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PB 67 of 2020 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS) and related matters.
Administered by: Health
Registered 31 Jul 2020

 

 

 

 

PB 67 of 2020

 

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 7)

 

National Health Act 1953

________________________________________________________________________

 

I, NIKOLAI TSYGANOV, Assistant Secretary (Acting), 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    30 july 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NIKOLAI TSYGANOV

Assistant Secretary (Acting)

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 2020 (No. 7).

(2)          This Instrument may also be cited as PB 67 of 2020.

2          Commencement

This Instrument commences on 1 August 2020.

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 4, definition for ‘Regulations’

omit: National Health (Pharmaceutical Benefits) Regulations 1960

substitute: National Health (Pharmaceutical Benefits) Regulations 2017

[2]              Subsection 12(1)(a)(ii)

omit: subregulation 19AA(2)

substitute: subsection 41(2)

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

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

 

 

 

a

NOUMED ATORVASTATIN

VO

MP NP

 

 

30

5

30

 

 

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

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

 

 

 

a

NOUMED ATORVASTATIN

VO

MP

 

P7598

30

11

30

 

 

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

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

 

 

 

a

NOUMED ATORVASTATIN

VO

MP NP

 

 

30

5

30

 

 

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

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

 

 

 

a

NOUMED ATORVASTATIN

VO

MP

 

P7598

30

11

30

 

 

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

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

 

 

 

a

NOUMED ATORVASTATIN

VO

MP NP

 

 

30

5

30

 

 

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

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

 

 

 

a

NOUMED ATORVASTATIN

VO

MP

 

P7598

30

11

30

 

 

[9]              Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

 

 

 

a

NOUMED ATORVASTATIN

VO

MP NP

 

 

30

5

30

 

 

[10]            Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

 

 

 

a

NOUMED ATORVASTATIN

VO

MP

 

P7598

30

11

30

 

 

[11]            Schedule 1, entry for Budesonide with formoterol

                             substitute:

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

 

Symbicort Turbuhaler 100/6

AP

MP

C4380 C10538

 

1

5

1

 

 

NP

C4380

 

1

5

1

 

 

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

a

DuoResp Spiromax

TB

MP

C7970 C10464 C10538

P10464

1

2

1

 

 

NP

C7970 C10464

P10464

1

2

1

 

 

a

Symbicort Turbuhaler 200/6

AP

MP

C7970 C10464 C10538

P10464

1

2

1

 

 

NP

C7970 C10464

P10464

1

2

1

 

 

a

DuoResp Spiromax

TB

MP

C7970 C10464 C10538

P7970 P10538

1

5

1

 

 

NP

C7970 C10464

P7970

1

5

1

 

 

a

Symbicort Turbuhaler 200/6

AP

MP

C7970 C10464 C10538

P7970 P10538

1

5

1

 

 

NP

C7970 C10464

P7970

1

5

1

 

 

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2

Inhalation by mouth

a

DuoResp Spiromax

TB

MP NP

C7979 C10121

 

1

5

1

 

 

a

Symbicort Turbuhaler 400/12

AP

MP NP

C7979 C10121

 

1

5

1

 

 

Pressurised inhalation containing budesonide 50 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

Inhalation by mouth

 

Symbicort Rapihaler 50/3

AP

MP

C4397 C10538

 

2

5

1

 

 

NP

C4397

 

2

5

1

 

 

Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

Inhalation by mouth

 

Symbicort Rapihaler 100/3

AP

MP

C4397 C10482 C10538

P10482

2

2

1

 

 

NP

C4397 C10482

P10482

2

2

1

 

 

MP

C4397 C10482 C10538

P4397 P10538

2

5

1

 

 

NP

C4397 C10482

P4397

2

5

1

 

 

Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

 

Symbicort Rapihaler 200/6

AP

MP

C4404 C10121 C10538

 

2

5

1

 

 

NP

C4404 C10121

 

2

5

1

 

 

[12]            Schedule 1, entry for Capecitabine in the form Tablet 150 mg

(a)        omit:

 

 

 

a

Capecitabine AN

JO

MP

 

 

60

2

60

 

 

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


 

[13]            Schedule 1, entry for Capecitabine in the form Tablet 500 mg

                             omit:

 

 

 

a

Capecitabine AN

JO

MP

 

 

120

2

120

 

 

[14]            Schedule 1, entry for Crizotinib in each of the forms: Capsule 200 mg; and Capsule 250 mg

(a)        omit from the column headed “Circumstances”: C8281 C8290 C8291

(b)        insert in numerical order in the column headed “Circumstances”: C10595 C10633

[15]            Schedule 1, entry for Electrolyte replacement, oral

                   omit from the column headed “Responsible Person” for the brand “O.R.S.”: AS        substitute: AF

[16]            Schedule 1, entry for Entacapone

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

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

                             insert:

Entrectinib

Capsule 200 mg

Oral

 

Rozlytrek

RO

MP

C10597 C10614 C10633

 

90

3

90

 

 

[18]            Schedule 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)

(a)        insert in numerical order in the column headed “Circumstances” for the brand “Escitalopram GH”: C4690 C4703

(b)        insert in numerical order in the column headed “Circumstances” for the brand “Escitalopram GH”: C4756 C4757

[19]            Schedule 1, entry for Famciclovir in the form Tablet 250 mg

(a)        omit:

 

 

 

a

Famciclovir Sandoz

SZ

MP NP

C5937 C5951 C5971

P5937

20

1

20

 

 

(b)        omit:

 

 

 

a

Famciclovir Sandoz

SZ

MP NP

C5937 C5951 C5971

P5951

21

0

21

 

 

(c)        omit:

 

 

 

a

Famlo

RA

MP NP

C5951 C5971

P5951

21

0

21

 

 


 

(d)        omit:

 

 

 

a

Famciclovir Sandoz

SZ

MP NP

C5937 C5951 C5971

P5971

56

5

56

 

