PB 55 of 2015
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015
(No. 6)
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 26 June 2015
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 2015 (No. 6).
(2) This Instrument may also be cited as PB 55 of 2015.
2 Commencement
This Instrument commences on 1 July 2015.
3 Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1 Amendments
[1] Section 4
omit from the definition of “I.V.”: mean substitute: means
[2] Section 4
insert after the definition of “I.V.”:
Medicare Benefits Schedule means the Health Insurance (General Medical Services Table) Regulations;
[3] Schedule 1, entry for Abacavir in each of the forms: Tablet 300 mg (as sulfate); and Oral solution 20 mg (as sulfate) per mL, 240 mL
omit from the column headed “Circumstances”: C4455 C4469
[4] Schedule 1, entry for Abacavir with Lamivudine
(a) omit from the column headed “Circumstances”: C4505
(b) omit from the column headed “Circumstances”: C4538
[5] Schedule 1, entry for Abacavir with Lamivudine and Zidovudine
(a) omit from the column headed “Circumstances”: C4472
(b) omit from the column headed “Circumstances”: C4523
[6] Schedule 1, entry for Adefovir
omit from the column headed “Circumstances” (twice occurring): C3971 C3972 C3973 C3974 substitute: C4490 C4510
[7] Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Chem mart Alendronate Plus D3 70 mg/70 mcg
CH
MP NP
C4070 C4087 C4110
4
5
4
(b) omit from the column headed “Brand”: FonatPLUS substitute: FonatPlus
(c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Terry White Chemists Alendronate Plus D3 70 mg/70 mcg
TW
MP NP
C4070 C4087 C4110
4
5
4
[8] Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Chem mart Alendronate Plus D3 70 mg/140 mcg
CH
MP NP
C4122 C4123 C4133
4
5
4
(b) omit from the column headed “Brand”: FonatPLUS substitute: FonatPlus
(c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Terry White Chemists Alendronate Plus D3 70 mg/140 mcg
TW
MP NP
C4122 C4123 C4133
4
5
4
[9] Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 0]
(a) omit from the column headed “Responsible Person” for the brand “Clavam 875 mg/125 mg”: NJ substitute: CR
(b) omit:
Pharmacor AmoxyClav 875/125
CR
PDP
C1836 C1837
10
0
10
[10] Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 1]
(a) omit from the column headed “Responsible Person” for the brand “Clavam 875 mg/125 mg”: NJ substitute: CR
(b) omit:
Pharmacor AmoxyClav 875/125
CR
MP NP
C1836 C1837
10
1
10
[11] Schedule 1, entry for Atazanavir in each of the forms: Capsule 150 mg (as sulfate); Capsule 200 mg (as sulfate); and Capsule 300 mg
(as sulfate)
omit from the column headed “Circumstances”: C4455 C4469
[12] Schedule 1, entry for Bimatoprost with timolol in the form Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, 3 mL
omit from the column headed “Circumstances” [Authorised Prescriber AO]: C4326 substitute: C5038
[13] Schedule 1, entry for Bimatoprost with timolol in the form Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, single dose units 0.4 mL, 30
omit from the column headed “Circumstances” [Authorised Prescriber AO]: C4326 substitute: C5038
[14] Schedule 1, entry for Brimonidine with timolol
omit from the column headed “Circumstances” [Authorised Prescriber AO]: C4326 substitute: C5038
[15] Schedule 1, entry for Brinzolamide with timolol
omit from the column headed “Circumstances” [Authorised Prescriber AO]: C4326 substitute: C5038
[16] Schedule 1, entry for Captopril in the form Oral solution 5 mg per mL, 95 mL
omit from the column headed “Circumstances”: C4966 substitute: C4996
[17] Schedule 1, entry for Ceftriaxone in the form Powder for injection 500 mg (as sodium)
(a) omit:
Ceftriaxone ICP
PP
MP NP
C1143 C1169 C1846 C1847
P1143
1
0
1
(b) omit:
Ceftriaxone ICP
PP
MP NP
C1143 C1169 C1846 C1847
P1169 P1846 P1847
5
0
1
[18] Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 0]
(a) omit from the column headed “Responsible Person” for the brand “Cephalex 500”: NJ substitute: CR
(b) omit:
Pharmacor Cephalexin 500
CR
PDP
20
0
20
[19] Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 1]
(a) omit from the column headed “Responsible Person” for the brand “Cephalex 500”: NJ substitute: CR
(b) omit:
Pharmacor Cephalexin 500
CR
MP NP MW
20
1
20
[20] Schedule 1, entry for Cetrorelix
substitute:
Cetrorelix
Powder for injection 250 micrograms (as acetate) with diluent
Injection
Cetrotide
SG
MP
C5046
10
0
10
D(100)
[21] Schedule 1, entry for Choriogonadotropin alfa
substitute:
Choriogonadotropin alfa
Solution for injection 250 micrograms in 0.5 mL pre-filled syringe
Injection
Ovidrel
SG
MP
C5019
10
0
1
D(100)
Solution for injection 250 micrograms in 0.5 mL pre-filled pen
Injection
Ovidrel
SG
MP
C5019
10
0
1
D(100)
[22] Schedule 1, entry for Chorionic Gonadotrophin
substitute:
Chorionic Gonadotrophin
Injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL
Injection
Pregnyl
MK
MP
C5027
1
0
1
C(100)
C1116 C1117 C1118 C1120 C1878
1
5
1
Powder for injection 5,000 units with solvent
Injection
Pregnyl
MK
MP
C5027
2
0
1
PB(100)
[23] Schedule 1, entry for Ciprofloxacin in the form Tablet 250 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Ciprofloxacin
TX
MP NP
C1143 C1431 C1432 C1572 C1573
14
0
14
[24] Schedule 1, entry for Ciprofloxacin in each of the forms: Tablet 500 mg (as hydrochloride); and Tablet 750 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Ciprofloxacin
TX
MP NP
C1431 C1432 C1572 C1573
14
0
14
[25] Schedule 1, entry for Clozapine in each of the forms: Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; Tablet 200 mg; and Oral liquid 50 mg
per mL, 100 mL
omit from the column headed “Circumstances”: C4371 C4411 substitute: C4998 C5001 C5015
[26] Schedule 1, entry for Corifollitropin Alfa
substitute:
Corifollitropin alfa
Solution for injection 100 micrograms in 0.5 mL single dose pre-filled syringe
Injection
Elonva
MK
MP
C5009
1
0
1
D(100)
Solution for injection 150 micrograms in 0.5 mL single dose pre-filled syringe
Injection
Elonva
MK
MP
C5009
1
0
1
D(100)
[27] Schedule 1, after entry for Cortisone in the form Tablet containing cortisone acetate 25 mg
insert:
Crizotinib
Capsule 200 mg
Oral
Xalkori
PF
MP
C5047 C5048 C5049
60
1
60
Capsule 250 mg
Oral
Xalkori
PF
MP
C5047 C5048 C5049
60
1
60
[28] Schedule 1, entry for Dabrafenib in each of the forms: Capsule 50 mg (as mesilate); and Capsule 75 mg (as mesilate)
omit from the column headed “Responsible Person”: GK substitute: NV
[29] Schedule 1, entry for Dapagliflozin
omit from the column headed “Circumstances”: C4825 C4844 substitute: C4983 C4991 C5062
[30] Schedule 1, entry for Darunavir in each of the forms: Tablet 150 mg (as ethanolate); and Tablet 600 mg (as ethanolate)
omit from the column headed “Circumstances”: C3594 C3595 substitute: C4313
[31] Schedule 1, entry for Darunavir in the form Tablet 800 mg (as ethanolate)
omit from the column headed “Circumstances”: C4346
[32] Schedule 1, entry for Didanosine in each of the forms: Capsule 125 mg (containing enteric coated beadlets); Capsule 200 mg (containing enteric coated beadlets); Capsule 250 mg (containing enteric coated beadlets); and Capsule 400 mg (containing enteric coated beadlets)
omit from the column headed “Circumstances”: C4455 C4469
[33] Schedule 1, entry for Dolutegravir
omit from the column headed “Circumstances”: C4455 C4469
[34] Schedule 1, entry for Dolutegravir with abacavir and lamivudine
(a) omit from the column headed “Circumstances”: C4472
(b) omit from the column headed “Circumstances”: C4523
[35] Schedule 1, entry for Dorzolamide with timolol
omit from the column headed “Circumstances” for the brand “Cosdor” [Authorised Prescriber AO]: C4326 substitute: C5038
[36] Schedule 1, entry for Dorzolamide with timolol
omit from the column headed “Circumstances” for the brand “Cosopt” [Authorised Prescriber AO]: C4326 substitute: C5038
[37] Schedule 1, entry for Dorzolamide with timolol
