Commencement information
1. The whole of this instrument	1 August 2023	1 August 2023

Schedule 1—Amendments

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

[1] Schedule 1, Part 1, entry for Acamprosate

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

ACAMPROSATE VIATRIS

MP NP

C5366

180

[2] Schedule 1, Part 1, entry for Acarbose in the form Tablet 50 mg

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

Acarbose Viatris

MP NP

[3] Schedule 1, Part 1, entry for Amino acid formula with vitamins and minerals without methionine

omit:

Oral powder 500 g (XMET Maxamum)

Oral

XMET Maxamum

MP NP

C5534

[4] Schedule 1, Part 1, entry for Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine

omit:

Oral powder 500 g (XMTVI Maxamum)

Oral

XMTVI Maxamum

MP NP

C5542 C5560

[5] Schedule 1, Part 1, entry for Amino acid formula with vitamins and minerals without phenylalanine

omit:

Sachets containing oral powder 24 g, 30 (PKU gel)

Oral

PKU gel

MP NP

C4295

[6] Schedule 1, Part 1, entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine

omit:

Oral powder 500 g (XPhen, Tyr Maxamum)

Oral

XPhen, Tyr Maxamum

MP NP

C5533

[7] Schedule 1, Part 1, entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine

omit:

Oral powder 500 g (MSUD AID III)

Oral

MSUD AID III

MP NP

C5571

[8] Schedule 1, Part 1, entry for Atovaquone with proguanil

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

AtovaquoPro Lupin 250/100

MP NP

C5981

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

[9] Schedule 1, Part 1, entry for Bendamustine

substitute:

Bendamustine

Powder for injection containing bendamustine hydrochloride 25 mg

Injection

Bendamustine Sandoz

C7943 C7944 C7972

See Note 3

D(100)

Bendamustine Viatris

C7943 C7944 C7972

See Note 3

D(100)

Ribomustin

C7943 C7944 C7972

See Note 3

D(100)

Powder for injection containing bendamustine hydrochloride 100 mg

Injection

Bendamustine Sandoz

C7943 C7944 C7972

See Note 3

D(100)

Bendamustine Viatris

C7943 C7944 C7972

See Note 3

D(100)

Ribomustin

C7943 C7944 C7972

See Note 3

D(100)

[10] Schedule 1, Part 1, entry for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

substitute:

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

DuoResp Spiromax

MP NP

C7979 C10121

MP NP

C7979 C10121

Rilast TURBUHALER 400/12

MP NP

C7979 C10121

Symbicort TURBUHALER 400/12

MP NP

C7979 C10121

BiResp Spiromax

MP NP

C7979 C10121

[11] Schedule 1, Part 1, entry for Budesonide with formoterol in the form Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

substitute:

Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

Inhalation by mouth

Rilast RAPIHALER 100/3

C4397 C10482 C10538

P10482

C4397 C10482

P10482

Symbicort Rapihaler 100/3

C4397 C10482 C10538

P10482

C4397 C10482

P10482

Rilast RAPIHALER 100/3

C4397 C10482 C10538

P4397 P10538

C4397 C10482

P4397

Symbicort Rapihaler 100/3

C4397 C10482 C10538

P4397 P10538

C4397 C10482

P4397

[12] Schedule 1, Part 1, entry for Budesonide with formoterol in the form Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

substitute:

Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses	Inhalation by mouth	a	Rilast RAPIHALER 200/6	ZA	MP	C4404 C10121 C10538	2	5	1
					NP	C4404 C10121	2	5	1
		a	Symbicort Rapihaler 200/6	AP	MP	C4404 C10121 C10538	2	5	1
					NP	C4404 C10121	2	5	1

[13] Schedule 1, Part 1, entry for Cefazolin in the form Powder for injection 2 g (as sodium)

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

Cephazolin Viatris

MP NP

C5826 C5867 C5881 C5890

[14] Schedule 1, Part 1, entry for Certolizumab pegol in the form Injection 200 mg in 1 mL single use pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C11430

(b) insert in numerical order in the column headed “Circumstances”: C14191

[15] Schedule 1, Part 1, entry for Certolizumab pegol in the form Injection 200 mg in 1 mL single use pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C11430

(b) insert in numerical order in the column headed “Circumstances”: C14191

[16] Schedule 1, Part 1, entry for Certolizumab pegol in the form Injection 200 mg in 1 mL single use pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C11430

(b) insert in numerical order in the column headed “Circumstances”: C14191

[17] Schedule 1, Part 1, entry for Certolizumab pegol in the form Injection 200 mg in 1 mL single use pre-filled syringe [Maximum Quantity: 6; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C11430

(b) insert in numerical order in the column headed “Circumstances”: C14191

(d) insert in numerical order in the column headed “Purposes”: P14191

[18] Schedule 1, Part 1, entry for Certolizumab pegol in the form Solution for injection 200 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C11430

(b) insert in numerical order in the column headed “Circumstances”: C14191

[19] Schedule 1, Part 1, entry for Certolizumab pegol in the form Solution for injection 200 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C11430

(b) insert in numerical order in the column headed “Circumstances”: C14191

[20] Schedule 1, Part 1, entry for Certolizumab pegol in the form Solution for injection 200 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C11430

(b) insert in numerical order in the column headed “Circumstances”: C14191

[21] Schedule 1, Part 1, entry for Certolizumab pegol in the form Solution for injection 200 mg in 1 mL pre-filled pen [Maximum Quantity: 6; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C11430

(b) insert in numerical order in the column headed “Circumstances”: C14191

(d) insert in numerical order in the column headed “Purposes”: P14191

[22] Schedule 1, Part 1, entry for Cinacalcet in the form Tablet 90 mg (as hydrochloride) [Maximum Quantity: 28; Number of Repeats: 5]

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

Cinacalcet Viatris

MP NP

C10068

[23] Schedule 1, Part 1, entry for Cinacalcet in the form Tablet 90 mg (as hydrochloride) [Maximum Quantity: 56; Number of Repeats: 5]

