National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 4) (PB 34 of 2017) (Cth)

Case

PB 34 of 2017

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017
(No. 4)

National Health Act 1953

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

Dated 30 May 2017

PENNY SHAKEPEARE

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health


1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical    Benefits) Amendment Instrument 2017 (No. 4).

(2)        This Instrument may also be cited as PB 34 of 2017.

2          Commencement

This Instrument commences on 1 June 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 Tablet 200 mg

omit:

a Acyclo‑V 200 AF MP NP C5936 C5942 P5936 50 0 25

  1. Schedule 1, entry for Aciclovir in the form Tablet 200 mg [Maximum Quantity: 90; Number of Repeats: 5]

(a)omit from the column headed “Circumstances” for the brand “Acyclo-V 200”:        C5936

(b)omit from the column headed “Purposes”:         P5942

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

omit:

a Acyclo‑V 800 AF MP NP C5959 C5967 35 0 35

  1. Schedule 1, entry for Adalimumab in the form Injection 20 mg in 0.4 mL pre‑filled syringe [Maximum Quantity: 2; Number of Repeats: 0]

insert in numerical order in the column headed “Circumstances”:         C6916 C6917 C6918 C6921 C6931 C6932

  1. Schedule 1, entry for Adalimumab in the form Injection 20 mg in 0.4 mL pre‑filled syringe [Maximum Quantity: 2; Number of Repeats: 3]

(a)insert in numerical order in the column headed “Circumstances”:               C6916 C6917 C6918 C6921 C6931 C6932

(b)insert in numerical order in the column headed “Purposes”:         P6918 P6931 P6932

  1. Schedule 1, entry for Adalimumab in the form Injection 20 mg in 0.4 mL pre‑filled syringe [Maximum Quantity: 2; Number of Repeats: 5]

(a)insert in numerical order in the column headed “Circumstances”:               C6916 C6917 C6918 C6921 C6931 C6932

(b)insert in numerical order in the column headed “Purposes”:         P6916 P6917 P6921

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre‑filled syringe [Maximum Quantity: 2; Number of Repeats: 0]

omit from the column headed “Circumstances”:          C5441 C5514 C5515
omit from the column headed “Circumstances”:          C6571 C6575 C6579 C6602 C6614 C6615
insert in numerical order:                  C6902 C6916 C6917 C6918 C6921 C6922 C6923 C6931 C6932

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

(a)omit from the column headed “Circumstances”:               C5441 C5514 C5515
omit from the column headed “Circumstances”:               C6571 C6575 C6579 C6602 C6614 C6615
insert in numerical order:       C6902 C6916 C6917 C6918 C6921 C6922 C6923 C6931 C6932

(b)omit from the column headed “Purposes”:         P6575 P6602 P6615
insert in numerical order:       P6918 P6931 P6932

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre‑filled syringe [Maximum Quantity: 2; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”:               C5441 C5514 C5515
omit from the column headed “Circumstances”:               C6571 C6575 C6579 C6602 C6614 C6615
insert in numerical order:                       C6902 C6916 C6917 C6918 C6921 C6922 C6923 C6931 C6932

(b)omit from the column headed “Purposes”:         P5441 P5514
insert in numerical order:       P6902 P6923

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre‑filled syringe [Maximum Quantity: 2; Number of Repeats: 4]

omit from the column headed “Circumstances”:          C5441 C5514 C5515
omit from the column headed “Circumstances”:          C6571 C6575 C6579 C6602 C6614 C6615
insert in numerical order:                  C6902 C6916 C6917 C6918 C6921 C6922 C6923 C6931 C6932

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

(a)omit from the column headed “Circumstances”:               C5441 C5514 C5515
omit from the column headed “Circumstances”:               C6571 C6575 C6579 C6602 C6614 C6615
insert in numerical order:       C6902 C6916 C6917 C6918 C6921 C6922 C6923 C6931 C6932

(b)omit from the column headed “Purposes”:         P5515
omit from the column headed “Purposes”:         P6571 P6579 P6614
insert in numerical order:       P6916 P6917 P6921 P6922

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 0]

omit from the column headed “Circumstances”:          C5441 C5514 C5515
omit from the column headed “Circumstances”:          C6571 C6575 C6579 C6602 C6614 C6615
insert in numerical order:                  C6902 C6916 C6917 C6918 C6921 C6922 C6923 C6931 C6932

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

(a)omit from the column headed “Circumstances”:               C5441 C5514 C5515
omit from the column headed “Circumstances”:               C6571 C6575 C6579 C6602 C6614 C6615
insert in numerical order:       C6902 C6916 C6917 C6918 C6921 C6922 C6923 C6931 C6932

(b)omit from the column headed “Purposes”:         P6575 P6602 P6615
insert in numerical order:       P6918 P6931 P6932

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”:               C5441 C5514 C5515
omit from the column headed “Circumstances”:               C6571 C6575 C6579 C6602 C6614 C6615
insert in numerical order:          C6902 C6916 C6917 C6918 C6921 C6922 C6923 C6931 C6932

(b)omit from the column headed “Purposes”:         P5441 P5514
insert in numerical order:          P6902 P6923

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 4]

omit from the column headed “Circumstances”:          C5441 C5514 C5515
omit from the column headed “Circumstances”:          C6571 C6575 C6579 C6602 C6614 C6615
insert in numerical order:                  C6902 C6916 C6917 C6918 C6921 C6922 C6923 C6931 C6932

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

(a)omit from the column headed “Circumstances”:               C5441 C5514 C5515
omit from the column headed “Circumstances”:               C6571 C6575 C6579 C6602 C6614 C6615
insert in numerical order:       C6902 C6916 C6917 C6918 C6921 C6922 C6923 C6931 C6932

(b)omit from the column headed “Purposes”:         P5515
omit from the column headed “Purposes”:         P6571 P6579 P6614
insert in numerical order:       P6916 P6917 P6921 P6922

  1. Schedule 1, entry for Adalimumab in each of the forms: Injection 40 mg in 0.8 mL pre‑filled syringe, 6; and Injection 40 mg in 0.8 mL pre‑filled pen, 6

omit from the column headed “Circumstances”:          C6575 C6602 C6615
insert in numerical order:                  C6918 C6931 C6932

  1. Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol

omit:

a Alendrobell plus D3 GQ MP NP C6307 C6315  C6320 4 5 4

  1. Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol

omit:

a Alendrobell plus D3 GQ MP NP C6306 C6319 C6325 4 5 4

  1. Schedule 1, entry for Alprazolam in the form Tablet 1 mg

omit:

a GenRx Alprazolam GX MP NP C6773 10 0 50

  1. Schedule 1, entry for Apraclonidine

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

  1. Schedule 1, entry for Baclofen in the form Intrathecal injection 10 mg in 5 mL

(a)omit from the column headed “Circumstances” (twice occurring):               C5985 C5990 C6000 C6003 C6025 C6051 C6052 C6054
substitute:   C6911 C6912 C6925 C6929 C6930 C6935 C6939 C6940

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

a Sintetica Baclofen Intrathecal BZ MP C6911 C6912 C6925 C6929 C6930 C6935 C6939 C6940 10 0 10 PB(100)

  1. Schedule 1, entry for Betaxolol in the form Eye drops, suspension, 2.5 mg (as hydrochloride) per mL, 5 mL

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

  1. Schedule 1, entry for Betaxolol in the form Eye drops, solution, 5 mg (as hydrochloride) per mL, 5 mL

(a)omit from the column headed “Responsible Person” for the brand “Betoptic”:        AQ       substitute:             NV

(b)omit from the column headed “Responsible Person” for the brand “BetoQuin”:      IQ         substitute:             NM

  1. Schedule 1, entry for Bisacodyl in the form Suppositories 10 mg, 10

omit from the column headed “Responsible Person” for the brand “Dulcolax” (all instances):       BY        substitute:             VZ

  1. Schedule 1, entry for Brentuximab vedotin

omit from the column headed “Circumstances”:          C6800 C6816 C6826 C6838        substitute:             C6903 C6904 C6936 C6941

  1. Schedule 1, entry for Brinzolamide

(a)omit from the column headed “Responsible Person” for the brand “Azopt”:             AQ       substitute:             NV

(b)omit from the column headed “Responsible Person” for the brand “BrinzoQuin”:   IQ         substitute:             NM

  1. Schedule 1, entry for Brinzolamide with brimonidine

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

  1. Schedule 1, entry for Brinzolamide with timolol

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

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

omit:

a Candesartan HCTZ RBX 32/25 RA MP NP C4374 30 5 30

  1. Schedule 1, entry for Capecitabine in the form Tablet 150 mg

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

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

a Xelocitabine JU MP 60 2 60

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

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

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

a Xelocitabine JU MP 120 2 120

  1. Schedule 1, entry for Carbomer 974

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

  1. Schedule 1, entry for Carboplatin in the form Solution for I.V. injection 450 mg in 45 mL

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

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

  1. Schedule 1, entry for Ciprofloxacin in the form Ear drops 3 mg (as hydrochloride) per mL, 5 mL

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

  1. Schedule 1, entry for Ciprofloxacin in the form Eye drops 3 mg (as hydrochloride) per mL, 5 mL

(a)omit from the column headed “Responsible Person” for the brand “CiloQuin”:      IQ         substitute:             NM

(b)omit from the column headed “Responsible Person” for the brand “Ciloxan”:         AQ       substitute:             NV

  1. Schedule 1, omit entry for Colestipol

  1. Schedule 1, entry for Daclatasvir in each of the forms: Tablet 30 mg; and Tablet 60 mg

omit from the column headed “Authorised Prescriber” (all instances):                  MP       substitute:             MP NP

  1. Schedule 1, entry for Dasatinib

substitute:

Dasatinib Tablet 20 mg Oral Sprycel BQ MP C6702 C6731 C6785 C6797 C6798 C6905 C6906 C6926 P6905 P6906 P6926 60 2 60
MP C6702 C6731 C6785 C6797 C6798 C6905 C6906 C6926 P6702 P6731 P6785 P6797 P6798 60 5 60
Tablet 50 mg Oral Sprycel BQ MP C6702 C6731 C6785 C6797 C6798 C6905 C6906 C6926 P6905 P6906 P6926 60 2 60
MP C6702 C6731 C6785 C6797 C6798 C6905 C6906 C6926 P6702 P6731 P6785 P6797 P6798 60 5 60
Tablet 70 mg Oral Sprycel BQ MP C6702 C6731 C6785 C6797 C6798 C6905 C6906 C6926 P6905 P6906 P6926 60 2 60
MP C6702 C6731 C6785 C6797 C6798 C6905 C6906 C6926 P6702 P6731 P6785 P6797 P6798 60 5 60
Tablet 100 mg Oral Sprycel BQ MP C6702 C6731 C6785 C6797 C6798 C6905 C6906 C6926 P6905 P6906 P6926 30 2 30
MP C6702 C6731 C6785 C6797 C6798 C6905 C6906 C6926 P6702 P6731 P6785 P6797 P6798 30 5 30

  1. Schedule 1, entry for Dexamethasone in the form Eye drops 1 mg per mL, 5 mL

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

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

(a)omit from the column headed “Circumstances”:               C6855  
insert in numerical order:       C6920

(b)omit from the column headed “Maximum Quantity”:       14         substitute:             28

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

omit from the column headed “Circumstances”:          C6883   substitute:             C6913

  1. Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 4 mL

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

Docetaxel Accord 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 Duloxetine Sandoz HX MP NP C5650 28 0 28

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

omit:

a Duloxetine Sandoz HX MP NP C5650 28 5 28

  1. Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL

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

Epirube TB MP See Note 3 See
Note 3 		1 D(100)

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

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

Epirube TB MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Everolimus

omit:

Everolimus Tablet 0.25 mg Oral Certican NV MP C5566 C5579 60 3 60
MP C5554 C5555 C5794 C5795 120 5 60 C(100)
Tablet 0.5 mg Oral Certican NV MP C5566 C5579 60 3 60
MP C5554 C5555 C5794 C5795 120 5 60 C(100)
Tablet 0.75 mg Oral Certican NV MP C5566 C5579 120 3 60
MP C5554 C5555 C5794 C5795 240 5 60 C(100)
Tablet 1 mg Oral Certican NV MP C5566 C5579 120 3 60
MP C5554 C5555 C5794 C5795 240 5 60 C(100)

substitute:

Everolimus Tablet 0.25 mg Oral Certican NV MP 60 3 60
MP P5554 P5555 P5794 P5795 120
CN5554 CN5555 CN5794 CN5795 		5
CN5554 CN5555 CN5794 CN5795 		60 C(100)
Tablet 0.5 mg Oral Certican NV MP 60 3 60
MP P5554 P5555 P5794 P5795 120
CN5554 CN5555 CN5794 CN5795 		5
CN5554 CN5555 CN5794 CN5795 		60 C(100)
Tablet 0.75 mg Oral Certican NV MP 120 3 60
MP P5554 P5555 P5794 P5795 240
CN5554 CN5555 CN5794 CN5795 		5
CN5554 CN5555 CN5794 CN5795 		60 C(100)
Tablet 1 mg Oral Certican NV MP 120 3 60
MP P5554 P5555 P5794 P5795 240
CN5554 CN5555 CN5794 CN5795 		5
CN5554 CN5555 CN5794 CN5795 		60 C(100)

  1. Schedule 1, entry for Famciclovir in the form Tablet 250 mg [Maximum Quantity: 56; Number of Repeats: 5]

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

a Famciclovir FBM FO MP NP C5971 56 5 56

  1. Schedule 1, entry for Famotidine in the form Tablet 20 mg

omit:

Pamacid 20 AF MP NP 60 5 60

  1. Schedule 1, entry for Famotidine in the form Tablet 40 mg

omit:

Pamacid 40 AF MP NP 30 5 30

  1. Schedule 1, entry for Fluorometholone in the form Eye drops 1 mg per mL, 5 mL

omit from the column headed “Responsible Person” for the brand “Flucon” (twice occurring):     AQ       substitute:             NV

  1. Schedule 1, entry for Fluorometholone in the form Eye drops containing fluorometholone acetate 1 mg per mL, 5 mL

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

  1. Schedule 1, omit entry for Fluphenazine Decanoate

  1. Schedule 1, entry for Fluticasone in the form Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC‑free formulation)

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

a Fluticasone Cipla Inhaler LR MP NP 1 5 1

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

  1. Schedule 1, entry for Fluticasone in the form Pressurised inhalation containing fluticasone propionate 250 micrograms per dose, 120 doses (CFC‑free formulation)

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

a Fluticasone Cipla Inhaler LR MP NP 1 1 1

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

  1. Schedule 1, after entry for Fluticasone in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms per dose, 60 doses

insert:

Fluticasone furoate with vilanterol Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses Inhalation by mouth Breo Ellipta 100/25 GK MP NP C4689 C4711 1 5 1
Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses Inhalation by mouth Breo Ellipta 200/25 GK MP NP C4731 1 5 1

  1. Schedule 1, entry for Fluticasone with Salmeterol in the form Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC‑free formulation)

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

a Fluticasone + Salmeterol Cipla 125/25 LR MP NP C4930 1 5 1

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

a SalplusF Inhaler 125/25 YC MP NP C4930 1 5 1

(c)insert in the column headed “Schedule Equivalent” for the brand “Seretide MDI 125/25”:  a

  1. Schedule 1, entry for Fluticasone with Salmeterol in the form Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC‑free formulation)

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

a Fluticasone + Salmeterol Cipla 250/25 LR MP NP C4689 C4930 1 5 1

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

a SalplusF Inhaler 250/25 YC MP NP C4689 C4930 1 5 1

(c)insert in the column headed “Schedule Equivalent” for the brand “Seretide MDI 250/25”:  a

  1. Schedule 1, omit entry for Fluticasone with vilanterol

  1. Schedule 1, entry for Grazoprevir with elbasvir

omit from the column headed “Authorised Prescriber” (twice occurring):            MP       substitute:             MP NP

  1. Schedule 1, entry for Hyoscine

omit from the column headed “Responsible Person”:                 BY        substitute:             VZ

  1. Schedule 1, entry for Hypromellose in the form Eye drops 3 mg per mL, 15 mL

(a)omit from the column headed “Responsible Person” for the brand “Genteal” (twice occurring):         AQ       substitute:   NV

(b)omit from the column headed “Responsible Person” for the brand “In a Wink Moisturising” (twice occurring):              IQ   substitute:      NM

  1. Schedule 1, entry for Hypromellose with Carbomer 980 in the form Ocular lubricating gel 3 mg‑2 mg per g, 10 g

(a)omit from the column headed “Responsible Person” for the brand “Genteal gel” (twice occurring):  AQ       substitute:   NV

(b)omit from the column headed “Responsible Person” for the brand “HPMC PAA” (twice occurring):  IQ         substitute:   NM

  1. Schedule 1, entry for Hypromellose with dextran in the form Eye drops containing 3 mg hypromellose 2900 with 1 mg dextran 70 per mL, single dose units 0.4 mL, 28

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

  1. Schedule 1, entry for Hypromellose with dextran in the form Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL,
    15 mL

(a)omit from the column headed “Responsible Person” for the brand “Poly-Tears” (twice occurring):    IQ         substitute:   NM

(b)omit from the column headed “Responsible Person” for the brand “Tears Naturale” (twice occurring):            AQ   substitute:      NV

  1. Schedule 1, entry for Imatinib

substitute:

Imatinib Capsule 100 mg (as mesilate) Oral a CIPLA IMATINIB ADULT LR MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6550 P6557 P6558 P6896 P6907 P6942 60 2 60
a IMATINIB AN EA MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6551 P6557 P6558 P6896 P6907 P6942 60 2 60
a Imatinib GH GQ MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6551 P6557 P6558 P6896 P6907 P6942 60 2 60
a Imatinib-APOTEX TX MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6551 P6557 P6558 P6896 P6907 P6942 60 2 60
a IMATINIB-DRLA RZ MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6551 P6557 P6558 P6896 P6907 P6942 60 2 60
a CIPLA IMATINIB ADULT LR MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6703 P6743 P6744 60 5 60
a IMATINIB AN EA MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6703 P6743 P6744 60 5 60
a Imatinib GH GQ MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6703 P6743 P6744 60 5 60
a Imatinib-APOTEX TX MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6703 P6743 P6744 60 5 60
a IMATINIB-DRLA RZ MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6703 P6743 P6744 60 5 60
Capsule 400 mg (as mesilate) Oral a CIPLA IMATINIB ADULT LR MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6550 P6557 P6558 P6896 P6907 P6942 30 2 30
a IMATINIB AN EA MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6551 P6557 P6558 P6896 P6907 P6942 30 2 30
a Imatinib GH GQ MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6551 P6557 P6558 P6896 P6907 P6942 30 2 30
a Imatinib-APOTEX TX MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6551 P6557 P6558 P6896 P6907 P6942 30 2 30
a IMATINIB-DRLA RZ MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6551 P6557 P6558 P6896 P6907 P6942 30 2 30
a CIPLA IMATINIB ADULT LR MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6703 P6743 P6744 30 5 30
a IMATINIB AN EA MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6703 P6743 P6744 30 5 30
a Imatinib GH GQ MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6703 P6743 P6744 30 5 30
a Imatinib-APOTEX TX MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6703 P6743 P6744 30 5 30
a IMATINIB-DRLA RZ MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6703 P6743 P6744 30 5 30
Tablet 100 mg (as mesilate) Oral Glivec AF MP C4342 C4355 C6496 C6498 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6559 C6703 C6743 C6744 C6896 C6907 C6942 P6496 P6498 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6551 P6557 P6558 P6559 P6896 P6907 P6942 60 2 60
a IMATINIB RBX RA MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6551 P6557 P6558 P6896 P6907 P6942 60 2 60
a Imatinib-Teva TB MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6550 P6557 P6558 P6896 P6907 P6942 60 2 60
Glivec AF MP C4342 C4355 C6496 C6498 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6559 C6703 C6743 C6744 C6896 C6907 C6942 P4342 P4355 P6703 P6743 P6744 60 5 60
a IMATINIB RBX RA MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6703 P6743 P6744 60 5 60
a Imatinib-Teva TB MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6703 P6743 P6744 60 5 60
Tablet 400 mg (as mesilate) Oral Glivec AF MP C4342 C4355 C6496 C6498 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6559 C6703 C6743 C6744 C6896 C6907 C6942 P6496 P6498 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6551 P6557 P6558 P6559 P6896 P6907 P6942 30 2 30
a IMATINIB RBX RA MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6551 P6557 P6558 P6896 P6907 P6942 30 2 30
a Imatinib-Teva TB MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6550 P6557 P6558 P6896 P6907 P6942 30 2 30
Glivec AF MP C4342 C4355 C6496 C6498 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6559 C6703 C6743 C6744 C6896 C6907 C6942 P4342 P4355 P6703 P6743 P6744 30 5 30
a IMATINIB RBX RA MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6551 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6703 P6743 P6744 30 5 30
a Imatinib-Teva TB MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6558 C6703 C6743 C6744 C6896 C6907 C6942 P6703 P6743 P6744 30 5 30

  1. Schedule 1, entry for Ledipasvir with sofosbuvir [Number of Repeats: 1; Number of Repeats: 2; and Number of Repeats: 5]

omit from the column headed “Authorised Prescriber”:             MP       substitute:             MP NP

  1. Schedule 1, entry for Ledipasvir with sofosbuvir

omit:      

MP See Note 2 See Note 2 See Note 2 See Note 2 28 C(100)

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

omit from the column headed “Brand”:         Kevtam substitute:             Kevtam 1000

  1. Schedule 1, entry for Netupitant with Palonosetron

insert in numerical order in the column headed “Circumstances”:         C6937

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

(a)omit:

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

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

  1. Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL

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

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

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

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

Paclitaxin TB MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL

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

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

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

Paclitaxin TB MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Paraffin in the form Eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g

omit from the column headed “Responsible Person”:                 IQ         substitute:             NV

  1. Schedule 1, entry for Paraffin in the form Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g

omit from the column headed “Responsible Person” for the brand “Poly Visc”:                 IQ         substitute:             NV

  1. Schedule 1, entry for Paritaprevir with ritonavir with ombitasvir and dasabuvir

omit from the column headed “Authorised Prescriber”:             MP       substitute:             MP NP

  1. Schedule 1, entry for Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin in each of the forms: Pack containing 56 tablets paritaprevir 75 mg with ritonavir 50 mg with ombitasvir 12.5 mg and 56 tablets dasabuvir 250 mg and 56 tablets ribavirin 600 mg; and Pack containing 56 tablets paritaprevir 75 mg with ritonavir 50 mg with ombitasvir 12.5 mg and 56 tablets dasabuvir 250 mg and 168 tablets ribavirin 200 mg

omit from the column headed “Authorised Prescriber” (all instances):  MP       substitute:             MP NP

  1. Schedule 1, entry for Peginterferon Alfa‑2a in the form Injection 180 micrograms in 0.5 mL single use pre-filled syringe
    [Maximum Quantity: 4; Number of Repeats: 2]

omit from the column headed “Authorised Prescriber”:             MP       substitute:             MP NP

  1. Schedule 1, entry for Pilocarpine in each of the forms: Eye drops containing pilocarpine hydrochloride 10 mg per mL, 15 mL; Eye drops containing pilocarpine hydrochloride 20 mg per mL, 15 mL; and Eye drops containing pilocarpine hydrochloride 40 mg per mL, 15 mL

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

  1. Schedule 1, entry for Polyethylene Glycol 400 with Propylene Glycol in each of the forms: Eye drops 4 mg‑3 mg per mL, 15 mL; and
    Eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 28

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

  1. Schedule 1, entry for Quetiapine in each of the forms: Tablet (modified release) 50 mg (as fumarate); Tablet (modified release) 150 mg
    (as fumarate); Tablet (modified release) 200 mg (as fumarate); Tablet (modified release) 300 mg (as fumarate); and Tablet (modified release) 400 mg (as fumarate)

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

a Tevatiapine XR TB MP NP C4246 C5611 C5639 60 5 60

  1. Schedule 1, entry for Ribavirin in each of the forms: Tablet 200 mg; Tablet 400 mg; and Tablet 600 mg

omit from the column headed “Authorised Prescriber” (all instances):                  MP       substitute:             MP NP

  1. Schedule 1, omit entry for Ribavirin and Peginterferon Alfa‑2b

  1. Schedule 1, entry for Risperidone in the form Oral solution 1 mg per mL, 100 mL [Maximum Quantity: 1; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”:               C5898
omit from the column headed “Circumstances”:               C5916
insert in numerical order:       C6897 C6938

(b)omit from the column headed “Purposes”:         P5898 P5916
insert in numerical order:       P6897 P6938

  1. Schedule 1, entry for Risperidone in the form Oral solution 1 mg per mL, 100 mL [Maximum Quantity: 1; Number of Repeats: 5]

omit from the column headed “Circumstances”:          C5898
omit from the column headed “Circumstances”:          C5916
insert in numerical order:  C6897 C6938

  1. Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 2]

(a)omit from the column headed “Circumstances” (all instances):     C5902
omit from the column headed “Circumstances” (all instances):     C5911
insert in numerical order:       C6898 C6899

(b)omit from the column headed “Purposes” (all instances):               P5902 P5911
insert in numerical order:       P6898 P6899

  1. Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 5]

omit from the column headed “Circumstances” (all instances):               C5902
omit from the column headed “Circumstances” (all instances):               C5911
insert in numerical order:  C6898 C6899

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

(a)omit from the column headed “Circumstances” (all instances):     C5898
omit from the column headed “Circumstances” (all instances):     C5916
insert in numerical order:       C6897 C6938

(b)omit from the column headed “Purposes” (all instances):               P5898 P5916
insert in numerical order:       P6897 P6938

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

omit from the column headed “Circumstances” (all instances):               C5898
omit from the column headed “Circumstances” (all instances):               C5916
insert in numerical order:  C6897 C6938

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

(a)omit from the column headed “Circumstances” (all instances):     C5898
omit from the column headed “Circumstances” (all instances):     C5916
insert in numerical order:       C6897 C6938

(b)omit from the column headed “Purposes” (all instances):               P5898 P5916
insert in numerical order:       P6897 P6938

  1. Schedule 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 5]

omit from the column headed “Circumstances” (all instances):               C5898
omit from the column headed “Circumstances” (all instances):               C5916
insert in numerical order:  C6897 C6938

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

omit from the column headed “Responsible Person” for the brand “Maxalt”:     MK       substitute:             AL

  1. Schedule 1, omit entry for Rosiglitazone

  1. Schedule 1, after entry for Ruxolitinib in the form Tablet 20 mg

insert:

Sacubitril with valsartan Tablet containing sacubitril 24.3 mg with valsartan 25.7 mg Oral Entresto NV MP NP C6915 56 5 56
Tablet containing sacubitril 48.6 mg with valsartan 51.4 mg Oral Entresto NV MP NP C6915 56 5 56
Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg Oral Entresto NV MP NP C6915 56 5 56

  1. Schedule 1, after entry for Salbutamol in the form Pressurised inhalation in breath actuated device 100 micrograms (as sulfate) per dose, 200 doses (CFC‑free formulation)

insert in the columns in the order indicated:

Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 20 Inhalation a Ventolin Nebules GK MP NP C6815 C6825 3 5 1

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

omit from the column headed “Circumstances” (all instances):               C6331 C6341    
insert in numerical order:  C6815 C6825

  1. Schedule 1, entry for Selegiline in the form Tablet containing selegiline hydrochloride 5 mg

omit:

Selgene AF MP NP C5338 100 5 100

  1. Schedule 1, entry for Sofosbuvir

omit from the column headed “Authorised Prescriber” (twice occurring):            MP       substitute:             MP NP

  1. Schedule 1, entry for Temozolomide in the form Capsule 180 mg [Maximum Quantity: 5; Number of Repeats: 5]

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

a Temozolomide Amneal ED MP 5 5 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 180 mg [Maximum Quantity: 15; 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 Temozolomide Amneal ED MP P4897 15 2 5

  1. Schedule 1, entry for Teriflunomide

omit from the column headed “Circumstances”:          C6853  
insert in numerical order:  C6914

  1. Schedule 1, entry for Testosterone in all forms

omit from the column headed “Circumstances”:          C6304 C6312 C6316 C6322       
insert in numerical order:  C6910 C6919 C6933 C6934

  1. Schedule 1, entry for Tobramycin in each of the forms: Eye drops 3 mg per mL, 5 mL; and Eye ointment 3 mg per g, 3.5 g

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

  1. Schedule 1, entry for Travoprost

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

  1. Schedule 1, entry for Travoprost with timolol

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

  1. Schedule 1, entry for Vemurafenib [Maximum Quantity: 224; Number of Repeats: 3]

omit from the column headed “Circumstances”:          C6804
insert in numerical order:  C6924

  1. Schedule 1, entry for Vemurafenib [Maximum Quantity: 224; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:               C6804
insert in numerical order:       C6924

(b)omit from the column headed “Purposes”:         P6804   substitute:             P6924

  1. Schedule 1, entry for Vismodegib

omit from the column headed “Number of Repeats”:  2          substitute:             3

  1. Schedule 1, entry for Zonisamide in each of the forms: Capsule 25 mg; and Capsule 50 mg

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

a APO-Zonisamide TX MP NP C4928 56 5 56

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

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

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

a APO-Zonisamide TX MP NP C4928 112 5 56

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

  1. Schedule 3, details relevant to Responsible Person code RA

omit from the column headed “Responsible Person”:                 Ranbaxy Australia Pty Limited             substitute:             Sun Pharma ANZ Pty Ltd

  1. Schedule 3, details relevant to Responsible Person code RN

omit from the column headed “Responsible Person”:                 Ranbaxy Australia Pty Limited             substitute:             Sun Pharma ANZ Pty Ltd

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

insert:

VZ Sanofi-aventis Healthcare Pty Ltd  43 076 651 959

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

insert:

YC Cipla Australia Pty Ltd  46 132 155 063

  1. Schedule 4, Part 1, entry for Adalimumab

(a)omit:

C5441 P5441

Severe active rheumatoid arthritis

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

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

 Compliance with Written Authority Required procedures
C5514 P5514

Severe active rheumatoid arthritis

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

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

 Compliance with Written Authority Required procedures
C5515 P5515

Severe active rheumatoid arthritis

Continuing treatment

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

 Compliance with Written Authority Required procedures

(b)omit:

C6571 P6571

Moderate to severe ulcerative colitis

Balance of supply for Continuing treatment and Initial 3 (Grandfathered patients)
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; OR
Patient must have received insufficient treatment with this drug to complete 24 weeks of treatment under the Initial 3 (Grandfathered patients).
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.

Authority approval for sufficient therapy to complete a maximum of 24 weeks of treatment may be requested by telephone by contacting the Department of Human Services.

 Compliance with Authority Required procedures
C6575 P6575

Moderate to severe ulcerative colitis

Balance of supply for Initial 1 and Initial 2
Patient must have received insufficient treatment with this drug under the Initial 1 (new patient or recommencement of treatment after more than 5 years break in therapy) restriction to complete 16 weeks of treatment; OR
Patient must have received insufficient treatment with this drug under the Initial 2 (Change or Re-commencing of treatment after less than 5 years break in therapy) to complete 16 weeks of treatment.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.

Authority approval for sufficient therapy to complete a maximum of 16 weeks of treatment may be requested by telephone by contacting the Department of Human Services.

 Compliance with Authority Required procedures
C6579 P6579

Moderate to severe ulcerative colitis

Initial 3 (Grandfathered patient)
Patient must have a documented history of moderate to severe ulcerative colitis; AND
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2016; AND
Patient must be receiving treatment with this drug at the time of application; AND
Patient must have a Mayo score greater than or equal to 6 prior to commencing treatment with this drug; OR
Patient must have a partial Mayo score is greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo score) prior to commencing treatment with this drug; OR
Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 prior to commencing treatment with this drug, if aged 6 to 17 years; OR
Patient must have a documented history of moderate to severe refractory ulcerative colitis prior to having commenced treatment with this drug where a Mayo clinic, partial Mayo clinic or PUCAI baseline assessment is not available, if aged 6 to 17 years; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Applications for authorisation of initial treatment must be in writing and must include: (a) a completed authority prescription form; and (b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current and baseline Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheets including the dates of assessment of the patient's condition; and (ii) the date of commencement of this drug; and (iii) the signed patient or guardian acknowledgement
The current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment must be no more than 1 month old at the time of application. The baseline assessment must be from immediately prior to commencing treatment with this drug. Where a baseline assessment is not available the prescriber must contact the Department of Human Services to discuss.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
A patient may qualify for PBS-subsidised treatment under this restriction once only.

For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

 Compliance with Written Authority Required procedures
C6602 P6602

Moderate to severe ulcerative colitis

Change or Re-commencement of treatment after a break of less than 5 years in therapy (Initial 2)
Patient must have previously received PBS-subsidised treatment with infliximab, vedolizumab or adalimumab for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised treatment with adalimumab for this condition in the current treatment cycle.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of this drug within the timelines specified in the relevant restriction. If the response assessment to the previous course of this drug is not submitted as detailed in the relevant restriction, the patient will be deemed to have failed therapy with this drug.
Applications for authorisation of initial treatment must be in writing and must include:(a) a completed authority prescription form; and(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition.
For patients weighing 40 kg or greater, a maximum quantity and number of repeats to provide for an initial 16 weeks course of this drug consisting of a 160 mg dose at week 0, 80 mg dose at week 2 and 40 mg dose at weeks 4, 6, 8, 10, 12 and 14 will be authorised.
For patients weighing less than 40 kg, a maximum quantity and number of repeats to provide for an initial 16 weeks of this drug consisting of a 80 mg dose at week 0, 40 mg dose at week 2 and a 20 mg dose at weeks 4, 6, 8, 10, 12 and 14 will be authorised.
Two completed authority prescriptions must be submitted with every initial application for this drug.For patients weighing 40 kg or greater, one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription must be written for 2 doses of 40 mg and 2 repeats.

For patients weighing less than 40 kg, one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.

 Compliance with Written Authority Required procedures
C6614 P6614

Moderate to severe ulcerative colitis

Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.
Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.

At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.

 Compliance with Authority Required procedures
C6615 P6615

Moderate to severe ulcerative colitis

Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)
Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg (for a child, 1 to 2 mg/kg up to 40 mg) prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); OR
Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the signed patient acknowledgement or guardian acknowledgement.
For patients weighing 40 kg or greater, a maximum quantity and number of repeats to provide for an initial 16 weeks course of this drug consisting of a 160 mg dose at week 0, 80 mg dose at week 2 and 40 mg dose at weeks 4, 6, 8, 10, 12 and 14 will be authorised.
For patients weighing less than 40 kg, a maximum quantity and number of repeats to provide for an initial 16 weeks of this drug consisting of a 80 mg dose at week 0, 40 mg dose at week 2 and a 20 mg dose at weeks 4, 6, 8, 10, 12 and 14 will be authorised.
Two completed authority prescriptions must be submitted with every initial application for this drug.For patients weighing 40 kg or greater, one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription must be written for 2 doses of 40 mg and 2 repeats.
For patients weighing less than 40 kg, one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 1 month old at the time of application.
Patients who fail to achieve a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 within the first 12 weeks of receiving this drug for ulcerative colitis, or have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or have failed to maintain a PUCAI score less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated.
The patient or guardian (required if patient is aged 6 to 17 years) must have signed a patient acknowledgement indicating that he or she understands and acknowledges that the PBS-subsidised treatment will cease if he or she does not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.

Details of the accepted toxicities including severity can be found on the Department of Human Services website.

 Compliance with Written Authority Required procedures

(c)insert in numerical order after existing text:

C6902 P6902

Severe active rheumatoid arthritis

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

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

 Compliance with Written Authority Required procedures
C6916 P6916

Moderate to severe ulcerative colitis

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.
Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.

 Compliance with Authority Required procedures
C6917 P6917

Moderate to severe ulcerative colitis

Initial 3 (Grandfathered patient)

Patient must have a documented history of moderate to severe ulcerative colitis; AND
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2016; AND
Patient must be receiving treatment with this drug at the time of application; AND
Patient must have a Mayo score greater than or equal to 6 prior to commencing treatment with this drug; OR
Patient must have a partial Mayo score is greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo score) prior to commencing treatment with this drug; OR
Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 prior to commencing treatment with this drug, if aged 6 to 17 years; OR
Patient must have a documented history of moderate to severe refractory ulcerative colitis prior to having commenced treatment with this drug where a Mayo clinic, partial Mayo clinic or PUCAI baseline assessment is not available, if aged 6 to 17 years; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Applications for authorisation of initial treatment must be in writing and must include: (a) a completed authority prescription form; and (b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current and baseline Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheets including the dates of assessment of the patient's condition; and (ii) the date of commencement of this drug; and (iii) the signed patient or guardian acknowledgement
The current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment must be no more than 1 month old at the time of application. The baseline assessment must be from immediately prior to commencing treatment with this drug. Where a baseline assessment is not available the prescriber must contact the Department of Human Services to discuss.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

 Compliance with Written Authority Required procedures
C6918 P6918

Moderate to severe ulcerative colitis

Balance of supply for Initial 1 and Initial 2

Patient must have received insufficient treatment with this drug under the Initial 1 (new patient or recommencement of treatment after more than 5 years break in therapy) restriction to complete 16 weeks of treatment; OR
Patient must have received insufficient treatment with this drug under the Initial 2 (Change or Re-commencing of treatment after less than 5 years break in therapy) to complete 16 weeks of treatment.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Authority approval for sufficient therapy to complete a maximum of 16 weeks of treatment may be requested by telephone by contacting the Department of Human Services.

 Compliance with Authority Required procedures
C6921 P6921

Moderate to severe ulcerative colitis

Balance of supply for Continuing treatment and Initial 3 (Grandfathered patients)

Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; OR
Patient must have received insufficient treatment with this drug to complete 24 weeks of treatment under the Initial 3 (Grandfathered patients).
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Authority approval for sufficient therapy to complete a maximum of 24 weeks of treatment may be requested by telephone by contacting the Department of Human Services.

 Compliance with Authority Required procedures
C6922 P6922

Severe active rheumatoid arthritis

Continuing treatment

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

 Compliance with Written Authority Required procedures
C6923 P6923

Severe active rheumatoid arthritis

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

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

 Compliance with Written Authority Required procedures
C6931 P6931

Moderate to severe ulcerative colitis

Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)

Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg (for a child, 1 to 2 mg/kg up to 40 mg) prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); OR
Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Applications for authorisation of initial treatment must be in writing and must include:(a) two completed authority prescription forms; and(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and(iii) the signed patient acknowledgement or guardian acknowledgement.
For patients weighing 40 kg or greater, a maximum quantity and number of repeats to provide for an initial 16 weeks course of this drug consisting of a 160 mg dose at week 0, 80 mg dose at week 2 and 40 mg dose at weeks 4, 6, 8, 10, 12 and 14 will be authorised.
For patients weighing less than 40 kg, a maximum quantity and number of repeats to provide for an initial 16 weeks of this drug consisting of a 80 mg dose at week 0, 40 mg dose at week 2 and a 20 mg dose at weeks 4, 6, 8, 10, 12 and 14 will be authorised.
Two completed authority prescriptions must be submitted with every initial application for this drug.For patients weighing 40 kg or greater, one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription must be written for 2 doses of 40 mg and 2 repeats.
For patients weighing less than 40 kg, one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 1 month old at the time of application.
Patients who fail to achieve a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 within the first 12 weeks of receiving this drug for ulcerative colitis, or have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or have failed to maintain a PUCAI score less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated.
The patient or guardian (required if patient is aged 6 to 17 years) must have signed a patient acknowledgement indicating that he or she understands and acknowledges that the PBS-subsidised treatment will cease if he or she does not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.

 Compliance with Written Authority Required procedures
C6932 P6932

Moderate to severe ulcerative colitis

Change or Re-commencement of treatment after a break of less than 5 years in therapy (Initial 2)

Patient must have previously received PBS-subsidised treatment with adalimumab, infliximab or vedolizumab for this condition in this treatment cycle; OR
Patient must have previously received PBS-subsidised treatment with adalimumab or infliximab for this condition in this treatment cycle if aged 6 to 17 years; AND
Patient must not have failed PBS-subsidised treatment with adalimumab for this condition in the current treatment cycle; OR
Patient must not have failed PBS-subsidised treatment with adalimumab for this condition in the current treatment cycle more than once if aged 6 to 17 years.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of this drug within the timelines specified in the relevant restriction. If the response assessment to the previous course of this drug is not submitted as detailed in the relevant restriction, the patient will be deemed to have failed therapy with this drug.
Applications for authorisation of initial treatment must be in writing and must include:
(a) two completed authority prescription forms; and(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].
Two completed authority prescriptions must be submitted with every initial application for this drug.For patients weighing 40 kg or greater, one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription must be written for 2 doses of 40 mg and 2 repeats.
For patients weighing less than 40 kg, one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Everolimus

(a)for Circumstances Code C5554:
omit from the column headed “Circumstances Code”:     C5554
insert in the column headed “Purposes Code”:                 P5554
insert in the column headed “Conditions Code”:             CN5554

(b)for Circumstances Code C5555:
omit from the column headed “Circumstances Code”:     C5555
insert in the column headed “Purposes Code”:                 P5555
insert in the column headed “Conditions Code”:             CN5555

(c)omit:

C5566

Maintenance of renal transplant

Maintenance therapy (following initiation and stabilisation of treatment with everolimus)

Patient must have undergone a renal transplant; AND
The treatment must be under the supervision and direction of a transplant unit.
The name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application.

 Compliance with Authority Required procedures
C5579

Maintenance of cardiac transplant

Maintenance therapy (following initiation and stabilisation of treatment with everolimus)

Patient must have undergone a cardiac transplant; AND
The treatment must be under the supervision and direction of a transplant unit.
The name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application.

 Compliance with Authority Required procedures

(d)for Circumstances Code C5794:
omit from the column headed “Circumstances Code”:     C5794
insert in the column headed “Purposes Code”:                 P5794
insert in the column headed “Conditions Code”:             CN5794

(e)for Circumstances Code C5795:
omit from the column headed “Circumstances Code”:     C5795
insert in the column headed “Purposes Code”:                 P5795
insert in the column headed “Conditions Code”:             CN5795

  1. Schedule 4, Part 1, omit entry for Fluphenazine Decanoate

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

insert:

Fluticasone furoate with vilanterol C4689

Chronic obstructive pulmonary disease (COPD)

Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy; AND
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND
The treatment must be for symptomatic treatment.
C4711

Asthma

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.
Patient must be aged 12 years or over.
C4731

Asthma

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.
Patient must be aged 12 years or over.

  1. Schedule 4, Part 1, omit entry for Fluticasone with vilanterol

  1. Schedule 4, Part 1, entry for Imatinib

(a)omit:

C6497 P6497

Acute lymphoblastic leukaemia

Initial treatment

Patient must be newly diagnosed; AND

The condition must be expressing the Philadelphia chromosome; OR

The condition must have the transcript BCR-ABL tyrosine kinase; AND

The treatment must be for induction and consolidation therapy; AND

The treatment must be in combination with chemotherapy.

The authority application must be made in writing and must include:

(a) a completed authority prescription form; and

(b) a completed Acute Lymphoblastic Leukaemia Imatinib PBS Authority Application - Supporting Information Form; and

(c) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow. (The date of the relevant pathology report needs to be provided); and

(d) a signed patient acknowledgement

 Compliance with Written Authority Required procedures

(b)omit:

C6528 P6528

Acute lymphoblastic leukaemia

Initial treatment

The condition must be expressing the Philadelphia chromosome; OR

The condition must have the transcript BCR-ABL tyrosine kinase; AND

Patient must have previously received treatment with this drug for this condition under the Imatinib Compassionate Program.

The authority application must be made in writing and must include:

(a) a completed authority prescription form; and

(b) a completed Acute Lymphoblastic Leukaemia Imatinib PBS Authority Application - Supporting Information Form; and

(c) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow. (The date of the relevant pathology report needs to be provided); and

(d) a signed patient acknowledgement

 Compliance with Written Authority Required procedures

(c)omit:

C6549 P6549

Acute lymphoblastic leukaemia

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The condition must be expressing the Philadelphia chromosome; OR

The condition must have the transcript BCR-ABL tyrosine kinase; AND

The treatment must be for maintenance of first complete remission; AND

The treatment must be in combination with chemotherapy.

Imatinib is available with a lifetime maximum of 24 months for continuing treatment with imatinib therapy for patients with acute lymphoblastic leukaemia reimbursed through the PBS.

 Compliance with Authority Required procedures

(d)insert in numerical order after existing text:

C6896 P6896

Acute lymphoblastic leukaemia

Initial treatment

Patient must be newly diagnosed; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL; AND
The treatment must be for induction and consolidation therapy; AND
The treatment must be in combination with chemotherapy.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Acute Lymphoblastic Leukaemia Imatinib PBS Authority Application - Supporting Information Form; and
(c) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow. (The date of the relevant pathology report needs to be provided); and
(d) a signed patient acknowledgement

 Compliance with Written Authority Required procedures
C6907 P6907

Acute lymphoblastic leukaemia

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL; AND
The treatment must be for maintenance of first complete remission; AND
The treatment must be in combination with chemotherapy.
Imatinib is available with a lifetime maximum of 24 months for continuing treatment with imatinib therapy for patients with acute lymphoblastic leukaemia reimbursed through the PBS.

 Compliance with Authority Required procedures
C6942 P6942

Acute lymphoblastic leukaemia

Initial treatment

The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL; AND
Patient must have previously received treatment with this drug for this condition under Imatinib Compassionate Program.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Acute Lymphoblastic Leukaemia Imatinib PBS Authority Application - Supporting Information Form; and
(c) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow. (The date of the relevant pathology report needs to be provided); and
(d) a signed patient acknowledgement

 Compliance with Written Authority Required procedures

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

insert in numerical order after existing text:

C6937

Nausea and vomiting

The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with dexamethasone on day 1 of a chemotherapy cycle; AND
Patient must have had a prior episode of chemotherapy induced nausea or vomiting; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following intravenous chemotherapy agents: arsenic trioxide; azacitidine; cyclophosphamide at a dose of less than 1500 mg per square metre per day; cytarabine at a dose of greater than 1 g per square metre per day; dactinomycin; daunorubicin; doxorubicin; epirubicin; fotemustine; idarubicin; ifosfamide; irinotecan; melphalan; methotrexate at a dose of 250 mg to 1 g per square metre; raltitrexed.
No more than 1 capsule of 300 mg netupitant/0.5 mg palonosetron fixed dose combination will be authorised per cycle of cytotoxic chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6937

  1. Schedule 4, Part 1, omit entry for Ribavirin and Peginterferon Alfa‑2b

  1. Schedule 4, Part 1, entry for Risperidone

(a)omit:

C5898 P5898

Severe behavioural disturbances

Continuing treatment

Patient must have autism; AND
Patient must have been commenced on PBS-subsidised treatment with risperidone prior to turning 18 years of age; AND
The treatment must be under the supervision of a paediatrician or psychiatrist; AND
The treatment must be in combination with non-pharmacological measures.
Patient must be aged 18 years or older.
Behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful.
The diagnosis of autism must be made based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or ICD-10 international classification of mental and behavioural disorders.

 Compliance with Authority Required procedures - Streamlined Authority Code 5898
C5902 P5902

Severe behavioural disturbances

Continuing treatment

Patient must have autism; AND
Patient must have been commenced on PBS-subsidised treatment with risperidone prior to turning 18 years of age; AND
The treatment must be under the supervision of a paediatrician or psychiatrist; AND
The treatment must be in combination with non-pharmacological measures.
Patient must be aged 18 years or older.
Behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful.
The diagnosis of autism must be made based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or ICD-10 international classification of mental and behavioural disorders.

 Compliance with Authority Required procedures - Streamlined Authority Code 5902

(b)omit:

C5911 P5911

Severe behavioural disturbances

Patient must have autism; AND
The treatment must be under the supervision of a paediatrician or psychiatrist; AND
The treatment must be in combination with non-pharmacological measures.
Patient must be under 18 years of age.
Behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful.
The diagnosis of autism must be made based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or ICD-10 international classification of mental and behavioural disorders.

 Compliance with Authority Required procedures - Streamlined Authority Code 5911

(c)omit:

C5916 P5916

Severe behavioural disturbances

Patient must have autism; AND
The treatment must be under the supervision of a paediatrician or psychiatrist; AND
The treatment must be in combination with non-pharmacological measures.
Patient must be under 18 years of age.
Behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful.
The diagnosis of autism must be made based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or ICD-10 international classification of mental and behavioural disorders.

 Compliance with Authority Required procedures - Streamlined Authority Code 5916

(d)insert in numerical order after existing text:

C6897 P6897

Severe behavioural disturbances

Patient must have autism spectrum disorder; AND
The treatment must be under the supervision of a paediatrician or psychiatrist; AND
The treatment must be in combination with non-pharmacological measures.
Patient must be under 18 years of age.
Behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful.
The diagnosis of autism spectrum disorder must be made based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) or ICD-10 international classification of mental and behavioural disorders.

 Compliance with Authority Required procedures - Streamlined Authority Code 6897
C6898 P6898

Severe behavioural disturbances

Patient must have autism spectrum disorder; AND
The treatment must be under the supervision of a paediatrician or psychiatrist; AND
The treatment must be in combination with non-pharmacological measures.
Patient must be under 18 years of age.
Behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful.
The diagnosis of autism spectrum disorder must be made based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) or ICD-10 international classification of mental and behavioural disorders.

 Compliance with Authority Required procedures - Streamlined Authority Code 6898
C6899 P6899

Severe behavioural disturbances

Continuing treatment

Patient must have autism spectrum disorder; AND
Patient must have been commenced on PBS-subsidised treatment with risperidone prior to turning 18 years of age; AND
The treatment must be under the supervision of a paediatrician or psychiatrist; AND
The treatment must be in combination with non-pharmacological measures.
Patient must be aged 18 years or older.
Behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful.
The diagnosis of autism spectrum disorder must be made based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) or ICD-10 international classification of mental and behavioural disorders.

 Compliance with Authority Required procedures - Streamlined Authority Code 6899
C6938 P6938

Severe behavioural disturbances

Continuing treatment

Patient must have autism spectrum disorder; AND
Patient must have been commenced on PBS-subsidised treatment with risperidone prior to turning 18 years of age; AND
The treatment must be under the supervision of a paediatrician or psychiatrist; AND
The treatment must be in combination with non-pharmacological measures.
Patient must be aged 18 years or older.
Behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful.
The diagnosis of autism spectrum disorder must be made based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) or ICD-10 international classification of mental and behavioural disorders.

 Compliance with Authority Required procedures - Streamlined Authority Code 6938

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

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

insert:

Sacubitril with valsartan C6915

Chronic heart failure

Patient must be symptomatic with NYHA classes II, III or IV; AND
Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND
Patient must receive concomitant optimal standard chronic heart failure treatment, which must include the maximum tolerated dose of a beta-blocker, unless contraindicated or not tolerated; AND
Patient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR
Patient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
The treatment must not be co-administered with an ACE inhibitor or an angiotensin II antagonist.

 Compliance with Authority Required procedures - Streamlined Authority Code 6915

  1. Schedule 4, Part 1, entry for Salbutamol

omit:

C6331

Asthma

Patient must be unable to use this drug delivered from an oral pressurised inhalation device via a spacer.
C6341

Chronic obstructive pulmonary disease (COPD)

Patient must be unable to use this drug delivered from an oral pressurised inhalation device via a spacer.

  1. Schedule 4, Part 1, entry for Teriflunomide

(a)omit:

C6853

Multiple sclerosis

Initial treatment

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

 Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C6914

Multiple sclerosis

Initial treatment

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

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Testosterone

(a)omit:

C6304

Androgen deficiency

Patient must have an established pituitary or testicular disorder.
Must be treated by a specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The name of the specialist must be included in the authority application.

 Compliance with Authority Required procedures
C6312

Pubertal induction

Patient must be under 18 years of age.
Must be treated by a specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The name of the specialist must be included in the authority application.

 Compliance with Authority Required procedures
C6316

Constitutional delay of growth or puberty

Patient must be under 18 years of age.
Must be treated by a specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The name of the specialist must be included in the authority application.

 Compliance with Authority Required procedures
C6322

Micropenis

Patient must be under 18 years of age.
Must be treated by a specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The name of the specialist must be included in the authority application.

 Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C6910

Androgen deficiency

Patient must have an established pituitary or testicular disorder.
Must be treated by a specialist general paediatrician,specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The name of the specialist must be included in the authority application.

 Compliance with Authority Required procedures
C6919

Pubertal induction

Patient must be under 18 years of age.
Must be treated by a specialist general paediatrician,specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The name of the specialist must be included in the authority application.

 Compliance with Authority Required procedures
C6933

Micropenis

Patient must be under 18 years of age.
Must be treated by a specialist general paediatrician,specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The name of the specialist must be included in the authority application.

 Compliance with Authority Required procedures
C6934

Constitutional delay of growth or puberty

Patient must be under 18 years of age.
Must be treated by a specialist general paediatrician,specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The name of the specialist must be included in the authority application.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Vemurafenib

(a)omit:

C6804 P6804

Unresectable Stage III or Stage IV malignant melanoma

Continuing

Patient must have previously been issued with an authority prescription for this drug; AND
Patient must have stable or responding disease.

 Compliance with Authority Required procedures - Streamlined Authority Code 6804

(b)insert in numerical order after existing text:

C6924 P6924

Unresectable Stage III or Stage IV malignant melanoma

Continuing treatment

Patient must be receiving PBS subsidised cobimetinib concomitantly for this condition; AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must have stable or responding disease.

 Compliance with Authority Required procedures - Streamlined Authority Code 6924

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

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

omit from subparagraph (3)

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

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

substitute:

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

b.  treated by a medical practitioner or an authorised nurse practitioner in consultation with:

  1. Schedule 5, entry for Salbutamol

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

GRP-21535 Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 20 Inhalation Ventolin Nebules
Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 Inhalation APO-Salbutamol
Asmol 2.5 uni-dose
Butamol 2.5
Salbutamol Actavis
Salbutamol Sandoz
Ventolin Nebules
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