National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 12) (No. PB 88 of 2014) (Cth)

PB 88 of 2014

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 12)

National Health Act 1953

I, FELICITY McNEILL, First Assistant Secretary, 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 25 November 2014

FELICITY McNEILL

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

1 Name of Instrument

(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 12).

(2) This Instrument may also be cited as PB 88 of 2014.

2 Commencement

This Instrument commences on 1 December 2014.

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

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”: C3996 C3997 C3998 substitute: C4664 C4720 C4739 C4745 C4746

(b)omit from the column headed “Purposes”: P3996 P3997 substitute: P4664 P4745 P4746

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”: C3996 C3997 C3998 substitute: C4664 C4720 C4739 C4745 C4746

(b)omit from the column headed “Purposes”: P3998 substitute: P4720 C4739

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

(a)omit from the column headed “Circumstances”: C3706 C3745 C3746

(b)insert in numerical order: C4666 C4700 C4710 C4724 C4751

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

(a)omit from the column headed “Circumstances”: C3706 C3745 C3746

(b)insert in numerical order: C4666 C4700 C4710 C4724 C4751

(c)omit from the column headed “Purposes”: P3706 P3745

(d)insert in numerical order: P4700 P4710 P4751

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

(a)omit from the column headed “Circumstances”: C3706 C3745 C3746

(b)insert in numerical order: C4666 C4700 C4710 C4724 C4751

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

(a)omit from the column headed “Circumstances”: C3706 C3745 C3746

(b)insert in numerical order: C4666 C4700 C4710 C4724 C4751

(c)omit from the column headed “Purposes”: P3746

(d)insert in numerical order: P4666 P4724

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

(a)omit from the column headed “Circumstances”: C3706 C3745 C3746

(b)insert in numerical order: C4666 C4700 C4710 C4724 C4751

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

(a)omit from the column headed “Circumstances”: C3706 C3745 C3746

(b)insert in numerical order: C4666 C4700 C4710 C4724 C4751

(c)omit from the column headed “Purposes”: P3706 P3745

(d)insert in numerical order: P4700 P4710 C4751

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

(a)omit from the column headed “Circumstances”: C3706 C3745 C3746

(b)insert in numerical order: C4666 C4700 C4710 C4724 C4751

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

(a)omit from the column headed “Circumstances”: C3706 C3745 C3746

(b)insert in numerical order: C4666 C4700 C4710 C4724 C4751

(c)omit from the column headed “Purposes”: P3746

(d)insert in numerical order: P4666 P4724

Schedule 1, entry for Adefovir

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

APO-Adefovir

MP
See Note 1

C3971 C3972 C3973 C3974

D(100)

Schedule 1, entry for Ampicillin in the form Powder for injection 500 mg (as sodium)

omit from the column headed “Responsible Person” for the brand “Austrapen” (twice occurring): LN substitute: AL

Schedule 1, entry for Ampicillin in the form Powder for injection 1 g (as sodium) [Maximum Quantity: 5; Number of Repeats: 0]

(a)omit from the column headed “Responsible Person” for the brand “Aspen Ampicyn”: AS substitute: AF

(b)omit from the column headed “Responsible Person” for the brand “Austrapen”: LN substitute: AL

Schedule 1, entry for Ampicillin in the form Powder for injection 1 g (as sodium) [Maximum Quantity: 5; Number of Repeats: 1]

(a)omit from the column headed “Responsible Person” for the brand “Aspen Ampicyn”: AS substitute: AF

(b)omit from the column headed “Responsible Person” for the brand “Austrapen”: LN substitute: AL

Schedule 1, after entry for Botulinum Toxin Type A Purified Neurotoxin Complex

insert:

Brentuximab vedotin

Powder for I.V. infusion 50 mg

Injection

Adcetris

MP
See Note 1

C4675 C4719

See Note 3

See
Note 3

D(100)

Schedule 1, entry for Budesonide with eformoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2

(a)omit from the column headed “Circumstances”: C4416

(b)substitute: C4689

Schedule 1, entry for Budesonide with eformoterol in the form Pressurised inhalation containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses

(a)omit from the column headed “Circumstances”: C4327

(b)insert in numerical order: C4689

Schedule 1, entry for Cabergoline in the form Tablet 500 micrograms

omit:

Tinexa

C2659 C2660 C2661 C2662

P2659 P2660 P2661 P2662

Schedule 1, entry for Cabergoline in the form Tablet 1 mg

omit:

Bergoline 1

MP NP

C1255

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

omit:

Bergoline 2

MP NP

C1255

Schedule 1, entry for Carmellose in each of the forms: Mouth spray containing carmellose sodium 10 mg per mL, 25 mL; and Mouth spray containing carmellose sodium 10 mg per mL, 100 mL

omit from the column headed “Responsible Person”: VT substitute: IA

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

omit:

Rocephin

MP NP

C1169 C1846 C1847

Schedule 1, entry for Celecoxib

substitute:

Celecoxib	Capsule 100 mg	Oral	APO-Celecoxib	TX	MP NP	C1547 C1848	60	3	60
Blooms the Chemist Celecoxib	IB	MP NP	C1547 C1848	60	3	60
Celaxib	AF	MP NP	C1547 C1848	60	3	60
Celebrex	PF	MP NP	C1547 C1848	60	3	60
Celecoxib Actavis	GN	MP NP	C1547 C1848	60	3	60
Celecoxib AN	EA	MP NP	C1547 C1848	60	3	60
Celecoxib GH	GQ	MP NP	C1547 C1848	60	3	60
Celecoxib RBX	RA	MP NP	C1547 C1848	60	3	60
Celecoxib Sandoz	SZ	MP NP	C1547 C1848	60	3	60
Celexi	QA	MP NP	C1547 C1848	60	3	60
Chem mart Celecoxib	CH	MP NP	C1547 C1848	60	3	60
Kudeq	FZ	MP NP	C1547 C1848	60	3	60
Terry White Chemists Celecoxib	TW	MP NP	C1547 C1848	60	3	60
Capsule 200 mg	Oral	APO-Celecoxib	TX	MP NP	C1547 C1848	30	3	30
Blooms the Chemist Celecoxib	IB	MP NP	C1547 C1848	30	3	30
Celaxib	AF	MP NP	C1547 C1848	30	3	30
Celebrex	PF	MP NP	C1547 C1848	30	3	30
Celecoxib Actavis	GN	MP NP	C1547 C1848	30	3	30
Celecoxib AN	EA	MP NP	C1547 C1848	30	3	30
Celecoxib GH	GQ	MP NP	C1547 C1848	30	3	30
Celecoxib RBX	RA	MP NP	C1547 C1848	30	3	30
Celecoxib Sandoz	SZ	MP NP	C1547 C1848	30	3	30
Celexi	QA	MP NP	C1547 C1848	30	3	30
Chem mart Celecoxib	CH	MP NP	C1547 C1848	30	3	30
Kudeq	FZ	MP NP	C1547 C1848	30	3	30
Terry White Chemists Celecoxib	TW	MP NP	C1547 C1848	30	3	30

