National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 9) (PB 84 of 2017) (Cth)

Case

PB 84 of 2017

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017
(No. 9)

National Health Act 1953

I, LISA LA RANCE, Assistant Secretary, Pricing and 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         20th October 2017

LISA LA RANCE

Assistant Secretary

Pricing and 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 2017 (No. 9).

(2)        This Instrument may also be cited as PB 84 of 2017.

2          Commencement

This Instrument commences on 1 November 2017.

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

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

Schedule 1     Amendments

  1. Schedule 1, entry for Aciclovir in the form Tablet 200 mg [Maximum Quantity: 90; Number of Repeats: 5]

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

a Aciclovir AN ED MP NP C5942 90 5 90

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

omit from the column headed “Circumstances”:          C5115                   insert in numerical order: C7151

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

(a)omit from the column headed “Circumstances”:               C5115                   insert in numerical order: C7151

(b)omit from the column headed “Purposes”:   P5115                    insert in numerical order: P7151

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

omit from the column headed “Circumstances”:          C5115                   insert in numerical order: C7151

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

omit from the column headed “Circumstances”:          C5115                   insert in numerical order: C7151

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

omit from the column headed “Circumstances”:          C5115                   insert in numerical order: C7151

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

omit from the column headed “Circumstances”:          C5115                   insert in numerical order: C7151

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

(a)omit from the column headed “Circumstances”:               C5115                   insert in numerical order: C7151

(b)omit from the column headed “Purposes”:   P5115                    insert in numerical order: P7151

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

omit from the column headed “Circumstances”:          C5115                   insert in numerical order: C7151

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

omit from the column headed “Circumstances”:          C5115                   insert in numerical order: C7151

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

omit from the column headed “Circumstances”:          C5115                   insert in numerical order: C7151

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe, 6 [Maximum Quantity: 1; Number of Repeats: 0]

omit from the column headed “Circumstances”:          C5115                   insert in numerical order: C7151

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen, 6 [Maximum Quantity: 1; Number of Repeats: 0]

omit from the column headed “Circumstances”:          C5115                   insert in numerical order: C7151

  1. Schedule 1, entry for Amino acid formula with vitamins and minerals without phenylalanine in the form Sachets containing oral powder
    27.8 g, 30 (Lophlex)

(a)omit from the column headed “Form”                  Lophlex            substitute:            PKU Lophlex

(b)omit from the column headed “Brand”:               Lophlex              substitute:            PKU Lophlex

(c)omit from the column headed “Maximum Quantity”:       3          substitute:             4

  1. Schedule 1, entry for Amino acid formula with vitamins and minerals without phenylalanine in the form Oral liquid 125 mL, 30 (PKU Lophlex LQ 20)

omit from the column headed “Maximum Quantity”:                  3                         substitute:             4

  1. Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 0]

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

a AMCLAVOX DUO 500/125 RW PDP C5833 C5894 10 0 10

  1. Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 1]

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

a AMCLAVOX DUO 500/125 RW MP NP MW C5832 C5893 10 1 10

  1. Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 0]

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

a AMCLAVOX DUO FORTE 875/125 RW PDP C5833 C5894 10 0 10

  1. Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 1]

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

a AMCLAVOX DUO FORTE 875/125 RW MP NP C5832 C5893 10 1 10

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

omit:

a Atenolol AN EA MP NP 30 5 30

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

(a)omit:

a Atorvachol ED MP C4238 C4263 P4263 30 5 30
NP C4263 30 5 30

(b)omit:

a Atorvastatin AN EA MP C4238 C4263 P4263 30 5 30
NP C4263 30 5 30

(c)omit:

a Atorvachol ED MP C4238 C4263 P4238 30 11 30

(d)omit:

a Atorvastatin AN EA MP C4238 C4263 P4238 30 11 30

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

(a)omit:

a Atorvachol ED MP C4238 C4263 P4263 30 5 30
NP C4263 30 5 30

(b)omit:

a Atorvastatin AN EA MP C4238 C4263 P4263 30 5 30
NP C4263 30 5 30

(c)omit:

a Atorvachol ED MP C4238 C4263 P4238 30 11 30

(d)omit:

a Atorvastatin AN EA MP C4238 C4263 P4238 30 11 30

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

(a)omit:

a Atorvachol ED MP C4238 C4263 P4263 30 5 30
NP C4263 30 5 30

(b)omit:

a Atorvastatin AN EA MP C4238 C4263 P4263 30 5 30
NP C4263 30 5 30

(c)omit:

a Atorvachol ED MP C4238 C4263 P4238 30 11 30

(d)omit:

a Atorvastatin AN EA MP C4238 C4263 P4238 30 11 30

  1. Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium)

