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PB 58 of 2019 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme and related matters.
Administered by: Health
Registered 30 Jul 2019
Tabling HistoryDate
Tabled HR31-Jul-2019
Tabled Senate01-Aug-2019
To be repealed 14 Nov 2019
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

 

 

 

 

PB 58 of 2019

 

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 7)

 

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   26 July 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. 7).

(2)          This Instrument may also be cited as PB 58 of 2019.

2          Commencement

This Instrument commences on 1 August 2019.

3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).


 


Schedule 1     Amendments

[1]             Schedule 1, entry for Acarbose in each of the forms: Tablet 50 mg; and Tablet 100 mg

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

 

 

 

a

GLYBOSAY

RW

MP NP

 

 

90

5

90

 

 

[2]             Schedule 1, entry for Aciclovir in the form Tablet 200 mg [Maximum Quantity: 50; Number of Repeats: 0]

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

 

 

 

a

Aciclovir APOTEX

TY

MP NP

C5936 C5942

P5936

50

0

50

 

 

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

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

 

 

 

a

Aciclovir APOTEX

TY

MP NP

C5936 C5942

P5942

90

5

90

 

 

[4]             Schedule 1, entry for Aciclovir in the form Tablet 800 mg

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

 

 

 

a

Aciclovir APOTEX

TY

MP NP

C5959 C5967

 

35

0

35

 

 

[5]             Schedule 1, entry for Acitretin in each of the forms: Capsule 10 mg; and Capsule 25 mg

                           omit from the column headed “Responsible Person” for the brand “Neotigason”: UA    substitute: TB

[6]             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”: C4845 C4851

                   (b)        omit from the column headed “Circumstances”: C6437 C6439 C6445

                   (c)        insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155

[7]             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”: C4845 C4851

                   (b)        omit from the column headed “Circumstances”: C6437 C6439 C6445

                   (c)        insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155

[8]             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”: C4845 C4851

                   (b)        omit from the column headed “Circumstances”: C6437 C6439 C6445

                   (c)        insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155

                   (d)        omit from the column headed “Purposes”: P4851 P6437 P6445

                   (e)        insert in numerical order in the column headed “Purposes”: P9064 P9069 P9078 P9155

[9]             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”: C4845 C4851

                   (b)        omit from the column headed “Circumstances”: C6437 C6439 C6445

                   (c)        insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155

[10]           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”: C4845 C4851

                   (b)        omit from the column headed “Circumstances”: C6437 C6439 C6445

                   (c)        insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155

                   (d)        omit from the column headed “Purposes”: P4845

                   (e)        omit from the column headed “Purposes”: P6439

                    (f)        insert in numerical order in the column headed “Purposes”: P9063 P9105

[11]           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”: C4845 C4851

                   (b)        omit from the column headed “Circumstances”: C6437 C6439 C6445

                   (c)        insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155

[12]           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”: C4845 C4851

                   (b)        omit from the column headed “Circumstances”: C6437 C6439 C6445

                   (c)        insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155

[13]           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”: C4845 C4851

                   (b)        omit from the column headed “Circumstances”: C6437 C6439 C6445

                   (c)        insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155

                   (d)        omit from the column headed “Purposes”: P4851 P6437 P6445

                   (e)        insert in numerical order in the column headed “Purposes”: P9064 P9069 P9078 P9155

[14]           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”: C4845 C4851

                   (b)        omit from the column headed “Circumstances”: C6437 C6439 C6445

                   (c)        insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155

[15]           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”: C4845 C4851

                   (b)        omit from the column headed “Circumstances”: C6437 C6439 C6445

                   (c)        insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155

                   (d)        omit from the column headed “Purposes”: P4845

                   (e)        omit from the column headed “Purposes”: P6439

                    (f)        insert in numerical order in the column headed “Purposes”: P9063 P9105

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

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

 

 

 

a

AMILOXYN

RF

PDP

 

 

20

0

20

 

 

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

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

 

 

 

a

AMILOXYN

RF

MP NP MW

 

 

20

1

20

 

 

[18]           Schedule 1, entry for Amoxicillin in the form Capsule 500 mg (as trihydrate) [Maximum Quantity: 20; Number of Repeats: 0]

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

 

 

 

a

AMILOXYN

RF

PDP

 

 

20

0

20

 

 

[19]           Schedule 1, entry for Amoxicillin in the form Capsule 500 mg (as trihydrate) [Maximum Quantity: 20; Number of Repeats: 1]

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

 

 

 

a

AMILOXYN

RF

MP NP MW

 

 

20

1

20

 

 

[20]           Schedule 1, omit entry for Aprepitant


 

[21]           Schedule 1, entry for Benzathine benzylpenicillin

                           substitute:

Benzathine benzylpenicillin

Injection containing 600,000 units benzathine benzylpenicillin tetrahydrate in 1.17 mL single use pre-filled syringe

Injection

 

Bicillin L-A

PF

MP NP PDP

 

 

10

0

10

 

 

 

Injection containing 1,200,000 units benzathine benzylpenicillin tetrahydrate in 2.3 mL single use pre-filled syringe

Injection

 

Bicillin L-A

PF

MP NP PDP

 

 

10

0

10

 

 

[22]           Schedule 1, entry for Bevacizumab in each of the forms: Solution for I.V. infusion 100 mg in 4 mL; and Solution for I.V. infusion 400 mg in 16 mL

                           insert in numerical order in the column headed “Circumstances”: C9102 C9149 C9166

[23]           Schedule 1, entry for Calcitriol

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

 

 

 

a

CALITROL

ED

MP NP

C5089 C5114 C5255 C5401 C5402

 

100

3

100

 

 

[24]           Schedule 1, entry for Calcium

                           substitute:

Calcium

Tablet, chewable, 500 mg (as carbonate)

Oral

 

Cal-500

PP

MP NP

C4586

 

240

1

60

 

 

 

 

 

 

 

 

MP NP

C4586

 

240

1

120

 

 

 

Tablet 600 mg (as carbonate)

Oral

 

Calci-Tab 600

AE

MP NP

C4586

 

240

1

240

 

 

[25]           Schedule 1, entry for Carbimazole

                           omit:

 

 

 

 

Carbimazol ARISTO

PQ

MP NP

 

 

200

2

100

 

 

[26]           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”: C4830 C4853 C6396 C6460 C6474

                   (b)        insert in numerical order in the column headed “Circumstances”: C9063 C9073 C9074 C9105 C9183 C9185

                   (c)        omit from the column headed “Purposes”: P4830

                   (d)        insert in numerical order in the column headed “Purposes”: P9185

[27]           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”: C4830 C4853 C6396 C6460 C6474

                   (b)        insert in numerical order in the column headed “Circumstances”: C9063 C9073 C9074 C9105 C9183 C9185

                   (c)        omit from the column headed “Purposes”: P4853 P6474

                   (d)        insert in numerical order in the column headed “Purposes”: P9063 P9105

[28]           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”: C4830 C4853 C6396 C6460 C6474

                   (b)        insert in numerical order in the column headed “Circumstances”: C9063 C9073 C9074 C9105 C9183 C9185

                   (c)        omit from the column headed “Purposes”: P6396 P6460

                   (d)        insert in numerical order in the column headed “Purposes”: P9073 P9074 P9183

[29]           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”: C4830 C4853 C6396 C6460 C6474

                   (b)        insert in numerical order in the column headed “Circumstances”: C9063 C9073 C9074 C9105 C9183 C9185

                   (c)        omit from the column headed “Purposes”: P4830

                   (d)        insert in numerical order in the column headed “Purposes”: P9185

[30]           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”: C4830 C4853 C6396 C6460 C6474

                   (b)        insert in numerical order in the column headed “Circumstances”: C9063 C9073 C9074 C9105 C9183 C9185

                   (c)        omit from the column headed “Purposes”: P4853 P6474

                   (d)        insert in numerical order in the column headed “Purposes”: P9063 P9105

[31]           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”: C4830 C4853 C6396 C6460 C6474

                   (b)        insert in numerical order in the column headed “Circumstances”: C9063 C9073 C9074 C9105 C9183 C9185

                   (c)        omit from the column headed “Purposes”: P6396 P6460

                   (d)        insert in numerical order in the column headed “Purposes”: P9073 P9074 P9183

[32]           Schedule 1, entry for Dasatinib in the form Tablet 20 mg [Maximum Quantity: 60; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C6905 C6906 C6926

                   (b)        insert in numerical order in the column headed “Circumstances”: C9059 C9098 C9100 C9136

                   (c)        omit from the column headed “Purposes”: P6905 P6906 P6926         substitute: P9059 P9098 P9100 P9136

[33]           Schedule 1, entry for Dasatinib in the form Tablet 20 mg [Maximum Quantity: 60; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C6905 C6906 C6926

                   (b)        insert in numerical order in the column headed “Circumstances”: C9059 C9098 C9100 C9136

[34]           Schedule 1, entry for Dasatinib in the form Tablet 50 mg [Maximum Quantity: 60; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C6905 C6906 C6926

                   (b)        insert in numerical order in the column headed “Circumstances”: C9059 C9098 C9100 C9136 

