national health (listing of pharmaceutical benefits

PB 1 of 2017

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 1)

National Health Act 1953

I, LOUISE CLARKE, First Assistant Secretary (Acting), Pharmaceutical Benefits

Division, Department of Health, delegate of the Minister for Health and Aged Care,

make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the

National Health Act 1953.

Dated 17 JANUARY 2017

LOUISE CLARKE

First Assistant Secretary (Acting)

Pharmaceutical Benefits Division

Department of Health

Authorised Version F2017L00070 registered 25/01/2017

Instrument Number PB 1 of 2017 2

1 Name of Instrument

(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 1).

(2) This Instrument may also be cited as PB 1 of 2017.

2 Commencement

This Instrument commences on 1 February 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 Abciximab

omit from the column headed “Responsible Person”: LY substitute: JC

[2] 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”: C5144 C5184 C5223 C5265 C5294 C5335 C5336 C5369

insert in numerical order: C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756








(a) omit from the column headed “Circumstances”: C5144 C5184 C5223 C5265 C5294 C5335 C5336 C5369


(b) omit from the column headed “Purposes”: P5144 P5184 P5223 P5294 P5335

substitute: P6695 P6726 P6727 P6728 P6753




(b) omit from the column headed “Purposes”: P5265 P5336 P5369

insert in numerical order: P6696 P6755 P6756

[7] 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]





















[12] Schedule 1, entry for Alprazolam

substitute:

Alprazolam Tablet 250 micrograms Oral a Alprax 0.25 QA MP NP C6773 10 0 50

a Kalma 0.25 AF MP NP C6773 10 0 50

Tablet 500 micrograms Oral a Alprax 0.5 QA MP NP C6773 10 0 50

a Kalma 0.5 AF MP NP C6773 10 0 50

Tablet 1 mg Oral a Alprax 1 QA MP NP C6773 10 0 50

a GenRx Alprazolam GX MP NP C6773 10 0 50

a Kalma 1 AF MP NP C6773 10 0 50

[13] Schedule 1, entry for Aripiprazole in each of the forms: Tablet 10 mg; Tablet 15 mg; Tablet 20 mg; and Tablet 30 mg

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

a APO-Aripiprazole TX MP NP C4246 30 5 30

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

a Tevaripiprazole TB MP NP C4246 30 5 30



[14] Schedule 1, entry for Atenolol in the form Tablet 50 mg

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


a Atenolol Amneal EF MP NP 30 5 30

[15] Schedule 1, entry for Atomoxetine in each of the forms: Capsule 10 mg (as hydrochloride); Capsule 18 mg (as hydrochloride); Capsule 25 mg (as hydrochloride); Capsule 40 mg (as hydrochloride); Capsule 60 mg (as hydrochloride); Capsule 80 mg (as hydrochloride); and Capsule 100 mg (as hydrochloride)

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

a ATOMERRA RW MP C4578 C6279 56 5 28

[16] Schedule 1, entry for Bromocriptine

substitute:

Bromocriptine Tablet 2.5 mg (as mesylate) Oral Parlodel SZ MP C5172 C6706 C6707 C6717 C6718 C6719 C6787

P5172 30 0 30

NP C5172 30 0 30

MP C5172 C6706 C6707 C6717 C6718 C6719 C6787

P6706 P6707 P6717 P6718 P6719 P6787

60 5 30

[17] Schedule 1, entry for Calcipotriol with betamethasone in the form Ointment containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g


a Calcipotriol/ Betamethasone Sandoz 50/500

SZ MP NP C6358 1 1 1

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

[18] Schedule 1, entry for Ceftriaxone in the form Powder for injection 2 g (as sodium)

omit:

Hospira Ceftriaxone

PF MP NP C5826 C5881 C5890

5 0 1



[19] Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous)

(a) omit:

Cephalexin generichealth

GQ PDP 20 0 20

(b) omit:

Cephalexin generichealth

GQ MP NP MW 20 1 20

(c) omit:

a Cephalexin generichealth

GQ MP P4243 40 CN4243

2 CN4243

20

[20] Schedule 1, after entry for Cephazolin in the form Powder for injection 2 g (as sodium)

insert:

Ceritinib Capsule 150 mg Oral Zykadia NV MP C6732 C6771 C6799

150 1 150

[21] Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Maximum Quantity: 20; Number of Repeats: 5]



a ANTERONE 50 RW MP P5532 20 CN5532

5 CN5532

20

[22] Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Maximum Quantity: 100; Number of Repeats: 5]



a ANTERONE 50 RW MP 100 5 50

[23] Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg


a ANTERONE 100 RW MP 50 5 50



[24] Schedule 1, entry for Dasatinib in the form Tablet 20 mg [Maximum Quantity: 60; Number of Repeats: 2]

omit from the column headed “Circumstances”: C3999 C4000 C4003 C4004

insert in numerical order: C6702 C6731 C6785 C6797 C6798


(a) omit from the column headed “Circumstances”: C3999 C4000 C4003 C4004


(b) omit from the column headed “Purposes”: P3999 P4000 P4003 P4004




























[32] Schedule 1, entry for Desvenlafaxine in the form Tablet (modified release) 50 mg


DESVEN RW MP NP C4855 28 5 28

[33] Schedule 1, entry for Desvenlafaxine in the form Tablet (modified release) 100 mg


DESVEN RW MP NP C4855 28 5 28

[34] Schedule 1, entry for Dorzolamide with timolol



a DORZOLAMIDE/ TIMOLOL AN 20/5

EA MP C4343 1 5 1

AO C5038 1 5 1

[35] Schedule 1, entry for Electrolyte replacement, oral

substitute:

Electrolyte replacement, oral

Oral rehydration salts containing glucose 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10

Oral a Repalyte New Formulation

SW MP C5889 C6786 P5889 1 0 1

NP C5889 1 0 1

a restore O.R.S. EA MP C5889 C6786 P5889 1 0 1

NP C5889 1 0 1

a Repalyte New Formulation

SW MP C5889 C6786 P6786 30 0 1

a restore O.R.S. EA MP C5889 C6786 P6786 30 0 1



[36] Schedule 1, entry for Eplerenone in each of the forms: Tablet 25 mg; and Tablet 50 mg


a Eplerenone AN EA MP NP C4937 30 5 30

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




insert in numerical order: P6695 P6726 P6727 P6728 P6753

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





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





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





[41] 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]







