PB 10 of 2015
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015
(No. 2)
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 23rd February 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. 2).
(2) This Instrument may also be cited as PB 10 of 2015.
2 Commencement
This Instrument commences on 1 March 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] 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)
(a) omit:
GenRx Amoxycillin and Clavulanic Acid
GX
PDP
C1836 C1837
10
0
10
(b) omit:
GenRx Amoxycillin and Clavulanic Acid
GX
MP NP
C1836 C1837
10
1
10
[2] Schedule 1, entry for Anastrozole
omit from the column headed “Circumstances” (all instances): C2213 substitute: C4795
[3] Schedule 1, after entry for Aripiprazole in the form Tablet 30 mg
insert in the columns in the order indicated:
Powder for injection 300 mg (as monohydrate) with diluent
Injection
Abilify Maintena
LU
MP NP
C4246
1
5
1
Powder for injection 400 mg (as monohydrate) with diluent
Injection
Abilify Maintena
LU
MP NP
C4246
1
5
1
[4] Schedule 1, entry for Bevacizumab in each of the forms: Solution for I.V. infusion 100 mg in 4 mL; and Solution for I.V. infusion 400 mg
in 16 mL
omit from the column headed “Circumstances”: C4598 substitute: C4814
[5] Schedule 1, entry for Capecitabine in the form Tablet 150 mg
(a) omit all codes from the column headed “Circumstances” for the brands “Capecitabine Actavis” and “Capecitabine Alphapharm”
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Capecitabine AN
EA
MP
60
2
60
(c) omit all codes from the column headed “Circumstances” for the brands “Capecitabine-DRLA”; “Capecitabine Sandoz”; “Xelabine”; and “Xeloda”
[6] Schedule 1, entry for Capecitabine in the form Tablet 500 mg
(a) omit all codes from the column headed “Circumstances” for the brands “Capecitabine Actavis” and “Capecitabine Alphapharm”
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Capecitabine AN
EA
MP
120
2
120
(c) omit all codes from the column headed “Circumstances” for the brands “Capecitabine Apotex”; “Capecitabine-DRLA”; “Capecitabine GH”; “Capecitabine Sandoz”; “Xelabine”; and “Xeloda”
[7] Schedule 1, entry for Cefalotin
(a) omit:
Cefalotin Sandoz
SZ
PDP
10
0
10
(b) omit:
Cefalotin Sandoz
SZ
MP NP
10
1
10
[8] Schedule 1, entry for Cephazolin in the form Powder for injection 1 g (as sodium)
omit from the column headed “Brand”: Hospira Pty Limited substitute: Hospira Cefazolin Sodium
[9] Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Plidogrel
FM
MP NP
C1719 C1720 C1721 C1722 C1723 C1724 C4165 C4166
28
5
28
[10] Schedule 1, after entry for Clozapine in the form Oral liquid 50 mg per mL, 100 mL
insert:
Coal tar
Foam 20 mg per g, 100 g
Application
Scytera
RZ
MP NP
1
2
1
[11] Schedule 1, entry for Dorzolamide with timolol
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Cosdor
QA
MP
C4343
1
5
1
AO
C4326
1
5
1
[12] Schedule 1, entry for Escitalopram
omit:
Oral solution 10 mg (as oxalate) per mL, 28 mL
Oral
Lexapro
LU
MP NP
C4680 C4681 C4707 C4721 C4747
1
5
1
[13] Schedule 1, entry for Everolimus in the form Tablet 5 mg [Maximum Quantity: 30; Number of Repeats 2]
(a) omit from the column headed “Circumstances”: C4557
(b) insert in numerical order: C4812
[14] Schedule 1, entry for Everolimus in the form Tablet 5 mg [Maximum Quantity: 30; Number of Repeats 5]
(a) omit from the column headed “Circumstances”: C4557
(b) insert in numerical order: C4812
(c) omit from the column headed “Purposes”: P4557
(d) insert in numerical order: P4812
[15] Schedule 1, entry for Everolimus in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats 2]
(a) omit from the column headed “Circumstances”: C4557
(b) insert in numerical order: C4812
[16] Schedule 1, entry for Everolimus in the form Tablet 5 mg [Maximum Quantity: 30; Number of Repeats 5]
(a) omit from the column headed “Circumstances”: C4557
(b) insert in numerical order: C4812
(c) omit from the column headed “Purposes”: P4557
(d) insert in numerical order: P4812
[17] Schedule 1, entry for Exemestane
(a) omit from the column headed “Circumstances” for Authorised Prescriber “MP” (all instances): C1541 C2457 C4552
substitute: C4796 C4802 C4808
(b) omit from the column headed “Circumstances” for Authorised Prescriber “NP” (all instances): C1541 C2457
substitute: C4802 C4808
[18] Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 50 (Glucoflex-R)
insert in the columns in the order indicated:
Test strips, 50 (GluNEO)
For external use
GluNEO
IF
MP NP
2
5
1
MP
P4241
2
11
1
Test strips, 50 (Healthpro)
For external use
Healthpro
IF
MP NP
2
5
1
MP
P4241
2
11
1
[19] Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 100 (Contour next)
insert in the columns in the order indicated:
Test strips, 100 (Dario)
For external use
Dario
UH
MP NP
1
5
1
MP
P4241
1
11
1
[20] Schedule 1, entry for Goserelin in the form Subcutaneous implant 3.6 mg (as acetate) in pre-filled injection syringe
omit from the column headed “Circumstances”: C1377 C1871 C1872 C3228 substitute: C4799 C4800 C4806 C4807
[21] Schedule 1, entry for Latanoprost
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Xalaprost
QA
MP AO
1
5
1
[22] Schedule 1, entry for Latanoprost with timolol