omit from the column headed “Circumstances” for the brand “Dorzolamide/Timolol Sandoz 20/5” [Authorised Prescriber AO]: C4326
substitute: C5038
[38] Schedule 1, entry for Efavirenz in each of the forms: Tablet 200 mg; Tablet 600 mg; and Oral solution 30 mg per mL, 180 mL
omit from the column headed “Circumstances”: C4455 C4469
[39] Schedule 1, entry for Eltrombopag in each of the forms: Tablet 25 mg (as olamine); and Tablet 50 mg (as olamine)
omit from the column headed “Responsible Person”: GK substitute: NV
[40] Schedule 1, entry for Emtricitabine
omit from the column headed “Circumstances”: C4455 C4469
[41] Schedule 1, entry for Enfuvirtide
omit from the column headed “Circumstances”: C3596 C3597 substitute: C5014
[42] Schedule 1, entry for Enoxaparin in the form Injection containing enoxaparin sodium 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre-filled syringe [Maximum Quantity: 20; Number of Repeats: 3]
omit from the column headed “Purposes”: P1148 substitute: P4910
[43] Schedule 1, entry for Enoxaparin in the form Injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in 0.4 mL pre-filled syringe [Maximum Quantity: 20; Number of Repeats: 3]
omit from the column headed “Purposes”: P1148 substitute: P4910
[44] Schedule 1, entry for Enoxaparin in the form Injection containing enoxaparin sodium 60 mg (6,000 I.U. anti-Xa) in 0.6 mL pre-filled syringe [Maximum Quantity: 20; Number of Repeats: 3]
omit from the column headed “Purposes”: P1148 substitute: P4910
[45] Schedule 1, entry for Enoxaparin in the form Injection containing enoxaparin sodium 80 mg (8,000 I.U. anti-Xa) in 0.8 mL pre-filled syringe [Maximum Quantity: 20; Number of Repeats: 3]
omit from the column headed “Purposes”: P1148 substitute: P4910
[46] Schedule 1, entry for Enoxaparin in the form Injection containing enoxaparin sodium 100 mg (10,000 I.U. anti-Xa) in 1 mL pre-filled syringe [Maximum Quantity: 20; Number of Repeats: 3]
omit from the column headed “Purposes”: P1148 substitute: P4910
[47] Schedule 1, entry for Entecavir in the form Tablet containing entecavir monohydrate 0.5 mg
omit from the column headed “Circumstances”: C3959 C3960 C3961 C3962 substitute: C4993 C5036
[48] Schedule 1, entry for Entecavir in the form Tablet containing entecavir monohydrate 1 mg
omit from the column headed “Circumstances”: C3963 C3964 C3965 C3966 substitute: C5037 C5044
[49] Schedule 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)
omit from the column headed “Responsible Person” for the brand “Esipram”: UA substitute: CF
[50] Schedule 1, entry for Esomeprazole
substitute:
Esomeprazole
Capsule (enteric) 20 mg (as magnesium)
Oral
Noxicid Caps
AL
MP NP
C4988 C5029 C5030 C5039
P4988
30
1
30
MP NP
C4988 C5029 C5030 C5039
P5029 P5030 P5039
30
5
30
Capsule (enteric) 40 mg (as magnesium)
Oral
Noxicid Caps
AL
MP NP
C5011 C5021 C5028
P5028
30
1
30
MP NP
C5011 C5021 C5028
P5011 P5021
30
5
30
Tablet (enteric coated) 20 mg (as magnesium trihydrate)
Oral
Esomeprazole AN
EA
MP NP
C4988 C5029 C5030 C5039
P4988
30
1
30
Esomeprazole Apotex
TX
MP NP
C4988 C5029 C5030 C5039
P4988
30
1
30
Esomeprazole GxP
AF
MP NP
C4988 C5029 C5030 C5039
P4988
30
1
30
Esomeprazole RBX
RA
MP NP
C4988 C5029 C5030 C5039
P4988
30
1
30
Esomeprazole Sandoz
SZ
MP NP
C4988 C5029 C5030 C5039
P4988
30
1
30
Nexium
AP
MP NP
C4988 C5029 C5030 C5039
P4988
30
1
30
Nexole
QA
MP NP
C4988 C5029 C5030 C5039
P4988
30
1
30
Esomeprazole AN
EA
MP NP
C4988 C5029 C5030 C5039
P5029 P5030 P5039
30
5
30
Esomeprazole Apotex
TX
MP NP
C4988 C5029 C5030 C5039
P5029 P5030 P5039
30
5
30
Esomeprazole GxP
AF
MP NP
C4988 C5029 C5030 C5039
P5029 P5030 P5039
30
5
30
Esomeprazole RBX
RA
MP NP
C4988 C5029 C5030 C5039
P5029 P5030 P5039
30
5
30
Esomeprazole Sandoz
SZ
MP NP
C4988 C5029 C5030 C5039
P5029 P5030 P5039
30
5
30
Nexium
AP
MP NP
C4988 C5029 C5030 C5039
P5029 P5030 P5039
30
5
30
Nexole
QA
MP NP
C4988 C5029 C5030 C5039
P5029 P5030 P5039
30
5
30
Tablet (enteric coated) 40 mg (as magnesium trihydrate)
Oral
Esomeprazole AN
EA
MP NP
C5011 C5021 C5028
P5028
30
1
30
Esomeprazole Apotex
TX
MP NP
C5011 C5021 C5028
P5028
30
1
30
Esomeprazole GxP
AF
MP NP
C5011 C5021 C5028
P5028
30
1
30
Esomeprazole RBX
RA
MP NP
C5011 C5021 C5028
P5028
30
1
30
Esomeprazole Sandoz
SZ
MP NP
C5011 C5021 C5028
P5028
30
1
30
Nexium
AP
MP NP
C5011 C5021 C5028
P5028
30
1
30
Nexole
QA
MP NP
C5011 C5021 C5028
P5028
30
1
30
Esomeprazole AN
EA
MP NP
C5011 C5021 C5028
P5011 P5021
30
5
30
Esomeprazole Apotex
TX
MP NP
C5011 C5021 C5028
P5011 P5021
30
5
30
Esomeprazole GxP
AF
MP NP
C5011 C5021 C5028
P5011 P5021
30
5
30
Esomeprazole RBX
RA
MP NP
C5011 C5021 C5028
P5011 P5021
30
5
30
Esomeprazole Sandoz
SZ
MP NP
C5011 C5021 C5028
P5011 P5021
30
5
30
Nexium
AP
MP NP
C5011 C5021 C5028
P5011 P5021
30
5
30
Nexole
QA
MP NP
C5011 C5021 C5028
P5011 P5021
30
5
30
[51] Schedule 1, entry for Etravirine
omit from the column headed “Circumstances”: C3596 C3597 substitute: C5014
[52] Schedule 1, entry for Follitropin Alfa
substitute:
Follitropin Alfa
Injection 300 I.U. in 0.5 mL multi‑dose cartridge
Injection
Gonal‑f Pen
SG
MP
C1119 C1878
3
5
1
MP
C5027
2
0
1
C(100)
Injection 450 I.U. in 0.75 mL multi-dose cartridge
Injection
Gonal‑f Pen
SG
MP
C1119 C1878
3
5
1
MP
C5027
2
0
1
C(100)
Injection 900 I.U. in 1.5 mL multi-dose cartridge
Injection
Gonal‑f Pen
SG
MP
C1119 C1878
2
5
1
MP
C5027
5
0
1
C(100)
[53] Schedule 1, entry for Follitropin Beta
substitute:
Follitropin Beta
Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge
Injection
Puregon 300 IU/0.36 mL
MK
MP
C1119 C1878
3
5
1
MP
C5027
2
0
1
C(100)
Solution for injection 600 I.U. in 0.72 mL multi-dose cartridge
Injection
Puregon 600 IU/0.72 mL
MK
MP
C1119 C1878
2
5
1
MP
C5027
4
0
1
C(100)
Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge
Injection
Puregon 900 IU/1.08 mL
MK
MP
C1119 C1878
2
5
1
MP
C5027
5
0
1
C(100)
[54] Schedule 1, entry for Fosamprenavir in each of the forms: Tablet 700 mg (as calcium); and Oral liquid 50 mg (as calcium) per mL, 225 mL
omit from the column headed “Circumstances”: C4455 C4469
[55] Schedule 1, entry for Foscarnet
omit from the column headed “Circumstances”: C1413 C1610 C3322 C3378 substitute: C4973 C4980
[56] Schedule 1, entry for Gabapentin in the form Capsule 100 mg
omit from the column headed “Responsible Person” for the brand “Gabacor”: NJ substitute: CR
[57] Schedule 1, entry for Gabapentin in the form Capsule 300 mg
(a) omit from the column headed “Responsible Person” for the brand “Gabacor”: NJ substitute: CR
(b) omit:
Gabapentin 300
CR
MP NP
C2664
100
5
100
[58] Schedule 1, entry for Gabapentin in the form Capsule 400 mg
(a) omit from the column headed “Responsible Person” for the brand “Gabacor”: NJ substitute: CR
(b) omit:
Gabapentin 400
CR
MP NP
C2664
100
5
100
[59] Schedule 1, entry for Ganciclovir
omit from the column headed “Circumstances”: C1612 C1830 C1831 C3379 C3380 C3381
substitute: C4972 C4990 C4999 C5000 C5025
[60] Schedule 1, entry for Ganirelix
substitute:
Ganirelix
Injection 250 micrograms (as acetate) in 0.5 mL pre-filled syringe
Injection
Orgalutran
MK
MP
C5046
10
0
1
D(100)
MP
C5046
10
0
5
D(100)
[61] Schedule 1, entry for Glucose Indicator—Blood
omit:
Test strips, 100 (Accu‑Chek Advantage/Sensor Comfort)
For external use
Accu‑Chek Advantage/
Sensor Comfort
RD
MP NP
1
5
1
MP
P4241
1
11
1
[62] Schedule 1, after entry for Glycomacropeptide and essential amino acids with vitamins and minerals in the form Bars 81 g, 7 (Camino Pro Complete)
insert in the columns in the order indicated:
Oral liquid 250 mL, 30 (PKU Glytactin RTD 10)
Oral
PKU Glytactin RTD 10
QH
MP NP
C5012
4
5
1
Oral liquid 250 mL, 30 (PKU Glytactin RTD 15)
Oral
PKU Glytactin RTD 15
QH
MP NP
C5012
4
5
1
[63] Schedule 1, entry for Human menopausal gonadotrophin
substitute:
Human menopausal gonadotrophin
Powder for injection 600 I.U. with solvent
Injection
Menopur 600
FP
MP
C5027
3
0
1
D(100)