                   (c)        omit from the column headed “Purposes”: P6905 P6906 P6926         substitute: P9059 P9098 P9100 P9136

[35]           Schedule 1, entry for Dasatinib in the form Tablet 50 mg [Maximum Quantity: 60; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C6905 C6906 C6926

                   (b)        insert in numerical order in the column headed “Circumstances”: C9059 C9098 C9100 C9136

[36]           Schedule 1, entry for Dasatinib in the form Tablet 70 mg [Maximum Quantity: 60; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C6905 C6906 C6926

                   (b)        insert in numerical order in the column headed “Circumstances”: C9059 C9098 C9100 C9136

                   (c)        omit from the column headed “Purposes”: P6905 P6906 P6926         substitute: P9059 P9098 P9100 P9136

[37]           Schedule 1, entry for Dasatinib in the form Tablet 70 mg [Maximum Quantity: 60; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C6905 C6906 C6926

                   (b)        insert in numerical order in the column headed “Circumstances”: C9059 C9098 C9100 C9136

[38]           Schedule 1, entry for Dasatinib in the form Tablet 100 mg [Maximum Quantity: 30; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C6905 C6906 C6926

                   (b)        insert in numerical order in the column headed “Circumstances”: C9059 C9098 C9100 C9136

                   (c)        omit from the column headed “Purposes”: P6905 P6906 P6926         substitute: P9059 P9098 P9100 P9136


 

[39]           Schedule 1, entry for Dasatinib in the form Tablet 100 mg [Maximum Quantity: 30; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C6905 C6906 C6926

                   (b)        insert in numerical order in the column headed “Circumstances”: C9059 C9098 C9100 C9136

[40]           Schedule 1, entry for Deferiprone in the form Tablet 500 mg

                           omit from the column headed “Maximum Quantity”: 600        substitute: 300

[41]           Schedule 1, after entry for Deferiprone in the form Tablet 500 mg

                           insert:

 

Tablet 1000 mg

Oral

 

Ferriprox

TX

MP

C6380 C6403 C6442 C6448

 

300

5

50

 

D(100)

[42]           Schedule 1, entry for Diltiazem in the form Tablet containing diltiazem hydrochloride 60 mg

                           omit:

 

 

 

a

Diltiazem Sandoz

SZ

MP NP

 

 

90

5

90

 

 

[43]           Schedule 1, entry for Enoxaparin in each of the forms: Injection containing enoxaparin sodium 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre-filled syringe; and Injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in 0.4 mL pre-filled syringe [Maximum Quantity: 20;
Number of Repeats: 0]

                           omit from the column headed “Number of Repeats” (all instances): 0  substitute: 1

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

                           substitute:

 

Powder for oral liquid 200 mg (as ethyl succinate) per 5 mL, 100 mL

Oral

 

E-Mycin 200

AF

PDP

 

 

1

0

1

 

 

 

 

 

 

 

 

MP NP

 

 

1

1

1

 

 

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

                           substitute:

 

Powder for oral liquid 400 mg (as ethyl succinate) per 5 mL, 100 mL

Oral

 

E-Mycin 400

AF

PDP

 

 

1

0

1

 

 

 

 

 

 

 

 

MP NP

 

 

1

1

1

 

 

[46]           Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances”: C7177 C7181 C7219 C7220 C7224 C7251

                   (b)        omit from the column headed “Circumstances”: C8880 C8888

                   (c)        insert in numerical order in the column headed “Circumstances”: C9064 C9081 C9082 C9084 C9123 C9140 C9152 C9162 C9177

                   (d)        omit from the column headed “Purposes”: P7177 P7220 P7224

                   (e)        omit from the column headed “Purposes”: P8888

                    (f)        insert in numerical order in the column headed “Purposes”: P9064 P9082 P9084 P9152 P9177

[47]           Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C7177 C7181 C7219 C7220 C7224 C7251

                   (b)        omit from the column headed “Circumstances”: C8880 C8888

                   (c)        insert in numerical order in the column headed “Circumstances”: C9064 C9081 C9082 C9084 C9123 C9140 C9152 C9162 C9177

                   (d)        omit from the column headed “Purposes”: P7181 P7219 P7251

                   (e)        omit from the column headed “Purposes”: P8880

                    (f)        insert in numerical order in the column headed “Purposes”: P9081 P9123 P9140 P9162

[48]           Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Brenzys; Maximum Quantity: 1;
Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances”: C7177 C7181 C7217 C7219 C7220 C7224 C7251

                   (b)        omit from the column headed “Circumstances”: C8880

                   (c)        omit from the column headed “Circumstances”: C8888

                   (d)        insert in numerical order in the column headed “Circumstances”: C9064 C9081 C9082 C9084 C9123 C9140 C9152 C9156 C9162 C9177

                   (e)        omit from the column headed “Purposes”: P7177 P7220 P7224

                    (f)        omit from the column headed “Purposes”: P8888

                   (g)        insert in numerical order in the column headed “Purposes”: P9064 P9082 P9084 P9152 P9177

[49]           Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Enbrel; Maximum Quantity: 1;
Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances”: C7177 C7181 C7219 C7220 C7224 C7251

                   (b)        omit from the column headed “Circumstances”: C8880 C8888

                   (c)        insert in numerical order in the column headed “Circumstances”: C9064 C9081 C9082 C9084 C9123 C9140 C9152 C9162 C9177

                   (d)        omit from the column headed “Purposes”: P7177 P7220 P7224

                   (e)        omit from the column headed “Purposes”: P8888

                    (f)        insert in numerical order in the column headed “Purposes”: P9064 P9082 P9084 P9152 P9177

[50]           Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Brenzys; Maximum Quantity: 1;
Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C7177 C7181 C7217 C7219 C7220 C7224 C7251

                   (b)        omit from the column headed “Circumstances”: C8880

                   (c)        omit from the column headed “Circumstances”: C8888

                   (d)        insert in numerical order in the column headed “Circumstances”: C9064 C9081 C9082 C9084 C9123 C9140 C9152 C9156 C9162 C9177

                   (e)        omit from the column headed “Purposes”: P7181 P7217 P7219 P7251

                    (f)        omit from the column headed “Purposes”: P8880

                   (g)        insert in numerical order in the column headed “Purposes”: P9081 P9123 P9140 P9156 P9162

[51]           Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Enbrel; Maximum Quantity: 1;
Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C7177 C7181 C7219 C7220 C7224 C7251

                   (b)        omit from the column headed “Circumstances”: C8880 C8888

                   (c)        insert in numerical order in the column headed “Circumstances”: C9064 C9081 C9082 C9084 C9123 C9140 C9152 C9162 C9177

                   (d)        omit from the column headed “Purposes”: P7181 P7219 P7251

                   (e)        omit from the column headed “Purposes”: P8880

                    (f)        insert in numerical order in the column headed “Purposes”: P9081 P9123 P9140 P9162

[52]           Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances”: C7177 C7181 C7217 C7219 C7220 C7224 C7251

                   (b)        omit from the column headed “Circumstances”: C8880

                   (c)        omit from the column headed “Circumstances”: C8888

                   (d)        insert in numerical order in the column headed “Circumstances”: C9064 C9081 C9082 C9084 C9123 C9140 C9152 C9156 C9162 C9177 

                   (e)        omit from the column headed “Purposes”: P7177 P7220 P7224

                    (f)        omit from the column headed “Purposes”: P8888

                   (g)        insert in numerical order in the column headed “Purposes”: P9064 P9082 P9084 P9152 P9177


 

[53]           Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances”: C7177 C7181 C7219 C7220 C7224 C7251

                   (b)        omit from the column headed “Circumstances”: C8880 C8888

                   (c)        insert in numerical order in the column headed “Circumstances”: C9064 C9081 C9082 C9084 C9123 C9140 C9152 C9162 C9177

                   (d)        omit from the column headed “Purposes”: P7177 P7220 P7224

                   (e)        omit from the column headed “Purposes”: P8888

                    (f)        insert in numerical order in the column headed “Purposes”: P9064 P9082 P9084 P9152 P9177

[54]           Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C7177 C7181 C7217 C7219 C7220 C7224 C7251

                   (b)        omit from the column headed “Circumstances”: C8880

                   (c)        omit from the column headed “Circumstances”: C8888

                   (d)        insert in numerical order in the column headed “Circumstances”: C9064 C9081 C9082 C9084 C9123 C9140 C9152 C9156 C9162 C9177

                   (e)        omit from the column headed “Purposes”: P7181 P7217 P7219 P7251

                    (f)        omit from the column headed “Purposes”: P8880

                   (g)        insert in numerical order in the column headed “Purposes”: P9081 P9123 P9140 P9156 P9162

[55]           Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C7177 C7181 C7219 C7220 C7224 C7251

                   (b)        omit from the column headed “Circumstances”: C8880 C8888

                   (c)        insert in numerical order in the column headed “Circumstances”: C9064 C9081 C9082 C9084 C9123 C9140 C9152 C9162 C9177

                   (d)        omit from the column headed “Purposes”: P7181 P7219 P7251

                   (e)        omit from the column headed “Purposes”: P8880      

                    (f)        insert in numerical order in the column headed “Purposes”: P9081 P9123 P9140 P9162

