National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 5) (PB 29 of 2018) (Cth)

PB 29 of 2018

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 5)

National Health Act 1953

___________________________________________________________________________

I, LISA LA RANCE, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated 27^th of April 2018

LISA LA RANCE

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

___________________________________________________________________________

1. Name of Instrument

(1)This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 5).

(2)This Instrument may also be cited as PB 29 of 2018.

1. Commencement

This Instrument commences on 1 May 2018.

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

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

Schedule 1     Amendments

1. Schedule 1, after entry for Adrenaline in the form I.M. injection 300 micrograms in 0.3 mL single dose syringe auto‑injector (EpiPen)

insert:

Afatinib	Tablet 20 mg	Oral	Giotrif	BY	MP	C4473 C7613	28	3	28
Tablet 30 mg	Oral	Giotrif	BY	MP	C4473 C7613	28	3	28
Tablet 40 mg	Oral	Giotrif	BY	MP	C4473 C7613	28	3	28
Tablet 50 mg	Oral	Giotrif	BY	MP	C4473 C7613	28	3	28

1. Schedule 1, after entry for Ambrisentan in the form Tablet 10 mg

insert:

Amino acid formula supplemented with prebiotics, probiotics and long chain polyunsaturated fatty acids	Oral powder 400 g (Neocate Syneo)	Oral	Neocate Syneo	SB	MP NP	C4305 C4312 C4323 C4330 C4337 C4338 C4339 C4345 C4352 C4368 C4414 C4415	P4305 P4312 P4323 P4330 P4337 P4338 P4339 P4345 P4352 P4415	8	5	1
MP NP	C4305 C4312 C4323 C4330 C4337 C4338 C4339 C4345 C4352 C4368 C4414 C4415	P4368 P4414	12	5	1

1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium)

omit:

Caduet 5/10 PF MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium)

omit:

Caduet 5/20 PF MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

1. Schedule 1, entry for Amlodipine with valsartan

substitute:

Amlodipine with valsartan	Tablet 5 mg (as besylate)-80 mg	Oral	a	Exforge 5/80	NV	MP NP	C4373	28	5	28
a	Valsartan/Amlodipine Novartis 80/5	NM	MP NP	C4373	28	5	28
Tablet 5 mg (as besylate)-160 mg	Oral	a	Exforge 5/160	NV	MP NP	C4373	28	5	28
a	Valsartan/Amlodipine Novartis 160/5	NM	MP NP	C4373	28	5	28
Tablet 5 mg (as besylate)-320 mg	Oral	a	Exforge 5/320	NV	MP NP	C4373	28	5	28
a	Valsartan/Amlodipine Novartis 320/5	NM	MP NP	C4373	28	5	28
Tablet 10 mg (as besylate)-160 mg	Oral	a	Exforge 10/160	NV	MP NP	C4373	28	5	28
a	Valsartan/Amlodipine Novartis 160/10	NM	MP NP	C4373	28	5	28
Tablet 10 mg (as besylate)-320 mg	Oral	a	Exforge 10/320	NV	MP NP	C4373	28	5	28
a	Valsartan/Amlodipine Novartis 320/10	NM	MP NP	C4373	28	5	28

1. Schedule 1, entry for Amlodipine with valsartan and hydrochlorothiazide

substitute:

Amlodipine with valsartan and hydrochlorothiazide	Tablet 5 mg (as besylate)-160 mg-12.5 mg	Oral	a	Exforge HCT 5/160/12.5	NV	MP NP	C4311	28	5	28
a	Valsartan/Amlodipine/HCT Novartis 160/5/12.5	NM	MP NP	C4311	28	5	28
Tablet 5 mg (as besylate)-160 mg-25 mg	Oral	a	Exforge HCT 5/160/25	NV	MP NP	C4311	28	5	28
a	Valsartan/Amlodipine/HCT Novartis 160/5/25	NM	MP NP	C4311	28	5	28
Tablet 10 mg (as besylate)-160 mg-12.5 mg	Oral	a	Exforge HCT 10/160/12.5	NV	MP NP	C4311	28	5	28
a	Valsartan/Amlodipine/HCT Novartis 160/10/12.5	NM	MP NP	C4311	28	5	28
Tablet 10 mg (as besylate)-160 mg-25 mg	Oral	a	Exforge HCT 10/160/25	NV	MP NP	C4311	28	5	28
a	Valsartan/Amlodipine/HCT Novartis 160/10/25	NM	MP NP	C4311	28	5	28
Tablet 10 mg (as besylate)-320 mg-25 mg	Oral	a	Exforge HCT 10/320/25	NV	MP NP	C4311	28	5	28
a	Valsartan/Amlodipine/HCT Novartis 320/10/25	NM	MP NP	C4311	28	5	28

1. Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL [Maximum Quantity: 1; Number of Repeats: 0]

omit:

Ranmoxy RA PDP 1 0 1

1. Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL [Maximum Quantity: 1; Number of Repeats: 1]

omit:

Ranmoxy RA MP NP 1 1 1

1. Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL [Maximum Quantity: 1; Number of Repeats: 0]

omit:

Ranmoxy RA PDP 1 0 1

1. Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL [Maximum Quantity: 1; Number of Repeats: 1]

omit:

Ranmoxy RA MP NP 1 1 1

1. Schedule 1, entry for Anastrozole

omit from the column headed “Responsible Person” for the brand “Anastrozole AN”: EA                  substitute: JO

1. Schedule 1, entry for Atorvastatin in each of the forms: Tablet 10 mg (as calcium); Tablet 20 mg (as calcium); Tablet 40 mg (as calcium); and Tablet 80 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

omit from the column headed “Purposes” (all brands): P4238               substitute: P7598

1. Schedule 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Maximum Quantity: 2; Number of Repeats: 0]

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

a ZITHRO RW MP NP C5637 C5718 C5772 P5718 P5772 2 0 2

1. Schedule 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Maximum Quantity: 2; Number of Repeats: 2]

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

a ZITHRO RW MP NP C5637 C5718 C5772 P5637 2 2 2

1. Schedule 1, entry for Balsalazide

substitute:

Balsalazide	Capsule containing balsalazide sodium 750 mg	Oral	Colazide	PK	MP NP	C4824 C7621	P4824	180	5	180
MP NP	C4824 C7621	P7621	280	5	280

1. Schedule 1, entry for Bicalutamide

omit from the column headed “Responsible Person” for the brand “Bicalutamide AN”: EA   substitute: JO

1. Schedule 1, entry for Bleomycin

omit from the column headed “Responsible Person” for the brand “Bleo 15K”: EA             substitute: JU

1. Schedule 1, entry for Brentuximab vedotin

omit from the column headed “Circumstances”: C7244            substitute: C7616

1. Schedule 1, after entry for Brinzolamide with timolol

insert:

Brivaracetam	Oral solution 10 mg per mL, 300 mL	Oral	Briviact	UC	MP	C7596 C7618	1	5	1
NP	C7596	1	5	1
Tablet 25 mg	Oral	Briviact	UC	MP	C7597 C7608	56	5	56
NP	C7608	56	5	56
Tablet 50 mg	Oral	Briviact	UC	MP	C7597 C7608	56	5	56
NP	C7608	56	5	56
Tablet 75 mg	Oral	Briviact	UC	MP	C7597 C7608	56	5	56
NP	C7608	56	5	56
Tablet 100 mg	Oral	Briviact	UC	MP	C7597 C7608	56	5	56
NP	C7608	56	5	56

1. Schedule 1, entry for Capecitabine in each of the forms: Tablet 150 mg; and Tablet 500 mg

omit from the column headed “Responsible Person” for the brand “Capecitabine AN”: EA   substitute: JO

1. Schedule 1, entry for Carbomer in the form Eye gel 2 mg per g, single dose units 0.6 mL, 30

omit from the column headed “Responsible Person” for the brand “Viscotears Gel PF”: IM               substitute: UO

1. Schedule 1, entry for Carbomer in the form Eye gel 2 mg per g, 10 g

(a)omit from the column headed “Responsible Person” for the brand “PAA” (twice occurring): IL   substitute: UL

(b)omit from the column headed “Responsible Person” for the brand “Viscotears” (twice occurring): IM                      substitute: UO

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

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

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

a Donepezil GH HQ MP NP C4219 C4220 C4224 28 5 28

1. Schedule 1, entry for Donepezil in the form Tablet containing donepezil hydrochloride 10 mg

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

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

a Donepezil GH HQ MP NP C4219 C4220 C4224 28 5 28

1. Schedule 1, entry for Dorzolamide with timolol

omit from the column headed “Responsible Person” for the brand “DORZOLAMIDE/ TIMOLOL AN 20/5”: EA            substitute: JU