[42] 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]





[43] Schedule 1, entry for Glucose and Ketone Indicator—Urine

omit:

Test strips, 50 (Keto-Diabur-Test 5000)

For external use

Keto-Diabur-Test 5000

RD MP NP C5852 2 2 1

[44] Schedule 1, entry for Glyceryl Trinitrate

omit:

Tablets 600 micrograms, 100 Buccal/ sublingual

Anginine Stabilised RW PDP 1 0 1

Lycinate RF PDP 1 0 1

Anginine Stabilised RW MP NP 1 5 1

Lycinate RF MP NP 1 5 1

substitute:


Nitrostat PF PDP 1 0 1

MP NP 1 5 1


a Anginine Stabilised RW PDP 1 0 1

a Lycinate RF PDP 1 0 1

Nitrostat PF PDP 1 0 1

a Anginine Stabilised RW MP NP 1 5 1

a Lycinate RF MP NP 1 5 1

Nitrostat PF MP NP 1 5 1



[45] Schedule 1, entry for Imatinib

substitute:

Imatinib Capsule 100 mg (as mesilate) Oral Imatinib-APOTEX TX MP C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6703 C6743 C6744

P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558

60 2 60

IMATINIB-DRLA RZ MP C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6703 C6743 C6744


60 2 60

Imatinib-APOTEX TX MP C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6703 C6743 C6744

P6703 P6743 P6744

60 5 60


P6703 P6743 P6744

60 5 60



Capsule 400 mg (as mesilate) Oral Imatinib-APOTEX TX MP C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6703 C6743 C6744


30 2 30



30 2 30

Imatinib-APOTEX TX MP C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6703 C6743 C6744

P6703 P6743 P6744

30 5 30


P6703 P6743 P6744

30 5 30



Tablet 100 mg (as mesilate) Oral Glivec AF MP C4342 C4355 C6496 C6497 C6498 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6559 C6703 C6743 C6744

P6496 P6497 P6498 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558 P6559

60 2 60

IMATINIB RBX RA MP C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6703 C6743 C6744


60 2 60

Imatinib-Teva TB MP C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6549 C6550 C6557 C6558 C6703 C6743 C6744

P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6549 P6550 P6557 P6558

60 2 60

Glivec AF MP C4342 C4355 C6496 C6497 C6498 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6559 C6703 C6743 C6744

P4342 P4355 P6703 P6743 P6744

60 5 60




P6703 P6743 P6744

60 5 60


P6703 P6743 P6744

60 5 60

Tablet 400 mg (as mesilate) Oral Glivec AF MP C4342 C4355 C6496 C6497 C6498 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6559 C6703 C6743 C6744

P6496 P6497 P6498 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558 P6559

30 2 30



30 2 30


P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6549 P6550 P6557 P6558

30 2 30



Glivec AF MP C4342 C4355 C6496 C6497 C6498 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6559 C6703 C6743 C6744

P4342 P4355 P6703 P6743 P6744

30 5 30


P6703 P6743 P6744

30 5 30


P6703 P6743 P6744

30 5 30

[46] Schedule 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 1.5 mg (sustained release)



a INDAPAMIDE AN SR

EA MP NP 90 1 90

[47] Schedule 1, entry for Interferon Beta-1a

omit:

Injection set comprising 1 vial powder for injection 30 micrograms (6,000,000 I.U.) with diluent

Injection Avonex BD MP C4881 C4887 4 5 4



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


a Irbesartan AMNEAL

EF MP NP 30 5 30

[49] Schedule 1, entry for Irbesartan with Hydrochlorothiazide in each of the forms: Tablet 150 mg-12.5 mg; Tablet 300 mg-12.5 mg; and Tablet 300 mg-25 mg


a Irbesartan HCTZ AMNEAL

EF MP NP C4374 30 5 30

[50] Schedule 1, after entry for Ivermectin

insert:

Ixekizumab Injection 80 mg in 1 mL single dose pre-filled pen

Injection Taltz LY MP C6695 C6726 C6727 C6728 C6740 C6753 C6754 C6755 C6756 C6779

P6740 P6754 P6755 P6756 P6779

2 2 2

MP C6695 C6726 C6727 C6728 C6740 C6753 C6754 C6755 C6756 C6779

P6695 P6726 P6727 P6728 P6753

2 3 2

[51] Schedule 1, entry for Lamotrigine in each of the forms: Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg

omit from the column headed “Brand”: Lamotrigine generichealth substitute: Lamotrigine GH

[52] Schedule 1, entry for Latanoprost with timolol



a Latanoprost/timolol AN 50/5

EA MP C4343 1 5 1

AO C5038 1 5 1



[53] Schedule 1, entry for Macrogol 3350 in the form Powder for oral solution 510 g

insert in the columns in the order indicated after existing items:

MP See Note 2 See Note 2 See Note 2

See Note 2

1 C(100)

[54] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg

omit:

a Glucophage MQ MP NP 60 5 60

[55] Schedule 1, entry for Milk protein and fat formula with vitamins and minerals—carbohydrate free

omit from the column headed “Circumstances”: C1578 C1579 C1580 C1581 substitute: C6658

[56] Schedule 1, entry for Nilotinib in the form Capsule 150 mg (as hydrochloride monohydrate

omit from the column headed “Circumstances”: C4005 C4006 substitute: C6701 C6759 C6770

[57] Schedule 1, entry for Nilotinib in the form Capsule 200 mg (as hydrochloride monohydrate)

omit from the column headed “Circumstances”: C4001 C4002 substitute: C6742 C6796

[58] Schedule 1, after entry for Olanzapine in the form Powder for injection 405 mg (as pamoate monohydrate) with diluent

insert:

Olaparib Capsule 50 mg Oral Lynparza AP MP C6704 C6705 C6714 C6715 C6716 C6772

P6704 P6714 P6772

448 2 448

MP C6704 C6705 C6714 C6715 C6716 C6772

P6705 P6715 P6716

448 5 448

[59] Schedule 1, entry for Peginterferon Alfa-2a

omit:

Injection 180 micrograms in 0.5 mL single use pre-filled syringe

Injection Pegasys RO MP C5004 C5010 C5016 C5067

8 5 4 D(100)



substitute:

Injection 180 micrograms in 0.5 mL single use pre-filled syringe

Injection Pegasys RO MP C6745 4 2 4

MP C5004 C5010 C5016 C5067

8 5 4 C(100)

