National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 3) (PB 17 of 2019) (Cth)

Case

PB 17 of 2019

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 3)

National Health Act 1953

___________________________________________________________________________

I, THEA DANIEL, 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    27 March 2019

THEA DANIEL

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 2019 (No. 3).

(2)This Instrument may also be cited as PB 17 of 2019.

  1. Commencement

This Instrument commences on 1 April 2019.

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

(a)omit from the column headed "Circumstances": C6849 C6859 C6866 C6867 C6874      substitute: C8627 C8638 C8651 C8652 C8655 C8746

(b)omit from the column headed "Purposes": P6849 P6867 P6874           substitute: P8638 P8651 P8652 P8746

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

(a)omit from the column headed "Circumstances": C6849 C6859 C6866 C6867 C6874      substitute: C8627 C8638 C8651 C8652 C8655 C8746

(b)omit from the column headed "Purposes": P6859 P6866         substitute: P8627 P8655

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

(a)omit from the column headed "Circumstances": C6849 C6859 C6866 C6867 C6874      substitute: C8627 C8638 C8651 C8652 C8655 C8746

(b)omit from the column headed "Purposes": P6849 P6867 P6874           substitute: P8638 P8651 P8652 P8746

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

(a)omit from the column headed "Circumstances": C6849 C6859 C6866 C6867 C6874      substitute: C8627 C8638 C8651 C8652 C8655 C8746

(b)omit from the column headed "Purposes": P6859 P6866         substitute: P8627 P8655 

  1. Schedule 1, after entry for Aciclovir in the form Eye ointment 30 mg per g, 4.5 g

insert:

Eye ointment 30 mg per g, 4.5 g (Acivision) Application to the eye AciVision DZ MP NP C5965 1 0 1
AO C5964 1 0 1

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

(a)omit from the column headed "Circumstances": C4700 C4724              

(b)omit from the column headed "Circumstances": C6902 C6922 C6923 

(c)insert in numerical order in the column headed “Circumstances”: C8627 C8631 C8638 C8678 C8702 C8725

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

(a)omit from the column headed "Circumstances": C4700 C4724              

(b)omit from the column headed "Circumstances": C6902 C6922 C6923 

(c)insert in numerical order in the column headed “Circumstances”: C8627 C8631 C8638 C8678 C8702 C8725

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

(a)omit from the column headed "Circumstances": C4700 C4724              

(b)omit from the column headed "Circumstances": C6902 C6922 C6923 

(c)insert in numerical order in the column headed “Circumstances”:C8627 C8631 C8638 C8678 C8702 C8725

(d)omit from the column headed "Purposes": P4700      

(e)omit from the column headed "Purposes": P6902 P6923        

(f)insert in numerical order in the column headed “Purposes”: P8631 P8638 P8678 P8702

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

(a)omit from the column headed "Circumstances": C4700 C4724               

(b)omit from the column headed "Circumstances": C6902 C6922 C6923 

(c)insert in numerical order in the column headed “Circumstances”: C8627 C8631 C8638 C8678 C8702 C8725

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

(a)omit from the column headed "Circumstances": C4700 C4724               

(b)omit from the column headed "Circumstances": C6902 C6922 C6923 

(c)insert in numerical order in the column headed “Circumstances”: C8627 C8631 C8638 C8678 C8702 C8725

(d)omit from the column headed "Purposes": P4724       

(e)omit from the column headed "Purposes": P6922       

(f)insert in numerical order in the column headed “Purposes”: P8627 P8725

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

(a)omit from the column headed "Circumstances": C4700 C4724               

(b)omit from the column headed "Circumstances": C6902 C6922 C6923 

(c)insert in numerical order in the column headed “Circumstances”: C8627 C8631 C8638 C8678 C8702 C8725

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

(a)omit from the column headed "Circumstances": C4700 C4724               

(b)omit from the column headed "Circumstances": C6902 C6922 C6923 

(c)insert in numerical order in the column headed “Circumstances”: C8627 C8631 C8638 C8678 C8702 C8725

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

(a)omit from the column headed "Circumstances": C4700 C4724               

(b)omit from the column headed "Circumstances": C6902 C6922 C6923 

(c)insert in numerical order in the column headed “Circumstances”: C8627 C8631 C8638 C8678 C8702 C8725

(d)omit from the column headed "Purposes": P4700       

(e)omit from the column headed "Purposes": P6902 P6923         

(f)insert in numerical order in the column headed “Purposes”: P8631 P8638 P8678 P8702

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

(a)omit from the column headed "Circumstances": C4700 C4724               

(b)omit from the column headed "Circumstances": C6902 C6922 C6923 

(c)insert in numerical order in the column headed “Circumstances”: C8627 C8631 C8638 C8678 C8702 C8725 

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

(a)omit from the column headed "Circumstances": C4700 C4724               

(b)omit from the column headed "Circumstances": C6902 C6922 C6923 

(c)insert in numerical order in the column headed “Circumstances”: C8627 C8631 C8638 C8678 C8702 C8725

(d)omit from the column headed "Purposes": P4724       

(e)omit from the column headed "Purposes": P6922       

(f)insert in numerical order in the column headed “Purposes”: P8627 P8725

  1. Schedule 1, entry for Adrenaline (epinephrine) in each of the forms: I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector; and I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector           

(a)omit from the column headed "Circumstances" (all instances): C4946  

(b)insert in numerical order in the column headed “Circumstances” (all instances): C8734 

  1. Schedule 1, after entry for Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine in the form Oral powder 400 g (PKU Anamix infant)

insert:

Oral powder 400 g (PKU Start) Oral PKU Start VF MP NP C4295 8 5 1

  1. Schedule 1, entry for Armodafinil in each of the forms: Tablet 50 mg; Tablet 150 mg; and Tablet 250 mg             

(a)omit from the column headed "Circumstances": C6503             

(b)insert in numerical order in the column headed “Circumstances”: C8694 

  1. Schedule 1, entry for Atazanavir in the form Capsule 200 mg (as sulfate)

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

a Atazanavir Mylan AF MP C4454 C4512 120 5 60 D(100)

