National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 12) (PB 110 of 2016) (Cth)

Case

PB 110 of 2016

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016
(No. 12)

National Health Act 1953

I, NICK HENDERSON, 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    20 December 2016

NICK HENDERSON

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 2016 (No. 12).

(2)        This Instrument may also be cited as PB 110 of 2016.

2          Commencement

This Instrument commences on 1 January 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 Aciclovir in the form Eye ointment 30 mg per g, 4.5 g

omit:

AciVision DZ MP NP C5965 1 0 1
AO C5964 1 0 1

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

(a)omit:

a Chem mart Aciclovir CH MP NP C5942 90 5 90

(b)omit:

a Terry White Chemists Aciclovir TW MP NP C5942 90 5 90

  1. Schedule 1, entry for Adrenaline

(a)omit:

I.M. injection 150 micrograms in 0.3 mL single dose syringe auto‑injector (Anapen Junior) Injection Anapen Junior LM MP NP C4909 C4946 C4947 1 0 1

(b)omit:

I.M. injection 300 micrograms in 0.3 mL single dose syringe auto‑injector (Anapen) Injection Anapen LM MP NP C4909 C4946 C4947 1 0 1

  1. Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride 10 mg in 1 mL

omit from the column headed “Responsible Person”:                 HH        substitute:             PF

  1. Schedule 1, entry for Azithromycin in the form Tablet 600 mg (as dihydrate)

omit from the column headed “Circumstances”:          C1299 C3317     substitute:             C6356 C6361

  1. Schedule 1, entry for Biperiden

omit from the column headed “Responsible Person”:                 ZC        substitute:             GH

  1. Schedule 1, entry for Bleomycin

omit from the column headed “Responsible Person” for the brand “Hospira Pty Limited”:              HH        substitute:             PF

  1. Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 4 mg

omit:

a Candesartan RBX RA MP NP 30 5 30

  1. Schedule 1, entry for Carbimazole

omit from the column headed “Responsible Person” for the brand “Neo-Mercazole”:       ZC        substitute:             GH

  1. Schedule 1, entry for Carboplatin in each of the forms: Solution for I.V. injection 50 mg in 5 mL; Solution for I.V. injection 150 mg in 15 mL; and Solution for I.V. injection 450 mg in 45 mL

omit from the column headed “Responsible Person”:                 HH        substitute:             PF

  1. Schedule 1, entry for Cefalotin

omit from the column headed “Responsible Person”:                 HH        substitute:             PF

  1. Schedule 1, entry for Cefepime in each of the forms: Powder for injection 1 g (as hydrochloride); and Powder for injection 2 g
    (as hydrochloride)

omit from the column headed “Responsible Person” for the brand “DBL Cefepime”:        HH        substitute:             PF

  1. Schedule 1, entry for Cefotaxime in each of the forms: Powder for injection 1 g (as sodium); and Powder for injection 2 g
    (as sodium)

omit from the column headed “Responsible Person” for the brand “Hospira Pty Limited”:              HH        substitute:             PF

  1. Schedule 1, entry for Ceftriaxone in each of the forms: Powder for injection 1 g (as sodium); and Powder for injection 2 g
    (as sodium)

omit from the column headed “Responsible Person” for the brand “Hospira Ceftriaxone”:             HH        substitute:             PF

  1. Schedule 1, entry for Cephazolin in the form Powder for injection 1 g (as sodium)

omit from the column headed “Responsible Person” for the brand “Hospira Cephazolin Sodium”:   HH            substitute:             PF

  1. Schedule 1, entry for Chlorthalidone

omit from the column headed “Responsible Person”:                 ZC        substitute:             GH

  1. Schedule 1, entry for Choriogonadotropin alfa

omit:

Solution for injection 250 micrograms in 0.5 mL pre-filled syringe Injection Ovidrel SG MP

 C5019 1 0 1 D(100)

  1. Schedule 1, entry for Cisplatin in each of the forms: I.V. injection 50 mg in 50 mL; and I.V. injection 100 mg in 100 mL

omit from the column headed “Responsible Person” for the brand “Hospira Pty Limited”:              HH        substitute:             PF

  1. Schedule 1, entry for Citrulline with carbohydrate

omit from the column headed “Circumstances”:          C3679   substitute:             C6683

  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”:      GO       substitute:             AL

  1. Schedule 1, entry for Clozapine in each of the forms: Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; Tablet 200 mg; and Oral liquid 50 mg
    per mL, 100 mL

omit from the column headed “Responsible Person” for the brands “Clopine 25”, “Clopine 50”, “Clopine 100”, “Clopine 200” and “Clopine Suspension” respectively”:     HH        substitute:             PF

  1. Schedule 1, entry for Cyclosporin

substitute:

Cyclosporin Capsule 10 mg Oral Neoral 10 NV MP 120 3 60
MP P6629 P6630 P6631 P6638 P6643 P6659 P6660 P6670 P6671 P6676 120
CN6629 CN6630 CN6631 CN6638 CN6643 CN6659 CN6660 CN6670 CN6671 CN6676 		5
CN6629 CN6630 CN6631 CN6638 CN6643 CN6659 CN6660 CN6670 CN6671 CN6676 		60 C(100)
Capsule 25 mg Oral a Cyclosporin Sandoz SZ MP 60 3 30
a Neoral 25 NV MP 60 3 30
a Cyclosporin Sandoz SZ MP P6629 P6630 P6631 P6638 P6643 P6659 P6660 P6670 P6671 P6676 120
CN6629 CN6630 CN6631 CN6638 CN6643 CN6659 CN6660 CN6670 CN6671 CN6676 		5
CN6629 CN6630 CN6631 CN6638 CN6643 CN6659 CN6660 CN6670 CN6671 CN6676 		30 C(100)
a Neoral 25 NV MP P6629 P6630 P6631 P6638 P6643 P6659 P6660 P6670 P6671 P6676 120
CN6629 CN6630 CN6631 CN6638 CN6643 CN6659 CN6660 CN6670 CN6671 CN6676 		5
CN6629 CN6630 CN6631 CN6638 CN6643 CN6659 CN6660 CN6670 CN6671 CN6676 		30 C(100)
Capsule 50 mg Oral a Cyclosporin Sandoz SZ MP 60 3 30
a Neoral 50 NV MP 60 3 30
a Cyclosporin Sandoz SZ MP P6629 P6630 P6631 P6638 P6643 P6659 P6660 P6670 P6671 P6676 120
CN6629 CN6630 CN6631 CN6638 CN6643 CN6659 CN6660 CN6670 CN6671 CN6676 		5
CN6629 CN6630 CN6631 CN6638 CN6643 CN6659 CN6660 CN6670 CN6671 CN6676 		30 C(100)
a Neoral 50 NV MP P6629 P6630 P6631 P6638 P6643 P6659 P6660 P6670 P6671 P6676 120
CN6629 CN6630 CN6631 CN6638 CN6643 CN6659 CN6660 CN6670 CN6671 CN6676 		5
CN6629 CN6630 CN6631 CN6638 CN6643 CN6659 CN6660 CN6670 CN6671 CN6676 		30 C(100)
Capsule 100 mg Oral a Cyclosporin Sandoz SZ MP 60 3 30
a Neoral 100 NV MP 60 3 30
a Cyclosporin Sandoz SZ MP P6629 P6630 P6631 P6638 P6643 P6659 P6660 P6670 P6671 P6676 120
CN6629 CN6630 CN6631 CN6638 CN6643 CN6659 CN6660 CN6670 CN6671 CN6676 		5
CN6629 CN6630 CN6631 CN6638 CN6643 CN6659 CN6660 CN6670 CN6671 CN6676 		30 C(100)
a Neoral 100 NV MP P6629 P6630 P6631 P6638 P6643 P6659 P6660 P6670 P6671 P6676 120
CN6629 CN6630 CN6631 CN6638 CN6643 CN6659 CN6660 CN6670 CN6671 CN6676 		5
CN6629 CN6630 CN6631 CN6638 CN6643 CN6659 CN6660 CN6670 CN6671 CN6676 		30 C(100)
Oral liquid 100 mg per mL, 50 mL Oral Neoral NV MP 2 3 1
MP P6629 P6630 P6631 P6638 P6643 P6659 P6660 P6670 P6671 P6676 4
CN6629 CN6630 CN6631 CN6638 CN6643 CN6659 CN6660 CN6670 CN6671 CN6676 		5
CN6629 CN6630 CN6631 CN6638 CN6643 CN6659 CN6660 CN6670 CN6671 CN6676 		1 C(100)
Solution concentrate for I.V. infusion 50 mg in 1 mL Injection Sandimmun NV MP C6628 C6677 10 0 10 PB(100)