Schedule 1, entry for Certolizumab pegol

(a)omit from the column headed “Circumstances”: C3714 C3768 C3769

(b)insert in numerical order: C4696 C4697 C4737 C4763 C4764

Schedule 1, entry for Clindamycin

substitute:

Clindamycin	Capsule 150 mg (as hydrochloride)	Oral	APO-Clindamycin	TX	MP NP MW PDP	C1145	24	0	24
Chem mart Clindamycin	CH	MP NP MW PDP	C1145	24	0	24
Cleocin	FZ	MP NP MW PDP	C1145	24	0	24
Dalacin C	PF	MP NP MW PDP	C1145	24	0	24
Terry White Chemists Clindamycin	TW	MP NP MW PDP	C1145	24	0	24

Schedule 1, entry for Clopidogrel with aspirin

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

DuoPlidogrel

MP NP

C1722 C3219 C3880

Schedule 1, entry for Dapagliflozin

omit from the column headed “Circumstances”: C4331 substitute: C4736

Schedule 1, entry for Deferiprone in each of the forms: Tablet 500 mg; and Oral solution 100 mg per mL, 250 mL

omit from the column headed “Responsible Person”: OA substitute: TX

Schedule 1, entry for Dexamethasone in each of the forms: Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL; and Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL

omit from the column headed “Responsible Person” for the brand “Dexmethsone”: AS substitute: AF

Schedule 1, entry for Diazepam in the form Tablet 2 mg

(a)omit:

Valium	RO	MP NP PDP	50	0	50
MP NP	P3656	50 CN3656	0	50

(b)omit:

Valium

MP NP

P3655

50
CN3655

3
CN3655

Schedule 1, entry for Dipyridamole with Aspirin

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

APO-Dipyridamole/ Aspirin 200/25

MP NP

C1728

Schedule 1, entry for Dorzolamide with timolol

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

Dorzolamide/ Timolol Sandoz 20/5	SZ	MP	C4343	1	5	1
AO	C4326	1	5	1

Schedule 1, after entry for Doxycycline in the form Tablet 100 mg (as hydrochloride) [Maximum Quantity: 21; Number of Repeats: 0;
Pack Quantity: 7; Brand: Doxylin 100]

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

Doxycycline AN

MP NP

P4485

Schedule 1, after entry for Dutasteride with tamsulosin

insert:

Eculizumab

Solution concentrate for I.V. infusion 300 mg in 30 mL

Injection

Soliris

MP
See Note 1

See Note 3

See
Note 3

D(100)

Schedule 1, entry for Enalapril in the form Tablet containing enalapril maleate 5 mg

omit:

Renitec M

MP NP

Schedule 1, after entry for Entecavir in the form Tablet containing entecavir monohydrate 1 mg

insert:

Enzalutamide

Capsule 40 mg

Oral

Xtandi

C4670

112

Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)

omit from the column headed “Circumstances” for the brands “APO‑Escitalopram”; “Chem mart Escitalopram”; “Cilopam-S”; “Escicor 10”;
“Escitalopram AN”; “Escitalopram-DRLA”; “Escitalopram GA”; and “Escitalopram generichealth”: C1211 substitute: C4755

Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)

omit from the column headed “Circumstances” for the brand “Esipram”: C1211 C2964 C2965 C2966 C2967 C2968 C2969
substitute: C4690 C4703 C4755 C4756 C4757

Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)

omit from the column headed “Circumstances” for the brands “Esitalo”; and “Lexam 10”: C1211 substitute: C4755

Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)

omit from the column headed “Circumstances” for the brand “Lexapro”: C1211 C2964 C2965 C2966 C2967 C2968 C2969
substitute: C4690 C4703 C4755 C4756 C4757

Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)

omit from the column headed “Circumstances” for the brands “LoxaLate”; “Pharmacor Escitalopram 10”; and “Terry White Chemists Escitalopram”: C1211
substitute: C4755

Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)

omit from the column headed “Circumstances” for the brands “APO‑Escitalopram”; “Chem mart Escitalopram”; “Cilopam-S”; “Escicor 20”;
“Escitalopram AN”; “Escitalopram-DRLA”; “Escitalopram GA”; and “Escitalopram generichealth”: C1211 substitute: C4755

Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)

omit from the column headed “Circumstances” for the brand “Esipram”: C1211 C2964 C2965 C2966 C2967 C2968 C2969
substitute: C4690 C4703 C4755 C4756 C4757

Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)

omit from the column headed “Circumstances” for the brands “Esitalo”; and “Lexam 20”: C1211 substitute: C4755

Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)

omit from the column headed “Circumstances” for the brand “Lexapro”: C1211 C2964 C2965 C2966 C2967 C2968 C2969
substitute: C4690 C4703 C4755 C4756 C4757

Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)

omit from the column headed “Circumstances” for the brands “LoxaLate”; “Pharmacor Escitalopram 20”; and “Terry White Chemists Escitalopram”: C1211
substitute: C4755

Schedule 1, entry for Escitalopram in the form Oral solution 10 mg (as oxalate) per mL, 28 mL

omit from the column headed “Circumstances”: C1211 C2964 C2965 C2967 C2968 C3092 C3093
substitute: C4680 C4681 C4707 C4721 C4747

