PB 36 of 2011
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011
(No. 6)1
National Health Act 1953
I, FELICITY McNEILL, Acting First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this Instrument under sections 84AF, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 24 May 2011
 
 
 
 
 
 
 
 
 
 
 
FELICITY McNEILL
Acting First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing
 
1          Name of Instrument
            (1)        This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 6).
            (2)        This Instrument may also be cited as PB 36 of 2011.
2          Commencement
            This Instrument commences on 1 June 2011.
3          Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010)
            Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).
Schedule 1     Amendments
 
[1] Schedule 1, entry for Acetazolamide
omit from the column headed “Responsible Person”:             SI         substitute:             QA      
[2] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe with Max Quantity 2 and Number of Repeats 2
omit from the column headed “Circumstances”:
C3568  C3569
 and insert in numerical order:
C3706  C3707
[3] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe with Max Quantity 2 and Number of Repeats 3
(a)        omit from the column headed “Circumstances”:
C3568  C3569
and insert in numerical order:
C3706  C3707
(b)        omit from the column headed “Purposes”:
P3568  P3569
substitute:
P3706  P3707
[4] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe with Max Quantity 2 and Number of Repeats 4
omit from the column headed “Circumstances”:
C3568  C3569
 and insert in numerical order:
C3706  C3707
[5] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe with Max Quantity 2 and Number of Repeats 5
omit from the column headed “Circumstances”:
C3568  C3569
 and insert in numerical order:
C3706  C3707
[6] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen with Max Quantity 2 and Number of Repeats 2
omit from the column headed “Circumstances”:
C3568  C3569
 and insert in numerical order:
C3706  C3707
[7] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen with Max Quantity 2 and Number of Repeats 3
(a)        omit from the column headed “Circumstances”:
C3568  C3569
and insert in numerical order:
C3706  C3707
(b)        omit from the column headed “Purposes”:
P3568  P3569
substitute:
P3706  P3707
[8] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen with Max Quantity 2 and Number of Repeats 4
omit from the column headed “Purposes”:
C3568  C3569
substitute:
C3706  C3707
[9] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen with Max Quantity 2 and Number of Repeats 5
omit from the column headed “Circumstances”:
C3568  C3569
 and insert in numerical order:
C3706  C3707
[10]         Schedule 1, entry for Adrenaline in the form Injection 1 mg (as acid tartrate) in 1 mL (1 in 1,000)
(a)        omit from the column headed “Brand”:                   AstraZeneca Pty Ltd                 substitute:          Link Medical Products Pty Ltd
(b)        omit from the column headed “Responsible Person”:                 AP          substitute:             LM
[11]         Schedule 1, entry for Alendronic Acid
omit from the column headed “Responsible Person”:             SI         substitute:             QA
[12]         Schedule 1, entry for Allopurinol
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[13]         Schedule 1, entry for Alprazolam
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[14]         Schedule 1, entry for Amiodarone
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[15]         Schedule 1, entry for Amisulpride
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[16]         Schedule 1, entry for Amoxycillin
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[17]         Schedule 1, entry for Amoxycillin in the form Capsule 500 mg (as trihydrate)
(a)        insert in the columns in the order indicated after the first instance of the brand “Amoxycillin-GA”:
 
 
 
Amoxycillin generichealth 500
GQ
PDP
 
 
20
0
 
(b)        insert in the columns in the order indicated after the second  instance of the brand “Amoxycillin-GA”:
 
 
 