  1. Schedule 1, entry for Desferrioxamine in each of the forms: Powder for injection containing desferrioxamine mesylate 500 mg; and Powder for injection containing desferrioxamine mesylate 2 g

omit from the column headed “Responsible Person”:                 HH        substitute:             PF

  1. Schedule 1, entry for Dexamethasone in each of the forms: Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL; and Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL

omit from the column headed “Responsible Person” for the brand “Hospira Pty Limited”:              HH        substitute:             PF

  1. Schedule 1, entry for Diazepam in the form Injection 10 mg in 2 mL

omit from the column headed “Responsible Person”:                 HH        substitute:             PF

  1. Schedule 1, entry for Didanosine

omit:

Capsule 125 mg (containing enteric coated beadlets) Oral Videx EC BQ MP C4454 C4512 60 5 30 D(100)
Capsule 200 mg (containing enteric coated beadlets) Oral Videx EC BQ MP C4454 C4512 60 5 30 D(100)

  1. Schedule 1, entry for Docetaxel in each of the forms: Solution concentrate for I.V. infusion 160 mg in 16 mL; Solution concentrate for
    I.V. infusion 20 mg in 2 mL; and Solution concentrate for I.V. infusion 80 mg in 8 mL

omit from the column headed “Responsible Person” for the brand “DBL Docetaxel Concentrated Injection”:            HH            substitute:             PF

  1. Schedule 1, entry for Doxorubicin in each of the forms: Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial; and Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial

omit from the column headed “Responsible Person” for the brand “Hospira Pty Limited”:              HH        substitute:             PF

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

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

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

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

omit:

a Deotine 30 SZ MP NP C5650 28 0 28

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

omit:

a Deotine 60 SZ MP NP C5650 28 5 28

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

omit from the column headed “Responsible Person” for the brand “Hospira Pty Limited”:              HH        substitute:             PF

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

omit from the column headed “Responsible Person” for the brand “DBL Epirubicin Hydrochloride Injection”:         HH            substitute:             PF

  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”:                 GO       substitute:             AF

  1. Schedule 1, entry for Eprosartan with Hydrochlorothiazide

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

  1. Schedule 1, entry for Erythromycin in the form Tablet 400 mg (as ethyl succinate)

omit from the column headed “Responsible Person” for the brand “E.E.S. 400 Filmtab” (all instances):      ZC        substitute:                GH

  1. Schedule 1, entry for Erythromycin in the form Powder for oral liquid 200 mg (as ethyl succinate) per 5 mL, 100 mL

omit from the column headed “Responsible Person” for the brand “E.E.S. 200” (twice occurring):               ZC        substitute:                GH

  1. Schedule 1, entry for Erythromycin in the form Powder for oral liquid 400 mg (as ethyl succinate) per 5 mL, 100 mL

omit from the column headed “Responsible Person” for the brand “E.E.S. Granules” (twice occurring):      ZC        substitute:                GH

  1. Schedule 1, entry for Ethosuximide in each of the forms: Capsule 250 mg; and Oral solution 250 mg per 5 mL, 200 mL

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

  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”:                 GO       substitute:             AF

  1. Schedule 1, entry for Filgrastim in each of the forms: Injection 120 micrograms in 0.2 mL single use pre‑filled syringe (Nivestim); Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Nivestim); and Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Nivestim)

omit from the column headed “Responsible Person”:                 HH        substitute:             PF

  1. Schedule 1, entry for Filgrastim in all forms

omit all codes from the column headed “Circumstances” and substitute:

C6488 C6489 C6490 C6491 C6492 C6493 C6494 C6501 C6502 C6507 C6512 C6513 C6514 C6515 C6516 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6546 C6554 C6555 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680

  1. Schedule 1, entry for Flucloxacillin

(a)omit:

Powder for injection 500 mg (as sodium) Injection Flubiclox JU MP NP PDP 5 0 5

(b)omit:

Powder for injection 1 g (as sodium) Injection Flubiclox JU PDP 5 0 5
Flucil AS PDP 5 0 5
Hospira Pty Limited HH PDP 5 0 5
PDP 5 0 10
Flubiclox JU MP NP 5 1 5
Flucil AS MP NP 5 1 5
Hospira Pty Limited HH MP NP 5 1 5
MP NP 5 1 10

substitute:

Powder for injection 1 g (as sodium) Injection a Flucil AS PDP 5 0 5
a Hospira Pty Limited PF PDP 5 0 10
a Flucil AS MP NP 5 1 5
a Hospira Pty Limited PF MP NP 5 1 10

  1. Schedule 1, entry for Fluorouracil in the form Injection 500 mg in 10 mL

omit from the column headed “Responsible Person”:                 HH        substitute:             PF

  1. Schedule 1, entry for Fluorouracil in each of the forms: Injection 1000 mg in 20 mL; and Injection 2500 mg in 50 mL

omit from the column headed “Responsible Person” for the brand “DBL Fluorouracil Injection BP”:          HH        substitute:                PF

  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”:       GO       substitute:             MQ

  1. Schedule 1, entry for Folinic acid in each of the forms: Tablet containing calcium folinate equivalent to 15 mg folinic acid; Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL; and Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL

omit from the column headed “Responsible Person” for the brand “Leucovorin Calcium (Hospira Pty Limited)”:     HH            substitute:             PF

  1. Schedule 1, entry for Fosinopril with Hydrochlorothiazide

omit:

Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg Oral Monoplus 10/12.5 BQ MP NP C4389 30 5 30

  1. Schedule 1, entry for Gemcitabine in the form Solution for injection 200 mg (as hydrochloride) in 5.3 mL

omit from the column headed “Responsible Person”:                 HH        substitute:             PF

  1. Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride)

omit from the column headed “Responsible Person” for the brand “DBL Gemcitabine for Injection”:           HH        substitute:                PF

  1. Schedule 1, entry for Gemcitabine in the form Solution for injection 1 g (as hydrochloride) in 26.3 mL

omit from the column headed “Responsible Person”:                 HH        substitute:             PF

  1. Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride)

omit from the column headed “Responsible Person” for the brand “DBL Gemcitabine for Injection”:           HH        substitute:                PF

  1. Schedule 1, entry for Gemcitabine in the form Solution for injection 2 g (as hydrochloride) in 52.6 mL

omit from the column headed “Responsible Person”:                 HH        substitute:             PF

