National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 10) (PB 90 of 2016) (Cth)

PB 90 of 2016

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016
(No. 10)

National Health Act 1953

I, PENNY SHAKESPEARE, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated 26 October   2016

PENNY SHAKESPEARE

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical    Benefits) Amendment Instrument 2016 (No. 10).

(2)        This Instrument may also be cited as PB 90 of 2016.

2          Commencement

This Instrument commences on 1 November 2016.

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

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

Schedule 1     Amendments

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

(a)omit from the column headed “Circumstances”:               C4153 C5467 C5468     

(b)insert in numerical order in the column headed “Circumstances”:           C6518 C6530 C6541

(c)omit from the column headed “Purposes”:         P4153 P5467

(d)insert in numerical order in the column headed “Purposes”:         P6530 P6541

[2]Schedule 1, entry for Aflibercept [Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:               C4153 C5467 C5468

(b)insert in numerical order in the column headed “Circumstances”:           C6518 C6530 C6541

(c)omit from the column headed “Purposes”:         P5468  

(d)insert in numerical order in the column headed “Purposes”:       P6518

[3]Schedule 1, entry for Allopurinol in the form Tablet 100 mg

omit:

GenRx Allopurinol GX MP NP 200 2 200

[4]Schedule 1, entry for Allopurinol in the form Tablet 300 mg

omit:

GenRx Allopurinol GX MP NP 60 2 60

[5]Schedule 1, after entry for Amino Acid Formula with Fat, Carbohydrate, Vitamins, Minerals and Trace Elements without Phenylalanine

insert:

Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine and tyrosine Bottles containing oral powder 34 g, 30 (TYR Easy Shake & Go) Oral TYR Easy Shake & Go OH MP NP C5533 4 5 1

[6]Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

(a)omit:

a Pharmacor AmoxyClav 500/125 CR PDP C5833 C5894 10 0 10

(b)omit:

a Pharmacor AmoxyClav 500/125 CR MP NP MW C5832 C5893 10 1 10

[7]Schedule 1, entry for Anastrozole

omit:

Pharmacor Anastrozole 1 CR MP NP C5464 30 5 30

[8]Schedule 1, after entry for Aripiprazole in the form Powder for injection 400 mg (as monohydrate) with diluent

insert:

Armodafinil	Tablet 50 mg	Oral	Nuvigil	TB	MP	C6503 C6547	60	5	30
Tablet 150 mg	Oral	Nuvigil	TB	MP	C6503 C6547	30	5	30
Tablet 250 mg	Oral	Nuvigil	TB	MP	C6503 C6547	30	5	30

[9]Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [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	Atorvastatin Amneal	EF	MP	C4238 C4263	P4263	30	5	30
NP	C4263	30	5	30

[10]Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

(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 Atorvastatin Amneal EF MP C4238 C4263 P4238 30 11 30

[11]Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [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	Atorvastatin Amneal	EF	MP	C4238 C4263	P4263	30	5	30
NP	C4263	30	5	30

[12]Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

(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 Atorvastatin Amneal EF MP C4238 C4263 P4238 30 11 30

[13]Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [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	Atorvastatin Amneal	EF	MP	C4238 C4263	P4263	30	5	30
NP	C4263	30	5	30

[14]Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

(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 Atorvastatin Amneal EF MP C4238 C4263 P4238 30 11 30

[15]Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [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	Atorvastatin Amneal	EF	MP	C4238 C4263	P4263	30	5	30
NP	C4263	30	5	30

[16]Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

(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 Atorvastatin Amneal EF MP C4238 C4263 P4238 30 11 30

[17]Schedule 1, entry for Auranofin

substitute:

Auranofin	Tablet 3 mg	Oral	Ridaura	GH	MP NP	60	5	60
MP NP	100	3	100

[18]Schedule 1, entry for Azacitidine

omit:

a Celazadine JU MP See Note 3 See Note 3 See Note 3 See
Note 3 1 D(100)

[19]Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 4 mg

omit:

a Pharmacor Candesartan 4 CR MP NP 30 5 30

[20]Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 8 mg

omit:

a Pharmacor Candesartan 8 CR MP NP 30 5 30

[21]Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 16 mg

omit:

a Pharmacor Candesartan 16 CR MP NP 30 5 30

[22]Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 32 mg

omit:

a Pharmacor Candesartan 32 CR MP NP 30 5 30

[23]Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg

omit:

a Pharmacor Candesartan HCT 16/12.5 CR MP NP C4374 30 5 30

[24]Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg

omit:

a Pharmacor Candesartan HCT 32/12.5 CR MP NP C4374 30 5 30

[25]Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg

omit:

a Pharmacor Candesartan HCT 32/25 CR MP NP C4374 30 5 30

[26]Schedule 1, entry for Ciclesonide in each of the forms: Pressurised inhalation 80 micrograms per dose, 120 doses (CFC-free formulation); and Pressurised inhalation 160 micrograms per dose, 120 doses (CFC‑free formulation)

omit from the column headed “Responsible Person” for the brands “Alvesco 80” and “Alvesco 160” respectively:   NQ            substitute:             AP

[27]Schedule 1, entry for Ciprofloxacin in the form Tablet 500 mg (as hydrochloride)

omit:

Ciprofloxacin 500 CR MP NP C5614 C5615 C5687 C5688 C5689 C5722 C5780 14 0 14

[28]Schedule 1, entry for Ciprofloxacin in the form Tablet 750 mg (as hydrochloride)

omit:

Ciprofloxacin 750 CR MP NP C5614 C5615 C5687 C5688 C5689 C5722 C5780 14 0 14

[29]Schedule 1, entry for Denosumab in the form Injection 60 mg in 1 mL pre-filled syringe

omit from the column headed “Circumstances”:          C6311  C6326    substitute:             C6524 C6548

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

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

Desvenlafaxine Sandoz SZ MP NP C4855 28 5 28

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

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

Desvenlafaxine Sandoz SZ MP NP C4855 28 5 28

[32]Schedule 1, after entry for Dexamethasone in the form Tablet 4 mg

insert in the columns in the order indicated:

Intravitreal injection 700 micrograms Injection Ozurdex AG MP C6506 C6542 C6560 1 1 1

[33]Schedule 1, entry for Donepezil in the form Tablet containing donepezil hydrochloride 5 mg

omit:

Pharmacor Donepezil 5 CR MP NP C4219 C4220 C4224 28 5 28

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

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

a DYTREX 30 RW MP NP C5650 28 0 28

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

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

a DYTREX 60 RW MP NP C5650 28 5 28

[36]Schedule 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)

(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 Blooms the Chemist Escitalopram IB MP NP C4755 28 5 28

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

omit from the column headed “Circumstances”:          P6445 P6458 substitute:            C6445  C6458

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

omit from the column headed “Circumstances”:          P6445 P6458 substitute:            C6445  C6458

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

omit from the column headed “Circumstances”:          P6445 P6458 substitute:            C6445  C6458

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

omit from the column headed “Circumstances”:          P6445 P6458 substitute:            C6445  C6458

[41]Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 3]

omit from the column headed “Circumstances”:          P6445 P6458 substitute:            C6445  C6458

[42]Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 5]

omit from the column headed “Circumstances”:           P6445 P6458 substitute:            C6445  C6458

[43]Schedule 1, entry for Etoposide in the form Solution for I.V. infusion 100 mg in 5 mL vial

omit from the column headed “Form”:           vial

[44]Schedule 1, entry for Exenatide in the form Injection (modified release) 2 mg single dose pre-filled pen

omit from the column headed “Circumstances”:          C6339 C6354     substitute:             C6505 C6519

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

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

a Blooms the Chemist Fluoxetine IB MP NP C4755 C6277 28 5 28

(b)omit

a Fluoxetine 20 CR MP NP C4755 C6277 28 5 28

[46]Schedule 1, entry for Foscarnet

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

[47]Schedule 1, entry for Gabapentin in each of the forms: Capsule 100 mg; and Capsule 300 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 GAPENTIN RF MP NP C4928 100 5 100

[48]Schedule 1, entry for Gabapentin in each of the forms: Tablet 600 mg; and Tablet 800 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 GAPENTIN RF MP NP C4928 100 5 100

[49]Schedule 1, entry for Hydroxyurea

omit from the column headed “Number of Repeats”:                  0          substitute:             3

[50]Schedule 1, entry for Imatinib

substitute:

Imatinib	Capsule 100 mg (as mesilate)	Oral	IMATINIB-DRLA	RZ	MP	C6495 C6496 C6497 C6499 C6509 C6510 C6525 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558	P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558	60	2	60
MP	C6495 C6496 C6497 C6499 C6509 C6510 C6525 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558	P6495 P6509 P6525	60	5	60
Capsule 400 mg (as mesilate)	Oral	IMATINIB-DRLA	RZ	MP	C6495 C6496 C6497 C6499 C6509 C6510 C6525 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558	P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558	30	2	30
MP	C6495 C6496 C6497 C6499 C6509 C6510 C6525 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558	P6495 P6509 P6525	30	5	30
Tablet 100 mg (as mesilate)	Oral	Glivec	AF	MP	C4342 C4355 C6495 C6496 C6497 C6498 C6499 C6509 C6510 C6525 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6559	P6496 P6497 P6498 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558 P6559	60	2	60
IMATINIB RBX	RA	MP	C6495 C6496 C6497 C6499 C6509 C6510 C6525 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558	P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558	60	2	60
Imatinib-Teva	TB	MP	C6495 C6496 C6497 C6499 C6509 C6510 C6525 C6526 C6527 C6528 C6538 C6539 C6549 C6550 C6557 C6558	P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6549 P6550 P6557 P6558	60	2	60
Glivec	AF	MP	C4342 C4355 C6495 C6496 C6497 C6498 C6499 C6509 C6510 C6525 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6559	P4342 P4355 P6495 P6509 P6525	60	5	60
IMATINIB RBX	RA	MP	C6495 C6496 C6497 C6499 C6509 C6510 C6525 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558	P6495 P6509 P6525	60	5	60
Imatinib-Teva	TB	MP	C6495 C6496 C6497 C6499 C6509 C6510 C6525 C6526 C6527 C6528 C6538 C6539 C6549 C6550 C6557 C6558	P6495 P6509 P6525	60	5	60
Tablet 400 mg (as mesilate)	Oral	Glivec	AF	MP	C4342 C4355 C6495 C6496 C6497 C6498 C6499 C6509 C6510 C6525 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6559	P6496 P6497 P6498 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558 P6559	30	2	30
IMATINIB RBX	RA	MP	C6495 C6496 C6497 C6499 C6509 C6510 C6525 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558	P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6540 P6549 P6550 P6551 P6557 P6558	30	2	30
Imatinib-Teva	TB	MP	C6495 C6496 C6497 C6499 C6509 C6510 C6525 C6526 C6527 C6528 C6538 C6539 C6549 C6550 C6557 C6558	P6496 P6497 P6499 P6510 P6526 P6527 P6528 P6538 P6539 P6549 P6550 P6557 P6558	30	2	30
Glivec	AF	MP	C4342 C4355 C6495 C6496 C6497 C6498 C6499 C6509 C6510 C6525 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558 C6559	P4342 P4355 P6495 P6509 P6525	30	5	30
IMATINIB RBX	RA	MP	C6495 C6496 C6497 C6499 C6509 C6510 C6525 C6526 C6527 C6528 C6538 C6539 C6540 C6549 C6550 C6551 C6557 C6558	P6495 P6509 P6525	30	5	30
Imatinib-Teva	TB	MP	C6495 C6496 C6497 C6499 C6509 C6510 C6525 C6526 C6527 C6528 C6538 C6539 C6549 C6550 C6557 C6558	P6495 P6509 P6525	30	5	30

[51]Schedule 1, entry for Isotretinoin in the form Capsule 10 mg

omit:

Isotretinoin SCP 10 CR MP C5224 60 3 60

[52]Schedule 1, entry for Lamotrigine in the form Tablet 25 mg

omit:

Lamotrust 25 CR MP NP C5138 56 5 56

[53]Schedule 1, entry for Lamotrigine in the form Tablet 50 mg

omit:

Lamotrust 50 CR MP NP C5138 56 5 56

[54]Schedule 1, entry for Lamotrigine in the form Tablet 100 mg

omit:

Lamotrust 100 CR MP NP C5138 56 5 56

[55]Schedule 1, entry for Lamotrigine in the form Tablet 200 mg

omit:

Lamotrust 200 CR MP NP C5138 56 5 56

[56]Schedule 1, after entry for Liothyronine

insert:

Lipegfilgrastim Injection 6 mg in 0.6 mL single use pre-filled syringe Injection Lonquex TB MP C6488 C6489 C6490 C6491 C6492 C6493 C6501 C6507 C6512 C6513 C6514 C6515 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6554 C6555 1 11 1 D(100)

[57]Schedule 1, entry for Mirtazapine in the form Tablet 30 mg

omit:

GenRx Mirtazapine GX MP NP C5650 30 5 30

[58]Schedule 1, entry for Modafinil

omit from the column headed “Circumstances” (twice occurring):           C5983 C6017      substitute:          C6537 C6556

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

(a)omit from the column headed “Responsible Person” for the brand “Lukair”:            FR        substitute:             AL

(b)omit:

Pharmacor Montelukast 4 CR MP NP C2617 28 5 28

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

(a)omit from the column headed “Responsible Person” for the brand “Lukair”:            FR        substitute:             AL

(b)omit:

Pharmacor Montelukast 5 CR MP NP C2618 C3217 28 5 28

[61]Schedule 1, entry for Nafarelin in the form Nasal spray (pump pack) 200 micrograms (as acetate) per dose, 60 doses [Maximum Quantity: 1; Number of Repeats: 5]

omit from the column headed “Circumstances”:           C6416 C6436      substitute:             C6517 C6552

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

omit:

I-Pantoprazole CR MP NP C5444 C5512 C5529 30 5 30

[63]Schedule 1, entry for Pegfilgrastim

omit from the column headed “Circumstances”:           C2912 C2917 C2918 C2919 C2923 C2924 C2925 C2926 C2927 C2928 C2929 C2930 C3087 C3187 C3357 C3362 C3363 C3364 C3365 C3369 C3370 C3371 C3372 C3373 C3374 C3375 C3376 C3377 C3833 C3834

substitute:C6488 C6489 C6490 C6491 C6492 C6493 C6494 C6501 C6502 C6507 C6512 C6513 C6514 C6515 C6516 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6546 C6554 C6555

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

omit from the column headed “Responsible Person” for the brand “PREXUM 2.5”:          RX        substitute:             RW

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

omit from the column headed “Responsible Person” for the brand “PREXUM 5”:              RX        substitute:             RW

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

omit from the column headed “Responsible Person” for the brand “PREXUM 10”:           RX        substitute:             RW

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

omit from the column headed “Responsible Person” for the brand “Reaptan 5/5”:            RX        substitute:             RW

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

omit from the column headed “Responsible Person” for the brand “Reaptan 5/10”:          RX        substitute:             RW

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

omit from the column headed “Responsible Person” for the brand “Reaptan 10/5”:          RX        substitute:             RW

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

omit from the column headed “Responsible Person” for the brand “Reaptan 10/10”:       RX        substitute:             RW

[71]Schedule 1, entry for Perindopril with indapamide in the form Tablet containing perindopril arginine 5 mg with indapamide hemihydrate 1.25 mg

omit from the column headed “Responsible Person” for the brand “Prexum Combi 5/1.25”:           RX        substitute:             RW

[72]Schedule 1, after entry for Phenoxymethylpenicillin in the form Powder for oral liquid 250 mg (as potassium) per 5 mL, 100 mL [Maximum Quantity: 2; Number of Repeats: 1]

insert:

Tablet 250 mg phenoxymethylpenicillin (as potassium)	Oral	Aspecillin VK	QA	MP NP PDP	50	0	25
MP NP	P5697	50	5	25
Tablet 500 mg phenoxymethylpenicillin (as potassium)	Oral	Aspecillin VK	QA	MP NP PDP	50	0	25

[73]Schedule 1, entry for Pioglitazone in the form Tablet 15 mg (as hydrochloride)

omit:

a Pharmacor Pioglitazone 15 CR MP NP C4363 C4364 C4388 28 5 28

[74]Schedule 1, entry for Pioglitazone in the form Tablet 30 mg (as hydrochloride)

omit:

a Pharmacor Pioglitazone 30 CR MP NP C4363 C4364 C4388 28 5 28

[75]Schedule 1, entry for Pioglitazone in the form Tablet 45 mg (as hydrochloride)

omit:

a Pharmacor Pioglitazone 45 CR MP NP C4363 C4364 C4388 28 5 28

[76]Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg

(a)omit:

Pharmacor Pravastat 10	CR	MP	C4238 C4263	P4263	30	5	30
NP	C4263	30	5	30

(b)omit:

Pharmacor Pravastat 10 CR MP C4238 C4263 P4238 30 11 30

[77]Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg

(a)omit:

Pharmacor Pravastat 20	CR	MP	C4238 C4263	P4263	30	5	30
NP	C4263	30	5	30

(b)omit:

Pharmacor Pravastat 20 CR MP C4238 C4263 P4238 30 11 30

[78]Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg

(a)omit:

Pharmacor Pravastat 40	CR	MP	C4238 C4263	P4263	30	5	30
NP	C4263	30	5	30

(b)omit:

Pharmacor Pravastat 40 CR MP C4238 C4263 P4238 30 11 30

[79]Schedule 1, entry for Prochlorperazine in the form Tablet containing prochlorperazine maleate 5 mg

omit:

Pharmacor Prozine 5 CR PDP MP NP 25 0 25

[80]Schedule 1, entry for Progesterone

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

Capsule 200 mg Vaginal Utrogestan HB MP C4997 42 0 42 D(100)

[81]Schedule 1, entry for Quinapril in the form Tablet 20 mg (as hydrochloride)

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

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

a ACQUIN RF MP NP 30 5 30

[82]Schedule 1, entry for Ramipril in the form Capsule 5 mg

omit:

Pharmacor Ramipril 5 CR MP NP 30 5 30

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

omit:

Pharmacor Ramipril 10 CR MP NP 30 5 30

[84]Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe
[Maximum Quantity: 1; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”:               C4803 C5051 C5054 C5055       

(b)insert in numerical order in the column headed “Circumstances”:           C6500 C6511 C6529 C6553

(c)omit from the column headed “Purposes”:         P4803 P5051 P5054

(d)insert in numerical order in the column headed “Purposes”: P6511 P6529 P6553

[85]Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe
[Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:               C4803 C5051 C5054 C5055

(b)insert in numerical order in the column headed “Circumstances”:           C6500 C6511 C6529 C6553

(c)omit from the column headed “Purposes”:         P5055

(d)insert in numerical order in the column headed “Purposes”:       P6500

[86]Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 2.3 mg in 0.23 mL [Maximum Quantity: 1;
Number of Repeats: 2]

(a)omit from the column headed “Circumstances”:               C4803 C5051 C5054 C5055       

(b)insert in numerical order in the column headed “Circumstances”:           C6500 C6511 C6529 C6553

(c)omit from the column headed “Purposes”:         P4803 P5051 P5054

(d)insert in numerical order in the column headed “Purposes”: P6511 P6529 P6553

[87]Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 2.3 mg in 0.23 mL [Maximum Quantity: 1;
Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:               C4803 C5051 C5054 C5055

(b)insert in numerical order in the column headed “Circumstances”:           C6500 C6511 C6529 C6553

(c)omit from the column headed “Purposes”:         P5055

(d)insert in numerical order in the column headed “Purposes”:       P6500

[88]Schedule 1, entry for Ribavirin

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

Tablet 200 mg	Oral	Ibavyr	IX	MP	C5957 C5958	P5957	28	2	28
MP	C5957 C5958	P5958	28	5	28

[89]Schedule 1, entry for Risperidone in the form Tablet 3 mg

omit:

a Rispericor 3 CR MP NP C4246 C5907 60 5 60

[90]      Schedule 1, entry for Risperidone in the form Tablet 4 mg

omit:

a Rispericor 4 CR MP NP C4246 C5907 60 5 60

[91]Schedule 1, entry for Roxithromycin in the form Tablet 150 mg

(a)omit:

Roxithromycin SCP 150 CR PDP 10 0 10

(b)omit:

Roxithromycin SCP 150 CR MP NP 10 1 10

[92]Schedule 1, entry for Roxithromycin in the form Tablet 300 mg

(a)omit:

Roxithromycin SCP 300 CR PDP 5 0 5

(b)omit:

Roxithromycin SCP 300 CR MP NP 5 1 5

[93]Schedule 1, entry for Ruxolitinib in the form Tablet 5 mg [Maximum Quantity: 112; Number of Repeats: 0]

omit from the column headed “Circumstances”:           C5919

[94]Schedule 1, entry for Ruxolitinib in the form Tablet 5 mg [Maximum Quantity: 112; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:               C5919  

(b)omit from the column headed “Purposes”:         P5919

[95]Schedule 1, after entry for Ruxolitinib in the form Tablet 5 mg [Maximum Quantity: 112; Number of Repeats: 5]

insert in the columns in the order indicated:

Tablet 10 mg	Oral	Jakavi	NV	MP	C5917 C5918 C5920 C5921	P5918 P5921	56	0	56
MP	C5917 C5918 C5920 C5921	P5917 P5920	56	5	56

[96]Schedule 1, entry for Ruxolitinib in the form Tablet 15 mg [Maximum Quantity: 56; Number of Repeats: 0]

omit from the column headed “Circumstances”:           C5919

[97]Schedule 1, entry for Ruxolitinib in the form Tablet 15 mg [Maximum Quantity: 56; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:               C5919

(b)omit from the column headed “Purposes”:         P5919

[98]Schedule 1, entry for Ruxolitinib in the form Tablet 20 mg [Maximum Quantity: 56; Number of Repeats: 0]

omit from the column headed “Circumstances”:           C5919

[99]Schedule 1, entry for Ruxolitinib in the form Tablet 20 mg [Maximum Quantity: 56; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:               C5919

(b)omit from the column headed “Purposes”:         P5919

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

omit:

Pharmacor Salbutamol 2.5 CR MP NP C6331 C6341 2 5 1

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

omit:

Pharmacor Salbutamol 5 CR MP NP C6331 C6341 2 5 1

[102]Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5mL [Maximum Quantity: 1; Number of Repeats: 1]

(a)insert in numerical order in the column headed “Circumstances”:               C6504 C6508

(b)insert in numerical order in the column headed “Purposes”:         P6508

[103]Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5mL [Maximum Quantity: 1; Number of Repeats: 2]

(a)insert in numerical order in the column headed “Circumstances”:               C6504 C6508

(b)insert in numerical order in the column headed “Purposes”:         P6504

[104]Schedule 1, entry for Venlafaxine in the form Capsule (modified release) 75 mg (as hydrochloride)

omit:

Venlafaxine SR SCP 75 CR MP NP C5650 28 5 28

[105]Schedule 1, entry for Venlafaxine in the form Capsule (modified release) 150 mg (as hydrochloride)

omit:

Venlafaxine SR SCP 150 CR MP NP C5650 28 5 28

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

(a)omit:

C4153 Subfoveal choroidal neovascularisation (CNV) Initial treatment Must be treated by an ophthalmologist; The condition must be due to age‑related macular degeneration (AMD); The condition must be diagnosed by fluorescein angiography; The treatment must be the sole PBS‑subsidised therapy for this condition Authority approval for initial treatment of each eye must be sought The first authority application for each eye must be made in writing or by telephone A written application must include: (a) a completed authority prescription form; (b) a completed Subfoveal Choroidal Neovascularisation (CNV) PBS Supporting Information Form; and (c) a copy of the fluorescein angiogram A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) ‑ PBS Supporting Information Form and a copy of the fluorescein angiogram. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised Where a fluorescein angiogram cannot be performed due to a contraindication as listed in the TGA‑approved product information, details of the contraindication must be provided. A copy of the report of an alternative method of diagnosis must be included in the application, for example, optical coherence tomography (OCT) or red free photography Compliance with Written or Telephone Authority Required procedures

(b)omit:

C5467	P5467	Central retinal vein occlusion with macular oedema Initial treatment Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND The condition must be diagnosed by fluorescein angiography; OR Patient must have a contraindication to fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition. Must be treated by an ophthalmologist. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made in writing or by telephone. A written application must include: a) a completed authority prescription form; b) a completed Central Retinal Vein Occlusion (CRVO) - PBS Supporting Information Form; and c) a copy of the fluorescein angiogram or alternative method of diagnosis where applicable. A telephone application must be made following submission by facsimile of a copy of a completed Central Retinal Vein Occlusion (CRVO) - PBS Supporting Information Form and a copy of the fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised. Where a fluorescein angiogram cannot be performed due to a contraindication as listed in the TGA-approved product information, details of the contraindication must be provided. A copy of the report of an alternative method of diagnosis must be included in the application, for example optical coherence tomography or red free photography.	Compliance with Written or Telephone Authority Required procedures
C5468	P5468	Diabetic macular oedema (DMO) Initial treatment Patient must have visual impairment due to diabetic macular oedema; AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND The condition must be diagnosed by fluorescein angiography; OR Patient must have a contraindication to fluorescein angiography; AND The treatment must be as monotherapy; OR The treatment must be in combination with laser photocoagulation; AND The treatment must be the sole PBS-subsidised therapy for this condition. Must be treated by an ophthalmologist. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made in writing or by telephone. A written application must include: a) a completed authority prescription form; b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and c) a copy of the fluorescein angiogram or alternative method of diagnosis where applicable. A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised. Where a fluorescein angiogram cannot be performed due to a contraindication as listed in the TGA-approved product information, details of the contraindication must be provided. A copy of the report of an alternative method of diagnosis must be included in the application, for example optical coherence tomography or red free photography.	Compliance with Written or Telephone Authority Required procedures

(c)insert in numerical order after existing text:

C6518	P6518	Diabetic macular oedema (DMO) Initial treatment Patient must have visual impairment due to diabetic macular oedema; AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND The treatment must be as monotherapy; OR The treatment must be in combination with laser photocoagulation; AND The treatment must be the sole PBS-subsidised therapy for this condition. Must be treated by an ophthalmologist. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made in writing or by telephone. A written application must include: a) a completed authority prescription form; b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and c) a copy of the optical coherence tomography or fluorescein angiogram report. A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.	Compliance with Authority Required procedures
C6530	P6530	Subfoveal choroidal neovascularisation (CNV) Initial treatment The condition must be due to age-related macular degeneration (AMD); AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition. Must be treated by an ophthalmologist. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made in writing or by telephone. A written application must include: a) a completed authority prescription form; b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and c) a copy of the optical coherence tomography or fluorescein angiogram report. A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.	Compliance with Authority Required procedures
C6541	P6541	Central retinal vein occlusion with macular oedema Initial treatment Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition. Must be treated by an ophthalmologist. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made in writing or by telephone. A written application must include: a) a completed authority prescription form; b) a completed Central Retinal Vein Occlusion (CRVO) - PBS Supporting Information Form; and c) a copy of the optical coherence tomography or fluorescein angiogram report. A telephone application must be made following submission by facsimile of a copy of a completed Central Retinal Vein Occlusion (CRVO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.	Compliance with Authority Required procedures

[107]Schedule 4, Part 1, after entry for Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine

insert:

Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine and tyrosine C5533 Tyrosinaemia

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

insert:

Armodafinil	C6503	Narcolepsy Initial treatment The treatment must be for use when therapy with dexamphetamine sulfate poses an unacceptable medical risk; OR The treatment must be for use when intolerance to dexamphetamine sulfate is of a severity to necessitate treatment withdrawal; AND Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; AND Patient must have a definite history of cataplexy; OR Patient must have a mean sleep latency less than or equal to 10 minutes on a Multiple Sleep Latency Test (MSLT); OR Patient must have an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep; AND Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia. Must be treated by a qualified sleep medicine practitioner or neurologist. The presence of any one of the following indicates treatment with dexamphetamine sulfate poses an unacceptable medical risk: (a) a psychiatric disorder; (b) a cardiovascular disorder; (c) a history of substance abuse; (d) glaucoma; (e) any other absolute contraindication to dexamphetamine sulfate as specified in the TGA-approved Product Information. The MSLT must be preceded by nocturnal polysomnography. Sleep prior to the MSLT must be at least 6 hours in duration. The authority application must be made in writing and must include the following: (a) a completed authority prescription form; and (b) a completed Narcolepsy Initial PBS authority application and Supporting information form; and (c) details of the contraindication or intolerance to dexamphetamine sulfate; and (d) either: (i) the result and date of the polysomnography test and Multiple Sleep Latency Test (MSLT) conducted by, or under the supervision of, a qualified sleep medicine practitioner; or (ii) the result and date of the electroencephalograph (EEG), conducted by, or under the supervision of, a neurologist. The polysomnography, MSLT or EEG test reports must be provided with the authority application.	Compliance with Written Authority Required procedures
C6547	Narcolepsy Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures

[109]Schedule 4, Part 1, after entry for Denosumab

(a)omit:

C6311	Osteoporosis Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. Patient must be aged 70 years or older. The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.	Compliance with Authority Required procedures - Streamlined Authority Code 6311
C6326	Established osteoporosis Patient must have fracture due to minimal trauma; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated. A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.	Compliance with Authority Required procedures - Streamlined Authority Code 6326

(b)insert in numerical order after existing text:

C6524	Established osteoporosis Patient must have fracture due to minimal trauma; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated. A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.	Compliance with Authority Required procedures - Streamlined Authority Code 6524
C6548	Osteoporosis Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. Patient must be aged 70 years or older. The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.	Compliance with Authority Required procedures - Streamlined Authority Code 6548

[110]Schedule 4, Part 1, after entry for Desvenlafaxine

insert:

Dexamethasone	C6506	Diabetic macular oedema (DMO) Continuing treatment Patient must have previously been issued with an authority prescription for this drug for the same eye; AND The treatment must be as monotherapy; OR The treatment must be in combination with laser photocoagulation; AND The treatment must be the sole PBS-subsidised therapy for this condition. Patient must have had a cataract removed in the treated eye; OR Patient must be scheduled for cataract surgery in the treated eye. Must be treated by an ophthalmologist.	Compliance with Authority Required procedures
C6542	Diabetic macular oedema (DMO) Initial treatment Patient must have visual impairment due to diabetic macular oedema; AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; OR Patient must be unsuitable for treatment with VEGF inhibitors; OR Patient must have failed prior treatment with VEGF inhibitors; AND The treatment must be as monotherapy; OR The treatment must be in combination with laser photocoagulation; AND The treatment must be the sole PBS-subsidised therapy for this condition. Patient must have had a cataract removed in the treated eye; OR Patient must be scheduled for cataract surgery in the treated eye. Must be treated by an ophthalmologist. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made in writing or by telephone. A written application must include: a) a completed authority prescription form; b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and c) a copy of the optical coherence tomography or fluorescein angiogram report. A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.	Compliance with Authority Required procedures
C6560	Diabetic macular oedema (DMO) Grandfathering treatment Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 November 2016; AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND The treatment must be as monotherapy; OR The treatment must be in combination with laser photocoagulation; AND The treatment must be the sole PBS-subsidised therapy for this condition. Patient must have had a cataract removed in the treated eye; OR Patient must be scheduled for cataract surgery in the treated eye. Must be treated by an ophthalmologist. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made in writing or by telephone. A written application must include: a) a completed authority prescription form; b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and c) a copy of the optical coherence tomography or fluorescein angiogram report. A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.	Compliance with Authority Required procedures

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

(a)omit:

C6339	Diabetes mellitus type 2 The treatment must be in combination with metformin; AND The treatment must be in combination with a sulfonylurea; AND Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea; OR Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea. The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated. The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated. Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: (a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or (b) Had red cell transfusion within the previous 3 months. The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 6339
C6354	Diabetes mellitus type 2 The treatment must be in combination with metformin; OR The treatment must be in combination with a sulfonylurea; AND Patient must have a contraindication to a combination of metformin and a sulfonylurea; OR Patient must not have tolerated a combination of metformin and a sulfonylurea; AND Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with either metformin or a sulfonylurea; OR Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with either metformin or a sulfonylurea. The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated. The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated. Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: (a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or (b) Had red cell transfusion within the previous 3 months. The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 6354

(b)insert in numerical order after existing text:

C6505	Diabetes mellitus type 2 The treatment must be in combination with metformin; AND The treatment must be in combination with a sulfonylurea; AND Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea; OR Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea. The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated. The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated. Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: (a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or (b) Had red cell transfusion within the previous 3 months. The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 6505
C6519	Diabetes mellitus type 2 The treatment must be in combination with metformin; OR The treatment must be in combination with a sulfonylurea; AND Patient must have a contraindication to a combination of metformin and a sulfonylurea; OR Patient must not have tolerated a combination of metformin and a sulfonylurea; AND Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with either metformin or a sulfonylurea; OR Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with either metformin or a sulfonylurea. The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated. The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated. Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: (a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or (b) Had red cell transfusion within the previous 3 months. The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 6519

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

substitute:

Imatinib	C4342	P4342	Gastrointestinal stromal tumour Continuing treatment The treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST); AND Patient must be at high risk of recurrence following complete surgical resection of primary GIST; AND The treatment must not exceed a dose of 400 mg per day for a period of 36 months in total (initial plus continuing therapy); AND Patient must have previously been issued with an authority prescription for imatinib for adjuvant treatment following complete resection of primary GIST. Applications for continuing therapy may be made by telephone.	Compliance with Authority Required procedures
C4355	P4355	Gastrointestinal stromal tumour Initial treatment The treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST); AND Patient must be at high risk of recurrence following complete surgical resection of primary GIST; AND The condition must be histologically confirmed by the detection of CD117 on immunohistochemical staining; AND The treatment must not exceed a dose of 400 mg per day for a period of 36 months in total (initial plus continuing therapy). Applications for authorisation of initial treatment must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Imatinib Mesylate (Glivec) PBS Authority Application for Use in Adjuvant Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following: (i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and (ii) a copy of the pathology report must include the size and mitotic rate of the tumour, and the date of tumour resection must be documented, which must not be more than 3 months prior to the date of this application. High risk of recurrence is defined as: Primary GIST greater than 5 cm with a mitotic count of greater than 5/50 high power fields (HPF); or Primary GIST greater than 10 cm with any mitotic rate; or Primary GIST with a mitotic count of greater than 10/50 HPF.	Compliance with Written Authority Required procedures
C6495	P6495	Chronic Myeloid Leukaemia (CML) Subsequent continuing The condition must be in the chronic phase of chronic myeloid leukaemia; AND Patient must have received initial continuing PBS-subsidised treatment with this drug as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure of response, to PBS-subsidised treatment with dasatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure of response, to PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND Patient must have maintained a major cytogenic response; OR Patient must have maintained a peripheral blood level of BCR-ABL of less than 1%; AND The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition. Second and subsequent authority applications for continuing therapy with imatinib mesilate may be made on the telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).	Compliance with Authority Required procedures
C6496	P6496	Dermatofibrosarcoma protuberans Initial treatment The condition must be unresectable; OR The condition must be locally recurrent; OR The condition must be metastatic; AND The treatment must not exceed a maximum dose of 800 mg per day. (1) Where the application for authority to prescribe is being sought on the basis of unresectable tumour, written evidence in support of that claim must be provided; and (2) Where the application for authority to prescribe is being sought on the basis of locally recurrent disease, the site of the local recurrence must be specified; and (3) Where the application for authority to prescribe is being sought on the basis of metastatic disease, the site(s) of metastatic disease must be provided. Applications for authorisation for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and (c) a signed patient acknowledgement	Compliance with Written Authority Required procedures
C6497	P6497	Acute lymphoblastic leukaemia Initial treatment Patient must be newly diagnosed; AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL tyrosine kinase; AND The treatment must be for induction and consolidation therapy; AND The treatment must be in combination with chemotherapy. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Acute Lymphoblastic Leukaemia Imatinib PBS Authority Application - Supporting Information Form; and (c) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow. (The date of the relevant pathology report needs to be provided); and (d) a signed patient acknowledgement	Compliance with Written Authority Required procedures
C6498	P6498	Malignant gastrointestinal stromal tumour Continuing treatment The condition must be metastatic; OR The condition must be unresectable; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be given at a dose not exceeding 600 mg per day. Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved. A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347: 472-80.) Applications for continuing treatment may be made by telephone	Compliance with Authority Required procedures
C6499	P6499	Chronic eosinophilic leukaemia or Hypereosinophilic syndrome Initial treatment Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene; AND The treatment must not exceed a maximum dose of 400 mg per day. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and (c) a copy of the pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene; and (d) a copy of the full blood examination report confirming the presence of hypereosinophilic syndrome or chronic eosinophilic leukaemia; and (e) details of organ involvement requiring treatment, including a copy of the radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate; and (f) a signed patient acknowledgement	Compliance with Written Authority Required procedures
C6509	P6509	Chronic Myeloid Leukaemia (CML) First Continuing The condition must be in the chronic phase of chronic myeloid leukaemia; AND Patient must have received initial PBS-subsidised treatment with this drug as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure of response, to PBS-subsidised treatment with dasatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure of response, to PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND Patient must have demonstrated a major cytogenic response; OR Patient must have demonstrated a peripheral blood level of BCR-ABL of less than 1%; AND The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition. First continuing applications for authorisation must be in writing and must include: (1) a completed authority prescription form; and (2) a response to treatment as evidenced by either: (a) a major cytogenetic response [see Note explaining requirements]; or (b) a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements].	Compliance with Written Authority Required procedures
C6510	P6510	Chronic Myeloid Leukaemia (CML) Initial treatment Patient must have a primary diagnosis of chronic myeloid leukaemia; AND The condition must be in the accelerated phase; AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL tyrosine kinase. Accelerated phase is defined by the presence of 1 or more of the following: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or 2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or 3. Peripheral basophils greater than or equal to 20%; or 4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or 5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome). Applications for authorisation must be in writing and must include: (a) a completed authority prescription form; and (b) a completed Imatinib Mesilate PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia - Supporting Information form, stating which of the above criteria are satisfied by the patient; and (c) a copy of the confirming pathology report from an Approved Pathology Authority in the case of criteria (1), (2), (3) and (5) above, or details of the dates of assessments in the case of progressive splenomegaly	Compliance with Written Authority Required procedures
C6525	P6525	Chronic Myeloid Leukaemia (CML) Initial Patient must have a primary diagnosis of chronic myeloid leukaemia; AND The condition must be in the chronic phase of chronic myeloid leukaemia; AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL tyrosine kinase; AND The treatment must be for first line therapy for this condition; AND Patient must not have previously experienced a failure of response to the PBS-subsidised treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure of response, to PBS-subsidised treatment with dasatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure of response, to PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND The treatment must not exceed a total maximum of 18 months of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. Applications for authorisation must be in writing and must include:(1) a completed authority prescription form; and(2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and(3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow; and(4) a signed patient acknowledgement form Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved. Patients should be commenced on a dose of imatinib mesilate of 400 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to imatinib mesilate therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter.	Compliance with Written Authority Required procedures
C6526	P6526	Chronic Myeloid Leukaemia (CML) Initial treatment Patient must a primary diagnosis of chronic myeloid leukaemia; AND The condition must be in the blast phase; AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL tyrosine kinase. Blast crisis is defined as either: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or 2. Extramedullary involvement other than spleen and liver. Applications for authorisation must be in writing and must include: (a) a completed authority prescription form; and (b) a completed Imatinib Mesilate PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia - Supporting Information form, stating which of the above criteria are satisfied by the patient; and (c) a copy of the confirming pathology report from an Approved Pathology Authority in the case of criterion (1) above, or details of the date of assessment in the case of extramedullary involvement	Compliance with Written Authority Required procedures
C6527	P6527	Dermatofibrosarcoma protuberans Continuing treatment The condition must be unresectable; OR The condition must be locally recurrent; OR The condition must be metastatic; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated a response to the PBS-subsidised treatment; AND The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed a maximum dose of 800 mg per day. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and (c) a statement that the disease has not progressed on imatinib therapy	Compliance with Written Authority Required procedures
C6528	P6528	Acute lymphoblastic leukaemia Initial treatment The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL tyrosine kinase; AND Patient must have previously received treatment with this drug for this condition under the Imatinib Compassionate Program. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Acute Lymphoblastic Leukaemia Imatinib PBS Authority Application - Supporting Information Form; and (c) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow. (The date of the relevant pathology report needs to be provided); and (d) a signed patient acknowledgement	Compliance with Written Authority Required procedures
C6538	P6538	Chronic Myeloid Leukaemia (CML) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The condition must be in the accelerated phase; AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL tyrosine kinase.	Compliance with Authority Required procedures
C6539	P6539	Myelodysplastic or myeloproliferative disorder Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The condition must be PDGFRB fusion gene-positive; AND Patient must must have achieved and maintained a complete haematological response; AND The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed a maximum dose of 400 mg per day. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and (c) a copy of the full blood examination report which demonstrates a complete haematological response; and (d) a statement that the disease has not progressed on imatinib therapy	Compliance with Written Authority Required procedures
C6540	P6540	Aggressive systemic mastocytosis with eosinophilia Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene; AND Patient must must have achieved and maintained a complete haematological response; AND The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed a maximum dose of 400 mg per day. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and (c) a copy of the full blood examination report which demonstrates a complete haematological response; and (d) a statement that the disease has not progressed on imatinib therapy	Compliance with Written Authority Required procedures
C6549	P6549	Acute lymphoblastic leukaemia Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL tyrosine kinase; AND The treatment must be for maintenance of first complete remission; AND The treatment must be in combination with chemotherapy. Imatinib is available with a lifetime maximum of 24 months for continuing treatment with imatinib therapy for patients with acute lymphoblastic leukaemia reimbursed through the PBS.	Compliance with Authority Required procedures
C6550	P6550	Chronic eosinophilic leukaemia or Hypereosinophilic syndrome Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must must have achieved and maintained a complete haematological response; AND The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed a maximum dose of 400 mg per day. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and (c) a copy of the full blood examination report which demonstrates a complete haematological response, with a normal eosinophil count; and (d) a statement that the disease has not progressed on imatinib therapy	Compliance with Written Authority Required procedures
C6551	P6551	Aggressive systemic mastocytosis with eosinophilia Initial treatment Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene; AND Patient must have previously failed an adequate trial of conventional therapy with corticosteroids; OR Patient must have previously failed an adequate trial of conventional therapy with hydroxyurea; AND The treatment must not exceed a maximum dose of 400 mg per day. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and (c) a copy of the pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene; and (d) a copy of the bone marrow biopsy report and/or other tissue biopsy report confirming the diagnosis of aggressive systemic mastocytosis and a copy of the full blood examination report demonstrating eosinophilia; and (e) details of symptomatic organ involvement requiring treatment, including a copy of the radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate; and (f) details of prior treatment trialled and the response; and (g) a signed patient acknowledgement	Compliance with Written Authority Required procedures
C6557	P6557	Chronic Myeloid Leukaemia (CML) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The condition must be in the blast phase; AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL tyrosine kinase.

C6558	P6558	Myelodysplastic or myeloproliferative disorder Initial treatment Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by standard karyotyping; OR Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by fluorescence in situ hybridization (FISH); OR Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by PDGFRB fusion gene transcript; AND Patient must have previously failed an adequate trial of conventional therapy with cytarabine; OR Patient must have previously failed an adequate trial of conventional therapy with etoposide; OR Patient must have previously failed an adequate trial of conventional therapy with hydroxyurea; AND The treatment must not exceed a maximum dose of 400 mg per day. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and (c) a copy of the pathology report confirming the platelet-derived growth factor receptor (PDGFR) gene re-arrangement; and (d) a copy of the bone marrow biopsy report which demonstrates the presence of a myelodysplastic or myeloproliferative disorder; and (e) details of the prior therapy trialled and the response; and (f) a signed patient acknowledgement	Compliance with Written Authority Required procedures
C6559	P6559	Malignant gastrointestinal stromal tumour Initial Treatment The condition must be metastatic; OR The condition must be unresectable; AND The condition must be histologically confirmed by the detection of CD117 on immunohistochemical staining; AND The treatment must be commenced at a dose not exceeding 400 mg per day; AND The treatment must not exceed 3 months under this restriction. Authority prescriptions for a higher dose will not be approved during this initial 3 month treatment period. Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved. A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347: 472-80.) Applications for authorisation must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Imatinib Mesilate PBS Authority Application for Use in the Treatment of Metastatic or Unresectable Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following: (i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and (ii) a copy of the most recent (within 2 months of the application) computed tomography (CT) scan, magnetic resonance imaging (MRI) or ultrasound assessment of the tumour(s), including whether or not there is evidence of metastatic disease; and (iii) where the application for authority to prescribe is being sought on the basis of an unresectable tumour, written evidence in support of that claim must be provided	Compliance with Written Authority Required procedures

[113]Schedule 4, Part 1, after entry for Liothyronine

insert:

Lipegfilgrastim	C6488	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving standard dose adjuvant chemotherapy for breast cancer; AND Patient must have had a prior episode of febrile neutropenia; OR Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.	Compliance with Authority Required procedures
C6489	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must must be receiving chemotherapy with fludarabine and cyclophosphamide for B-cell chronic lymphocytic leukaemia; AND Patient must have had a prior episode of febrile neutropenia; OR Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.	Compliance with Authority Required procedures
C6490	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving first-line chemotherapy for Hodgkin disease; AND Patient must have had a prior episode of febrile neutropenia; OR Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.	Compliance with Authority Required procedures
C6491	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving neoadjuvant treatment with docetaxel in combination with cisplatin and fluorouracil for inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx; AND Patient must have had a prior episode of febrile neutropenia; OR Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.	Compliance with Authority Required procedures
C6492	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving neoadjuvant treatment with docetaxel in combination with cisplatin and fluorouracil for inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx; AND Patient must have had a prior episode of febrile neutropenia; OR Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.	Compliance with Authority Required procedures - Streamlined Authority Code 6492
C6493	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy (first-line chemotherapy with escalated BEACOPP) with the intention of achieving a cure or substantial remission in Hodgkin disease.	Compliance with Authority Required procedures - Streamlined Authority Code 6493
C6501	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin lymphoma (aggressive grades; or low grade receiving an anthracycline-containing regimen).	Compliance with Authority Required procedures
C6507	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia.	Compliance with Authority Required procedures - Streamlined Authority Code 6507
C6512	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia.	Compliance with Authority Required procedures
C6513	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy (adjuvant chemotherapy with docetaxel in combination with an anthracycline and cyclophosphamide) with the intention of achieving a cure or substantial remission in breast cancer.	Compliance with Authority Required procedures
C6514	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in sarcoma.	Compliance with Authority Required procedures
C6515	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving chemotherapy for myeloma; AND Patient must have had a prior episode of febrile neutropenia; AND The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.	Compliance with Authority Required procedures - Streamlined Authority Code 6515
C6521	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours.	Compliance with Authority Required procedures
C6522	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving standard dose adjuvant chemotherapy for breast cancer; AND Patient must have had a prior episode of febrile neutropenia; OR Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.	Compliance with Authority Required procedures - Streamlined Authority Code 6522
C6523	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours.	Compliance with Authority Required procedures - Streamlined Authority Code 6523
C6531	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy (first-line chemotherapy with escalated BEACOPP) with the intention of achieving a cure or substantial remission in Hodgkin disease.	Compliance with Authority Required procedures
C6532	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving first-line chemotherapy for Hodgkin disease; AND Patient must have had a prior episode of febrile neutropenia; OR Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.	Compliance with Authority Required procedures - Streamlined Authority Code 6532
C6533	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy (adjuvant chemotherapy with docetaxel in combination with an anthracycline and cyclophosphamide) with the intention of achieving a cure or substantial remission in breast cancer.	Compliance with Authority Required procedures - Streamlined Authority Code 6533
C6534	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin lymphoma (aggressive grades; or low grade receiving an anthracycline-containing regimen).	Compliance with Authority Required procedures - Streamlined Authority Code 6534
C6535	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease.	Compliance with Authority Required procedures - Streamlined Authority Code 6535
C6536	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in sarcoma.	Compliance with Authority Required procedures - Streamlined Authority Code 6536
C6543	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease.	Compliance with Authority Required procedures
C6544	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be undergoing induction or consolidation therapy for acute myeloid leukaemia.	Compliance with Authority Required procedures - Streamlined Authority Code 6544
C6545	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must must be receiving chemotherapy with fludarabine and cyclophosphamide for B-cell chronic lymphocytic leukaemia; AND Patient must have had a prior episode of febrile neutropenia; OR Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.	Compliance with Authority Required procedures - Streamlined Authority Code 6545
C6554	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be undergoing induction or consolidation therapy for acute myeloid leukaemia.	Compliance with Authority Required procedures
C6555	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving chemotherapy for myeloma; AND Patient must have had a prior episode of febrile neutropenia; AND The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.	Compliance with Authority Required procedures

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

substitute:

Modafinil	C6537	Narcolepsy Initial treatment The treatment must be for use when therapy with dexamphetamine sulfate poses an unacceptable medical risk; OR The treatment must be for use when intolerance to dexamphetamine sulfate is of a severity to necessitate treatment withdrawal; AND Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; AND Patient must have a definite history of cataplexy; OR Patient must have a mean sleep latency less than or equal to 10 minutes on a Multiple Sleep Latency Test (MSLT); OR Patient must have an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep; AND Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia. Must be treated by a qualified sleep medicine practitioner or neurologist. The presence of any one of the following indicates treatment with dexamphetamine sulfate poses an unacceptable medical risk: (a) a psychiatric disorder; (b) a cardiovascular disorder; (c) a history of substance abuse; (d) glaucoma; (e) any other absolute contraindication to dexamphetamine sulfate as specified in the TGA-approved Product Information. The MSLT must be preceded by nocturnal polysomnography. Sleep prior to the MSLT must be at least 6 hours in duration. The authority application must be made in writing and must include the following: (a) a completed authority prescription form; and (b) a completed Narcolepsy Initial PBS authority application and Supporting information form; and (c) details of the contraindication or intolerance to dexamphetamine sulfate; and (d) either: (i) the result and date of the polysomnography test and Multiple Sleep Latency Test (MSLT) conducted by, or under the supervision of, a qualified sleep medicine practitioner; or (ii) the result and date of the electroencephalograph (EEG), conducted by, or under the supervision of, a neurologist. The polysomnography, MSLT or EEG test reports must be provided with the authority application.	Compliance with Written Authority Required procedures
C6556	Narcolepsy Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures

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

(a)omit:

C6416

Endometriosis

Intial treatment, for up to 6 months

The condition must be visually proven.

C6436

Endometriosis

Subsequent treatment, for up to 6 months

The condition must be visually proven; AND

The treatment must not be within 2 years of the end of the previous course of treatment with this drug; AND

Patient must have had a recent bone density assessment.

The date of the bone density assessment must be provided.

(b)insert in numerical order after existing text:

C6517

Endometriosis

Subsequent treatment, for up to 6 months

The condition must be visually proven; AND

The treatment must not be within 2 years of the end of the previous course of treatment with this drug; AND

Patient must have had a recent bone density assessment.

The date of the bone density assessment must be recorded in the patient's medical records.

C6552

Endometriosis

Initial treatment, for up to 6 months

The condition must be visually proven.

[116]Schedule 4, Part 1, entry for Pegfilgrastim

substitute:

Pegfilgrastim	C6488	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving standard dose adjuvant chemotherapy for breast cancer; AND Patient must have had a prior episode of febrile neutropenia; OR Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.	Compliance with Authority Required procedures
C6489	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must must be receiving chemotherapy with fludarabine and cyclophosphamide for B-cell chronic lymphocytic leukaemia; AND Patient must have had a prior episode of febrile neutropenia; OR Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.	Compliance with Authority Required procedures
C6490	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving first-line chemotherapy for Hodgkin disease; AND Patient must have had a prior episode of febrile neutropenia; OR Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.	Compliance with Authority Required procedures
C6491	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving neoadjuvant treatment with docetaxel in combination with cisplatin and fluorouracil for inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx; AND Patient must have had a prior episode of febrile neutropenia; OR Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.	Compliance with Authority Required procedures
C6492	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving neoadjuvant treatment with docetaxel in combination with cisplatin and fluorouracil for inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx; AND Patient must have had a prior episode of febrile neutropenia; OR Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.	Compliance with Authority Required procedures - Streamlined Authority Code 6492
C6493	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy (first-line chemotherapy with escalated BEACOPP) with the intention of achieving a cure or substantial remission in Hodgkin disease.	Compliance with Authority Required procedures - Streamlined Authority Code 6493
C6494	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in an infant or child with central nervous system tumours.	Compliance with Authority Required procedures
C6501	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin lymphoma (aggressive grades; or low grade receiving an anthracycline-containing regimen).	Compliance with Authority Required procedures
C6502	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in an infant or child with central nervous system tumours.	Compliance with Authority Required procedures - Streamlined Authority Code 6502
C6507	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia.	Compliance with Authority Required procedures - Streamlined Authority Code 6507
C6512	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia.	Compliance with Authority Required procedures
C6513	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy (adjuvant chemotherapy with docetaxel in combination with an anthracycline and cyclophosphamide) with the intention of achieving a cure or substantial remission in breast cancer.	Compliance with Authority Required procedures
C6514	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in sarcoma.	Compliance with Authority Required procedures
C6515	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving chemotherapy for myeloma; AND Patient must have had a prior episode of febrile neutropenia; AND The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.	Compliance with Authority Required procedures - Streamlined Authority Code 6515
C6516	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma.	Compliance with Authority Required procedures - Streamlined Authority Code 6516
C6521	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours.	Compliance with Authority Required procedures
C6522	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving standard dose adjuvant chemotherapy for breast cancer; AND Patient must have had a prior episode of febrile neutropenia; OR Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.	Compliance with Authority Required procedures - Streamlined Authority Code 6522
C6523	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours.	Compliance with Authority Required procedures - Streamlined Authority Code 6523
C6531	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy (first-line chemotherapy with escalated BEACOPP) with the intention of achieving a cure or substantial remission in Hodgkin disease.	Compliance with Authority Required procedures
C6532	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving first-line chemotherapy for Hodgkin disease; AND Patient must have had a prior episode of febrile neutropenia; OR Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.	Compliance with Authority Required procedures - Streamlined Authority Code 6532
C6533	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy (adjuvant chemotherapy with docetaxel in combination with an anthracycline and cyclophosphamide) with the intention of achieving a cure or substantial remission in breast cancer.	Compliance with Authority Required procedures - Streamlined Authority Code 6533
C6534	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin lymphoma (aggressive grades; or low grade receiving an anthracycline-containing regimen).	Compliance with Authority Required procedures - Streamlined Authority Code 6534
C6535	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease.	Compliance with Authority Required procedures - Streamlined Authority Code 6535
C6536	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in sarcoma.	Compliance with Authority Required procedures - Streamlined Authority Code 6536
C6543	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease.	Compliance with Authority Required procedures
C6544	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must be undergoing induction or consolidation therapy for acute myeloid leukaemia.	Compliance with Authority Required procedures - Streamlined Authority Code 6544
C6545	Where the patient is receiving treatment at/from a public hospital Chemotherapy-induced neutropenia Patient must must be receiving chemotherapy with fludarabine and cyclophosphamide for B-cell chronic lymphocytic leukaemia; AND Patient must have had a prior episode of febrile neutropenia; OR Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.	Compliance with Authority Required procedures - Streamlined Authority Code 6545
C6546	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma.	Compliance with Authority Required procedures
C6554	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be undergoing induction or consolidation therapy for acute myeloid leukaemia.	Compliance with Authority Required procedures
C6555	Where the patient is receiving treatment at/from a private hospital Chemotherapy-induced neutropenia Patient must be receiving chemotherapy for myeloma; AND Patient must have had a prior episode of febrile neutropenia; AND The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.	Compliance with Authority Required procedures

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

(a)omit:

C4803 P4803 Subfoveal choroidal neovascularisation (CNV) Initial treatment The condition must be due to age-related macular degeneration (AMD); AND
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition Must be treated by an ophthalmologist Authority approval for initial treatment of each eye must be sought The first authority application for each eye must be made in writing or by telephone A written application must include:
a) a completed authority prescription form;
b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and
c) a copy of the fluorescein angiogram A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorized Where a fluorescein angiogram cannot be performed due to a contraindication as listed in the TGA-approved product information, details of the contraindication must be provided. A copy of the report of an alternative method of diagnosis must be included in the application, for example, optical coherence tomography (OCT) or red free photography Compliance with Written or Telephone Authority Required procedures

(b)omit:

C5051 P5051 Branch retinal vein occlusion with macular oedema Initial treatment Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND
The condition must be diagnosed by fluorescein angiography; OR
Patient must have a contraindication to fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition Must be treated by an ophthalmologist Authority approval for initial treatment of each eye must be sought The first authority application for each eye must be made in writing or by telephone A written application must include:
a) a completed authority prescription form;
b) a completed Branched Retinal Vein Occlusion (BRVO) - PBS Supporting Information Form; and
c) a copy of the fluorescein angiogram or alternative method of diagnosis where applicable A telephone application must be made following submission by facsimile of a copy of a completed Branched Retinal Vein Occlusion (BRVO) - PBS Supporting Information Form and a copy of the fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised Where a fluorescein angiogram cannot be performed due to a contraindication as listed in the TGA-approved product information, details of the contraindication must be provided. A copy of the report of an alternative method of diagnosis must be included in the application, for example optical coherence tomography or red free photography Compliance with Written or Telephone Authority Required procedures

(c)omit:

C5054	P5054	Central retinal vein occlusion with macular oedema Initial treatment Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND The condition must be diagnosed by fluorescein angiography; OR Patient must have a contraindication to fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition Must be treated by an ophthalmologist Authority approval for initial treatment of each eye must be sought The first authority application for each eye must be made in writing or by telephone A written application must include: a) a completed authority prescription form; b) a completed Central Retinal Vein Occlusion (CRVO) - PBS Supporting Information Form; and c) a copy of the fluorescein angiogram or alternative method of diagnosis where applicable A telephone application must be made following submission by facsimile of a copy of a completed Central Retinal Vein Occlusion (CRVO) - PBS Supporting Information Form and a copy of the fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised Where a fluorescein angiogram cannot be performed due to a contraindication as listed in the TGA-approved product information, details of the contraindication must be provided. A copy of the report of an alternative method of diagnosis must be included in the application, for example optical coherence tomography or red free photography	Compliance with Written or Telephone Authority Required procedures
C5055	P5055	Diabetic macular oedema (DMO) Initial treatment Patient must have visual impairment due to diabetic macular oedema; AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND The condition must be diagnosed by fluorescein angiography; OR Patient must have a contraindication to fluorescein angiography; AND The treatment must be as monotherapy; OR The treatment must be in combination with laser photocoagulation; AND The treatment must be the sole PBS-subsidised therapy for this condition Must be treated by an ophthalmologist Authority approval for initial treatment of each eye must be sought The first authority application for each eye must be made in writing or by telephone A written application must include: a) a completed authority prescription form; b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and c) a copy of the fluorescein angiogram or alternative method of diagnosis where applicable A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised Where a fluorescein angiogram cannot be performed due to a contraindication as listed in the TGA-approved product information, details of the contraindication must be provided. A copy of the report of an alternative method of diagnosis must be included in the application, for example optical coherence tomography or red free photography	Compliance with Written or Telephone Authority Required procedures

(d)insert in numerical order after existing text:

C6500	P6500	Diabetic macular oedema (DMO) Initial treatment Patient must have visual impairment due to diabetic macular oedema; AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND The treatment must be as monotherapy; OR The treatment must be in combination with laser photocoagulation; AND The treatment must be the sole PBS-subsidised therapy for this condition. Must be treated by an ophthalmologist. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made in writing or by telephone. A written application must include: a) a completed authority prescription form; b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and c) a copy of the optical coherence tomography or fluorescein angiogram report. A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.	Compliance with Authority Required procedures
C6511	P6511	Central retinal vein occlusion with macular oedema Initial treatment Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition. Must be treated by an ophthalmologist. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made in writing or by telephone. A written application must include: a) a completed authority prescription form; b) a completed Central Retinal Vein Occlusion (CRVO) - PBS Supporting Information Form; and c) a copy of the optical coherence tomography or fluorescein angiogram report. A telephone application must be made following submission by facsimile of a copy of a completed Central Retinal Vein Occlusion (CRVO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.	Compliance with Authority Required procedures
C6529	P6529	Branch retinal vein occlusion with macular oedema Initial treatment Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition. Must be treated by an ophthalmologist. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made in writing or by telephone. A written application must include: a) a completed authority prescription form; b) a completed Branched Retinal Vein Occlusion (BRVO) - PBS Supporting Information Form; and c) a copy of the optical coherence tomography or fluorescein angiogram report. A telephone application must be made following submission by facsimile of a copy of a completed Branched Retinal Vein Occlusion (BRVO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.	Compliance with Authority Required procedures
C6553	P6553	Subfoveal choroidal neovascularisation (CNV) Initial treatment The condition must be due to age-related macular degeneration (AMD); AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition. Must be treated by an ophthalmologist. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made in writing or by telephone. A written application must include: a) a completed authority prescription form; b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and c) a copy of the optical coherence tomography or fluorescein angiogram report. A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.	Compliance with Authority Required procedures

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

omit:

C5919 P5919 High risk, intermediate-2 risk and intermediate-1 risk myelofibrosis Grandfathering treatment The condition must be primary myelofibrosis or post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis; AND
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition before 1 February 2016. Compliance with Written Authority Required procedures

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

insert in numerical order after existing text:

C6504	P6504	Severe psoriatic arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more), Initial 2 (change or recommencement of treatment) - balance of supply Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 28 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment) restriction to complete 28 weeks treatment; AND The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restrictions. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.	Compliance with Authority Required procedures
C6508	P6508	Severe psoriatic arthritis Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) or Continuing treatment - balance of supply Patient must have received insufficient therapy with this drug under the Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) 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 psoriatic arthritis.	Compliance with Authority Required procedures

[120]Schedule 4, Part 3, General statement for drugs for the treatment of hepatitis C

substitute:

Part 3—General statement for drugs for the treatment of hepatitis C

1  Criteria for eligibility for drugs for the treatment of chronic hepatitis C

The criteria for patient eligibility for drugs for the treatment of chronic hepatitis C are that:

(1)  the patient is 18 years or older; and

(2)  the patient has been assessed in accordance with paragraph 2 of this Part; and

(3)  the patient is:

a.  treated by a medical practitioner who is experienced in the treatment of patients with chronic hepatitis C infection; or

b.  treated in consultation with a medical practitioner who is experienced in the treatment of patients with chronic hepatitis C infection and who is:

i.  a gastroenterologist; or

ii.  a hepatologist; or

iii.  an infectious diseases physician

2  Assessment of patient

For the purpose of subparagraph 1(2) of this Part, the patient has been assessed if the treating medical practitioner has:

(1)  documented the following information in the patient’s medical records:

a.  evidence of chronic hepatitis C infection; and

b.  evidence of the patient’s hepatitis C virus genotype; and

(2)  chosen a regimen in accordance with paragraph 3 of this Part; and

(3)  collected the following information for the purposes of the authority application:

a.  the patient’s hepatitis C virus genotype; and

b.  whether the patient is:

i.  cirrhotic; or

ii.  Non-cirrhotic

(4)  In this paragraph, evidence of chronic hepatitis C infection is documentation of:

a.  repeat test results showing antibody to hepatitis C virus (anti-HCV) positive; and

b.  test result showing hepatitis C virus ribonucleic acid (RNA) positive

3  Treatment regimen

For the purpose of subparagraph 2(2) of this Part, the treating medical practitioner has chosen a regimen in accordance with this paragraph if the patient:

(1)  is a kind of patient mentioned for an Item in column 2 of the following table; and

(2)  is to receive one of the regimens mentioned in column 3 of the same Item of the following table

Item	Kind of patient	Regimen
1	Patient: (a)     with Genotype 1; and (b)     who is treatment naïve; and (c)     who is non-cirrhotic	Either: (a)     LEDIPASVIR with SOFOSBUVIR for 8 weeks; or (b)     LEDIPASVIR with SOFOSBUVIR for 12 weeks; or (c)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or (d)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or (e)     PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR for 12 weeks; or (f)   PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks.
2	Patient: (a)     with Genotype 1; and (b)     who is treatment experienced; and (c)     who is non-cirrhotic	Either: (a)     LEDIPASVIR with SOFOSBUVIR for 12 weeks; or (b)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or (c)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or (d)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or (e)     PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR for 12 weeks; or (f)   PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks.
3	Patient: (a)     with Genotype 2; and (b)     who is treatment naïve; and (c)     who is non-cirrhotic	SOFOSBUVIR and RIBAVIRIN for 12 weeks.
4	Patient: (a)     with Genotype 2; and (b)     who is treatment experienced; and (c)     who is non-cirrhotic	SOFOSBUVIR and RIBAVIRIN for 12 weeks.
5	Patient: (a)     with Genotype 3; and (b)     who is treatment naïve; and (c)     who is non-cirrhotic	Either: (a)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or (b)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
6	Patient: (a)     with Genotype 3; and (b)     who is treatment experienced; and (c)     who is non-cirrhotic	Either: (a)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or (b)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
7	Patient: (a)     with: (i)    Genotype 4; or (ii)     Genotype 5; or (iii)    Genotype 6; and (b)     who is treatment naïve; and (c)     who is non-cirrhotic	SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
8	Patient: (a)     with: (i)    Genotype 4; or (ii)     Genotype 5; or (iii)    Genotype 6; and (b)     who is treatment experienced; and (c)     who is non-cirrhotic	SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
9	Patient: (a)     with Genotype 1; and (b)   who is treatment naïve; and (c)    who is cirrhotic	Either: (a)     LEDIPASVIR with SOFOSBUVIR for 12 weeks; or (b)     DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (c)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or (d)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or (e)     PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks.
10	Patient: (a)     with Genotype 1; and (b)     who is treatment experienced; and (c)     who is cirrhotic	Either: (a)     LEDIPASVIR with SOFOSBUVIR for 24 weeks; or (b)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or (c)     DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (d)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or (e)     PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or (f)   PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 24 weeks.
11	Patient: (a)     with Genotype 2; and (b)     who is treatment naïve; and (c)     who is cirrhotic	SOFOSBUVIR and RIBAVIRIN for 12 weeks.
12	Patient: (a)     with Genotype 2; and (b)     who is treatment experienced; and (c)     who is cirrhotic	SOFOSBUVIR and RIBAVIRIN for 12 weeks.
13	Patient: (a)     with Genotype 3; and (b)     who is treatment naïve; and (c)     who is cirrhotic	Either: (a)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (b)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or (c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or (d)     DACLATASVIR and SOFOSBUVIR and RBV for 12 weeks; or (e)     DACLATASVIR and SOFOSBUVIR and RBV for  24 weeks.
14	Patient: (a)     with Genotype 3; and (b)     who is treatment experienced; and (c)     who is cirrhotic	Either: (a)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or (b)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or (d)     DACLATASVIR and SOFOSBUVIR and RBV for 12 weeks; or (e)     DACLATASVIR and SOFOSBUVIR and RBV for  24 weeks.
15	Patient: (a)     with: (i)    Genotype 4; or (ii)     Genotype 5; or (iii)    Genotype 6; and (b)   who is treatment naïve; and (c)    who is cirrhotic	SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
16	Patient: (a)     with: (i)    Genotype 4; or (ii)     Genotype 5; or (iii)    Genotype 6; and (b)   who is treatment experienced; and (c)    who is cirrhotic	SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.

[121]Schedule 5, entry for Desvenlafaxine

substitute:

Desvenlafaxine	GRP-16219	Tablet (extended release) 100 mg (as succinate)	Oral	Pristiq
		Tablet (modified release) 100 mg	Oral	Desvenlafaxine Sandoz Desvenlafaxine Actavis Desfax
		Tablet (modified release) 100 mg (as benzoate)	Oral	Desvenlafaxine GH XR APO-Desvenlafaxine MR
	GRP-16220	Tablet (extended release) 50 mg (as succinate)	Oral	Pristiq
		Tablet (modified release) 50 mg	Oral	Desvenlafaxine Sandoz Desvenlafaxine Actavis Desfax
		Tablet (modified release) 50 mg (as benzoate)	Oral	Desvenlafaxine GH XR APO-Desvenlafaxine MR

[122]Schedule 5, after entry for Hydroxocobalamin

insert:

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

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

omit from the column headed “Brand”:        Pharmacor Ramipril 10