[60] Schedule 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)


Pemetrexed Accord

OD MP C4789 C4792 See Note 3

See Note 3

1 D(100)

[61] Schedule 1, entry for Pemetrexed in the form Powder for I.V. infusion 1 g (as disodium)


Pemetrexed Accord

OD MP C4789 C4792 See Note 3

See Note 3

1 D(100)

(b) omit from the column headed “Responsible Person” for the brand “Pemetrexed MYX”: YN substitute: OC

[62] Schedule 1, entry for Perindopril in each of the forms: Tablet containing perindopril erbumine 2 mg; Tablet containing perindopril erbumine 4 mg; and Tablet containing perindopril erbumine 8 mg

omit:

Ozapace RA MP NP 30 5 30

[63] Schedule 1, entry for Pramipexole in each of the forms: Tablet (extended release) containing pramipexole hydrochloride 375 micrograms; Tablet (extended release) containing pramipexole hydrochloride 750 micrograms; Tablet (extended release) containing pramipexole hydrochloride 1.5 mg; Tablet (extended release) containing pramipexole hydrochloride 2.25 mg;Tablet (extended release) containing pramipexole hydrochloride 3 mg; Tablet (extended release) containing pramipexole hydrochloride 3.75 mg; and Tablet (extended release) containing pramipexole hydrochloride 4.5 mg


a SIMIPEX XR RW MP NP C5131 30 5 30



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

omit:

Seronia 25 RF MP NP C4385 C4391 C4396

60 0 60

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



a Quetiapine AN EA MP NP C4246 C5611 C5639

60 5 60

[66] Schedule 1, entry for Quinapril in the form Tablet 5 mg (as hydrochloride)



a ACQUIN RF MP NP 30 5 30

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

omit:

Prabez AF MP NP C5444 C5512 28 5 28

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

(a) omit:

a Prabez AF MP NP C5444 C5445 C5512

P5445 30 2 30

(b) omit:

a Prabez AF MP NP C5444 C5445 C5512

P5444 P5512 30 5 30

[69] Schedule 1, entry for Ramipril in the form Tablet 2.5 mg

omit:

Prilace 2.5 RW MP NP 30 5 30



[70] Schedule 1, entry for Ramipril in the form Tablet 5 mg

omit:

Prilace 5 RW MP NP 30 5 30

[71] Schedule 1, entry for Ramipril in the form Capsule 10 mg

omit:

Prilace 10 RW MP NP 30 5 30

[72] Schedule 1, omit entry for Ribavirin and Peginterferon Alfa-2a

[73] Schedule 1, entry for Secukinumab [Maximum Quantity: 1; Number of Repeats: 2]

omit from the column headed “Circumstances”: C6392 C6393 C6402 C6405 C6406 C6407

omit from the column headed “Circumstances”: C6417













(a) omit from the column headed “Circumstances”: C6392 C6393 C6402 C6405 C6406 C6407






(b) omit from the column headed “Purposes”: P6417

insert in numerical order: P6781



























insert in numerical order: P6697 P6713 P6730 P6769

[79] Schedule 1, omit entry for Simeprevir

[80] Schedule 1, entry for Sodium Acid Phosphate

omit from the column headed “Responsible Person”: NV substitute: PL

[81] Schedule 1, entry for Soy protein and fat formula with vitamins and minerals—carbohydrate free

omit from the column headed “Circumstances”: C1578 C1579 C1580 C1581 substitute: C6658



[82] Schedule 1, entry for Sucralfate

omit:

Ulcyte AF MP NP 120 2 120

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

omit:

Sumagran Aspen 50

RW MP NP C5259 4 5 2

[84] Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg [Maximum Quantity: 100; Number of Repeats: 3]


a Pacrolim AF MP 100 3 100

[85] Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg [Maximum Quantity: 200; Number of Repeats: 5]


a Pacrolim AF MP P5569 P5602 200 CN5569 CN5602

5 CN5569 CN5602

100 C(100)

[86] Schedule 1, entry for Tacrolimus in the form Capsule 1 mg [Maximum Quantity: 100; Number of Repeats: 3]






5 CN5569 CN5602

100 C(100)









5 CN5569 CN5602

50 C(100)

[90] Schedule 1, entry for Tiotropium in the form Solution for oral inhalation 2.5 micrograms (as bromide monohydrate) per actuation (60 doses)

(a) omit from the column headed “Form”: (60 doses) substitute: (60 actuations)

(b) insert in numerical order in the column headed “Circumstances”: C6777

[91] Schedule 1, entry for Trametinib in the form Tablet 500 micrograms [Maximum Quantity: 90; Number of Repeats: 3]

(a) omit from the column headed “Circumstances”: C6021 C6029 substitute: C6752 C6778

(b) omit from the column headed “Purposes”: P6021 substitute: P6778

[92] Schedule 1, entry for Trametinib in the form Tablet 500 micrograms [Maximum Quantity: 90; Number of Repeats: 5]



[93] Schedule 1, entry for Trametinib in the form Tablet 2 mg [Maximum Quantity: 30; Number of Repeats: 3]



[94] Schedule 1, entry for Trametinib in the form Tablet 2 mg [Maximum Quantity: 30; Number of Repeats: 5]



[95] Schedule 1, entry for Ustekinumab [Maximum Quantity: 1; Number of Repeats: 1]





[96] Schedule 1, entry for Ustekinumab [Maximum Quantity: 1; Number of Repeats: 2]







[97] Schedule 1, entry for Valaciclovir

(a) omit:

a Valnir QA MP NP C5940 C5960 C5961 C5962 C5968

P5960 20 0 10

(b) omit:


P5940 P5961 30 5 30

(c) omit:


P5962 P5968 42 0 42

(d) omit:

a Zelitrex FM MP C5939 C5975 500 2 100 C(100)

[98] Schedule 3, after details relevant to Responsible Person code OC

insert:

OD Accord Healthcare Pty Ltd 49 110 502 513

[99] Schedule 3

omit:

RD Roche Diagnostics Australia Pty Limited 29 003 001 205

[100] Schedule 4, Part 1, entry for Adalimumab

(a) omit:

C5144 P5144 Severe chronic plaque psoriasis Initial treatment - 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) - 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) 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

Compliance with Written or Telephone Authority Required procedures



Patient must have received insufficient therapy with this drug under the Initial 2, Face, hand, foot (change or recommencement of treatment) 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

C5184 P5184 Severe chronic plaque psoriasis Initial treatment – Initial 2, Face, hand, foot (change or recommencement of treatment) 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, 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 Written Authority Required procedures

C5223 P5223 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, 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

C5265 P5265 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, 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

C5294 P5294 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, 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

C5335 P5335 Severe chronic plaque psoriasis Initial treatment – Initial 2, Whole body (change or recommencement of treatment) 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, 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

C5336 P5336 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, 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


C5369 P5369 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




(b) insert in numerical order after existing text:

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.


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).


Compliance with Authority Required procedures


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









(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.


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












(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



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.



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 provide no more than the balance of up to 16 weeks treatment available under the above restrictions.



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 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









(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;









(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




Continuing treatment, Whole body


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


Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.





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.




(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.


Continuing treatment, Face, hand, foot

















(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 PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.




[101] Schedule 4, Part 1, entry for Alprazolam

substitute:

Alprazolam C6773 Panic disorder

The treatment must be for use when other treatments have failed; OR

The treatment must be for use when other treatments are inappropriate.


[102] Schedule 4, Part 1, entry for Bromocriptine

(a) omit:

C5134 P5134 Acromegaly

C5170 P5170 Parkinson disease

C5171 P5171 Pathological hyperprolactinaemia Patient must be one in whom surgery is not indicated

(b) omit:

C5213 P5213 Pathological hyperprolactinaemia Patient must have had radiotherapy for this condition with incomplete resolution

C5356 P5356 Pathological hyperprolactinaemia Patient must have had surgery for this condition with incomplete resolution

C5397 P5397 Pathological hyperprolactinaemia Patient must be one in whom radiotherapy is not indicated

(c) insert in numerical order after existing text:

C6706 P6706 Pathological hyperprolactinaemia

Patient must have had surgery for this condition with incomplete resolution.


Patient must be one in whom radiotherapy is not indicated.

C6717 P6717 Acromegaly

C6718 P6718 Parkinson disease


Patient must have had radiotherapy for this condition with incomplete resolution.


Patient must be one in whom surgery is not indicated.



[103] Schedule 4, Part 1, after entry for Cephazolin

insert:

Ceritinib C6732 Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Initial treatment

The treatment must be as monotherapy; AND

The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND

Patient must have a WHO performance status of 2 or less.

Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing.


C6771 Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Grandfathering treatment

Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 February 2017; AND


The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND

Patient must have a WHO performance status of 2 or less; AND

Patient must not have progressive disease.

Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing.

A patient may qualify for PBS-subsidised treatment under this restriction once only.


C6799 Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Continuing treatment


Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND



[104] Schedule 4, Part 1, entry for Dasatinib

omit:

C3999 P3999 Initial treatment, as the sole PBS-subsidised therapy, of a patient with chronic myeloid leukaemia in any disease phase who has failed an adequate trial of imatinib or nilotinib as first-line treatment Failure of an adequate trial of imatinib or nilotinib is defined as: (i) Lack of response to initial imatinib or nilotinib therapy, defined as either: — failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or nilotinib for patients initially treated in chronic phase; or — failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or nilotinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or




— failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or nilotinib; OR (ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or nilotinib therapy; OR (iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or nilotinib therapy; OR (iv) Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or nilotinib for any phase of chronic myeloid leukaemia Accelerated phase is defined by the presence of 1 or more of the following: (1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or (2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or (3) Peripheral basophils greater than or equal to 20%; or (4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or (5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); OR Blast crisis is defined as either: (1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or (2) Extramedullary involvement other than spleen and liver; OR (v) Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia Patients should be commenced on a dose of dasatinib of at least 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to dasatinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals Applications for authorisation must be in writing and must include: (a) a completed authority prescription form; and (b) a completed Chronic Myeloid Leukaemia - Second and Third Line - Supporting Information Form; and (c) a signed patient acknowledgement; and (d) a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale. (The date of the relevant pathology report needs to be provided); and (e) where there has been a loss of response to imatinib or nilotinib, a copy of the current confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement

C4000 P4000 Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial PBS-subsidised treatment with dasatinib for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response, or less than 1% BCR-ABL level in the blood, to dasatinib in the preceding 18 months and thereafter at 12 monthly intervals Applications for authorisation must be in writing and must include:




(1) a completed authority prescription form; and (2) a completed Chronic Myeloid Leukaemia - Second and Third Line - Application Form for continuing treatment; and (3) demonstration of continued response to treatment as evidenced by either: (a) major cytogenetic response. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report needs to be provided; or (b) a peripheral blood level of BCR-ABL of less than 1% on the international scale. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report needs to be provided Definitions of response A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic response

C4003 P4003 Initial treatment, as the sole PBS-subsidised therapy, of a patient in the chronic phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, BCR-ABL tyrosine kinase, and who has a primary diagnosis of chronic myeloid leukaemia Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved Patients should be commenced on a dose of dasatinib of at least 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to dasatinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter Applications for authorisation must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and (3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow; and (4) a signed patient acknowledgement form


C4004 P4004 Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial PBS-subsidised treatment with dasatinib for the chronic phase of chronic myeloid leukaemia and who has demonstrated either a major cytogenetic response or less than 1% BCR-ABL level in the blood Applications for authorisation must be in writing and must include: (1) a completed authority prescription form; and (2) demonstration of continued response to treatment as evidenced by either: (a) major cytogenetic response. Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided; or (b) a peripheral blood level of BCR-ABL of less than 1% on the international scale. Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided Definitions of response A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic response




substitute:

C6702 P6702 Chronic Myeloid Leukaemia (CML)


Patient must have received initial PBS- subsidised second line treatment with this drug for this condition; OR

Patient must have experienced intolerance, not a failure to respond, to PBS-subsidised second line treatment with nilotinib for this condition; AND

Patient must have demonstrated a major cytogenetic response in the preceding 18 months and thereafter at 12 monthly intervals; OR

Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Applications for authorisation must be in writing and must include:(1) a completed authority prescription form; and(2) a completed Chronic Myeloid Leukaemia - Second and Third Line - Application Form for continuing treatment; and (3) demonstration of continued response to treatment as evidenced by either: (a) major cytogenetic response [see Note explaining definitions of response]. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report need be provided; or (b) a peripheral blood level of BCR-ABL of less than 1% on the international scale on the international scale [see Note explaining definitions of response]. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report need be provided.



Initial treatment

Patient must not have failed PBS-subsidised first line treatment with this drug for this condition; AND

Patient must have failed an adequate trial of PBS-subsidised first line treatment with imatinib for this condition; OR

Patient must have failed an adequate trial of PBS-subsidised first line treatment with nilotinib for this condition; OR

Patient must have experienced intolerance, not a failure of response, to PBS-subsidised second line treatment with nilotinib for this condition; AND


Failure of an adequate trial of imatinib or nilotinib is defined as:(i) Lack of response to initial imatinib or nilotinib therapy, defined as either:- failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or nilotinib for patients initially treated in chronic phase; or- failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or nilotinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or- failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or nilotinib; OR(ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or nilotinib therapy; OR(iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or nilotinib therapy; OR(iv) Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or nilotinib for any phase of chronic myeloid leukaemia.

Accelerated phase is defined by the presence of 1 or more of the following:(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or(2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or(3) Peripheral basophils greater than or equal to 20%; or(4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or(5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); ORBlast crisis is defined as




either:(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or(2) Extramedullary involvement other than spleen and liver; OR(v) Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia.Patients should be commenced on a dose of dasatinib of at least 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to dasatinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals.

Applications for authorisation must be in writing and must include:(a) a completed authority prescription form; and(b) a completed Chronic Myeloid Leukaemia - Second and Third Line - Supporting Information Form; and(c) a signed patient acknowledgement; and(d) a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale. (The date of the relevant pathology report needs to be provided); and(e) where there has been a loss of response to imatinib or nilotinib, a copy of the current confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement


First continuing treatment

The condition must be in the chronic phase; AND

Patient must have received initial PBS-subsidised first line treatment with this drug for this condition; OR

Patient must have experienced intolerance, not a failure of response, to PBS-subsidised first line treatment with imatinib for this condition; OR

Patient must have experienced intolerance, not a failure of response, to PBS-subsidised first line treatment with nilotinib for this condition; AND

Patient must have demonstrated a major cytogenic response; OR

Patient must have demonstrated a peripheral blood level of BCR-ABL of less than 1%; AND

The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND


First continuing applications for authorisation must be in writing and must include:(1) a completed authority prescription form; and(2) demonstration of continued response to treatment as evidenced by either:(a) a major cytogenetic response [see Note explaining requirements]; or(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements].Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided.



Initial treatment

The condition must be a primary diagnosis; AND


The condition must be expressing the Philadelphia chromosome; OR

The condition must have the transcript BCR-ABL tyrosine kinase; AND

The treatment must be for first line therapy for this condition; AND

Patient must not have previously experienced a failure of response to the PBS-subsidised first line treatment with this drug for this condition; OR

Patient must have experienced intolerance, not a failure of response, to PBS-subsidised first line treatment with imatinib for this




condition; OR

Patient must have experienced intolerance, not a failure of response, to PBS-subsidised first line treatment with nilotinib for this condition; AND

The treatment must not exceed a total maximum of 18 months of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition; AND


Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved.

Patients should be commenced on a dose of dasatinib of 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to dasatinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter.

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and

(3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow; and

(4) a signed patient acknowledgement form


Subsequent continuing treatment


Patient must have received the First continuing PBS-subsidised treatment with this drug as a first line therapy for this condition; OR

Patient must have experienced intolerance, not a failure of response, to PBS-subsidised first line treatment with imatinib as a first line therapy for this condition; OR

Patient must have experienced intolerance, not a failure of response, to PBS-subsidised first line treatment with nilotinib as a first line therapy for this condition; AND

Patient must have maintained a major cytogenic response; OR

Patient must have maintained a peripheral blood level of BCR-ABL of less than 1%; AND



Subsequent authority applications for continuing therapy with this drug may be made by telephoning the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).




[105] Schedule 4, Part 1, entry for Electrolyte replacement, oral

(a) insert in column headed “Purposes Code” for Circumstances Code C5889: P5889


C6786 P6786 Rehydration in intestinal failure Compliance with Authority Required procedures

[106] Schedule 4, Part 1, entry for Etanercept

(a) omit:

C5144 P5144 Severe chronic plaque psoriasis Initial treatment - 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) - 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) 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) 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



Initial treatment – Initial 2, Face, hand, foot (change or recommencement of treatment) 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, 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


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, 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


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, 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



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, 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


Initial treatment – Initial 2, Whole body (change or recommencement of treatment) 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, 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


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, 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


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















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.







































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


























[107] Schedule 4, Part 1, entry for Imatinib

(a) omit:


Subsequent continuing

The condition must be in the chronic phase of chronic myeloid leukaemia; AND

Patient must have received initial continuing PBS-subsidised treatment with this drug as a first line therapy for this condition; OR

Patient must have experienced intolerance, not a failure of response, to PBS-subsidised treatment with dasatinib as a first line therapy for this condition; OR

Patient must have experienced intolerance, not a failure of response, to PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND





Second and subsequent authority applications for continuing therapy with imatinib mesilate may be made on the telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).


(b) omit:


First Continuing


Patient must have received initial PBS-subsidised treatment with this drug as a first line therapy for this condition; OR


Patient must have experienced intolerance, not a failure of response, to PBS-subsidised treatment with nilotinib as a first line therapy




for this condition; AND





First continuing applications for authorisation must be in writing and must include:


(2) a response to treatment as evidenced by either:

(a) a major cytogenetic response [see Note explaining requirements]; or

(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements].

(c) omit:


Initial

Patient must have a primary diagnosis of chronic myeloid leukaemia; AND





Patient must not have previously experienced a failure of response to the PBS-subsidised treatment with this drug for this condition; OR





Applications for authorisation must be in writing and must include:(1) a completed authority prescription form; and(2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and(3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow; and(4) a signed patient acknowledgement form


Patients should be commenced on a dose of imatinib mesilate of 400 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to imatinib mesilate therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter.




(d) insert in numerical order after existing text:


Subsequent continuing


Patient must have received initial continuing PBS-subsidised treatment with this drug as a first line therapy for this condition; OR







Second and subsequent authority applications for continuing therapy with imatinib mesilate may be made on the telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).



Initial

Patient must have a primary diagnosis of chronic myeloid leukaemia; AND





Patient must not have previously experienced a failure of response to the PBS-subsidised treatment with this drug for this condition; OR





Applications for authorisation must be in writing and must include:(1) a completed authority prescription form; and(2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and(3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow; and(4) a signed patient acknowledgement form





Patients should be commenced on a dose of imatinib mesilate of 400 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to imatinib mesilate therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter.


First Continuing


Patient must have received initial PBS-subsidised treatment with this drug as a first line therapy for this condition; OR







First continuing applications for authorisation must be in writing and must include:


(2) a response to treatment as evidenced by either:

(a) a major cytogenetic response [see Note explaining requirements]; or

(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements].


[108] Schedule 4, Part 1, after entry for Ivermectin

insert:

Ixekizumab C6695 P6695 Severe chronic plaque psoriasis



































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.















Initial treatment – Initial 3, Whole body or Face, hand, foot (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) or Continuing treatment, Whole body or Face, hand, foot - balance of supply

Patient must have received insufficient therapy with this drug under the Initial 3, Whole body (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) restriction to complete 24 weeks treatment; OR

Patient must have received insufficient therapy with this drug under the Initial 3, Face, hand, foot (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) restriction to complete 24 weeks treatment; OR














Initial treatment – Initial 3, Whole body (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy)


Patient must have been receiving treatment with this drug for this condition prior to 1 February 2017; AND

Patient must have had a Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing treatment with this drug; AND

Patient must have demonstrated a response to treatment as specified in the criterion included in the restriction for continuing PBS-subsidised treatment with this drug (whole body); AND









(i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition at baseline (prior to initiation of therapy with this drug) and the most recent PASI assessment; and















For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or




ustekinumab.

























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.









Initial treatment – Initial 3, Face, hand, foot (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy)


Patient must have been receiving treatment with this drug for this condition prior to 1 February 2017; AND

Patient must have had disease, prior to treatment with this drug, 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 were rated as severe or very severe; or (ii) the skin area affected was 30% or more of the face, palm of a hand or sole of a foot; AND

Patient must have demonstrated a response to treatment as specified in the criterion included in the restriction for continuing PBS-subsidised treatment with this drug (face, hand, foot); AND









(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 at baseline (prior to initiation of therapy with this drug) and the most recent PASI assessment; and







The PASI assessment must be performed on the same affected area as assessed at baseline or prior to initiation of treatment with this drug.


[109] Schedule 4, Part 1, entry for Milk protein and fat formula with vitamins and minerals—carbohydrate free

substitute:

Milk protein and fat formula with vitamins and minerals -- carbohydrate free

C6658 Ketogenic diet

Patient must have intractable seizures requiring treatment with a ketogenic diet; OR

Patient must have a glucose transport protein defect; OR

Patient must have pyruvate dehydrogenase deficiency; OR

Patient must be an infant or young child with glucose-galactose intolerance and multiple monosaccharide intolerance.

[110] Schedule 4, Part 1, entry for Nilotinib

substitute:

Nilotinib C6701 Chronic Myeloid Leukaemia (CML)

First continuing treatment


Patient must have received initial PBS-subsidised first line treatment with this drug for this condition; OR

Patient must have experienced intolerance, not a failure to respond, to PBS-subsidised first line treatment with imatinib for this condition; OR

Patient must have experienced intolerance, not a failure to respond, to PBS-subsidised first line treatment with dasatinib for this condition; AND





First continuing applications for authorisation must be in writing and must include:(1) a completed authority prescription form; and(2) demonstration of continued response to treatment as evidenced by either:(a) a major cytogenetic response [see Note explaining requirements]; or(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements].Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided.


C6742 Chronic Myeloid Leukaemia (CML)


Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must have demonstrated a major cytogenetic response to dasatinib in the preceding 18 months and thereafter at 12 monthly intervals; OR

Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% to dasatinib in the preceding 18 months and




thereafter at 12 monthly intervals; AND


Applications for authorisation must be in writing and must include:(1) a completed authority prescription form; and(2) a completed Chronic Myeloid Leukaemia - Second and Third Line - Application Form for continuing treatment; and(3) demonstration of continued response to treatment as evidenced by either:(a) major cytogenetic response [see Note explaining definitions of response]. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report needs to be provided; or(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining definitions of response]. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report needs to be provided


Subsequent continuing treatment


Patient must have received the First continuing PBS-subsidised treatment with this drug as a first line therapy for this condition; OR

Patient must have experienced intolerance, not a failure of response, to PBS-subsidised first line treatment with imatinib as a first line therapy for this condition; OR

Patient must have experienced intolerance, not a failure of response, to PBS-subsidised first line treatment with dasatinib as a first line therapy for this condition; AND





Subsequent authority applications for continuing therapy with this drug may be made by telephoning the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).



Initial treatment

The condition must be a primary diagnosis; AND





Patient must not have previously experienced a failure to respond to the PBS-subsidised first line treatment with this drug for this condition; OR

Patient must have experienced intolerance, not a failure to respond, to PBS-subsidised first line treatment with imatinib for this condition; OR

Patient must have experienced intolerance, not a failure of response, to PBS-subsidised first line treatment with dasatinib for this condition; AND






Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved.Patients should be commenced on a dose of nilotinib of 300 mg twice daily. Continuing therapy is dependent on patients demonstrating a response to nilotinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter.Applications for authorisation must be in writing and must include:(1) a completed authority prescription form; and(2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and(3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow; and(4) a signed patient acknowledgement formThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of tyrosine kinase inhibitors (TKI) agents for the chronic phase of chronic myeloid leukaemia. Where the term TKI agent appears in the following notes and restrictions it refers to imatinib mesilate, dasatinib or nilotinib.

Patients are eligible for PBS-subsidised treatment with only one TKI agent at any one time and must not be receiving concomitant interferon alfa therapy. Eligible patients may only swap between TKI agents if they have not failed prior PBS-subsidised treatment with that agent.

1. Initial First-line treatment From 1 April 2012, under the PBS, a patient will be able to be prescribed any of imatinib mesilate, dasatinib or nilotinib within the initial 18 month treatment period, as long as only one agent is used at a time and providing the patient has not failed to respond to any one of these TKIs.During the initial 18 month treatment period, switching between approved first-line agents may only occur for reasons of intolerance, not failure to respond 2. Continuing First-line treatment -

Patients must maintain a major cytogenetic response or have a peripheral blood BCR-ABL of less than 1% to receive continuing therapy.

First continuing applications are to be written and must include a pathology report demonstrating the patient has responded to the initial course of treatment.

Second and subsequent authority applications for continuing therapy may be made by telephoning the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).

During continuing therapy beyond the initial 18 month treatment period, switching between approved first-line agents may only occur for reason ofintolerance. Where there is failure to respond, switching may only occur through application for prescription of second-line agents.Where a patient has previously received PBS-subsidised treatment with imatinib mesilate, dasatinib or nilotinib no approval will be granted for PBS-subsidised re-treatment in the chronic phase of chronic myeloid leukaemia, where that patient has at any time failed to meet the response criteria whilst on that TKI agent.

3. Authority approval requirements.Response criteria to initial first-line treatment with imatinib mesilate, dasatinib or nilotinib:For the purposes of assessing response to PBS-subsidised treatment with imatinib mesilate, dasatinib or nilotinib either cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale, must be submitted. For bone marrow analyses, where the standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be submitted. The cytogenetic or peripheral blood quantitative PCR analyses must be submitted within 18 months of the commencement of treatment with imatinib mesilate, dasatinib or nilotinib (patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% is demonstrable by 18 months are eligible to receive continuing treatment with that agent).

4. Definitions of response.A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells.A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic response.

5. Definitions of loss of response.Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing tyrosine kinase inhibitor (TKI) therapy.Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value



by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing tyrosine kinase inhibitor therapy.


Initial treatment

The condition must be in the chronic phase; OR

The condition must be in the accelerated phase; AND

Patient must have failed an adequate trial of PBS-subsidised first line treatment with imatinib for this condition; OR

Patient must have failed an adequate trial of PBS-subsidised first line treatment with dasatinib for this condition; AND


Failure of an adequate trial of imatinib or dasatinib is defined as:(i) Lack of response to initial imatinib or dasatinib therapy, defined as either:- failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or dasatinib for patients initially treated in chronic phase; or- failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or dasatinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or- failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or dasatinib; OR(ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or dasatinib therapy; OR(iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or dasatinib therapy; OR(iv) Development of accelerated phase in a patient previously prescribed imatinib or dasatinib for the chronic phase of chronic myeloid leukaemia.

Accelerated phase is defined by the presence of 1 or more of the following:(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or(2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or(3) Peripheral basophils greater than or equal to 20%; or(4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or(5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); OR(v) Disease progression (defined as a greater than or equal to.50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib or dasatinib therapy in patients with accelerated phase chronic myeloid leukaemia, provided that blast crisis has been excluded on bone marrow biopsy.

Patients should be commenced on a dose of nilotinib of 400 mg twice daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to nilotinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals.

Applications for authorisation must be in writing and must include:(a) a completed authority prescription form; and(b) a completed Chronic Myeloid Leukaemia - Second and Third Line - Supporting Information Form; and(c) a signed patient acknowledgement; and(d) a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale. (The date of the relevant pathology report needs to be provided); and(e) where there has been a loss of response to imatinib or dasatinib, a copy of the current confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.




[111] Schedule 4, Part 1, after entry for Olanzapine

insert:

Olaparib C6704 P6704 High grade serous fallopian tube cancer

Initial treatment

The condition must be platinum sensitive; AND

Patient must have received at least two previous platinum-containing regimens; AND

Patient must have relapsed following a previous platinum-containing regimen; AND

Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

The treatment must be maintenance therapy; AND

Patient must not have previously received PBS-subsidised treatment with this drug for this condition.

Patient must have evidence of a germline class 4 or 5 BRCA1 or BRCA2 gene mutation.

Platinum sensitivity is defined as disease progression greater than 6 months after completion of the penultimate platinum regimen.

A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.

Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline testing.


C6705 P6705 High grade serous fallopian tube cancer






Compliance with Authority Required procedures - Streamlined Authority Code 6705

C6714 P6714 High grade serous primary peritoneal cancer

Initial treatment















C6715 P6715 High grade serous ovarian cancer







C6716 P6716 High grade serous primary peritoneal cancer







C6772 P6772 High grade serous ovarian cancer

Initial treatment













[112] Schedule 4, Part 1, entry for Peginterferon Alfa-2a

insert in numerical order after existing text:

C6745 Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND

Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND

The treatment must be limited to a maximum duration of 12 weeks.




[113] Schedule 4, Part 1, omit entry for Ribavirin and Peginterferon Alfa-2a

[114] Schedule 4, Part 1, entry for Secukinumab

(a) omit:

C6392 P6392 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, 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.

C6393 P6393 Severe chronic plaque psoriasis Initial treatment – Initial 2, Whole body (change or recommencement of treatment) 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, 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.


C6402 P6402 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, 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.

C6405 P6405 Severe chronic plaque psoriasis Initial treatment – Initial 3, Whole body (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy)




Patient must have a documented history of severe chronic plaque psoriasis; AND Patient must have been receiving treatment with this drug for this condition prior to 1 September 2015; AND Patient must have had a Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing treatment with this drug; AND Patient must have demonstrated a response to treatment as specified in the criterion included in the restriction for continuing PBS-subsidised treatment with this drug (whole body); 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 24 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. 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 at baseline (prior to initiation of therapy with this drug) and the most recent PASI assessment; 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. The most recent PASI assessment must be no more than 1 month old at the time of application. A patient may qualify for PBS-subsidised treatment under this restriction once only.

C6406 P6406 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, 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.

C6407 P6407 Severe chronic plaque psoriasis Initial treatment – Initial 3, Face, hand, foot (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) 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 been receiving treatment with this drug for this condition prior to 1 September 2015; AND Patient must have had disease, prior to treatment with this drug, 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 were rated as severe or very severe; or (ii) the skin area affected was 30% or more of the face, palm of a hand or sole of a foot; AND Patient must have demonstrated a response to treatment as specified in the criterion included in the restriction for continuing PBS-subsidised treatment with this drug (face, hand, foot); 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 24 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. 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 at baseline (prior to initiation of therapy with this drug) and the most recent PASI assessment; 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. The most recent PASI assessment must be no more than 1 month old at the time of application. The PASI assessment must be performed on the same affected area as assessed at baseline or prior to initiation of treatment with this drug. A patient may qualify for PBS-subsidised treatment under this restriction once only.