  1. Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 2 g (as hydrochloride)

omit from the column headed “Responsible Person” for the brand “DBL Gemcitabine for Injection”:           HH        substitute:                PF

  1. Schedule 1, omit entry for Glycomacropeptide and essential amino acids

  1. Schedule 1, after entry for Glycomacropeptide and essential amino acids with vitamins and minerals in the form Sachets containing
    oral powder 49 g, 30 (Camino Pro Bettermilk)

insert in the columns in the order indicated:

Sachets containing oral powder 51 g, 30 (PKU Bettermilk Lite) Oral PKU Bettermilk Lite QH MP NP C4295 4 5 1

  1. Schedule 1, after entry for Granisetron in the form Concentrated injection 3 mg (as hydrochloride)
    in 3 mL [Brand: Kytril]

insert:

Grazoprevir with elbasvir Tablet containing grazoprevir 100 mg with elbasvir 50 mg Oral Zepatier MK MP C5969 C6625 P5969 28 2 28
MP C5969 C6625 P6625 28 3 28

  1. Schedule 1, entry for Heparin in each of the forms: Injection 5,000 units (as sodium) in 0.2 mL; and Injection 35,000 units (as sodium)
    in 35 mL

omit from the column headed “Responsible Person”:                 HH        substitute:             PF

  1. Schedule 1, entry for Hydroxocobalamin in the form Injection 1 mg (as chloride) in 1 mL

omit from the column headed “Responsible Person” for the brand “Neo-B12”:                  HH        substitute:             PF

  1. Schedule 1, entry for Ibuprofen

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

  1. Schedule 1, entry for Imipramine in each of the forms: Tablet containing imipramine hydrochloride 10 mg; and Tablet containing imipramine hydrochloride 25 mg

omit from the column headed “Responsible Person” for the brands “Tofranil 10” and “Tofranil 25” respectively:   ZC            substitute:             GH

  1. Schedule 1, entry for Infliximab

omit from the column headed “Responsible Person” for the brand “Inflectra”:   HH        substitute:             PF

  1. Schedule 1, entry for Insect Allergen Extract—Paper Wasp Venom

omit:

Injection set containing 550 micrograms with diluent Injection Hymenoptera Paper Wasp Venom DE MP 1 0 1

  1. Schedule 1, entry for Insect Allergen Extract— Yellow Jacket Venom

omit:

Injection set containing 550 micrograms with diluent Injection Hymenoptera Yellow Jacket Venom DE MP 1 0 1

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

substitute:

Interferon alfa-2a Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe Injection Roferon-A RO MP C6632 C6648 C6672 P6648 P6672 15 4 1
MP C4993 C5003 C5036 C5042 C6661 C6662 C6678 P6662 P6678 15 4 1 C(100)
MP C6632 C6648 C6672 P6632 15 5 1
MP C4993 C5003 C5036 C5042 C6661 C6662 C6678 P6661 15 5 1 C(100)
MP C4993 C5003 C5036 C5042 C6661 C6662 C6678 P4993 P5003 P5036 P5042 30 5 1 C(100)
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)
Injection 9,000,000 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 alfa-2b

substitute:

Interferon alfa-2b Solution for injection 10,000,000 I.U. in 1 mL single dose vial Injection Intron A MK MP C4974 C4993 C5003 C5033 C5036 C5042 15 5 5 PB(100)
Solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen Injection Intron A Redipen MK MP C4974 C4993 C5003 C5033 C5036 C5042 C6639 C6661 C6662 P4974 P4993 P5003 P5033 P5036 P5042 2 5 1 C(100)
MP C6618 C6632 C6648 P6648 3 4 1
MP C4974 C4993 C5003 C5033 C5036 C5042 C6639 C6661 C6662 P6662 3 4 1 C(100)
MP C6618 C6632 C6648 P6618 P6632 3 5 1
MP C4974 C4993 C5003 C5033 C5036 C5042 C6639 C6661 C6662 P6639 P6661 3 5 1 C(100)
Solution for injection 18,000,000 I.U. in 3 mL single dose vial Injection Intron A MK MP C4974 C4993 C5003 C5033 C5036 C5042 15 5 1 PB(100)
Solution for injection 25,000,000 I.U. in 2.5 mL single dose vial Injection Intron A MK MP C4974 C4993 C5003 C5033 C5036 C5042 15 5 1 PB(100)
Solution for injection 30,000,000 I.U. in 1.2 mL multi-dose injection pen Injection Intron A Redipen MK MP C4974 C4993 C5003 C5033 C5036 C5042 C6639 C6661 P4974 P4993 P5003 P5033 P5036 P5042 2 5 1 C(100)
MP C6618 C6632 3 5 1
MP C4974 C4993 C5003 C5033 C5036 C5042 C6639 C6661 P6639 P6661 3 5 1 C(100)
Solution for injection 60,000,000 I.U. in 1.2 mL multi-dose injection pen Injection Intron A Redipen MK MP C4974 C4993 C5003 C5033 C5036 C5042 2 5 1 PB(100)

  1. Schedule 1, entry for Ipilimumab in each of the forms: Injection concentrate for I.V. infusion 50 mg in 10 mL; and Injection concentrate for I.V. infusion 200 mg in 40 mL

omit from the column headed “Circumstances”:          C4251 C4252

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

(a)omit from the column headed “Responsible Person” for the brand “Hospira Pty Limited”:   HHsubstitute:             PF

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

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

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

omit from the column headed “Responsible Person” for the brand “Hospira Pty Limited”:              HHsubstitute:             PF

  1. Schedule 1, entry for Lenograstim in each of the forms Powder for injection 13,400,000 I.U. (105 micrograms); and Powder for injection 33,600,000 I.U. (263 micrograms)

(a)omit from the column headed “Responsible Person”:      HHsubstitute:             PF

(b)omit all codes from the column headed “Circumstances” and substitute:

C6488 C6490 C6494 C6502 C6507 C6512 C6516 C6521 C6522 C6523 C6532 C6535 C6543 C6546 C6622 C6623 C6633 C6634 C6644 C6649 C6653 C6654 C6656 C6657 C6663 C6673 C6681 C6682

  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”:    GO       substitute:             AL

  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”:                 GO       substitute:             AF

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

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

(b)omit from the column headed “Brand”:               Levetiracetam generichealth     substitute:             Levetiracetam GH

  1. Schedule 1, after entry for Memantine in the form Tablet containing memantine hydrochloride 20 mg [Brand: Memantine RBX]

insert:

Mepolizumab Powder for injection 100 mg Injection Nucala GK MP See Note 3 See Note 3 See
Note 3 		See
Note 3 		1 D(100)

  1. Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg

omit:

a Metformin generichealth GQ MP NP 60 5 60

  1. Schedule 1, entry for Methotrexate in each of the forms: Injection 5 mg in 2 mL vial; Injection 50 mg in 2 mL vial; Solution concentrate for I.V. infusion 500 mg in 20 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 “Hospira Pty Limited” (all instances):   HH        substitute:                PF

  1. Schedule 1, entry for Metoclopramide in the form Tablet containing metoclopramide hydrochloride 10 mg

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

a EMEXLON RW MP NP MW PDP 25 0 25

  1. Schedule 1, entry for Metronidazole

omit:

I.V. infusion 500 mg in 100 mL Injection Metronidazole‑
Claris 		AE MP NP C4592 C4593 10 0 10
PDP C4581 10 0 10
Metronidazole Sandoz IV SZ MP NP C4592 C4593 10 0 10
PDP C4581 10 0 10

substitute:

I.V. infusion 500 mg in 100 mL Injection Metronidazole Sandoz IV SZ MP NP C6675 C6685 10 0 10
PDP C6667 10 0 10

  1. Schedule 1, entry for Milk powder—lactose free formula in the form Oral powder 900 g (S‑26 LF) [Maximum Quantity: 5;
    Number of Repeats: 0]

(a)omit from the column headed “Circumstances”:               C2760 C2762     substitute:             C4324 C4336

(b)omit from the column headed “Purposes”:         P2762   substitute:             P4324

  1. Schedule 1, entry for Milk powder—lactose free formula in the form Oral powder 900 g (S‑26 LF) [Maximum Quantity: 5;
    Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:               C2760 C2762     substitute:             C4324 C4336

(b)omit from the column headed “Purposes”:         P2760   substitute:             P4336

  1. Schedule 1, omit entry for Milk powder—lactose modified

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

omit from the column headed “Responsible Person” for the brand “Hospira Pty Limited”:              HH        substitute:             PF

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

omit from the column headed “Circumstances” (all instances):               C2617   substitute:             C6666

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

omit from the column headed “Circumstances” (all instances):               C2618 C3217     substitute:             C6674 C6684

  1. Schedule 1, entry for Morphine in each of the forms: Injection containing morphine sulfate 10 mg in 1 mL; Injection containing morphine tartrate 120 mg in 1.5 mL; Injection containing morphine sulfate 15 mg in 1 mL; and Injection containing morphine sulfate 30 mg in 1 mL

omit from the column headed “Responsible Person”:                 HH        substitute:             PF

  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”:                 GO       substitute:             AF

  1. Schedule 1, entry for Mupirocin

omit from the column headed “Circumstances”:          C3136   substitute:             C6647

  1. Schedule 1, entry for Naloxone

omit from the column headed “Responsible Person”:                 HHsubstitute:             PF

  1. Schedule 1, entry for Octreotide in each of the forms: Injection 50 micrograms (as acetate) in 1 mL; Injection 100 micrograms (as acetate)
    in 1 mL; and Injection 500 micrograms (as acetate) in 1 mL

omit from the column headed “Responsible Person” for the brand “Hospira Pty Limited”:              HH        substitute:             PF

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

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

  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”: GO       substitute:             AF

  1. Schedule 1, entry for Oestradiol with dydrogesterone

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

  1. Schedule 1, entry for Olanzapine in each of the forms: Tablet 5 mg; Tablet 7.5 mg; and Tablet 10 mg

omit:

Olanzapine GH GQ MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Olanzapine in each of the forms: Tablet 5 mg (orally disintegrating); and Tablet 10 mg (orally disintegrating)

omit:

Olanzapine RBX ODT RA MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Olanzapine in each of the forms: Tablet 15 mg (orally disintegrating); and Tablet 20 mg (orally disintegrating)

(a)omit:

Chem mart Olanzapine ODT CH MP NP C5856 C5869 28 5 28

(b)omit:

Terry White Chemists Olanzapine ODT TW MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Oxaliplatin in each of the forms: Solution concentrate for I.V. infusion 50 mg in 10 mL; and Solution concentrate for I.V. infusion 100 mg in 20 mL

omit from the column headed “Responsible Person” for the brand “DBL Oxaliplatin Concentrate”:             HH        substitute:                PF

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

omit from the column headed “Responsible Person” for the brand “Anzatax”:                    HH        substitute:             PF

  1. Schedule 1, entry for Pamidronic Acid in all forms

omit from the column headed “Responsible Person”:                 HH        substitute:             PF

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

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

  1. Schedule 1, entry for Paroxetine in the form Tablet 20 mg (as hydrochloride)

omit from the column headed “Circumstances” (all instances):               C6219 C6267 C6290      substitute:             C4755 C6277 C6636

  1. Schedule 1, entry for Paroxetine

omit:

Tablet 20 mg (as mesilate) Oral Paroxetine generichealth GQ MP NP C6219 C6267 C6290 30 5 30

  1. Schedule 1, entry for Pemetrexed in each of the forms: Powder for I.V. infusion 100 mg (as disodium); Powder for I.V. infusion 500 mg
    (as disodium); and Powder for I.V. infusion 1 g (as disodium)

omit from the column headed “Responsible Person” for the brand “DBL Pemetrexed”:    HH        substitute:             PF

  1. Schedule 1, entry for Perindopril with Indapamide in the form Tablet containing perindopril arginine 2.5 mg with indapamide hemihydrate 0.625 mg

(a)insert in the column headed “Schedule Equivalent” for the brand “Coversyl Plus LD 2.5mg/0.625mg”:            a

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

a PREXUM Combi LD 2.5/0.625 RW MP NP 30 5 30

  1. Schedule 1, entry for Promethazine

omit from the column headed “Responsible Person”:                 HH        substitute:             PF

  1. Schedule 1, entry for Raltitrexed

omit from the column headed “Responsible Person”:                 HH        substitute:             PF

  1. Schedule 1, after entry for Riluzole [Brand: Riluzole Winthrop]

insert:

Riociguat Tablet 500 micrograms Oral Adempas BN MP See Note 3 See Note 3 See Note 3 See
Note 3 		1 D(100)
MP See Note 3 See Note 3 See Note 3 See
Note 3 		1 D(100)
Tablet 1 mg Oral Adempas BN MP See Note 3 See Note 3 See Note 3 See
Note 3 		1 D(100)
MP See Note 3 See Note 3 See Note 3 See
Note 3 		1 D(100)
Tablet 1.5 mg Oral Adempas BN MP See Note 3 See Note 3 See Note 3 See
Note 3 		1 D(100)
MP See Note 3 See Note 3 See Note 3 See
Note 3 		1 D(100)
Tablet 2 mg Oral Adempas BN MP See Note 3 See Note 3 See Note 3 See
Note 3 		1 D(100)
MP See Note 3 See Note 3 See Note 3 See
Note 3 		1 D(100)
Tablet 2.5 mg Oral Adempas BN MP See Note 3 See Note 3 See Note 3 See
Note 3 		1 D(100)
MP See Note 3 See Note 3 See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Somatropin

omit:

Injection 8 mg (24 i.u.) vial with 1.37 mL diluent cartridge (with preservative) (for use with one.click auto-injector) Injection Saizen 8 mg click.easy SG MP C5146 C5147 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5227 C5228 C5229 C5230 C5231 C5238 C5239 C5269 C5270 C5273 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Tobramycin in the form Injection 80 mg in 2 mL

omit from the column headed “Responsible Person” for the brand “Hospira Pty Limited”:              HH        substitute:             PF

  1. Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg [Maximum Quantity: 20;
    Number of Repeats: 0]

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

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

a Tramadol AMNEAL EF MP NP C5848 C5877 P5877 20 0 20
PDP C5875 C5876 20 0 20

  1. Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg [Maximum Quantity: 20;
    Number of Repeats: 2]

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

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

a Tramadol AMNEAL EF MP NP C5848 C5877 P5848 20 2 20

  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”:     GO       substitute:             AL

  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 4/280”:      GO       substitute:                AF

  1. Schedule 1, entry for Vancomycin in each of the forms: Powder for injection 500 mg (500,000 I.U.) (as hydrochloride); and Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)

omit from the column headed “Responsible Person” for the brand “Hospira Pty Limited” (all instances):   HH        substitute:                PF

  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”:      GO       substitute:             MQ

  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”:         GT        substitute:             AL

