National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 2) (PB 15 of 2017) (Cth)

PB 15 of 2017

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017
(No. 2)

National Health Act 1953

I, LOUISE CLARKE, First Assistant Secretary (Acting), Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated 30^th March 2017

LOUISE CLARKE

First Assistant Secretary  (Acting)

Pharmaceutical Benefits Division

Department of Health

1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical    Benefits) Amendment Instrument 2017 (No. 2).

(2)        This Instrument may also be cited as PB 15 of 2017.

2          Commencement

This Instrument commences on 1 April 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 Abatacept

insert as first item in the columns in the order indicated:

Injection 125 mg in 1 mL single dose autoinjector	Injection	Orencia ClickJect	BQ	MP	C4720 C4746 C6805 C6827 C6835	P4746 P6805 P6835	4	3	4
MP	C4720 C4746 C6805 C6827 C6835	P4720 P6827	4	5	4

1. Schedule 1, entry for Abatacept in the form Injection 125 mg in 1 mL single dose pre‑filled syringe [Maximum Quantity: 4; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”:               C5448 C5495 C5503      substitute:             C6805 C6827 C6835

(b)omit from the column headed “Purposes”:         P5448 P5495 substitute:             P6805 P6835

1. Schedule 1, entry for Abatacept in the form Injection 125 mg in 1 mL single dose pre‑filled syringe [Maximum Quantity: 4; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:               C5448 C5495 C5503      substitute:             C6805 C6827 C6835

(b)omit from the column headed “Purposes”:         P5503   substitute:             P6827

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

omit:

Acitretin Actavis GN MP C5727 C5789 100 2 100

1. Schedule 1, entry for Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine

omit from the column headed “Maximum Quantity”:  4          substitute:             5

1. Schedule 1, entry for Amino acid formula with fat, carbohydrate, without phenylalanine

omit from the column headed “Maximum Quantity”:  5          substitute:             7

1. Schedule 1, entry for Amoxycillin in the form Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL

omit:

MP NP P5863 1 1 1

substitute:

MP NP P5863 1
CN5863 1
CN5863 1

1. Schedule 1, after entry for Apomorphine in the form Injection containing apomorphine hydrochloride 50 mg in 5 mL

insert in the columns in the order indicated:

Injection containing apomorphine hydrochloride 100 mg in 20 mL Injection Apomine Solution for Infusion PF MP C4860 C6813 90 5 5 D(100)

1. 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)

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

a Atomoxetine Sandoz SZ MP C4578 C6279 56 5 28

1. Schedule 1, entry for Atomoxetine in each of the forms: Capsule 80 mg (as hydrochloride); and Capsule 100 mg (as hydrochloride)

(a)omit from the column headed “Maximum Quantity for the brand “ATOMERRA”:     56         substitute:             28

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

a Atomoxetine Sandoz SZ MP C4578 C6279 28 5 28

1. Schedule 1, entry for Bicalutamide

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

a Bicalide JU MP NP C5729 28 5 28

1. Schedule 1, entry for Brentuximab vedotin

insert in numerical order in the column headed “Circumstances”:         C6800 C6816 C6826 C6838       

1. Schedule 1, entry for Calcipotriol with betamethasone

insert as first item in the columns in the order indicated:

Foam containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 60 g Application Enstilar LO MP NP C6809 1 1 1

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

omit:

Capecitabine Alphapharm AF MP 60 2 60

1. Schedule 1, entry for Cefepime in each of the forms: Powder for injection 1 g (as hydrochloride); and Powder for injection 2 g
   (as hydrochloride)

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

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

a Cefepime Kabi PK MP NP C5842 10 0 1

1. Schedule 1, entry for Ceftriaxone in the form Powder for injection 1 g (as sodium)

omit:

Max Pharma Ceftriaxone GQ MP NP C5830 C5862 C5868 5 0 5

1. Schedule 1, entry for Ceritinib

omit from the column headed “Circumstances”:          C6799   substitute:             C6824

1. Schedule 1, entry for Ciprofloxacin in the form Tablet 250 mg (as hydrochloride)

omit:

GenRx Ciprofloxacin GX MP NP C5614 C5615 C5666 C5687 C5688 C5689 C5722 C5780 14 0 14

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

omit:

GenRx Ciprofloxacin GX MP NP C5614 C5615 C5687 C5688 C5689 C5722 C5780 14 0 14

1. Schedule 1, entry for Clonidine in the form Tablet containing clonidine hydrochloride 100 micrograms

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

a APO-Clonidine TX MP NP 100 5 100

(b)insert in  the column headed “Responsible Person” for the brand “Catapres 100”:                a

1. Schedule 1, after entry for Coal Tar ‑ Prepared

insert:

Cobimetinib	Tablet 20 mg	Oral	Cotellic	RO	MP	C6803 C6839	P6839	63	3	63
C6803 C6839	P6803	63	5	63

1. Schedule 1, entry for Dorzolamide

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

a APO-Dorzolamide TX MP AO 1 5 1

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

1. Schedule 1, entry for Dorzolamide with timolol

(a)omit from the column headed “Schedule Equivalent” where “Authorised Prescriber” is “AO” (3 instances):   a

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

a	APO-Dorzolamide/ Timolol 20/5	TX	MP	C4343	1	5	1
AO	C5038	1	5	1

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

omit:

a Coperin AF MP NP C5650 28 0 28

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

omit:

a Coperin AF MP NP C5650 28 5 28

1. Schedule 1, entry for Electrolyte replacement, oral

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

a O.R.S. AS MP NP C5889 1 0 1

1. Schedule 1, entry for Entecavir in the form Tablet 0.5 mg (as monohydrate)

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

a ENTAC LR MP C4993 C5036 60 5 30 D(100)

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

a Entecavir GH GQ MP C4993 C5036 60 5 30 D(100)

1. Schedule 1, entry for Entecavir in the form Tablet 1 mg (as monohydrate)

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

a ENTAC LR MP C5037 C5044 60 5 30 D(100)

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

a Entecavir GH GQ MP C5037 C5044 60 5 30 D(100)

1. Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL

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

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

1. Schedule 1, after entry for Epoprostenol in the form Powder for I.V. infusion 500 micrograms (as sodium)

insert in the columns in the order indicated:

Powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL Injection Flolan GK MP See Note 3 See Note 3 See Note 3 See
Note 3 1 D(100)

1. Schedule 1, after entry for Epoprostenol in the form Powder for I.V. infusion 1.5 mg (as sodium)

insert in the columns in the order indicated:

Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL Injection Flolan GK MP See Note 3 See Note 3 See Note 3 See
Note 3 1 D(100)