Powder for injection 1,200 I.U. with solvent
Injection
Menopur 1200
FP
MP
C5027
4
0
1
D(100)
[64] Schedule 1, entry for Hydroxychloroquine
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Hequinel
QA
MP NP
100
1
100
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Hydroxychloroquine AN
EA
MP NP
100
1
100
[65] Schedule 1, entry for Indinavir
omit from the column headed “Circumstances”: C4455 C4469
[66] Schedule 1, entry for Insect Allergen Extract—Honey Bee Venom
omit from the column headed “Responsible Person”: HL substitute: DE
[67] Schedule 1, entry for Insect Allergen Extract—Paper Wasp Venom
omit from the column headed “Responsible Person”: HL substitute: DE
[68] Schedule 1, entry for Insect Allergen Extract—Yellow Jacket Venom
omit from the column headed “Responsible Person”: HL substitute: DE
[69] Schedule 1, entry for Interferon Alfa-2a in the form Injection 3,000,000 I.U. in 0.5 mL single dose pre‑filled syringe [Maximum Quantity: 30; Number of Repeats: 5]
omit from the column headed “Circumstances”: C1463 C3382 C3959 C3960 C3961 C3962 substitute: C4993 C5003 C5036 C5042
[70] Schedule 1, entry for Interferon Alfa-2a in the form Injection 4,500,000 I.U. in 0.5 mL single dose pre‑filled syringe [Maximum Quantity: 30; Number of Repeats: 5]
omit from the column headed “Circumstances”: C1463 C3382 C3959 C3960 C3961 C3962 substitute: C4993 C5003 C5036 C5042
[71] Schedule 1, entry for Interferon Alfa-2a in the form Injection 6,000,000 I.U. in 0.5 mL single dose pre‑filled syringe [Maximum Quantity: 30; Number of Repeats: 5]
omit from the column headed “Circumstances”: C1463 C3382 C3959 C3960 C3961 C3962 substitute: C4993 C5003 C5036 C5042
[72] Schedule 1, entry for Interferon Alfa-2a in the form Injection 9000,000 I.U. in 0.5 mL single dose pre‑filled syringe [Maximum Quantity: 30; Number of Repeats: 5]
omit from the column headed “Circumstances”: C1463 C3382 C3959 C3960 C3961 C3962 substitute: C4993 C5003 C5036 C5042
[73] Schedule 1, entry for Interferon Alfa-2b
substitute:
Interferon Alfa‑2b
Solution for injection 10,000,000 I.U. in 1 mL single dose vial
Injection
Intron A
MK
MP
C4974 C4993 C5003 C5033 C5036 C5042
15
5
5
PB(100)
Solution for injection 18,000,000 I.U. in 1.2 mL multi‑dose injection pen
Injection
Intron A Redipen
MK
MP
C4974 C4993 C5003 C5033 C5036 C5042
2
5
1
C(100)
MP
C1149 C1196 C1206 C3180 C3895 C3898
P1149 P3180
3
4
1
MP
C1149 C1196 C1206 C3180 C3895 C3898
P1196 P1206 P3895 P3898
3
5
1
Solution for injection 18,000,000 I.U. in 3 mL single dose vial
Injection
Intron A
MK
MP
C4974 C4993 C5003 C5033 C5036 C5042
15
5
1
PB(100)
Solution for injection 25,000,000 I.U. in 2.5 mL single dose vial
Injection
Intron A
MK
MP
C4974 C4993 C5003 C5033 C5036 C5042
15
5
1
PB(100)
Solution for injection 30,000,000 I.U. in 1.2 mL multi‑dose injection pen
Injection
Intron A Redipen
MK
MP
C4974 C4993 C5003 C5033 C5036 C5042
2
5
1
C(100)
MP
C1196 C1206 C3895 C3898
3
5
1
Solution for injection 60,000,000 I.U. in 1.2 mL multi‑dose injection pen
Injection
Intron A Redipen
MK
MP
C4974 C4993 C5003 C5033 C5036 C5042
2
5
1
PB(100)
[74] Schedule 1, entry for Ivabradine in each of the forms: Tablet 5 mg (as hydrochloride); and Tablet 7.5 mg (as hydrochloride)
omit from the column headed “Circumstances”: C4310 substitute: C4979
[75] Schedule 1, entry for Lacosamide
omit:
Tablet 50 mg
Oral
Vimpat
UC
MP NP
C4271
14
1
14
substitute:
Tablet 50 mg
Oral
Vimpat
UC
MP NP
C4249 C4271
P4271
14
1
14
MP NP
C4249 C4271
P4249
56
5
14
[76] Schedule 1, entry for Lamivudine in the form Tablet 100 mg
omit from the column headed “Circumstances” (twice occurring): C3959 C3960 C3961 C3962 substitute: C4993 C5036
[77] Schedule 1, entry for Lamivudine in each of the forms: Tablet 150 mg; and Tablet 300 mg
omit from the column headed “Circumstances” (all instances): C4455 C4469
[78] Schedule 1, entry for Lamivudine in the form Oral solution 5 mg per mL, 240 mL
omit from the column headed “Circumstances”: C3959 C3960 C3961 C3962 substitute: C4993 C5036
[79] Schedule 1, entry for Lamivudine in the form Oral solution 10 mg per mL, 240 mL
omit from the column headed “Circumstances”: C4455 C4469
[80] Schedule 1, entry for Lamivudine with Zidovudine
omit from the column headed “Circumstances” (twice occurring): C4455 C4469
[81] Schedule 1, entry for Lapatinib
(a) omit from the column headed “Responsible Person”: GK substitute: NV
(b) omit from the column headed “Circumstances”: C2890 C3433 substitute: C4985 C5040
[82] Schedule 1, entry for Latanoprost with timolol
omit from the column headed “Circumstances” for the brand “APO-Latanoprost/Timolol 0.05/5” [Authorised Prescriber AO]: C4326
substitute: C5038
[83] Schedule 1, entry for Latanoprost with timolol
omit from the column headed “Circumstances” for the brand “Latanocom” [Authorised Prescriber AO]: C4326 substitute: C5038
[84] Schedule 1, entry for Latanoprost with timolol
omit from the column headed “Circumstances” for the brand “Latanoprost/Timolol Sandoz 50/5” [Authorised Prescriber AO]: C4326
substitute: C5038
[85] Schedule 1, entry for Latanoprost with timolol
omit from the column headed “Circumstances” for the brand “Xalacom” [Authorised Prescriber AO]: C4326 substitute: C5038
[86] Schedule 1, entry for Latanoprost with timolol
omit from the column headed “Circumstances” for the brand “Xalamol 50/5” [Authorised Prescriber AO]: C4326 substitute: C5038
[87] Schedule 1, entry for Lopinavir with Ritonavir in each of the forms: Tablet 100 mg-25 mg; Tablet 200 mg-50 mg; and Oral liquid
400 mg-100 mg per 5 mL, 60 mL
omit from the column headed “Circumstances”: C4455 C4469
[88] Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30 [Maximum Quantity: 1; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Chemists’ Own Macrogol with Electrolytes
FM
MP NP
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4576 P4577 P4580 P4596 P4601
See Note 2
1
See Note 2
5
See
Note 2
1
[89] Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30 [Maximum Quantity: 2; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Chemists’ Own Macrogol with Electrolytes
FM
MP NP
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4590
See Note 2
2
See Note 2
0
See
Note 2
1
[90] Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30 [Maximum Quantity: 2; Number of Repeats: 3]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Chemists’ Own Macrogol with Electrolytes
FM
MP NP
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4595
See Note 2
2
See Note 2
3
See
Note 2
1
[91] Schedule 1, entry for Maraviroc in each of the forms: Tablet 150 mg; and Tablet 300 mg
omit from the column headed “Circumstances”: C3598 C3599 substitute: C5008
[92] Schedule 1, entry for Meloxicam in each of the forms: Capsule 7.5 mg; and Capsule 15 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Meloxicam Sandoz
SZ
MP NP
C1547 C1848
30
3
30
[93] Schedule 1, entry for Nafarelin
substitute:
Nafarelin
Nasal spray (pump pack) 200 micrograms (as acetate) per dose, 60 doses
Nasal
Synarel
PF
MP
C1172 C1389
1
5
1
MP
C5046
2
0
1
C(100)
[94] Schedule 1, entry for Nevirapine in the form Tablet 200 mg
omit from the column headed “Circumstances”: C4455 C4469
[95] Schedule 1, entry for Nevirapine in the form Tablet 400 mg (extended release)
omit from the column headed “Circumstances”: C4460 C4469
[96] Schedule 1, entry for Nevirapine in the form Oral suspension 50 mg (as hemihydrate) per 5 mL, 240 mL
omit from the column headed “Circumstances”: C4455 C4469
[97] Schedule 1, entry for Norfloxacin
omit:
Norfloxacin AN
EA
MP NP
C1002 C1070
14
1
14
[98] Schedule 1, entry for Ofatumumab in each of the forms: Solution concentrate for I.V. infusion 100 mg in 5 mL; and Solution concentrate for I.V. infusion 1000 mg in 50 mL
omit from the column headed “Responsible Person”: GK substitute: NV
[99] Schedule 1, entry for Pazopanib in each of the forms: Tablet 200 mg (as hydrochloride); and Tablet 400 mg (as hydrochloride)
omit from the column headed “Responsible Person”: GK substitute: NV
[100] Schedule 1, entry for Peginterferon Alfa-2a in each of the forms: Injection 135 micrograms in 0.5 mL single use pre-filled syringe; and Injection 180 micrograms in 0.5 mL single use pre-filled syringe
omit from the column headed “Circumstances”: C2334 C3412 C3975 C3976 C3977 C3978 substitute: C5004 C5010 C5016 C5067
[101] Schedule 1, after entry for Permethrin
insert:
Pertuzumab
Solution for I.V. infusion 420 mg in 14 mL
Injection
Perjeta
RO
MP
C4971 C5013 C5023
See Note 3
See Note 3
1
D(100)
MP
C4971 C5013 C5023
See Note 3
See Note 3
1
D(100)
MP
C4971 C5013 C5023
See Note 3
See Note 3
1
D(100)
[102] Schedule 1, entry for Progesterone
substitute:
Progesterone
Vaginal gel (prolonged release) 90 mg in single dose pre-filled applicator
Vaginal
Crinone 8%
SG
MP
C5045
30
0
15
D(100)
Vaginal tablet 100 mg
Vaginal
Endometrin
FP
MP
C4997
42
0
21
D(100)
Pessary 100 mg
Vaginal
Oripro
ON
MP
C4997
45
0
15
D(100)
Pessary 200 mg
Vaginal
Oripro
ON
MP
C4997
45
0
15
D(100)
[103] Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 10 mg (enteric coated)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Parbezol
QA
MP NP
C1337 C1533
28
5
28
[104] Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Parbezol
QA
MP NP
C1177 C1337 C1533
P1177
30
2
30
[105] Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Parbezol
QA
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
[106] Schedule 1, entry for Raltegravir in each of the forms: Tablet 25 mg (as potassium); and Tablet 100 mg (as potassium)
(a) omit from the column headed “Circumstances”: C4273
(b) omit from the column headed “Circumstances”: C4276
[107] Schedule 1, entry for Raltegravir in the form Tablet 400 mg (as potassium)
omit from the column headed “Circumstances”: C4455 C4469
[108] Schedule 1, entry for Ranibizumab
substitute:
Ranibizumab
Solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe
Injection
Lucentis
NV
MP
C4803 C4804 C5050 C5051 C5052 C5053 C5054 C5055
P4803 P4804 P5050 P5051 P5053 P5054
1
2
1
C4803 C4804 C5050 C5051 C5052 C5053 C5054 C5055
P5052 P5055
1
5
1
Solution for intravitreal injection 2.3 mg in 0.23 mL
Injection
Lucentis
NV
MP
C4803 C4804 C5050 C5051 C5052 C5053 C5054 C5055
P4803 P4804 P5050 P5051 P5053 P5054
1
2
1
C4803 C4804 C5050 C5051 C5052 C5053 C5054 C5055
P5052 P5055
1
5
1
[109] Schedule 1, entry for Rilpivirine
omit from the column headed “Circumstances”: C4455 C4469
[110] Schedule 1, entry for Ritonavir in each of the forms: Tablet 100 mg; and Oral solution 600 mg per 7.5 mL (80 mg per mL), 90 mL
omit from the column headed “Circumstances”: C4455 C4469
[111] Schedule 1, entry for Saquinavir
omit from the column headed “Circumstances”: C4455 C4469
[112] Schedule 1, entry for Stavudine in each of the forms: Capsule 20 mg; Capsule 30 mg; and Capsule 40 mg
omit from the column headed “Circumstances”: C4455 C4469
[113] Schedule 1, entry for Telbivudine
omit from the column headed “Circumstances”: C3967 C3968 C3969 C3970 substitute: C4994 C4995
[114] Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 5; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Temozolomide
TX
MP
5
5
5
[115] Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 15; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Temozolomide
TX
MP
P4897
15
CN4897
2
CN4897
5
[116] Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 5; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Temozolomide
TX
MP
5
5
5
[117] Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 15; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Temozolomide
TX
MP
P4897
15
CN4897
2
CN4897
5
[118] Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 5; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Temozolomide
TX
MP
5
5
5
[119] Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 15; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Temozolomide
TX
MP
P4897
15
CN4897
2
CN4897
5
[120] Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 5; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Temozolomide
TX
MP
5
5
5
[121] Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 15; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Temozolomide
TX
MP
P4897
15
CN4897
2
CN4897
5
[122] Schedule 1, entry for Temozolomide in the form Capsule 180 mg [Maximum Quantity: 5; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Temozolomide
TX
MP
5
5
5
[123] Schedule 1, entry for Temozolomide in the form Capsule 180 mg [Maximum Quantity: 15; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Temozolomide
TX
MP
P4897
15
CN4897
2
CN4897
5
[124] Schedule 1, entry for Temozolomide in the form Capsule 250 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Temozolomide
TX
MP
5
5
5
[125] Schedule 1, entry for Tenofovir
(a) omit from the column headed “Circumstances”: C4455 C4469
(b) omit from the column headed “Circumstances”: C4499 C4509
(c) omit from the column headed “Circumstances”: C4544 C4545
[126] Schedule 1, entry for Tenofovir with Emtricitabine
omit from the column headed “Circumstances”: C4455 C4469
[127] Schedule 1, entry for Tenofovir with emtricitabine and efavirenz
(a) omit from the column headed “Circumstances”: C4494
(b) omit from the column headed “Circumstances”: C4533
[128] Schedule 1, entry for Tenofovir with Emtricitabine and Rilpivirine
(a) omit from the column headed “Circumstances”: C4494
(b) omit from the column headed “Circumstances”: C4533
[129] Schedule 1, entry for Tenofovir with emtricitabine, elvitegravir and cobicistat
(a) omit from the column headed “Circumstances”: C4494
(b) omit from the column headed “Circumstances”: C4533
[130] Schedule 1, entry for Tipranavir
omit from the column headed “Circumstances”: C3600 C3601 substitute: C4981
[131] Schedule 1, entry for Topotecan
omit from the column headed “Responsible Person”: GK substitute: NV
[132] Schedule 1, entry for Trastuzumab
substitute:
Trastuzumab
Powder for I.V. infusion 60 mg
Injection
Herceptin
RO
MP
C4083 C4093 C4104 C4142 C4143 C4144 C4156 C4164 C5024 C5032 C5041
See Note 3
See Note 3
1
D(100)
Powder for I.V. infusion 150 mg
Injection
Herceptin
RO
MP
C4083 C4093 C4104 C4142 C4143 C4144 C4156 C4164 C5024 C5032 C5041
See Note 3
See Note 3
1
D(100)
[133] Schedule 1, after entry for Trastuzumab
insert:
Trastuzumab emtansine
Powder for I.V. infusion 100 mg
Injection
Kadcyla
RO
MP
C4978 C4986 C4987
See Note 3
See Note 3
1
D(100)
Powder for I.V. infusion 160 mg
Injection
Kadcyla
RO
MP
C4978 C4986 C4987
See Note 3
See Note 3
1
D(100)
[134] Schedule 1, entry for Travoprost with timolol
omit from the column headed “Circumstances” [Authorised Prescriber AO]: C4326 substitute: C5038
[135] Schedule 1, entry for Valganciclovir in each of the forms: Tablet 450 mg (as hydrochloride); and Powder for oral solution 50 mg
(as hydrochloride) per mL, 100 mL
omit from the column headed “Circumstances”: C1620 C1964 C3420 C3421 substitute: C4980 C4989 C5031
[136] Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 160 mg-12.5 mg
omit:
Dilart HCT 160/12.5
AF
MP NP
C4374
28
5
28
[137] Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 160 mg-25 mg
omit:
Dilart HCT 160/25
AF
MP NP
C4374
28
5
28
[138] Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 320 mg-12.5 mg
omit:
Dilart HCT 320/12.5
AF
MP NP
C4361
28
5
28
[139] Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 320 mg-25 mg
omit:
Dilart HCT 320/25
AF
MP NP
C4361
28
5
28
[140] Schedule 1, entry for Zidovudine in each of the forms: Capsule 100 mg; Capsule 250 mg; and Syrup 10 mg per mL, 200 mL
omit from the column headed “Circumstances”: C4455 C4469
[141] Schedule 3, after details relevant to Responsible Person code BZ
insert:
CF
CNS Pharma Pty Ltd
76 121 515 400
[142] Schedule 3, after details relevant to Responsible Person code CX
insert:
DE
Stallergenes Australia Pty Ltd
17 151 366 540
[143] Schedule 3
omit:
HL
Helex-A Pty. Ltd.