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

  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”: GT        substitute:             AL

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

  1. Schedule 1, entry for Vinblastine

omit from the column headed “Responsible Person”:                 HH        substitute:             PF

  1. Schedule 1, entry for Vincristine

omit from the column headed “Responsible Person”:                 HH        substitute:             PF

  1. Schedule 1, entry for Vinorelbine in each of the forms: Solution for I.V. infusion 10 mg (as tartrate) in 1 mL; and Solution for I.V. infusion
    50 mg (as tartrate) in 5 mL

omit from the column headed “Responsible Person” for the brand “Hospira Pty Limited”:              HH        substitute:             PF

  1. Schedule 1, entry for Zoledronic acid in each of the forms: Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL; and Solution for I.V. infusion 4 mg (as monohydrate) in 100 mL

omit from the column headed “Responsible Person” for the brand “DBL Zoledronic Acid”:            HH        substitute:             PF

  1. Schedule 1, entry for Zoledronic acid in the form Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL

omit from the column headed “Responsible Person” for the brand “Ostira”:       HH        substitute:             PF

  1. Schedule 3

omit:

GO BGP Products Pty Ltd  29 601 608 771

  1. Schedule 3

omit:

GT BGP Products Pty Ltd  29 601 608 771

  1. Schedule 3

omit:

HH Hospira Pty Limited  13 107 058 328

  1. Schedule 3

omit:

SJ Sharpe Laboratories Pty Ltd  55 001 334 854

  1. Schedule 3

omit:

ZC Anspec Pty Limited  13 056 263 239

  1. Schedule 4, Part 1, entry for Azithromycin

(a)omit:

C1299

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

Prophylaxis against Mycobacterium avium complex infections in human immunodeficiency virus‑positive patients with CD4 cell counts of less than 75 per cubic millimetre

 Compliance with Written or Telephone Authority Required procedures
C3317

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

Prophylaxis against Mycobacterium avium complex infections in human immunodeficiency virus‑positive patients with CD4 cell counts of less than 75 per cubic millimetre

 Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3317

(b)insert in numerical order after existing text:

C6356

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

Mycobacterium avium complex infection

The treatment must be for prophylaxis; AND

Patient must be human immunodeficiency virus (HIV) positive; AND

Patient must have CD4 cell counts of less than 75 per cubic millimetre.

 Compliance with Authority Required procedures - Streamlined Authority Code 6356
C6361

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

Mycobacterium avium complex infection

The treatment must be for prophylaxis; AND

Patient must be human immunodeficiency virus (HIV) positive; AND

Patient must have CD4 cell counts of less than 75 per cubic millimetre.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Citrulline with carbohydrate

substitute:

Citrulline with carbohydrate C6683

Urea cycle disorders

The treatment must be for preventing low plasma arginine levels; OR

The treatment must be for preventing low citrulline levels.

  1. Schedule 4, Part 1, entry for Cyclosporin

substitute:

Cyclosporin C6628

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

Management of transplant rejection

The treatment must be used by organ or tissue transplant recipients.

 Compliance with Authority Required procedures - Streamlined Authority Code 6628
P6629 CN6629

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

Severe atopic dermatitis

Management (initiation, stabilisation and review of therapy)

The condition must be ineffective to other systemic therapies; OR

The condition must be inappropriate for other systemic therapies.

Must be treated by a dermatologist; OR

Must be treated by a clinical immunologists.

 Compliance with Authority Required procedures
P6630 CN6630

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

Severe psoriasis

Management (initiation, stabilisation and review of therapy)

The condition must be ineffective to other systemic therapies; OR

The condition must be inappropriate for other systemic therapies; AND

The condition must have caused significant interference with quality of life.

Must be treated by a dermatologist.

 Compliance with Authority Required procedures
P6631 CN6631

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

Nephrotic syndrome

Management (initiation, stabilisation and review of therapy)

Patient must have failed prior treatment with steroids and cytostatic drugs; OR

Patient must be intolerant to treatment with steroids and cytostatic drugs; OR

The condition must be considered inappropriate for treatment with steroids and cytostatic drugs; AND

Patient must not have renal impairment.

Must be treated by a nephrologist.

 Compliance with Authority Required procedures - Streamlined Authority Code 6631
P6638 CN6638

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

Severe active rheumatoid arthritis

Management (initiation, stabilisation and review of therapy)

The condition must have been ineffective to prior treatment with classical slow-acting anti-rheumatic agents (including methotrexate); OR

The condition must be considered inappropriate for treatment with slow-acting anti-rheumatic agents (including methotrexate).

Must be treated by a rheumatologist; OR

Must be treated by a clinical immunologist.

 Compliance with Authority Required procedures - Streamlined Authority Code 6638
P6643 CN6643

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

Management of transplant rejection

Management (initiation, stabilisation and review of therapy)

Patient must have had an organ or tissue transplantation; AND

The treatment must be under the supervision and direction of a transplant unit.

 Compliance with Authority Required procedures - Streamlined Authority Code 6643
P6659 CN6659

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

Severe active rheumatoid arthritis

Management (initiation, stabilisation and review of therapy)

The condition must have been ineffective to prior treatment with classical slow-acting anti-rheumatic agents (including methotrexate); OR

The condition must be considered inappropriate for treatment with slow-acting anti-rheumatic agents (including methotrexate).

Must be treated by a rheumatologist; OR

Must be treated by a clinical immunologist.

 Compliance with Authority Required procedures
P6660 CN6660

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

Severe atopic dermatitis

Management (initiation, stabilisation and review of therapy)

The condition must be ineffective to other systemic therapies; OR

The condition must be inappropriate for other systemic therapies.

Must be treated by a dermatologist; OR

Must be treated by a clinical immunologists.

 Compliance with Authority Required procedures - Streamlined Authority Code 6660
P6670 CN6670

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

Management of transplant rejection

Management (initiation, stabilisation and review of therapy)

Patient must have had an organ or tissue transplantation; AND

The treatment must be under the supervision and direction of a transplant unit.

 Compliance with Authority Required procedures
P6671 CN6671

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

Nephrotic syndrome

Management (initiation, stabilisation and review of therapy)

Patient must have failed prior treatment with steroids and cytostatic drugs; OR

Patient must be intolerant to treatment with steroids and cytostatic drugs; OR

The condition must be considered inappropriate for treatment with steroids and cytostatic drugs; AND

Patient must not have renal impairment.

Must be treated by a nephrologist.

 Compliance with Authority Required procedures
P6676 CN6676

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

Severe psoriasis

Management (initiation, stabilisation and review of therapy)

The condition must be ineffective to other systemic therapies; OR

The condition must be inappropriate for other systemic therapies; AND

The condition must have caused significant interference with quality of life.

Must be treated by a dermatologist.