1. Schedule 1, entry for Erythromycin in the form Tablet 400 mg (as ethyl succinate)

(a)omit:

E.E.S. 400 Filmtab GH PDP 25 0 25

(b)omit:

E.E.S. 400 Filmtab GH MP NP 25 1 25

(c)omit from the column headed “Schedule Equivalent” for the brand “E-Mycin” [Purposes Code P6160]:         a

(d)omit:

a E.E.S. 400 Filmtab GH MP P6160 50
CN6160 5
CN6160 25

1. Schedule 1, entry for Etanercept

omit:

Injection 50 mg in 1 mL single use auto‑injector, 4	Injection	Enbrel	PF	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	C(100)
MP	C4088 C4114 C4115 C4116 C4125 C4136 C4137 C4151 C4457 C4458 C4482 C4483 C4503 C4610 C4643 C4676 C4766 C4845 C4851 C5462 C5479 C5528 C6423 C6430 C6437 C6439 C6445 C6458  C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756	P4088 P4114 P4115 P4116 P4125 P4136 P4137 P4151 P4458 P4483 P4503 P4610 P4766 P4851 P5462 P5479 P6430 P6437 P6445 P6458 P6695 P6726 P6727 P6728 P6753	1	3	1
MP	C4088 C4114 C4115 C4116 C4125 C4136 C4137 C4151 C4457 C4458 C4482 C4483 C4503 C4610 C4643 C4676 C4766 C4845 C4851 C5462 C5479 C5528 C6423 C6430 C6437 C6439 C6445 C6458 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756	P4457 P4482 P4643 P4676 P4845 P5528 P6423 P6439 P6696 P6755 P6756	1	5	1
Injections 50 mg in 1 mL single use pre‑filled syringes, 4	Injection	Enbrel	PF	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	C(100)
MP	C4088 C4114 C4115 C4116 C4125 C4136 C4137 C4151 C4457 C4458 C4482 C4483 C4503 C4610 C4643 C4676 C4766 C4845 C4851 C5462 C5479 C5528 C6423 C6430 C6437 C6439 C6445 C6458 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756	P4088 P4114 P4115 P4116 P4125 P4136 P4137 P4151 P4458 P4483 P4503 P4610 P4766 P4851 P5462 P5479 P6430 P6437 P6445 P6458 P6695 P6726 P6727 P6728 P6753	1	3	1
C4088 C4114 C4115 C4116 C4125 C4136 C4137 C4151 C4457 C4458 C4482 C4483 C4503 C4610 C4643 C4676 C4766 C4845 C4851 C5462 C5479 C5528 C6423 C6430 C6437 C6439 C6445 C6458 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756	P4457 P4482 P4643 P4676 P4845 P5528 P6423 P6439 P6696 P6765 P6756	1	5	1

substitute:

Injection 50 mg in 1 mL single use auto-injector, 4	Injection	Enbrel	PF	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	C(100)
Brenzys	MK	MP	C4610 C4643 C4676 C4766 C4845 C4851 C6423 C6430 C6437 C6439 C6445 C6458 C6807 C6808 C6821 C6833 C6834 C6836 C6837 C6840 C6841 C6842 C6844	P4610 P4766 P4851 P6430 P6437 P6445 P6458 P6808 P6821 P6834 P6836 P6837 P6841 P6844	1	3	1
Enbrel	PF	MP	C4457 C4458 C4482 C4483 C4503 C4610 C4643 C4676 C4766 C4845 C4851 C6423 C6430 C6437 C6439 C6445 C6458 C6807 C6808 C6811 C6814 C6818 C6819 C6821 C6822 C6823 C6830 C6833 C6834 C6836 C6837 C6840 C6841 C6842 C6843 C6844	P4458 P4483 P4503 P4610 P4766 P4851 P6430 P6437 P6445 P6458 P6808 P6811 P6814 P6818 P6819 P6821 P6822 P6823 P6830 P6834 P6836 P6837 P6841 P6843 P6844	1	3	1
Brenzys	MK	MP	C4610 C4643 C4676 C4766 C4845 C4851 C6423 C6430 C6437 C6439 C6445 C6458 C6807 C6808 C6821 C6833 C6834 C6836 C6837 C6840 C6841 C6842 C6844	P4643 P4676 P4845 P6423 P6439 P6807 P6833 P6840 P6842	1	5	1
Enbrel	PF	MP	C4457 C4458 C4482 C4483 C4503 C4610 C4643 C4676 C4766 C4845 C4851 C6423 C6430 C6437 C6439 C6445 C6458 C6807 C6808 C6811 C6814 C6818 C6819 C6821 C6822 C6823 C6830 C6833 C6834 C6836 C6837 C6840 C6841 C6842 C6843 C6844	P4457 P4482 P4643 P4676 P4845 P6423 P6439 P6807 P6833 P6840 P6842	1	5	1
Injections 50 mg in 1 mL single use pre-filled syringes, 4	Injection	Enbrel	PF	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	C(100)
Brenzys	MK	MP	C4610 C4643 C4676 C4766 C4845 C4851 C6423 C6430 C6437 C6439 C6445 C6458 C6807 C6808 C6821 C6833 C6834 C6836 C6837 C6840 C6841 C6842 C6844	P4610 P4766 P4851 P6430 P6437 P6445 P6458 P6808 P6821 P6834 P6836 P6837 P6841 P6844	1	3	1
Enbrel	PF	MP	C4457 C4458 C4482 C4483 C4503 C4610 C4643 C4676 C4766 C4845 C4851 C6423 C6430 C6437 C6439 C6445 C6458 C6807 C6808 C6811 C6814 C6818 C6819 C6821 C6822 C6823 C6830 C6833 C6834 C6836 C6837 C6840 C6841 C6842 C6843 C6844	P4458 P4483 P4503 P4610 P4766 P4851 P6430 P6437 P6445 P6458 P6808 P6811 P6814 P6818 P6819 P6821 P6822 P6823 P6830 P6834 P6836 P6837 P6841 P6843 P6844	1	3	1
Brenzys	MK	MP	C4610 C4643 C4676 C4766 C4845 C4851 C6423 C6430 C6437 C6439 C6445 C6458 C6807 C6808 C6821 C6833 C6834 C6836 C6837 C6840 C6841 C6842 C6844	P4643 P4676 P4845 P6423 P6439 P6807 P6833 P6840 P6842	1	5	1
Enbrel	PF	MP	C4457 C4458 C4482 C4483 C4503 C4610 C4643 C4676 C4766 C4845 C4851 C6423 C6430 C6437 C6439 C6445 C6458 C6807 C6808 C6811 C6814 C6818 C6819 C6821 C6822 C6823 C6830 C6833 C6834 C6836 C6837 C6840 C6841 C6842 C6843 C6844	P4457 P4482 P4643 P4676 P4845 P6423 P6439 P6807 P6833 P6840 P6842	1	5	1

