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PB 84 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 (PBS) and related matters.
Administered by: Health
Registered 31 Oct 2019
Tabling HistoryDate
Tabled Senate11-Nov-2019

 

 

 

 

PB 84 of 2019

 

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 10)

 

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   30th October 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. 10).

(2)          This Instrument may also be cited as PB 84 of 2019.

2          Commencement

This Instrument commences on 1 November 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 Adalimumab in the form Injection 20 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 0]

                   (a)        omit from the column headed “Circumstances”: C5076 C5091 C5105 C5117 C7652 C7654 C7655 C7663 C7664                                                                                                                                                                                                                         substitute: C9662 C9663 C9666 C9672 C9673 C9674 C9715 C9717 C9722 C9748 C9798

                   (b)        omit from the column headed “Purposes”: P5105            substitute: P9798

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

                   (a)        omit from the column headed “Circumstances”: C5076 C5091 C5105 C5117 C7652 C7654 C7655 C7663 C7664                                                                                                                                                                                                                         substitute: C9662 C9663 C9666 C9672 C9673 C9674 C9715 C9717 C9722 C9748 C9798

                   (b)        omit from the column headed “Purposes”: P5076 P5117 P7652 P7655 P7664              substitute: P9662 P9663 P9672 P9673 P9715 P9722 P9748

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

                   (a)        omit from the column headed “Circumstances”: C5076 C5091 C5105 C5117 C7652 C7654 C7655 C7663 C7664                                                                                                                                                                                                                         substitute: C9662 C9663 C9666 C9672 C9673 C9674 C9715 C9717 C9722 C9748 C9798

                   (b)        omit from the column headed “Purposes”: P5091 P7654 P7663                      substitute: P9666 P9674 P9717

[4]              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”: C5075 C5076 C5090 C5091 C5105 C5117

                   (b)        omit from the column headed “Circumstances”: C7151 C7443 C7652 C7654 C7655 C7663 C7664 C8547 C8567 C8587 C8594

                   (c)        insert in numerical order in the column headed “Circumstances”: C9658 C9661 C9662 C9663 C9666 C9672 C9673 C9674 C9679 C9713 C9714 C9715 C9717 C9722 C9735 C9748 C9789 C9790 C9798 C9837

                   (d)        omit from the column headed “Purposes”: P5105            substitute: P9798

[5]              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”: C5075 C5076 C5090 C5091 C5105 C5117

                   (b)        omit from the column headed “Circumstances”: C7151 C7443 C7652 C7654 C7655 C7663 C7664 C8547 C8567 C8587 C8594

                   (c)        insert in numerical order in the column headed “Circumstances”: C9658 C9661 C9662 C9663 C9666 C9672 C9673 C9674 C9679 C9713 C9714 C9715 C9717 C9722 C9735 C9748 C9789 C9790 C9798 C9837

                   (d)        omit from the column headed “Purposes”: P5076 P5090 P5117 P7151 P7443 P7652 P7655 P7664 P8547 P8587 P8594                                                                                                                                                                                                                         substitute: P9658 P9662 P9663 P9672 P9673 P9679 P9713 P9714 P9715 P9722 P9735 P9748 P9789 P9837

[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: 3]

                   (a)        omit from the column headed “Circumstances”: C5075 C5076 C5090 C5091 C5105 C5117

                   (b)        omit from the column headed “Circumstances”: C7151 C7443 C7652 C7654 C7655 C7663 C7664 C8547 C8567 C8587 C8594

                   (c)        insert in numerical order in the column headed “Circumstances”: C9658 C9661 C9662 C9663 C9666 C9672 C9673 C9674 C9679 C9713 C9714 C9715 C9717 C9722 C9735 C9748 C9789 C9790 C9798 C9837

[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: 4]

                   (a)        omit from the column headed “Circumstances”: C5075 C5076 C5090 C5091 C5105 C5117

                   (b)        omit from the column headed “Circumstances”: C7151 C7443 C7652 C7654 C7655 C7663 C7664 C8547 C8567 C8587 C8594

                   (c)        insert in numerical order in the column headed “Circumstances”: C9658 C9661 C9662 C9663 C9666 C9672 C9673 C9674 C9679 C9713 C9714 C9715 C9717 C9722 C9735 C9748 C9789 C9790 C9798 C9837

[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: 5]

                   (a)        omit from the column headed “Circumstances”: C5075 C5076 C5090 C5091 C5105 C5117

                   (b)        omit from the column headed “Circumstances”: C7151 C7443 C7652 C7654 C7655 C7663 C7664 C8547 C8567 C8587 C8594

                   (c)        insert in numerical order in the column headed “Circumstances”: C9658 C9661 C9662 C9663 C9666 C9672 C9673 C9674 C9679 C9713 C9714 C9715 C9717 C9722 C9735 C9748 C9789 C9790 C9798 C9837

                   (d)        omit from the column headed “Purposes”: P5075 P5091

                   (e)        omit from the column headed “Purposes”: P7654 P7663 P8567

                    (f)        insert in numerical order in the column headed “Purposes”: P9661 P9666 P9674 P9717 P9790

[9]              Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe, 6

omit from the column headed “Circumstances”: C5076 C5090 C5117 C7151 C7443 C7652 C7655 C7664 C8547 C8587 C8594                                                                                                                                                                             substitute: C9658 C9662 C9663 C9672 C9673 C9679 C9713 C9714 C9715 C9722 C9735 C9748 C9789 C9837

[10]            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”: C5075 C5076 C5090 C5091 C5105 C5117

                   (b)        omit from the column headed “Circumstances”: C7151 C7443 C7652 C7654 C7655 C7663 C7664 C8547 C8567 C8587 C8594

                   (c)        insert in numerical order in the column headed “Circumstances”: C9658 C9661 C9662 C9663 C9666 C9672 C9673 C9674 C9679 C9713 C9714 C9715 C9717 C9722 C9735 C9748 C9789 C9790 C9798 C9837

                   (d)        omit from the column headed “Purposes”: P5105            substitute: P9798

[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: 2]

                   (a)        omit from the column headed “Circumstances”: C5075 C5076 C5090 C5091 C5105 C5117

                   (b)        omit from the column headed “Circumstances”: C7151 C7443 C7652 C7654 C7655 C7663 C7664 C8547 C8567 C8587 C8594

                   (c)        insert in numerical order in the column headed “Circumstances”: C9658 C9661 C9662 C9663 C9666 C9672 C9673 C9674 C9679 C9713 C9714 C9715 C9717 C9722 C9735 C9748 C9789 C9790 C9798 C9837

                   (d)        omit from the column headed “Purposes”: P5076 P5090 P5117 P7151 P7443 P7652 P7655 P7664 P8547 P8587 P8594                                                                                                                                                                                                                         substitute: P9658 P9662 P9663 P9672 P9673 P9679 P9713 P9714 P9715 P9722 P9735 P9748 P9789 P9837

[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: 3]

                   (a)        omit from the column headed “Circumstances”: C5075 C5076 C5090 C5091 C5105 C5117

                   (b)        omit from the column headed “Circumstances”: C7151 C7443 C7652 C7654 C7655 C7663 C7664 C8547 C8567 C8587 C8594

                   (c)        insert in numerical order in the column headed “Circumstances”: C9658 C9661 C9662 C9663 C9666 C9672 C9673 C9674 C9679 C9713 C9714 C9715 C9717 C9722 C9735 C9748 C9789 C9790 C9798 C9837

[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: 4]

                   (a)        omit from the column headed “Circumstances”: C5075 C5076 C5090 C5091 C5105 C5117

                   (b)        omit from the column headed “Circumstances”:C7151 C7443 C7652 C7654 C7655 C7663 C7664 C8547 C8567 C8587 C8594

                   (c)        insert in numerical order in the column headed “Circumstances”: C9658 C9661 C9662 C9663 C9666 C9672 C9673 C9674 C9679 C9713 C9714 C9715 C9717 C9722 C9735 C9748 C9789 C9790 C9798 C9837

[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: 5]

                   (a)        omit from the column headed “Circumstances”: C5075 C5076 C5090 C5091 C5105 C5117

                   (b)        omit from the column headed “Circumstances”: C7151 C7443 C7652 C7654 C7655 C7663 C7664 C8547 C8567 C8587 C8594

                   (c)        insert in numerical order in the column headed “Circumstances”: C9658 C9661 C9662 C9663 C9666 C9672 C9673 C9674 C9679 C9713 C9714 C9715 C9717 C9722 C9735 C9748 C9789 C9790 C9798 C9837

                   (d)        omit from the column headed “Purposes”: P5075 P5091

                   (e)        omit from the column headed “Purposes”: P7654 P7663 P8567

                    (f)        insert in numerical order in the column headed “Purposes”: P9661 P9666 P9674 P9717 P9790

[15]            Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen, 6

                   (a)        omit from the column headed “Circumstances”: C5076 C5090 C5117

                   (b)        omit from the column headed “Circumstances”: C7151 C7443 C7652 C7655 C7664 C8547 C8587 C8594

                   (c)        insert in numerical order in the column headed “Circumstances”: C9658 C9662 C9663 C9672 C9673 C9679 C9713 C9714 C9715 C9722 C9735 C9748 C9789 C9837

[16]            Schedule 1, entry for Amisulpride in the form Tablet 200 mg

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

 

 

 

a

Amisulpride Sandoz Pharma

HX

MP NP

C4246

 

60

5

60

 

 

[17]            Schedule 1, entry for Bosentan in the form Tablet 62.5 mg (as monohydrate)

omit from the column headed “Responsible Person” for the brand “Tracleer”: AT    substitute: JC

[18]            Schedule 1, entry for Bosentan in the form Tablet 125 mg (as monohydrate)

omit from the column headed “Responsible Person” for the brand “Tracleer”: AT    substitute: JC

[19]            Schedule 1, entry for Calcium

substitute:

Calcium

Tablet, chewable, 500 mg (as carbonate)

Oral

 

Cal-500

PP

MP NP

C4586

 

240

1

120

 

 

 

Tablet 600 mg (as carbonate)

Oral

 

Calci-Tab 600

AE

MP NP

C4586

 

240

1

240

 

 

[20]            Schedule 1, entry for Ciclosporin in the form Capsule 10 mg [Maximum Quantity: 120; Number of Repeats: 5]

                   (a)        omit from the column headed “Purposes”: P6629 P6630

                   (b)        omit from the column headed “Purposes”: P6659

                   (c)        omit from the column headed “Purposes”: P6670 P6671

                   (d)        insert in numerical order in the column headed “Purposes”: P9694 P9695 P9742 P9763 P9764

                   (e)        omit from the column headed “Maximum Quantity”: CN6629 CN6630

                    (f)        omit from the column headed “Maximum Quantity”: CN6659

                   (g)        omit from the column headed “Maximum Quantity”: CN6670 CN6671

                   (h)        insert in numerical order in the column headed “Maximum Quantity”: CN9694 CN9695 CN9742 CN9763 CN9764

                    (i)        omit from the column headed “Number of Repeats”: CN6629 CN6630

                    (j)        omit from the column headed “Number of Repeats”: CN6659

                   (k)        omit from the column headed “Number of Repeats”: CN6670 CN6671

                    (l)        insert in numerical order in the column headed “Number of Repeats”: CN9694 CN9695 CN9742 CN9763 CN9764

[21]            Schedule 1, entry for Ciclosporin in the form Capsule 25 mg

substitute:

 

Capsule 25 mg

Oral

a

Cyclosporin Sandoz

SZ

MP

 

 

60

3

30

 

 

 

 

 

a

Neoral 25

NV

MP

 

 

60

3

30

 

 

 

 

 

a

Cyclosporin Sandoz

SZ

MP

 

P6631 P6638 P6643 P6660 P6676 P9694 P9695 P9742 P9763 P9764

120
CN6631 CN6638 CN6643 CN6660 CN6676 CN9694 CN9695 CN9742 CN9763 CN9764

5
CN6631 CN6638 CN6643 CN6660 CN6676 CN9694 CN9695 CN9742 CN9763 CN9764

30

 

C(100)

 

 

 

a

Neoral 25

NV

MP

 

P6631 P6638 P6643 P6660 P6676 P9694 P9695 P9742 P9763 P9764

120
CN6631 CN6638 CN6643 CN6660 CN6676 CN9694 CN9695 CN9742 CN9763 CN9764

5
CN6631 CN6638 CN6643 CN6660 CN6676 CN9694 CN9695 CN9742 CN9763 CN9764

30

 

C(100)

[22]            Schedule 1, entry for Ciclosporin in the form Capsule 50 mg

substitute:

 

Capsule 50 mg

Oral

a

Cyclosporin Sandoz

SZ

MP

 

 

60

3

30

 

 

 

 

 

a

Neoral 50

NV

MP

 

 

60

3

30

 

 

 

 

 

a

Cyclosporin Sandoz

SZ

MP

 

P6631 P6638 P6643 P6660 P6676 P9694 P9695 P9742 P9763 P9764

120
CN6631 CN6638 CN6643 CN6660 CN6676 CN9694 CN9695 CN9742 CN9763 CN9764

5
CN6631 CN6638 CN6643 CN6660 CN6676 CN9694 CN9695 CN9742 CN9763 CN9764

30

 

C(100)

 

 

 

a

Neoral 50

NV

MP

 

P6631 P6638 P6643 P6660 P6676 P9694 P9695 P9742 P9763 P9764

120
CN6631 CN6638 CN6643 CN6660 CN6676 CN9694 CN9695 CN9742 CN9763 CN9764

5
CN6631 CN6638 CN6643 CN6660 CN6676 CN9694 CN9695 CN9742 CN9763 CN9764

30

 

C(100)

[23]            Schedule 1, entry for Ciclosporin in the form Capsule 100 mg

substitute:

 

Capsule 100 mg

Oral

a

Cyclosporin Sandoz

SZ

MP

 

 

60

3

30

 

 

 

 

 

a

Neoral 100

NV

MP

 

 

60

3

30

 

 

 

 

 

a

Cyclosporin Sandoz

SZ

MP

 

P6631 P6638 P6643 P6660 P6676 P9694 P9695 P9742 P9763 P9764

120
CN6631 CN6638 CN6643 CN6660 CN6676 CN9694 CN9695 CN9742 CN9763 CN9764

5
CN6631 CN6638 CN6643 CN6660 CN6676 CN9694 CN9695 CN9742 CN9763 CN9764

30

 

C(100)

 

 

 

a

Neoral 100

NV

MP

 

P6631 P6638 P6643 P6660 P6676 P9694 P9695 P9742 P9763 P9764

120
CN6631 CN6638 CN6643 CN6660 CN6676 CN9694 CN9695 CN9742 CN9763 CN9764

5
CN6631 CN6638 CN6643 CN6660 CN6676 CN9694 CN9695 CN9742 CN9763 CN9764

30

 

C(100)

[24]            Schedule 1, entry for Ciclosporin in the form Oral liquid 100 mg per mL, 50 mL [Maximum Quantity: 4; Number of Repeats: 5]

                   (a)        omit from the column headed “Purposes”: P6629 P6630

                   (b)        omit from the column headed “Purposes”: P6659

                   (c)        omit from the column headed “Purposes”: P6670 P6671

                   (d)        insert in numerical order in the column headed “Purposes”: P9694 P9695 P9742 P9763 P9764

                   (e)        omit from the column headed “Maximum Quantity”: CN6629 CN6630

                    (f)        omit from the column headed “Maximum Quantity”: CN6659

                   (g)        omit from the column headed “Maximum Quantity”: CN6670 CN6671

                   (h)        insert in numerical order in the column headed “Maximum Quantity”: CN9694 CN9695 CN9742 CN9763 CN9764

                    (i)        omit from the column headed “Number of Repeats”: CN6629 CN6630

                    (j)        omit from the column headed “Number of Repeats”: CN6659

                   (k)        omit from the column headed “Number of Repeats”: CN6670 CN6671

                    (l)        insert in numerical order in the column headed “Number of Repeats”: CN9694 CN9695 CN9742 CN9763 CN9764

[25]            Schedule 1, entry for Ciclosporin in the form Solution concentrate for I.V. infusion 50 mg in 1 mL

                   (a)        omit from the column headed “Circumstances”: C6677

                   (b)        insert in numerical order in the column headed “Circumstances”: C9831

[26]            Schedule 1, entry for Dabrafenib in the form Capsule 50 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances”: C6044

                   (b)        insert in numerical order in the column headed “Circumstances”: C9643 C9645 C9646 C9842

                   (c)        omit from the column headed “Purposes”: P6044            substitute: P9643 P9645 P9646 P9842

[27]            Schedule 1, entry for Dabrafenib in the form Capsule 50 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C6044

                   (b)        insert in numerical order in the column headed “Circumstances”: C9643 C9645 C9646 C9842

[28]            Schedule 1, entry for Dabrafenib in the form Capsule 75 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances”: C6044

                   (b)        insert in numerical order in the column headed “Circumstances”: C9643 C9645 C9646 C9842

                   (c)        omit from the column headed “Purposes”: P6044            substitute: P9643 P9645 P9646 P9842

[29]            Schedule 1, entry for Dabrafenib in the form Capsule 75 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C6044

                   (b)        insert in numerical order in the column headed “Circumstances”: C9643 C9645 C9646 C9842

[30]            Schedule 1, entry for Darbepoetin alfa in all forms

                   (a)        omit from the column headed “Circumstances”: C6260

                   (b)        insert in numerical order in the column headed “Circumstances”: C9688

[31]            Schedule 1, entry for Desferrioxamine in each of the forms: Powder for injection containing desferrioxamine mesilate 500 mg; and Powder for injection containing desferrioxamine mesilate 2 g

                   (a)        omit from the column headed “Circumstances”: C6408

                   (b)        insert in numerical order in the column headed “Circumstances”: C9696

[32]            Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL

omit:

 

 

 

 

Docetaxel Sandoz

SZ

MP

 

 

See Note 3

See Note 3

1

 

D(100)

[33]            Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as hyclate) [Brand: Doxsig; Maximum Quantity: 21; Number of Repeats: 0]

substitute:

 

 

 

 

Doxsig

RW

MP NP

 

P4485

21

0

7

 

 

 

 

 

 

 

 

MP NP

 

P4485

21

0

21

 

 

[34]            Schedule 1, entry for Enoxaparin in the form Injection containing enoxaparin sodium 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre-filled syringe [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

Clexane Safety‑Lock

AV

MP NP

 

 

20

1

10

 

 

[35]            Schedule 1, entry for Enoxaparin in the form Injection containing enoxaparin sodium 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre-filled syringe [Maximum Quantity: 20; Number of Repeats: 3]

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

 

 

 

a

Clexane Safety‑Lock

AV

MP NP

 

P4910

20

3

10

 

 

[36]            Schedule 1, entry for Enoxaparin in the form 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: 1]

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

 

 

 

a

Clexane Safety‑Lock

AV

MP NP

 

 

20

1

10

 

 

[37]            Schedule 1, entry for Enoxaparin in the form 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: 3]

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

 

 

 

a

Clexane Safety‑Lock

AV

MP NP

 

P4910

20

3

10

 

 

[38]            Schedule 1, entry for Enoxaparin in the form Injection containing enoxaparin sodium 60 mg (6,000 I.U. anti-Xa) in 0.6 mL pre-filled syringe [Maximum Quantity: 10; Number of Repeats: 1]

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

 

 

 

a

Clexane Safety‑Lock

AV

MP NP

 

 

10

1

10

 

 

[39]            Schedule 1, entry for Enoxaparin in the form Injection containing enoxaparin sodium 60 mg (6,000 I.U. anti-Xa) in 0.6 mL pre-filled syringe [Maximum Quantity: 20; Number of Repeats: 3]

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

 

 

 

a

Clexane Safety‑Lock

AV

MP NP

 

P4910

20

3

10

 

 

[40]            Schedule 1, entry for Enoxaparin in the form Injection containing enoxaparin sodium 80 mg (8,000 I.U. anti-Xa) in 0.8 mL pre-filled syringe [Maximum Quantity: 10; Number of Repeats: 1]

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

 

 

 

a

Clexane Safety‑Lock

AV

MP NP

 

 

10

1

10

 

 

[41]            Schedule 1, entry for Enoxaparin in the form Injection containing enoxaparin sodium 80 mg (8,000 I.U. anti-Xa) in 0.8 mL pre-filled syringe [Maximum Quantity: 20; Number of Repeats: 3]

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

 

 

 

a

Clexane Safety‑Lock

AV

MP NP

 

P4910

20

3

10

 

 

[42]            Schedule 1, entry for Enoxaparin in the form Injection containing enoxaparin sodium 100 mg (10,000 I.U. anti-Xa) in 1 mL pre-filled syringe [Maximum Quantity: 10; Number of Repeats: 1]

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

 

 

 

a

Clexane Safety‑Lock

AV

MP NP

 

 

10

1

10

 

 

[43]            Schedule 1, entry for Enoxaparin in the form Injection containing enoxaparin sodium 100 mg (10,000 I.U. anti-Xa) in 1 mL pre-filled syringe [Maximum Quantity: 20; Number of Repeats: 3]

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

 

 

 

a

Clexane Safety‑Lock

AV

MP NP

 

P4910

20

3

10

 

 

[44]            Schedule 1, entry for Epoetin alfa in all forms

                   (a)        omit from the column headed “Circumstances”: C6260

                   (b)        insert in numerical order in the column headed “Circumstances”: C9688

[45]            Schedule 1, entry for Epoetin beta in all forms

                   (a)        omit from the column headed “Circumstances”: C6260

                   (b)        insert in numerical order in the column headed “Circumstances”: C9688

[46]            Schedule 1, entry for Epoetin lambda in all forms

                   (a)        omit from the column headed “Circumstances”: C6260

                   (b)        insert in numerical order in the column headed “Circumstances”: C9688

[47]            Schedule 1, entry for Epoprostenol in the form Powder for I.V. infusion 500 micrograms (as sodium)

omit from the column headed “Responsible Person”: AT            substitute: JC

[48]            Schedule 1, entry for Epoprostenol in the form Powder for I.V. infusion 1.5 mg (as sodium)

omit from the column headed “Responsible Person”: AT            substitute: JC

[49]            Schedule 1, entry for Etoposide in the form Capsule 50 mg

omit from the column headed “Responsible Person”: BQ           substitute: LM

[50]            Schedule 1, entry for Etoposide in the form Capsule 100 mg

omit from the column headed “Responsible Person”: BQ           substitute: LM

[51]            Schedule 1, entry for Etoposide in the form Powder for I.V. infusion 1 g (as phosphate)

omit from the column headed “Responsible Person”: BQ           substitute: LM

[52]            Schedule 1, entry for Everolimus in the form Tablet 0.25 mg [Maximum Quantity: 120; Number of Repeats: 5]

                   (a)        omit from the column headed “Purposes”: P5555 P5794

                   (b)        insert in numerical order in the column headed “Purposes”: P9691 P9693

                   (c)        omit from the column headed “Maximum Quantity”: CN5555 CN5794

                   (d)        insert in numerical order in the column headed “Maximum Quantity”: CN9691 CN9693

                   (e)        omit from the column headed “Number of Repeats”: CN5555 CN5794

                    (f)        insert in numerical order in the column headed “Number of Repeats”: CN9691 CN9693

[53]            Schedule 1, entry for Everolimus in the form Tablet 0.5 mg [Maximum Quantity: 120; Number of Repeats: 5]

                   (a)        omit from the column headed “Purposes”: P5555 P5794

                   (b)        insert in numerical order in the column headed “Purposes”: P9691 P9693

                   (c)        omit from the column headed “Maximum Quantity”: CN5555 CN5794

                   (d)        insert in numerical order in the column headed “Maximum Quantity”: CN9691 CN9693

                   (e)        omit from the column headed “Number of Repeats”: CN5555 CN5794

                    (f)        insert in numerical order in the column headed “Number of Repeats”: CN9691 CN9693

[54]            Schedule 1, entry for Everolimus in the form Tablet 0.75 mg [Maximum Quantity: 240; Number of Repeats: 5]

                   (a)        omit from the column headed “Purposes”: P5555 P5794

                   (b)        insert in numerical order in the column headed “Purposes”: P9691 P9693

                   (c)        omit from the column headed “Maximum Quantity”: CN5555 CN5794

                   (d)        insert in numerical order in the column headed “Maximum Quantity”: CN9691 CN9693

                   (e)        omit from the column headed “Number of Repeats”: CN5555 CN5794

                    (f)        insert in numerical order in the column headed “Number of Repeats”: CN9691 CN9693

[55]            Schedule 1, entry for Everolimus in the form Tablet 1 mg [Maximum Quantity: 240; Number of Repeats: 5]

                   (a)        omit from the column headed “Purposes”: P5555 P5794

                   (b)        insert in numerical order in the column headed “Purposes”: P9691 P9693

                   (c)        omit from the column headed “Maximum Quantity”: CN5555 CN5794

                   (d)        insert in numerical order in the column headed “Maximum Quantity”: CN9691 CN9693

                   (e)        omit from the column headed “Number of Repeats”: CN5555 CN5794

                    (f)        insert in numerical order in the column headed “Number of Repeats”: CN9691 CN9693

[56]            Schedule 1, entry for Fingolimod

insert as first entry:

 

Capsule 250 micrograms (as hydrochloride)

Oral

 

Gilenya

NV

MP

C9794 C9810

 

28

5

28

 

 

[57]            Schedule 1, entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg

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

 

 

 

 

Fludarabine Juno

JO

MP

 

 

See Note 3

See Note 3

1

 

PB(100)

[58]            Schedule 1, entry for Furosemide in the form Injection 20 mg in 2 mL

omit:

 

 

 

a

Frusemide Sandoz

SZ

MP NP

 

 

5

0

5

 

 

[59]            Schedule 1, entry for Gabapentin in the form Tablet 600 mg

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

 

 

 

a

Gabapentin APOTEX

TY

MP NP

C4928

 

100

5

100

 

 

[60]            Schedule 1, entry for Gabapentin in the form Tablet 800 mg

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

 

 

 

a

Gabapentin APOTEX

TY

MP NP

C4928

 

100

5

100

 

 

[61]            Schedule 1, entry for Golimumab in the form Injection 100 mg in 1 mL single use pre-filled pen [Maximum Quantity: 1; Number of Repeats: 1]

                   (a)        omit from the column headed “Circumstances”: C7666 C7671 C7684 C7685 C7827 C7853                  substitute: C9651 C9705 C9745 C9770 C9822 C9823

                   (b)        omit from the column headed “Purposes”: P7684            substitute: P9745

[62]            Schedule 1, entry for Golimumab in the form Injection 100 mg in 1 mL single use pre-filled pen [Maximum Quantity: 1; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C7666 C7671 C7684 C7685 C7827 C7853                  substitute: C9651 C9705 C9745 C9770 C9822 C9823

                   (b)        omit from the column headed “Purposes”: P7666 P7671 P7685   substitute: P9651 P9770

[63]            Schedule 1, entry for Golimumab in the form Injection 100 mg in 1 mL single use pre-filled pen [Maximum Quantity: 3; Number of Repeats: 0]

                   (a)        omit from the column headed “Circumstances”: C7666 C7671 C7684 C7685 C7827 C7853                  substitute: C9651 C9705 C9745 C9770 C9822 C9823

                   (b)        omit from the column headed “Purposes”: P7827 P7853                 substitute: P9705 P9822 P9823

[64]            Schedule 1, entry for Imatinib in the form Capsule 100 mg (as mesilate)

                   (a)        omit:

 

 

 

 

Glivanib

JU

MP

C6510 C6526 C6538 C6557 C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

P6510 P6526 P6538 P6557 P9203 P9207

60

2

60

 

 

                   (b)        omit:

 

 

 

 

Glivanib

JU

MP

C6510 C6526 C6538 C6557 C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

P9200 P9204 P9206 P9209 P9240 P9242 P9243 P9274 P9276 P9295 P9296

60

5

60

 

 

[65]            Schedule 1, entry for Imatinib in the form Capsule 400 mg (as mesilate)

                   (a)        omit:

 

 

 

 

Glivanib

JU

MP

C6510 C6526 C6538 C6557 C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

P6510 P6526 P6538 P6557 P9203 P9207

30

2

30

 

 

                   (b)        omit:

 

 

 

 

Glivanib

JU

MP

C6510 C6526 C6538 C6557 C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

P9200 P9204 P9206 P9209 P9240 P9242 P9243 P9274 P9276 P9295 P9296

30

5

30

 

 

[66]            Schedule 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 50 mg in 10 mL

                   (a)        omit from the column headed “Circumstances”: C8142

                   (b)        insert in numerical order in the column headed “Circumstances”: C9840

[67]            Schedule 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 200 mg in 40 mL

                   (a)        omit from the column headed “Circumstances”: C8142

                   (b)        insert in numerical order in the column headed “Circumstances”: C9840

[68]            Schedule 1, entry for Lanthanum in the form Tablet, chewable, 500 mg (as carbonate hydrate) [Maximum Quantity: 180; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C5454

                   (b)        insert in numerical order in the column headed “Circumstances”: C9762

[69]            Schedule 1, entry for Lanthanum in the form Tablet, chewable, 750 mg (as carbonate hydrate) [Maximum Quantity: 180; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C5454

                   (b)        insert in numerical order in the column headed “Circumstances”: C9762

[70]            Schedule 1, entry for Lanthanum in the form Tablet, chewable, 1000 mg (as carbonate hydrate) [Maximum Quantity: 180; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C5454

                   (b)        insert in numerical order in the column headed “Circumstances”: C9762

[71]            Schedule 1, entry for Latanoprost with timolol in the form Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

omit:

 

 

 

a

Lantim

JU

AO

C5038

 

1

5

1

 

 

 

 

 

 

 

 

MP

C4343

 

1

5

1

 

 

 

 

 

a

Latanoprost/timolol AN 50/5

JO

AO

C5038

 

1

5

1

 

 

 

 

 

 

 

 

MP

C4343

 

1

5

1

 

 

[72]            Schedule 1, entry for Macitentan

omit from the column headed “Responsible Person”: AT            substitute: JC

[73]            Schedule 1, entry for Methoxy polyethylene glycol-epoetin beta in all forms

                   (a)        omit from the column headed “Circumstances”: C6260

                   (b)        insert in numerical order in the column headed “Circumstances”: C9688

[74]            Schedule 1, after entry for Mupirocin in the form Nasal ointment 20 mg (as calcium) per g, 3 g

insert:

 

Nasal ointment 20 mg (as calcium) per g, 5 g

Nasal

 

Mupirocin Nasal (Medsurge)

DZ

MP NP

C6647

 

1

0

1

 

 

[75]            Schedule 1, entry for Mycophenolic acid in the form Capsule containing mycophenolate mofetil 250 mg

substitute:

 

Capsule containing mycophenolate mofetil 250 mg

Oral

a

Ceptolate

AF

MP

 

 

300

5

50

 

 

 

 

 

a

APO-Mycophenolate

TX

MP

 

 

300

5

100

 

 

 

 

 

a

CellCept

RO

MP

 

 

300

5

100

 

 

 

 

 

a

Mycophenolate Sandoz

SZ

MP

 

 

300

5

100

 

 

 

 

 

a

Pharmacor Mycophenolate 250

CR

MP

 

 

300

5

100

 

 

 

 

 

a

Ceptolate

AF

MP

 

P5600 P5653 P9689 P9690

600
CN5600 CN5653 CN9689 CN9690

5
CN5600 CN5653 CN9689 CN9690

50

 

C(100)

 

 

 

a

APO-Mycophenolate

TX

MP

 

P5600 P5653 P9689 P9690

600
CN5600 CN5653 CN9689 CN9690

5
CN5600 CN5653 CN9689 CN9690

100

 

C(100)

 

 

 

a

CellCept

RO

MP

 

P5600 P5653 P9689 P9690

600
CN5600 CN5653 CN9689 CN9690

5
CN5600 CN5653 CN9689 CN9690

100

 

C(100)

 

 

 

a

Mycophenolate Sandoz

SZ

MP

 

P5600 P5653 P9689 P9690

600
CN5600 CN5653 CN9689 CN9690

5
CN5600 CN5653 CN9689 CN9690

100

 

C(100)

 

 

 

a

Pharmacor Mycophenolate 250

CR

MP

 

P5600 P5653 P9689 P9690

600
CN5600 CN5653 CN9689 CN9690

5
CN5600 CN5653 CN9689 CN9690

100

 

C(100)

[76]            Schedule 1, entry for Mycophenolic acid in the form Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL [Maximum Quantity: 2; Number of Repeats: 5]

                   (a)        omit from the column headed “Purposes”: P5555 P5794

                   (b)        insert in numerical order in the column headed “Purposes”: P9691 P9693

                   (c)        omit from the column headed “Maximum Quantity”: CN5555 CN5794

                   (d)        insert in numerical order in the column headed “Maximum Quantity”: CN9691 CN9693

                   (e)        omit from the column headed “Number of Repeats”: CN5555 CN5794

                    (f)        insert in numerical order in the column headed “Number of Repeats”: CN9691 CN9693

[77]            Schedule 1, entry for Mycophenolic acid in the form Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid [Maximum Quantity: 240; Number of Repeats: 5]

                   (a)        omit from the column headed “Purposes”: P4108 P4146

                   (b)        insert in numerical order in the column headed “Purposes”: P9692 P9809

                   (c)        omit from the column headed “Maximum Quantity”: CN4108 CN4146

                   (d)        insert in numerical order in the column headed “Maximum Quantity”: CN9692 CN9809

                   (e)        omit from the column headed “Number of Repeats”: CN4108 CN4146

                    (f)        insert in numerical order in the column headed “Number of Repeats”: CN9692 CN9809

[78]            Schedule 1, entry for Mycophenolic acid in the form Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid [Maximum Quantity: 240; Number of Repeats: 5]

                   (a)        omit from the column headed “Purposes”: P4108 P4146

                   (b)        insert in numerical order in the column headed “Purposes”: P9692 P9809

                   (c)        omit from the column headed “Maximum Quantity”: CN4108 CN4146

                   (d)        insert in numerical order in the column headed “Maximum Quantity”: CN9692 CN9809

                   (e)        omit from the column headed “Number of Repeats”: CN4108 CN4146

                    (f)        insert in numerical order in the column headed “Number of Repeats”: CN9692 CN9809

[79]            Schedule 1, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg

substitute:

 

Tablet containing mycophenolate mofetil 500 mg

Oral

a

APO-Mycophenolate

TX

MP

 

 

150

5

50

 

 

 

 

 

a

CellCept

RO

MP

 

 

150

5

50

 

 

 

 

 

a

Ceptolate

AF

MP

 

 

150

5

50

 

 

 

 

 

a

MycoCept

RF

MP

 

 

150

5

50

 

 

 

 

 

a

Mycophenolate AN

EA

MP

 

 

150

5

50

 

 

 

 

 

a

Mycophenolate Sandoz

SZ

MP

 

 

150

5

50

 

 

 

 

 

a

Pharmacor Mycophenolate 500

CR

MP

 

 

150

5

50

 

 

 

 

 

a

APO-Mycophenolate

TX

MP

 

P5554 P5795 P9691 P9693

300
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

50

 

C(100)

 

 

 

a

CellCept

RO

MP

 

P5554 P5795 P9691 P9693

300
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

50

 

C(100)

 

 

 

a

Ceptolate

AF

MP

 

P5554 P5795 P9691 P9693

300
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

50

 

C(100)

 

 

 

a

MycoCept

RF

MP

 

P5554 P5795 P9691 P9693

300
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

50

 

C(100)

 

 

 

a

Mycophenolate AN

EA

MP

 

P5554 P5795 P9691 P9693

300
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

50

 

C(100)

 

 

 

a

Mycophenolate Sandoz

SZ

MP

 

P5554 P5795 P9691 P9693

300
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

50

 

C(100)

 

 

 

a

Pharmacor Mycophenolate 500

CR

MP

 

P5554 P5795 P9691 P9693

300
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

50

 

C(100)

[80]            Schedule 1, after entry for Naloxone in the form Injection containing naloxone hydrochloride 2 mg in 2 mL pre-filled syringe

insert:

 

Nasal spray 1.8 mg (as hydrochloride dihydrate) in 0.1 mL single dose unit, 2

Nasal

 

Nyxoid

MF

PDP MP NP

 

 

1

0

1

 

 

[81]            Schedule 1, entry for Natalizumab

omit from the column headed “Circumstances”: C7697 C9406 substitute: C9744 C9818

[82]            Schedule 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL

                   (a)        omit from the column headed “Circumstances”: C8141

                   (b)        omit from the column headed “Circumstances”: C9219

                   (c)        insert in numerical order in the column headed “Circumstances”: C9832 C9844

[83]            Schedule 1, entry for Omeprazole in the form Tablet 20 mg

                   (a)        omit:

 

 

 

 

Meprazol

SZ

MP NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

                   (b)        omit:

 

 

 

 

Meprazol

SZ

MP NP

C8774 C8775 C8776 C8780 C8866

P8776 P8780 P8866

30

5

30

 

 

[84]            Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [Maximum Quantity: 4; Number of Repeats: 0]

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

 

 

 

 

APO-Ondansetron ODT

TX

MP NP

C5618 C5777

P5618

4

0

4

 

 

 

 

 

 

 

 

MP

C5743

 

4

0

4

 

C(100)

[85]            Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [Maximum Quantity: 10; Number of Repeats: 1]

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

 

 

 

 

APO-Ondansetron ODT

TX

MP NP

C5618 C5777

P5777

10

1

10

 

 

[86]            Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [Maximum Quantity: 4; Number of Repeats: 0]

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

 

 

 

 

APO-Ondansetron ODT

TX

MP NP

C5618 C5777

P5618

4

0

4

 

 

 

 

 

 

 

 

MP

C5743

 

4

0

4

 

C(100)

[87]            Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [Maximum Quantity: 10; Number of Repeats: 1]

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

 

 

 

 

APO-Ondansetron ODT

TX

MP NP

C5618 C5777

P5777

10

1

10

 

 

[88]            Schedule 1, entry for Pembrolizumab

                   (a)        omit from the column headed “Circumstances”: C9178

                   (b)        insert in numerical order in the column headed “Circumstances”: C9843

[89]            Schedule 1, entry for Sevelamer in the form Tablet containing sevelamer hydrochloride 800 mg [Maximum Quantity: 360; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C5454

                   (b)        insert in numerical order in the column headed “Circumstances”: C9762

[90]            Schedule 1, entry for Sirolimus in the form Oral solution 1 mg per mL, 60 mL [Maximum Quantity: 2; Number of Repeats: 5]

                   (a)        omit from the column headed “Purposes”: P5794

                   (b)        insert in numerical order in the column headed “Purposes”: P9693

                   (c)        omit from the column headed “Maximum Quantity”: CN5794

                   (d)        insert in numerical order in the column headed “Maximum Quantity”: CN9693

                   (e)        omit from the column headed “Number of Repeats”: CN5794

                    (f)        insert in numerical order in  the column headed “Number of Repeats”: CN9693

[91]            Schedule 1, entry for Sirolimus in the form Tablet 0.5 mg [Maximum Quantity: 200; Number of Repeats: 5]

                   (a)        omit from the column headed “Purposes”: P5794

                   (b)        insert in numerical order in the column headed “Purposes”: P9693

                   (c)        omit from the column headed “Maximum Quantity”: CN5794

                   (d)        insert in numerical order in the column headed “Maximum Quantity”: CN9693

                   (e)        omit from the column headed “Number of Repeats”: CN5794

                    (f)        insert in numerical order in  the column headed “Number of Repeats”: CN9693

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

                   (a)        omit from the column headed “Purposes”: P5794

                   (b)        insert in numerical order in the column headed “Purposes”: P9693

                   (c)        omit from the column headed “Maximum Quantity”: CN5794

                   (d)        insert in numerical order in the column headed “Maximum Quantity”: CN9693

                   (e)        omit from the column headed “Number of Repeats”: CN5794

                    (f)        insert in numerical order in  the column headed “Number of Repeats”: CN9693

[93]            Schedule 1, entry for Sirolimus in the form Tablet 2 mg [Maximum Quantity: 200; Number of Repeats: 5]

                   (a)        omit from the column headed “Purposes”: P5794

                   (b)        insert in numerical order in the column headed “Purposes”: P9693

                   (c)        omit from the column headed “Maximum Quantity”: CN5794

                   (d)        insert in numerical order in the column headed “Maximum Quantity”: CN9693

                   (e)        omit from the column headed “Number of Repeats”: CN5794

                    (f)        insert in numerical order in the column headed “Number of Repeats”: CN9693

[94]            Schedule 1, entry for Sucroferric oxyhydroxide in the form Tablet, chewable, 2.5 g (equivalent to 500 mg iron) [Maximum Quantity: 180; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C5454

                   (b)        insert in numerical order in the column headed “Circumstances”: C9762

[95]            Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg

substitute:

Tacrolimus

Capsule 0.5 mg

Oral

a

Pacrolim

AF

MP

 

 

100

3

100

 

 

 

 

 

a

Pharmacor Tacrolimus 0.5

CR

MP

 

 

100

3

100

 

 

 

 

 

a

Prograf

LL

MP

 

 

100

3

100

 

 

 

 

 

a

Tacrograf

RW

MP

 

 

100

3

100

 

 

 

 

 

a

TACROLIMUS APOTEX

TX

MP

 

 

100

3

100

 

 

 

 

 

a

Tacrolimus Sandoz

SZ

MP

 

 

100

3

100

 

 

 

 

 

a

Pacrolim

AF

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

 

 

a

Pharmacor Tacrolimus 0.5

CR

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

 

 

a

Prograf

LL

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

 

 

a

Tacrograf

RW

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

 

 

a

TACROLIMUS APOTEX

TX

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

 

 

a

Tacrolimus Sandoz

SZ

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

[96]            Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg (once daily prolonged release) [Maximum Quantity: 60; Number of Repeats: 5]

                   (a)        omit from the column headed “Purposes”: P5602

                   (b)        insert in numerical order in the column headed “Purposes”: P9697

                   (c)        omit from the column headed “Maximum Quantity”: CN5602

                   (d)        insert in numerical order in the column headed “Maximum Quantity”: CN9697

                   (e)        omit from the column headed “Number of Repeats”: CN5602

                    (f)        insert in numerical order in the column headed “Number of Repeats”: CN9697

[97]            Schedule 1, entry for Tacrolimus in the form Capsule 0.75 mg [Maximum Quantity: 200; Number of Repeats: 5]

                   (a)        omit from the column headed “Purposes”: P5602

                   (b)        insert in numerical order in the column headed “Purposes”: P9697

                   (c)        omit from the column headed “Maximum Quantity”: CN5602

                   (d)        insert in numerical order in the column headed “Maximum Quantity”: CN9697

                   (e)        omit from the column headed “Number of Repeats”: CN5602

                    (f)        insert in numerical order in the column headed “Number of Repeats”: CN9697

[98]            Schedule 1, entry for Tacrolimus in the form Capsule 1 mg

substitute:

 

Capsule 1 mg

Oral

a

Pacrolim

AF

MP

 

 

100

3

100

 

 

 

 

 

a

Pharmacor Tacrolimus 1

CR

MP

 

 

100

3

100

 

 

 

 

 

a

Prograf

LL

MP

 

 

100

3

100

 

 

 

 

 

a

Tacrograf

RW

MP

 

 

100

3

100

 

 

 

 

 

a

TACROLIMUS APOTEX

TX

MP

 

 

100

3

100

 

 

 

 

 

a

Tacrolimus Sandoz

SZ

MP

 

 

100

3

100

 

 

 

 

 

a

Pacrolim

AF

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

 

 

a

Pharmacor Tacrolimus 1

CR

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

 

 

a

Prograf

LL

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

 

 

a

Tacrograf

RW

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

 

 

a

TACROLIMUS APOTEX

TX

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

 

 

 

a

Tacrolimus Sandoz

SZ

MP

 

P5569 P9697

200
CN5569 CN9697

5
CN5569 CN9697

100

 

C(100)

[99]            Schedule 1, entry for Tacrolimus in the form Capsule 1 mg (once daily prolonged release) [Maximum Quantity: 120; Number of Repeats: 5]

                   (a)        omit from the column headed “Purposes”: P5602

                   (b)        insert in numerical order in the column headed “Purposes”: P9697

                   (c)        omit from the column headed “Maximum Quantity”: CN5602

                   (d)        insert in numerical order in the column headed “Maximum Quantity”: CN9697

                   (e)        omit from the column headed “Number of Repeats”: CN5602

                    (f)        insert in numerical order in the column headed “Number of Repeats”: CN9697

[100]          Schedule 1, entry for Tacrolimus in the form Capsule 2 mg [Maximum Quantity: 200; Number of Repeats: 5]

                   (a)        omit from the column headed “Purposes”: P5602

                   (b)        insert in numerical order in the column headed “Purposes”: P9697

                   (c)        omit from the column headed “Maximum Quantity”: CN5602

                   (d)        insert in numerical order in the column headed “Maximum Quantity”: CN9697

                   (e)        omit from the column headed “Number of Repeats”: CN5602

                    (f)        insert in numerical order in the column headed “Number of Repeats”: CN9697

[101]          Schedule 1, entry for Tacrolimus in the form Capsule 5 mg

substitute:

 

Capsule 5 mg

Oral

a

Pacrolim

AF

MP

 

 

50

3

50

 

 

 

 

 

a

Pharmacor Tacrolimus 5

CR

MP

 

 

50

3

50

 

 

 

 

 

a

Prograf

LL

MP

 

 

50

3

50

 

 

 

 

 

a

Tacrograf

RW

MP

 

 

50

3

50

 

 

 

 

 

a

TACROLIMUS APOTEX

TX

MP

 

 

50

3

50

 

 

 

 

 

a

Tacrolimus Sandoz

SZ

MP

 

 

50

3

50

 

 

 

 

 

a

Pacrolim

AF

MP

 

P5569 P9697

100
CN5569 CN9697

5
CN5569 CN9697

50

 

C(100)

 

 

 

a

Pharmacor Tacrolimus 5

CR

MP

 

P5569 P9697

100
CN5569 CN9697

5
CN5569 CN9697

50

 

C(100)

 

 

 

a

Prograf

LL

MP

 

P5569 P9697

100
CN5569 CN9697

5
CN5569 CN9697

50

 

C(100)

 

 

 

a

Tacrograf

RW

MP

 

P5569 P9697

100
CN5569 CN9697

5
CN5569 CN9697

50

 

C(100)

 

 

 

a

TACROLIMUS APOTEX

TX

MP

 

P5569 P9697

100
CN5569 CN9697

5
CN5569 CN9697

50

 

C(100)

 

 

 

a

Tacrolimus Sandoz

SZ

MP

 

P5569 P9697

100
CN5569 CN9697

5
CN5569 CN9697

50

 

C(100)

[102]          Schedule 1, entry for Tacrolimus in the form Capsule 5 mg (once daily prolonged release) [Maximum Quantity: 60; Number of Repeats: 5]

                   (a)        omit from the column headed “Purposes”: P5602

                   (b)        insert in numerical order in the column headed “Purposes”: P9697

                   (c)        omit from the column headed “Maximum Quantity”: CN5602

                   (d)        insert in numerical order in the column headed “Maximum Quantity”: CN9697

                   (e)        omit from the column headed “Number of Repeats”: CN5602

                    (f)        insert in numerical order in the column headed “Number of Repeats”: CN9697

[103]          Schedule 1, entry for Temozolomide in the form Capsule 5 mg

                   (a)        omit:

 

 

 

a

Temolide

JU

MP

 

 

5

5

5

 

 

                   (b)        omit:

 

 

 

a

Temolide

JU

MP

 

P4897

15

2

5

 

 

[104]          Schedule 1, entry for Temozolomide in the form Capsule 140 mg

                   (a)        omit:

 

 

 

a

Temolide

JU

MP

 

 

5

5

5

 

 

                   (b)        omit:

 

 

 

a

Temolide

JU

MP

 

P4897

15

2

5

 

 

[105]          Schedule 1, entry for Terbutaline in the form Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 100 doses

insert in the column headed “Circumstances”: C9828

[106]          Schedule 1, entry for Teriflunomide

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

 

 

 

a

APO-TERIFLUNOMIDE

TX

MP

C6854 C7741

 

28

5

28

 

 

[107]          Schedule 1, entry for Timolol

omit:

 

Eye drops (gellan gum solution) 2.5 mg (as maleate) per mL, 2.5 mL

Application to the eye

 

Timoptol XE

MF

MP AO

 

 

1

5

1

 

 

[108]          Schedule 1, entry for Tinidazole

                   (a)        omit:

 

 

 

a

Fasigyn

PF

MP NP

 

 

4

0

4

 

 

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

[109]          Schedule 1, entry for Trametinib in the form Tablet 500 micrograms [Maximum Quantity: 90; Number of Repeats: 3]

                   (a)        insert in numerical order in the column headed “Circumstances”: C9643 C9645 C9646

                   (b)        insert in numerical order in the column headed “Purposes”: P9643 P9645 P9646

[110]          Schedule 1, entry for Trametinib in the form Tablet 500 micrograms [Maximum Quantity: 90; Number of Repeats: 5]

insert in numerical order in the column headed “Circumstances”: C9643 C9645 C9646

[111]          Schedule 1, entry for Trametinib in the form Tablet 2 mg [Maximum Quantity: 30; Number of Repeats: 3]

                   (a)        insert in numerical order in the column headed “Circumstances”: C9643 C9645 C9646

                   (b)        insert in numerical order in the column headed “Purposes”: P9643 P9645 P9646

[112]          Schedule 1, entry for Trametinib in the form Tablet 2 mg [Maximum Quantity: 30; Number of Repeats: 5]

insert in numerical order in the column headed “Circumstances”: C9643 C9645 C9646

[113]          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”:

 

 

 

 

Herzuma

EW

MP

C9349 C9353 C9354 C9356 C9461 C9571 C9573 C9628

 

See Note 3

See Note 3

1

 

PB(100)

[114]          Schedule 1, omit entry for Triglycerides, long chain

[115]          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”: C7035 C7049 C7059 C7061 C7463

                   (b)        insert in numerical order in the column headed “Circumstances”: C9655 C9656 C9657 C9710 C9711

[116]          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”: C7035 C7049 C7059 C7061 C7463

                   (b)        insert in numerical order in the column headed “Circumstances”: C9655 C9656 C9657 C9710 C9711

[117]          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”: C7035 C7049 C7059 C7061 C7463

                   (b)        insert in numerical order in the column headed “Circumstances”: C9655 C9656 C9657 C9710 C9711

                   (c)        omit from the column headed “Purposes”: P7035 P7049 P7059 P7061 P7463              substitute: P9655 P9656 P9657 P9710 P9711

[118]          Schedule 1, entry for Valganciclovir in the form Tablet 450 mg (as hydrochloride)

omit:

 

 

 

a

Valganciclovir AN

JO

MP

C4980 C4989 C9316

 

120

5

60

 

D(100)

 

 

 

a

Valganciclovir Juno

JU

MP

C4980 C4989 C9316

 

120

5

60

 

D(100)

[119]          Schedule 1, entry for Vemurafenib in the form Tablet 240 mg [Maximum Quantity: 224; Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances”: C6044

                   (b)        insert in numerical order in the column headed “Circumstances”: C9842

                   (c)        omit from the column headed “Purposes”: P6044            substitute: P9842

[120]          Schedule 1, entry for Vemurafenib in the form Tablet 240 mg [Maximum Quantity: 224; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C6044

                   (b)        insert in numerical order in the column headed “Circumstances”: C9842

[121]          Schedule 1, entry for Verteporfin

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

[122]          Schedule 3

omit:

AT

Actelion Pharmaceuticals Australia Pty Ltd

 32 097 278 512

[123]          Schedule 3, after details relevant to Responsible Person code EV

insert:

EW

Celltrion Healthcare Australia Pty Ltd

66 625 407 105

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

                   (a)        omit:

 

C5075

P5075

 

Severe Crohn disease
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have a documented history of severe Crohn disease; AND
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment with this drug.
Patient must be aged 18 years or older.
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment.
All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.
If the application is the first application for continuing treatment with this drug, an assessment of the patient's response to the initial course of treatment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient dose. Up to a maximum of 5 repeats will be authorised.
If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase.

Compliance with Written Authority Required procedures

 

C5076

P5076

 

Severe Crohn disease
Initial treatment (new paediatric patient) of Crohn disease in a paediatric patient assessed by PCDAI (Initial 1)
Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist, consultant physician, paediatrician or specialist paediatric gastroenterologist; AND
Patient must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; OR
Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra-indication to each of prednisolone (or equivalent), azathioprine, 6-mercaptopurine and methotrexate; AND
Patient must have, at the time of application, disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40 preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment and which is no more than 1 month old at the time of application.
Patient must be aged 6 to 17 years inclusive.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Applications for authorisation of initial treatment must be in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed paediatric Crohn Disease PBS Authority Application -Supporting Information Form [may be downloaded from the Department of Human Services website (www.humanservices.gov.au)] which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) details of previous systemic drug therapy [dosage, date of commencement and duration of therapy] or dates of enteral nutrition; and
(iii) the signed patient or guardian acknowledgement indicating they understand and acknowledge that the PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application. Details of the accepted toxicities including severity can be found on the Human Services website (www.humanservices.gov.au).
A maximum quantity and number of repeats to provide for an initial 16 week course of this drug consisting of a 160 mg dose at week 0, 80 mg dose at week 2 and 40 mg dose at weeks 4, 6, 8, 10, 12 and 14 for patients 40 kg or greater (for patients 40 kg or less, the course is a 80 mg dose at week 0, 40 mg dose at week 2 and a 20 mg dose at weeks 4, 6, 8, 10, 12 and 14) will be authorised.
Two completed authority prescriptions should be submitted with every initial application for this drug. For patients weighing 40 kg or greater: one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription should be written for 2 doses of 40 mg and 2 repeats. For patients weighing less than 40 kg: one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.
If fewer than 2 repeats (for patients 40 kg or greater) or 3 repeats (for patients less than 40 kg) are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with this drug may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
A PCDAI assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks therapy 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 submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these time-frames, the patient will be deemed to have failed to respond to treatment with this drug.
It is recommended that an application for continuing treatment is posted to the Department of Human Services at the time of the 12 week assessment, to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug.

Compliance with Written Authority Required procedures

 

C5090

P5090

 

Severe Crohn disease
Balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete the initial dose (i.e. the initial infusion regimen at weeks 0 and 2); OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 2 doses (new patients) or 5 repeats (Continuing treatment).
Patient must be aged 18 years or older.
Authority approval for sufficient therapy to complete a maximum of 2 initial doses or 5 repeats may be requested by telephone by contacting the Department of Human Services

Compliance with Authority Required procedures

 

C5091

P5091

 

Severe Crohn disease
Continuing treatment of Crohn disease in a paediatric patient assessed by PCDAI
Patient must have a documented history of severe Crohn disease; AND
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug as defined as a reduction in PCDAI Score by at least 15 points as compared to baseline and a total of PCDAI score of 40 points or less with the PCDAI assessment being no more than 1 month old at the time of application.
Patient must be aged 6 to 17 years inclusive.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form [may be downloaded from the Department of Human Services website (www.humanservices.gov.au)] which includes the following:
(i) the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient's condition.
The PCDAI assessment must be no more than 1 month old at the time of application.
If the application is the first application for continuing treatment with adalimumab, a PCDAI assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of therapy so that there is adequate time for a response to be demonstrated.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
A maximum of 24 weeks treatment will be authorised under this criterion.
Where fewer than 5 repeats are requested at the time of application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment may be requested by telephone by contacting Medicare Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) and authorised through the Balance of Supply treatment phase PBS restriction.

Compliance with Written Authority Required procedures

 

C5105

P5105

 

Severe Crohn disease
Balance of supply for paediatric patient
Patient must have received insufficient therapy with this drug under Initial 1 (new patient or patient recommencing treatment after break of more than 5 years) or Initial 2 (change or recommencement of treatment after a break of less than 5 years) or Initial 3 (grandfathered patients) or Continuing treatment to complete the maximum duration of treatment specified in the relevant treatment phase; AND
The treatment must provide no more than the balance of up to 16 weeks of therapy (new patients or change/re-commencement patients; Initial 1 or Initial 2) or 24 weeks of therapy (Continuing patients or Grandfathered patients).
Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician or a specialist paediatric gastroenterologist.

Compliance with Authority Required procedures

 

C5117

P5117

 

Severe Crohn disease
Change or re-commencement of treatment of Crohn disease in a paediatric patient assessed by PCDAI (Initial 2)
Patient must have a documented history of severe Crohn disease; AND
Patient must in this treatment cycle, have received prior PBS-subsidised treatment with this drug for this condition; OR
Patient must in this treatment cycle, have received prior PBS-subsidised treatment with infliximab for this condition and have a current PCDAI score of 40 or greater; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.
Patient must be aged 6 to 17 years inclusive.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of TNF-alfa antagonist therapy within the timeframes specified in the relevant restriction.
Where the most recent course of PBS-subsidised TNF-alfa antagonist treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
If the response assessment to the previous course of TNF-alfa antagonist treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of TNF-alfa antagonist.
Applications for authorisation of initial treatment must be in writing and must include:
(a) two completed authority prescription form; and
(b) a completed paediatric Crohn Disease PBS Authority Application -Supporting Information Form [may be downloaded from the Department of Human Services website (www.humanservices.gov.au)] which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) Score calculation sheet; and
(ii) details of prior TNF-alfa antagonist treatment including details of date and duration of treatment.
Two completed authority prescriptions should be submitted with every initial application for this drug. For patients weighing 40 kg or greater: one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription should be written for 2 doses of 40 mg and 2 repeats. For patients weighing less than 40 kg: one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.
If fewer than 2 repeats (for patients 40 kg or greater) or 3 repeats (for patients less than 40 kg) are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with this drug may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
A PCDAI assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks therapy 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 submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these time-frames, the patient will be deemed to have failed to respond to treatment with this drug.
It is recommended that an application for continuing treatment is posted to the Department of Human Services at the time of the 12 week assessment, to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug.

Compliance with Written Authority Required procedures

                   (b)        omit:

 

C7151

P7151

 

Severe Crohn disease
Change or Re-commencement of treatment (initial 2)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have a documented history of severe Crohn disease; AND
Patient must have received prior PBS-subsidised treatment with a biological disease modifying drug for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form, which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment; and
(iv) the details of prior biological disease modifying drug treatment including the details of date and duration of treatment.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological disease modifying drug (bDMD) therapy within the timeframes specified in the relevant restriction.
Where the most recent course of PBS-subsidised bDMD treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
If the response assessment to the previous course of bDMD treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of bDMD.
A maximum quantity and number of repeats to provide for an initial 16 week course of this drug will be authorised.
If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase.
The assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of therapy 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 submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
It is recommended that an application for continuing treatment is posted to the Department of Human Services at the time of the 12 week assessment, to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug.

Compliance with Written Authority Required procedures

 

C7443

P7443

 

Severe Crohn disease
Initial treatment (new patient - initial 1)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more months.
Patient must be aged 18 years or older.
Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR
Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR
Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iv) the date of the most recent clinical assessment; and
(v) the signed patient acknowledgement indicating they understand and acknowledge that the PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.
Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:(a) patient must have evidence of intestinal inflammation;(b) patient must be assessed clinically as being in a high faecal output state; (c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.Evidence of intestinal inflammation includes: (i) blood: higher than normal platelet count, or, 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; or (ii) faeces: higher than normal lactoferrin or calprotectin level; or (iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery;
Two completed authority prescriptions must be submitted with every initial application for adalimumab. One prescription must be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats. The second prescription must be written for 2 doses of 40 mg and 2 repeats.
Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested by telephone by contacting the Department of Human Services.
Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.
A maximum quantity and number of repeats to provide for an initial 16 week course of this drug will be authorised.
If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase.
The assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of therapy so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for further continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this course of treatment.
Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.

Compliance with Written Authority Required procedures

 

C7652

P7652

 

Moderate to severe ulcerative colitis
Change or Re-commencement of treatment after a break in therapy of less than 5 years (Initial 2)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have previously received PBS-subsidised treatment with adalimumab, golimumab, infliximab or vedolizumab for this condition in this treatment cycle; OR
Patient must have previously received PBS-subsidised treatment with adalimumab or infliximab for this condition in this treatment cycle if aged 6 to 17 years; AND
Patient must not have failed PBS-subsidised treatment with adalimumab for this condition in the current treatment cycle; OR
Patient must not have failed PBS-subsidised treatment with adalimumab for this condition in the current treatment cycle more than once if aged 6 to 17 years.
Patient must be 6 years of age or older.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of this drug within the timelines specified in the relevant restriction. If the response assessment to the previous course of this drug is not submitted as detailed in the relevant restriction, the patient will be deemed to have failed therapy with this drug.
Applications for authorisation of change or recommencement treatment must be in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].
Two completed authority prescriptions must be submitted with every initial application for this drug.For patients weighing 40 kg or greater, one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription must be written for 2 doses of 40 mg and 2 repeats.
For patients weighing less than 40 kg, one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.

Compliance with Written Authority Required procedures

 

C7654

P7654

 

Moderate to severe ulcerative colitis
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.

Compliance with Authority Required procedures

 

C7655

P7655

 

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

Compliance with Authority Required procedures

 

C7663

P7663

 

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

Compliance with Authority Required procedures

 

C7664

P7664

 

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

Compliance with Written Authority Required procedures

 

C8547

P8547

 

Complex refractory Fistulising Crohn disease
Change or Re-commencement of treatment after a break in therapy of less than 5 years (Initial 2)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy following a minimum of 12 weeks of therapy.
It is recommended that an application for continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not undertaken within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) details of prior biological medicine treatment including details of date and duration of treatment.
The most recent fistula assessment must be no more than 1 month old at the time of application.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
Two completed authority prescriptions must be submitted with every initial application for adalimumab. One prescription must be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats. The second prescription must be written for 2 doses of 40 mg and 2 repeats.

Compliance with Written Authority Required procedures

 

C8567

P8567

 

Complex refractory Fistulising Crohn disease
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
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 for this condition.
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition.
The most recent fistula assessment must be no more than 1 month old at the time of application.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy following a minimum of 12 weeks of therapy.
It is recommended that an application for continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not undertaken within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient dose. Up to a maximum of 5 repeats will be authorised.
A maximum of 24 weeks treatment will be authorised under this restriction.

Compliance with Written Authority Required procedures

 

C8587

P8587

 

Complex refractory Fistulising Crohn disease
Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have an externally draining enterocutaneous or rectovaginal fistula.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed current Fistula Assessment Form including the date of assessment of the patient's condition of no more than 1 month old at the time of application.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
Two completed authority prescriptions must be submitted with every initial application for adalimumab. One prescription must be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats. The second prescription must be written for 2 doses of 40 mg and 2 repeats.
The assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of therapy so that there is adequate time for a response to be demonstrated.
It is recommended that an application for continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not undertaken within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.

Compliance with Written Authority Required procedures

 

C8594

P8594

 

Complex refractory Fistulising Crohn disease
Initial 1 (new patient or Recommencement of treatment after more than 5 years break in therapy), Initial 2 (Change or Re-commencement of treatment after a break in therapy of less than 5 years) - Balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
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.

Compliance with Authority Required procedures

                   (c)        insert in numerical order after existing text:

 

C9658

P9658

 

Complex refractory Fistulising Crohn disease
Change or Recommencement of treatment after a break in therapy of less than 5 years (Initial 2)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy following a minimum of 12 weeks of therapy.
It is recommended that an application for continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) details of prior biological medicine treatment including details of date and duration of treatment.
The most recent fistula assessment must be no more than 1 month old at the time of application.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
Two completed authority prescriptions must be submitted with every initial application for adalimumab. One prescription must be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats. The second prescription must be written for 2 doses of 40 mg and 2 repeats.

Compliance with Written Authority Required procedures

 

C9661

P9661

 

Complex refractory Fistulising Crohn disease
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
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 for this condition.
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition.
The most recent fistula assessment must be no more than 1 month old at the time of application.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy following a minimum of 12 weeks of therapy.
It is recommended that an application for continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient dose. Up to a maximum of 5 repeats will be authorised.
A maximum of 24 weeks treatment will be authorised under this restriction.

Compliance with Written Authority Required procedures

 

C9662

P9662

 

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

Compliance with Written Authority Required procedures

 

C9663

P9663

 

Moderate to severe ulcerative colitis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); OR
Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years.
Patient must be 6 years of age or older.
Applications for authorisation must be in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
For patients weighing 40 kg or greater, a maximum quantity and number of repeats to provide for an initial 16 weeks course of this drug consisting of a 160 mg dose at week 0, 80 mg dose at week 2 and 40 mg dose at weeks 4, 6, 8, 10, 12 and 14 will be authorised.
For patients weighing less than 40 kg, a maximum quantity and number of repeats to provide for an initial 16 weeks of this drug consisting of a 80 mg dose at week 0, 40 mg dose at week 2 and a 20 mg dose at weeks 4, 6, 8, 10, 12 and 14 will be authorised.
Two completed authority prescriptions must be submitted with every initial application for this drug.For patients weighing 40 kg or greater, one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription must be written for 2 doses of 40 mg and 2 repeats.
For patients weighing less than 40 kg, one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 4 weeks old at the time of application.
A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.
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.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.

Compliance with Written Authority Required procedures

 

C9666

P9666

 

Moderate to severe ulcerative colitis
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years.
Patient must be 6 years of age or older.
Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
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.
If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Compliance with Authority Required procedures

 

C9672

P9672

 

Severe Crohn disease
Initial treatment - Initial 1 (new patient)
Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND
Patient must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; OR
Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra-indication to each of prednisolone (or equivalent), azathioprine, 6-mercaptopurine and methotrexate; AND
Patient must have, at the time of application, disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40 preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment and which is no more than 1 month old at the time of application; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 6 to 17 years inclusive.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Applications for authorisation of initial treatment must be in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed paediatric Crohn Disease PBS Authority Application -Supporting Information Form [may be downloaded from the Department of Human Services website (www.humanservices.gov.au)] which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) details of previous systemic drug therapy [dosage, date of commencement and duration of therapy] or dates of enteral nutrition.
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application. Details of the accepted toxicities including severity can be found on the Human Services website (www.humanservices.gov.au).
A maximum quantity and number of repeats to provide for an initial 16 week course of this drug consisting of a 160 mg dose at week 0, 80 mg dose at week 2 and 40 mg dose at weeks 4, 6, 8, 10, 12 and 14 for patients 40 kg or greater (for patients 40 kg or less, the course is a 80 mg dose at week 0, 40 mg dose at week 2 and a 20 mg dose at weeks 4, 6, 8, 10, 12 and 14) will be authorised.
Two completed authority prescriptions should be submitted with every initial application for this drug. For patients weighing 40 kg or greater: one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription should be written for 2 doses of 40 mg and 2 repeats. For patients weighing less than 40 kg: one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.
If fewer than 2 repeats (for patients 40 kg or greater) or 3 repeats (for patients less than 40 kg) are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with this drug may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
A PCDAI assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks therapy so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

Compliance with Written Authority Required procedures

 

C9673

P9673

 

Severe Crohn disease
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have a documented history of severe Crohn disease; AND
Patient must in this treatment cycle, have received prior PBS-subsidised treatment with this drug for this condition; OR
Patient must in this treatment cycle, have received prior PBS-subsidised treatment with infliximab for this condition and have a current PCDAI score of 40 or greater; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition more than once in the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 6 to 17 years inclusive.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Applications for authorisation of initial treatment must be in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed paediatric Crohn Disease PBS Authority Application -Supporting Information Form [may be downloaded from the Department of Human Services website (www.humanservices.gov.au)] which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) Score calculation sheet; and
(ii) details of prior TNF-alfa antagonist treatment including details of date and duration of treatment.
The PCDAI assessment must be no more than 1 month old at the time of application.
Two completed authority prescriptions should be submitted with every initial application for this drug. For patients weighing 40 kg or greater: one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription should be written for 2 doses of 40 mg and 2 repeats. For patients weighing less than 40 kg: one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.
If fewer than 2 repeats (for patients 40 kg or greater) or 3 repeats (for patients less than 40 kg) are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with this drug may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or 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 an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.
A PCDAI assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks therapy so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

Compliance with Written Authority Required procedures

 

C9674

P9674

 

Severe Crohn disease
Continuing treatment of Crohn disease in a paediatric patient assessed by PCDAI
Patient must have a documented history of severe Crohn disease; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND
Patient must have a total PCDAI score of 40 points or less; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 6 to 17 years inclusive.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Crohn Disease PBS Authority Application - Supporting Information Form, which includes the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient's condition.
The PCDAI assessment must be no more than 1 month old at the time of application.
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.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.

Compliance with Written Authority Required procedures

 

C9679

P9679

 

Severe Crohn disease
Balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
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; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; OR
The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.

Compliance with Authority Required procedures

 

C9713

P9713

 

Complex refractory Fistulising Crohn disease
Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have an externally draining enterocutaneous or rectovaginal fistula.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed current Fistula Assessment Form including the date of assessment of the patient's condition of no more than 1 month old at the time of application.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
Two completed authority prescriptions must be submitted with every initial application for adalimumab. One prescription must be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats. The second prescription must be written for 2 doses of 40 mg and 2 repeats.
The assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of therapy so that there is adequate time for a response to be demonstrated.
It is recommended that an application for continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

Compliance with Written Authority Required procedures

 

C9714

P9714

 

Complex refractory Fistulising Crohn disease
Initial 1 (new patient or Recommencement of treatment after more than 5 years break in therapy ), 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 gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
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.

Compliance with Authority Required procedures

 

C9715

P9715

 

Moderate to severe ulcerative colitis
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 gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
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.

Compliance with Authority Required procedures

 

C9717

P9717

 

Moderate to severe ulcerative colitis
Continuing treatment - balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under this restriction.

Compliance with Authority Required procedures

 

C9722

P9722

 

Severe Crohn disease
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Patient must have received prior 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
Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist, consultant physician, paediatrician or specialist paediatric gastroenterologist; AND
Patient must have, at the time of application, disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 6 to 17 years inclusive.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed paediatric Crohn Disease PBS Authority Application - Supporting Information Form [may be downloaded from the Department of Human Services website (www.humanservices.gov.au)] which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient's condition.
The PCDAI assessment must be no more than 1 month old at the time of application.
A maximum quantity and number of repeats to provide for an initial 16 week course of this drug consisting of a 160 mg dose at week 0, 80 mg dose at week 2 and 40 mg dose at weeks 4, 6, 8, 10, 12 and 14 for patients 40 kg or greater (for patients 40 kg or less, the course is a 80 mg dose at week 0, 40 mg dose at week 2 and a 20 mg dose at weeks 4, 6, 8, 10, 12 and 14) will be authorised.
Two completed authority prescriptions should be submitted with every initial application for this drug. For patients weighing 40 kg or greater: one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription should be written for 2 doses of 40 mg and 2 repeats. For patients weighing less than 40 kg: one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.
If fewer than 2 repeats (for patients 40 kg or greater) or 3 repeats (for patients less than 40 kg) are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with this drug may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
A PCDAI assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks therapy so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

Compliance with Authority Required procedures

 

C9735

P9735

 

Severe Crohn disease
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 gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in 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.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form, which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment; and
(iv) the details of prior biological medicine treatment including the details of date and duration of treatment.
Two completed authority prescriptions must be submitted with every initial application for adalimumab. One prescription must be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats. The second prescription must be written for 2 doses of 40 mg and 2 repeats.
Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested by telephone by contacting the Department of Human Services.
Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction.
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 for adalimumab or ustekinumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
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

 

C9748

P9748

 

Moderate to severe ulcerative colitis
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 gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; OR
Patient must have previously received PBS-subsidised treatment with a biological medicine (adalimumab or infliximab) for this condition in this treatment cycle if aged 6 to 17 years; 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; OR
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 more than once if aged 6 to 17 years.
Patient must be 6 years of age or older.
Applications for authorisation must be in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
Two completed authority prescriptions must be submitted with every initial application for this drug.For patients weighing 40 kg or greater, one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription must be written for 2 doses of 40 mg and 2 repeats.
For patients weighing less than 40 kg, one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or 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 for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab 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 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 approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Compliance with Written Authority Required procedures

 

C9789

P9789

 

Severe Crohn disease
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior 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
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; OR
Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR
Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND
Patient must have evidence of intestinal inflammation; OR
Patient must be assessed clinically as being in a high faecal output state; OR
Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iii) the date of the most recent clinical assessment.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, 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; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
Two completed authority prescriptions must be submitted with every initial application for adalimumab. One prescription must be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats. The second prescription must be written for 2 doses of 40 mg and 2 repeats.
Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested by telephone by contacting the Department of Human Services.
Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.
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

 

C9790

P9790

 

Severe Crohn disease
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment.
All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.
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.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, 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.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient dose. Up to a maximum of 5 repeats will be authorised.
Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.

Compliance with Written Authority Required procedures

 

C9798

P9798

 

Severe Crohn disease
Balance of supply for paediatric patient
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; OR
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; OR
The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.

Compliance with Authority Required procedures

 

C9837

P9837

 

Severe Crohn disease
Initial treatment - Initial 1 (new patient)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must be aged 18 years or older.
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR
Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR
Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iv) the date of the most recent clinical assessment.
Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:
(a) patient must have evidence of intestinal inflammation;
(b) patient must be assessed clinically as being in a high faecal output state;
(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, 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; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
Two completed authority prescriptions must be submitted with every initial application for adalimumab. One prescription must be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats. The second prescription must be written for 2 doses of 40 mg and 2 repeats.
Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested by telephone by contacting the Department of Human Services.
Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 1 month following cessation of the most recent prior treatment
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.
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

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

                   (a)        omit:

 

 

P6629

CN6629

Severe atopic dermatitis
Management (initiation, stabilisation and review of therapy)
Must be treated by a dermatologist; OR
Must be treated by a clinical immunologists.
The condition must be ineffective to other systemic therapies; OR
The condition must be inappropriate for other systemic therapies.

Compliance with Authority Required procedures

 

 

P6630

CN6630

Severe psoriasis
Management (initiation, stabilisation and review of therapy)
The condition must be ineffective to other systemic therapies; OR
The condition must be inappropriate for other systemic therapies; AND
The condition must have caused significant interference with quality of life.
Must be treated by a dermatologist.

Compliance with Authority Required procedures

                   (b)        omit:

 

 

P6659

CN6659

Severe active rheumatoid arthritis
Management (initiation, stabilisation and review of therapy)
The condition must have been ineffective to prior treatment with classical slow-acting anti-rheumatic agents (including methotrexate); OR
The condition must be considered inappropriate for treatment with slow-acting anti-rheumatic agents (including methotrexate).
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist.

Compliance with Authority Required procedures

                   (c)        omit:

 

 

P6670

CN6670

Management of transplant rejection
Management (initiation, stabilisation and review of therapy)
Patient must have had an organ or tissue transplantation; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures

 

 

P6671

CN6671

Nephrotic syndrome
Management (initiation, stabilisation and review of therapy)
Patient must have failed prior treatment with steroids and cytostatic drugs; OR
Patient must be intolerant to treatment with steroids and cytostatic drugs; OR
The condition must be considered inappropriate for treatment with steroids and cytostatic drugs; AND
Patient must not have renal impairment.
Must be treated by a nephrologist.

Compliance with Authority Required procedures

                   (d)        omit:

 

C6677

 

 

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

Compliance with Authority Required procedures

                   (e)        insert in numerical order after existing text:

 

 

P9694

CN9694

Nephrotic syndrome
Management (initiation, stabilisation and review of therapy)
Patient must have failed prior treatment with steroids and cytostatic drugs; OR
Patient must be intolerant to treatment with steroids and cytostatic drugs; OR
The condition must be considered inappropriate for treatment with steroids and cytostatic drugs; AND
Patient must not have renal impairment.
Must be treated by a nephrologist.

Compliance with Authority Required procedures - Streamlined Authority Code 9694

 

 

P9695

CN9695

Severe atopic dermatitis
Management (initiation, stabilisation and review of therapy)
Must be treated by a dermatologist; OR
Must be treated by a clinical immunologists.
The condition must be ineffective to other systemic therapies; OR
The condition must be inappropriate for other systemic therapies.

Compliance with Authority Required procedures - Streamlined Authority Code 9695

 

 

P9742

CN9742

Severe active rheumatoid arthritis
Management (initiation, stabilisation and review of therapy)
The condition must have been ineffective to prior treatment with classical slow-acting anti-rheumatic agents (including methotrexate); OR
The condition must be considered inappropriate for treatment with slow-acting anti-rheumatic agents (including methotrexate).
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist.

Compliance with Authority Required procedures - Streamlined Authority Code 9742

 

 

P9763

CN9763

Severe psoriasis
Management (initiation, stabilisation and review of therapy)
The condition must be ineffective to other systemic therapies; OR
The condition must be inappropriate for other systemic therapies; AND
The condition must have caused significant interference with quality of life.
Must be treated by a dermatologist.

Compliance with Authority Required procedures - Streamlined Authority Code 9763

 

 

P9764

CN9764

Management of transplant rejection
Management (initiation, stabilisation and review of therapy)
Patient must have had an organ or tissue transplantation; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures - Streamlined Authority Code 9764

 

C9831

 

 

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

Compliance with Authority Required procedures - Streamlined Authority Code 9831

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

                   (a)        omit:

 

C6044

P6044

 

Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
The condition must be positive for a BRAF V600 mutation; AND
The condition must not have been treated previously with PBS subsidised therapy; OR
Patient must have developed intolerance to another BRAF inhibitor of a severity necessitating permanent treatment withdrawal; AND
Patient must have a WHO performance status of 2 or less.

Compliance with Authority Required procedures - Streamlined Authority Code 6044

                   (b)        insert in numerical order after existing text:

 

C9643

P9643

 

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Initial treatment
The treatment must be adjuvant to complete surgical resection; AND
The condition must be positive for a BRAF V600 mutation; AND
Patient must have a WHO performance status of 1 or less; AND
Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
The treatment must commence within 12 weeks of complete resection, unless delay is necessary due to post-surgery recovery; AND
The treatment must not exceed a maximum duration of 12 months for adjuvant treatment of completely resected Stage IIIB, IIIC or IIID melanoma.

Compliance with Authority Required procedures

 

C9645

P9645

 

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Grandfathered treatment
Patient must have previously received non-PBS subsidised drug for adjuvant treatment following complete surgical resection prior to 1 November 2019; AND
The condition must be positive for a BRAF V600 mutation; AND
Patient must have a WHO performance status of 1 or less; AND
Patient must not have evidence of recurrence; AND
Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
Patient must have commenced non-PBS subsidised treatment within 12 weeks of complete surgical resection, unless delay is necessary due to post-surgery recovery; AND
The treatment must not exceed a maximum duration of 12 months for adjuvant treatment of completely resected Stage IIIB, IIIC or IIID melanoma.

Compliance with Authority Required procedures

 

C9646

P9646

 

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Continuing treatment
Patient must have previously been issued with an authority prescription for trametinib and dabrafenib concomitantly for adjuvant treatment following complete surgical resection; AND
Patient must not have experienced disease recurrence; AND
The treatment must not exceed a maximum duration of 12 months for adjuvant treatment of completely resected Stage IIIB, IIIC or IIID melanoma.

Compliance with Authority Required procedures

 

C9842

P9842

 

Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
The condition must be positive for a BRAF V600 mutation; AND
The condition must not have been treated previously with PBS subsidised therapy for unresectable Stage III or Stage IV disease; OR
Patient must have developed intolerance to other BRAF inhibitors of a severity necessitating permanent treatment withdrawal; AND
Patient must not have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment if previously treated with adjuvant BRAF inhibitor with MEK inhibitor for resected Stage IIIB, IIIC or IIID melanoma; AND
Patient must have a WHO performance status of 2 or less.

Compliance with Authority Required procedures - Streamlined Authority Code 9842

[127]          Schedule 4, Part 1, entry for Darbepoetin alfa

                   (a)        omit:

 

C6260

 

 

Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9688

 

 

Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures - Streamlined Authority Code 9688

[128]          Schedule 4, Part 1, entry for Desferrioxamine

                   (a)        omit:

 

C6408

 

 

Disorders of erythropoiesis
The condition must be associated with treatment-related chronic iron overload.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9696

 

 

Disorders of erythropoiesis
The condition must be associated with treatment-related chronic iron overload.

Compliance with Authority Required procedures - Streamlined Authority Code 9696

[129]          Schedule 4, Part 1, entry for Epoetin alfa

                   (a)        omit:

 

C6260

 

 

Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9688

 

 

Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures - Streamlined Authority Code 9688

[130]          Schedule 4, Part 1, entry for Epoetin beta

                   (a)        omit:

 

C6260

 

 

Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9688

 

 

Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures - Streamlined Authority Code 9688

[131]          Schedule 4, Part 1, entry for Epoetin lambda

                   (a)        omit:

 

C6260

 

 

Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9688

 

 

Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures - Streamlined Authority Code 9688

[132]          Schedule 4, Part 1, entry for Everolimus

                   (a)        omit:

 

 

P5555

CN5555

Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures

 

 

P5794

CN5794

Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

 

P9691

CN9691

Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures - Streamlined Authority Code 9691

 

 

P9693

CN9693

Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures - Streamlined Authority Code 9693

[133]          Schedule 4, Part 1, entry for Fingolimod

insert in numerical order after existing text:

 

C9794

 

 

Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Patient must weigh 40 kg or less.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

Compliance with Authority Required procedures

 

C9810

 

 

Multiple sclerosis
Continuing treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Patient must weigh 40 kg or less.

Compliance with Authority Required procedures

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

                   (a)        omit:

 

C7666

P7666

 

Moderate to severe ulcerative colitis
Balance of supply for Continuing treatment and Initial 3 (Grandfathered patients)
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; OR
Patient must have received insufficient treatment with this drug to complete 24 weeks of treatment under the Initial 3 (Grandfathered patients).
Patient must be aged 18 years or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].

Compliance with Authority Required procedures

 

C7671

P7671

 

Moderate to severe ulcerative colitis
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must be 18 years or older.
Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.

Compliance with Authority Required procedures

 

C7684

P7684

 

Moderate to severe ulcerative colitis
Balance of supply for Initial 1 and Initial 2
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug under the Initial 1 restriction to complete 14 weeks of treatment (weeks 0, 2, 6 and 10); OR
Patient must have received insufficient therapy with this drug under the Initial 2 restriction to complete 14 weeks of treatment (weeks 0, 2, 6 and 10).
Patient must be aged 18 years or older.

Compliance with Authority Required procedures

 

C7685

P7685

 

Moderate to severe ulcerative colitis
Initial 3 (Grandfathered patients)
Patient must have previously received non-PBS-subsidised therapy with this drug for this condition prior to 1 June 2018; AND
Patient must have had a Mayo clinic score greater than or equal to 6 prior to commencing treatment with this drug; OR
Patient must have had a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores were both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo score) prior to commencing treatment with this drug; OR
Patient must have a documented history of moderate to severe refractory ulcerative colitis prior to having commenced treatment with this drug where a Mayo clinic, partial Mayo clinic baseline assessment is not available; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 after receiving doses of this drug at weeks 0, 2, 6 and 10 for this condition.
Patient must be aged 18 years or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed baseline Mayo clinic or partial Mayo clinic calculation sheet prior to initiating treatment (if available) and current Mayo clinic or partial Mayo clinic calculation sheet to demonstrate response, including the date of assessment;
(ii) If the baseline Mayo or partial Mayo clinic calculation is not available, reason must be provided;
(iii) the date of commencement of this drug; and
(iv) the signed patient acknowledgement.
The current Mayo clinic or partial Mayo clinic assessment must be no more than 1 month old at the time of application. The baseline assessment must be from immediately prior to commencing treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
Where a grandfather patient has received all four doses at weeks, 0, 2, 6 and 10 by 1 June 2018, one completed authority prescription should be submitted with the application for this drug, specifying a quantity of 1 injection of 100 mg and up to 5 repeats.
Where a grandfather patient has not received doses at weeks 2, 6 and 10 by 1 June 2018, one completed authority prescription should be submitted with the application for this drug specifying a quantity of 1 injection of 100 mg and 2 repeats.
Where a grandfather patient has not received doses at weeks 6 and 10 by 1 June 2018, one completed authority prescription should be submitted with the application for this drug specifying a quantity of 1 injection of 100 mg and 1 repeat.
Where a grandfather patient has not received the dose at week 10 by 1 June 2018, one completed authority prescription should be submitted with the application for this drug specifying a quantity of 1 injection of 100 mg and 0 repeats.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Written Authority Required procedures

 

C7827

P7827

 

Moderate to severe ulcerative colitis
Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score).
Patient must be aged 18 years or older.
Application for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the signed patient acknowledgement.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 1 month old at the time of application.
Patients who fail to achieve a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 or have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose for patients administered doses at weeks 0, 2, 6 and 10 so that there is adequate time for a response to be demonstrated.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment.
A maximum of 14 weeks of treatment with this drug will be approved under this criterion. A loading dose of 200 mg at week 0 and a dose of 100 mg at weeks 2, 6 and 10.
Patients must have signed a patient acknowledgement indicating they understand and acknowledge that the PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.

Compliance with Written Authority Required procedures

 

C7853

P7853

 

Moderate to severe ulcerative colitis
Change or Re-commencement of treatment after a break in therapy of less than 5 years (Initial 2)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS-subsidised treatment with adalimumab, golimumab, infliximab or vedolizumab for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with golimumab for this condition in the current treatment cycle.
Patient must be aged 18 years or older.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of this drug within the timelines specified in the relevant restriction. If the response assessment to the previous course of this drug is not submitted as detailed in the relevant restriction, the patient will be deemed to have failed therapy with this drug.
A maximum of 14 weeks of treatment with this drug will be approved under this criterion. A loading dose of 200 mg at week 0 and a dose of 100 mg at weeks 2, 6 and 10.
Application for authorisation of change or recommencement treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) Mayo clinical assessment (to demonstrate response to prior treatment).

Compliance with Written Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9651

P9651

 

Moderate to severe ulcerative colitis
Continuing treatment - balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
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 this restriction.

Compliance with Authority Required procedures

 

C9705

P9705

 

Moderate to severe ulcerative colitis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score).
Patient must be aged 18 years or older.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
A maximum of 14 weeks of treatment with this drug will be approved under this criterion. A loading dose of 200 mg at week 0 and a dose of 100 mg at weeks 2, 6 and 10.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.
A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.
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.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.

Compliance with Written Authority Required procedures

 

C9745

P9745

 

Moderate to severe ulcerative colitis
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 gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 14 weeks of treatment (weeks 0, 2, 6 and 10); 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 14 weeks of treatment (weeks 0, 2, 6 and 10); 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 14 weeks of treatment (weeks 0, 2, 6 and 10); AND
The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment.

Compliance with Authority Required procedures

 

C9770

P9770

 

Moderate to severe ulcerative colitis
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug.
Patient must be aged 18 years or older.
Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
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 Authority Required procedures

 

C9822

P9822

 

Moderate to severe ulcerative colitis
Initial treatment - Initial 1 (new patient)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score).
Patient must be aged 18 years or older.
Application for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.
A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.
A maximum of 14 weeks of treatment with this drug will be approved under this criterion. A loading dose of 200 mg at week 0 and a dose of 100 mg at weeks 2, 6 and 10.
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
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.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.

Compliance with Written Authority Required procedures

 

C9823

P9823

 

Moderate to severe ulcerative colitis
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 gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
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 this drug for this condition during the current treatment cycle.
Patient must be aged 18 years or older.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
A maximum of 14 weeks of treatment with this drug will be approved under this criterion. A loading dose of 200 mg at week 0 and a dose of 100 mg at weeks 2, 6 and 10.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or 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 for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab 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 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 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

[135]          Schedule 4, Part 1, entry for Ipilimumab

                   (a)        omit:

 

C8142

 

 

Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
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); OR
Patient must be contraindicated to treatment with a BRAF inhibitor according to the TGA approved Product Information; OR
Patient must have developed intolerance to a BRAF inhibitor of a severity necessitating permanent treatment withdrawal; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 8142

                   (b)        insert in numerical order after existing text:

 

C9840

 

 

Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
The condition must be positive for a BRAF V600 mutation; AND
Patient must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; OR
Patient must have experienced disease recurrence whilst receiving a BRAF inhibitor with MEK inhibitor as an adjuvant treatment for resected Stage IIIB, IIIC or IIID melanoma; OR
Patient must have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 9840

[136]          Schedule 4, Part 1, entry for Lanthanum

                   (a)        omit:

 

C5454

 

 

Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non-calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9762

 

 

Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non-calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.

Compliance with Authority Required procedures - Streamlined Authority Code 9762

[137]          Schedule 4, Part 1, entry for Methoxy polyethylene glycol-epoetin beta

                   (a)        omit:

 

C6260

 

 

Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9688

 

 

Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures - Streamlined Authority Code 9688

[138]          Schedule 4, Part 1, entry for Mycophenolic acid

                   (a)        omit:

 

 

P4108

CN4108

Prophylaxis of renal allograft rejection
Management
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures

 

 

P4146

CN4146

WHO Class III, IV or V lupus nephritis
Management
The condition must be proven by biopsy.
Must be treated by a nephrologist or in consultation with a nephrologist.
The name of the consulting nephrologist must be included in the patient medical records.

Compliance with Authority Required procedures

                   (b)        omit:

 

 

P5555

CN5555

Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures

                   (c)        omit:

 

 

P5601

CN5601

Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy )
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures

 

 

P5626

CN5626

Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures

                   (d)        omit:

 

 

P5794

CN5794

Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures

                   (e)        insert in numerical order after existing text:

 

 

P9689

CN9689

Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures - Streamlined Authority Code 9689

 

 

P9690

CN9690

Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy )
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures - Streamlined Authority Code 9690

 

 

P9691

CN9691

Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures - Streamlined Authority Code 9691

 

 

P9692

CN9692

Prophylaxis of renal allograft rejection
Management
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures - Streamlined Authority Code 9692

 

 

P9693

CN9693

Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures - Streamlined Authority Code 9693

 

 

P9809

CN9809

WHO Class III, IV or V lupus nephritis
Management
The condition must be proven by biopsy.
Must be treated by a nephrologist or in consultation with a nephrologist.
The name of the consulting nephrologist must be included in the patient medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 9809

[139]          Schedule 4, Part 1, entry for Natalizumab

substitute:

Natalizumab

C9744

 

 

Clinically definite relapsing-remitting multiple sclerosis
Must be treated by a neurologist.
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support); AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; OR
Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.
The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.
Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug.
For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug.
Neurologists prescribing natalizumab under the PBS listing must be registered with the Tysabri Australian Prescribing Program.

Compliance with Authority Required procedures - Streamlined Authority Code 9744

 

C9818

 

 

Clinically definite relapsing-remitting multiple sclerosis
Must be treated by a neurologist.
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support); AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; OR
Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.
The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.
Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug.
For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug.
Neurologists prescribing natalizumab under the PBS listing must be registered with the Tysabri Australian Prescribing Program.

Compliance with Authority Required procedures - Streamlined Authority Code 9818

[140]          Schedule 4, Part 1, entry for Nivolumab

                   (a)        omit:

 

C8141

P8141

 

Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
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); OR
Patient must be contraindicated to treatment with a BRAF inhibitor according to the TGA approved Product Information; OR
Patient must have developed intolerance to a BRAF inhibitor of a severity necessitating permanent treatment withdrawal; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 8141

                   (b)        omit:

 

C9219

 

 

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 dose of 3 mg/kg or 240 mg every two weeks or 480 mg every four weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.

Compliance with Authority Required procedures - Streamlined Authority Code 9219

                   (c)        insert in numerical order after existing text:

 

C9832

 

 

Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 1
The condition must be positive for a BRAF V600 mutation; AND
Patient must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; OR
Patient must have experienced disease recurrence whilst receiving a BRAF inhibitor with MEK inhibitor as an adjuvant treatment for resected Stage IIIB, IIIC or IIID melanoma; OR
Patient must have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a dose of 3 mg/kg or 240 mg every two weeks or 480 mg every four weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.

Compliance with Authority Required procedures - Streamlined Authority Code 9832

 

C9844

 

 

Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
The condition must be positive for a BRAF V600 mutation; AND
Patient must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; OR
Patient must have experienced disease recurrence whilst receiving a BRAF inhibitor with MEK inhibitor as an adjuvant treatment for resected Stage IIIB, IIIC or IIID melanoma; OR
Patient must have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 9844

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

                   (a)        omit:

 

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

                   (b)        insert in numerical order after existing text:

 

C9843

 

 

Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 1
The condition must be positive for a BRAF V600 mutation; AND
Patient must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; OR
Patient must have experienced disease recurrence whilst receiving a BRAF inhibitor with MEK inhibitor as an adjuvant treatment for resected Stage IIIB, IIIC or IIID melanoma; OR
Patient must have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; 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 9843

[142]          Schedule 4, Part 1, entry for Sevelamer

                   (a)        omit:

 

C5454

 

 

Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non-calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9762

 

 

Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non-calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.

Compliance with Authority Required procedures - Streamlined Authority Code 9762

[143]          Schedule 4, Part 1, entry for Sirolimus

                   (a)        omit:

 

 

P5794

CN5794

Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

 

P9693

CN9693

Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

Compliance with Authority Required procedures - Streamlined Authority Code 9693

[144]          Schedule 4, Part 1, entry for Sucroferric oxyhydroxide

                   (a)        omit:

 

C5454

 

 

Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non-calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9762

 

 

Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non-calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.

Compliance with Authority Required procedures - Streamlined Authority Code 9762

[145]          Schedule 4, Part 1, entry for Tacrolimus

                   (a)        omit:

 

 

P5602

CN5602

Management of rejection in patients following organ or tissue transplantation
The treatment must be under the supervision and direction of a transplant unit; AND
The treatment must include initiation, stabilisation, and review of therapy as required.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

 

P9697

CN9697

Management of rejection in patients following organ or tissue transplantation
The treatment must be under the supervision and direction of a transplant unit; AND
The treatment must include initiation, stabilisation, and review of therapy as required.

Compliance with Authority Required procedures - Streamlined Authority Code 9697

[146]          Schedule 4, Part 1, after entry for Terbinafine

insert:

Terbutaline

C9828

 

 

Bronchospasm
Patient must be unable to achieve co-ordinated use of a metered dose inhaler containing a short-acting beta-2 agonist; OR
Patient must have developed a clinically important product-related adverse event during treatment with another short-acting beta-2 agonist.
Device (inhaler) technique should be reviewed at each clinical visit and before initiating treatment with this medicine.

Compliance with Authority Required procedures - Streamlined Authority Code 9828

[147]          Schedule 4, Part 1, entry for Trametinib

insert in numerical order after existing text:

 

C9643

P9643

 

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Initial treatment
The treatment must be adjuvant to complete surgical resection; AND
The condition must be positive for a BRAF V600 mutation; AND
Patient must have a WHO performance status of 1 or less; AND
Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
The treatment must commence within 12 weeks of complete resection, unless delay is necessary due to post-surgery recovery; AND
The treatment must not exceed a maximum duration of 12 months for adjuvant treatment of completely resected Stage IIIB, IIIC or IIID melanoma.

Compliance with Authority Required procedures

 

C9645

P9645

 

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Grandfathered treatment
Patient must have previously received non-PBS subsidised drug for adjuvant treatment following complete surgical resection prior to 1 November 2019; AND
The condition must be positive for a BRAF V600 mutation; AND
Patient must have a WHO performance status of 1 or less; AND
Patient must not have evidence of recurrence; AND
Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
Patient must have commenced non-PBS subsidised treatment within 12 weeks of complete surgical resection, unless delay is necessary due to post-surgery recovery; AND
The treatment must not exceed a maximum duration of 12 months for adjuvant treatment of completely resected Stage IIIB, IIIC or IIID melanoma.

Compliance with Authority Required procedures

 

C9646

P9646

 

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Continuing treatment
Patient must have previously been issued with an authority prescription for trametinib and dabrafenib concomitantly for adjuvant treatment following complete surgical resection; AND
Patient must not have experienced disease recurrence; AND
The treatment must not exceed a maximum duration of 12 months for adjuvant treatment of completely resected Stage IIIB, IIIC or IIID melanoma.

Compliance with Authority Required procedures

[148]          Schedule 4, Part 1, omit entry for Triglycerides, long chain

[149]          Schedule 4, Part 1, entry for Ustekinumab

                   (a)        omit: