National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 3) (PB 26 of 2017) (Cth)

Case

PB 26 of 2017

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017
(No. 3)

National Health Act 1953

I, LOUISE CLARKE, First Assistant Secretary (Acting), 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 27th April 2017

LOUISE CLARKE

First Assistant Secretary (Acting)

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. 3).

(2)        This Instrument may also be cited as PB 26 of 2017.

2          Commencement

This Instrument commences on 1 May 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]

(a)omit from the column headed “Circumstances”:               C4720 C4746 C6805 C6827 C6835         
substitute:   C6849 C6859 C6866 C6867 C6874

(b)omit from the column headed “Purposes”:         P4746 P6805 P6835 substitute:             P6849 P6867 C6874

  1. Schedule 1, entry for Abatacept in the form Injection 125 mg in 1 mL single dose autoinjector [Maximum Quantity: 4; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:               C4720 C4746 C6805 C6827 C6835         
substitute:   C6849 C6859 C6866 C6867 C6874

(b)omit from the column headed “Purposes”:         P4720 P6827 substitute:             P6859 P6866

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

(a)omit from the column headed “Circumstances”:               C4720 C4746 C6805 C6827 C6835         
substitute:   C6849 C6859 C6866 C6867 C6874

(b)omit from the column headed “Purposes”:         P4746 P6805 P6835 substitute:             P6849 P6867 P6874

  1. Schedule 1, entry for Abatacept in the form Injection 125 mg in 1 mL single dose pre‑filled syringe [Maximum Quantity: 4; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:               C4720 C4746 C6805 C6827 C6835         
substitute:   C6849 C6859 C6866 C6867 C6874

(b)omit from the column headed “Purposes”:         P4720 P6827 substitute:             P6859 P6866

  1. Schedule 1, entry for Aciclovir in the form Tablet 800 mg [Maximum Quantity: 35; Number of Repeats: 0]

(a)omit from the column headed “Circumstances” for the brand “Acyclo-V 800”:        C5946

(b)omit from the column headed “Purposes”:         P5959 P5967

  1. Schedule 1, entry for Aciclovir in the form Tablet 800 mg

omit:

Acyclo‑V 800 AF MP NP C5946 C5959 C5967 P5946 120 5 120

  1. Schedule 1, entry for Alemtuzumab in the form Solution concentrate for I.V. infusion 12 mg in 1.2 mL [Maximum Quantity: 3; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”:               C4829 C4834 C4838 C4850        substitute:             C6847 C6877 C6878 C6884

(b)omit from the column headed “Purposes”:         P4829 P4850 substitute:             P6847 P6878

  1. Schedule 1, entry for Alemtuzumab in the form Solution concentrate for I.V. infusion 12 mg in 1.2 mL [Maximum Quantity: 5; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”:               C4829 C4834 C4838 C4850        substitute:             C6847 C6877 C6878 C6884

(b)omit from the column headed “Purposes”:         P4834 P4838 substitute:             P6877 P6884

  1. Schedule 1, entry for Amino acid formula with fat, carbohydrate, without phenylalanine

omit from the column headed “Form”:           Tablet: modified release, 70.8 g protein per 100 g, 110 g (PKU Easy Microtabs)
substitute:             Tablets (modified release), 70.8 g protein per 100 g, 110 g, 4 (PKU Easy Microtabs)

  1. Schedule 1, entry for Amino acid formula with vitamins and minerals without lysine and low in tryptophan

omit:

Oral powder 500 g (XLYS, LOW TRY Maxamaid) Oral XLYS, LOW TRY Maxamaid SB MP NP C5323 8 5 1

  1. Schedule 1, entry for Amino acid formula with vitamins and minerals without methionine

omit:

Oral powder 500 g (XMET Maxamaid) Oral XMET Maxamaid SB MP NP C5534 8 5 1

  1. Schedule 1, entry for Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine

omit:

Oral powder 500 g (XMTVI Maxamaid) Oral XMTVI Maxamaid SB MP NP C5542 C5560 8 5 1

  1. Schedule 1, entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine

omit:

Oral powder 500 g (XPhen, Tyr Maxamaid) Oral XPhen, Tyr Maxamaid SB MP NP C5533 8 5 1

  1. Schedule 1, entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine

omit:

Oral powder 500 g (MSUD Maxamaid) Oral MSUD Maxamaid SB MP NP C5571 8 5 1

  1. Schedule 1, entry for Amisulpride in the form Tablet 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 Amisulpride AN EA MP NP C4246 30 5 30

  1. Schedule 1, entry for Amisulpride in each of the forms: Tablet 200 mg; and Tablet 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 Amisulpride AN EA MP NP C4246 60 5 60

  1. Schedule 1, entry for Anastrozole

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

(b)omit from the column headed “Brand”:   Arianna            substitute:             Arianna 1

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

a Astzol JU MP NP C5464 30 5 30

  1. Schedule 1, omit entry for Bacillus Calmette and Guerin, Connaught strain

  1. Schedule 1, after entry for Bleomycin [Brand: Hospira Pty Limited]

insert:

Blinatumomab Powder for I.V. infusion 38.5 micrograms Injection Blincyto AN MP C6892 C6893 C6894 C6895 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, omit entry for Boceprevir

  1. Schedule 1, entry for Bupropion in the form Tablet containing bupropion hydrochloride 150 mg (sustained release) [Maximum Quantity: 30; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”:               C5438 C5475 C5518      substitute:             C6881 C6882

(b)omit from the column headed “Purposes”:         P5438 P5475 substitute:             P6882

  1. Schedule 1, entry for Bupropion in the form Tablet containing bupropion hydrochloride 150 mg (sustained release) [Maximum Quantity: 90; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”:               C5438 C5475 C5518      substitute:             C6881 C6882

(b)omit from the column headed “Purposes”:         P5518   substitute:             P6881

  1. Schedule 1, entry for Calcipotriol with betamethasone in the form Ointment containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g

omit from the column headed “Circumstances” (twice occurring):          C6358   substitute:             C6809

  1. Schedule 1, entry for Calcipotriol with betamethasone in the form Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g

omit from the column headed “Circumstances”:          C5955   substitute:             C6809