Schedule 1, after entry for Escitalopram in the form Oral solution 10 mg (as oxalate) per mL, 28 mL

insert in the columns in the order indicated:

Oral solution 20 mg (as oxalate) per mL, 15 mL

Oral

Lexapro

MP NP

C4680 C4681 C4707 C4721 C4747

Schedule 1, entry for Fluticasone with Salmeterol in each of the forms: Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation); and Powder for oral inhalation
in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose,
60 doses

(a)omit from the column headed “Circumstances”: C4372

(b)insert in numerical order: C4689

Schedule 1, after entry for Fluticasone with Salmeterol in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

insert:

Fluticasone with vilanterol	Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses	Inhalation by mouth	Breo Ellipta 100/25	GK	MP NP	C4689 C4711	1	5	1
Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses	Inhalation by mouth	Breo Ellipta 200/25	GK	MP NP	C4731	1	5	1

Schedule 1, entry for Galantamine in each of the forms: Capsule (prolonged release) 8 mg (as hydrobromide); Capsule (prolonged release) 16 mg (as hydrobromide); and Capsule (prolonged release) 24 mg (as hydrobromide)

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

Galantamine AN SR

MP NP

C4219 C4220 C4224

Schedule 1, entry for Gliclazide in the form Tablet 60 mg (modified release)

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

ARDIX GLICLAZIDE 60mg MR

MP NP

Schedule 1, after entry for Glyceryl Trinitrate in the form Transdermal patch 120 mg

insert:

Glycine with carbohydrate

Sachets of oral powder 4 g containing 500 mg glycine, 30 (Glycine500)

Oral

Glycine500

MP NP

C4704

Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1;
Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C3718 C3782 C3783

(b)insert in numerical order: C4676 C4702 C4744 C4754 C4766

(c)omit from the column headed “Purposes”: P3718 P3782

(d)insert in numerical order: P4702 P4754 P4766

Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1;
Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C3718 C3782 C3783

(b)insert in numerical order: C4676 C4702 C4744 C4754 C4766

(c)omit from the column headed “Purposes”: P3783

(d)insert in numerical order: P4676 P4744

Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1;
Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C3718 C3782 C3783

(b)insert in numerical order: C4676 C4702 C4744 C4754 C4766

(c)omit from the column headed “Purposes”: P3718 P3782

(d)insert in numerical order: P4702 P4754 P4766

Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1;
Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C3718 C3782 C3783

(b)insert in numerical order: C4676 C4702 C4744 C4754 C4766

(c)omit from the column headed “Purposes”: P3783

(d)insert in numerical order: P4676 P4744

Schedule 1, entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate

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

Oral liquid 200 mL, 32 (KetoCal 4:1 LQ)

Oral

KetoCal 4:1 LQ

MP NP

C4709

Schedule 1, entry for Hypromellose in the form Oral gel 20 mg per g, 100 g

omit from the column headed “Responsible Person”: VT substitute: IA

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

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

Tenaxil SR

MP NP

Schedule 1, after entry for Ivabradine in the form Tablet 7.5 mg (as hydrochloride)

insert:

Ivacaftor

Tablet 150 mg

Oral

Kalydeco

MP
See Note 1

See Note 3

See
Note 3

D(100)

Schedule 1, entry for Leflunomide in the form Tablet 10 mg

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

Leflunomide AN

C2644

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

Leflunomide Sandoz

C2644 C2682

Schedule 1, entry for Leflunomide in the form Tablet 20 mg

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

Leflunomide AN

C2644

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

Leflunomide Sandoz

C2644 C2682

Schedule 1, entry for Methylprednisolone in the form Powder for injection 40 mg (as sodium succinate)

omit from the column headed “Responsible Person”: AS substitute: AL

Schedule 1, entry for Methylprednisolone in the form Powder for injection 1 g (as sodium succinate)

omit from the column headed “Responsible Person” for the brand “Methylpred”: AS substitute: AL

Schedule 1, entry for Metoclopramide in each of the forms: Tablet containing metoclopramide hydrochloride 10 mg; and Injection containing metoclopramide hydrochloride 10 mg in 2 mL

omit from the column headed “Responsible Person” for the brand “Maxolon”: VT substitute: IA

Schedule 1, after entry for Miconazole in the form Tincture 20 mg per mL, 30 mL

insert:

Midazolam

Injection 5 mg (as hydrochloride) in
1 mL

Injection

Pfizer Australia Pty Ltd

See Note 4

D(MP NP)

Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 10 mg (controlled release)

(a)omit:

APOTEX-
MORPHINE MR

MP NP

C1062

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

MORPHINE MR APOTEX

MP NP

C1062

Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 30 mg (controlled release)

(a)omit:

APOTEX-
MORPHINE MR

MP NP

C1062

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

MORPHINE MR APOTEX

MP NP

C1062

Schedule 1, entry for Nitrazepam in the form Tablet 5 mg

omit from the column headed “Responsible Person” for the brand “Mogadon” (all instances): VT substitute: IA

Schedule 1, entry for Olsalazine in each of the forms: Capsule containing olsalazine sodium 250 mg; and Tablet containing olsalazine sodium 500 mg

omit from the column headed “Responsible Person”: UC substitute: IX

Schedule 1, entry for Omalizumab

omit:

Powder for injection 150 mg with diluent

Injection

Xolair

MP
See Note 1

See Note 3

See
Note 3

D(100)

Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 10 mg (controlled release)

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

Oxycodone Sandoz

MP NP

C4583

(b)omit from the column headed “Circumstances” for the brand “OxyContin”: C1062 substitute: C4583

Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 15 mg (controlled release)

omit from the column headed “Circumstances”: C1062 substitute: C4583

Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 20 mg (controlled release)

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

Oxycodone Sandoz

MP NP

C4583

(b)omit from the column headed “Circumstances” for the brand “OxyContin”: C1062 substitute: C4583

Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 30 mg (controlled release)

omit from the column headed “Circumstances”: C1062 substitute: C4583

Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 40 mg (controlled release)