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Xalamol 50/5
QA
MP
C4343
1
5
1
AO
C4326
1
5
1
[23] Schedule 1, entry for Letrozole
omit from the column headed “Circumstances” (all instances): C1608 C2691 C2692 substitute: C4795 C4801
[24] Schedule 1, entry for Levidopa with Carbidopa in the form Tablet 250 mg-25 mg (anhydrous)
omit:
Levo/Carbidopa Sandoz
SZ
MP NP
100
5
100
[25] Schedule 1, entry for Megestrol
omit from the column headed “Circumstances”: C1543
[26] Schedule 1, entry for Memantine in the form Tablet containing memantine hydrochloride 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Memantine RBX
RA
MP NP
C4214 C4218 C4221
56
5
56
[27] Schedule 1, entry for Memantine in the form Tablet containing memantine hydrochloride 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Memantine RBX
RA
MP NP
C4214 C4218 C4221
28
5
28
[28] Schedule 1, after entry for Mercaptopurine in the form Tablet 50 mg
insert in the columns in the order indicated:
Oral suspension 20 mg per mL, 100 mL
Oral
Allmercap
LM
MP
1
2
1
[29] Schedule 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 1 g
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Metformin XR 1000
TX
MP NP
60
5
60
[30] Schedule 1, after entry for Peginterferon Alfa-2a in the form Injection 180 micrograms in 0.5 mL single use pre-filled syringe
insert:
Peginterferon beta-1a
Pack containing single use injection pens containing 63 micrograms in 0.5 mL and 94 micrograms in 0.5 mL
Injection
Plegridy
BD
MP
C4798
1
0
1
Single use injection pen containing 125 micrograms in 0.5 mL
Injection
Plegridy
BD
MP
C4798 C4811
P4798
2
4
2
MP
C4798 C4811
P4811
2
5
2
[31] Schedule 1, after entry for Phenytoin in the form Oral suspension 30 mg per 5 mL, 500 mL
insert:
Phytomenadione
Injection 10 mg in 1 mL
Injection/oral
Konakion MM
RO
See Note 4
See Note 4
See Note 4
5
D(MP)
[32] Schedule 1, entry for Ranibizumab
(a) omit from the column headed “Form”: Solution for intravitreal injection 1.65 mg in 0.165 mL
substitute: Solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe
(b) omit from the column headed “Circumstances”: C4607 C4640 substitute: C4803 C4804
[33] Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 2.3 mg in 0.23 mL
omit from the column headed “Circumstances”: C4607 C4640 substitute: C4803 C4804
[34] Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
(a) insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin” (Authorised Prescriber “MP”):
C4238 C4248
(b) insert in numerical order the column headed “Purposes” for the brand “APO-Rosuvastatin” (Authorised Prescriber “MP”):
P4248
(c) insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin” (Authorised Prescriber “NP”):
C4248
(d) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Blooms the Chemist Rosuvastatin
IB
MP
C4225 C4228 C4238 C4248
P4228 P4248
30
5
30
NP
C4228 C4248
30
5
30
(e) insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “MP”):
C4238 C4248
(f) insert in numerical order the column headed “Purposes” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “MP”):
P4248
(g) insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “NP”):
C4248
(h) insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “MP”):
C4238 C4248
(i) insert in numerical order the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “MP”):
P4248
(j) insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “NP”):
C4248
[35] Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
(a) insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin”: C4238 C4248
(b) insert in numerical order the column headed “Purposes” for the brand “APO-Rosuvastatin”: P4238
(c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Blooms the Chemist Rosuvastatin
IB
MP
C4225 C4228 C4238 C4248
P4225 P4238
30
11
30
(d) omit from the column headed “Purposes” for the brand “Cavstat”: P4228 P4248 substitute: P4225 P4238
(e) insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin”: C4238 C4248
(f) insert in numerical order the column headed “Purposes” for the brand “Chem mart Rosuvastatin”: P4238
(g) insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin”: C4238 C4248
(h) insert in numerical order the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin”: P4238
[36] Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
(a) insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin” (Authorised Prescriber “MP”):
C4238 C4248
(b) insert in numerical order the column headed “Purposes” for the brand “APO-Rosuvastatin” (Authorised Prescriber “MP”):
P4248
(c) insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin” (Authorised Prescriber “NP”):
C4248
(d) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Blooms the Chemist Rosuvastatin
IB
MP
C4225 C4228 C4238 C4248
P4228 P4248
30
5
30
NP
C4228 C4248
30
5
30
(e) insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “MP”):
C4238 C4248
(f) insert in numerical order the column headed “Purposes” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “MP”):
P4248
(g) insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “NP”):
C4248
(h) insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “MP”):
C4238 C4248
