National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 13) (No. PB 101 of 2014)

Link to law: https://www.comlaw.gov.au/Details/F2014L01780

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now
PB 101 of 2014
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 13)
National Health Act 1953
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits 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   17 December 2014
 
 
 
 
 
 
 
 
 
 
 
FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health
 
1          Name of Instrument
            (1)        This Instrument is the National Health (Listing of Pharmaceutical                            Benefits) Amendment Instrument 2014 (No. 13).
            (2)        This Instrument may also be cited as PB 101 of 2014.
2          Commencement
This Instrument commences on 1 January 2015.
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 Amlodipine in each of the forms: Tablet 5 mg (as besylate); and Tablet 10 mg (as besylate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Amlodipine
CR
MP NP
 
 
30
5
30
 
 
[2]           Schedule 1, entry for Ampicillin in the form Powder for injection 1 g (as sodium)
omit from the column headed “Brand”:       Aspen Ampicyn (twice occurring)               substitute:             Ampicyn
[3]           Schedule 1, entry for Baclofen in the form Tablet 25 mg
omit:
 
 
 
Terry White Chemists Baclofen
TW
MP NP
 
 
100
5
100
 
 
[4]           Schedule 1, entry for Canagliflozin in each of the forms: Tablet 100 mg (as hemihydrate); and Tablet 300 mg (as hemihydrate)
omit from the column headed “Circumstances”:        C4321   substitute:             C4770
[5]           Schedule 1, entry for Cetuximab in each of the forms: Solution for I.V. infusion 100 mg in 20 mL; and Solution for I.V. infusion 500 mg
in 100 mL
omit from the column headed “Circumstances”:        C4468  C4477  C4511  C4532     insert in numerical order:                 C4771  C4775  C4779  C4780
[6]           Schedule 1, entry for Clarithromycin in the form Tablet 250 mg
omit from the column headed “Responsible Person” for the brand “Klacid” (twice occurring):                AB          substitute:                GO
[7]           Schedule 1, entry for Clarithromycin in each of the forms: Tablet 500 mg; and Powder for oral liquid 250 mg per 5 mL, 50 mL
omit from the column headed “Responsible Person”:             AB          substitute:             GO
[8]           Schedule 1, entry for Cromoglycic Acid in the form Eye drops containing sodium cromoglycate 20 mg per mL, 10 mL
omit:
 
 
 
Cromolux
AE
MP NP AO
C1466
 
1
5
1
 
 
[9]           Schedule 1, entry for Docetaxel
(a)      omit:
 
Powder for I.V. infusion 20 mg with solvent
Injection
Docetaxel SUN
ZF
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
 
(b)      omit:
 
Powder for I.V. infusion 80 mg with solvent
Injection
Docetaxel SUN
ZF
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[10]         Schedule 1, after entry for Eltrombopag in the form Tablet 50 mg (as olamine)
insert:
Empagliflozin
Tablet 10 mg
Oral
Jardiance
BY
MP NP
C4770
 
30
5
30
 
 

 
Tablet 25 mg
Oral
Jardiance
BY
MP NP
C4770
 
30
5
30
 
 

[11]         Schedule 1, entry for Epoetin Lambda
omit from the column headed “Responsible Person” (all instances):                 NV          substitute:             SZ
[12]         Schedule 1, entry for Eprosartan in each of the forms: Tablet 400 mg (as mesylate); and Tablet 600 mg (as mesylate)
omit from the column headed “Responsible Person”:             AB          substitute:             GO
[13]         Schedule 1, entry for Eprosartan with Hydrochlorothiazide
omit from the column headed “Responsible Person”:             AB          substitute:             GO
[14]         Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [Maximum Quantity: 30; Number of Repeats: 1]
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Esomeprazole Actavis
GN
MP NP
C1337 C1629 C2273 C3429
P2273
30
1
30
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Esomeprazole Apotex
TX
MP NP
C1337 C1629 C2273 C3429
P2273
30
1
30
 
 
[15]         Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [Maximum Quantity: 30; Number of Repeats: 5]
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Esomeprazole Actavis
GN
MP NP
C1337 C1629 C2273 C3429
P1337 P1629 P3429
30
5
30
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Esomeprazole Apotex
TX
MP NP
C1337 C1629 C2273 C3429
P1337 P1629 P3429
30
5
30
 
 
 
[16]         Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [Maximum Quantity: 30; Number of Repeats: 1]
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Esomeprazole Actavis
GN
MP NP
C1337 C1628 C3429
P1628
30
1
30
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Esomeprazole Apotex
TX
MP NP
C1337 C1628 C3429
P1628
30
1
30
 
 
[17]         Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [Maximum Quantity: 30; Number of Repeats: 5]
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Esomeprazole Actavis
GN
MP NP
C1337 C1628 C3429
P1337 P3429
30
5
30
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Esomeprazole Apotex
TX
MP NP
C1337 C1628 C3429
P1337 P3429
30
5
30
 
 
[18]         Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Maximum Quantity: 1;
Number of Repeats: 3]
(a)      omit from the column headed “Circumstances”:            C3708  C3772  C3773
(b)      insert in numerical order:       C4676  C4766  C4777  C4778  C4782
(c)      omit from the column headed “Purposes”:       P3708  P3772
(d)      insert in numerical order:       P4766  P4777  P4782
[19]         Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Maximum Quantity: 1;
Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:            C3708  C3772  C3773
(b)      insert in numerical order:       C4676  C4766  C4777  C4778  C4782
(c)      omit from the column headed “Purposes”:       P3773
(d)      insert in numerical order:       P4676  P4778
[20]         Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Maximum Quantity: 1;
Number of Repeats: 3]
(a)      omit from the column headed “Circumstances”:            C3708  C3772  C3773
(b)      insert in numerical order:       C4676  C4766  C4777  C4778  C4782
(c)      omit from the column headed “Purposes”:       P3708  P3772
(d)      insert in numerical order:       P4766  P4777  P4782
 
[21]         Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Maximum Quantity: 1;
Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:            C3708  C3772  C3773
(b)      insert in numerical order:       C4676  C4766  C4777  C4778  C4782
(c)      omit from the column headed “Purposes”:       P3773
(d)      insert in numerical order:       P4676  P4778
[22]         Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes
solvent 1 mL [Maximum Quantity: 2; Number of Repeats: 3]
(a)      omit from the column headed “Circumstances”:            C3708  C3772  C3773
(b)      insert in numerical order:       C4676  C4766  C4777  C4778  C4782
(c)      omit from the column headed “Purposes”:       P3708  P3772
(d)      insert in numerical order:       P4766  P4777  P4782
[23]         Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes
solvent 1 mL [Maximum Quantity: 2; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:            C3708  C3772  C3773
(b)      insert in numerical order:       C4676  C4766  C4777  C4778  C4782
(c)      omit from the column headed “Purposes”:       P3773
(d)      insert in numerical order:       P4676  P4778
[24]         Schedule 1, after entry for Ezetimibe
insert:
Ezetimibe and rosuvastatin
Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 5 mg (as calcium)
Oral
Rosuzet Composite Pack
MK
MP NP
C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 C4147
 
1
5
1
 
 

 
Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 10 mg (as calcium)
Oral
Rosuzet Composite Pack
MK
MP NP
C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121
 
1
5
1
 
 

 
Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 20 mg (as calcium)
Oral
Rosuzet Composite Pack
MK
MP NP
C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121
 
1
5
1
 
 

 
Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 40 mg (as calcium)
Oral
Rosuzet Composite Pack
MK
MP NP
C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121
 
1
5
1
 
 

[25]         Schedule 1, entry for Fenofibrate in each of the forms: Tablet 48 mg; and Tablet 145 mg
omit from the column headed “Responsible Person”:             AB          substitute:             GO
[26]         Schedule 1, entry for Fluvoxamine in each of the forms: Tablet containing fluvoxamine maleate 50 mg; and Tablet containing fluvoxamine maleate 100 mg
omit from the column headed “Responsible Person” for the brand “Luvox”:      AB          substitute:             GO
[27]         Schedule 1, entry for Glucose Indicator—Blood in the form Test strips, 50 (CareSens)
omit from the column headed “Responsible Person”:             LB          substitute:             PB
[28]         Schedule 1, entry for Glucose Indicator—Blood in the form Test strips, 50 (CareSens N)
omit from the column headed “Responsible Person”:             LB          substitute:             PB
[29]         Schedule 1, entry for Ibuprofen
omit from the column headed “Responsible Person”:             AB          substitute:             GO
[30]         Schedule 1, entry for Lercanidipine in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg; and Tablet containing lercanidipine hydrochloride 20 mg
omit from the column headed “Responsible Person” for the brand “Zanidip”:   AB          substitute:             GO
[31]         Schedule 1, entry for Lercanidipine with enalapril in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg with enalapril maleate 10 mg; and Tablet containing lercanidipine hydrochloride 10 mg with enalapril maleate 20 mg
omit from the column headed “Responsible Person”:             AB          substitute:             GO
[32]         Schedule 1, entry for Levonorgestrel with Ethinyloestradiol in the form Pack containing 21 tablets 150 micrograms-30 micrograms and
7 inert tablets
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Eleanor 150/30 ED
EA
MP NP
 
 
4
2
4
 
 
[33]         Schedule 1, entry for Lignocaine
omit:
 
Injection containing lignocaine hydrochloride 100 mg in 5 mL
Injection
Pfizer Australia Pty Ltd
PF
MP NP PDP
 
 
5
0
5
 
 
[34]         Schedule 1, entry for Macrogol 3350 in the form Oral liquid 13.125 g with electrolytes, 500 mL
omit from the column headed “Form”:           13.125 g with electrolytes            substitute:             13.125 g in 25 mL with electrolytes
[35]         Schedule 1, entry for Moxonidine in each of the forms: Tablet 200 micrograms; and Tablet 400 micrograms
omit from the column headed “Responsible Person”:             AB          substitute:             GO
[36]         Schedule 1, entry for Nifedipine in the form Tablet 20 mg
omit:
 
 
 
Nifehexal
SZ
MP NP
 
 
60
5
60
 
 
 
[37]         Schedule 1, entry for Oestradiol in the form Tablet 2 mg
omit from the column headed “Responsible Person”:             AB          substitute:             GO
[38]         Schedule 1, after entry for Oestradiol in the form Transdermal patches 1.56 mg, 8
insert in the columns in the order indicated:
 
Pessary (modified release) 10 micrograms (as hemihydrate)
Vaginal
Vagifem Low
NO
MP NP
 
 
18
2
18
 
 
[39]         Schedule 1, entry for Oestradiol and Oestradiol with Dydrogesterone in each of the forms: Pack containing 14 tablets oestradiol 1 mg and 14 tablets oestradiol 1 mg with dydrogesterone 10 mg; and Pack containing 14 tablets oestradiol 2 mg and 14 tablets oestradiol 2 mg with dydrogesterone 10 mg
omit from the column headed “Responsible Person”:             AB          substitute:             GO
[40]         Schedule 1, entry for Oestradiol with dydrogesterone
omit from the column headed “Responsible Person”:             AB          substitute:             GO
[41]         Schedule 1, entry for Pancreatic Extract in the form Capsule (containing enteric coated minimicrospheres) providing not less than 10,000 BP units of lipase activity
omit from the column headed “Responsible Person”:             AB          substitute:             GO
[42]         Schedule 1, entry for Pancreatic Extract in the form Capsule (containing enteric coated minimicrospheres) providing not less than 25,000 BP units of lipase activity [Maximum Quantity: 200; Number of Repeats: 10]
omit from the column headed “Responsible Person”:             AB          substitute:             GO
[43]         Schedule 1, entry for Pancreatic Extract in the form Capsule (containing enteric coated minimicrospheres) providing not less than 40,000 BP units of lipase activity [Maximum Quantity: 200; Number of Repeats: 10]
omit from the column headed “Responsible Person”:             AB          substitute:             GO
[44]         Schedule 1, entry for Pancreatic Extract in the form Granules (enteric coated) providing not less than 5,000 BP units of lipase activity per 100 mg, 20 g
omit from the column headed “Responsible Person”:             AB          substitute:             GO
[45]         Schedule 1, entry for Panitumumab in each of the forms: Solution concentrate for I.V. infusion 100 mg in 5 mL; and Solution concentrate for I.V. infusion 400 mg in 20 mL
omit from the column headed “Circumstances”:        C4462  C4498  C4530  C4543     substitute:             C4774  C4776  C4783  C4784
[46]         Schedule 1, entry for Paracetamol in the form Tablet 665 mg (modified release) [Maximum Quantity: 192; Number of Repeats: 0]
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Osteo Paracetamol 665 mg
TX
MP NP
C2094 C3649 C3650
P3650
192
0
96
 
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Blooms the Chemist Osteo Pain Relief Paracetamol 665 mg
IB
MP NP
C2094 C3649 C3650
P3650
192
0
96
 
 
(c)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Chem mart Pharmacy Osteo Relief Paracetamol 665 mg
CH
MP NP
C2094 C3649 C3650
P3650
192
0
96
 
 
(d)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terry White Chemists Osteo Relief Paracetamol 665 mg
TW
MP NP
C2094 C3649 C3650
P3650
192
0
96
 
 
[47]         Schedule 1, entry for Paracetamol in the form Tablet 665 mg (modified release) [Maximum Quantity: 192; Number of Repeats: 3]
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Osteo Paracetamol 665 mg
TX
MP NP
C2094 C3649 C3650
P3649
192
3
96
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Blooms the Chemist Osteo Pain Relief Paracetamol 665 mg
IB
MP NP
C2094 C3649 C3650
P3649
192
3
96
 
 
(c)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Chem mart Pharmacy Osteo Relief Paracetamol 665 mg
CH
MP NP
C2094 C3649 C3650
P3649
192
3
96
 
 
 
(d)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terry White Chemists Osteo Relief Paracetamol 665 mg
TW
MP NP
C2094 C3649 C3650
P3649
192
3
96
 
 
[48]         Schedule 1, entry for Paracetamol in the form Tablet 665 mg (modified release) [Maximum Quantity: 192; Number of Repeats: 5]
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Osteo Paracetamol 665 mg
TX
MP NP
C2094 C3649 C3650
P2094
192
5
96
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Blooms the Chemist Osteo Pain Relief Paracetamol 665 mg
IB
MP NP
C2094 C3649 C3650
P2094
192
5
96
 
 
(c)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Chem mart Pharmacy Osteo Relief Paracetamol 665 mg
CH
MP NP
C2094 C3649 C3650
P2094
192
5
96
 
 
(d)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terry White Chemists Osteo Relief Paracetamol 665 mg
TW
MP NP
C2094 C3649 C3650
P2094
192
5
96
 
 
[49]         Schedule 1, entry for Phenoxybenzamine in each of the forms: Capsule containing phenoxybenzamine hydrochloride 10 mg; Capsule containing 10 mg phenoxybenzamine hydrochloride; and Capsules containing phenoxybenzamine hydrochloride 10 mg, 30
omit from the column headed “Circumstances”:        C1239  C1285    substitute:             C4772  C4781
[50]         Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 125 micrograms [Maximum Quantity: 30; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pramipexole GH
GQ
MP NP
C3216
 
30
0
30
 
 
 
[51]         Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 250 micrograms [Maximum Quantity: 100; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pramipexole GH
GQ
MP NP
C3216
 
100
5
100
 
 
[52]         Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 1 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pramipexole GH
GQ
MP NP
C3216
 
100
5
100
 
 
[53]         Schedule 1, entry for Raloxifene
omit:
 
 
 
Raloxifene AN
EA
MP NP
C4071
 
28
5
28
 
 
[54]         Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 5 mg
omit from the column headed “Responsible Person”:             SW         substitute:             UA
[55]         Schedule 1, entry for Risedronic Acid in the form Tablet (enteric coated) containing risedronate sodium 35 mg
omit from the column headed “Responsible Person”:             SW         substitute:             UA
[56]         Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 150 mg
omit from the column headed “Responsible Person” for the brand “Actonel Once-a-Month”:                   SW         substitute:                UA
[57]         Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 30 mg
omit from the column headed “Responsible Person”:             SW         substitute:             UA
[58]         Schedule 1, entry for Risedronic Acid and Calcium in the form Pack containing 4 enteric coated tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate)
(a)      omit from the column headed “Responsible Person” for the brand “Actonel EC Combi”:                 SW       substitute:    UA
(b)      omit:
 
 
 
Risedronate Winthrop  EC Combi
WA
MP NP
C4122 C4123 C4133
 
1
5
1
 
 
[59]         Schedule 1, entry for Risedronic acid and calcium with colecalciferol
(a)      omit from the column headed “Responsible Person” for the brand “Actonel EC Combi D”:              SW       substitute:    UA
(b)      omit:
 
 
 
Risedronate Winthrop  EC Combi D
WA
MP NP
C4122 C4123 C4133
 
1
5
1
 
 
 
[60]         Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Risperidone Actavis 0.5
UA
MP NP
C1589 C2061 C3083
P2061 P3083
60
2
60
 
 
[61]         Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Risperidone Actavis 0.5
UA
MP NP
C1589 C2061 C3083
P1589
60
5
60
 
 
[62]         Schedule 1, entry for Risperidone in the form Tablet 1 mg [Maximum Quantity: 60; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Risperidone Actavis 1
UA
MP NP
C1589 C2061 C2272 C3083
P2061 P3083
60
2
60
 
 
[63]         Schedule 1, entry for Risperidone in the form Tablet 1 mg [Maximum Quantity: 60; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Risperidone Actavis 1
UA
MP NP
C1589 C2061 C2272 C3083
P1589 P2272
60
5
60
 
 
[64]         Schedule 1, entry for Sapropterin in the form Tablet (soluble) containing sapropterin dihydrochloride 100 mg [Maximum Quantity: 180; Number of Repeats: 0]
omit from the column headed “Circumstances”:          C4548    substitute:             C4773
[65]         Schedule 1, entry for Sapropterin in the form Tablet (soluble) containing sapropterin dihydrochloride 100 mg [Maximum Quantity: 180; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:            C4548   substitute:          C4773
(b)      omit from the column headed “Purposes”:       P4548   substitute:          P4773
[66]         Schedule 1, entry for Sildenafil
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
SILDENAFIL-DRx
RZ
MP
See Note 1
See Note 3
See Note 3
See Note 3
See
Note 3
90
 
D(100)
[67]         Schedule 1, entry for Sodium Chloride in the form I.V. infusion 154 mmol per L. 1 L
omit from the column headed “Form”:           per L. 1 L         substitute:             per L, 1 L
[68]         Schedule 1, entry for Sodium Chloride in the form I.V. infusion 154 mmol per L, 1 L [Maximum Quantity: 5; Number of Repeats: 1]
(a)      omit from the column headed “Brand”:           Baxter Healthcare Pty Ltd
(b)      omit from the column headed “Responsible Person”:     BX
 
[69]         Schedule 1, entry for Sodium Chloride
omit:
 
I.V. infusion 513 mmol per L, 1 L
Injection
Baxter Healthcare Pty Ltd
BX
PDP
 
 
2
0
1
 
 

 
 
 
 
 
MP NP
 
 
2
1
1
 
 

[70]         Schedule 1, omit entry for Sodium Chloride Compound
[71]         Schedule 1, entry for Sodium Chloride with Glucose
omit:
 
I.V. infusion 19 mmol‑104 mmol (anhydrous) per 500 mL, 500 mL
Injection
Baxter Healthcare Pty Ltd
BX
PDP
 
 
5
0
1
 
 

 
 
 
 
 
MP NP
 
 
5
1
1
 
 

 
I.V. infusion 39 mmol‑69 mmol (anhydrous) per 500 mL, 500 mL
Injection
Baxter Healthcare Pty Ltd
BX
PDP
 
 
5
0
1
 
 

 
 
 
 
 
MP NP
 
 
5
1
1
 
 

[72]         Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Maximum Quantity: 42; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terbinafine AN
EA
MP NP
C2191 C2865 C3244
P2865 P3244
42
0
42
 
 
[73]         Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Maximum Quantity: 42; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terbinafine AN
EA
MP NP
C2191 C2865 C3244
P2191
42
1
42
 
 
[74]         Schedule 1, entry for Trandolapril in each of the forms: Capsule 500 micrograms; Capsule 1 mg; Capsule 2 mg; and Capsule 4 mg
omit from the column headed “Responsible Person” for the brand “Gopten”:    AB          substitute:             GO
[75]         Schedule 1, entry for Trandolapril with Verapamil in each of the forms: Tablet containing trandolapril 2 mg with verapamil hydrochloride 180 mg (sustained release); and Tablet containing trandolapril 4 mg with verapamil hydrochloride 240 mg (sustained release)
omit from the column headed “Responsible Person”:             AB          substitute:             GO
[76]         Schedule 1, entry for Verapamil in the form Tablet containing verapamil hydrochloride 80 mg
omit from the column headed “Responsible Person” for the brand “Isoptin”:    AB          substitute:             GO
[77]         Schedule 1, entry for Verapamil in the form Tablet containing verapamil hydrochloride 180 mg (sustained release)
omit from the column headed “Responsible Person” for the brand “Cordilox 180 SR”:   KN          substitute:             GT
[78]          Schedule 1, entry for Verapamil in the form Tablet containing verapamil hydrochloride 180 mg (sustained release)
omit from the column headed “Responsible Person” for the brand “Isoptin 180 SR”:      AB          substitute:             GO
[79]         Schedule 1, entry for Verapamil in the form Tablet containing verapamil hydrochloride 240 mg (sustained release)
omit from the column headed “Responsible Person” for the brand “Cordilox SR”:         KN          substitute:             GT
[80]          Schedule 1, entry for Verapamil in the form Tablet containing verapamil hydrochloride 240 mg (sustained release)
omit from the column headed “Responsible Person” for the brand “Isoptin SR”:                        AB          substitute:             GO
[81]         Schedule 3, after details relevant to Responsible Person code GN
insert:
GO
BGP Products Pty Ltd
 29 601 608 771
[82]         Schedule 3, after details relevant to Responsible Person code GQ
insert:
GT
BGP Products Pty Ltd
 29 601 608 771
[83]         Schedule 3
omit:
KN
Abbott Australasia Pty Ltd
 95 000 180 389
[84]         Schedule 3
omit:
LB
Life Bioscience Pty Ltd
13 108 135 191
[85]         Schedule 3, after details relevant to Responsible Person code OZ
insert:
PB
Pharmaco (Australia) Limited
 89 113 383 501
[86]         Schedule 4, Part 1, entry for Canagliflozin
substitute:
Canagliflozin
C4770
 
 
Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
The condition must not be able to be adequately controlled by treatment with metformin and a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co- transporter 2 (SGLT2) inhibitor; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records
Compliance with Authority Required procedures

[87]         Schedule 4, Part 1, entry for Cetuximab
(a)      omit:

 
C4468
 
 
Where the patient is receiving treatment at/from a Public Hospital
Metastatic colorectal cancer
Initial treatment
Patient must have KRAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have failed to respond to first-line chemotherapy; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab
Compliance with Authority Required procedures – Streamlined Authority Code 4468


 
C4477
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Metastatic colorectal cancer
Initial treatment
Patient must have KRAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have failed to respond to first-line chemotherapy; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab
Compliance with Authority Required procedures


 
C4511
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Metastatic colorectal cancer
Continuing treatment
Patient must have received an initial authority prescription for cetuximab for treatment of K-RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND
Patient must not have progressive disease; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab
Compliance with Authority Required procedures


 
C4532
 
 
Where the patient is receiving treatment at/from a Public Hospital
Metastatic colorectal cancer
Continuing treatment
Patient must have received an initial authority prescription for cetuximab for treatment of K-RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND
Patient must not have progressive disease; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab
Compliance with Authority Required procedures – Streamlined Authority Code 4532


(b)      insert in numerical order following existing text:

 
C4771
 
 
Where the patient is receiving treatment at/from a Public Hospital
Metastatic colorectal cancer
Continuing treatment
Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND
Patient must not have progressive disease; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab
Compliance with Authority Required procedures - Streamlined Authority Code 4771


 
C4775
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Metastatic colorectal cancer
Initial treatment
Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have failed to respond to first-line chemotherapy; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab
Compliance with Authority Required procedures


 
C4779
 
 
Where the patient is receiving treatment at/from a Public Hospital
Metastatic colorectal cancer
Initial treatment
Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have failed to respond to first-line chemotherapy; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab
Compliance with Authority Required procedures - Streamlined Authority Code 4779


 
 
C4780
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Metastatic colorectal cancer
Continuing treatment
Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND
Patient must not have progressive disease; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab
Compliance with Authority Required procedures

[88]         Schedule 4, Part 1, after entry for Eletriptan
insert:
Empagliflozin
C4770
 
 
Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
The condition must not be able to be adequately controlled by treatment with metformin and a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co- transporter 2 (SGLT2) inhibitor; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records
Compliance with Authority Required procedures

[89]         Schedule 4, Part 1, entry for Etanercept
(a)      omit:

 
C3708
P3708
 
Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 24 months)
Initial PBS‑subsidised treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS‑subsidised treatment with a biological disease modifying anti‑rheumatic drug (bDMARD) for this condition in the previous 24 months; and
(c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA‑approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA‑approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS‑subsidised treatment with etanercept for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS‑subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 16 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of initial treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C3772
P3772
 
Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS‑subsidised treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS‑subsidised treatment with etanercept for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS‑subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS‑subsidised treatment with rituximab and who wish to transfer to treatment with etanercept are not eligible to commence treatment with etanercept until they have completed a period free from PBS‑subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form;
where a patient has received PBS‑subsidised treatment with etanercept and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient’s most recent course of PBS‑subsidised etanercept treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS‑subsidised etanercept treatment is a 16‑week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 16 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of initial treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C3773
P3773
 
Rheumatoid arthritis — continuing treatment
Continuing PBS‑subsidised treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with etanercept; and
(c) whose most recent course of PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment was with etanercept; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of etanercept therapy is a 16‑week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment is limited to a maximum of 24 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of continuing treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

(b)      insert in numerical order following existing text:

 
C4676
P4676
 
Severe active rheumatoid arthritis
Continuing Treatment – balance of supply
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
Compliance with Written or Telephone Authority Required procedures


 
C4766
P4766
 
Severe active rheumatoid arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
Compliance with Written or Telephone Authority Required procedures


 
C4777
P4777
 
Severe active rheumatoid arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)
Patient must have severe active rheumatoid arthritis; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND
Patient must not have failed previous PBS-subsidised treatment with this drug for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction
Patient must be aged 18 years or older
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab
If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement
Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied
Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response
Compliance with Written Authority Required procedures


 
C4778
P4778
 
Severe active rheumatoid arthritis
Continuing treatment
Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction
Patient must be aged 18 years or older
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form
All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition
Compliance with Written Authority Required procedures


 
C4782
P4782
 
Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months)
Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND
Patient must not receive more than 16 weeks of treatment under this restriction
Patient must be aged 18 years or older
Must be treated by a rheumatologist; OR
*Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form
Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
If a patient fails to demonstrate a response to a treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug for this condition
A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
Compliance with Written Authority Required procedures


[90]         Schedule 4, Part 1, after entry for Ezetimibe
insert:

Ezetimibe and rosuvastatin
C4068
 
 
Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have coronary heart disease
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4068


 
C4069
 
 
Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have heterozygous familial hypercholesterolaemia
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4069


 
C4085
 
 
Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have diabetes mellitus
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4085


 
C4086
 
 
Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have peripheral vascular disease
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4086


 
C4096
 
 
Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have symptomatic cerebrovascular disease
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4096


 
C4097
 
 
Hypercholesterolaemia
Patient must have homozygous familial hypercholesterolaemia; AND
Patient must be eligible for PBS-subsidised lipid-lowering medication (according to the criteria set out in the General Statement for Lipid-Lowering Drugs)
Compliance with Authority Required procedures - Streamlined Authority Code 4097

 
C4120
 
 
Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have a family history of coronary heart disease
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4120


 
C4121
 
 
Hypercholesterolaemia
The treatment must be in conjunction with dietary therapy and exercise; AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have hypertension
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4121


 
C4147
 
 
Hypercholesterolaemia
Patient must be eligible for PBS-subsidised lipid-lowering medication (according to the criteria set out in the General Statement for Lipid-Lowering Drugs); AND
Patient must have developed a clinically important product-related adverse event during treatment with an HMG CoA reductase inhibitor (statin) necessitating a reduction in the statin dose
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin
Compliance with Authority Required procedures - Streamlined Authority Code 4147


[91]         Schedule 4, Part 1, entry for Panitumumab
substitute:

Panitumumab
C4774
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Metastatic colorectal cancer
Continuing treatment
Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND
Patient must not have progressive disease; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab
Compliance with Authority Required procedures


 
C4776
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Metastatic colorectal cancer
Initial treatment
Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have failed to respond to first-line chemotherapy; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab
Compliance with Authority Required procedures


 
C4783
 
 
Where the patient is receiving treatment at/from a Public Hospital
Metastatic colorectal cancer
Continuing treatment
Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND
Patient must not have progressive disease; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab
Compliance with Authority Required procedures - Streamlined Authority Code 4783


 
C4784
 
 
Where the patient is receiving treatment at/from a Public Hospital
Metastatic colorectal cancer
Initial treatment
Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have failed to respond to first-line chemotherapy; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab
Compliance with Authority Required procedures - Streamlined Authority Code 4784


[92]         Schedule 4, Part 1, entry for Phenoxybenzamine
substitute:

Phenoxybenzamine
C4772
 
 
Phaeochromocytoma

Compliance with Authority Required procedures

 
C4781
 
 
Neurogenic urinary retention

Compliance with Authority Required procedures

[93]         Schedule 4, Part 1, entry for Sapropterin
omit:
 
C4548
P4548
 
Hyperphenylalaninaemia
Continuing treatment
Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND
Patient must have demonstrated a 30% or greater reduction in blood phenylalanine levels in response to treatment with sapropterin; OR
Patient must have accessed non-PBS-subsidised treatment prior to 1 May 2014
Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured
The authority application must be made in writing
Compliance with Written Authority Required procedures
substitute:
 
C4773
P4773
 
Hyperphenylalaninaemia
Continuing treatment
Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND
Patient must have previously been issued with an authority prescription for this drug; OR
Patient must have accessed non-PBS-subsidised treatment prior to 1 May 2014
Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured
The authority application must be made in writing
Compliance with Written Authority Required procedures

[94]         Schedule 4, Part 1, entry for Teriparatide
omit from the column headed “Circumstances Code”:               4113       substitute:             C4113