National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 11) (PB 91 of 2018) (Cth)

Case

PB 91 of 2018

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 11)

National Health Act 1953

___________________________________________________________________________

I, LISA LA RANCE, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access 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   25th October 2018

LISA LA RANCE

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health


___________________________________________________________________________

  1. Name of Instrument

(1)This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 11).

(2)This Instrument may also be cited as PB 91 of 2018.

  1. Commencement

This Instrument commences on 1 November 2018.

  1. 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 Aciclovir 200 CR MP NP C5942 90 5 90

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

omit:

a Aciclovir 800 CR MP NP C5959 C5967 35 0 35

  1. Schedule 1, entry for Adalimumab

substitute:

Adalimumab Injection 20 mg in 0.4 mL pre-filled syringe Injection Humira VE MP See Note 3 See Note 3 See Note 3 See Note 3 2 C(100)
MP C5076 C5091 C5105 C5117 C7652 C7654 C7655 C7663 C7664 P5105 2 0 2
MP C5076 C5091 C5105 C5117 C7652 C7654 C7655 C7663 C7664 P5076 P5117 P7652 P7655 P7664 2 3 2
MP C5076 C5091 C5105 C5117 C7652 C7654 C7655 C7663 C7664 P5091 P7654 P7663 2 5 2
Injection 40 mg in 0.8 mL pre-filled syringe Injection Humira VE MP See Note 3 See Note 3 See Note 3 See Note 3 2 C(100)
MP C3695 C3697 C3747 C3748 C4492 C4501 C4517 C4518 C4531 C4700 C4724 C4845 C4851 C5075 C5076 C5090 C5091 C5105 C5117 C6437 C6439 C6445 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756 C6902 C6922 C6923 C7151 C7443 C7652 C7654 C7655 C7663 C7664 C8041 C8059 C8060 C8073 C8074 P5105 2 0 2
MP C3695 C3697 C3747 C3748 C4492 C4501 C4517 C4518 C4531 C4700 C4724 C4845 C4851 C5075 C5076 C5090 C5091 C5105 C5117 C6437 C6439 C6445 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756 C6902 C6922 C6923 C7151 C7443 C7652 C7654 C7655 C7663 C7664 C8041 C8059 C8060 C8073 C8074 P3695 P3747 P5076 P5090 P5117 P7151 P7443 P7652 P7655 P7664 2 2 2
MP C3695 C3697 C3747 C3748 C4492 C4501 C4517 C4518 C4531 C4700 C4724 C4845 C4851 C5075 C5076 C5090 C5091 C5105 C5117 C6437 C6439 C6445 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756 C6902 C6922 C6923 C7151 C7443 C7652 C7654 C7655 C7663 C7664 C8041 C8059 C8060 C8073 C8074 P4492 P4501 P4518 P4700 P4851 P6437 P6445 P6902 P6923 P8059 P8060 P8073 2 3 2
MP C3695 C3697 C3747 C3748 C4492 C4501 C4517 C4518 C4531 C4700 C4724 C4845 C4851 C5075 C5076 C5090 C5091 C5105 C5117 C6437 C6439 C6445 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756 C6902 C6922 C6923 C7151 C7443 C7652 C7654 C7655 C7663 C7664 C8041 C8059 C8060 C8073 C8074 P6695 P6726 P6727 P6728 P6753 2 4 2
MP C3695 C3697 C3747 C3748 C4492 C4501 C4517 C4518 C4531 C4700 C4724 C4845 C4851 C5075 C5076 C5090 C5091 C5105 C5117 C6437 C6439 C6445 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756 C6902 C6922 C6923 C7151 C7443 C7652 C7654 C7655 C7663 C7664 C8041 C8059 C8060 C8073 C8074 P3697 P3748 P4517 P4531 P4724 P4845 P5075 P5091 P6439 P6696 P6755 P6756 P6922 P7654 P7663 P8041 P8074 2 5 2
Injection 40 mg in 0.8 mL pre-filled syringe, 6 Injection Humira VE MP C3695 C3747 C5076 C5090 C5117 C7151 C7443 C7652 C7655 C7664 1 0 1
Injection 40 mg in 0.8 mL pre-filled pen Injection Humira VE MP See Note 3 See Note 3 See Note 3 See Note 3 2 C(100)
MP C3695 C3697 C3747 C3748 C4492 C4501 C4517 C4518 C4531 C4700 C4724 C4845 C4851 C5075 C5076 C5090 C5091 C5105 C5117 C6437 C6439 C6445 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756 C6902 C6922 C6923 C7151 C7443 C7652 C7654 C7655 C7663 C7664 C8041 C8059 C8060 C8073 C8074 P5105 2 0 2
MP C3695 C3697 C3747 C3748 C4492 C4501 C4517 C4518 C4531 C4700 C4724 C4845 C4851 C5075 C5076 C5090 C5091 C5105 C5117 C6437 C6439 C6445 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756 C6902 C6922 C6923 C7151 C7443 C7652 C7654 C7655 C7663 C7664 C8041 C8059 C8060 C8073 C8074 P3695 P3747 P5076 P5090 P5117 P7151 P7443 P7652 P7655 P7664 2 2 2
MP C3695 C3697 C3747 C3748 C4492 C4501 C4517 C4518 C4531 C4700 C4724 C4845 C4851 C5075 C5076 C5090 C5091 C5105 C5117 C6437 C6439 C6445 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756 C6902 C6922 C6923 C7151 C7443 C7652 C7654 C7655 C7663 C7664 C8041 C8059 C8060 C8073 C8074 P4492 P4501 P4518 P4700 P4851 P6437 P6445 P6902 P6923 P8059 P8060 P8073 2 3 2
MP C3695 C3697 C3747 C3748 C4492 C4501 C4517 C4518 C4531 C4700 C4724 C4845 C4851 C5075 C5076 C5090 C5091 C5105 C5117 C6437 C6439 C6445 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756 C6902 C6922 C6923 C7151 C7443 C7652 C7654 C7655 C7663 C7664 C8041 C8059 C8060 C8073 C8074 P6695 P6726 P6727 P6728 P6753 2 4 2
MP C3695 C3697 C3747 C3748 C4492 C4501 C4517 C4518 C4531 C4700 C4724 C4845 C4851 C5075 C5076 C5090 C5091 C5105 C5117 C6437 C6439 C6445 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756 C6902 C6922 C6923 C7151 C7443 C7652 C7654 C7655 C7663 C7664 C8041 C8059 C8060 C8073 C8074 P3697 P3748 P4517 P4531 P4724 P4845 P5075 P5091 P6439 P6696 P6755 P6756 P6922 P7654 P7663 P8041 P8074 2 5 2
Injection 40 mg in 0.8 mL pre-filled pen, 4 Injection Humira VE MP C6946 C6971 C6972 P6946 1 2 1
MP C6946 C6971 C6972 P6971 P6972 1 5 1
Injection 40 mg in 0.8 mL pre-filled pen, 6 Injection Humira VE MP C3695 C3747 C5076 C5090 C5117 C6951 C6963 C7151 C7443 C7652 C7655 C7664 1 0 1

  1. Schedule 1, entry for Allopurinol

substitute:

Allopurinol Tablet 100 mg Oral a Allopurinol APOTEX GX MP NP 200 2 200
a Allopurinol Sandoz SZ MP NP 200 2 200
a Allosig RF MP NP 200 2 200
a APO-Allopurinol TX MP NP 200 2 200
a Progout 100 AF MP NP 200 2 200
a Zyloprim RW MP NP 200 2 200
Tablet 300 mg Oral a Allopurinol APOTEX GX MP NP 60 2 60
a Allopurinol Sandoz SZ MP NP 60 2 60
a Allosig RF MP NP 60 2 60
a APO-Allopurinol TX MP NP 60 2 60
a Progout 300 AF MP NP 60 2 60
a Zyloprim RW MP NP 60 2 60

  1. Schedule 1, after entry for Apomorphine in the form Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL

insert:

Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre-filled pen Injection Movapo Pen TD MP C4833 C4860 100 5 5 D(100)

  1. Schedule 1, entry for Betaxolol

omit:

Eye drops, suspension, 2.5 mg (as hydrochloride) per mL, 5 mL Application to the eye Betoptic S NV MP AO 1 5 1

  1. Schedule 1, entry for Carmellose

(a)omit:

Eye drops containing carmellose sodium 2.5 mg per mL, single dose units 0.6 mL, 24 Application to the eye TheraTears CX AO MP NP C6172 4 5 1

(b)omit:

Ocular lubricating gel containing carmellose sodium 10 mg per mL, single dose units 0.6 mL, 28 Application to the eye TheraTears CX AO MP NP C6172 3 5 1

  1. Schedule 1, entry for Cefalexin in the form Capsule 250 mg (as monohydrate) [Maximum Quantity: 20; Number of Repeats: 0]

omit:

a Cephalex 250 CR PDP 20 0 20

  1. Schedule 1, entry for Cefalexin in the form Capsule 250 mg (as monohydrate) [Maximum Quantity: 20; Number of Repeats: 1]

omit:

a Cephalex 250 CR MP NP MW 20 1 20

  1. Schedule 1, entry for Cefalexin in the form Capsule 250 mg (as monohydrate) [Maximum Quantity: 40; Number of Repeats: 2]

omit:

a Cephalex 250 CR MP P4243 40
CN4243 		2
CN4243 		20

  1. Schedule 1, entry for Cefuroxime in the form Tablet 250 mg (as axetil)

substitute:

Oral Pharmacor Cefuroxime CR PDP 14 0 14
Pharmacor Cefuroxime CR MP 14 1 14
a Pharmacor Cefuroxime CR PDP 20 0 20
a Zinnat AS PDP 20 0 20
a Pharmacor Cefuroxime CR MP 20 1 20
a Zinnat AS MP 20 1 20

  1. Schedule 1, entry for Certolizumab pegol

substitute:

Certolizumab pegol Injection 200 mg in 1 mL single use pre-filled syringe Injection Cimzia UC MP C4737 C4764 C4830 C4853 C6374 C6396 C6455 C6456 C6460 C6474 C8041 C8074 C8076 C8097 C8113 P4737 P4830 P8113 2 2 2
MP C4737 C4764 C4830 C4853 C6374 C6396 C6455 C6456 C6460 C6474 C8041 C8074 C8076 C8097 C8113 P4764 P4853 P6374 P6474 P8041 P8074 2 5 2
MP C4737 C4764 C4830 C4853 C6374 C6396 C6455 C6456 C6460 C6474 C8041 C8074 C8076 C8097 C8113 P6396 P6455 P6456 P6460 P8076 P8097 6 0 2
Solution for injection 200 mg in 1 mL pre-filled pen Injection Cimzia UC MP C4737 C4764 C4830 C4853 C6374 C6396 C6455 C6456 C6460 C6474 C8041 C8074 C8076 C8097 C8113 P4737 P4830 P8113 2 2 2
MP C4737 C4764 C4830 C4853 C6374 C6396 C6455 C6456 C6460 C6474 C8041 C8074 C8076 C8097 C8113 P4764 P4853 P6374 P6474 P8041 P8074 2 5 2
MP C4737 C4764 C4830 C4853 C6374 C6396 C6455 C6456 C6460 C6474 C8041 C8074 C8076 C8097 C8113 P6396 P6455 P6456 P6460 P8076 P8097 6 0 2

  1. Schedule 1, entry for Citalopram in the form Tablet 20 mg (as hydrobromide)

omit:

a Pharmacor Citalo 20 CR MP NP C4755 28 5 28

  1. Schedule 1, entry for Clomipramine

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

a APO-Clomipramine TX MP NP C6250 C6251 C6299 50 2 50

  1. Schedule 1, entry for Clozapine in the form Tablet 25 mg

omit from the column headed "Schedule Equivalent" (all instances): a

  1. Schedule 1, entry for Clozapine in the form Tablet 100 mg

omit from the column headed "Schedule Equivalent" (all instances): a

  1. Schedule 1, entry for Dexamethasone in the form Intravitreal injection 700 micrograms [Maximum Quantity: 1; Number of Repeats: 0]

insert in numerical order in the column headed “Circumstances”: C8020 C8023 C8032 C8033

  1. Schedule 1, entry for Dexamethasone in the form Intravitreal injection 700 micrograms [Maximum Quantity: 1; Number of Repeats: 1]

(a)insert in numerical order in the column headed “Circumstances”: C8020 C8023 C8032 C8033

(b)insert in numerical order in the column headed “Purposes”: P8020 P8023 P8032 P8033

  1. Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)

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

a Escitalopram GH HQ MP NP C4755 28 5 28

  1. Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)

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

a Escitalopram GH HQ MP NP C4755 28 5 28

  1. Schedule 1, entry for Etanercept

substitute:

Etanercept Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL Injection Enbrel PF MP See Note 3 See Note 3 See Note 3 See Note 3 1 C(100)
MP C4457 C4458 C4482 C4483 C4503 C6808 C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6836 C6843 C7177 C7179 C7180 C7181 C7209 C7219 C7220 C7222 C7224 C7237 C7251 C7287 C7288 C7289 C7300 C7307 C7308 C7309 C7320 C7336 C8039 C8040 C8054 C8079 C8093 C8095 C8103 P4458 P4483 P4503 P6808 P6811 P6814 P6818 P6819 P6822 P6823 P6830 P6836 P6843 P7177 P7209 P7220 P7224 P7237 P7288 P7308 P7309 P7336 P8039 P8040 P8093 2 3 1
MP C4457 C4458 C4482 C4483 C4503 C6808 C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6836 C6843 C7177 C7179 C7180 C7181 C7209 C7219 C7220 C7222 C7224 C7237 C7251 C7287 C7288 C7289 C7300 C7307 C7308 C7309 C7320 C7336 C8039 C8040 C8054 C8079 C8093 C8095 C8103 P4457 P4482 P7179 P7180 P7181 P7219 P7222 P7251 P7287 P7289 P7300 P7307 P7320 P8054 P8079 P8095 P8103 2 5 1
Injection 50 mg in 1 mL single use auto-injector, 4 Injection Enbrel PF MP See Note 3 See Note 3 See Note 3 See Note 3 1 C(100)
Brenzys MK MP C6808 C6836 C7177 C7179 C7181 C7209 C7217 C7219 C7220 C7222 C7224 C7237 C7276 C7288 C7289 C7296 C7300 C7308 C7309 C7317 C7320 C7336 C8039 C8040 C8079 C8092 C8093 C8095 P6808 P6836 P7177 P7209 P7220 P7224 P7237 P7288 P7308 P7309 P7336 P8039 P8040 P8093 1 3 1
Enbrel PF MP C4457 C4458 C4482 C4483 C4503 C6808 C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6836 C6843 C7177 C7179 C7180 C7181 C7209 C7219 C7220 C7222 C7224 C7237 C7251 C7287 C7288 C7289 C7300 C7307 C7308 C7309 C7320 C7336 C8039 C8040 C8054 C8079 C8093 C8095 C8103 P4458 P4483 P4503 P6808 P6811 P6814 P6818 P6819 P6822 P6823 P6830 P6836 P6843 P7177 P7209 P7220 P7224 P7237 P7288 P7308 P7309 P7336 P8039 P8040 P8093 1 3 1
Brenzys MK MP C6808 C6836 C7177 C7179 C7181 C7209 C7217 C7219 C7220 C7222 C7224 C7237 C7276 C7288 C7289 C7296 C7300 C7308 C7309 C7317 C7320 C7336 C8039 C8040 C8079 C8092 C8093 C8095 P7179 P7181 P7217 P7219 P7222 P7276 P7289 P7296 P7300 P7317 P7320 P8079 P8092 P8095 1 5 1
Enbrel PF MP C4457 C4458 C4482 C4483 C4503 C6808 C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6836 C6843 C7177 C7179 C7180 C7181 C7209 C7219 C7220 C7222 C7224 C7237 C7251 C7287 C7288 C7289 C7300 C7307 C7308 C7309 C7320 C7336 C8039 C8040 C8054 C8079 C8093 C8095 C8103 P4457 P4482 P7179 P7180 P7181 P7219 P7222 P7251 P7287 P7289 P7300 P7307 P7320 P8054 P8079 P8095 P8103 1 5 1
Injections 50 mg in 1 mL single use pre-filled syringes, 4 Injection Enbrel PF MP See Note 3 See Note 3 See Note 3 See Note 3 1 C(100)
Brenzys MK MP C6808 C6836 C7177 C7179 C7181 C7209 C7217 C7219 C7220 C7222 C7224 C7237 C7276 C7288 C7289 C7296 C7300 C7308 C7309 C7317 C7320 C7336 C8039 C8040 C8079 C8092 C8093 C8095 P6808 P6836 P7177 P7209 P7220 P7224 P7237 P7288 P7308 P7309 P7336 P8039 P8040 P8093 1 3 1
Enbrel PF MP C4457 C4458 C4482 C4483 C4503 C6808 C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6836 C6843 C7177 C7179 C7180 C7181 C7209 C7219 C7220 C7222 C7224 C7237 C7251 C7287 C7288 C7289 C7300 C7307 C7308 C7309 C7320 C7336 C8039 C8040 C8054 C8079 C8093 C8095 C8103 P4458 P4483 P4503 P6808 P6811 P6814 P6818 P6819 P6822 P6823 P6830 P6836 P6843 P7177 P7209 P7220 P7224 P7237 P7288 P7308 P7309 P7336 P8039 P8040 P8093 1 3 1
Brenzys MK MP C6808 C6836 C7177 C7179 C7181 C7209 C7217 C7219 C7220 C7222 C7224 C7237 C7276 C7288 C7289 C7296 C7300 C7308 C7309 C7317 C7320 C7336 C8039 C8040 C8079 C8092 C8093 C8095 P7179 P7181 P7217 P7219 P7222 P7276 P7289 P7296 P7300 P7317 P7320 P8079 P8092 P8095 1 5 1
Enbrel PF MP C4457 C4458 C4482 C4483 C4503 C6808 C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6836 C6843 C7177 C7179 C7180 C7181 C7209 C7219 C7220 C7222 C7224 C7237 C7251 C7287 C7288 C7289 C7300 C7307 C7308 C7309 C7320 C7336 C8039 C8040 C8054 C8079 C8093 C8095 C8103 P4457 P4482 P7179 P7180 P7181 P7219 P7222 P7251 P7287 P7289 P7300 P7307 P7320 P8054 P8079 P8095 P8103 1 5 1

  1. Schedule 1, entry for Evolocumab

substitute:

Evolocumab Injection 140 mg in 1 mL single use pre-filled pen Injection Repatha AN MP C6597 C8064 C8078 C8094 C8108 P8064 P8078 P8108 2 5 1
MP C6597 C8064 C8078 C8094 C8108 P6597 P8094 3 5 1
Injection 420 mg in 3.5 mL single use pre-filled cartridge Injection Repatha AN MP C6597 C8064 C8078 C8094 C8108 1 5 1

  1. Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1; Number of Repeats: 3]

(a)omit from the column headed "Circumstances":  C4610 C4643

(b)omit from the column headed "Circumstances":  C6423 C6430

(c)omit from the column headed "Circumstances":  C6458

(d)insert in numerical order in the column headed "Circumstances":  C8041 C8059 C8060 C8073 C8074

(e)omit from the column headed "Purposes": P4610

(f)omit from the column headed "Purposes": P6430

(g)omit from the column headed "Purposes": P6458

(h)insert in numerical order in the column headed "Purposes”: P8059 P8060 P8073

  1. Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed "Circumstances":  C4610 C4643

(b)omit from the column headed "Circumstances":  C6423 C6430

(c)omit from the column headed "Circumstances":  C6458

(d)insert in numerical order in the column headed "Circumstances":  C8041 C8059 C8060 C8073 C8074

(e)omit from the column headed "Purposes": P4643

(f)omit from the column headed "Purposes": P6423

(g)insert in numerical order in the column headed "Purposes”: P8041 P8074

  1. Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1;
    Number of Repeats: 3]

(a)omit from the column headed "Circumstances":  C4610 C4643

(b)omit from the column headed "Circumstances":  C6423 C6430

(c)omit from the column headed "Circumstances":  C6458

(d)insert in numerical order in the column headed "Circumstances":  C8041 C8059 C8060 C8073 C8074

(e)omit from the column headed "Purposes": P4610

(f)omit from the column headed "Purposes": P6430

(g)omit from the column headed "Purposes": P6458

(h)insert in numerical order in the column headed "Purposes”: P8059 P8060 P8073

  1. Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1;
    Number of Repeats: 5]

(a)omit from the column headed "Circumstances":  C4610 C4643

(b)omit from the column headed "Circumstances":  C6423 C6430

(c)omit from the column headed "Circumstances":  C6458

(d)insert in numerical order in the column headed "Circumstances":  C8041 C8059 C8060 C8073 C8074

(e)omit from the column headed "Purposes": P4643

(f)omit from the column headed "Purposes": P6423

(g)insert in numerical order in the column headed "Purposes”: P8041 P8074

  1. Schedule 1, after entry for Hydromorphone in the form Injection containing hydromorphone hydrochloride 10 mg in 1 mL

insert:

Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 200 mL Oral Dilaudid MF PDP C4926 1 0 1
MP NP C4959 1 0 1

  1. Schedule 1, entry for Infliximab

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

  1. Schedule 1, entry for Isosorbide mononitrate in the form Tablet 60 mg (sustained release)

(a)omit from the column headed "Responsible Person" for the brand “Imdur Durule”: AP substitute: IX

(b)omit from the column headed "Responsible Person" for the brand “Monodur 60 mg”: PM substitute: IY

  1. Schedule 1, entry for Isosorbide mononitrate in the form Tablet 120 mg (sustained release)

(a)omit from the column headed "Responsible Person" for the brand “Imdur 120 mg”: AP substitute: IX

(b)omit from the column headed "Responsible Person" for the brand “Monodur 120 mg”: PM substitute: IY

  1. Schedule 1, entry for Lamotrigine in the form Tablet 100 mg

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

a Sandoz Lamotrigine HX MP NP C5138 56 5 56

  1. Schedule 1, entry for Loperamide in the form Capsule containing loperamide hydrochloride 2 mg

(a)omit:

a Imodium JT MP NP C6343 C6364 P6364 12 0 12

(b)omit:

a Imodium JT MP NP C6343 C6364 P6343 60 0 12

  1. Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg

omit:

a Metformin 500 CR MP NP 100 5 100

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

omit:

a Metformin 850 CR MP NP 60 5 60

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

omit:

a Pharmacor Metformin 1000 CR MP NP 90 5 90

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

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

a Moxonidine GH GQ MP NP C4944 30 5 30

  1. Schedule 1, entry for Olanzapine in the form Tablet 2.5 mg

omit:

a Olanzacor 2.5 CR MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Olanzapine in the form Tablet 5 mg

omit:

Olanzacor 5 CR MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Olanzapine in the form Tablet 7.5 mg

omit:

Olanzacor 7.5 CR MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Olanzapine in the form Tablet 10 mg

omit:

Olanzacor 10 CR MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Pegfilgrastim

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

a Tezmota JX MP C7822 C7823 C7843 C7862 1 11 1 D(100)

  1. Schedule 1, entry for Peginterferon alfa-2a in the form Injection 135 micrograms in 0.5 mL single use pre-filled syringe [Maximum Quantity: 8; Number of Repeats: 5]

(a)omit from the column headed "Purposes": P5010

(b)omit from the column headed "Purposes": P5067

(c)omit from the column headed "Maximum Quantity": CN5010

(d)omit from the column headed "Maximum Quantity": CN5067

(e)omit from the column headed "Number of Repeats": CN5010

(f)omit from the column headed "Number of Repeats": CN5067

  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: 8; Number of Repeats: 5]

(a)omit from the column headed "Purposes": P5010

(b)omit from the column headed "Purposes": P5067

(c)omit from the column headed "Maximum Quantity": CN5010

(d)omit from the column headed "Maximum Quantity": CN5067

(e)omit from the column headed "Number of Repeats": CN5010

(f)omit from the column headed "Number of Repeats": CN5067

  1. Schedule 1, entry for Pembrolizumab in the form Solution concentrate for I.V. infusion 100 mg in 4 mL

insert in numerical order in the column headed “Circumstances”:  C8122 C8123 C8124

  1. Schedule 1, entry for Pemetrexed in the form Powder for I.V. infusion 100 mg (as disodium)

omit:

Pemetrexed APOTEX TX MP C4792 C7195 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Phytomenadione

omit from the column headed "Responsible Person": RO        substitute: PB

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

(a)insert in numerical order in the column headed “Circumstances”: C8012 C8017 C8026 C8027 C8029

(b)insert in numerical order in the column headed “Purposes”: P8012 P8017 P8026 P8027 P8029

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

insert in numerical order in the column headed “Circumstances”: C8012 C8017 C8026 C8027 C8029

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

(a)insert in numerical order in the column headed “Circumstances”: C8012 C8017 C8026 C8027 C8029

(b)in numerical order in the column headed “Purposes”: P8012 P8017 P8026 P8027 P8029

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

insert in numerical order in the column headed “Circumstances”: C8012 C8017 C8026 C8027 C8029

  1. Schedule 1, entry for Secukinumab

substitute:

Secukinumab Injection 150 mg in 1 mL pre-filled pen Injection Cosentyx NV MP C6415 C6427 C6438 C6439 C6482 C6484 C6697 C6713 C6730 C6769 C6781 C6782 C6792 C6793 C8061 C8074 C8085 C8100 C8105 C8120 P6415 P8120 1 2 1
MP C6415 C6427 C6438 C6439 C6482 C6484 C6697 C6713 C6730 C6769 C6781 C6782 C6792 C6793 C8061 C8074 C8085 C8100 C8105 C8120 P6427 P6438 P6439 P8061 P8074 P8100 1 5 1
MP C6415 C6427 C6438 C6439 C6482 C6484 C6697 C6713 C6730 C6769 C6781 C6782 C6792 C6793 C8061 C8074 C8085 C8100 C8105 C8120 P6415 P6781 2 2 2
MP C6415 C6427 C6438 C6439 C6482 C6484 C6697 C6713 C6730 C6769 C6781 C6782 C6792 C6793 C8061 C8074 C8085 C8100 C8105 C8120 P6427 P6438 P6439 P6782 P6792 P6793 2 5 2
MP C6415 C6427 C6438 C6439 C6482 C6484 C6697 C6713 C6730 C6769 C6781 C6782 C6792 C6793 C8061 C8074 C8085 C8100 C8105 C8120 P6482 P6484 P8085 P8105 4 0 1
MP C6415 C6427 C6438 C6439 C6482 C6484 C6697 C6713 C6730 C6769 C6781 C6782 C6792 C6793 C8061 C8074 C8085 C8100 C8105 C8120 P6482 P6484 P6697 P6713 P6730 P6769 8 0 2

  1. Schedule 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)

omit:

a Sertracor 50 CR MP NP C4755 30 5 30

  1. Schedule 1, entry for Sertraline in the form Tablet 100 mg (as hydrochloride)

omit:

a Sertracor 100 CR MP NP C4755 30 5 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats: 5]

omit:

a Simvacor 10 CR MP NP 30 5 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit:

a Simvacor 10 CR MP P7598 30 11 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 5]

omit:

a Simvacor 20 CR MP NP 30 5 30     

  1. Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit:

a Simvacor 20 CR MP P7598 30 11 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Maximum Quantity: 30; Number of Repeats: 5]

omit:

a Simvacor 40 CR MP NP 30 5 30     

  1. Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit:

a Simvacor 40 CR MP P7598 30 11 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Maximum Quantity: 30; Number of Repeats: 5]

omit:

a Simvacor 80 CR MP NP 30 5 30  

  1. Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit:

a Simvacor 80 CR MP P7598 30 11 30

  1. Schedule 1, entry for Tofacitinib

omit from the column headed "Circumstances" (all instances): C5480

  1. Schedule 1, entry for Tofacitinib [Maximum Quantity: 56; Number of Repeats: 3]

omit from the column headed "Purposes": P5480

  1. Schedule 1, entry for Zoledronic acid in the form Solution for I.V. infusion 4 mg (as monohydrate) in 100 mL

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

Zoledronic Acid 4 mg/100 mL APOTEX TX MP C5605 C5606 C5676 C5677 C5703 C5704 C5735 C5736 1 11 1 PB(100)

  1. Schedule 3

omit:

CX Contact Lens Centre Australia Limited 42 092 190 040 

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

insert:

JX Juno Pharmaceuticals Pty Ltd 55 156 303 650 

  1. Schedule 3

omit:

PM Pharmaceutical Manufacturing Company Pty Limited 99 004 481 529 

  1. Schedule 4, entry for Adalimumab

(a)omit:

C4610 P4610 Ankylosing spondylitis
Initial treatment – Initial 1 (new patients) or Initial 2 (change or recommencement for all patients) – balance of supply
Patient must have active, or a documented history of active, ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Initial 1 (new patients) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement for all patients) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Patient must be an adult.
Must be treated by a rheumatologist. 		Compliance with Authority Required procedures
C4643 P4643 Ankylosing spondylitis
Continuing treatment – balance of supply
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Patient must be an adult.
Must be treated by a rheumatologist. 		Compliance with Authority Required procedures

(b)omit:

C6423 P6423 Ankylosing spondylitis
Continuing treatment
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug.
Patient must be an adult.
Must be treated by a rheumatologist.
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
All measurements provided must be no more than 1 month old at the time of application.
A maximum of 24 weeks of treatment with this drug will be authorised under this criterion.
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 following an initial treatment course it must be made following a minimum of 12 weeks of treatment with this drug. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
Patients who fail 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 in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle. 		Compliance with Written Authority Required procedures
C6430 P6430 Ankylosing spondylitis
Initial 2 (change or recommencement for all patients)
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND
Patient must be eligible to receive further bDMARD therapy.
Patient must be an adult.
Must be treated by a rheumatologist.
Where the most recent course of PBS-subsidised bDMARD treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised bDMARD therapy or, under this restriction, for patients who have received previous PBS-subsidised bDMARD therapy) the patient must have been assessed for response to that course following a minimum of 12 weeks of treatment. These assessments must be provided to the Department of Human Services no later than 4 weeks from the date the course was ceased. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, patients must have been assessed for response, and the assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
Patients who fail 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 in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle. 		Compliance with Written Authority Required procedures

(c)omit:

C6458 P6458 Active ankylosing spondylitis
Initial 1 (new patients)
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must not have received any PBS-subsidised treatment with either adalimumab, certolizumab pegol, etanercept, golimumab, infliximab or secukinumab in this treatment cycle; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months.
Patient must be an adult.
Must be treated by a rheumatologist.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; AND
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.
The BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. The BASDAI must be no more than 1 month old at the time of initial application.
Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which must include the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
(iv) a signed patient acknowledgment.
The assessment of the patient's response to the initial course of treatment must be made following a minimum of 12 weeks of treatment and submitted no later than 4 weeks from the cessation of that treatment course. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
Patients who fail 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 in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) was approved in this cycle and the date of the first application under a new cycle. 		Compliance with Written Authority Required procedures

(d)omit entry for circumstances code “C6902” and substitute

C6902 P6902 Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must be aged 18 years or older.
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.
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 they 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.
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

(e)insert in numerical order after existing text:

C8041 P8041 Ankylosing spondylitis
Continuing treatment – balance of supply
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. 		Compliance with Authority Required procedures
C8059 P8059 Ankylosing spondylitis
Initial 1 (new patients)
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must not have received any PBS-subsidised treatment with either adalimumab, certolizumab pegol, etanercept, golimumab, infliximab or secukinumab in this treatment cycle; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; AND
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.
The BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. The BASDAI must be no more than 1 month old at the time of initial application.
Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which must include the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
(iv) a signed patient acknowledgment.
The assessment of the patient's response to the initial course of treatment must be made following a minimum of 12 weeks of treatment and submitted no later than 4 weeks from the cessation of that treatment course. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
Patients who fail 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 in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) was approved in this cycle and the date of the first application under a new cycle. 		Compliance with Written Authority Required procedures
C8060 P8060 Ankylosing spondylitis
Initial 2 (change or recommencement for all patients)
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND
Patient must be eligible to receive further bDMARD therapy.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
Where the most recent course of PBS-subsidised bDMARD treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised bDMARD therapy or, under this restriction, for patients who have received previous PBS-subsidised bDMARD therapy) the patient must have been assessed for response to that course following a minimum of 12 weeks of treatment. These assessments must be provided to the Department of Human Services no later than 4 weeks from the date the course was ceased. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, patients must have been assessed for response, and the assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
Patients who fail 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 in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle. 		Compliance with Written Authority Required procedures
C8073 P8073 Ankylosing spondylitis
Initial treatment – Initial 1 (new patients) or Initial 2 (change or recommencement for all patients) – balance of supply
Patient must have active, or a documented history of active, ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Initial 1 (new patients) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement for all patients) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. 		Compliance with Authority Required procedures
C8074 P8074 Ankylosing spondylitis
Continuing treatment
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
All measurements provided must be no more than 1 month old at the time of application.
A maximum of 24 weeks of treatment with this drug will be authorised under this criterion.
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 following an initial treatment course it must be made following a minimum of 12 weeks of treatment with this drug. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
Patients who fail 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 in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle. 		Compliance with Written Authority Required procedures

  1. Schedule 4, entry for Atezolizumab

omit entry for circumstances code “C7572” and substitute:

C7572 Locally advanced or metastatic non-small cell lung cancer
Grandfathering treatment
Patient must have received treatment with this drug for this condition prior to 1 April 2018; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
Patient must have stable or responding disease; AND
Patient must have had a WHO performance status of 0 or 1 at the time non-PBS subsidised treatment with this drug for this condition was initiated.
A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. 		Compliance with Authority Required procedures - Streamlined Authority Code 7572

  1. Schedule 4, entry for Baricitinib

omit entry for circumstances code” C7925” and substitute:

C7925 P7925 Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
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.
For the purposes of this restriction bDMARD means abatacept, adalimumab, baricitinib, 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.
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.
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.
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

  1. Schedule 4, entry for Certolizumab pegol

(a)omit:

C4606 P4606 Ankylosing spondylitis
Initial treatment – Initial 1 (new patients) or Initial 2 (change or recommencement for all patients) – balance of supply
Patient must have active, or a documented history of active, ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Initial 1 (new patients) restriction to complete 18 to 20 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement for all patients) restriction to complete 18 to 20 weeks treatment; AND
The treatment must provide no more than the balance of up to 18 to 20 weeks treatment available under the above restrictions.
Patient must be an adult.
Must be treated by a rheumatologist. 		Compliance with Authority Required procedures
C4643 P4643 Ankylosing spondylitis
Continuing treatment – balance of supply
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Patient must be an adult.
Must be treated by a rheumatologist. 		Compliance with Authority Required procedures

(b)omit:

C6398 P6398 Active ankylosing spondylitis
Initial 1 (new patients)
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must not have received any PBS-subsidised treatment with either adalimumab, certolizumab pegol, etanercept, golimumab, infliximab or secukinumab in this treatment cycle; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months.
Patient must be an adult.
Must be treated by a rheumatologist.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; AND
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.
The BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. The BASDAI must be no more than 1 month old at the time of initial application.
Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which must include the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
(iv) a signed patient acknowledgment.
The assessment of the patient's response to the initial course of treatment must be made following a minimum of 12 weeks of treatment and submitted no later than 4 weeks from the cessation of that treatment course. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
A maximum of 18 to 20 weeks of treatment with this drug will be approved under this criterion.
Patients who fail 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 in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) was approved in this cycle and the date of the first application under a new cycle. 		Compliance with Written Authority Required procedures
C6399 P6399 Ankylosing spondylitis
Initial 2 (change or recommencement for all patients)
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND
Patient must be eligible to receive further bDMARD therapy.
Patient must be an adult.
Must be treated by a rheumatologist.
Where the most recent course of PBS-subsidised bDMARD treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised bDMARD therapy or, under this restriction, for patients who have received previous PBS-subsidised bDMARD therapy) the patient must have been assessed for response to that course following a minimum of 12 weeks of treatment. These assessments must be provided to the Department of Human Services no later than 4 weeks from the date the course was ceased. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, patients must have been assessed for response, and the assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
A maximum of 18 to 20 weeks of treatment with this drug will be approved under this criterion.
Patients who fail 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 in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle. 		Compliance with Written Authority Required procedures
C6423 P6423 Ankylosing spondylitis
Continuing treatment
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug.
Patient must be an adult.
Must be treated by a rheumatologist.
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
All measurements provided must be no more than 1 month old at the time of application.
A maximum of 24 weeks of treatment with this drug will be authorised under this criterion.
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 following an initial treatment course it must be made following a minimum of 12 weeks of treatment with this drug. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
Patients who fail 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 in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle. 		Compliance with Written Authority Required procedures

(c)omit entry for circumstances code “C6456” and substitute:

C6456 P6456 Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months).
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
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 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction..
Patient must be aged 18 years or older.
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 they 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.
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

(d)insert in numerical order after existing text:

C8041 P8041 Ankylosing spondylitis
Continuing treatment – balance of supply
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. 		Compliance with Authority Required procedures
C8074 P8074 Ankylosing spondylitis
Continuing treatment
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
All measurements provided must be no more than 1 month old at the time of application.
A maximum of 24 weeks of treatment with this drug will be authorised under this criterion.
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 following an initial treatment course it must be made following a minimum of 12 weeks of treatment with this drug. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
Patients who fail 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 in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle. 		Compliance with Written Authority Required procedures
C8076 P8076 Ankylosing spondylitis
Initial 1 (new patients)
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must not have received any PBS-subsidised treatment with either adalimumab, certolizumab pegol, etanercept, golimumab, infliximab or secukinumab in this treatment cycle; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; AND
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.
The BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. The BASDAI must be no more than 1 month old at the time of initial application.
Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which must include the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
(iv) a signed patient acknowledgment.
The assessment of the patient's response to the initial course of treatment must be made following a minimum of 12 weeks of treatment and submitted no later than 4 weeks from the cessation of that treatment course. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
A maximum of 18 to 20 weeks of treatment with this drug will be approved under this criterion.
Patients who fail 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 in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) was approved in this cycle and the date of the first application under a new cycle. 		Compliance with Written Authority Required procedures
C8097 P8097 Ankylosing spondylitis
Initial 2 (change or recommencement for all patients)
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND
Patient must be eligible to receive further bDMARD therapy.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
Where the most recent course of PBS-subsidised bDMARD treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised bDMARD therapy or, under this restriction, for patients who have received previous PBS-subsidised bDMARD therapy) the patient must have been assessed for response to that course following a minimum of 12 weeks of treatment. These assessments must be provided to the Department of Human Services no later than 4 weeks from the date the course was ceased. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, patients must have been assessed for response, and the assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
A maximum of 18 to 20 weeks of treatment with this drug will be approved under this criterion.
Patients who fail 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 in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle. 		Compliance with Written Authority Required procedures
C8113 P8113 Ankylosing spondylitis
Initial treatment – Initial 1 (new patients) or Initial 2 (change or recommencement for all patients) – balance of supply
Patient must have active, or a documented history of active, ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Initial 1 (new patients) restriction to complete 18 to 20 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement for all patients) restriction to complete 18 to 20 weeks treatment; AND
The treatment must provide no more than the balance of up to 18 to 20 weeks treatment available under the above restrictions.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. 		Compliance with Authority Required procedures

  1. Schedule 4, entry for Dexamethasone

insert in numerical order after existing text:

C8020 P8020 Central retinal vein occlusion with macular oedema
Continuing treatment
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND
The treatment must be the sole PBS-subsidised therapy for this condition. 		Compliance with Authority Required procedures
C8023 P8023 Branch retinal vein occlusion with macular oedema
Continuing treatment
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND
The treatment must be the sole PBS-subsidised therapy for this condition. 		Compliance with Authority Required procedures
C8032 P8032 Branch retinal vein occlusion with macular oedema
Initial treatment
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; OR
Patient must have failed prior treatment with VEGF inhibitors; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report. 		Compliance with Written Authority Required procedures
C8033 P8033 Central retinal vein occlusion with macular oedema
Initial treatment
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; OR
Patient must have failed prior treatment with VEGF inhibitors; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report. 		Compliance with Written Authority Required procedures

  1. Schedule 4, entry for Etanercept

(a)omit:

C7168 P7168 Active ankylosing spondylitis
Subsequent continuing treatment
Must be treated by a rheumatologist.
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug.
Patient must be aged 18 years or older.
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
A maximum of 24 weeks of treatment with this drug will be authorised under this criterion.
The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
Patients who fail 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 in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was issued in this cycle and the date of the first application under a new cycle. 		Compliance with Authority Required procedures - Streamlined Authority Code 7168
C7169 P7169 Active ankylosing spondylitis
Continuing treatment – balance of supply
Must be treated by a rheumatologist.
Patient must be aged 18 years or older.
Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions. 		Compliance with Authority Required procedures
C7170 P7170 Active ankylosing spondylitis
Subsequent continuing treatment
Must be treated by a rheumatologist.
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug.
Patient must be 18 years or older.
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
A maximum of 24 weeks of treatment with this drug will be authorised under this criterion.
Each application for continuing treatment with this drug must include a measurement of response to the prior course of therapy. If the response assessment is not submitted, the patient will be deemed to have failed this course of treatment.
Patients who fail 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 in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological agent was issued in this cycle and the date of the first application under a new cycle. 		Compliance with Written Authority Required procedures
C7174 P7174 Ankylosing spondylitis
First continuing treatment
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist.
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be used to determine response for all subsequent continuing treatments.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
All measurements provided must be no more than 1 month old at the time of application.
A maximum of 24 weeks of treatment with this drug will be authorised under this criterion.
The application for first continuing treatment following an initial treatment course must be made following a minimum of 12 weeks of treatment with this drug. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.
If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
Patients who fail 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 in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was issued in this cycle and the date of the first application under a new cycle. 		Compliance with Written Authority Required procedures

(e)insert in numerical order after existing text:

C8061 P8061 Ankylosing spondylitis
Initial 3 (grandfather treatment)
Patient must have confirmed ankylosing spondylitis, defined radiographically (plain X-ray) of Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, with the diagnosis confirmed by a rheumatologist; AND
Patient must have been receiving treatment with this drug for this condition prior to 1 October 2016; AND
Patient must be receiving treatment with this drug for this condition at the time of application; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
The baseline BASDAI assessment must be from immediately prior to commencing treatment with this drug. The patient's current BASDAI assessment and ESR and/or CRP measurements must be no more than 1 month old at the time of application. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form; and
(c) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(d) a completed BASDAI Assessment Form; and
(e) a signed patient acknowledgment form;
(f) the date commencement of this drug;
(g) results of the baseline BASDAI assessment prior to commencing treatment with this drug.
Patients may qualify for PBS-subsidised treatment under this restriction once only. Further applications for treatment with this drug will be assessed under the continuing treatment restriction. 		Compliance with Written Authority Required procedures
C8074 P8074 Ankylosing spondylitis
Continuing treatment
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
All measurements provided must be no more than 1 month old at the time of application.
A maximum of 24 weeks of treatment with this drug will be authorised under this criterion.
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 following an initial treatment course it must be made following a minimum of 12 weeks of treatment with this drug. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
Patients who fail 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 in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle. 		Compliance with Written Authority Required procedures
C8085 P8085 Ankylosing spondylitis
Initial treatment – initial 1 (new patients or patients recommencing treatment after a break of 5 years or more)
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must not have received any PBS-subsidised treatment with either adalimumab, certolizumab pegol, etanercept, golimumab, infliximab or secukinumab in this treatment cycle; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; AND
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.
The BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. The BASDAI must be no more than 1 month old at the time of initial application.
Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which must include the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
(iv) a signed patient acknowledgment.
The assessment of the patient's response to the initial course of treatment must be made following a minimum of 12 weeks of treatment and submitted no later than 4 weeks from the cessation of that treatment course. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
Patients who fail 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 in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) was approved in this cycle and the date of the first application under a new cycle. 		Compliance with Written Authority Required procedures
C8100 P8100 Ankylosing spondylitis
Initial 3 or Continuing treatment – balance of supply
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the initial 3 treatment restriction to complete 24 weeks of treatment; AND
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. 		Compliance with Authority Required procedures
C8105 P8105 Ankylosing spondylitis
Initial treatment - Initial 2 (change or recommencing treatment after a break of less than 5 years)
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND
Patient must be eligible to receive further bDMARD therapy.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
Where the most recent course of PBS-subsidised bDMARD treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised bDMARD therapy or, under this restriction, for patients who have received previous PBS-subsidised bDMARD therapy) the patient must have been assessed for response to that course following a minimum of 12 weeks of treatment. These assessments must be provided to the Department of Human Services no later than 4 weeks from the date the course was ceased. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, patients must have been assessed for response, and the assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
Patients who fail 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 in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle. 		Compliance with Written Authority Required procedures
C8120 P8120 Ankylosing spondylitis
Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2 (change or recommencement of treatment after a break of less than 5 years) - balance of supply
Patient must have active, or had a documented history of active ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks of treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after a break of less than 5 years) restriction to complete 16 weeks of treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the initial 1 or 2 restrictions.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. 		Compliance with Authority Required procedures

  1. Schedule 4, entry for Tiotropium

omit entry for circumstances code “C6777” and substitute:

C6777 Severe asthma
Patient must have experienced at least one severe exacerbation, which has required documented use of systemic corticosteroids, in the previous 12 months while receiving optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta-2 agonist (LABA) unless a LABA is contraindicated.
Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.

  1. Schedule 4, entry for Tofacitinib

(a)omit:

C5480 P5480 Severe active rheumatoid arthritis
Initial treatment - Initial 3 (Grandfather patients)
Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have been receiving treatment with this drug for this condition prior to 1 October 2015; AND
Patient must be receiving treatment with this drug for this condition at the time of application; 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.
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; and
(c) a signed patient acknowledgement.
All applications for treatment with this drug for this condition under this restriction must include baseline joint count and ESR and/or CRP as determined at the completion of a 6 month intensive DMARD trial but prior to ceasing DMARD therapy.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
A patient may qualify for PBS-subsidised treatment under this restriction once only. 		Compliance with Written Authority Required procedures

(b)omit entry for circumstances code “C5496” and substitute:

C5496 P5496 Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
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.
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 they 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.
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

  1. Schedule 5, after entry for Imiquimod in the form Cream 50 mg per g, 250 mg single use sachets, 12 [GRP- 17129]

insert:

Infliximab GRP-20382 Powder for I.V. infusion 100 mg Injection Inflectra
Remicade
Renflexis
GRP-22461 Powder for I.V. infusion 100 mg Injection Inflectra
Renflexis

  1. Schedule 5, entry for Olanzapine in the form Tablet 10 mg [GRP-15513]

omit from the column headed “Brand”:    Olanzacor 10

  1. Schedule 5, entry for Olanzapine in the form Tablet 7.5 mg [GRP-15884]

omit from the column headed “Brand”:    Olanzacor 7.5

  1. Schedule 5, entry for Olanzapine in the form Tablet 5 mg [GRP-15921]

omit from the column headed “Brand”:    Olanzacor 5

  1. Schedule 5, entry for Zoledronic acid in the form Solution for I.V. infusion 4 mg (as monohydrate) in 100 mL [GRP-17614]

insert in alphabetical order in the column headed “Brand”:    Zoledronic Acid 4 mg/100 mL APOTEX

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