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

Cinacalcet Viatris

C10063 C10067 C10073

C(100)

[24] Schedule 1, Part 1, entry for Colestyramine

substitute:

Colestyramine	Sachet containing 4 g oral powder (s19A)	Oral	JAMP-Cholestyramine	DZ	MP NP		100	5	30
					MP	P6429	100	11	30
	Sachets containing 4.7 g oral powder (equivalent to 4 g colestyramine), 50	Oral	Questran Lite	GO	MP NP		2	5	1
					MP	P6429	2	11	1

[25] Schedule 1, Part 1, entry for Diroximel fumarate

omit from the column headed “Circumstances”: C13090

[26] Schedule 1, Part 1, entry for Dosulepin in the form Tablet containing dosulepin hydrochloride 75 mg

omit:

Dosulepin Mylan

MP NP

[27] Schedule 1, Part 1, omit entry for Efavirenz

[28] Schedule 1, Part 1, entry for Enzalutamide in the form Capsule 40 mg [Maximum Quantity: 112; Number of Repeats: 2]

insert in numerical order in the column headed “Circumstances”: C14034

[29] Schedule 1, Part 1, entry for Enzalutamide in the form Capsule 40 mg [Maximum Quantity: 112; Number of Repeats: 5]

(a) insert in numerical order in the column headed “Circumstances”: C14034

(b) insert in numerical order in the column headed “Purposes”: P14034

[30] Schedule 1, Part 1, entry for Epirubicin

omit:

Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL

Injection/intravesical

Epirube

See Note 3

D(100)

[31] Schedule 1, Part 1, entry for Eprosartan

omit:

Tablet 400 mg (as mesilate)

Oral

Teveten

MP NP

P6328 P6329 P6332 P6351

56
CN6328 CN6329 CN6332 CN6351

5
CN6328 CN6329 CN6332 CN6351

[32] Schedule 1, Part 1, after entry for Eprosartan with hydrochlorothiazide

insert:

Eptinezumab

Solution concentrate for I.V. infusion 100 mg in 1 mL

Injection

Vyepti

C12029 C14189

P14189

C12029 C14189

P12029

[33] Schedule 1, Part 1, omit entry for Ertugliflozin

[34] Schedule 1, Part 1, omit entry for Ertugliflozin with sitagliptin

[35] Schedule 1, Part 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL

substitute:

Etanercept

Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL

Injection

Enbrel

See Note 3

C(100)

C7289 C8638 C8662 C8692 C8718 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9410 C9429 C9473 C9487 C9502 C9554 C11107 C12164 C12260 C12261 C12262 C12265 C12266 C12287 C12289 C12327 C12434 C12457 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108

P8638 P9064 P9386 P9388 P9410 P9429 P9473 P11107 P12164 P12260 P12261 P12262 P12265 P12266 P12287 P12289 P12327 P12434 P12457 P13532 P13533 P13535 P13537 P13538 P13539 P13540 P13542 P13593 P13598 P13646 P13647 P13707 P14108

P7289 P8662 P8692 P8718 P8839 P8842 P8873 P8879 P9081 P9123 P9140 P9162 P9377 P9380 P9487 P9502 P9554

C14154 C14155

C(100)

[36] Schedule 1, Part 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)

omit:

Blooms the Chemist Fluoxetine

MP NP

C4755 C6277

[37] Schedule 1, Part 1, entry for Fluticasone propionate with salmeterol in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

omit from the column headed “Brand”: FLUTICASONE SALMETEROL CIPHALER 250/50 substitute: Fluticasone Salmeterol Ciphaler 250/50

[38] Schedule 1, Part 1, entry for Gefitinib

(a) omit from the column headed “Schedule Equivalent” for the brand “Cipla Gefitinib”: a

(b) omit:

Iressa

C4473 C7447

[39] Schedule 1, Part 1, entry for Gentamicin

omit:

	Eye drops 3 mg (as sulfate) per mL, 5 mL	Application to the eye		Genoptic	VE	MP	C5451 C5483 C5499		1	2	1
						AO	C5476 C5477		1	2	1

[40] Schedule 1, Part 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”: C11387

(b) insert in numerical order in the column headed “Circumstances”: C14190

(d) insert in numerical order in the column headed “Purposes”: P14190

[41] Schedule 1, Part 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”: C11387

(b) insert in numerical order in the column headed “Circumstances”: C14190

[42] Schedule 1, Part 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”: C11387

(b) insert in numerical order in the column headed “Circumstances”: C14190

(d) insert in numerical order in the column headed “Purposes”: P14190

[43] Schedule 1, Part 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”: C11387

(b) insert in numerical order in the column headed “Circumstances”: C14190

[44] Schedule 1, Part 1, entry for Hydrocortisone in the form Tablet 20 mg

substitute:

Tablet 20 mg	Oral	a	Hydrocortisone Viatris 20	AL	MP NP		60	4	60
		a	Hysone 20	AF	MP NP		60	4	60
Injection 100 mg (as sodium succinate) with 2 mL solvent	Injection		Solu-Cortef	PF	MP NP		2	0	1
					MP NP PDP	P6252	6	0	1

[45] Schedule 1, Part 1, entry for Hyoscine

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

HYOSCINE BUTYLBROMIDE-AFT

MP NP

C6207

[46] Schedule 1, Part 1, entry for Ketoconazole

omit:

Shampoo 20 mg per g, 60 mL

Application

Nizoral 2%

MP NP

C6434

[47] Schedule 1, Part 1, entry for Lanreotide in the form Injection 60 mg (as acetate) in single dose pre-filled syringe

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

Mytolac

C4575 C7025 C7509 C7532 C9260 C9261

D(100)

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

[48] Schedule 1, Part 1, entry for Lanreotide in the form Injection 90 mg (as acetate) in single dose pre-filled syringe

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

Mytolac

C4575 C7025 C7509 C7532 C9260 C9261

D(100)

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

[49] Schedule 1, Part 1, entry for Lanreotide in the form Injection 120 mg (as acetate) in single dose pre-filled syringe

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

Mytolac

C4575 C7025 C7509 C7532 C9260 C9261 C10061 C10075 C10077

D(100)

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

[50] Schedule 1, Part 1, entry for Larotrectinib

omit:

Oral solution 20 mg per mL (as sulfate), 100 mL

Oral

Vitrakvi

C12980 C12981 C12982

P12981 P12982

C12980 C12981 C12982

P12980

[51] Schedule 1, Part 1, entry for Levodopa with carbidopa

omit:

Tablet (prolonged release) 200 mg-50 mg

Oral

Sinemet CR Prolonged-Release Tablets

MP NP

C5253

100

[52] Schedule 1, Part 1, entry for Meloxicam in the form Tablet 15 mg

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

Meloxicam Viatris

MP NP

C4907 C4962

[53] Schedule 1, Part 1, entry for Mifepristone and misoprostol

substitute:

Mifepristone and misoprostol

Pack containing 1 tablet mifepristone 200 mg and 4 tablets misoprostol 200 micrograms

Oral

MS-2 Step

MP NP

C14202

[54] Schedule 1, Part 1, entry for Morphine

omit:

Tablet containing morphine sulfate pentahydrate 30 mg	Oral	Anamorph	RW	MP NP	C10758 C10764 C10770 C10777	P10758	10	20
				PDP	C10758 C10859	P10758	10	20
				MP NP	C10758 C10764 C10770 C10777	P10764 P10770 P10777	20	20
				PDP	C10758 C10859	P10859	20	20

[55] Schedule 1, Part 1, entry for Paclitaxel

omit:

Solution concentrate for I.V. infusion 100 mg in 16.7 mL

Injection

Paclitaxin

See Note 3

D(100)

Solution concentrate for I.V. infusion 150 mg in 25 mL

Injection

Paclitaxin

See Note 3

D(100)

[56] Schedule 1, Part 1, entry for Palbociclib in each of the forms: Tablet 75 mg; Tablet 100 mg; and Tablet 125 mg

omit from the column headed “Circumstances”: C13085

[57] Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril arginine 2.5 mg

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

APX-Perindopril Arginine

MP NP

[58] Schedule 1, Part 1, entry for Perindopril in form Tablet containing perindopril arginine 5 mg

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

APX-Perindopril Arginine

MP NP

[59] Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril arginine 10 mg

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

APX-Perindopril Arginine

MP NP

[60] Schedule 1, Part 1, entry for Perindopril with amlodipine in the form Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besilate)

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

APX-Perindopril Arginine/Amlodipine 5/5

MP NP

C4398 C4418

[61] Schedule 1, Part 1, entry for Perindopril with amlodipine in the form Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besilate)

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

APX-Perindopril Arginine/Amlodipine 5/10

MP NP

C4398 C4418

[62] Schedule 1, Part 1, entry for Perindopril with amlodipine in the form Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besilate)

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

APX-Perindopril Arginine/Amlodipine 10/5

MP NP

C4398 C4418

[63] Schedule 1, Part 1, entry for Perindopril with amlodipine in the form Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besilate)

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

APX-Perindopril Arginine/Amlodipine 10/10

MP NP

C4398 C4418

[64] Schedule 1, Part 1, omit entry for Reteplase

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

(a) omit from the column headed “Circumstances”: C11447

(b) insert in numerical order in the column headed “Circumstances”: C14220

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

(a) omit from the column headed “Circumstances”: C11447

(b) insert in numerical order in the column headed “Circumstances”: C14220

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

(a) omit from the column headed “Circumstances”: C11447

(b) insert in numerical order in the column headed “Circumstances”: C14220

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

(a) omit from the column headed “Circumstances”: C11447

(b) insert in numerical order in the column headed “Circumstances”: C14220

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

(a) omit from the column headed “Circumstances”: C11447

(b) insert in numerical order in the column headed “Circumstances”: C14220

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

(a) omit from the column headed “Circumstances”: C11447

(b) insert in numerical order in the column headed “Circumstances”: C14220

[71] Schedule 1, Part 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C11447

(b) insert in numerical order in the column headed “Circumstances”: C14220

(d) insert in numerical order in the column headed “Purposes”: P14220

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

(a) omit from the column headed “Circumstances”: C11447

(b) insert in numerical order in the column headed “Circumstances”: C14220

[73] Schedule 1, Part 1, entry for Sitagliptin

substitute:

Sitagliptin	Tablet 25 mg	Oral	a	Januvia	XW	MP	C6346 C6363 C6376 C7505 C7541	28	5	28
						NP	C6346 C6363 C6376 C7505	28	5	28
			a	Sitagliptin Lupin	GQ	MP	C6346 C6363 C6376 C7505 C7541	28	5	28
						NP	C6346 C6363 C6376 C7505	28	5	28
			a	Sitagliptin Sandoz Pharma	SZ	MP	C6346 C6363 C6376 C7505 C7541	28	5	28
						NP	C6346 C6363 C6376 C7505	28	5	28
			a	Sitagliptin SUN	RA	MP	C6346 C6363 C6376 C7505 C7541	28	5	28
						NP	C6346 C6363 C6376 C7505	28	5	28
			a	Sitaglo	CR	MP	C6346 C6363 C6376 C7505 C7541	28	5	28
						NP	C6346 C6363 C6376 C7505	28	5	28
			a	Xelevia	XT	MP	C6346 C6363 C6376 C7505 C7541	28	5	28
						NP	C6346 C6363 C6376 C7505	28	5	28
	Tablet 50 mg	Oral	a	Januvia	XW	MP	C6346 C6363 C6376 C7505 C7541	28	5	28
						NP	C6346 C6363 C6376 C7505	28	5	28
			a	Sitagliptin Lupin	GQ	MP	C6346 C6363 C6376 C7505 C7541	28	5	28
						NP	C6346 C6363 C6376 C7505	28	5	28
			a	Sitagliptin Sandoz Pharma	SZ	MP	C6346 C6363 C6376 C7505 C7541	28	5	28
						NP	C6346 C6363 C6376 C7505	28	5	28
			a	Sitagliptin SUN	RA	MP	C6346 C6363 C6376 C7505 C7541	28	5	28
						NP	C6346 C6363 C6376 C7505	28	5	28
			a	Sitaglo	CR	MP	C6346 C6363 C6376 C7505 C7541	28	5	28
						NP	C6346 C6363 C6376 C7505	28	5	28
			a	Xelevia	XT	MP	C6346 C6363 C6376 C7505 C7541	28	5	28
						NP	C6346 C6363 C6376 C7505	28	5	28
	Tablet 100 mg	Oral	a	Januvia	XW	MP	C6346 C6363 C6376 C7505 C7541	28	5	28
						NP	C6346 C6363 C6376 C7505	28	5	28
			a	Sitagliptin Lupin	GQ	MP	C6346 C6363 C6376 C7505 C7541	28	5	28
						NP	C6346 C6363 C6376 C7505	28	5	28
			a	Sitagliptin Sandoz Pharma	SZ	MP	C6346 C6363 C6376 C7505 C7541	28	5	28
						NP	C6346 C6363 C6376 C7505	28	5	28
			a	Sitagliptin SUN	RA	MP	C6346 C6363 C6376 C7505 C7541	28	5	28
						NP	C6346 C6363 C6376 C7505	28	5	28
			a	Sitaglo	CR	MP	C6346 C6363 C6376 C7505 C7541	28	5	28
						NP	C6346 C6363 C6376 C7505	28	5	28
			a	Xelevia	XT	MP	C6346 C6363 C6376 C7505 C7541	28	5	28
						NP	C6346 C6363 C6376 C7505	28	5	28

[74] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C14174

(b) insert in numerical order in the column headed “Circumstances”: C14195

[75] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 1]

(a) omit from the column headed “Circumstances”: C14174

(b) insert in numerical order in the column headed “Circumstances”: C14195

[76] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C14174

(b) insert in numerical order in the column headed “Circumstances”: C14195

[77] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 3]

(a) omit from the column headed “Circumstances”: C14174

(b) insert in numerical order in the column headed “Circumstances”: C14195

[78] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14174

(b) insert in numerical order in the column headed “Circumstances”: C14195

(d) insert in numerical order in the column headed “Purposes”: P14195

[79] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 6]

(a) omit from the column headed “Circumstances”: C14174

(b) insert in numerical order in the column headed “Circumstances”: C14195

[80] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C14174

(b) insert in numerical order in the column headed “Circumstances”: C14195

[81] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 1]

(a) omit from the column headed “Circumstances”: C14174

(b) insert in numerical order in the column headed “Circumstances”: C14195

[82] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C14174

(b) insert in numerical order in the column headed “Circumstances”: C14195

[83] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 3]

(a) omit from the column headed “Circumstances”: C14174

(b) insert in numerical order in the column headed “Circumstances”: C14195

[84] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14174

(b) insert in numerical order in the column headed “Circumstances”: C14195

(d) insert in numerical order in the column headed “Purposes”: P14195

[85] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 6]

(a) omit from the column headed “Circumstances”: C14174

(b) insert in numerical order in the column headed “Circumstances”: C14195

[86] Schedule 1, Part 1, entry for Tofacitinib in the form Tablet 5 mg [Maximum Quantity: 56; Number of Repeats: 3]

(a) insert in numerical order in the column headed “Circumstances”: C9429 C9431

(b) insert in numerical order in the column headed “Circumstances”: C14207 C14210 C14211 C14224 C14225

(d) insert in numerical order in the column headed “Purposes”: P14210 P14224 P14225

[87] Schedule 1, Part 1, entry for Tofacitinib in the form Tablet 5 mg [Maximum Quantity: 56; Number of Repeats: 5]

(a) insert in numerical order in the column headed “Circumstances”: C9429 C9431

(b) insert in numerical order in the column headed “Circumstances”: C14207 C14210 C14211 C14224 C14225

(d) insert in numerical order in the column headed “Purposes”: P14207 P14211

[88] Schedule 1, Part 1, after entry for Toremifene

insert:

Trabectedin

Powder for I.V. infusion 1 mg

Injection

Yondelis

C14188 C14196 C14197

See Note 3

D(100)

[89] Schedule 1, Part 1, entry for Tranexamic acid

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

Tranexamic Acid Lupin

MP NP

100

[90] Schedule 1, Part 1, entry for Upadacitinib in the form Tablet 15 mg [Maximum Quantity: 28; Number of Repeats: 1]

(a) insert in numerical order in the column headed “Circumstances”: C10434

(b) insert in numerical order in the column headed “Circumstances”: C14198 C14199 C14208 C14213 C14216 C14217

[91] Schedule 1, Part 1, entry for Upadacitinib in the form Tablet 15 mg [Maximum Quantity: 28; Number of Repeats: 3]

(a) insert in numerical order in the column headed “Circumstances”: C10434

(b) insert in numerical order in the column headed “Circumstances”: C14198 C14199 C14208 C14213 C14216 C14217

[92] Schedule 1, Part 1, entry for Upadacitinib in the form Tablet 15 mg [Maximum Quantity: 28; Number of Repeats: 4]

(a) insert in numerical order in the column headed “Circumstances”: C10434

(b) insert in numerical order in the column headed “Circumstances”: C14198 C14199 C14208 C14213 C14216 C14217

[93] Schedule 1, Part 1, entry for Upadacitinib in the form Tablet 15 mg [Maximum Quantity: 28; Number of Repeats: 5]

(a) insert in numerical order in the column headed “Circumstances”: C10434

(b) insert in numerical order in the column headed “Circumstances”: C14198 C14199 C14208 C14213 C14216 C14217

(d) insert in numerical order in the column headed “Purposes”: P14198 P14199

[94] Schedule 1, Part 1, entry for Varenicline

insert as first entry:

Tablet 0.5 mg (as tartrate) (s19A)

Oral

APO-Varenicline (Canada)

MP NP

C6871

112

[95] Schedule 1, Part 2

insert as first entry:

Amino acid formula with vitamins and minerals without phenylalanine

Sachets containing oral powder 24 g, 30 (PKU gel)

Oral

PKU gel

MP NP

C4295

[96] Schedule 1, Part 2, after entry for Donepezil in the form Tablet containing donepezil hydrochloride 10 mg

insert:

Efavirenz

Tablet 200 mg

Oral

Stocrin

MP NP

C4454 C4512

180

D(100)

Tablet 600 mg

Oral

Stocrin

MP NP

C4454 C4512

D(100)

Eprosartan

Tablet 400 mg (as mesilate)

Oral

Teveten

MP NP

P6328 P6329 P6332 P6351

56
CN6328 CN6329 CN6332 CN6351

5
CN6328 CN6329 CN6332 CN6351

Ertugliflozin

Tablet 5 mg

Oral

Steglatro 5

C7495 C7506 C7528

C7495 C7506

Tablet 15 mg

Oral

Steglatro 15

C7495 C7506 C7528

C7495 C7506

Ertugliflozin with sitagliptin

Tablet containing 5 mg ertugliflozin with 100 mg sitagliptin

Oral

Steglujan 5/100

C7524 C7556

C7556

Tablet containing 15 mg ertugliflozin with 100 mg sitagliptin

Oral

Steglujan 15/100

C7524 C7556

C7556

[97] Schedule 1, Part 2, after entry for Galantamine in the form Capsule (prolonged release) 24 mg (as hydrobromide)

insert:

Gentamicin	Eye drops 3 mg (as sulfate) per mL, 5 mL	Application to the eye		Genoptic	VE	MP	C5451 C5483 C5499		1	2	1
						AO	C5476 C5477		1	2	1

[98] Schedule 1, Part 2, after entry for Insulin aspart in the form Injections (human analogue) (fast acting), pre-filled pen, 100 units per mL, 3 mL, 5

insert:

Ketoconazole

Shampoo 20 mg per g, 60 mL

Application

Nizoral 2%

MP NP

C6434

[99] Schedule 1, Part 2, omit entry for Roxithromycin

[100] Schedule 3, after details relevant to Responsible Person code ZE

insert:

Specialised Therapeutics Pharma Pty Ltd

77 609 261 430

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

omit:

C11526

Severe active juvenile idiopathic arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
An adequate response to treatment is defined as:
(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, cervical spine 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).
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count submitted with the initial treatment application.
The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Compliance with Authority Required procedures - Streamlined Authority Code 11526

[102] Schedule 4, Part 1, entry for Certolizumab pegol

(a) omit:

C11430

P11430

Non-radiographic axial spondyloarthritis
Initial treatment - Initial 2 (Change or re-commencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with biological medicines more than three times for this PBS-indication during the current treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle; 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 non-radiographic axial spondyloarthritis.
An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment.
A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application.
An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:
(a) a CRP measurement no greater than 10 mg per L; or
(b) a CRP measurement reduced by at least 20% from baseline.
The assessment of the patient's response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment.
BASDAI scores and CRP levels must be documented in the patient's medical records.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
The following must be provided at the time of application and documented in the patient's medical records:
(a) the BASDAI score; and
(b) the C-reactive protein (CRP) level.

Compliance with Authority Required procedures

(b) insert in numerical order after existing text:

C14191

P14191

Non-radiographic axial spondyloarthritis
Initial treatment - Initial 2 (Change or re-commencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle; 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 non-radiographic axial spondyloarthritis.
An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment.
A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application.
An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:
(a) a CRP measurement no greater than 10 mg per L; or
(b) a CRP measurement reduced by at least 20% from baseline.
The assessment of the patient's response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment.
BASDAI scores and CRP levels must be documented in the patient's medical records.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
The following must be provided at the time of application and documented in the patient's medical records:
(a) the BASDAI score; and
(b) the C-reactive protein (CRP) level.

Compliance with Authority Required procedures

[103] Schedule 4, Part 1, entry for Diroximel fumarate

omit:

C13090

Multiple sclerosis
Grandfather treatment
Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 August 2022; AND
The condition must be/have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of at least one of the brain/spinal cord; OR
The condition must be/have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis supported by written certification, which is documented in the patient's medical records, from a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support); AND
Patient must not show continuing progression of disability while on treatment with this drug.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 13090

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

insert in numerical order after existing text:

C14034

P14034

Metastatic castration sensitive carcinoma of the prostate
The treatment must be/have been initiated within 6 months of treatment initiation with androgen deprivation therapy; AND
Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); OR
Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.
Patient must be undergoing concurrent androgen deprivation therapy.

Compliance with Authority Required procedures

[105] Schedule 4, Part 1, after entry for Eprosartan with hydrochlorothiazide

insert:

Eptinezumab	C12029	P12029		Chronic migraine Continuing treatment Must be treated by a specialist neurologist or in consultation with a specialist neurologist; AND Patient must not be undergoing concurrent treatment with the following PBS benefits: (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication. Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have achieved and maintained a 50% or greater reduction from baseline in the number of migraine days per month; AND Patient must continue to be appropriately managed for medication overuse headache. Patient must have the number of migraine days per month documented in their medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 12029
	C14189	P14189		Chronic migraine Initial treatment Must be treated by a neurologist; AND Patient must not be undergoing concurrent treatment with the following PBS benefits: (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication. Patient must have experienced an average of 15 or more headache days per month, with at least 8 days of migraine, over a period of at least 6 months, prior to commencement of treatment with this medicine for this condition; AND Patient must have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications prior to commencement of treatment with this drug for this condition; AND Patient must be appropriately managed by their practitioner for medication overuse headache, prior to initiation of treatment with this drug. Patient must be at least 18 years of age. Prophylactic migraine medications are propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate or topiramate. Patient must have the number of migraine days per month documented in their medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 14189

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

(a) omit:

C11387

P11387

Non-radiographic axial spondyloarthritis
Initial treatment - Initial 2 (Change or re-commencement of treatment after a break of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with biological medicines more than three times for this PBS-indication during the current treatment cycle; AND
The treatment must not exceed a maximum of 16 weeks with this drug 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 non-radiographic axial spondyloarthritis.
Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle.
An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment.
A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application.
An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:
(a) a CRP measurement no greater than 10 mg per L; or
(b) a CRP measurement reduced by at least 20% from baseline.
The assessment of the patient's response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment.
BASDAI scores and CRP levels must be documented in the patient's medical records.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
The following must be provided at the time of application and documented in the patient's medical records:
(a) the BASDAI score; and
(b) the C-reactive protein (CRP) level.

Compliance with Authority Required procedures

(b) insert in numerical order after existing text:

C14190

P14190

Non-radiographic axial spondyloarthritis
Initial treatment - Initial 2 (Change or re-commencement of treatment after a break of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND
The treatment must not exceed a maximum of 16 weeks with this drug 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 non-radiographic axial spondyloarthritis.
Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle.
An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment.
A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application.
An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:
(a) a CRP measurement no greater than 10 mg per L; or
(b) a CRP measurement reduced by at least 20% from baseline.
The assessment of the patient's response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment.
BASDAI scores and CRP levels must be documented in the patient's medical records.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
The following must be provided at the time of application and documented in the patient's medical records:
(a) the BASDAI score; and
(b) the C-reactive protein (CRP) level.

Compliance with Authority Required procedures

[107] Schedule 4, Part 1, entry for Mifepristone and misoprostol

substitute:

Mifepristone and misoprostol

C14202

Termination of an intra-uterine pregnancy
The condition must be an intra-uterine pregnancy of up to 63 days of gestation.

Compliance with Authority Required procedures - Streamlined Authority Code 14202

[108] Schedule 4, Part 1, entry for Morphine

(a) omit:

C10758

P10758

Severe pain
The treatment must be for short term therapy of acute severe pain; AND
Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; OR
Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.

(b) omit from the column headed “Purposes Code” for circumstances code “C10859”: P10859

[109] Schedule 4, Part 1, entry for Palbociclib

omit:

C13085

Locally advanced or metastatic breast cancer
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 August 2022; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
Patient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS supply was initiated; OR
Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have had a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 2 at the time non-PBS supply was initiated; AND
The treatment must be in combination with fulvestrant only, where at the time non-PBS supply was initiated, the patient had recurrent/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease; AND
The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.
Patient must not be premenopausal.

Compliance with Authority Required procedures

[110] Schedule 4, Part 1, omit entry for Reteplase

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

(a) omit:

C11447

P11447

Non-radiographic axial spondyloarthritis
Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with biological medicines more than three times for this PBS-indication during the current treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle; AND
Patient must not receive more than 20 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 non-radiographic axial spondyloarthritis.
An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment.
A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application.
An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:
(a) a CRP measurement no greater than 10 mg per L; or
(b) a CRP measurement reduced by at least 20% from baseline.
The assessment of the patient's response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment.
BASDAI scores and CRP levels must be documented in the patient's medical records.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
The following must be provided at the time of application and documented in the patient's medical records:
(a) the BASDAI score; and
(b) the C-reactive protein (CRP) level.
The stated maximum quantity of 5 with zero repeats is intended for a patient undergoing the loading dose regimen of 150 mg administered at weeks 0, 1, 2, 3, and 4 (a total of 5 doses) followed by monthly administration thereafter.
State in the application whether a loading dose regimen is intended or not.
Where a loading dose regimen is intended, request a maximum quantity of 5 and zero repeats to cover doses at weeks 0, 1, 2, 3 and 4. Doses at week 8, 12, and 16 can be sought under the relevant 'Balance of supply' listing.
Where no loading dose regimen is intended, request a maximum quantity of 1 and seek an increase in the number of repeats from zero to 4 repeats to cover dosing at weeks 4, 8, 12 and 16. Where increased repeats are sought, the maximum quantity sought must not be greater than 1.

Compliance with Authority Required procedures

(b) insert in numerical order after existing text:

C14220

P14220

Non-radiographic axial spondyloarthritis
Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle; AND
Patient must not receive more than 20 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 non-radiographic axial spondyloarthritis.
An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment.
A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application.
An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:
(a) a CRP measurement no greater than 10 mg per L; or
(b) a CRP measurement reduced by at least 20% from baseline.
The assessment of the patient's response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment.
BASDAI scores and CRP levels must be documented in the patient's medical records.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
The following must be provided at the time of application and documented in the patient's medical records:
(a) the BASDAI score; and
(b) the C-reactive protein (CRP) level.
The stated maximum quantity of 5 with zero repeats is intended for a patient undergoing the loading dose regimen of 150 mg administered at weeks 0, 1, 2, 3, and 4 (a total of 5 doses) followed by monthly administration thereafter.
State in the application whether a loading dose regimen is intended or not.
Where a loading dose regimen is intended, request a maximum quantity of 5 and zero repeats to cover doses at weeks 0, 1, 2, 3 and 4. Doses at week 8, 12, and 16 can be sought under the relevant 'Balance of supply' listing.
Where no loading dose regimen is intended, request a maximum quantity of 1 and seek an increase in the number of repeats from zero to 4 repeats to cover dosing at weeks 4, 8, 12 and 16. Where increased repeats are sought, the maximum quantity sought must not be greater than 1.

Compliance with Authority Required procedures

[112] Schedule 4, Part 1, entry for Tocilizumab

(a) omit:

C14174

P14174

Active giant cell arteritis
Initial treatment
Must be treated by a rheumatologist, clinical immunologist or neurologist experienced in the management of giant cell arteritis.
Patient must have clinical symptoms of active giant cell arteritis in the absence of any other identifiable cause; AND
Patient must have an ESR equal to or greater than 30 mm/hour within the past 6 weeks; OR
Patient must have a CRP equal to or greater than 10 mg/L within the past 6 weeks; OR
Patient must have active giant cell arteritis confirmed by positive temporal artery biopsy or imaging; AND
Patient must have had a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis; AND
Patient must have had temporal artery biopsy revealing features of giant cell arteritis at diagnosis; OR
Patient must have had evidence of large-vessel vasculitis by magnetic resonance (MR) or computed tomography (CT) angiography or PET/CT; OR
Patient must have had evidence of positive temporal artery halo sign by ultrasound (US) at diagnosis; AND
The treatment must be in combination with a tapering course of corticosteroids; AND
The treatment must not exceed 52 weeks in total including initial and continuing applications.
Patient must be aged 50 years or older.
Clinical symptoms of giant cell arteritis at diagnosis include unequivocal cranial symptoms of giant cell arteritis (new onset localized headache, scalp tenderness, temporal artery tenderness or decreased pulsation, ischemia related vision loss, or otherwise unexplained mouth or jaw pain upon mastication); or symptoms of polymyalgia rheumatica, defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness.
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS and must include:
(a) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has active giant cell arteritis including pathology reports outlining the patient's ESR or CRP levels within the last 6 weeks, or positive temporal artery biopsy or imaging; and
(b) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has been diagnosed with giant cell arteritis with a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

(b) insert in numerical order after existing text:

C14195

P14195

Active giant cell arteritis
Initial treatment
Must be treated by a rheumatologist, clinical immunologist or neurologist experienced in the management of giant cell arteritis.
Patient must have clinical symptoms of active giant cell arteritis in the absence of any other identifiable cause; AND
Patient must have an ESR equal to or greater than 30 mm/hour within the past 6 weeks; OR
Patient must have a CRP equal to or greater than 10 mg/L within the past 6 weeks; OR
Patient must have active giant cell arteritis confirmed by positive temporal artery biopsy or imaging; AND
Patient must have had a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis; AND
Patient must have had temporal artery biopsy revealing features of giant cell arteritis at diagnosis; OR
Patient must have had evidence of large-vessel vasculitis by magnetic resonance (MR) or computed tomography (CT) angiography or PET/CT at diagnosis; OR
Patient must have had evidence of positive temporal artery halo sign by ultrasound (US) at diagnosis; AND
The treatment must be in combination with a tapering course of corticosteroids; AND
The treatment must not exceed 52 weeks in total including initial and continuing applications.
Patient must be aged 50 years or older.
Clinical symptoms of giant cell arteritis at diagnosis include unequivocal cranial symptoms of giant cell arteritis (new onset localized headache, scalp tenderness, temporal artery tenderness or decreased pulsation, ischemia related vision loss, or otherwise unexplained mouth or jaw pain upon mastication); or symptoms of polymyalgia rheumatica, defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness.
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS and must include:
(a) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has active giant cell arteritis including pathology reports outlining the patient's ESR or CRP levels within the last 6 weeks, or positive temporal artery biopsy or imaging; and
(b) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has been diagnosed with giant cell arteritis with a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

[113] Schedule 4, Part 1, entry for Tofacitinib

(a) insert after entry for Circumstances Code “C9064”:

	C9429	P9429		Ankylosing spondylitis Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.	Compliance with Authority Required procedures
	C9431	P9431		Ankylosing spondylitis 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 ankylosing spondylitis.	Compliance with Authority Required procedures

(b) insert in numerical order after existing text:

C14207	P14207	Ankylosing spondylitis Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 August 2023; AND Patient must have had at least 2 of the following prior to commencing non-PBS-subsidised treatment: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be at least 18 years of age. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The application must include details of the NSAIDs trialled, their doses and duration of treatment. If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used. If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication. If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance. The following criteria indicate failure to achieve an adequate response to NSAIDs and must have been demonstrated prior to initiation of non-PBS subsidised treatment with this biological medicine for this condition: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L. The baseline BASDAI score and ESR or CRP level must have been determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. If the above requirement to demonstrate an elevated ESR or CRP could not be met, the application must state the reason this criterion could not be satisfied. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Ankylosing Spondylitis PBS Authority Application Form which includes the following: (i) details of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a baseline BASDAI score; and (iii) a completed Exercise Program Self Certification Form included in the supporting information form; and (iv) baseline ESR and/or CRP level An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following: (a) an ESR measurement no greater than 25 mm per hour; or (b) a CRP measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications. An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Written Authority Required procedures
C14210	P14210	Ankylosing spondylitis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be at least 18 years of age. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Ankylosing Spondylitis PBS Authority Application Form. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following: (a) an ESR measurement no greater than 25 mm per hour; or (b) a CRP measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications. All measurements provided must be no more than 4 weeks old at the time of application. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C14211	P14211	Ankylosing spondylitis Continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be at least 18 years of age. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Ankylosing Spondylitis PBS Authority Application Form. An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following: (a) an ESR measurement no greater than 25 mm per hour; or (b) a CRP measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications. All measurements provided must be no more than 4 weeks old at the time of application. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C14224	P14224	Ankylosing spondylitis Initial treatment - Initial 1 (new patient) The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be at least 18 years of age. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The application must include details of the NSAIDs trialled, their doses and duration of treatment. If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used. If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication. If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance. The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L. The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks 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 reason this criterion cannot be satisfied. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Ankylosing Spondylitis PBS Authority Application Form which includes the following: (i) details of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a baseline BASDAI score; and (iii) a completed Exercise Program Self Certification Form included in the supporting information form; and (iv) baseline ESR and/or CRP level An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Written Authority Required procedures
C14225	P14225	Ankylosing spondylitis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; OR Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; OR Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be at least 18 years of age. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Ankylosing Spondylitis PBS Authority Application Form which includes the following: (i) details of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a BASDAI score. An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Written Authority Required procedures

[114] Schedule 4, Part 1, after entry for Topiramate

insert:

Trabectedin	C14188	Advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements Patient must have been receiving treatment with this drug for this condition prior to 1 August 2023; AND Patient must have had a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 2 at the time non-PBS supply was initiated; AND Patient must have received chemotherapy treatment including an anthracycline, prior to initiating non-PBS-subsidised treatment; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The condition must be one of the following subtypes for patients with liposarcoma: (i) dedifferentiated, (ii) myxoid, (iii) round-cell, (iv) pleomorphic. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.	Compliance with Authority Required procedures - Streamlined Authority Code 14188
	C14196	Advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma Initial treatment Patient must have an ECOG performance status of 2 or less; AND Patient must have received prior chemotherapy treatment including an anthracycline; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The condition must be one of the following subtypes for patients with liposarcoma: (i) dedifferentiated, (ii) myxoid, (iii) round-cell, (iv) pleomorphic. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.	Compliance with Authority Required procedures - Streamlined Authority Code 14196
	C14197	Advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.	Compliance with Authority Required procedures - Streamlined Authority Code 14197

[115] Schedule 4, Part 1, entry for Upadacitinib

(a) insert after entry for Circumstances Code “C10356”:

C10434

P10434

Non-radiographic axial spondyloarthritis
Continuing treatment - balance of supply
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.

Compliance with Authority Required procedures

(b) insert in numerical order after existing text:

C14198	P14198	Non-radiographic axial spondyloarthritis Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must have commenced treatment with this biological medicine for this condition prior to 1 August 2023; AND The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction. Patient must be at least 18 years of age. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. The application must include details of the NSAIDs trialled, their doses and duration of treatment. If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used. If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication. If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance. The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and (b) C-reactive protein (CRP) level greater than 10 mg per L. The baseline BASDAI score and CRP level must be determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application. If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The baseline BASDAI score and CRP level must also be documented in the patient's medical records.	Compliance with Written Authority Required procedures
C14199	P14199	Non-radiographic axial spondyloarthritis Continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction. Patient must be at least 18 years of age. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following: (a) a CRP measurement no greater than 10 mg per L; or (b) a CRP measurement reduced by at least 20% from baseline. If the requirement to demonstrate an elevated CRP level could not be met under an initial treatment restriction, a reduction in the BASDAI score from baseline will suffice for the purposes of administering this continuing treatment restriction. The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.	Compliance with Authority Required procedures
C14208	P14208	Non-radiographic axial spondyloarthritis Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle; AND The treatment must not exceed a maximum of 16 weeks with this drug under this restriction. Patient must be at least 18 years of age. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment. A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application. An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following: (a) a CRP measurement no greater than 10 mg per L; or (b) a CRP measurement reduced by at least 20% from baseline. The assessment of the patient's response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment. BASDAI scores and CRP levels must be documented in the patient's medical records. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. The following must be provided at the time of application and documented in the patient's medical records: (a) the BASDAI score; and (b) the C-reactive protein (CRP) level.	Compliance with Authority Required procedures
C14213	P14213	Non-radiographic axial spondyloarthritis Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND The treatment must not exceed a maximum of 16 weeks with this drug under this restriction. Patient must be at least 18 years of age. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. The following must be provided at the time of application and documented in the patient's medical records: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and (b) C-reactive protein (CRP) level greater than 10 mg per L. The BASDAI score and CRP level must be no more than 4 weeks old at the time of this application. If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.	Compliance with Authority Required procedures
C14216	P14216	Non-radiographic axial spondyloarthritis Initial treatment - Initial 1 (New patient) Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND The treatment must not exceed a maximum of 16 weeks with this drug under this restriction. Patient must be at least 18 years of age. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. The application must include details of the NSAIDs trialled, their doses and duration of treatment. If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used. If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication. If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance. The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and (b) C-reactive protein (CRP) level greater than 10 mg per L. The baseline BASDAI score and CRP level must be determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application. If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The baseline BASDAI score and CRP level must also be documented in the patient's medical records.	Compliance with Written Authority Required procedures
C14217	P14217	Non-radiographic axial spondyloarthritis Initial 1 (New patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.	Compliance with Authority Required procedures

[116] Schedule 5, after entry for Clopidogrel

insert:

Colestyramine	GRP-27566	Sachet containing 4 g oral powder (s19A)	Oral	JAMP-Cholestyramine
		Sachets containing 4.7 g oral powder (equivalent to 4 g colestyramine), 50	Oral	Questran Lite

[117] Schedule 5, omit entry for Larotrectinib

[118] Schedule 5, omit entry for Levodopa with carbidopa

[119] Schedule 5, entry for Meloxicam in the form Tablet 15 mg [GRP-15468]

insert in alphabetical order in the column headed “Brand”: Meloxicam Viatris

[120] Schedule 5, entry for Perindopril in the form Tablet containing perindopril arginine 5 mg [GRP-15442]

insert in alphabetical order in the column headed “Brand”: APX-Perindopril Arginine

[121] Schedule 5, entry for Perindopril in the form Tablet containing perindopril arginine 10 mg [GRP-15525]

insert in alphabetical order in the column headed “Brand”: APX-Perindopril Arginine

[122] Schedule 5, entry for Perindopril in the form Tablet containing perindopril arginine 2.5 mg [GRP-15965]

insert in alphabetical order in the column headed “Brand”: APX-Perindopril Arginine

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1. The whole of this instrument	1 August 2023	1 August 2023