 Compliance with Authority Required procedures - Streamlined Authority Code 6676
C6677

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

Management of transplant rejection

The treatment must be used by organ or tissue transplant recipients.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Filgrastim

substitute:

Filgrastim C6488

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

Chemotherapy-induced neutropenia

Patient must be receiving standard dose adjuvant chemotherapy for breast cancer; AND

Patient must have had a prior episode of febrile neutropenia; OR

Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND

The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND

Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

 Compliance with Authority Required procedures
C6489

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

Chemotherapy-induced neutropenia

Patient must must be receiving chemotherapy with fludarabine and cyclophosphamide for B-cell chronic lymphocytic leukaemia; AND

Patient must have had a prior episode of febrile neutropenia; OR

Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND

The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND

Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

 Compliance with Authority Required procedures
C6490

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

Chemotherapy-induced neutropenia

Patient must be receiving first-line chemotherapy for Hodgkin disease; AND

Patient must have had a prior episode of febrile neutropenia; OR

Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND

The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND

Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

 Compliance with Authority Required procedures
C6491

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

Chemotherapy-induced neutropenia

Patient must be receiving neoadjuvant treatment with docetaxel in combination with cisplatin and fluorouracil for inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx; AND

Patient must have had a prior episode of febrile neutropenia; OR

Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND

The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND

Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

 Compliance with Authority Required procedures
C6492

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

Chemotherapy-induced neutropenia

Patient must be receiving neoadjuvant treatment with docetaxel in combination with cisplatin and fluorouracil for inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx; AND

Patient must have had a prior episode of febrile neutropenia; OR

Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND

The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND

Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

 Compliance with Authority Required procedures - Streamlined Authority Code 6492
C6493

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy (first-line chemotherapy with escalated BEACOPP) with the intention of achieving a cure or substantial remission in Hodgkin disease.

 Compliance with Authority Required procedures - Streamlined Authority Code 6493
C6494

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in an infant or child with central nervous system tumours.

 Compliance with Authority Required procedures
C6501

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin lymphoma (aggressive grades; or low grade receiving an anthracycline-containing regimen).

 Compliance with Authority Required procedures
C6502

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in an infant or child with central nervous system tumours.

 Compliance with Authority Required procedures - Streamlined Authority Code 6502
C6507

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia.

 Compliance with Authority Required procedures - Streamlined Authority Code 6507
C6512

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia.

 Compliance with Authority Required procedures
C6513

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy (adjuvant chemotherapy with docetaxel in combination with an anthracycline and cyclophosphamide) with the intention of achieving a cure or substantial remission in breast cancer.

 Compliance with Authority Required procedures
C6514

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in sarcoma.

 Compliance with Authority Required procedures
C6515

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

Chemotherapy-induced neutropenia

Patient must be receiving chemotherapy for myeloma; AND

Patient must have had a prior episode of febrile neutropenia; AND

The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND

Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

 Compliance with Authority Required procedures - Streamlined Authority Code 6515
C6516

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma.

 Compliance with Authority Required procedures - Streamlined Authority Code 6516
C6521

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours.

 Compliance with Authority Required procedures
C6522

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

Chemotherapy-induced neutropenia

Patient must be receiving standard dose adjuvant chemotherapy for breast cancer; AND

Patient must have had a prior episode of febrile neutropenia; OR

Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND

The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND

Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

 Compliance with Authority Required procedures - Streamlined Authority Code 6522
C6523

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours.

 Compliance with Authority Required procedures - Streamlined Authority Code 6523
C6531

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy (first-line chemotherapy with escalated BEACOPP) with the intention of achieving a cure or substantial remission in Hodgkin disease.

 Compliance with Authority Required procedures
C6532

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

Chemotherapy-induced neutropenia

Patient must be receiving first-line chemotherapy for Hodgkin disease; AND

Patient must have had a prior episode of febrile neutropenia; OR

Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND

The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND

Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

 Compliance with Authority Required procedures - Streamlined Authority Code 6532
C6533

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy (adjuvant chemotherapy with docetaxel in combination with an anthracycline and cyclophosphamide) with the intention of achieving a cure or substantial remission in breast cancer.

 Compliance with Authority Required procedures - Streamlined Authority Code 6533
C6534

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin lymphoma (aggressive grades; or low grade receiving an anthracycline-containing regimen).

 Compliance with Authority Required procedures - Streamlined Authority Code 6534
C6535

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease.

 Compliance with Authority Required procedures - Streamlined Authority Code 6535
C6536

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in sarcoma.

 Compliance with Authority Required procedures - Streamlined Authority Code 6536
C6543

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease.

 Compliance with Authority Required procedures
C6544

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

Chemotherapy-induced neutropenia

Patient must be undergoing induction or consolidation therapy for acute myeloid leukaemia.

 Compliance with Authority Required procedures - Streamlined Authority Code 6544
C6545

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

Chemotherapy-induced neutropenia

Patient must must be receiving chemotherapy with fludarabine and cyclophosphamide for B-cell chronic lymphocytic leukaemia; AND

Patient must have had a prior episode of febrile neutropenia; OR

Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND

The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND

Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

 Compliance with Authority Required procedures - Streamlined Authority Code 6545
C6546

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma.

 Compliance with Authority Required procedures
C6554

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

Chemotherapy-induced neutropenia

Patient must be undergoing induction or consolidation therapy for acute myeloid leukaemia.

 Compliance with Authority Required procedures
C6555

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

Chemotherapy-induced neutropenia

Patient must be receiving chemotherapy for myeloma; AND

Patient must have had a prior episode of febrile neutropenia; AND

The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND

Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

 Compliance with Authority Required procedures
C6619

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

Assisting autologous peripheral blood progenitor cell transplantation

The treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation.

 Compliance with Authority Required procedures
C6620

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

Chronic cyclical neutropenia

Patient must have an absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles; AND

Patient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics; OR

Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months.

 Compliance with Authority Required procedures
C6621

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

Severe chronic neutropenia

Patient must have an absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; OR

Patient must have neutrophil dysfunction; AND

Patient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months; OR

Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months.

 Compliance with Authority Required procedures - Streamlined Authority Code 6621
C6633

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

Mobilisation of peripheral blood progenitor cells

The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy.

 Compliance with Authority Required procedures
C6640

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

Chronic cyclical neutropenia

Patient must have an absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles; AND

Patient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics; OR

Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months.

 Compliance with Authority Required procedures - Streamlined Authority Code 6640
C6649

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

Mobilisation of peripheral blood progenitor cells

The treatment must be in a normal volunteer for use in allogeneic transplantation.

 Compliance with Authority Required procedures
C6650

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

Assisting bone marrow transplantation

Patient must be receiving marrow-ablative chemotherapy prior to the transplantation.

 Compliance with Authority Required procedures
C6651

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

Severe congenital neutropenia

Patient must have an absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; AND

Patient must have had a bone marrow examination that has shown evidence of maturational arrest of the neutrophil lineage.

 Compliance with Authority Required procedures
C6652

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

Severe chronic neutropenia

Patient must have an absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; OR

Patient must have neutrophil dysfunction; AND

Patient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months; OR

Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months.

 Compliance with Authority Required procedures
C6653

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

Mobilisation of peripheral blood progenitor cells

The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6653
C6654

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

Mobilisation of peripheral blood progenitor cells

The treatment must be in a normal volunteer for use in allogeneic transplantation.

 Compliance with Authority Required procedures - Streamlined Authority Code 6654
C6655

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

Assisting autologous peripheral blood progenitor cell transplantation

The treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation.

 Compliance with Authority Required procedures - Streamlined Authority Code 6655
C6679

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

Assisting bone marrow transplantation

Patient must be receiving marrow-ablative chemotherapy prior to the transplantation.

 Compliance with Authority Required procedures - Streamlined Authority Code 6679
C6680

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

Severe congenital neutropenia

Patient must have an absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; AND

Patient must have had a bone marrow examination that has shown evidence of maturational arrest of the neutrophil lineage.

 Compliance with Authority Required procedures - Streamlined Authority Code 6680

  1. Schedule 4, Part 1, omit entry for Glycomacropeptide and essential amino acids

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

insert:

Grazoprevir with elbasvir C5969 P5969

Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND

Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND

The treatment must be limited to a maximum duration of 12 weeks.