(a)omit:

a Atorvachol ED MP C4238 C4263 P4263 30 5 30
NP C4263 30 5 30

(b)omit:

a Atorvastatin AN EA MP C4238 C4263 P4263 30 5 30
NP C4263 30 5 30

(c)omit:

a Atorvachol ED MP C4238 C4263 P4238 30 11 30

(d)omit:

a Atorvastatin AN EA MP C4238 C4263 P4238 30 11 30

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

omit:

Azamun ED MP NP 100 5 100

  1. Schedule 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate)

(a)omit:

a Azithromycin-GA EA MP NP C5637 C5718 C5772 P5718 P5772 2 0 2

(b)omit:

a Azithromycin-GA EA MP NP C5637 C5718 C5772 P5637 2 2 2

  1. Schedule 1, entry for Baclofen in each of the forms: Tablet 10 mg; and Tablet 25 mg

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

a APO-Baclofen TX MP NP 100 5 100

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

  1. Schedule 1, after entry for Baclofen in the form Intrathecal injection 10 mg in 5 mL [Brand: Sintetica Baclofen Intrathecal]

insert in the columns in the order indicated:

Intrathecal injection 40 mg in 20 mL Injection Sintetica Baclofen Intrathecal BZ MP C7134 C7148 C7152 C7153 C7156 C7157 C7159 C7162 2 0 1 PB(100)

  1. Schedule 1, entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 2.5 mg

omit:

Biso 2.5 ED MP NP C5324 28 5 28

  1. Schedule 1, entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 5 mg

omit:

Biso 5 ED MP NP C5324 28 5 28

  1. Schedule 1, entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 10 mg

omit:

Biso 10 ED MP NP C5324 28 5 28

  1. Schedule 1, entry for Calcium in the form Tablet, chewable, 500 mg (as carbonate)

omit:

Cal‑Sup IA MP NP C4586 240 1 60

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

omit in the column headed “Responsible Person” for the brands “Dilatrend 6.25”, “Dilatrend 12.5” and “Dilatrend 25” respectively:         RO
substitute:             PB

  1. Schedule 1, entry for Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate)

(a)omit:

Cefaclor‑GA EA PDP 10 0 10

(b)omit:

Cefaclor‑GA EA MP 10 1 10

  1. Schedule 1, after entry for Cefuroxime in the form Powder for oral suspension 125 mg (as axetil) per 5 mL, 70 mL

insert in the columns in the order indicated:

Powder for oral suspension 125 mg (as axetil) per 5 mL, 100 mL Oral Zinnat AS PDP 1 0 1
MP 1 1 1

  1. Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous)

(a)omit:

Cilex ED PDP 20 0 20

(b)omit:

Cilex ED MP NP MW 20 1 20

(c)omit:

a Cilex ED MP P4243 40 CN4243 2
CN4243 		20

  1. Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous)

(a)omit:

Cilex ED PDP 20 0 20

(b)omit:

Cilex ED MP NP MW 20 1 20

(c)omit:

a Cilex ED MP P6188 40
CN6188 		1
CN6188 		20

  1. Schedule 1, entry for Ciprofloxacin in the form Tablet 750 mg (as hydrochloride)

omit:

Ciprofloxacin‑BW GQ MP NP C5614 C5615 C5687 C5688 C5689 C5722 C5780 14 0 14

  1. Schedule 1, after entry for Docetaxel in the form Solution concentrate for I.V. infusion 140 mg in 7 mL

insert in the columns in the order indicated:

Solution concentrate for I.V. infusion 160 mg in 8 mL Injection Docetaxel Accord OC MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 4 mL

omit:

Oncotaxel 80 EA MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Donepezil in the form Tablet containing donepezil hydrochloride 5 mg

omit:

Donepezil RBX RA MP NP C4219 C4220 C4224 28 5 28

  1. Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; Tablet containing enalapril maleate 10 mg; and Tablet containing enalapril maleate 20 mg

omit:

Enalapril AN EA MP NP 30 5 30

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

(a)omit:

Esomeprazole AN EA MP NP C4988 C5029 C5030 C5039 P4988 30 1 30

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

Pharmacor Esomeprazole CR MP NP C4988 C5029 C5030 C5039 P4988 30 1 30

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

(a)omit:

Esomeprazole AN EA MP NP C4988 C5029 C5030 C5039 P5029 P5030 P5039 30 5 30

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

Pharmacor Esomeprazole CR MP NP C4988 C5029 C5030 C5039 P5029 P5030 P5039 30 5 30

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

(a)omit:

Esomeprazole AN EA MP NP C5011 C5021 C5028 P5028 30 1 30

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

Pharmacor Esomeprazole CR MP NP C5011 C5021 C5028 P5028 30 1 30

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

(a)omit:

Esomeprazole AN EA MP NP C5011 C5021 C5028 P5011 P5021 30 5 30

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

Pharmacor Esomeprazole CR MP NP C5011 C5021 C5028 P5011 P5021 30 5 30

  1. Schedule 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”:               C4088 C4114 C4115 C4116 C4125 C4136 C4137 C4151

omit from the column headed “Circumstances”:               C5462 C5479 C5528

omit from the column headed “Circumstances”:               C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756

insert in numerical order in the column headed “Circumstances”:
C6807 C6808 C6811 C6814 C6818 C6819 C6821 C6822 C6823 C6830 C6833 C6834 C6836 C6837 C6840 C6841 C6842 C6843 C6844

(b)omit from the column headed “Purposes”:         P4088 P4114 P4115 P4116 P4125 P4136 P4137 P4151

omit from the column headed “Purposes”:         P5462 P5479

omit from the column headed “Purposes”:         P6695 P6726 P6727 P6728 P6753

insert in numerical order in the column headed “Purposes”:

P6808 P6811 P6814 P6818 P6819 P6821 P6822 P6823 P6830 P6834 P6836 P6837 P6841 P6843 P6844

  1. Schedule 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”:               C4088 C4114 C4115 C4116 C4125 C4136 C4137 C4151

omit from the column headed “Circumstances”:               C5462 C5479 C5528

omit from the column headed “Circumstances”:               C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756

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

C6807 C6808 C6811 C6814 C6818 C6819 C6821 C6822 C6823 C6830 C6833 C6834 C6836 C6837 C6840 C6841 C6842 C6843 C6844

(b)omit from the column headed “Purposes”:         P5528

omit from the column headed “Purposes”:         P6696 P6755 P6756

insert in numerical order in the column headed “Purposes”:         P6807 P6833 P6840 P6842

  1. Schedule 1, after the entry for Evolocumab, in the form Injection 140 mg in 1 mL single use pre-filled pen

insert in the columns in the order indicated:

Injection 420 mg in 3.5 mL single use pre-filled cartridge Injection Repatha AN MP C6597 C6608 1 5 1

  1. Schedule 1, entry for Fentanyl in the form Tablet (sublingual) 100 micrograms (as citrate) [Maximum Quantity: 10; Number of Repeats: 0]

omit from the column headed “Maximum Quantity”:                  10        substitute:             20

  1. Schedule 1, entry for Fentanyl in the form Tablet (sublingual) 200 micrograms (as citrate) [Maximum Quantity: 10; Number of Repeats: 0]

omit from the column headed “Maximum Quantity”:                  10         substitute:             20

  1. Schedule 1, entry for Gabapentin in the form Capsule 400 mg

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

a GAPENTIN RF MP NP C4928 100 5 100

  1. Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride)

omit:

Gemaccord EA MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride)

omit:

Gemaccord EA MP See Note 3 See
Note 3 		1 D(100)

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

omit:

a Irbesartan Winthrop WA MP NP 30 5 30

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

omit:

a Irbesartan HCT Winthrop 150/12.5 WA MP NP C4374 30 5 30

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

omit:

a Irbesartan HCT Winthrop 300/12.5 WA MP NP C4374 30 5 30

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

omit:

a Irbesartan HCT Winthrop 300/25 WA MP NP C4374 30 5 30

  1. Schedule 1, entry for Irinotecan in each of the forms: I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL; and
    I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL

(a)omit:

Irinoccord EA MP See Note 3 See
Note 3 		1 D(100)

(b)omit:

IRINOTECAN ACT ED MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Leflunomide in each of the forms: Tablet 10 mg; and Tablet 20 mg

omit:

a Leflunomide‑GA ED MP C5681 30 5 30

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

omit:

a Kepcet ED MP NP C4928 60 5 60

  1. Schedule 1, entry for Loperamide

(a)omit:

a Gastro-Stop Loperamide AS MP NP C6343 C6364 P6364 12 0 12

(b)omit:

a Gastro-Stop Loperamide AS MP NP C6343 C6364 P6343 60 0 12

  1. Schedule 1, entry for Methotrexate in the form Injection 50 mg in 2 mL vial

(a)omit:

a Methaccord EA MP 5 5 1

(b)omit:

Methaccord EA MP See Note 2 See Note 2 1 C(100)

(c)omit:

Methaccord EA MP P6276 See Note 2 See Note 2 1 C(100)

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

omit:

a Mirtazapine‑GA ED MP NP C5650 30 5 30

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

omit:

a Mirtazapine‑GA ED MP NP C5650 30 5 30

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

(a)omit:

Onsetron ODT 4 ED MP NP C5618 C5777 P5618 4 0 4
MP C5743 4 0 4 C(100)

(b)omit:

Onsetron ODT 4 ED MP NP C5618 C5777 P5777 10 1 10

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

(a)omit:

Onsetron ODT 8 ED MP NP C5618 C5777 P5618 4 0 4
MP C5743 4 0 4 C(100)

(b)omit:

Onsetron ODT 8 ED MP NP C5618 C5777 P5777 10 1 10

  1. Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 30 mg in 5 mL

omit:

Paclitaxel Actavis EA MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Perindopril in each of the forms: Tablet containing perindopril erbumine 4 mg; and Tablet containing perindopril erbumine 8 mg

omit:

Perindopril CH EA MP NP 30 5 30

  1. Schedule 1, entry for Perindopril with Indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg

omit:

Perindopril and Indapamide CH 4/1.25 EA MP NP C4375 30 5 30

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

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

a Blooms The Chemist Pregabalin IB MP NP C4172 56 5 56

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

a Neuroccord CR MP NP C4172 56 5 56

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

a Pregabalin AMNEAL EA MP NP C4172 56 5 56

  1. Schedule 1, entry for Pregabalin in the form Capsule 75 mg

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

a Blooms The Chemist Pregabalin IB MP NP C4172 56 5 56

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

a Neuroccord CR MP NP C4172 56 5 56

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

a Pregabalin AMNEAL EA MP NP C4172 56 5 56

  1. Schedule 1, entry for Pregabalin in the form Capsule 150 mg

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

a Blooms The Chemist Pregabalin IB MP NP C4172 56 5 56

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

a Neuroccord CR MP NP C4172 56 5 56

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

a Pregabalin AMNEAL EA MP NP C4172 56 5 56

  1. Schedule 1, entry for Pregabalin in the form Capsule 300 mg

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

a Blooms The Chemist Pregabalin IB MP NP C4172 56 5 56

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

a Neuroccord CR MP NP C4172 56 5 56

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

a Pregabalin AMNEAL EA MP NP C4172 56 5 56

  1. Schedule 1, entry for Prochlorperazine in the form Tablet containing prochlorperazine maleate 5 mg

omit:

Prochlorperazine‑GA ED PDP MP NP 25 0 25

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

(a)omit:

Quetiaccord EF MP NP C4385 C4391 C4396 60 0 60

(b)omit:

Quetiapine Actavis 25 ED MP NP C4385 C4391 C4396 60 0 60

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

omit:

Quetiaccord EF MP NP C4246 C5611 C5639 90 5 90

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

omit:

Quetiaccord EF MP NP C4246 C5611 C5639 60 5 60

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

omit:

a Quetiaccord EF MP NP C4246 C5611 C5639 60 5 60

  1. Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated)

(a)omit:

a Rabeprazole Actavis 20 ED MP NP C5444 C5445 C5512 P5445 30 2 30

(b)omit:

a Rabeprazole Actavis 20 ED MP NP C5444 C5445 C5512 P5444 P5512 30 5 30

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

omit:

Ramipril AN EA MP NP 30 5 30

  1. Schedule 1, entry for Risperidone in the form Tablet 0.5 mg

(a)omit:

a Risperidone AN EA MP NP C5903  C6010 C6898 C6899 P6010 P6898 P6899 60 2 60

(b)omit:

a Risperidone AN EA MP NP C5903 C6010 C6898 C6899 P5903 60 5 60

  1. Schedule 1, entry for Risperidone in the form Tablet 1 mg

(a)omit:

a Risperidone AN EA MP NP C4246 C5907
C5993 C6897 C6938 		P5993 P6897 P6938 60 2 60

(b)omit:

a Risperidone AN EA MP NP C4246 C5907 C5993 C6897 C6938 P4246 P5907 60 5 60

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

(a)omit:

a Risperidone AN EA MP NP C4246 C5907 C6897 C6938 P6897 P6938 60 2 60

(b)omit:

a Risperidone AN EA MP NP C4246 C5907 C6897 C6938 P4246 P5907 60 5 60

  1. Schedule 1, entry for Risperidone each of the forms: Tablet 3 mg; and Tablet 4 mg

omit:

a Risperidone AN EA MP NP C4246 C5907 60 5 60

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

(a)omit:

a Rosuvastatin Actavis 10 ED MP C4225 C4226 C4238 C4263 P4226 P4263 30 5 30
NP C4226 C4263 30 5 30

(b)omit:

a Rosuvastatin Actavis 10 ED MP C4225 C4226 C4238 C4263 P4225 P4238 30 11 30

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

(a)omit:

a Rosuvastatin Actavis 20 ED MP C4225 C4226 C4238 C4263 P4226 P4263 30 5 30
NP C4226 C4263 30 5 30