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

Oxycodone Sandoz

MP NP

C4583

(b)omit from the column headed “Circumstances” for the brand “OxyContin”: C1062 substitute: C4583

Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 80 mg (controlled release)

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

Oxycodone Sandoz

MP NP

C4583

(b)omit from the column headed “Circumstances” for the brand “OxyContin”: C1062 substitute: C4583

Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 100; Number of Repeats: 0]

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

Parapane

PDP

100

Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 100; Number of Repeats: 1]

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

Parapane

MP NP

100

Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 300; Number of Repeats: 0]

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

Parapane

PDP

P2046

300

100

Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 300; Number of Repeats: 4]

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

Parapane

MP NP

P2046

300

100

Schedule 1, entry for Paracetamol

omit:

Tablet 665 mg (modified release)	Oral	Panadol Osteo	GC	MP NP	C2094 C3649 C3650	P3650	192	0	96
MP NP	C2094 C3649 C3650	P3649	192	3	96
MP NP	C2094 C3649 C3650	P2094	192	5	96

substitute:

Tablet 665 mg (modified release)	Oral	Osteomol 665 Paracetamol	CR	MP NP	C2094 C3649 C3650	P3650	192	0	96
Panadol Osteo	GC	MP NP	C2094 C3649 C3650	P3650	192	0	96
Osteomol 665 Paracetamol	CR	MP NP	C2094 C3649 C3650	P3649	192	3	96
Panadol Osteo	GC	MP NP	C2094 C3649 C3650	P3649	192	3	96
Osteomol 665 Paracetamol	CR	MP NP	C2094 C3649 C3650	P2094	192	5	96
Panadol Osteo	GC	MP NP	C2094 C3649 C3650	P2094	192	5	96

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

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

Perindopril CH

MP NP

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

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

Perindopril CH

MP NP

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

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

Perindopril and Indapamide CH 4/1.25

MP NP

C4375

Schedule 1, entry for Phenoxymethylpenicillin in the form Capsule 250 mg phenoxymethylpenicillin (as potassium)

omit from the column headed “Responsible Person” for the brand “LPV” (twice occurring): VT substitute: IA

Schedule 1, entry for Phenoxymethylpenicillin in the form Capsule 500 mg phenoxymethylpenicillin (as potassium)

omit from the column headed “Responsible Person” for the brand “LPV”: VT substitute: IA

Schedule 1, entry for Pioglitazone in each of the forms: Tablet 15 mg (as hydrochloride); Tablet 30 mg (as hydrochloride); and
Tablet 45 mg (as hydrochloride)

omit from the column headed “Responsible Person” for the brand “Actos”: LY substitute: TK

Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 125 micrograms [Maximum Quantity: 30; Number of Repeats: 0]

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

Simpral

MP NP

C3216

Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 250 micrograms [Maximum Quantity: 100; Number of Repeats: 5]

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

Simpral

MP NP

C3216

100

Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 1 mg

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

Simpral

MP NP

C3216

100

Schedule 1, entry for Prednisolone in each of the forms: Tablet 5 mg; and Tablet 25 mg

omit from the column headed “Responsible Person” for the brand “Solone”: VT substitute: IA

Schedule 1, entry for Prednisone in each of the forms: Tablet 5 mg; and Tablet 25 mg

omit from the column headed “Responsible Person” for the brand “Sone”: VT substitute: IA

Schedule 1, entry for Pyridostigmine in each of the forms: Tablet containing pyridostigmine bromide 10 mg; Tablet containing pyridostigmine bromide 60 mg; and Tablet containing pyridostigmine bromide 180 mg (modified release)

omit from the column headed “Responsible Person”: VT substitute: IA

Schedule 1, entry for Raloxifene

substitute:

Raloxifene	Tablet containing raloxifene hydrochloride 60 mg	Oral	APO-Raloxifene	TX	MP NP	C4071	28	5	28
Chem mart Raloxifene	CH	MP NP	C4071	28	5	28
Evifyne	EL	MP NP	C4071	28	5	28
Evista	LY	MP NP	C4071	28	5	28
Raloxifene AN	EA	MP NP	C4071	28	5	28
Terry White Chemists Raloxifene	TW	MP NP	C4071	28	5	28

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

omit:

Prilace 1.25

MP NP

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

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

Ramipril RBX Tabs

MP NP

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

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

Ramipril RBX Tabs

MP NP

Schedule 1, entry for Ramipril in the form Tablet 10 mg

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

Ramipril RBX Tabs

MP NP

Schedule 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)

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

Ranitidine AN

MP NP MW

Schedule 1, entry for Rituximab in each of the forms: Solution for I.V. infusion 100 mg in 10 mL; and Solution for I.V. infusion
500 mg in 50 mL

omit from the column headed “Circumstances”: C1744 C1745 C2068 C2386 C3908 C3909 C3912 C3915 C3931 C3932
substitute: C4671 C4674 C4677 C4678 C4679 C4686 C4687 C4701 C4706 C4726 C4727 C4728 C4752 C4765

Schedule 1, after entry for Silver sulfadiazine

insert:

Simeprevir

Capsule 150 mg (as sodium)

Oral

Olysio

MP
See Note 1

C4669 C4684 C4758 C4759

D(100)

Schedule 1, entry for Simvastatin in the form Tablet 5 mg

(a)omit:

Zocor	MK	MP	C1540 C3047	P1540	30	5	30
NP	C1540	30	5	30

(b)omit:

Zocor

C1540 C3047

P3047

Schedule 1, entry for Telmisartan with Hydrochlorothiazide in the form Tablet 40 mg-12.5 mg

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

Telmisartan HCT GH 40/12.5

MP NP

C4374

Schedule 1, entry for Telmisartan with Hydrochlorothiazide in the form Tablet 80 mg-12.5 mg

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

Telmisartan HCT GH 80/12.5

MP NP

C4374

Schedule 1, entry for Telmisartan with Hydrochlorothiazide in the form Tablet 80 mg-25 mg

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

Telmisartan HCT GH 80/25

MP NP

C4374

Schedule 1, entry for Triglycerides, long chain with glucose polymer

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

Oral liquid 200 mL, 27 (Sno-Pro)

Oral

Sno-Pro

MP NP

C4438

Schedule 1, after entry for Tyrosine with carbohydrate

insert:

Umeclidinium	Powder for oral inhalation in breath actuated device 62.5 micrograms (as bromide) per dose, 30 doses	Inhalation by mouth	Incruse Ellipta	GK	MP NP	C4516	1	5	1
Umeclidinium with vilanterol	Powder for oral inhalation in breath actuated device containing umeclidinium 62.5 micrograms (as bromide) with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses	Inhalation by mouth	Anoro Ellipta 62.5/25	GK	MP NP	C4655	1	5	1

Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 160 mg-12.5 mg

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

APO-Valsartan HCTZ 160/12.5

MP NP

C4374

Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 320 mg-12.5 mg

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

APO-Valsartan HCTZ 320/12.5

MP NP

C4361

Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 320 mg-25 mg

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

APO-Valsartan HCTZ 320/25

MP NP

C4361

Schedule 1, entry for Voriconazole

substitute:

Voriconazole	Tablet 50 mg	Oral	Vfend	PF	MP NP	C4665 C4682 C4683 C4685 C4748	P4685	56	0	56
C4665 C4682 C4683 C4685 C4748	P4665 P4682 P4683 P4748	56	2	56
Tablet 200 mg	Oral	Vfend	PF	MP NP	C4665 C4682 C4683 C4685 C4748	P4685	56	0	56
C4665 C4682 C4683 C4685 C4748	P4665 P4682 P4683 P4748	56	2	56
Powder for oral suspension 40 mg per mL, 70 mL	Oral	Vfend	PF	MP NP	C4685 C4699 C4722 C4723 C4749	1	0	1

Schedule 3, after details relevant to Responsible Person code LB

insert:

Astellas Pharma Australia Pty Ltd

81 147 915 482

Schedule 3, after details relevant to Responsible Person code VP

insert:

Vertex Pharmaceuticals (Australia) Pty Ltd

34 160 157 157

Schedule 3

omit:

Valeant Pharmaceuticals Australasia Pty Limited

64 001 083 352

Schedule 3, after details relevant to Responsible Person code XH

insert:

Alexion Pharmaceuticals Australasia Pty Ltd

59 132 343 036

Schedule 4, Part 1, entry for Abatacept

substitute:

Abatacept	C4664	P4664	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 or tocilizumab 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
C4720	P4720	Severe active rheumatoid arthritis Continuing Treatment – balance of supply Patient must have received insufficient therapy with this drug under the Continuing treatment 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 restriction Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis	Compliance with Written or Telephone Authority Required procedures
C4739	P4739	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 or tocilizumab 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
C4745	P4745	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 or tocilizumab 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
C4746	P4746	Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis	Compliance with Written or Telephone Authority Required procedures

Schedule 4, Part 1, entry for Abiraterone

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

Patient must have failed treatment with docetaxel due to resistance or intolerance; AND

substitute:

Patient must have failed treatment with docetaxel due to resistance or intolerance; OR
Patient must be unsuitable for docetaxel treatment on the basis of predicted intolerance to docetaxel; AND

(b)insert in the column headed “Circumstances and Purposes” following existing text:

; AND
Patient must not have received prior treatment with enzalutamide; OR
Patient must have developed intolerance to enzalutamide of a severity necessitating permanent treatment withdrawal

Schedule 4, Part 1, entry for Adalimumab

(a)omit:

C3706	P3706	Rheumatoid arthritis — initial treatment 1 (new patient or patient recommencing after a break of more than 24 months) Initial PBS‑subsidised treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: (a) have severe active rheumatoid arthritis; and (b) have received no PBS‑subsidised treatment with a biological disease modifying anti‑rheumatic drug (bDMARD) for this condition in the previous 24 months; and (c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs), which must include: (i) 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: — hydroxychloroquine at a dose of at least 200 mg daily; or — leflunomide at a dose of at least 10 mg daily; or — sulfasalazine at a dose of at least 2 g daily; or (ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs: — hydroxychloroquine at a dose of at least 200 mg daily; and/or — leflunomide at a dose of at least 10 mg daily; and/or — sulfasalazine at a dose of at least 2 g daily; or (iii) 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 — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: — azathioprine at a dose of at least 1 mg/kg per day; and/or — cyclosporin at a dose of at least 2 mg/kg/day; and/or — sodium aurothiomalate at a dose of 50 mg weekly; and where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and where the following conditions apply: if methotrexate is contraindicated according to the TGA‑approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable; the authority application includes 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, the authority application provides details of the contraindication or intolerance and dose for each DMARD; failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following: (a) 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 (b) either: (i) a total active joint count of at least 20 active (swollen and tender) joints; or (ii) at least 4 active joints from the following list of major joints: — elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or — shoulder and/or hip (assessed as active if there is 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 are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are 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 authority application states the reason this criterion cannot be satisfied; the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form and a signed patient acknowledgement; a patient is eligible for treatment if they have not failed previous PBS‑subsidised treatment with adalimumab for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS‑subsidised bDMARD treatment for this condition 5 times; a course of initial treatment is limited to a maximum of 16 weeks of treatment	Compliance with Written Authority Required procedures
Continuation of a course of initial treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total	Compliance with Written or Telephone Authority Required procedures
C3745	P3745	Rheumatoid arthritis — initial treatment 2 (change or recommencement after a break of less than 24 months) Initial PBS‑subsidised treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: (a) have a documented history of severe active rheumatoid arthritis; and (b) have received prior PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and (c) have not failed previous PBS‑subsidised treatment with adalimumab for this condition; and where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and where the following conditions apply: patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS‑subsidised bDMARD treatment for this condition 5 times; patients who demonstrate a response to a course of PBS‑subsidised treatment with rituximab and who wish to transfer to treatment with adalimumab are not eligible to commence treatment with adalimumab until they have completed a period free from PBS‑subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion; the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form; where a patient has received PBS‑subsidised treatment with adalimumab and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient’s most recent course of PBS‑subsidised adalimumab treatment; the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS‑subsidised adalimumab treatment is a 16‑week initial treatment course, is made following a minimum of 12 weeks of therapy; a course of initial treatment is limited to a maximum of 16 weeks of treatment	Compliance with Written Authority Required procedures
Continuation of a course of initial treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total	Compliance with Written or Telephone Authority Required procedures
C3746	P3746	Rheumatoid arthritis — continuing treatment Continuing PBS‑subsidised treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults: (a) who have a documented history of severe active rheumatoid arthritis; and (b) who have demonstrated an adequate response to treatment with adalimumab; and (c) whose most recent course of PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment was with adalimumab; and where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and where the following conditions apply: an adequate response to treatment is defined as: (a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and (b) either of the following: (i) 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 (ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or — shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment; the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab; the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course; if the most recent course of adalimumab therapy is a 16‑week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment; a course of continuing treatment is limited to a maximum of 24 weeks of treatment	Compliance with Written Authority Required procedures
Continuation of a course of continuing treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total	Compliance with Written or Telephone Authority Required procedures

