National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 9) (PB 61 of 2014)

Link to law: https://www.comlaw.gov.au/Details/F2014L01121

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PB 61 of 2014
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 9)
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 15 August 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. 9).
            (2)        This Instrument may also be cited as PB 61 of 2014.
2          Commencement
This Instrument commences on 1 September 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 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”:            C3502
(b)      omit:         C3751  C3752
(c)      insert in numerical order:     C4609  C4610  C4629  C4642  C4643
[2]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 3]
(a)      omit from the column headed “Circumstances”:            C3502
(b)      omit:         C3751  C3752
(c)      insert in numerical order:     C4609  C4610  C4629  C4642  C4643
(d)      omit from the column headed “Purposes”:       P3502 
(e)      omit:         P3751
(f)       insert in numerical order:     P4609  P4610  P4629
[3]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 4]
(a)      omit from the column headed “Circumstances”:            C3502
(b)      omit:         C3751  C3752
(c)      insert in numerical order:     C4609  C4610  C4629  C4642  C4643
[4]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:            C3502
(b)      omit:         C3751  C3752
(c)      insert in numerical order:     C4609  C4610  C4629  C4642  C4643
(d)      omit from the column headed “Purposes”:       P3752
(e)      insert in numerical order:     P4642  P4643
[5]           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”:            C3502
(b)      omit:         C3751  C3752
(c)      insert in numerical order:     C4609  C4610  C4629  C4642  C4643
[6]           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”:            C3502
(b)      omit:         C3751  C3752
(c)      insert in numerical order:     C4609  C4610  C4629  C4642  C4643
(d)      omit from the column headed “Purposes”:       P3502 
(e)      omit:         P3751
(f)       insert in numerical order:     P4609  P4610  P4629
[7]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 4]
(a)      omit from the column headed “Circumstances”:            C3502
(b)      omit:         C3751  C3752
(c)      insert in numerical order:     C4609  C4610  C4629  C4642  C4643
[8]           Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:            C3502
(b)      omit:         C3751  C3752
(c)      insert in numerical order:     C4609  C4610  C4629  C4642  C4643
(d)      omit from the column headed “Purposes”:       P3752
(e)      insert in numerical order:     P4642  P4643
[9]           Schedule 1, entry for Alendronic Acid in the form Tablet 70 mg (as alendronate sodium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Alendronate AN
EA
MP NP
C4122 C4123 C4133
 
4
5
4
 
 
[10]         Schedule 1, entry for Amoxycillin in the form Capsule 250 mg (as trihydrate) [Maximum Quantity: 20; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Amoxycillin AN
EA
PDP
 
 
20
0
20
 
 
[11]         Schedule 1, entry for Amoxycillin in the form Capsule 250 mg (as trihydrate) [Maximum Quantity: 20; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Amoxycillin AN
EA
MP NP MW
 
 
20
1
20
 
 
[12]         Schedule 1, entry for Amoxycillin in the form Capsule 500 mg (as trihydrate) [Maximum Quantity: 20; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Amoxycillin AN
EA
PDP
 
 
20
0
20
 
 
[13]         Schedule 1, entry for Amoxycillin in the form Capsule 500 mg (as trihydrate) [Maximum Quantity: 20; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Amoxycillin AN
EA
MP NP MW
 
 
20
1
20
 
 
[14]         Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Amoxiclav AN 500/125
EA
PDP
C1836 C1837
 
10
0
10
 
 
[15]         Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Amoxiclav AN 500/125
EA
MP NP MW
C1836 C1837
 
10
1
10
 
 
[16]         Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 0]
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Amoxiclav AN 875/125
EA
PDP
C1836 C1837
 
10
0
10
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
AmoxyClav RBX 875/125
RA
PDP
C1836 C1837
 
10
0
10
 
 
[17]         Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 1]
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Amoxiclav AN 875/125
EA
MP NP
C1836 C1837
 
10
1
10
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
AmoxyClav RBX 875/125
RA
MP NP
C1836 C1837
 
10
1
10
 
 
[18]         Schedule 1, entry for Anastrozole
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Anastrozole AN
EA
MP NP
C2213
 
30
5
30
 
 
[19]         Schedule 1, entry for Aprepitant
omit from the column headed “Section 100/Prescriber Bag only”:         C(100)
[20]         Schedule 1, entry for Atenolol in the form Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Atenolol AN
EA
MP NP
 
 
30
5
30
 
 
[21]         Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Atorvastatin AN
EA
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[22]         Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Atorvastatin AN
EA
MP
C1540 C3047
P3047
30
11
30
 
 
[23]         Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Atorvastatin AN
EA
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[24]         Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Atorvastatin AN
EA
MP
C1540 C3047
P3047
30
11
30
 
 
[25]         Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Atorvastatin AN
EA
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[26]         Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Atorvastatin AN
EA
MP
C1540 C3047
P3047
30
11
30
 
 
[27]         Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Atorvastatin AN
EA
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[28]         Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Atorvastatin AN
EA
MP
C1540 C3047
P3047
30
11
30
 
 
[29]         Schedule 1, entry for Azathioprine in the form Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Azathioprine AN
EA
MP NP
 
 
100
5
100
 
 
[30]         Schedule 1, entry for Bicalutamide
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Bicalutamide AN
EA
MP NP
C3674
 
28
5
28
 
 
 
[31]         Schedule 1, entry for Bisoprolol in each of the forms: Tablet containing bisoprolol fumarate 2.5 mg; Tablet containing bisoprolol fumarate 5 mg; and Tablet containing bisoprolol fumarate 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Bisoprolol AN
EA
MP NP
C3234
 
28
5
28
 
 
[32]         Schedule 1, entry for Calcitriol
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Calcitriol AN
EA
MP NP
C1165 C1166 C1167 C1467 C2636
 
100
3
100
 
 
[33]         Schedule 1, entry for Candesartan in each of the forms: Tablet containing candesartan cilexetil 4 mg; Tablet containing candesartan cilexetil 8 mg; Tablet containing candesartan cilexetil 16 mg; and Tablet containing candesartan cilexetil 32 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Candesartan AN
EA
MP NP
 
 
30
5
30
 
 
[34]         Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Candesartan HCTZ AN 16/12.5
EA
MP NP
C4374
 
30
5
30
 
 
[35]         Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Candesartan HCTZ AN 32/12.5
EA
MP NP
C4374
 
30
5
30
 
 
[36]         Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Candesartan HCTZ AN 32/25
EA
MP NP
C4374
 
30
5
30
 
 
[37]         Schedule 1, entry for Carboplatin in each of the forms: Solution for I.V. injection 50 mg in 5 mL; Solution for I.V. injection 150 mg
in 15 mL; and Solution for I.V. injection 450 mg in 45 mL
omit:
 
 
 
Carboplatin Ebewe
SZ
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[38]         Schedule 1, entry for Carvedilol in the form Tablet 3.125 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Carvedilol AN
EA
MP NP
C1735 C3234
 
30
0
30
 
 
[39]         Schedule 1, entry for Carvedilol in each of the forms: Tablet 6.25 mg; Tablet 12.5 mg; and Tablet 25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Carvedilol AN
EA
MP NP
C1735 C3234
 
60
5
60
 
 
[40]         Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cephalexin AN
EA
PDP
 
 
20
0
20
 
 
[41]         Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cephalexin AN
EA
MP NP MW
 
 
20
1
20
 
 
[42]         Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Maximum Quantity: 40; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cephalexin AN
EA
MP
 
P4243
40
2
20
 
 
[43]         Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 0]
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cephalex 500
NJ
PDP
 
 
20
0
20
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cephalexin AN
EA
PDP
 
 
20
0
20
 
 
[44]         Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 1]
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cephalex 500
NJ
MP NP MW
 
 
20
1
20
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cephalexin AN
EA
MP NP MW
 
 
20
1
20
 
 
[45]         Schedule 1, entry for Cephazolin in the form Powder for injection 1 g (as sodium)
omit:
 
 
 
Cephazolin Alphapharm
AF
MP NP
C1169 C1846 C1847 C3132
 
10
0
10
 
 
[46]         Schedule 1, entry for Certolizumab pegol
                insert in numerical order in the column headed “Circumstances”:         C4605  C4606  C4614  C4642  C4643
[47]         Schedule 1, entry for Ciprofloxacin in each of the forms: Tablet 500 mg (as hydrochloride); and Tablet 750 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ciprofloxacin AN
EA
MP NP
C1431 C1432 C1572 C1573
 
14
0
14
 
 
[48]         Schedule 1, entry for Citalopram in each of the forms: Tablet 20 mg (as hydrobromide); and Tablet 40 mg (as hydrobromide)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Citalopram AN
EA
MP NP
C1211
 
28
5
28
 
 
[49]         Schedule 1, entry for Clarithromycin in the form Tablet 250 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Clarithromycin AN
EA
MP NP
 
 
14
1
14
 
 
[50]         Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Clopidogrel AN
EA
MP NP
C1719 C1720 C1721 C1722 C1723 C1724 C4165 C4166
 