1. Schedule 1, after entry for Ferric carboxymaltose

insert:

Ferrous fumarate	Tablet 200 mg (equivalent to 65.7 mg iron)	Oral	Ferro-tab	AE	MP NP	C6812	60	1	60
Ferrous fumarate with folic acid	Tablet 310 mg (equivalent to 100 mg iron)-350 micrograms	Oral	Ferro-f-tab	AE	MP NP	C6812	60	1	60

1. Schedule 1, entry for Glibenclamide

omit:

a Glimel AF MP NP 100 5 100

1. Schedule 1, after entry for Glycomacropeptide and essential amino acids with vitamins and minerals in the form Oral liquid 250 mL, 30 (Tylactin RTD)

insert in the columns in the order indicated:

Sachets containing oral powder 20 g, 60 (PKU Restore) Oral PKU Restore QH MP NP C4295 5 5 1

1. Schedule 1, after entry for Glycomacropeptide and essential amino acids with vitamins and minerals in the form Sachets containing oral powder 51 g, 30 (PKU Bettermilk Lite)

insert:

Glycomacropeptide formula with long chain polyunsaturated fatty acids and docosahexaenoic acid and low in phenylalanine Sachets containing oral powder 35 g, 30 (PKU Sphere) Oral PKU Sphere VF MP NP C4295 4 5 1

1. Schedule 1, entry for Imatinib

omit:

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	P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558	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
IMATINIB-DRLA	RZ	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
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	P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558	30	2	30
IMATINIB-DRLA	RZ	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	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
IMATINIB-DRLA	RZ	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

substitute:

Capsule 100 mg (as mesilate)	Oral	CIPLA IMATINIB ADULT	LR	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
IMATINIB AN	EA	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 GH	GQ	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-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	P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558	60	2	60
CIPLA IMATINIB ADULT	LR	MP	C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6549 C6550 C6557 C6558 C6703 C6743 C6744	P6703 P6743 P6744	60	5	60
IMATINIB AN	EA	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
Imatinib GH	GQ	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
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
IMATINIB-DRLA	RZ	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
Capsule 400 mg (as mesilate)	Oral	CIPLA IMATINIB ADULT	LR	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	30	2	30
IMATINIB AN	EA	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	30	2	30
Imatinib GH	GQ	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	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	P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558	30	2	30
IMATINIB-DRLA	RZ	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	30	2	30
CIPLA IMATINIB ADULT	LR	MP	C6496 C6497 C6499 C6510 C6526 C6527 C6528 C6538 C6539 C6549 C6550 C6557 C6558 C6703 C6743 C6744	P6703 P6743 P6744	30	5	30
IMATINIB AN	EA	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
Imatinib GH	GQ	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
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
IMATINIB-DRLA	RZ	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

1. Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL

omit:

Irinotecan Alphapharm AF MP See Note 3 See
Note 3 1 D(100)

1. Schedule 1, entry for Lamotrigine in each of the forms: Tablet 100 mg; and Tablet 200 mg

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

a Lamotrigine generichealth HQ MP NP C5138 56 5 56

1. Schedule 1, entry for Latanoprost

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

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

a Lanpro JU MP AO 1 5 1

1. Schedule 1, entry for Letrozole

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

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

a Letroz JU MP NP C5464 30 5 30

1. Schedule 1, entry for Methotrexate in the form Injection 50 mg in 2 mL vial [Maximum Quantity: 5; Number of Repeats: 5]

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

a Methotrexate Accord OD MP 5 5 1

1. Schedule 1, entry for Methotrexate in the form Injection 50 mg in 2 mL vial [Purposes Code blank; Maximum Quantity: See Note 2]

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

Methotrexate Accord OD MP See Note 2 See Note 2 1 C(100)

1. Schedule 1, entry for Methotrexate in the form Injection 50 mg in 2 mL vial [Purposes Code: P6276; Maximum Quantity: See Note 2]

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

Methotrexate Accord OD MP P6276 See Note 2 See Note 2 1 C(100)

1. Schedule 1, entry for Methotrexate in the form Solution concentrate for I.V. infusion 1000 mg in 10 mL vial [Purposes Code blank; Maximum Quantity: See Note 3]

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

Methotrexate Accord OD MP See Note 3 See Note 3 1 PB(100)

1. Schedule 1, entry for Methotrexate in the form Solution concentrate for I.V. infusion 1000 mg in 10 mL vial [Purposes Code: P6276; Maximum Quantity: See Note 3]

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

Methotrexate Accord OD MP P6276 See Note 3 See Note 3 1 PB(100)

1. Schedule 1, entry for Montelukast in the form Tablet, chewable, 4 mg (as sodium)

omit:

T Lukast AF MP NP C6666 28 5 28

1. Schedule 1, entry for Montelukast in the form Tablet, chewable, 5 mg (as sodium)

omit:

T Lukast AF MP NP C6674 C6684 28 5 28

1. Schedule 1, entry for Naloxone

(a)insert in the column headed “Schedule Equivalent” for the brand “Naloxone Hydrochloride (DBL)”:                               a

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

a Naloxone Juno JU MP NP PDP 5 0 5

1. Schedule 1, entry for Naloxone

insert as next item in the columns in the order indicated:

Injection containing naloxone hydrochloride 2 mg in 2 mL pre-filled syringe Injection Prenoxad PL MP NP PDP 1 0 1

1. Schedule 1, entry for Olmesartan

substitute:

Olmesartan	Tablet containing olmesartan medoxomil 20 mg	Oral	a	APO-Olmesartan	TX	MP NP	30	5	30
a	OLMERTAN	RW	MP NP	30	5	30
a	Olmesartan AN	EA	MP NP	30	5	30
a	Olmesartan - MYL	AF	MP NP	30	5	30
a	Olmesartan Sandoz	SZ	MP NP	30	5	30
a	Olmetec	MK	MP NP	30	5	30
a	Pharmacor Olmesartan 20	CR	MP NP	30	5	30
Tablet containing olmesartan medoxomil 40 mg	Oral	a	APO-Olmesartan	TX	MP NP	30	5	30
a	OLMERTAN	RW	MP NP	30	5	30
a	Olmesartan AN	EA	MP NP	30	5	30
a	Olmesartan - MYL	AF	MP NP	30	5	30
a	Olmesartan Sandoz	SZ	MP NP	30	5	30
a	Olmetec	MK	MP NP	30	5	30
a	Pharmacor Olmesartan 40	CR	MP NP	30	5	30