[56]           Schedule 1, entry for Fenofibrate in the form Tablet 145 mg [Maximum Quantity: 30; Number of Repeats: 5]

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

 

 

 

a

Fenocol

YC

MP NP

 

 

30

5

30

 

 


 

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

 

 

 

a

Fenofibrate Cipla

LR

MP NP

 

 

30

5

30

 

 

[57]           Schedule 1, entry for Fenofibrate in the form Tablet 145 mg [Maximum Quantity: 30; Number of Repeats: 11]

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

 

 

 

a

Fenocol

YC

MP

 

P7640

30

11

30

 

 

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

 

 

 

a

Fenofibrate Cipla

LR

MP

 

P7640

30

11

30

 

 

[58]           Schedule 1, entry for Flucloxacillin

                           insert as first entry:

 

Capsule 250 mg (as sodium)

Oral

 

Medsurge

DZ

PDP

C5298

 

24

0

28

 

 

 

 

 

 

 

 

MP NP MW

C5414

 

24

0

28

 

 

[59]           Schedule 1, entry for Flucloxacillin in the form Capsule 250 mg (as sodium monohydrate)

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

[60]           Schedule 1, after entry for Flucloxacillin in the form Capsule 250 mg (as sodium monohydrate)

                           insert:

 

Capsule 500 mg (as sodium)

Oral

 

Medsurge

DZ

PDP

C5298

 

24

0

100

 

 

 

 

 

 

 

 

MP

C5414 C6169

P5414

24

0

100

 

 

 

 

 

 

 

 

NP MW

C5414

 

24

0

100

 

 

 

 

 

 

 

 

MP

C5414 C6169

P6169

48

1

100

 

 

[61]           Schedule 1, entry for Flucloxacillin in the form Capsule 500 mg (as sodium monohydrate)

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

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

                           insert:

Fluticasone furoate

Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms per dose, 30 doses

Inhalation by mouth

 

Arnuity Ellipta

GK

MP NP

 

 

1

5

1

 

 

 

Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms per dose, 30 doses

Inhalation by mouth

 

Arnuity Ellipta

GK

MP NP

 

 

1

5

1

 

 

[63]           Schedule 1, entry for Furosemide in the form Tablet 40 mg

                           omit:

 

 

 

a

Frusemide Sandoz

SZ

MP NP

 

 

100

1

100

 

 

[64]           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”: C4845 C4851 C6437 C6439 C6445

                   (b)        insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9105 C9153 C9155

                   (c)        omit from the column headed “Purposes”: P4851 P6437 P6445

                   (d)        insert in numerical order in the column headed “Purposes”: P9064 P9069 P9153 P9155

[65]           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”: C4845 C4851 C6437 C6439 C6445

                   (b)        insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9105 C9153 C9155

                   (c)        omit from the column headed “Purposes”: P4845 P6439

                   (d)        insert in numerical order in the column headed “Purposes”: P9063 P9105

[66]           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”: C4845 C4851 C6437 C6439 C6445

                   (b)        insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9105 C9153 C9155

                   (c)        omit from the column headed “Purposes”: P4851 P6437 P6445

                   (d)        insert in numerical order in the column headed “Purposes”: P9064 P9069 P9153 P9155

[67]           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”: C4845 C4851 C6437 C6439 C6445

                   (b)        insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9105 C9153 C9155

                   (c)        omit from the column headed “Purposes”: P4845 P6439

                   (d)        insert in numerical order in the column headed “Purposes”: P9063 P9105

[68]           Schedule 1, entry for Hydromorphone in the form Injection containing hydromorphone hydrochloride 2 mg in 1 mL

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

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

 

 

 

a

HYDROMORPHONE JUNO

JU

MP NP

 

 

5

0

5

 

 

[69]           Schedule 1, entry for Hydromorphone in the form Injection containing hydromorphone hydrochloride 10 mg in 1 mL

                   (a)        insert in the column headed “Schedule Equivalent” for the brand “Dilaudid-HP”: a

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

 

 

 

a

HYDROMORPHONE JUNO-HP

JU

MP NP

 

 

5

0

5

 

 

[70]           Schedule 1, entry for Hypromellose

                           omit:

 

Eye drops 3 mg per mL, 15 mL

Application to the eye

a

Genteal

AQ

AO

C6120

 

1

5

1

 

 

 

 

 

 

 

 

MP

C6073 C6098

P6073

1

5

1

 

 

 

 

 

 

 

 

NP

C6073

 

1

5

1

 

 

 

 

 

a

In a Wink Moisturising

IQ

AO

C6120

 

1

5

1

 

 

 

 

 

 

 

 

MP

C6073 C6098

P6073

1

5

1

 

 

 

 

 

 

 

 

NP

C6073

 

1

5

1

 

 

 

 

 

a

Genteal

AQ

MP

C6073 C6098

P6098

1

11

1

 

 

 

 

 

a

In a Wink Moisturising

IQ

MP

C6073 C6098

P6098

1

11

1

 

 

[71]           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 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6510 P6526 P6538 P6557 P9086 P9124

60

2

60

 

 

 

 

 

 

Glivanib

JU

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6510 P6526 P6538 P6557 P9086 P9124

60

2

60

 

 

 

 

 

 

IMATINIB AN

JO

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6510 P6526 P6538 P6557 P9086 P9124

60

2

60

 

 

 

 

 

 

Imatinib GH

GQ

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6510 P6526 P6538 P6557 P9086 P9124

60

2

60

 

 

 

 

 

 

Imatinib-APOTEX

TX

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6510 P6526 P6538 P6557 P9086 P9124

60

2

60

 

 

 

 

 

 

IMATINIB-DRLA

RZ

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6510 P6526 P6538 P6557 P9086 P9124

60

2

60

 

 

 

 

 

 

CIPLA IMATINIB ADULT

LR

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698

60

5

60

 

 

 

 

 

 

Glivanib

JU

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698

60

5

60

 

 

 

 

 

 

IMATINIB AN

JO

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698

60

5

60

 

 

 

 

 

 

Imatinib GH

GQ

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698

60

5

60

 

 

 

 

 

 

Imatinib-APOTEX

TX

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698

60

5

60

 

 

 

 

 

 

IMATINIB-DRLA

RZ

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698

60

5

60

 

 

 

Capsule 400 mg (as mesilate)

Oral

 

CIPLA IMATINIB ADULT

LR

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6510 P6526 P6538 P6557 P9086 P9124

30

2

30

 

 

 

 

 

 

Glivanib

JU

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6510 P6526 P6538 P6557 P9086 P9124

30

2

30

 

 

 

 

 

 

IMATINIB AN

JO

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6510 P6526 P6538 P6557 P9086 P9124

30

2

30

 

 

 

 

 

 

Imatinib GH

GQ

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6510 P6526 P6538 P6557 P9086 P9124

30

2

30

 

 

 

 

 

 

Imatinib-APOTEX

TX

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6510 P6526 P6538 P6557 P9086 P9124

30

2

30

 

 

 

 

 

 

IMATINIB-DRLA

RZ

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6510 P6526 P6538 P6557 P9086 P9124

30

2

30

 

 

 

 

 

 

CIPLA IMATINIB ADULT

LR

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698

30

5

30

 

 

 

 

 

 

Glivanib

JU

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698

30

5

30

 

 

 

 

 

 

IMATINIB AN

JO

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698

30

5

30

 

 

 

 

 

 

Imatinib GH

GQ

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698

30

5

30

 

 

 

 

 

 

Imatinib-APOTEX

TX

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698

30

5

30

 

 

 

 

 

 

IMATINIB-DRLA

RZ

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698

30

5

30

 

 

 

Tablet 100 mg (as mesilate)

Oral

 

Gilmat

CR

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6948 C6949 C6973 C8697 C9086 C9124

P6510 P6526 P6538 P6557 P9086 P9124

60

2

60

 

 

 

 

 

 

Glivec

AF

MP

C4342 C4355 C6496 C6498 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6559 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6498 P6510 P6526 P6538 P6557 P6559 P9086 P9124

60

2

60

 

 

 

 

 

 

IMATINIB RBX

RA

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6510 P6526 P6538 P6557 P9086 P9124

60

2

60

 

 

 

 

 

 

Imatinib-Teva

SZ

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6948 C6949 C6973 C8697 C9086 C9124

P6510 P6526 P6538 P6557 P9086 P9124

60

2

60

 

 

 

 

 

 

Gilmat

CR

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6948 C6949 C6973 C8697 C9086 C9124

P6496 P6499 P6527 P6539 P6550 P6948 P6949 P6973 P8697

60

5

60

 

 

 

 

 

 

Glivec

AF

MP

C4342 C4355 C6496 C6498 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6559 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P4342 P4355 P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698

60

5

60

 

 

 

 

 

 

IMATINIB RBX

RA

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698

60

5

60

 

 

 

 

 

 

Imatinib-Teva

SZ

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6948 C6949 C6973 C8697 C9086 C9124

P6496 P6499 P6527 P6539 P6550 P6948 P6949 P6973 P8697

60

5

60

 

 

 

Tablet 400 mg (as mesilate)

Oral

 

Gilmat

CR

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6948 C6949 C6973 C8697 C9086 C9124

P6510 P6526 P6538 P6557 P9086 P9124

30

2

30

 

 

 

 

 

 

Glivec

AF

MP

C4342 C4355 C6496 C6498 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6559 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6498 P6510 P6526 P6538 P6557 P6559 P9086 P9124

30

2

30

 

 

 

 

 

 

IMATINIB RBX

RA

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6510 P6526 P6538 P6557 P9086 P9124

30

2

30

 

 

 

 

 

 

Imatinib-Teva

SZ

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6948 C6949 C6973 C8697 C9086 C9124

P6510 P6526 P6538 P6557 P9086 P9124

30

2

30

 

 

 

 

 

 

Gilmat

CR

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6948 C6949 C6973 C8697 C9086 C9124

P6496 P6499 P6527 P6539 P6550 P6948 P6949 P6973 P8697

30

5

30

 

 

 

 

 

 

Glivec

AF

MP

C4342 C4355 C6496 C6498 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6559 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P4342 P4355 P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698

30

5

30

 

 

 

 

 

 

IMATINIB RBX

RA

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6540 C6550 C6557 C6948 C6949 C6973 C8697 C8698 C9086 C9124

P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698

30

5

30

 

 

 

 

 

 

Imatinib-Teva

SZ

MP

C6496 C6499 C6510 C6526 C6527 C6538 C6539 C6550 C6557 C6948 C6949 C6973 C8697 C9086 C9124

P6496 P6499 P6527 P6539 P6550 P6948 P6949 P6973 P8697

30

5

30

 

 

[72]           Schedule 1, entry for Ixekizumab in the form Injection 80 mg in 1 mL single dose pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C8562 C8583 C8591 C8592 C8602 C8612

                   (b)        insert in numerical order in the column headed “Circumstances”: C9116 C9118 C9141 C9164 C9172 C9184 C9194

                   (c)        omit from the column headed “Purposes”: P8562 P8583 P8591 P8592 P8602 P8612

                   (d)        insert in numerical order in the column headed “Purposes”: P9116 P9118 P9141 P9164 P9172 P9184 P9194

[73]           Schedule 1, entry for Ixekizumab in the form Injection 80 mg in 1 mL single dose pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances”: C8562 C8583 C8591 C8592 C8602 C8612

                   (b)        insert in numerical order in the column headed “Circumstances”: C9116 C9118 C9141 C9164 C9172 C9184 C9194

[74]           Schedule 1, entry for Lanreotide in the form Injection 120 mg (as acetate) in single dose pre-filled syringe

                           insert in numerical order in the column headed “Circumstances”: C9161

[75]           Schedule 1, entry for Methylprednisolone in the form Powder for injection 40 mg (as sodium succinate) with diluent

                           omit from the column headed “Pack Quantity”: 5     substitute: 1

[76]           Schedule 1, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg [Maximum Quantity: 150;
Number of Repeats: 5]

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

 

 

 

a

MycoCept

RF

MP

 

 

150

5

50

 

 

[77]           Schedule 1, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg [Maximum Quantity: 300;
Number of Repeats: 5]

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

 

 

 

a

MycoCept

RF

MP

 

P5554 P5555 P5794 P5795

300
CN5554 CN5555 CN5794 CN5795

5
CN5554 CN5555 CN5794 CN5795

50

 

C(100)

[78]           Schedule 1, entry for Pembrolizumab in each of the forms: Powder for injection 50 mg; and Solution concentrate for I.V. infusion 100 mg in 4 mL

                   (a)        omit from the column headed “Circumstances”: C6801 C6806 C6817

                   (b)        insert in numerical order in the column headed “Circumstances”: C9044 C9127 C9178

[79]           Schedule 1, entry for Potassium chloride

                   (a)        omit:

 

 

 

a

Duro-K

NM

MP NP

 

 

200

1

100

 

 

 

 

 

a

Slow-K

NV

MP NP

 

 

200

1

100

 

 

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

[80]           Schedule 1, entry for Raloxifene

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

 

 

 

a

RALOVISTA

RF

MP NP

C6314

 

28

5

28

 

 

[81]           Schedule 1, entry for Reteplase

                           omit from the column headed “Responsible Person”: GN        substitute: TB

[82]           Schedule 1, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate)

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

 

 

 

 

RIXALT

RF

MP NP

C5708

 

4

5

2

 

 

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

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

 

 

 

a

Noumed Rosuvastatin

VO

MP NP

 

 

30

5

30

 

 

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

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

 

 

 

a

Noumed Rosuvastatin

VO

MP

 

P7598

30

11

30

 

 

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

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

 

 

 

a

Noumed Rosuvastatin

VO

MP NP

 

 

30

5

30

 

 

 

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

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

 

 

 

a

Noumed Rosuvastatin

VO

MP

 

P7598

30

11

30

 

 

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

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

 

 

 

a

Noumed Rosuvastatin

VO

MP NP

 

 

30

5

30

 

 

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

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

 

 

 

a

Noumed Rosuvastatin

VO

MP

 

P7598

30

11

30

 

 

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

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

 

 

 

a

Noumed Rosuvastatin

VO

MP NP

 

 

30

5

30

 

 

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

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

 

 

 

a

Noumed Rosuvastatin

VO

MP

 

P7598

30

11

30

 

 

[91]           Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C6415 C6439 C6482 C6484

                   (b)        omit from the column headed “Circumstances”: C8217

                   (c)        insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155

                   (d)        omit from the column headed “Purposes”: P6415

                   (e)        insert in numerical order in the column headed “Purposes”: P9064

 

[92]           Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C6415 C6439 C6482 C6484

                   (b)        omit from the column headed “Circumstances”: C8217

                   (c)        insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155

                   (d)        omit from the column headed “Purposes”: P6439

                   (e)        omit from the column headed “Purposes”: P8217

                    (f)        insert in numerical order in the column headed “Purposes”: P9063 P9105 

[93]           Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C6415 C6439 C6482 C6484   

                   (b)        omit from the column headed “Circumstances”: C8217

                   (c)        insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155

                   (d)        omit from the column headed “Purposes”: P6415

                   (e)        insert in numerical order in the column headed “Purposes”: P9064

[94]           Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C6415 C6439 C6482 C6484

                   (b)        omit from the column headed “Circumstances”: C8217

                   (c)        insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155

                   (d)        omit from the column headed “Purposes”: P6439

                   (e)        omit from the column headed “Purposes”: P8217

                    (f)        insert in numerical order in the column headed “Purposes”: P9063 P9105

[95]           Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 4; Number of Repeats: 0]

                   (a)        omit from the column headed “Circumstances”: C6415 C6439 C6482 C6484

                   (b)        omit from the column headed “Circumstances”: C8217

                   (c)        insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155

                   (d)        omit from the column headed “Purposes”: P6482 P6484

                   (e)        insert in numerical order in the column headed “Purposes”: P9069 P9078 P9155

[96]           Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 8; Number of Repeats: 0]

                   (a)        omit from the column headed “Circumstances”: C6415 C6439 C6482 C6484

                   (b)        omit from the column headed “Circumstances”: C8217

                   (c)        insert in numerical order in the column headed “Circumstances”: C9063 C9064 C9069 C9078 C9105 C9155

                   (d)        omit from the column headed “Purposes”: P6482 P6484

                   (e)        insert in numerical order in the column headed “Purposes”: P9069 P9078 P9155

[97]           Schedule 1, entry for Sodium acid phosphate

                   (a)        omit from the column headed “Schedule Equivalent” for the brand “PHOSPHATE PHEBRA”: a

                   (b)        omit:

 

 

 

a

Phosphate Sandoz

FF

MP NP

C5089 C5095 C5114 C5123

 

100

5

100

 

 

[98]           Schedule 1, after entry for Tenofovir with emtricitabine and efavirenz in the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and efavirenz 600 mg

                           insert:

 

Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg and efavirenz 600 mg

Oral

 

Tenofovir Disoproxil/Emtricitabine/Efavirenz Mylan 300/200/600

AF

MP

C4470 C4522

 

60

5

30

 

D(100)

[99]           Schedule 1, entry for Testosterone in each of the forms: Transdermal patches 12.2 mg, 60; and Transdermal patches 24.3 mg, 30

                           omit from the column headed “Responsible Person”: GN        substitute: TB

[100]        Schedule 1, after entry for Testosterone in the form Transdermal gel (pump pack) 12.5 mg per 1.25 g dose, 60 doses, 2

                           insert:

 

Transdermal gel (pump pack) 23 mg per 1.15 g dose, 56 doses

Transdermal

 

Testavan

FP

MP

C6324 C6910 C6919 C6933 C6934

 

1

5

1

 

 

[101]        Schedule 1, entry for Tocilizumab

                           omit:

 

Injection 162 mg in 0.9 mL single use pre-filled pen

Injection

 

Actemra ACTPen

RO

MP

C8627 C8631 C8633 C8638 C8739 C8740

P8631 P8638 P8739 P8740

4

3

4

 

 

 

 

 

 

 

 

MP

C8627 C8631 C8633 C8638 C8739 C8740

P8627 P8633

4

5

4

 

 

 

Injection 162 mg in 0.9 mL single use pre-filled syringe

Injection

 