28
5
28
 
 
[51]         Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Maximum Quantity: 20;
Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cyproterone AN
EA
MP
C1014 C1230 C1404
P1230
20
5
20
 
 
[52]         Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Maximum Quantity: 100;
Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cyproterone AN
EA
MP
C1014 C1230 C1404
P1014 P1404
100
5
50
 
 
[53]         Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cyproterone AN
EA
MP
C1014 C1404
 
50
5
50
 
 
 
[54]         Schedule 1, entry for Darunavir
omit:
 
Tablet 400 mg (as ethanolate)
Oral
Prezista
JC
MP
See Note 1
C4313 C4346
 
120
5
60
D(100)
[55]         Schedule 1, entry for Diltiazem in the form Tablet containing diltiazem hydrochloride 60 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Diltiazem AN
EA
MP NP
 
 
90
5
90
 
 
[56]         Schedule 1, entry for Donepezil in each of the forms: Tablet containing donepezil hydrochloride 5 mg; and Tablet containing donepezil hydrochloride 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Donepezil AN
EA
MP NP
C4219 C4220 C4224
 
28
5
28
 
 
[57]         Schedule 1, entry for Dorzolamide with timolol
omit from the column headed “Determined Quantity” (twice occurring)                :               1
[58]         Schedule 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Duloxetine AN
EA
MP NP
C1211
 
28
0
28
 
 
[59]         Schedule 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Duloxetine AN
EA
MP NP
C1211
 
28
5
28
 
 
[60]         Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL
(a)      omit from the column headed “Brand”:               Epirubicin Actavis 50   substitute:             Epirubicin ACT
(b)      omit from the column headed “Responsible Person”:      UA        substitute:             VN
[61]         Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL
(a)      omit from the column headed “Brand”:               Epirubicin Actavis 200             substitute:             Epirubicin ACT
(b)      omit from the column headed “Responsible Person”:      UA        substitute:             VN
[62]         Schedule 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Escitalopram AN
EA
MP NP
C1211
 
28
5
28
 
 
 
[63]         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”:            C3510
(b)      omit:         C3774  C3775
(c)      insert in numerical order:     C4609  C4610  C4629  C4642  C4643
(d)      omit from the column headed “Purposes”:       P3510
(e)      omit:         P3774
(f)       insert in numerical order:     P4609  P4610  P4629
[64]         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”:            C3510
(b)      omit:         C3774  C3775
(c)      insert in numerical order:     C4609  C4610  C4629  C4642  C4643
(d)      omit from the column headed “Purposes”:       P3775
(e)      insert in numerical order:     P4642  P4643
[65]         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”:            C3510
(b)      omit:         C3774  C3775
(c)      insert in numerical order:     C4609  C4610  C4629  C4642  C4643
(d)      omit from the column headed “Purposes”:       P3510
(e)      omit:         P3774
(f)       insert in numerical order:     P4609  P4610  P4629
[66]         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”:            C3510
(b)      omit:         C3774  C3775
(c)      insert in numerical order:     C4609  C4610  C4629  C4642  C4643
(d)      omit from the column headed “Purposes”:       P3775
(e)      insert in numerical order:     P4642  P4643
[67]         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”:            C3510
(b)      omit:         C3774  C3775
(c)      insert in numerical order:     C4609  C4610  C4629  C4642  C4643
(d)      omit from the column headed “Purposes”:       P3510
(e)      omit:         P3774
(f)       insert in numerical order:     P4609  P4610  P4629
[68]         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”:            C3510
(b)      omit:         C3774  C3775
(c)      insert in numerical order:     C4609  C4610  C4629  C4642  C4643
(d)      omit from the column headed “Purposes”:       P3775
(e)      insert in numerical order:     P4642  P4643
[69]         Schedule 1, entry for Everolimus
omit:
 
Tablet 5 mg
Oral
Afinitor
NV
MP
C4334 C4351 C4557
 
30
5
30
 

 
Tablet 10 mg
Oral
Afinitor
NV
MP
C4334 C4351 C4557
 
30
5
30
 
 

substitute:
 
Tablet 5 mg
Oral
Afinitor
NV
MP
C4334 C4351 C4557 C4604 C4632
P4604
30
2
30
 
 

 
 
 
 
 
MP
C4334 C4351 C4557 C4604 C4632
P4334 P4351  P4557 P4632
30
5
30
 
 

 
Tablet 10 mg
Oral
Afinitor
NV
MP
C4334 C4351 C4557 C4604 C4632
P4604
30
2
30
 
 

 
 
 
 
 
MP
C4334 C4351 C4557 C4604 C4632
P4334 P4351  P4557 P4632
30
5
30
 
 

[70]         Schedule 1, entry for Exemestane in the form Tablet 25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Exemestane AN
EA
MP
C1541 C2457 C4552
 
30
5
30
 
 

 
 
 
 
 
NP
C1541 C2457
 
30
5
30
 
 

[71]         Schedule 1, entry for Famciclovir in the form Tablet 125 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Famciclovir AN
EA
MP NP
C3624
 
40
1
40
 
 
 
[72]         Schedule 1, entry for Famciclovir in the form Tablet 250 mg [Maximum Quantity: 20; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Famciclovir AN
EA
MP NP
C3622 C3623 C3624
P3624
20
1
20
 
 
[73]         Schedule 1, entry for Famciclovir in the form Tablet 250 mg [Maximum Quantity: 21; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Famciclovir AN
EA
MP NP
C3622 C3623 C3624
P3622
21
0
21
 
 
[74]         Schedule 1, entry for Famciclovir in the form Tablet 250 mg [Maximum Quantity: 56; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Famciclovir AN
EA
MP NP
C3622 C3623 C3624
P3623
56
5
56
 
 
[75]         Schedule 1, entry for Famciclovir in the form Tablet 500 mg [Maximum Quantity: 30; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Famciclovir AN
EA
MP NP
C3625 C3626 C3627 C3628 C3629
P3625
30
0
30
 
 
[76]         Schedule 1, entry for Famciclovir in the form Tablet 500 mg [Maximum Quantity: 56; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Famciclovir AN
EA
MP NP
C3625 C3626 C3627 C3628 C3629
P3626 P3627 P3628 P3629
56
5
56
 
 
[77]         Schedule 1, entry for Famotidine in the form Tablet 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Famotidine AN
EA
MP NP
 
 
60
5
60
 
 
[78]         Schedule 1, entry for Famotidine in the form Tablet 40 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Famotidine AN
EA
MP NP
 
 
30
5
30
 
 
[79]         Schedule 1, entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Fludarabine ACT
VN
MP
C3887
 
See Note 3
See
Note 3
1
 
PB(100)
[80]         Schedule 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Fluoxetine AN
EA
MP NP
C1211 C1241
 
28
5
28
 
 
[81]         Schedule 1, entry for Frusemide in each of the forms: Tablet 20 mg; and Tablet 40 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Frusemide AN
EA
MP NP
 
 
100
1
100
 
 
[82]         Schedule 1, entry for Gabapentin in each of the forms: Tablet 600 mg; and Tablet 800 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Gabapentin AN
EA
MP NP
C2664
 
100
5
100
 
 
[83]         Schedule 1, entry for Gemcitabine
omit:
 
Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 5 mL
Injection
Gemcitabine Ebewe
SZ
MP
 
See
Note 3
See
Note 3
1
D(100)

 
Solution concentrate for I.V. infusion 1 g (as hydrochloride) in 25 mL
Injection
Gemcitabine Ebewe
SZ
MP
 
 
See
Note 3
See
Note 3
1
 
D(100)

 
Solution concentrate for I.V. infusion 2 g (as hydrochloride) in 50 mL
Injection
Gemcitabine Ebewe
SZ
MP
 
 
See Note 3
See
Note 3
1
 
D(100)

[84]         Schedule 1, entry for Glimepiride in each of the forms: Tablet 1 mg; Tablet 2 mg; Tablet 3 mg; and Tablet 4 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Glimepiride AN
EA
MP NP
 
 
30
5
30
 
 
[85]         Schedule 1, entry for Glucose
(a)      omit:
 
I.V. infusion 69.5 mmol (anhydrous) per 250 mL, 250 mL
Injection
Glucose 5% Freeflex
PK
MP NP
 
 
5
1
1
 
 
(b)      omit:
 
I.V. infusion 139 mmol (anhydrous) per 500 mL, 500 mL
Injection
Fresenius Kabi Australia Pty Limited
PK
PDP
 
 
5
0
1
 
 

 
 
 
Fresenius Kabi Australia Pty Limited
PK
MP NP
 
 
5
1
1
 
 

 
I.V. infusion 278 mmol (anhydrous) per 500 mL, 500 mL
Injection
Fresenius Kabi Australia Pty Limited
PK
MP NP
 
 
5
1
1
 
 

[86]         Schedule 1, entry for Glucose Indicator—Blood
omit:
 
Test strips, 50 (Glucocard 01 Sensor)
For external use
Glucocard 01 Sensor
OZ
MP NP
 
2
5
1
 

 
 
 
 
 
MP
 
P4241
2
11
1
 
 

[87]         Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 3]
(a)      omit from the column headed “Circumstances”:            C3516  C3518
(b)      omit:         C3786  C3787
(c)      insert in numerical order:     C4609  C4610  C4629  C4642  C4643
(d)      omit from the column headed “Purposes”:       P3516
(e)      omit:         P3786
(f)       insert in numerical order:     P4609  P4610  P4629
[88]         Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:            C3516  C3518
(b)      omit:         C3786  C3787
(c)      insert in numerical order:     C4609  C4610  C4629  C4642  C4643
(d)      omit from the column headed “Purposes”:       P3518
(e)      omit:         P3787
(f)       insert in numerical order:     P4642  P4643
[89]         Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1; Number of Repeats: 3]
(a)      omit from the column headed “Circumstances”:            C3516  C3518
(b)      omit:         C3786  C3787
(c)      insert in numerical order:     C4609  C4610  C4629  C4642  C4643
(d)      omit from the column headed “Purposes”:       P3516
(e)      omit:         P3786
(f)       insert in numerical order:     P4609  P4610  P4629
[90]         Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:            C3516  C3518
(b)      omit:         C3786  C3787
(c)      insert in numerical order:     C4609  C4610  C4629  C4642  C4643
(d)      omit from the column headed “Purposes”:       P3518
(e)      omit:         P3787
(f)       insert in numerical order:     P4642  P4643
 
[91]         Schedule 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Indapamide AN
EA
MP NP
 
 
90
1
90
 
 
[92]         Schedule 1, entry for Irbesartan in the form Tablet 75 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irbesartan AN
EA
MP NP
 
 
30
5
30
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irbesartan GH
GQ
MP NP
 
 
30
5
30
 
 
(c)      omit:
 
 
 
Irbesat GH
GQ
MP NP
 
 
30
5
30
 
 
[93]         Schedule 1, entry for Irbesartan in the form Tablet 150 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irbesartan AN
EA
MP NP
 
 
30
5
30
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irbesartan GH
GQ
MP NP
 
 
30
5
30
 
 
(c)      omit:
 
 
 
Irbesat GH
GQ
MP NP
 
 
30
5
30
 
 
[94]         Schedule 1, entry for Irbesartan in the form Tablet 300 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irbesartan AN
EA
MP NP
 
 
30
5
30
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irbesartan GH
GQ
MP NP
 
 
30
5
30
 
 
(c)      omit:
 
 
 
Irbesat GH
GQ
MP NP
 
 
30
5
30
 
 
[95]         Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 150 mg-12.5 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irbesartan HCT GH 150/12.5
GQ
MP NP
C4374
 
30
5
30
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irbesartan HCTZ AN 150/12.5
EA
MP NP
C4374
 
30
5
30
 
 
(c)      omit:
 
 
 
Irbesatzide GH 150/12.5
GQ
MP NP
C4374
 
30
5
30
 
 
[96]         Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-12.5 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irbesartan HCT GH 300/12.5
GQ
MP NP
C4374
 
30
5
30
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irbesartan HCTZ AN 300/12.5
EA
MP NP
C4374
 
30
5
30
 
 
(c)      omit:
 
 
 
Irbesatzide GH 300/12.5
GQ
MP NP
C4374
 
30
5
30
 
 
[97]         Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-25 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irbesartan HCT GH 300/25
GQ
MP NP
C4374
 
30
5
30
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irbesartan HCTZ AN 300/25
EA
MP NP
C4374
 
30
5
30
 
 
(c)      omit:
 
 
 
Irbesatzide GH 300/25
GQ
MP NP
C4374
 
30
5
30
 
 
[98]         Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL
omit:
 
 
 
Irinotecan SZ
HX
MP
 
 
See Note 3
See
Note 3
1
D(100)
 
[99]         Schedule 1, entry for Isosorbide Mononitrate in the form Tablet 60 mg (sustained release)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Isosorbide AN
EA
MP NP
 
 
30
5
30
 
 
[100]       Schedule 1, entry for Isotretinoin in the form Capsule 10 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Dermatane
ER
MP
C1354
 
60
3
60
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Isotretinoin AN
EA
MP
C1354
 
60
3
60
 
 
[101]       Schedule 1, entry for Isotretinoin in the form Capsule 20 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Dermatane
ER
MP
C1354
 
60
3
60
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Isotretinoin AN
EA
MP
C1354
 
60
3
60
 
 
[102]       Schedule 1, entry for Isotretinoin in the form Capsule 40 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Dermatane
ER
MP
C1354
 
30
3
30
 
 
[103]       Schedule 1, entry for Lercanidipine in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg; and
Tablet containing lercanidipine hydrochloride 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Lercanidipine AN
EA
MP NP
 
 
28
5
28
 
 
[104]        Schedule 1, entry for Letrozole
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Letrozole AN
EA
MP NP
C1608 C2691 C2692
 
30
5
30
 
 
[105]       Schedule 1, entry for Levetiracetam in each of the forms: Tablet 250 mg; Tablet 500 mg; and Tablet 1 g
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Levetiracetam AN
EA
MP NP
C2664
 
60
5
60
 
 
 
[106]       Schedule 1, entry for Levodopa with Carbidopa
omit:
 
Intestinal gel 20 mg‑5 mg per mL, 100 mL
Intra-intestinal
Duodopa
VE
MP NP
C3703
 
56
5
7
 

 
 
 
 
 
MP
See Note 1
C3704 C3705
 
56
5
7
 
C(100)

substitute:
 
Intestinal gel 20 mg‑5 mg per mL, 100 mL
Intra-intestinal
Duodopa
VE
MP
See Note 1
C3703 C3704 C3705
 
56
5
7
 

 
 
 
 
 
NP
C3703
 
56
5
7
 
 

[107]       Schedule 1, entry for Levonorgestrel with Ethinyloestradiol in the form Pack containing 21 tablets 150 micrograms-30 micrograms and
7 inert tablets
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Evelyn 150/30 ED
GQ
MP NP
 
 
4
2
4
 
 
[108]       Schedule 1, entry for Lisinopril in each of the forms: Tablet 5 mg; Tablet 10 mg; and Tablet 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Lisinopril AN
EA
MP NP
 
 
30
5
30
 
 
[109]       Schedule 1, after entry for Losartan in the form Tablet containing losartan potassium 50 mg
insert:
Macitentan
Tablet 10 mg
Oral
Opsumit
AT
MP
See Note 1
See Note 3
 
See Note 3
See Note 3
30
 
D(100)
[110]       Schedule 1, entry for Meloxicam in each of the forms: Tablet 7.5 mg; and Tablet 15 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Meloxicam AN
EA
MP NP
C1547 C1848
 
30
3
30
 
 
[111]       Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metformin AN
EA
MP NP
 
 
100
5
100
 
 
[112]       Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metformin AN
EA
MP NP
 
 
60
5
60
 
 
[113]       Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metformin AN
EA
MP NP
 
 
90
5
90
 
 
[114]       Schedule 1, entry for Mirtazapine in the form Tablet 15 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Mirtazapine AN
EA
MP NP
C1211
 
30
5
30
 
 
[115]       Schedule 1, entry for Mirtazapine in the form Tablet 15 mg (orally disintegrating)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Mirtazapine AN ODT
EA
MP NP
C1211
 
30
5
30
 
 
[116]       Schedule 1, entry for Mirtazapine in the form Tablet 30 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Mirtazapine AN
EA
MP NP
C1211
 
30
5
30
 
 
[117]       Schedule 1, entry for Mirtazapine in the form Tablet 30 mg (orally disintegrating)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Mirtazapine AN ODT
EA
MP NP
C1211
 
30
5
30
 
 
[118]       Schedule 1, entry for Mirtazapine in the form Tablet 45 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Mirtazapine AN
EA
MP NP
C1211
 
30
5
30
 
 
[119]       Schedule 1, entry for Mirtazapine in the form Tablet 45 mg (orally disintegrating)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Mirtazapine AN ODT
EA
MP NP
C1211
 
30
5
30
 
 
[120]       Schedule 1, entry for Moclobemide in each of the forms: Tablet 150 mg; and Tablet 300 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Moclobemide AN
EA
MP NP
C1211
 
60
5
60
 
 
 
[121]       Schedule 1, entry for Montelukast in the form Tablet, chewable, 4 mg (as sodium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Montelukast AN
EA
MP NP
C2617
 
28
5
28
 
 
[122]       Schedule 1, entry for Montelukast in the form Tablet, chewable, 5 mg (as sodium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Montelukast AN
EA
MP NP
C2618 C3217
 
28
5
28
 
 
[123]       Schedule 1, entry for Norfloxacin
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Norfloxacin AN
EA
MP NP
C1002 C1070
 
14
1
14
 
 
[124]       Schedule 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg; Tablet 5 mg; Tablet 7.5 mg; and Tablet 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Olanzapine AN
EA
MP NP
C1589 C2044
 
28
5
28
 
 
[125]       Schedule 1, entry for Olanzapine in each of the forms: Tablet 5 mg (orally disintegrating); Tablet 10 mg (orally disintegrating);
Tablet 15 mg (orally disintegrating); and Tablet 20 mg (orally disintegrating)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Olanzapine AN ODT
EA
MP NP
C1589 C2044
 
28
5
28
 
 
[126]       Schedule 1, entry for Omeprazole in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Omeprazole AN
EA
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 
[127]       Schedule 1, entry for Omeprazole in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Omeprazole AN
EA
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 
[128]       Schedule 1, omit entry for Omeprazole and Clarithromycin and Amoxycillin
[129]       Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [Maximum Quantity: 4; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ondansetron AN ODT
EA
MP NP
See Note 1
C3050 C3611 See Note 2
P3050
See Note 2
4
See Note 2
0
See
Note 2
4
 
 
[130]       Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [Maximum Quantity: 10; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ondansetron AN ODT
EA
MP NP
C3050 C3611
P3611
10
1
10
 
 
[131]       Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [Maximum Quantity: 4; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ondansetron AN ODT
EA
MP NP
See Note 1
C3050 C3611 See Note 2
P3050
See Note 2
4
See Note 2
0
See
Note 2
4
 
 
[132]       Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [Maximum Quantity: 10; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ondansetron AN ODT
EA
MP NP
C3050 C3611
P3611
10
1
10
 
 
[133]       Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Maximum Quantity: 4; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ondansetron AN
EA
MP NP
See Note 1
C3050 C3611 See Note 2
P3050
See Note 2
4
See Note 2
0
See
Note 2
4
 
 
[134]       Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Maximum Quantity: 10; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ondansetron AN
EA
MP NP
C3050 C3611
P3611
10
1
10
 
 
[135]       Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Maximum Quantity: 4; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ondansetron AN
EA
MP NP
See Note 1
C3050 C3611 See Note 2
P3050
See Note 2
4
See Note 2
0
See
Note 2
4
 
 
[136]       Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Maximum Quantity: 10; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ondansetron AN
EA
MP NP
C3050 C3611
P3611
10
1
10
 
 
 
[137]       Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 50 mg
omit:
 
 
 
Oxaliplatin Alphapharm
AF
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[138]       Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 100 mg
omit:
 
 
 
Oxaliplatin Alphapharm
AF
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[139]       Schedule 1, entry for Oxprenolol
omit:
 
Tablet containing oxprenolol hydrochloride 20 mg
Oral
Corbeton 20
AF
MP NP
 
 
100
5
100
 
 
[140]       Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pantoprazole AN
EA
MP NP
C1177 C1337 C1476 C1533
P1177
30
2
30
 
 
[141]       Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pantoprazole AN
EA
MP NP
C1177 C1337 C1476 C1533
P1337 P1476 P1533
30
5
30
 
 
[142]       Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pantoprazole AN
EA
MP NP
C1337 C1476 C1533
 
30
5
30
 
 
[143]       Schedule 1, entry for Paroxetine in the form Tablet 20 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Paroxetine AN
EA
MP NP
C1211 C1241 C1862
 
30
5
30
 
 
 
[144]       Schedule 1, entry for Pioglitazone in each of the forms: Tablet 15 mg (as hydrochloride); Tablet 30 mg (as hydrochloride); and
Tablet 45 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pioglitazone AN
EA
MP NP
C4363 C4364 C4388
 
28
5
28
 
 
[145]       Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pravastatin AN
EA
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[146]       Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Maximum Quantity: 30;
Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pravastatin AN
EA
MP
C1540 C3047
P3047
30
11
30
 
 
[147]       Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pravastatin AN
EA
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[148]       Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Maximum Quantity: 30;
Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pravastatin AN
EA
MP
C1540 C3047
P3047
30
11
30
 
 
[149]       Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pravastatin AN
EA
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[150]       Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Maximum Quantity: 30;
Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pravastatin AN
EA
MP
C1540 C3047
P3047
30
11
30
 
 
 
[151]       Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pravastatin AN
EA
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[152]       Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg [Maximum Quantity: 30;
Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pravastatin AN
EA
MP
C1540 C3047
P3047
30
11
30
 
 
[153]       Schedule 1, entry for Prochlorperazine in the form Tablet containing prochlorperazine maleate 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Prochlorperazine AN
EA
PDP MP NP
 
 
25
0
25
 
 
[154]       Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Quetiapine AN
EA
MP NP
C4385 C4391 C4396
 
60
0
60
 
 
[155]       Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Quetiapine AN
EA
MP NP
C1589 C2044 C2765
 
90
5
90
 
 
[156]       Schedule 1, entry for Quetiapine in each of the forms: Tablet 200 mg (as fumarate); and Tablet 300 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Quetiapine AN
EA
MP NP
C1589 C2044 C2765
 
60
5
60
 
 
[157]       Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 10 mg (enteric coated)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rabeprazole AN
EA
MP NP
C1337 C1533
 
28
5
28
 
 
[158]       Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rabeprazole AN
EA
MP NP
C1177 C1337 C1533
P1177
30
2
30
 
 
[159]       Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rabeprazole AN
EA
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
 
 
[160]       Schedule 1, entry for Ramipril in the form Tablet 1.25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ramipril AN
EA
MP NP
 
 
30
5
30
 
 
[161]       Schedule 1, entry for Ramipril in the form Tablet 2.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ramipril AN
EA
MP NP
 
 
30
5
30
 
 
[162]       Schedule 1, entry for Ramipril in the form Tablet 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ramipril AN
EA
MP NP
 
 
30
5
30
 
 
[163]       Schedule 1, entry for Ramipril in the form Tablet 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ramipril AN
EA
MP NP
 
 
30
5
30
 
 
[164]       Schedule 1, entry for Ramipril in the form Capsule 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ramipril CH
EA
MP NP
 
 
30
5
30
 
 
[165]       Schedule 1, entry for Ranibizumab
insert as first item in the columns in the order indicated:
 
Solution for intravitreal injection 1.65 mg in 0.165 mL
Injection
Lucentis
NV
MP
C4607 C4640
 
1
2
1
 
 
[166]       Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 2.3 mg in 0.23 mL
omit from the column headed “Circumstances”:           C2677  C3859    substitute:             C4607  C4640
[167]       Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 35 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Risedronate AN
EA
MP NP
C4122 C4123 C4133
 
4
5
4
 
 
[168]       Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Risperidone AN
EA
MP NP
C1589 C2061 C3083
P2061 P3083
60
2
60
 
 
[169]       Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Risperidone AN
EA
MP NP
C1589 C2061 C3083
P1589
60
5
60
 
 
[170]       Schedule 1, entry for Risperidone in the form Tablet 1 mg [Maximum Quantity: 60; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Risperidone AN
EA
MP NP
C1589 C2061 C2272 C3083
P2061 P3083
60
2
60
 
 
[171]       Schedule 1, entry for Risperidone in the form Tablet 1 mg [Maximum Quantity: 60; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Risperidone AN
EA
MP NP
C1589 C2061 C2272 C3083
P1589 P2272
60
5
60
 
 
[172]       Schedule 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Risperidone AN
EA
MP NP
C1589 C2272 C3083
P3083
60
2
60
 
 
[173]       Schedule 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Risperidone AN
EA
MP NP
C1589 C2272 C3083
P1589 P2272
60
5
60
 
 
[174]       Schedule 1, entry for Risperidone in the form Tablet 3 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Risperidone AN
EA
MP NP
C1589 C2272
 
60
5
60
 
 
[175]       Schedule 1, entry for Risperidone in the form Tablet 4 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Risperidone AN
EA
MP NP
C1589 C2272
 
60
5
60
 
 
 
[176]       Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rosuvastatin AN
EA
MP
C4225 C4228
P4228
30
5
30
 
 

 
 
 
 
 
NP
C4228
 
30
5
30
 
 

[177]       Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rosuvastatin AN
EA
MP
C4225 C4228
P4225
30
11
30
 
 
[178]       Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rosuvastatin AN
EA
MP
C4225 C4228
P4228
30
5
30
 
 

 
 
 
 
 
NP
C4228
 
30
5
30
 
 

[179]       Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rosuvastatin AN
EA
MP
C4225 C4228
P4225
30
11
30
 
 
[180]       Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rosuvastatin AN
EA
MP
C4225 C4227
P4227
30
5
30
 
 

 
 
 
 
 
NP
C4227
 
30
5
30
 
 

[181]       Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rosuvastatin AN
EA
MP
C4225 C4227
P4225
30
11
30
 
 
[182]       Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rosuvastatin AN
EA
MP
C4225 C4226
P4226
30
5
30
 
 

 
 
 
 
 
NP
C4226
 
30
5
30
 
 

[183]       Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rosuvastatin AN
EA
MP
C4225 C4226
P4225
30
11
30
 
 
 
[184]       Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Simvastatin AN
EA
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[185]       Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Simvastatin AN
EA
MP
C1540 C3047
P3047
30
11
30
 
 
[186]       Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Simvastatin AN
EA
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[187]       Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Simvastatin AN
EA
MP
C1540 C3047
P3047
30
11
30
 
 
[188]       Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Simvastatin AN
EA
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[189]       Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Simvastatin AN
EA
MP
C1540 C3047
P3047
30
11
30
 
 
[190]       Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Simvastatin AN
EA
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[191]       Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Simvastatin AN
EA
MP
C1540 C3047
P3047
30
11
30
 
 
 
[192]       Schedule 1, entry for Sodium Chloride
omit:
 
I.V. infusion 38.5 mmol per 250 mL, 250 mL
Injection
Sodium Chloride 0.9% Freeflex
PK
MP NP
 
5
1
1
 

 
I.V. infusion 77 mmol per 500 mL, 500 mL
Injection
Fresenius Kabi Australia Pty Limited
PK
PDP
 
 
5
0
1
 
 

 
 
 
Fresenius Kabi Australia Pty Limited
PK
MP NP
 
 
5
1
1
 
 

[193]       Schedule 1, entry for Sodium Lactate Compound
omit:
 
I.V. infusion containing approximately 65 mmol sodium (as lactate and chloride), 2.7 mmol potassium (as chloride), 0.9 mmol calcium (as chloride), 14 mmol bicarbonate (as lactate) and 56 mmol chloride per 500 mL, 500 mL
Injection
Fresenius Kabi Australia Pty Limited
PK
MP NP
 
5
1
1
 
[194]       Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate) [Maximum Quantity: 4; Number of Repeats: 5; Pack Quantity: 4]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Sumatriptan AN
EA
MP NP
C4558
 
4
5
4
 
 
[195]       Schedule 1, entry for Telmisartan
substitute:
Telmisartan
Tablet 40 mg
Oral
APO-Telmisartan
TX
MP NP
 
28
5
28
 

 
 
 
Chem mart Telmisartan
CH
MP NP
 
 
28
5
28
 
 

 
 
 
Micardis
BY
MP NP
 
 
28
5
28
 
 

 
 
 
Mizart
AF
MP NP
 
 
28
5
28
 
 

 
 
 
Pharmacor Telmisartan 40
CR
MP NP
 
 
28
5
28
 
 

 
 
 
 
Telmigen
GN
MP NP
 
 
28
5
28
 
 

 
 
 
Telmisartan AN
EA
MP NP
 
 
28
5
28
 
 

 
 
 
Telmisartan-DRLA
RZ
MP NP
 
 
28
5
28
 
 

 
 
 
Telmisartan GH
GQ
MP NP
 
 
28
5
28
 
 

 
 
 
Telmisartan Sandoz
SZ
MP NP
 
 
28
5
28
 
 

 
 
 
Teltartan
QA
MP NP
 
 
28
5
28
 
 

 
 
 
Terry White Chemists Telmisartan
TW
MP NP
 
 
28
5
28
 
 

 
Tablet 80 mg
Oral
APO-Telmisartan
TX
MP NP
 
 
28
5
28
 
 

 
 
 
Chem mart Telmisartan
CH
MP NP
 
 
28
5
28
 
 

 
 
 
Micardis
BY
MP NP
 
 
28
5
28
 
 

 
 
 
Mizart
AF
MP NP
 
 
28
5
28
 
 

 
 
 
Pharmacor Telmisartan 80
CR
MP NP
 
 
28
5
28
 
 

 
 
 
Telmigen
GN
MP NP
 
 
28
5
28
 
 

 
 
 
Telmisartan AN
EA
MP NP
 
 
28
5
28
 
 

 
 
 
Telmisartan-DRLA
RZ
MP NP
 
 
28
5
28
 
 

 
 
 
Telmisartan GH
GQ
MP NP
 
 
28
5
28
 
 

 
 
 
Telmisartan Sandoz
SZ
MP NP
 
 
28
5
28
 
 

 
 
 
Teltartan
QA
MP NP
 
 
28
5
28
 
 

 
 
 
Terry White Chemists Telmisartan
TW
MP NP
 
 
28
5
28
 
 

[196]       Schedule 1, entry for Telmisartan with Hydrochlorothiazide
substitute:
Telmisartan with Hydrochlorothiazide
Tablet 40 mg-12.5 mg
Oral
APO-Telmisartan HCTZ 40/12.5
TX
MP NP
C4374
 
28
5
28
 
 

 
 
 
Chem mart Telmisartan HCTZ 40/12.5
CH
MP NP
C4374
 
28
5
28
 
 

 
 
 
Micardis Plus 40/12.5 mg
BY
MP NP
C4374
 
28
5
28
 
 

 
 
 
Mizart HCT 40/12.5
AF
MP NP
C4374
 
28
5
28
 
 

 
 
 
Pritor Plus 40/12.5 mg
FI
MP NP
C4374
 
28
5
28
 
 

 
 
 
Telmigen HCT 40/12.5
GN
MP NP
C4374
 
28
5
28
 
 

 
 
 
Telmisartan/HCT Sandoz
SZ
MP NP
C4374
 
28
5
28
 
 

 
 
 
Telmisartan HCTZ AN 40/12.5
EA
MP NP
C4374
 
28
5
28
 
 

 
 
 
Teltartan HCT 40/12.5
QA
MP NP
C4374
 
28
5
28
 
 

 
 
 
Terry White Chemists Telmisartan HCTZ 40/12.5
TW
MP NP
C4374
 
28
5
28
 
 

 
Tablet 80 mg-12.5 mg
Oral
APO-Telmisartan HCTZ 80/12.5
TX
MP NP
C4374
 
28
5
28
 
 

 
 
 
Chem mart Telmisartan HCTZ 80/12.5
CH
MP NP
C4374
 
28
5
28
 
 

 
 
 
Micardis Plus 80/12.5 mg
BY
MP NP
C4374
 
28
5
28
 
 

 
 
 
Mizart HCT 80/12.5
AF
MP NP
C4374
 
28
5
28
 
 

 
 
 
Pritor Plus 80/12.5 mg
FI
MP NP
C4374
 
28
5
28
 
 

 
 
 
Telmigen HCT 80/12.5
GN
MP NP
C4374
 
28
5
28
 
 

 
 
 
Telmisartan/HCT Sandoz
SZ
MP NP
C4374
 
28
5
28
 
 

 
 
 
Telmisartan HCTZ AN 80/12.5
EA
MP NP
C4374
 
28
5
28
 
 

 
 
 
Teltartan HCT 80/12.5
QA
MP NP
C4374
 
28
5
28
 
 

 
 
 
Terry White Chemists Telmisartan HCTZ 80/12.5
TW
MP NP
C4374
 
28
5
28
 
 

 
Tablet 80 mg-25 mg
Oral
APO-Telmisartan HCTZ 80/25
TX
MP NP
C4374
 
28
5
28
 
 

 
 
 
Chem mart Telmisartan HCTZ 80/25
CH
MP NP
C4374
 
28
5
28
 
 

 
 
 
Micardis Plus 80/25 mg
BY
MP NP
C4374
 
28
5
28
 
 

 
 
 
Mizart HCT 80/25
AF
MP NP
C4374
 
28
5
28
 
 

 
 
 
Pritor Plus 80/25 mg
FI
MP NP
C4374
 
28
5
28
 
 

 
 
 
Telmigen HCT 80/25
GN
MP NP
C4374
 
28
5
28
 
 

 
 
 
Telmisartan/HCT Sandoz
SZ
MP NP
C4374
 
28
5
28
 
 

 
 
 
Telmisartan HCTZ AN 80/25
EA
MP NP
C4374
 
28
5
28
 
 

 
 
 
Teltartan HCT 80/25
QA
MP NP
C4374
 
28
5
28
 
 

 
 
 
Terry White Chemists Telmisartan HCTZ 80/25
TW
MP NP
C4374
 
28
5
28
 
 

[197]       Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 5; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Temozolomide AN
EA
MP
C1736 C1737 C2101 C4496
P1736 P1737 P2101
5
5
5
 
 
[198]       Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 15; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Temozolomide AN
EA
MP
C1736 C1737 C2101 C4496
P4496
15
2
5
 
 
[199]       Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 5; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Temozolomide AN
EA
MP
C1736 C1737 C2101 C4496
P1736 P1737 P2101
5
5
5
 
 
[200]       Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 15; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Temozolomide AN
EA
MP
C1736 C1737 C2101 C4496
P4496
15
2
5
 
 
[201]       Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 5; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Temozolomide AN
EA
MP
C1736 C1737 C2101 C4496
P1736 P1737 P2101
5
5
5
 
 
[202]       Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 15; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Temozolomide AN
EA
MP
C1736 C1737 C2101 C4496
P4496
15
2
5
 
 
 
[203]       Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 5; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Temozolomide AN
EA
MP
C1736 C1737 C2101 C4496
P1736 P1737 P2101
5
5
5
 
 
[204]       Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 15; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Temozolomide AN
EA
MP
C1736 C1737 C2101 C4496
P4496
15
2
5
 
 
[205]       Schedule 1, entry for Temozolomide in the form Capsule 250 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Temozolomide AN
EA
MP
C1736 C1737 C2101
 
5
5
5
 
 
[206]       Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Maximum Quantity: 42; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terbinafine Actavis
VN
MP NP
C2191 C2865 C3244
P2865 P3244
42
0
42
 
 
[207]       Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Maximum Quantity: 42; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terbinafine Actavis
VN
MP NP
C2191 C2865 C3244
P2191
42
1
42
 
 
[208]       Schedule 1, entry for Testosterone
(a)      omit:
 
Subcutaneous implant 100 mg
Implantation
Merck Sharp & Dohme (Australia) Pty Ltd
MK
MP
C1021 C1022 C1226
 
6
0
1
 
 
(b)      omit:
 
Subcutaneous implant 200 mg
Implantation
Merck Sharp & Dohme (Australia) Pty Ltd
MK
MP
C1021 C1022 C1226
 
3
0
1
 
 
[209]       Schedule 1, entry for Topiramate in each of the forms: Tablet 25 mg; and Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Topiramate GH
GQ
MP NP
C2797 C2799
 
60
5
60
 
 
[210]       Schedule 1, entry for Topiramate in each of the forms: Tablet 100 mg; and Tablet 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Topiramate GH
GQ
MP NP
C2797
 
60
5
60
 
 
[211]       Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg [Maximum Quantity: 20;
Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Tramadol AN
EA
MP NP
C1497 C1615
P1497
20
0
20
 
 

 
 
 
 
 
PDP
C1497 C1615
 
20
0
20
 
 

[212]       Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg [Maximum Quantity: 20;
Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Tramadol AN
EA
MP NP
C1497 C1615
P1615
20
2
20
 
 
[213]       Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 20; Number of Repeats: 0]
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Valaciclovir Actavis
VN
MP NP
C3622 C3623 C3624 C3631 C3632
P3632
20
0
10
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Valaciclovir AN
EA
MP NP
C3622 C3623 C3624 C3631 C3632
P3632
20
0
10
 
 
[214]       Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Valaciclovir Actavis
VN
MP NP
C3622 C3623 C3624 C3631 C3632
P3623 P3624
30
5
30
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Valaciclovir AN
EA
MP NP
C3622 C3623 C3624 C3631 C3632
P3623 P3624
30
5
30
 
 
 
[215]       Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 42; Number of Repeats: 0]
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Valaciclovir Actavis
VN
MP NP
C3622 C3623 C3624 C3631 C3632
P3622 P3631
42
0
42
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Valaciclovir AN
EA
MP NP
C3622 C3623 C3624 C3631 C3632
P3622 P3631
42
0
42
 
 
[216]       Schedule 1, entry for Valsartan in the form Tablet 40 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Valsartan
TX
MP NP
 
 
28
0
28
 
 
[217]       Schedule 1, entry for Valsartan in each of the forms: Tablet 80 mg; Tablet 160 mg; and Tablet 320 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Valsartan
TX
MP NP
 
 
28
5
28
 
 
[218]       Schedule 1, entry for Venlafaxine in the form Capsule (modified release) 37.5 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Venlafaxine AN SR
EA
MP NP
C1211
 
28
0
28
 
 
[219]       Schedule 1, entry for Venlafaxine in each of the forms: Capsule (modified release) 75 mg (as hydrochloride); and Capsule (modified release) 150 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Venlafaxine AN SR
EA
MP NP
C1211
 
28
5
28
 
 
[220]       Schedule 3, after details relevant to Responsible Person code DV
insert:
EA
Amneal Pharmaceuticals Pty Ltd
 11 163 167 851
[221]       Schedule 4, Part 1, entry for Adalimumab
(a)      omit:

 
C3502
P3502
 
Ankylosing spondylitis — initial treatment 1
Initial treatment with adalimumab commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:
(a) who has not received any PBS‑subsidised treatment with a tumour necrosis factor (TNF)‑alfa antagonist, or, where the patient has previously received PBS‑subsidised TNF‑alfa antagonist treatment for this condition, has received no such treatment for a period of 5 years or more starting from the date the last course of PBS‑subsidised treatment was approved; and
(b) who has at least 2 of the following:
(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or
(ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or
(iii) limitation of chest expansion relative to normal values for age and gender; and
(c) who has failed to achieve an adequate response following treatment with at least 2 non‑steroidal anti‑inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS‑subsidised TNF‑alfa antagonist therapy of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and
where TNF‑alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF‑alfa antagonists which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a TNF‑alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 TNF‑alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised treatment with 3 TNF‑alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is demonstrated by:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0‑10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 10 mg per L;
both ESR and CRP measurements are included in the authority application and are no more than 1 month old;
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied;
the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;
if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)‑approved Product Information, the authority application includes the reason why a higher dose cannot be used;
if treatment with NSAIDs is contraindicated according to the relevant TGA‑approved Product Information, the authority application includes details of the contraindication;
if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;
an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;
if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a signed patient acknowledgment form; and
(iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;
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 with adalimumab in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

(b)      omit:

 
C3751
P3751
 
Ankylosing spondylitis — initial treatment 2
Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS‑subsidised tumour necrosis factor (TNF)‑alfa antagonist treatment for this condition and is eligible to receive further TNF‑alfa antagonist therapy, and has not failed PBS‑subsidised therapy with adalimumab in the current treatment cycle; and
where TNF‑alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF‑alfa antagonists which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a TNF‑alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 TNF‑alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised treatment with 3 TNF‑alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
a patient is eligible to receive further therapy with a TNF‑alfa antagonist within this treatment cycle provided they have not already failed, or ceased to respond to, PBS‑subsidised treatment with 3 TNF‑alfa antagonists within this treatment cycle;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form;
an assessment of response to the patient’s most recent course of PBS‑subsidised TNF‑alfa antagonist treatment is provided to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased;
where the most recent course of TNF‑antagonist treatment is an initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;
if the response assessment to the previous course of TNF‑alfa antagonist treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of 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, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C3752
P3752
 
Ankylosing spondylitis — continuing treatment
Continuing treatment with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated an adequate response to treatment with adalimumab, and whose most recent course of PBS‑subsidised therapy in this treatment cycle was with adalimumab; and
where TNF‑alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF‑alfa antagonists which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a TNF‑alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 TNF‑alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised treatment with 3 TNF‑alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response is defined as an improvement from baseline of at least 2 in the patient’s Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:
(a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or
(b) a C‑reactive protein (CRP) measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline;
all measurements provided are no more than 1 month old at the time of application;
where only 1 acute phase reactant measurement is supplied to establish baseline in the first application for PBS‑subsidised treatment, that same marker is measured and supplied in all subsequent continuing treatment applications;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis 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 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 with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

(c)      insert in numerical order following existing text:

 
C4609
P4609
 
Active ankylosing spondylitis
Initial treatment – Initial 1 (new patients)
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must not have received any PBS-subsidised treatment with either adalimumab, certolizumab pegol, etanercept, golimumab or infliximab in this treatment cycle; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months
Patient must be an adult
Must be treated by a rheumatologist
The application must include details of the NSAIDs trialled, their doses and duration of treatment
If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used
If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; AND
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L
The BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment
The BASDAI must be no more than 1 month old at the time of initial application
Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which must include the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
(iv) a signed patient acknowledgment
The assessment of the patient's response to the initial course of treatment must be made following a minimum of 12 weeks of treatment and submitted no later than 4 weeks from the cessation of that treatment course. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment
A maximum of 16 weeks of treatment with this drug will be approved under this criterion
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) was approved in this cycle and the date of the first application under a new cycle
Compliance with Written Authority Required procedures


 
C4610
P4610
 
Ankylosing spondylitis
Initial treatment – Initial 1 (new patients) or Initial 2 (change or recommencement for all patients) – balance of supply
Patient must have active, or a documented history of active, ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Initial 1 (new patients) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement for all patients) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions
Patient must be an adult
Must be treated by a rheumatologist
Compliance with Written or Telephone Authority Required procedures


 
C4629
P4629
 
Ankylosing spondylitis
Initial treatment – Initial 2 (change or recommencement for all patients)
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND
Patient must be eligible to receive further bDMARD therapy
Patient must be an adult
Must be treated by a rheumatologist
Where the most recent course of PBS-subsidised bDMARD treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised bDMARD therapy or, under this restriction, for patients who have received previous PBS-subsidised bDMARD therapy) the patient must have been assessed for response to that course following a minimum of 12 weeks of treatment. These assessments must be provided to the Department of Human Services no later than 4 weeks from the date the course was ceased. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, patients must have been assessed for response, and the assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form
A maximum of 16 weeks of treatment with this drug will be approved under this criterion
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle
Compliance with Written Authority Required procedures


 
C4642
P4642
 
Ankylosing spondylitis
Continuing treatment
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug
Patient must be an adult
Must be treated by a rheumatologist
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form
All measurements provided must be no more than 1 month old at the time of application
A maximum of 24 weeks of treatment with this drug will be authorised under this criterion
All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment following an initial treatment course it must be made following a minimum of 12 weeks of treatment with this drug. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle
Compliance with Written Authority Required procedures


 
C4643
P4643
 
Ankylosing spondylitis
Continuing treatment – balance of supply
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction
Patient must be an adult
Must be treated by a rheumatologist
Compliance with Written or Telephone Authority Required procedures


[222]       Schedule 4, Part 1, entry for Aflibercept [Circumstances Code: C4153; and C4154]
omit from the column headed “Circumstances and Purposes”:                                Must be treated by a ophthalmologist  
substitute:             Must be treated by an ophthalmologist
[223]       Schedule 4, Part 1, entry for Certolizumab pegol
insert in numerical order in the columns in the order indicated:

 
C4605
 
 
Active ankylosing spondylitis
Initial treatment – Initial 1 (new patients)
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must not have received any PBS-subsidised treatment with either adalimumab, certolizumab pegol, etanercept, golimumab or infliximab in this treatment cycle; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months
Patient must be an adult
Must be treated by a rheumatologist
The application must include details of the NSAIDs trialled, their doses and duration of treatment
If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used
If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; AND
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L
The BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment
The BASDAI must be no more than 1 month old at the time of initial application
Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which must include the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
(iv) a signed patient acknowledgment
The assessment of the patient's response to the initial course of treatment must be made following a minimum of 12 weeks of treatment and submitted no later than 4 weeks from the cessation of that treatment course. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment
A maximum of 18 to 20 weeks of treatment with this drug will be approved under this criterion
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) was approved in this cycle and the date of the first application under a new cycle
Compliance with Written Authority Required procedures


 
C4606
 
 
Ankylosing spondylitis
Initial treatment – Initial 1 (new patients) or Initial 2 (change or recommencement for all patients) – balance of supply
Patient must have active, or a documented history of active, ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Initial 1 (new patients) restriction to complete 18 to 20 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement for all patients) restriction to complete 18 to 20 weeks treatment; AND
The treatment must provide no more than the balance of up to 18 to 20 weeks treatment available under the above restrictions
Patient must be an adult
Must be treated by a rheumatologist
Compliance with Written or Telephone Authority Required procedures


 
C4614
 
 
Ankylosing spondylitis
Initial treatment – Initial 2 (change or recommencement for all patients)
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND
Patient must be eligible to receive further bDMARD therapy
Patient must be an adult
Must be treated by a rheumatologist
Where the most recent course of PBS-subsidised bDMARD treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised bDMARD therapy or, under this restriction, for patients who have received previous PBS-subsidised bDMARD therapy) the patient must have been assessed for response to that course following a minimum of 12 weeks of treatment. These assessments must be provided to the Department of Human Services no later than 4 weeks from the date the course was ceased. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, patients must have been assessed for response, and the assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form
A maximum of 18 to 20 weeks of treatment with this drug will be approved under this criterion
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle
Compliance with Written Authority Required procedures


 
C4642
 
 
Ankylosing spondylitis
Continuing treatment
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug
Patient must be an adult
Must be treated by a rheumatologist
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form
All measurements provided must be no more than 1 month old at the time of application
A maximum of 24 weeks of treatment with this drug will be authorised under this criterion
All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment following an initial treatment course it must be made following a minimum of 12 weeks of treatment with this drug. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle
Compliance with Written Authority Required procedures


 
C4643
 
 
Ankylosing spondylitis
Continuing treatment – balance of supply
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction
Patient must be an adult
Must be treated by a rheumatologist
Compliance with Written or Telephone Authority Required procedures


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

 
C3510
P3510
 
Ankylosing spondylitis — initial treatment 1
Initial treatment with etanercept commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:
(a) who has not received any PBS‑subsidised treatment with a tumour necrosis factor (TNF)‑alfa antagonist, or, where the patient has previously received PBS‑subsidised TNF‑alfa antagonist treatment for this condition, has received no such treatment for a period of 5 years or more starting from the date the last course of PBS‑subsidised treatment was approved; and
(b) who has at least 2 of the following:
(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or
(ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or
(iii) limitation of chest expansion relative to normal values for age and gender; and
(c) who has failed to achieve an adequate response following treatment with at least 2 non‑steroidal anti‑inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS‑subsidised TNF‑alfa antagonist therapy of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and
where TNF‑alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF‑alfa antagonists which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a TNF‑alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 TNF‑alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised treatment with 3 TNF‑alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is demonstrated by:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0‑10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 10 mg per L;
both ESR and CRP measurements are included in the authority application and are no more than 1 month old;
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied;
the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;
if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)‑approved Product Information, the authority application includes the reason why a higher dose cannot be used;
if treatment with NSAIDs is contraindicated according to the relevant TGA‑approved Product Information, the authority application includes details of the contraindication;
if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;
an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;
if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a signed patient acknowledgment form; and
(iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;
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 with etanercept in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

(b)      omit:

 
C3774
P3774
 
Ankylosing spondylitis — initial treatment 2
Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS‑subsidised tumour necrosis factor (TNF)‑alfa antagonist treatment for this condition and is eligible to receive further TNF‑alfa antagonist therapy, and has not failed PBS‑subsidised therapy with etanercept in the current treatment cycle; and
where TNF‑alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF‑alfa antagonists which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a TNF‑alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 TNF‑alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised treatment with 3 TNF‑alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
a patient is eligible to receive further therapy with a TNF‑alfa antagonist within this treatment cycle provided they have not already failed, or ceased to respond to, PBS‑subsidised treatment with 3 TNF‑alfa antagonists within this treatment cycle;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form;
an assessment of response to the patient’s most recent course of PBS‑subsidised TNF‑alfa antagonist treatment is provided to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased;
where the most recent course of TNF‑antagonist treatment is an initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;
if the response assessment to the previous course of TNF‑alfa antagonist treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of 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, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C3775
P3775
 
Ankylosing spondylitis — continuing treatment
Continuing treatment with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated an adequate response to treatment with etanercept, and whose most recent course of PBS‑subsidised therapy in this treatment cycle was with etanercept; and
where TNF‑alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF‑alfa antagonists which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a TNF‑alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 TNF‑alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised treatment with 3 TNF‑alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response is defined as an improvement from baseline of at least 2 in the patient’s Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:
(a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or
(b) a C‑reactive protein (CRP) measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline;
all measurements provided are no more than 1 month old at the time of application;
where only 1 acute phase reactant measurement is supplied to establish baseline in the first application for PBS‑subsidised treatment, that same marker is measured and supplied in all subsequent continuing treatment applications;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept;
the response assessment included in the application is provided to the Chief Executive Medicare  no later than 4 weeks from the cessation of the treatment course;
if the most recent course of etanercept therapy is a 16‑week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment 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 with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

(c)      insert in numerical order following existing text:

 
C4609
P4609
 
Active ankylosing spondylitis
Initial treatment – Initial 1 (new patients)
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must not have received any PBS-subsidised treatment with either adalimumab, certolizumab pegol, etanercept, golimumab or infliximab in this treatment cycle; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months
Patient must be an adult
Must be treated by a rheumatologist
The application must include details of the NSAIDs trialled, their doses and duration of treatment
If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used
If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; AND
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L
The BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment
The BASDAI must be no more than 1 month old at the time of initial application
Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which must include the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
(iv) a signed patient acknowledgment
The assessment of the patient's response to the initial course of treatment must be made following a minimum of 12 weeks of treatment and submitted no later than 4 weeks from the cessation of that treatment course. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment
A maximum of 16 weeks of treatment with this drug will be approved under this criterion
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) was approved in this cycle and the date of the first application under a new cycle
Compliance with Written Authority Required procedures


 
C4610
P4610
 
Ankylosing spondylitis
Initial treatment – Initial 1 (new patients) or Initial 2 (change or recommencement for all patients) – balance of supply
Patient must have active, or a documented history of active, ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Initial 1 (new patients) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement for all patients) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions
Patient must be an adult
Must be treated by a rheumatologist
Compliance with Written or Telephone Authority Required procedures


 
C4629
P4629
 
Ankylosing spondylitis
Initial treatment – Initial 2 (change or recommencement for all patients)
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND
Patient must be eligible to receive further bDMARD therapy
Patient must be an adult
Must be treated by a rheumatologist
Where the most recent course of PBS-subsidised bDMARD treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised bDMARD therapy or, under this restriction, for patients who have received previous PBS-subsidised bDMARD therapy) the patient must have been assessed for response to that course following a minimum of 12 weeks of treatment. These assessments must be provided to the Department of Human Services no later than 4 weeks from the date the course was ceased. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, patients must have been assessed for response, and the assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form
A maximum of 16 weeks of treatment with this drug will be approved under this criterion
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle
Compliance with Written Authority Required procedures


 
C4642
P4642
 
Ankylosing spondylitis
Continuing treatment
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug
Patient must be an adult
Must be treated by a rheumatologist
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form
All measurements provided must be no more than 1 month old at the time of application
A maximum of 24 weeks of treatment with this drug will be authorised under this criterion
All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment following an initial treatment course it must be made following a minimum of 12 weeks of treatment with this drug. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle
Compliance with Written Authority Required procedures


 
C4643
P4643
 
Ankylosing spondylitis
Continuing treatment – balance of supply
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction
Patient must be an adult
Must be treated by a rheumatologist
Compliance with Written or Telephone Authority Required procedures


[225]       Schedule 4, Part 1, entry for Everolimus [Circumstances Code: C4334; C4351 and C4557]
insert in  the column headed “Purposes Code”respectively:
P4334
P4351
P4557
[226]       Schedule 4, Part 1, entry for Everolimus
insert in numerical order following existing text:

 
C4604
P4604
 
Stage IV clear cell variant renal cell carcinoma (RCC)
Initial treatment
Patient must have progressive disease according to the Response Evaluation Criteria In Solid Tumours (RECIST) following first-line treatment with a tyrosine kinase inhibitor; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Patients who have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised everolimus
Patients who have progressive disease with everolimus are no longer eligible for PBS-subsidised everolimus
Compliance with Authority Required procedures


 
C4632
P4632
 
Stage IV clear cell variant renal cell carcinoma (RCC)
Continuing treatment beyond 3 months
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND
The treatment must be the sole PBS-subsidised therapy for this condition
Patients who have progressive disease with everolimus are no longer eligible for PBS-subsidised everolimus
Compliance with Authority Required procedures


[227]       Schedule 4, Part 1, entry for Golimumab
(a)      omit:

 
C3516
P3516
 
Ankylosing spondylitis — initial treatment 1
Initial treatment with golimumab commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:
(a) who has not received any PBS‑subsidised treatment with a tumour necrosis factor (TNF)‑alfa antagonist, or, where the patient has previously received PBS‑subsidised TNF‑alfa antagonist treatment for this condition, has received no such treatment for a period of 5 years or more starting from the date the last course of PBS‑subsidised treatment was approved; and
(b) who has at least 2 of the following:
(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or
(ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or
(iii) limitation of chest expansion relative to normal values for age and gender; and
(c) who has failed to achieve an adequate response following treatment with at least 2 non‑steroidal anti‑inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS‑subsidised TNF‑alfa antagonist therapy of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and
where TNF‑alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF‑alfa antagonists which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a TNF‑alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 TNF‑alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised treatment with 3 TNF‑alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is demonstrated by:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0‑10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 10 mg per L;
both ESR and CRP measurements are included in the authority application and are no more than 1 month old;
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied;
the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;
if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)‑approved Product Information, the authority application includes the reason why a higher dose cannot be used;
if treatment with NSAIDs is contraindicated according to the relevant TGA‑approved Product Information, the authority application includes details of the contraindication;
if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;
an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;
if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a signed patient acknowledgment form; and
(iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;
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 with golimumab in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C3518
P3518
 
Ankylosing spondylitis — initial treatment 3
Commencement of a treatment cycle with an initial PBS‑subsidised course of golimumab for continuing treatment, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who was receiving treatment with golimumab prior to 1 March 2010; and
(a) who has demonstrated a response as specified in the criteria for continuing PBS‑subsidised treatment with golimumab; and
(b) who is receiving treatment with golimumab at the time of application; and
where TNF‑alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF‑alfa antagonists which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a TNF‑alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 TNF‑alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised treatment with 3 TNF‑alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a signed patient acknowledgment form;
the BASDAI assessment and the ESR and/or CRP measurements provided are no more than 1 month old at the time of application;
the course of treatment is limited to a maximum of 24 weeks of treatment;
patients are 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 with golimumab commencing a treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who was receiving non‑PBS‑subsidised treatment with golimumab 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 this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

(b)      omit:

 
C3786
P3786
 
Ankylosing spondylitis — initial treatment 2
Initial treatment, or recommencement of treatment, with golimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS‑subsidised tumour necrosis factor (TNF)‑alfa antagonist treatment for this condition and is eligible to receive further TNF‑alfa antagonist therapy, and has not failed PBS‑subsidised therapy with golimumab in the current treatment cycle; and
where TNF‑alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF‑alfa antagonists which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a TNF‑alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 TNF‑alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised treatment with 3 TNF‑alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
a patient is eligible to receive further therapy with a TNF‑alfa antagonist within this treatment cycle provided they have not already failed, or ceased to respond to, PBS‑subsidised treatment with 3 TNF‑alfa antagonists within this treatment cycle;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form;
an assessment of response to the patient’s most recent course of PBS‑subsidised TNF‑alfa antagonist treatment is provided to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased;
where the most recent course of TNF‑antagonist treatment is an initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;
if the response assessment to the previous course of TNF‑alfa antagonist treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of 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 golimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C3787
P3787
 
Ankylosing spondylitis — continuing treatment
Continuing treatment with golimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated an adequate response to treatment with golimumab, and whose most recent course of PBS‑subsidised therapy in this treatment cycle was with golimumab; and
where TNF‑alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF‑alfa antagonists which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a TNF‑alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 TNF‑alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised treatment with 3 TNF‑alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response is defined as an improvement from baseline of at least 2 in the patient’s Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:
(a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or
(b) a C‑reactive protein (CRP) measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline;
all measurements provided are no more than 1 month old at the time of application;
where only 1 acute phase reactant measurement is supplied to establish baseline in the first application for PBS‑subsidised treatment, that same marker is measured and supplied in all subsequent continuing treatment applications;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with golimumab;
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 golimumab therapy is a 16‑week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment 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 with golimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

(c)      insert in numerical order following existing text:

 
C4609
P4609
 
Active ankylosing spondylitis
Initial treatment – Initial 1 (new patients)
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must not have received any PBS-subsidised treatment with either adalimumab, certolizumab pegol, etanercept, golimumab or infliximab in this treatment cycle; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months
Patient must be an adult
Must be treated by a rheumatologist
The application must include details of the NSAIDs trialled, their doses and duration of treatment
If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used
If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; AND
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L
The BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment
The BASDAI must be no more than 1 month old at the time of initial application
Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which must include the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
(iv) a signed patient acknowledgment
The assessment of the patient's response to the initial course of treatment must be made following a minimum of 12 weeks of treatment and submitted no later than 4 weeks from the cessation of that treatment course. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment
A maximum of 16 weeks of treatment with this drug will be approved under this criterion
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) was approved in this cycle and the date of the first application under a new cycle
Compliance with Written Authority Required procedures


 
C4610
P4610
 
Ankylosing spondylitis
Initial treatment – Initial 1 (new patients) or Initial 2 (change or recommencement for all patients) – balance of supply
Patient must have active, or a documented history of active, ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Initial 1 (new patients) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement for all patients) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions
Patient must be an adult
Must be treated by a rheumatologist
Compliance with Written or Telephone Authority Required procedures


 
C4629
P4629
 
Ankylosing spondylitis
Initial treatment – Initial 2 (change or recommencement for all patients)
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND
Patient must be eligible to receive further bDMARD therapy
Patient must be an adult
Must be treated by a rheumatologist
Where the most recent course of PBS-subsidised bDMARD treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised bDMARD therapy or, under this restriction, for patients who have received previous PBS-subsidised bDMARD therapy) the patient must have been assessed for response to that course following a minimum of 12 weeks of treatment. These assessments must be provided to the Department of Human Services no later than 4 weeks from the date the course was ceased. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, patients must have been assessed for response, and the assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form
A maximum of 16 weeks of treatment with this drug will be approved under this criterion
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle
Compliance with Written Authority Required procedures


 
C4642
P4642
 
Ankylosing spondylitis
Continuing treatment
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug
Patient must be an adult
Must be treated by a rheumatologist
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline
Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form
All measurements provided must be no more than 1 month old at the time of application
A maximum of 24 weeks of treatment with this drug will be authorised under this criterion
All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment following an initial treatment course it must be made following a minimum of 12 weeks of treatment with this drug. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment
Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle
Compliance with Written Authority Required procedures


 
C4643
P4643
 
Ankylosing spondylitis
Continuing treatment – balance of supply
Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction
Patient must be an adult
Must be treated by a rheumatologist
Compliance with Written or Telephone Authority Required procedures


[228]       Schedule 4, Part 1, omit entry for Omeprazole and Clarithromycin and Amoxycillin
[229]       Schedule 4, Part 1, entry for Ranibizumab
substitute:

Ranibizumab
C4607
 
 
Subfoveal choroidal neovascularisation (CNV)
Continuing treatment
The condition must be due to age-related macular degeneration (AMD); AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been granted an authority prescription for the same eye
Must be treated by an ophthalmologist
Compliance with Written or Telephone Authority Required procedures


 
C4640
 
 
Subfoveal choroidal neovascularisation (CNV)
Initial treatment
The condition must be due to age-related macular degeneration (AMD); AND
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Must be treated by an ophthalmologist
Authority approval for initial treatment of each eye must be sought
The first authority application for each eye must be made in writing or by telephone
A written application must include:
a) a completed authority prescription form;
b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and
c) a copy of the fluorescein angiogram
A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised
Where a fluorescein angiogram cannot be performed due to a contraindication as listed in the TGA-approved product information, details of the contraindication must be provided. A copy of the report of an alternative method of diagnosis must be included in the application, for example, optical coherence tomography (OCT) or red free photography
Compliance with Written or Telephone Authority Required procedures