  1. Schedule 1, entry for Calcipotriol with betamethasone in the form Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 60 g

omit from the column headed “Circumstances”:          C5963   substitute:             C6873

  1. Schedule 1, entry for Carbamazepine in the form Tablet 200 mg

(a)omit:

Teril AF PDP 200 0 200

(b)omit:

Teril AF MP NP 200 2 200

  1. Schedule 1, after entry for Chlorambucil

insert:

Chloramphenicol Eye drops 5 mg per mL, 10 mL Application to the eye Chlorsig QA MP NP AO MW C5835 1 2 1

  1. Schedule 1, entry for Clarithromycin in each of the forms: Tablet 250 mg; and Powder for oral liquid 250 mg per 5 mL, 50 mL

omit from the column headed “Responsible Person” for the brand “Klacid”:      AL        substitute:             GO

  1. Schedule 1, entry for Clomipramine

(a)omit:

Chem mart Clomipramine CH MP NP C6250 C6251 C6299 50 2 50

(b)omit:

Terry White Chemists Clomipramine TW MP NP C6250 C6251 C6299 50 2 50

  1. Schedule 1, after entry for Daclatasvir

insert:

Daclizumab Injection 150 mg in 1 mL pre-filled pen Injection Zinbryta BD         MP C6846 C6851 C6888 1 5 1

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

(a)omit:

a Ranzepam RA MP NP PDP 50 0 50

(b)omit:

a Ranzepam RA MP NP P6176 50
CN6176 		3
C6176 		50

  1. Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg

(a)omit:

a Chem mart Diclofenac CH PDP C6256 C6282 100 0 50

(b)omit:

a Terry White Chemists Diclofenac TW PDP C6256 C6282 100 0 50

(c)omit:

a Chem mart Diclofenac CH MP NP C6149 C6214  C6283 100 3 50

(d)omit:

a Terry White Chemists Diclofenac TW 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

(a)omit:

a Chem mart Diclofenac CH PDP C6256 C6282 50 0 50

(b)omit:

a Terry White Chemists Diclofenac TW PDP C6256 C6282 50 0 50

(c)omit:

a Chem mart Diclofenac CH MP NP C6149 C6214  C6283 50 3 50

(d)omit:

a Terry White Chemists Diclofenac TW MP NP C6149 C6214  C6283 50 3 50

  1. Schedule 1, entry for Dimethyl fumarate in the form Capsule (modified release) 120 mg

omit from the column headed “Circumstances”:          C4370 C4410     substitute:             C6855 C6876

  1. Schedule 1, entry for Dimethyl fumarate in the form Capsule (modified release) 240 mg

omit from the column headed “Circumstances”:          C4417   substitute:             C6883

  1. Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity: 7; Number of Repeats: 0]

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

APO- Doxycycline TX PDP 7 0 7

  1. Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity: 7; Number of Repeats: 1]

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

APO- Doxycycline TX MP NP 7 1 7

  1. Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity: 21; Number of Repeats: 0]

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

APO- Doxycycline TX MP NP P4485 21 0 21

  1. Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity: 28; Number of Repeats: 0]

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

APO- Doxycycline TX MP NP P4514 28 0 7

  1. Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity: 28; Number of Repeats: 5]

(a)omit from 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”:

APO- Doxycycline TX MP P6200 28 5 7

  1. Schedule 1, entry for Doxycycline in the form Tablet 50 mg (as monohydrate)

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

APO- Doxycycline TX MP NP C4475 C4529 C4539 25 5 25

  1. Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as hydrochloride) [Maximum Quantity: 28; Number of Repeats: 5]

omit from the column headed “Schedule Equivalent” for all brands:     a

  1. Schedule 1, entry for Doxycycline in the form Capsule 100 mg (as hydrochloride) (containing enteric coated pellets) [Maximum Quantity: 28; Number of Repeats: 5]

omit from the column headed “Schedule Equivalent” for all brands:     a

  1. Schedule 1, after entry for Emtricitabine

insert:

Emtricitabine with rilpivirine with tenofovir alafenamide Tablet containing emtricitabine 200 mg with rilpivirine 25 mg with tenofovir alafenamide 25 mg Oral Odefsey GI MP C4470 C4522 60 5 30 D(100)
Emtricitabine with tenofovir alafenamide Tablet containing emtricitabine 200 mg with tenofovir alafenamide 10 mg Oral Descovy GI MP C4454 C4512 60 5 30 D(100)
Tablet containing emtricitabine 200 mg with tenofovir alafenamide 25 mg Oral Descovy GI MP C4454 C4512 60 5 30 D(100)

  1. Schedule 1, entry for Eprosartan in each of the forms: Tablet 400 mg (as mesylate); and Tablet 600 mg (as mesylate)

omit from the column headed “Responsible Person”:                 AF        substitute:             GO

  1. Schedule 1, entry for Eprosartan with Hydrochlorothiazide

omit from the column headed “Responsible Person”:                 AF        substitute:             GO

  1. Schedule 1, entry for Felodipine in the form Tablet 2.5 mg (extended release)

(a)omit from the column headed “Responsible Person” for the brand “Felodur ER 2.5 mg”:      ZA        substitute:             TX

(b)omit from the column headed “Responsible Person” for the brand “Plendil ER”:    AP        substitute:             GX

  1. Schedule 1, entry for Felodipine in the form Tablet 5 mg (extended release)

(a)omit from the column headed “Responsible Person” for the brand “Felodur ER 5 mg”:         ZA        substitute:             TX

(b)omit from the column headed “Responsible Person” for the brand “Plendil ER”:    AP        substitute:             GX

  1. Schedule 1, entry for Felodipine in the form Tablet 10 mg (extended release)

(a)omit from the column headed “Responsible Person” for the brand “Felodur ER 10 mg”:       ZA        substitute:             TX

(b)omit from the column headed “Responsible Person” for the brand “Plendil ER”:    AP        substitute:             GX

  1. Schedule 1, entry for Fenofibrate in each of the forms: Tablet 48 mg; and Tablet 145 mg

omit from the column headed “Responsible Person”:                 AF        substitute:             GO

  1. Schedule 1, entry for Fingolimod

omit from the column headed “Circumstances”:          C6418 C6457     substitute:             C6856 C6868

  1. Schedule 1, entry for Fludarabine in each of the forms: Powder for I.V. injection containing fludarabine phosphate 50 mg; and Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL

omit from the column headed “Circumstances”:          C6248

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

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

a APO-Fluoxetine TX MP NP C4755 C6277 28 5 28

  1. Schedule 1, entry for Fluvoxamine in each of the forms: Tablet containing fluvoxamine maleate 50 mg; and Tablet containing fluvoxamine maleate 100 mg

omit from the column headed “Responsible Person” for the brand “Luvox”:       MQ       substitute:             GO

  1. Schedule 1, after entry for Fosamprenavir

insert:

Fosaprepitant Powder for I.V. infusion 150 mg Injection Emend IV MK MP NP C6852 C6886 C6887 C6891 1 5 1

  1. Schedule 1, entry for Frusemide in each of the forms: Tablet 20 mg; and Tablet 40 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 FUROSEMIDE AN EA MP NP 100 1 100

  1. Schedule 1, omit entry for Gestrinone

  1. Schedule 1, entry for Glatiramer in each of the forms: Injection containing glatiramer acetate 20 mg in 1 mL single dose pre‑filled syringe; and Injection containing glatiramer acetate 40 mg in 1 mL single dose pre‑filled syringe

omit from the column headed “Circumstances”:          C4887   substitute:             C6860

  1. Schedule 1, entry for Granisetron in the form Concentrated injection 3 mg (as hydrochloride) in 3 mL

omit:

a GRANISETRON APOTEX TX MP NP C4077 C4092

1

 0

 1
MP C4139 1 0 1 C(100)

  1. Schedule 1, after entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate in the form
    Oral liquid 200 mL, 32 (KetoCal 4:1 LQ)

insert in the columns in the order indicated:

Oral semi-solid 100 g, 48 (Keyo) Oral Keyo VF MP NP C6858 3 5 1

  1. Schedule 1, entry for Ibuprofen

omit from the column headed “Responsible Person”:                 AF        substitute:             GO

  1. Schedule 1, entry for Interferon alfa-2a

omit:

Injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe Injection Roferon-A RO MP C6632 C6672 P6672 5 4 1
MP C4993 C5003 C5036 C5042 C6661 C6678 P6678 5 4 1 C(100)
MP C6632 C6672 P6632 5 5 1
MP C4993 C5003 C5036 C5042 C6661 C6678 P6661 5 5 1 C(100)
MP C4993 C5003 C5036 C5042 C6661 C6678 P4993 P5003 P5036 P5042 30 5 1 C(100)

  1. Schedule 1, entry for Interferon Beta-1a in each of the forms: Injection 30 micrograms (6,000,000 I.U.) in 0.5 mL single dose pre‑filled syringe; Injection 44 micrograms (12,000,000 I.U.) in 0.5 mL single dose pre‑filled syringe; Injection 44 micrograms (12,000,000 I.U.) in
    0.5 mL single dose autoinjector; and Solution for injection 132 micrograms in 1.5 mL multidose cartridge

omit from the column headed “Circumstances”:          C4887   substitute:             C6860

  1. Schedule 1, entry for Interferon Beta-1b

omit from the column headed “Circumstances”:          C4887   substitute:             C6860

  1. Schedule 1, entry for Irbesartan in the form Tablet 75 mg

omit:

a Irbesartan RBX RA MP NP 30 5 30

  1. Schedule 1, entry for Ivacaftor

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

Sachet containing granules 50 mg Oral Kalydeco VR MP See Note 3 See Note 3 See
Note 3 		56 D(100)
Sachet containing granules 75 mg Oral Kalydeco VR MP See Note 3 See Note 3 See
Note 3 		56 D(100)

  1. Schedule 1, entry for Lercanidipine in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg; and Tablet containing lercanidipine hydrochloride 20 mg

omit from the column headed “Responsible Person” for the brand “Zanidip”:    AL        substitute:             GO

  1. Schedule 1, entry for Lercanidipine with enalapril in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg with enalapril maleate 10 mg; and Tablet containing lercanidipine hydrochloride 10 mg with enalapril maleate 20 mg

omit from the column headed “Responsible Person”:                 AF        substitute:             GO

  1. Schedule 1, entry for Levodopa with Carbidopa in the form Intestinal gel 20 mg-5 mg per mL, 100 mL

omit from the column headed “Circumstances” (Authorised Prescriber MP):       C6154 C6179     substitute:             C6863 C6880

  1. Schedule 1, entry for Methotrexate in each of the forms: Injection 50 mg in 2 mL vial; and Solution concentrate for I.V. infusion 1000 mg in 10 mL vial

omit from the column headed “Responsible Person” for the brand “Methotrexate MYX” (all instances):      YN        substitute:                OC

  1. Schedule 1, entry for Moxonidine in each of the forms: Tablet 200 micrograms; and Tablet 400 micrograms

omit from the column headed “Responsible Person”:                 AF        substitute:             GO

  1. Schedule 1, entry for Nadroparin in each of the forms: Injection containing nadroparin calcium (1,900 I.U. anti-Xa) in 0.2 mL pre-filled syringe; Injection containing nadroparin calcium (2,850 I.U. anti-Xa) in 0.3 mL pre-filled syringe; Injection containing nadroparin calcium (3,800 I.U. anti-Xa) in 0.4 mL pre-filled syringe; and Injection containing nadroparin calcium (5,700 I.U. anti-Xa) in 0.6 mL pre-filled syringe

omit from the column headed “Maximum Quantity” (all instances):       4          substitute:             20

  1. Schedule 1, entry for Nadroparin in each of the forms: Injection containing nadroparin calcium (7,600 I.U. anti-Xa) in 0.8 mL pre-filled syringe; and Injection containing nadroparin calcium (9,500 I.U. anti-Xa) in 1 mL pre-filled syringe

(a)omit from the column headed “Maximum Quantity”:       2          substitute:             10

(b)omit from the column headed “Maximum Quantity”:       4          substitute:             20

  1. Schedule 1, entry for Nadroparin in each of the forms: Injection containing nadroparin calcium (11,400 I.U. anti-Xa) in 0.6 mL pre-filled syringe; Injection containing nadroparin calcium (15,200 I.U. anti-Xa) in 0.8 mL pre-filled syringe; and Injection containing nadroparin calcium (19,000 I.U. anti-Xa) in 1 mL pre-filled syringe

omit from the column headed “Maximum Quantity”:                  2          substitute:             10

  1. Schedule 1, entry for Naltrexone

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

a APO-Naltrexone TX MP NP C5364 30 1 30

(b)insert in the column headed “Schedule Equivalent” for the brands “Naltrexone GH” and “ReVia”:  a

  1. Schedule 1, entry for Natalizumab

omit from the column headed “Circumstances”:          C5987 C6012 C6043      substitute:             C6845 C6850 C6875

  1. Schedule 1, entry for Netupitant with Palonosetron

insert in numerical order in the column headed “Circumstances”:         C6879

  1. Schedule 1, entry for Nevirapine in the form Tablet 400 mg (extended release)

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

a Nevirapine XR APOTEX TX MP C4454 C4526 60 5 30 D(100)

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

  1. Schedule 1, entry for Nicotine in each of the forms: Transdermal patch 17.5 mg; and Transdermal patch 35 mg

omit from the column headed “Circumstances”:          C5142 C5219     substitute:             C6848

  1. Schedule 1, entry for Nicotine in the form Transdermal patch 39.4 mg; Transdermal patch 52.5 mg; and Transdermal patch 114 mg

omit from the column headed “Circumstances”:          C5142 C5219    
insert in numerical order:  C6848

  1. Schedule 1, after entry for Nilutamide

insert:

Nintedanib Capsule 100 mg Oral Ofev BY MP C6869 C6870 C6889 60 5 60
Capsule 150 mg Oral Ofev BY MP C6869 C6870 C6889 60 5 60

  1. Schedule 1, entry for Oestradiol in the form Tablet 2 mg

omit from the column headed “Responsible Person”:                 AF        substitute:             GO

  1. Schedule 1, entry for Oestradiol and Oestradiol with Dydrogesterone in each of the forms: Pack containing 14 tablets oestradiol 1 mg and 14 tablets oestradiol 1 mg with dydrogesterone 10 mg; and Pack containing 14 tablets oestradiol 2 mg and 14 tablets oestradiol 2 mg with dydrogesterone 10 mg

omit from the column headed “Responsible Person”:                 AF        substitute:             GO

  1. Schedule 1, entry for Oestradiol with dydrogesterone

omit from the column headed “Responsible Person”:                 AF        substitute:             GO

  1. Schedule 1, after entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 40 mg with naloxone hydrochloride 20 mg

insert in the columns in the order indicated:

Tablet (controlled release) containing oxycodone hydrochloride 60 mg with naloxone hydrochloride 30 mg Oral Targin 60/30 MF MP NP C4951 28 0 28
Tablet (controlled release) containing oxycodone hydrochloride 80 mg with naloxone hydrochloride 40 mg Oral Targin 80/40 MF MP NP C4951 28 0 28

  1. Schedule 1, entry for Pancreatic Extract in all forms

omit from the column headed “Responsible Person”:                 AF        substitute:             GO

  1. Schedule 1, entry for Peginterferon beta-1a in the form Single use injection pen containing 125 micrograms in 0.5 mL
    [Maximum Quantity: 2; Number of Repeats: 4]

omit from the column headed “Circumstances”:          C4887   substitute:             C6860

  1. Schedule 1, entry for Peginterferon beta-1a in the form Single use injection pen containing 125 micrograms in 0.5 mL
    [Maximum Quantity: 2; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:               C4887   substitute:             C6860

(b)omit from the column headed “Purposes”:         P4887   substitute:             P6860

  1. Schedule 1, entry for Phenobarbitone in the form Tablet 30 mg

omit from the column headed “Brand”:         Phenobarbitone Aspen substitute:             Phenobarb

  1. Schedule 1, after entry for Protein formula with amino acids, carbohydrates, vitamins and minerals without phenylalanine, and supplemented with docosahexaenoic acid

insert:

Protein formula with carbohydrate, fat, vitamins and minerals Oral liquid 500 mL, 8 (Nutrini Peptisorb Energy) Oral Nutrini Peptisorb Energy NU MP NP C6890 10 5 1

  1. Schedule 1, entry for Quinapril in the form Tablet 5 mg (as hydrochloride)

omit:

a APO-Quinapril TX MP NP 30 5 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

a Rosuvastatin generichealth HQ MP C4225 C4226 C4238 C4263 P4226 P4263 30 5 30
NP C4226 C4263 30 5 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

a Rosuvastatin generichealth HQ MP C4225 C4226 C4238 C4263 P4225 P4238 30 11 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

a Rosuvastatin generichealth HQ MP C4225 C4226 C4238 C4263 P4226 P4263 30 5 30
NP C4226 C4263 30 5 30

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

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

a Rosuvastatin generichealth HQ MP C4225 C4226 C4238 C4263 P4225 P4238 30 11 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

(a)insert in the column headed “Pack Quantity” for the brand “Rostor 20” [Authorised Prescriber MP and NP]:                     30

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

a Rosuvastatin generichealth HQ MP C4225 C4226 C4238 C4263 P4226 P4263 30 5 30
NP C4226 C4263 30 5 30

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

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

a Rosuvastatin generichealth HQ MP C4225 C4226 C4238 C4263 P4225 P4238 30 11 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

a Rosuvastatin generichealth HQ MP C4225 C4226 C4238 C4263 P4226 P4263 30 5 30
NP C4226 C4263 30 5 30

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

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

a Rosuvastatin generichealth HQ MP C4225 C4226 C4238 C4263 P4225 P4238 30 11 30

  1. Schedule 1, entry for Salcatonin

omit from the column headed “Circumstances”:          C5260 C5331     substitute:             C6865 C6872

  1. Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 5; Number of Repeats: 5]

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

a Temolide JU MP 5 5 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 15; Number of Repeats: 2]

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

a Temolide JU MP P4897 15 2 5

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

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

a Temolide JU MP 5 5 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 15; Number of Repeats: 2]

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

a Temolide JU MP P4897 15 2 5

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

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

a Temolide JU MP 5 5 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 15; Number of Repeats: 2]

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

a Temolide JU MP P4897 15 2 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 5; Number of Repeats: 5]

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

a Temolide JU MP 5 5 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 15; Number of Repeats: 2]