(b)omit:

a Rosuvastatin Actavis 20 ED MP C4225 C4226 C4238 C4263 P4225 P4238 30 11 30

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

(a)omit:

a Rosuvastatin Actavis 40 ED MP C4225 C4226 C4238 C4263 P4226 P4263 30 5 30
NP C4226 C4263 30 5 30

(b)omit:

a Rosuvastatin Actavis 40 ED MP C4225 C4226 C4238 C4263 P4225 P4238 30 11 30

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

(a)omit:

a Temozolomide AN EA MP 5 5 5

(b)omit:

a Temozolomide AN EA MP P4897 15 2 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 20 mg

(a)omit:

a Temozolomide AN EA MP 5 5 5

(b)omit:

a Temozolomide AN EA MP P4897 15 2 5

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

(a)omit:

a Temozolomide AN EA MP 5 5 5

(b)omit:

a Temozolomide AN EA MP P4897 15 2 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 140 mg

(a)omit:

a Temozolomide AN EA MP 5 5 5

(b)omit:

a Temozolomide AN EA MP P4897 15 2 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 250 mg

omit:

a Temozolomide AN EA MP 5 5 5

  1. Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg

(a)omit:

a Tramadol Actavis ED MP NP C5848 C5877 P5877 20 0 20
PDP C5875 C5876 20 0 20

(b)omit:

a Tramadol Actavis ED MP NP C5848 C5877 P5848 20 2 20

  1. Schedule 1, entry for Valaciclovir

(a)omit:

a Valaciclovir Actavis ED MP NP C5940 C5960 C5961 C5962 C5968 P5960 20 0 10

(b)omit:

a Valaciclovir Actavis ED MP NP C5940 C5960 C5961 C5962 C5968 P5940 P5961 30 5 30

(c)omit:

a Valaciclovir Actavis ED MP NP C5940 C5960 C5961 C5962 C5968 P5962 P5968 42 0 42

  1. Schedule 1, entry for Venlafaxine in each of the forms: Capsule (modified release) 75 mg (as hydrochloride); and Capsule (modified release) 150 mg (as hydrochloride)

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

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

a Sandoz Venlafaxine XR HX MP NP C5650 28 5 28

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

insert:

PB Pharmaco (Australia) Limited  89 113 383 501

  1. Schedule 4, Part 1, entry for Adalimumab

(a)omit:

C5115 P5115

Severe Crohn disease

Change or Re-commencement of treatment (initial 2)

Patient must have a documented history of severe Crohn disease; AND
Patient must have received prior PBS-subsidised treatment with a biological disease modifying drug for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle
Patient must be aged 18 years or older
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form, which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment; and
(iv) the details of prior biological disease modifying drug treatment including the details of date and duration of treatment
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological disease modifying drug (bDMD) therapy within the timeframes specified in the relevant restriction
Where the most recent course of PBS-subsidised bDMD treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased
If the response assessment to the previous course of bDMD treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of bDMD
A maximum quantity and number of repeats to provide for an initial 16 week course of this drug will be authorised
If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase
The assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of therapy so that there is adequate time for a response to be demonstrated
This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment
Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
It is recommended that an application for continuing treatment is posted to the Department of Human Services at the time of the 12 week assessment, to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug

 Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C7151 P7151

Severe Crohn disease

Change or Re-commencement of treatment (initial 2)

Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have a documented history of severe Crohn disease; AND
Patient must have received prior PBS-subsidised treatment with a biological disease modifying drug for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form, which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment; and
(iv) the details of prior biological disease modifying drug treatment including the details of date and duration of treatment.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological disease modifying drug (bDMD) therapy within the timeframes specified in the relevant restriction.
Where the most recent course of PBS-subsidised bDMD treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
If the response assessment to the previous course of bDMD treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of bDMD.
A maximum quantity and number of repeats to provide for an initial 16 week course of this drug will be authorised.
If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase.
The assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of therapy so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
It is recommended that an application for continuing treatment is posted to the Department of Human Services at the time of the 12 week assessment, to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug.

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Azithromycin

(a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C6356:

Where the patient is receiving treatment at/from a public hospital

(b)omit from the column headed “Circumstances and Purposes” for Circumstances Code C6361:

Where the patient is receiving treatment at/from a private hospital

  1. Schedule 4, Part 1, entry for Baclofen

insert in numerical order after existing text:

C7134

Severe chronic spasticity

Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to multiple sclerosis.

 Compliance with Authority Required procedures - Streamlined Authority Code 7134
C7148

Severe chronic spasticity

Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord disease.

 Compliance with Authority Required procedures - Streamlined Authority Code 7148
C7152

Severe chronic spasticity

Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity of cerebral origin.

 Compliance with Authority Required procedures - Streamlined Authority Code 7152
C7153

Severe chronic spasticity

Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord injury.

 Compliance with Authority Required procedures - Streamlined Authority Code 7153
C7156

Severe chronic spasticity

Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to multiple sclerosis.

 Compliance with Authority Required procedures
C7157

Severe chronic spasticity

Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord injury.

 Compliance with Authority Required procedures
C7159

Severe chronic spasticity

Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity of cerebral origin.

 Compliance with Authority Required procedures
C7162

Severe chronic spasticity

Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord disease.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Etanercept

(a)omit:

C4088 P4088

Severe chronic plaque psoriasis

Initial treatment or Re‑treatment (Whole body) ‑ completion of course

Must be treated by a dermatologist;

The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate;
Patient must have received 16 weeks treatment under the Initial treatment (whole body) restriction for severe chronic plaque psoriasis; OR
Patient must have received 16 weeks treatment under the Re‑treatment (whole body) restriction for severe chronic plaque psoriasis;
Patient must have demonstrated an adequate response to treatment;
Patient must not receive more than 8 weeks of treatment with etanercept under this restriction
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, when compared with the pre‑etanercept treatment baseline value
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of assessment of the patient’s condition
The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment
A PASI assessment of the patient’s response to the initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept

 Compliance with Authority Required procedures
C4114 P4114

Severe chronic plaque psoriasis

Initial treatment or Re‑treatment (Whole body) ‑ balance of first supply

Must be treated by a dermatologist;

The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate;
Patient must have received insufficient therapy under the Initial treatment (whole body) restriction for severe chronic plaque psoriasis to complete 16 weeks treatment; OR
Patient must have received insufficient therapy under the Re‑treatment (whole body) restriction for severe chronic plaque psoriasis to complete 16 weeks treatment;
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions

 Compliance with Authority Required procedures
C4115 P4115

Severe chronic plaque psoriasis

Initial treatment (Face, hand, foot)

Must be treated by a dermatologist;

Patient must be under 18 years of age and a parent or authorised guardian must have signed a patient acknowledgement;
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate;
Patient must have the plaque or plaques of the face, or palm of hand or sole of foot present for at least 6 months from the time of initial diagnosis;
Patient must not have received any prior PBS‑subsidised treatment with etanercept for this condition; OR
Patient must not have received any PBS‑subsidised treatment with etanercept for this condition for at least 12 months;
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 3 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 or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; and/or (iii)acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;
Patient must not receive more than 16 weeks of treatment with etanercept under this restriction
Where treatment with any of the above‑mentioned drugs was contraindicated according to the relevant TGA‑approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application
Where intolerance to phototherapy, methotrexate and/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
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in a 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; and
(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years 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
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and
(iii) the parent or authorised guardian signed patient and prescriber acknowledgements
Where a patient has had a 12 month treatment break, the length of the break is measured from the date the most recent treatment was stopped to the date of the application to re‑commence treatment

 Compliance with Authority Required procedures
C4116 P4116

Severe chronic plaque psoriasis

Initial treatment or Re‑treatment (Face, hand, foot) ‑ completion of course

Must be treated by a dermatologist;

The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate;
Patient must have received 16 weeks treatment under the Initial treatment (Face, hand, foot) restriction for severe chronic plaque psoriasis; OR
Patient must have received 16 weeks treatment under the Re‑treatment (Face, hand, foot) restriction for severe chronic plaque psoriasis;
Patient must have demonstrated an adequate response to treatment;
Patient must not receive more than 8 weeks of treatment with etanercept under this restriction
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the PASI symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre‑biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre‑biological treatment baseline value
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of assessment of the patient’s condition
The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment
A PASI assessment of the patient’s response to the initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept

 Compliance with Authority Required procedures
C4125 P4125

Severe chronic plaque psoriasis

Re‑treatment (Whole body)

Must be treated by a dermatologist;

Patient must be under 18 years of age;
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate;
Patient must have a documented history of severe chronic plaque psoriasis of the whole body;
Patient must have received prior PBS‑subsidised treatment with etanercept for this condition in the past 12 months;
Patient must have demonstrated a response to etanercept and experienced a disease flare; OR
Patient must not have failed more than once to achieve an adequate response with etanercept;
Patient must not receive more than 16 weeks of treatment with etanercept under this restriction
A patient is eligible for re‑treatment due to disease flare if there is a 50% or greater change in the patients PASI score or the patient has a current PASI score of greater than 15, compared to the most recent response assessment following cessation of the most recent 24 weeks of PBS‑subsidised etanercept
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application ‑ Supporting Information 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 prior etanercept treatment, including date ceased
Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment

 Compliance with Authority Required procedures
C4136 P4136

Severe chronic plaque psoriasis

Initial treatment of Re‑treatment (Face, hand, foot) ‑ balance of first supply

Must be treated by a dermatologist;

The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate;
Patient must have received insufficient therapy under the Initial treatment (Face, hand, foot) restriction for severe chronic plaque psoriasis to complete 16 weeks treatment; OR
Patient must have received insufficient therapy under the Re‑treatment (Face, hand, foot) restriction for severe chronic plaque psoriasis to complete 16 weeks treatment;
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions

 Compliance with Authority Required procedures
C4137 P4137

Severe chronic plaque psoriasis

Re‑treatment (Face, hand, foot)

Must be treated by a dermatologist;

Patient must be under 18 years of age;
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate;
Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot;
Patient must have received prior PBS‑subsidised treatment with etanercept for this condition in the past 12 months
Patient must have demonstrated a response to etanercept and experienced a disease flare; OR
Patient must not have failed more than once to achieve an adequate response with etanercept;
Patient must not receive more than 16 weeks of treatment with etanercept under this restriction
A patient is eligible for re‑treatment due to disease flare if:
(i) all subscores are rated moderate to severe or 2 of the 3 subscores are rated severe to very severe; or
(ii) the skin area affected is a 50% or greater change or the area affected is 30% or more of the face, palm of a hand or sole of a foot, compared to the most recent response assessment following cessation of the most recent 24 weeks of PBS‑subsidised etanercept
The authority application must be made in writing and must include :
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application ‑ Supporting Information which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area digrams including the dates of assessment of the patient’s condition; and
(ii) details of prior etanercept treatment, including date ceased
Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment

 Compliance with Authority Required procedures
C4151 P4151

Severe chronic plaque psoriasis

Initial treatment (whole body)

Must be treated by a dermatologist;

Patient must be under 18 years of age and a parent or authorised guardian must have signed a patient acknowledgement;
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate;
Patient must have lesions present for at least 6 months from the time of initial diagnosis;
Patient must not have received any prior PBS‑subsidised treatment with etanercept for this condition; OR
Patient must not have received any PBS‑subsidised treatment with etanercept for this condition for at least 12 months;
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 3 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 or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; and/or (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;
Patient must not receive more than 16 weeks of treatment with etanercept under this restriction
Where treatment with any of the above‑mentioned drugs was contraindicated according to the relevant TGA‑approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application
Where intolerance to phototherapy, methotrexate and/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
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in a 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; and
(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years 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]; and
(iii) the parent or authorised guardian signed patient and prescriber acknowledgements
Where a patient has had a 12 month treatment break, the length of the break is measured from the date the most recent treatment was stopped to the date of the application to re‑commence treatment

 Compliance with Authority Required procedures

(b)omit:

C5462 P5462

Severe active rheumatoid arthritis

Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months)

Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; 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 rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
Applications 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 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to a treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).

 Compliance with Authority Required procedures
C5479 P5479

Severe active rheumatoid arthritis

Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)

Patient must have severe active rheumatoid arthritis; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND
Patient must not have failed previous PBS-subsidised treatment with this drug for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; 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 rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib.
If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement.
Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
Applications 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 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased.
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.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response.

 Compliance with Authority Required procedures
C5528 P5528

Severe active rheumatoid arthritis

Continuing treatment

Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.

 Compliance with Authority Required procedures

(c)omit:

C6695 P6695

Severe chronic plaque psoriasis

Initial treatment – Initial 1, Whole body (new patient (no prior biological agent) or patient recommencing treatment after a break of 5 years or more)

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 any prior PBS-subsidised treatment with a biological agent for this condition; OR
Patient must not have received PBS-subsidised treatment with a biological agent for at least 5 years, if they have previously received PBS-subsidised treatment with a biological agent for this condition and wish to commence a new Treatment Cycle; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 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
Patient must have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment (whole body); 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.
For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab.
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.
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; 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]; and
(iii) the signed patient and prescriber acknowledgements.

 Compliance with Authority Required procedures
C6696 P6696

Severe chronic plaque psoriasis

Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply

Patient must have received insufficient therapy with this drug under the Continuing treatment, Whole body restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND
The treatment must be as systemic monotherapy (other than methotrexate).
Must be treated by a dermatologist.

 Compliance with Authority Required procedures
C6726 P6726

Severe chronic plaque psoriasis

Initial treatment – Initial 2, Whole body (change or recommencement of treatment after a break of less than 5 years)

Patient must have a documented history of severe chronic plaque psoriasis; AND
Patient must have received prior PBS-subsidised treatment with a biological agent 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 agents for this condition within this Treatment Cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised therapy with this drug for the treatment of 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.
For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; 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.
Applications for patients who have demonstrated a response to PBS-subsidised treatment with this drug within this Treatment Cycle and who wish to recommence treatment with this drug within the same Cycle following a break in therapy, will only be approved where evidence of the patient's response to their most recent course of PBS-subsidised treatment with this drug has been submitted within 1 month of cessation of treatment.
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 prebiological treatment baseline value for this Treatment Cycle.

 Compliance with Authority Required procedures
C6727 P6727

Severe chronic plaque psoriasis

Initial treatment – Initial 2, Face, hand, foot (change or recommencement of treatment after a break of less than 5 years)

Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND
Patient must have received prior PBS-subsidised treatment with a biological agent 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 agents for this condition within this Treatment Cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised therapy with this drug for the treatment of 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.
For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; 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.
Applications for patients who have demonstrated a response to PBS-subsidised treatment with this drug within this Treatment Cycle and who wish to recommence treatment with this drug within the same Cycle following a break in therapy, will only be approved where evidence of the patient's response to their most recent course of PBS-subsidised treatment with this drug has been submitted within 1 month of cessation of treatment.
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 pre-biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value.

 Compliance with Authority Required procedures
C6728 P6728

Severe chronic plaque psoriasis

Initial 1, Whole body or Face, hand, foot (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break of less than 5 years) - balance of supply

Patient must have received insufficient therapy with this drug under the Initial 1, Whole body (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2, Whole body (change or recommencement of treatment after a break of less than 5 years ) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 1, Face, hand, foot (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break of less 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
C6753 P6753

Severe chronic plaque psoriasis

Initial treatment – Initial 1, Face, hand, foot (new patient (no prior biological agent) or patient recommencing treatment after a break of 5 years or more)

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 any prior PBS-subsidised treatment with a biological agent for this condition; OR
Patient must not have received PBS-subsidised treatment with a biological agent for at least 5 years, if they have previously received PBS-subsidised treatment with a biological agent for this condition and wish to commence a new Treatment Cycle; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 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
Patient must have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment (face, hand, 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.
For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab.
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.
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; 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]; and
(iii) the signed patient and prescriber acknowledgements.

 Compliance with Authority Required procedures
C6755 P6755

Severe chronic plaque psoriasis

Continuing treatment, Whole body

Patient must have a documented history of severe chronic plaque psoriasis; AND
Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND
Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab.
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 prebiological treatment baseline value for this Treatment Cycle.
All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.
Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 1 month old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.

 Compliance with Authority Required procedures
C6756 P6756

Severe chronic plaque psoriasis

Continuing treatment, Face, hand, foot

Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND
Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND
Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab.
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 pre-biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value.
All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.
Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 1 month old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Methotrexate

omit from the column headed “Circumstances Code”:                        C6276

  1. Schedule 4, Part 1, entry for Risperidone

omit from the column headed “Purposes Code” for Circumstances Code C5912:                        P5912

  1. Schedule 4, Part 1, entry for Valaciclovir

(a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C5939:
Where the patient is receiving treatment at/from a private hospital

(b)omit from the column headed “Circumstances and Purposes” for Circumstances Code C5975:
Where the patient is receiving treatment at/from a public hospital

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

omit from the column headed “Brand”:       Esomeprazole AN

insert in alphabetical order in the column headed “Brand”:    Pharmacor Esomeprazole

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

omit from the column headed “Brand”:       Esomeprazole AN

insert in alphabetical order in the column headed “Brand”:    Pharmacor Esomeprazole

  1. Schedule 5, entry Ondansetron

substitute:

Ondansetron GRP-15983 Tablet (orally disintegrating) 4 mg Oral Ondansetron AN ODT
Ondansetron ODT-DRLA
Ondansetron ODT GH
Ondansetron SZ ODT
Zilfojim ODT
Wafer 4 mg Oral Zofran Zydis
GRP-15402 Tablet (orally disintegrating) 8 mg Oral Ondansetron AN ODT
Ondansetron ODT-DRLA
Ondansetron ODT GH
Ondansetron SZ ODT
Zilfojim ODT 8
Wafer 8 mg Oral Zofran Zydis

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

omit from the column headed “Brand”:       Perindopril CH

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

omit from the column headed “Brand”:       Perindopril CH

  1. Schedule 5, entry Perindopril with indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg [GRP-15765]

omit from the column headed “Brand”:       Perindopril and Indapamide CH 4/1.25

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