(b)insert in numerical order following existing text:

C4666	P4666	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 or tocilizumab 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
C4700	P4700	Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis	Compliance with Written or Telephone Authority Required procedures
C4710	P4710	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 or tocilizumab 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) a completed authority prescription form; and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and (3) a signed patient acknowledgement 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
C4724	P4724	Severe active rheumatoid arthritis Continuing Treatment – balance of supply Patient must have received insufficient therapy with this drug under the Continuing treatment 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 restriction Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis	Compliance with Written or Telephone Authority Required procedures
C4751	P4751	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 or tocilizumab 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 Application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 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 will not be eligible to receive further PBS-subsidised treatment with this drug for this condition 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 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

Schedule 4, Part 1, after entry for Bortezomib

insert:

Brentuximab vedotin

C4675

CD30 positive systemic anaplastic large cell lymphoma

Continuing treatment

Patient must not have progressive disease; AND
Patient must have previously been issued with an authority prescription for this drug

The treatment must not exceed a lifetime total of 16 cycles

Compliance with Authority Required procedures

C4719

CD30 positive systemic anaplastic large cell lymphoma

Initial treatment

The treatment must be for curative intent; AND
Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND
Patient must demonstrate relapsed or chemotherapy-refractory disease

Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Systemic anaplastic large cell lymphoma Brentuximab PBS Authority Application - Supporting Information Form which includes the following:
(i) a histology report including evidence of the tumour's CD30 positivity from a biopsy subsequent to the most recently delivered prior treatment with radiation, chemotherapy, biologics, immunotherapy or other agents;
(ii) The date of initial diagnosis of systemic anaplastic large cell lymphoma;
(iii) Dates of commencement and completion of front-line curative intent chemotherapy;
(iv) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory;
(v) a declaration of whether the patient has had, or is planned to have, a transplant

A maximum quantity and number of repeats to provide for an initial course of brentuximab vedotin of 4 cycles will be authorised as part of the initiating restriction

Compliance with Written Authority Required procedures

Schedule 4, Part 1, entry for Budesonide with eformoterol

(a)omit:

C4327

Chronic obstructive pulmonary disease (COPD)

Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy;
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta‑2 agonist bronchodilator therapy

(b)omit:

C4416

Chronic obstructive pulmonary disease (COPD)

(c)insert in numerical order following existing text:

C4689

Chronic obstructive pulmonary disease (COPD)

Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy; AND
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND
The treatment must be for symptomatic treatment

Schedule 4, Part 1, entry for Certolizumab pegol

(a)omit:

C3714	Rheumatoid arthritis — initial treatment 1 (new patient or patient recommencing after a break of more than 24 months) Initial PBS‑subsidised treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: (a) have severe active rheumatoid arthritis; and (b) have received no PBS‑subsidised treatment with a biological disease modifying anti‑rheumatic drug (bDMARD) for this condition in the previous 24 months; and (c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs), which must include: (i) 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: — hydroxychloroquine at a dose of at least 200 mg daily; or — leflunomide at a dose of at least 10 mg daily; or — sulfasalazine at a dose of at least 2 g daily; or (ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs: — hydroxychloroquine at a dose of at least 200 mg daily; and/or — leflunomide at a dose of at least 10 mg daily; and/or — sulfasalazine at a dose of at least 2 g daily; or (iii) 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 — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: — azathioprine at a dose of at least 1 mg/kg per day; and/or — cyclosporin at a dose of at least 2 mg/kg/day; and/or — sodium aurothiomalate at a dose of 50 mg weekly; and where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and where the following conditions apply: if methotrexate is contraindicated according to the TGA‑approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable; the authority application includes 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, the authority application provides details of the contraindication or intolerance and dose for each DMARD; failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following: (a) 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 (b) either: (i) a total active joint count of at least 20 active (swollen and tender) joints; or (ii) at least 4 active joints from the following list of major joints: — elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or — shoulder and/or hip (assessed as active if there is 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 are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are 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 authority application states the reason this criterion cannot be satisfied; the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form and a signed patient acknowledgement; a patient is eligible for treatment if they have not failed previous PBS‑subsidised treatment with certolizumab pegol for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS‑subsidised bDMARD treatment for this condition 5 times; a course of initial treatment is limited to a maximum of 18 to 20 weeks of treatment, depending on the dosage regimen	Compliance with Written Authority Required procedures
Continuation of a course of initial treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than the maximum allowed based on their dosage regimen, and where approval of the application would enable the patient to complete a course of 18 or 20 weeks of treatment in total	Compliance with Written or Telephone Authority Required procedures
C3768	Rheumatoid arthritis — continuing treatment Continuing PBS‑subsidised treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults: (a) who have a documented history of severe active rheumatoid arthritis; and (b) who have demonstrated an adequate response to treatment with certolizumab pegol; and (c) whose most recent course of PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment was with certolizumab pegol; and where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and where the following conditions apply: an adequate response to treatment is defined as: (a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and (b) either of the following: (i) 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 (ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or — shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment; the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with certolizumab pegol; the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course; if the most recent course of certolizumab pegol therapy is an 18 or 20 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment; a course of continuing treatment is limited to a maximum of 24 weeks of treatment	Compliance with Written Authority Required procedures