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

a Temolide JU MP P4897 15 2 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 180 mg [Maximum Quantity: 5; 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 Temolide JU MP 5 5 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 180 mg [Maximum Quantity: 15; Number of Repeats: 2]

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

a Temolide JU MP P4897 15 2 5

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

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

a Temolide JU MP 5 5 5

  1. Schedule 1, after entry for Tenofovir

insert:

Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat Tablet containing tenofovir alafenamide 10 mg with emtricitabine 200 mg, elvitegravir 150 mg and cobicistat 150 mg Oral Genvoya GI MP C4470 C4522 60 5 30 D(100)

  1. Schedule 1, entry for Tenofovir with Emtricitabine

omit:

Tablet containing tenofovir alafenamide 10 mg with emtricitabine 200 mg Oral Descovy 10/200 GI MP C4454 C4512 60 5 30 D(100)
Tablet containing tenofovir alafenamide 25 mg with emtricitabine 200 mg Oral Descovy 25/200 GI MP C4454 C4512 60 5 30 D(100)

  1. Schedule 1, entry for Tenofovir with emtricitabine, elvitegravir and cobicistat

omit:

Tablet containing tenofovir alafenamide 10 mg with emtricitabine 200 mg, elvitegravir 150 mg and cobicistat 150 mg Oral Genvoya GI MP C4470 C4522 60 5 30 D(100)

  1. Schedule 1, entry for Teriflunomide

omit from the column headed “Circumstances”:          C4316 C4329     substitute:             C6853 C6854

  1. Schedule 1, entry for Trandolapril in each of the forms: Capsule 500 micrograms; Capsule 1 mg; Capsule 2 mg; and Capsule 4 mg

omit from the column headed “Responsible Person” for the brand “Gopten”:     AL        substitute:             GO

  1. Schedule 1, entry for Trandolapril with Verapamil in each of the forms: Tablet containing trandolapril 2 mg with verapamil hydrochloride
    180 mg (sustained release); and Tablet containing trandolapril 4 mg with verapamil hydrochloride 240 mg (sustained release)

omit from the column headed “Responsible Person” for the brands “Tarka 2/180” and “Tarka 4/240”:      AF        substitute:                GO

  1. Schedule 1, entry for Tranexamic Acid

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

a APO-Tranexamic Acid TX MP NP 100 2 100

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

  1. Schedule 1, entry for Varenicline in the form Box containing 11 tablets 0.5 mg (as tartrate) and 14 tablets 1 mg (as tartrate) in the first pack and 28 tablets 1 mg (as tartrate) in the second pack

omit from the column headed “Circumstances”:          C4645               substitute:             C6871

  1. Schedule 1, entry for Varenicline in the form Tablet 1 mg (as tartrate) [Maximum Quantity: 56; Number of repeats: 2]

(a)omit from the column headed “Circumstances”:               C4648 C4835     substitute:             C6864 C6885

(b)omit from the column headed “Purposes”:         P4835   substitute:             P6885

  1. Schedule 1, entry for Varenicline in the form Tablet 1 mg (as tartrate) [Maximum Quantity: 112; Number of repeats: 0]

(a)omit from the column headed “Circumstances”:               C4648 C4835     substitute:             C6864 C6885

(b)omit from the column headed “Purposes”:         P4648   substitute:             P6864

  1. Schedule 1, entry for Verapamil in the form Tablet containing verapamil hydrochloride 80 mg

omit from the column headed “Responsible Person” for the brand “Isoptin”:      MQ       substitute:             GO

  1. Schedule 1, entry for Verapamil in the form Tablet containing verapamil hydrochloride 180 mg (sustained release)

(a)omit from the column headed “Responsible Person” for the brand “Cordilox 180 SR”:         AL        substitute:             GT

(b)omit from the column headed “Responsible Person” for the brand “Isoptin 180 SR”:             MQ       substitute:             GO

  1. Schedule 1, entry for Verapamil in the form Tablet containing verapamil hydrochloride 240 mg (sustained release)

(a)omit from the column headed “Responsible Person” for the brand “Cordilox SR”: AL        substitute:             GT

(b)omit from the column headed “Responsible Person” for the brand “Isoptin SR”:     MQ       substitute:             GO

  1. Schedule 1, entry for Verapamil

omit:

Capsule containing verapamil hydrochloride 160 mg (sustained release) Oral Veracaps SR RW MP NP 30 5 30
Capsule containing verapamil hydrochloride 240 mg (sustained release) Oral Veracaps SR RW MP NP 30 5 30

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

insert:

GO BGP Products Pty Ltd  29 601 608 771

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

insert:

GT BGP Products Pty Ltd  29 601 608 771

  1. Schedule 3

omit:

MQ Alphapharm Pty Ltd  93 002 359 739

  1. Schedule 4, Part 1, entry for Abatacept

substitute:

Abatacept C6849 P6849

Severe active rheumatoid arthritis

Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)

Patient must have severe active rheumatoid arthritis; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND
Patient must not have failed previous PBS-subsidised treatment with this drug for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib.
If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.
The authority application must be made in writing and must include:
(1) completed authority prescription forms; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement.
Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats.
Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.
Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response.

 Compliance with Written Authority Required procedures
C6859 P6859

Severe active rheumatoid arthritis

Continuing Treatment – balance of supply

Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.

 Compliance with Authority Required procedures
C6866 P6866

Severe active rheumatoid arthritis

Continuing treatment

Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.

 Compliance with Written Authority Required procedures
C6867 P6867

Severe active rheumatoid arthritis

Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months)

Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib.
The authority application must be made in writing and must include:
(a) completed authority prescription forms; and
(b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
Applications for a patient who has received PBS-subsidised treatment with this drugt and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment, within the timeframes specified below.
Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats.
Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to a treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).

 Compliance with Written Authority Required procedures
C6874 P6874

Severe active rheumatoid arthritis

Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply

Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Aciclovir

(a)omit:

C5946 P5946

Advanced human immunodeficiency virus (HIV) disease

Patient must have CD4 cell counts of less than 150 million per litre.

 Compliance with Authority Required procedures - Streamlined Authority Code 5946

(b)omit from the column headed “Purposes Code” for Circumstances Code C5959:     P5959

(c)omit from the column headed “Purposes Code” for Circumstances Code C5967:     P5967

  1. Schedule 4, Part 1, entry for Alemtuzumab

substitute:

Alemtuzumab C6847 P6847

Multiple sclerosis

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must not receive more than one PBS-subsidised treatment per year; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Must be treated by a neurologist.

 Compliance with Authority Required procedures - Streamlined Authority Code 6847
C6877 P6877

Multiple sclerosis

Initial treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND
Patient must be ambulatory (without assistance or support).
Must be treated by a neurologist.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

 Compliance with Authority Required procedures
C6878 P6878

Multiple sclerosis

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND

Patient must not receive more than one PBS-subsidised treatment per year; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Must be treated by a neurologist.

 Compliance with Authority Required procedures
C6884 P6884

Multiple sclerosis

Initial treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND
Patient must be ambulatory (without assistance or support).
Must be treated by a neurologist.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

 Compliance with Authority Required procedures - Streamlined Authority Code 6884

  1. Schedule 4, Part 1, omit entry for Bacillus Calmette and Guerin, Connaught strain

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

insert:

Blinatumomab C6892

Acute lymphoblastic leukaemia (ALL)

Consolidation treatment

Patient must have previously received PBS-subsidised induction treatment with this drug for this condition; AND
Patient must have achieved a complete remission; OR
Patient must have achieved a complete remission with partial haematological recovery; AND
The treatment must not be more than 3 treatment cycles under this restriction in a lifetime.

 Compliance with Authority Required procedures
C6893

Acute lymphoblastic leukaemia (ALL)

Induction treatment – balance of supply

The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of less than 2; AND
The condition must not be present in the central nervous system or testis; AND
The condition must be Philadelphia chromosome negative; AND
Patient must have received insufficient therapy with this agent for this condition under the Induction treatment restriction to complete a maximum of 2 treatment cycles in a lifetime.
According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.
An amount of 784 mcg will be sufficient for a continuous infusion of bllinatumomab over 28 days in cycle 2.
Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.

 Compliance with Authority Required procedures
C6894

Acute lymphoblastic leukaemia (ALL)

Grandfathering treatment

Patient must have a documented history of relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of less than 2; AND
The condition must not be present in the central nervous system or testis; AND
The condition must be Philadelphia chromosome negative; AND
Patient must have a documented history of receiving intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND
Patient must have a documented history of more than 5% blasts in bone marrow; AND
Patient must have received treatment with this drug for this condition prior to 1 May 2017.
According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.
Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
Treatment with blinatumomab for ALL must not exceed 2 treatment cycles for induction therapy, and 3 treatment cycles for consolidation therapy in a lifetime.
Patients who have received two treatment cycles as induction therapy with this drug for this condition prior to 1 May 2017 must have achieved a complete remission, or a complete remission with partial haematological recovery in order to continue with PBS-subsidised treatment with this drug.
Patients who have received at least one treatment cycle as consolidation therapy with this drug for this condition prior to 1 May 2017 must have achieved a complete remission, or a complete remission with partial haematological recovery in order to continue with PBS-subsidised treatment with this drug.
A complete remission is defined as bone marrow blasts of less than or equal to 5%, no evidence of disease and a full recovery of peripheral blood counts with platelets of greater than 100,000 per microliter, and absolute neutrophil count (ANC) of greater than 1,000 per microliter.
A complete remission with partial haematological recovery is defined as bone marrow blasts of less than or equal to 5%, no evidence of disease and a partial recovery of peripheral blood counts with platelets of greater than 50,000 per microliter, and absolute neutrophil count (ANC) of greater than 500 per microliter.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
The authority application must be made in writing and must include:
(1) a completed authority prescription form;
(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement.
(4) date of most recent blinatumomab dose, and if this was for induction or consolidation therapy. If for consolidation therapy, how many treatment cycle(s) of PBS-subsidised blinatumomab will be required for completion of consolidation therapy; and
(5) date of latest chemotherapy prior to receiving non-PBS subsidised blinatumomab, and if it was the initial chemotherapy regimen or for salvage therapy; and
(6) a copy of bone marrow biopsy report prior to receiving non-PBS subsidised blinatumomab.

 Compliance with Written Authority Required procedures
C6895

Acute lymphoblastic leukaemia (ALL)

Induction treatment

The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of less than 2; AND
The condition must not be present in the central nervous system or testis; AND
The condition must be Philadelphia chromosome negative; AND
Patient must have received intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND

The condition must have more than 5% blasts in bone marrow; AND
The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.
According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.
An amount of 651 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 1. An amount of 784 microgram, which may be obtained under Induction treatment - balance of supply restriction, will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.
Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
The authority application must be made in writing and must include:
(1) a completed authority prescription form;
(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement.
(4) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy; and
(5) a copy of the most recent bone marrow biopsy report of no more than one month old at the time of application.

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, omit entry for Boceprevir

  1. Schedule 4, Part 1, entry for Bupropion

substitute:

Bupropion C6881 P6881

Nicotine dependence

Completion of a short-term (9 weeks) course of treatment

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 previously received PBS-subsidised treatment with this drug during this current course of treatment; AND
Patient must not receive more than 9 weeks of PBS-subsidised treatment with this drug per 12-month period.
Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program.

 Compliance with Authority Required procedures - Streamlined Authority Code 6881
C6882 P6882

Nicotine dependence

Commencement of a short-term (9 weeks) course of treatment

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 9 weeks of PBS-subsidised treatment with this drug 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.

 Compliance with Authority Required procedures - Streamlined Authority Code 6882

  1. Schedule 4, Part 1, entry for Calcipotriol with betamethasone

substitute:

Calcipotriol with betamethasone C6809

Chronic stable plaque type psoriasis vulgaris

The condition must be inadequately controlled by potent topical corticosteroid monotherapy.
C6873

Chronic stable plaque type psoriasis vulgaris

The condition must be inadequately controlled by potent topical corticosteroid monotherapy; AND
Patient must require more than 30 grams of product per month.

