PB 88 of 2014
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 12)
National Health Act 1953
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 25 November 2014
FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health
1 Name of Instrument
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 12).
(2) This Instrument may also be cited as PB 88 of 2014.
2 Commencement
This Instrument commences on 1 December 2014.
3 Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1 Amendments
[1] Schedule 1, entry for Abatacept in the form Injection 125 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 4;
Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C3996 C3997 C3998 substitute: C4664 C4720 C4739 C4745 C4746
(b) omit from the column headed “Purposes”: P3996 P3997 substitute: P4664 P4745 P4746
[2] Schedule 1, entry for Abatacept in the form Injection 125 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 4;
Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C3996 C3997 C3998 substitute: C4664 C4720 C4739 C4745 C4746
(b) omit from the column headed “Purposes”: P3998 substitute: P4720 C4739
[3] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]
(a) omit from the column headed “Circumstances”: C3706 C3745 C3746
(b) insert in numerical order: C4666 C4700 C4710 C4724 C4751
[4] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C3706 C3745 C3746
(b) insert in numerical order: C4666 C4700 C4710 C4724 C4751
(c) omit from the column headed “Purposes”: P3706 P3745
(d) insert in numerical order: P4700 P4710 P4751
[5] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 4]
(a) omit from the column headed “Circumstances”: C3706 C3745 C3746
(b) insert in numerical order: C4666 C4700 C4710 C4724 C4751
[6] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C3706 C3745 C3746
(b) insert in numerical order: C4666 C4700 C4710 C4724 C4751
(c) omit from the column headed “Purposes”: P3746
(d) insert in numerical order: P4666 P4724
[7] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
(a) omit from the column headed “Circumstances”: C3706 C3745 C3746
(b) insert in numerical order: C4666 C4700 C4710 C4724 C4751
[8] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C3706 C3745 C3746
(b) insert in numerical order: C4666 C4700 C4710 C4724 C4751
(c) omit from the column headed “Purposes”: P3706 P3745
(d) insert in numerical order: P4700 P4710 C4751
[9] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 4]
(a) omit from the column headed “Circumstances”: C3706 C3745 C3746
(b) insert in numerical order: C4666 C4700 C4710 C4724 C4751
[10] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C3706 C3745 C3746
(b) insert in numerical order: C4666 C4700 C4710 C4724 C4751
(c) omit from the column headed “Purposes”: P3746
(d) insert in numerical order: P4666 P4724
[11] Schedule 1, entry for Adefovir
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Adefovir
TX
MP
See Note 1
C3971 C3972 C3973 C3974
60
5
30
D(100)
[12] Schedule 1, entry for Ampicillin in the form Powder for injection 500 mg (as sodium)
omit from the column headed “Responsible Person” for the brand “Austrapen” (twice occurring): LN substitute: AL
[13] Schedule 1, entry for Ampicillin in the form Powder for injection 1 g (as sodium) [Maximum Quantity: 5; Number of Repeats: 0]
(a) omit from the column headed “Responsible Person” for the brand “Aspen Ampicyn”: AS substitute: AF
(b) omit from the column headed “Responsible Person” for the brand “Austrapen”: LN substitute: AL
[14] Schedule 1, entry for Ampicillin in the form Powder for injection 1 g (as sodium) [Maximum Quantity: 5; Number of Repeats: 1]
(a) omit from the column headed “Responsible Person” for the brand “Aspen Ampicyn”: AS substitute: AF
(b) omit from the column headed “Responsible Person” for the brand “Austrapen”: LN substitute: AL
[15] Schedule 1, after entry for Botulinum Toxin Type A Purified Neurotoxin Complex
insert:
Brentuximab vedotin
Powder for I.V. infusion 50 mg
Injection
Adcetris
TK
MP
See Note 1
C4675 C4719
See Note 3
See
Note 3
1
D(100)
[16] Schedule 1, entry for Budesonide with eformoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2
(a) omit from the column headed “Circumstances”: C4416
(b) substitute: C4689
[17] Schedule 1, entry for Budesonide with eformoterol in the form Pressurised inhalation containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses
(a) omit from the column headed “Circumstances”: C4327
(b) insert in numerical order: C4689
[18] Schedule 1, entry for Cabergoline in the form Tablet 500 micrograms
omit:
Tinexa
QA
MP
C2659 C2660 C2661 C2662
P2659 P2660 P2661 P2662
8
5
8
[19] Schedule 1, entry for Cabergoline in the form Tablet 1 mg
omit:
Bergoline 1
QA
MP NP
C1255
30
5
30
[20] Schedule 1, entry for Cabergoline in the form Tablet 2 mg
omit:
Bergoline 2
QA
MP NP
C1255
30
5
30
[21] Schedule 1, entry for Carmellose in each of the forms: Mouth spray containing carmellose sodium 10 mg per mL, 25 mL; and Mouth spray containing carmellose sodium 10 mg per mL, 100 mL
omit from the column headed “Responsible Person”: VT substitute: IA
[22] Schedule 1, entry for Ceftriaxone in each of the forms: Powder for injection 1 g (as sodium); and Powder for injection 2 g (as sodium)
omit:
Rocephin
RO
MP NP
C1169 C1846 C1847
5
0
1
[23] Schedule 1, entry for Celecoxib
substitute:
Celecoxib
Capsule 100 mg
Oral
APO-Celecoxib
TX
MP NP
C1547 C1848
60
3
60
Blooms the Chemist Celecoxib
IB
MP NP
C1547 C1848
60
3
60
Celaxib
AF
MP NP
C1547 C1848
60
3
60
Celebrex
PF
MP NP
C1547 C1848
60
3
60
Celecoxib Actavis
GN
MP NP
C1547 C1848
60
3
60
Celecoxib AN
EA
MP NP
C1547 C1848
60
3
60
Celecoxib GH
GQ
MP NP
C1547 C1848
60
3
60
Celecoxib RBX
RA
MP NP
C1547 C1848
60
3
60
Celecoxib Sandoz
SZ
MP NP
C1547 C1848
60
3
60
Celexi
QA
MP NP
C1547 C1848
60
3
60
Chem mart Celecoxib
CH
MP NP
C1547 C1848
60
3
60
Kudeq
FZ
MP NP
C1547 C1848
60
3
60
Terry White Chemists Celecoxib
TW
MP NP
C1547 C1848
60
3
60
Capsule 200 mg
Oral
APO-Celecoxib
TX
MP NP
C1547 C1848
30
3
30
Blooms the Chemist Celecoxib
IB
MP NP
C1547 C1848
30
3
30
Celaxib
AF
MP NP
C1547 C1848
30
3
30
Celebrex
PF
MP NP
C1547 C1848
30
3
30
Celecoxib Actavis
GN
MP NP
C1547 C1848
30
3
30
Celecoxib AN
EA
MP NP
C1547 C1848
30
3
30
Celecoxib GH
GQ
MP NP
C1547 C1848
30
3
30
Celecoxib RBX
RA
MP NP
C1547 C1848
30
3
30
Celecoxib Sandoz
SZ
MP NP
C1547 C1848
30
3
30
Celexi
QA
MP NP
C1547 C1848
30
3
30
Chem mart Celecoxib
CH
MP NP
C1547 C1848
30
3
30
Kudeq
FZ
MP NP
C1547 C1848
30
3
30
Terry White Chemists Celecoxib
TW
MP NP
C1547 C1848
30
3
30
[24] Schedule 1, entry for Certolizumab pegol
(a) omit from the column headed “Circumstances”: C3714 C3768 C3769
(b) insert in numerical order: C4696 C4697 C4737 C4763 C4764
[25] Schedule 1, entry for Clindamycin
substitute:
Clindamycin
Capsule 150 mg (as hydrochloride)
Oral
APO-Clindamycin
TX
MP NP MW PDP
C1145
24
0
24
Chem mart Clindamycin
CH
MP NP MW PDP
C1145
24
0
24
Cleocin
FZ
MP NP MW PDP
C1145
24
0
24
Dalacin C
PF
MP NP MW PDP
C1145
24
0
24
Terry White Chemists Clindamycin
TW
MP NP MW PDP
C1145
24
0
24
[26] Schedule 1, entry for Clopidogrel with aspirin
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
DuoPlidogrel
GZ
MP NP
C1722 C3219 C3880
30
5
30
[27] Schedule 1, entry for Dapagliflozin
omit from the column headed “Circumstances”: C4331 substitute: C4736
[28] Schedule 1, entry for Deferiprone in each of the forms: Tablet 500 mg; and Oral solution 100 mg per mL, 250 mL
omit from the column headed “Responsible Person”: OA substitute: TX
[29] Schedule 1, entry for Dexamethasone in each of the forms: Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL; and Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL
omit from the column headed “Responsible Person” for the brand “Dexmethsone”: AS substitute: AF
[30] Schedule 1, entry for Diazepam in the form Tablet 2 mg
(a) omit:
Valium
RO
MP NP PDP
50
0
50
MP NP
P3656
50
CN3656
0
50
(b) omit:
Valium
RO
MP NP
P3655
50
CN3655
3
CN3655
50
[31] Schedule 1, entry for Dipyridamole with Aspirin
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Dipyridamole/ Aspirin 200/25
TX
MP NP
C1728
60
5
60
[32] Schedule 1, entry for Dorzolamide with timolol
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Dorzolamide/ Timolol Sandoz 20/5
SZ
MP
C4343
1
5
1
AO
C4326
1
5
1
[33] Schedule 1, after entry for Doxycycline in the form Tablet 100 mg (as hydrochloride) [Maximum Quantity: 21; Number of Repeats: 0;
Pack Quantity: 7; Brand: Doxylin 100]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Doxycycline AN
EA
MP NP
P4485
21
0
21
[34] Schedule 1, after entry for Dutasteride with tamsulosin
insert:
Eculizumab
Solution concentrate for I.V. infusion 300 mg in 30 mL
Injection
Soliris
XI
MP
See Note 1
See Note 3
See Note 3
See Note 3
See
Note 3
1
D(100)
[35] Schedule 1, entry for Enalapril in the form Tablet containing enalapril maleate 5 mg
omit:
Renitec M
MK
MP NP
30
5
30
[36] Schedule 1, after entry for Entecavir in the form Tablet containing entecavir monohydrate 1 mg
insert:
Enzalutamide
Capsule 40 mg
Oral
Xtandi
LL
MP
C4670
112
2
112
[37] Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)
omit from the column headed “Circumstances” for the brands “APO‑Escitalopram”; “Chem mart Escitalopram”; “Cilopam-S”; “Escicor 10”;
“Escitalopram AN”; “Escitalopram-DRLA”; “Escitalopram GA”; and “Escitalopram generichealth”: C1211 substitute: C4755
[38] Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)
omit from the column headed “Circumstances” for the brand “Esipram”: C1211 C2964 C2965 C2966 C2967 C2968 C2969
substitute: C4690 C4703 C4755 C4756 C4757
[39] Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)
omit from the column headed “Circumstances” for the brands “Esitalo”; and “Lexam 10”: C1211 substitute: C4755
[40] Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)
omit from the column headed “Circumstances” for the brand “Lexapro”: C1211 C2964 C2965 C2966 C2967 C2968 C2969
substitute: C4690 C4703 C4755 C4756 C4757
[41] Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)
omit from the column headed “Circumstances” for the brands “LoxaLate”; “Pharmacor Escitalopram 10”; and “Terry White Chemists Escitalopram”: C1211
substitute: C4755
[42] Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)
omit from the column headed “Circumstances” for the brands “APO‑Escitalopram”; “Chem mart Escitalopram”; “Cilopam-S”; “Escicor 20”;
“Escitalopram AN”; “Escitalopram-DRLA”; “Escitalopram GA”; and “Escitalopram generichealth”: C1211 substitute: C4755
[43] Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)
omit from the column headed “Circumstances” for the brand “Esipram”: C1211 C2964 C2965 C2966 C2967 C2968 C2969
substitute: C4690 C4703 C4755 C4756 C4757
[44] Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)
omit from the column headed “Circumstances” for the brands “Esitalo”; and “Lexam 20”: C1211 substitute: C4755
[45] Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)
omit from the column headed “Circumstances” for the brand “Lexapro”: C1211 C2964 C2965 C2966 C2967 C2968 C2969
substitute: C4690 C4703 C4755 C4756 C4757
[46] Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)
omit from the column headed “Circumstances” for the brands “LoxaLate”; “Pharmacor Escitalopram 20”; and “Terry White Chemists Escitalopram”: C1211
substitute: C4755
[47] Schedule 1, entry for Escitalopram in the form Oral solution 10 mg (as oxalate) per mL, 28 mL
omit from the column headed “Circumstances”: C1211 C2964 C2965 C2967 C2968 C3092 C3093
substitute: C4680 C4681 C4707 C4721 C4747
[48] Schedule 1, after entry for Escitalopram in the form Oral solution 10 mg (as oxalate) per mL, 28 mL
insert in the columns in the order indicated:
Oral solution 20 mg (as oxalate) per mL, 15 mL
Oral
Lexapro
LU
MP NP
C4680 C4681 C4707 C4721 C4747
1
5
1
[49] Schedule 1, entry for Fluticasone with Salmeterol in each of the forms: Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation); and Powder for oral inhalation
in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose,
60 doses
(a) omit from the column headed “Circumstances”: C4372
(b) insert in numerical order: C4689
[50] Schedule 1, after entry for Fluticasone with Salmeterol in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses
insert:
Fluticasone with vilanterol
Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses
Inhalation by mouth
Breo Ellipta 100/25
GK
MP NP
C4689 C4711
1
5
1
Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses
Inhalation by mouth
Breo Ellipta 200/25
GK
MP NP
C4731
1
5
1
[51] Schedule 1, entry for Galantamine in each of the forms: Capsule (prolonged release) 8 mg (as hydrobromide); Capsule (prolonged release) 16 mg (as hydrobromide); and Capsule (prolonged release) 24 mg (as hydrobromide)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Galantamine AN SR
EA
MP NP
C4219 C4220 C4224
28
5
28
[52] Schedule 1, entry for Gliclazide in the form Tablet 60 mg (modified release)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
ARDIX GLICLAZIDE 60mg MR
RX
MP NP
60
5
60
[53] Schedule 1, after entry for Glyceryl Trinitrate in the form Transdermal patch 120 mg
insert:
Glycine with carbohydrate
Sachets of oral powder 4 g containing 500 mg glycine, 30 (Glycine500)
Oral
Glycine500
VF
MP NP
C4704
4
5
1
[54] Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1;
Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C3718 C3782 C3783
(b) insert in numerical order: C4676 C4702 C4744 C4754 C4766
(c) omit from the column headed “Purposes”: P3718 P3782
(d) insert in numerical order: P4702 P4754 P4766
[55] Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1;
Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C3718 C3782 C3783
(b) insert in numerical order: C4676 C4702 C4744 C4754 C4766
(c) omit from the column headed “Purposes”: P3783
(d) insert in numerical order: P4676 P4744
[56] Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1;
Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C3718 C3782 C3783
(b) insert in numerical order: C4676 C4702 C4744 C4754 C4766
(c) omit from the column headed “Purposes”: P3718 P3782
(d) insert in numerical order: P4702 P4754 P4766
[57] Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1;
Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C3718 C3782 C3783
(b) insert in numerical order: C4676 C4702 C4744 C4754 C4766
(c) omit from the column headed “Purposes”: P3783
(d) insert in numerical order: P4676 P4744
[58] Schedule 1, entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate
insert as first item in the columns in the order indicated:
Oral liquid 200 mL, 32 (KetoCal 4:1 LQ)
Oral
KetoCal 4:1 LQ
SB
MP NP
C4709
5
5
1
[59] Schedule 1, entry for Hypromellose in the form Oral gel 20 mg per g, 100 g
omit from the column headed “Responsible Person”: VT substitute: IA
[60] Schedule 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 1.5 mg (sustained release)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Tenaxil SR
QA
MP NP
90
1
90
[61] Schedule 1, after entry for Ivabradine in the form Tablet 7.5 mg (as hydrochloride)
insert:
Ivacaftor
Tablet 150 mg
Oral
Kalydeco
VR
MP
See Note 1
See Note 3
See Note 3
See
Note 3
1
D(100)
[62] Schedule 1, entry for Leflunomide in the form Tablet 10 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Leflunomide AN
EA
MP
C2644
30
5
30
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Leflunomide Sandoz
SZ
MP
C2644 C2682
30
5
30
[63] Schedule 1, entry for Leflunomide in the form Tablet 20 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Leflunomide AN
EA
MP
C2644
30
5
30
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Leflunomide Sandoz
SZ
MP
C2644 C2682
30
5
30
[64] Schedule 1, entry for Methylprednisolone in the form Powder for injection 40 mg (as sodium succinate)
omit from the column headed “Responsible Person”: AS substitute: AL
[65] Schedule 1, entry for Methylprednisolone in the form Powder for injection 1 g (as sodium succinate)
omit from the column headed “Responsible Person” for the brand “Methylpred”: AS substitute: AL
[66] Schedule 1, entry for Metoclopramide in each of the forms: Tablet containing metoclopramide hydrochloride 10 mg; and Injection containing metoclopramide hydrochloride 10 mg in 2 mL
omit from the column headed “Responsible Person” for the brand “Maxolon”: VT substitute: IA
[67] Schedule 1, after entry for Miconazole in the form Tincture 20 mg per mL, 30 mL
insert:
Midazolam
Injection 5 mg (as hydrochloride) in
1 mL
Injection
Pfizer Australia Pty Ltd
PF
See Note 4
See Note 4
See Note 4
See Note 4
See Note 4
10
D(MP NP)
[68] Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 10 mg (controlled release)
(a) omit:
APOTEX-
MORPHINE MR
TX
MP NP
C1062
28
0
28
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
MORPHINE MR APOTEX
TX
MP NP
C1062
28
0
28
[69] Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 30 mg (controlled release)
(a) omit:
APOTEX-
MORPHINE MR
TX
MP NP
C1062
28
0
28
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
MORPHINE MR APOTEX
TX
MP NP
C1062
28
0
28
[70] Schedule 1, entry for Nitrazepam in the form Tablet 5 mg
omit from the column headed “Responsible Person” for the brand “Mogadon” (all instances): VT substitute: IA
[71] Schedule 1, entry for Olsalazine in each of the forms: Capsule containing olsalazine sodium 250 mg; and Tablet containing olsalazine sodium 500 mg
omit from the column headed “Responsible Person”: UC substitute: IX
[72] Schedule 1, entry for Omalizumab
omit:
Powder for injection 150 mg with diluent
Injection
Xolair
NV
MP
See Note 1
See Note 3
See Note 3
See Note 3
See
Note 3
1
D(100)
[73] Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 10 mg (controlled release)
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Oxycodone Sandoz
SZ
MP NP
C4583
28
0
28
(b) omit from the column headed “Circumstances” for the brand “OxyContin”: C1062 substitute: C4583
[74] Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 15 mg (controlled release)
omit from the column headed “Circumstances”: C1062 substitute: C4583
[75] Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 20 mg (controlled release)
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Oxycodone Sandoz
SZ
MP NP
C4583
28
0
28
(b) omit from the column headed “Circumstances” for the brand “OxyContin”: C1062 substitute: C4583
[76] Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 30 mg (controlled release)
omit from the column headed “Circumstances”: C1062 substitute: C4583
[77] Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 40 mg (controlled release)
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Oxycodone Sandoz
SZ
MP NP
C4583
28
0
28
(b) omit from the column headed “Circumstances” for the brand “OxyContin”: C1062 substitute: C4583
[78] Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 80 mg (controlled release)
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Oxycodone Sandoz
SZ
MP NP
C4583
28
0
28
(b) omit from the column headed “Circumstances” for the brand “OxyContin”: C1062 substitute: C4583
[79] Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 100; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Parapane
AF
PDP
100
0
100
[80] Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 100; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Parapane
AF
MP NP
100
1
100
[81] Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 300; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Parapane
AF
PDP
P2046
300
0
100
[82] Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 300; Number of Repeats: 4]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Parapane
AF
MP NP
P2046
300
4
100
[83] Schedule 1, entry for Paracetamol
omit:
Tablet 665 mg (modified release)
Oral
Panadol Osteo
GC
MP NP
C2094 C3649 C3650
P3650
192
0
96
MP NP
C2094 C3649 C3650
P3649
192
3
96
MP NP
C2094 C3649 C3650
P2094
192
5
96
substitute:
Tablet 665 mg (modified release)
Oral
Osteomol 665 Paracetamol
CR
MP NP
C2094 C3649 C3650
P3650
192
0
96
Panadol Osteo
GC
MP NP
C2094 C3649 C3650
P3650
192
0
96
Osteomol 665 Paracetamol
CR
MP NP
C2094 C3649 C3650
P3649
192
3
96
Panadol Osteo
GC
MP NP
C2094 C3649 C3650
P3649
192
3
96
Osteomol 665 Paracetamol
CR
MP NP
C2094 C3649 C3650
P2094
192
5
96
Panadol Osteo
GC
MP NP
C2094 C3649 C3650
P2094
192
5
96
[84] Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Perindopril CH
EA
MP NP
30
5
30
[85] Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Perindopril CH
EA
MP NP
30
5
30
[86] Schedule 1, entry for Perindopril with Indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Perindopril and Indapamide CH 4/1.25
EA
MP NP
C4375
30
5
30
[87] Schedule 1, entry for Phenoxymethylpenicillin in the form Capsule 250 mg phenoxymethylpenicillin (as potassium)
omit from the column headed “Responsible Person” for the brand “LPV” (twice occurring): VT substitute: IA
[88] Schedule 1, entry for Phenoxymethylpenicillin in the form Capsule 500 mg phenoxymethylpenicillin (as potassium)
omit from the column headed “Responsible Person” for the brand “LPV”: VT substitute: IA
[89] 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)
omit from the column headed “Responsible Person” for the brand “Actos”: LY substitute: TK
[90] Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 125 micrograms [Maximum Quantity: 30; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simpral
AF
MP NP
C3216
30
0
30
[91] Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 250 micrograms [Maximum Quantity: 100; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simpral
AF
MP NP
C3216
100
5
100
[92] Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 1 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simpral
AF
MP NP
C3216
100
5
100
[93] Schedule 1, entry for Prednisolone in each of the forms: Tablet 5 mg; and Tablet 25 mg
omit from the column headed “Responsible Person” for the brand “Solone”: VT substitute: IA
[94] Schedule 1, entry for Prednisone in each of the forms: Tablet 5 mg; and Tablet 25 mg
omit from the column headed “Responsible Person” for the brand “Sone”: VT substitute: IA
[95] Schedule 1, entry for Pyridostigmine in each of the forms: Tablet containing pyridostigmine bromide 10 mg; Tablet containing pyridostigmine bromide 60 mg; and Tablet containing pyridostigmine bromide 180 mg (modified release)
omit from the column headed “Responsible Person”: VT substitute: IA
[96] Schedule 1, entry for Raloxifene
substitute:
Raloxifene
Tablet containing raloxifene hydrochloride 60 mg
Oral
APO-Raloxifene
TX
MP NP
C4071
28
5
28
Chem mart Raloxifene
CH
MP NP
C4071
28
5
28
Evifyne
EL
MP NP
C4071
28
5
28
Evista
LY
MP NP
C4071
28
5
28
Raloxifene AN
EA
MP NP
C4071
28
5
28
Terry White Chemists Raloxifene
TW
MP NP
C4071
28
5
28
[97] Schedule 1, entry for Ramipril in the form Tablet 1.25 mg
omit:
Prilace 1.25
QA
MP NP
30
5
30
[98] Schedule 1, entry for Ramipril in the form Tablet 2.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Ramipril RBX Tabs
RA
MP NP
30
5
30
[99] Schedule 1, entry for Ramipril in the form Tablet 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Ramipril RBX Tabs
RA
MP NP
30
5
30
[100] Schedule 1, entry for Ramipril in the form Tablet 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Ramipril RBX Tabs
RA
MP NP
30
5
30
[101] Schedule 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Ranitidine AN
EA
MP NP MW
60
5
60
[102] Schedule 1, entry for Rituximab in each of the forms: Solution for I.V. infusion 100 mg in 10 mL; and Solution for I.V. infusion
500 mg in 50 mL
omit from the column headed “Circumstances”: C1744 C1745 C2068 C2386 C3908 C3909 C3912 C3915 C3931 C3932
substitute: C4671 C4674 C4677 C4678 C4679 C4686 C4687 C4701 C4706 C4726 C4727 C4728 C4752 C4765
[103] Schedule 1, after entry for Silver sulfadiazine
insert:
Simeprevir
Capsule 150 mg (as sodium)
Oral
Olysio
JC
MP
See Note 1
C4669 C4684 C4758 C4759
42
0
7
D(100)
[104] Schedule 1, entry for Simvastatin in the form Tablet 5 mg
(a) omit:
Zocor
MK
MP
C1540 C3047
P1540
30
5
30
NP
C1540
30
5
30
(b) omit:
Zocor
MK
MP
C1540 C3047
P3047
30
11
30
[105] Schedule 1, entry for Telmisartan with Hydrochlorothiazide in the form Tablet 40 mg-12.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Telmisartan HCT GH 40/12.5
GQ
MP NP
C4374
28
5
28
[106] Schedule 1, entry for Telmisartan with Hydrochlorothiazide in the form Tablet 80 mg-12.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Telmisartan HCT GH 80/12.5
GQ
MP NP
C4374
28
5
28
[107] Schedule 1, entry for Telmisartan with Hydrochlorothiazide in the form Tablet 80 mg-25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Telmisartan HCT GH 80/25
GQ
MP NP
C4374
28
5
28
[108] Schedule 1, entry for Triglycerides, long chain with glucose polymer
insert as first item in the columns in the order indicated:
Oral liquid 200 mL, 27 (Sno-Pro)
Oral
Sno-Pro
SB
MP NP
C4438
2
5
1
[109] Schedule 1, after entry for Tyrosine with carbohydrate
insert:
Umeclidinium
Powder for oral inhalation in breath actuated device 62.5 micrograms (as bromide) per dose, 30 doses
Inhalation by mouth
Incruse Ellipta
GK
MP NP
C4516
1
5
1
Umeclidinium with vilanterol
Powder for oral inhalation in breath actuated device containing umeclidinium 62.5 micrograms (as bromide) with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses
Inhalation by mouth
Anoro Ellipta 62.5/25
GK
MP NP
C4655
1
5
1
[110] Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 160 mg-12.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Valsartan HCTZ 160/12.5
TX
MP NP
C4374
28
5
28
[111] Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 320 mg-12.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Valsartan HCTZ 320/12.5
TX
MP NP
C4361
28
5
28
[112] Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 320 mg-25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Valsartan HCTZ 320/25
TX
MP NP
C4361
28
5
28
[113] Schedule 1, entry for Voriconazole
substitute:
Voriconazole
Tablet 50 mg
Oral
Vfend
PF
MP NP
C4665 C4682 C4683 C4685 C4748
P4685
56
0
56
C4665 C4682 C4683 C4685 C4748
P4665 P4682 P4683 P4748
56
2
56
Tablet 200 mg
Oral
Vfend
PF
MP NP
C4665 C4682 C4683 C4685 C4748
P4685
56
0
56
C4665 C4682 C4683 C4685 C4748
P4665 P4682 P4683 P4748
56
2
56
Powder for oral suspension 40 mg per mL, 70 mL
Oral
Vfend
PF
MP NP
C4685 C4699 C4722 C4723 C4749
1
0
1
[114] Schedule 3, after details relevant to Responsible Person code LB
insert:
LL
Astellas Pharma Australia Pty Ltd
81 147 915 482
[115] Schedule 3, after details relevant to Responsible Person code VP
insert:
VR
Vertex Pharmaceuticals (Australia) Pty Ltd
34 160 157 157
[116] Schedule 3
omit:
VT
Valeant Pharmaceuticals Australasia Pty Limited
64 001 083 352
[117] Schedule 3, after details relevant to Responsible Person code XH
insert:
XI
Alexion Pharmaceuticals Australasia Pty Ltd
59 132 343 036
[118] Schedule 4, Part 1, entry for Abatacept
substitute:
Abatacept
C4664
P4664
Severe active rheumatoid arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)
Patient must have severe active rheumatoid arthritis; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND
Patient must not have failed previous PBS-subsidised treatment with this drug for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly
Patient must be aged 18 years or older
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab
If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application
The authority application must be made in writing and must include:
(1) completed authority prescription forms; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement
Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the pre-filled syringes, with a maximum quantity of 4 and up to 3 repeats
Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats
Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment, within the timeframes specified below
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied
Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response
Compliance with Written Authority Required procedures
C4720
P4720
Severe active rheumatoid arthritis
Continuing Treatment – balance of supply
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
Compliance with Written or Telephone Authority Required procedures
C4739
P4739
Severe active rheumatoid arthritis
Continuing treatment
Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly
Patient must be aged 18 years or older
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form
All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition
Compliance with Written Authority Required procedures
C4745
P4745
Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months)
Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly
Patient must be aged 18 years or older
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab
The authority application must be made in writing and must include:
(a) completed authority prescription forms; and
(b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form
Applications for a patient who has received PBS-subsidised treatment with this drugt and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment, within the timeframes specified below
Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the pre-filled syringes, with a maximum quantity of 4 and up to 3 repeats
Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
If a patient fails to demonstrate a response to a treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug for this condition
A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
Compliance with Written Authority Required procedures
C4746
P4746
Severe active rheumatoid arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
Compliance with Written or Telephone Authority Required procedures
[119] Schedule 4, Part 1, entry for Abiraterone
(a) omit from the column headed “Circumstances and Purposes”:
Patient must have failed treatment with docetaxel due to resistance or intolerance; AND
substitute:
Patient must have failed treatment with docetaxel due to resistance or intolerance; OR
Patient must be unsuitable for docetaxel treatment on the basis of predicted intolerance to docetaxel; AND
(b) insert in the column headed “Circumstances and Purposes” following existing text:
; AND
Patient must not have received prior treatment with enzalutamide; OR
Patient must have developed intolerance to enzalutamide of a severity necessitating permanent treatment withdrawal
[120] Schedule 4, Part 1, entry for Adalimumab
(a) omit:
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
C3745
P3745
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 Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS‑subsidised adalimumab treatment is a 16‑week initial treatment course, is made following a minimum of 12 weeks of therapy;
a 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
C3746
P3746
Rheumatoid arthritis — continuing treatment
Continuing PBS‑subsidised treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with adalimumab; and
(c) whose most recent course of PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment was with adalimumab; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of adalimumab therapy is a 16‑week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment is limited to a maximum of 24 weeks of treatment
Compliance with Written Authority Required procedures
Continuation of a course of continuing treatment with adalimumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures
(b) insert in numerical order following existing text:
C4666
P4666
Severe active rheumatoid arthritis
Continuing treatment
Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly
Patient must be aged 18 years or older
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form
All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition
Compliance with Written Authority Required procedures
C4700
P4700
Severe active rheumatoid arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
Compliance with Written or Telephone Authority Required procedures
C4710
P4710
Severe active rheumatoid arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)
Patient must have severe active rheumatoid arthritis; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND
Patient must not have failed previous PBS-subsidised treatment with this drug for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction
Patient must be aged 18 years or older
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab
If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement
Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied
Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response
Compliance with Written Authority Required procedures
C4724
P4724
Severe active rheumatoid arthritis
Continuing Treatment – balance of supply
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
Compliance with Written or Telephone Authority Required procedures
C4751
P4751
Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months)
Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND
Patient must not receive more than 16 weeks of treatment under this restriction
Patient must be aged 18 years or older
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab
The authority application must be made in writing and must include:
(a) a completed authority prescription form and
(b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form
Application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased
If a patient fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug for this condition
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
If a patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
Compliance with Written Authority Required procedures
[121] Schedule 4, Part 1, after entry for Bortezomib
insert:
Brentuximab vedotin
C4675
CD30 positive systemic anaplastic large cell lymphoma
Continuing treatment
Patient must not have progressive disease; AND
Patient must have previously been issued with an authority prescription for this drug
The treatment must not exceed a lifetime total of 16 cycles
Compliance with Authority Required procedures
C4719
CD30 positive systemic anaplastic large cell lymphoma
Initial treatment
The treatment must be for curative intent; AND
Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND
Patient must demonstrate relapsed or chemotherapy-refractory disease
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Systemic anaplastic large cell lymphoma Brentuximab PBS Authority Application - Supporting Information Form which includes the following:
(i) a histology report including evidence of the tumour's CD30 positivity from a biopsy subsequent to the most recently delivered prior treatment with radiation, chemotherapy, biologics, immunotherapy or other agents;
(ii) The date of initial diagnosis of systemic anaplastic large cell lymphoma;
(iii) Dates of commencement and completion of front-line curative intent chemotherapy;
(iv) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory;
(v) a declaration of whether the patient has had, or is planned to have, a transplant
A maximum quantity and number of repeats to provide for an initial course of brentuximab vedotin of 4 cycles will be authorised as part of the initiating restriction
Compliance with Written Authority Required procedures
[122] Schedule 4, Part 1, entry for Budesonide with eformoterol
(a) omit:
C4327
Chronic obstructive pulmonary disease (COPD)
Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy;
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta‑2 agonist bronchodilator therapy
(b) omit:
C4416
Chronic obstructive pulmonary disease (COPD)
Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy;
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta‑2 agonist bronchodilator therapy;
The treatment must be for symptomatic treatment
(c) insert in numerical order following existing text:
C4689
Chronic obstructive pulmonary disease (COPD)
Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy; AND
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND
The treatment must be for symptomatic treatment
[123] Schedule 4, Part 1, entry for Certolizumab pegol
(a) omit:
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
C3768
Rheumatoid arthritis — continuing treatment
Continuing PBS‑subsidised treatment with certolizumab pegol, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with certolizumab pegol; and
(c) whose most recent course of PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment was with certolizumab pegol; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with certolizumab pegol;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of certolizumab pegol therapy is an 18 or 20 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment is limited to a maximum of 24 weeks of treatment
Compliance with Written Authority Required procedures
Continuation of a course of continuing treatment with 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 continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures
C3769
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 Chief Executive Medicare 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
(b) insert in numerical order following existing text:
C4696
Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months)
Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND
Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction
Patient must be aged 18 years or older
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab
The authority application must be made in writing and must include:
(a) a completed authority prescription form and
(b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
Application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased
If a patient fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug for this condition
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
If a patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
Compliance with Written Authority Required procedures
C4697
Severe active rheumatoid arthritis
Continuing treatment
Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction
Patient must be aged 18 years or older
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form
All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition
Compliance with Written Authority Required procedures
C4737
Severe active rheumatoid arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 18 to 20 weeks treatment, depending on the dosage regimen; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 18 to 20 weeks treatment, depending on the dosage regimen; AND
The treatment must provide no more than the balance of up to 18 to 20 weeks treatment available under the above restrictions
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
Compliance with Written or Telephone Authority Required procedures
C4763
Severe active rheumatoid arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)
Patient must have severe active rheumatoid arthritis; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND
Patient must not have not failed previous PBS-subsidised treatment with this drug for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction
Patient must be aged 18 years or older
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab
If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement
Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied
Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response
Compliance with Written Authority Required procedures
C4764
Severe active rheumatoid arthritis
Continuing Treatment – balance of supply
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
Compliance with Written or Telephone Authority Required procedures
[124] Schedule 4, Part 1, entry for Dapagliflozin
substitute:
Dapagliflozin
C4736
Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug
Compliance with Authority Required procedures - Streamlined Authority Code 4736
[125] Schedule 4, Part 1, after entry for Entecavir
insert:
Enzalutamide
C4670
Castration resistant metastatic carcinoma of the prostate
The treatment must not be used in combination with chemotherapy; AND
Patient must have failed treatment with docetaxel due to resistance or intolerance; OR
Patient must be unsuitable for docetaxel treatment on the basis of predicted intolerance to docetaxel; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
Patient must not have received prior treatment with abiraterone; OR
Patient must have developed intolerance to abiraterone of a severity necessitating permanent treatment withdrawal
Compliance with Authority Required procedures
[126] Schedule 4, Part 1, entry for Escitalopram
substitute:
Escitalopram
C4680
Major depressive disorders
C4681
Moderate to severe social anxiety disorder (social phobia, SAD)
The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND
Patient must not have responded to non-pharmacological therapy; AND
Patient must have been assessed by a psychiatrist
C4690
Moderate to severe social anxiety disorder (social phobia, SAD)
The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND
Patient must not have responded to non-pharmacological therapy; AND
Patient must have been assessed by a psychiatrist
C4703
Moderate to severe generalised anxiety disorder (GAD)
The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND
Patient must not have responded to non-pharmacological therapy; AND
Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared
C4707
Moderate to severe generalised anxiety disorder (GAD)
The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND
Patient must not have responded to non-pharmacological therapy; AND
Patient must have been assessed by a psychiatrist
C4721
Moderate to severe social anxiety disorder (social phobia, SAD)
The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND
Patient must not have responded to non-pharmacological therapy; AND
Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared
C4747
Moderate to severe generalised anxiety disorder (GAD)
The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND
Patient must not have responded to non-pharmacological therapy; AND
Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared
C4755
Major depressive disorders
C4756
Moderate to severe generalised anxiety disorder (GAD)
The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND
Patient must not have responded to non-pharmacological therapy; AND
Patient must have been assessed by a psychiatrist
C4757
Moderate to severe social anxiety disorder (social phobia, SAD)
The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND
Patient must not have responded to non-pharmacological therapy; AND
Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared
[127] Schedule 4, Part 1, entry for Fluticasone with salmeterol
(a) omit:
C4372
Chronic obstructive pulmonary disease (COPD)
Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy;
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta‑2 agonist bronchodilator therapy;
The treatment must be for symptomatic treatment
(b) insert in numerical order following existing text:
C4689
Chronic obstructive pulmonary disease (COPD)
Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy; AND
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND
The treatment must be for symptomatic treatment
[128] Schedule 4, Part 1, after entry for Fluticasone with salmeterol
insert:
Fluticasone with vilanterol
C4689
Chronic obstructive pulmonary disease (COPD)
Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy; AND
Patient must have a history of repeated exacerbations with significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND
The treatment must be for symptomatic treatment
C4711
Asthma
Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids
Patient must be aged 12 years or over
C4731
Asthma
Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids
Patient must be aged 12 years or over
[129] Schedule 4, Part 1, after entry for Glycerol
insert:
Glycine with carbohydrate
C4704
Isovaleric acidaemia
[130] Schedule 4, Part 1, entry for Golimumab
(a) omit:
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
C3782
P3782
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 Chief Executive Medicare 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
C3783
P3783
Rheumatoid arthritis — continuing treatment
Continuing 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:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with golimumab; and
(c) whose most recent course of PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment was with golimumab; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with golimumab;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of golimumab therapy is a 16‑week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment is limited to a maximum of 24 weeks of treatment
Compliance with Written Authority Required procedures
Continuation of a course of continuing treatment with golimumab, 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 continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures
(b) insert in numerical order following existing text:
C4676
P4676
Severe active rheumatoid arthritis
Continuing Treatment – balance of supply
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
Compliance with Written or Telephone Authority Required procedures
C4702
P4702
Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months)
Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly
Patient must be aged 18 years or older
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab
The authority application must be made in writing and must include:
(a) a completed authority prescription form and
(b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form
Application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased
If a patient fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug for this condition
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
If a patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
Compliance with Written Authority Required procedures
C4744
P4744
Severe active rheumatoid arthritis
Continuing treatment
Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly
Patient must be aged 18 years or older
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response
The authority application must be made in writing and must include:
(1) a completed authority prescription form and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form
All applications for continuing treatment with golimumab must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with golimumab, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with golimumab
If a patient fails to demonstrate a response to treatment with golimumab under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition
Compliance with Written Authority Required procedures
C4754
P4754
Severe active rheumatoid arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)
Patient must have severe active rheumatoid arthritis; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND
Patient must not have failed previous PBS-subsidised treatment with this drug for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly
Patient must be aged 18 years or older
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab
If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement
Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied
Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response
Compliance with Written Authority Required procedures
C4766
P4766
Severe active rheumatoid arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
Compliance with Written or Telephone Authority Required procedures
[131] Schedule 4, Part 1, entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate
insert in numerical order following existing text:
C4709
Ketogenic diet
Patient must have intractable seizures requiring treatment with a ketogenic diet; OR
Patient must have a glucose transport protein defect; OR
Patient must have pyruvate dehydrogenase deficiency
KetoCal 4:1 should only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist
[132] Schedule 4, Part 1, entry for Oxycodone
(a) omit:
C1062
Chronic severe disabling pain not responding to non-narcotic analgesics
(b) insert in numerical order following existing text:
C4583
Chronic severe disabling pain
The condition must be unresponsive to non-narcotic analgesics
[133] Schedule 4, Part 1, entry for Ribavirin and Peginterferon Alfa-2a
substitute:
Ribavirin and Peginterferon Alfa‑2a
C4184
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with telaprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with simeprevir; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4184
C4185
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and in whom plasma HCV RNA is undetectable by an HCV RNA quantitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and for whom the results of an HCV RNA qualitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures
C4187
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis; AND
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4187
C4188
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with telaprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with simeprevir; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
C4193
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
C4197
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and in whom plasma HCV RNA is undetectable by an HCV RNA quantitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and for whom the results of an HCV RNA qualitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4197
C4206
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre.
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4206
C4207
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis; AND
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures
[134] Schedule 4, Part 1, entry for Ribavirin and Peginterferon Alfa-2b
substitute:
Ribavirin and Peginterferon Alfa‑2b
C4184
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with telaprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with simeprevir; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4184
C4185
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and in whom plasma HCV RNA is undetectable by an HCV RNA quantitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and for whom the results of an HCV RNA qualitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures
C4187
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis; AND
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4187
C4188
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with telaprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with simeprevir; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
C4189
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4189
C4192
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis; AND
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre.
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4192
C4193
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
C4197
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and in whom plasma HCV RNA is undetectable by an HCV RNA quantitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and for whom the results of an HCV RNA qualitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4197
C4198
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop
Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4198
C4199
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4199
C4200
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
C4203
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop
Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures
C4206
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4206
C4207
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis; AND
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant
Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre.
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures
C4208
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
C4209
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis; AND
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures
[135] Schedule 4, Part 1, entry for Rituximab
substitute:
Rituximab
C4671
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Chronic lymphocytic leukaemia (CLL)
The condition must be CD20 positive chronic lymphocytic leukaemia (CLL); AND
The treatment must be in combination with chemotherapy
Compliance with Authority Required procedures
C4674
Where the patient is receiving treatment at/from a Public Hospital
Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
Maintenance therapy
Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND
The treatment must be maintenance therapy; AND
Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction
Compliance with Authority Required procedures - Streamlined Authority Code 4674
C4677
Where the patient is receiving treatment at/from a Public Hospital
Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma
Re-induction treatment
The treatment must be for re-induction treatment purposes only; AND
The condition must have relapsed or be refractory to treatment; AND
Patient must not receive more than 4 doses under this restriction
Compliance with Authority Required procedures - Streamlined Authority Code 4677
C4678
Where the patient is receiving treatment at/from a Public Hospital
Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma
Re-induction treatment
The treatment must be for re-induction treatment purposes only; AND
The condition must have relapsed or be refractory to treatment; AND
Patient must not receive more than 4 doses under this restriction
Compliance with Authority Required procedures - Streamlined Authority Code 4678
C4679
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
Maintenance therapy
Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND
The treatment must be maintenance therapy; AND
Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction
Compliance with Authority Required procedures
C4686
Where the patient is receiving treatment at/from a Public Hospital
Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
Maintenance therapy
The treatment must be maintenance therapy; AND
Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND
Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction
Compliance with Authority Required procedures - Streamlined Authority Code 4686
C4687
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Previously untreated Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
Induction treatment
The treatment must be in combination with chemotherapy; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than 8 doses under this restriction
Compliance with Authority Required procedures
C4701
Where the patient is receiving treatment at/from a Public Hospital
Previously untreated CD20 positive diffuse large B-cell non-Hodgkin's lymphoma
Induction treatment
The treatment must be in combination with chemotherapy; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
*Patient must not receive more than 8 doses under this restriction
Compliance with Authority Required procedures - Streamlined Authority Code 4701
C4706
Where the patient is receiving treatment at/from a Public Hospital
Chronic lymphocytic leukaemia (CLL)
The condition must be CD20 positive chronic lymphocytic leukaemia (CLL); AND
The treatment must be in combination with chemotherapy
Compliance with Authority Required procedures - Streamlined Authority Code 4706
C4726
Where the patient is receiving treatment at/from a Public Hospital
Previously untreated Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
Induction treatment
The treatment must be in combination with chemotherapy; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than 8 doses under this restriction
Compliance with Authority Required procedures - Streamlined Authority Code 4726
C4727
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Previously untreated CD20 positive diffuse large B-cell non-Hodgkin's lymphoma
Induction treatment
The treatment must be in combination with chemotherapy; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than 8 doses under this restriction
Compliance with Authority Required procedures
C4728
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
Maintenance therapy
The treatment must be maintenance therapy; AND
Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND
Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction
Compliance with Authority Required procedures
C4752
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma
Re-induction treatment
The treatment must be for re-induction treatment purposes only; AND
The condition must have relapsed or be refractory to treatment; AND
Patient must not receive more than 4 doses under this restriction
Compliance with Authority Required procedures
C4765
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma
Re-induction treatment
The treatment must be for re-induction treatment purposes only; AND
The condition must have relapsed or be refractory to treatment; AND
Patient must not receive more than 4 doses under this restriction
Compliance with Authority Required procedures
[136] Schedule 4, Part 1, after entry for Silver sulfadiazine
insert:
Simeprevir
C4669
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be in combination with peginterferon alfa and ribavirin; AND
The treatment must be limited to a maximum duration of 12 weeks; AND
The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greater
Patient must be 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records
Compliance with Written and Telephone Authority Required procedures
C4684
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be in combination with peginterferon alfa and ribavirin; AND
The treatment must be limited to a maximum duration of 12 weeks; AND
The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greater
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records
Compliance with Written and Telephone Authority Required procedures
C4758
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be in combination with peginterferon alfa and ribavirin; AND
The treatment must be limited to a maximum duration of 12 weeks; AND
The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greater
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4758
C4759
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be in combination with peginterferon alfa and ribavirin; AND
The treatment must be limited to a maximum duration of 12 weeks; AND
The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greater
Patient must be 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4759
[137] Schedule 4, Part 1, entry for Triglycerides, long chain with glucose polymer
insert in numerical order following existing text:
C4438
Proven inborn errors of protein metabolism
Patient must be unable to meet their energy requirements with permitted food and formulae
[138] Schedule 4, Part 1, after entry for Tyrosine with carbohydrate
insert:
Umeclidinium
C4516
Chronic obstructive pulmonary disease (COPD)
Umeclidinium with vilanterol
C4655
Chronic obstructive pulmonary disease (COPD)
Patient must have been stabilised on a combination of a long acting muscarinic antagonist and long acting beta-2 agonist
Compliance with Authority Required procedures - Streamlined Authority Code 4655
[139] Schedule 4, Part 1, entry for Voriconazole
substitute:
Voriconazole
C4665
P4665
Serious Candida infections
Treatment and maintenance therapy
The condition must be caused by species not susceptible to fluconazole; OR
The condition must be resistant to fluconazole; OR
Patient must not tolerate fluconazole
Compliance with Authority Required procedures
C4682
P4682
Definite or probable invasive aspergillosis
Treatment and maintenance therapy
Patient must be immunocompromised
Compliance with Authority Required procedures
C4683
P4683
Serious invasive mycosis infections
Treatment and maintenance therapy
The treatment must be for invasive mycosis infections other than definite or probable invasive aspergillosis
Compliance with Authority Required procedures
C4685
P4685
Prophylaxis of invasive fungal infections including both yeasts and moulds
Patient must be considered at high risk of developing an invasive fungal infection due to anticipated neutropenia (an absolute neutrophil count less than 500 cells per cubic millimetre) for at least 10 days whilst receiving chemotherapy for acute myeloid leukaemia or myelodysplastic syndrome; OR
Patient must be considered at high risk of developing an invasive fungal infection due to having acute graft versus host disease (GVHD) grade II, III or IV, or, extensive chronic GVHD, whilst receiving intensive immunosuppressive therapy after allogeneic haematopoietic stem cell transplant; OR
Patient must be undergoing allogeneic haematopoietic stem cell transplant using either bone marrow from an unrelated donor or umbilical cord blood (related or unrelated), and, be considered to be at high risk of developing an invasive fungal infection during the neutropenic phase prior to engraftment
Compliance with Authority Required procedures
C4699
Definite or probable invasive aspergillosis
Treatment and maintenance therapy
Patient must be immunocompromised
Compliance with Authority Required procedures
C4722
Serious Candida infections
Treatment and maintenance therapy
The condition must be caused by species not susceptible to fluconazole; OR
The condition must be resistant to fluconazole; OR
Patient must not tolerate fluconazole
Compliance with Authority Required procedures
C4723
Serious invasive mycosis infections
Treatment and maintenance therapy
The treatment must be for invasive mycosis infections other than definite or probable invasive aspergillosis
Compliance with Authority Required procedures
C4748
P4748
Serious fungal infections
Treatment and maintenance therapy
The condition must be caused by Scedosporium species or Fusarium species
Compliance with Authority Required procedures
C4749
Serious fungal infections
Treatment and maintenance therapy
The condition must be caused by Scedosporium species or Fusarium species
Compliance with Authority Required procedures