1. Schedule 1, entry for Olmesartan with hydrochlorothiazide

substitute:

Olmesartan with hydrochlorothiazide	Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg	Oral	a	APO-Olmesartan/ HCTZ 20/12.5	TX	MP NP	C4374	30	5	30
a	OLMERTAN COMBI 20/12.5	RW	MP NP	C4374	30	5	30
a	Olmesartan HCT AN 20/12.5	EA	MP NP	C4374	30	5	30
a	Olmesartan HCT - MYL 20/12.5	AF	MP NP	C4374	30	5	30
a	Olmesartan/ HCT Sandoz	SZ	MP NP	C4374	30	5	30
a	Olmetec Plus	MK	MP NP	C4374	30	5	30
Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg	Oral	a	APO-Olmesartan/ HCTZ 40/12.5	TX	MP NP	C4374	30	5	30
a	OLMERTAN COMBI 40/12.5	RW	MP NP	C4374	30	5	30
a	Olmesartan HCT AN 40/12.5	EA	MP NP	C4374	30	5	30
a	Olmesartan HCT - MYL 40/12.5	AF	MP NP	C4374	30	5	30
a	Olmesartan/ HCT Sandoz	SZ	MP NP	C4374	30	5	30
a	Olmetec Plus	MK	MP NP	C4374	30	5	30
Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg	Oral	a	APO-Olmesartan/ HCTZ 40/25	TX	MP NP	C4374	30	5	30
a	OLMERTAN COMBI 40/25	RW	MP NP	C4374	30	5	30
a	Olmesartan HCT AN 40/25	EA	MP NP	C4374	30	5	30
a	Olmesartan HCT - MYL 40/25	AF	MP NP	C4374	30	5	30
a	Olmesartan/ HCT Sandoz	SZ	MP NP	C4374	30	5	30
a	Olmetec Plus	MK	MP NP	C4374	30	5	30

1. Schedule 1, after entry for Paliperidone in the form I.M. injection (modified release) 150 mg (as palmitate) in pre‑filled syringe

insert in the columns in the order indicated:

I.M. injection (modified release) 175 mg (as palmitate) in pre‑filled syringe	Injection	Invega Trinza	JC	MP NP	C6832	1	1	1
I.M. injection (modified release) 263 mg (as palmitate) in pre‑filled syringe	Injection	Invega Trinza	JC	MP NP	C6832	1	1	1
I.M. injection (modified release) 350 mg (as palmitate) in pre‑filled syringe	Injection	Invega Trinza	JC	MP NP	C6832	1	1	1
I.M. injection (modified release) 525 mg (as palmitate) in pre‑filled syringe	Injection	Invega Trinza	JC	MP NP	C6832	1	1	1

1. Schedule 1, entry for Pegfilgrastim

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

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

a Ristempa GV MP C6488 C6489 C6490 C6491 C6492 C6493 C6494 C6501 C6502 C6507 C6512 C6513 C6514 C6515 C6516 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6546 C6554 C6555 1 11 1 D(100)

1. Schedule 1, entry for Pembrolizumab

omit from the column headed “Circumstances”:          C5362 C6093 C6094 C6103 C6104          substitute:             C6801 C6806 C6817 C6828 C6829

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

(a)omit:

Chem mart Piroxicam CH PDP C6214 25 0 25

(b)omit:

Terry White Chemists Piroxicam TW PDP C6214 25 0 25

(c)omit:

Chem mart Piroxicam CH MP NP C6214 25 3 25

(d)omit:

Terry White Chemists Piroxicam TW MP NP C6214 25 3 25

1. Schedule 1, entry for Protein formula with amino acids, carbohydrates, vitamins and minerals without phenylalanine, and supplemented with docosahexaenoic acid

omit from the column headed “Maximum Quantity”:  4          substitute:             5

1. Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 35 mg

omit:

Risedronate‑GA GN MP NP C6310 C6323 C6327 4 5 4

1. Schedule 1, after entry for Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30
   [Brand: Ventolin Nebules]

insert in the columns in the order indicated:

Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 20 Inhalation Ventolin Nebules GK MP NP C6815 C6825 3 5 1

1. Schedule 1, entry for Salbutamol in the form Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30

omit from the column headed “Circumstances” (all instances):               C6331 C6341     substitute:             C6815 C6825

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

in the column headed “Purposes” list existing codes in numerical order, i.e.:      P6487 P6781

1. Schedule 1, entry for Somatropin in the form Solution for injection 6 mg (18 i.u.) in 1.03 mL cartridge (with preservative) [Brand: Saizen]

omit all codes from the column headed “Circumstances” and substitute:             
C5146 C5147 C5152 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5227 C5228 C5229 C5230 C5231 C5237 C5238 C5239 C5269 C5270 C5273 C5286 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5348 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5433

1. Schedule 1, entry for Somatropin in the form Solution for injection 12 mg (36 i.u.) in 1.5 mL cartridge (with preservative) [Brand: Saizen]

omit all codes from the column headed “Circumstances” and substitute:             
C5146 C5147 C5152 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5227 C5228 C5229 C5230 C5231 C5237 C5238 C5239 C5269 C5270 C5273 C5286 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5348 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5433

1. Schedule 1, entry for Somatropin in the form Solution for injection 20 mg (60 i.u.) in 2.5 mL cartridge (with preservative) [Brand: Saizen]

omit all codes from the column headed “Circumstances” and substitute:             
C5146 C5147 C5152 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5227 C5228 C5229 C5230 C5231 C5237 C5238 C5239 C5269 C5270 C5273 C5286 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5348 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5433

1. Schedule 1, entry for Tamoxifen

omit:

Tablet 20 mg (as citrate)	Oral	Nolvadex-D	AP	MP NP	C6421 C6449	P6421	30	5	30
a	Genox 20	AF	MP NP	C6381	60	5	60
a	GenRx Tamoxifen	GX	MP NP	C6381	60	5	60
a	Nolvadex-D	AP	MP NP	C6421 C6449	P6449	60	5	30
a	Tamosin	QA	MP NP	C6381	60	5	60
a	Tamoxifen Sandoz	SZ	MP NP	C6381	60	5	60

substitute:

Tablet 20 mg (as citrate)	Oral	a	Genox 20	AF	MP NP	C6381 C6421	P6421	30	5	30
a	Nolvadex-D	AP	MP NP	C6421 C6449	P6421	30	5	30
a	Genox 20	AF	MP NP	C6381 C6421	P6381	60	5	60
a	GenRx Tamoxifen	GX	MP NP	C6381	60	5	60
a	Nolvadex-D	AP	MP NP	C6421 C6449	P6449	60	5	30
a	Tamosin	QA	MP NP	C6381	60	5	60
a	Tamoxifen Sandoz	SZ	MP NP	C6381	60	5	60

