P5717 1 0 1
PDP C5801 1 0 1
MP C5716 C5717 C5769 P5716 P5769 3 0 1

  1. Schedule 4, Part 1, entry for Adalimumab

(a)omit:

C8804 P8804 Severe chronic plaque psoriasis
Initial treatment - Initial 1, Whole body (new patient)
Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, cyclosporin or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, cyclosporin, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment.
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment.
(c) The most recent PASI assessment 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(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. 		Compliance with Written Authority Required procedures
C8808 P8808 Severe chronic plaque psoriasis
Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment 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(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. 		Compliance with Written Authority Required procedures
C8809 P8809 Severe chronic plaque psoriasis
Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a dermatologist. 		Compliance with Authority Required procedures
C8811 P8811 Severe chronic plaque psoriasis
Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. 		Compliance with Written Authority Required procedures

(b)omit:

C8836 P8836 Severe chronic plaque psoriasis
Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. 		Compliance with Written Authority Required procedures
C8851 P8851 Severe chronic plaque psoriasis
Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment 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(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. 		Compliance with Written Authority Required procedures
C8867 P8867 Severe chronic plaque psoriasis
Initial treatment - Initial 1, Face, hand, foot (new patient)
Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, cyclosporin or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, cyclosporin, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment.
(c) The most recent PASI assessment 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(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. 		Compliance with Written Authority Required procedures

(c)insert in numerical order after existing text:

C11089 P11089 Severe chronic plaque psoriasis
Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. 		Compliance with Written Authority Required procedures
C11096 P11096 Severe chronic plaque psoriasis
Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. 		Compliance with Written Authority Required procedures
C11107 P11107 Severe chronic plaque psoriasis
Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a dermatologist. 		Compliance with Authority Required procedures
C11113 P11113 Severe chronic plaque psoriasis
Initial treatment - Initial 1, Whole body (new patient)
Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 5 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. 		Compliance with Written Authority Required procedures
C11122 P11122 Severe chronic plaque psoriasis
Initial treatment - Initial 1, Face, hand, foot (new patient)
Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 5 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. 		Compliance with Written Authority Required procedures
C11138 P11138 Severe chronic plaque psoriasis
Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. 		Compliance with Written Authority Required procedures
C11154 P11154 Severe chronic plaque psoriasis
Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. 		Compliance with Written Authority Required procedures

(c)insert in numerical order after existing text:

C11086 P11086 Severe chronic plaque psoriasis
Initial treatment - Initial 1, Whole body (new patient)
Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 5 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. 		Compliance with Written Authority Required procedures
C11119 P11119 Severe chronic plaque psoriasis
Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. 		Compliance with Written Authority Required procedures
C11120 P11120 Severe chronic plaque psoriasis
Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction.
Must be treated by a dermatologist. 		Compliance with Authority Required procedures
C11137 P11137 Severe chronic plaque psoriasis
Initial treatment - Initial 1, Face, hand, foot (new patient)
Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 5 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. 		Compliance with Written Authority Required procedures
C11145 P11145 Severe chronic plaque psoriasis
Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. 		Compliance with Written Authority Required procedures
C11153 P11153 Severe chronic plaque psoriasis
Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. 		Compliance with Written Authority Required procedures
C11161 P11161 Severe chronic plaque psoriasis
Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. 		Compliance with Written Authority Required procedures

  1. Schedule 5, omit entry for Amino acid formula with vitamins and minerals without phenylalanine

  1. Schedule 5, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [GRP-17061]

insert in alphabetical order in the column headed “Brand”: NOUMED ESOMEPRAZOLE

  1. Schedule 5, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [GRP-17188]

insert in alphabetical order in the column headed “Brand”: NOUMED ESOMEPRAZOLE

  1. Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg [GRP-15442]

insert in alphabetical order in the column headed “Brand”: NOUMED PERINDOPRIL

  1. Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg [GRP-15525]

insert in alphabetical order in the column headed “Brand”: NOUMED PERINDOPRIL

  1. Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg [GRP-15965]

insert in alphabetical order in the column headed “Brand”: NOUMED PERINDOPRIL

  1. Schedule 5, after entry for Perindopril with indapamide

insert:

Pindolol GRP-24492 Tablet 5 mg Oral Barbloc 5
Tablet 5 mg (USP) Oral APO-PINDOL
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