(i) insert in numerical order the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “MP”):
P4248
(j) insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “NP”):
C4248
[37] Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
(a) insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin”: C4238 C4248
(b) insert in numerical order the column headed “Purposes” for the brand “APO-Rosuvastatin”: P4238
(c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Blooms the Chemist Rosuvastatin
IB
MP
C4225 C4228 C4238 C4248
P4225 P4238
30
11
30
(d) insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin”: C4238 C4248
(e) insert in numerical order the column headed “Purposes” for the brand “Chem mart Rosuvastatin”: P4238
(f) insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin”: C4238 C4248
(g) insert in numerical order the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin”: P4238
[38] Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
(a) insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin” (Authorised Prescriber “MP”):
C4238 C4259
(b) insert in numerical order the column headed “Purposes” for the brand “APO-Rosuvastatin” (Authorised Prescriber “MP”):
P4259
(c) insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin” (Authorised Prescriber “NP”):
C4259
(d) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Blooms the Chemist Rosuvastatin
IB
MP
C4225 C4227 C4238 C4259
P4227 P4259
30
5
30
NP
C4227 C4259
30
5
30
(e) insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “MP”):
C4238 C4259
(f) insert in numerical order the column headed “Purposes” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “MP”):
P4259
(g) insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “NP”):
C4259
(h) insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “MP”):
C4238 C4259
(i) insert in numerical order the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “MP”):
P4259
(j) insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “NP”):
C4259
[39] Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
(a) insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin”: C4238 C4259
(b) insert in numerical order the column headed “Purposes” for the brand “APO-Rosuvastatin”: P4238
(c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Blooms the Chemist Rosuvastatin
IB
MP
C4225 C4227 C4238 C4259
P4225 P4238
30
11
30
(d) insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin”: C4238 C4259
(e) insert in numerical order the column headed “Purposes” for the brand “Chem mart Rosuvastatin”: P4238
(f) insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin”: C4238 C4259
(g) insert in numerical order the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin”: P4238
[40] Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
(a) insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin” (Authorised Prescriber “MP”):
C4238 C4263
(b) insert in numerical order the column headed “Purposes” for the brand “APO-Rosuvastatin” (Authorised Prescriber “MP”):
P4263
(c) insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin” (Authorised Prescriber “NP”):
C4263
(d) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Blooms the Chemist Rosuvastatin
IB
MP
C4225 C4226 C4238 C4263
P4226 P4263
30
5
30
NP
C4226 C4263
30
5
30
(e) insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “MP”):
C4238 C4263
(f) insert in numerical order the column headed “Purposes” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “MP”):
P4263
(g) insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “NP”):
C4263
(h) insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “MP”):
C4238 C4263
(i) insert in numerical order the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “MP”):
P4263
(j) insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “NP”):
C4263
[41] Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
(a) insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin”: C4238 C4263
(b) insert in numerical order the column headed “Purposes” for the brand “APO-Rosuvastatin”: P4238
(c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Blooms the Chemist Rosuvastatin
IB
MP
C4225 C4226 C4238 C4263
P4225 P4238
30
11
30
(d) insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin”: C4238 C4263
(e) insert in numerical order the column headed “Purposes” for the brand “Chem mart Rosuvastatin”: P4238
(f) insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin”: C4238 C4263
(g) insert in numerical order the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin”: P4238
[42] Schedule 1, entry for Testosterone in each of the forms: Capsule containing testosterone undecanoate 40 mg; Injection containing testosterone enanthate 250 mg in 1 mL; I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL; Transdermal gel 50 mg in 5 g sachet, 30; Transdermal patches 12.2 mg, 60; Transdermal patches 24.3 mg, 30; and Transdermal solution (pump pack) 30 mg per
1.5 mL dose, 60 doses
omit from the column headed “Circumstances”: C1021 C1022 C1226 substitute: C4815 C4816 C4817 C4818 C4819
[43] Schedule 1, entry for Topiramate in each of the forms: Tablet 25 mg; and Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Topiramate AN
EA
MP NP
C2797 C2799
60
5
60
[44] Schedule 1, entry for Topiramate in each of the forms: Tablet 100 mg; and Tablet 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Topiramate AN
EA
MP NP
C2797
60
5
60
[45] Schedule 1, entry for Toremifene
omit from the column headed “Circumstances”: C1750
[46] Schedule 1, entry for Venlafaxine in each of the forms: Capsule (modified release) 75 mg (as hydrochloride); and Capsule (modified release) 150 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Blooms the Chemist Venlafaxine XR
IB
MP NP
C1211
28
5
28
[47] Schedule 1, entry for Vinorelbine in each of the forms: Solution for I.V. infusion 10 mg (as tartrate) in 1 mL; and Solution for I.V. infusion 50 mg (as tartrate) in 5 mL
omit from the column headed “Circumstances” (all instances): C3890 C3907
[48] Schedule 3, after details relevant to Responsible Person code IB
insert:
IF
Infopia Australia Pty Ltd
65 166 458 751
[49] Schedule 3, after details relevant to Responsible Person code UC
insert:
UH
uHealth Australia Pty Limited
86 159 107 258
[50] Schedule 4, Part 1, entry for Anastrozole
substitute:
Anastrozole
C4795
Breast cancer
The condition must be hormone receptor positive
Patient must not be pre-menopausal
[51] Schedule 4, Part 1, entry for Aripiprazole
insert in numerical order following existing text:
C4246
Schizophrenia
Compliance with Authority Required procedures – Streamlined Authority Code 4246
[52] Schedule 4, Part 1, entry for Bevacizumab
omit:
C4598
Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Initial treatment
The condition must be suboptimally debulked (maximum diameter of any gross residual disease greater than 1 cm); AND
Patient must have a WHO performance status of 2 or less; AND
The condition must be previously untreated; AND
The treatment must be commenced in combination with platinum-based chemotherapy; AND
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks; AND
The treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer
The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated
Compliance with Authority Required procedures – Streamlined Authority Code 4598
substitute:
C4814
Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Initial treatment
The condition must be suboptimally debulked (maximum diameter of any gross residual disease greater than 1 cm) only if the patient presents with Stage IIIB or Stage IIIC disease; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must be previously untreated; AND
The treatment must be commenced in combination with platinum-based chemotherapy; AND
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks; AND
The treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer
The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4814
[53] Schedule 4, Part 1, omit entry for Capecitabine
[54] Schedule 4, Part 1, entry for Everolimus
(a) omit:
C4557
P4557
Metastatic (Stage IV) breast cancer
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must have acquired endocrine resistance as demonstrated by initial response and then recurrence or progression of disease after treatment with letrozole or anastrozole; AND
The treatment must be in combination with exemestane
Patient must be female; AND
Patient must be post-menopausal
Compliance with Authority Required procedures
(b) insert in numerical order following existing text:
C4812
P4812
Metastatic (Stage IV) breast cancer
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must have acquired endocrine resistance as demonstrated by initial response and then recurrence or progression of disease after treatment with letrozole or anastrozole; AND
The treatment must be in combination with exemestane
Patient must not be pre-menopausal
Compliance with Authority Required procedures
[55] Schedule 4, Part 1, entry for Exemestane
substitute:
Exemestane
C4796
Metastatic (Stage IV) breast cancer
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
Patient must be receiving PBS-subsidised everolimus concomitantly for this condition
Patient must not be pre-menopausal
C4802
Advanced breast cancer
The condition must be hormone receptor positive; AND
The condition must have progressed following treatment with tamoxifen
Patient must not be pre-menopausal
C4808
Early breast cancer
The condition must be hormone receptor positive; AND
The condition must have previously been treated with tamoxifen for a minimum of 2 years
Patient must not be pre-menopausal
[56] Schedule 4, Part 1, entry for Goserelin
(a) omit:
C1377
Treatment of visually proven endometriosis where the duration of treatment provided for by this prescription, in combination with any previous prescriptions, does not exceed 6 months’ uninterrupted therapy
Compliance with Authority Required procedures
C1871
Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate
Compliance with Authority Required procedures
C1872
Hormone‑dependent locally advanced (equivalent to stage III) or metastatic (equivalent to stage IV) breast cancer in pre‑menopausal women
Compliance with Authority Required procedures
C3228
Hormone‑dependent breast cancer as an alternative to adjuvant chemotherapy in peri‑ or pre‑menopausal women.
Compliance with Authority Required procedures
(b) insert in numerical order following existing text:
C4799
Endometriosis
The condition must be visually proven; AND
The treatment must be for the short-term (up to 6 months
Compliance with Authority Required procedures
C4800
Locally advanced (Stage III) or metastatic (Stage IV) breast cancer
The condition must be hormone receptor positive
Compliance with Authority Required procedures
C4806
Locally advanced (stage C) or metastatic (stage D) carcinoma of the prostate
Compliance with Authority Required procedures
C4807
Breast cancer
The condition must be hormone receptor positive; AND
The treatment must be an alternative to adjuvant chemotherapy
Compliance with Authority Required procedures
[57] Schedule 4, Part 1, entry for Letrozole
substitute:
Letrozole
C4795
Breast cancer
The condition must be hormone receptor positive
Patient must not be pre-menopausal
C4801
Early breast cancer
The condition must be hormone receptor positive; AND
The treatment must be for extended adjuvant treatment of the condition commencing within 6 months of ceasing treatment with tamoxifen
Patient must not be pre-menopausal
[58] Schedule 4, Part 1, omit entry for Megestrol
[59] Schedule 4, Part 1, after entry for Peginterferon Alfa-2a
insert:
Peginterferon beta-1a
C4798
P4798
Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND
Patient must be ambulatory (without assistance or support)
Where applicable, the date of the magnetic resonance imaging scan must be provided with the authority application
Compliance with Authority Required procedures
C4811
P4811
Multiple sclerosis
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy
Compliance with Authority Required procedures
[60] Schedule 4, Part 1, entry for Ranibizumab
substitute:
Ranibizumab
C4803
Subfoveal choroidal neovascularisation (CNV)
Initial treatment
The condition must be due to age-related macular degeneration (AMD); AND
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Must be treated by an ophthalmologist
Authority approval for initial treatment of each eye must be sought
The first authority application for each eye must be made in writing or by telephone
A written application must include:
a) a completed authority prescription form;
b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and
c) a copy of the fluorescein angiogram
A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorized
Where a fluorescein angiogram cannot be performed due to a contraindication as listed in the TGA-approved product information, details of the contraindication must be provided. A copy of the report of an alternative method of diagnosis must be included in the application, for example, optical coherence tomography (OCT) or red free photography
Compliance with Written or Telephone Authority Required procedures
C4804
Subfoveal choroidal neovascularisation (CNV)
Continuing treatment
The condition must be due to age-related macular degeneration (AMD); AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been granted an authority prescription for the same eye
Must be treated by an ophthalmologist
Compliance with Written or Telephone Authority Required procedures
[61] Schedule 4, Part 1, entry for Rituximab [Circumstances Code C4701]
(a) omit from the column headed “Circumstances and Purposes”:
Where the patient is receiving treatment at/from a Public Hospital
(b) omit from the column headed “Circumstances and Purposes”: *Patient substitute: Patient
[62] Schedule 4, Part 1, entry for Testosterone
substitute:
Testosterone
C4815
Androgen deficiency
Patient must not have established pituitary or testicular disorders other than ageing
Patient must be male; AND
Patient must be aged 40 years or older
Androgen deficiency is defined as:
(i) testosterone level of less than 8 nmol per litre; OR
(ii) testosterone level between 8 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men)
Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings
Compliance with Authority Required procedures
C4816
Constitutional delay of growth or puberty
Patient must be male; AND
Patient must be under 18 years of age
Compliance with Authority Required procedures
C4817
Androgen deficiency
Patient must have an established pituitary or testicular disorder
Patient must be male
Compliance with Authority Required procedures
C4818
Micropenis
Patient must be male; AND
Patient must be under 18 years of age
Compliance with Authority Required procedures
C4819
Pubertal induction
Patient must be male; AND
Patient must be under 18 years of age
Compliance with Authority Required procedures
[63] Schedule 4, Part 1, omit entry for Toremifene
[64] Schedule 4, Part 1, entry for Vinorelbine
omit:
C3890
Locally advanced or metastatic non‑small cell lung cancer
Compliance with Authority Required procedures – Streamlined Authority Code 3890
C3907
Advanced breast cancer after failure of prior therapy which includes an anthracycline
Compliance with Authority Required procedures – Streamlined Authority Code 3907