1. Schedule 1, entry for Vancomycin in the form Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)

(a)omit:

Vancomycin Sandoz	SZ	MP	C5716 C5717 C5769	P5717	2	0	1
PDP	C5801	2	0	1

(b)omit:

Vancomycin Sandoz SZ MP C5716 C5717 C5769 P5716 P5769 5 0 1

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

(a)omit:

Vancomycin Sandoz	SZ	MP	C5716 C5717 C5769	P5717	1	0	1
PDP	C5801	1	0	1

(b)omit:

Vancomycin Sandoz SZ MP C5716 C5717 C5769 P5716 P5769 3 0 1

1. Schedule 1, after entry for Vedolizumab

insert:

Vemurafenib	Tablet 240 mg	Oral	Zelboraf	RO	MP	C6804 C6831	P6831	224	3	56
MP	C6804 C6831	P6804	224	5	56

1. Schedule 1, after entry for Vinorelbine in the form Solution for I.V. infusion 50 mg (as tartrate) in 5 mL [Brand: Vinorelbine Ebewe]

insert:

Vismodegib Capsule 150 mg Oral Erivedge RO MP C6802 C6810 C6820 28 2 28

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

insert:

GV Amgen Australia Pty Limited  31 051 057 428

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

insert:

HQ Generic Health Pty Ltd  93 110 617 859

1. Schedule 4, Part 1, entry for Abatacept

omit:

C5448	P5448	Severe active rheumatoid arthritis Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months) Patient must have a documented history of severe active rheumatoid arthritis; AND Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND Patient must not receive more than 16 weeks of treatment under this restriction; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib. The authority application must be made in writing and must include: (a) completed authority prescription forms; and (b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. Applications for a patient who has received PBS-subsidised treatment with this drugt and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment, within the timeframes specified below. Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the pre-filled syringes, with a maximum quantity of 4 and up to 3 repeats. Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased. Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to a treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).	Compliance with Written Authority Required procedures
C5495	P5495	Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) Patient must have severe active rheumatoid arthritis; AND Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND Patient must not have failed previous PBS-subsidised treatment with this drug for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND Patient must not receive more than 16 weeks of treatment under this restriction; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib. If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application. The authority application must be made in writing and must include: (1) completed authority prescription forms; and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and (3) a signed patient acknowledgement. Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the pre-filled syringes, with a maximum quantity of 4 and up to 3 repeats. Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats. Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased. Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response.	Compliance with Written Authority Required procedures
C5503	P5503	Severe active rheumatoid arthritis Continuing treatment Patient must have a documented history of severe active rheumatoid arthritis; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Written Authority Required procedures

substitute

C6805	P6805	Severe active rheumatoid arthritis Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months). Patient must have a documented history of severe active rheumatoid arthritis; AND Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND Patient must not receive more than 16 weeks of treatment under this restriction; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib. The authority application must be made in writing and must include: (a) completed authority prescription forms; and (b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. Applications for a patient who has received PBS-subsidised treatment with this drugt and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment, within the timeframes specified below. Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats. Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased. Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to a treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).	Compliance with Written Authority Required procedures
C6827	P6827	Severe active rheumatoid arthritis Continuing treatment Patient must have a documented history of severe active rheumatoid arthritis; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Written Authority Required procedures
C6835	P6835	Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) Patient must have severe active rheumatoid arthritis; AND Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND Patient must not have failed previous PBS-subsidised treatment with this drug for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND Patient must not receive more than 16 weeks of treatment under this restriction; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib. If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application. The authority application must be made in writing and must include: (1) completed authority prescription forms; and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and (3) a signed patient acknowledgement. Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats. Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats. Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased. Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response.	Compliance with Written Authority Required procedures

1. Schedule 4, Part 1, entry for Amoxycillin

insert in the column headed “Conditions Code” (Purposes Code P5863):            CN5863

1. Schedule 4, Part 1, entry for Apomorphine

insert in numerical order after existing text:

C6813 Parkinson disease Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy. Compliance with Authority Required procedures - Streamlined Authority Code 6813

1. Schedule 4, Part 1, entry for Brentuximab vedotin

insert in numerical order after existing text:

C6800	P6800	Relapsed or Refractory Hodgkin lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND Patient must not receive more than 12 cycles of treatment under this restriction. Authority applications for continuing treatment may be made by telephone to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) The treatment must not exceed a total of 16 cycles in a lifetime	Compliance with Authority Required procedures
C6816	P6816	Relapsed or Refractory Hodgkin lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND Patient must not receive more than 12 cycles of treatment under this restriction. Authority applications for continuing treatment may be made by telephone to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) The treatment must not exceed a total of 16 cycles in a lifetime	Compliance with Authority Required procedures
C6826	P6826	Relapsed or Refractory Hodgkin lymphoma Initial treatment Patient must have undergone a primary autologous stem cell transplant (ASCT); AND Patient must have experienced a relapsed CD30+ Hodgkin lymphoma post ASCT; OR Patient must have experienced a refractory CD30+ Hodgkin lymphoma post ASCT; AND Patient must not receive more than 4 cycles of treatment under this restriction. Applications for authorisation of initial treatment must be in writing and must include: (a) a completed authority prescription form; (b) a completed Hodgkin lymphoma brentuximab PBS Authority Application; and (c) a signed patient acknowledgement.	Compliance with Written Authority Required procedures
C6838	P6838	Relapsed or Refractory Hodgkin lymphoma Initial treatment Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND Patient must not be suitable for ASCT for this condition; OR Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND Patient must have experienced a relapsed CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; OR Patient must have experienced a refractory CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; AND Patient must not receive more than 4 cycles of treatment under this restriction. Applications for authorisation of initial treatment must be in writing and must include: (a) a completed authority prescription form; (b) a completed Hodgkin lymphoma brentuximab PBS Authority Application; and (c) a signed patient acknowledgement.	Compliance with Written Authority Required procedures

1. Schedule 4, Part 1, entry for Calcipotriol with betamethasone

insert in numerical order after existing text:

C6809

Chronic stable plaque type psoriasis vulgaris

The condition must be inadequately controlled by potent topical corticosteroid monotherapy.

