National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 5) (PB 45 of 2017) (Cth)

PB 45 of 2017

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017
(No. 5)

National Health Act 1953

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

Dated       27 June 2017

PENNY SHAKEPEARE

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 2017 (No. 5).

(2)        This Instrument may also be cited as PB 45 of 2017.

2          Commencement

This Instrument commences on 1 July 2017.

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

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

Schedule 1     Amendments

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

omit from the column headed “Purposes”:    C6874   substitute:             P6874

1. Schedule 1, entry for Abiraterone

omit from the column headed “Circumstances”:          C4654   substitute:             C6944

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

insert in the columns in the order indicated:

Injection 40 mg in 0.8 mL pre-filled pen, 4	Injection	Humira	VE	MP	C6946 C6971 C6972	P6946	1	2	1
MP	C6946 C6971 C6972	P6971 P6972	1	5	1

1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen, 6

insert in numerical order in the column headed “Circumstances”:         C6951 C6963    

1. Schedule 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 200 mg

(a)omit:

Chem mart Amiodarone CH MP NP C5665 30 5 30

(b)omit:

Terry White Chemists Amiodarone TW MP NP C5665 30 5 30

1. Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 0]

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

a AmoxyClav generichealth 875/125 HQ PDP C5833 C5894 10 0 10

1. Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 1]

(a)omit from the column headed “Authorised Prescriber” for the brand “AlphaClav Duo Forte”:            MW

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

a AmoxyClav generichealth 875/125 HQ MP NP C5832 C5893 10 1 10

1. Schedule 1, entry for Anastrozole

(a)omit:

a Chem mart Anastrozole CH MP NP C5464 30 5 30

(b)omit:

a Terry White Chemists Anastrozole TW MP NP C5464 30 5 30

1. Schedule 1, entry for Aripiprazole in each of the forms: Tablet 10 mg; Tablet 15 mg; Tablet 20 mg; and Tablet 30 mg

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

a Abyraz AF MP NP C4246 30 5 30

1. Schedule 1, entry for Azacitadine

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

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

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

(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 Azithromycin Mylan AF MP NP C5637 C5718 C5772 P5718 P5772 2 0 2

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

(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 Azithromycin Mylan AF MP NP C5637 C5718 C5772 P5637 2 2 2

1. Schedule 1, entry for Botulinum toxin type A purified neurotoxin complex

omit from the column headed “Circumstances”:          C5333  
insert in numerical order:  C6953

1. Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 8 mg

omit:

a Candesartan GH GQ MP NP 30 5 30

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

omit from the column headed “Responsible Person”: AQ       substitute:             IV

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

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

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

1. Schedule 1, entry for Carvedilol in each of the forms: Tablet 12.5 mg; and Tablet 25 mg

omit:

Carvedilol generichealth GQ MP NP C5324 C5394 60 5 60

1. Schedule 1, entry for Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate)

(a)omit:

Chem mart Cefaclor CD CH PDP 10 0 10

(b)omit:

Terry White Chemists Cefaclor CD TW PDP 10 0 10

(c)omit:

Chem mart Cefaclor CD CH MP 10 1 10

(d)omit:

Terry White Chemists Cefaclor CD TW MP 10 1 10

1. Schedule 1, entry for Cefuroxime

omit:

Tablet 250 mg (as axetil)	Oral	Zinnat	AS	PDP	14	0	14
MP	14	1	14

substitute:

Tablet 250 mg (as axetil)	Oral	a	Pharmacor Cefuroxime	CR	PDP	14	0	14
a	Zinnat	AS	PDP	14	0	14
a	Pharmacor Cefuroxime	CR	MP	14	1	14
a	Zinnat	AS	MP	14	1	14

1. Schedule 1, entry for Dasatinib in the form Tablet 20 mg [Maximum Quantity; 60; Number of Repeats: 2]

omit from the column headed “Circumstances”:          C6785 C6797 C6798     
insert in numerical order:  C6947 C6959 C6968

1. Schedule 1, entry for Dasatinib in the form Tablet 20 mg [Maximum Quantity; 60; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:               C6785 C6797 C6798     
insert in numerical order:       C6947 C6959 C6968

(b)omit from the column headed “Purposes”:         P6785 P6797 P6798 substitute:             P6947 P6959 P6968

1. Schedule 1, entry for Dasatinib in the form Tablet 50 mg [Maximum Quantity; 60; Number of Repeats: 2]

omit from the column headed “Circumstances”:          C6785 C6797 C6798     
insert in numerical order:  C6947 C6959 C6968

1. Schedule 1, entry for Dasatinib in the form Tablet 50 mg [Maximum Quantity; 60; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:               C6785 C6797 C6798     
insert in numerical order:       C6947 C6959 C6968

(b)omit from the column headed “Purposes”:         P6785 P6797 P6798 substitute:             P6947 P6959 P6968

1. Schedule 1, entry for Dasatinib in the form Tablet 70 mg [Maximum Quantity; 60; Number of Repeats: 2]

omit from the column headed “Circumstances”:          C6785 C6797 C6798     
insert in numerical order:  C6947 C6959 C6968

1. Schedule 1, entry for Dasatinib in the form Tablet 70 mg [Maximum Quantity; 60; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:               C6785 C6797 C6798     
insert in numerical order:       C6947 C6959 C6968

(b)omit from the column headed “Purposes”:         P6785 P6797 P6798 substitute:             P6947 P6959 P6968

1. Schedule 1, entry for Dasatinib in the form Tablet 100 mg [Maximum Quantity; 30; Number of Repeats: 2]

omit from the column headed “Circumstances”:          C6785 C6797 C6798     
insert in numerical order:  C6947 C6959 C6968

1. Schedule 1, entry for Dasatinib in the form Tablet 100 mg [Maximum Quantity; 30; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:               C6785 C6797 C6798     
insert in numerical order:       C6947 C6959 C6968

(b)omit from the column headed “Purposes”:         P6785 P6797 P6798 substitute:             P6947 P6959 P6968

1. Schedule 1, entry for Degarelix in the form Powder for injection 80 mg (as acetate), injection set

omit from the column headed “Circumstances”:          C5646   substitute:             C6952

1. Schedule 1, entry for Degarelix in the form Powder for injection 120 mg (as acetate), 2, injection set

omit from the column headed “Circumstances”:          C5786   substitute:             C6976

1. Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg [Maximum Quantity: 100;
   Number of Repeats: 0]

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

a Diclofenac Amneal ED PDP C6256 C6282 100 0 50

1. Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg [Maximum Quantity: 100;
   Number of Repeats: 3]

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

a Diclofenac Amneal ED MP NP C6149 C6214  C6283 100 3 50

1. Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg [Maximum Quantity: 50;
   Number of Repeats: 0]

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

a Diclofenac Amneal ED PDP C6256 C6282 50 0 50

1. Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg [Maximum Quantity: 50;
   Number of Repeats: 3]

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

a Diclofenac Amneal ED MP NP C6149 C6214  C6283 50 3 50

1. Schedule 1, entry for Dipyridamole with Aspirin

omit:

APO-Dipyridamole/ Aspirin 200/25 TX MP NP C6424 60 5 60

1. Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial

omit:

Doxorubicin MYX OC MP See Note 3 See
Note 3 1 D(100)

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

omit:

Hospira Pty Limited PF MP See Note 3 See
Note 3 1 D(100)

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

omit:

DBL Epirubicin Hydrochloride Injection PF MP See Note 3 See
Note 3 1 D(100)

1. Schedule 1, entry for Epoprostenol

(a)omit:

Powder for I.V. infusion, 500 micrograms (as sodium) infusion administration set Injection Flolan Kit GK MP See Note 3 See Note 3 See Note 3 See
Note 3 1 D(100)

(b)omit:

Powder for I.V. infusion, 1.5 mg (as sodium) infusion administration set Injection Flolan Kit GK MP See Note 3 See Note 3 See Note 3 See
Note 3 1 D(100)

1. Schedule 1, entry for Exemestane

(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	Estamane	JU	MP	C4796 C5522	30	5	30
NP	C5522	30	5	30

1. Schedule 1, entry for Fentanyl in the form Transdermal patch 2.1 mg

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

APO-Fentanyl TX MP NP C4952 5 0 5

1. Schedule 1, entry for Fentanyl in the form Transdermal patch 4.2 mg

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

APO-Fentanyl TX MP NP C4952 5 0 5

1. Schedule 1, entry for Fentanyl in the form Transdermal patch 8.4 mg

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

APO-Fentanyl TX MP NP C4952 5 0 5

1. Schedule 1, entry for Fentanyl in the form Transdermal patch 12.6 mg

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

APO-Fentanyl TX MP NP C4952 5 0 5

1. Schedule 1, entry for Fentanyl in the form Transdermal patch 16.8 mg

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

APO-Fentanyl TX MP NP C4952 5 0 5

1. Schedule 1, entry for Fluconazole in the form Solution for I.V. infusion 200 mg in 100 mL

omit from the column headed “Circumstances” (twice occurring):          C5978 C5989 C5996 C6002 C6023 C6030           
substitute:             C6956 C6960 C6965 C6969 C6974 C6978

1. Schedule 1, entry for Fluvoxamine in each of the forms: Tablet containing fluvoxamine maleate 50 mg; and Tablet containing fluvoxamine maleate 100 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 Fluvoxamine AN ED MP NP C4755 C6277 30 5 30

1. Schedule 1, entry for Gabapentin in the form Capsule 300 mg

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

a Gabapentin AN EA MP NP C4928 100 5 100

1. Schedule 1, entry for Gabapentin in the form Capsule 400 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 Gabapentin AN EA MP NP C4928 100 5 100

1. Schedule 1, entry for Gemcitabine in each of the forms: Powder for I.V. infusion 200 mg (as hydrochloride); Powder for I.V. infusion 1 g (as hydrochloride); and Powder for I.V. infusion 2 g (as hydrochloride)

omit:

DBL Gemcitabine for Injection PF MP See Note 3 See
Note 3 1 D(100)

1. Schedule 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Maximum Quantity; 60; Number of Repeats: 2]

omit from the column headed “Circumstances” (all instances):               C6703 C6743 C6744     
insert in numerical order:  C6948 C6949 C6973

1. Schedule 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Maximum Quantity; 60; Number of Repeats: 5]

(a)omit from the column headed “Circumstances” (all instances):     C6703 C6743 C6744     
insert in numerical order:       C6948 C6949 C6973

(b)omit from the column headed “Purposes” (all instances):               P6703 P6743 P6744 substitute:             P6948 P6949 P6973

1. Schedule 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Maximum Quantity; 30; Number of Repeats: 2]

omit from the column headed “Circumstances” (all instances):               C6703 C6743 C6744     
insert in numerical order:  C6948 C6949 C6973

1. Schedule 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Maximum Quantity; 30; Number of Repeats: 5]

(a)omit from the column headed “Circumstances” (all instances):     C6703 C6743 C6744     
insert in numerical order:       C6948 C6949 C6973

(b)omit from the column headed “Purposes” (all instances):               P6703 P6743 P6744 substitute:             P6948 P6949 P6973

1. Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Maximum Quantity; 60; Number of Repeats: 2]

omit from the column headed “Circumstances” (all instances):               C6703 C6743 C6744     
insert in numerical order:  C6948 C6949 C6973

1. Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Maximum Quantity; 60; Number of Repeats: 5; Brand: Glivec]

(a)omit from the column headed “Circumstances”:               C6703 C6743 C6744     
insert in numerical order:       C6948 C6949 C6973

(b)omit from the column headed “Purposes”:         P6703 P6743 P6744
insert in numerical order:       P6948 P6949 P6973

1. Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Maximum Quantity; 60; Number of Repeats: 5;
   Brands: IMATINIB RBX; Imatinib-Teva]

(a)omit from the column headed “Circumstances”:               C6703 C6743 C6744     
insert in numerical order:       C6948 C6949 C6973

(b)omit from the column headed “Purposes”:         P6703 P6743 P6744 substitute:             P6948 P6949 P6973

1. Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Maximum Quantity; 30; Number of Repeats: 2]

omit from the column headed “Circumstances” (all instances):               C6703 C6743 C6744     
insert in numerical order:  C6948 C6949 C6973

1. Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Maximum Quantity; 30; Number of Repeats: 5; Brand: Glivec]

(a)omit from the column headed “Circumstances”:               C6703 C6743 C6744     
insert in numerical order:       C6948 C6949 C6973

(b)omit from the column headed “Purposes”:         P6703 P6743 P6744
insert in numerical order:       P6948 P6949 P6973

1. Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Maximum Quantity; 30; Number of Repeats: 5;
   Brands: IMATINIB RBX; Imatinib-Teva]

(a)omit from the column headed “Circumstances”:               C6703 C6743 C6744     
insert in numerical order:       C6948 C6949 C6973

(b)omit from the column headed “Purposes”:         P6703 P6743 P6744 substitute:             P6948 P6949 P6973

1. Schedule 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg

(a)omit:

Chem mart Indapamide CH MP NP 90 1 90

(b)omit:

Terry White Chemists Indapamide TW MP NP 90 1 90

1. Schedule 1, after entry for Insect Allergen Extract—Honey Bee Venom in the form Injection set containing 550 micrograms

insert in the columns in the order indicated:

Injection set containing 550 micrograms with diluent Injection Hymenoptera Honey Bee Venom DE MP 1 0 1

1. Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL

omit:

Irinotecan MYX OC MP See Note 3 See
Note 3 1 D(100)

1. Schedule 1, entry for Levetiracetam in the form Tablet 250 mg

(a)omit:

a Chem mart Levetiracetam CH MP NP C4928 60 5 60

(b)omit:

a Terry White Chemists Levetiracetam TW MP NP C4928 60 5 60

1. Schedule 1, entry for Levetiracetam in the form Tablet 500 mg

(a)omit:

a Chem mart Levetiracetam CH MP NP C4928 60 5 60

(b)omit:

a Terry White Chemists Levetiracetam TW MP NP C4928 60 5 60

1. Schedule 1, entry for Levetiracetam in the form Tablet 1 g

(a)omit:

a Chem mart Levetiracetam CH MP NP C4928 60 5 60

(b)omit:

a Terry White Chemists Levetiracetam TW MP NP C4928 60 5 60

1. Schedule 1, entry for Methotrexate in the form Injection 50 mg in 2 mL vial

(a)omit:

a Methotrexate MYX OC MP 5 5 1

(b)omit:

Methotrexate MYX OC MP See Note 2 See Note 2 1 C(100)

(c)omit:

Methotrexate MYX OC MP P6276 See Note 2 See Note 2 1 C(100)

1. Schedule 1, entry for Methotrexate in the form Solution concentrate for I.V. infusion 1000 mg in 10 mL vial

(a)omit:

Methotrexate MYX OC MP See Note 3 See Note 3 1 PB(100)

(b)omit:

Methotrexate MYX OC MP P6276 See Note 3 See Note 3 1 PB(100)

1. Schedule 1, entry for Mitozantrone in the form Injection 20 mg (as hydrochloride) in 10 mL

omit:

Hospira Pty Limited PF MP See Note 3 See
Note 3 1 D(100)

1. Schedule 1, entry for Modafinil

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

a APO-Modafinil TX MP C6537 C6556 120 5 60

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

a Modafinil AN EA MP C6537 C6556 120 5 60

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

a Modafinil Sandoz SZ MP C6537 C6556 120 5 60

1. Schedule 1, entry for Nilotinib in the form Capsule 150 mg (as hydrochloride monohydrate)

omit from the column headed “Circumstances”:          C6701 C6759 C6770      substitute:             C6958 C6966 C6967

1. Schedule 1, entry for Nilotinib in the form Capsule 200 mg (as hydrochloride monohydrate)

omit from the column headed “Circumstances”:          C6742 C6796     substitute:             C6954 C6977

1. Schedule 1, entry for Nintedanib in each of the forms: Capsule 100 mg; and Capsule 150 mg

omit from the column headed “Circumstances”:          C6869 C6870 C6889      substitute:             C6950 C6961 C6970 C6975

1. Schedule 1, entry for Pembrolizumab in the form Powder for injection 50 mg

omit from the column headed “Circumstances”:          C6828 C6829

1. Schedule 1, after entry for Pembrolizumab in the form Powder for injection 50 mg

insert in the columns in the order indicated:

Solution concentrate for I.V. infusion 100 mg in 4 mL Injection Keytruda MK MP C6801 C6806 C6817 See Note 3 See Note 3 1 D(100)

1. Schedule 1, after entry for Pioglitazone in the form Tablet 45 mg (as hydrochloride) [Brand: Vexazone]

insert:

Pirfenidone Capsule 267 mg Oral Esbriet RO MP C6950 C6961 C6962 C6975 270 5 270

1. Schedule 1, entry for Raloxifene

(a)omit:

Chem mart Raloxifene CH MP NP C6314 28 5 28

(b)omit:

Terry White Chemists  Raloxifene TW MP NP C6314 28 5 28

1. Schedule 1, after entry for Rotigotine in the form Transdermal patch 13.5 mg

insert in the columns in the order indicated:

Transdermal patch 18 mg Transdermal Neupro UC MP C4204 28 5 28

1. Schedule 1, entry for Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 20

omit from the column headed “Schedule Equivalent”:   a

1. Schedule 1, entry for Sotalol in the form Tablet containing sotalol hydrochloride 80 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 Cardol AF MP NP C5664 60 5 60

1. Schedule 1, entry for Topotecan

omit:

Topotecan Agila AF MP C6238 See Note 3 See
Note 3 1 D(100)

1. Schedule 1, entry for Ursodeoxycholic Acid

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

a APO-Ursodeoxycholic acid TX MP NP C5757 200 2 100

1. Schedule 1, after entry for Voriconazole in the form Powder for oral suspension 40 mg per mL, 70 mL

insert:

Vorinostat	Capsule 100 mg	Oral	Zolinza	MK	MP	C6957 C6964	P6964	120	1	120
MP	C6957 C6964	P6957	120	2	120

1. Schedule 3

(a)omit:

AQ Alcon Laboratories (Australia) Pty Ltd  88 000 740 830

(b)omit:

IQ Alcon Laboratories (Australia) Pty Ltd  88 000 740 830

1. Schedule 4, Part 1, entry for Abiraterone

substitute:

Abiraterone C6944 Castration resistant metastatic carcinoma of the prostate The treatment must be used in combination with a corticosteroid; AND
The treatment must not be used in combination with chemotherapy; AND
Patient must have failed treatment with docetaxel due to resistance or intolerance; OR
Patient must be unsuitable for docetaxel treatment on the basis of predicted intolerance to docetaxel; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not receive PBS-subsidised abiraterone if progressive disease develops while on abiraterone; AND
Patient must not have received prior treatment with enzalutamide; OR
Patient must have developed intolerance to enzalutamide of a severity necessitating permanent treatment withdrawal. Compliance with Authority Required procedures

1. Schedule 4, Part 1, entry for Adalimumab

insert in numerical order after existing text:

C6946	P6946	Moderate to severe hidradenitis suppurativa Initial treatment 1 - New patient or Initial treatment 2 - Recommencement of treatment – balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial treatment 1 - New patient restriction to complete a maximum of 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial treatment 2 - Recommencement of treatment restriction to complete a maximum of 16 weeks treatment. Must be treated by a dermatologist. A maximum of 12 weeks of treatment will be authorised under this restriction.	Compliance with Authority Required procedures
C6951	Moderate to severe hidradenitis suppurativa Initial treatment 1 - New patient Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; OR Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; OR Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; AND The treatment must be limited to a maximum duration of 16 weeks. Must be treated by a dermatologist. Assessment of disease severity must be no more than 1 month old at the time of application. An assessment of the patient's response to this recommencement course of treatment must be made following a minimum of 12 weeks of treatment. At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial treatment 1 - New patient or Initial treatment 2 - Recommencement of treatment - balance of supply The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed hidradenitis suppurativa PBS authority application supporting Information form which must include: (i) the Hurley stage grading; and (ii) the AN count; and (iii) the name of the antibiotic/s received for two separate courses each of three months; or (iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics. The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics (v) a signed patient acknowledgement.	Compliance with Written Authority Required procedures
C6963	Moderate to severe hidradenitis suppurativa Initial treatment 2 - Recommencement of treatment Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND Patient must have demonstrated a response to the most recent PBS-subsidised treatment with this drug for this condition; AND The treatment must be limited to a maximum duration of 16 weeks. Must be treated by a dermatologist. Assessment of disease severity must be no more than 1 month old at the time of application. A response to treatment is defined as: Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae. An assessment of the patient's response to this recommencement course of treatment must be made following a minimum of 12 weeks of treatment. At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial treatment 1 - New patient or Initial treatment 2 - Recommencement of treatment - balance of supply The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed hidradenitis suppurativa PBS authority application supporting Information form which must include: (i) the Hurley stage grading; and (ii) the AN count.	Compliance with Written Authority Required procedures
C6971	P6971	Moderate to severe hidradenitis suppurativa Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated a response to treatment with this drug for this condition. Must be treated by a dermatologist. A response to treatment is defined as: Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae. For the first application for continuing treatment a Hidradenitis Suppurativa Clinical Response (HiSCR) assessment must be made following a minimum of 12 weeks of treatment. For subsequent continuing treatment a HiSCR assessment must be made every 24 weeks. The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and provided to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion. Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug. A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed hidradenitis suppurativa PBS authority application supporting Information form which must include the Hidradenitis Suppurativa Clinical Response (HiSCR) result.	Compliance with Written Authority Required procedures
C6972	P6972	Moderate to severe hidradenitis suppurativa Initial treatment 3 - Grandfathered patient Patient must have been receiving treatment with this drug for this condition prior to 1 July 2017; AND Patient must have had a Hurley stage II or III with an abscess and inflammatory nodule (AN) count greater than or equal to 3 prior to starting treatment with this drug; AND Patient must have demonstrated a response to treatment by achieving Hidradenitis Suppurativa Clinical Response (HiSCR) after 12 weeks of treatment if the patient has been treated with this drug for this condition for 12 weeks or longer; AND Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; OR Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; OR Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition. Must be treated by a dermatologist. A response to treatment is defined as: Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae. For the first application for continuing treatment a Hidradenitis Suppurativa Clinical Response (HiSCR) assessment must be made following a minimum of 12 weeks of treatment. For subsequent continuing treatment a HiSCR assessment must be made every 24 weeks. The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and provided to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion. Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug. Assessment of disease severity must be no more than 1 month old at the time treatment with this drug was initiated. A maximum of 24 weeks treatment will be authorised under this restriction. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria or recommencement of treatment criteria where there is a break in treatment. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) completed hidradenitis suppurativa PBS authority application supporting Information form which must include: (i) the Hurley stage grading; and (ii) the AN count; and (iii) the name of the antibiotic/s received for two separate courses each of three months; or (iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics. The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics (v) the Hidradenitis Suppurativa Clinical Response (HiSCR) result if the patient has received 12 weeks or more of treatment (vi) a signed patient acknowledgement.	Compliance with Written Authority Required procedures

1. Schedule 4, Part 1, entry for Botulinum toxin type A purified neurotoxin complex

(a)omit:

C5333 Urinary incontinence The condition must be due to idiopathic overactive bladder; AND
The condition must have been inadequately controlled by therapy involving at least two alternative anti-cholinergic agents; AND
Patient must experience at least 14 episodes of urinary incontinence per week prior to commencement of treatment with botulinum toxin type A neurotoxin complex; AND
Patient must be willing and able to self-catheterise; AND
The treatment must not continue if the patient does not achieve a 50% or greater reduction from baseline in urinary incontinence episodes 6-12 weeks after the first treatment Patient must be aged 18 years or older Must be treated by a urologist; OR
Must be treated by a urogynaecologist Compliance with Authority Required procedures - Streamlined Authority Code 5333

(b)insert in numerical order after existing text:

C6953 Urinary incontinence The condition must be due to idiopathic overactive bladder; AND
The condition must have been inadequately controlled by therapy involving at least two alternative anti-cholinergic agents; AND
Patient must experience at least 14 episodes of urinary incontinence per week prior to commencement of treatment with botulinum toxin type A neurotoxin complex; AND
Patient must be willing and able to self-catheterise; AND
The treatment must not continue if the patient does not achieve a 50% or greater reduction from baseline in urinary incontinence episodes 6-12 weeks after the first treatment.
Patient must be aged 18 years or older.
Must be treated by a urologist; OR
Must be treated by a gynaecologist. Compliance with Authority Required procedures - Streamlined Authority Code 6953

1. Schedule 4, Part 1, entry for Dasatinib

(a)omit:

C6785	P6785	Chronic Myeloid Leukaemia (CML) First continuing treatment The condition must be in the chronic phase; AND Patient must have received initial PBS-subsidised first line treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure of response, to PBS-subsidised first line treatment with imatinib for this condition; OR Patient must have experienced intolerance, not a failure of response, to PBS-subsidised first line treatment with nilotinib 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) demonstration of continued 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].Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided.	Compliance with Written Authority Required procedures
C6797	P6797	Chronic Myeloid Leukaemia (CML) Initial treatment The condition must be a primary diagnosis; AND The condition must be in the chronic phase; 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 first line treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure of response, to PBS-subsidised first line treatment with imatinib for this condition; OR Patient must have experienced intolerance, not a failure of response, to PBS-subsidised first line treatment with nilotinib 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 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 dasatinib of 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to dasatinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter. 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	Compliance with Written Authority Required procedures

C6798 P6798 Chronic Myeloid Leukaemia (CML) Subsequent continuing treatment The condition must be in the chronic phase; AND Patient must have received the First 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 first line treatment with imatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure of response, to PBS-subsidised first line 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. Subsequent authority applications for continuing therapy with this drug may be made by telephoning 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

(b)insert in numerical order after existing text:

C6947	P6947	Chronic Myeloid Leukaemia (CML) First continuing treatment The condition must be in the chronic phase; AND Patient must have received initial PBS-subsidised first line treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure to respond, to first continuing PBS-subsidised treatment with imatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to first continuing 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) demonstration of continued 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].Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided.	Compliance with Written Authority Required procedures
C6959	P6959	Chronic Myeloid Leukaemia (CML) Initial treatment The condition must be a primary diagnosis; AND The condition must be in the chronic phase; 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 to respond to the PBS-subsidised first line treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial 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 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 dasatinib of 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to dasatinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter. 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	Compliance with Written Authority Required procedures
C6968	P6968	Chronic Myeloid Leukaemia (CML) Subsequent continuing treatment The condition must be in the chronic phase; AND Patient must have received the First continuing PBS-subsidised treatment with this drug as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to subsequent continuing PBS-subsidised treatment with imatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to subsequent continuing 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. Subsequent authority applications for continuing therapy with this drug may be made by telephoning 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

1. Schedule 4, Part 1, entry for Degarelix

substitute:

Degarelix	C6952	Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate
C6976	Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate

1. Schedule 4, Part 1, entry for Fluconazole

insert in numerical order after existing text:

C6956

Cryptococcal meningitis

C6960

Candida infections

The condition must be serious or life-threatening.

C6965

Oropharyngeal candidiasis

The treatment must be for prophylaxis; AND
Patient must be immunosuppressed.

C6969

Oesophageal candidiasis

Patient must be immunosuppressed.

C6974

Oropharyngeal candidiasis

Patient must be immunosuppressed.

C6978

Cryptococcal meningitis

The treatment must be maintenance therapy; AND
Patient must be immunosuppressed.

1. Schedule 4, Part 1, entry for Imatinib

(a)omit:

C6703 P6703 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

C6743	P6743	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
C6744	P6744	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

(b)insert in numerical order after existing text:

C6948	P6948	Chronic Myeloid Leukaemia (CML) Initial treatment 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 to respond to the PBS-subsidised treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial 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
C6949	P6949	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 to respond, to subsequent continuing PBS-subsidised treatment with dasatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to subsequent continuing 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
C6973	P6973	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 to respond, to first continuing PBS-subsidised treatment with dasatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to first continuing 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

1. Schedule 4, Part 1, entry for Nicotine

omit:

C6879 Nausea and vomiting The condition must must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with dexamethasone on day 1 of a chemotherapy cycle; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes either carboplatin or oxaliplatin.
No more than 1 capsule of 300 mg netupitant/0.5 mg palonosetron fixed dose combination will be authorised per cycle of cytotoxic chemotherapy. Compliance with Authority Required procedures - Streamlined Authority Code 6879

substitute:

C6848

Nicotine dependence

The treatment must be as an aid to achieving abstinence from smoking; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have indicated they are ready to cease smoking; AND
Patient must not receive more than 12 weeks of PBS-subsidised nicotine replacement therapy per 12-month period.
Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program or is about to enter such a program at the time PBS-subsidised treatment is initiated.
Details of the support and counselling program must be documented in the patient's medical records at the time treatment is initiated.

1. Schedule 4, Part 1, entry for Nilotinib

substitute:

Nilotinib	C6954	Chronic Myeloid Leukaemia (CML) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated a major cytogenetic response to nilotinib in the preceding 18 months and thereafter at 12 monthly intervals; OR Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% to nilotinib in the preceding 18 months and thereafter at 12 monthly intervals; 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 - Second and Third Line - Application Form for continuing treatment; and(3) demonstration of continued response to treatment as evidenced by either:(a) major cytogenetic response [see Note explaining definitions of response]. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report needs to be provided; or(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining definitions of response]. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report needs to be provided	Compliance with Written Authority Required procedures
C6958	Chronic Myeloid Leukaemia (CML) Subsequent continuing treatment The condition must be in the chronic phase; AND Patient must have received the First continuing PBS-subsidised treatment with this drug as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to subsequent continuing PBS-subsidised treatment with imatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to subsequent continuing PBS-subsidised treatment with dasatinib 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. Subsequent authority applications for continuing therapy with this drug may be made by telephoning 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
C6966	Chronic Myeloid Leukaemia (CML) Initial treatment The condition must be a primary diagnosis; AND The condition must be in the chronic phase; 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 to respond to the PBS-subsidised first line treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib 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 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 nilotinib of 300 mg twice daily. Continuing therapy is dependent on patients demonstrating a response to nilotinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter.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 formThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of tyrosine kinase inhibitors (TKI) agents for the chronic phase of chronic myeloid leukaemia. Where the term TKI agent appears in the following notes and restrictions it refers to imatinib mesilate, dasatinib or nilotinib. Patients are eligible for PBS-subsidised treatment with only one TKI agent at any one time and must not be receiving concomitant interferon alfa therapy. Eligible patients may only swap between TKI agents if they have not failed prior PBS-subsidised treatment with that agent. 1. Initial First-line treatment From 1 April 2012, under the PBS, a patient will be able to be prescribed any of imatinib mesilate, dasatinib or nilotinib within the initial 18 month treatment period, as long as only one agent is used at a time and providing the patient has not failed to respond to any one of these TKIs.During the initial 18 month treatment period, switching between approved first-line agents may only occur for reasons of intolerance, not failure to respond 2. Continuing First-line treatment - Patients must maintain a major cytogenetic response or have a peripheral blood BCR-ABL of less than 1% to receive continuing therapy. First continuing applications are to be written and must include a pathology report demonstrating the patient has responded to the initial course of treatment. Second and subsequent authority applications for continuing therapy may be made by telephoning the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday). During continuing therapy beyond the initial 18 month treatment period, switching between approved first-line agents may only occur for reason ofintolerance. Where there is failure to respond, switching may only occur through application for prescription of second-line agents.Where a patient has previously received PBS-subsidised treatment with imatinib mesilate, dasatinib or nilotinib no approval will be granted for PBS-subsidised re-treatment in the chronic phase of chronic myeloid leukaemia, where that patient has at any time failed to meet the response criteria whilst on that TKI agent. 3. Authority approval requirements.Response criteria to initial first-line treatment with imatinib mesilate, dasatinib or nilotinib:For the purposes of assessing response to PBS-subsidised treatment with imatinib mesilate, dasatinib or nilotinib either cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale, must be submitted. For bone marrow analyses, where the standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be submitted. The cytogenetic or peripheral blood quantitative PCR analyses must be submitted within 18 months of the commencement of treatment with imatinib mesilate, dasatinib or nilotinib (patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% is demonstrable by 18 months are eligible to receive continuing treatment with that agent). 4. Definitions of response.A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells.A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic response. 5. Definitions of loss of response.Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing tyrosine kinase inhibitor (TKI) therapy.Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing tyrosine kinase inhibitor therapy.	Compliance with Written Authority Required procedures
C6967	Chronic Myeloid Leukaemia (CML) First continuing treatment The condition must be in the chronic phase; AND Patient must have received initial PBS-subsidised first line treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure to respond, to first continuing PBS-subsidised treatment with imatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to first continuing PBS-subsidised treatment with dasatinib 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) demonstration of continued 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].Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided.	Compliance with Written Authority Required procedures
C6977	Chronic Myeloid Leukaemia (CML) Initial treatment The condition must be in the chronic phase; OR The condition must be in the accelerated phase; AND Patient must have failed an adequate trial of PBS-subsidised first line treatment with imatinib for this condition; OR Patient must have failed an adequate trial of PBS-subsidised first line treatment with dasatinib for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. Failure of an adequate trial of imatinib or dasatinib is defined as:(i) Lack of response to initial imatinib or dasatinib therapy, defined as either:- failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or dasatinib for patients initially treated in chronic phase; or- failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or dasatinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or- failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or dasatinib; OR(ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or dasatinib therapy; OR(iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or dasatinib therapy; OR(iv) Development of accelerated phase in a patient previously prescribed imatinib or dasatinib for the chronic phase of chronic myeloid leukaemia. 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); OR(v) Disease progression (defined as a greater than or equal to.50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib or dasatinib therapy in patients with accelerated phase chronic myeloid leukaemia, provided that blast crisis has been excluded on bone marrow biopsy. Patients should be commenced on a dose of nilotinib of 400 mg twice daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to nilotinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals. Applications for authorisation must be in writing and must include:(a) a completed authority prescription form; and(b) a completed Chronic Myeloid Leukaemia - Second and Third Line - Supporting Information Form; and(c) a signed patient acknowledgement; and(d) a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale. (The date of the relevant pathology report needs to be provided); and(e) where there has been a loss of response to imatinib or dasatinib, a copy of the current confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.	Compliance with Written Authority Required procedures

1. Schedule 4, Part 1, entry for Nintedanib

substitute:

Nintedanib	C6950	Idiopathic pulmonary fibrosis Initial treatment 1 - new patient The condition must be diagnosed through a multidisciplinary team; AND Patient must have chest high resolution computed tomography (HRCT) consistent with diagnosis of idiopathic pulmonary fibrosis within the previous 12 months; AND Patient must have a forced vital capacity (FVC) greater than or equal to 50% predicted for age, gender and height; AND Patient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7; AND Patient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin equal to or greater than 30%; AND Patient must not have interstitial lung disease due to other known causes including domestic and occupational environmental exposures, connective tissue disease, or drug toxicity; AND The treatment must be the sole PBS-subsidised treatment for this condition. Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician. A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis. Patient must have not have an acute respiratory infection at the time of FVC testing. Applications for authorisation of initial treatment must be in writing and must include: a) a completed authority prescription form; and b) a completed IPF Authority Application Supporting Information Form; and c) a signed patient acknowledgement.	Compliance with Written Authority Required procedures
C6961	Idiopathic pulmonary fibrosis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised treatment for this condition. Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician.	Compliance with Authority Required procedures

C6970	Idiopathic pulmonary fibrosis Initial treatment 3 - Grandfathering treatment Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 May 2017; AND The condition must have been diagnosed through a multidisciplinary team; AND Patient must have had a forced vital capacity (FVC) greater than or equal to 50% predicted for age, gender and height at the time treatment with this drug for this condition was initiated; AND Patient must have had a forced expiratory volume in 1 second (FEV1)/FVC ratio greater than 0.7 at the time treatment with this drug for this condition was initiated; AND Patient must have had diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin equal to or greater than 30% at the time treatment with this drug for this condition was initiated; AND Patient must not have interstitial lung disease due to other known causes including domestic and occupational environmental exposures, connective tissue disease, or drug toxicity; AND The treatment must be the sole PBS-subsidised treatment for this condition. Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician. A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis. Patient must have not have an acute respiratory infection at the time of FVC testing. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. A patient may qualify for PBS-subsidised treatment under this restriction once only. Applications for authorisation of initial treatment must be in writing and must include: a) a completed authority prescription form; and b) a completed IPF Authority Application Supporting Information Form; and c) a signed patient acknowledgement.	Compliance with Written Authority Required procedures
C6975	Idiopathic pulmonary fibrosis Initial treatment 2 - change or re-commencement of treatment Patient must have previously received PBS-subsidised treatment with nintedanib or pirfenidone for this condition; AND The treatment must be the sole PBS-subsidised treatment for this condition. Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician.	Compliance with Authority Required procedures

1. Schedule 4, Part 1, entry for Pembrolizumab

omit:

C6828	Unresectable Stage III or Stage IV malignant melanoma Grandfathering treatment 2 The condition must be negative for a BRAF V600 mutation; AND Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 September 2015; AND Patient must not have received prior treatment with ipilimumab or any other PD-1 (programmed cell death-1) inhibitor for this condition; AND Patient must have stable or responding disease; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a maximum dose of 2 mg per kg every 3 weeks.	Compliance with Authority Required procedures - Streamlined Authority Code 6828
C6829	Unresectable Stage III or Stage IV malignant melanoma Grandfathering treatment 1 The condition must be positive for a BRAF V600 mutation; AND The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) unless contraindicated or not tolerated according to the TGA approved Product Information; AND Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 September 2015; AND Patient must not have received prior treatment with ipilimumab or any other PD-1 (programmed cell death-1) inhibitor for this condition; AND Patient must have stable or responding disease; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a maximum dose of 2 mg per kg every 3 weeks.	Compliance with Authority Required procedures - Streamlined Authority Code 6829

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

insert:

Pirfenidone	C6950	Idiopathic pulmonary fibrosis Initial treatment 1 - new patient The condition must be diagnosed through a multidisciplinary team; AND Patient must have chest high resolution computed tomography (HRCT) consistent with diagnosis of idiopathic pulmonary fibrosis within the previous 12 months; AND Patient must have a forced vital capacity (FVC) greater than or equal to 50% predicted for age, gender and height; AND Patient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7; AND Patient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin equal to or greater than 30%; AND Patient must not have interstitial lung disease due to other known causes including domestic and occupational environmental exposures, connective tissue disease, or drug toxicity; AND The treatment must be the sole PBS-subsidised treatment for this condition. Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician. A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis. Patient must have not have an acute respiratory infection at the time of FVC testing. Applications for authorisation of initial treatment must be in writing and must include: a) a completed authority prescription form; and b) a completed IPF Authority Application Supporting Information Form; and c) a signed patient acknowledgement.	Compliance with Written Authority Required procedures
C6961	Idiopathic pulmonary fibrosis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised treatment for this condition. Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician.	Compliance with Authority Required procedures

C6962	Idiopathic pulmonary fibrosis Initial treatment 3 - Grandfathering treatment Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 July 2017; AND The condition must have been diagnosed through a multidisciplinary team; AND Patient must have had a forced vital capacity (FVC) greater than or equal to 50% predicted for age, gender and height at the time treatment with this drug for this condition was initiated; AND Patient must have had a forced expiratory volume in 1 second (FEV1)/FVC ratio greater than 0.7 at the time treatment with this drug for this condition was initiated; AND Patient must have had diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin equal to or greater than 30% at the time treatment with this drug for this condition was initiated; AND Patient must not have interstitial lung disease due to other known causes including domestic and occupational environmental exposures, connective tissue disease, or drug toxicity; AND The treatment must be the sole PBS-subsidised treatment for this condition. Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician. A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis. Patient must have not have an acute respiratory infection at the time of FVC testing. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria or change or recommencement of treatment criteria. A patient may qualify for PBS-subsidised treatment under this restriction once only. Applications for authorisation of initial treatment must be in writing and must include: a) a completed authority prescription form; and b) a completed IPF Authority Application Supporting Information Form; and c) a signed patient acknowledgement.	Compliance with Written Authority Required procedures
C6975	Idiopathic pulmonary fibrosis Initial treatment 2 - change or re-commencement of treatment Patient must have previously received PBS-subsidised treatment with nintedanib or pirfenidone for this condition; AND The treatment must be the sole PBS-subsidised treatment for this condition. Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician.	Compliance with Authority Required procedures

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

insert:

Vorinostat	C6957	P6957	Cutaneous T-cell lymphoma Initial treatment Patient must have received systemic treatment with chemotherapy; AND Patient must demonstrate relapsed or chemotherapy-refractory disease; AND Patient must be ineligible for stem cell transplant; AND The treatment must be the sole PBS-subsidised therapy for this condition. Applications for authorisation of initial treatment must be in writing and must include: (a) a completed authority prescription form; and (b) a completed cutaneous T-cell lymphoma (CTCL) initial PBS Authority Application - Supporting Information Form.	Compliance with Written Authority Required procedures
C6964	P6964	Cutaneous T-cell lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures

1. Schedule 5, after entry for Esomeprazole and clarithromycin and amoxycillin

insert:

Fentanyl	GRP-15510	Transdermal patch 7.65 mg	Transdermal	Denpax
Transdermal patch 12.375 mg	Transdermal	Dutran 75 Fenpatch 75
Transdermal patch 12.6 mg	Transdermal	APO-Fentanyl Durogesic 75 Fentanyl Sandoz
GRP-15577	Transdermal patch 2.55 mg	Transdermal	Denpax
Transdermal patch 4.125 mg	Transdermal	Dutran 25 Fenpatch 25
Transdermal patch 4.2 mg	Transdermal	APO-Fentanyl Durogesic 25 Fentanyl Sandoz
GRP-15659	Transdermal patch 5.10 mg	Transdermal	Denpax
Transdermal patch 8.25 mg	Transdermal	Dutran 50 Fenpatch 50
Transdermal patch 8.4 mg	Transdermal	APO-Fentanyl Durogesic 50 Fentanyl Sandoz
GRP-15747	Transdermal patch 10.20 mg	Transdermal	Denpax
Transdermal patch 16.5 mg	Transdermal	Dutran 100 Fenpatch 100
Transdermal patch 16.8 mg	Transdermal	APO-Fentanyl Durogesic 100 Fentanyl Sandoz
GRP-15898	Transdermal patch 1.28 mg	Transdermal	Denpax
Transdermal patch 2.063 mg	Transdermal	Dutran 12 Fenpatch 12
Transdermal patch 2.1 mg	Transdermal	APO-Fentanyl Durogesic 12 Fentanyl Sandoz