Continuation of a course of continuing treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total	Compliance with Written or Telephone Authority Required procedures
C3769	Rheumatoid arthritis — initial treatment 2 (change or recommencement after a break of less than 24 months) Initial PBS‑subsidised treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: (a) have a documented history of severe active rheumatoid arthritis; and (b) have received prior PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and (c) have not failed previous PBS‑subsidised treatment with certolizumab pegol for this condition; and where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and where the following conditions apply: patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS‑subsidised bDMARD treatment for this condition 5 times; patients who demonstrate a response to a course of PBS‑subsidised treatment with rituximab and who wish to transfer to treatment with certolizumab pegol are not eligible to commence treatment with certolizumab pegol until they have completed a period free from PBS‑subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion; the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form; where a patient has received PBS‑subsidised treatment with certolizumab pegol and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient’s most recent course of PBS‑subsidised certolizumb pegol treatment; the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS‑subsidised certolizumab pegol treatment is an 18 or 20 week initial treatment course, is made following a minimum of 12 weeks of therapy; a course of initial treatment is limited to a maximum of 18 to 20 weeks of treatment, depending on the dosage regimen	Compliance with Written Authority Required procedures
Continuation of a course of initial treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than the maximum allowed based on their dosage regimen, and where approval of the application would enable the patient to complete a course of 18 or 20 weeks of treatment in total	Compliance with Written or Telephone Authority Required procedures

(b)insert in numerical order following existing text:

C4696	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 18 to 20 weeks of treatment, depending on the dosage regimen, 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 or tocilizumab 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. Application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 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 will not be eligible to receive further PBS-subsidised treatment with this drug for this condition 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 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
C4697	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 or tocilizumab 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
C4737	Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 18 to 20 weeks treatment, depending on the dosage regimen; OR Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 18 to 20 weeks treatment, depending on the dosage regimen; AND The treatment must provide no more than the balance of up to 18 to 20 weeks treatment available under the above restrictions Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis	Compliance with Written or Telephone Authority Required procedures
C4763	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 not 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 18 to 20 weeks of treatment, depending on the dosage regimen, 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 or tocilizumab 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
C4764	Severe active rheumatoid arthritis Continuing Treatment – balance of supply Patient must have received insufficient therapy with this drug under the Continuing treatment 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 restriction Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis	Compliance with Written or Telephone Authority Required procedures

C4206

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

Chronic non-genotype 1 hepatitis C infection

The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12

Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4206

C4207

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

Chronic non-genotype 1 hepatitis C infection

The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis; AND
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24

Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant

Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre.

Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary

For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12

For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed

For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed

Compliance with Written or Telephone Authority Required procedures

C4208

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

Chronic non-genotype 1 hepatitis C infection

Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

Compliance with Written or Telephone Authority Required procedures

C4209

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

Chronic non-genotype 1 hepatitis C infection

Must be treated in an accredited treatment centre

Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary

For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12

For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed

For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed

Compliance with Written or Telephone Authority Required procedures

Schedule 4, Part 1, entry for Rituximab

substitute:

Rituximab	C4671	Where the patient is receiving treatment in the community setting or at/from a Private Hospital Chronic lymphocytic leukaemia (CLL) The condition must be CD20 positive chronic lymphocytic leukaemia (CLL); AND The treatment must be in combination with chemotherapy	Compliance with Authority Required procedures
C4674	Where the patient is receiving treatment at/from a Public Hospital Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Maintenance therapy Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND The treatment must be maintenance therapy; AND Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction	Compliance with Authority Required procedures - Streamlined Authority Code 4674
C4677	Where the patient is receiving treatment at/from a Public Hospital Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma Re-induction treatment The treatment must be for re-induction treatment purposes only; AND The condition must have relapsed or be refractory to treatment; AND Patient must not receive more than 4 doses under this restriction	Compliance with Authority Required procedures - Streamlined Authority Code 4677
C4678	Where the patient is receiving treatment at/from a Public Hospital Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma Re-induction treatment The treatment must be for re-induction treatment purposes only; AND The condition must have relapsed or be refractory to treatment; AND Patient must not receive more than 4 doses under this restriction	Compliance with Authority Required procedures - Streamlined Authority Code 4678
C4679	Where the patient is receiving treatment in the community setting or at/from a Private Hospital Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Maintenance therapy Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND The treatment must be maintenance therapy; AND Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction	Compliance with Authority Required procedures
C4686	Where the patient is receiving treatment at/from a Public Hospital Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Maintenance therapy The treatment must be maintenance therapy; AND Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction	Compliance with Authority Required procedures - Streamlined Authority Code 4686
C4687	Where the patient is receiving treatment in the community setting or at/from a Private Hospital Previously untreated Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Induction treatment The treatment must be in combination with chemotherapy; AND The condition must be previously untreated; AND The condition must be symptomatic; AND The treatment must be for induction treatment purposes only; AND Patient must not receive more than 8 doses under this restriction	Compliance with Authority Required procedures
C4701	Where the patient is receiving treatment at/from a Public Hospital Previously untreated CD20 positive diffuse large B-cell non-Hodgkin's lymphoma Induction treatment The treatment must be in combination with chemotherapy; AND The condition must be previously untreated; AND The condition must be symptomatic; AND The treatment must be for induction treatment purposes only; AND *Patient must not receive more than 8 doses under this restriction	Compliance with Authority Required procedures - Streamlined Authority Code 4701
C4706	Where the patient is receiving treatment at/from a Public Hospital Chronic lymphocytic leukaemia (CLL) The condition must be CD20 positive chronic lymphocytic leukaemia (CLL); AND The treatment must be in combination with chemotherapy	Compliance with Authority Required procedures - Streamlined Authority Code 4706
C4726	Where the patient is receiving treatment at/from a Public Hospital Previously untreated Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Induction treatment The treatment must be in combination with chemotherapy; AND The condition must be previously untreated; AND The condition must be symptomatic; AND The treatment must be for induction treatment purposes only; AND Patient must not receive more than 8 doses under this restriction	Compliance with Authority Required procedures - Streamlined Authority Code 4726
C4727	Where the patient is receiving treatment in the community setting or at/from a Private Hospital Previously untreated CD20 positive diffuse large B-cell non-Hodgkin's lymphoma Induction treatment The treatment must be in combination with chemotherapy; AND The condition must be previously untreated; AND The condition must be symptomatic; AND The treatment must be for induction treatment purposes only; AND Patient must not receive more than 8 doses under this restriction	Compliance with Authority Required procedures
C4728	Where the patient is receiving treatment in the community setting or at/from a Private Hospital Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma Maintenance therapy The treatment must be maintenance therapy; AND Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction	Compliance with Authority Required procedures
C4752	Where the patient is receiving treatment in the community setting or at/from a Private Hospital Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma Re-induction treatment The treatment must be for re-induction treatment purposes only; AND The condition must have relapsed or be refractory to treatment; AND Patient must not receive more than 4 doses under this restriction	Compliance with Authority Required procedures
C4765	Where the patient is receiving treatment in the community setting or at/from a Private Hospital Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma Re-induction treatment The treatment must be for re-induction treatment purposes only; AND The condition must have relapsed or be refractory to treatment; AND Patient must not receive more than 4 doses under this restriction	Compliance with Authority Required procedures

Schedule 4, Part 1, after entry for Silver sulfadiazine

insert:

Simeprevir	C4669	Where the patient is receiving treatment at/from a private hospital Chronic genotype 1 hepatitis C infection Patient must have compensated liver disease; AND Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND The treatment must be in combination with peginterferon alfa and ribavirin; AND The treatment must be limited to a maximum duration of 12 weeks; AND The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greater Patient must be 18 years or older; AND Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age Must be treated in an accredited treatment centre Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records	Compliance with Written and Telephone Authority Required procedures
C4684	Where the patient is receiving treatment at/from a private hospital Chronic genotype 1 hepatitis C infection Patient must have compensated liver disease; AND Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND The treatment must be in combination with peginterferon alfa and ribavirin; AND The treatment must be limited to a maximum duration of 12 weeks; AND The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greater Patient must be aged 18 years or older; AND Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age Must be treated in an accredited treatment centre Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records	Compliance with Written and Telephone Authority Required procedures
C4758	Where the patient is receiving treatment at/from a public hospital Chronic genotype 1 hepatitis C infection Patient must have compensated liver disease; AND Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND The treatment must be in combination with peginterferon alfa and ribavirin; AND The treatment must be limited to a maximum duration of 12 weeks; AND The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greater Patient must be aged 18 years or older; AND Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age Must be treated in an accredited treatment centre Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4758
C4759	Where the patient is receiving treatment at/from a public hospital Chronic genotype 1 hepatitis C infection Patient must have compensated liver disease; AND Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND The treatment must be in combination with peginterferon alfa and ribavirin; AND The treatment must be limited to a maximum duration of 12 weeks; AND The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greater Patient must be 18 years or older; AND Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age Must be treated in an accredited treatment centre Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4759

Schedule 4, Part 1, entry for Triglycerides, long chain with glucose polymer

insert in numerical order following existing text:

C4438

Proven inborn errors of protein metabolism

Patient must be unable to meet their energy requirements with permitted food and formulae

Schedule 4, Part 1, after entry for Tyrosine with carbohydrate

insert:

Umeclidinium

C4516

Chronic obstructive pulmonary disease (COPD)

Umeclidinium with vilanterol

C4655

Chronic obstructive pulmonary disease (COPD)

Patient must have been stabilised on a combination of a long acting muscarinic antagonist and long acting beta-2 agonist

Compliance with Authority Required procedures - Streamlined Authority Code 4655

Schedule 4, Part 1, entry for Voriconazole

substitute:

Voriconazole	C4665	P4665	Serious Candida infections Treatment and maintenance therapy The condition must be caused by species not susceptible to fluconazole; OR The condition must be resistant to fluconazole; OR Patient must not tolerate fluconazole	Compliance with Authority Required procedures
C4682	P4682	Definite or probable invasive aspergillosis Treatment and maintenance therapy Patient must be immunocompromised	Compliance with Authority Required procedures
C4683	P4683	Serious invasive mycosis infections Treatment and maintenance therapy The treatment must be for invasive mycosis infections other than definite or probable invasive aspergillosis	Compliance with Authority Required procedures
C4685	P4685	Prophylaxis of invasive fungal infections including both yeasts and moulds Patient must be considered at high risk of developing an invasive fungal infection due to anticipated neutropenia (an absolute neutrophil count less than 500 cells per cubic millimetre) for at least 10 days whilst receiving chemotherapy for acute myeloid leukaemia or myelodysplastic syndrome; OR Patient must be considered at high risk of developing an invasive fungal infection due to having acute graft versus host disease (GVHD) grade II, III or IV, or, extensive chronic GVHD, whilst receiving intensive immunosuppressive therapy after allogeneic haematopoietic stem cell transplant; OR Patient must be undergoing allogeneic haematopoietic stem cell transplant using either bone marrow from an unrelated donor or umbilical cord blood (related or unrelated), and, be considered to be at high risk of developing an invasive fungal infection during the neutropenic phase prior to engraftment	Compliance with Authority Required procedures
C4699	Definite or probable invasive aspergillosis Treatment and maintenance therapy Patient must be immunocompromised	Compliance with Authority Required procedures
C4722	Serious Candida infections Treatment and maintenance therapy The condition must be caused by species not susceptible to fluconazole; OR The condition must be resistant to fluconazole; OR Patient must not tolerate fluconazole	Compliance with Authority Required procedures

C4723

Serious invasive mycosis infections

Treatment and maintenance therapy

The treatment must be for invasive mycosis infections other than definite or probable invasive aspergillosis

Compliance with Authority Required procedures

C4748

P4748

Serious fungal infections

Treatment and maintenance therapy

The condition must be caused by Scedosporium species or Fusarium species

Compliance with Authority Required procedures

C4749

Serious fungal infections

Treatment and maintenance therapy

The condition must be caused by Scedosporium species or Fusarium species

Compliance with Authority Required procedures