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

  1. Schedule 1, entry for Atazanavir in the form Capsule 300 mg (as sulfate)

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

a Atazanavir Mylan AF MP C4454 C4512 60 5 60 D(100)

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

  1. Schedule 1, entry for Baricitinib in the form Tablet 2 mg [Maximum Quantity: 28; Number of Repeats: 3]

(a)omit from the column headed "Circumstances": C7881 C7882 C7899 C7905 C7907 C7925        substitute: C8631 C8638 C8680 C8725 C8726 C8727 C8750

(b)omit from the column headed "Purposes": P7905 P7907 P7925           substitute: P8631 P8638 P8726 P8750

  1. Schedule 1, entry for Baricitinib in the form Tablet 2 mg [Maximum Quantity: 28; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C7881 C7882 C7899 C7905 C7907 C7925        substitute: C8631 C8638 C8680 C8725 C8726 C8727 C8750

(b)omit from the column headed "Purposes": P7881 P7882 P7899           substitute: P8680 P8725 P8727

  1. Schedule 1, entry for Baricitinib in the form Tablet 4 mg [Maximum Quantity: 28; Number of Repeats: 3]

(a)omit from the column headed "Circumstances": C7881 C7882 C7899 C7905 C7907 C7925        substitute: C8631 C8638 C8680 C8725 C8726 C8727 C8750

(b)omit from the column headed "Purposes": P7905 P7907 P7925           substitute: P8631 P8638 P8726 P8750

  1. Schedule 1, entry for Baricitinib in the form Tablet 4 mg [Maximum Quantity: 28; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C7881 C7882 C7899 C7905 C7907 C7925        substitute: C8631 C8638 C8680 C8725 C8726 C8727 C8750

(b)omit from the column headed "Purposes": P7881 P7882 P7899           substitute: P8680 P8725 P8727

  1. Schedule 1, entry for Brentuximab vedotin

insert in numerical order in the column headed “Circumstances”: C8722 C8736 

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

 omit:

a Xeloda RO MP 120 2 120

  1. Schedule 1, entry for Certolizumab pegol in the form Injection 200 mg in 1 mL single use pre-filled syringe [Maximum Quantity: 2;
    Number of Repeats: 2]

(a)omit from the column headed "Circumstances": C4737 C4764               

(b)omit from the column headed "Circumstances": C6374             

(c)omit from the column headed "Circumstances": C6455 C6456               

(d)insert in numerical order in the column headed “Circumstances”: C8626 C8627 C8679 C8705 C8706 C8753

(e)omit from the column headed "Purposes": P4737       

(f)insert in numerical order in the column headed “Purposes”: P8706

  1. Schedule 1, entry for Certolizumab pegol in the form Injection 200 mg in 1 mL single use pre-filled syringe [Maximum Quantity: 2;
    Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C4737 C4764               

(b)omit from the column headed "Circumstances": C6374             

(c)omit from the column headed "Circumstances": C6455 C6456               

(d)insert in numerical order in the column headed “Circumstances”: C8626 C8627 C8679 C8705 C8706 C8753

(e)omit from the column headed "Purposes": P4764       

(f)omit from the column headed "Purposes": P6374       

(g)insert in numerical order in the column headed “Purposes”: P8627 P8679

  1. Schedule 1, entry for Certolizumab pegol in the form Injection 200 mg in 1 mL single use pre-filled syringe [Maximum Quantity: 6;
    Number of Repeats: 0]

(a)omit from the column headed "Circumstances": C4737 C4764               

(b)omit from the column headed "Circumstances": C6374             

(c)omit from the column headed "Circumstances": C6455 C6456               

(d)insert in numerical order in the column headed “Circumstances”: C8626 C8627 C8679 C8705 C8706 C8753

(e)omit from the column headed "Purposes": P6455 P6456         

(f)insert in numerical order in the column headed “Purposes”: P8626 P8705 P8753

  1. Schedule 1, entry for Certolizumab pegol in the form Solution for injection 200 mg in 1 mL pre-filled pen [Maximum Quantity: 2;
    Number of Repeats: 2]

(a)omit from the column headed "Circumstances": C4737 C4764               

(b)omit from the column headed "Circumstances": C6374             

(c)omit from the column headed "Circumstances": C6455 C6456               

(d)insert in numerical order in the column headed “Circumstances”: C8626 C8627 C8679 C8705 C8706 C8753

(e)omit from the column headed "Purposes": P4737       

(f)insert in numerical order in the column headed “Purposes”: P8706

  1. Schedule 1, entry for Certolizumab pegol in the form Solution for injection 200 mg in 1 mL pre-filled pen [Maximum Quantity: 2;
    Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C4737 C4764               

(b)omit from the column headed "Circumstances": C6374             

(c)omit from the column headed "Circumstances": C6455 C6456               

(d)insert in numerical order in the column headed “Circumstances”: C8626 C8627 C8679 C8705 C8706 C8753

(e)omit from the column headed "Purposes": P4764       

(f)omit from the column headed "Purposes": P6374       

(g)insert in numerical order in the column headed “Purposes”: P8627 P8679

  1. Schedule 1, entry for Certolizumab pegol in the form Solution for injection 200 mg in 1 mL pre-filled pen [Maximum Quantity: 6;
    Number of Repeats: 0]

(a)omit from the column headed "Circumstances": C4737 C4764               

(b)omit from the column headed "Circumstances": C6374             

(c)omit from the column headed "Circumstances": C6455 C6456               

(d)insert in numerical order in the column headed “Circumstances”: C8626 C8627 C8679 C8705 C8706 C8753