1. Schedule 1, entry for Epirubicin in each of the forms: Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL; Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL; and Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL

omit from the column headed “Responsible Person” for the brand “Epirubicin ACT”: EA                  substitute: JU

1. Schedule 1, entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg

omit from the column headed “Responsible Person” for the brand “Fludarabine ACT”: EA              substitute: JU

1. Schedule 1, entry for Flutamide

omit:

Tablet 250 mg, 30 Oral Flutamide MYLAN AF MP NP C6611 3 5 1

1. Schedule 1, entry for Fluvastatin [Maximum Quantity: 28; Number of Repeats: 11]

omit from the column headed “Purposes”: P4238       substitute: P7598

1. Schedule 1, entry for Imatinib in the form Capsule 100 mg (as mesilate)

omit from the column headed “Responsible Person” for the brand “IMATINIB AN” (twice occurring): EA                     substitute: JO

1. Schedule 1, entry for Imatinib in the form Capsule 400 mg (as mesilate)

omit from the column headed “Responsible Person” for the brand “IMATINIB AN” (twice occurring): EA   substitute: JO

1. Schedule 1, entry for Interferon Gamma‑1b

omit from the column headed “Responsible Person” for the brand “Imukin”: BY                  substitute: EU

1. Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL

omit from the column headed “Responsible Person” for the brand “IRINOTECAN ACT”: ED            substitute: JU

1. Schedule 1, entry for Latanoprost with timolol

omit from the column headed “Responsible Person” for the brand “Latanoprost/timolol AN 50/5”: EA          substitute: JO

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

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

a Leflunomide generichealth HQ MP C5681 C5766 30 5 30

1. Schedule 1, entry for Letrozole

omit from the column headed “Responsible Person” for the brand “Letrozole AN”: EA   substitute: JO

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

omit from the column headed “Circumstances” (all instances): C4928    substitute: C7603

1. Schedule 1, entry for Levetiracetam in the form Oral solution 100 mg per mL, 300 mL

omit from the column headed “Circumstances” (all instances): C5215     substitute: C7620

1. Schedule 1, entry for Paclitaxel in each of the forms: Solution concentrate for I.V. infusion 30 mg in 5 mL; Solution concentrate for I.V. infusion 100 mg in 16.7 mL; Solution concentrate for I.V. infusion 150 mg in 25 mL; and Solution concentrate for I.V. infusion 300 mg in 50 mL

omit from the column headed “Responsible Person” for the brand “Paclitaxel ACT”: EF                   substitute: JU

1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

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

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

a Pantoprazole generichealth HQ MP NP C5444 C5512 C5529 30 5 30

1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30; Number of Repeats: 2]

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

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

a Pantoprazole generichealth HQ MP NP C5444 C5445 C5512 C5529 P5445 30 2 30

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

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

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

a Pantoprazole generichealth HQ MP NP C5444 C5445 C5512 C5529 P5444 P5512 P5529 30 5 30

1. Schedule 1, entry for Pembrolizumab in each of the forms: Powder for injection 50 mg; and Solution concentrate for I.V. infusion 100 mg in 4 mL

insert in numerical order in the column headed “Circumstances”: C7606 C7610

1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Maximum Quantity: 30; Number of Repeats:11]

omit from the column headed “Purposes” (all instances): P4238           substitute: P7598

1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit from the column headed “Purposes” (all instances): P4238           substitute: P7598

1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit from the column headed “Purposes” (all instances): P4238           substitute: P7598

1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit from the column headed “Purposes” (all instances): P4238           substitute: P7598

1. Schedule 1, omit entry for Risedronic acid and calcium with colecalciferol

1. Schedule 1, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate)

omit:

MAXATAN RW MP NP C5708 4 5 2

1. Schedule 1, entry for Rosuvastatin

substitute:

Rosuvastatin	Tablet 5 mg (as calcium)	Oral	a	APO-Rosuvastatin	TX	MP NP	30	5	30
a	Blooms the Chemist Rosuvastatin	IB	MP NP	30	5	30
a	Cavstat	AF	MP NP	30	5	30
a	Chem mart Rosuvastatin	CH	MP NP	30	5	30
a	Crestor	AP	MP NP	30	5	30
a	Crosuva 5	ZP	MP NP	30	5	30
a	Pharmacor Rosuvastatin 5	CR	MP NP	30	5	30
a	Rostor 5	DO	MP NP	30	5	30
a	Rosuvastatin AMNEAL	EF	MP NP	30	5	30
a	Rosuvastatin generichealth	HQ	MP NP	30	5	30
a	Rosuvastatin RBX	RA	MP NP	30	5	30
a	Rosuvastatin Sandoz	SZ	MP NP	30	5	30
a	Rosuvastatin-DRLA	RI	MP NP	30	5	30
a	Terry White Chemists Rosuvastatin	TW	MP NP	30	5	30
a	APO-Rosuvastatin	TX	MP	P7598	30	11	30
a	Blooms the Chemist Rosuvastatin	IB	MP	P7598	30	11	30
a	Cavstat	AF	MP	P7598	30	11	30
a	Chem mart Rosuvastatin	CH	MP	P7598	30	11	30
a	Crestor	AP	MP	P7598	30	11	30
a	Crosuva 5	ZP	MP	P7598	30	11	30
a	Pharmacor Rosuvastatin 5	CR	MP	P7598	30	11	30
a	Rostor 5	DO	MP	P7598	30	11	30
a	Rosuvastatin AMNEAL	EF	MP	P7598	30	11	30
a	Rosuvastatin generichealth	HQ	MP	P7598	30	11	30
a	Rosuvastatin RBX	RA	MP	P7598	30	11	30
a	Rosuvastatin Sandoz	SZ	MP	P7598	30	11	30
a	Rosuvastatin-DRLA	RI	MP	P7598	30	11	30
a	Terry White Chemists Rosuvastatin	TW	MP	P7598	30	11	30
Tablet 10 mg (as calcium)	Oral	a	APO-Rosuvastatin	TX	MP NP	30	5	30
a	Blooms the Chemist Rosuvastatin	IB	MP NP	30	5	30
a	Cavstat	AF	MP NP	30	5	30
a	Chem mart Rosuvastatin	CH	MP NP	30	5	30
a	Crestor	AP	MP NP	30	5	30
a	Crosuva 10	ZP	MP NP	30	5	30
a	Pharmacor Rosuvastatin 10	CR	MP NP	30	5	30
a	Rostor 10	DO	MP NP	30	5	30
a	Rosuvastatin AMNEAL	EF	MP NP	30	5	30
a	Rosuvastatin generichealth	HQ	MP NP	30	5	30
a	Rosuvastatin RBX	RA	MP NP	30	5	30
a	Rosuvastatin Sandoz	SZ	MP NP	30	5	30
a	Rosuvastatin-DRLA	RI	MP NP	30	5	30
a	Terry White Chemists Rosuvastatin	TW	MP NP	30	5	30
a	APO-Rosuvastatin	TX	MP	P7598	30	11	30
a	Blooms the Chemist Rosuvastatin	IB	MP	P7598	30	11	30
a	Cavstat	AF	MP	P7598	30	11	30
a	Chem mart Rosuvastatin	CH	MP	P7598	30	11	30
a	Crestor	AP	MP	P7598	30	11	30
a	Crosuva 10	ZP	MP	P7598	30	11	30
a	Pharmacor Rosuvastatin 10	CR	MP	P7598	30	11	30
a	Rostor 10	DO	MP	P7598	30	11	30
a	Rosuvastatin AMNEAL	EF	MP	P7598	30	11	30
a	Rosuvastatin generichealth	HQ	MP	P7598	30	11	30
a	Rosuvastatin RBX	RA	MP	P7598	30	11	30
a	Rosuvastatin Sandoz	SZ	MP	P7598	30	11	30
a	Rosuvastatin-DRLA	RI	MP	P7598	30	11	30
a	Terry White Chemists Rosuvastatin	TW	MP	P7598	30	11	30
Tablet 20 mg (as calcium)	Oral	a	APO-Rosuvastatin	TX	MP NP	30	5	30
a	Blooms the Chemist Rosuvastatin	IB	MP NP	30	5	30
a	Cavstat	AF	MP NP	30	5	30
a	Chem mart Rosuvastatin	CH	MP NP	30	5	30
a	Crestor	AP	MP NP	30	5	30
a	Crosuva 20	ZP	MP NP	30	5	30
a	Pharmacor Rosuvastatin 20	CR	MP NP	30	5	30
a	Rostor 20	DO	MP NP	30	5	30
a	Rosuvastatin AMNEAL	EF	MP NP	30	5	30
a	Rosuvastatin generichealth	HQ	MP NP	30	5	30
a	Rosuvastatin RBX	RA	MP NP	30	5	30
a	Rosuvastatin Sandoz	SZ	MP NP	30	5	30
a	Rosuvastatin-DRLA	RI	MP NP	30	5	30
a	Terry White Chemists Rosuvastatin	TW	MP NP	30	5	30
a	APO-Rosuvastatin	TX	MP	P7598	30	11	30
a	Blooms the Chemist Rosuvastatin	IB	MP	P7598	30	11	30
a	Cavstat	AF	MP	P7598	30	11	30
a	Chem mart Rosuvastatin	CH	MP	P7598	30	11	30
a	Crestor	AP	MP	P7598	30	11	30
a	Crosuva 20	ZP	MP	P7598	30	11	30
a	Pharmacor Rosuvastatin 20	CR	MP	P7598	30	11	30
a	Rostor 20	DO	MP	P7598	30	11	30
a	Rosuvastatin AMNEAL	EF	MP	P7598	30	11	30
a	Rosuvastatin generichealth	HQ	MP	P7598	30	11	30
a	Rosuvastatin RBX	RA	MP	P7598	30	11	30
a	Rosuvastatin Sandoz	SZ	MP	P7598	30	11	30
a	Rosuvastatin-DRLA	RI	MP	P7598	30	11	30
a	Terry White Chemists Rosuvastatin	TW	MP	P7598	30	11	30
Tablet 40 mg (as calcium)	Oral	a	APO-Rosuvastatin	TX	MP NP	30	5	30
a	Blooms the Chemist Rosuvastatin	IB	MP NP	30	5	30
a	Cavstat	AF	MP NP	30	5	30
a	Chem mart Rosuvastatin	CH	MP NP	30	5	30
a	Crestor	AP	MP NP	30	5	30
a	Crosuva 40	ZP	MP NP	30	5	30
a	Pharmacor Rosuvastatin 40	CR	MP NP	30	5	30
a	Rostor 40	DO	MP NP	30	5	30
a	Rosuvastatin AMNEAL	EF	MP NP	30	5	30
a	Rosuvastatin generichealth	HQ	MP NP	30	5	30
a	Rosuvastatin RBX	RA	MP NP	30	5	30
a	Rosuvastatin Sandoz	SZ	MP NP	30	5	30
a	Rosuvastatin-DRLA	RI	MP NP	30	5	30
a	Terry White Chemists Rosuvastatin	TW	MP NP	30	5	30
a	APO-Rosuvastatin	TX	MP	P7598	30	11	30
a	Blooms the Chemist Rosuvastatin	IB	MP	P7598	30	11	30
a	Cavstat	AF	MP	P7598	30	11	30
a	Chem mart Rosuvastatin	CH	MP	P7598	30	11	30
a	Crestor	AP	MP	P7598	30	11	30
a	Crosuva 40	ZP	MP	P7598	30	11	30
a	Pharmacor Rosuvastatin 40	CR	MP	P7598	30	11	30
a	Rostor 40	DO	MP	P7598	30	11	30
a	Rosuvastatin AMNEAL	EF	MP	P7598	30	11	30
a	Rosuvastatin generichealth	HQ	MP	P7598	30	11	30
a	Rosuvastatin RBX	RA	MP	P7598	30	11	30
a	Rosuvastatin Sandoz	SZ	MP	P7598	30	11	30
a	Rosuvastatin-DRLA	RI	MP	P7598	30	11	30
a	Terry White Chemists Rosuvastatin	TW	MP	P7598	30	11	30

1. Schedule 1, entry for Simvastatin in the form Tablet 5 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit from the column headed “Purposes” (all instances): P4238           substitute: P7598

1. Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit from the column headed “Purposes” (all instances): P4238           substitute: P7598

1. Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit from the column headed “Purposes” (all instances): P4238           substitute: P7598

1. Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit from the column headed “Purposes” (all instances): P4238           substitute: P7598

1. Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit from the column headed “Purposes” (all instances): P4238           substitute: P7598

1. Schedule 1, entry for Somatropin in the form Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative)

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

SciTropin A SA MP C5150 C5151 C5152 C5153 C5156 C5157 C5158 C5165 C5166 C5167 C5198 C5199 C5201 C5202 C5211 C5235 C5236 C5237 C5242 C5247 C5285 C5286 C5287 C5305 C5306 C5310 C5318 C5319 C5320 C5346 C5348 C5352 C5353 C5354 C5355 C5378 C5379 C5380 C5419 C5420 C5432 C5433 See Note 3 See Note 3 1 D(100)

1. Schedule 1, entry for Telmisartan with amlodipine in the form Tablet 40 mg‑5 mg (as besylate)

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

a APO-Telmisartan/Amlodipine 40/5 TX MP NP C4373 28 5 28

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

1. Schedule 1, entry for Telmisartan with amlodipine in the form Tablet 40 mg‑10 mg (as besylate)

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

a APO-Telmisartan/Amlodipine 40/10 TX MP NP C4373 28 5 28

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

1. Schedule 1, entry for Telmisartan with amlodipine in the form Tablet 80 mg‑5 mg (as besylate)

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

a APO-Telmisartan/Amlodipine 80/5 TX MP NP C4373 28 5 28

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

1. Schedule 1, entry for Telmisartan with amlodipine in the form Tablet 80 mg‑10 mg (as besylate)

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

a APO-Telmisartan/Amlodipine 80/10 TX MP NP C4373 28 5 28

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

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

omit from the column headed “Responsible Person” for the brand “Temozolomide Amneal” (twice occurring): ED                     substitute: JO

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

omit from the column headed “Responsible Person” for the brand “Temozolomide Amneal” (twice occurring): ED                     substitute: JO

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

omit from the column headed “Responsible Person” for the brand “Temozolomide Amneal” (twice occurring): ED                     substitute: JO

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

omit from the column headed “Responsible Person” for the brand “Temozolomide Amneal” (twice occurring): ED                     substitute: JO

1. Schedule 1, entry for Temozolomide in the form Capsule 180 mg

omit from the column headed “Responsible Person” for the brand “Temozolomide Amneal” (twice occurring): ED                     substitute: JO

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

omit from the column headed “Responsible Person” for the brand “Temozolomide Amneal”: ED   substitute: JO

1. Schedule 1, entry for Tobramycin in the form Solution for inhalation 300 mg in 5 mL

omit from the column headed “Responsible Person” for the brand “Tobramycin AN”: EA                  substitute: JU

1. Schedule 1, entry for Tramadol in the form Injection containing tramadol hydrochloride 100 mg in 2 mL

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

(b)omit from the column headed “Responsible Person” for the brand “Tramadol ACT”: EA   substitute: JO

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

a	Tramadol AN	JU	MP NP	C5886	5	0	5
PDP	C5818	5	0	5

1. Schedule 1, entry for Valganciclovir in the form Tablet 450 mg (as hydrochloride)

omit from the column headed “Responsible Person” for the brand “Valganciclovir AN”: EA            substitute: JO

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

insert:

SA SciGen (Australia) Pty Limited 76 055 016 969

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

insert:

UL	Bausch & Lomb (Australia) Pty Ltd	88 000 222 408
UO	Bausch & Lomb (Australia) Pty Ltd	88 000 222 408

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

insert:

Afatinib	C4473	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be as monotherapy; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must not have received previous PBS-subsidised treatment with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI); OR Patient must have developed intolerance to another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal; AND Patient must have a WHO performance status of 2 or less. Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material.	Compliance with Authority Required procedures
C7613	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be as monotherapy; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition. Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material.	Compliance with Authority Required procedures - Streamlined Authority Code 7613

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

insert:

Amino acid formula supplemented with prebiotics, probiotics and long chain polyunsaturated fatty acids	C4305	P4305	Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae Initial treatment for up to 6 months Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist. The condition must not be isolated infant colic or reflux. Patient must be older than 24 months of age. The name of the specialist and the date of birth of the patient must be included in the authority application.	Compliance with Authority Required procedures
C4312	P4312	Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein Initial treatment for up to 6 months Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist. Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides). Patient must be up to the age of 24 months. The name of the specialist and the date of birth of the patient must be included in the authority application.	Compliance with Authority Required procedures
C4323	P4323	Cows' milk protein enteropathy Initial treatment for up to 6 months Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist. The condition must not be isolated infant colic or reflux; AND Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula. Patient must be up to the age of 24 months. The name of the specialist and the date of birth of the patient must be included in the authority application.	Compliance with Authority Required procedures
C4330	P4330	Cows' milk anaphylaxis Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist. Patient must be up to the age of 24 months. Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction. The name of the specialist and the date of birth of the patient must be included in the authority application.	Compliance with Authority Required procedures
C4337	P4337	Cows' milk protein enteropathy Continuing treatment Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have an appointment to be assessed by one of these specialists. The condition must not be isolated infant colic or reflux; AND Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula. Patient must be up to the age of 24 months. The name of the specialist and the date of birth of the patient must be included in the authority application.	Compliance with Authority Required procedures
C4338	P4338	Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae Continuing treatment Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist at intervals not greater than 12 months. The condition must not be isolated infant colic or reflux. Patient must be older than 24 months of age. The name of the specialist and the date of birth of the patient must be included in the authority application.	Compliance with Authority Required procedures
C4339	P4339	Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein Continuing treatment Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist. Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides) prior to commencement with initial treatment. Patient must be up to the age of 24 months. The name of the specialist and the date of birth of the patient must be included in the authority application.	Compliance with Authority Required procedures
C4345	P4345	Severe cows' milk protein enteropathy with failure to thrive Continuing treatment Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have been assessed at least once or have an appointment to be assessed by one of these specialists. The condition must not be isolated infant colic or reflux; AND Patient must have had failure to thrive prior to commencement with initial treatment. Patient must be up to the age of 24 months. The name of the specialist and the date of birth of the patient must be included in the authority application.	Compliance with Authority Required procedures
C4352	P4352	Severe cows' milk protein enteropathy with failure to thrive Initial treatment for up to 6 months Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist. The condition must not be isolated infant colic or reflux. Patient must be up to the age of 24 months. The name of the specialist and the date of birth of the patient must be included in the authority application.	Compliance with Authority Required procedures
C4368	P4368	Eosinophilic oesophagitis Initial treatment for up to 3 months Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist. Patient must require an amino acid based formula as a component of a dietary elimination program. Patient must be 18 years of age or less. Treatment with oral steroids should not be commenced during the period of initial treatment. Eosinophilic oesophagitis is demonstrated by the following criteria: (i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and (ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and (iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The date of birth of the patient must be included in the authority application.	Compliance with Authority Required procedures
C4414	P4414	Eosinophilic oesophagitis Continuing treatment Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist. Patient must have responded to an initial course of PBS-subsidised treatment. Patient must be 18 years of age or less. Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment.	Compliance with Authority Required procedures
C4415	P4415	Severe intestinal malabsorption including short bowel syndrome Patient must have failed to respond to protein hydrolysate formulae; OR Patient must have been receiving parenteral nutrition.	Compliance with Authority Required procedures

1. Schedule 4, Part 1, entry for Atorvastatin

substitute:

Atorvastatin P7598 For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements.

1. Schedule 4, Part 1, entry for Balsalazide

(a)insert in the column headed “Purposes Code”: P4824

(b)insert in numerical order after existing text:

C7621 P7621 Ulcerative colitis Patient must have had a documented hypersensitivity reaction to a sulphonamide; OR
Patient must be intolerant to sulfasalazine. Compliance with Authority Required procedures - Streamlined Authority Code 7621

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

(a)omit:

C7244 CD30 positive systemic anaplastic large cell lymphoma Initial treatment The treatment must be for curative intent; AND
Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND
Patient must demonstrate relapsed or chemotherapy-refractory disease. Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Systemic anaplastic large cell lymphoma Brentuximab PBS Authority Application - Supporting Information Form which includes the following:
(i) a histology report including evidence of the tumour's CD30 positivity from a biopsy subsequent to the most recently delivered prior treatment with radiation, chemotherapy, biologics, immunotherapy or other agents;
(ii) The date of initial diagnosis of systemic anaplastic large cell lymphoma;
(iii) Dates of commencement and completion of front-line curative intent chemotherapy; and
(iv) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory. A maximum quantity and number of repeats to provide for an initial course of brentuximab vedotin of 4 cycles will be authorised as part of the initiating restriction. Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C7616 CD30 positive systemic anaplastic large cell lymphoma Initial treatment The treatment must be for curative intent; AND
Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND
Patient must demonstrate relapsed or chemotherapy-refractory disease.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Systemic anaplastic large cell lymphoma Brentuximab PBS Authority Application - Supporting Information Form which includes the following:
(i) a histology report including evidence of the tumour's CD30 positivity;
(ii) The date of initial diagnosis of systemic anaplastic large cell lymphoma;
(iii) Dates of commencement and completion of front-line curative intent chemotherapy; and
(iv) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory.
A maximum quantity and number of repeats to provide for an initial course of brentuximab vedotin of 4 cycles will be authorised as part of the initiating restriction. Compliance with Written Authority Required procedures