 

(e)        omit:

 

 

 

a

Famlo

RA

MP NP

C5951 C5971

P5971

56

5

56

 

 

[20]            Schedule 1, entry for Famciclovir in the form Tablet 500 mg

(a)        omit:

 

 

 

a

Famciclovir Sandoz

SZ

MP NP

C5943 C5947 C5948 C5949 C5954

P5943

30

0

30

 

 

(b)        omit:

 

 

 

a

Famciclovir Sandoz

SZ

MP NP

C5943 C5947 C5948 C5949 C5954

P5947 P5948 P5949 P5954

56

5

56

 

 

[21]            Schedule 1, entry for Guanfacine in each of the forms: Tablet 1 mg (as hydrochloride); Tablet 2 mg (as hydrochloride); Tablet 3 mg (as hydrochloride); and Tablet 4 mg (as hydrochloride)

                   omit from the column headed “Responsible Person”: ZI              substitute: TK

[22]            Schedule 1, entry for Icatibant

                   omit from the column headed “Responsible Person”: ZI              substitute: TK

[23]            Schedule 1, entry for IncobotulinumtoxinA

                   insert in numerical order in the column headed “Circumstances”: C9547 C10594

[24]            Schedule 1, entry for Lanthanum in each of the forms: Tablet, chewable, 500 mg (as carbonate hydrate); Tablet, chewable, 750 mg (as carbonate hydrate); and Tablet, chewable, 1000 mg (as carbonate hydrate)

                   omit from the column headed “Responsible Person”: ZI              substitute: TK

[25]            Schedule 1, entry for Levodopa with carbidopa and entacapone in the form Tablet 50 mg-12.5 mg (as monohydrate)-200 mg

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

 

 

 

a

Lecteva

TB

MP NP

C5212 C5288

 

200

4

100

 

 

(b)        insert in the column headed “Schedule Equivalent” for the brand “Stalevo 50/12.5/200mg”: a

(c)        omit from the column headed “Responsible Person” for the brand “Stalevo 50/12.5/200mg”: NV          substitute: SZ

[26]            Schedule 1, entry for Levodopa with carbidopa and entacapone in the form Tablet 75 mg-18.75 mg (as monohydrate)-200 mg

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

 

 

 

a

Lecteva

TB

MP NP

C5212 C5288

 

200

4

100

 

 

(b)        insert in the column headed “Schedule Equivalent” for the brand “Stalevo 75/18.75/200mg”: a

(c)        omit from the column headed “Responsible Person” for the brand “Stalevo 75/18.75/200mg”: NV           substitute: SZ

[27]            Schedule 1, entry for Levodopa with carbidopa and entacapone in the form Tablet 100 mg-25 mg (as monohydrate)-200 mg

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

 

 

 

a

Lecteva

TB

MP NP

C5212 C5288

 

200

4

100

 

 

(b)        insert in the column headed “Schedule Equivalent” for the brand “Stalevo 100/25/200mg”: a

(c)        omit from the column headed “Responsible Person” for the brand “Stalevo 100/25/200mg”: NV           substitute: SZ

[28]            Schedule 1, entry for Levodopa with carbidopa and entacapone in the form Tablet 125 mg-31.25 mg (as monohydrate)-200 mg

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

 

 

 

a

Lecteva

TB

MP NP

C5212 C5288

 

200

4

100

 

 

(b)        insert in the column headed “Schedule Equivalent” for the brand “Stalevo 125/31.25/200mg”: a

(c)        omit from the column headed “Responsible Person” for the brand “Stalevo 125/31.25/200mg”: NV            substitute: SZ

[29]            Schedule 1, entry for Levodopa with carbidopa and entacapone in the form Tablet 150 mg-37.5 mg (as monohydrate)-200 mg

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

 

 

 

a

Lecteva

TB

MP NP

C5212 C5288

 

200

4

100

 

 

(b)        insert in the column headed “Schedule Equivalent” for the brand “Stalevo 150/37.5/200mg”: a

(c)        omit from the column headed “Responsible Person” for the brand “Stalevo 150/37.5/200mg”: NV         substitute: SZ

[30]            Schedule 1, entry for Levodopa with carbidopa and entacapone in the form Tablet 200 mg-50 mg (as monohydrate)-200 mg

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

 

 

 

a

Lecteva

TB

MP NP

C5212 C5288

 

200

4

100

 

 

(b)        insert in the column headed “Schedule Equivalent” for the brand “Stalevo 200/50/200mg”: a

(c)        omit from the column headed “Responsible Person” for the brand “Stalevo 200/50/200mg”: NV               substitute: SZ


 

[31]            Schedule 1, entry for Lisdexamfetamine in each of the forms: Capsule containing lisdexamfetamine dimesilate 20 mg; and Capsule containing lisdexamfetamine dimesilate 30 mg

                   omit from the column headed “Responsible Person”: ZI              substitute: TK

[32]            Schedule 1, entry for Lisdexamfetamine in each of the forms: Capsule containing lisdexamfetamine dimesilate 40 mg; and Capsule containing lisdexamfetamine dimesilate 50 mg

                   omit from the column headed “Responsible Person”: ZI              substitute: TK

[33]            Schedule 1, entry for Lisdexamfetamine in each of the forms: Capsule containing lisdexamfetamine dimesilate 60 mg; and Capsule containing lisdexamfetamine dimesilate 70 mg

                   omit from the column headed “Responsible Person”: ZI              substitute: TK

[34]            Schedule 1, after entry for Lopinavir with ritonavir in the form Tablet 200 mg-50 mg

                             insert:

Lorlatinib

Tablet 25 mg

Oral

 

Lorviqua

PF

MP

C10530 C10563 C10641

 

90

3

90

 

 

Tablet 100 mg

Oral

 

Lorviqua

PF

MP

C10530 C10563 C10641

 

30

3

30

 

 

[35]            Schedule 1, entry for Lurasidone in each of the forms: Tablet containing lurasidone hydrochloride 40 mg; and Tablet containing lurasidone hydrochloride 80 mg

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

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

 

 

 

a

Lurasidone Lupin

GQ

MP NP

C4246

 

30

5

30

 

 

[36]            Schedule 1, entry for Mercaptopurine in the form Tablet containing mercaptopurine monohydrate 50 mg

(a)        omit:

 

 

 

a

MERCAPTOPURINE-LINK

LM

MP

 

 

100

2

25

 

 

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

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

                   omit from the column headed “Responsible Person”: ZI              substitute: TK

[38]            Schedule 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 500 mg

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


 

[39]            Schedule 1, after entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 500 mg

                             insert:

 

Tablet (prolonged release) containing metformin hydrochloride 500 mg

Oral

 

Metformin (Medsurge)

DZ

MP NP

 

 

120

5

56

 

 

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

                             omit:

 

 

 

a

Montelukast GH

GQ

MP NP

C6674 C7781

 

28

5

28

 

 

[41]            Schedule 1, entry for Nitrofurantoin in each of the forms: Capsule 50 mg; and Capsule 100 mg

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

 

 

 

a

APO-Nitrofurantoin

TX

MP NP MW

 

 

30

1

30

 

 

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

[42]            Schedule 1, entry for Olaparib in the form Tablet 100 mg [Maximum Quantity: 112; Number of Repeats: 2]

(a)        omit from the column headed “Circumstances”: C8132

(b)        omit from the column headed “Circumstances”: C8202 C8203

(c)        insert in numerical order in the column headed “Circumstances”: C10615 C10634 C10642

(d)        omit from the column headed “Purposes”: P8132 P8202 P8203                     substitute: P10615 P10634 P10642

[43]            Schedule 1, entry for Olaparib in the form Tablet 100 mg [Maximum Quantity: 112; Number of Repeats: 5]

(a)        omit from the column headed “Circumstances”: C8132

(b)        omit from the column headed “Circumstances”: C8202 C8203

(c)        insert in numerical order in the column headed “Circumstances”: C10615 C10634 C10642

[44]            Schedule 1, entry for Olaparib in the form Tablet 150 mg [Maximum Quantity: 112; Number of Repeats: 2]

(a)        omit from the column headed “Circumstances”: C8132

(b)        omit from the column headed “Circumstances”: C8202 C8203

(c)        insert in numerical order in the column headed “Circumstances”: C10615 C10634 C10642

(d)        omit from the column headed “Purposes”: P8132 P8202 P8203                     substitute: P10615 P10634 P10642

[45]            Schedule 1, entry for Olaparib in the form Tablet 150 mg [Maximum Quantity: 112; Number of Repeats: 5]

(a)        omit from the column headed “Circumstances”: C8132


 

(b)        omit from the column headed “Circumstances”: C8202 C8203

(c)        insert in numerical order in the column headed “Circumstances”: C10615 C10634 C10642

[46]            Schedule 1, entry for Osimertinib in each of the forms: Tablet 40 mg; and Tablet 80 mg

                   omit from the column headed “Circumstances”: C8538

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

                             omit:

 

 

 

a

Panto

TK

MP NP

C5444 C5512 C5529

 

30

5

30

 

 

[48]            Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

(a)        omit:

 

 

 

a

Panto

TK

MP NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

(b)        omit:

 

 

 

a

Panto

TK

MP NP

C8774 C8775 C8776 C8780 C8866

P8776 P8780 P8866

30

5

30

 

 

[49]            Schedule 1, entry for Paracetamol in the form Tablet 500 mg 

(a)        omit:

 

 

 

a

Paracetamol Generic Health

GQ

PDP

C5846 C5885

P5846

100

0

100

 

 

(b)        omit:

 

 

 

a

Paracetamol Generic Health

GQ

MP NP

C5835 C5865

P5835

100

1

100

 

 

(c)        omit:

 

 

 

a

Paracetamol Generic Health

GQ

PDP

C5846 C5885

P5885

300

0

100

 

 


 

(d)        omit:

 

 

 

a

Paracetamol Generic Health

GQ

MP NP

C5835 C5865

P5865

300

4

100

 

 

[50]            Schedule 1, entry for Pegfilgrastim

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

 

 

 

a

Pelgraz

OC

MP

C7822 C7843 C9235 C9303

 

1

11

1

 

D(100)

[51]            Schedule 1, entry for Pregabalin in each of the forms: Capsule 25 mg; Capsule 75 mg; Capsule 150 mg; and Capsule 300 mg

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

 

 

 

a

Cipla Pregabalin

LR

MP NP

C4172

 

56

5

56

 

 

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

(a)        omit:

 

 

 

a

APO-Risperidone

TX

MP NP

C5903 C6898 C6899 C10020 C10021 C10052

P6898 P6899 P10020 P10021 P10052

60

2

20

 

 

 

 

 

 

 

 

MP NP

C5903 C6898 C6899 C10020 C10021 C10052

P6898 P6899 P10020 P10021 P10052

60

2

60

 

 

(b)        insert after entry for the brand “Risperdal”:

 

 

 

a

APO-Risperidone

TX

MP NP

C5903 C6898 C6899 C10020 C10021 C10052

P6898 P6899 P10020 P10021 P10052

60

2

60

 

 

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

(a)        omit:

 

 

 

a

APO-Risperidone

TX

MP NP

C5903 C6898 C6899 C10020 C10021 C10052

P5903

60

5

20

 

 

 

 

 

 

 

 

MP NP

C5903 C6898 C6899 C10020 C10021 C10052

P5903

60

5

60

 

 

(b)        insert after entry for the brand “Risperdal”:

 

 

 

a

APO-Risperidone

TX

MP NP

C5903 C6898 C6899 C10020 C10021 C10052

P5903

60

5

60

 

 

[54]            Schedule 1, entry for Risperidone in the form Tablet 4 mg

                             omit:

 

 

 

a

Ozidal

RA

MP NP

C4246 C5907

 

60

5

60

 

 

[55]            Schedule 1, entry for Salbutamol in the form Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation)

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

[56]            Schedule 1, after entry for Salbutamol in the form Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation)

                             insert:

 

Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation)

Inhalation by mouth

 

Ventolin

GK

MP NP

 

 

2

5

1

 

 

 

Zempreon

GC

MP NP

 

 

2

5

1

 

 

[57]            Schedule 1, after entry for Sterculia with frangula bark

                             insert:

Stiripentol

Capsule 250 mg

Oral

 

Diacomit

EU

MP

C10632

 

120

3

60

 

 

Capsule 500 mg

Oral

 

Diacomit

EU

MP

C10632

 

120

3

60

 

 

Powder for oral suspension 250 mg

Oral

 

Diacomit

EU

MP

C10632

 

120

3

60

 

 

Powder for oral suspension 500 mg

Oral

 

Diacomit

EU

MP

C10632

 

120

3

60

 

 

[58]            Schedule 1, entry for Teduglutide

                   omit from the column headed “Responsible Person”: ZI              substitute: TK


 

[59]            Schedule 1, entry for Tocilizumab

                             substitute:

Tocilizumab

Concentrate for injection 80 mg in 4 mL

Injection

 

Actemra

RO

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

PB(100)

Concentrate for injection 200 mg in 10 mL

Injection

 

Actemra

RO

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

PB(100)

Concentrate for injection 400 mg in 20 mL

Injection

 

Actemra

RO

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

PB(100)

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

Injection

 

Actemra ACTPen

RO

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9148 C9180 C9380 C9384 C9386 C9390 C9391 C9477 C9478 C9553 C9609 C10555 C10556 C10558 C10559 C10560 C10562 C10591 C10593 C10610 C10625 C10628 C10629 C10638 C10645

P10560 P10610

4

0

4

 

 

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9148 C9180 C9380 C9384 C9386 C9390 C9391 C9477 C9478 C9553 C9609 C10555 C10556 C10558 C10559 C10560 C10562 C10591 C10593 C10610 C10625 C10628 C10629 C10638 C10645

P9384 P9477 P10555 P10559 P10591 P10593 P10625 P10628 P10629

4

1

4

 

 

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9148 C9180 C9380 C9384 C9386 C9390 C9391 C9477 C9478 C9553 C9609 C10555 C10556 C10558 C10559 C10560 C10562 C10591 C10593 C10610 C10625 C10628 C10629 C10638 C10645

P9384 P9609 P10556

4

2

4

 

 

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9148 C9180 C9380 C9384 C9386 C9390 C9391 C9477 C9478 C9553 C9609 C10555 C10556 C10558 C10559 C10560 C10562 C10591 C10593 C10610 C10625 C10628 C10629 C10638 C10645

P8631 P8638 P8739 P8740 P9386 P9390 P9391 P9478 P10558 P10638 P10645

4

3

4

 

 

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9148 C9180 C9380 C9384 C9386 C9390 C9391 C9477 C9478 C9553 C9609 C10555 C10556 C10558 C10559 C10560 C10562 C10591 C10593 C10610 C10625 C10628 C10629 C10638 C10645

P8627 P8633 P9148 P9380 P9553 P10562

4

5

4

 

 

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9148 C9180 C9380 C9384 C9386 C9390 C9391 C9477 C9478 C9553 C9609 C10555 C10556 C10558 C10559 C10560 C10562 C10591 C10593 C10610 C10625 C10628 C10629 C10638 C10645

P9180

4

6

4

 

 

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

Injection

 

Actemra Subcutaneous Injection

RO

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9148 C9180 C9380 C9384 C9386 C9390 C9391 C9477 C9478 C9553 C9609 C10555 C10556 C10558 C10559 C10560 C10562 C10591 C10593 C10610 C10625 C10628 C10629 C10638 C10645

P10560 P10610

4

0

4

 

 

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9148 C9180 C9380 C9384 C9386 C9390 C9391 C9477 C9478 C9553 C9609 C10555 C10556 C10558 C10559 C10560 C10562 C10591 C10593 C10610 C10625 C10628 C10629 C10638 C10645

P9384 P9477 P10555 P10559 P10591 P10593 P10625 P10628 P10629

4

1

4

 

 

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9148 C9180 C9380 C9384 C9386 C9390 C9391 C9477 C9478 C9553 C9609 C10555 C10556 C10558 C10559 C10560 C10562 C10591 C10593 C10610 C10625 C10628 C10629 C10638 C10645

P9384 P9609 P10556

4

2

4

 

 

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9148 C9180 C9380 C9384 C9386 C9390 C9391 C9477 C9478 C9553 C9609 C10555 C10556 C10558 C10559 C10560 C10562 C10591 C10593 C10610 C10625 C10628 C10629 C10638 C10645

P8631 P8638 P8739 P8740 P9386 P9390 P9391 P9478 P10558 P10638 P10645

4

3

4

 

 

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9148 C9180 C9380 C9384 C9386 C9390 C9391 C9477 C9478 C9553 C9609 C10555 C10556 C10558 C10559 C10560 C10562 C10591 C10593 C10610 C10625 C10628 C10629 C10638 C10645

P8627 P8633 P9148 P9380 P9553 P10562

4

5

4

 

 

MP

C8627 C8631 C8633 C8638 C8739 C8740 C9148 C9180 C9380 C9384 C9386 C9390 C9391 C9477 C9478 C9553 C9609 C10555 C10556 C10558 C10559 C10560 C10562 C10591 C10593 C10610 C10625 C10628 C10629 C10638 C10645

P9180

4

6

4

 

 

[60]            Schedule 3

omit:

ZI

Shire Australia Pty Limited

 29 128 941 819

[61]            Schedule 4, Part 1, entry for Atomoxetine

omit entry for Circumstances Code “C7876” and substitute:

 

C7876

 

 

Attention deficit hyperactivity disorder
Initial treatment
Must be treated by a paediatrician or psychiatrist.
The condition must be or have been diagnosed according to the DSM-5 criteria; AND
Patient must have a contraindication to dexamfetamine, methylphenidate or lisdexamfetamine as specified in TGA-approved product information; OR
Patient must have a comorbid mood disorder that has developed or worsened as a result of dexamfetamine, methylphenidate or lisdexamfetamine treatment and is of a severity necessitating treatment withdrawal; OR
Patient must be at an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal if given a stimulant treatment with another agent; OR
Patient must have experienced adverse reactions of a severity necessitating permanent treatment withdrawal following treatment with dexamfetamine, methylphenidate and lisdexamfetamine (not simultaneously).
Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive.

Compliance with Authority Required procedures - Streamlined Authority Code 7876

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

omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code “C9102”: Written

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

(a)        omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code “C9369”: Written

(b)        omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code “C9519”: Written

(c)        omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code “C9936”: Written

[64]            Schedule 4, Part 1, entry for Brentuximab vedotin

                   omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code “C8736”: Written

[65]            Schedule 4, Part 1, entry for Budesonide with formoterol

                             insert in numerical order after existing text:

 

C10538

P10538

 

Asthma
Patient must have failed PBS-subsidised fluticasone proprionate and salmeterol as a fixed dose combination for this condition.
Must be treated by a respiratory physician; OR
Must be treated by a paediatrician.

Compliance with Authority Required procedures - Streamlined Authority Code 10538

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

(a)        omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code “C10431”: Written

(b)        omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code “C10459”: Written

(c)        omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code “C10489”: Written

(d)        omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code “C10507”: Written

(e)        omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code “C10513”: Written

[67]            Schedule 4, Part 1, entry for Crizotinib

(a)        omit:

 

C8281

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be as monotherapy; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.

Compliance with Authority Required procedures

 

C8290

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed ROS1-Positive Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form, which includes details of ROS1 gene rearrangement in tumour material.

Compliance with Written Authority Required procedures

 

C8291

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfathering treatment
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 January 2019; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
The treatment must be as monotherapy; AND
Patient must have a WHO performance status of 2 or less prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing prior to initiating non-PBS subsidised treatment with this drug for this condition.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed ROS1-Positive Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form, which includes details of ROS1 gene rearrangement in tumour material.
A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Written Authority Required procedures

(b)        insert in numerical order after existing text:

 

C10595

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing; AND
Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; OR
Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed ROS1-Positive Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form, which includes details of ROS1 gene rearrangement in tumour material.

Compliance with Written Authority Required procedures

 

C10633

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be as monotherapy; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition.

Compliance with Authority Required procedures

[68]            Schedule 4, Part 1, after entry for Entecavir

                             insert:

Entrectinib

C10597

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; OR
Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal; AND
Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed ROS1-Positive Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form, which includes details of ROS1 gene rearrangement in tumour material.

Compliance with Written Authority Required procedures

 

C10614

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfather treatment
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 August 2020; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
The treatment must be as monotherapy; AND
Patient must have had a WHO performance status of 2 or less prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR
Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing prior to initiating non-PBS subsidised treatment with this drug for this condition.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed ROS1-Positive Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form, which includes details of ROS1 gene rearrangement in tumour material.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Written Authority Required procedures

 

C10633

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be as monotherapy; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition.

Compliance with Authority Required procedures

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

(a)        omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code “C10461”: Written

(b)        omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code “C10506”: Written

(c)        omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code “C10515”: Written


 

[70]            Schedule 4, Part 1, entry for Guselkumab

(a)        omit entry for Circumstances Code “C8496” and substitute:

 

C8496

 

 

Severe chronic plaque psoriasis
Continuing treatment, Whole body or Continuing treatment, Face, hand, foot or Grandfathered patients - balance of supply
Patient must have received insufficient therapy with this drug under the continuing treatment, Whole body restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Grandfathered treatment, Whole body restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Grandfathered treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.
Must be treated by a dermatologist.

Compliance with Authority Required procedures

(b)        omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code “C8877”: Written

[71]            Schedule 4, Part 1, entry for IncobotulinumtoxinA

                             insert in numerical order after existing text:

 

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

 

C10594

 

 

Moderate to severe spasticity of the upper limb following an acute event
Grandfather treatment
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 August 2020; 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 10594

[72]            Schedule 4, Part 1, entry for Inotuzumab ozogamicin

                   omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code “C9601”: Written

[73]            Schedule 4, Part 1, after entry for Lopinavir with ritonavir

                             insert:

Lorlatinib

C10530

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be as monotherapy; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.

Compliance with Authority Required procedures

 

C10563

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfather treatment
Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 August 2020; AND
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have had a WHO performance status of 2 or less prior to initiating non-PBS-subsidised treatment; AND
The condition must have progressed following treatment with an ALK inhibitor other than crizotinib prior to commencement of non-PBS-subsidised treatment with this drug for this PBS indication; AND
Patient must not have progressive disease while receiving treatment with this drug for this condition.
Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Authority Required procedures

 

C10641

 

 

Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have progressed following treatment with an anaplastic lymphoma kinase (ALK) inhibitor other than crizotinib.
Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement.

Compliance with Authority Required procedures


 

[74]            Schedule 4, Part 1, entry for Olaparib

(a)        omit from the column headed “Purposes Code” for Circumstances Code “C6705”: P6705

(b)        omit from the column headed “Purposes Code” for Circumstances Code “C6715”: P6715

(c)        omit from the column headed “Purposes Code” for Circumstances Code “C6716”: P6716

(d)        omit:

 

C8132

P8132

 

High grade serous ovarian cancer
Initial treatment
The condition must be platinum sensitive; AND
The condition must be a germline class 4 or 5 BRCA1 or BRCA2 gene mutation; AND
Patient must have received at least two previous platinum-containing regimens; AND
Patient must have relapsed following a previous platinum-containing regimen; AND
Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must be maintenance therapy; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition.
Platinum sensitivity is defined as disease progression greater than 6 months after completion of the penultimate platinum regimen.
A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.
Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline testing.

Compliance with Authority Required procedures

(e)        omit:

 

C8202

P8202

 

High grade serous fallopian tube cancer
Initial treatment
The condition must be platinum sensitive; AND
The condition must be a germline class 4 or 5 BRCA1 or BRCA2 gene mutation; AND
Patient must have received at least two previous platinum-containing regimens; AND
Patient must have relapsed following a previous platinum-containing regimen; AND
Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must be maintenance therapy; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition.
Platinum sensitivity is defined as disease progression greater than 6 months after completion of the penultimate platinum regimen.
A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.
Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline testing.

Compliance with Authority Required procedures

 

C8203

P8203

 

High grade serous primary peritoneal cancer
Initial treatment
The condition must be platinum sensitive; AND
The condition must be a germline class 4 or 5 BRCA1 or BRCA2 gene mutation; AND
Patient must have received at least two previous platinum-containing regimens; AND
Patient must have relapsed following a previous platinum-containing regimen; AND
Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must be maintenance therapy; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition.
Platinum sensitivity is defined as disease progression greater than 6 months after completion of the penultimate platinum regimen.
A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.
Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline testing.

Compliance with Authority Required procedures

(f)         insert in numerical order after existing text:

 

C10615

P10615

 

High grade serous ovarian cancer
Initial treatment
The condition must be platinum sensitive; AND
The condition must be a class 4 or 5 BRCA1 or BRCA2 gene mutation; AND
Patient must have received at least two previous platinum-containing regimens; AND
Patient must have relapsed following a previous platinum-containing regimen; AND
Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must be maintenance therapy; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition.
Platinum sensitivity is defined as disease progression greater than 6 months after completion of the penultimate platinum regimen.
A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.
Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing.

Compliance with Authority Required procedures

 

C10634

P10634

 

High grade serous fallopian tube cancer
Initial treatment
The condition must be platinum sensitive; AND
The condition must be a class 4 or 5 BRCA1 or BRCA2 gene mutation; AND
Patient must have received at least two previous platinum-containing regimens; AND
Patient must have relapsed following a previous platinum-containing regimen; AND
Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must be maintenance therapy; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition.
Platinum sensitivity is defined as disease progression greater than 6 months after completion of the penultimate platinum regimen.
A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.
Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing.

Compliance with Authority Required procedures

 

C10642

P10642

 

High grade serous primary peritoneal cancer
Initial treatment
The condition must be platinum sensitive; AND
The condition must be a class 4 or 5 BRCA1 or BRCA2 gene mutation; AND
Patient must have received at least two previous platinum-containing regimens; AND
Patient must have relapsed following a previous platinum-containing regimen; AND
Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must be maintenance therapy; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition.
Platinum sensitivity is defined as disease progression greater than 6 months after completion of the penultimate platinum regimen.
A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.
Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing.

Compliance with Authority Required procedures

[75]            Schedule 4, Part 1, entry for Osimertinib

                             omit:

 

C8538

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfather treatment
Patient must have received non-PBS subsidised therapy with this drug for this condition prior to 1 February 2019; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have had a WHO performance status of 2 or less prior to initiating non-PBS-subsidised treatment; AND
The condition must have progressed on or after epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy as first line treatment for this condition prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must have evidence of EGFR T790M mutation following progression on first line EGFR TKI treatment; AND
Patient must not have developed disease progression while receiving non-PBS-subsidised treatment with this drug for this condition.
A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form;
(b) a completed EGFR T790M mutation positive non-small cell lung cancer initial PBS authority application - supporting information form;
(c) copy of the pathology report from an Approved Pathology Authority confirming evidence of EGFR T790M mutation in tumour material while on or after first line EGFR TKI treatment; and
(d) date of commencement of first line EGFR TKI treatment and date of progression whilst on first line EGFR TKI treatment.
For patients commencing non-PBS-subsidised treatment between 1 June 2018 and 1 February 2019, evidence of EGFR T790M mutation must be from tumour material.

Compliance with Written Authority Required procedures

[76]            Schedule 4, Part 1, entry for Perampanel

omit from the column headed “Purposes Code” for Circumstances Code “C4658”: P4568                   substitute: P4658

[77]            Schedule 4, Part 1, entry for Risankizumab

omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code “C9986”: Written

[78]            Schedule 4, Part 1, entry for Sodium phenylbutyrate

substitute:

Sodium phenylbutyrate

C9888

 

 

Urea cycle disorders
Grandfathered treatment
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2019.
An increase in the maximum quantity will be authorised to provide for up to one month's supply at a dose of up to 600 mg/kg/day in patients weighing less than 20 kg and up to 13 g/m2/day in patients weighing more than 20 kg.

Compliance with Authority Required procedures - Streamlined Authority Code 9888

 

C9919

 

 

Urea cycle disorders
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition.
An increase in the maximum quantity will be authorised to provide for up to one month's supply at a dose of up to 600 mg/kg/day in patients weighing less than 20 kg and up to 13 g/m2/day in patients weighing more than 20 kg.

Compliance with Authority Required procedures - Streamlined Authority Code 9919

 

C9993

 

 

Urea cycle disorders
Initial treatment
Patient must have elevated ammonia levels that are not controlled with diet alone and other adjunct care alone.
An increase in the maximum quantity will be authorised to provide for up to one month's supply at a dose of up to 600 mg/kg/day in patients weighing less than 20 kg and up to 13 g/m2/day in patients weighing more than 20 kg.

Compliance with Authority Required procedures - Streamlined Authority Code 9993

[79]            Schedule 4, Part 1, entry for Somatropin

(a)        omit entry for Circumstances Code “C8407” and substitute:

 

C8407

 

 

Short stature and slow growth
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature and slow growth; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have previously received treatment under the indication short stature associated with chronic renal insufficiency, have undergone a renal transplant and a 12 month period of observation following the transplant, and have an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; OR
Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment; OR
(b) Confirmation that the patient has previously received treatment under the indication short stature associated with chronic renal insufficiency, has undergone a renal transplant and a 12 month period of observation following the transplant, and has an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; AND
4. Recent growth data (height and weight, not older than three months); AND
5. A bone age result performed within the last 12 months; AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

(b)        omit entry for Circumstances Code “C8433” and substitute:

 

C8433

 

 

Short stature associated with chronic renal insufficiency
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with chronic renal insufficiency; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity less than or equal to the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; OR
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND
4. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2; AND
5. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
6. Recent growth data (height and weight, not older than three months); AND
7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

(c)        omit entry for Circumstances Code “C8439” and substitute:

 

C8439

 

 

Short stature associated with chronic renal insufficiency
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND
Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
Patient must be prepubertal.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2; AND
6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
If a patient receiving treatment under the indication 'short stature associated with chronic renal insufficiency' undergoes a renal transplant and 12 months post-transplant has an eGFR of equal to or greater than 30mL/min/1.73m2 prescribers should seek reclassification to the indication short stature and slow growth.

Compliance with Written Authority Required procedures

(d)        omit entry for Circumstances Code “C8472” and substitute:

 

C8472

 

 

Short stature associated with chronic renal insufficiency
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with chronic renal insufficiency; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity less than or equal to the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; OR
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be prepubertal.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND
4. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2; AND
5. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
6. Recent growth data (height and weight, not older than three months); AND
7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures


 

(e)        omit entry for Circumstances Code “C8494” and substitute:

 

C8494

 

 

Short stature and slow growth
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature and slow growth; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have previously received treatment under the indication short stature associated with chronic renal insufficiency, have undergone a renal transplant and a 12 month period of observation following the transplant, and have an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; OR
Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment; OR
(b) Confirmation that the patient has previously received treatment under the indication short stature associated with chronic renal insufficiency, has undergone a renal transplant and a 12 month period of observation following the transplant, and has an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; AND
4. Recent growth data (height and weight, not older than three months); AND
5. A bone age result performed within the last 12 months; AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures

(f)         omit entry for Circumstances Code “C8503” and substitute:

 

C8503

 

 

Short stature associated with chronic renal insufficiency
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with chronic renal insufficiency; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity less than or equal to the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; OR
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND
4. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2; AND
5. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
6. Recent growth data (height and weight, not older than three months); AND
7. A bone age result performed within the last 12 months; AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

Compliance with Written Authority Required procedures


 

[80]            Schedule 4, Part 1, after entry for Sterculia with frangula bark

                             insert:

Stiripentol

C10632

 

 

Severe myoclonic epilepsy in infancy (Dravet syndrome)
Patient must have, or have had, generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with a benzodiazepine and valproate; AND
The treatment must be as adjunctive therapy to a benzodiazepine and valproate.
Must be treated by a neurologist if treatment is being initiated; OR
Must be treated by a neurologist if treatment is being continued or re-initiated; OR
Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued; OR
Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued.

Compliance with Authority Required procedures - Streamlined Authority Code 10632

[81]            Schedule 4, Part 1, entry for Sunitinib

omit entry for Circumstances Code “C5249” and substitute:

 

C5249

P5249

 

Metastatic or unresectable malignant gastrointestinal stromal tumour
Initial treatment
The treatment must be as monotherapy; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have previously failed or be intolerant to imatinib mesilate.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Sunitinib Malate (Sutent) PBS Authority Application for Use in the Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form; and
(3) a signed patient acknowledgement.
Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib

Compliance with Written Authority Required procedures

[82]            Schedule 4, Part 1, entry for Tildrakizumab

omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code “C8475”: Written

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

(a)        omit:

 

C9382

P9382

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; 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.
Patient must be under 18 years of age.
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.
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 active joints, the response must be demonstrated on the total number of active joints.
Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.
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 recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C9383

P9383

 

Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
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 be under 30kg; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
An adequate response to treatment is defined as:
(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, 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).
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count submitted with the initial treatment 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 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 12 months 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

(b)        omit:

 

C9474

P9474

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle.
Patient must be under 18 years of age.
An adequate response to treatment is defined as:
(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, 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).
Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.
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 12 months 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

(c)        omit:

 

C9520

P9520

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or (ii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months.
Patient must be under 18 years of age.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
(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 assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
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.
Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.
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

(d)        insert in numerical order after existing text:

 

C10555

P10555

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; 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.
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.
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 active joints, the response must be demonstrated on the total number of active joints.
Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.
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 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 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 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

 

C10556

P10556

 

Systemic juvenile idiopathic arthritis
Continuing treatment in a patient weighing less than 30 kg
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
An adequate response to treatment is defined as:
(a) in a patient with polyarticular course disease:
(i) 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
(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
- 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).
(b) in a patient with refractory systemic symptoms:
(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity submitted with the initial treatment application.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Systemic Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form which includes baseline and current pathology reports detailing CRP and platelet count where appropriate.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months 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

 

C10558

P10558

 

Systemic juvenile idiopathic arthritis
Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months in a patient weighing at least 30 kg)
Patient must have received prior PBS-subsidised treatment with this drug for this condition in the previous 12 months; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
An adequate response to treatment is defined as:
(a) in a patient with polyarticular course disease:
(i) 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
(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
- 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).
(b) in a patient with refractory systemic symptoms:
(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Systemic Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form which includes pathology reports detailing C-reactive protein (CRP) level and platelet count where appropriate.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to retrial 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.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months 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

 

C10559

P10559

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received 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.
An adequate response to treatment is defined as:
(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, 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).
Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.
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 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 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 12 months 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

 

C10560

P10560

 

Systemic juvenile idiopathic arthritis
Balance of supply for Initial treatment - Initial 1 (new patient) or Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) or Initial 3 (recommencement of treatment after a break of more than 12 months) - in a patient of any weight being administered a subcutaneous form of this biological medicine
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 (retrial or recommencement of treatment after a break of less than 12 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under Initial 3 (recommencement of treatment after a break of more than 12 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.

Compliance with Authority Required procedures

 

C10562

P10562

 

Systemic juvenile idiopathic arthritis
Continuing treatment in a patient weighing at least 30 kg
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
An adequate response to treatment is defined as:
(a) in a patient with polyarticular course disease:
(i) 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
(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
- 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).
(b) in a patient with refractory systemic symptoms:
(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity submitted with the initial treatment application.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Systemic Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form which includes baseline and current pathology reports detailing CRP and platelet count where appropriate.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months 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

 

C10591

P10591

 

Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
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 be under 30kg; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
An adequate response to treatment is defined as:
(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, 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).
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count submitted with the initial treatment 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 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 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 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 12 months 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

 

C10593

P10593

 

Systemic juvenile idiopathic arthritis
Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months in a patient weighing less than 30 kg)
Patient must have received prior PBS-subsidised treatment with this drug for this condition in the previous 12 months; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
An adequate response to treatment is defined as:
(a) in a patient with polyarticular course disease:
(i) 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
(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
- 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).
(b) in a patient with refractory systemic symptoms:
(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Systemic Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form which includes pathology reports detailing C-reactive protein (CRP) level and platelet count where appropriate.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to retrial 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.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months 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

 

C10610

P10610

 

Systemic juvenile idiopathic arthritis
Balance of supply - Continuing treatment in a patient of any weight being administered a subcutaneous form of this biological medicine
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 therapy available under Continuing treatment.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.

Compliance with Authority Required procedures

 

C10625

P10625

 

Systemic juvenile idiopathic arthritis
Initial treatment - Initial 3 (recommencement of a new treatment cycle after a break of more than 12 months in a patient weighing less than 30 kg)
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have had a break in treatment of 12 months or more from this drug for this condition; AND
Patient must have polyarticular course disease and the condition must have (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, 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); OR
Patient must have refractory systemic symptoms and the condition must have (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must be under 18 years of age.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Systemic Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form which includes the following:
(i) the date of assessment of severe active systemic juvenile idiopathic arthritis;
(ii) pathology reports detailing C-reactive protein (CRP) level and platelet count where appropriate.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C10628

P10628

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or (ii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months.
Patient must be under 18 years of age.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
(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 assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
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.
Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.
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 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

 

C10629

P10629

 

Systemic juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient weighing less than 30 kg)
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have polyarticular course disease which has failed to respond adequately to oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; OR
Patient must have polyarticular course disease and have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have refractory systemic symptoms, demonstrated by an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 2 months of therapy; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy in a patient with polyarticular course disease and must be demonstrated in the patient at the time of the initial application:
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, 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 following criteria indicate failure to achieve an adequate response to prior therapy in a patient with refractory systemic symptoms and must be demonstrated in the patient at the time of the initial application:
(a) an active joint count of at least 2 active joints; and
(b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or
(c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN).
The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Systemic Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form which includes the following:
(i) the date of assessment of severe active systemic juvenile idiopathic arthritis;
(ii) details of prior treatment including dose and duration of treatment;
(iii) pathology reports detailing CRP and platelet count where appropriate.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.

Compliance with Written Authority Required procedures

 

C10638

P10638

 

Systemic juvenile idiopathic arthritis
Initial treatment - Initial 3 (recommencement of treatment after a break of more than 12 months in a patient weighing at least 30 kg)
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have had a break in treatment of 12 months or more from this drug for this condition; AND
Patient must have polyarticular course disease and the condition must have (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, 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); OR
Patient must have refractory systemic symptoms and the condition must have (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must be under 18 years of age.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Systemic Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form which includes the following:
(i) the date of assessment of severe active systemic juvenile idiopathic arthritis;
(ii) pathology reports detailing C-reactive protein (CRP) level and platelet count where appropriate.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C10645

P10645

 

Systemic juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient weighing at least 30 kg)
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have polyarticular course disease which has failed to respond adequately to oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; OR
Patient must have polyarticular course disease and have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have refractory systemic symptoms, demonstrated by an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 2 months of therapy; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy in a patient with polyarticular course disease and must be demonstrated in the patient at the time of the initial application:
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, 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 following criteria indicate failure to achieve an adequate response to prior therapy in a patient with refractory systemic symptoms and must be demonstrated in the patient at the time of the initial application:
(a) an active joint count of at least 2 active joints; and
(b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or
(c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN).
The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Systemic Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form which includes the following:
(i) the date of assessment of severe active systemic juvenile idiopathic arthritis;
(ii) details of prior treatment including dose and duration of treatment;
(iii) pathology reports detailing CRP and platelet count where appropriate.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.

Compliance with Written Authority Required procedures

[84]            Schedule 5, after entry for Meloxicam in the form Tablet 7.5 mg [GRP-15658]

                             insert:

Metformin

GRP-24200

Tablet (extended release) containing metformin hydrochloride 500 mg

Oral

APO-Metformin XR 500
Blooms the Chemist Metformin XR 500
Diabex XR
Diaformin XR
Metex XR
Metformin XR 500 APOTEX

 

 

Tablet (prolonged release) containing metformin hydrochloride 500 mg

Oral

Metformin (Medsurge)

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

                             insert:

 

GRP-24211

Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation)

Inhalation by mouth

Asmol CFC-free
Ventolin CFC-free

 

 

Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation)

Inhalation by mouth

Ventolin
Zempreon