National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 3) - PB 17 of 2014

Link to law: https://www.comlaw.gov.au/Details/F2014L00342

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PB 17 of 2014
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 3)
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 21 March 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. 3).
            (2)        This Instrument may also be cited as PB 17 of 2014.
2          Commencement
This Instrument commences on 1 April 2014.
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 Abacavir in each of the forms: Tablet 300 mg (as sulfate); and Oral solution 20 mg (as sulfate) per mL, 240 mL
omit from the column headed “Circumstances”:          C3586  C3587  C3588  C3589     substitute:          C4454  C4455  C4469  C4512
[2]           Schedule 1, entry for Abacavir with Lamivudine
omit from the column headed “Circumstances”:          C3590  C3591  C3592  C3593     substitute:          C4505  C4527  C4528  C4538
[3]           Schedule 1, entry for Abacavir with Lamivudine and Zidovudine
omit from the column headed “Circumstances”:          C3979  C3980  C3981  C3982     substitute:          C4472  C4480  C4495  C4523
[4]           Schedule 1, entry for Acitretin in each of the forms: Capsule 10 mg; and Capsule 25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Novatin
IA
MP
C1363 C1366
 
100
2
100
 
 
[5]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2;
Number of Repeats: 2]
(a)      omit from the column headed “Circumstances”:               C3520  C3522
(b)      omit from the column headed “Circumstances”:               C3743  C3744
(c)      insert in numerical order:       C4492  C4501  C4517  C4518  C4531
[6]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2;
Number of Repeats: 3]
(a)      omit from the column headed “Circumstances”:               C3520  C3522
(b)      omit from the column headed “Circumstances”:               C3743  C3744
(c)      insert in numerical order:       C4492  C4501  C4517  C4518  C4531
(d)      omit from the column headed “Purposes”:         P3520
(e)      omit from the column headed “Purposes”:         P3743
(f)       insert in numerical order:       P4492  P4501  P4518
[7]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2;
Number of Repeats: 4]
(a)      omit from the column headed “Circumstances”:               C3520  C3522
(b)      omit from the column headed “Circumstances”:               C3743  C3744
(c)      insert in numerical order:       C4492  C4501  C4517  C4518  C4531
 
[8]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2;
Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:               C3520  C3522
(b)      omit from the column headed “Circumstances”:               C3743  C3744
(c)      insert in numerical order:       C4492  C4501  C4517  C4518  C4531
(d)      omit from the column headed “Purposes”:         P3522
(e)      omit from the column headed “Purposes”:         P3744
(f)       insert in numerical order:       P4517  P4531
[9]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2;
Number of Repeats: 2]
(a)      omit from the column headed “Circumstances”:               C3520  C3522
(b)      omit from the column headed “Circumstances”:               C3743  C3744
(c)      insert in numerical order:       C4492  C4501  C4517  C4518  C4531
[10]         Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2;
Number of Repeats: 3]
(a)      omit from the column headed “Circumstances”:               C3520  C3522
(b)      omit from the column headed “Circumstances”:               C3743  C3744
(c)      insert in numerical order:       C4492  C4501  C4517  C4518  C4531
(d)      omit from the column headed “Purposes”:         P3520
(e)      omit from the column headed “Purposes”:         P3743
(f)       insert in numerical order:       P4492  P4501  P4518
[11]         Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2;
Number of Repeats: 4]
(a)      omit from the column headed “Circumstances”:               C3520  C3522
(b)      omit from the column headed “Circumstances”:               C3743  C3744
(c)      insert in numerical order:       C4492  C4501  C4517  C4518  C4531
[12]         Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2;
Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:               C3520  C3522
(b)      omit from the column headed “Circumstances”:               C3743  C3744
(c)      insert in numerical order:       C4492  C4501  C4517  C4518  C4531
(d)      omit from the column headed “Purposes”:         P3522
(e)      omit from the column headed “Purposes”:         P3744
(f)       insert in numerical order:       P4517  P4531
 
[13]         Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Alendronate plus D3-DRLA
RZ
MP NP
C4122 C4123 C4133
 
4
5
4
 
 
[14]         Schedule 1, entry for Atazanavir in each of the forms: Capsule 100 mg (as sulfate); Capsule 150 mg (as sulfate); Capsule 200 mg (as sulfate); and Capsule 300 mg (as sulfate)
omit from the column headed “Circumstances”:          C3586  C3587  C3588  C3589     substitute:          C4454  C4455  C4469  C4512
[15]         Schedule 1, entry for Azathioprine in the form Tablet 25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Azathioprine
TX
MP NP
 
 
100
5
100
 
 
[16]         Schedule 1, after entry for Calcipotriol with betamethasone in the form Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g
insert in the columns in the order indicated:
 
Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 60 g
Application
Daivobet 50/500 gel
LO
MP NP
C4506
 
1
1
1
 
 
[17]         Schedule 1, entry for Carbomer in the form Eye gel 2 mg per g, 10 g [Maximum Quantity: 1; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Optifresh eye gel
PP
MP
C1362 C3036
P1362
1
5
1
 
 

 
 
 
 
 
NP AO
C1362
 
1
5
1
 
 

[18]         Schedule 1, entry for Carbomer in the form Eye gel 2 mg per g, 10 g [Maximum Quantity: 1; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Optifresh eye gel
PP
MP
C1362 C3036
P3036
1
11
1
 
 
[19]         Schedule 1, entry for Carmellose in the form Eye drops containing carmellose sodium 5 mg per mL, single dose units 0.4 mL, 30
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Optifresh Tears
PP
MP NP
C1359
 
3
5
1
 
 

 
 
 
 
 
AO
C2802
 
3
5
1
 
 

[20]         Schedule 1, entry for Carmellose in the form Eye drops containing carmellose sodium 10 mg per mL, single dose units 0.4 mL, 30
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Optifresh Plus
PP
MP NP
C1359
 
3
5
1
 
 

 
 
 
 
 
AO
C2802
 
3
5
1
 
 

[21]         Schedule 1, entry for Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate) [Maximum Quantity: 10;
Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Cefaclor CD
TX
PDP
 
 
10
0
10
 
 
[22]         Schedule 1, entry for Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate) [Maximum Quantity: 10;
Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Cefaclor CD
TX
MP
 
 
10
1
10
 
 
[23]         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
(a)      omit from the column headed “Circumstances”:            C3843  C3844  C3903  C3904
(b)      insert in numerical order:       C4468  C4477  C4511  C4532
[24]         Schedule 1, after entry for Clindamycin
insert:
Clobetasol
Shampoo containing clobetasol propionate 500 micrograms per mL, 125 mL
Application
Clobex
GA
MP
C4507
 
1
1
1
 
 
[25]         Schedule 1, entry for Denosumab in the form Injection 120 mg in 1.7 mL
insert in numerical order in the column headed “Circumstances”:         C4504 
[26]         Schedule 1, entry for Didanosine in each of the forms: Capsule 125 mg (containing enteric coated beadlets); Capsule 200 mg (containing enteric coated beadlets); Capsule 250 mg (containing enteric coated beadlets); and Capsule 400 mg (containing enteric coated beadlets)
omit from the column headed “Circumstances”:          C3586  C3587  C3588  C3589     substitute:          C4454  C4455  C4469  C4512
[27]         Schedule 1, after entry for Docosahexaenoic acid with carbohydrate
insert:
Dolutegravir
Tablet 50 mg (as sodium)
Oral
Tivicay
VI
MP
See Note 1
C4454 C4455 C4469 C4512
 
60
5
30
 
D(100)
 
[28]         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
omit from the column headed “Brand”:         Lipodox           substitute:          Liposomal Doxorubicin SUN
[29]         Schedule 1, entry for Doxorubicin – Pegylated Liposomal in the form Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL
omit from the column headed “Brand”:         Lipodox 50       substitute:          Liposomal Doxorubicin SUN
[30]         Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity: 21; Number of Repeats: 0]
omit from the column headed “Purposes” (all instances):         P1459   substitute:          P4485
[31]         Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity: 28; Number of Repeats: 0]
omit from the column headed “Purposes” (all instances):         P1279   substitute:          P4514
[32]         Schedule 1, entry for Doxycycline in each of the forms: Tablet 50 mg (as monohydrate); Tablet 50 mg (as hydrochloride); and
Capsule 50 mg (as hydrochloride) (containing enteric coated pellets)
omit from the column headed “Circumstances” (all instances):               C1346  C1851  C1852    substitute:          C4475  C4529  C4539 
[33]         Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as hydrochloride) [Maximum Quantity: 21; Number of Repeats: 0]
omit from the column headed “Purposes” (all instances):         P1459   substitute:          P4485
[34]         Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as hydrochloride) [Maximum Quantity: 28; Number of Repeats: 0]
omit from the column headed “Purposes” (all instances):         P1279   substitute:          P4514
[35]         Schedule 1, entry for Doxycycline in the form Capsule 100 mg (as hydrochloride) (containing enteric coated pellets)
[Maximum Quantity: 21; Number of Repeats: 0]
omit from the column headed “Purposes” (twice occurring):    P1459   substitute:          P4485
[36]         Schedule 1, entry for Doxycycline in the form Capsule 100 mg (as hydrochloride) (containing enteric coated pellets)
[Maximum Quantity: 28; Number of Repeats: 0]
omit from the column headed “Purposes” (twice occurring):    P1279   substitute:          P4514
[37]         Schedule 1, entry for Efavirenz in each of the forms: Tablet 200 mg; Tablet 600 mg; and Oral solution 30 mg per mL, 180 mL
omit from the column headed “Circumstances”:          C3586  C3587  C3588  C3589     substitute:          C4454  C4455  C4469  C4512
[38]         Schedule 1, entry for Emtricitabine
omit from the column headed “Circumstances”:          C3586  C3587  C3588  C3589     substitute:          C4454  C4455  C4469  C4512
[39]         Schedule 1, entry for Erlotinib in each of the forms: Tablet 25 mg (as hydrochloride); Tablet 100 mg (as hydrochloride); and
Tablet 150 mg (as hydrochloride)
omit from the column headed “Circumstances”:          C4362  C4386  C4387  C4403  C4406      substitute:             C4473  C4481  C4525  C4536  C4537
 
[40]         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”:               C3524
(b)      omit from the column headed “Circumstances”:               C3770  C3771
(c)      insert in numerical order:       C4457  C4458  C4482  C4483  C4503
(d)      omit from the column headed “Purposes”:         P3524
(e)      omit from the column headed “Purposes”:         P3770
(f)       insert in numerical order:       P4458  P4483  P4503
[41]         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”:               C3524
(b)      omit from the column headed “Circumstances”:               C3770  C3771
(c)      insert in numerical order:       C4457  C4458  C4482  C4483  C4503
(d)      omit from the column headed “Purposes”:         P3771
(e)      insert in numerical order:       P4457  P4482 
[42]         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”:               C3524
(b)      omit from the column headed “Circumstances”:               C3770  C3771
(c)      insert in numerical order:       C4457  C4458  C4482  C4483  C4503
(d)      omit from the column headed “Purposes”:         P3524
(e)      omit from the column headed “Purposes”:         P3770
(f)       insert in numerical order:       P4458  P4483  P4503
[43]         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”:               C3524
(b)      omit from the column headed “Circumstances”:               C3770  C3771
(c)      insert in numerical order:       C4457  C4458  C4482  C4483  C4503
(d)      omit from the column headed “Purposes”:         P3771
(e)      insert in numerical order:       P4457  P4482 
 
[44]         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”:               C3524
(b)      omit from the column headed “Circumstances”:               C3770  C3771
(c)      insert in numerical order:       C4457  C4458  C4482  C4483  C4503
(d)      omit from the column headed “Purposes”:         P3524
(e)      omit from the column headed “Purposes”:         P3770
(f)       insert in numerical order:       P4458  P4483  P4503
[45]         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”:               C3524
(b)      omit from the column headed “Circumstances”:               C3770  C3771
(c)      insert in numerical order:       C4457  C4458  C4482  C4483  C4503
(d)      omit from the column headed “Purposes”:         P3771
(e)      insert in numerical order:       P4457  P4482 
[46]         Schedule 1, entry for Fluconazole in the form Solution for I.V. infusion 200 mg in 100 mL
omit:
 
 
 
Baxter Healthcare Pty Ltd
BX
MP NP
C3613 C3614 C3615 C3616 C3617 C3618
 
7
0
1
 
[47]         Schedule 1, entry for Fluconazole in the form Solution for I.V. infusion 400 mg in 200 mL
omit:
 
 
 
Baxter Healthcare Pty Ltd
BX
MP NP
C3613 C3614 C3615 C3616 C3617 C3618
 
1
0
1
 
[48]         Schedule 1, entry for Flutamide
omit:
 
Tablet 250 mg, 30
Oral
Flutamide MYLAN
AF
MP NP
C3674
 
3
5
1
 
 
[49]         Schedule 1, entry for Fosamprenavir in each of the forms: Tablet 700 mg (as calcium); and Oral liquid 50 mg (as calcium) per mL, 225 mL
omit from the column headed “Circumstances”:          C3586  C3587  C3588  C3589     substitute:          C4454  C4455  C4469  C4512
[50]         Schedule 1, entry for Gefitinib
omit from the column headed “Circumstances”:          C4384  C4387    substitute:          C4473  C4474
 
[51]         Schedule 1, after entry for Glycomacropeptide and essential amino acids with vitamins and minerals in the form Sachets containing oral powder 49 g, 28 (Camino Pro Bettermilk)
insert:
Glycopyrronium
Capsule containing powder for oral inhalation 50 micrograms (as bromide) (for use in Breezhaler)
Inhalation by mouth
seebri breezhaler
NV
MP NP
C4516
 
30
5
30
 
 
[52]         Schedule 1, entry for Homatropine
omit from the column headed “Authorised Prescriber”:             MP NP  substitute:          MP NP AO
[53]         Schedule 1, entry for Hydrocortisone in the form Rectal foam containing hydrocortisone acetate 90 mg per applicatorful, 14 applications, aerosol 21.1 g
omit from the column headed “Responsible Person”:                 AS        substitute:          HM
[54]         Schedule 1, entry for Indinavir
omit from the column headed “Circumstances”:          C3586  C3587  C3588  C3589     substitute:          C4454  C4455  C4469  C4512
[55]         Schedule 1, entry for Infliximab
substitute:
Infliximab
Powder for I.V. infusion 100 mg
Injection
Remicade
JC
MP
See Note 1
See Note 3
See Note 3
See Note 3
See
Note 3
1
 