Amoxycillin generichealth 500
GQ
MP NP MW
 
 
20
1
 
[18]         Schedule 1, entry for Amoxycillin with Clavulanic Acid
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[19]         Schedule 1, entry for Amphotericin
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[20]         Schedule 1, entry for Atenolol
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[21]         Schedule 1, entry for Atropine
omit from the column headed “Responsible Person”:            SI         substitute:          QA
[22]         Schedule 1, entry for Azathioprine
omit from the column headed “Responsible Person”:            SI         substitute:          QA
[23]         Schedule 1, entry for Baclofen
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[24]         Schedule 1, entry for Benzhexol
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[25]         Schedule 1, entry for Betamethasone
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[26]         Schedule 1, entry for Bicalutamide
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[27]         Schedule 1, entry for Bisoprolol
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[28]         Schedule 1, entry for Bleomycin
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[29]         Schedule 1, entry for Cabergoline
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[30]         Schedule 1, entry for Calcitriol
omit from the column headed “Responsible Person”:             SI         substitute:          QA
[31]         Schedule 1, entry for Captopril
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[32]         Schedule 1, entry for Carvedilol
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:             QA
[33]         Schedule 1, entry for Cefaclor
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[34]         Schedule 1, entry for Certolizumab pegol
            substitute:
Certolizumab pegol
Injection 200 mg in 1 mL single use pre-filled syringe
Injection
Cimzia
UC
MP
C3476 C3564 C3714 C3715
 
2
5
 
[35]         Schedule 1, entry for Chloramphenicol
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[36]         Schedule 1, entry for Cholestyramine
omit from the column headed “Responsible Person” (wherever occurring):         SI        substitute:          QA
[37]         Schedule 1, entry for Ciprofloxacin
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[38]         Schedule 1, entry for Citalopram in the form Tablet 20 mg (as hydrobromide)
(a)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Citalopram Pfizer
FZ
MP NP
C1211
 
28
5
 
(b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Citalo 20
MI
MP NP
C1211
 
28
5
 
(c)        omit from the column headed “Responsible Person”:                SI            substitute:             QA
 
[39]         Schedule 1, entry for Citalopram in the form Tablet 40 mg (as hydrobromide)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Citalopram Pfizer
FZ
MP NP
C1211
 
28
5
 
[40]         Schedule 1, entry for Clarithromycin in the form Tablet 250 mg
omit from the column headed “Responsible Person”:             SI         substitute:          QA
[41]         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 RBX
RA
MP NP
C1719 C1720 C1721 C1722 C1723 C1724
 
28
5
 
 
[42]         Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)
omit from the column headed “Responsible Person”:             SI         substitute:          QA
[43]         Schedule 1, entry for Dexamphetamine
(a)        omit from the column headed “Brand”:         Sigma Pharmaceuticals (Australia) Pty Ltd       substitute:                Aspen Pharma Pty Ltd
(b)        omit from the column headed “Responsible Person”:             SI         substitute:          QA
[44]         Schedule 1, entry for Diazepam
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:             QA
[45]         Schedule 1, entry for Diclofenac
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[46]         Schedule 1, entry for Dicloxacillin
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[47]         Schedule 1, entry for Digoxin
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[48]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL for the brand Docetaxel Ebewe with Max Quantity 1 and Number of Repeats 0
omit from the column headed “Circumstances”:
C2439
C3292
[49]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL for the brand Docetaxel Ebewe with Max Quantity 2 and Number of Repeats 0
(a)        omit from the column headed “Circumstances”:
C2439
C3292
(b)        omit from the column headed “Purposes”:
P2439
P3292
[50]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL for the brand Docetaxel Ebewe
omit from the column headed “Circumstances”:
C2439
C3292
[51]         Schedule 1, entry for Dolasetron
omit:
 
I.V. injection containing dolasetron mesylate 100 mg in 5 mL
Injection
Anzemet
SW
MP NP
See Note 1
C3050
 
1
0
 
[52]         Schedule 1, entry for Doxycycline
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[53]         Schedule 1, entry for Enalapril
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[54]         Schedule 1, entry for Escitalopram
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[55]         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 with Max Quantity 2 and Number of Repeats 3
(a)        omit from the column headed “Circumstances”:
C3565 C3566
and insert in numerical order:
C3708  C3709
(b)        omit from the column headed “Purposes”:
P3565  P3566
substitute:
P3708  P3709
[56]         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 with Max Quantity 2 and Number of Repeats 5
omit from the column headed “Circumstances”:
C3565 C3566
and insert in numerical order:
C3708  C3709
[57]         Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 with Max Quantity 1 and Number of Repeats 3
(a)        omit from the column headed “Circumstances”:
C3565 C3566
and insert in numerical order:
C3708  C3709
(b)        omit from the column headed “Purposes”:
P3565  P3566
substitute:
P3708  P3709
[58]         Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 with Max Quantity 1 and Number of Repeats 5
omit from the column headed “Circumstances”:
C3565 C3566
and insert in numerical order:
C3708  C3709
[59]         Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use auto-injector, 4 with Max Quantity 1 and Number of Repeats 3
(a)        omit from the column headed “Circumstances”:
C3565 C3566
and insert in numerical order:
C3708  C3709
(b)        omit from the column headed “Purposes”:
P3565  P3566
substitute:
P3708  P3709
[60]         Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use auto-injector, 4 with Max Quantity 1 and Number of Repeats 5
omit from the column headed “Circumstances”:
C3565 C3566
and insert in numerical order:
C3708  C3709
[61]         Schedule 1, entry for Etonogestrel
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Implanon NXT
MK
MP NP
 
 
1
0
 
 
[62]         Schedule 1, entry for Famciclovir
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[63]         Schedule 1, entry for Famotidine
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[64]         Schedule 1, entry for Felodipine
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[65]         Schedule 1, entry for Fluconazole
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[66]         Schedule 1, entry for Fludrocortisone
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[67]         Schedule 1, entry for Fluoxetine
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[68]         Schedule 1, entry for Fluvoxamine
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[69]         Schedule 1, after entry for Folinic acid in the form Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL
insert in the columns in the order indicated:
 
Injection containing calcium folinate equivalent to 1000 mg folinic acid in 100 mL
Injection
Calcium Folinate Ebewe
IT
MP
 
 
1
1
 
[70]         Schedule 1, entry for Fosinopril
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[71]         Schedule 1, entry for Gabapentin
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[72]         Schedule 1, entry for Gemfibrozil
omit from the column headed “Responsible Person”:            SI         substitute:          QA
[73]         Schedule 1, entry for Gliclazide
omit from the column headed “Responsible Person”:            SI         substitute:          QA
[74]         Schedule 1, entry for Glimepiride
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[75]         Schedule 1, entry for Glyceryl Trinitrate
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[76]         Schedule 1, entry for Glucose Indicator—Blood
omit:
 
Test strips, 50 (MWD Pen Sensor Strips)
For external use
MWD Pen Sensor Strips
WF
MP NP
 
 
2
5
 

 
 
 
 
 
MP
 
P3035
2
11
 

[77]         Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe with Max Quantity 1 and Number of Repeats 3
 (a)       omit from the column headed “Circumstances”:
C3575  C3577
and insert in numerical order:
C3718  C3719
(b)        omit from the column headed “Purposes”:
P3575  P3577
substitute:
P3718  P3719
[78]         Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe with Max Quantity 1 and Number of Repeats 5
omit from the column headed “Circumstances”:
C3575  C3577
and insert in numerical order:
C3718  C3719
[79]         Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen with Max Quantity 1 and Number of Repeats 3
 (a)       omit from the column headed “Circumstances”:
C3575  C3577
and insert in numerical order:
C3718  C3719
(b)        omit from the column headed “Purposes”:
P3575  P3577
substitute:
P3718  P3719
[80]         Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen with Max Quantity 1 and Number of Repeats 5
omit from the column headed “Circumstances”:
C3575  C3577
and insert in numerical order:
C3718  C3719
[81]         Schedule 1, entry for Griseofulvin
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[82]         Schedule 1, entry for Haloperidol
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[83]         Schedule 1, entry for Hydrocortisone
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[84]         Schedule 1, entry for Hypromellose
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[85]         Schedule 1, entry for Indapamide
omit from the column headed “Responsible Person”:            SI         substitute:          QA
[86]         Schedule 1, entry for Ipratropium
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[87]         Schedule 1, entry for Isosorbide Dinitrate
omit from the column headed “Responsible Person”:            SI                     substitute:          QA
[88]         Schedule 1, entry for Isotretinoin
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[89]         Schedule 1, entry for Labetalol
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[90]         Schedule 1, entry for Lactulose
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[91]         Schedule 1, entry for Lamotrigine
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[92]         Schedule 1, entry for Lercanidipine
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[93]         Schedule 1, entry for Levetiracetam
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[94]         Schedule 1, entry for Liothyronine
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[95]         Schedule 1, entry for Lisinopril
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[96]         Schedule 1, entry for Megestrol
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[97]         Schedule 1, entry for Meloxicam
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[98]         Schedule 1, entry for Memantine
(a)        omit from the column headed “Responsible Person”:            SI         substitute:          QA
(b)        omit:
 
Oral drops containing memantine hydrochloride
10 mg per g, 50 g
Oral
Ebixa
LU
MP NP
C2608 C2609
C2610 C2611
 
1
5
 
[99]         Schedule 1, entry for Metformin
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[100]       Schedule 1, entry for Methadone
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[101]       Schedule 1, entry for Metoprolol
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[102]       Schedule 1, entry for Milk powder — lactose free formula in the form Oral powder 900 g (S-26 LF)
omit from the column headed “Responsible Person”:                 WX         substitute:             PF
[103]       Schedule 1, entry for Minocycline
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[104]       Schedule 1, entry for Mirtazapine
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[105]       Schedule 1, entry for Morphine
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[106]       Schedule 1, entry for Nifedipine
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[107]       Schedule 1, entry for Norfloxacin
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[108]       Schedule 1, entry for Nystatin
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[109]       Schedule 1, entry for Omeprazole
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[110]       Schedule 1, entry for Oxazepam
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[111]       Schedule 1, entry for Oxycodone
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[112]       Schedule 1, entry for Pantoprazole
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[113]       Schedule 1, entry for Paroxetine
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[114]       Schedule 1, entry for Perhexiline
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[115]       Schedule 1, entry for Perindopril
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[116]       Schedule 1, entry for Phenobarbitone in the form Tablet 30 mg
(a)        omit from the column headed “Brand”:         Sigma Pharmaceuticals (Australia) Pty Ltd       substitute:                Aspen Pharma Pty Ltd
(b)        omit from the column headed “Responsible Person”:                 SI         substitute:             QA
[117]       Schedule 1, entry for Phenoxymethylpenicillin
omit from the column headed “Responsible Person” (wherever occurring):         SI           substitute:             QA
[118]       Schedule 1, after entry for Phenoxymethylpenicillin in the form Capsule 500 mg phenoxymethylpenicillin (as potassium)
insert in the columns in the order indicated:               
 
Powder for oral liquid 125 mg (as potassium) per 5 mL, 100 mL
Oral
Phenoxymethyl- penicillin-AFT
AE
PDP
 
 
2
0
 

 
 
 
 
 
MP NP
 
 
2
1
 

[119]       Schedule 1, after entry for Phenoxymethylpenicillin in the form Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL
insert in the columns in the order indicated:               
 
Powder for oral liquid 250 mg (as potassium) per 5 mL, 100 mL
Oral
Phenoxymethyl- penicillin-AFT
AE
PDP
 
 
2
0
 

 
 
 
 
 
MP NP
 
 
2
1
 

[120]       Schedule 1, entry for Pioglitazone
            omit from the column headed “Responsible Person” (wherever occurring):         SI                           substitute:             QA
[121]       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 Sandoz
SZ
MP NP
C3540 C3541 C3542
 
28
5
 
[122]       Schedule 1, entry for Pravastatin
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[123]       Schedule 1, entry for Prednisolone
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[124]       Schedule 1, entry for Procaine Penicillin
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[125]       Schedule 1, entry for Prochlorperazine
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[126]       Schedule 1, entry for Propantheline
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[127]       Schedule 1, entry for Quinapril
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[128]       Schedule 1, entry for Ramipril
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[129]       Schedule 1, entry for Ranitidine
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[130]       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”:
 