1. Schedule 4, Part 1, entry for Ceritinib

omit:

C6799 Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be as monotherapy; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have progressive disease. Compliance with Authority Required procedures

substitute:

C6824 Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be as monotherapy; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease. Compliance with Authority Required procedures

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

insert:

Cobimetinib	C6803	P6803	Unresectable Stage III or Stage IV malignant melanoma Continuing treatment Patient must have previously been issued with an authority prescription for this drug; AND Patient must be receiving PBS-subsidised vemurafenib concomitantly for this condition; AND Patient must have stable or responding disease.	Compliance with Authority Required procedures - Streamlined Authority Code 6803
C6839	P6839	Unresectable Stage III or Stage IV malignant melanoma Initial treatment Patient must be receiving PBS subsidised vemurafenib concomitantly for this condition; AND Patient must not have progressive disease when treated with a BRAF inhibitor.	Compliance with Authority Required procedures - Streamlined Authority Code 6839

1. Schedule 4, Part 1, entry for Etanercept

insert in numerical order after existing text:

C6807	P6807	Severe chronic plaque psoriasis Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply Patient must have received insufficient therapy with this drug under the Continuing treatment, Whole body restriction to complete 24 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND The treatment must be as systemic monotherapy (other than methotrexate). Must be treated by a dermatologist.	Compliance with Authority Required procedures
C6808	P6808	Severe chronic plaque psoriasis Initial treatment – Initial 1, Whole body (new patient (no prior biological agent) or patient recommencing treatment after a break of 5 years or more) Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received any prior PBS-subsidised treatment with a biological agent for this condition; OR Patient must not have received PBS-subsidised treatment with a biological agent for at least 5 years, if they have previously received PBS-subsidised treatment with a biological agent for this condition and wish to commence a new Treatment Cycle; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND Patient must have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment (whole body); AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab. Where treatment with methotrexate, cyclosporin or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application: (a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment. (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 1 month old at the time of application. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and (iii) the signed patient and prescriber acknowledgements.	Compliance with Written Authority Required procedures
C6811	P6811	Severe chronic plaque psoriasis Initial treatment or Re-treatment (Whole body) - completion of course The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have received 16 weeks treatment under the Initial treatment (whole body) restriction for severe chronic plaque psoriasis; OR Patient must have received 16 weeks treatment under the Re-treatment (whole body) restriction for severe chronic plaque psoriasis; AND Patient must have demonstrated an adequate response to treatment; AND Patient must not receive more than 8 weeks of treatment with etanercept under this restriction. Must be treated by a dermatologist. An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, when compared with the pre-etanercept treatment baseline value. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of assessment of the patient's condition. The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment. A PASI assessment of the patient's response to the initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept.	Compliance with Written Authority Required procedures
C6814	P6814	Severe chronic plaque psoriasis Initial treatment or Re-treatment (Face, hand, foot) - completion of course The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have received 16 weeks treatment under the Initial treatment (Face, hand, foot) restriction for severe chronic plaque psoriasis; OR Patient must have received 16 weeks treatment under the Re-treatment (Face, hand, foot) restriction for severe chronic plaque psoriasis; AND Patient must have demonstrated an adequate response to treatment; AND Patient must not receive more than 8 weeks of treatment with etanercept under this restriction. Must be treated by a dermatologist. An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of assessment of the patient's condition. The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment. A PASI assessment of the patient's response to the initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept.	Compliance with Written Authority Required procedures
C6818	P6818	Severe chronic plaque psoriasis Initial treatment (whole body) The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have lesions present for at least 6 months from the time of initial diagnosis; AND Patient must not have received any prior PBS-subsidised treatment with etanercept for this condition; OR Patient must not have received any PBS-subsidised treatment with etanercept for this condition for at least 12 months; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; and/or (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND Patient must not receive more than 16 weeks of treatment with etanercept under this restriction. Patient must be under 18 years of age and a parent or authorised guardian must have signed a patient acknowledgement. Must be treated by a dermatologist. Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application. Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in 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 in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and (iii) the parent or authorised guardian signed patient and prescriber acknowledgements. Where a patient has had a 12 month treatment break, the length of the break is measured from the date the most recent treatment was stopped to the date of the application to re-commence treatment.	Compliance with Written Authority Required procedures
C6819	P6819	Severe chronic plaque psoriasis Initial treatment (Face, hand, foot) The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have the plaque or plaques of the face, or palm of hand or sole of foot present for at least 6 months from the time of initial diagnosis; AND Patient must not have received any prior PBS-subsidised treatment with etanercept for this condition; OR Patient must not have received any PBS-subsidised treatment with etanercept for this condition for at least 12 months; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; and/or (iii)acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND Patient must not receive more than 16 weeks of treatment with etanercept under this restriction. Patient must be under 18 years of age and a parent or authorised guardian must have signed a patient acknowledgement. Must be treated by a dermatologist. Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application. Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in 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 in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and face, hand, foot area diagrams including the dates of assessment of the patient's condition (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and (iii) the parent or authorised guardian signed patient and prescriber acknowledgements. Where a patient has had a 12 month treatment break, the length of the break is measured from the date the most recent treatment was stopped to the date of the application to re-commence treatment.	Compliance with Written Authority Required procedures
C6821	P6821	Severe chronic plaque psoriasis Initial 1, Whole body or Face, hand, foot (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break of less than 5 years) - balance of supply Patient must have received insufficient therapy with this drug under the Initial 1, Whole body (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 2, Whole body (change or recommencement of treatment after a break of less than 5 years ) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 1, Face, hand, foot (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break of less than 5 years) restriction to complete 16 weeks treatment; AND The treatment must be as systemic monotherapy (other than methotrexate); AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. Must be treated by a dermatologist.	Compliance with Authority Required procedures
C6822	P6822	Severe chronic plaque psoriasis Initial treatment or Re-treatment (Whole body) - balance of first supply The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have received insufficient therapy under the Initial treatment (whole body) restriction for severe chronic plaque psoriasis to complete 16 weeks treatment; OR Patient must have received insufficient therapy under the Re-treatment (whole body) restriction for severe chronic plaque psoriasis to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. Must be treated by a dermatologist.	Compliance with Authority Required procedures
C6823	P6823	Severe chronic plaque psoriasis Initial treatment of Re-treatment (Face, hand, foot) - balance of first supply The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have received insufficient therapy under the Initial treatment (Face, hand, foot) restriction for severe chronic plaque psoriasis to complete 16 weeks treatment; OR Patient must have received insufficient therapy under the Re-treatment (Face, hand, foot) restriction for severe chronic plaque psoriasis to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. Must be treated by a dermatologist.	Compliance with Authority Required procedures
C6830	P6830	Severe chronic plaque psoriasis Re-treatment (Face, hand, foot) The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND 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 etanercept for this condition in the past 12 months; AND Patient must have demonstrated a response to etanercept and experienced a disease flare; OR Patient must not have failed more than once to achieve an adequate response with etanercept; AND Patient must not receive more than 16 weeks of treatment with etanercept under this restriction. Patient must be under 18 years of age. Must be treated by a dermatologist. A patient is eligible for re-treatment due to disease flare if: (i) all subscores are rated moderate to severe or 2 of the 3 subscores are rated severe to very severe; or (ii) the skin area affected is a 50% or greater change or the area affected is 30% or more of the face, palm of a hand or sole of a foot, compared to the most recent response assessment following cessation of the most recent 24 weeks of PBS-subsidised etanercept. The authority application must be made in writing and must include : (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information which includes the following: (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area digrams including the dates of assessment of the patient's condition; and (ii) details of prior etanercept treatment, including date ceased. Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment.	Compliance with Written Authority Required procedures
C6833	P6833	Severe active rheumatoid arthritis Continuing treatment Patient must have a documented history of severe active rheumatoid arthritis; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Written Authority Required procedures
C6834	P6834	Severe chronic plaque psoriasis Initial treatment – Initial 2, Whole body (change or recommencement of treatment after a break of less than 5 years) Patient must have a documented history of severe chronic plaque psoriasis; AND Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents for this condition within this Treatment Cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised therapy with this drug for the treatment of this condition in the current Treatment Cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. Applications for patients who have demonstrated a response to PBS-subsidised treatment with this drug within this Treatment Cycle and who wish to recommence treatment with this drug within the same Cycle following a break in therapy, will only be approved where evidence of the patient's response to their most recent course of PBS-subsidised treatment with this drug has been submitted within 1 month of cessation of treatment. An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the prebiological treatment baseline value for this Treatment Cycle.	Compliance with Written Authority Required procedures
C6836	P6836	Severe chronic plaque psoriasis Initial treatment – Initial 1, Face, hand, foot (new patient (no prior biological agent) or patient recommencing treatment after a break of 5 years or more) Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received any prior PBS-subsidised treatment with a biological agent for this condition; OR Patient must not have received PBS-subsidised treatment with a biological agent for at least 5 years, if they have previously received PBS-subsidised treatment with a biological agent for this condition and wish to commence a new Treatment Cycle; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND Patient must have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment (face, hand, foot); AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab. Where treatment with methotrexate, cyclosporin or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application: (a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 1 month old at the time of application. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and (iii) the signed patient and prescriber acknowledgements.	Compliance with Written Authority Required procedures
C6837	P6837	Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) Patient must have severe active rheumatoid arthritis; AND Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND Patient must not have failed previous PBS-subsidised treatment with this drug for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib. If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and (3) a signed patient acknowledgement. Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased. Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response.	Compliance with Written Authority Required procedures
C6840	P6840	Severe chronic plaque psoriasis Continuing treatment, Face, hand, foot Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab. An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value. All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course. Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition. The most recent PASI assessment must be no more than 1 month old at the time of application. Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug. The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.