D(100)

 
 
 
 
 
MP
See Note 1
C4524 C4535
P4535
1
1
1
 
D(100)

 
 
 
 
 
MP
See Note 1
C4524 C4535
P4524
5
1
1
 
D(100)

[56]         Schedule 1, entry for Irinotecan in each of the forms: I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL;
I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL; I.V. injection containing irinotecan hydrochloride trihydrate
300 mg in 15 mL; and I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL
omit from the column headed “Circumstances” (all instances):               C3184
[57]         Schedule 1, entry for Lamivudine in each of the forms: Tablet 150 mg; and Tablet 300 mg
omit from the column headed “Circumstances” (all instances):               C3586  C3587  C3588  C3589     substitute:            C4454  C4455  C4469  C4512
[58]         Schedule 1, entry for Lamivudine in the form Oral solution 10 mg per mL, 240 mL
omit from the column headed “Circumstances”:          C3586  C3587  C3588  C3589     substitute:          C4454  C4455  C4469  C4512
[59]         Schedule 1, entry for Lamivudine with Zidovudine
omit from the column headed “Circumstances” (twice occurring):          C3586  C3587  C3588  C3589     substitute:            C4454  C4455  C4469  C4512
 
[60]         Schedule 1, entry for Leuprorelin in each of the forms: Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 7.5 mg, injection set; Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 22.5 mg, injection set; Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 30 mg, injection set; and Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 45 mg, injection set
omit from the column headed “Responsible Person”:                 HH        substitute:          TL
[61]         Schedule 1, entry for Linagliptin
omit from the column headed “Circumstances”:          C4350   substitute:          C4488 
[62]         Schedule 1, entry for Lopinavir with Ritonavir in each of the forms: Tablet 100 mg-25 mg; Tablet 200 mg-50 mg; and
Oral liquid 400 mg-100 mg per 5 mL, 60 mL
omit from the column headed “Circumstances”:          C3586  C3587  C3588  C3589     substitute:          C4454  C4455  C4469  C4512
[63]         Schedule 1, entry for Metoclopramide in the form Tablet containing metoclopramide hydrochloride 10 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Metoclopramide
TX
MP NP MW PDP
 
 
25
0
25
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metoclopramide Actavis
GN
MP NP MW PDP
 
 
25
0
25
 
 
[64]         Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metoprolol Actavis
GN
MP NP
 
 
100
5
100
 
 
[65]         Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metoprolol Actavis
GN
MP NP
 
 
60
5
60
 
 
[66]         Schedule 1, entry for Misoprostol
omit from the column headed “Circumstances”:          C4266   substitute:          C4463
[67]         Schedule 1, entry for Morphine
omit:
 
Injection containing morphine sulphate 10 mg in 1 mL (with preservative)
Injection
Morphine Sulphate Wockhardt
HH
MP NP MW PDP
 
10
0
10
 
 
[68]         Schedule 1, entry for Nevirapine in the form Tablet 200 mg
omit from the column headed “Circumstances” (all instances):               C3586  C3587  C3588  C3589     substitute            C4454  C4455  C4469  C4512
[69]         Schedule 1, entry for Nevirapine in the form Tablet 400 mg (extended release)
omit from the column headed “Circumstances”:          C3587  C3589  C3994  C3995       substitute:          C4454  C4460  C4469  C4526
[70]         Schedule 1, entry for Nevirapine in the form Oral suspension 50 mg (as hemihydrate) per 5 mL, 240 mL
omit from the column headed “Circumstances”:          C3586  C3587  C3588  C3589     substitute:          C4454  C4455  C4469  C4512
[71]         Schedule 1, after entry for Nicotine in the form Transdermal patch 35 mg
insert in the columns in the order indicated:
 
Transdermal patch 39.4 mg
Transdermal
nicorette 16hr Invisipatch
JT
MP NP
C4307 C4344 C4348
 
28
2
28
 
 
[72]         Schedule 1, entry for Oxaliplatin in each of the forms: Solution concentrate for I.V. infusion 50 mg in 10 mL; Powder for I.V. infusion
50 mg; I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL; Solution concentrate for I.V. infusion 100 mg in
20 mL; Powder for I.V. infusion 100 mg; and Solution concentrate for I.V. infusion 200 mg in 40 mL
omit from the column headed “Circumstances” (all instances):               C3900  C3901  C3930  C3939
[73]         Schedule 1, entry for Oxycodone
omit:
 
Tablet containing oxycodone hydrochloride 5 mg (controlled release)
Oral
OxyContin
MF
MP NP
C1062
 
28
0
28
 
[74]         Schedule 1, after entry for Pancrelipase
insert:
Panitumumab
Solution concentrate for I.V. infusion 100 mg in 5 mL
Injection
Vectibix
AN
MP
C4462 C4498 C4530 C4543
See Note 3
See Note 3
See
Note 3
1
 
D(100)
[75]         Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg
omit:
 
 
 
GenRx Perindopril
GX
MP NP
 
30
5
30
 
[76]         Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg
omit:
 
 
 
GenRx Perindopril
GX
MP NP
 
30
5
30
 
 
[77]         Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg
omit:
 
 
 
GenRx Perindopril
GX
MP NP
 
30
5
30
 
[78]         Schedule 1, entry for Raltegravir in the form Tablet 400 mg (as potassium)
omit from the column headed “Circumstances”:          C3586  C3587  C3588  C3589     substitute:          C4454  C4455  C4469  C4512
[79]         Schedule 1, entry for Rilpivirine
omit from the column headed “Circumstances”:          C3586  C3587  C3588  C3589     substitute:          C4454  C4455  C4469  C4512
[80]         Schedule 1, entry for Ritonavir in each of the forms: Tablet 100 mg; and Oral solution 600 mg per 7.5 mL (80 mg per mL), 90 mL
omit from the column headed “Circumstances”:          C3586  C3587  C3588  C3589     substitute:          C4454  C4455  C4469  C4512
[81]         Schedule 1, entry for Salbutamol in each of the forms: Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30;
and Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Salbutamol
TX
MP NP
C1754 C1755
 
2
5
1
 
 
[82]         Schedule 1, entry for Saquinavir
omit from the column headed “Circumstances”:          C3586  C3587  C3588  C3589     substitute:          C4454  C4455  C4469  C4512
[83]         Schedule 1, entry for Saxagliptin
omit from the column headed “Circumstances”:          C4350   substitute:          C4520 
[84]         Schedule 1, entry for Sitagliptin in each of the forms: Tablet 25 mg (as phosphate monohydrate); Tablet 50 mg
(as phosphate monohydrate); and Tablet 100 mg (as phosphate monohydrate)
omit from the column headed “Circumstances”:          C4350   substitute:          C4519 
[85]         Schedule 1, entry for Sitagliptin with metformin in each of the forms: Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 500 mg metformin hydrochloride; Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 850 mg metformin hydrochloride; and Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride
omit from the column headed “Circumstances”:          C4325   substitute:          C4423
[86]         Schedule 1, omit entry for Sitagliptin with simvastatin
[87]         Schedule 1, entry for Stavudine in each of the forms: Capsule 20 mg; Capsule 30 mg; and Capsule 40 mg
omit from the column headed “Circumstances”:          C3586  C3587  C3588  C3589     substitute:          C4454  C4455  C4469  C4512
[88]         Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 5; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances” (all instances):    C2100  
(b)      insert in numerical order:       C4496 
 
[89]         Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 15; Number of Repeats: 2]
(a)      omit from the column headed “Circumstances” (all instances):    C2100  
(b)      insert in numerical order:       C4496 
(c)      omit from the column headed “Purposes” (all instances):           P2100   substitute:             P4496
[90]         Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 5; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances” (all instances):    C2100  
(b)      insert in numerical order:       C4496 
[91]         Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 15; Number of Repeats: 2]
(a)      omit from the column headed “Circumstances” (all instances):    C2100  
(b)      insert in numerical order:       C4496 
(c)      omit from the column headed “Purposes” (all instances):           P2100   substitute:             P4496
[92]         Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 5; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances” (all instances):    C2100  
(b)      insert in numerical order:       C4496 
[93]         Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 15; Number of Repeats: 2]
(a)      omit from the column headed “Circumstances” (all instances):    C2100  
(b)      insert in numerical order:       C4496 
(c)      omit from the column headed “Purposes” (all instances):           P2100   substitute:             P4496
[94]         Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 5; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances” (all instances):    C2100  
(b)      insert in numerical order:       C4496 
[95]         Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 15; Number of Repeats: 2]
(a)      omit from the column headed “Circumstances” (all instances):    C2100  
(b)      insert in numerical order:       C4496 
(c)      omit from the column headed “Purposes” (all instances):           P2100   substitute:             P4496
[96]         Schedule 1, entry for Temozolomide
omit:
 
Capsule 180 mg
Oral
Astromide
GN
MP
C1736 C1737 C2101
 
5
5
5
 

 
 
 
Orion Temozolomide
ON
MP
C1736 C1737 C2101
 
5
5
5
 
 

 
 
 
Temodal
MK
MP
C1736 C1737 C2101
 
5
5
5
 
 

 
substitute:
 
Capsule 180 mg
Oral
Astromide
GN
MP
C1736 C1737 C2101 C4496
P1736 P1737 P2101
5
5
5
 

 
 
 
Orion Temozolomide
ON
MP
C1736 C1737 C2101 C4496
P1736 P1737 P2101
5
5
5
 
 

 
 
 
Temodal
MK
MP
C1736 C1737 C2101 C4496
P1736 P1737 P2101
5
5
5
 
 

 
 
 
Astromide
GN
MP
C1736 C1737 C2101 C4496
P4496
15
2
5
 
 

 
 
 
Orion Temozolomide
ON
MP
C1736 C1737 C2101 C4496
P4496
15
2
5
 
 

 
 
 
Temodal
MK
MP
C1736 C1737 C2101 C4496
P4496
15
2
5
 
 

[97]         Schedule 1, entry for Tenofovir
omit all codes from the column headed “Circumstances” and substitute:          
C4454  C4455  C4469  C4476  C4489  C4490  C4499  C4509  C4510  C4512  C4544  C4545
[98]         Schedule 1, entry for Tenofovir with Emtricitabine
omit from the column headed “Circumstances”:          C3586  C3587  C3588  C3589     substitute:          C4454  C4455  C4469  C4512
[99]         Schedule 1, entry for Tenofovir with emtricitabine and efavirenz
omit from the column headed “Circumstances”:          C3983  C3984  C3985  C3986     substitute:          C4470  C4494  C4522  C4533 
[100]       Schedule 1, entry for Tenofovir with Emtricitabine and Rilpivirine
omit from the column headed “Circumstances”:          C3983  C3984  C3985  C3986     substitute:          C4470  C4494  C4522  C4533 
[101]       Schedule 1, entry for Testosterone in the form Subcutaneous implant 200 mg
omit from the column headed “Brand”:         Schering-Plough Pty Limited   substitute:          Merck Sharp & Dohme (Australia) Pty Ltd
[102]       Schedule 1, after entry for Tobramycin in the form Injection 500 mg (as sulfate) in 5 mL (without preservative)
insert in the columns in the order indicated:
 
Capsule containing powder for oral inhalation 28 mg (for use in podhaler)
Inhalation by mouth
TOBI podhaler
NV
MP
C4456 C4513
P4456
224
0
224
 
 

 
 
 
 
 
MP
C4456 C4513
P4513
224
2
224
 
 

[103]       Schedule 1, entry for Tropisetron
omit:
 
Capsule 5 mg (as hydrochloride)
Oral
Navoban
NV
MP NP
See Note 1
C3050
 
2
0
2
 
 
[104]       Schedule 1, entry for Tropisetron in the form I.V. injection 5 mg (as hydrochloride) in 5 mL
omit:
 
 
 
Navoban
NV
MP NP
See Note 1
C3050
 
1
0
1
 
[105]       Schedule 1, entry for Vildagliptin
omit from the column headed “Circumstances”:          C4350   substitute:          C4467 
[106]       Schedule 1, entry for Vildagliptin with metformin in each of the forms: Tablet containing 50 mg vildagliptin with 500 mg metformin hydrochloride; Tablet containing 50 mg vildagliptin with 850 mg metformin hydrochloride; and Tablet containing 50 mg vildagliptin with 1000 mg metformin hydrochloride
omit from the column headed “Circumstances”:          C4325   substitute:          C4423
[107]       Schedule 1, entry for Zidovudine in each of the forms: Capsule 100 mg; Capsule 250 mg; and Syrup 10 mg per mL, 200 mL
omit from the column headed “Circumstances”:          C3586  C3587  C3588  C3589     substitute:          C4454  C4455  C4469  C4512
[108]       Schedule 3, after details relevant to Responsible Person code TK
insert:
TL
Tolmar Australia Pty Ltd
 53 162 640 708
[109]       Schedule 4, Part 1, entry for Abacavir
substitute:

Abacavir
C4454
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512


[110]       Schedule 4, Part 1, entry for Abacavir with Lamivudine
substitute:

Abacavir with Lamivudine
C4505
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures


 
C4527
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4527


 
C4528
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4528


 
C4538
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures


[111]       Schedule 4, Part 1, entry for Abacavir with Lamivudine and Zidovudine
substitute:

Abacavir with Lamivudine and Zidovudine
C4472
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures


 
C4480
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4480


 
C4495
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4495


 
C4523
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures


[112]       Schedule 4, Part 1, entry for Adalimumab
(a)      omit:

 
C3520
P3520
 
Juvenile idiopathic arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 12 months)
Initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:
(a) has a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) has received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and
(c) has failed 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 per day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means adalimumab or etanercept; 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) an active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder, cervical spine 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 application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient whose previous treatment cycle was ceased due to their failure to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is eligible to commence a new treatment cycle with an initial course of adalimumab provided a minimum of 5 years have elapsed between the date of the last approval for PBS-subsidised bDMARD therapy in their previous treatment cycle and the date of the first application under the new treatment cycle;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with adalimumab 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

 
C3522
P3522
 
Juvenile idiopathic arthritis — initial treatment 3
Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:
(a) has a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) was receiving treatment with adalimumab prior to 1 March 2010; and
(c) has demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and
(d) is receiving treatment with adalimumab at the time of application; and
where the following conditions apply: the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
the course of treatment is limited to a maximum of 24 weeks of treatment;
a patient is eligible for PBS-subsidised treatment under the above criteria once only
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who was receiving non-PBS-subsidised treatment with adalimumab prior to 1 March 2010 and at the time of the initial application for PBS-subsidised therapy, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab 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)      omit:

 
C3743
P3743
 
Juvenile idiopathic arthritis — initial treatment 2
(change or recommencement after a break of less than 12 months)
Initial PBS-subsidised treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:
(a) has a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or etanercept for this condition; and
(c) has not failed PBS-subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with adalimumab in this treatment cycle 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 adalimumab 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 adalimumab treatment is a 16 week initial treatment course, is made following a minimum of 12 weeks of therapy;
a patient who has failed to respond to treatment with adalimumab and etanercept 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with adalimumab 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

 
C3744
P3744
 
Juvenile idiopathic arthritis — continuing treatment
Continuing PBS-subsidised treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older:
(a) who has a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) who has demonstrated an adequate response to treatment with adalimumab; and
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with adalimumab; and
where bDMARD means adalimumab or etanercept; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) 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
(b) either of the following:
(i) an active joint count of fewer than 10 active (swollen and tender) joints; or
(ii) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(iii) a reduction in the number of the following 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, cervical spine 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 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 Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab;
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 adalimumab 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 patient who has failed to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of continuing treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab 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

(c)      insert in numerical order following existing text:

 
C4492
P4492
 
Severe active juvenile idiopathic arthritis
Initial treatment ― Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; OR
Patient must have received no PBS-subsidised bDMARD treatment for at least 5 years if they failed or ceased to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) in their last treatment cycle, AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction;
Patient must be aged 18 years or older;
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 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab
If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement
If a patient fails to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle. A patient may re-trial adalimumab after a minimum of 5 years have elapsed between the date of the last approval for PBS-subsidised bDMARD therapy in the last treatment cycle and the date of the first application under a new treatment cycle
Compliance with Written Authority Required procedures


 
C4501
P4501
 
Severe active juvenile idiopathic arthritis
Initial treatment ― Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply
Patient must have received insufficient adalimumab therapy under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient adalimumab therapy under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions
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


 
C4517
P4517
 
Severe active juvenile idiopathic arthritis
Continuing treatment ― balance of supply
Patient must have received insufficient adalimumab therapy under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction
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


 
C4518
P4518
 
Severe active juvenile idiopathic arthritis
Initial treatment ― Initial 2 (change or recommencement of treatment after break of less than 24 months)
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have received prior PBS-subsidised treatment with adalimumab, etanercept or tocilizumab for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with adalimumab for this condition in the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction;
Patient must be aged 18 years or older;
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 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form
Applications for a patient who has received PBS-subsidised treatment with adalimumab in this treatment cycle and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised adalimumab treatment, within the timeframes specified below
Where the most recent course of PBS-subsidised adalimumab treatment was approved under either of the Initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased
Where the most recent course of PBS-subsidised adalimumab treatment was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with adalimumab
If a patient fails to respond to PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following:
(a) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
Compliance with Written Authority Required procedures


 
C4531
P4531
 
Severe active juvenile idiopathic arthritis
Continuing treatment
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have demonstrated an adequate response to treatment with adalimumab; AND
Patient must have received adalimumab as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction;
Patient must be aged 18 years or older
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 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following:
(a) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form
All applications for continuing treatment with adalimumab must include a measurement of response to the prior course of therapy
This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with adalimumab, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with adalimumab
If a patient fails to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle
Compliance with Written Authority Required procedures


[113]       Schedule 4, Part 1, entry for Atazanavir
substitute:

Atazanavir
C4454
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512


[114]       Schedule 4, Part 1, entry for Calcipotriol with betamethasone
insert in numerical order following existing text:
 
C4506
 
 
Chronic stable plaque type psoriasis vulgaris
The condition must be on the patient's scalp; AND
The condition must be inadequately controlled with either a vitamin D analogue or potent topical corticosteroid as monotherapy; AND
Patient must require more than 30 grams of the product per month
Compliance with Authority Required procedures

[115]       Schedule 4, Part 1, entry for Carbomer with Triglyceride Lipids [Circumstances Code: C3036; Purposes Code: P3036]
omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)”:                 C3036
[116]       Schedule 4, Part 1, entry for Cetuximab
(a)      omit:

 
C3843
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Initial PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with a World Health Organisation performance status of 2 or less and with K-RAS wild type metastatic colorectal cancer after failure of first-line chemotherapy
Compliance with Authority Required procedures

 
C3844
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Continuing PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with K-RAS wild type metastatic colorectal cancer who has previously been issued with an authority prescription for cetuximab and who does not have progressive disease
Compliance with Authority Required procedures

 
C3903
 
 
Where the patient is receiving treatment at/from a Public Hospital
Initial PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with a World Health Organisation performance status of 2 or less and with K-RAS wild type metastatic colorectal cancer after failure of first-line chemotherapy
Compliance with Authority Required procedures - Streamlined Authority Code 3903

 
C3904
 
 
Where the patient is receiving treatment at/from a Public Hospital
Continuing PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with K-RAS wild type metastatic colorectal cancer who has previously been issued with an authority prescription for cetuximab and who does not have progressive disease
Compliance with Authority Required procedures - Streamlined Authority Code 3904

(b)      insert in numerical order following existing text:

 
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


[117]       Schedule 4, Part 1, after entry for Clindamycin
insert:
Clobetasol
C4507
 
 
Moderate to severe scalp psoriasis
The condition must be inadequately controlled with either a vitamin D analogue or potent topical corticosteroid as monotherapy; OR
The condition must be inadequately controlled with combination use of a vitamin D analogue and potent topical corticosteroid
Patient must be aged 18 years or older
Compliance with Authority Required procedures

[118]       Schedule 4, Part 1, entry for Denosumab
insert in numerical order following existing text:
 
C4504
 
 
Giant cell tumour of bone
Patient must be one in whom surgical resection is not feasible; OR
Patient must be one in whom surgical resection is possible but surgery would result in significant morbidity;
Patient must be an adult; OR
Patient must be a skeletally mature adolescent
Compliance with Authority Required procedures - Streamlined Authority Code 4504
[119]       Schedule 4, Part 1, entry for Didanosine
substitute:

Didanosine
C4454
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512


[120]       Schedule 4, Part 1, after entry for Docosahexaenoic acid with carbohydrate
insert:

Dolutegravir
C4454
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512

[121]       Schedule 4, Part 1, entry for Doxycycline
substitute:

Doxycycline
C4475
 
 
Chronic bronchitis
Patient must be aged 8 years or older
 

 
 
P4485
 
Urethritis
 

 
 
P4514
 
Pelvic inflammatory disease
 

 
C4529
 
 
Severe acne
 

 
C4539
 
 
Bronchiectasis
Patient must be aged 8 years or older
 

[122]       Schedule 4, Part 1, entry for Efavirenz
substitute:

Efavirenz
C4454
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512


[123]       Schedule 4, Part 1, entry for Emtricitabine
substitute:

Emtricitabine
C4454
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512


[124]       Schedule 4, Part 1, entry for Erlotinib
substitute:

Erlotinib
C4473
 
 
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must not have received previous PBS-subsidised treatment with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI); OR
Patient must have developed intolerance to another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal; AND
Patient must have a WHO performance status of 2 or less
Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material
Compliance with Authority Required procedures


 
C4481
 
 
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy; AND
Patient must not have received previous PBS-subsidised treatment with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI); OR
Patient must have developed intolerance to another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal; AND
Patient must have failed prior therapy which included a platinum compound; AND
Patient must have a WHO performance status of 3 or less; AND
The condition must have progressed following treatment with docetaxel or pemetrexed; OR
Patient must have a contraindication or intolerance to treatment with docetaxel and pemetrexed; AND
Patient must not be able to receive further chemotherapy subsidised by the PBS or from other sources following treatment with erlotinib
Patient must have a wild type epidermal growth factor receptor (EGFR) gene; OR
Patient must have an epidermal growth factor receptor (EGFR) gene of unknown type
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Non-Small Cell Lung Cancer Erlotinib Authority Application - Supporting Information Form, which includes:
(i) evidence that the patient has been treated with platinum-based chemotherapy; AND
(ii) evidence that disease progression has occurred following treatment with docetaxel or pemetrexed. In patients in whom docetaxel or pemetrexed is contraindicated or cannot be tolerated the prescriber must state the reasons for intolerance or the contraindication; AND
(iii) a declaration from the prescriber that the patient has exhausted all opportunities for treatment with chemotherapy either on the PBS, through special access schemes or in a clinical trial; and
(3) a signed patient acknowledgement
Compliance with Written Authority Required procedures


 
C4525
 
 
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be as monotherapy; AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not have progressive disease
Patient must have a wild type epidermal growth factor receptor (EGFR) gene; OR
Patient must have an epidermal growth factor receptor (EGFR) gene of unknown type
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Non-Small Cell Lung Cancer Erlotinib Authority Application - Supporting Information Form, which includes:
(i) evidence that the patient has been treated with platinum-based chemotherapy; AND
(ii) evidence that disease progression has occurred following treatment with docetaxel or pemetrexed. In patients in whom docetaxel or pemetrexed is contraindicated or cannot be tolerated the prescriber must state the reasons for intolerance or the contraindication; AND
(iii) a declaration from the prescriber that the patient has exhausted all opportunities for treatment with chemotherapy either on the PBS, through special access schemes or in a clinical trial; and
(3) a signed patient acknowledgement
Compliance with Written Authority Required procedures


 
C4536
 
 
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be as monotherapy; AND
Patient must have previously been issued with an authority prescription for this drug prior to 1 January 2014; AND
Patient must not have progressive disease
Patient must have a wild type epidermal growth factor receptor (EGFR) gene; OR
Patient must have an epidermal growth factor receptor (EGFR) gene of unknown type
Compliance with Authority Required procedures


 
C4537
 
 
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be as monotherapy; AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not have progressive disease
Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material
Compliance with Authority Required procedures


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

 
C3524
P3524
 
Juvenile idiopathic arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 12 months)
Initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:
(a) has a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) has received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and
(c) has failed 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 per day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means adalimumab or etanercept; 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) an active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder, cervical spine 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 application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient whose previous treatment cycle was ceased due to their failure to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is eligible to commence a new treatment cycle with an initial course of etanercept provided a minimum of 5 years have elapsed between the date of the last approval for PBS-subsidised bDMARD therapy in their previous treatment cycle and the date of the first application under the new treatment cycle;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with etanercept 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

 
(b)       

 
C3770
P3770
 
Juvenile idiopathic arthritis — initial treatment 2
(change or recommencement after a break of less than 12 months)
Initial PBS-subsidised treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:
(a) has a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or etanercept for this condition; and
(c) has not failed PBS-subsidised therapy with etanercept for this condition more than once in the current treatment cycle; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with etanercept in this treatment cycle 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 patient who has failed to respond to treatment with adalimumab and etanercept 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with etanercept 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

 
C3771
P3771
 
Juvenile idiopathic arthritis — continuing treatment
Continuing PBS-subsidised treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older:
(a) who has a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) who has 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 adalimumab or etanercept; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) 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
(b) either of the following:
(i) an active joint count of fewer than 10 active (swollen and tender) joints; or
(ii) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(iii) a reduction in the number of the following 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, cervical spine 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 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 Juvenile Idiopathic 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 patient who has failed to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of continuing treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with etanercept 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

(c)      insert in numerical order following existing text:

 
C4457
P4457
 
Severe active juvenile idiopathic arthritis
Continuing treatment ― balance of supply
Patient must have received insufficient etanercept therapy under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction;
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


 
C4458
P4458
 
Severe active juvenile idiopathic arthritis
Initial treatment ― Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; OR
Patient must have received no PBS-subsidised bDMARD treatment for at least 5 years if they failed or ceased to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) in their last treatment cycle; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction
Patient must be aged 18 years or older
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 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab
If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement
If a patient fails to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle. A patient may re-trial etanercept after a minimum of 5 years have elapsed between the date of the last approval for PBS-subsidised bDMARD therapy in the last treatment cycle and the date of the first application under a new treatment cycle
Compliance with Written Authority Required procedures


 
C4482
P4482
 
Severe active juvenile idiopathic arthritis
Continuing treatment
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have demonstrated an adequate response to treatment with etanercept; AND
Patient must have received etanercept as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction
Patient must be aged 18 years or older
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 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following:
(a) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form
All applications for continuing treatment with etanercept 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 etanercept, 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 etanercept
If a patient fails to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle
Compliance with Written Authority Required procedures


 
C4483
P4483
 
Severe active juvenile idiopathic arthritis
Initial treatment ― Initial 2 (change or recommencement of treatment after break of less than 24 months)
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have received prior PBS-subsidised treatment with adalimumab, etanercept or tocilizumab for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with etanercept for this condition in the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction
Patient must be aged 18 years or older
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 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form
Applications for a patient who has received PBS-subsidised treatment with etanercept in this treatment cycle and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised etanercept treatment, within the timeframes specified below
Where the most recent course of PBS-subsidised etanercept treatment was approved under either of the Initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased
Where the most recent course of PBS-subsidised etanercept treatment was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept
If a patient fails to respond to PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following:
(a) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth
Compliance with Written Authority Required procedures


 
C4503
P4503
 
Severe active juvenile idiopathic arthritis
Initial treatment ― Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply
Patient must have received insufficient etanercept therapy under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient etanercept therapy under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions
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


[126]       Schedule 4, Part 1, entry for Fosamprenavir
substitute:

Fosamprenavir
C4454
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512


[127]       Schedule 4, Part 1, entry for Gefitinib
substitute:

Gefitinib
C4473
 
 
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must not have received previous PBS-subsidised treatment with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI); OR
Patient must have developed intolerance to another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal; AND
Patient must have a WHO performance status of 2 or less
Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material
Compliance with Authority Required procedures


 
C4474
 
 
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be as monotherapy; AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not have progressive disease
Compliance with Authority Required procedures


[128]       Schedule 4, Part 1, after entry for Glycomacropeptide and essential amino acids with vitamins and minerals
insert:
Glycopyrronium
C4516
 
 
Chronic obstructive pulmonary disease (COPD)
 
[129]       Schedule 4, Part 1, entry for Indinavir
substitute:

Indinavir
C4454
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512


[130]       Schedule 4, Part 1, after entry for Indomethacin
insert:

Infliximab
C4524
P4524
 
Where the patient is receiving treatment at/from a public hospital
Acute severe ulcerative colitis
Patient must have received an infusion of infliximab for the treatment of this condition as a hospital inpatient no more than two weeks prior to the date of the authority application; AND
Patient must be an adult aged 18 years or older, and prior to initiation of infliximab treatment in hospital must have been experiencing six or more bloody stools per day, plus at least one of the following: (i) Temperature greater than 37.8 degrees Celsius; (ii) Pulse rate greater than 90 beats per minute; (iii) Haemoglobin less than 105 g/L; (iv) Erythrocyte sedimentation rate greater than 30 mm/h; OR
Patient must be a child aged 6 to 17 years inclusive, and prior to initiation of infliximab treatment in hospital must have had a Paediatric Ulcerative Colitis Activity Index (PUCAI) greater than or equal to 65, with the diagnosis confirmed by a gastroenterologist, or a consultant physician as specified below; AND
Patient must have failed to achieve an adequate response to at least 72 hours treatment with intravenous corticosteroids prior to initiation of infliximab treatment in hospital
Patient must be 6 years of age or older
Must be treated by a gastroenterologist; OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology, or general medicine specialising in gastroenterology]
For adults aged 18 years or older, failure to achieve an adequate response to intravenous corticosteroid treatment is defined by the Oxford criteria where:
(i) If assessed on day 3, patients pass 8 or more stools per day or 3 or more stools per day with a C-reactive protein (CRP) greater than 45 mg/L
(ii) If assessed on day 7, patients pass 3 or more stools per day with visible blood
For children aged 6 to 17 years, failure to achieve an adequate response to intravenous corticosteroids means a PUCAI score greater than 45 at 72 hours
At the time of authority application, prescribers should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg
Before administering infliximab to a child aged 6 to 17 years, the treating clinician must have consulted with a paediatric gastroenterologist or with an institution experienced in performance of paediatric colectomy. The name of the specialist or institution must be included in the patient's medical records
Evidence that the patient meets the PBS restriction criteria must be recorded in the patient's medical records
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4524


 
C4535
P4535
 
Where the patient is receiving treatment at/from a private hospital
Acute severe ulcerative colitis
Patient must have received an infusion of infliximab for the treatment of this condition as a hospital inpatient no more than two weeks prior to the date of the authority application; AND
Patient must be an adult aged 18 years or older, and prior to initiation of infliximab treatment in hospital must have been experiencing six or more bloody stools per day, plus at least one of the following: (i) Temperature greater than 37.8 degrees Celsius; (ii) Pulse rate greater than 90 beats per minute; (iii) Haemoglobin less than 105 g/L; (iv) Erythrocyte sedimentation rate greater than 30 mm/h; OR
Patient must be a child aged 6 to 17 years inclusive, and prior to initiation of infliximab treatment in hospital must have had a Paediatric Ulcerative Colitis Activity Index (PUCAI) greater than or equal to 65, with the diagnosis confirmed by a gastroenterologist, or a consultant physician as specified below; AND
Patient must have failed to achieve an adequate response to at least 72 hours treatment with intravenous corticosteroids prior to initiation of infliximab treatment in hospital
Patient must be 6 years of age or older
Must be treated by a gastroenterologist; OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology, or general medicine specialising in gastroenterology]
For adults aged 18 years or older, failure to achieve an adequate response to intravenous corticosteroid treatment is defined by the Oxford criteria where:
(i) If assessed on day 3, patients pass 8 or more stools per day or 3 or more stools per day with a C-reactive protein (CRP) greater than 45 mg/L
(ii) If assessed on day 7, patients pass 3 or more stools per day with visible blood
For children aged 6 to 17 years, failure to achieve an adequate response to intravenous corticosteroids means a PUCAI score greater than 45 at 72 hours
At the time of authority application, prescribers should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg
Before administering infliximab to a child aged 6 to 17 years, the treating clinician must have consulted with a paediatric gastroenterologist or with an institution experienced in performance of paediatric colectomy. The name of the specialist or institution must be included in the patient's medical records
Evidence that the patient meets the PBS restriction criteria must be recorded in the patient's medical records
Compliance with Written or Telephone Authority Required procedures

[131]       Schedule 4, Part 1, omit entry for Irinotecan
[132]       Schedule 4, Part 1, entry for Lamivudine
(a)      omit:

 
C3586
 
 
Where the patient is receiving treatment at/from a private hospital
Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease
Compliance with Written or Telephone Authority Required procedures

 
C3587
 
 
Where the patient is receiving treatment at/from a private hospital
Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures

 
C3588
 
 
Where the patient is receiving treatment at/from a public hospital
Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588

 
C3589
 
 
Where the patient is receiving treatment at/from a public hospital
Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

(b)      insert in numerical order following existing text:

 
C4454
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454

 
C4455
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512

[133]       Schedule 4, Part 1, entry for Lamivudine with Zidovudine
substitute:

Lamivudine with Zidovudine
C4454
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4454

 
C4455
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written and Telephone Authority Required procedures


 
C4469
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written and Telephone Authority Required procedures


 
C4512
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4512

[134]       Schedule 4, Part 1, entry for Linagliptin
substitute:
Linagliptin
C4488
 
 
Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; 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 despite treatment with either metformin or a sulfonylurea
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 dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (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
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with linagliptin
Compliance with Authority Required procedures - Streamlined Authority Code 4488

[135]       Schedule 4, Part 1, entry for Lopinavir with Ritonavir
substitute:

Lopinavir with Ritonavir
C4454
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454

 
C4455
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512

[136]       Schedule 4, Part 1, entry for Misoprostol
substitute:
Misoprostol
C4463
 
 
Termination of an intra-uterine pregnancy
The condition must be an intra-uterine pregnancy of up to 49 days of gestation; AND
The treatment must be in sequential combination with mifepristone 200 mg
Must be treated by a prescriber who is registered with the MS 2 Step Prescribing Program
Compliance with Authority Required procedures

[137]       Schedule 4, Part 1, entry for Nevirapine
substitute:

Nevirapine
C4454
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454

 
C4455
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4460
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must have been stabilised on nevirapine immediate release; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4512


 
C4526
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must have been stabilised on nevirapine immediate release; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4526

[138]       Schedule 4, Part 1, omit entry for Oxaliplatin
[139]       Schedule 4, Part 1, after entry for Pancrelipase
insert:

Panitumumab
C4462
 
 
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 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 4462


 
C4498
 
 
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 panitumumab for treatment of KRAS 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 4498


 
C4530
 
 
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 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


 
C4543
 
 
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 panitumumab for treatment of KRAS 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


[140]       Schedule 4, Part 1, entry for Raltegravir
(a)      omit:

 
C3586
 
 
Where the patient is receiving treatment at/from a private hospital
Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease
Compliance with Written or Telephone Authority Required procedures

 
C3587
 
 
Where the patient is receiving treatment at/from a private hospital
Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures

 
C3588
 
 
Where the patient is receiving treatment at/from a public hospital
Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588

 
C3589
 
 
Where the patient is receiving treatment at/from a public hospital
Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

(b)      insert in numerical order following existing text:

 
C4454
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454

 
C4455
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures

 
C4469
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512


[141]       Schedule 4, Part 1, entry for Rilpivirine
substitute:

Rilpivirine
C4454
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512

[142]       Schedule 4, Part 1, entry for Ritonavir
substitute:

Ritonavir
C4454
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512

[143]       Schedule 4, Part 1, entry for Saquinavir
substitute:

Saquinavir
C4454
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454

 
C4455
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512

[144]       Schedule 4, Part 1, entry for Saxagliptin
substitute:
Saxagliptin
C4520
 
 
Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea, AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; 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 despite treatment with either metformin or a sulfonylurea
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 dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (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
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with saxagliptin
Compliance with Authority Required procedures - Streamlined Authority Code 4520

[145]       Schedule 4, Part 1, entry for Sitagliptin
substitute:
Sitagliptin
C4519
 
 
Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; 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 despite treatment with either metformin or a sulfonylurea
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 dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (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
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with sitagliptin
Compliance with Authority Required procedures - Streamlined Authority Code 4519

[146]       Schedule 4, Part 1, entry for Sitagliptin with metformin
(a)      omit:
 
C4325
 
 
Diabetes mellitus type 2
Patient must have a contraindication to a combination of metformin and a sulfonylurea; OR
Patient must not have tolerated a combination of metformin and a sulfonylurea;
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 despite treatment with metformin; 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 despite treatment with metformin
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 - Streamlined Authority Code 4325

(b)      insert in numerical order following existing text:
 
C4423
 
 
Diabetes mellitus type 2
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; 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 despite treatment with metformin
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 dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (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
A patient whose diabetes was previously demonstrated unable to be controlled with metformin does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination
Compliance with Authority Required procedures - Streamlined Authority Code 4423

[147]       Schedule 4, Part 1, omit entry for Sitagliptin with simvastatin
[148]       Schedule 4, Part 1, entry for Stavudine
substitute:

Stavudine
C4454
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512

[149]       Schedule 4, Part 1, entry for Temozolomide
(a)      omit:
 
C2100
P2100
 
Glioblastoma multiforme concomitantly with radiotherapy
Compliance with Authority Required procedures
(b)      insert in numerical order following existing text:
 
C4496
P4496
 
Glioblastoma multiforme
Patient must be undergoing concomitant radiotherapy
Compliance with Authority Required procedures
[150]       Schedule 4, Part 1, entry for Tenofovir
substitute:

Tenofovir
C4454
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4476
 
 
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B
Patient must have cirrhosis; AND
Patient must be nucleoside analogue naïve; AND
Patient must have detectable HBV DNA; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4476


 
C4489
 
 
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B
Patient must not have cirrhosis; AND
Patient must be nucleoside analogue naïve; AND
Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR
Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND
Patient must have evidence of chronic liver injury determined by: (i) confirmed elevated serum ALT; or (ii) liver biopsy; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4489


 
C4490
 
 
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B
Patient must not have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR
Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4490


 
C4499
 
 
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B
Patient must not have cirrhosis; AND
Patient must be nucleoside analogue naïve; AND
Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR
Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND
Patient must have evidence of chronic liver injury determined by: (i) confirmed elevated serum ALT; or (ii) liver biopsy; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Compliance with Written or Telephone Authority Required procedures


 
C4509
 
 
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B
Patient must have cirrhosis; AND
Patient must be nucleoside analogue naïve; AND
Patient must have detectable HBV DNA; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures


 
C4510
 
 
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B
Patient must have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4510


 
C4512
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512

 
C4544
 
 
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B
Patient must not have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR
Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance
Compliance with Written or Telephone Authority Required procedures


 
C4545
 
 
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B
Patient must have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures


[151]       Schedule 4, Part 1, entry for Tenofovir with Emtricitabine
substitute:

Tenofovir with Emtricitabine
C4454
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454

 
C4455
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512

[152]       Schedule 4, Part 1, entry for Tenofovir with emtricitabine and efavirenz
substitute:

Tenofovir with emtricitabine and efavirenz
C4470
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4470

 
C4494
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures


 
C4522
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naive
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4522

 
C4533
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naive
Compliance with Written or Telephone Authority Required procedures


[153]       Schedule 4, Part 1, entry for Tenofovir with Emtricitabine and Rilpivirine
substitute:

Tenofovir with Emtricitabine and Rilpivirine
C4470
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4470

 
C4494
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures

 
C4522
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naive
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4522

 
C4533
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naive
Compliance with Written or Telephone Authority Required procedures

[154]       Schedule 4, Part 1, entry for Tobramycin
insert in numerical order following existing text:

 
C4456
 
 
Proven Pseudomonas aeruginosa infection
Initial treatment
Patient must have cystic fibrosis; AND
Patient must have been assessed for bronchial hyperresponsiveness as per the TGA-approved Product Information, with a negative test result; AND
Patient must be participating in a four week trial of tobramycin inhalation powder and will be assessed for ability to tolerate the dry powder formulation in order to qualify for continued PBS-subsidised therapy. The trial commencement date must be documented in the patient's medical records
Patient must be 6 years of age or older
Compliance with Authority Required procedures - Streamlined Authority Code 4456


 
C4513
 
 
Proven Pseudomonas aeruginosa infection
Continuing treatment
Patient must have cystic fibrosis; AND
Patient must have previously been issued with an authority prescription for tobramycin inhalation capsules; AND
Patient must have demonstrated ability to tolerate the dry powder formulation following the initial 4-week treatment period, as agreed by the patient, the patient's family (in the case of paediatric patients) and the treating physician(s)
Patient must be 6 years of age or older
Compliance with Authority Required procedures - Streamlined Authority Code 4513


[155]       Schedule 4, Part 1, entry for Vildagliptin
substitute:
Vildagliptin
C4467
 
 
Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; 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 despite treatment with either metformin or a sulfonylurea
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 dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (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
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with vildagliptin
Compliance with Authority Required procedures - Streamlined Authority Code 4467

[156]       Schedule 4, Part 1, entry for Vildagliptin with metformin
(a)      omit:
 
C4325
 
 
Diabetes mellitus type 2
Patient must have a contraindication to a combination of metformin and a sulfonylurea; OR
Patient must not have tolerated a combination of metformin and a sulfonylurea;
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 despite treatment with metformin; 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 despite treatment with metformin
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 - Streamlined Authority Code 4325

(b)      insert in numerical order following existing text:
 
C4423
 
 
Diabetes mellitus type 2
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; 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 despite treatment with metformin
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 dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (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
A patient whose diabetes was previously demonstrated unable to be controlled with metformin does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination
Compliance with Authority Required procedures - Streamlined Authority Code 4423

[157]       Schedule 4, Part 1, entry for Zidovudine
substitute:

Zidovudine
C4454
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection;
AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512