 Compliance with Authority Required procedures - Streamlined Authority Code 6873

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

insert:

Chloramphenicol C5835 For treatment of a patient identifying as Aboriginal or Torres Strait Islander

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

insert:

Daclizumab C6846

Multiple sclerosis

Grandfathering treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years prior to initiation of this drug; AND
Patient must have received treatment with this drug for this condition prior to 1 May 2017; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support); AND
The treatment must not exceed 24 weeks under this restriction.
Must be treated by a neurologist.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
Patients should undergo monthly liver function testing while being treated with this drug.
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.

 Compliance with Authority Required procedures
C6851

Multiple sclerosis

Initial treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Must be treated by a neurologist.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
Patients should undergo monthly liver function testing while being treated with this drug.

 Compliance with Authority Required procedures
C6888

Multiple sclerosis

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Must be treated by a neurologist.
Patients should undergo monthly liver function testing while being treated with this drug.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Dimethyl fumarate

substitute:

Dimethyl fumarate C6855

Multiple sclerosis

Continuing treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR
Patient must have been receiving treatment with this drug prior to 1 December 2013; AND
Patient must not show continuing progression of disability while on treatment with this drug.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

 Compliance with Authority Required procedures
C6876

Multiple sclerosis

Initial treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND
Patient must be ambulatory (without assistance or support).
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

 Compliance with Authority Required procedures
C6883

Multiple sclerosis

Continuing treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR
Patient must have been receiving treatment with this drug prior to 1 December 2013; AND
Patient must not show continuing progression of disability while on treatment with this drug.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

 Compliance with Authority Required procedures

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

insert:

Emtricitabine with rilpivirine with tenofovir alafenamide C4470

HIV infection

Continuing

Patient must have previously received PBS-subsidised therapy for HIV infection.

 Compliance with Authority Required procedures - Streamlined Authority Code 4470
C4522

HIV infection

Initial

Patient must be antiretroviral treatment naive.

 Compliance with Authority Required procedures - Streamlined Authority Code 4522
Emtricitabine with tenofovir alafenamide C4454

HIV infection

Continuing

Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents.

 Compliance with Authority Required procedures - Streamlined Authority Code 4454
C4512

HIV infection

Initial

Patient must be antiretroviral treatment naive; AND
The treatment must be in combination with other antiretroviral agents.

 Compliance with Authority Required procedures - Streamlined Authority Code 4512

  1. Schedule 4, Part 1, entry for Fingolimod

substitute:

Fingolimod C6856

Multiple sclerosis

Initial treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND
Patient must be ambulatory (without assistance or support).
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

 Compliance with Authority Required procedures
C6868

Multiple sclerosis

Continuing treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, omit entry for Fludarabine

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

insert:

Fosaprepitant C6852

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and 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 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy.
Concomitant use of a 5HT3 antagonist should not occur with fosaprepitant on days 2 and 3 of any chemotherapy cycle.

 Compliance with Authority Required procedures - Streamlined Authority Code 6852
C6886

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following agents: altretamine; carmustine; cisplatin when a single dose constitutes a cycle of chemotherapy; cyclophosphamide at a dose of 1500 mg per square metre per day or greater; dacarbazine; procarbazine when a single dose constitutes a cycle of chemotherapy; streptozocin.
No more than 1 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6886
C6887

Nausea and vomiting

The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND
Patient must have had a prior episode of chemotherapy induced nausea or vomiting; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following intravenous chemotherapy agents: arsenic trioxide; azacitidine; cyclophosphamide at a dose of less than 1500 mg per square metre per day; cytarabine at a dose of greater than 1 g per square metre per day; dactinomycin; daunorubicin; doxorubicin; epirubicin; fotemustine; idarubicin; ifosfamide; irinotecan; melphalan; methotrexate at a dose of 250 mg to 1 g per square metre; raltitrexed.
No more than 1 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy.
Concomitant use of a 5HT3 antagonist should not occur with fosaprepitant on days 2 and 3 of any chemotherapy cycle.

 Compliance with Authority Required procedures - Streamlined Authority Code 6887
C6891

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND
Patient must be scheduled to be co-administered cyclophosphamide and an anthracycline.
No more than 1 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6891

  1. Schedule 4, Part 1, omit entry for Gestrinone

  1. Schedule 4, Part 1, entry for Glatiramer

omit:

C4887

Multiple sclerosis
Continuing treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy

 Compliance with Authority Required procedures - Streamlined Authority Code 4887

substitute:

C6860

Multiple sclerosis

Continuing treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6860

  1. Schedule 4, Part 1, entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate

insert in numerical order after existing text:

C6858

Ketogenic diet

Patient must have intractable seizures requiring treatment with a ketogenic diet; OR
Patient must have a glucose transport protein defect; OR
Patient must have pyruvate dehydrogenase deficiency.
Keyo should only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist.

  1. Schedule 4, Part 1, entry for Interferon Beta 1a

omit:

C4887

Multiple sclerosis
Continuing treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy

 Compliance with Authority Required procedures - Streamlined Authority Code 4887

substitute:

C6860

Multiple sclerosis

Continuing treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6860

  1. Schedule 4, Part 1, entry for Interferon Beta 1b

omit:

C4887

Multiple sclerosis
Continuing treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy

 Compliance with Authority Required procedures - Streamlined Authority Code 4887

substitute:

C6860

Multiple sclerosis

Continuing treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6860

  1. Schedule 4, Part 1, entry for Levodopa with Carbidopa

omit:

C6154

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

Advanced Parkinson disease

Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
The treatment must be commenced in a hospital-based movement disorder clinic.

 Compliance with Authority Required procedures
C6179

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

Advanced Parkinson disease

Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
The treatment must be commenced in a hospital-based movement disorder clinic.

 Compliance with Authority Required procedures - Streamlined Authority Code 6179

substitute:

C6863

Advanced Parkinson disease

Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
The treatment must be commenced in a hospital-based movement disorder clinic.

 Compliance with Authority Required procedures - Streamlined Authority Code 6863
C6880

Advanced Parkinson disease

Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
The treatment must be commenced in a hospital-based movement disorder clinic.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Natalizumab

substitute:

Natalizumab C6845

Clinically definite relapsing-remitting multiple sclerosis

Continuing treatment

The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate, this therapy.
Neurologists prescribing natalizumab under the PBS listing must be registered with the Tysabri Australian Prescribing Program.

 Compliance with Authority Required procedures
C6850

Clinically definite relapsing-remitting multiple sclerosis

Initial treatment

The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support); AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years; AND
The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; OR
Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.
Patient must be aged 18 years or older.
Must be treated by a neurologist.
The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.
Neurologists prescribing natalizumab under the PBS listing must be registered with the Tysabri Australian Prescribing Program.

 Compliance with Authority Required procedures
C6875

Clinically definite relapsing-remitting multiple sclerosis

The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support); AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years; AND
The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; OR
Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.
Patient must be aged 18 years or older.
Must be treated by a neurologist.
The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.
Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug.
For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug.
Neurologists prescribing natalizumab under the PBS listing must be registered with the Tysabri Australian Prescribing Program.

 Compliance with Authority Required procedures - Streamlined Authority Code 6875

  1. Schedule 4, Part 1, entry for Netupitant with Palonosetron

insert in numerical order after existing text:

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

  1. Schedule 4, Part 1, entry for Nicotine

omit:

C5142

Nicotine dependence

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 be entering a comprehensive support and counselling program during the consultation at which this prescription is written; AND
Patient must not receive more than 12 weeks of PBS-subsidised nicotine replacement therapy per 12-month period.
Details of the support and counselling program must be documented in the patient's medical records at the time treatment is initiated
C5219

Nicotine dependence

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 have entered a comprehensive support and counselling program; AND
Patient must not receive more than 12 weeks of PBS-subsidised nicotine replacement therapy per 12-month period.
Details of the support and counselling program must be documented in the patient's medical records at the time treatment is initiated

insert in numerical order after existing text:

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

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

insert:

Nintedanib C6869

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.
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.
Application for authorisation for initial treatment must be in writing and must include:
A completed authority prescription form
A completed IPF Authority Application Supporting Information Form; and
A signed patient acknowledgement.
Patient must have not have an acute respiratory infection at the time of FVC testing.

 Compliance with Written Authority Required procedures
C6870

Idiopathic pulmonary fibrosis

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug 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
C6889

Idiopathic pulmonary fibrosis

Initial treatment 2 - 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, and drug toxicity.
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.
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.
Application for of initial treatment authorisation must be in writing and must include:
A completed authority prescription form
A completed IPF Authority Application Supporting Information Form; and
A signed patient acknowledgement.
Patient must have not have an acute respiratory infection at the time of FVC testing.

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Peginterferon beta-1a

omit:

C4887 P4887

Multiple sclerosis
Continuing treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy

 Compliance with Authority Required procedures - Streamlined Authority Code 4887

substitute:

C6860 P6860

Multiple sclerosis

Continuing treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6860

  1. Schedule 4, Part 1, after entry for Protein formula with amino acids, carbohydrates, vitamins and minerals without phenylalanine, and supplemented with docosahexaenoic acid

insert:

Protein formula with carbohydrate, fat, vitamins and minerals C6890

Dietary management of conditions requiring a source of medium chain triglycerides

Patient must have fat malabsorption due to liver disease; OR
Patient must have fat malabsorption due to short gut syndrome; OR
Patient must have fat malabsorption due to cystic fibrosis; OR
Patient must have fat malabsorption due to gastrointestinal disorders.
Patient must be aged from 1 to 10 years inclusive.

  1. Schedule 4, Part 1, entry for Salcatonin

substitute:

Salcatonin C6865

Hypercalcaemia

The treatment must be initiated in a hospital.
C6872 Symptomatic Paget disease of bone

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

insert:

Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat C4470

HIV infection

Continuing

Patient must have previously received PBS-subsidised therapy for HIV infection.

 Compliance with Authority Required procedures - Streamlined Authority Code 4470
C4522

HIV infection

Initial

Patient must be antiretroviral treatment naive.

 Compliance with Authority Required procedures - Streamlined Authority Code 4522

  1. Schedule 4, Part 1, entry for Teriflunomide

substitute:

Teriflunomide C6853

Multiple sclerosis

Initial treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; OR
Patient must have been receiving treatment with this drug prior to 1 December 2013; AND
Patient must be ambulatory (without assistance or support).
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

 Compliance with Authority Required procedures
C6854

Multiple sclerosis

Continuing treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Varenicline

substitute:

Varenicline C6864 P6864

Nicotine dependence

Continuation of a short-term (12 weeks or 24 weeks) course of treatment

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 previously received PBS-subsidised treatment with this drug during this current course of treatment.
Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program.

 Compliance with Authority Required procedures - Streamlined Authority Code 6864
C6871

Nicotine dependence

Commencement of a short-term (12 weeks or 24 weeks) course of treatment

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 24 weeks of PBS-subsidised treatment with this drug 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.
Clinical review is recommended within 2 to 3 weeks of the initial prescription being requested.

 Compliance with Authority Required procedures - Streamlined Authority Code 6871
C6885 P6885

Nicotine dependence

Completion of a short-term (24 weeks) course of treatment

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 previously received PBS-subsidised treatment with this drug during this current course of treatment; AND
Patient must have ceased smoking in the process of completing an initial 12-weeks or ceased smoking following an initial 12-weeks of PBS-subsidised treatment with this drug in the current course of treatment.
Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program.

 Compliance with Authority Required procedures - Streamlined Authority Code 6885

  1. Schedule 5, after entry for Desvenlafaxine

insert:

Doxycycline GRP-14639 Capsule 100 mg (as hydrochloride) (containing enteric coated pellets) Oral Doryx
Mayne Pharma Doxycycline
Tablet 100 mg (as hydrochloride) Oral Doxsig
Doxycycline AN
Doxylin 100
Tablet 100 mg (as monohydrate) Oral APO-Doxycycline
Chem mart Doxycycline
Doxycycline Sandoz
GenRx Doxycycline
Terry White Chemists Doxycycline
GRP-15635 Capsule 50 mg (as hydrochloride) (containing enteric coated pellets) Oral Doryx
Mayne Pharma Doxycycline
Tablet 50 mg (as hydrochloride) Oral Doxycycline AN
Doxylin 50
Tablet 50 mg (as monohydrate) Oral APO-Doxycycline
Chem mart Doxycycline
Doxycycline Sandoz
Frakas
GenRx Doxycycline
Terry White Chemists Doxycycline
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