Actemra Subcutaneous Injection

RO

MP

C8627 C8631 C8633 C8638 C8739 C8740

P8631 P8638 P8739 P8740

4

3

4

 

 

 

 

 

 

 

 

MP

C8627 C8631 C8633 C8638 C8739 C8740

P8627 P8633

4

5

4

 

 

[102]        Schedule 1, after entry for Tocilizumab in the form Concentrate for injection 400 mg in 20 mL

                           insert:

 

Injection 162 mg in 0.9 mL single use pre-filled pen

Injection

 

Actemra ACTPen

RO

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135 C9148 C9180

P9052 P9096 P9133 P9134 P9135

4

1

4

 

 

 

 

 

 

 

 

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135 C9148 C9180

P9129 P9130

4

2

4

 

 

 

 

 

 

 

 

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135 C9148 C9180

P8631 P8638 P8739 P8740 P9046 P9047 P9048

4

3

4

 

 

 

 

 

 

 

 

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135 C9148 C9180

P8627 P8633 P9049 P9131 P9148

4

5

4

 

 

 

 

 

 

 

 

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135 C9148 C9180

P9180

4

6

4

 

 

 

Injection 162 mg in 0.9 mL single use pre-filled syringe

Injection

 

Actemra Subcutaneous Injection

RO

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135 C9148 C9180

P9052 P9096 P9133 P9134 P9135

4

1

4

 

 

 

 

 

 

 

 

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135 C9148 C9180

P9129 P9130

4

2

4

 

 

 

 

 

 

 

 

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135 C9148 C9180

P8631 P8638 P8739 P8740 P9046 P9047 P9048

4

3

4

 

 

 

 

 

 

 

 

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135 C9148 C9180

P8627 P8633 P9049 P9131 P9148

4

5

4

 

 

 

 

 

 

 

 

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135 C9148 C9180

P9180

4

6

4

 

 

[103]        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”: C8816 C8860 C8861 C8862 C8894 C8895

                   (b)        insert in numerical order in the column headed “Circumstances”: C9064 C9069 C9116 C9141 C9155 C9157 C9170

                   (c)        omit from the column headed “Purposes”: P8816 P8861 P8862

                   (d)        insert in numerical order in the column headed “Purposes”: P9064 P9069 P9155 P9157

[104]        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”: C8816 C8860 C8861 C8862 C8894 C8895

                   (b)        insert in numerical order in the column headed “Circumstances”: C9064 C9069 C9116 C9141 C9155 C9157 C9170

                   (c)        omit from the column headed “Purposes”: P8860 P8894 P8895

                   (d)        insert in numerical order in the column headed “Purposes”: P9116 P9141 P9170

[105]        Schedule 1, entry for Trastuzumab in the form Powder for I.V. infusion 150 mg

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

 

 

 

 

Ogivri

AF

MP

C4083 C4093 C4104 C4142 C4143 C4156 C5024 C5032 C5041 C5834 C5844 C7718 C7746

 

See Note 3

See Note 3

1

 

PB(100)

[106]        Schedule 1, entry for Trimethoprim with sulfamethoxazole in the form Paediatric oral suspension 40 mg-200 mg per 5 mL, 100 mL

                           substitute:

 

Paediatric oral suspension 40 mg-200 mg per 5 mL, 100 mL

Oral

 

Septrin

RW

PDP

 

 

1

0

1

 

 

 

 

 

 

 

 

MP NP

 

 

1

1

1

 

 

[107]        Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Maximum Quantity: 1; Number of Repeats: 1]

                   (a)        omit from the column headed “Circumstances”: C6378 C6419 C6459 C6469 C6504 C6588

                   (b)        insert in numerical order in the column headed “Circumstances”: C9063 C9116 C9122 C9160 C9175 C9176

                   (c)        omit from the column headed “Purposes”: P6419 P6459 P6588

                   (d)        insert in numerical order in the column headed “Purposes”: P9063 P9116

[108]        Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Maximum Quantity: 1; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C6378 C6419 C6459 C6469 C6504 C6588

                   (b)        insert in numerical order in the column headed “Circumstances”: C9063 C9116 C9122 C9160 C9175 C9176

                   (c)        omit from the column headed “Purposes”: P6378 P6469 P6504

                   (d)        insert in numerical order in the column headed “Purposes”: P9122 P9160 P9175 P9176

[109]        Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Maximum Quantity: 2; Number of Repeats: 0]

                   (a)        omit from the column headed “Circumstances”: C6378 C6419 C6459 C6469 C6504 C6588

                   (b)        insert in numerical order in the column headed “Circumstances”: C9063 C9116 C9122 C9160 C9175 C9176

[110]        Schedule 3

                           omit:

GN

Actavis Pty Ltd

17 003 854 626

[111]        Schedule 3

                           omit:

PQ

PIMP Pty Ltd

39 114 633 117


 

[112]        Schedule 3

                           omit:

UA

Actavis Pty Ltd

17 003 854 626

[113]        Schedule 3, after details relevant to Responsible Person code VL

                           insert:

VO

Avallon Pharmaceuticals Pty Limited

63 126 872 848

[114]        Schedule 3, after details relevant to Responsible Person code XM

                           insert:

YC

Cipla Australia Pty Ltd

46 132 155 063

[115]        Schedule 4, Part 1, entry for Adalimumab

                   (a)        omit:

 

C4845

P4845

 

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

Compliance with Authority Required procedures

 

C4851

P4851

 

Severe psoriatic arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2 (change or recommencement of treatment) - balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

Compliance with Authority Required procedures

                   (b)        omit:

 

C6437

P6437

 

Severe psoriatic arthritis
Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more)
Patient must have severe active psoriatic arthritis; AND
Patient must have received no prior PBS-subsidised treatment with a biological agent for this condition; OR
Patient must have received no PBS-subsidised treatment with a biological agent for at least 5 years if they have previously received PBS-subsidised treatment with a biological agent for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation 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) an 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).
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.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement.

Compliance with Written Authority Required procedures

 

C6439

P6439

 

Severe psoriatic arthritis
Continuing treatment
Patient must have a documented history of severe active psoriatic arthritis; AND
Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND
Patient must demonstrate, at the time of application, 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 an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications.
All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.
Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.

Compliance with Written Authority Required procedures

 

C6445

P6445

 

Severe psoriatic arthritis
Initial treatment – Initial 2 (change or recommencement of treatment)
Patient must have a documented history of severe active psoriatic arthritis; AND
Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug during the current Treatment Cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug.
Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been 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 submitted no later than 4 weeks from the date that course was ceased.
Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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

                   (c)        insert in numerical order after existing text:

 

C9063

P9063

 

Severe psoriatic arthritis
Continuing treatment - balance of supply
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.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

Compliance with Authority Required procedures

 

C9064

P9064

 

Severe psoriatic arthritis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
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 5 years) 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 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

Compliance with Authority Required procedures

 

C9069

P9069

 

Severe psoriatic arthritis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic 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 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; 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 Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C9078

P9078

 

Severe psoriatic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in in biological medicine of less than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; 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 erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9105

P9105

 

Severe psoriatic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic 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.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9155

P9155

 

Severe psoriatic 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 psoriatic arthritis.
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation 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) an 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).
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.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

[116]        Schedule 4, Part 1, omit entry for Aprepitant

[117]        Schedule 4, Part 1, entry for Bevacizumab

                           insert in numerical order after existing text:

 

C9102

 

 

Relapsed or recurrent glioblastoma
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed further symptomatic progression while being treated with this drug for this condition; AND
The treatment must not exceed a dose of 10 mg per kg every 2 weeks; OR
The treatment must not exceed a dose of 15 mg per kg every 3 weeks.
Symptomatic progression is defined as:
i) Deterioration of neurologic function which may include motor dysfunction, seizures, lack of co-ordination, changes to personality, reduced ability to communicate, neurocognitive decline; OR
ii) Increasing symptoms of raised intracranial pressure which may include headache, nausea, vomiting or poorly controlled vasogenic oedema.

Compliance with Written Authority Required procedures

 

C9149

 

 

Relapsed or recurrent glioblastoma
Grandfathering treatment
Patient must have confirmed glioblastoma; AND
Patient must have had radiologic evidence of evaluable disease at the time non-PBS subsidised treatment with this drug for this condition was initiated; AND
Patient must have had evidence of symptomatic progression at the time non-PBS subsidised treatment with this drug for this condition was initiated; AND
Patient must have failed to achieve an adequate response to, or be intolerant to, temozolomide; AND
Patient must have been receiving non-PBS subsidised treatment with this drug for this condition prior to 1 August 2019; AND
Patient must have had an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less at the time non-PBS subsidised treatment with this drug for this condition was initiated; AND
Patient must not have developed further symptomatic progression while being treated with this drug for this condition; AND
The treatment must not exceed a dose of 10 mg per kg every 2 weeks; OR
The treatment must not exceed a dose of 15 mg per kg every 3 weeks.
A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria.
The authority application must be made in writing and must include:
(1) a completed authority prescription form;
(2) a completed Glioblastoma PBS Authority Application - Supporting Information Form, which includes the following:
(a) evidence of confirmed glioblastoma confirmed by radiology report; and
(b) confirmation that the patient has failed to achieve an adequate response to, or is intolerant to, temozolomide.
Symptomatic progression is defined as:
i) Deterioration of neurologic function which may include motor dysfunction, seizures, lack of co-ordination, changes to personality, reduced ability to communicate, neurocognitive decline; OR
ii) Increasing symptoms of raised intracranial pressure which may include headache, nausea, vomiting or poorly controlled vasogenic oedema.