89 070 826 176
[144] Schedule 3
omit:
NJ
Norac Pharma Australia Pty Ltd
22 164 670 008
[145] Schedule 4, Part 1, entry for Abacavir
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4455
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4469
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:
Where the patient is receiving treatment at/from a public hospital
[146] Schedule 4, Part 1, entry for Abacavir with Lamivudine
(a) omit:
C4505
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures
(b) omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4527 and C4528:
Where the patient is receiving treatment at/from a public hospital
(c) omit:
C4538
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures
[147] Schedule 4, Part 1, entry for Abacavir with Lamivudine and Zidovudine
(a) omit:
C4472
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures
(b) omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4480 and C4495:
Where the patient is receiving treatment at/from a public hospital
(c) omit:
C4523
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures
[148] Schedule 4, Part 1, entry for Adefovir
substitute:
Adefovir
C4490
Chronic hepatitis B infection
Patient must not have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR
Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4490
C4510
Chronic hepatitis B infection
Patient must have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4510
[149] Schedule 4, Part 1, entry for Atazanavir
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4455
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4469
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:
Where the patient is receiving treatment at/from a public hospital
[150] Schedule 4, Part 1, entry for Bimatoprost with timolol
(a) omit:
C4326
Elevated intra‑ocular pressure
The condition must have been inadequately controlled with monotherapy;
Patient must have open‑angle glaucoma; OR
Patient must have ocular hypertension
(b) insert in numerical order after existing text:
C5038
Elevated intra-ocular pressure
The condition must have been inadequately controlled with monotherapy; AND
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension
[151] Schedule 4, Part 1, entry for Brimonidine with timolol
(a) omit:
C4326
Elevated intra‑ocular pressure
The condition must have been inadequately controlled with monotherapy;
Patient must have open‑angle glaucoma; OR
Patient must have ocular hypertension
(b) insert in numerical order after existing text:
C5038
Elevated intra-ocular pressure
The condition must have been inadequately controlled with monotherapy; AND
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension
[152] Schedule 4, Part 1, entry for Brinzolamide with timolol
(a) omit:
C4326
Elevated intra‑ocular pressure
The condition must have been inadequately controlled with monotherapy;
Patient must have open‑angle glaucoma; OR
Patient must have ocular hypertension
(b) insert in numerical order after existing text:
C5038
Elevated intra-ocular pressure
The condition must have been inadequately controlled with monotherapy; AND
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension
[153] Schedule 4, Part 1, entry for Captopril
substitute:
Captopril
C4996
Patients unable to take a solid dose form of an ACE inhibitor
[154] Schedule 4, Part 1, after entry for Certolizumab pegol
insert:
Cetrorelix
C5046
Assisted Reproductive Technology
The treatment must be for prevention of premature luteinisation and ovulation; AND
Patient must be undergoing controlled ovarian stimulation; AND
Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule
Compliance with Authority Required procedures - Streamlined Authority Code 5046
[155] Schedule 4, Part 1, after entry for Cholestyramine
insert:
Choriogonadotropin alfa
C5019
Assisted Reproductive Technology
Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule
Compliance with Authority Required procedures - Streamlined Authority Code 5019
[156] Schedule 4, Part 1, entry for Chorionic Gonadotrophin
insert in numerical order:
C5027
Assisted Reproductive Technology
Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule
Compliance with Authority Required procedures - Streamlined Authority Code 5027
[157] Schedule 4, Part 1, entry for Clozapine
substitute:
Clozapine
C4998
Schizophrenia
Continuing treatment
Patient must have previously received PBS-subsidised therapy with this drug for this condition; AND
Patient must have completed at least 18 weeks therapy; AND
Patient must be on a clozapine dosage considered stable by a treating psychiatrist; AND
The treatment must be under the supervision and direction of a psychiatrist reviewing the patient at regular intervals
Must be treated by a psychiatrist; OR
Must be treated by an authorised medical practitioner, with the agreement of the treating psychiatrist
A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised
Compliance with Authority Required procedures - Streamlined Authority Code 4998
C5001
Schizophrenia
Initial treatment
Patient must be non-responsive to other neuroleptic agents; OR
Patient must be intolerant of other neuroleptic agents
Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient
Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction
The name of the consulting psychiatrist should be included in the patient's medical records
A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised
Compliance with Written or Telephone Authority Required procedures
C5015
Schizophrenia
Initial treatment
Patient must be non-responsive to other neuroleptic agents; OR
Patient must be intolerant of other neuroleptic agents
Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient
Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction
The name of the consulting psychiatrist should be included in the patient's medical records
A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorisedt
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5015
[158] Schedule 4, Part 1, after entry for Colestipol
insert:
Corifollitropin alfa
C5009
Assisted Reproductive Technology
The treatment must be for controlled ovarian stimulation; AND
Patient must have an antral follicle count of 20 or less; AND
Patient must be receiving medical services as described in items 13200, 13201, or 13202 of the Medicare Benefits Schedule; AND
Patient must be undergoing a gonadotrophin releasing antagonist cycle
Compliance with Authority Required procedures - Streamlined Authority Code 5009
[159] Schedule 4, Part 1, after entry for Corifollitropin alfa
insert:
Crizotinib
C5047
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfathering treatment
Patient must have received treatment with crizotinib for this condition prior to 1 July 2015; AND
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not have progressive disease
Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed ALK-Positive Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form, which includes details of ALK gene rearrangement in tumour material by FISH testing
Compliance with Written Authority Required procedures
C5048
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be as monotherapy; AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not have progressive disease
Compliance with Written or Telephone Authority Required procedures
C5049
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have a WHO performance status of 2 or less
Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed ALK-Positive Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form, which includes details of ALK gene rearrangement in tumour material by FISH testing
Compliance with Written Authority Required procedures
[160] Schedule 4, Part 1, entry for Dapagliflozin
substitute:
Dapagliflozin
C4983
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 4983
C4991
Diabetes mellitus type 2
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records
Compliance with Authority Required procedures - Streamlined Authority Code 4991
C5062
Diabetes mellitus type 2
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with maximally tolerated doses of metformin and 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 prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with maximally tolerated doses of metformin and 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 gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records
Compliance with Authority Required procedures - Streamlined Authority Code 5062
[161] Schedule 4, Part 1, entry for Darunavir
(a) omit:
C3594
Where the patient is receiving treatment at/from a private hospital
Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co‑administered with 100 mg ritonavir twice daily in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity
Compliance with Written or Telephone Authority Required procedures
C3595
Where the patient is receiving treatment at/from a public hospital
Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co‑administered with 100 mg ritonavir twice daily in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3595
(b) omit:
C4346
Human immunodeficiency virus (HIV) infection
The treatment must be in addition to optimised background therapy;
The treatment must be in combination with other antiretroviral agents;
The treatment must be co‑administered with 100 mg ritonavir;
Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen;
Patient must not have demonstrated darunavir resistance associated mutations detected on resistance testing
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity
Compliance with Written and Telephone Authority Required procedures
[162] Schedule 4, Part 1, entry for Didanosine
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4455
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4469
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:
Where the patient is receiving treatment at/from a public hospital
[163] Schedule 4, Part 1, entry for Dolutegravir
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4455
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4469
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:
Where the patient is receiving treatment at/from a public hospital
[164] Schedule 4, Part 1, entry for Dolutegravir with abacavir and lamivudine
(a) omit:
C4472
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures
(b) omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4480 and C4495:
Where the patient is receiving treatment at/from a public hospital
(c) omit:
C4523
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures
[165] Schedule 4, Part 1, entry for Dorzolamide with timolol
(a) omit:
C4326
Elevated intra‑ocular pressure
The condition must have been inadequately controlled with monotherapy;
Patient must have open‑angle glaucoma; OR
Patient must have ocular hypertension
(b) insert in numerical order after existing text:
C5038
Elevated intra-ocular pressure
The condition must have been inadequately controlled with monotherapy; AND
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension
[166] Schedule 4, Part 1, entry for Efavirenz
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4455
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4469
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:
Where the patient is receiving treatment at/from a public hospital
[167] Schedule 4, Part 1, entry for Emtricitabine
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4455
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4469
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:
Where the patient is receiving treatment at/from a public hospital
[168] Schedule 4, Part 1, entry for Enfuvirtide
substitute:
Enfuvirtide
C5014
HIV infection
The treatment must be in addition to optimised background therapy; AND
The treatment must be in combination with other antiretroviral agents; AND
Patient must be antiretroviral experienced; AND
Patient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5014
[169] Schedule 4, Part 1, entry for Enoxaparin
omit:
P1148
Haemodialysis
[170] Schedule 4, Part 1, entry for Entecavir
substitute:
Entecavir
C4993
Chronic hepatitis B infection
Patient must not have cirrhosis; AND
Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR
Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND
Patient must have evidence of chronic liver injury determined by confirmed elevated serum ALT or liver biopsy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4993
C5036
Chronic hepatitis B infection
Patient must have cirrhosis; AND
Patient must have detectable HBV DNA
Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5036
C5037
Chronic hepatitis B infection
Patient must have cirrhosis; AND
Patient must have failed lamivudine; AND
Patient must have detectable HBV DNA
Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5037
C5044
Chronic hepatitis B infection
Patient must not have cirrhosis; AND
Patient must have failed lamivudine; AND
Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR
Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5044
[171] Schedule 4, Part 1, entry for Esomeprazole
substitute:
Esomeprazole
C4988
P4988
Gastric ulcer
Initial treatment
C5011
P5011
Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion
Compliance with Authority Required procedures
C5021
P5021
Scleroderma oesophagus
Compliance with Authority Required procedures
C5028
P5028
Gastro-oesophageal reflux disease
The treatment must be for the healing of gastro-oesophageal reflux disease
C5029
P5029
Gastro-oesophageal reflux disease
The treatment must be maintenance therapy; AND
The condition must be healed
C5030
P5030
Scleroderma oesophagus
C5039
P5039
Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion
[172] Schedule 4, Part 1, entry for Etravirine
substitute:
Etravirine
C5014
HIV infection
The treatment must be in addition to optimised background therapy; AND
The treatment must be in combination with other antiretroviral agents; AND
Patient must be antiretroviral experienced; AND
Patient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5014
[173] Schedule 4, Part 1, entry for Follitropin Alfa
insert in numerical order:
C5027
Assisted Reproductive Technology
Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule
Compliance with Authority Required procedures - Streamlined Authority Code 5027
[174] Schedule 4, Part 1, entry for Follitropin Beta
insert in numerical order:
C5027
Assisted Reproductive Technology
Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule
Compliance with Authority Required procedures - Streamlined Authority Code 5027
[175] Schedule 4, Part 1, entry for Fosamprenavir
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4455
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4469
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:
Where the patient is receiving treatment at/from a public hospital
[176] Schedule 4, Part 1, entry for Foscarnet
substitute:
Foscarnet
C4973
Herpes simplex virus infection
The condition must be aciclovir resistant; AND
Patient must have HIV infection
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4973
C4980
Cytomegalovirus retinitis
Patient must have HIV infection
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4980
[177] Schedule 4, Part 1, entry for Ganciclovir
substitute:
Ganciclovir
C4972
Cytomegalovirus disease
Prophylaxis
Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4972
C4990
Cytomegalovirus disease
Prophylaxis
Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease
Compliance with Written or Telephone Authority Required procedures
C4999
Cytomegalovirus disease
Prophylaxis
Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4999
C5000
Cytomegalovirus retinitis
Patient must be severely immunocompromised, inculding due to HIV infection
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5000
C5025
Cytomegalovirus disease
Prophylaxis
Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease
Compliance with Written or Telephone Authority Required procedures
[178] Schedule 4, Part 1, after entry for Ganciclovir
insert:
Ganirelix
C5046
Assisted Reproductive Technology
The treatment must be for prevention of premature luteinisation and ovulation; AND
Patient must be undergoing controlled ovarian stimulation; AND
Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule
Compliance with Authority Required procedures - Streamlined Authority Code 5046
[179] Schedule 4, Part 1, entry for Glycomacropeptide and essential amino acids with vitamins and minerals
insert in numerical order:
C5012
Phenylketonuria
[180] Schedule 4, Part 1, after entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate
insert:
Human menopausal gonadotrophin
C5027
Assisted Reproductive Technology
Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule
Compliance with Authority Required procedures - Streamlined Authority Code 5027
[181] Schedule 4, Part 1, entry for Indinavir
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4455
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4469
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:
Where the patient is receiving treatment at/from a public hospital
[182] Schedule 4, Part 1, entry for Interferon Alfa-2a
(a) omit:
C1463
Where the patient is receiving treatment at/from a private hospital
Use in the treatment of Philadelphia chromosome positive myelogenous leukaemia in the chronic phase
Compliance with Written or Telephone Authority Required procedures
(b) omit from the column headed “Circumstances and Purposes” for Circumstances Code C3180:
Where the patient is receiving treatment at/from a public hospital
(c) omit:
C3382
Where the patient is receiving treatment at/from a public hospital
Use in the treatment of Philadelphia chromosome positive myelogenous leukaemia in the chronic phase
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3382
(d) omit from the column headed “Circumstances and Purposes” for Circumstances Codes C3895 and C3899:
Where the patient is receiving treatment at/from a public hospital
(e) omit:
C3959
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA
Persons with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures
C3960
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels ‑ greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative ‑ in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy
Compliance with Written or Telephone Authority Required procedures
C3961
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels ‑ greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative ‑ in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3961
C3962
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA.