(e)omit from the column headed "Purposes": P6455 P6456         

(f)insert in numerical order in the column headed “Purposes”: P8626 P8705 P8753

  1. Schedule 1, entry for Dexamethasone in the form Intravitreal injection 700 micrograms

omit from the column headed "Manner of Administration": Injection substitute: Implantation 

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

(a)omit:

a Ranzepam RA MP NP PDP 50 0 50

(b)omit:

a Ranzepam RA MP NP P6176 50
CN6176 		3
CN6176 		50

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

 omit:

Epirubicin SZ HX MP See Note 3 See Note 3 1 D(100)

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

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

a APO-Eplerenone TX MP NP C4937 30 5 30

  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 C7181 C7219 C7220 C7224 C7251 C7287 C7288 C7289 C7300 C7307 C7308 C7320 C7336 C8039 C8040 C8054 C8079 C8093 C8095 C8103 C8631 C8638 C8661 C8662 C8692 C8718 C8760 P4458 P4483 P4503 P6808 P6811 P6814 P6818 P6819 P6822 P6823 P6830 P6836 P6843 P7177 P7220 P7224 P7288 P7308 P7336 P8039 P8040 P8093 P8631 P8638 P8661 P8760 2 3 1
MP C4457 C4458 C4482 C4483 C4503 C6808 C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6836 C6843 C7177 C7181 C7219 C7220 C7224 C7251 C7287 C7288 C7289 C7300 C7307 C7308 C7320 C7336 C8039 C8040 C8054 C8079 C8093 C8095 C8103 C8631 C8638 C8661 C8662 C8692 C8718 C8760 P4457 P4482 P7181 P7219 P7251 P7287 P7289 P7300 P7307 P7320 P8054 P8079 P8095 P8103 P8662 P8692 P8718 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 C7181 C7217 C7219 C7220 C7224 C7276 C7288 C7289 C7296 C7300 C7308 C7317 C7320 C7336 C8039 C8040 C8079 C8092 C8093 C8095 C8631 C8638 C8661 C8662 C8718 C8760 P6808 P6836 P7177 P7220 P7224 P7288 P7308 P7336 P8039 P8040 P8093 P8631 P8638 P8661 P8760 1 3 1
Enbrel PF MP C4457 C4458 C4482 C4483 C4503 C6808 C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6836 C6843 C7177 C7181 C7219 C7220 C7224 C7251 C7287 C7288 C7289 C7300 C7307 C7308 C7320 C7336 C8039 C8040 C8054 C8079 C8093 C8095 C8103 C8631 C8638 C8661 C8662 C8692 C8718 C8760 P4458 P4483 P4503 P6808 P6811 P6814 P6818 P6819 P6822 P6823 P6830 P6836 P6843 P7177 P7220 P7224 P7288 P7308 P7336 P8039 P8040 P8093 P8631 P8638 P8661 P8760 1 3 1
Brenzys MK MP C6808 C6836 C7177 C7181 C7217 C7219 C7220 C7224 C7276 C7288 C7289 C7296 C7300 C7308 C7317 C7320 C7336 C8039 C8040 C8079 C8092 C8093 C8095 C8631 C8638 C8661 C8662 C8718 C8760 P7181 P7217 P7219 P7276 P7289 P7296 P7300 P7317 P7320 P8079 P8092 P8095 P8662 P8718 1 5 1
Enbrel PF MP C4457 C4458 C4482 C4483 C4503 C6808 C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6836 C6843 C7177 C7181 C7219 C7220 C7224 C7251 C7287 C7288 C7289 C7300 C7307 C7308 C7320 C7336 C8039 C8040 C8054 C8079 C8093 C8095 C8103 C8631 C8638 C8661 C8662 C8692 C8718 C8760 P4457 P4482 P7181 P7219 P7251 P7287 P7289 P7300 P7307 P7320 P8054 P8079 P8095 P8103 P8662 P8692 P8718 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 C7181 C7217 C7219 C7220 C7224 C7276 C7288 C7289 C7296 C7300 C7308 C7317 C7320 C7336 C8039 C8040 C8079 C8092 C8093 C8095 C8631 C8638 C8661 C8662 C8718 C8760 P6808 P6836 P7177 P7220 P7224 P7288 P7308 P7336 P8039 P8040 P8093 P8631 P8638 P8661 P8760 1 3 1
Enbrel PF MP C4457 C4458 C4482 C4483 C4503 C6808 C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6836 C6843 C7177 C7181 C7219 C7220 C7224 C7251 C7287 C7288 C7289 C7300 C7307 C7308 C7320 C7336 C8039 C8040 C8054 C8079 C8093 C8095 C8103 C8631 C8638 C8661 C8662 C8692 C8718 C8760 P4458 P4483 P4503 P6808 P6811 P6814 P6818 P6819 P6822 P6823 P6830 P6836 P6843 P7177 P7220 P7224 P7288 P7308 P7336 P8039 P8040 P8093 P8631 P8638 P8661 P8760 1 3 1
Brenzys MK MP C6808 C6836 C7177 C7181 C7217 C7219 C7220 C7224 C7276 C7288 C7289 C7296 C7300 C7308 C7317 C7320 C7336 C8039 C8040 C8079 C8092 C8093 C8095 C8631 C8638 C8661 C8662 C8718 C8760 P7181 P7217 P7219 P7276 P7289 P7296 P7300 P7317 P7320 P8079 P8092 P8095 P8662 P8718 1 5 1
Enbrel PF MP C4457 C4458 C4482 C4483 C4503 C6808 C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6836 C6843 C7177 C7181 C7219 C7220 C7224 C7251 C7287 C7288 C7289 C7300 C7307 C7308 C7320 C7336 C8039 C8040 C8054 C8079 C8093 C8095 C8103 C8631 C8638 C8661 C8662 C8692 C8718 C8760 P4457 P4482 P7181 P7219 P7251 P7287 P7289 P7300 P7307 P7320 P8054 P8079 P8095 P8103 P8662 P8692 P8718 1 5 1