Compliance with Written Authority Required procedures

 

C9166

 

 

Relapsed or recurrent glioblastoma
Initial treatment
Patient must have confirmed glioblastoma; AND
Patient must have radiologic evidence of evaluable disease; AND
Patient must have evidence of symptomatic progression; AND
Patient must have failed to achieve an adequate response to, or be intolerant to, temozolomide; AND
Patient must not receive more than 8 weeks of treatment per initial treatment course authorised under this restriction; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
Patient must not have received prior treatment with this drug for this condition; AND
The treatment must not exceed a dose of 10 mg per kg every 2 weeks; OR
The treatment must not exceed a dose of 15 mg per kg every 3 weeks.
The authority application must be made in writing and must include:
(1) a completed authority prescription form;
(2) a completed Glioblastoma PBS Authority Application - Supporting Information Form, which includes the following:
(a) evidence of confirmed glioblastoma confirmed by radiology report; and
(b) confirmation that the patient has failed to achieve an adequate response to, or is intolerant to, temozolomide.
Symptomatic progression is defined as:
i) Deterioration of neurologic function which may include motor dysfunction, seizures, lack of co-ordination, changes to personality, reduced ability to communicate, neurocognitive decline; OR
ii) Increasing symptoms of raised intracranial pressure which may include headache, nausea, vomiting or poorly controlled vasogenic oedema.

Compliance with Written Authority Required procedures

[118]        Schedule 4, Part 1, entry for Certolizumab pegol

                   (a)        omit:

 

C4830

P4830

 

Severe psoriatic arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2 (change or recommencement of treatment) - balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 18 to 20 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment) restriction to complete 18 to 20 weeks treatment; AND
The treatment must provide no more than the balance of up to 18 to 20 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

Compliance with Authority Required procedures

 

C4853

P4853

 

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

Compliance with Authority Required procedures

 

C6396

P6396

 

Severe psoriatic arthritis
Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more)
Patient must have severe active psoriatic arthritis; AND
Patient must have received no prior PBS-subsidised treatment with a biological agent for this condition; OR
Patient must have received no PBS-subsidised treatment with a biological agent for at least 5 years if they have previously received PBS-subsidised treatment with a biological agent for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation 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) an 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).
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.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement.

Compliance with Written Authority Required procedures

 

C6460

P6460

 

Severe psoriatic arthritis
Initial treatment – Initial 2 (change or recommencement of treatment)
Patient must have a documented history of severe active psoriatic arthritis; AND
Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug during the current Treatment Cycle; AND
Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug.
Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been 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 submitted no later than 4 weeks from the date that course was ceased.
Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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

 

C6474

P6474

 

Severe psoriatic arthritis
Continuing treatment
Patient must have a documented history of severe active psoriatic arthritis; AND
Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND
Patient must demonstrate, at the time of application, 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 an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications.
All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.
Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.

Compliance with Written Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9063

P9063

 

Severe psoriatic arthritis
Continuing treatment - balance of supply
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.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

Compliance with Authority Required procedures

 

C9073

P9073

 

Severe psoriatic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9074

P9074

 

Severe psoriatic arthritis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic 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 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; 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 18 to 20 weeks of treatment, depending on the dosage regimen, 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 Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C9105

P9105

 

Severe psoriatic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic 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.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9183

P9183

 

Severe psoriatic arthritis
Initial treatment - Initial 1 (new patient)
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation 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) an 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).
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.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C9185

P9185

 

Severe psoriatic arthritis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 18 to 20 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 5 years) restriction to complete 18 to 20 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 5 years) restriction to complete 18 to 20 weeks treatment; AND
The treatment must provide no more than the balance of up to 18 to 20 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

Compliance with Authority Required procedures

[119]        Schedule 4, Part 1, entry for Dasatinib

                   (a)        omit: 

 

C6905

P6905

 

Acute lymphoblastic leukaemia
Initial treatment
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL; AND
Patient must have failed treatment with chemotherapy; AND
Patient must have failed treatment with imatinib; AND
Patient must have failed an allogeneic haemopoeitic stem cell transplantation if applicable; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Failure of treatment is defined as either:
(i) Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with intensive chemotherapy and imatinib;
(ii) Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by chemotherapy and imatinib;
(iii) Morphological or cytogenetic relapse or persistence of leukaemia after allogeneic haemopoietic stem cell transplantation.
Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; OR the presence of cells expressing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Acute Lymphoblastic Leukaemia Dasatinib PBS Authority Application - Supporting Information Form; and
(c) a signed patient acknowledgement; and
(d) a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript. The date of the relevant pathology report(s) need(s) to be provided.

Compliance with Authority Required procedures

 

C6906

P6906

 

Acute lymphoblastic leukaemia
Continuing treatment
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must not have progressed; AND
The treatment must be the sole PBS-subsidised therapy for this condition.

Compliance with Authority Required procedures

 

C6926

P6926

 

Acute lymphoblastic leukaemia
Initial Treatment
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL; AND
Patient must have been treated for this condition prior to 1 December 2007; AND
Patient must have failed treatment with chemotherapy; AND
Patient must have failed an allogeneic haemopoeitic stem cell transplantation if applicable; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; OR the presence of cells expressing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Acute Lymphoblastic Leukaemia Dasatinib PBS Authority Application - Supporting Information Form; and
(c) a signed patient acknowledgement; and
(d) a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript. The date of the relevant pathology report(s) need(s) to be provided.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9059

P9059

 

Acute lymphoblastic leukaemia
Initial treatment
Patient must be newly diagnosed; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL; AND
The treatment must be for induction and consolidation therapy; AND
The treatment must be in combination with chemotherapy or corticosteroids; AND
Patient must not have previously experienced a failure to respond to the PBS-subsidised first line treatment with this drug for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first-line therapy for this condition.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Acute Lymphoblastic Leukaemia Dasatinib PBS Authority Application - Supporting Information Form; and
(c) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow. (The date of the relevant pathology report needs to be provided).

Compliance with Written Authority Required procedures

 

C9098

P9098

 

Acute lymphoblastic leukaemia
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised treatment with imatinib as a first-line therapy for this condition; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL; AND
The treatment must be for maintenance of first complete remission; AND
The treatment must be in combination with chemotherapy or corticosteroids.
Dasatinib and imatinib are available with a lifetime maximum of 24 months for continuing treatment for patients with acute lymphoblastic leukaemia reimbursed through the PBS in this treatment setting.

Compliance with Authority Required procedures

 

C9100

P9100

 

Acute lymphoblastic leukaemia
Initial treatment
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL; AND
Patient must have failed treatment with chemotherapy; AND
Patient must have failed treatment with imatinib; AND
Patient must have failed an allogeneic haemopoeitic stem cell transplantation if applicable; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Failure of treatment is defined as either:
(i) Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with intensive chemotherapy and imatinib;
(ii) Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by chemotherapy and imatinib;
(iii) Morphological or cytogenetic relapse or persistence of leukaemia after allogeneic haemopoietic stem cell transplantation.
Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; OR the presence of cells expressing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Acute Lymphoblastic Leukaemia Dasatinib PBS Authority Application - Supporting Information Form; and
(c) a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript. The date of the relevant pathology report(s) need(s) to be provided.

Compliance with Written Authority Required procedures

 

C9136

P9136

 

Acute lymphoblastic leukaemia
Continuing treatment
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition as second-line therapy following treatment with imatinib; AND
The condition must not have progressed; AND
The treatment must be the sole PBS-subsidised therapy for this condition.

Compliance with Authority Required procedures

[120]        Schedule 4, Part 1, entry for Etanercept

                   (a)        omit:

 

C7177

P7177

 

Severe psoriatic arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2 (change or recommencement of treatment after a break of less than 5 years) - balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) 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 of less than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

Compliance with Authority Required procedures

 

C7181

P7181

 

Severe psoriatic arthritis
First continuing treatment
Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND
Patient must demonstrate, at the time of application, an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used for all subsequent continuing treatments.
The application for first continuing treatment with this drug must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.
Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this Treatment Cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological agent was approved in this Cycle and the date of the first application under the new Cycle.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.

Compliance with Written Authority Required procedures

 

C7217

P7217

 

Severe psoriatic arthritis
Subsequent continuing treatment
Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; 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 under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological agent was issued in this cycle and the date of the first application under a new cycle.

Compliance with Authority Required procedures - Streamlined Authority Code 7217

 

C7219

P7219

 

Severe psoriatic arthritis
Continuing treatment - balance of supply
Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

Compliance with Authority Required procedures

 

C7220

P7220

 

Severe psoriatic arthritis
Initial treatment – Initial 2 (change or recommencement of treatment after a break of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents for this condition within this Treatment Cycle; AND
Patient must not failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current Treatment Cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug.
Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy with this biological agent), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been submitted to the Department of Human Services 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 accessed under the continuing treatment criteria, the patient must have been assessed for response, and the assessment submitted, where applicable to the Department of Human Services.
Where this is the initial course of treatment with a particular biological agent (change of treatment) the assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of treatment and submitted to the Department of Human Services no later than 4 weeks from the cessation of the treatment course.
Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment.
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological agent was issued in this cycle and the date of the first application under a new cycle.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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

 

C7224

P7224

 

Severe psoriatic arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more)
Patient must have received no prior PBS-subsidised treatment with a biological agent for this condition; OR
Patient must have received no PBS-subsidised treatment with a biological agent for at least 5 years if they have previously received PBS-subsidised treatment with a biological agent for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation 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) an 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).
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.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement.
The assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of treatment and submitted to the Department of Human Services no later than 4 weeks from the cessation of the treatment course. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this Treatment Cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological agent was approved in this Cycle and the date of the first application under the new Cycle.

Compliance with Written Authority Required procedures

 

C7251

P7251

 

Severe psoriatic arthritis
Subsequent continuing treatment
Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
Each application for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. Where a response assessment is not submitted the patient will be deemed to have failed to respond to treatment with this drug.
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this Treatment Cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological agent was approved in this Cycle and the date of the first application under the new Cycle.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.

Compliance with Written Authority Required procedures

                   (b)        omit:

 

C8880

P8880

 

Severe chronic plaque psoriasis
First continuing treatment, Whole body
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
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 1 month old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
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 conducted within the required 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 within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Authority Required procedures

                   (c)        omit:

 

C8888

P8888

 

Severe chronic plaque psoriasis
Initial 1, Whole body or Face, hand, foot (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break of less than 5 years) - balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (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, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (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, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a dermatologist.

Compliance with Authority Required procedures


 

                   (d)        insert in numerical order after existing text:

 

C9064

P9064

 

Severe psoriatic arthritis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
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 5 years) 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 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

Compliance with Authority Required procedures

 

C9081

P9081

 

Severe psoriatic arthritis
Continuing treatment - balance of supply
Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

Compliance with Authority Required procedures

 

C9082

P9082

 

Severe psoriatic arthritis
Initial treatment - Initial 1 (new patient)
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation 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) an 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).
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.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C9084

P9084

 

Severe psoriatic arthritis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic 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 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; 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 Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C9123

P9123

 

Severe psoriatic arthritis
First continuing treatment
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.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9140

P9140

 

Severe psoriatic arthritis
Subsequent continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; 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 subsequent continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
Where the most recent course of PBS-subsidised treatment with this drug was approved under the first continuing treatment restriction, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9152

P9152

 

Severe chronic plaque psoriasis
: Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (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, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (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, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a dermatologist.

Compliance with Authority Required procedures

 

C9156

P9156

 

Severe psoriatic arthritis
Subsequent continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; 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 subsequent continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
The measurement of response to the prior course of therapy must have been conducted following a minimum of 12 weeks of therapy with this drug and must be documented in the patient's medical records.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 9156

 

C9162

P9162

 

Severe chronic plaque psoriasis
First continuing treatment, Whole body
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
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 1 month old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
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 conducted within the required 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 within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9177

P9177

 

Severe psoriatic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

[121]        Schedule 4, Part 1, entry for Golimumab

                   (a)        omit:

 

C4845

P4845

 

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

Compliance with Authority Required procedures

 

C4851

P4851

 

Severe psoriatic arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2 (change or recommencement of treatment) - balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

Compliance with Authority Required procedures

 

C6437

P6437

 

Severe psoriatic arthritis
Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more)
Patient must have severe active psoriatic arthritis; AND
Patient must have received no prior PBS-subsidised treatment with a biological agent for this condition; OR
Patient must have received no PBS-subsidised treatment with a biological agent for at least 5 years if they have previously received PBS-subsidised treatment with a biological agent for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation 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) an 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).
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.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement.

Compliance with Written Authority Required procedures

 

C6439

P6439

 

Severe psoriatic arthritis
Continuing treatment
Patient must have a documented history of severe active psoriatic arthritis; AND
Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND
Patient must demonstrate, at the time of application, 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 an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications.
All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.
Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.

Compliance with Written Authority Required procedures

 

C6445

P6445

 

Severe psoriatic arthritis
Initial treatment – Initial 2 (change or recommencement of treatment)
Patient must have a documented history of severe active psoriatic arthritis; AND
Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug during the current Treatment Cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug.
Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been 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 submitted no later than 4 weeks from the date that course was ceased.
Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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

                   (b)        insert in numerical order after existing text:

 

C9063

P9063

 

Severe psoriatic arthritis
Continuing treatment - balance of supply
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.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

Compliance with Authority Required procedures

 

C9064

P9064

 

Severe psoriatic arthritis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
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 5 years) 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 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

Compliance with Authority Required procedures

 

C9069

P9069

 

Severe psoriatic arthritis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic 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 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; 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 Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C9105

P9105

 

Severe psoriatic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic 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.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9153

P9153

 

Severe psoriatic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in in biological medicine of less than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; 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 erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9155

P9155

 

Severe psoriatic 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 psoriatic arthritis.
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation 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) an 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).
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.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

[122]        Schedule 4, Part 1, entry for Imatinib

                   (a)        omit entries for “C6539”, “C6540” and “C6550” and substitute:

 

C6539

P6539

 

Myelodysplastic or myeloproliferative disorder
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be PDGFRB fusion gene-positive; AND
Patient must have achieved and maintained a complete haematological response; AND
The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must not exceed a maximum dose of 400 mg per day.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and
(c) a copy of the full blood examination report which demonstrates a complete haematological response; and
(d) a statement that the disease has not progressed on imatinib therapy

Compliance with Written Authority Required procedures

 

C6540

P6540

 

Aggressive systemic mastocytosis with eosinophilia
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene; AND
Patient must have achieved and maintained a complete haematological response; AND
The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must not exceed a maximum dose of 400 mg per day.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and
(c) a copy of the full blood examination report which demonstrates a complete haematological response; and
(d) a statement that the disease has not progressed on imatinib therapy

Compliance with Written Authority Required procedures

 

C6550

P6550

 

Chronic eosinophilic leukaemia or Hypereosinophilic syndrome
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have achieved and maintained a complete haematological response; AND
The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must not exceed a maximum dose of 400 mg per day.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and
(c) a copy of the full blood examination report which demonstrates a complete haematological response, with a normal eosinophil count; and
(d) a statement that the disease has not progressed on imatinib therapy

Compliance with Written Authority Required procedures

                   (b)        omit:

 

C6896

P6896

 

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

Compliance with Written Authority Required procedures

 

C6942

P6942

 

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

Compliance with Written Authority Required procedures

                   (c)        omit:

 

C7884

P7884

 

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

Compliance with Authority Required procedures

                   (d)        insert in numerical order after existing text:

 

C9086

P9086

 

Acute lymphoblastic leukaemia
Initial treatment
Patient must be newly diagnosed; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL; AND
The treatment must be for induction and consolidation therapy; AND
The treatment must be in combination with chemotherapy or corticosteroids; AND
Patient must not have previously experienced a failure to respond to the PBS-subsidised first line treatment with this drug for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first line therapy for this condition.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Acute Lymphoblastic Leukaemia Imatinib PBS Authority Application - Supporting Information Form; and
(c) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow. (The date of the relevant pathology report needs to be provided).

Compliance with Written Authority Required procedures

 

C9124

P9124

 

Acute lymphoblastic leukaemia
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised treatment with dasatinib as a first-line therapy for this condition; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL; AND
The treatment must be for maintenance of first complete remission; AND
The treatment must be in combination with chemotherapy or corticosteroids.
Dasatinib and imatinib are available with a lifetime maximum of 24 months for continuing treatment for patients with acute lymphoblastic leukaemia reimbursed through the PBS in this treatment setting.

Compliance with Authority Required procedures

[123]        Schedule 4, Part 1, entry for Ixekizumab

                   (a)        omit:

 

C8562

P8562

 

Severe psoriatic arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break in therapy of 5 years or more)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must not have received prior PBS-subsidised treatment with a biological medicine for this condition; OR
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition in the previous 5 years; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 20 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation 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) an 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).
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.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
The assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of treatment and conducted no later than 4 weeks from the cessation of the treatment course. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was issued in this cycle and the date of the first application under a new cycle.

Compliance with Written Authority Required procedures

 

C8583

P8583

 

Severe psoriatic arthritis
Initial treatment - Initial 1 (new patient or recommencement of treatment after more than 5 years break in therapy ) or Initial 2 (change or recommencement of treatment after a break in therapy of less than 5 years) - balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient or recommencement of treatment after more than 5 years break in therapy) restriction to complete 20 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 therapy of less than 5 years) restriction to complete 20 weeks treatment; AND
The treatment must provide no more than the balance of up to 20 weeks treatment available under the above restrictions.
Patient must be aged 18 years or older.

