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PB 66 of 2019 Other as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to determine the pharmaceutical benefits that are on the PBS.
Administered by: Health
Registered 30 Aug 2019
Tabling HistoryDate
Tabled HR09-Sep-2019
Tabled Senate09-Sep-2019
To be repealed 15 Nov 2019
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

 

 

 

 

PB 66 of 2019

 

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 8)

 

National Health Act 1953

________________________________________________________________________

 

I, THEA DANIEL, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

 

Dated   29 August                                              2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

THEA DANIEL

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

 

1          Name of Instrument

(1)          This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 8).

(2)          This Instrument may also be cited as PB 66 of 2019.

2          Commencement

This Instrument commences on 1 September 2019.

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

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


 


Schedule 1     Amendments

[1]             Schedule 1, entry for Alendronic acid with colecalciferol and calcium

                           omit:

 

 

 

a

Fosamax Plus D-Cal

MK

MP NP

C6306 C6319 C6325

 

1

5

1

 

 

[2]             Schedule 1, entry for Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine

                           omit:

 

Oral liquid 130 mL, 30 (MMA/PA cooler 15)

Oral

 

MMA/PA cooler 15

VF

MP NP

C5542 C5560

 

4

5

1

 

 

[3]             Schedule 1, entry for Azacitidine

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

 

 

 

a

Azacitidine Juno

JO

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

D(100)

[4]             Schedule 1, entry for Botulinum toxin type A purified neurotoxin complex

                           insert in numerical order in the column headed CircumstancesC9271 C9334

[5]             Schedule 1, entry for Buprenorphine

                           insert as first entry:

 

Injection (modified release) 8 mg in 0.16 mL pre-filled syringe

Injection

 

Buvidal Weekly

UR

MP NP

C9212

 

See Note 3

See Note 3

1

 

PB(100)

 

Injection (modified release) 16 mg in 0.32 mL pre-filled syringe

Injection

 

Buvidal Weekly

UR

MP NP

C9212

 

See Note 3

See Note 3

1

 

PB(100)

 

Injection (modified release) 24 mg in 0.48 mL pre-filled syringe

Injection

 

Buvidal Weekly

UR

MP NP

C9212

 

See Note 3

See Note 3

1

 

PB(100)

 

Injection (modified release) 32 mg in 0.64 mL pre-filled syringe

Injection

 

Buvidal Weekly

UR

MP NP

C9212

 

See Note 3

See Note 3

1

 

PB(100)

 

Injection (modified release) 64 mg in 0.18 mL pre-filled syringe

Injection

 

Buvidal Monthly

UR

MP NP

C9212

 

See Note 3

See Note 3

1

 

PB(100)

 

Injection (modified release) 96 mg in 0.27 mL pre-filled syringe

Injection

 

Buvidal Monthly

UR

MP NP

C9212

 

See Note 3

See Note 3

1

 

PB(100)

 

Injection (modified release) 128 mg in 0.36 mL pre-filled syringe

Injection

 

Buvidal Monthly

UR

MP NP

C9212

 

See Note 3

See Note 3

1

 

PB(100)

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

                   (a)        omit from the column headed “Circumstances”: C6959 C6968

                   (b)        insert in numerical order in the column headed “Circumstances”: C9197 C9293

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

                   (a)        omit from the column headed “Circumstances”: C6959 C6968

                   (b)        insert in numerical order in the column headed “Circumstances”: C9197 C9293

                   (c)        omit from the column headed “Purposes”: P6959 P6968

                   (d)        insert in numerical order in the column headed “Purposes”: P9197 P9293

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

                   (a)        omit from the column headed “Circumstances”: C6959 C6968

                   (b)        insert in numerical order in the column headed “Circumstances”: C9197 C9293

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

                   (a)        omit from the column headed “Circumstances”: C6959 C6968

                   (b)        insert in numerical order in the column headed “Circumstances”: C9197 C9293

                   (c)        omit from the column headed “Purposes”: P6959 P6968

                   (d)        insert in numerical order in the column headed “Purposes”: P9197 P9293

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

                   (a)        omit from the column headed “Circumstances”: C6959 C6968

                   (b)        insert in numerical order in the column headed “Circumstances”: C9197 C9293

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

                   (a)        omit from the column headed “Circumstances”: C6959 C6968

                   (b)        insert in numerical order in the column headed “Circumstances”: C9197 C9293

                   (c)        omit from the column headed “Purposes”: P6959 P6968

                   (d)        insert in numerical order in the column headed “Purposes”: P9197 P9293


 

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

                   (a)        omit from the column headed “Circumstances”: C6959 C6968

                   (b)        insert in numerical order in the column headed “Circumstances”: C9197 C9293

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

                   (a)        omit from the column headed “Circumstances”: C6959 C6968

                   (b)        insert in numerical order in the column headed “Circumstances”: C9197 C9293

                   (c)        omit from the column headed “Purposes”: P6959 P6968

                   (d)        insert in numerical order in the column headed “Purposes”: P9197 P9293

[14]           Schedule 1, entry for Deferasirox in the form Tablet 90 mg [Maximum Quantity: 180; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C8444 C8445 C8446

                   (b)        insert in numerical order in the column headed “Circumstances”: C9222 C9258 C9302

                   (c)        omit from the column headed “Purposes”: P8444 P8445 P8446

                   (d)        insert in numerical order in the column headed “Purposes”: P9222 P9258 P9302

[15]           Schedule 1, entry for Deferasirox in the form Tablet 90 mg [Maximum Quantity: 180; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C8444 C8445 C8446

                   (b)        insert in numerical order in the column headed “Circumstances”: C9222 C9258 C9302

[16]           Schedule 1, entry for Deferasirox in the form Tablet 180 mg [Maximum Quantity: 180; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C8444 C8445 C8446

                   (b)        insert in numerical order in the column headed “Circumstances”: C9222 C9258 C9302

                   (c)        omit from the column headed “Purposes”: P8444 P8445 P8446

                   (d)        insert in numerical order in the column headed “Purposes”: P9222 P9258 P9302

[17]           Schedule 1, entry for Deferasirox in the form Tablet 180 mg [Maximum Quantity: 180; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C8444 C8445 C8446

                   (b)        insert in numerical order in the column headed “Circumstances”: C9222 C9258 C9302

[18]           Schedule 1, entry for Deferasirox in the form Tablet 360 mg [Maximum Quantity: 180; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C8444 C8445 C8446

                   (b)        insert in numerical order in the column headed “Circumstances”: C9222 C9258 C9302

                   (c)        omit from the column headed “Purposes”: P8444 P8445 P8446

                   (d)        insert in numerical order in the column headed “Purposes”: P9222 P9258 P9302

[19]           Schedule 1, entry for Deferasirox in the form Tablet 360 mg [Maximum Quantity: 180; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C8444 C8445 C8446

                   (b)        insert in numerical order in the column headed “Circumstances”: C9222 C9258 C9302

[20]           Schedule 1, entry for Deferiprone in the form Oral solution 100 mg per mL, 250 mL

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

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

                   (c)        insert in numerical order in the column headed “Circumstances”: C9228 C9286

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

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

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

                   (c)        insert in numerical order in the column headed “Circumstances”: C9228 C9286

[22]           Schedule 1, entry for Doxorubicin - pegylated liposomal in the form Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL

                           substitute:

 

Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL

Injection

a

Caelyx

JC

MP

C6234 C6274 C9223 C9287

 

4

5

1

 

D(100)

 

 

 

a

Liposomal Doxorubicin SUN

RA

MP

C6234 C6274 C9223 C9287

 

4

5

1

 

D(100)

 

 

 

 

Caelyx

JC

MP

C4786 C4787 C4791

 

See Note 3

See Note 3

1

 

D(100)

 

 

 

 

Liposomal Doxorubicin SUN

RA

MP

C4786 C4787 C4791

 

See Note 3

See Note 3

1

 

D(100)

[23]           Schedule 1, entry for Exemestane

                           omit:

 

 

 

a

Exaccord

RA

MP

C4796 C5522

 

30

5

30

 

 

 

 

 

 

 

 

NP

C5522

 

30

5

30

 

 


 

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

                           omit:

 

 

 

a

Famciclovir FBM

FO

MP NP

C5971

 

56

5

56

 

 

[25]           Schedule 1, entry for Flecainide in each of the forms: Tablet containing flecainide acetate 50 mg; and Tablet containing flecainide acetate
100 mg                                                                                          

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

 

 

 

a

APO-Flecainide

TX

MP NP

C5550 C5584

 

60

5

60

 

 

[26]           Schedule 1, omit entry for Hydrochlorothiazide with triamterene

[27]           Schedule 1, entry for Ibandronic acid in the form Concentrated injection for I.V. infusion 6 mg (as ibandronate sodium monohydrate) in 6 mL

                   (a)        omit from the column headed “Circumstances”: C5257            

                   (b)        insert in numerical order in the column headed “Circumstances”: C9333           

[28]           Schedule 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Maximum Quantity: 60; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances” (all instances): C6496 C6499   

                   (b)        omit from the column headed “Circumstances” (all instances): C6527 

                   (c)        omit from the column headed “Circumstances” (all instances): C6539 C6540 C6550      

                   (d)        omit from the column headed “Circumstances” (all instances): C6948 C6949 C6973 C8697 C8698 C9086 C9124               

                   (e)        insert in numerical order in the column headed “Circumstances” (all instances): C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

                    (f)        omit from the column headed “Purposes” (all instances): P9086 P9124             

                   (g)        insert in numerical order in the column headed “Purposes” (all instances): P9203 P9207 

[29]           Schedule 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Maximum Quantity: 60; Number of Repeats: 5] 

                   (a)        omit from the column headed “Circumstances” (all instances): C6496 C6499   

                   (b)        omit from the column headed “Circumstances” (all instances): C6527 

                   (c)        omit from the column headed “Circumstances” (all instances): C6539 C6540 C6550      

                   (d)        omit from the column headed “Circumstances” (all instances): C6948 C6949 C6973 C8697 C8698 C9086 C9124               

                   (e)        insert in numerical order in the column headed “Circumstances” (all instances): C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296


 

                    (f)        omit from the column headed “Purposes” (all instances): P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698         substitute: P9200 P9204 P9206 P9209 P9240 P9242 P9243 P9274 P9276 P9295 P9296 

[30]           Schedule 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances” (all instances): C6496 C6499   

                   (b)        omit from the column headed “Circumstances” (all instances): C6527 

                   (c)        omit from the column headed “Circumstances” (all instances): C6539 C6540 C6550      

                   (d)        omit from the column headed “Circumstances” (all instances): C6948 C6949 C6973 C8697 C8698 C9086 C9124               

                   (e)        insert in numerical order in the column headed “Circumstances” (all instances): C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296 

                    (f)        omit from the column headed “Purposes” (all instances): P9086 P9124             

                   (g)        insert in numerical order in the column headed “Purposes” (all instances): P9203 P9207

[31]           Schedule 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances” (all instances): C6496 C6499   

                   (b)        omit from the column headed “Circumstances” (all instances): C6527 

                   (c)        omit from the column headed “Circumstances” (all instances): C6539 C6540 C6550        

                   (d)        omit from the column headed “Circumstances” (all instances): C6948 C6949 C6973 C8697 C8698 C9086 C9124               

                   (e)        insert in numerical order in the column headed “Circumstances” (all instances): C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

                    (f)        omit from the column headed “Purposes” (all instances): P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698         substitute: P9200 P9204 P9206 P9209 P9240 P9242 P9243 P9274 P9276 P9295 P9296

[32]           Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Gilmat; Maximum Quantity: 60; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C6496 C6499              

                   (b)        omit from the column headed “Circumstances”: C6527            

                   (c)        omit from the column headed “Circumstances”: C6539 C6550              

                   (d)        omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C9086 C9124       

                   (e)        insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296  

                    (f)        omit from the column headed “Purposes”: P9086 P9124        

                   (g)        insert in numerical order in the column headed “Purposes”: P9203 P9207

[33]           Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Glivec; Maximum Quantity: 60; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C4342 C4355 C6496 C6498 C6499     

                   (b)        omit from the column headed “Circumstances”: C6527            

                   (c)        omit from the column headed “Circumstances”: C6539 C6540 C6550

                   (d)        omit from the column headed “Circumstances”: C6559 C6948 C6949 C6973 C8697 C8698 C9086 C9124            

                   (e)        insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9242 C9243 C9274 C9276 C9278 C9295 C9296 C9319  

                    (f)        omit from the column headed “Purposes”: P6498      

                   (g)        omit from the column headed “Purposes”: P6559 P9086 P9124          

                   (h)        insert in numerical order in the column headed “Purposes”: P9203 P9207 P9208 P9319

[34]           Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: IMATINIB RBX; Maximum Quantity: 60; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C6496 C6499              

                   (b)        omit from the column headed “Circumstances”: C6527            

                   (c)        omit from the column headed “Circumstances”: C6539 C6540 C6550

                   (d)        omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C8698 C9086 C9124          

                   (e)        insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296  

                    (f)        omit from the column headed “Purposes”: P9086 P9124        

                   (g)        insert in numerical order in the column headed “Purposes”: P9203 P9207

[35]           Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Imatinib-Teva; Maximum Quantity: 60; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C6496 C6499              

                   (b)        omit from the column headed “Circumstances”: C6527            

                   (c)        omit from the column headed “Circumstances”: C6539 C6550              

                   (d)        omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C9086 C9124       

                   (e)        insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296  

                    (f)        omit from the column headed “Purposes”: P9086 P9124        

                   (g)        insert in numerical order in the column headed “Purposes”: P9203 P9207

[36]           Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Gilmat; Maximum Quantity: 60; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C6496 C6499              

                   (b)        omit from the column headed “Circumstances”: C6527            

                   (c)        omit from the column headed “Circumstances”: C6539 C6550              

                   (d)        omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C9086 C9124       

                   (e)        insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296  

                    (f)        omit from the column headed “Purposes”: P6496 P6499 P6527 P6539 P6550 P6948 P6949 P6973 P8697            substitute: P9200 P9209 P9240 P9242 P9243 P9274 P9276 P9295 P9296

[37]            Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Glivec; Maximum Quantity: 60; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C4342 C4355 C6496 C6498 C6499     

                   (b)        omit from the column headed “Circumstances”: C6527            

                   (c)        omit from the column headed “Circumstances”: C6539 C6540 C6550

                   (d)        omit from the column headed “Circumstances”: C6559 C6948 C6949 C6973 C8697 C8698 C9086 C9124            

                   (e)        insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9242 C9243 C9274 C9276 C9278 C9295 C9296 C9319  

                    (f)        omit from the column headed “Purposes”: P4342 P4355 P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698       substitute: P9200 P9204 P9206 P9209 P9238 P9240 P9242 P9243 P9274 P9276 P9278 P9295 P9296

[38]           Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: IMATINIB RBX; Maximum Quantity: 60; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C6496 C6499              

                   (b)        omit from the column headed “Circumstances”: C6527            

                   (c)        omit from the column headed “Circumstances”: C6539 C6540 C6550

                   (d)        omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C8698 C9086 C9124          

                   (e)        insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296  

                    (f)        omit from the column headed “Purposes”: P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698    substitute: P9200 P9204 P9206 P9209 P9240 P9242 P9243 P9274 P9276 P9295 P9296

[39]           Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Imatinib-Teva; Maximum Quantity: 60; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C6496 C6499              

                   (b)        omit from the column headed “Circumstances”: C6527            

                   (c)        omit from the column headed “Circumstances”: C6539 C6550              

                   (d)        omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C9086 C9124       

                   (e)        insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296  

                    (f)        omit from the column headed “Purposes”: P6496 P6499 P6527 P6539 P6550 P6948 P6949 P6973 P8697                substitute: P9200 P9209 P9240 P9242 P9243 P9274 P9276 P9295 P9296

[40]           Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Gilmat; Maximum Quantity: 30; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C6496 C6499              

                   (b)        omit from the column headed “Circumstances”: C6527            

                   (c)        omit from the column headed “Circumstances”: C6539 C6550              

                   (d)        omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C9086 C9124       

                   (e)        insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296  

                    (f)        omit from the column headed “Purposes”: P9086 P9124        

                   (g)        insert in numerical order in the column headed “Purposes”: P9203 P9207

[41]           Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Glivec; Maximum Quantity: 30; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C4342 C4355 C6496 C6498 C6499     

                   (b)        omit from the column headed “Circumstances”: C6527            

                   (c)        omit from the column headed “Circumstances”: C6539 C6540 C6550

                   (d)        omit from the column headed “Circumstances”: C6559 C6948 C6949 C6973 C8697 C8698 C9086 C9124            

                   (e)        insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9242 C9243 C9274 C9276 C9278 C9295 C9296 C9319  

                    (f)        omit from the column headed “Purposes”: P6498      

                   (g)        omit from the column headed “Purposes”: P6559 P9086 P9124          

                   (h)        insert in numerical order in the column headed “Purposes”: P9203 P9207 P9208 P9319

[42]           Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: IMATINIB RBX; Maximum Quantity: 30; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C6496 C6499              

                   (b)        omit from the column headed “Circumstances”: C6527            

                   (c)        omit from the column headed “Circumstances”: C6539 C6540 C6550

                   (d)        omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C8698 C9086 C9124          

                   (e)        insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296  

                    (f)        omit from the column headed “Purposes”: P9086 P9124        

                   (g)        insert in numerical order in the column headed “Purposes”: P9203 P9207

[43]           Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Imatinib-Teva; Maximum Quantity: 30; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C6496 C6499              

                   (b)        omit from the column headed “Circumstances”: C6527            

                   (c)        omit from the column headed “Circumstances”: C6539 C6550              

                   (d)        omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C9086 C9124       

                   (e)        insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296  

                    (f)        omit from the column headed “Purposes”: P9086 P9124        

                   (g)        insert in numerical order in the column headed “Purposes”: P9203 P9207

[44]           Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Gilmat; Maximum Quantity: 30; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C6496 C6499              

                   (b)        omit from the column headed “Circumstances”: C6527            

                   (c)        omit from the column headed “Circumstances”: C6539 C6550              

                   (d)        omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C9086 C9124       

                   (e)        insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296  

                    (f)        omit from the column headed “Purposes”: P6496 P6499 P6527 P6539 P6550 P6948 P6949 P6973 P8697                substitute: P9200 P9209 P9240 P9242 P9243 P9274 P9276 P9295 P9296

[45]           Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Glivec; Maximum Quantity: 30; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C4342 C4355 C6496 C6498 C6499     

                   (b)        omit from the column headed “Circumstances”: C6527            

                   (c)        omit from the column headed “Circumstances”: C6539 C6540 C6550

                   (d)        omit from the column headed “Circumstances”: C6559 C6948 C6949 C6973 C8697 C8698 C9086 C9124            

                   (e)        insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9242 C9243 C9274 C9276 C9278 C9295 C9296 C9319  

                    (f)        omit from the column headed “Purposes”: P4342 P4355 P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698         substitute: P9200 P9204 P9206 P9209 P9238 P9240 P9242 P9243 P9274 P9276 P9278 P9295 P9296

[46]           Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: IMATINIB RBX; Maximum Quantity: 30; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C6496 C6499              

                   (b)        omit from the column headed “Circumstances”: C6527            

                   (c)        omit from the column headed “Circumstances”: C6539 C6540 C6550

                   (d)        omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C8698 C9086 C9124          

                   (e)        insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296  


 

                    (f)        omit from the column headed “Purposes”: P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698    substitute: P9200 P9204 P9206 P9209 P9240 P9242 P9243 P9274 P9276 P9295 P9296

[47]           Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Imatinib-Teva; Maximum Quantity: 30; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C6496 C6499              

                   (b)        omit from the column headed “Circumstances”: C6527            

                   (c)        omit from the column headed “Circumstances”: C6539 C6550              

                   (d)        omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C9086 C9124       

                   (e)        insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296  

                    (f)        omit from the column headed “Purposes”: P6496 P6499 P6527 P6539 P6550 P6948 P6949 P6973 P8697                substitute: P9200 P9209 P9240 P9242 P9243 P9274 P9276 P9295 P9296

[48]           Schedule 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg

                           omit:

 

 

 

a

Indapamide Sandoz

SZ

MP NP

 

 

90

1

90

 

 

[49]           Schedule 1, entry for Insulin isophane 

                           omit:

 

Injection (bovine) 100 units per mL, 10 mL

Injection

 

Hypurin Isophane

AS

MP NP

C4332

 

5

2

1

 

 

[50]           Schedule 1, entry for Insulin neutral 

                           omit:

 

Injection (bovine) 100 units per mL, 10 mL

Injection

 

Hypurin Neutral

AS

MP NP

C4332

 

5

2

1

 

 

[51]           Schedule 1, entry for Interferon alfa-2a in the form Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe [Maximum Quantity: 15; Number of Repeats: 4; Section 100/Prescriber Bag only: C(100)]

                   (a)        omit from the column headed “Circumstances”: C5003            

                   (b)        insert in numerical order in the column headed “Circumstances”: C9259 

[52]           Schedule 1, entry for Interferon alfa-2a in the form Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe [Maximum Quantity: 15; Number of Repeats: 5; Section 100/Prescriber Bag only: C(100)]

                   (a)        omit from the column headed “Circumstances”: C5003            

                   (b)        insert in numerical order in the column headed “Circumstances”: C9259 

[53]           Schedule 1, entry for Interferon alfa-2a in the form Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe [Maximum Quantity: 30; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C5003            

                   (b)        insert in numerical order in the column headed “Circumstances”: C9259 

                   (c)        omit from the column headed “Purposes”: P5003      

                   (d)        insert in numerical order in the column headed “Purposes”: P9259 

[54]           Schedule 1, entry for Interferon alfa-2a in the form Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe [Maximum Quantity: 5;
Number of Repeats: 4; Section 100/Prescriber Bag only: C(100)]

                   (a)        omit from the column headed “Circumstances”: C5003            

                   (b)        insert in numerical order in the column headed “Circumstances”: C9259 

[55]           Schedule 1, entry for Interferon alfa-2a in the form Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe [Maximum Quantity: 5;
Number of Repeats: 5; Section 100/Prescriber Bag only: C(100)]

                   (a)        omit from the column headed “Circumstances”: C5003            

                   (b)        insert in numerical order in the column headed “Circumstances”: C9259 

[56]           Schedule 1, entry for Interferon alfa-2a in the form Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe [Maximum Quantity: 30; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C5003            

                   (b)        insert in numerical order in the column headed “Circumstances”: C9259 

                   (c)        omit from the column headed “Purposes”: P5003      

                   (d)        insert in numerical order in the column headed “Purposes”: P9259 

[57]           Schedule 1, entry for Lanreotide in each of the forms: Injection 60 mg (as acetate) in single dose pre-filled syringe; and Injection 90 mg (as acetate) in single dose pre-filled syringe

                   (a)        omit from the column headed “Circumstances”: C4569 

                   (b)        omit from the column headed “Circumstances”: C7041

                   (c)        insert in numerical order in the column headed “Circumstances”: C9260 C9261

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

                   (a)        omit from the column headed “Circumstances”: C4569

                   (b)        omit from the column headed “Circumstances”: C7041

                   (c)        omit from the column headed “Circumstances”: C8261

                   (d)        insert in numerical order in the column headed “Circumstances”: C9260 C9261 C9323

[59]           Schedule 1, entry for Lanreotide in the form Powder for suspension for injection 30 mg (as acetate) with diluent

                   (a)        omit from the column headed “Circumstances”: C7063

                   (b)        insert in numerical order in the column headed “Circumstances”: C9225

[60]           Schedule 1, entry for Lenograstim in each of the forms: Powder for injection 13,400,000 I.U. (105 micrograms); and Powder for injection 33,600,000 I.U. (263 micrograms)

                   (a)        omit from the column headed “Circumstances”: C6488 C6490 C6494

                   (b)        omit from the column headed “Circumstances”: C6512

                   (c)        omit from the column headed “Circumstances”: C6521

                   (d)        omit from the column headed “Circumstances”: C6543 C6546 C6622 C6623 C6633

                   (e)        omit from the column headed “Circumstances”: C6649

                    (f)        omit from the column headed “Circumstances”: C6656

                   (g)        omit from the column headed “Circumstances”: C6663

                   (h)        omit from the column headed “Circumstances”: C6681

                    (i)        insert in numerical order in the column headed “Circumstances”: C9226 C9227 C9229 C9230 C9231 C9263 C9264 C9265 C9266 C9314 C9324 C9325 C9326 C9327

[61]           Schedule 1, entry for Lipegfilgrastim

                   (a)        omit from the column headed “Circumstances”: C7823

                   (b)        omit from the column headed “Circumstances”: C7862

                   (c)        insert in numerical order in the column headed “Circumstances”: C9224 C9322

[62]           Schedule 1, entry for Macrogol 3350

                           substitute:

Macrogol 3350

Oral liquid 13.125 g in 25 mL with electrolytes, 500 mL

Oral

 

Movicol Liquid

NE

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P6171

2

3

1

 

 

 

 

 

 

 

 

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P4576 P4577 P4580 P4596 P4601

2

5

1

 

 

 

Sachets containing powder for oral solution 13.125 g with electrolytes, 30

Oral

a

APO-MACROGOL plus ELECTROLYTES

TX

MP

See Note 2

See Note 2

See Note 2

See Note 2

1

 

C(100)

 

 

 

a

Chemists' Own Macrogol with Electrolytes

RW

MP

See Note 2

See Note 2

See Note 2

See Note 2

1

 

C(100)

 

 

 

a

lax-sachets

AE

MP

See Note 2

See Note 2

See Note 2

See Note 2

1

 

C(100)

 

 

 

a

LaxaCon

EA

MP

See Note 2

See Note 2

See Note 2

See Note 2

1

 

C(100)

 

 

 

a

Macrovic

RF

MP

See Note 2

See Note 2

See Note 2

See Note 2

1

 

C(100)

 

 

 

a

Molaxole

GO

MP

See Note 2

See Note 2

See Note 2

See Note 2

1

 

C(100)

 

 

 

a

Movicol

NE

MP

See Note 2

See Note 2

See Note 2

See Note 2

1

 

C(100)

 

 

 

a

APO-MACROGOL plus ELECTROLYTES

TX

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P4576 P4577 P4580 P4596 P4601

1

5

1

 

 

 

 

 

a

Chemists' Own Macrogol with Electrolytes

RW

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P4576 P4577 P4580 P4596 P4601

1

5

1

 

 

 

 

 

a

lax-sachets

AE

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P4576 P4577 P4580 P4596 P4601

1

5

1

 

 

 

 

 

a

LaxaCon

EA

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P4576 P4577 P4580 P4596 P4601

1

5

1

 

 

 

 

 

a

Macrovic

RF

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P4576 P4577 P4580 P4596 P4601

1

5

1

 

 

 

 

 

a

Molaxole

GO

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P4576 P4577 P4580 P4596 P4601

1

5

1

 

 

 

 

 

a

Movicol

NE

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P4576 P4577 P4580 P4596 P4601

1

5

1

 

 

 

 

 

a

APO-MACROGOL plus ELECTROLYTES

TX

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P6171

2

3

1

 

 

 

 

 

a

Chemists' Own Macrogol with Electrolytes

RW

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P6171

2

3

1

 

 

 

 

 

a

lax-sachets

AE

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P6171

2

3

1

 

 

 

 

 

a

LaxaCon

EA

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P6171

2

3

1

 

 

 

 

 

a

Macrovic

RF

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P6171

2

3

1

 

 

 

 

 

a

Molaxole

GO

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P6171

2

3

1

 

 

 

 

 

a

Movicol

NE

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P6171

2

3

1

 

 

 

Powder for oral solution 510 g

Oral

 

OsmoLax

KY

MP

See Note 2

See Note 2

See Note 2

See Note 2

1

 

C(100)

 

 

 

 

 

 

MP NP

C4171 C4173 C4177 C4179 C4180 C6170

P4171 P4173 P4177 P4179 P4180

1

5

1

 

 

 

 

 

 

 

 

MP NP

C4171 C4173 C4177 C4179 C4180 C6170

P6170

2

3

1

 

 

[63]           Schedule 1, entry for Mirtazapine in the form Tablet 15 mg (orally disintegrating)

                           omit:

 

 

 

a

Avanza SolTab

MK

MP NP

C5650

 

30

5

30

 

 

[64]           Schedule 1, entry for Mirtazapine in the form Tablet 30 mg (orally disintegrating)

                           omit:

 

 

 

a

Avanza SolTab

MK

MP NP

C5650

 

30

5

30

 

 

[65]           Schedule 1, entry for Mirtazapine in the form Tablet 45 mg (orally disintegrating)

                           omit:

 

 

 

a

Avanza SolTab

MK

MP NP

C5650

 

30

5

30

 

 

[66]           Schedule 1, entry for Morphine in each of the forms: Capsule containing morphine sulfate pentahydrate 10 mg (containing sustained release pellets); and Capsule containing morphine sulfate pentahydrate 20 mg (containing sustained release pellets)

                           insert in numerical order in the column headed CircumstancesC9248

[67]           Schedule 1, entry for Morphine in the form Injection containing morphine hydrochloride trihydrate 10 mg in 1 mL

                           omit from the column headed “Schedule Equivalent” for the brand “Morphine Juno”: a

[68]           Schedule 1, entry for Morphine in the form Injection containing morphine sulfate pentahydrate 10 mg in 1 mL

                   (a)        omit from the column headed “Schedule Equivalent” for the brand “Hospira Pty Limited”: a 

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

 

 

 

 

MORPHINE SULFATE 10 mg/1 mL MEDSURGE

DZ

MP NP MW PDP

 

 

5

0

5

 

 

[69]           Schedule 1, entry for Morphine in the form Injection containing morphine sulfate pentahydrate 15 mg in 1 mL 

                   (a)        insert in the column headed “Schedule Equivalent” for the brand “Hospira Pty Limited”: a 

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

 

 

 

a

MORPHINE SULFATE 15 mg/1 mL MEDSURGE

DZ

MP NP MW PDP

 

 

5

0

5

 

 

[70]           Schedule 1, entry for Morphine in the form Injection containing morphine sulfate pentahydrate 30 mg in 1 mL

                   (a)        insert in the column headed “Schedule Equivalent” for the brand “Hospira Pty Limited”:  a 

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

 

 

 

a

MORPHINE SULFATE 30 mg/1 mL MEDSURGE

DZ

MP NP PDP

 

 

5

0

5

 

 

 

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

                   (a)        omit from the column headed “Circumstances”: C6070 C6095 C6111 C6997 C6999 C7567 C7787 C7802 C7864                

                   (b)        omit from the column headed “Circumstances”: C8143            

                   (c)        omit from the column headed “Circumstances”: C8552 C8568              

                   (d)        omit from the column headed “Circumstances”: C8581            

                   (e)        insert in numerical order in the column headed “Circumstances”: C9214 C9216 C9217 C9219 C9252 C9253 C9298 C9299 C9311 C9312 C9320 C9321 C9331

[72]           Schedule 1, entry for Octreotide in each of the forms: Injection 50 micrograms (as acetate) in 1 mL; Injection 100 micrograms (as acetate) in
1 mL; and Injection 500 micrograms (as acetate) in 1 mL

                   (a)        omit from the column headed “Circumstances” (all instances): C6388

                   (b)        omit from the column headed “Circumstances” (all instances): C6477 C8148

                   (c)        insert in numerical order in the column headed “Circumstances” (all instances): C9232 C9233 C9289

[73]           Schedule 1, entry for Octreotide in each of the forms: Injection (modified release) 10 mg (as acetate), vial and diluent syringe; Injection (modified release) 20 mg (as acetate), vial and diluent syringe; and Injection (modified release) 30 mg (as acetate), vial and diluent syringe

                   (a)        omit from the column headed “Circumstances”: C5899

                   (b)        omit from the column headed “Circumstances”: C5910

                   (c)        omit from the column headed “Circumstances”: C8196

                   (d)        insert in numerical order in the column headed “Circumstances”: C9262 C9288 C9313

[74]           Schedule 1, omit entry for Ofatumumab

[75]           Schedule 1, entry for Olmesartan with amlodipine in each of the forms: Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate); Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate); and Tablet containing olmesartan medoxomil
40 mg with amlodipine 10 mg (as besilate)

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

 

 

 

a

OLMEKAR

RW

MP NP

C4373

 

30

5

30

 

 

[76]           Schedule 1, entry for Pamidronic acid in the form Concentrated injection containing pamidronate disodium 15 mg in 5 mL [Maximum Quantity: 4; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C4430            

                   (b)        insert in numerical order in the column headed “Circumstances”: C9234 


 

[77]           Schedule 1, entry for Pamidronic acid in the form Concentrated injection containing pamidronate disodium 30 mg in 10 mL
[Maximum Quantity: 2; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C4430            

                   (b)        insert in numerical order in the column headed “Circumstances”: C9234 

[78]           Schedule 1, entry for Pamidronic acid in the form Concentrated injection containing pamidronate disodium 60 mg in 10 mL
[Maximum Quantity: 1; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C4430            

                   (b)        insert in numerical order in the column headed “Circumstances”: C9234 

[79]           Schedule 1, entry for Pamidronic acid in the form Concentrated injection containing pamidronate disodium 90 mg in 10 mL

                   (a)        omit from the column headed “Circumstances”: C4430

                   (b)        omit from the column headed “Circumstances”: C5256 C5257

                   (c)        insert in numerical order in the column headed “Circumstances”: C9234 C9315 C9335

[80]           Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C4444

                   (b)        omit from the column headed “Circumstances”: C7457

                   (c)        omit from the column headed “Circumstances”: C8551

                   (d)        insert in numerical order in the column headed “Circumstances”: C9247 C9281 

[81]           Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 90; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C4444

                   (b)        omit from the column headed “Circumstances”: C7457

                   (c)        omit from the column headed “Circumstances”: C8551

                   (d)        insert in numerical order in the column headed “Circumstances”: C9247 C9281

                   (e)        omit from the column headed “Purposes”: P4444 P8551         substitute: P9247 P9281

[82]           Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 90; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C4444

                   (b)        omit from the column headed “Circumstances”: C7457

                   (c)        omit from the column headed “Circumstances”: C8551

                   (d)        insert in numerical order in the column headed “Circumstances”: C9247 C9281

                   (e)        omit from the column headed “Purposes”: P7457

[83]           Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C4444

                   (b)        omit from the column headed “Circumstances”: C7457

                   (c)        omit from the column headed “Circumstances”: C8551

                   (d)        insert in numerical order in the column headed “Circumstances”: C9247 C9281

[84]           Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C4444

                   (b)        omit from the column headed “Circumstances”: C7457

                   (c)        omit from the column headed “Circumstances”: C8551

                   (d)        insert in numerical order in the column headed “Circumstances”: C9247 C9281

                   (e)        omit from the column headed “Purposes”: P4444 P8551         substitute: P9247 P9281

[85]           Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C4444

                   (b)        omit from the column headed “Circumstances”: C7457

                   (c)        omit from the column headed “Circumstances”: C8551

                   (d)        insert in numerical order in the column headed “Circumstances”: C9247 C9281

                   (e)        omit from the column headed “Purposes”: P7457

[86]           Schedule 1, entry for Pegfilgrastim 

                   (a)        omit from the column headed “Circumstances” (all instances): C7823 

                   (b)        omit from the column headed “Circumstances” (all instances): C7862 

                   (c)        insert in numerical order in the column headed “Circumstances” (all instances): C9235 C9303

[87]           Schedule 1, entry for Pembrolizumab 

                           omit:

 

Powder for injection 50 mg

Injection

 

Keytruda

MK

MP

C7606 C7610 C7773 C9044 C9127 C9178

 

See Note 3

See Note 3

1

 

D(100)

[88]           Schedule 1, entry for Plerixafor 

                   (a)        omit from the column headed “Circumstances”: C4550            

                   (b)        insert in numerical order in the column headed “Circumstances”: C9329

[89]           Schedule 1, entry for Pravastatin in each of the forms: Tablet containing pravastatin sodium 20 mg; and Tablet containing pravastatin sodium
40 mg 

                   (a)        omit:

 

 

 

a

Cholvastin

RA

MP NP

 

 

30

5

30

 

 

                   (b)        omit: 

 

 

 

a

Cholvastin

RA

MP

 

P7598

30

11

30

 

 

[90]           Schedule 1, entry for Ramipril in the form Tablet 10 mg

                   (a)        omit: 

 

 

 

 

Chem mart Ramipril

CH

MP NP

 

 

30

5

30

 

 

                   (b)        omit: 

 

 

 

 

Terry White Chemists Ramipril

TW

MP NP

 

 

30

5

30

 

 

[91]           Schedule 1, entry for Ribavirin 

                           omit:

 

Tablet 200 mg

Oral

 

Ibavyr

IX

MP NP

C5957 C5958

P5957

28

2

28

 

 

 

 

 

 

 

 

MP NP

C5957 C5958

P5958

28

5

28

 

 

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

                           omit:

 

 

 

a

ATELVIA ONCE-A-MONTH

TU

MP NP

C6310 C6323 C6327

 

1

5

1

 

 

[93]           Schedule 1, entry for Salbutamol

                           omit:

 

Capsule containing powder for oral inhalation 200 micrograms (as sulfate) (for use in Ventolin Rotahaler)

Inhalation by mouth

 

Ventolin Rotacaps

GK

MP NP

 

 

256

4

128

 

 

[94]           Schedule 1, entry for Somatropin in the form Injection 0.4 mg (1.2 i.u.) with diluent in single use syringe (without preservative)

                   (a)        omit from the column headed “Circumstances”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances”: C9221

[95]           Schedule 1, entry for Somatropin in the form Injection 0.6 mg (1.8 i.u.) with diluent in single use syringe (without preservative)

                   (a)        omit from the column headed “Circumstances”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances”: C9221

[96]           Schedule 1, entry for Somatropin in the form Injection 0.8 mg (2.4 i.u.) with diluent in single use syringe (without preservative)

                   (a)        omit from the column headed “Circumstances”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances”: C9221

[97]           Schedule 1, entry for Somatropin in the form Injection 1 mg (3 i.u.) with diluent in single use syringe (without preservative)

                   (a)        omit from the column headed “Circumstances”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances”: C9221

[98]           Schedule 1, entry for Somatropin in the form Injection 1.2 mg (3.6 i.u.) with diluent in single use syringe (without preservative)

                   (a)        omit from the column headed “Circumstances”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances”: C9221

[99]           Schedule 1, entry for Somatropin in the form Injection 1.4 mg (4.2 i.u.) with diluent in single use syringe (without preservative)

                   (a)        omit from the column headed “Circumstances”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances”: C9221

[100]        Schedule 1, entry for Somatropin in the form Injection 1.6 mg (4.8 i.u.) with diluent in single use syringe (without preservative)

                   (a)        omit from the column headed “Circumstances”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances”: C9221

[101]        Schedule 1, entry for Somatropin in the form Injection 1.8 mg (5.4 i.u.) with diluent in single use syringe (without preservative)

                   (a)        omit from the column headed “Circumstances”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances”: C9221

[102]        Schedule 1, entry for Somatropin in the form Injection 2 mg (6 i.u.) with diluent in single use syringe (without preservative)

                   (a)        omit from the column headed “Circumstances”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances”: C9221

[103]        Schedule 1, entry for Somatropin in the form Injection 4 mg (12 i.u.) vial with diluent (with preservative)

                   (a)        omit from the column headed “Circumstances”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances”: C9221

[104]        Schedule 1, entry for Somatropin in the form Injection 10 mg (30 i.u.) vial with diluent (with preservative)

                   (a)        omit from the column headed “Circumstances”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances”: C9221

[105]        Schedule 1, entry for Somatropin in the form Injection 18 i.u. (6 mg) cartridge with 3.15 mL diluent (with preservative)

                   (a)        omit from the column headed “Circumstances”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances”: C9221

[106]        Schedule 1, entry for Somatropin in the form Injection 72 i.u. (24 mg) cartridge with 3.15 mL diluent (with preservative)

                   (a)        omit from the column headed “Circumstances”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances”: C9221

[107]        Schedule 1, entry for Somatropin in the form Powder for injection 5 mg (15 i.u.) with diluent in pre-filled pen (with preservative)

                   (a)        omit from the column headed “Circumstances”: C8121 C8242

                   (b)        omit from the column headed “Circumstances”: C8381

                   (c)        insert in numerical order in the column headed “Circumstances”: C9221 C9300 C9301

[108]        Schedule 1, entry for Somatropin in the form Powder for injection 12 mg (36 i.u.) with diluent in pre-filled pen (with preservative)

                   (a)        omit from the column headed “Circumstances”: C8121 C8242

                   (b)        omit from the column headed “Circumstances”: C8381

                   (c)        insert in numerical order in the column headed “Circumstances”: C9221 C9300 C9301

[109]        Schedule 1, entry for Somatropin in the form Injection 36 i.u. (12 mg) cartridge with 3.15 mL diluent (with preservative)

                   (a)        omit from the column headed “Circumstances”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances”: C9221

[110]        Schedule 1, entry for Somatropin in the form Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen

                   (a)        omit from the column headed “Circumstances”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances”: C9221

[111]        Schedule 1, entry for Somatropin in the form Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative)

                   (a)        omit from the column headed “Circumstances” for the brand “Norditropin SimpleXx”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances” for the brand “Norditropin SimpleXx”: C9221

                   (c)        omit from the column headed “Circumstances” for the brand “Omnitrope Surepal 10”: C8382

                   (d)        insert in numerical order in the column headed “Circumstances” for the brand “Omnitrope Surepal 10”: C9257

                   (e)        omit from the column headed “Circumstances” for the brand “SciTropin A”: C8382

                    (f)        insert in numerical order in the column headed “Circumstances” for the brand “SciTropin A”: C9257

[112]        Schedule 1, entry for Somatropin in the form Solution for injection 6 mg (18 i.u.) in 1.03 mL cartridge (with preservative)

                   (a)        omit from the column headed “Circumstances”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances”: C9221

[113]        Schedule 1, entry for Somatropin in the form Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative)

                   (a)        omit from the column headed “Circumstances” for the brand “Norditropin SimpleXx”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances” for the brand “Norditropin SimpleXx”: C9221

                   (c)        omit from the column headed “Circumstances” for the brand “Omnitrope Surepal 10”: C8382

                   (d)        insert in numerical order in the column headed “Circumstances” for the brand “Omnitrope Surepal 10”: C9257

                   (e)        omit from the column headed “Circumstances” for the brand “SciTropin A”: C8382

                    (f)        insert in numerical order in the column headed “Circumstances” for the brand “SciTropin A”: C9257

[114]        Schedule 1, entry for Somatropin in the form Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen

                   (a)        omit from the column headed “Circumstances”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances”: C9221

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

                   (a)        omit from the column headed “Circumstances”: C8121 C8242

                   (b)        omit from the column headed “Circumstances”: C8381

                   (c)        insert in numerical order in the column headed “Circumstances”: C9221 C9300 C9301

[116]        Schedule 1, entry for Somatropin in the form Solution for injection 12 mg (36 i.u.) in 1.5 mL cartridge (with preservative)

                   (a)        omit from the column headed “Circumstances”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances”: C9221

[117]        Schedule 1, entry for Somatropin in the form Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative)

                   (a)        omit from the column headed “Circumstances” for the brand “Norditropin SimpleXx”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances” for the brand “Norditropin SimpleXx”: C9221

                   (c)        omit from the column headed “Circumstances” for the brand “Omnitrope Surepal 15”: C8382

                   (d)        insert in numerical order in the column headed “Circumstances” for the brand “Omnitrope Surepal 15”: C9257

[118]        Schedule 1, entry for Somatropin in the form Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen

                   (a)        omit from the column headed “Circumstances”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances”: C9221

[119]        Schedule 1, entry for Somatropin in the form Solution for injection 20 mg (60 i.u.) in 2.5 mL cartridge (with preservative)

                   (a)        omit from the column headed “Circumstances”: C8381

                   (b)        insert in numerical order in the column headed “Circumstances”: C9221

[120]        Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]

                   (a)        omit from the column headed “Circumstances”: C8549

                   (b)        insert in numerical order in the column headed “Circumstances”: C9210

                   (c)        omit from the column headed “Purposes”: P8549

                   (d)        insert in numerical order in the column headed “Purposes”: P9210

[121]        Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C8549

                   (b)        insert in numerical order in the column headed “Circumstances”: C9210

[122]        Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances”: C8549

                   (b)        insert in numerical order in the column headed “Circumstances”: C9210

[123]        Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C8549

                   (b)        insert in numerical order in the column headed “Circumstances”: C9210

[124]        Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]

                   (a)        omit from the column headed “Circumstances”: C8549

                   (b)        insert in numerical order in the column headed “Circumstances”: C9210

                   (c)        omit from the column headed “Purposes”: P8549

                   (d)        insert in numerical order in the column headed “Purposes”: P9210

[125]        Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C8549

                   (b)        insert in numerical order in the column headed “Circumstances”: C9210

[126]        Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances”: C8549

                   (b)        insert in numerical order in the column headed “Circumstances”: C9210

[127]        Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C8549

                   (b)        insert in numerical order in the column headed “Circumstances”: C9210

[128]        Schedule 1, entry for Sunitinib in the form Capsule 37.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]

                   (a)        omit from the column headed “Circumstances”: C8549

                   (b)        insert in numerical order in the column headed “Circumstances”: C9210

                   (c)        omit from the column headed “Purposes”: P8549

                   (d)        insert in numerical order in the column headed “Purposes”: P9210

[129]        Schedule 1, entry for Sunitinib in the form Capsule 37.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C8549

                   (b)        insert in numerical order in the column headed “Circumstances”: C9210

[130]        Schedule 1, entry for Sunitinib in the form Capsule 37.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances”: C8549

                   (b)        insert in numerical order in the column headed “Circumstances”: C9210

[131]        Schedule 1, entry for Sunitinib in the form Capsule 37.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C8549

                   (b)        insert in numerical order in the column headed “Circumstances”: C9210

[132]        Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]

                   (a)        omit from the column headed “Circumstances”: C8549

                   (b)        insert in numerical order in the column headed “Circumstances”: C9210

                   (c)        omit from the column headed “Purposes”: P8549

                   (d)        insert in numerical order in the column headed “Purposes”: P9210

[133]        Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances”: C8549

                   (b)        insert in numerical order in the column headed “Circumstances”: C9210

[134]        Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances”: C8549

                   (b)        insert in numerical order in the column headed “Circumstances”: C9210


 

[135]        Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C8549

                   (b)        insert in numerical order in the column headed “Circumstances”: C9210

[136]        Schedule 1, entry for Teriflunomide

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

 

 

 

a

TERIFLAGIO

RW

MP

C6854 C7741

 

28

5

28

 

 

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

                   (a)        omit from the column headed “Circumstances”: C5909

                   (b)        insert in numerical order in the column headed “Circumstances”: C9290

[138]        Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 500; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances” (all instances): C5939 

                   (b)        insert in numerical order in the column headed “Circumstances” (all instances): C9267

[139]        Schedule 1, entry for Valganciclovir in the form Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL

                   (a)        omit from the column headed “Circumstances”: C5031            

                   (b)        insert in numerical order in the column headed “Circumstances”: C9316 

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

                   (a)        omit from the column headed “Circumstances” (all instances): C5031 

                   (b)        insert in numerical order in the column headed “Circumstances” (all instances): C9316 

[141]        Schedule 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

                   (a)        omit from the column headed “Circumstances” (all instances): C5606 C5676 C5677

                   (b)        omit from the column headed “Circumstances” (all instances): C5736

                   (c)        insert in numerical order in the column headed “Circumstances” (all instances): C9268 C9304 C9317 C9328

[142]        Schedule 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL vial 

                   (a)        omit from the column headed “Circumstances”: C5606 C5676 C5677

                   (b)        omit from the column headed “Circumstances”: C5736

                   (c)        insert in numerical order in the column headed “Circumstances”: C9236 C9269 C9270 C9291

[143]        Schedule 1, entry for Zoledronic acid in the form Solution for I.V. infusion 4 mg (as monohydrate) in 100 mL

                   (a)        omit from the column headed “Circumstances” for the brand “DBL Zoledronic Acid”: C5606 C5676 C5677

                   (b)        omit from the column headed “Circumstances” for the brand “DBL Zoledronic Acid”: C5736

                   (c)        insert in numerical order in the column headed “Circumstances” for the brand “DBL Zoledronic Acid”: C9268 C9304 C9317 C9328

                   (d)        omit:

 

 

 

 

Zoledronic Acid 4 mg/100 mL APOTEX

TX

MP

C5605 C5606 C5676 C5677 C5703 C5704 C5735 C5736

 

1

11

1

 

PB(100)

[144]        Schedule 3

                           omit:

TU

Theramex Australia Pty Ltd

 37 623 186 845

[145]        Schedule 3, after details relevant to Responsible Person code UO

                           insert:

UR

Camurus Pty Ltd

79 627 784 605

[146]        Schedule 4, Part 1, entry for Botulinum toxin type A purified neurotoxin complex

                           insert in numerical order after existing text:

 

C9271

 

 

Moderate to severe spasticity of the lower limb following an acute event
Grandfathered treatment
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.
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 September 2019; AND
The condition must have been moderate to severe spasticity of the lower 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 does not respond (defined as not having had a decrease in spasticity rating of at least 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND
Patient must not have established severe contracture in the limb to be treated; AND
The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per lower limb in the the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per lower limb each year thereafter.
Patient must be aged 18 years or older.
Standard management includes physiotherapy and/or oral spasticity agents.

Compliance with Authority Required procedures - Streamlined Authority Code 9271

 

C9334

 

 

Moderate to severe spasticity of the lower limb following an acute event
Must be treated by a neurologist; OR
Must be treated by an orthopaedic surgeon; OR
Must be treated by a rehabilitation specialist; OR
Must be treated by a plastic surgeon; OR
Must be treated by a geriatrician.
The condition must be moderate to severe spasticity of the lower limb/s following stroke or other acute neurological 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 of at least 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND
Patient must not have established severe contracture in the limb to be treated; AND
The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per lower limb in the the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per lower limb each year thereafter.
Patient must be aged 18 years or older.
Standard management includes physiotherapy and/or oral spasticity agents.

Compliance with Authority Required procedures - Streamlined Authority Code 9334

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

                           insert in numerical order after existing text:

 

C9212

 

 

Opiate dependence
Must be treated by a health care professional.
The treatment must be within a framework of medical, social and psychological treatment; AND
Patient must be stabilised on sublingual buprenorphine or buprenorphine/naloxone prior to commencing treatment with this drug for this condition.

 

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

                   (a)        omit entry for circumstances code “C6947” and substitute:

 

C6947

P6947

 

Chronic Myeloid Leukaemia (CML)
First continuing treatment
The condition must be in the chronic phase; AND
Patient must have received initial PBS-subsidised first line treatment with this drug for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to first continuing PBS-subsidised treatment with imatinib as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to first continuing PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND
Patient must have demonstrated a major cytogenic response; OR
Patient must have demonstrated a peripheral blood level of BCR-ABL of less than 1%; AND
The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
First continuing applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) demonstration of continued response to treatment as evidenced by either:
(a) a major cytogenetic response [see Note explaining requirements]; or
(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements].Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided.

Compliance with Authority Required procedures

 

                   (b)        omit:

 

C6959

P6959

 

Chronic Myeloid Leukaemia (CML)
Initial treatment
The condition must be a primary diagnosis; AND
The condition must be in the chronic phase; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL tyrosine kinase; AND
The treatment must be for first line therapy for this condition; AND
Patient must not have previously experienced a failure to respond to the PBS-subsidised first line treatment with this drug for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND
The treatment must not exceed a total maximum of 18 months of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved.
Patients should be commenced on a dose of dasatinib of 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to dasatinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and
(3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow; and
(4) a signed patient acknowledgement form

Compliance with Authority Required procedures

 

C6968

P6968

 

Chronic Myeloid Leukaemia (CML)
Subsequent continuing treatment
The condition must be in the chronic phase; AND
Patient must have received the First continuing PBS-subsidised treatment with this drug as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to subsequent continuing PBS-subsidised treatment with imatinib as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to subsequent continuing PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND
Patient must have maintained a major cytogenic response; OR
Patient must have maintained a peripheral blood level of BCR-ABL of less than 1%; AND
The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Subsequent authority applications for continuing therapy with this drug may be made by telephoning the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).

Compliance with Authority Required procedures

 

 

                   (c)        insert in numerical order after existing text:

 

C9197

P9197

 

Chronic Myeloid Leukaemia (CML)
Subsequent continuing treatment
The condition must be in the chronic phase; AND
Patient must have received the First continuing PBS-subsidised treatment with this drug as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to subsequent continuing PBS-subsidised treatment with imatinib as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to subsequent continuing PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND
Patient must have maintained a major cytogenic response; OR
Patient must have maintained a peripheral blood level of BCR-ABL of less than 1%; AND
The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND
The treatment must be the sole PBS-subsidised therapy for this condition.

Compliance with Authority Required procedures

 

C9293

P9293

 

Chronic Myeloid Leukaemia (CML)
Initial treatment
The condition must be a primary diagnosis; AND
The condition must be in the chronic phase; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL tyrosine kinase; AND
The treatment must be for first line therapy for this condition; AND
Patient must not have previously experienced a failure to respond to the PBS-subsidised first line treatment with this drug for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND
The treatment must not exceed a total maximum of 18 months of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved.
Patients should be commenced on a dose of dasatinib of 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to dasatinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and
(3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow.

Compliance with Written Authority Required procedures


 

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

                   (a)        omit:

 

C8444

P8444

 

Chronic iron overload
Continuing treatment
Patient must be transfusion dependent; AND
Patient must not have a malignant disorder of erythropoiesis; AND
Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.

Compliance with Authority Required procedures

 

C8445

P8445

 

Chronic iron overload
Continuing treatment
Patient must not be transfusion dependent; AND
The condition must be thalassaemia; AND
Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.

Compliance with Authority Required procedures

 

C8446

P8446

 

Chronic iron overload
Continuing treatment
Patient must be red blood cell transfusion dependent; AND
Patient must have a malignant disorder of haemopoieisis; AND
Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9222

P9222

 

Chronic iron overload
Continuing treatment
Patient must not be transfusion dependent; AND
The condition must be thalassaemia; AND
Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9222

 

C9258

P9258

 

Chronic iron overload
Continuing treatment
Patient must be red blood cell transfusion dependent; AND
Patient must have a malignant disorder of haemopoieisis; AND
Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9258

 

C9302

P9302

 

Chronic iron overload
Continuing treatment
Patient must be transfusion dependent; AND
Patient must not have a malignant disorder of erythropoiesis; AND
Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9302

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

                           insert in numerical order after existing text:

 

C9228

 

 

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

Compliance with Authority Required procedures - Streamlined Authority Code 9228

 

C9286

 

 

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

Compliance with Authority Required procedures - Streamlined Authority Code 9286

[151]        Schedule 4, Part 1, entry for Doxorubicin - pegylated liposomal

                   (a)        omit:

 

C6233

P6233

 

Kaposi sarcoma
The condition must be AIDS-related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive visceral involvement.

Compliance with Authority Required procedures

                   (b)        omit:

 

C6264

P6264

 

Kaposi sarcoma
The condition must be AIDS-related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive mucocutaneous involvement.

Compliance with Authority Required procedures

                   (c)        insert in numerical order after existing text:

 

C9223

P9223

 

Kaposi sarcoma
The condition must be AIDS-related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive visceral involvement.

Compliance with Authority Required procedures - Streamlined Authority Code 9223

 

C9287

P9287

 

Kaposi sarcoma
The condition must be AIDS-related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive mucocutaneous involvement.

Compliance with Authority Required procedures - Streamlined Authority Code 9287

[152]        Schedule 4, Part 1, entry for Ibandronic acid

                   (a)        omit:

 

C5257

 

 

Bone metastases
The condition must be due to breast cancer.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text: 

 

C9333

 

 

Bone metastases
The condition must be due to breast cancer.

Compliance with Authority Required procedures - Streamlined Authority Code 9333

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

                   (a)        omit: 

 

C4342

P4342

 

Gastrointestinal stromal tumour
Continuing treatment
The treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST); AND
Patient must be at high risk of recurrence following complete surgical resection of primary GIST; AND
The treatment must not exceed a dose of 400 mg per day for a period of 36 months in total (initial plus continuing therapy); AND
Patient must have previously been issued with an authority prescription for imatinib for adjuvant treatment following complete resection of primary GIST.
Applications for continuing therapy may be made by telephone.

Compliance with Written Authority Required procedures

 

C4355

P4355

 

Gastrointestinal stromal tumour
Initial treatment
The treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST); AND
Patient must be at high risk of recurrence following complete surgical resection of primary GIST; AND
The condition must be histologically confirmed by the detection of CD117 on immunohistochemical staining; AND
The treatment must not exceed a dose of 400 mg per day for a period of 36 months in total (initial plus continuing therapy).
Applications for authorisation of initial treatment must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Imatinib Mesilate (Glivec) PBS Authority Application for Use in Adjuvant Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following:
(i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and
(ii) a copy of the pathology report must include the size and mitotic rate of the tumour, and the date of tumour resection must be documented, which must not be more than 3 months prior to the date of this application.
High risk of recurrence is defined as:
Primary GIST greater than 5 cm with a mitotic count of greater than 5/50 high power fields (HPF); or
Primary GIST greater than 10 cm with any mitotic rate; or
Primary GIST with a mitotic count of greater than 10/50 HPF.

Compliance with Written Authority Required procedures

 

C6496

P6496

 

Dermatofibrosarcoma protuberans
Initial treatment
The condition must be unresectable; OR
The condition must be locally recurrent; OR
The condition must be metastatic; AND
The treatment must not exceed a maximum dose of 800 mg per day.
(1) Where the application for authority to prescribe is being sought on the basis of unresectable tumour, written evidence in support of that claim must be provided; and
(2) Where the application for authority to prescribe is being sought on the basis of locally recurrent disease, the site of the local recurrence must be specified; and
(3) Where the application for authority to prescribe is being sought on the basis of metastatic disease, the site(s) of metastatic disease must be provided.
Applications for authorisation for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and
(c) a signed patient acknowledgement

Compliance with Written Authority Required procedures

 

C6498

P6498

 

Malignant gastrointestinal stromal tumour
Continuing treatment
The condition must be metastatic; OR
The condition must be unresectable; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be given at a dose not exceeding 600 mg per day.
Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib
Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved.
A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347: 472-80.)
Applications for continuing treatment may be made by telephone

Compliance with Authority Required procedures

 

C6499

P6499

 

Chronic eosinophilic leukaemia or Hypereosinophilic syndrome
Initial treatment
Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene; AND
The treatment must not exceed a maximum dose of 400 mg per day.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and
(c) a copy of the pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene; and
(d) a copy of the full blood examination report confirming the presence of hypereosinophilic syndrome or chronic eosinophilic leukaemia; and
(e) details of organ involvement requiring treatment, including a copy of the radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate; and
(f) a signed patient acknowledgement

Compliance with Written Authority Required procedures

                   (b)        omit:

 

C6527

P6527

 

Dermatofibrosarcoma protuberans
Continuing treatment
The condition must be unresectable; OR
The condition must be locally recurrent; OR
The condition must be metastatic; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated a response to the PBS-subsidised treatment; AND
The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must not exceed a maximum dose of 800 mg per day.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and
(c) a statement that the disease has not progressed on imatinib therapy

Compliance with Written Authority Required procedures

 

                   (c)        omit:

 

C6539

P6539

 

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

Compliance with Written Authority Required procedures

 

C6540

P6540

 

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

Compliance with Written Authority Required procedures

 

C6550

P6550

 

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

Compliance with Written Authority Required procedures

                   (d)        omit:

 

C6559

P6559

 

Malignant gastrointestinal stromal tumour
Initial Treatment
The condition must be metastatic; OR
The condition must be unresectable; AND
The condition must be histologically confirmed by the detection of CD117 on immunohistochemical staining; AND
The treatment must be commenced at a dose not exceeding 400 mg per day; AND
The treatment must not exceed 3 months under this restriction.
Authority prescriptions for a higher dose will not be approved during this initial 3 month treatment period.
Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved.
A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347: 472-80.)
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Imatinib Mesilate PBS Authority Application for Use in the Treatment of Metastatic or Unresectable Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following:
(i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and
(ii) a copy of the most recent (within 2 months of the application) computed tomography (CT) scan, magnetic resonance imaging (MRI) or ultrasound assessment of the tumour(s), including whether or not there is evidence of metastatic disease; and
(iii) where the application for authority to prescribe is being sought on the basis of an unresectable tumour, written evidence in support of that claim must be provided

Compliance with Written Authority Required procedures

 

C6948

P6948

 

Chronic Myeloid Leukaemia (CML)
Initial treatment
Patient must have a primary diagnosis of chronic myeloid leukaemia; AND
The condition must be in the chronic phase of chronic myeloid leukaemia; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL tyrosine kinase; AND
The treatment must be for first line therapy for this condition; AND
Patient must not have previously experienced a failure to respond to the PBS-subsidised treatment with this drug for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND
The treatment must not exceed a total maximum of 18 months of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Applications for authorisation must be in writing and must include:(1) a completed authority prescription form; and(2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and(3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow; and(4) a signed patient acknowledgement form
Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved.
Patients should be commenced on a dose of imatinib mesilate of 400 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to imatinib mesilate therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter.

Compliance with Written Authority Required procedures

 

C6949

P6949

 

Chronic Myeloid Leukaemia (CML)
Subsequent continuing
The condition must be in the chronic phase of chronic myeloid leukaemia; AND
Patient must have received initial continuing PBS-subsidised treatment with this drug as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to subsequent continuing PBS-subsidised treatment with dasatinib as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to subsequent continuing PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND
Patient must have maintained a major cytogenic response; OR
Patient must have maintained a peripheral blood level of BCR-ABL of less than 1%; AND
The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Second and subsequent authority applications for continuing therapy with imatinib mesilate may be made on the telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).

Compliance with Authority Required procedures

 

C6973

P6973

 

Chronic Myeloid Leukaemia (CML)
First Continuing
The condition must be in the chronic phase of chronic myeloid leukaemia; AND
Patient must have received initial PBS-subsidised treatment with this drug as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to first continuing PBS-subsidised treatment with dasatinib as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to first continuing PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND
Patient must have demonstrated a major cytogenic response; OR
Patient must have demonstrated a peripheral blood level of BCR-ABL of less than 1%; AND
The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
First continuing applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a response to treatment as evidenced by either:
(a) a major cytogenetic response [see Note explaining requirements]; or
(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements].

Compliance with Written Authority Required procedures

 

C8697

P8697

 

Myelodysplastic or myeloproliferative disorder
Initial treatment
Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by standard karyotyping; OR
Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by fluorescence in situ hybridization (FISH); OR
Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by PDGFRB fusion gene transcript; AND
Patient must have previously failed an adequate trial of conventional therapy with cytarabine; OR
Patient must have previously failed an adequate trial of conventional therapy with etoposide; OR
Patient must have previously failed an adequate trial of conventional therapy with hydroxycarbamide (hydroxyurea); AND
The treatment must not exceed a maximum dose of 400 mg per day.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and
(c) a copy of the pathology report confirming the platelet-derived growth factor receptor (PDGFR) gene re-arrangement; and
(d) a copy of the bone marrow biopsy report which demonstrates the presence of a myelodysplastic or myeloproliferative disorder; and
(e) details of the prior therapy trialled and the response; and
(f) a signed patient acknowledgement

Compliance with Written Authority Required procedures

 

C8698

P8698

 

Aggressive systemic mastocytosis with eosinophilia
Initial treatment
Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene; AND
Patient must have previously failed an adequate trial of conventional therapy with corticosteroids; OR
Patient must have previously failed an adequate trial of conventional therapy with hydroxycarbamide (hydroxyurea); AND
The treatment must not exceed a maximum dose of 400 mg per day.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and
(c) a copy of the pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene; and
(d) a copy of the bone marrow biopsy report and/or other tissue biopsy report confirming the diagnosis of aggressive systemic mastocytosis and a copy of the full blood examination report demonstrating eosinophilia; and
(e) details of symptomatic organ involvement requiring treatment, including a copy of the radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate; and
(f) details of prior treatment trialled and the response; and
(g) a signed patient acknowledgement

Compliance with Written Authority Required procedures

 

C9086

P9086

 

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

Compliance with Written Authority Required procedures

 

C9124

P9124

 

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

Compliance with Authority Required procedures

                   (e)        insert in numerical order after existing text: 

 

C9200

P9200

 

Chronic Myeloid Leukaemia (CML)
Initial treatment
Patient must have a primary diagnosis of chronic myeloid leukaemia; AND
The condition must be in the chronic phase of chronic myeloid leukaemia; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL tyrosine kinase; AND
The treatment must be for first line therapy for this condition; AND
Patient must not have previously experienced a failure to respond to the PBS-subsidised treatment with this drug for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND
The treatment must not exceed a total maximum of 18 months of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved.
Patients should be commenced on a dose of imatinib mesilate of 400 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to imatinib mesilate therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter.
A pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records.

Compliance with Authority Required procedures

 

C9203

P9203

 

Acute lymphoblastic leukaemia
Initial treatment
Patient must be newly diagnosed; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL; AND
The treatment must be for induction and consolidation therapy; AND
The treatment must be in combination with chemotherapy or corticosteroids; AND
Patient must not have previously experienced a failure to respond to the PBS-subsidised first line treatment with this drug for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first line therapy for this condition.
A pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records.

Compliance with Authority Required procedures

 

C9204

P9204

 

Aggressive systemic mastocytosis with eosinophilia
Initial treatment
Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene; AND
Patient must have previously failed an adequate trial of conventional therapy with corticosteroids; OR
Patient must have previously failed an adequate trial of conventional therapy with hydroxycarbamide (hydroxyurea); AND
The treatment must not exceed a maximum dose of 400 mg per day.
A pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene, a bone marrow biopsy report and/or other tissue biopsy report confirming the diagnosis of aggressive systemic mastocytosis and a full blood examination report demonstrating eosinophilia must be documented in the patient's medical records.
The details of symptomatic organ involvement requiring treatment, including radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate must be documented in the patient's medical records.

Compliance with Authority Required procedures

 

C9206

P9206

 

Aggressive systemic mastocytosis with eosinophilia
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene; AND
Patient must have achieved and maintained a complete haematological response; AND
The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must not exceed a maximum dose of 400 mg per day.
A full blood examination report which demonstrates a complete haematological response and evidence that the disease has not progressed on imatinib therapy must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 9206

 

C9207

P9207

 

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

Compliance with Authority Required procedures - Streamlined Authority Code 9207

 

C9208

P9208

 

Malignant gastrointestinal stromal tumour
Continuing treatment
The condition must be metastatic; OR
The condition must be unresectable; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be given at a dose not exceeding 600 mg per day.
Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib
Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved.
A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347: 472-80.)

Compliance with Authority Required procedures - Streamlined Authority Code 9208

 

C9209

P9209

 

Dermatofibrosarcoma protuberans
Continuing treatment
The condition must be unresectable; OR
The condition must be locally recurrent; OR
The condition must be metastatic; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated a response to the PBS-subsidised treatment; AND
The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must not exceed a maximum dose of 800 mg per day.
Evidence that the disease has not progressed on imatinib therapy must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 9209

 

C9238

P9238

 

Gastrointestinal stromal tumour
Initial treatment
The treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST); AND
Patient must be at high risk of recurrence following complete surgical resection of primary GIST; AND
The condition must be histologically confirmed by the detection of CD117 on immunohistochemical staining; AND
The treatment must not exceed a dose of 400 mg per day for a period of 36 months in total (initial plus continuing therapy).
High risk of recurrence is defined as:
Primary GIST greater than 5 cm with a mitotic count of greater than 5/50 high power fields (HPF); or
Primary GIST greater than 10 cm with any mitotic rate; or
Primary GIST with a mitotic count of greater than 10/50 HPF.
A pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining must be documented in the patient's medical records.
The pathology report must include the size and mitotic rate of the tumour, and the date of tumour resection, which must not be more than 3 months prior to treatment initiation must be recorded in the patient's medical records.

Compliance with Authority Required procedures

 

C9240

P9240

 

Dermatofibrosarcoma protuberans
Initial treatment
The condition must be unresectable; OR
The condition must be locally recurrent; OR
The condition must be metastatic; AND
The treatment must not exceed a maximum dose of 800 mg per day.
Details of unresectable tumour or site of the local recurrence or site(s) of metastatic disease must be documented in the patient's medical records.

Compliance with Authority Required procedures

 

C9242

P9242

 

Chronic Myeloid Leukaemia (CML)
First Continuing
The condition must be in the chronic phase of chronic myeloid leukaemia; AND
Patient must have received initial PBS-subsidised treatment with this drug as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to first continuing PBS-subsidised treatment with dasatinib as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to first continuing PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND
Patient must have demonstrated a major cytogenic response; OR
Patient must have demonstrated a peripheral blood level of BCR-ABL of less than 1%; AND
The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records.

Compliance with Authority Required procedures

 

C9243

P9243

 

Myelodysplastic or myeloproliferative disorder
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be PDGFRB fusion gene-positive; AND
Patient must have achieved and maintained a complete haematological response; AND
The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must not exceed a maximum dose of 400 mg per day.
A full blood examination report which demonstrates a complete haematological response and evidence that the disease has not progressed on imatinib therapy must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 9243

 

C9274

P9274

 

Chronic eosinophilic leukaemia or Hypereosinophilic syndrome
Initial treatment
Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene; AND
The treatment must not exceed a maximum dose of 400 mg per day.
A pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene, a full blood examination report and details of organ involvement requiring treatment, including a copy of the radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate must be documented in the patient's medical records.

Compliance with Authority Required procedures

 

C9276

P9276

 

Myelodysplastic or myeloproliferative disorder
Initial treatment
Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by standard karyotyping; OR
Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by fluorescence in situ hybridization (FISH); OR
Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by PDGFRB fusion gene transcript; AND
Patient must have previously failed an adequate trial of conventional therapy with cytarabine; OR
Patient must have previously failed an adequate trial of conventional therapy with etoposide; OR
Patient must have previously failed an adequate trial of conventional therapy with hydroxycarbamide (hydroxyurea); AND
The treatment must not exceed a maximum dose of 400 mg per day.
A bone marrow biopsy report demonstrating the presence of a myelodysplastic or myeloproliferative disorder, a pathology report confirming the platelet-derived growth factor receptor (PDGFR) gene re-arrangement and details of the prior trialled therapy and the response must be documented in the patient's medical records.

Compliance with Authority Required procedures

 

C9278

P9278

 

Gastrointestinal stromal tumour
Continuing treatment
The treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST); AND
Patient must be at high risk of recurrence following complete surgical resection of primary GIST; AND
The treatment must not exceed a dose of 400 mg per day for a period of 36 months in total (initial plus continuing therapy); AND
Patient must have previously been issued with an authority prescription for imatinib for adjuvant treatment following complete resection of primary GIST.

Compliance with Authority Required procedures - Streamlined Authority Code 9278

 

C9295

P9295

 

Chronic Myeloid Leukaemia (CML)
Subsequent continuing
The condition must be in the chronic phase of chronic myeloid leukaemia; AND
Patient must have received initial continuing PBS-subsidised treatment with this drug as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to subsequent continuing PBS-subsidised treatment with dasatinib as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to subsequent continuing PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND
Patient must have maintained a major cytogenic response; OR
Patient must have maintained a peripheral blood level of BCR-ABL of less than 1%; AND
The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND
The treatment must be the sole PBS-subsidised therapy for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 9295

 

C9296

P9296

 

Chronic eosinophilic leukaemia or Hypereosinophilic syndrome
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have achieved and maintained a complete haematological response; AND
The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must not exceed a maximum dose of 400 mg per day.
A full blood examination report which demonstrates a complete haematological response, with a normal eosinophil count and a statement that the disease has not progressed on imatinib therapy must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 9296

 

C9319

P9319

 

Malignant gastrointestinal stromal tumour
Initial Treatment
The condition must be metastatic; OR
The condition must be unresectable; AND
The condition must be histologically confirmed by the detection of CD117 on immunohistochemical staining; AND
The treatment must be commenced at a dose not exceeding 400 mg per day; AND
The treatment must not exceed 3 months under this restriction.
Authority prescriptions for a higher dose will not be approved during this initial 3 month treatment period.
Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved.
A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347: 472-80.)
A pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining must be documented in the patient's medical records.
Details of the most recent (within 2 months of the application) computed tomography (CT) scan, magnetic resonance imaging (MRI) or ultrasound assessment of the tumour(s), including whether or not there is evidence of metastatic disease must be documented in the patient's medical records.
Where the application for authority to prescribe is being sought on the basis of an unresectable tumour, written evidence must be documented in the patient's medical records.

Compliance with Authority Required procedures

[154]        Schedule 4, Part 1, omit entry for Insulin isophane

[155]        Schedule 4, Part 1, omit entry for Insulin neutral

[156]        Schedule 4, Part 1, entry for Interferon alfa-2a

                   (a)        omit: 

 

C5003

P5003

 

Chronic Myeloid Leukaemia (CML)
The condition must be Philadelphia chromosome positive.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text: 

 

C9259

P9259

 

Chronic Myeloid Leukaemia (CML)
The condition must be Philadelphia chromosome positive.

Compliance with Authority Required procedures - Streamlined Authority Code 9259

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

                   (a)        omit:

 

C4569

 

 

Functional carcinoid tumour
The condition must be causing intractable symptoms; AND
Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures

                   (b)        omit:

 

C7041

 

 

Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.

Compliance with Authority Required procedures

                   (c)        omit:

 

C7063

 

 

Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (6 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.

Compliance with Authority Required procedures

                   (d)        omit:

 

C8261

 

 

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

Compliance with Authority Required procedures

                   (e)        insert in numerical order after existing text:

 

C9225

 

 

Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (6 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.

Compliance with Authority Required procedures - Streamlined Authority Code 9225

 

C9260

 

 

Functional carcinoid tumour
The condition must be causing intractable symptoms; AND
Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures - Streamlined Authority Code 9260

 

C9261

 

 

Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.

Compliance with Authority Required procedures - Streamlined Authority Code 9261

 

C9323

 

 

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

Compliance with Authority Required procedures - Streamlined Authority Code 9323

[158]        Schedule 4, Part 1, entry for Lenograstim

                   (a)        omit:

 

C6488

 

 

Chemotherapy-induced neutropenia
Patient must be receiving standard dose adjuvant chemotherapy for breast cancer; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND
The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND
Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

Compliance with Authority Required procedures

 

C6490

 

 

Chemotherapy-induced neutropenia
Patient must be receiving first-line chemotherapy for Hodgkin disease; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND
The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND
Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

Compliance with Authority Required procedures

 

C6494

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in an infant or child with central nervous system tumours.

Compliance with Authority Required procedures

                   (b)        omit:

 

C6512

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia.

Compliance with Authority Required procedures

                   (c)        omit:

 

C6521

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours.

Compliance with Authority Required procedures

                   (d)        omit:

 

C6543

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease.

Compliance with Authority Required procedures

 

C6546

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma.

Compliance with Authority Required procedures

 

C6622

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in rhabdomyosarcoma.

Compliance with Authority Required procedures

 

C6623

 

 

Assisting peripheral blood progenitor cell or bone marrow transplantation
The treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation.

Compliance with Authority Required procedures

 

C6633

 

 

Mobilisation of peripheral blood progenitor cells
The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy.

Compliance with Authority Required procedures

                   (e)        omit:

 

C6649

 

 

Mobilisation of peripheral blood progenitor cells

The treatment must be in a normal volunteer for use in allogeneic transplantation.

Compliance with Authority Required procedures

                    (f)        omit:

 

C6656

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Ewing's sarcoma.

Compliance with Authority Required procedures

                   (g)        omit:

 

C6663

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in osteosarcoma.

Compliance with Authority Required procedures

                   (h)        omit:

 

C6681

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin's lymphoma (intermediate or high grade).

Compliance with Authority Required procedures


 

                    (i)        insert in numerical order after existing text:

 

C9226

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in osteosarcoma.

Compliance with Authority Required procedures - Streamlined Authority Code 9226

 

C9227

 

 

Assisting peripheral blood progenitor cell or bone marrow transplantation
The treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation.

Compliance with Authority Required procedures - Streamlined Authority Code 9227

 

C9229

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease.

Compliance with Authority Required procedures - Streamlined Authority Code 9229

 

C9230

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in an infant or child with central nervous system tumours.

Compliance with Authority Required procedures - Streamlined Authority Code 9230

 

C9231

 

 

Mobilisation of peripheral blood progenitor cells
The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 9231

 

C9263

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours.

Compliance with Authority Required procedures - Streamlined Authority Code 9263

 

C9264

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin's lymphoma (intermediate or high grade).

Compliance with Authority Required procedures - Streamlined Authority Code 9264

 

C9265

 

 

Chemotherapy-induced neutropenia
Patient must be receiving standard dose adjuvant chemotherapy for breast cancer; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND
The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND
Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

Compliance with Authority Required procedures - Streamlined Authority Code 9265

 

C9266

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma.

Compliance with Authority Required procedures - Streamlined Authority Code 9266

 

C9314

 

 

Mobilisation of peripheral blood progenitor cells
The treatment must be in a normal volunteer for use in allogeneic transplantation.

Compliance with Authority Required procedures - Streamlined Authority Code 9314

 

C9324

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia.

Compliance with Authority Required procedures - Streamlined Authority Code 9324

 

C9325

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in rhabdomyosarcoma.

Compliance with Authority Required procedures - Streamlined Authority Code 9325

 

C9326

 

 

Chemotherapy-induced neutropenia
Patient must be receiving first-line chemotherapy for Hodgkin disease; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND
The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND
Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

Compliance with Authority Required procedures - Streamlined Authority Code 9326

 

C9327

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Ewing's sarcoma.

Compliance with Authority Required procedures - Streamlined Authority Code 9327

[159]        Schedule 4, Part 1, entry for Lipegfilgrastim

                   (a)        omit:

 

C7823

 

 

Chemotherapy-induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must be at greater than 20% risk of developing febrile neutropenia; OR
Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.

Compliance with Authority Required procedures

                   (b)        omit:

 

C7862

 

 

Chemotherapy-induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.

Compliance with Authority Required procedures

                   (c)        insert in numerical order after existing text:

 

C9224

 

 

Chemotherapy-induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must be at greater than 20% risk of developing febrile neutropenia; OR
Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.

Compliance with Authority Required procedures - Streamlined Authority Code 9224

 

C9322

 

 

Chemotherapy-induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.

Compliance with Authority Required procedures - Streamlined Authority Code 9322

[160]        Schedule 4, Part 1, entry for Macrogol 3350 

                   (a)        omit entry for purposes code “P6170” and substitute:

 

C6170

P6170

 

Constipation

Patient must be receiving palliative care.

Compliance with 
Authority Required 
procedures - 
Streamlined Authority 
Code 6170

                   (b)        omit entry for purposes code “P6171” and substitute:

 

C6171

P6171

 

Constipation

Patient must be receiving palliative care.

Compliance with 
Authority Required 
procedures - 
Streamlined Authority 
Code 6171

[161]        Schedule 4, Part 1, entry for Morphine

                           insert in numerical order after existing text:

 

C9248

 

 

Chronic Breathlessness
Patient must be receiving palliative care.

 


 

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

                   (a)        omit: 

 

C6070

 

 

Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 2
The condition must be negative for a BRAF V600 mutation; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 9 doses at a maximum dose of 3 mg per kg every 2 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 6070

 

C6095

 

 

Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 1
The condition must be positive for a BRAF V600 mutation; AND
The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) unless contraindicated or not tolerated according to the TGA approved Product Information; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a total of 9 doses at a maximum dose of 3 mg per kg every 2 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 6095

 

C6111

 

 

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

Compliance with Authority Required procedures - Streamlined Authority Code 6111

 

C6997

 

 

Locally advanced or metastatic non-small cell lung cancer
Grandfathering treatment
Patient must have received treatment with this drug for this condition prior to 1 August 2017; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
Patient must have stable or responding disease; AND
Patient must have a WHO performance status of 0 or 1.
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 - Streamlined Authority Code 6997

 

C6999

 

 

Locally advanced or metastatic non-small cell lung cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
Patient must have stable or responding disease.

Compliance with Authority Required procedures - Streamlined Authority Code 6999

 

C7567

 

 

Locally advanced or metastatic non-small cell lung cancer
Initial treatment
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 7567

 

C7787

 

 

Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must be the sole PBS-subsidised therapy for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 7787

 

C7802

 

 

Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Grandfather treatment
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 August 2018; AND
Patient must have had a WHO performance status of 0 or 1; AND
The condition must have progressed within 6 months of the last dose of prior platinum based chemotherapy, prior to commencing non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy 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.

Compliance with Authority Required procedures - Streamlined Authority Code 7802

 

C7864

 

 

Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Initial treatment
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must have progressed within 6 months of the last dose of prior platinum based chemotherapy; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor for this condition.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 7864

                   (b)        omit:

 

C8143

P8143

 

Unresectable Stage III or Stage IV malignant melanoma
Maintenance treatment
Patient must have previously received of up to maximum 4 doses of PBS-subsidised combined therapy with nivolumab and ipilimumab as induction for this condition; AND
The treatment must be as monotherapy for this condition; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
Maintenance treatment with nivolumab must not exceed a maximum dose of 3 mg per kg every 2 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 8143

                   (c)        omit:

 

C8552

 

 

Stage IV clear cell variant renal cell carcinoma (RCC)
Continuing treatment
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; AND
The treatment must be the sole PBS-subsidised therapy for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 8552

 

C8568

 

 

Stage IV clear cell variant renal cell carcinoma (RCC)
Maintenance treatment
Patient must have previously received of up to maximum 4 doses of PBS-subsidised combined therapy with nivolumab and ipilimumab as induction for this condition; AND
The treatment must be as monotherapy for this condition; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
Maintenance treatment with nivolumab must not exceed a maximum dose of 3 mg per kg every 2 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 8568

                   (d)        omit:

 

C8581

 

 

Stage IV clear cell variant renal cell carcinoma (RCC)
Initial Treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following prior treatment with a tyrosine kinase inhibitor; OR
Patient must have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 8581

                   (e)        insert in numerical order after existing text: 

 

C9214

 

 

Unresectable Stage III or Stage IV malignant melanoma
Maintenance treatment
Patient must have previously received of up to maximum 4 doses of PBS-subsidised combined therapy with nivolumab and ipilimumab as induction for this condition; AND
The treatment must be as monotherapy for this condition; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 9214

 

C9216

 

 

Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Initial treatment
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must have progressed within 6 months of the last dose of prior platinum based chemotherapy; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor for this condition.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.

Compliance with Authority Required procedures - Streamlined Authority Code 9216

 

C9217

 

 

Locally advanced or metastatic non-small cell lung cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
Patient must have stable or responding disease.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.

Compliance with Authority Required procedures - Streamlined Authority Code 9217

 

C9219

 

 

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

Compliance with Authority Required procedures - Streamlined Authority Code 9219

 

C9252

 

 

Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.

Compliance with Authority Required procedures - Streamlined Authority Code 9252

 

C9253

 

 

Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Grandfather treatment
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 August 2018; AND
Patient must have had a WHO performance status of 0 or 1; AND
The condition must have progressed within 6 months of the last dose of prior platinum based chemotherapy, prior to commencing non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy 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.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.

Compliance with Authority Required procedures - Streamlined Authority Code 9253

 

C9298

 

 

Unresectable Stage III or Stage IV malignant melanoma
Continuing treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have stable or responding disease.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.

Compliance with Authority Required procedures - Streamlined Authority Code 9298

 

C9299

 

 

Stage IV clear cell variant renal cell carcinoma (RCC)
Continuing treatment
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; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.

Compliance with Authority Required procedures - Streamlined Authority Code 9299

 

C9311

 

 

Locally advanced or metastatic non-small cell lung cancer
Grandfathering treatment
Patient must have received treatment with this drug for this condition prior to 1 August 2017; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
Patient must have stable or responding disease; AND
Patient must have a WHO performance status of 0 or 1.
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.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.

Compliance with Authority Required procedures - Streamlined Authority Code 9311

 

C9312

 

 

Stage IV clear cell variant renal cell carcinoma (RCC)
Initial Treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following prior treatment with a tyrosine kinase inhibitor; OR
Patient must have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.

Compliance with Authority Required procedures - Streamlined Authority Code 9312

 

C9320

 

 

Unresectable Stage III or Stage IV malignant melanoma
Initial treatment 2
The condition must be negative for a BRAF V600 mutation; AND
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The treatment must not exceed a dose of 3 mg/kg or 240 mg every two weeks or 480 mg every four weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.

Compliance with Authority Required procedures - Streamlined Authority Code 9320

 

C9321

 

 

Stage IV clear cell variant renal cell carcinoma (RCC)
Maintenance treatment
Patient must have previously received of up to maximum 4 doses of PBS-subsidised combined therapy with nivolumab and ipilimumab as induction for this condition; AND
The treatment must be as monotherapy for this condition; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 9321

 

C9331

 

 

Locally advanced or metastatic non-small cell lung cancer
Initial treatment
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.

Compliance with Authority Required procedures - Streamlined Authority Code 9331

[163]        Schedule 4, Part 1, entry for Octreotide

                   (a)        omit:

 

C5899

 

 

Vasoactive intestinal peptide secreting tumour (VIPoma)
Patient must have achieved symptom control on octreotide immediate release injections; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures

                   (b)        omit:

 

C5910

 

 

Functional carcinoid tumour
Patient must have achieved symptom control on octreotide immediate release injections; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures

                   (c)        omit:

 

C6388

 

 

Vasoactive intestinal peptide secreting tumour (VIPoma)
The condition must be causing intractable symptoms; AND
Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures


 

                   (d)        omit:

 

C6477

 

 

Functional carcinoid tumour
The condition must be causing intractable symptoms; AND
Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures

 

C8148

 

 

Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND
The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily; AND
The treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission

Compliance with Authority Required procedures

                   (e)        omit:

 

C8196

 

 

Acromegaly
The condition must be controlled with octreotide immediate release injections; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission

Compliance with Authority Required procedures

                    (f)        insert in numerical order after existing text:

 

C9232

 

 

Vasoactive intestinal peptide secreting tumour (VIPoma)
The condition must be causing intractable symptoms; AND
Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures - Streamlined Authority Code 9232

 

C9233

 

 

Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND
The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily; AND
The treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission

Compliance with Authority Required procedures - Streamlined Authority Code 9233

 

C9262

 

 

Acromegaly
The condition must be controlled with octreotide immediate release injections; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission

Compliance with Authority Required procedures - Streamlined Authority Code 9262

 

C9288

 

 

Vasoactive intestinal peptide secreting tumour (VIPoma)
Patient must have achieved symptom control on octreotide immediate release injections; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures - Streamlined Authority Code 9288

 

C9289

 

 

Functional carcinoid tumour
The condition must be causing intractable symptoms; AND
Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures - Streamlined Authority Code 9289

 

C9313

 

 

Functional carcinoid tumour
Patient must have achieved symptom control on octreotide immediate release injections; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures - Streamlined Authority Code 9313

[164]        Schedule 4, Part 1, omit entry for Ofatumumab

[165]        Schedule 4, Part 1, entry for Pamidronic acid

                   (a)        omit:

 

C4430

 

 

Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti-neoplastic therapy.

Compliance with Authority Required procedures

                   (b)        omit:

 

C5256

 

 

Multiple myeloma

Compliance with Authority Required procedures

 

C5257

 

 

Bone metastases

The condition must be due to breast cancer.

Compliance with Authority Required procedures

                   (c)        insert in numerical order after existing text:

 

C9234

 

 

Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti-neoplastic therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 9234

 

C9315

 

 

Bone metastases
The condition must be due to breast cancer.

Compliance with Authority Required procedures - Streamlined Authority Code 9315

 

C9335

 

 

Multiple myeloma

Compliance with Authority Required procedures - Streamlined Authority Code 9335

[166]        Schedule 4, Part 1, entry for Pazopanib

                   (a)        omit:

 

C4444

P4444

 

Advanced (unresectable and/or metastatic) soft tissue sarcoma
Initial treatment
Patient must have a WHO performance status of 2 or less; AND
Patient must have received prior chemotherapy treatment including an anthracycline; AND
Patient must not have received prior treatment with an angiogenesis inhibitor; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must not have any of the following conditions:
adipocytic soft tissue sarcoma;
gastrointestinal stromal tumour (GIST);
rhabdomyosarcoma other than alveolar or pleomorphic;
chondrosarcoma;
osteosarcoma;
Ewings tumour/primitive neuroectodermal tumour;
dermofibromatosis sarcoma protuberans;
inflammatory myofibroblastic sarcoma;
malignant mesothelioma;
mixed mesodermal tumour of the uterus.
The authority application must be made in writing.

Compliance with Written Authority Required procedures

                   (b)        omit: 

 

C7457

P7457

 

Stage IV clear cell variant renal cell carcinoma (RCC)
Initial treatment
Patient must have been receiving treatment with pazopanib prior to 1 October 2012; AND
The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.

Compliance with Authority Required procedures

                   (c)        omit:

 

C8551

P8551

 

Stage IV clear cell variant renal cell carcinoma (RCC)
Initial treatment
The condition must be classified as favourable to intermediate risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.
Patients who have progressive disease on sunitinib are not eligible to receive PBS-subsidised pazopanib.

Compliance with Authority Required procedures

                   (d)        insert in numerical order after existing text:

 

C9247

P9247

 

Advanced (unresectable and/or metastatic) soft tissue sarcoma
Initial treatment
Patient must have a WHO performance status of 2 or less; AND
Patient must have received prior chemotherapy treatment including an anthracycline; AND
Patient must not have received prior treatment with an angiogenesis inhibitor; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must not have any of the following conditions:
adipocytic soft tissue sarcoma;
gastrointestinal stromal tumour (GIST);
rhabdomyosarcoma other than alveolar or pleomorphic;
chondrosarcoma;
osteosarcoma;
Ewings tumour/primitive neuroectodermal tumour;
dermofibromatosis sarcoma protuberans;
inflammatory myofibroblastic sarcoma;
malignant mesothelioma;
mixed mesodermal tumour of the uterus.

Compliance with Authority Required procedures - Streamlined Authority Code 9247

 

C9281

P9281

 

Stage IV clear cell variant renal cell carcinoma (RCC)
Initial treatment
The condition must be classified as favourable to intermediate risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.
Patients who have progressive disease on sunitinib are not eligible to receive PBS-subsidised pazopanib.

Compliance with Authority Required procedures - Streamlined Authority Code 9281

[167]        Schedule 4, Part 1, entry for Pegfilgrastim

                   (a)        omit: 

 

C7823

 

 

Chemotherapy-induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must be at greater than 20% risk of developing febrile neutropenia; OR
Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.

Compliance with Authority Required procedures

                   (b)        omit: 

 

C7862

 

 

Chemotherapy-induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.

Compliance with Authority Required procedures

                   (c)        insert in numerical order after existing text:

 

C9235

 

 

Chemotherapy-induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must be at greater than 20% risk of developing febrile neutropenia; OR
Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.

Compliance with Authority Required procedures - Streamlined Authority Code 9235

 

C9303

 

 

Chemotherapy-induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.

Compliance with Authority Required procedures - Streamlined Authority Code 9303

[168]        Schedule 4, Part 1, entry for Plerixafor

                   (a)        omit: 

 

C4550

 

 

Mobilisation of haematopoietic stem cells
The treatment must be in combination with granulocyte-colony stimulating factor (G-CSF); AND
Patient must have lymphoma; OR
Patient must have multiple myeloma; AND
Patient must require autologous stem cell transplantation; AND
Patient must have failed previous stem cell collection; OR
Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per millilitre or less than 10 million per litre on the day of planned collection; OR
Patient must be undergoing chemotherapy plus G-CSF mobilisation and the first apheresis has yielded less than 1 million CD34+ cells/kg.
Evidence that the patient meets the PBS restriction criteria must be recorded in the patient's medical records.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text: 

 

C9329

 

 

Mobilisation of haematopoietic stem cells
The treatment must be in combination with granulocyte-colony stimulating factor (G-CSF); AND
Patient must have lymphoma; OR
Patient must have multiple myeloma; AND
Patient must require autologous stem cell transplantation; AND
Patient must have failed previous stem cell collection; OR
Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per millilitre or less than 10 million per litre on the day of planned collection; OR
Patient must be undergoing chemotherapy plus G-CSF mobilisation and the first apheresis has yielded less than 1 million CD34+ cells/kg.
Evidence that the patient meets the PBS restriction criteria must be recorded in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 9329

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

                   (a)        omit:

 

C8121

 

 

Severe growth hormone deficiency
Continuing treatment
Must be treated by an endocrinologist or in consultation with an endocrinologist.
Patient must have previously received PBS-subsidised therapy with this drug for this condition at the age of 18 years or older; AND
Patient must maintain IGF-1 levels within the normal range for age and sex; AND
Patient must maintain a quality of life (QoL) score on the Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA) instrument with a reduction of more than 7 points from baseline.
Patient must be aged 18 years or older.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
A serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application; AND
The patient's QoL score on the QoL-AGHDA instrument, including the date of testing, of less than 12 weeks old at the time of application.

Compliance with Written Authority Required procedures

 

C8242

 

 

Severe growth hormone deficiency
Initial treatment
Must be treated by an endocrinologist.
Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; OR
Patient must have adult onset growth hormone deficiency secondary to organic hypothalamic or pituitary disease; AND
Patient must have an insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; OR
Patient must have an arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; OR
Patient must have a glucagon provocation test with maximum serum GH less than 3 micrograms per litre; AND
Patient must have a quality of life (QoL) score on the Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA) instrument of 16 or greater.
Patient must be aged 18 years or older.
Grandfathered patient who has previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2018 must have met all the initial restriction criteria prior to initiating non-PBS subsidised treatment. Additional information of a baseline serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks prior to initiating non-PBS subsidised treatment with this drug for this condition; and QoL score on the QoL-AGHDA instrument of 16 or greater, of less than 12 weeks prior to initiating non-PBS-subsidised treatment with this drug for this condition must be provided at the time of application. A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
Confirmation of childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; OR
Confirmation of adult onset growth hormone deficiency due to organic hypothalamic or pituitary disease; AND
Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender; AND
A baseline serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application; AND
The patient's QoL score on the QoL-AGHDA instrument, including the date of testing, of less than 12 weeks old at the time of application.

Compliance with Written Authority Required procedures

                   (b)        omit:

 

C8381

 

 

Short stature due to short stature homeobox (SHOX) gene disorders
Continuing 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 due to short stature homeobox (SHOX) gene disorders; 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 diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had a growth velocity below the 25thpercentile 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 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 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 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 (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); 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 continuing treatment phase is 26 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 13 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 continuing treatment as a reclassified patient; AND
3. 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); AND
4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND
5. If the patient's condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient's increased risk of gonadoblastoma is in place; AND
6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be 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 13 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

 

C8382

 

 

Short stature due to short stature homeobox (SHOX) gene disorders
Continuing 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 due to short stature homeobox (SHOX) gene disorders; 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 diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had a growth velocity below the 25thpercentile 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 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 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 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 (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); 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 continuing treatment phase is 26 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 13 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 continuing treatment as a reclassified patient; AND
3. 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); AND
4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND
5. If the patient's condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient's increased risk of gonadoblastoma is in place; AND
6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be 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 13 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)        insert in numerical order after existing text:

 

C9221

 

 

Short stature due to short stature homeobox (SHOX) gene disorders
Continuing 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 due to short stature homeobox (SHOX) gene disorders; 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 diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; AND
Patient must have had a growth velocity below the 25thpercentile 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 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 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 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 (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); 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 continuing treatment phase is 26 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 13 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 continuing treatment as a reclassified patient; AND
3. 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); AND
4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND
5. If the patient's condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient's increased risk of gonadoblastoma is in place; AND
6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be 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 13 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

 

C9257

 

 

Short stature due to short stature homeobox (SHOX) gene disorders
Continuing 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 due to short stature homeobox (SHOX) gene disorders; 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 diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; AND
Patient must have had a growth velocity below the 25thpercentile 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 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 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 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 (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); 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 continuing treatment phase is 26 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 13 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 continuing treatment as a reclassified patient; AND
3. 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); AND
4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND
5. If the patient's condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient's increased risk of gonadoblastoma is in place; AND
6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be 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 13 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

 

C9300

 

 

Severe growth hormone deficiency
Initial treatment
Must be treated by an endocrinologist.
Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; OR
Patient must have adult onset growth hormone deficiency secondary to organic hypothalamic or pituitary disease; AND
Patient must have an insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; OR
Patient must have an arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; OR
Patient must have a glucagon provocation test with maximum serum GH less than 3 micrograms per litre.
Patient must be aged 18 years or older.
Grandfathered patient who has previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2018 must have met all the initial restriction criteria prior to initiating non-PBS subsidised treatment. Additional information of a baseline serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks prior to initiating non-PBS subsidised treatment with this drug for this condition must be provided at the time of application. A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
Confirmation of childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; OR
Confirmation of adult onset growth hormone deficiency due to organic hypothalamic or pituitary disease; AND
Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender; AND
A baseline serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application.

Compliance with Written Authority Required procedures

 

C9301

 

 

Severe growth hormone deficiency
Continuing treatment
Must be treated by an endocrinologist or in consultation with an endocrinologist.
Patient must have previously received PBS-subsidised therapy with this drug for this condition at the age of 18 years or older; AND
Patient must maintain IGF-1 levels within the normal range for age and sex.
Patient must be aged 18 years or older.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
A serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application.

Compliance with Written Authority Required procedures

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

                   (a)        omit:

 

C8549

P8549

 

Stage IV clear cell variant renal cell carcinoma (RCC)
Initial treatment
The condition must be classified as favourable to intermediate risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.
Patients who have developed progressive disease on pazopanib are not eligible to receive PBS-subsidised sunitinib.

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9210

P9210

 

Stage IV clear cell variant renal cell carcinoma (RCC)
Initial treatment
The condition must be classified as favourable to intermediate risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.
Patients who have developed progressive disease on pazopanib are not eligible to receive PBS-subsidised sunitinib.

Compliance with Authority Required procedures - Streamlined Authority Code 9210

[171]        Schedule 4, Part 1, entry for Thalidomide

                   (a)        omit:

 

C5909

 

 

Multiple myeloma

Compliance with Authority Required procedures

                   (b)        insert in numerical order after existing text:

 

C9290

 

 

Multiple myeloma

Compliance with Authority Required procedures - Streamlined Authority Code 9290

[172]        Schedule 4, Part 1, entry for Valaciclovir

                   (a)        omit:

 

C5939