1. Schedule 4, Part 1, after entry for Brinzolamide with timolol

insert:

Brivaracetam	C7596	Intractable partial epileptic seizures Continuing treatment Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent; AND Patient must be unable to take a solid dose form of this drug; AND The treatment must not be given concomitantly with levetiracetam. Patient must be aged 16 years or older.	Compliance with Authority Required procedures - Streamlined Authority Code 7596
C7597	Intractable partial epileptic seizures Initial treatment Must be treated by a neurologist. The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent; AND The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs, which includes at least one first-line anti-epileptic agent and at least two second-line adjunctive anti-epileptic agents; AND The treatment must not be given concomitantly with levetiracetam, except for cross titration. Patient must be aged 16 years or older.	Compliance with Authority Required procedures - Streamlined Authority Code 7597
C7608	Intractable partial epileptic seizures Continuing treatment Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent; AND The treatment must not be given concomitantly with levetiracetam. Patient must be aged 16 years or older.	Compliance with Authority Required procedures - Streamlined Authority Code 7608
C7618	Intractable partial epileptic seizures Initial treatment Must be treated by a neurologist. The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent; AND The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs, which includes at least one first-line anti-epileptic agent and at least two second-line adjunctive anti-epileptic agents; AND Patient must be unable to take a solid dose form of this drug; AND The treatment must not be given concomitantly with levetiracetam, except for cross titration. Patient must be aged 16 years or older.	Compliance with Authority Required procedures - Streamlined Authority Code 7618

1. Schedule 4, Part 1, entry for Flutamide

omit:

C6611 Metastatic (stage D) carcinoma of the prostate The treatment must be in combination with GnRH (LH-RH) analogue therapy. Compliance with Authority Required procedures - Streamlined Authority Code 6611

1. Schedule 4, Part 1, entry for Fluvastatin

substitute:

Fluvastatin P7598 For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements.

1. Schedule 4, Part 1, entry for Levetiracetam

substitute:

Levetiracetam	C7603	Partial epileptic seizures The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; AND The treatment must not be given concomitantly with brivaracetam, except for cross titration.	Compliance with Authority Required procedures - Streamlined Authority Code 7603
C7620	Partial epileptic seizures The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; AND Patient must be unable to take a solid dose form of levetiracetam; AND The treatment must not be given concomitantly with brivaracetam, except for cross titration.	Compliance with Authority Required procedures - Streamlined Authority Code 7620

1. Schedule 4, Part 1, entry for Pembrolizumab

insert in numerical order after existing text:

C7606	Relapsed or Refractory Hodgkin lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition. The treatment must not exceed a total of 35 cycles in a lifetime.	Compliance with Authority Required procedures
C7610	Relapsed or Refractory Hodgkin lymphoma Initial treatment Patient must have undergone an autologous stem cell transplant (ASCT) for this condition and have experienced relapsed or refractory disease post ASCT; OR Patient must not be suitable for ASCT for this condition and have experienced relapsed or refractory disease following at least 2 prior treatments for this condition; AND Patient must not have received prior treatment with a PD-1 (programmed cell death-1) inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. Applications for authorisation of initial treatment must be in writing and must include: (a) a completed authority prescription form; (b) a completed Hodgkin lymphoma pembrolizumab PBS Authority Application.	Compliance with Written Authority Required procedures

1. Schedule 4, Part 1, entry for Pravastatin

substitute:

Pravastatin P7598 For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements.

1. Schedule 4, Part 1, omit entry for Risedronic acid and calcium with colecalciferol

1. Schedule 4, Part 1, entry for Rosuvastatin

substitute:

Rosuvastatin P7598 For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements.

1. Schedule 4, Part 1, entry for Simvastatin

substitute:

Simvastatin P7598 For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements.

1. Schedule 5, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate) [GRP-17623]

omit from the column headed “Brand”: MAXATAN