C6841	P6841	Severe chronic plaque psoriasis Initial treatment – Initial 2, Face, hand, foot (change or recommencement of treatment after a break of less than 5 years) Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents for this condition within this Treatment Cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised therapy with this drug for the treatment of this condition in the current Treatment Cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. Applications for patients who have demonstrated a response to PBS-subsidised treatment with this drug within this Treatment Cycle and who wish to recommence treatment with this drug within the same Cycle following a break in therapy, will only be approved where evidence of the patient's response to their most recent course of PBS-subsidised treatment with this drug has been submitted within 1 month of cessation of treatment. An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value.	Compliance with Written Authority Required procedures
C6842	P6842	Severe chronic plaque psoriasis Continuing treatment, Whole body Patient must have a documented history of severe chronic plaque psoriasis; AND Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab. An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the prebiological treatment baseline value for this Treatment Cycle. All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course. Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition. The most recent PASI assessment must be no more than 1 month old at the time of application. Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.	Compliance with Written Authority Required procedures
C6843	P6843	Severe chronic plaque psoriasis Re-treatment (Whole body) The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have a documented history of severe chronic plaque psoriasis of the whole body; AND Patient must have received prior PBS-subsidised treatment with etanercept for this condition in the past 12 months; AND Patient must have demonstrated a response to etanercept and experienced a disease flare; OR Patient must not have failed more than once to achieve an adequate response with etanercept; AND Patient must not receive more than 16 weeks of treatment with etanercept under this restriction. Patient must be under 18 years of age. Must be treated by a dermatologist. A patient is eligible for re-treatment due to disease flare if there is a 50% or greater change in the patients PASI score or the patient has a current PASI score of greater than 15, compared to the most recent response assessment following cessation of the most recent 24 weeks of PBS-subsidised etanercept. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information which includes the following: (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of prior etanercept treatment, including date ceased. Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment.	Compliance with Written Authority Required procedures
C6844	P6844	Severe active rheumatoid arthritis Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months) Patient must have a documented history of severe active rheumatoid arthritis; AND Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased. Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to a treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).	Compliance with Written Authority Required procedures

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

insert:

Ferrous fumarate	C6812	For treatment of a patient identifying as Aboriginal or Torres Strait Islander
Ferrous fumarate with folic acid	C6812	For treatment of a patient identifying as Aboriginal or Torres Strait Islander

1. Schedule 4, Part 1, after entry for Glycomacropeptide and essential amino acids with vitamins and minerals

insert:

Glycomacropeptide formula with long chain polyunsaturated fatty acids and docosahexaenoic acid and low in phenylalanine C4295 Phenylketonuria

1. Schedule 4, Part 1, entry for Paliperidone

insert in numerical order after existing text:

C6832 Schizophrenia Patient must have previously received and be stabilised on PBS-subsidised paliperidone once-monthly injection for at least 4 consecutive months. Compliance with Authority Required procedures - Streamlined Authority Code 6832

1. Schedule 4, Part 1, entry for Pembrolizumab

substitute:

Pembrolizumab	C6801	Unresectable Stage III or Stage IV malignant melanoma Continuing treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously been issued with an authority prescription for this drug for this condition; AND Patient must have stable or responding disease; AND The treatment must not exceed a maximum dose of 2 mg per kg every 3 weeks.	Compliance with Authority Required procedures - Streamlined Authority Code 6801
C6806	Unresectable Stage III or Stage IV malignant melanoma Initial treatment 1 The condition must be positive for a BRAF V600 mutation; AND The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) unless contraindicated or not tolerated according to the TGA approved Product Information; AND Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a total of 6 doses at a maximum dose of 2 mg per kg every 3 weeks. The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.	Compliance with Authority Required procedures - Streamlined Authority Code 6806
C6817	Unresectable Stage III or Stage IV malignant melanoma Initial treatment 2 The condition must be negative for a BRAF V600 mutation; AND Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a total of 6 doses at a maximum dose of 2 mg per kg every 3 weeks. The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.	Compliance with Authority Required procedures - Streamlined Authority Code 6817
C6828	Unresectable Stage III or Stage IV malignant melanoma Grandfathering treatment 2 The condition must be negative for a BRAF V600 mutation; AND Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 September 2015; AND Patient must not have received prior treatment with ipilimumab or any other PD-1 (programmed cell death-1) inhibitor for this condition; AND Patient must have stable or responding disease; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a maximum dose of 2 mg per kg every 3 weeks.	Compliance with Authority Required procedures - Streamlined Authority Code 6828
C6829	Unresectable Stage III or Stage IV malignant melanoma Grandfathering treatment 1 The condition must be positive for a BRAF V600 mutation; AND The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) unless contraindicated or not tolerated according to the TGA approved Product Information; AND Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 September 2015; AND Patient must not have received prior treatment with ipilimumab or any other PD-1 (programmed cell death-1) inhibitor for this condition; AND Patient must have stable or responding disease; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a maximum dose of 2 mg per kg every 3 weeks.	Compliance with Authority Required procedures - Streamlined Authority Code 6829

1. Schedule 4, Part 1, entry for Salbutamol

insert in numerical order after existing text:

C6815

Asthma

Patient must be unable to use this drug delivered from an oral pressurised inhalation device via a spacer.

C6825

Chronic obstructive pulmonary disease (COPD)

Patient must be unable to use this drug delivered from an oral pressurised inhalation device via a spacer.

1. Schedule 4, Part 1, entry for Tamoxifen

insert in the column headed “Purposes Code” (Circumstances Code C6381):     P6381

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

insert:

Vemurafenib	C6804	P6804	Unresectable Stage III or Stage IV malignant melanoma Continuing Patient must have previously been issued with an authority prescription for this drug; AND Patient must have stable or responding disease.	Compliance with Authority Required procedures - Streamlined Authority Code 6804
C6831	P6831	Unresectable Stage III or Stage IV malignant melanoma Initial treatment The condition must be positive for a BRAF V600 mutation; AND Patient must be receiving PBS subsidised cobimetinib concomitantly for this condition; AND The condition must not have been treated previously with PBS subsidised therapy; OR Patient must have developed intolerance to another BRAF inhibitor of a severity necessitating permanent treatment withdrawal; AND Patient must have a WHO performance status of 2 or less.	Compliance with Authority Required procedures - Streamlined Authority Code 6831

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

insert:

Vismodegib	C6802	Metastatic or locally advanced basal cell carcinoma Continuing treatment Patient must have previously received an authority prescription for this condition with this drug; AND The condition must not have progressed; AND The condition must remain inappropriate for surgery; AND The condition must remain inappropriate for curative radiotherapy; AND Patient must not receive more than 16 weeks of treatment per continuing treatment under this restriction. The authority application must be made in writing and must include: a) A completed authority prescription form; and b) a completed Basal Cell Carcinoma Continuing PBS Authority Application Form - Supporting Information Form; and c) A letter from a surgically qualified clinician demonstrating inappropriateness for surgery; and d) A letter from a radiation oncologist demonstrating inappropriateness for curative radiotherapy; and e) A confirmation statement from the treating doctor that the disease has not progressed The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. It is recommended that an application is submitted to the Department of Human Services no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria. Inappropriate for surgery is defined as: i/ Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or ii/ Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or iii/ Medical contraindication to surgery Inappropriate for curative radiotherapy is defined as: i/ Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or ii/ Limitations due to location of tumour; or iii/ Limitations due to cumulative prior radiotherapy dose; or iv/ Progressive disease despite prior irradiation of locally advanced BCC	Compliance with Written Authority Required procedures
C6810	Metastatic or locally advanced basal cell carcinoma Initial treatment or Continuing treatment - balance of supply Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete maximum of 16 weeks of treatment; OR Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete maximum of 16 weeks of treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.	Compliance with Authority Required procedures
C6820	Metastatic or locally advanced basal cell carcinoma Initial treatment The condition must be inappropriate for surgery; AND The condition must be inappropriate for curative radiotherapy; AND Patient must not receive more than 16 weeks of treatment under this restriction. The authority application must be made in writing and must include: a) A completed authority prescription form; and b) a completed Basal Cell Carcinoma Initial PBS Authority Application Form - Supporting Information Form; and c) A histological confirmation of BCC; and d) A letter from a surgically qualified clinician demonstrating inappropriateness for surgery; and e) A letter from a radiation oncologist demonstrating inappropriateness for curative radiotherapy; and f) A signed patient acknowledgement. The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. It is recommended that an application is submitted to the Department of Human Services no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria. Inappropriate for surgery is defined as: i/ Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or ii/ Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or iii/ Medical contraindication to surgery Inappropriate for curative radiotherapy is defined as: i/Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or ii/ Limitations due to location of tumour; or iii/ Limitations due to cumulative prior radiotherapy dose; or iv/ Progressive disease despite prior irradiation of locally advanced BCC.	Compliance with Written Authority Required procedures

1. Schedule 5, entry for Imatinib

substitute:

Imatinib	GRP-21074	Capsule 100 mg (as mesilate)	Oral	Imatinib-APOTEX CIPLA IMATINIB ADULT Imatinib GH IMATINIB AN IMATINIB-DRLA
Tablet 100 mg (as mesilate)	Oral	Glivec IMATINIB RBX Imatinib-Teva
GRP-21076	Capsule 100 mg (as mesilate)	Oral	Imatinib-APOTEX Imatinib GH IMATINIB AN IMATINIB-DRLA
Tablet 100 mg (as mesilate)	Oral	Glivec IMATINIB RBX
GRP-21079	Capsule 400 mg (as mesilate)	Oral	Imatinib-APOTEX CIPLA IMATINIB ADULT Imatinib GH IMATINIB AN IMATINIB-DRLA
Tablet 400 mg (as mesilate)	Oral	Glivec IMATINIB RBX Imatinib-Teva
GRP-21080	Capsule 400 mg (as mesilate)	Oral	Imatinib-APOTEX Imatinib GH IMATINIB AN IMATINIB-DRLA
Tablet 400 mg (as mesilate)	Oral	Glivec IMATINIB RBX

1. Schedule 5, after entry for Rizatriptan

insert:

Salbutamol	GRP-21361	Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 20	Inhalation	Ventolin Nebules
Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30	Inhalation	Ventolin Nebules Asmol 5 uni-dose Butamol 5 APO-Salbutamol Salbutamol Sandoz Salbutamol Actavis