(b) omit:

C6417 P6417 Severe chronic plaque psoriasis Initial treatment - 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) - 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) 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) 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.


(c) omit:

C6440 P6440 Severe chronic plaque psoriasis Initial treatment – Initial 3, Whole body or Face, hand, foot (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) or Continuing treatment, Whole body or Face, hand, foot - balance of supply Patient must have received insufficient therapy with this drug under the Initial 3, Whole body (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) restriction to complete 24 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 3, Face, hand, foot (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) restriction to complete 24 weeks treatment; OR 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.




(d) omit:

C6462 P6462 Severe chronic plaque psoriasis Initial treatment – Initial 2, Face, hand, foot (change or recommencement of treatment) 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, 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.


(e) omit:

C6468 P6468 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, 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.

(f) insert in numerical order after existing text:















ustekinumab.






















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.



















































(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.










Initial treatment - 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






















ustekinumab.

























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.









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







[115] Schedule 4, Part 1, omit entry for Simeprevir

[116] Schedule 4, Part 1, entry for Soy protein and fat formula with vitamins and minerals—carbohydrate free

substitute:

Soy protein and fat formula with vitamins and minerals -- carbohydrate free

C6658 Ketogenic diet

Patient must have intractable seizures requiring treatment with a ketogenic diet; OR

Patient must have a glucose transport protein defect; OR

Patient must have pyruvate dehydrogenase deficiency; OR

Patient must be an infant or young child with glucose-galactose intolerance and multiple monosaccharide intolerance.

[117] Schedule 4, Part 1, entry for Tiotropium

insert in numerical order after existing text:

C6777 Severe asthma

Patient must have experienced at least one severe exacerbation, which has required documented use of systemic corticosteroids, in the previous 12 months while receiving optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND

The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid and a long acting beta-2 agonist.



Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.

[118] Schedule 4, Part 1, entry for Trametinib

substitute:

Trametinib C6752 P6752 Unresectable Stage III or Stage IV malignant melanoma


Patient must have previously been issued with an authority prescription for this drug; AND

Patient must be receiving PBS-subsidised dabrafenib concomitantly for this condition; AND

Patient must have stable or responding disease.


C6778 P6778 Unresectable Stage III or Stage IV malignant melanoma

Initial treatment

Patient must be receiving PBS-subsidised dabrafenib concomitantly for this condition; AND

Patient must not have had progressive disease when treated with a BRAF inhibitor.


[119] Schedule 4, Part 1, entry for Ustekinumab

(a) omit:

C5159 P5159 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 28 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, 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. 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

C5203 P5203 Severe chronic plaque psoriasis Initial treatment – Initial 2, Whole body (change or recommencement of treatment) 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 28 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, 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. 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. 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

C5204 P5204 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 28 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, 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. 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

C5205 P5205 Severe chronic plaque psoriasis Initial treatment - 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) - 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 28 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 2, Whole body (change or recommencement of treatment) restriction to complete 28 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 28 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 2, Face, hand, foot (change or recommencement of treatment) 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 restrictions. Must be treated by a dermatologist


C5206 P5206 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


C5276 P5276 Severe chronic plaque psoriasis Initial treatment – Initial 2, Face, hand, foot (change or recommencement of treatment) 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 28 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, 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. 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. 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

C5425 P5425 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, 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. 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 1 repeat will be authorised


C5426 P5426 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, 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. 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 1 repeat will be authorised













(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











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 1 repeat will be authorised.
















ustekinumab.













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.


Initial treatment - 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 2, Whole body (change or recommencement of treatment after a break of less than 5 years) restriction to complete 28 weeks treatment; OR







C6758 P6758 Severe chronic plaque psoriasis Compliance with









Authority Required procedures





















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 1 repeat will be authorised.































Compliance with Written Authority






















Required procedures

[120] Schedule 4, Part 3, Section 3

(a) Item 1, column 3 of the table, omit from (d): with RIBAVIRIN substitute: and RIBAVIRIN

(b) Item 2, column 3 of the table, omit from (d): with RIBAVIRIN substitute: and RIBAVIRIN

(c) Item 5, column 3 of the table, omit from (c): with RIBAVIRIN substitute: and RIBAVIRIN

(d) Item 6, column 3 of the table, omit from (c): with RIBAVIRIN substitute: and RIBAVIRIN

(e) Item 7, column 3 of the table, omit from (a): with RIBAVIRIN substitute: and RIBAVIRIN

(f) Item 8, column 3 of the table, omit from (a): with RIBAVIRIN substitute: and RIBAVIRIN

(g) Item 9, column 3 of the table, omit: with RIBAVIRIN substitute: and RIBAVIRIN



(h) Item 10, column 3 of the table, omit: with RIBAVIRIN substitute: and RIBAVIRIN

(i) Item 11, column 3 of the table, omit from (d): with RIBAVIRIN substitute: and RIBAVIRIN

(j) Item 12, column 3 of the table, omit from (d): with RIBAVIRIN substitute: and RIBAVIRIN

(k) Item 15, column 3 of the table, omit from (c): with RIBAVIRIN substitute: and RIBAVIRIN

(l) Item 16, column 3 of the table, omit from (c): with RIBAVIRIN substitute: and RIBAVIRIN

(m) Item 17, column 3 of the table, omit from (a): with RIBAVIRIN substitute: and RIBAVIRIN

(n) Item 18, column 3 of the table, omit from (a): with RIBAVIRIN substitute: and RIBAVIRIN

(o) Item 19, column 3 of the table, omit: with RIBAVIRIN substitute: and RIBAVIRIN

(p) Item 20, column 3 of the table, omit: with RIBAVIRIN substitute: and RIBAVIRIN

[121] Schedule 5, entry for Desvenlafaxine in the form Tablet (modified release) 100 mg [GRP-16219]

insert in alphabetical order in the column headed “Brand”: DESVEN

[122] Schedule 5, entry for Desvenlafaxine in the form Tablet (modified release) 50 mg [GRP-16220]

insert in alphabetical order in the column headed “Brand”: DESVEN

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

omit from the column headed “Brand”: Ozapace

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


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


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

omit from the column headed “Brand”: Prilace 10

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

omit from the column headed “Brand”: Sumagran Aspen 50


national health (listing of pharmaceutical benefits

Documents