 Compliance with Authority Required procedures
C6625 P6625

Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND

Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND

The treatment must be limited to a maximum duration of 16 weeks.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Interferon alfa-2a

(a)omit:

C1149 P1149

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Hairy cell leukaemia

 Compliance with Authority Required procedures
C1196 P1196

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Low grade non‑Hodgkin’s lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline‑based chemotherapy

 Compliance with Authority Required procedures
C1234 P1234

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Myeloproliferative disease with excessive thrombocytosis

 Compliance with Authority Required procedures
C3180 Hairy cell leukaemia Compliance with Authority Required procedures – Streamlined Authority Code 3180
C3895 Low grade non‑Hodgkin’s lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline‑based chemotherapy Compliance with Authority Required procedures – Streamlined Authority Code 3895
C3899 Myeloproliferative disease with excessive thrombocytosis Compliance with Authority Required procedures – Streamlined Authority Code 3899

(b)insert in numerical order after existing text:

C6632 P6632

Low grade non-Hodgkin's lymphoma

The condition must have clinical features suggestive of a poor prognosis; AND

The treatment must be in combination with anthracycline-based chemotherapy.

 Compliance with Authority Required procedures
C6648 P6648 Hairy cell leukaemia Compliance with Authority Required procedures
C6661 P6661

Low grade non-Hodgkin's lymphoma

The condition must have clinical features suggestive of a poor prognosis; AND

The treatment must be in combination with anthracycline-based chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6661
C6662 P6662 Hairy cell leukaemia Compliance with Authority Required procedures - Streamlined Authority Code 6662
C6672 P6672

Myeloproliferative disease

Patient must have excessive thrombocytosis.

 Compliance with Authority Required procedures
C6678 P6678

Myeloproliferative disease

Patient must have excessive thrombocytosis.

 Compliance with Authority Required procedures - Streamlined Authority Code 6678

  1. Schedule 4, Part 1, entry for Interferon alfa-2b

(a)omit:

C1149 P1149

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Hairy cell leukaemia

 Compliance with Authority Required procedures
C1196 P1196

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Low grade non‑Hodgkin’s lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline‑based chemotherapy

 Compliance with Authority Required procedures
C1206 P1206

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Maintenance treatment of multiple myeloma once remission has been achieved with chemotherapy

 Compliance with Authority Required procedures
C3180 Hairy cell leukaemia Compliance with Authority Required procedures – Streamlined Authority Code 3180
C3895 Low grade non‑Hodgkin’s lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline‑based chemotherapy Compliance with Authority Required procedures – Streamlined Authority Code 3895
C3898 Maintenance treatment of multiple myeloma once remission has been achieved with chemotherapy Compliance with Authority Required procedures – Streamlined Authority Code 3898

(b)insert in numerical order after existing text:

C6618 P6618

Multiple myeloma

Maintenance treatment

The condition must be in remission following chemotherapy.

 Compliance with Authority Required procedures
C6632 P6632

Low grade non-Hodgkin's lymphoma

The condition must have clinical features suggestive of a poor prognosis; AND

The treatment must be in combination with anthracycline-based chemotherapy.

 Compliance with Authority Required procedures
C6639 P6639

Multiple myeloma

Maintenance treatment

The condition must be in remission following chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6639
C6648 P6648 Hairy cell leukaemia Compliance with Authority Required procedures
C6661 P6661

Low grade non-Hodgkin's lymphoma

The condition must have clinical features suggestive of a poor prognosis; AND

The treatment must be in combination with anthracycline-based chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6661
C6662 P6662 Hairy cell leukaemia Compliance with Authority Required procedures - Streamlined Authority Code 6662

  1. Schedule 4, Part 1, entry for Ipilimumab

substitute:

Ipilimumab C6562

Unresectable Stage III or Stage IV malignant melanoma

Induction treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must not have received prior treatment with ipilimumab; AND

The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.

The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6562
C6585

Unresectable Stage III or Stage IV malignant melanoma

Re-induction treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction); AND

The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.

An initial objective response to treatment is defined as either:

(i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or

(ii) a partial or complete response.

The patient's body weight must be documented in the patient's medical records at the time treatment with ipilimumab is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6585

  1. Schedule 4, Part 1, entry for Lenograstim

substitute:

Lenograstim C6488

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

Chemotherapy-induced neutropenia

Patient must be receiving standard dose adjuvant chemotherapy for breast cancer; AND

Patient must have had a prior episode of febrile neutropenia; OR

Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND

The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND

Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

 Compliance with Authority Required procedures
C6490

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

Chemotherapy-induced neutropenia

Patient must be receiving first-line chemotherapy for Hodgkin disease; AND

Patient must have had a prior episode of febrile neutropenia; OR

Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND

The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND

Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

 Compliance with Authority Required procedures
C6494

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in an infant or child with central nervous system tumours.

 Compliance with Authority Required procedures
C6502

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in an infant or child with central nervous system tumours.

 Compliance with Authority Required procedures - Streamlined Authority Code 6502
C6507

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia.

 Compliance with Authority Required procedures - Streamlined Authority Code 6507
C6512

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia.

 Compliance with Authority Required procedures
C6516

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma.

 Compliance with Authority Required procedures - Streamlined Authority Code 6516
C6521

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours.

 Compliance with Authority Required procedures
C6522

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

Chemotherapy-induced neutropenia

Patient must be receiving standard dose adjuvant chemotherapy for breast cancer; AND

Patient must have had a prior episode of febrile neutropenia; OR

Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND

The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND

Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

 Compliance with Authority Required procedures - Streamlined Authority Code 6522
C6523

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours.

 Compliance with Authority Required procedures - Streamlined Authority Code 6523
C6532

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

Chemotherapy-induced neutropenia

Patient must be receiving first-line chemotherapy for Hodgkin disease; AND

Patient must have had a prior episode of febrile neutropenia; OR

Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND

The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND

Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

 Compliance with Authority Required procedures - Streamlined Authority Code 6532
C6535

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease.

 Compliance with Authority Required procedures - Streamlined Authority Code 6535
C6543

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease.

 Compliance with Authority Required procedures
C6546

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma.

 Compliance with Authority Required procedures
C6622

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in rhabdomyosarcoma.

 Compliance with Authority Required procedures
C6623

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

Assisting peripheral blood progenitor cell or bone marrow transplantation

The treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation.

 Compliance with Authority Required procedures
C6633

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

Mobilisation of peripheral blood progenitor cells

The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy.

 Compliance with Authority Required procedures
C6634

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in osteosarcoma.

 Compliance with Authority Required procedures - Streamlined Authority Code 6634
C6644

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Ewing's sarcoma.

 Compliance with Authority Required procedures - Streamlined Authority Code 6644
C6649

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

Mobilisation of peripheral blood progenitor cells

The treatment must be in a normal volunteer for use in allogeneic transplantation.

 Compliance with Authority Required procedures
C6653

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

Mobilisation of peripheral blood progenitor cells

The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6653
C6654

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

Mobilisation of peripheral blood progenitor cells

The treatment must be in a normal volunteer for use in allogeneic transplantation.

 Compliance with Authority Required procedures - Streamlined Authority Code 6654
C6656

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Ewing's sarcoma.

 Compliance with Authority Required procedures
C6657

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

Assisting peripheral blood progenitor cell or bone marrow transplantation

The treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation.

 Compliance with Authority Required procedures - Streamlined Authority Code 6657
C6663

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in osteosarcoma.

 Compliance with Authority Required procedures
C6673

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin's lymphoma (intermediate or high grade).

 Compliance with Authority Required procedures - Streamlined Authority Code 6673
C6681

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin's lymphoma (intermediate or high grade).

 Compliance with Authority Required procedures
C6682

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

Chemotherapy-induced neutropenia

Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in rhabdomyosarcoma.

 Compliance with Authority Required procedures - Streamlined Authority Code 6682

  1. Schedule 4, Part 1, entry for Metronidazole

(a)omit:

C4581

Acute anaerobic sepsis

Must be treated in a hospital
C4592

Prophylaxis to prevent infection

Patient must be undergoing large bowel surgery
C4593

Acute anaerobic sepsis

Must be treated in a hospital

(b)insert in numerical order after existing text:

C6667

Acute anaerobic sepsis

Must be treated in a hospital.
C6675

Acute anaerobic sepsis

Must be treated in a hospital.
C6685

Prophylaxis to prevent infection

Patient must be undergoing large bowel surgery.

  1. Schedule 4, Part 1, entry for Milk powder—lactose free formula

omit:

C2760 P2760

Proven chronic lactose intolerance in infants up to the age of 12 months, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven by:

(a) relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re‑emergence of symptoms on rechallenge with lactose containing formulae or milk or food; or
(b) not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet; or
(c) hydrogen breath test

 Compliance with Authority Required procedures
C2762 P2762 Acute lactose intolerance in infants up to the age of 12 months, where the date of birth of the patient is included in the authority application and where the patient has not previously been issued with an authority prescription for this medicinal preparation for this purpose Compliance with Authority Required procedures

  1. Schedule 4, Part 1, omit entry for Milk powder—lactose modified

  1. Schedule 4, Part 1, entry for Montelukast

substitute:

Montelukast C6666

Asthma

First-line prevention

The condition must be frequent intermittent; OR

The condition must be mild persistent; AND

The treatment must be the single preventer agent; AND

The treatment must be an alternative to sodium cromoglycate; OR

The treatment must be an alternative to nedocromil sodium.

Patient must be aged 2 to 5 years inclusive.

 Compliance with Authority Required procedures - Streamlined Authority Code 6666
C6674

Asthma

First-line prevention

The condition must be frequent intermittent; OR

The condition must be mild persistent; AND

The treatment must be the single preventer agent; AND

The treatment must be an alternative to sodium cromoglycate; OR

The treatment must be an alternative to nedocromil sodium.

Patient must be aged 6 to 14 years inclusive.

 Compliance with Authority Required procedures - Streamlined Authority Code 6674
C6684

Asthma

Prevention of condition

The condition must be exercise-induced; AND

The treatment must be as an alternative to adding salmeterol xinafoate; OR

The treatment must be as an alternative to adding eformoterol fumarate; AND

The condition must be otherwise well controlled while receiving optimal dose inhaled corticosteroid; AND

Patient must require short-acting beta-2 agonist 3 or more times per week for prevention or relief of residual exercise-related symptoms.

Patient must be aged 6 to 14 years inclusive.

 Compliance with Authority Required procedures - Streamlined Authority Code 6684

  1. Schedule 4, Part 1, entry for Mupirocin

substitute:

Mupirocin C6647

Staphylococcus aureus infection

Patient must have nasal colonisation with the bacteria.

Patient must be an Aboriginal or a Torres Strait Islander person.

 Compliance with Authority Required procedures - Streamlined Authority Code 6647

  1. Schedule 4, Part 1, entry for Paroxetine

substitute:

Paroxetine C4755 Major depressive disorders
C6277 Obsessive-compulsive disorder
C6636 Panic disorder

  1. Schedule 4, Part 3, General statement for drugs for the treatment of hepatitis C

Section 3 Treatment regimen

substitute:

3  Treatment regimen

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

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

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

Item Kind of patient Regimen
1

Patient:

(a)     with Genotype 1; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

Either:

(a)     LEDIPASVIR with SOFOSBUVIR for 8 weeks; or

(b)     LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(c)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(d)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or

(e)     PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR for 12 weeks; or

(f)   PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or

(g)     GRAZOPREVIR with ELBASVIR for 12 weeks.
2

Patient:

(a)     with Genotype 1; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

Either:

(a)     LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(b)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(c)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(d)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or

(e)     PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR for 12 weeks; or

(f)   PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or

(g)     GRAZOPREVIR with ELBASVIR for 12 weeks; or

(h)     GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.
3

Patient:

(a)     with Genotype 2; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
4

Patient:

(a)     with Genotype 2; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
5

Patient:

(a)     with Genotype 3; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

Either:

(a)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(b)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
6

Patient:

(a)     with Genotype 3; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

Either:

(a)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(b)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
7

Patient:

(a)     with Genotype 4; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

Either:

(a)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or

(b)     GRAZOPREVIR with ELBASVIR for 12 weeks.
8

Patient:

(a)     with Genotype 4; and

(b)     who is treatment experienced; and

(c)                     who is non-cirrhotic

Either:

(a)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or

(b)     GRAZOPREVIR with ELBASVIR for 12 weeks; or

(c)     GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.
9

Patient:

(a)     with:

(i)    Genotype 5; or

(ii)     Genotype 6; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
10

Patient:

(a)     with:

(i)    Genotype 5; or

(ii)     Genotype 6; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
11

Patient:

(a)     with Genotype 1; and

(b)   who is treatment naïve; and

(c)    who is cirrhotic

Either:

(a)     LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(b)     DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or

(c)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(d)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or

(e)     PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or

(f)   GRAZOPREVIR with ELBASVIR for 12 weeks.
12

Patient:

(a)     with Genotype 1; and

(b)     who is treatment experienced; and

(c)     who is cirrhotic

Either:

(a)     LEDIPASVIR with SOFOSBUVIR for 24 weeks; or

(b)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(c)     DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or

(d)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or

(e)     PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or

(f)   PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 24 weeks; or

(g)     GRAZOPREVIR with ELBASVIR for 12 weeks; or

(h)     GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.
13

Patient:

(a)     with Genotype 2; and

(b)     who is treatment naïve; and

(c)     who is cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
14

Patient:

(a)     with Genotype 2; and

(b)     who is treatment experienced; and

(c)     who is cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
15

Patient:

(a)     with Genotype 3; and

(b)     who is treatment naïve; and

(c)     who is cirrhotic

Either:

(a)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(b)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or

(d)     DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or

(e)     DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 24 weeks.
16

Patient:

(a)     with Genotype 3; and

(b)     who is treatment experienced; and

(c)     who is cirrhotic

Either:

(a)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(b)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or

(d)     DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or

(e)     DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 24 weeks.

17

Patient:

(a)     with Genotype 4; and

(b)     who is treatment naïve; and

(c)     who is cirrhotic

Either:

(a)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or

(b)     GRAZOPREVIR with ELBASVIR for 12 weeks.
18

Patient:

(a)     with Genotype 4; and

(b)     who is treatment experienced; and

(c)   who is cirrhotic

Either:

(a)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or

(b)     GRAZOPREVIR with ELBASVIR for 12 weeks; or

(c)     GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.
19

Patient:

(a)     with:

(i)    Genotype 5; or

(ii)     Genotype 6; and

(b)   who is treatment naïve; and

(c)    who is cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
20

Patient:

(a)     with:

(i)    Genotype 5; or

(ii)     Genotype 6; and

(b)   who is treatment experienced; and

(c)    who is cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
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