 
 
Risedro once a week
QA
MP NP
C2645 C2646 C3070
 
4
5
 
[131]       Schedule 1, after entry for Risedronic Acid in the form Tablet containing risedronate sodium 35 mg
insert in the columns in the order indicated:
 
Tablet (enteric coated) containing risedronate sodium 35 mg
Oral
Actonel EC
SW
MP NP
C2645 C2646 C3070
 
4
5
 
[132]       Schedule 1, after entry for Risedronic Acid and Calcium in the form Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate)
insert in the columns in the order indicated:
 
Pack containing 4 enteric coated tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate)
Oral
Actonel EC Combi
SW
MP NP
C2645 C2646 C3070
 
1
5
 
[133]       Schedule 1, after entry for Risedronic acid and calcium with colecalciferol in the form Pack containing 4 tablets risedronate sodium 35 mg and 24 sachets containing granules of calcium carbonate 2.5 g with colecalciferol 22 micrograms
insert in the columns in the order indicated:
 
Pack containing 4 enteric coated tablets risedronate sodium 35 mg and 24 sachets containing granules of calcium carbonate 2.5 g with colecalciferol 22 micrograms
Oral
Actonel EC Combi D
SW
MP NP
C2645 C2646 C3070
 
1
5
 
[134]       Schedule 1, entry for Risperidone
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[135]       Schedule 1, entry for Roxithromycin
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[136]       Schedule 1, entry for Salbutamol
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[137]       Schedule 1, after entry for Saquinavir
insert:
Saxagliptin
Tablet 5 mg (as hydrochloride)
Oral
Onglyza
BQ
MP NP
C3540
 
28
5
 
[138]       Schedule 1, entry for Sertraline
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[139]       Schedule 1, entry for Simvastatin
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[140]       Schedule 1, entry for Simvastatin in each of the forms Tablet 10 mg; Tablet 20 mg; Tablet 40 mg; and Tablet 80 mg
(a)        insert in the columns in the order indicated after the first instance of the brand “Simvastatin generichealth”:
 
 
 
Simvastatin Pfizer
FZ
MP
C1540 C3047
P1540
30
5
 

 
 
 
 
 
NP
C1540
 
30
5
 

(b)        insert in the columns in the order indicated after the second instance of the brand “Simvastatin generichealth”:
 
 
 
Simvastatin Pfizer
FZ
MP
C1540 C3047
P3047
30
11
 
[141]       Schedule 1, entry for Sirolimus
insert as first entry in the columns in the order indicated:
 
Tablet 0.5 mg
Oral
Rapamune (Pfizer Australia Pty Ltd)
PF
MP
C1952
 
100
3
 

 
 
 
 
 
MP
See Note 1
C1650 C3355
 
200
5
C

[142]       Schedule 1, entry for Sotalol
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[143]       Schedule 1, entry for Sumatriptan
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[144]       Schedule 1, entry for Sulfacetamide
omit:
Sulfacetamide
Eye drops containing sulfacetamide sodium 100 mg  per mL, 15 mL
Application to
the eye
Bleph 10
AG
MP NP AO
 
 
1
2
 
[145]       Schedule 1, entry for Tamoxifen
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[146]       Schedule 1, after entry for Telmisartan
insert:
Telmisartan with amlodipine
Tablet 40 mg-5 mg (as besylate)
Oral
Twynsta
BY
MP NP
C3307
 
28
5
 

 
Tablet 40 mg-10 mg (as besylate)
Oral
Twynsta
BY
MP NP
C3307
 
28
5
 

 
Tablet 80 mg-5 mg (as besylate)
Oral
Twynsta
BY
MP NP
C3307
 
28
5
 

 
Tablet 80 mg-10 mg (as besylate)
Oral
Twynsta
BY
MP NP
C3307
 
28
5
 

 
[147]       Schedule 1, entry for Temazepam
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[148]       Schedule 1, entry for Terbinafine
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[149]       Schedule 1, entry for Thiotepa
(a)        omit from the column headed “Brand”:         Sigma Pharmaceuticals (Australia) Pty Ltd       substitute:                Aspen Pharma Pty Ltd
(b)        omit from the column headed “Responsible Person”:                SI            substitute:             QA
[150]       Schedule 1, entry for Thyroxine
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[151]       Schedule 1, entry for Timolol
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[152]       Schedule 1, entry for Topiramate
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[153]       Schedule 1, entry for Tramadol
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[154]       Schedule 1, entry for Trandolapril
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[155]       Schedule 1, entry for Triamcinolone
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[156]       Schedule 1, entry for Triamcinolone with Neomycin, Gramicidin and Nystatin
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[157]       Schedule 1, entry for Trimethoprim
omit from the column headed “Responsible Person”:                 SI         substitute:          QA
[158]       Schedule 1, entry for Trimethoprim with Sulfamethoxazole
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[159]       Schedule 1, entry for Valaciclovir
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[160]       Schedule 1, entry for Valproic Acid
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[161]       Schedule 1, entry for Verapamil
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[162]       Schedule 1, entry for Warfarin
omit from the column headed “Responsible Person” (wherever occurring):         SI         substitute:          QA
[163]       Schedule 3, entry for Responsible Person code AW
omit:       Sigma Pharmaceuticals (Australia) Pty Ltd       substitute:             Aspen Pharma Pty Ltd
[164]       Schedule 3, after details relevant to Responsible Person code PZ
insert:
QA
Aspen Pharma Pty Ltd
88 004 118 594
[165]       Schedule 3, entry for Responsible Person code SI
omit:       Sigma Pharmaceuticals (Australia) Pty Ltd       substitute:             Sigma Company Limited
omit:       88 004 118 594              substitute:             44 004 132 923
[166]       Schedule 3
omit:
WF
Skyline Productions Pty Limited
22 135 408 374
[167]       Schedule 4, Part 1, entry for Adalimumab
omit:
 
C3568
P3568
Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 12 months)
Initial PBS-subsidised treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and
(c) have failed to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with adalimumab for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 16 weeks of treatment
Compliance with Written Authority Required procedures

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

 
C3569
P3569
Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 12 months)
Initial PBS-subsidised treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 12 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS-subsidised treatment with adalimumab for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with adalimumab are not eligible to commence treatment with adalimumab until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with adalimumab and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised adalimumab treatment;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised adalimumab treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 16 weeks of treatment
Compliance with Written Authority Required procedures

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

insert as the final entry in the columns in the order indicated:
 
C3706
P3706
Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 24 months)
Initial PBS-subsidised treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; and
(c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with adalimumab for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 16 weeks of treatment
Compliance with Written Authority Required procedures


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

 
C3707
P3707
Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS-subsidised treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS-subsidised treatment with adalimumab for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with adalimumab are not eligible to commence treatment with adalimumab until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with adalimumab and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised adalimumab treatment;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised adalimumab treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 16 weeks of treatment

Compliance with Written Authority Required procedures


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

[168]       Schedule 4, Part 1, entry for Certolizumab pegol
omit:
 
C3562
 
Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 12 months)
Initial PBS-subsidised treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and
(c) have failed to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with certolizumab pegol for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 18 to 20 weeks of treatment, depending on the dosage regimen
Compliance with Written Authority Required procedures

 
 
 
Continuation of a course of initial treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than the maximum allowed based on their dosage regimen, and where approval of the application would enable the patient to complete a course of 18 or 20 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C3563
 
Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 12 months)
Initial PBS-subsidised treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 12 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS-subsidised treatment with certolizumab pegol for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with certolizumab pegol are not eligible to commence treatment with certolizumab pegol until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with certolizumab pegol and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised certolizumb pegol treatment;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised certolizumab pegol treatment is an 18 or 20 week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 18 to 20 weeks of treatment, depending on the dosage regimen
Compliance with Written Authority Required procedures

 
 
 
Continuation of a course of initial treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than the maximum allowed based on their dosage regimen, and where approval of the application would enable the patient to complete a course of 18 or 20 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

insert as the final entry in the columns in the order indicated:
 
C3714
 
Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 24 months)
Initial PBS-subsidised treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; and
(c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with certolizumab pegol for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 18 to 20 weeks of treatment, depending on the dosage regimen

Compliance with Written Authority Required procedures


 
 
 
Continuation of a course of initial treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than the maximum allowed based on their dosage regimen, and where approval of the application would enable the patient to complete a course of 18 or 20 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C3715
 
Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS-subsidised treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS-subsidised treatment with certolizumab pegol for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with certolizumab pegol are not eligible to commence treatment with certolizumab pegol until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with certolizumab pegol and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised certolizumb pegol treatment;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised certolizumab pegol treatment is an 18 or 20 week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 18 to 20 weeks of treatment, depending on the dosage regimen
Compliance with Written Authority Required procedures

 
 
 
Continuation of a course of initial treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than the maximum allowed based on their dosage regimen, and where approval of the application would enable the patient to complete a course of 18 or 20 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

[169]       Schedule 4, Part 1, entry for Etanercept
omit:
 
C3565
C3565
Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 12 months)
Initial PBS-subsidised treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and
(c) have failed to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with etanercept for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 16 weeks of treatment
Compliance with Written Authority Required procedures

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

 
C3566
P3566
Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 12 months)
Initial PBS-subsidised treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 12 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS-subsidised treatment with etanercept for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with etanercept are not eligible to commence treatment with etanercept until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with etanercept and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised etanercept treatment;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised etanercept treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 16 weeks of treatment
Compliance with Written Authority Required procedures

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

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


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

 
C3709
P3709
Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS-subsidised treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS-subsidised treatment with etanercept for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with etanercept are not eligible to commence treatment with etanercept until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with etanercept and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised etanercept treatment;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised etanercept treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 16 weeks of treatment
Compliance with Written Authority Required procedures


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

[170]       Schedule 4, Part 1, entry for Golimumab
omit:
 
C3575
P3575
Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 12 months)
Initial PBS-subsidised treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and
(c) have failed to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with golimumab for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 16 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
Continuation of a course of initial treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C3577
P3577
Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 12 months)
Initial PBS-subsidised treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 12 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS-subsidised treatment with golimumab for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with golimumab are not eligible to commence treatment with golimumab until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with golimumab and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised golimumab treatment;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised golimumab treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 16 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
Continuation of a course of initial treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

insert after existing text in the columns in the order indicated:
 
C3718
P3718
Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 24 months)
Initial PBS-subsidised treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; and
(c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with golimumab for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 16 weeks of treatment

Compliance with Written Authority Required procedures


 
 
 
Continuation of a course of initial treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C3719
P3719
Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS-subsidised treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS-subsidised treatment with golimumab for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with golimumab are not eligible to commence treatment with golimumab until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with golimumab and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised golimumab treatment;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised golimumab treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 16 weeks of treatment

Compliance with Written Authority Required procedures


 
 
 
Continuation of a course of initial treatment with golimumab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

[171]       Schedule 4, Part 1, after entry for Saquinavir
insert:
Saxagliptin
C3540
 
Treatment of type 2 diabetes, in combination with either metformin or a sulfonylurea, in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and:
(a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 is greater than 7%, despite treatment with either metformin or a sulfonylurea; or
(b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a gliptin, a glitazone or a glucagon-like peptide-1 shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with either metformin or a sulfonylurea; and
where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and
where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 3540

[172]       Schedule 4, Part 1, after entry for Telbivudine
insert:
Telmisartan with amlodipine
C3307
 
Hypertension in a patient who is not adequately controlled with either of the drugs in the combination.
 
 
 
 
 
1Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. 
See http://www.frli.gov.au