Persons with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3962
(f) insert in numerical order:
C4993
Chronic hepatitis B infection
Patient must not have cirrhosis; AND
Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR
Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND
Patient must have evidence of chronic liver injury determined by confirmed elevated serum ALT or liver biopsy
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4993
C5003
Treatment with interferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored
Chronic Myeloid Leukaemia (CML)
The condition must be Philadelphia chromosome positive
Compliance with Written and Telephone Authority Required procedures
C5036
Chronic hepatitis B infection
Patient must have cirrhosis; AND
Patient must have detectable HBV DNA
Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5036
C5042
Treatment with interferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored
Chronic Myeloid Leukaemia (CML)
The condition must be Philadelphia chromosome positive
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5042
[183] Schedule 4, Part 1, entry for Interferon Alfa-2b
(a) omit:
C1009
Where the patient is receiving treatment at/from a private hospital
Adjunctive therapy of malignant melanoma following surgery in patients with nodal involvement
Compliance with Written or Telephone Authority Required procedures
(b) omit:
C1463
Where the patient is receiving treatment at/from a private hospital
Use in the treatment of Philadelphia chromosome positive myelogenous leukaemia in the chronic phase
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C3180:
Where the patient is receiving treatment at/from a public hospital
(d) omit:
C3382
Where the patient is receiving treatment at/from a public hospital
Use in the treatment of Philadelphia chromosome positive myelogenous leukaemia in the chronic phase
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3382
C3384
Where the patient is receiving treatment at/from a public hospital
Adjunctive therapy of malignant melanoma following surgery in patients with nodal involvement
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3384
(e) omit from the column headed “Circumstances and Purposes” for Circumstances Codes C3895 and C3898:
Where the patient is receiving treatment at/from a public hospital
(f) omit:
C3959
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA
Persons with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures
C3960
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels ‑ greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative ‑ in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy
Compliance with Written or Telephone Authority Required procedures
C3961
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels ‑ greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative ‑ in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3961
C3962
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA.
Persons with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3962
(g) insert in numerical order:
C4974
Treatment with interferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored
Malignant melanoma
The treatment must be as adjunctive therapy to current standard care; AND
Patient must have undergone surgery; AND
The condition must include nodal involvement
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4974
C4993
Chronic hepatitis B infection
Patient must not have cirrhosis; AND
Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR
Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND
Patient must have evidence of chronic liver injury determined by confirmed elevated serum ALT or liver biopsy
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4993
C5003
Treatment with interferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored
Chronic Myeloid Leukaemia (CML)
The condition must be Philadelphia chromosome positive
Compliance with Written and Telephone Authority Required procedures
C5033
Treatment with interferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored
Malignant melanoma
The treatment must be as adjunctive therapy to current standard care; AND
Patient must have undergone surgery; AND
The condition must include nodal involvement
Compliance with Written and Telephone Authority Required procedures
C5036
Chronic hepatitis B infection
Patient must have cirrhosis; AND
Patient must have detectable HBV DNA
Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5036
C5042
Treatment with interferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored
Chronic Myeloid Leukaemia (CML)
The condition must be Philadelphia chromosome positive
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5042
[184] Schedule 4, Part 1, entry for Ivabradine
substitute:
Ivabradine
C4979
Chronic heart failure
Patient must be symptomatic with NYHA classes II or III; AND
Patient must be in sinus rhythm; AND
Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 35%; AND
Patient must have a resting heart rate at or above 77 bpm at the time ivabradine treatment is initiated; AND
Patient must receive concomitant optimal standard chronic heart failure treatment, which must include the maximum tolerated dose of a beta-blocker, unless contraindicated or not tolerated
Resting heart rate should be measured by ECG or echocardiography, after 5 minutes rest
The ECG or echocardiography, result must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4979
[185] Schedule 4, Part 1, entry for Lamivudine
(a) omit:
C3959
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA
Persons with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures
C3960
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels ‑ greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative ‑ in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy
Compliance with Written or Telephone Authority Required procedures
C3961
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels ‑ greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative ‑ in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3961
C3962
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA.
Persons with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3962
(b) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:
Where the patient is receiving treatment at/from a public hospital
(c) omit:
C4455
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4469
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
(d) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:
Where the patient is receiving treatment at/from a public hospital
(e) insert in numerical order:
C4993
Chronic hepatitis B infection
Patient must not have cirrhosis; AND
Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR
Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND
Patient must have evidence of chronic liver injury determined by confirmed elevated serum ALT or liver biopsy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4993
C5036
Chronic hepatitis B infection
Patient must have cirrhosis; AND
Patient must have detectable HBV DNA
Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5036
[186] Schedule 4, Part 1, entry for Lamivudine with Zidovudine
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4455
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4469
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:
Where the patient is receiving treatment at/from a public hospital
[187] Schedule 4, Part 1, entry for Lapatinib
substitute:
Lapatinib
C4985
Metastatic (Stage IV) HER2 positive breast cancer
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
The treatment must be in combination with capecitabine; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
The treatment must be the sole PBS-subsidised anti-HER2 therapy for this condition; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug
The treatment must not exceed a lifetime total of one continuous course
Compliance with Written or Telephone Authority Required procedures
C5040
Metastatic (Stage IV) HER2 positive breast cancer
Initial treatment
Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND
The treatment must be in combination with capecitabine; AND
Patient must have received prior therapy with a taxane for at least 3 cycles; OR
Patient must have developed intolerance to treatment with a taxane of a severity necessitating permanent treatment withdrawal; AND
The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; AND
The treatment must be the sole PBS-subsidised anti-HER2 therapy for this condition; AND
Patient must not have received prior treatment with trastuzumab emtansine; OR
Patient must have developed intolerance to trastuzumab emtansine of a severity necessitating permanent treatment withdrawal; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the person has Stage IV disease;
(ii) date of last treatment with a taxane and total number of cycles;
(iii) a copy of the signed patient acknowledgement form;
(iv) dates of treatment with trastuzumab and pertuzumab; and
(v) date of demonstration of progression whilst on treatment with trastuzumab and pertuzumab
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment
Patients who have progressive disease on trastuzumab emtansine are not eligible to receive PBS-subsidised lapatinib
Patients who have developed intolerance to trastuzumab emtansine of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised lapatinib
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application
Compliance with Written Authority Required procedures
[188] Schedule 4, Part 1, entry for Latanoprost with timolol
(a) omit:
C4326
Elevated intra‑ocular pressure
The condition must have been inadequately controlled with monotherapy;
Patient must have open‑angle glaucoma; OR
Patient must have ocular hypertension
(b) insert in numerical order after existing text:
C5038
Elevated intra-ocular pressure
The condition must have been inadequately controlled with monotherapy; AND
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension
[189] Schedule 4, Part 1, entry for Lopinavir with Ritonavir
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4455
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4469
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:
Where the patient is receiving treatment at/from a public hospital
[190] Schedule 4, Part 1, entry for Maraviroc
substitute:
Maraviroc
C5008
HIV infection
Patient must be infected with CCR5-tropic HIV-1; AND
The treatment must be in addition to optimised background therapy; AND
The treatment must be in combination with other antiretroviral agents; AND
Patient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity
A tropism assay to determine CCR5 only strain status must be performed prior to initiation. Individuals with CXCR4 tropism demonstrated at any time point are not eligible
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5008
[191] Schedule 4, Part 1, entry for Nafarelin
insert in numerical order:
C5046
Assisted Reproductive Technology
The treatment must be for prevention of premature luteinisation and ovulation; AND
Patient must be undergoing controlled ovarian stimulation; AND
Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule
Compliance with Authority Required procedures - Streamlined Authority Code 5046
[192] Schedule 4, Part 1, entry for Nevirapine
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4455
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4460
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must have been stabilised on nevirapine immediate release; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4469
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4512 and C4526:
Where the patient is receiving treatment at/from a public hospital
[193] Schedule 4, Part 1, entry for Peginterferon Alfa-2a
substitute:
C5004
Treatment with peginterferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored
Chronic 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
Patient must have a contraindication to ribavirin; 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; AND
The treatment must be limited to a maximum duration of 48 weeks
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding, and must be using an effective form of contraception if female and of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic 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 5004
C5010
Treatment with peginterferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored
Chronic hepatitis B infection
Patient must not have cirrhosis; AND
Patient must not have previously received peginterferon alfa therapy for the treatment of hepatitis B; AND
Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR
Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND
Patient must have evidence of chronic liver injury determined by confirmed elevated serum ALT or liver biopsy; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5010
C5016
Treatment with peginterferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored
Chronic 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
Patient must have a contraindication to ribavirin; 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; AND
The treatment must be limited to a maximum duration of 48 weeks
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding, and must be using an effective form of contraception if female and of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic 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
C5067
Treatment with peginterferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored
Chronic hepatitis B infection
The treatment must be limited to a maximum duration of 48 weeks; AND
Patient must have cirrhosis; AND
Patient must have detectable HBV DNA; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5067
[194] Schedule 4, Part 1, entry for Perinopril with amlodipine
omit from the column headed “Listed Drug”: Perinopril substitute: Perindopril
[195] Schedule 4, Part 1, entry for Perinopril with indapamide
omit from the column headed “Listed Drug”: Perinopril substitute: Perindopril
[196] Schedule 4, Part 1, after entry for Perindopril with indapamide
insert:
Pertuzumab
C4971
Metastatic (Stage IV) HER2 positive breast cancer
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
The treatment must be in combination with trastuzumab; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug
The treatment must not exceed a lifetime total of one continuous course. However, short treatment breaks are permitted. A patient who has a treatment break of less than 6 weeks in PBS-subsidised treatment with this drug for reasons other than disease progression is eligible to continue to receive PBS-subsidised treatment with this drug. A patient who has a treatment break of more than 6 weeks in PBS-subsidised treatment with this drug is not eligible to receive PBS-subsidised treatment with this drug
Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment
Compliance with Written or Telephone Authority Required procedures
C5013
Metastatic (Stage IV) HER2 positive breast cancer
Initial treatment
Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must not have received prior anti-HER2 therapy for this condition; AND
Patient must not have received prior chemotherapy for this condition; AND
The treatment must be in combination with trastuzumab and a taxane; AND
The treatment must not be in combination with nab-paclitaxel; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the person has Stage IV disease; and
(ii) a copy of the signed patient acknowledgement form
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment
Compliance with Written Authority Required procedures
C5023
HER2 positive breast cancer
Grandfathering treatment
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition before 1 July 2015; OR
Patient must have received non-PBS-subsidised trastuzumab for this condition before 1 July 2015; AND
Patient must not have received non-PBS-subsidised treatment with trastuzumab for this condition before 1 July 2014; AND
Patient must not have received prior therapy with trastuzumab emtansine or lapatinib for this condition; AND
The treatment must be in combination with trastuzumab; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure
Authority applications for treatment must be made in writing and must include a completed authority prescription form and a copy of the signed patient acknowledgement form
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment
Compliance with Written Authority Required procedures
[197] Schedule 4, Part 1, after entry for Pregabalin
insert:
Progesterone
C4997
Assisted Reproductive Technology
The treatment must be for luteal phase support as part of an assisted reproductive technology (ART) treatment cycle for infertile women; AND
Patient must be receiving medical services as described in items 13200 or 13201 of the Medicare Benefits Schedule
The luteal phase is defined as the time span from embryo transfer until implantation confirmed by positive B-hCG measurement
Compliance with Authority Required procedures - Streamlined Authority Code 4997
C5045
Assisted Reproductive Technology
The treatment must be for luteal phase support as part of an assisted reproductive technology (ART) treatment cycle for infertile women; AND
Patient must be receiving medical services as described in items 13200 or 13201 of the Medicare Benefits Schedule
The luteal phase is defined as the time span from embryo transfer until implantation confirmed by positive B-hCG measurement
Compliance with Authority Required procedures - Streamlined Authority Code 5045
[198] Schedule 4, Part 1, entry for Raltegravir
(a) omit:
C4273
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
The treatment must be in combination with other antiretroviral agents,
Patient must be antiretroviral experienced with at least 6 months therapy with 2 alternate classes of anti‑retroviral therapy,
Patient must have previously received PBS‑subsidised therapy for HIV infection,
Patient must be aged 2 years or older
Compliance with Written and Telephone Authority Required procedures
(b) omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4274 and C4275:
Where the patient is receiving treatment at/from a public hospital
(c) omit:
C4276
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
The treatment must be in combination with other antiretroviral agents,
Patient must be antiretroviral experienced with at least 6 months therapy with 2 alternate classes of anti‑retroviral therapy,
Patient must have a CD4 count of less than 500 per cubic millimetre; OR
Patient must have symptomatic HIV disease,
Patient must be aged 2 years or older
Compliance with Written and Telephone Authority Required procedures
(d) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:
Where the patient is receiving treatment at/from a public hospital
(e) omit:
C4455
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4469
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
(f) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:
Where the patient is receiving treatment at/from a public hospital
[199] Schedule 4, Part 1, entry for Ranibizumab
(a) insert in the column headed “Purposes Code” for Circumstances Code C4803: P4803
(b) insert in the column headed “Purposes Code” for Circumstances Code C4804: P4804
(c) insert in numerical order:
C5050
P5050
Central retinal vein occlusion with macular oedema
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Must be treated by an ophthalmologist
Compliance with Written or Telephone Authority Required procedures
C5051
P5051
Branch retinal vein occlusion with macular oedema
Initial treatment
Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND
The condition must be diagnosed by fluorescein angiography; OR
Patient must have a contraindication to fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Must be treated by an ophthalmologist
Authority approval for initial treatment of each eye must be sought
The first authority application for each eye must be made in writing or by telephone
A written application must include:
a) a completed authority prescription form;
b) a completed Branched Retinal Vein Occlusion (BRVO) - PBS Supporting Information Form; and
c) a copy of the fluorescein angiogram or alternative method of diagnosis where applicable
A telephone application must be made following submission by facsimile of a copy of a completed Branched Retinal Vein Occlusion (BRVO) - PBS Supporting Information Form and a copy of the fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised
Where a fluorescein angiogram cannot be performed due to a contraindication as listed in the TGA-approved product information, details of the contraindication must be provided. A copy of the report of an alternative method of diagnosis must be included in the application, for example optical coherence tomography or red free photography
Compliance with Written or Telephone Authority Required procedures
C5052
P5052
Diabetic macular oedema (DMO)
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Must be treated by an ophthalmologist
Compliance with Written or Telephone Authority Required procedures
C5053
P5053
Branch retinal vein occlusion with macular oedema
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Must be treated by an ophthalmologist
Compliance with Written or Telephone Authority Required procedures
C5054
P5054
Central retinal vein occlusion with macular oedema
Initial treatment
Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND
The condition must be diagnosed by fluorescein angiography; OR
Patient must have a contraindication to fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Must be treated by an ophthalmologist
Authority approval for initial treatment of each eye must be sought
The first authority application for each eye must be made in writing or by telephone
A written application must include:
a) a completed authority prescription form;
b) a completed Central Retinal Vein Occlusion (CRVO) - PBS Supporting Information Form; and
c) a copy of the fluorescein angiogram or alternative method of diagnosis where applicable
A telephone application must be made following submission by facsimile of a copy of a completed Central Retinal Vein Occlusion (CRVO) - PBS Supporting Information Form and a copy of the fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised
Where a fluorescein angiogram cannot be performed due to a contraindication as listed in the TGA-approved product information, details of the contraindication must be provided. A copy of the report of an alternative method of diagnosis must be included in the application, for example optical coherence tomography or red free photography
Compliance with Written or Telephone Authority Required procedures
C5055
P5055
Diabetic macular oedema (DMO)
Initial treatment
Patient must have visual impairment due to diabetic macular oedema; AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND
The condition must be diagnosed by fluorescein angiography; OR
Patient must have a contraindication to fluorescein angiography; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Must be treated by an ophthalmologist
Authority approval for initial treatment of each eye must be sought
The first authority application for each eye must be made in writing or by telephone
A written application must include:
a) a completed authority prescription form;
b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and
c) a copy of the fluorescein angiogram or alternative method of diagnosis where applicable
A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised
Where a fluorescein angiogram cannot be performed due to a contraindication as listed in the TGA-approved product information, details of the contraindication must be provided. A copy of the report of an alternative method of diagnosis must be included in the application, for example optical coherence tomography or red free photography
Compliance with Written or Telephone Authority Required procedures
[200] Schedule 4, Part 1, entry for Rilpivirine
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4455
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4469
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:
Where the patient is receiving treatment at/from a public hospital
[201] Schedule 4, Part 1, entry for Ritonavir
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4455
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4469
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:
Where the patient is receiving treatment at/from a public hospital
[202] Schedule 4, Part 1, entry for Saquinavir
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4455
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4469
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:
Where the patient is receiving treatment at/from a public hospital
[203] Schedule 4, Part 1, entry for Stavudine
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4455
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4469
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:
Where the patient is receiving treatment at/from a public hospital
[204] Schedule 4, Part 1, entry for Telbivudine
substitute:
Telbivudine
C4994
Chronic hepatitis B infection
Patient must have cirrhosis; AND
Patient must be nucleoside analogue naïve; AND
Patient must have detectable HBV DNA; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4994
C4995
Chronic hepatitis B infection
Patient must not have cirrhosis; AND
Patient must be nucleoside analogue naïve; AND
Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR
Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND
Patient must have evidence of chronic liver injury determined by: (i) confirmed elevated serum ALT; or (ii) liver biopsy; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4995
[205] Schedule 4, Part 1, entry for Tenofovir
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4455
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4469
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4476, C4489 and C4490:
Where the patient is receiving treatment at/from a public hospital
(d) omit:
C4499
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B
Patient must not have cirrhosis; AND
Patient must be nucleoside analogue naïve; AND
Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR
Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND
Patient must have evidence of chronic liver injury determined by: (i) confirmed elevated serum ALT; or (ii) liver biopsy; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Compliance with Written or Telephone Authority Required procedures
C4509
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B
Patient must have cirrhosis; AND
Patient must be nucleoside analogue naïve; AND
Patient must have detectable HBV DNA; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures
(e) omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4510 and C4512:
Where the patient is receiving treatment at/from a public hospital
(f) omit:
C4544
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B
Patient must not have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR
Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance
Compliance with Written or Telephone Authority Required procedures
C4545
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B
Patient must have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures
[206] Schedule 4, Part 1, entry for Tenofovir with Emtricitabine
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4455
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4469
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:
Where the patient is receiving treatment at/from a public hospital
[207] Schedule 4, Part 1, entry for Tenofovir with emtricitabine and efavirenz
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4470:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4494
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4522:
Where the patient is receiving treatment at/from a public hospital
(d) omit:
C4533
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naive
Compliance with Written or Telephone Authority Required procedures
[208] Schedule 4, Part 1, entry for Tenofovir with Emtricitabine and Rilpivirine
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4470:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4494
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4522:
Where the patient is receiving treatment at/from a public hospital
(d) omit:
C4533
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naive
Compliance with Written or Telephone Authority Required procedures
[209] Schedule 4, Part 1, entry for Tenofovir with emtricitabine, and elvitegravir and cobicistat
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4470:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4494
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4522:
Where the patient is receiving treatment at/from a public hospital
(d) omit:
C4533
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naive
Compliance with Written or Telephone Authority Required procedures
[210] Schedule 4, Part 1, entry for Tipranavir
substitute:
Tipranavir
C4981
HIV infection
The treatment must be in addition to optimised background therapy; AND
The treatment must be in combination with other antiretroviral agents; AND
Patient must be antiretroviral experienced; AND
The treatment must be co-administered with 200 mg ritonavir twice daily; AND
Patient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4981
[211] Schedule 4, Part 1, after entry for Trandolapril with Verapamil
insert:
Trastuzumab
C4083
Locally advanced HER2 positive breast cancer
Continuing treatment (3 weekly regimen)
Patient must have previously received treatment with PBS-subsidised trastuzumab; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment
For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 6 mg per kg
Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose
Compliance with Written or Telephone Authority Required procedures
C4093
Early HER2 positive breast cancer
Continuing treatment (3 weekly regimen)
Patient must have previously received treatment with PBS-subsidised trastuzumab; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment
For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 6 mg per kg
Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose
Compliance with Written or Telephone Authority Required procedures
C4104
Locally advanced HER2 positive breast cancer
Continuing treatment (weekly regimen)
Patient must have previously received treatment with PBS-subsidised trastuzumab; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment
For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 2 mg per kg
Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose
Compliance with Written or Telephone Authority Required procedures
C4142
Locally advanced HER2 positive breast cancer
Initial treatment (weekly regimen)
Patient must commence treatment concurrently with neoadjuvant chemotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy
HER2 positivity must be demonstrated by in situ hybridisation (ISH)
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Early Breast Cancer - PBS Supporting Information Form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment
For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 4 mg per kg
Compliance with Written Authority Required procedures
C4143
Locally advanced HER2 positive breast cancer
Initial treatment (3 weekly regimen)
Patient must commence treatment concurrently with neoadjuvant chemotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy
HER2 positivity must be demonstrated by in situ hybridisation (ISH)
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Early Breast Cancer - PBS Supporting Information Form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment
For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 8 mg per kg
Compliance with Written Authority Required procedures
C4144
Early HER2 positive breast cancer
Initial treatment (3 weekly regimen)
Patient must commence treatment concurrently with adjuvant chemotherapy; AND
Patient must have undergone surgery; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy
HER2 positivity must be demonstrated by in situ hybridisation (ISH)
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Early Breast Cancer - PBS Supporting Information Form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment
For a patient on the 3 weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 8 mg per kg
Compliance with Written Authority Required procedures
C4156
Early HER2 positive breast cancer
Continuing treatment (weekly regimen)
Patient must have previously received treatment with PBS-subsidised trastuzumab; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at 3 monthly intervals during treatment
For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a dose of 2 mg per kg
Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose
Compliance with Written or Telephone Authority Required procedures
C4164
Early HER2 positive breast cancer
Initial treatment (weekly regimen)
Patient must commence treatment concurrently with adjuvant chemotherapy; AND
Patient must have undergone surgery; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy
HER2 positivity must be demonstrated by in situ hybridisation (ISH)
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Early Breast Cancer - PBS Supporting Information Form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and
(ii) a copy of the signed patient acknowledgement form
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment
For a patient on the weekly regimen the medical practitioner should request sufficient quantity based on the weight of the patient to provide for a single loading dose of 4 mg per kg
Compliance with Written Authority Required procedures
C5024
Metastatic (Stage IV) HER2 positive breast cancer
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure
Where a patient has a break in trastuzumab therapy of more than 1 week from when the last dose was due, authority approval will be granted for a new loading dose
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment
Compliance with Written or Telephone Authority Required procedures
C5032
Metastatic (Stage IV) HER2 positive breast cancer
Initial treatment
Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND
The treatment must not be in combination with nab-paclitaxel; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the patient has Stage IV disease
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment
Compliance with Written Authority Required procedures
C5041
HER2 positive breast cancer
Grandfathering treatment
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition before 1 July 2015; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment
Compliance with Written or Telephone Authority Required procedures
Trastuzumab emtansine
C4978
Metastatic (Stage IV) HER2 positive breast cancer
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
The treatment must be as monotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug
The treatment must not exceed a lifetime total of one continuous course
Compliance with Written or Telephone Authority Required procedures
C4986
Metastatic (Stage IV) HER2 positive breast cancer
Grandfathering treatment
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition before 1 July 2015; OR
Patient must have received non-PBS-subsidised trastuzumab for this condition before 1 July 2015; OR
Patient must have received PBS-subsidised lapatinib for this condition before 1 July 2015; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
The treatment must be as monotherapy; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure
Authority applications for treatment must be made in writing and must include a completed authority prescription form and a copy of the signed patient acknowledgement form
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment
Compliance with Written Authority Required procedures
C4987
Metastatic (Stage IV) HER2 positive breast cancer
Initial treatment
Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND
The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; OR
The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be as monotherapy; AND
Patient must not have received prior treatment with lapatinib; OR
Patient must have developed intolerance to lapatinib of a severity necessitating permanent treatment withdrawal; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure
Authority applications for initial treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes:
(i) a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the person has Stage IV disease;
(ii) a copy of the signed patient acknowledgement form;
(iii) dates of treatment with trastuzumab and pertuzumab; and
(iv) date of demonstration of progression whilst on treatment with trastuzumab and pertuzumab; or
(v) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment
Patients who have progressive disease on lapatinib are not eligible to receive PBS-subsidised trastuzumab emtansine
Patients who have developed intolerance to lapatinib of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised trastuzumab emtansine
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application
Compliance with Written Authority Required procedures
[212] Schedule 4, Part 1, entry for Travoprost with timolol
(a) omit:
C4326
Elevated intra‑ocular pressure
The condition must have been inadequately controlled with monotherapy;
Patient must have open‑angle glaucoma; OR
Patient must have ocular hypertension
(b) insert in numerical order after existing text:
C5038
Elevated intra-ocular pressure
The condition must have been inadequately controlled with monotherapy; AND
Patient must have open-angle glaucoma; OR
Patient must have ocular hypertension
[213] Schedule 4, Part 1, entry for Valganciclovir
substitute:
Valganciclovir
C4980
Cytomegalovirus retinitis
Patient must have HIV infection
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4980
C4989
Cytomegalovirus infection and disease
Prophylaxis
Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4989
C5031
Cytomegalovirus infection and disease
Prophylaxis
Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease
Compliance with Written or Telephone Authority Required procedures
[214] Schedule 4, Part 1, entry for Zidovudine
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4454:
Where the patient is receiving treatment at/from a public hospital
(b) omit:
C4455
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
C4469
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures
(c) omit from the column headed “Circumstances and Purposes” for Circumstances Code C4512:
Where the patient is receiving treatment at/from a public hospital