Compliance with Authority Required procedures

 

C8591

P8591

 

Severe psoriatic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in therapy of less than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 20 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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.
Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for continuing treatment, must be conducted no later than 1 month from the date of completion of this initial course of treatment.
Where the most recent course of PBS-subsidised treatment with this drug was accessed under the continuing treatment restriction, the patient must have been assessed for response, and the assessment conducted no later than 4 weeks from the date that course was ceased.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to 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.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was issued in this cycle and the date of the first application under a new cycle.

Compliance with Written Authority Required procedures

 

C8592

P8592

 

Severe psoriatic arthritis
Continuing treatment or Grandfathered patients - balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received insufficient therapy with this drug for this condition under the Continuing treatment restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Grandfathered treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Patient must be aged 18 years or older.

Compliance with Authority Required procedures

 

C8602

P8602

 

Severe psoriatic arthritis
Initial treatment - Initial 3 (Grandfather patients)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 March 2019; AND
Patient must be receiving treatment with this drug for this condition at the time of application; AND
Patient must have demonstrated an adequate response following at least 12 weeks of non-PBS subsidised treatment with this drug for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months prior to initiating non-PBS subsidised treatment with this drug for this condition; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
The following initiation 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) an 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).
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.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all continuing treatment applications.
The assessment of the patient's response to this PBS-subsidised course of therapy must be conducted no later than 4 weeks from the cessation of the treatment course.
Where an assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond, or to have failed to sustain a response to treatment with this drug.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and
(3) the date of commencement of this drug; and
(4) results of the baseline patient assessment prior to initiation of non-PBS subsidised therapy with this drug.

Compliance with Written Authority Required procedures

 

C8612

P8612

 

Severe psoriatic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have previously received PBS-subsidised treatment with this drug 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.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all continuing treatment applications.
An application for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be conducted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was issued in this cycle and the date of the first application under a new cycle.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.

Compliance with Written Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9116

P9116

 

Severe psoriatic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic 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.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9118

P9118

 

Severe psoriatic arthritis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic 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 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; 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 20 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 Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C9141

P9141

 

Severe psoriatic arthritis
Continuing treatment or Grandfathered patients - balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received insufficient therapy with this drug for this condition under the Continuing treatment restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Grandfathered 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

 

C9164

P9164

 

Severe psoriatic arthritis
Initial treatment - Grandfather treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 March 2019; AND
Patient must be receiving treatment with this drug for this condition at the time of application; AND
Patient must have demonstrated an adequate response following at least 12 weeks of non-PBS subsidised treatment with this drug for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months prior to initiating non-PBS subsidised treatment with this drug for this condition; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
The following initiation 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) an 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).
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.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
The assessment of the patient's response to this PBS-subsidised course of therapy must be conducted no later than 4 weeks from the cessation of the treatment course.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and
(3) the date of commencement of this drug; and
(4) results of the baseline patient assessment prior to initiation of non-PBS subsidised therapy with this drug.

Compliance with Written Authority Required procedures

 

C9172

P9172

 

Severe psoriatic arthritis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 20 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 5 years) restriction to complete 20 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 5 years) restriction to complete 20 weeks treatment; AND
The treatment must provide no more than the balance of up to 20 weeks treatment available under the above restrictions.

Compliance with Authority Required procedures

 

C9184

P9184

 

Severe psoriatic 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 psoriatic arthritis.
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 20 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation 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) an 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).
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.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C9194

P9194

 

Severe psoriatic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 20 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

[124]        Schedule 4, Part 1, entry for Lanreotide

                           insert in numerical order after existing text:

 

C9161

 

 

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be as monotherapy.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.
Lanreotide is not PBS-subsidised for use in combination with everolimus or sunitinib for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9161

[125]        Schedule 4, Part 1, entry for Pembrolizumab

                   (a)        omit:

 

C6801

 

 

Unresectable Stage III or Stage IV malignant melanoma
Continuing treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must not exceed a maximum dose of 2 mg per kg every 3 weeks.

Compliance with Authority Required procedures - Streamlined Authority Code 6801

 

C6806

 

 

Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 1
The condition must be positive for a BRAF V600 mutation; AND
The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) unless contraindicated or not tolerated according to the TGA approved Product Information; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 6 doses at a maximum dose of 2 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 6806

 

C6817

 

 

Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 2
The condition must be negative for a BRAF V600 mutation; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 6 doses at a maximum dose of 2 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 6817

                   (b)        insert in numerical order after existing text:

 

C9044

 

 

Unresectable Stage III or Stage IV malignant melanoma
Continuing treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must not exceed a maximum dose administered every 3 weeks fixed at 200 mg.

Compliance with Authority Required procedures - Streamlined Authority Code 9044

 

C9127

 

 

Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 2
The condition must be negative for a BRAF V600 mutation; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 6 doses administered every 3 weeks, with each maximum dose fixed at 200 mg.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 9127

 

C9178

 

 

Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 1
The condition must be positive for a BRAF V600 mutation; AND
The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) unless contraindicated or not tolerated according to the TGA approved Product Information; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 6 doses administered every 3 weeks, with each maximum dose fixed at 200 mg.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 9178

[126]        Schedule 4, Part 1, entry for Secukinumab

                   (a)        omit:

 

C6415

P6415

 

Severe psoriatic arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2 (change or recommencing treatment after a break of less than 5 years) - balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete maximum of 16 weeks of treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencing treatment after a break of less than 5 years) restriction to complete maximum of 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.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

Compliance with Authority Required procedures

 

C6439

P6439

 

Severe psoriatic arthritis
Continuing treatment
Patient must have a documented history of severe active psoriatic arthritis; AND
Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND
Patient must demonstrate, at the time of application, 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 an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications.
All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.
Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.

Compliance with Written Authority Required procedures

 

C6482

P6482

 

Severe psoriatic arthritis
initial treatment - Initial 2 (change or recommencing treatment after a break of less than 5 years )
Patient must have a documented history of severe active psoriatic arthritis; AND
Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug during the current Treatment Cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug.
Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been 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 submitted no later than 4 weeks from the date that course was ceased.
Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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

 

C6484

P6484

 

Severe psoriatic arthritis
Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more)
Patient must have severe active psoriatic arthritis; AND
Patient must have received no prior PBS-subsidised treatment with a biological agent for this condition; OR
Patient must have received no PBS-subsidised treatment with a biological agent for at least 5 years if they have previously received PBS-subsidised treatment with a biological agent for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation 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) an 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).
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.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement.

Compliance with Written Authority Required procedures

                   (b)        omit:

 

C8217

P8217

 

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

Compliance with Authority Required procedures

                   (c)        insert in numerical order after existing text:

 

C9063

P9063

 

Severe psoriatic arthritis
Continuing treatment - balance of supply
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.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

Compliance with Authority Required procedures

 

C9064

P9064

 

Severe psoriatic arthritis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
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 5 years) 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 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

Compliance with Authority Required procedures

 

C9069

P9069

 

Severe psoriatic arthritis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic 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 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; 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 Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C9078

P9078

 

Severe psoriatic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in in biological medicine of less than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; 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 erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9105

P9105

 

Severe psoriatic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic 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.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9155

P9155

 

Severe psoriatic 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 psoriatic arthritis.
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation 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) an 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).
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.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

[127]        Schedule 4, Part 1, entry for Tocilizumab

                           insert in numerical order after existing text:

 

C9046

P9046

 

Severe active juvenile idiopathic 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 have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; 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; OR
Patient must have received no PBS-subsidised bDMARD treatment for at least 5 years if they failed or ceased to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) in their last treatment cycle; 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.
For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab.
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 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) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine 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.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
If a patient fails to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle. A patient may re-trial tocilizumab after a minimum of 5 years have elapsed between the date of the last approval for PBS-subsidised bDMARD therapy in the last treatment cycle and the date of the first application under a new treatment cycle.

Compliance with Written Authority Required procedures

 

C9047

P9047

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after break of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have received prior PBS-subsidised treatment with adalimumab, etanercept or tocilizumab for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with tocilizumab for this condition in the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
Applications for a patient who has received PBS-subsidised treatment with tocilizumab in this treatment cycle and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised tocilizumab treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised tocilizumab treatment 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 tocilizumab treatment was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with tocilizumab.
If a patient fails to respond to PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle.
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) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) 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, cervical spine 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

 

C9048

P9048

 

Severe active juvenile idiopathic 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 tocilizumab therapy 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 tocilizumab therapy 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

 

C9049

P9049

 

Severe active juvenile idiopathic 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 tocilizumab therapy 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

 

C9052

P9052

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 12 months) or Initial 2 (change or recommencement of treatment after break of less than 12 months) - balance of supply.
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received insufficient tocilizumab therapy under the Initial 1 (new patient or patient recommencing treatment after break of more than 12 months) restriction to complete 16 or 24 weeks treatment; OR
Patient must have received insufficient tocilizumab therapy under the Initial 2 (change or recommencement of treatment after break of less than 12 months) restriction to complete 16 or 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions for patients 30 kg or over; OR
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions for patients under 30 kg.

Compliance with Authority Required procedures

 

C9096

P9096

 

Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have a documented history of severe active juvenile idiopathic arthritis; AND
Patient must have demonstrated an adequate response to treatment with tocilizumab; AND
Patient must have received tocilizumab as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must be under 30kg; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept