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PB 76 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 30 Sep 2019
Tabling HistoryDate
Tabled HR14-Oct-2019
Tabled Senate14-Oct-2019
To be repealed 06 Dec 2019
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

 

 

 

 

PB 76 of 2019

 

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 9)

 

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 September                                       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. 9).

(2)          This Instrument may also be cited as PB 76 of 2019.

2          Commencement

This Instrument commences on 1 October 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]             Section 11 Authority required procedures

omit:

(3)     In all circumstances mentioned in Part 1 of Schedule 4 for a circumstances code mentioned in Schedule 1 for the pharmaceutical benefit, except those which include a Streamlined Authority Code, a medication chart prescription for a person receiving treatment in a residential care service may not be authorised under the authority required procedures in sections 11 to 15.

[2]             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”: C4492 C4501 C4517 C4518 C4531

                   (b)        omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074

                   (c)        insert in numerical order in the column headed “Circumstances”: C9380 C9386 C9409 C9414 C9428 C9429 C9430 C9431 C9498 C9503 C9564 C9631

[3]             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”: C4492 C4501 C4517 C4518 C4531

                   (b)        omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074

                   (c)        insert in numerical order in the column headed “Circumstances”: C9380 C9386 C9409 C9414 C9428 C9429 C9430 C9431 C9498 C9503 C9564 C9631

[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: 3]

                   (a)        omit from the column headed “Circumstances”: C4492 C4501 C4517 C4518 C4531

                   (b)        omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074

                   (c)        insert in numerical order in the column headed “Circumstances”: C9380 C9386 C9409 C9414 C9428 C9429 C9430 C9431 C9498 C9503 C9564 C9631

                   (d)        omit from the column headed “Purposes”: P4492 P4501 P4518 P8059 P8060 P8073

                   (e)        insert in numerical order in the column headed “Purposes”: P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564

[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: 4]

                   (a)        omit from the column headed “Circumstances”: C4492 C4501 C4517 C4518 C4531

                   (b)        omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074

                   (c)        insert in numerical order in the column headed “Circumstances”: C9380 C9386 C9409 C9414 C9428 C9429 C9430 C9431 C9498 C9503 C9564 C9631

[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: 5]

                   (a)        omit from the column headed “Circumstances”: C4492 C4501 C4517 C4518 C4531

                   (b)        omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074

                   (c)        insert in numerical order in the column headed “Circumstances”: C9380 C9386 C9409 C9414 C9428 C9429 C9430 C9431 C9498 C9503 C9564 C9631

                   (d)        omit from the column headed “Purposes”: P4517 P4531

                   (e)        omit from the column headed “Purposes”: P8041 P8074

                    (f)        insert in numerical order in the column headed “Purposes”: P9380 P9430 P9431 P9631

[7]             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”: C4492 C4501 C4517 C4518 C4531

                   (b)        omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074

                   (c)        insert in numerical order in the column headed “Circumstances”: C9380 C9386 C9409 C9414 C9428 C9429 C9430 C9431 C9498 C9503 C9564 C9631

[8]             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”: C4492 C4501 C4517 C4518 C4531

                   (b)        omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074

                   (c)        insert in numerical order in the column headed “Circumstances”: C9380 C9386 C9409 C9414 C9428 C9429 C9430 C9431 C9498 C9503 C9564 C9631

[9]             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”: C4492 C4501 C4517 C4518 C4531

                   (b)        omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074

                   (c)        insert in numerical order in the column headed “Circumstances”: C9380 C9386 C9409 C9414 C9428 C9429 C9430 C9431 C9498 C9503 C9564 C9631

                   (d)        omit from the column headed “Purposes”: P4492 P4501 P4518 P8059 P8060 P8073

                   (e)        insert in numerical order in the column headed “Purposes”: P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564

[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: 4]

                   (a)        omit from the column headed “Circumstances”: C4492 C4501 C4517 C4518 C4531

                   (b)        omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074

                   (c)        insert in numerical order in the column headed “Circumstances”: C9380 C9386 C9409 C9414 C9428 C9429 C9430 C9431 C9498 C9503 C9564 C9631

[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: 5]

                   (a)        omit from the column headed “Circumstances”: C4492 C4501 C4517 C4518 C4531

                   (b)        omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074

                   (c)        insert in numerical order in the column headed “Circumstances”: C9380 C9386 C9409 C9414 C9428 C9429 C9430 C9431 C9498 C9503 C9564 C9631

                   (d)        omit from the column headed “Purposes”: P4517 P4531

                   (e)        omit from the column headed “Purposes”: P8041 P8074

                    (f)        insert in numerical order in the column headed “Purposes”: P9380 P9430 P9431 P9631


 

[12]           Schedule 1, entry for Alemtuzumab in the form Solution concentrate for I.V. infusion 12 mg in 1.2 mL [Maximum Quantity: 3;
Number of Repeats: 0]

                   (a)        omit from the column headed “Circumstances”: C6878

                   (b)        omit from the column headed “Circumstances”: C7743

                   (c)        insert in numerical order in the column headed “Circumstances”: C9589 C9636

                   (d)        omit from the column headed “Purposes”: P6878

                   (e)        insert in numerical order in the column headed “Purposes”: P9589

[13]           Schedule 1, entry for Alemtuzumab in the form Solution concentrate for I.V. infusion 12 mg in 1.2 mL [Maximum Quantity: 5;
Number of Repeats: 0]

                   (a)        omit from the column headed “Circumstances”: C6878 

                   (b)        omit from the column headed “Circumstances”: C7743

                   (c)        insert in numerical order in the column headed “Circumstances”: C9589 C9636

                   (d)        omit from the column headed “Purposes”: P7743

                   (e)        insert in numerical order in the column headed “Purposes”: P9636

[14]           Schedule 1, entry for Amoxicillin in the form Capsule 250 mg (as trihydrate)

                           omit from the column headed “Responsible Person” for the brand “Cilamox” (twice occurring): QA         substitute: AL

[15]           Schedule 1, entry for Amoxicillin in the form Capsule 500 mg (as trihydrate)

                           omit from the column headed “Responsible Person” for the brand “Cilamox” (twice occurring): QA         substitute: AL 

[16]           Schedule 1, entry for Apomorphine in each of the forms: Injection containing apomorphine hydrochloride hemihydrate 20 mg in 2 mL; and Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL

                   (a)        omit from the column headed "Circumstances": C4860

                   (b)        insert in numerical order in the column headed “Circumstances”: C9561

[17]           Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20

                   (a)        omit from the column headed "Circumstances": C4860

                   (b)        insert in numerical order in the column headed “Circumstances”: C9561

[18]           Schedule 1, entry for Apomorphine in the form Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre-filled pen

                   (a)        omit from the column headed "Circumstances" (twice occurring): C4860

                   (b)        insert in numerical order in the column headed “Circumstances” (twice occurring): C9561


 

[19]           Schedule 1, entry for Apomorphine in the form Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre-filled syringe

                   (a)        omit from the column headed "Circumstances": C4860

                   (b)        insert in numerical order in the column headed “Circumstances”: C9561

[20]           Schedule 1, after entry for Apraclonidine in the form Eye drops 5 mg (as hydrochloride) per mL, 10 mL

                           insert:

Aprepitant

Capsule 165 mg

Oral

 

Aprepitant APOTEX

TX

MP NP

C4211 C4215 C6370 C6444

 

1

5

1

 

 

 

 

 

 

 

 

MP

C4216 C4223 C6383 C6464

 

1

5

1

 

C(100)

[21]           Schedule 1, entry for Aripiprazole in each of the forms: Tablet 10 mg; Tablet 15 mg; Tablet 20 mg; and Tablet 30 mg 

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

 

 

 

a

Aripiprazole generichealth

HQ

MP NP

C4246

 

30

5

30

 

 

[22]           Schedule 1, entry for Atezolizumab

                           insert in numerical order in the column headed “Circumstances”: C9345 C9348 C9514 C9567

[23]           Schedule 1, entry for Aurothiomalate

                           omit:

 

Injection containing sodium aurothiomalate 50 mg

Injection

 

Myocrisin

SW

MP NP

 

 

10

1

10

 

 

[24]           Schedule 1, entry for Azithromycin in the form Tablet 600 mg (as dihydrate)

                   (a)        omit from the column headed “Circumstances”: C6361

                   (b)        insert in numerical order in the column headed “Circumstances”: C9604 

[25]           Schedule 1, entry for Baclofen in the form Intrathecal injection 10 mg in 5 mL

                   (a)        omit from the column headed “Circumstances”  for the brand “Bacthecal” (twice occurring): C6912

                   (b)        omit from the column headed “Circumstances”  for the brand “Bacthecal” (twice occurring): C6929 C6930 C6935

                   (c)        insert in numerical order in the column headed “Circumstances” for the brand “Bacthecal” (twice occurring): C9488 C9489 C9524 C9637

                   (d)        omit from the column headed “Circumstances” for the brand “Lioresal Intrathecal”: C6912

                   (e)        omit from the column headed “Circumstances” for the brand “Lioresal Intrathecal”: C6929 C6930 C6935

                    (f)        insert in numerical order in the column headed “Circumstances” for the brand “Lioresal Intrathecal”:  C9488 C9489 C9524 C9637

                   (g)        omit from the column headed “Circumstances” for the brand “Sintetica Baclofen Intrathecal”: C6912

                   (h)        omit from the column headed “Circumstances” for the brand “Sintetica Baclofen Intrathecal”: C6929 C6930 C6935

                    (i)        insert in numerical order in the column headed “Circumstances” for the brand “Sintetica Baclofen Intrathecal”: C9488 C9489 C9524 C9637

[26]           Schedule 1, entry for Baclofen in the form Intrathecal injection 40 mg in 20 mL

                   (a)        omit from the column headed “Circumstances”: C7156 C7157 C7159 C7162

                   (b)        insert in numerical order in the column headed “Circumstances”: C9525 C9562 C9606 C9638

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

                           insert in numerical order in the column headed “Circumstances”: C9346 C9347 C9454 C9566 

[28]           Schedule 1, omit entry for Biperiden

[29]           Schedule 1, entry for Blinatumomab

                           omit from the column headed “Circumstances”: C8812 C8924 C8949 C8966  substitute: C9369 C9373 C9519 C9551

[30]           Schedule 1, entry for Cefaclor in the form Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL

                   (a)        omit from the column headed “Responsible Person” for the brand “Aclor 125” (twice occurring): QA         substitute: MQ

                   (b)        omit from the column headed “Responsible Person” for the brand “Ceclor” (twice occurring): AS               substitute: AL

[31]           Schedule 1, entry for Cefaclor in the form Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL

                   (a)        omit from the column headed “Responsible Person” for the brand “Aclor 250” (twice occurring): QA         substitute: MQ

                   (b)        omit from the column headed “Responsible Person” for the brand “Ceclor” (twice occurring): AS               substitute: AL

[32]           Schedule 1, entry for Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate) 

                   (a)        omit from the column headed “Responsible Person” for the brand “Ceclor CD” (twice occurring): AS        substitute: AL

                   (b)        omit from the column headed “Responsible Person” for the brand “Karlor CD” (twice occurring): LN        substitute: MQ

[33]           Schedule 1, entry for Cefepime in each of the forms: Powder for injection 1 g (as hydrochloride); and Powder for injection 2 g (as hydrochloride)

                           omit:

 

 

 

a

DBL Cefepime

PF

MP NP

C5842

 

10

0

1

 

 


 

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

                   (a)        omit from the column headed “Circumstances”: C8041 C8074 C8076 C8097 C8113

                   (b)        insert in numerical order in the column headed “Circumstances”: C9430 C9431 C9442 C9537 C9610 C9625

                   (c)        omit from the column headed “Purposes”: P8113

                   (d)        insert in numerical order in the column headed “Purposes”: P9625

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

                   (a)        omit from the column headed “Circumstances”: C8041 C8074 C8076 C8097 C8113

                   (b)        insert in numerical order in the column headed “Circumstances”: C9430 C9431 C9442 C9537 C9610 C9625

                   (c)        omit from the column headed “Purposes”: P8041 P8074

                   (d)        insert in numerical order in the column headed “Purposes”: P9430 P9431

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

                   (a)        omit from the column headed “Circumstances”: C8041 C8074 C8076 C8097 C8113

                   (b)        insert in numerical order in the column headed “Circumstances”: C9430 C9431 C9442 C9537 C9610 C9625

                   (c)        omit from the column headed “Purposes”: P8076 P8097

                   (d)        insert in numerical order in the column headed “Purposes”: P9442 P9537 P9610

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

                   (a)        omit from the column headed “Circumstances”: C8041 C8074 C8076 C8097 C8113

                   (b)        insert in numerical order in the column headed “Circumstances”: C9430 C9431 C9442 C9537 C9610 C9625

                   (c)        omit from the column headed “Purposes”: P8113      

                   (d)        insert in numerical order in the column headed “Purposes”: P9625

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

                   (a)        omit from the column headed “Circumstances”: C8041 C8074 C8076 C8097 C8113

                   (b)        insert in numerical order in the column headed “Circumstances”: C9430 C9431 C9442 C9537 C9610 C9625

                   (c)        omit from the column headed “Purposes”: P8041 P8074

                   (d)        insert in numerical order in the column headed “Purposes”: P9430 P9431

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

                   (a)        omit from the column headed “Circumstances”: C8041 C8074 C8076 C8097 C8113

                   (b)        insert in numerical order in the column headed “Circumstances”: C9430 C9431 C9442 C9537 C9610 C9625

                   (c)        omit from the column headed “Purposes”: P8076 P8097

                   (d)        insert in numerical order in the column headed “Purposes”: P9442 P9537 P9610

[40]           Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)

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

 

 

 

 

Clopidogrel Sandoz Pharma

HX

MP NP

C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525

 

28

5

28

 

 

[41]           Schedule 1, entry for Clostridium botulinum type A toxin - haemagglutinin complex in each of the forms: Lyophilised powder for I.M. injection 300 units; and Lyophilised powder for I.M. injection 500 units

                   (a)        omit from the column headed “Circumstances”: C5220

                   (b)        insert in numerical order in the column headed “Circumstances”: C9463 C9547 

[42]           Schedule 1, entry for Clozapine in the form Oral liquid 50 mg per mL, 100 mL

                   (a)        omit from the column headed "Circumstances" (twice occurring): C5001

                   (b)        insert in numerical order in the column headed “Circumstances” (twice occurring): C9490

[43]           Schedule 1, entry for Clozapine in the form Tablet 25 mg

                   (a)        omit from the column headed "Circumstances" (twice occurring): C5001

                   (b)        insert in numerical order in the column headed “Circumstances” (twice occurring): C9490

[44]           Schedule 1, entry for Clozapine in the form Tablet 50 mg

                   (a)        omit from the column headed "Circumstances": C5001

                   (b)        insert in numerical order in the column headed “Circumstances”: C9490

[45]           Schedule 1, entry for Clozapine in the form Tablet 100 mg

                   (a)        omit from the column headed "Circumstances" (twice occurring): C5001

                   (b)        insert in numerical order in the column headed “Circumstances” (twice occurring): C9490

[46]           Schedule 1, entry for Clozapine in the form Tablet 200 mg

                   (a)        omit from the column headed "Circumstances": C5001

                   (b)        insert in numerical order in the column headed “Circumstances”: C9490

[47]           Schedule 1, entry for Codeine with paracetamol

                           omit from the column headed "Responsible Person" for the brand “Codalgin Forte” (twice occurring): FM             substitute: AF

[48]           Schedule 1, entry for Colestyramine

                           omit from the column headed “Responsible Person”: QA        substitute: GO

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

                   (a)        omit from the column headed “Circumstances”: C9059 C9098 C9100 C9136

                   (b)        insert in numerical order in the column headed “Circumstances”: C9367 C9468 C9469 C9549

                   (c)        omit from the column headed “Purposes”: P9059 P9098 P9100 P9136              substitute: P9367 P9468 P9469 P9549

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

                   (a)        omit from the column headed “Circumstances”: C9059 C9098 C9100 C9136

                   (b)        insert in numerical order in the column headed “Circumstances”: C9367 C9468 C9469 C9549

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

                   (a)        omit from the column headed “Circumstances”: C9059 C9098 C9100 C9136

                   (b)        insert in numerical order in the column headed “Circumstances”: C9367 C9468 C9469 C9549

                   (c)        omit from the column headed “Purposes”: P9059 P9098 P9100 P9136              substitute: P9367 P9468 P9469 P9549

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

                   (a)        omit from the column headed “Circumstances”: C9059 C9098 C9100 C9136

                   (b)        insert in numerical order in the column headed “Circumstances”: C9367 C9468 C9469 C9549

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

                   (a)        omit from the column headed “Circumstances”: C9059 C9098 C9100 C9136

                   (b)        insert in numerical order in the column headed “Circumstances”: C9367 C9468 C9469 C9549

                   (c)        omit from the column headed “Purposes”: P9059 P9098 P9100 P9136              substitute: P9367 P9468 P9469 P9549

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

                   (a)        omit from the column headed “Circumstances”: C9059 C9098 C9100 C9136

                   (b)        insert in numerical order in the column headed “Circumstances”: C9367 C9468 C9469 C9549

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

                   (a)        omit from the column headed “Circumstances”: C9059 C9098 C9100 C9136

                   (b)        insert in numerical order in the column headed “Circumstances”: C9367 C9468 C9469 C9549

                   (c)        omit from the column headed “Purposes”: P9059 P9098 P9100 P9136              substitute: P9367 P9468 P9469 P9549

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

                   (a)        omit from the column headed “Circumstances”: C9059 C9098 C9100 C9136

                   (b)        insert in numerical order in the column headed “Circumstances”: C9367 C9468 C9469 C9549 

[57]           Schedule 1, entry for Deferiprone in the form Tablet 1000 mg

                   (a)        omit from the column headed “Circumstances”: C6380

                   (b)        omit from the column headed “Circumstances”: C6442

                   (c)        insert in numerical order in the column headed “Circumstances”: C9590 C9623

[58]           Schedule 1, entry for Dornase alfa

                   (a)        omit from the column headed “Circumstances”: C5715

                   (b)        omit from the column headed “Circumstances”: C5768 C5800

                   (c)        insert in numerical order in the column headed “Circumstances”: C9591 C9592 C9624

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

                   (a)        omit from the column headed “Circumstances”: C4457 C4458 C4482 C4483 C4503

                   (b)        omit from the column headed “Circumstances”: C8039 C8040 C8054 C8079 C8093 C8095 C8103

                   (c)        insert in numerical order in the column headed “Circumstances”: C9375 C9377 C9380 C9386 C9388 C9410 C9428 C9429 C9473 C9487 C9501 C9502 C9554

                   (d)        omit from the column headed “Purposes”: P4458 P4483 P4503

                   (e)        omit from the column headed “Purposes”: P8039 P8040 P8093

                    (f)        insert in numerical order in the column headed “Purposes”: P9375 P9386 P9388 P9410 P9428 P9429 P9473 P9501

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

                   (a)        omit from the column headed “Circumstances”: C4457 C4458 C4482 C4483 C4503

                   (b)        omit from the column headed “Circumstances”: C8039 C8040 C8054 C8079 C8093 C8095 C8103

                   (c)        insert in numerical order in the column headed “Circumstances”: C9375 C9377 C9380 C9386 C9388 C9410 C9428 C9429 C9473 C9487 C9501 C9502 C9554

                   (d)        omit from the column headed “Purposes”: P4457 P4482

                   (e)        omit from the column headed “Purposes”: P8054 P8079 P8095 P8103

                    (f)        insert in numerical order in the column headed “Purposes”: P9377 P9380 P9487 P9502 P9554

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

                   (a)        omit from the column headed “Circumstances”: C8039 C8040 C8054 C8079 C8092 C8093 C8095 C8103

                   (b)        insert in numerical order in the column headed “Circumstances”: C9410 C9428 C9429 C9481 C9487 C9501 C9502 C9554

                   (c)        omit from the column headed “Purposes”: P8039 P8040 P8093

                   (d)        insert in numerical order in the column headed “Purposes”: P9410 P9428 P9429 P9501

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

                   (a)        omit from the column headed “Circumstances”: C4457 C4458 C4482 C4483 C4503

                   (b)        omit from the column headed “Circumstances”: C8039 C8040 C8054 C8079 C8093 C8095 C8103

                   (c)        insert in numerical order in the column headed “Circumstances”: C9375 C9377 C9380 C9386 C9388 C9410 C9428 C9429 C9473 C9487 C9501 C9502 C9554

                   (d)        omit from the column headed “Purposes”: P4458 P4483 P4503

                   (e)        omit from the column headed “Purposes”: P8039 P8040 P8093

                    (f)        insert in numerical order in the column headed “Purposes”: P9375 P9386 P9388 P9410 P9428 P9429 P9473 P9501

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

                   (a)        omit from the column headed “Circumstances”: C8039 C8040 C8054 C8079 C8092 C8093 C8095 C8103

                   (b)        insert in numerical order in the column headed “Circumstances”: C9410 C9428 C9429 C9481 C9487 C9501 C9502 C9554

                   (c)        omit from the column headed “Purposes”: P8054 P8079 P8092 P8095 P8103

                   (d)        insert in numerical order in the column headed “Purposes”: P9481 P9487 P9502 P9554

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

                   (a)        omit from the column headed “Circumstances”: C4457 C4458 C4482 C4483 C4503

                   (b)        omit from the column headed “Circumstances”: C8039 C8040 C8054 C8079 C8093 C8095 C8103

                   (c)        insert in numerical order in the column headed “Circumstances”: C9375 C9377 C9380 C9386 C9388 C9410 C9428 C9429 C9473 C9487 C9501 C9502 C9554

                   (d)        omit from the column headed “Purposes”: P4457 P4482

                   (e)        omit from the column headed “Purposes”: P8054 P8079 P8095 P8103

                    (f)        insert in numerical order in the column headed “Purposes”: P9377 P9380 P9487 P9502 P9554


 

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

                   (a)        omit from the column headed “Circumstances”: C8039 C8040 C8054 C8079 C8092 C8093 C8095 C8103

                   (b)        insert in numerical order in the column headed “Circumstances”: C9410 C9428 C9429 C9481 C9487 C9501 C9502 C9554

                   (c)        omit from the column headed “Purposes”: P8039 P8040 P8093

                   (d)        insert in numerical order in the column headed “Purposes”: P9410 P9428 P9429 P9501

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

                   (a)        omit from the column headed “Circumstances”: C4457 C4458 C4482 C4483 C4503

                   (b)        omit from the column headed “Circumstances”: C8039 C8040 C8054 C8079 C8093 C8095 C8103

                   (c)        insert in numerical order in the column headed “Circumstances”: C9375 C9377 C9380 C9386 C9388 C9410 C9428 C9429 C9473 C9487 C9501 C9502 C9554

                   (d)        omit from the column headed “Purposes”: P4458 P4483 P4503

                   (e)        omit from the column headed “Purposes”: P8039 P8040 P8093

                    (f)        insert in numerical order in the column headed “Purposes”: P9375 P9386 P9388 P9410 P9428 P9429 P9473 P9501

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

                   (a)        omit from the column headed “Circumstances”: C8039 C8040 C8054 C8079 C8092 C8093 C8095 C8103

                   (b)        insert in numerical order in the column headed “Circumstances”: C9410 C9428 C9429 C9481 C9487 C9501 C9502 C9554

                   (c)        omit from the column headed “Purposes”: P8054 P8079 P8092 P8095 P8103

                   (d)        insert in numerical order in the column headed “Purposes”: P9481 P9487 P9502 P9554

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

                   (a)        omit from the column headed “Circumstances”: C4457 C4458 C4482 C4483 C4503

                   (b)        omit from the column headed “Circumstances”: C8039 C8040 C8054 C8079 C8093 C8095 C8103

                   (c)        insert in numerical order in the column headed “Circumstances”: C9375 C9377 C9380 C9386 C9388 C9410 C9428 C9429 C9473 C9487 C9501 C9502 C9554

                   (d)        omit from the column headed “Purposes”: P4457 P4482

                   (e)        omit from the column headed “Purposes”: P8054 P8079 P8095 P8103

                    (f)        insert in numerical order in the column headed “Purposes”: P9377 P9380 P9487 P9502 P9554


 

[69]           Schedule 1, entry for Filgrastim

                           substitute:

Filgrastim

Injection 120 micrograms in 0.2 mL single-use pre-filled syringe

Injection

 

Nivestim

PF

MP

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

 

20

11

10

 

D(100)

 

Injection 300 micrograms in 0.5 mL single-use pre-filled syringe

Injection

 

Zarzio

SZ

MP

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

 

20

11

5

 

D(100)

 

 

 

 

Neupogen

AN

MP

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

 

20

11

10

 

D(100)

 

 

 

 

Nivestim

PF

MP

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

 

20

11

10

 

D(100)

 

Injection 300 micrograms in 1 mL

Injection

 

Neupogen

AN

MP

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

 

20

11

10

 

D(100)

 

Injection 480 micrograms in 0.5 mL single-use pre-filled syringe

Injection

 

Zarzio

SZ

MP

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

 

20

11

5

 

D(100)

 

 

 

 

Neupogen

AN

MP

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

 

20

11

10

 

D(100)

 

 

 

 

Nivestim

PF

MP

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

 

20

11

10

 

D(100)

 

Injection 480 micrograms in 1.6 mL

Injection

 

Neupogen

AN

MP

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

 

20

11

10

 

D(100)

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

                           omit from the column headed “Responsible Person”: AS        substitute: AL


 

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

                           omit from the column headed “Responsible Person”: AS        substitute: AL

[72]           Schedule 1, omit entry for Fluticasone 

[73]           Schedule 1, after entry for Fluticasone furoate with vilanterol in the form Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

                           insert:

Fluticasone propionate

Pressurised inhalation containing fluticasone propionate 50 micrograms per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

 

Flixotide Junior

GK

MP NP

 

 

1

5

1

 

 

 

Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

a

Flixotide

GK

MP NP

 

 

1

5

1

 

 

 

 

 

a

Fluticasone Cipla Inhaler

LR

MP NP

 

 

1

5

1

 

 

 

Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms per dose, 60 doses

Inhalation by mouth

 

Flixotide Junior Accuhaler

GK

MP NP

 

 

1

5

1

 

 

 

Pressurised inhalation containing fluticasone propionate 250 micrograms per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

a

Flixotide

GK

MP NP

 

 

1

1

1

 

 

 

 

 

a

Fluticasone Cipla Inhaler

LR

MP NP

 

 

1

1

1

 

 

 

Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms per dose, 60 doses

Inhalation by mouth

 

Flixotide Accuhaler

GK

MP NP

 

 

1

5

1

 

 

 

Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms per dose, 60 doses

Inhalation by mouth

 

Flixotide Accuhaler

GK

MP NP

 

 

1

1

1

 

 

[74]           Schedule 1, entry for Fluticasone with formoterol

                           omit from the column headed “Listed Drug”: Fluticasone with formoterol   substitute: Fluticasone propionate with formoterol

[75]           Schedule 1, entry for Fluticasone with salmeterol           

omit from the column headed “Listed Drug”: Fluticasone with salmeterol  substitute: Fluticasone propionate with salmeterol

[76]           Schedule 1, entry for Ganciclovir

                   (a)        omit from the column headed “Circumstances” (all instances): C4990

                   (b)        omit from the column headed “Circumstances” (all instances): C5025

                   (c)        insert in numerical order in the column headed “Circumstances” (all instances): C9404 C9526

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

                   (a)        omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074

                   (b)        insert in numerical order in the column headed “Circumstances”: C9414 C9428 C9429 C9430 C9431 C9503

                   (c)        omit from the column headed “Purposes”: P8059 P8060 P8073

                   (d)        insert in numerical order in the column headed “Purposes”: P9414 P9428 P9429 P9503

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

                   (a)        omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074

                   (b)        insert in numerical order in the column headed “Circumstances”: C9414 C9428 C9429 C9430 C9431 C9503

                   (c)        omit from the column headed “Purposes”: P8041 P8074

                   (d)        insert in numerical order in the column headed “Purposes”: P9430 P9431

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

                   (a)        omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074

                   (b)        insert in numerical order in the column headed “Circumstances”: C9414 C9428 C9429 C9430 C9431 C9503

                   (c)        omit from the column headed “Purposes”: P8059 P8060 P8073

                   (d)        insert in numerical order in the column headed “Purposes”: P9414 P9428 P9429 P9503

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

                   (a)        omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074

                   (b)        insert in numerical order in the column headed “Circumstances”: C9414 C9428 C9429 C9430 C9431 C9503

                   (c)        omit from the column headed “Purposes”: P8041 P8074

                   (d)        insert in numerical order in the column headed “Purposes”: P9430 P9431

[81]           Schedule 1, entry for Imiquimod in the form Cream 50 mg per g, 250 mg single use sachets, 12

                           omit from the column headed “Responsible Person”: QA        substitute: AF

[82]           Schedule 1, entry for Inotuzumab ozogamicin

                           omit from the column headed “Circumstances”: C8768 C8857 C8858               substitute: C9470 C9600 C9601

[83]           Schedule 1, entry for Insulin glargine

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

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

 

 

 

a

Semglee

AF

MP NP

 

 

5

1

1

 

 

[84]           Schedule 1, entry for Interferon gamma-1b 

                   (a)        omit from the column headed “Circumstances”: C6286

                   (b)        insert in numerical order in the column headed “Circumstances”: C9639

[85]           Schedule 1, entry for Irbesartan in the form Tablet 75 mg

                           omit:

 

 

 

a

Irprestan 75

ZP

MP NP

 

 

30

5

30

 

 

[86]           Schedule 1, entry for Irbesartan in the form Tablet 150 mg

                           omit:

 

 

 

a

Irprestan 150

ZP

MP NP

 

 

30

5

30

 

 

[87]           Schedule 1, entry for Irbesartan in the form Tablet 300 mg

                           omit:

 

 

 

a

Irprestan 300

ZP

MP NP

 

 

30

5

30

 

 

[88]           Schedule 1, entry for Lapatinib

                           omit from the column headed “Circumstances”: C6105 C7441             substitute: C9360 C9544


 

[89]           Schedule 1, entry for Letrozole

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

 

 

 

a

Letrozole GH

HQ

MP NP

C5464

 

30

5

30

 

 

[90]           Schedule 1, entry for Levodopa with carbidopa in the form Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL [Maximum Quantity: 56; Number of Repeats: 5; Section 100/Prescriber Bag only: C(100)]          

                   (a)        omit from the column headed “Circumstances”: C6880

                   (b)        insert in numerical order in the column headed “Circumstances”: C9405

[91]           Schedule 1, entry for Mannitol

                   (a)        omit from the column headed “Circumstances”: C7349

                   (b)        omit from the column headed “Circumstances”: C7364

                   (c)        insert in numerical order in the column headed “Circumstances”: C9527 C9593

[92]           Schedule 1, entry for Meloxicam in each of the forms: Capsule 7.5 mg; and Capsule 15 mg                

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

 

 

 

 

MELOBIC

RF

MP NP

C4907 C4962

 

30

3

30

 

 

[93]           Schedule 1, entry for Mesalazine in the form Sachet containing granules, 500 mg per sachet

                           omit from the column headed “Circumstances”: C4824           substitute: C9444

[94]           Schedule 1, entry for Mesalazine in the form Sachet containing granules, 1 g per sachet

                           omit from the column headed “Circumstances”: C4824           substitute: C9444

[95]           Schedule 1, entry for Mesalazine in the form Sachet containing prolonged release granules, 1 g per sachet

                           omit from the column headed “Circumstances”: C4873 C4896             substitute: C9443 C9444

[96]           Schedule 1, entry for Mesalazine in the form Sachet containing granules, 1.5 g per sachet

                           omit from the column headed “Circumstances”: C4824           substitute: C9444

[97]           Schedule 1, entry for Mesalazine in the form Sachet containing prolonged release granules, 2 g per sachet

                           omit from the column headed “Circumstances”: C4873 C4896             substitute: C9443 C9444

[98]           Schedule 1, entry for Mesalazine in the form Sachet containing granules, 3 g per sachet

                           omit from the column headed “Circumstances”: C4824           substitute: C9444


 

[99]           Schedule 1, entry for Mesalazine in the form Sachet containing prolonged release granules, 4 g per sachet

                           omit from the column headed “Circumstances”: C4824           substitute: C9444

[100]        Schedule 1, entry for Mesalazine in the form Tablet 250 mg (enteric coated)

                   (a)        omit from the column headed “Responsible Person”: AS          substitute: GO

                   (b)        omit from the column headed “Circumstances”: C4873 C4896                               substitute: C9443 C9444

[101]        Schedule 1, entry for Mesalazine in the form Tablet 500 mg (enteric coated)

                           omit from the column headed “Circumstances”: C4873 C4896             substitute: C9443 C9444

[102]        Schedule 1, entry for Mesalazine in the form Tablet 500 mg (prolonged release)

                           omit from the column headed “Circumstances”: C4873 C4896             substitute: C9443 C9444

[103]        Schedule 1, entry for Mesalazine in the form Tablet 800 mg (enteric coated)

                           omit from the column headed “Circumstances”: C4824           substitute: C9510

[104]        Schedule 1, entry for Mesalazine in the form Tablet 1 g (enteric coated)

                           omit from the column headed “Circumstances”: C4873 C4896             substitute: C9443 C9444

[105]        Schedule 1, entry for Mesalazine in the form Tablet 1 g (prolonged release)

                           omit from the column headed “Circumstances”: C4873 C4896             substitute: C9443 C9444

[106]        Schedule 1, entry for Mesalazine in the form Tablet 1.2 g (prolonged release)

                           omit from the column headed “Circumstances”: C4824           substitute: C9444

[107]        Schedule 1, entry for Methylprednisolone in the form Cream containing methylprednisolone aceponate 1 mg per g, 15 g

                           omit from the column headed “Responsible Person”: BN        substitute: LO

[108]        Schedule 1, entry for Methylprednisolone in the form Lotion containing methylprednisolone aceponate 1 mg per g, 20 g

                           omit from the column headed “Responsible Person”: BN        substitute: LO

[109]        Schedule 1, entry for Methylprednisolone in the form Fatty ointment containing methylprednisolone aceponate 1 mg per g, 15 g

                           omit from the column headed “Responsible Person”: BN        substitute: LO

[110]        Schedule 1, entry for Methylprednisolone in the form Ointment containing methylprednisolone aceponate 1 mg per g, 15 g

                           omit from the column headed “Responsible Person”: BN        substitute: LO

[111]        Schedule 1, entry for Montelukast in the form Tablet, chewable, 4 mg (as sodium)

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

 

 

 

a

MONTELAIR 4

RF

MP NP

C6666

 

28

5

28

 

 

[112]        Schedule 1, entry for Montelukast in the form Tablet, chewable, 5 mg (as sodium)

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

 

 

 

a

MONTELAIR 5

RF

MP NP

C6674 C7781

 

28

5

28

 

 

[113]        Schedule 1, entry for Natalizumab

                   (a)        omit from the column headed “Circumstances”: C6845

                   (b)        omit from the column headed “Circumstances”: C7769

                   (c)        insert in numerical order in the column headed “Circumstances”: C9406

[114]        Schedule 1, entry for Nicorandil in each of the forms: Tablets 10 mg, 60; and Tablets 20 mg, 60                  

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

 

 

 

a

APO-Nicorandil

TX

MP NP

 

 

1

5

1

 

 

[115]        Schedule 1, entry for Norfloxacin

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

 

 

 

a

APO-Norfloxacin

TX

MP NP

C5744 C5806

 

14

1

14

 

 

[116]        Schedule 1, entry for Ocrelizumab

                   (a)        omit from the column headed “Circumstances”: C7412

                   (b)        omit from the column headed “Circumstances”: C7771

                   (c)        insert in numerical order in the column headed “Circumstances”: C9523 C9635

[117]        Schedule 1, entry for Ocriplasmin

                           insert as first entry:

 

Solution for intravitreal injection 0.375 mg in 0.3 mL

Injection

 

Jetrea RTU

IJ

MP

C9363

 

1

0

1

 

 

[118]        Schedule 1, entry for Ocriplasmin in the form Solution concentrate for intravitreal injection 0.5 mg in 0.2 mL 

                            omit from the column headed “Circumstances”: C6601              substitute: C9363

[119]        Schedule 1, entry for Ondansetron in the form I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL

                   (a)        omit from the column headed “Schedule Equivalent” for the brand “Ondansetron Alphapharm”: a 


 

                   (b)        omit:

 

 

 

a

Onsetron

ZP

MP NP

C4077 C4092

 

1

0

1

 

 

 

 

 

 

 

 

MP

C5749

 

1

0

1

(C100)

 

[120]        Schedule 1, entry for Ondansetron in the form I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL

                   (a)        omit from the column headed “Schedule Equivalent” for the brand “Ondansetron Alphapharm”: a

                   (b)        omit:

 

 

 

a

Onsetron

ZP

MP NP

C4077 C4092

 

1

0

1

 

 

 

 

 

 

 

 

MP

C5749

 

1

0

1

(C100)

 

[121]        Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Maximum Quantity: 4; Number of Repeats: 0]

                           omit:

 

 

 

a

Onsetron 4

ZP

MP NP

C4102 C4118

P4118

4

0

4

 

 

 

 

 

 

 

 

MP

C5778

 

4

0

4

C(100)

 

[122]        Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Maximum Quantity: 10; Number of Repeats: 1]

                           omit:

 

 

 

a

Onsetron 4

ZP

MP NP

C4102 C4118

P4102

10

1

10

 

 

[123]        Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Maximum Quantity: 4; Number of Repeats: 0]

                           omit:

 

 

 

a

Onsetron 8

ZP

MP NP

C4102 C4118

P4118

4

0

4

 

 

 

 

 

 

 

 

MP

C5778

 

4

0

4

C(100)

 

[124]        Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Maximum Quantity: 10; Number of Repeats: 1]

                           omit:

 

 

 

a

Onsetron 8

ZP

MP NP

C4102 C4118

P4102

10

1

10

 

 


 

[125]        Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 5 mg

                   (a)        omit from the column headed “Responsible Person”: QA          substitute: AF

                   (b)        omit from the column headed “Responsible Person”: FM          substitute: AL

[126]        Schedule 1, entry for Peginterferon alfa-2a in the form Injection 135 micrograms in 0.5 mL single use pre-filled syringe [Maximum Quantity: 8; Number of Repeats: 5; Section 100/Prescriber Bag only: C(100)]

                   (a)        omit from the column headed “Purposes”: P5016

                   (b)        insert in numerical order in the column headed “Purposes”: P9603

                   (c)        omit from the column headed “Maximum Quantity”: CN5016

                   (d)        insert in numerical order in the column headed “Maximum Quantity”: CN9603

                   (e)        omit from the column headed “Number of Repeats”: CN5016

                    (f)        insert in numerical order in the column headed “Number of Repeats”: CN9603

[127]        Schedule 1, entry for Peginterferon alfa-2a in the form Injection 180 micrograms in 0.5 mL single use pre-filled syringe [Maximum Quantity: 8; Number of Repeats: 5; Section 100/Prescriber Bag only: C(100)]

                   (a)        omit from the column headed “Purposes”: P5016

                   (b)        insert in numerical order in the column headed “Purposes”: P9603

                   (c)        omit from the column headed “Maximum Quantity”: CN5016

                   (d)        insert in numerical order in the column headed “Maximum Quantity”: CN9603

                   (e)        omit from the column headed “Number of Repeats”: CN5016

                    (f)        insert in numerical order in the column headed “Number of Repeats”: CN9603

[128]        Schedule 1, entry for Pertuzumab

                           omit from the column headed “Circumstances”: C4971 C5013 C5023               substitute: C9516 C9517 C9579

[129]        Schedule 1, entry for Phenoxymethylpenicillin in the form Capsule 250 mg phenoxymethylpenicillin (as potassium)

omit from the column headed “Responsible Person” for the brand “Cilicaine VK” (twice occurring): FM substitute: AF

[130]        Schedule 1, entry for Phenoxymethylpenicillin in the form Capsule 500 mg phenoxymethylpenicillin (as potassium)

                           omit from the column headed “Responsible Person”: FM        substitute: AF

[131]        Schedule 1, entry for Phenoxymethylpenicillin in each of the forms: Tablet 250 mg phenoxymethylpenicillin (as potassium); and Tablet 500 mg phenoxymethylpenicillin (as potassium)                  

                           omit from the column headed “Responsible Person”: QA        substitute: AF 

[132]        Schedule 1, entry for Ponatinib in the form Tablet 15 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C7901 C7914 C7926

                   (b)        insert in numerical order in the column headed “Circumstances”: C9465 C9466 C9614

                   (c)        omit from the column headed “Purposes”: P7901 P7914 P7926

                   (d)        insert in numerical order in the column headed “Purposes”: P9465 P9466 P9614

[133]        Schedule 1, entry for Ponatinib in the form Tablet 15 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C7901 C7914 C7926

                   (b)        insert in numerical order in the column headed “Circumstances”: C9465 C9466 C9614

[134]        Schedule 1, entry for Ponatinib in the form Tablet 45 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C7901 C7914 C7926

                   (b)        insert in numerical order in the column headed “Circumstances”: C9465 C9466 C9614

                   (c)        omit from the column headed “Purposes”: P7901 P7914 P7926

                   (d)        insert in numerical order in the column headed “Circumstances”: P9465 P9466 P9614

[135]        Schedule 1, entry for Ponatinib in the form Tablet 45 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C7901 C7914 C7926

                   (b)        insert in numerical order in the column headed “Circumstances”: C9465 C9466 C9614

[136]        Schedule 1, entry for Procaine benzylpenicillin

                           omit from the column headed “Responsible Person”: QA        substitute: AF

[137]        Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 10 mg (enteric coated)

                           omit:

 

 

 

a

Parzol 10

ZP

MP NP

C5444 C5512

 

28

5

28

 

 

[138]        Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated)

                   (a)        omit:

 

 

 

a

Parzol 20

ZP

MP NP

C8774 C8775 C8776 C8780

P8774 P8775

30

1

30

 

 

                   (b)        omit:

 

 

 

a

Parzol 20

ZP

MP NP

C8774 C8775 C8776 C8780

P8776 P8780

30

5

30

 

 


 

[139]        Schedule 1, entry for Rifabutin

                   (a)        omit from the column headed “Circumstances”: C6349

                   (b)        omit from the column headed “Circumstances”: C6361

                   (c)        insert in numerical order in the column headed “Circumstances”: C9560 C9622

[140]        Schedule 1, entry for Rituximab

                           substitute:

Rituximab

Solution for I.V. infusion 100 mg in 10 mL

Injection

a

Mabthera

RO

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

PB(100)

 

 

 

a

Riximyo

SZ

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

PB(100)

 

 

 

 

Mabthera

RO

MP

C7399 C7400 C9451 C9542

 

See Note 3

See Note 3

2

 

PB(100)

 

 

 

 

Riximyo

SZ

MP

C7399 C7400 C9451 C9542

 

See Note 3

See Note 3

2

 

PB(100)

 

Solution for I.V. infusion 500 mg in 50 mL

Injection

a

Mabthera

RO

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

PB(100)

 

 

 

a

Riximyo

SZ

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

PB(100)

 

 

 

 

Mabthera

RO

MP

C7399 C7400 C9451 C9542

 

See Note 3

See Note 3

1

 

PB(100)

 

 

 

 

Riximyo

SZ

MP

C7399 C7400 C9451 C9542

 

See Note 3

See Note 3

1

 

PB(100)

 

Solution for subcutaneous injection containing rituximab 1400 mg in 11.7 mL

Injection

 

Mabthera SC

RO

MP

C6011 C6161 C7399 C7400

P7399

1

5

1

 

 

 

 

 

 

 

 

MP

C6011 C6161 C7399 C7400

P7400

1

6

1

 

 

 

 

 

 

 

 

MP

C6011 C6161 C7399 C7400

P6011

1

7

1

 

 

 

 

 

 

 

 

MP

C6011 C6161 C7399 C7400

P6161

1

11

1

 

 

[141]        Schedule 1, entry for Rivastigmine in the form Transdermal patch 9 mg

                   (a)        omit from the column headed “Schedule Equivalent” for the brand “Exelon Patch 5”: a 

                   (b)        omit:

 

 

 

a

Rivastigmelon Patch 5

AF

MP NP

C4219 C4220 C4224

 

30

5

30

 

 

[142]        Schedule 1, entry for Rivastigmine in the form Transdermal patch 18 mg

                   (a)        omit from the column headed “Schedule Equivalent” for the brand “Exelon Patch 10”: a 

                   (b)        omit:

 

 

 

a

Rivastigmelon Patch 10

AF

MP NP

C4219 C4220 C4224

 

30

5

30

 

 

[143]        Schedule 1, entry for Rivastigmine in the form Transdermal patch 27 mg

                   (a)        omit from the column headed “Schedule Equivalent” for the brand “Exelon Patch 15”: a 

                   (b)        omit:

 

 

 

a

Rivastigmelon Patch 15

AF

MP NP

C4219 C4220 C4224

 

30

5

30

 

 

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

                   (a)        omit from the column headed “Circumstances”: C8061 C8074 C8085 C8100 C8105 C8120

                   (b)        insert in numerical order in the column headed “Circumstances”: C9414 C9428 C9429 C9430 C9431 C9503

                   (c)        omit from the column headed “Purposes”: P8120

                   (d)        insert in numerical order in the column headed “Purposes”: P9429

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

                   (a)        omit from the column headed “Circumstances”: C8061 C8074 C8085 C8100 C8105 C8120

                   (b)        insert in numerical order in the column headed “Circumstances”: C9414 C9428 C9429 C9430 C9431 C9503

                   (c)        omit from the column headed “Purposes”: P8061 P8074 P8100

                   (d)        insert in numerical order in the column headed “Purposes”: P9430 P9431

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

                   (a)        omit from the column headed “Circumstances”: C8061 C8074 C8085 C8100 C8105 C8120

                   (b)        insert in numerical order in the column headed “Circumstances”: C9414 C9428 C9429 C9430 C9431 C9503

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

                   (a)        omit from the column headed “Circumstances”: C8061 C8074 C8085 C8100 C8105 C8120

                   (b)        insert in numerical order in the column headed “Circumstances”: C9414 C9428 C9429 C9430 C9431 C9503

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

                   (a)        omit from the column headed “Circumstances”: C8061 C8074 C8085 C8100 C8105 C8120

                   (b)        insert in numerical order in the column headed “Circumstances”: C9414 C9428 C9429 C9430 C9431 C9503

                   (c)        omit from the column headed “Purposes”: P8085 P8105

                   (d)        insert in numerical order in the column headed “Purposes”: P9414 P9428 P9503

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

                   (a)        omit from the column headed “Circumstances”: C8061 C8074 C8085 C8100 C8105 C8120

                   (b)        insert in numerical order in the column headed “Circumstances”: C9414 C9428 C9429 C9430 C9431 C9503

[150]        Schedule 1, entry for Somatropin

                           omit:

 

Injection 10 mg (30 i.u.) vial with diluent (with preservative)

Injection

 

Zomacton

FP

MP

C5146 C5147 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8376 C8377 C8380 C8393 C8394 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8424 C8425 C8426 C9221

 

See Note 3

See Note 3

1

 

D(100)

[151]        Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg (once daily prolonged release)

                           substitute:

 

Capsule 0.5 mg (once daily prolonged release)

Oral

 

ADVAGRAF XL

LQ

MP

 

 

30

3

30

 

 

 

 

 

 

 

 

MP

 

P5569 P5602

60
CN5569 CN5602

5
CN5569 CN5602

30

 

C(100)

[152]        Schedule 1, entry for Tacrolimus in the form Capsule 1 mg (once daily prolonged release) 

                           substitute:

 

Capsule 1 mg (once daily prolonged release)

Oral

 

ADVAGRAF XL

LQ

MP

 

 

60

3

60

 

 

 

 

 

 

 

 

MP

 

P5569 P5602

120
CN5569 CN5602

5
CN5569 CN5602

60

 

C(100)

[153]        Schedule 1, entry for Tacrolimus in the form Capsule 5 mg (once daily prolonged release) 

                           substitute:

 

Capsule 5 mg (once daily prolonged release)

Oral

 

ADVAGRAF XL

LQ

MP

 

 

30

3

30

 

 

 

 

 

 

 

 

MP

 

P5569 P5602

60
CN5569 CN5602

5
CN5569 CN5602

30

 

C(100)

[154]        Schedule 1, after entry for Tapentadol in the form Tablet (modified release) 250 mg (as hydrochloride)

                           insert:

Teduglutide

Powder for injection 5 mg with diluent

Injection

 

Revestive

ZI

MP

See Note 3

See Note 3

See Note 3

See Note 3

28

 

D(100)

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

                   (a)        omit from the column headed “Circumstances”: C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135        

                   (b)        insert in numerical order in the column headed “Circumstances”: C9380 C9382 C9383 C9384 C9386 C9390 C9391 C9474 C9477 C9478 C9520 C9553 C9609

                   (c)        omit from the column headed “Purposes”: P9052 P9096 P9133 P9134 P9135                substitute: P9382 P9383 P9384 P9474 P9477 P9520

[156]        Schedule 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135        

                   (b)        insert in numerical order in the column headed “Circumstances”: C9380 C9382 C9383 C9384 C9386 C9390 C9391 C9474 C9477 C9478 C9520 C9553 C9609

                   (c)        omit from the column headed “Purposes”: P9129 P9130         substitute: P9384 P9609

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

                   (a)        omit from the column headed “Circumstances”: C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135        

                   (b)        insert in numerical order in the column headed “Circumstances”: C9380 C9382 C9383 C9384 C9386 C9390 C9391 C9474 C9477 C9478 C9520 C9553 C9609

                   (c)        omit from the column headed “Purposes”: P9046 P9047 P9048           

                   (d)        insert in numerical order in the column headed “Purposes”: P9386 P9390 P9391 P9478

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

                   (a)        omit from the column headed “Circumstances”: C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135        

                   (b)        insert in numerical order in the column headed “Circumstances”: C9380 C9382 C9383 C9384 C9386 C9390 C9391 C9474 C9477 C9478 C9520 C9553 C9609

                   (c)        omit from the column headed “Purposes”: P9049 P9131        

                   (d)        insert in numerical order in the column headed “Purposes”: P9380 P9553

[159]        Schedule 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 6]

                   (a)        omit from the column headed “Circumstances”: C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135        

                   (b)        insert in numerical order in the column headed “Circumstances”:  C9380 C9382 C9383 C9384 C9386 C9390 C9391 C9474 C9477 C9478 C9520 C9553 C9609

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

                   (a)        omit from the column headed “Circumstances”: C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135        

                   (b)        insert in numerical order in the column headed “Circumstances”: C9380 C9382 C9383 C9384 C9386 C9390 C9391 C9474 C9477 C9478 C9520 C9553 C9609

                   (c)        omit from the column headed “Purposes”: P9052 P9096 P9133 P9134 P9135            substitute: P9382 P9383 P9384 P9474 P9477 P9520

[161]        Schedule 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of
Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135        

                   (b)        insert in numerical order in the column headed “Circumstances”: C9380 C9382 C9383 C9384 C9386 C9390 C9391 C9474 C9477 C9478 C9520 C9553 C9609

                   (c)        omit from the column headed “Purposes”: P9129 P9130         substitute: P9384 P9609

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

                   (a)        omit from the column headed “Circumstances”: C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135        

                   (b)        insert in numerical order in the column headed “Circumstances”: C9380 C9382 C9383 C9384 C9386 C9390 C9391 C9474 C9477 C9478 C9520 C9553 C9609

                   (c)        omit from the column headed “Purposes”: P9046 P9047 P9048           

                   (d)        insert in numerical order in the column headed “Purposes”: P9386 P9390 P9391 P9478

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

                   (a)        omit from the column headed “Circumstances”: C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135        

                   (b)        insert in numerical order in the column headed “Circumstances”: C9380 C9382 C9383 C9384 C9386 C9390 C9391 C9474 C9477 C9478 C9520 C9553 C9609

                   (c)        omit from the column headed “Purposes”: P9049 P9131        

                   (d)        insert in numerical order in the column headed “Purposes”: P9380 P9553

[164]        Schedule 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of
Repeats: 6]

                   (a)        omit from the column headed “Circumstances”: C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135        

                   (b)        insert in numerical order in the column headed “Circumstances”: C9380 C9382 C9383 C9384 C9386 C9390 C9391 C9474 C9477 C9478 C9520 C9553 C9609 

[165]        Schedule 1, entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 100 mg

                            omit:

 

 

 

a

Lodam SR 100

ZP

MP NP

C5822

 

20

0

20

 

 

[166]        Schedule 1, entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 150 mg

                            omit:

 

 

 

a

Lodam SR 150

ZP

MP NP

C5822

 

20

0

20

 

 

[167]        Schedule 1, entry for Trastuzumab in the form Powder for I.V. infusion 60 mg

                  omit from the column headed “Circumstances”: C4083 C4093 C4104 C4142 C4143 C4156 C5024 C5032 C5041 C5834 C5844 C7718 C7746       substitute: C9349 C9353 C9354 C9356 C9461 C9571 C9573 C9628 


 

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

                   (a)        omit from the column headed “Circumstances” for the brand “Herceptin”: C4083 C4093 C4104 C4142 C4143 C4156 C5024 C5032 C5041 C5834 C5844 C7718 C7746  substitute: C9349 C9353 C9354 C9356 C9461 C9571 C9573 C9628

                   (b)        omit from the column headed “Circumstances” for the brand “Ogivri”: C4083 C4093 C4104 C4142 C4143 C4156 C5024 C5032 C5041 C5834 C5844 C7718 C7746  substitute: C9349 C9353 C9354 C9356 C9461 C9571 C9573 C9628

[169]        Schedule 1, entry for Trastuzumab in the form Solution for subcutaneous injection containing trastuzumab 600 mg in 5 mL [Maximum
Quantity: 1; Number of Repeats: 0]

                   (a)        omit from the column headed “Circumstances”: C5024 C5032 C5041 C6060 C6061 C6062 C7717           substitute: C9351 C9353 C9462

                   (b)        omit from the column headed “Purposes”: P5032 P6060 P7717            substitute: P9353

[170]        Schedule 1, entry for Trastuzumab in the form Solution for subcutaneous injection containing trastuzumab 600 mg in 5 mL [Maximum
Quantity: 1; Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances”: C5024 C5032 C5041 C6060 C6061 C6062 C7717           substitute: C9351 C9353 C9462

                   (b)        omit from the column headed “Purposes”: P5024 P5041 P6061 P6062              substitute: P9351 P9462

[171]        Schedule 1, entry for Trastuzumab emtansine in each of the forms: Powder for I.V. infusion 100 mg; and Powder for I.V. infusion 160 mg

                           omit from the column headed “Circumstances”: C4978 C4986 C6096 C6129                  substitute: C9359 C9577 C9599

[172]        Schedule 1, entry for Warfarin in the form Tablet containing warfarin sodium 1 mg

                   (a)        omit from the column headed “Responsible Person”: QA          substitute: GO

                   (b)        omit from the column headed “Responsible Person”: FM          substitute: GT

[173]        Schedule 1, entry for Warfarin in the form Tablet containing warfarin sodium 2 mg

                           omit from the column headed “Responsible Person”: QA        substitute: GO 

[174]        Schedule 1, entry for Warfarin in the form Tablet containing warfarin sodium 3 mg

                           omit from the column headed “Responsible Person”: FM        substitute: GT 

[175]        Schedule 1, entry for Warfarin in the form Tablet containing warfarin sodium 5 mg

                   (a)        omit from the column headed “Responsible Person”: QA          substitute: GO

                   (b)        omit from the column headed “Responsible Person”: FM          substitute: GT

[176]        Schedule 1, entry for Zoledronic acid

                            omit:

 

Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL vial

Injection

 

Claris Lifesciences Zoledronic Acid

DZ

MP

C5605 C5703 C5704 C5735 C9236 C9269 C9270 C9291

 

5

0

5

 

PB(100)

[177]        Schedule 3, after details relevant to Responsible Person code MK

                           insert:

MQ

Alphapharm Pty Ltd

 93 002 359 739

[178]        Schedule 4, Part 1, entry for Abatacept

                   (a)        omit entry for circumstances code “C8651” and substitute:

 

C8651

P8651

 

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

Compliance with Written Authority Required procedures

                   (b)        omit entry for circumstances code “C8652” and substitute:

 

C8652

P8652

 

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

Compliance with Written Authority Required procedures

                   (c)        omit entry for circumstances code “C8655” and substitute:

 

C8655

P8655

 

Severe active rheumatoid arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.

Compliance with Written Authority Required procedures

                   (d)        omit entry for circumstances code “C8746” and substitute:

 

C8746

P8746

 

Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine of less than 24 months).
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats.
Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.

Compliance with Written Authority Required procedures

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

                   (a)        omit:

 

C4492

P4492

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; OR
Patient must have received no PBS-subsidised bDMARD treatment for at least 5 years if they failed or ceased to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) in their last treatment cycle; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab.
If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement.
If a patient fails to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle. A patient may re-trial adalimumab after a minimum of 5 years have elapsed between the date of the last approval for PBS-subsidised bDMARD therapy in the last treatment cycle and the date of the first application under a new treatment cycle.

Compliance with Written Authority Required procedures

 

C4501

P4501

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient adalimumab therapy under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient adalimumab therapy under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.

Compliance with Authority Required procedures

 

C4517

P4517

 

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

Compliance with Authority Required procedures

 

C4518

P4518

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after break of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have received prior PBS-subsidised treatment with adalimumab, etanercept or tocilizumab for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with adalimumab for this condition in the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
Applications for a patient who has received PBS-subsidised treatment with adalimumab in this treatment cycle and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised adalimumab treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised adalimumab treatment was approved under either of the Initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where the most recent course of PBS-subsidised adalimumab treatment was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with adalimumab.
If a patient fails to respond to PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).

Compliance with Written Authority Required procedures

 

C4531

P4531

 

Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have demonstrated an adequate response to treatment with adalimumab; AND
Patient must have received adalimumab as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
All applications for continuing treatment with adalimumab must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with adalimumab, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with adalimumab.
If a patient fails to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle.

Compliance with Written Authority Required procedures

                   (b)        omit:

 

C8041

P8041

 

Ankylosing spondylitis
Continuing treatment – balance of supply
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.

Compliance with Authority Required procedures

 

C8059

P8059

 

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

Compliance with Written Authority Required procedures

 

C8060

P8060

 

Ankylosing spondylitis
Initial 2 (change or recommencement for all patients)
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND
Patient must be eligible to receive further bDMARD therapy.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
Where the most recent course of PBS-subsidised bDMARD treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised bDMARD therapy or, under this restriction, for patients who have received previous PBS-subsidised bDMARD therapy) the patient must have been assessed for response to that course following a minimum of 12 weeks of treatment. These assessments must be provided to the Department of Human Services no later than 4 weeks from the date the course was ceased. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, patients must have been assessed for response, and the assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle.

Compliance with Written Authority Required procedures

 

C8073

P8073

 

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

Compliance with Authority Required procedures

 

C8074

P8074

 

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

Compliance with Written Authority Required procedures

                   (c)        omit entry for circumstances code “C8631” and substitute:

 

C8631

P8631

 

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

Compliance with Written Authority Required procedures

                   (d)        omit entry for circumstances code “C8678” and substitute:

 

C8678

P8678

 

Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.

Compliance with Written Authority Required procedures

                   (e)        omit entry for circumstances code “C8702” and substitute:

 

C8702

P8702

 

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

Compliance with Written Authority Required procedures

                    (f)        omit entry for circumstances code “C8725” and substitute:

 

C8725

P8725

 

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

Compliance with Written Authority Required procedures

                   (g)        omit entry for circumstances code “C9078” and substitute: 

 

C9078

P9078

 

Severe psoriatic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in in biological medicine of less than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or 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.
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

                   (h)        insert in numerical order after existing text:

 

C9380

P9380

 

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

Compliance with Authority Required procedures

 

C9386

P9386

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.

Compliance with Authority Required procedures

 

C9409

P9409

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 24 months or more from the most recently approved PBS-subsidised biological medicine for this condition; OR
Patient must not have received PBS-subsidised biological medicine for at least 5 years if they failed or ceased to respond to PBS-subsidised biological medicine treatment 3 times in their last treatment cycle; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Active joints are defined as:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count must be no more than 4 weeks old at the time of this application.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C9414

P9414

 

Ankylosing spondylitis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
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 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.
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
All measurements provided must be no more than 1 month old at the time of application.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9428

P9428

 

Ankylosing spondylitis
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
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND
Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; OR
Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; OR
Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form.
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

 

C9429

P9429

 

Ankylosing spondylitis
Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.

Compliance with Authority Required procedures

 

C9430

P9430

 

Ankylosing spondylitis
Continuing treatment
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
All measurements provided must be no more than 1 month old 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.
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

 

C9431

P9431

 

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

Compliance with Authority Required procedures

 

C9498

P9498

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after break in biological medicine of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have received prior PBS-subsidised treatment with 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; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
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 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 a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Compliance with Written Authority Required procedures

 

C9503

P9503

 

Ankylosing spondylitis
Initial treatment - Initial 1 (new patient)
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; AND
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.
The BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. The BASDAI must be no more than 1 month old at the time of initial application.
Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form.
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

 

C9564

P9564

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
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

 

C9631

P9631

 

Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Compliance with Written Authority Required procedures

[180]        Schedule 4, Part 1, entry for Alemtuzumab

                   (a)        omit:

 

C6878

P6878

 

Multiple sclerosis
Continuing treatment
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 not receive more than one PBS-subsidised treatment per year; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Must be treated by a neurologist.

Compliance with Authority Required procedures

                   (b)        omit:

 

C7743

P7743

 

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).
Must be treated by a neurologist.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

Compliance with Authority Required procedures

                   (c)        insert in numerical order after existing text:

 

C9589

P9589

 

Multiple sclerosis
Continuing treatment
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 not receive more than one PBS-subsidised treatment per year; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Must be treated by a neurologist.

Compliance with Authority Required procedures - Streamlined Authority Code 9589

 

C9636

P9636

 

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).
Must be treated by a neurologist.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 9636

[181]        Schedule 4, Part 1, entry for Apomorphine

                   (a)        omit:

 

C4860

 

 

Parkinson disease
Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9561

 

 

Parkinson disease
Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 9561

[182]        Schedule 4, Part 1, after entry for Apraclonidine

                           insert:

Aprepitant

C4211

 

 

Nausea and vomiting
The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following agents: altretamine; carmustine; cisplatin when a single dose constitutes a cycle of chemotherapy; cyclophosphamide at a dose of 1500 mg per square metre per day or greater; dacarbazine; procarbazine when a single dose constitutes a cycle of chemotherapy; streptozocin.
No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.

Compliance with Authority Required procedures - Streamlined Authority Code 4211

 

C4215

 

 

Nausea and vomiting
The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND
Patient must be scheduled to be co-administered cyclophosphamide and an anthracycline.
No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.

Compliance with Authority Required procedures - Streamlined Authority Code 4215

 

C4216

 

 

Nausea and vomiting
The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND
Patient must be scheduled to be co-administered cyclophosphamide and an anthracycline.
No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.

Compliance with Authority Required procedures - Streamlined Authority Code 4216

 

C4223

 

 

Nausea and vomiting
The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following agents: altretamine; carmustine; cisplatin when a single dose constitutes a cycle of chemotherapy; cyclophosphamide at a dose of 1500 mg per square metre per day or greater; dacarbazine; procarbazine when a single dose constitutes a cycle of chemotherapy; streptozocin.
No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.

Compliance with Authority Required procedures - Streamlined Authority Code 4223

 

C6370

 

 

Nausea and vomiting
The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes either carboplatin or oxaliplatin.
No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.
Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.

Compliance with Authority Required procedures - Streamlined Authority Code 6370

 

C6383

 

 

Nausea and vomiting
The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes either carboplatin or oxaliplatin.
No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.
Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.

Compliance with Authority Required procedures - Streamlined Authority Code 6383

 

C6444

 

 

Nausea and vomiting
The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND
Patient must have had a prior episode of chemotherapy induced nausea or vomiting; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following intravenous chemotherapy agents: arsenic trioxide; azacitidine; cyclophosphamide at a dose of less than 1500 mg per square metre per day; cytarabine at a dose of greater than 1 g per square metre per day; dactinomycin; daunorubicin; doxorubicin; epirubicin; fotemustine; idarubicin; ifosfamide; irinotecan; melphalan; methotrexate at a dose of 250 mg to 1 g per square metre; raltitrexed.
No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.
Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.

Compliance with Authority Required procedures - Streamlined Authority Code 6444

 

C6464

 

 

Nausea and vomiting
The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND
Patient must have had a prior episode of chemotherapy induced nausea or vomiting; AND
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following intravenous chemotherapy agents: arsenic trioxide; azacitidine; cyclophosphamide at a dose of less than 1500 mg per square metre per day; cytarabine at a dose of greater than 1 g per square metre per day; dactinomycin; daunorubicin; doxorubicin; epirubicin; fotemustine; idarubicin; ifosfamide; irinotecan; melphalan; methotrexate at a dose of 250 mg to 1 g per square metre; raltitrexed.
No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.
Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.

Compliance with Authority Required procedures - Streamlined Authority Code 6464

[183]        Schedule 4, Part 1, entry for Atezolizumab

                           insert in numerical order after existing text:

 

C9345

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfathering treatment
Patient must be undergoing combination treatment with bevacizumab and atezolizumab until disease progression, unless not tolerated.
The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND
Patient must have previously received treatment with these drugs for this condition prior to 1 October 2019; AND
Patient must have stable or responding disease; AND
Patient must have a WHO performance status of 0 or 1.

Compliance with Authority Required procedures - Streamlined Authority Code 9345

 

C9348

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment 2
Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy.
The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material; AND
Patient must have progressive disease following treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) OR an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI); AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9348

 

C9514

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment 1
Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy.
The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND
Patient must not have previously been treated for this condition in the metastatic setting; AND
Patient must have a WHO performance status of 0 or 1; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material.

Compliance with Authority Required procedures - Streamlined Authority Code 9514

 

C9567

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated.
Patient must have previously received PBS-subsidised treatment with this drug in this line of treatment; AND
Patient must have stable or responding disease.

Compliance with Authority Required procedures - Streamlined Authority Code 9567

[184]        Schedule 4, Part 1, entry for Azithromycin

                   (a)        omit:

 

C6361

 

 

Mycobacterium avium complex infection
The treatment must be for prophylaxis; AND
Patient must be human immunodeficiency virus (HIV) positive; AND
Patient must have CD4 cell counts of less than 75 per cubic millimetre.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9604

 

 

Mycobacterium avium complex infection
The treatment must be for prophylaxis; AND
Patient must be human immunodeficiency virus (HIV) positive; AND
Patient must have CD4 cell counts of less than 75 per cubic millimetre.

Compliance with Authority Required procedures - Streamlined Authority Code 9604

[185]        Schedule 4, Part 1, entry for Baclofen

                   (a)        omit:

 

C6912

 

 

Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity of cerebral origin.

Compliance with Authority Required procedures

                   (b)        omit:

 

C6929

 

 

Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to multiple sclerosis.

Compliance with Authority Required procedures

 

C6930

 

 

Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord injury.

Compliance with Authority Required procedures

 

C6935

 

 

Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord disease.

Compliance with Authority Required procedures


 

                   (c)        omit:

 

C7156

 

 

Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to multiple sclerosis.

Compliance with Authority Required procedures

 

C7157

 

 

Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord injury.

Compliance with Authority Required procedures

 

C7159

 

 

Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity of cerebral origin.

Compliance with Authority Required procedures

 

C7162

 

 

Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord disease.

Compliance with Authority Required procedures

                   (d)        insert in numerical order after existing text:

 

C9488

 

 

Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity of cerebral origin.

Compliance with Authority Required procedures - Streamlined Authority Code 9488

 

C9489

 

 

Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord injury.

Compliance with Authority Required procedures - Streamlined Authority Code 9489

 

C9524

 

 

Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord disease.

Compliance with Authority Required procedures - Streamlined Authority Code 9524

 

C9525

 

 

Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to multiple sclerosis.

Compliance with Authority Required procedures - Streamlined Authority Code 9525

 

C9562

 

 

Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity of cerebral origin.

Compliance with Authority Required procedures - Streamlined Authority Code 9562

 

C9606

 

 

Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord disease.

Compliance with Authority Required procedures - Streamlined Authority Code 9606

 

C9637

 

 

Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to multiple sclerosis.

Compliance with Authority Required procedures - Streamlined Authority Code 9637

 

C9638

 

 

Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord injury.

Compliance with Authority Required procedures - Streamlined Authority Code 9638

[186]        Schedule 4, Part 1, entry for Baricitinib

                   (a)        omit entry for circumstances code “C8631” and substitute:

 

C8631

P8631

 

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

Compliance with Written Authority Required procedures

                   (b)        omit entry for circumstances code “C8725” and substitute: 

 

C8725

P8725

 

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

Compliance with Written Authority Required procedures

                   (c)        omit entry for circumstances code “C8726” and substitute:

 

C8726

P8726

 

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

Compliance with Written Authority Required procedures

                   (d)        omit entry for circumstances code “C8727” and substitute:

 

C8727

P8727

 

Severe active rheumatoid arthritis
Initial treatment - Grandfathered patients
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have previously received non-PBS-subsidised therapy with this drug for this condition prior to 1 September 2018; AND
Patient must be receiving treatment with this drug for this condition at the time of application; AND
Patient must have failed to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
All applications for treatment with this drug for this condition under this restriction must include baseline joint count and ESR and/or CRP as determined at the completion of a 6 month intensive DMARD trial but prior to ceasing DMARD therapy, and measurement of response to the prior course of non-PBS-subsidised therapy with this drug. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.

Compliance with Written Authority Required procedures

                   (e)        omit entry for circumstances code “C8750” and substitute:

 

C8750

P8750

 

Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.

Compliance with Written Authority Required procedures

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

                           insert in numerical order after existing text:

 

C9346

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment 1
Patient must be undergoing combination treatment with atezolizumab and platinum-doublet chemotherapy.
The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND
Patient must not have previously been treated for this condition in the metastatic setting; AND
Patient must have a WHO performance status of 0 or 1; AND
The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material.

Compliance with Authority Required procedures - Streamlined Authority Code 9346

 

C9347

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment 2
Patient must be undergoing combination treatment with atezolizumab and platinum-doublet chemotherapy.
The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material; AND
Patient must have progressive disease following treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) OR an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI); AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9347

 

C9454

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfathering treatment
Patient must be undergoing combination treatment with bevacizumab and atezolizumab until disease progression, unless not tolerated.
The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND
Patient must have previously received treatment with these drugs for this condition prior to 1 October 2019; AND
Patient must have stable or responding disease; AND
Patient must have a WHO performance status of 0 or 1.

Compliance with Authority Required procedures - Streamlined Authority Code 9454

 

C9566

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
Patient must be undergoing combination treatment with atezolizumab until disease progression, unless not tolerated.
The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9566

[188]        Schedule 4, Part 1, entry for Blinatumomab

                           substitute:

Blinatumomab

C9369

 

 

Acute lymphoblastic leukaemia
Consolidation treatment
Patient must have previously received PBS-subsidised induction treatment with this drug for this condition; AND
Patient must have achieved a complete remission; OR
Patient must have achieved a complete remission with partial haematological recovery; AND
The treatment must not be more than 3 treatment cycles under this restriction in a lifetime; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.

Compliance with Written Authority Required procedures

 

C9373

 

 

Acute lymphoblastic leukaemia
Grandfather treatment
Patient must have a documented history of relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND
Patient must have a documented history of receiving intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND
Patient must not have received more than 1 line of salvage therapy; AND
Patient must have a documented history of more than 5% blasts in bone marrow; AND
Patient must have received treatment with this drug for this condition prior to 1 October 2019; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.
An amount of 651 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 1. An amount of 784 microgram, which may be obtained under Induction treatment - balance of supply restriction, will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.
Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
Treatment with this drug for this condition must not exceed 5 treatment cycles in a lifetime.
Patients who have received up to 2 treatment cycles as induction therapy with this drug for this condition prior to 1 October 2019 must have achieved a complete remission or a complete remission with partial haematological recovery in order to continue with PBS-subsidised treatment with this drug.
Patients who have received at least 1 treatment cycle as consolidation therapy with this drug for this condition prior to 1 October 2019 must have achieved a complete remission or a complete remission with partial haematological recovery in order to continue with PBS-subsidised treatment with this drug.
Patients who fail to demonstrate a complete remission (CR) or complete remission with incomplete haematological recovery (CRi) after 2 cycles of PBS-subsidised treatment with this agent must cease PBS-subsidised treatment with this agent.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and
(3) date of the most recent blinatumomab dose, if this was for induction or consolidation therapy, and how many treatment cycle(s) of PBS-subsidised blinatumomab will be required for completion of induction or consolidation therapy; and
(4) date of most recent chemotherapy prior to receiving non-PBS subsidised blinatumomab, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and
(5) a copy of the most recent bone marrow biopsy report prior to receiving non-PBS subsidised blinatumomab.

Compliance with Written Authority Required procedures

 

C9519

 

 

Acute lymphoblastic leukaemia
Induction treatment - balance of supply
The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND
The condition must not be present in the central nervous system or testis; AND
Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND
Patient must have received insufficient therapy with this agent for this condition under the Induction treatment restriction to complete a maximum of 2 treatment cycles in a lifetime.
According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.
An amount of 784 mcg will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.
Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.

Compliance with Written Authority Required procedures

 

C9551

 

 

Acute lymphoblastic leukaemia
Induction treatment
The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND
The condition must not be present in the central nervous system or testis; AND
Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND
Patient must have received intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND
Patient must not have received more than 1 line of salvage therapy; AND
The condition must have more than 5% blasts in bone marrow; AND
The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.
According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.
An amount of 651 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 1. An amount of 784 microgram, which may be obtained under Induction treatment - balance of supply restriction, will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.
Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
The authority application must be made in writing and must include:
(1) a completed authority prescription form;
(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and
(3) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and
(4) a copy of the most recent bone marrow biopsy report of no more than one month old at the time of application.

Compliance with Written Authority Required procedures

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

                   (a)        omit:

 

C8041

P8041

 

Ankylosing spondylitis
Continuing treatment – balance of supply
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.

Compliance with Authority Required procedures

 

C8074

P8074

 

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

Compliance with Written Authority Required procedures

 

C8076

P8076

 

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

Compliance with Written Authority Required procedures

 

C8097

P8097

 

Ankylosing spondylitis
Initial 2 (change or recommencement for all patients)
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND
Patient must be eligible to receive further bDMARD therapy.
Patient must be an adult.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
Where the most recent course of PBS-subsidised bDMARD treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised bDMARD therapy or, under this restriction, for patients who have received previous PBS-subsidised bDMARD therapy) the patient must have been assessed for response to that course following a minimum of 12 weeks of treatment. These assessments must be provided to the Department of Human Services no later than 4 weeks from the date the course was ceased. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, patients must have been assessed for response, and the assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
A maximum of 18 to 20 weeks of treatment with this drug will be approved under this criterion.
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle.

Compliance with Written Authority Required procedures

 

C8113

P8113

 

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

Compliance with Authority Required procedures

                   (b)        omit entry for circumstances code “C8626” and substitute:

 

C8626

P8626

 

Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine of less than 24 months).
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.

Compliance with Written Authority Required procedures

                   (c)        omit entry for circumstances code “C8679” and substitute:

 

C8679

P8679

 

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

Compliance with Written Authority Required procedures

                   (d)        omit entry for circumstances code “C8705” and substitute:

 

C8705

P8705

 

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

Compliance with Written Authority Required procedures


 

                   (e)        omit entry for circumstances code “C8753” and substitute:

 

C8753

P8753

 

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

Compliance with Written Authority Required procedures

                    (f)        omit entry for circumstances code “C9073” and substitute:

 

C9073

P9073

 

Severe psoriatic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or 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.
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

                   (g)        insert in numerical order after existing text:

 

C9430

P9430

 

Ankylosing spondylitis
Continuing treatment
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
All measurements provided must be no more than 1 month old 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.
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

 

C9431

P9431

 

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

Compliance with Authority Required procedures

 

C9442

P9442

 

Ankylosing spondylitis
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
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND
Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; OR
Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; OR
Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND
Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form.
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

 

C9537

P9537

 

Ankylosing spondylitis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
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 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.
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications.
All measurements provided must be no more than 1 month old at the time of application.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

 

C9610

P9610

 

Ankylosing spondylitis
Initial treatment - Initial 1 (new patient)
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND
Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; AND
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.
The BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. The BASDAI must be no more than 1 month old at the time of initial application.
Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form.
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

 

C9625

P9625

 

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

Compliance with Authority Required procedures

[190]        Schedule 4, Part 1, entry for Clostridium botulinum type A toxin - haemagglutinin complex

                   (a)        omit:

 

C5220

 

 

Moderate to severe spasticity of the upper limb following a stroke
The condition must be moderate to severe spasticity of the upper limb/s following stroke, defined as a Modified Ashworth Scale rating of 3 or more; AND
The treatment must not be initiated until three months post-stroke; AND
The treatment must only be used as second line therapy when standard management has failed; OR
The treatment must only be used as an adjunct to physical therapy; AND
The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating greater than 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (total Botox, Dysport, and Xeomin); AND
The treatment must not exceed 4 treatment periods (total Botox, Dysport, and Xeomin) per upper limb per lifetime; AND
Patient must not have established severe contracture in the limb to be treated.
Patient must be aged 18 years or older.
Must be treated by a neurologist; OR
Must be treated by an orthopaedic surgeon; OR
Must be treated by a rehabilitation specialist; OR
Must be treated by a plastic surgeon; OR
Must be treated by a geriatrician.
The date of the stroke must be documented in the patient's medical records when treatment is initiated.
Standard management includes physiotherapy and/or oral spasticity agents.

Compliance with Authority Required procedures - Streamlined Authority Code 5220

                   (b)        insert in numerical order after existing text:

 

C9463

 

 

Moderate to severe spasticity of the upper limb following an acute event
Grandfathered treatment
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 October 2019; AND
The condition must have been moderate to severe spasticity of the upper limb/s following an acute event, defined as a Modified Ashworth Scale rating of 3 or more prior to commencing non-PBS subsidised treatment; AND
The treatment must only be used as second line therapy when standard management has failed; OR
The treatment must only be used as an adjunct to physical therapy; AND
The treatment must not continue if the patient did not respond (defined as not having had a decrease in spasticity rating greater than 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND
The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per upper limb in the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per upper limb each year thereafter; AND
Patient must not have established severe contracture in the limb to be treated.
Patient must be aged 18 years or older.
Must be treated by a neurologist; OR
Must be treated by an orthopaedic surgeon; OR
Must be treated by a rehabilitation specialist; OR
Must be treated by a plastic surgeon; OR
Must be treated by a geriatrician.
Standard management includes physiotherapy and/or oral spasticity agents.

Compliance with Authority Required procedures - Streamlined Authority Code 9463

 

C9547

 

 

Moderate to severe spasticity of the upper limb following an acute event
The condition must be moderate to severe spasticity of the upper limb/s following an acute event, defined as a Modified Ashworth Scale rating of 3 or more; AND
The treatment must only be used as second line therapy when standard management has failed; OR
The treatment must only be used as an adjunct to physical therapy; AND
The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating greater than 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND
The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per upper limb in the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per upper limb each year thereafter; AND
Patient must not have established severe contracture in the limb to be treated.
Patient must be aged 18 years or older.
Must be treated by a neurologist; OR
Must be treated by an orthopaedic surgeon; OR
Must be treated by a rehabilitation specialist; OR
Must be treated by a plastic surgeon; OR
Must be treated by a geriatrician.
Standard management includes physiotherapy and/or oral spasticity agents.

Compliance with Authority Required procedures - Streamlined Authority Code 9547

[191]        Schedule 4, Part 1, entry for Clozapine

                   (a)        omit:

 

C5001

 

 

Schizophrenia
Initial treatment
Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient.
Patient must be non-responsive to other neuroleptic agents; OR
Patient must be intolerant of other neuroleptic agents.
Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction.
The name of the consulting psychiatrist should be included in the patient's medical records.
A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised.

Compliance with Authority Required procedures


 

                   (b)        insert in numerical order after existing text:

 

C9490

 

 

Schizophrenia
Initial treatment
Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient.
Patient must be non-responsive to other neuroleptic agents; OR
Patient must be intolerant of other neuroleptic agents.
Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction.
The name of the consulting psychiatrist should be included in the patient's medical records.
A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised.

Compliance with Authority Required procedures - Streamlined Authority Code 9490

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

                   (a)        omit:

 

C9059

P9059

 

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

Compliance with Written Authority Required procedures

 

C9098

P9098

 

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

Compliance with Authority Required procedures

 

C9100

P9100

 

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

Compliance with Written Authority Required procedures

 

C9136

P9136

 

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

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9367

P9367

 

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

Compliance with Written Authority Required procedures

 

C9468

P9468

 

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

Compliance with Written Authority Required procedures

 

C9469

P9469

 

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

Compliance with Authority Required procedures

 

C9549

P9549

 

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

Compliance with Authority Required procedures


 

[193]        Schedule 4, Part 1, entry for Deferiprone

                   (a)        omit:

 

C6380

 

 

Iron overload
Patient must have thalassaemia major; AND
Patient must be unable to take desferrioxamine therapy.

Compliance with Authority Required procedures

                   (b)        omit:

 

C6442

 

 

Iron overload
Patient must have thalassaemia major; AND
Patient must be one in whom desferrioxamine therapy has proven ineffective.

Compliance with Authority Required procedures

                   (c)        insert in numerical order after existing text:

 

C9590

 

 

Iron overload
Patient must have thalassaemia major; AND
Patient must be one in whom desferrioxamine therapy has proven ineffective.

Compliance with Authority Required procedures - Streamlined Authority Code 9590

 

C9623

 

 

Iron overload
Patient must have thalassaemia major; AND
Patient must be unable to take desferrioxamine therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 9623

[194]        Schedule 4, Part 1, entry for Dornase alfa

                   (a)        omit:

 

C5715

 

 

Cystic fibrosis
Continuing treatment
Patient must have initiated treatment with dornase alfa at an age of less than 5 years; AND
Patient must have undergone a comprehensive assessment which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit.
Patient must be 5 years of age or older.
Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with this drug should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use.

Compliance with Authority Required procedures

                   (b)        omit:

 

C5768

 

 

Cystic fibrosis
Patient must be 5 years of age or older.
Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.
Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.
Initial therapy is limited to 3 months treatment with dornase alfa at a dose of 2.5 mg daily.
To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:
(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND
(2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.
Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.

Compliance with Authority Required procedures

 

C5800

 

 

Cystic fibrosis
Patient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; OR
Patient must have significant bronchiectasis on chest high resolution computed tomography scan; OR
Patient must have severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; OR
Patient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy.
Patient must be less than 5 years of age.
Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.
Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented. Treatment with this drug should cease if there is not agreement of benefit, as there is always the possibility of harm from unnecessary use. Further reassessments must be undertaken and documented at six-monthly intervals.

Compliance with Authority Required procedures

                   (c)        insert in numerical order after existing text:

 

C9591

 

 

Cystic fibrosis
Patient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; OR
Patient must have significant bronchiectasis on chest high resolution computed tomography scan; OR
Patient must have severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; OR
Patient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy.
Patient must be less than 5 years of age.
Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.
Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented. Treatment with this drug should cease if there is not agreement of benefit, as there is always the possibility of harm from unnecessary use. Further reassessments must be undertaken and documented at six-monthly intervals.

Compliance with Authority Required procedures - Streamlined Authority Code 9591

 

C9592

 

 

Cystic fibrosis
Continuing treatment
Patient must have initiated treatment with dornase alfa at an age of less than 5 years; AND
Patient must have undergone a comprehensive assessment which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit.
Patient must be 5 years of age or older.
Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with this drug should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use.

Compliance with Authority Required procedures - Streamlined Authority Code 9592

 

C9624

 

 

Cystic fibrosis
Patient must be 5 years of age or older.
Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.
Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.
Initial therapy is limited to 3 months treatment with dornase alfa at a dose of 2.5 mg daily.
To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:
(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND
(2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.
Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.

Compliance with Authority Required procedures - Streamlined Authority Code 9624

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

                   (a)        omit:

 

C4457