  1. Schedule 1, entry for Filgrastim

substitute:

Filgrastim Injection 120 micrograms in 0.2 mL single use pre-filled syringe (Nivestim) Injection Nivestim PF MP C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 20 11 10 D(100)
Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Neupogen) Injection Neupogen AN MP C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 20 11 10 D(100)
Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Nivestim) Injection Nivestim PF MP C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 20 11 10 D(100)
Injection 300 micrograms in 0.5 mL single use pre-filled syringe (TevaGrastim) Injection TevaGrastim TB MP C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 20 11 10 D(100)
Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Zarzio) Injection Zarzio SZ MP C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 20 11 5 D(100)
Injection 300 micrograms in 1 mL Injection Neupogen AN MP C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 20 11 10 D(100)
Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Neupogen) Injection Neupogen AN MP C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 20 11 10 D(100)
Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Nivestim) Injection Nivestim PF MP C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 20 11 10 D(100)
Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Zarzio) Injection Zarzio SZ MP C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 20 11 5 D(100)
Injection 480 micrograms in 0.8 mL single use pre-filled syringe (TevaGrastim) Injection TevaGrastim TB MP C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 20 11 10 D(100)
Injection 480 micrograms in 1.6 mL Injection Neupogen AN MP C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 20 11 10 D(100)

  1. Schedule 1, entry for Follitropin alfa with lutropin alfa

insert as first entry:

Injection 900 I.U. - 450 I.U. in 1.44 mL multi-dose cartridge Injection Pergoveris SG MP C5250 2 0 1 D(100)

  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": C4676 C4766               

(b)omit from the column headed "Circumstances": C6024 C6033 C6047 

(c)insert in numerical order in the column headed “Circumstances”: C8641 C8642 C8710 C8713 C8729 C8741       

(d)omit from the column headed "Purposes": P4766       

(e)omit from the column headed "Purposes": P6024 P6033         

(f)insert in numerical order in the column headed “Purposes”: P8710 P8713 P8729 P8741            

  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": C4676 C4766               

(b)omit from the column headed "Circumstances": C6024 C6033 C6047 

(c)insert in numerical order in the column headed “Circumstances”: C8641 C8642 C8710 C8713 C8729 C8741       

(d)omit from the column headed "Purposes": P4676       

(e)omit from the column headed "Purposes": P6047       

(f)insert in numerical order in the column headed “Purposes”: P8641 P8642        

  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": C4676 C4766              

(b)omit from the column headed "Circumstances": C6024 C6033 C6047 

(c)insert in numerical order in the column headed “Circumstances”: C8641 C8642 C8710 C8713 C8729 C8741

(d)omit from the column headed "Purposes": P4766

(e)omit from the column headed "Purposes": P6024 P6033         

(f)insert in numerical order in the column headed “Purposes”: P8710 P8713 P8729 P8741

  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": C4676 C4766

(b)omit from the column headed "Circumstances": C6024 C6033 C6047 

(c)insert in numerical order in the column headed “Circumstances”: C8641 C8642 C8710 C8713 C8729 C8741

(d)omit from the column headed "Purposes": P4676      

(e)omit from the column headed "Purposes": P6047       

(f)insert in numerical order in the column headed “Purposes”: P8641 P8642

  1. Schedule 1, entry for Guselkumab

(a)omit from the column headed "Circumstances": C8507 C8516              

(b)insert in numerical order in the column headed “Circumstances”: C8765 C8766 

  1. Schedule 1, entry for Imatinib

substitute:

Imatinib Capsule 100 mg (as mesilate) Oral CIPLA IMATINIB ADULT LR MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6557 P6896 P6942 P7884 P8697 P8698 60 2 60
Glivanib JU MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6557 P6896 P6942 P7884 P8697 P8698 60 2 60
IMATINIB AN JO MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6557 P6896 P6942 P7884 P8697 P8698 60 2 60
Imatinib GH GQ MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6557 P6896 P6942 P7884 P8697 P8698 60 2 60
Imatinib-APOTEX TX MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6557 P6896 P6942 P7884 P8697 P8698 60 2 60
IMATINIB-DRLA RZ MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6557 P6896 P6942 P7884 P8697 P8698 60 2 60
CIPLA IMATINIB ADULT LR MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6948 P6949 P6973 60 5 60
Glivanib JU MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6948 P6949 P6973 60 5 60
IMATINIB AN JO MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6948 P6949 P6973 60 5 60
Imatinib GH GQ MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6948 P6949 P6973 60 5 60
Imatinib-APOTEX TX MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6948 P6949 P6973 60 5 60
IMATINIB-DRLA RZ MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6948 P6949 P6973 60 5 60
Capsule 400 mg (as mesilate) Oral CIPLA IMATINIB ADULT LR MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6557 P6896 P6942 P7884 P8697 P8698 30 2 30
Glivanib JU MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6557 P6896 P6942 P7884 P8697 P8698 30 2 30
IMATINIB AN JO MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6557 P6896 P6942 P7884 P8697 P8698 30 2 30
Imatinib GH GQ MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6557 P6896 P6942 P7884 P8697 P8698 30 2 30
Imatinib-APOTEX TX MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6557 P6896 P6942 P7884 P8697 P8698 30 2 30
IMATINIB-DRLA RZ MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6557 P6896 P6942 P7884 P8697 P8698 30 2 30
CIPLA IMATINIB ADULT LR MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6948 P6949 P6973 30 5 30
Glivanib JU MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6948 P6949 P6973 30 5 30
IMATINIB AN JO MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6948 P6949 P6973 30 5 30
Imatinib GH GQ MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6948 P6949 P6973 30 5 30
Imatinib-APOTEX TX MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6948 P6949 P6973 30 5 30
IMATINIB-DRLA RZ MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6948 P6949 P6973 30 5 30
Tablet 100 mg (as mesilate) Oral Glivec AF MP C4342 C4355 C6496 C6498 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6559 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6496 P6498 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6557 P6559 P6896 P6942 P7884 P8697 P8698 60 2 60
IMATINIB RBX RA MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6557 P6896 P6942 P7884 P8697 P8698 60 2 60
Imatinib-Teva SZ MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6550 P6557 P6896 P6942 P7884 P8697 60 2 60
Glivec AF MP C4342 C4355 C6496 C6498 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6559 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P4342 P4355 P6948 P6949 P6973 60 5 60
IMATINIB RBX RA MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6948 P6949 P6973 60 5 60
Imatinib-Teva SZ MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 P6948 P6949 P6973 60 5 60
Tablet 400 mg (as mesilate) Oral Glivec AF MP C4342 C4355 C6496 C6498 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6559 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6496 P6498 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6557 P6559 P6896 P6942 P7884 P8697 P8698 30 2 30
IMATINIB RBX RA MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6540 P6550 P6557 P6896 P6942 P7884 P8697 P8698 30 2 30
Imatinib-Teva SZ MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 P6496 P6499 P6510 P6526 P6527 P6538 P6539 P6550 P6557 P6896 P6942 P7884 P8697 30 2 30
Glivec AF MP C4342 C4355 C6496 C6498 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6559 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P4342 P4355 P6948 P6949 P6973 30 5 30
IMATINIB RBX RA MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 C8698 P6948 P6949 P6973 30 5 30
Imatinib-Teva SZ MP C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6896 C6942 C6948 C6949 C6973 C7884 C8697 P6948 P6949 P6973 30 5 30

  1. Schedule 1, after entry for Levodopa with carbidopa in the form Tablet 100 mg-25 mg (as monohydrate) 

insert:

Tablet (modified release) 200 mg-50 mg Oral Carbidopa and Levodopa Extended-release Tablets DZ MP NP C5253 100 5 100

  1. Schedule 1, after entry for Levodopa with carbidopa in the form Tablet 250 mg-25 mg (as monohydrate)

insert:

Tablet 250 mg-25 mg (USP) Oral Carbidopa and Levodopa Tablets, USP DZ MP NP 100 5 100

  1. Schedule 1, entry for Modafinil

omit from the column headed "Circumstances" (all instances): C6537 C6556   substitute (all instances): C6547 C8694 

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

insert in numerical order in the column headed “Circumstances”: C7024 

  1. Schedule 1, entry for Oxybutynin in the form Transdermal patches 36 mg, 8

omit from the column headed "Responsible Person": GN       substitute: TT 

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

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

a Pantoprazole APOTEX TY MP NP C5444 C5512 C5529 30 5 30

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
    Number of Repeats: 2]

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

a Pantoprazole APOTEX TY MP NP C5444 C5445 C5512 C5529 P5445 30 2 30

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
    Number of Repeats: 5]

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

a Pantoprazole APOTEX TY MP NP C5444 C5445 C5512 C5529 P5444 P5512 P5529 30 5 30

  1. Schedule 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)

omit:

Ulcaid RA MP NP MW 60 5 60

  1. Schedule 1, entry for Riluzole

insert as first entry:

Oral suspension 50 mg per 10 mL, 300 mL Oral Teglutik CS MP NP C5341 C8738 2 5 1

  1. Schedule 1, entry for Riluzole in the form Tablet 50 mg

(a)omit from the column headed “Circumstances” (all instances): C5365 

(b)insert in numerical order in the column headed “Circumstances” (all instances): C8738 

  1. Schedule 1, entry for Risedronic acid in each of the forms: Tablet containing risedronate sodium 5 mg; Tablet containing risedronate sodium
    30 mg; and Tablet (enteric coated) containing risedronate sodium 35 mg

omit from the column headed "Responsible Person": UA       substitute: TT

  1. Schedule 1, entry for Risedronic acid in the form Tablet containing risedronate sodium 150 mg

(a)omit from the column headed "Responsible Person" for the brand “Actonel Once-a-Month”: UA   substitute: TT

(b)omit from the column headed "Responsible Person" for the brand ATELVIA ONCE-A-MONTH”: GN            substitute: TU  

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

substitute:

a APO-Risperidone TX MP NP C5903 C6010 C6898 C6899 P6010 P6898 P6899 60 2 20
MP NP C5903 C6010 C6898 C6899 P6010 P6898 P6899 60 2 60

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

substitute:

a APO-Risperidone TX MP NP C5903 C6010 C6898 C6899 P5903 60 5 20
MP NP C5903 C6010 C6898 C6899 P5903 60 5 60

  1. Schedule 1, entry for Rituximab

substitute:

Rituximab Solution for I.V. infusion 100 mg in 10 mL Injection Mabthera RO MP See Note 3 See Note 3 See Note 3 See Note 3 2 PB(100)
MP C6011 C6161 C7399 C7400 See Note 3 See Note 3 2 PB(100)
MP C6011 C6161 C7399 C7400 See Note 3 See Note 3 2 PB(100)
MP C6011 C6161 C7399 C7400 See Note 3 See Note 3 2 PB(100)
Solution for I.V. infusion 500 mg in 50 mL Injection Mabthera RO MP See Note 3 See Note 3 See Note 3 See Note 3 1 PB(100)
MP C6011 C6161 C7399 C7400 See Note 3 See Note 3 1 PB(100)
MP C6011 C6161 C7399 C7400 See Note 3 See Note 3 1 PB(100)
MP C6011 C6161 C7399 C7400 See Note 3 See Note 3 1 PB(100)
Solution for subcutaneous injection containing rituximab 1400 mg in 11.7 mL Injection Mabthera SC RO MP C6011 C6161 C7399 C7400 P7399 1 5 1
MP C6011 C6161 C7399 C7400 P7400 1 6 1
MP C6011 C6161 C7399 C7400 P6011 1 7 1
MP C6011 C6161 C7399 C7400 P6161 1 11 1

  1. Schedule 1, after entry for Sacubitril with valsartan in the form Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg

insert:

Safinamide Tablet 50 mg Oral Xadago CS MP NP C8624 30 5 30
Tablet 100 mg Oral Xadago CS MP NP C8624 30 5 30

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

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

Salbutamol Cipla LR MP NP C6815 C6825 2 5 1

  1. Schedule 1, entry for Salbutamol in the form Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30

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

Salbutamol Cipla LR MP NP C6815 C6825 2 5 1

  1. Schedule 1, after entry for Sofosbuvir with velpatasvir

insert:

Sofosbuvir with velpatasvir and voxilaprevir Tablet containing 400 mg sofosbuvir with 100 mg velpatasvir and 100 mg voxilaprevir Oral Vosevi GI MP NP C5969 28 2 28

  1. Schedule 1, entry for Somatropin in the form Solution for injection 10 mg (30 i.u.) in 2 mL cartridge (with preservative)

insert in numerical order in the column headed “Circumstances”: C8121 C8242 

  1. Schedule 1, entry for Tildrakizumab in the form Injection 100 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 1]

(a)omit from the column headed "Circumstances": C8318

(b)omit from the column headed "Circumstances": C8441

(c)insert in numerical order in the column headed “Circumstances”: C8765 C8766

(d)omit from the column headed "Purposes": P8318 P8441

(e)insert in numerical order in the column headed “Purposes”: P8765 P8766

  1. Schedule 1, entry for Tildrakizumab in the form Injection 100 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 2]

(a)omit from the column headed "Circumstances": C8318

(b)omit from the column headed "Circumstances": C8441

(c)insert in numerical order in the column headed “Circumstances”: C8765 C8766 

  1. Schedule 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 3]

(a)omit from the column headed "Circumstances": C6573 C6593 C6606 C8256 C8257      substitute: C8627 C8631 C8633 C8638 C8739 C8740

(b)omit from the column headed "Purposes": P6573 P6593 P8256           substitute: P8631 P8638 P8739 P8740

  1. Schedule 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C6573 C6593 C6606 C8256 C8257      substitute: C8627 C8631 C8633 C8638 C8739 C8740

(b)omit from the column headed "Purposes": P6606 P8257         substitute: P8627 P8633

  1. Schedule 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 3]

(a)omit from the column headed "Circumstances": C6573 C6593 C6606 C8256 C8257      substitute: C8627 C8631 C8633 C8638 C8739 C8740

(b)omit from the column headed "Purposes": P6573 P6593 P8256           substitute: P8631 P8638 P8739 P8740

  1. Schedule 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 5]

(a)omit from the column headed "Circumstances": C6573 C6593 C6606 C8256 C8257      substitute: C8627 C8631 C8633 C8638 C8739 C8740

(b)omit from the column headed "Purposes": P6606 P8257         substitute: P8627 P8633

  1. Schedule 1, entry for Tofacitinib in the form Tablet 5 mg [Maximum Quantity: 56; Number of Repeats: 3]

(a)omit from the column headed "Circumstances": C5496 C5504 C5510  substitute: C8627 C8631 C8638 C8725 C8726 C8750

(b)omit from the column headed "Purposes": P5496 P5510         substitute: P8631 P8638 P8726 P8750

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

(a)omit from the column headed "Circumstances": C5496 C5504 C5510  substitute: C8627 C8631 C8638 C8725 C8726 C8750

(b)omit from the column headed "Purposes": P5504       substitute: P8627 P8725

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

 omit:

a Topiramate GH GQ MP NP C5516 60 5 60

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

(a)omit:

a APO-Valsartan TX MP NP 28 0 28

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

  1. Schedule 1, entry for Valsartan in each of the forms: Tablet 80 mg; Tablet 160 mg; and Tablet 320 mg

(a)omit:

a APO-Valsartan TX MP NP 28 5 28

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

  1. Schedule 1, entry for Venetoclax in each of the forms: Tablet 10 mg; and Tablet 50 mg

omit from the column headed "Circumstances": C8565          substitute: C8699 

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

insert:

TT Theramex Australia Pty Ltd  37 623 186 845
TU Theramex Australia Pty Ltd  37 623 186 845

  1. Schedule 4, Part 1, entry for Abatacept

substitute:

Abatacept C8627 P8627

Severe active rheumatoid arthritis

Continuing Treatment - balance of supply.
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 received insufficient therapy with this drug for this condition 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.

 Compliance with Authority Required procedures
C8638 P8638

Severe active rheumatoid arthritis

Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply
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 received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) 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 above restrictions.

 Compliance with Authority Required procedures
C8651 P8651

Severe active rheumatoid arthritis

Initial treatment - Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion.
Up to a maximum of 4 repeats will be authorised.
The authority application must be made in writing and must include:
(1)a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats.
Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.

 Compliance with Written Authority Required procedures
C8652 P8652

Severe active rheumatoid arthritis

Initial treatment - Initial 3 (re-commencement of treatment after a break in biological medicine of more 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 previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
Major joints are defined as (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).
All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1)a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats.
Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.

 Compliance with Written Authority Required procedures
C8655 P8655

Severe active rheumatoid arthritis

Continuing treatment
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 received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; 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; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1)a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.

 Compliance with Written Authority Required procedures
C8746 P8746

Severe active rheumatoid arthritis

Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine 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 received prior PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
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).
An 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, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's responce is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(1)a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats.
Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.
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.
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 biological medicine.

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Adalimumab

(a)omit:

C4700 P4700

Severe active rheumatoid arthritis

Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply.
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 received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.

 Compliance with Authority Required procedures
C4724 P4724

Severe active rheumatoid arthritis

Continuing Treatment – balance of supply.
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 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.

 Compliance with Authority Required procedures

(b)omit:

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
C6922 P6922

Severe active rheumatoid arthritis

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

 Compliance with Written Authority Required procedures
C6923 P6923

Severe active rheumatoid arthritis

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

 Compliance with Written Authority Required procedures

(c)insert in numerical order after existing text:

C8627 P8627

Severe active rheumatoid arthritis

Continuing Treatment - balance of supply.
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 received insufficient therapy with this drug for this condition 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.

 Compliance with Authority Required procedures
C8631 P8631

Severe active rheumatoid arthritis

Initial treatment - Initial 3 (re-commencement of treatment after a break in biological medicine of more 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 previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Major joints are defined as (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).
All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1)a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.

 Compliance with Written Authority Required procedures
C8638 P8638

Severe active rheumatoid arthritis

Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply
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 received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) 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 above restrictions.

 Compliance with Authority Required procedures
C8678 P8678

Severe active rheumatoid arthritis

Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine 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 received prior PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
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).
An 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, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's responce is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(1)a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
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.
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 biological medicine.

 Compliance with Written Authority Required procedures
C8702 P8702

Severe active rheumatoid arthritis

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

 Compliance with Written Authority Required procedures
C8725 P8725

Severe active rheumatoid arthritis

Continuing treatment
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 received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1)a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.

 Compliance with Written Authority Required procedures

  1. Schedule 4, entry for Tofacitinib

substitute:

Tofacitinib C8627 P8627

Severe active rheumatoid arthritis

Continuing Treatment - balance of supply.
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 received insufficient therapy with this drug for this condition 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.

 Compliance with Authority Required procedures
C8631 P8631

Severe active rheumatoid arthritis

Initial treatment - Initial 3 (re-commencement of treatment after a break in biological medicine of more 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 previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Major joints are defined as (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).
All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1)a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.

 Compliance with Written Authority Required procedures
C8638 P8638

Severe active rheumatoid arthritis

Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply
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 received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) 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 above restrictions.

 Compliance with Authority Required procedures
C8725 P8725

Severe active rheumatoid arthritis

Continuing treatment
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 received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1)a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.

 Compliance with Written Authority Required procedures
C8726 P8726

Severe active rheumatoid arthritis

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

 Compliance with Written Authority Required procedures
C8750 P8750

Severe active rheumatoid arthritis

Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine 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 received prior PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
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).
An 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, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's responce is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(1)a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
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.
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 biological medicine.

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Venetoclax

(a)omit:

C8565

Chronic lymphocytic leukaemia (CLL)

Initial treatment - Extension of dose titration
Patient must have experienced a treatment interruption during the PBS-subsidised dose titration with this drug for this condition; OR
Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; OR
The treatment must be used as monotherapy for this condition under this restriction.

 Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C8699

Chronic lymphocytic leukaemia (CLL)

Initial treatment - Extension of dose titration
Patient must have experienced a treatment interruption during the PBS-subsidised dose titration with this drug for this condition; AND
Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must be used as monotherapy for this condition under this restriction.

 Compliance with Authority Required procedures

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

omit table following subparagraph 3(2) and substitute:

Item Kind of patient Regimen
1

Patient:

(a)   with Genotype 1; and

(b)   who is treatment naïve; and

(c)   who is non-cirrhotic

Either:

(a)   LEDIPASVIR with SOFOSBUVIR for 8 weeks; or

(b)   LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(c)   DACLATASVIR and SOFOSBUVIR for 12 weeks; or

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

(e)   GRAZOPREVIR with ELBASVIR for 12 weeks; or

(f)    SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(g)   GLECAPREVIR with PIBRENTASVIR for 8 weeks.
2

Patient:

(a)   with Genotype 1; and

(b)   who is treatment experienced; and

(c)   who is non-cirrhotic

Either:

(a)   LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(b)   DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(c)   DACLATASVIR and SOFOSBUVIR for 24 weeks; or

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

(e)   GRAZOPREVIR with ELBASVIR for 12 weeks; or

(f)    GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks; or

(g)   SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(h)   GLECAPREVIR with PIBRENTASVIR for 8 weeks; or

(i)    GLECAPREVIR with PIBRENTASVIR for 12 weeks; or

(j)    GLECAPREVIR with PIBRENTASVIR for 16 weeks; or

(k)   SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks.

3

Patient:

(a)   with Genotype 2; and

(b)   who is treatment naïve; and

(c)   who is non-cirrhotic

Either:

(a)   SOFOSBUVIR and RIBAVIRIN for 12 weeks; or

(b)   SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(c)   GLECAPREVIR with PIBRENTASVIR for 8 weeks.
4

Patient:

(a)   with Genotype 2; and

(b)   who is treatment experienced; and

(c)   who is non-cirrhotic

Either:

(a)   SOFOSBUVIR and RIBAVIRIN for 12 weeks; or

(b)   SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(c)   GLECAPREVIR with PIBRENTASVIR for 8 weeks; or

(d)   SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks.
5

Patient:

(a)   with Genotype 3; and

(b)   who is treatment naïve; and

(c)   who is non-cirrhotic

Either:

(a)   DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(b)   SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

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

(d)   SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(e)   GLECAPREVIR with PIBRENTASVIR for 8 weeks.
6

Patient:

(a)   with Genotype 3; and

(b)   who is treatment experienced; and

(c)   who is non-cirrhotic

Either:

(a)   DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(b)   SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

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

(d)   SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(e)   GLECAPREVIR with PIBRENTASVIR for 16 weeks; or

(f)    SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks.

7

Patient:

(a)   with Genotype 4; and

(b)   who is treatment naïve; and

(c)   who is non-cirrhotic

Either:

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

(b)   GRAZOPREVIR with ELBASVIR for 12 weeks; or

(c)   SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(d)   GLECAPREVIR with PIBRENTASVIR for 8 weeks.
8

Patient:

(a)   with Genotype 4; and

(b)   who is treatment experienced; and

(c)   who is non-cirrhotic

Either:

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

(b)   GRAZOPREVIR with ELBASVIR for 12 weeks; or

(c)   GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks; or

(d)   SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(e)   GLECAPREVIR with PIBRENTASVIR for 8 weeks; or

(f)    SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks.
9

Patient:

(a)   with:

(i)    Genotype 5; or

(ii)   Genotype 6; and

(b)   who is treatment naïve; and

(c)   who is non-cirrhotic

Either:

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

(b)   SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(c)   GLECAPREVIR with PIBRENTASVIR for 8 weeks.
10

Patient:

(a)   with:

(i)    Genotype 5; or

(ii)   Genotype 6; and

(b)   who is treatment experienced; and

(c)   who is non-cirrhotic

Either:

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

(b)   SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(c)   GLECAPREVIR with PIBRENTASVIR for 8 weeks; or

(d)   SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks.
11

Patient:

(a)   with Genotype 1; and

(b)   who is treatment naïve; and

(c)   who is cirrhotic

Either:

(a)   LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

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

(c)   DACLATASVIR and SOFOSBUVIR for 24 weeks; or

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

(e)   GRAZOPREVIR with ELBASVIR for 12 weeks; or

(f)    SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(g)   GLECAPREVIR with PIBRENTASVIR for 12 weeks.
12

Patient:

(a)   with Genotype 1; and

(b)   who is treatment experienced; and

(c)   who is cirrhotic

Either:

(a)   LEDIPASVIR with SOFOSBUVIR for 24 weeks; or

(b)   DACLATASVIR and SOFOSBUVIR for 24 weeks; or

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

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

(e)   GRAZOPREVIR with ELBASVIR for 12 weeks; or

(f)    GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks; or

(g)   SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(h)   GLECAPREVIR with PIBRENTASVIR for 12 weeks; or

(i)    GLECAPREVIR with PIBRENTASVIR for 16 weeks; or

(j)    SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks.
13

Patient:

(a)   with Genotype 2; and

(b)   who is treatment naïve; and

(c)   who is cirrhotic

Either:

(a)   SOFOSBUVIR and RIBAVIRIN for 12 weeks; or

(b)   SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(c)   GLECAPREVIR with PIBRENTASVIR for 12 weeks.
14

Patient:

(a)   with Genotype 2; and

(b)   who is treatment experienced; and

(c)   who is cirrhotic

Either:

(a)   SOFOSBUVIR and RIBAVIRIN for 12 weeks; or

(b)   SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(c)   GLECAPREVIR with PIBRENTASVIR for 12 weeks; or

(d)   SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks.
15

Patient:

(a)   with Genotype 3; and

(b)   who is treatment naïve; and

(c)   who is cirrhotic

Either:

(a)   SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(b)   DACLATASVIR and SOFOSBUVIR for 24 weeks; or

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

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

(e)   DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(f)    SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(g)   GLECAPREVIR with PIBRENTASVIR for 12 weeks.
16

Patient:

(a)   with Genotype 3; and

(b)   who is treatment experienced; and

(c)   who is cirrhotic

Either:

(a)   DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(b)   SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

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

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

(e)   DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(f)    SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(g)   GLECAPREVIR with PIBRENTASVIR for 16 weeks; or

(h)   SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks.
17

Patient:

(a)   with Genotype 4; and

(b)   who is treatment naïve; and

(c)   who is cirrhotic

Either:

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

(b)   GRAZOPREVIR with ELBASVIR for 12 weeks; or

(c)   SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(d)   GLECAPREVIR with PIBRENTASVIR for 12 weeks.
18

Patient:

(a)   with Genotype 4; and

(b)   who is treatment experienced; and

(c)   who is cirrhotic

Either:

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

(b)   GRAZOPREVIR with ELBASVIR for 12 weeks; or

(c)   GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks; or

(d)   SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(e)   GLECAPREVIR with PIBRENTASVIR for 12 weeks; or

(f)    SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks.
19

Patient:

(a)   with:

(i)    Genotype 5; or

(ii)   Genotype 6; and

(b)   who is treatment naïve; and

(c)   who is cirrhotic

Either:

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

(b)   SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(c)   GLECAPREVIR with PIBRENTASVIR for 12 weeks.
20

Patient:

(a)   with:

(i)    Genotype 5; or

(ii)   Genotype 6; and

(b)   who is treatment experienced; and

(c)   who is cirrhotic

Either:

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

(b)   SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(c)   GLECAPREVIR with PIBRENTASVIR for 12 weeks; or

(d)   SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks.

  1. Schedule 5, after entry for Abacavir with lamivudine [GRP-21981]

insert:

Aciclovir GRP-22959 Eye ointment 30 mg per g, 4.5 g Application to the eye Zovirax
Eye ointment 30 mg per g, 4.5 g (Acivision) Application to the eye AciVision

  1. Schedule 5, after entry for Lansoprazole [GRP-14641]

insert:

Levodopa with carbidopa GRP-22957 Tablet (modified release) 200 mg-50 mg Oral Carbidopa and Levodopa Extended-release Tablets
Tablet (modified release) 200 mg-50 mg (as monohydrate) Oral Sinemet CR
GRP-22958 Tablet 250 mg-25 mg (as monohydrate) Oral Sinemet
Tablet 250 mg-25 mg (USP) Oral Carbidopa and Levodopa Tablets, USP

  1. Schedule 5, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride) [GRP-20724]

omit from the column headed "Brand": Ulcaid         

  1. Schedule 5, entry for Salbutamol in the form Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 [GRP-21361]

insert in alphabetical order in the column headed “Brand”: Salbutamol Cipla

  1. Schedule 5, entry for Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 [GRP-21535]

insert in alphabetical order in the column headed “Brand”: Salbutamol Cipla

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