PB 9 of 2014
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(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 12th February 2014
FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health
1 Name of Instrument
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 2).
(2) This Instrument may also be cited as PB 9 of 2014.
2 Commencement
This Instrument commences on 1 March 2014.
3 Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1 Amendments
[1] Schedule 1, entry for Amino acid formula with vitamins and minerals without phenylalanine
omit:
Oral powder 400 g (Phenex‑2)
Oral
Phenex-2
AB
MP NP
C4295
8
5
1
[2] Schedule 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besylate); and Tablet 10 mg (as besylate)
omit:
Amlodipine Pfizer
FZ
MP NP
30
5
30
[3] 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]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Clavam 875 mg/125 mg
NJ
PDP
C1836 C1837
10
0
10
[4] 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]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Clavam 875 mg/125 mg
NJ
MP NP
C1836 C1837
10
1
10
[5] Schedule 1, entry for Anastrozole in the form Tablet 1 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Azastrole
ER
MP NP
C2213
30
5
30
[6] Schedule 1, after entry for Aprepitant
insert:
Arachidonic acid and docosahexaenoic acid with carbohydrate
Sachets of oral powder 4 g containing 200 mg arachidonic acid and 100 mg docosahexaenoic acid , 30 (keyomega)
Oral
keyomega
VF
MP NP
C4434
4
5
1
[7] Schedule 1, entry for Bicalutamide in the form Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Bicalox
ER
MP NP
C3674
28
5
28
[8] Schedule 1, after entry for Bimatoprost in the form Eye drops 300 micrograms per mL, 3 mL
insert in the columns in the order indicated:
Eye drops 300 micrograms per mL, single dose units 0.4 mL, 30
Application to the eye
Lumigan PF
AG
MP AO
1
5
1
[9] Schedule 1, entry for Carbohydrate, fat, vitamins, minerals and trace elements
omit from the column headed “Circumstances”: C1276 substitute: C4438
[10] Schedule 1, after entry for Carbohydrate, fat, vitamins, minerals and trace elements
insert:
Carbohydrate, fat, vitamins, minerals and trace elements and supplemented with arachidonic acid and docosahexaenoic acid
Sachets containing oral powder 21.5 g, 30 (basecal 100)
Oral
basecal 100
VF
MP NP
C4438
4
5
1
Sachets containing oral powder 43 g, 30 (basecal 200)
Oral
basecal 200
VF
MP NP
C4438
4
5
1
[11] Schedule 1, entry for Carboplatin in the form Solution for I.V. injection 150 mg in 15 mL
omit:
Pfizer Australia Pty Ltd
PF
MP
See Note 3
See
Note 3
1
D(100)
[12] Schedule 1, entry for Cisplatin in each of the forms: I.V. injection 50 mg in 50 mL; and I.V. injection 100 mg in 100 mL
omit:
Pfizer Australia Pty Ltd
PF
MP
See Note 3
See
Note 3
1
D(100)
[13] Schedule 1, entry for Dicloxacillin in the form Capsule 500 mg (as sodium)
omit:
Diclocil
BQ
MP NP MW PDP
C1345
24
0
24
[14] Schedule 1, entry for Docetaxel in the form Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous)
in 2 mL with solvent
omit from the column headed “Responsible Person”: YA substitute: AF
[15] Schedule 1, after entry for Docetaxel in the form Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous)
in 2 mL with solvent
insert:
Docosahexaenoic acid with carbohydrate
Sachets of oral powder 4 g containing 200 mg docosahexaenoic acid, 30 (docomega)
Oral
docomega
VF
MP NP
C4434
4
5
1
[16] Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL
omit:
Epirubicin Kabi
PK
MP
See Note 3
See
Note 3
1
D(100)
[17] Schedule 1, entry for Felodipine in each of the forms: Tablet 2.5 mg (extended release); Tablet 5 mg (extended release); and
Tablet 10 mg (extended release)
omit from the column headed “Responsible Person” for the brand “Plendil ER”: AP substitute: GX
[18] Schedule 1, entry for Fludarabine in the form Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL
omit:
AS-Fludarabine
YA
MP
C3887
See Note 3
See
Note 3
1
PB(100)
[19] Schedule 1, entry for Gabapentin in each of the forms: Capsule 100 mg; Capsule 300 mg; and Capsule 400 mg
omit:
Gabapentin Pfizer
FZ
MP NP
C2664
100
5
100
[20] Schedule 1, entry for Gabapentin in the form Tablet 800 mg
omit:
Gabapentin Pfizer
FZ
MP NP
C2664
100
5
100
[21] Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride)
omit:
Gemcitabine Kabi
PK
MP
See Note 3
See
Note 3
1
D(100)
[22] Schedule 1, entry for Gemcitabine in the form Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL
omit:
Gemcitabine-AS
YA
MP
See Note 3
See
Note 3
1
D(100)
[23] Schedule 1, entry for Gemcitabine in the form Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL
omit:
Gemcitabine-AS
YA
MP
See Note 3
See
Note 3
1
D(100)
[24] Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 2 g (as hydrochloride)
omit:
Gemcitabine Kabi
PK
MP
See Note 3
See
Note 3
1
D(100)
[25] Schedule 1, entry for Imiquimod in the form Cream 50 mg per g, 250 mg single use sachets, 12
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Aldiq
QA
MP
C4229
1
1
1
[26] Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL
omit:
Irinotecan Kabi
PK
MP
C3184
See Note 3
See
Note 3
1
D(100)
[27] Schedule 1, entry for Lactulose in the form Solution BP 3.34 g per 5 mL, 500 mL
(a) omit:
Lactocur
SZ
MP NP
C1150 C1613 C3642 C3643
P3643
3
0
1
(b) omit:
Lactocur
SZ
MP NP
C1150 C1613 C3642 C3643
P3642
3
3
1
(c) omit:
Lactocur
SZ
MP NP
C1150 C1613 C3642 C3643
P1150 P1613
1
5
1
[28] Schedule 1, after entry for Linagliptin
insert:
Linagliptin with metformin
Tablet containing 2.5 mg linagliptin with 500 mg metformin hydrochloride
Oral
Trajentamet
BY
MP NP
C4423 C4448
60
5
60
Tablet containing 2.5 mg linagliptin with 850 mg metformin hydrochloride
Oral
Trajentamet
BY
MP NP
C4423 C4448
60
5
60
Tablet containing 2.5 mg linagliptin with 1000 mg metformin hydrochloride
Oral
Trajentamet
BY
MP NP
C4423 C4448
60
5
60
[29] Schedule 1, entry for Lisinopril in the form Tablet 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Auro‑Lisinopril 5
DO
MP NP
30
5
30
[30] Schedule 1, entry for Lisinopril in the form Tablet 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Auro-Lisinopril 10
DO
MP NP
30
5
30
[31] Schedule 1, entry for Lisinopril in the form Tablet 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Auro-Lisinopril 20
DO
MP NP
30
5
30
[32] Schedule 1, entry for Mitozantrone in the form Injection 20 mg (as hydrochloride) in 10 mL
omit:
Pfizer Australia Pty Ltd
PF
MP
See Note 3
See
Note 3
1
D(100)
[33] Schedule 1, entry for Nevirapine in the form Tablet 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Nevipin
GN
MP
See Note 1
C3586 C3587 C3588 C3589
120
5
60
D(100)
[34] Schedule 1, entry for Olanzapine in the form Tablet 2.5 mg
omit:
Zylap 2.5
QA
MP NP
C1589 C2044
28
5
28
[35] Schedule 1, entry for Olanzapine in the form Tablet 5 mg
omit:
Zylap 5
QA
MP NP
C1589 C2044
28
5
28
[36] Schedule 1, entry for Olanzapine in the form Tablet 7.5 mg
omit:
Zylap 7.5
QA
MP NP
C1589 C2044
28
5
28
[37] Schedule 1, entry for Olanzapine in the form Tablet 10 mg
omit:
Zylap 10
QA
MP NP
C1589 C2044
28
5
28
[38] Schedule 1, entry for Olanzapine in the form Tablet 5 mg (orally disintegrating)
omit:
Zylap ODT 5
QA
MP NP
C1589 C2044
28
5
28
[39] Schedule 1, entry for Olanzapine in the form Tablet 10 mg (orally disintegrating)
omit:
Zylap ODT 10
QA
MP NP
C1589 C2044
28
5
28
[40] Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 50 mg in 10 mL
omit:
Oxaliplatin Kabi
PK
MP
C3900 C3901 C3930 C3939
See Note 3
See
Note 3
1
D(100)
[41] Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 30 mg in 5 mL
omit:
Taxol
BQ
MP
C3186 C3890 C3902 C3917 C3955 C3956
See Note 3
See
Note 3
1
D(100)
[42] Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 100 mg in 16.7 mL
(a) omit:
Paclitaxel Kabi
PK
MP
C3186 C3890 C3902 C3917 C3955 C3956
See Note 3
See
Note 3
1
D(100)
(b) omit:
Taxol
BQ
MP
C3186 C3890 C3902 C3917 C3955 C3956
See Note 3
See
Note 3
1
D(100)
[43] Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL
omit:
Taxol
BQ
MP
C3186 C3890 C3902 C3917 C3955 C3956
See Note 3
See
Note 3
1
D(100)
[44] Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Topra 40
DO
MP NP
C1177 C1337 C1476 C1533
P1177
30
2
30
[45] Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Topra 40
DO
MP NP
C1177 C1337 C1476 C1533
P1337 P1476 P1533
30
5
30
[46] Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]
(a) insert in numerical order in the column headed “Circumstances”: C4435 C4439 C4444
(b) insert in numerical order in the column headed “Purposes”: P4439
[47] Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 90; Number of Repeats: 2]
(a) insert in numerical order in the column headed “Circumstances”: C4435 C4439 C4444
(b) insert in numerical order in the column headed “Purposes”: P4444
[48] Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 90; Number of Repeats: 5]
(a) insert in numerical order in the column headed “Circumstances”: C4435 C4439 C4444
(b) insert in numerical order in the column headed “Purposes”: P4435
[49] Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]
(a) insert in numerical order in the column headed “Circumstances”: C4435 C4439 C4444
(b) insert in numerical order in the column headed “Purposes”: P4439
[50] Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 2]
(a) insert in numerical order in the column headed “Circumstances”: C4435 C4439 C4444
(b) insert in numerical order in the column headed “Purposes”: P4444
[51] Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 5]
(a) insert in numerical order in the column headed “Circumstances”: C4435 C4439 C4444
(b) insert in numerical order in the column headed “Purposes”: P4435
[52] Schedule 1, entry for Quinapril in each of the forms: Tablet 5 mg (as hydrochloride); Tablet 10 mg (as hydrochloride); and Tablet 20 mg
(as hydrochloride)
omit:
Quinapril Pfizer
FZ
MP NP
30
5
30
[53] Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Rispernia
ER
MP NP
C1589 C2061 C3083
P2061 P3083
60
2
60
[54] Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Rispernia
ER
MP NP
C1589 C2061 C3083
P1589
60
5
60
[55] Schedule 1, entry for Risperidone in the form Tablet 1 mg [Maximum Quantity: 60; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Rispernia
ER
MP NP
C1589 C2061 C2272 C3083
P2061 P3083
60
2
60
[56] Schedule 1, entry for Risperidone in the form Tablet 1 mg [Maximum Quantity: 60; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Rispernia
ER
MP NP
C1589 C2061 C2272 C3083
P1589 P2272
60
5
60
[57] Schedule 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Rispernia
ER
MP NP
C1589 C2272 C3083
P3083
60
2
60
[58] Schedule 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Rispernia
ER
MP NP
C1589 C2272 C3083
P1589 P2272
60
5
60
[59] Schedule 1, entry for Risperidone in the form Tablet 3 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Rispernia
ER
MP NP
C1589 C2272
60
5
60
[60] Schedule 1, entry for Risperidone in the form Tablet 4 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Rispernia
ER
MP NP
C1589 C2272
60
5
60
[61] Schedule 1, after entry for Saxagliptin
insert:
Saxagliptin with metformin
Tablet (modified release) containing 2.5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride
Oral
Kombiglyze XR 2.5/1000
BQ
MP NP
C4423 C4451
56
5
56
Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 500 mg metformin hydrochloride
Oral
Kombiglyze XR 5/500
BQ
MP NP
C4423 C4451
28
5
28
Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride
Oral
Kombiglyze XR 5/1000
BQ
MP NP
C4423 C4451
28
5
28
[62] Schedule 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Sertraline Actavis
UA
MP NP
C1211 C1241 C1975
30
5
30
(b) omit:
Sertraline‑GA
UA
MP NP
C1211
30
5
30
(c) omit:
Sertraline Pfizer
FZ
MP NP
C1211 C1241 C1975
30
5
30
[63] Schedule 1, entry for Sertraline in the form Tablet 100 mg (as hydrochloride)
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Sertraline Actavis
UA
MP NP
C1211 C1241 C1975
30
5
30
(b) omit:
Sertraline‑GA
UA
MP NP
C1211
30
5
30
(c) omit:
Sertraline Pfizer
FZ
MP NP
C1211 C1241 C1975
30
5
30
[64] Schedule 1, entry for Somatropin
omit:
Injection 5 mg (15 i.u.) in 1 mL cartridge (with preservative)
Injection
Genotropin
PF
MP
See Note 1
See Note 3
See Note 3
See Note 3
See
Note 3
1
D(100)
[65] Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 5; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Temozolomide Alphapharm
AF
MP
C1736 C1737 C2100 C2101
P1736 P1737 P2101
5
5
5
[66] Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 15; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Temozolomide Alphapharm
AF
MP
C1736 C1737 C2100 C2101
P2100
15
2
5
[67] Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 5; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Temozolomide Alphapharm
AF
MP
C1736 C1737 C2100 C2101
P1736 P1737 P2101
5
5
5
[68] Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 15; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Temozolomide Alphapharm
AF
MP
C1736 C1737 C2100 C2101
P2100
15
2
5
[69] Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 5; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Temozolomide Alphapharm
AF
MP
C1736 C1737 C2100 C2101
P1736 P1737 P2101
5
5
5
[70] Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 15; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Temozolomide Alphapharm
AF
MP
C1736 C1737 C2100 C2101
P2100
15
2
5
[71] Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 5; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Temozolomide Alphapharm
AF
MP
C1736 C1737 C2100 C2101
P1736 P1737 P2101
5
5
5
[72] Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 15; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Temozolomide Alphapharm
AF
MP
C1736 C1737 C2100 C2101
P2100
15
2
5
[73] Schedule 1, entry for Temozolomide in the form Capsule 250 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Temozolomide Alphapharm
AF
MP
C1736 C1737 C2101
5
5
5
[74] Schedule 1, entry for Terbutaline
omit:
Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 200 doses
Inhalation by mouth
Bricanyl Turbuhaler
AP
MP NP
1
5
1
[75] Schedule 1, entry for Topotecan in the form Powder for I.V. infusion 4 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Topotecan Agila”: YA substitute: AF
[76] Schedule 1, after entry for Trifluoperazine in the form Tablet 5 mg (as hydrochloride)
insert:
Triglycerides, long chain
Oral liquid 250 mL, 18 (carbzero)
Oral
carbzero
VF
MP NP
C4437
2
5
1
[77] Schedule 1, after entry for Triglycerides, medium chain in the form Oral emulsion 250 mL (Liquigen)
insert in the columns in the order indicated:
Oral liquid 250 mL, 18 (betaquik)
Oral
betaquik
VF
MP NP
C4443 C4447
2
5
1
[78] Schedule 3, after details relevant to Responsible Person code NI
insert:
NJ
Norac Pharma Australia Pty Ltd
22 164 670 008
[79] Schedule 3
omit:
YA
Agila Australasia Pty Ltd
12 154 055 339
[80] Schedule 4, Part 1, after entry for Aprepitant
insert:
Arachidonic acid and docosahexaenoic acid with carbohydrate
C4434
Peroxisomal biogenesis disorders
Compliance with Authority Required procedures
[81] Schedule 4, Part 1, entry for Carbohydrate, fat, vitamins, minerals and trace elements
substitute:
Carbohydrate, fat, vitamins, minerals and trace elements
C4438
Proven inborn errors of protein metabolism
Patient must be unable to meet their energy requirements with permitted food and formulae
[82] Schedule 4, Part 1, after entry for Carbohydrate, fat, vitamins, minerals and trace elements
insert:
Carbohydrate, fat, vitamins, minerals and trace elements and supplemented with arachidonic acid and docosahexaenoic acid
C4438
Proven inborn errors of protein metabolism
Patient must be unable to meet their energy requirements with permitted food and formulae
[83] Schedule 4, Part 1, after entry for Docetaxel
insert:
Docosahexaenoic acid with carbohydrate
C4434
Peroxisomal biogenesis disorders
Compliance with Authority Required procedures
[84] Schedule 4, Part 1, after entry for Linagliptin
insert:
Linagliptin with metformin
C4423
Diabetes mellitus type 2
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; 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 metformin
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 does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination
Compliance with Authority Required procedures - Streamlined Authority Code 4423
C4448
Diabetes mellitus type 2
Continuing treatment
Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and linagliptin
Compliance with Authority Required procedures - Streamlined Authority Code 4448
[85] Schedule 4, Part 1, entry for Pazopanib
insert in numerical order following existing text:
C4435
P4435
Advanced (unresectable and/or metastatic) soft tissue sarcoma
Continuing treatment beyond 3 months
Patient must have previously been issued with an authority prescription for pazopanib; AND
Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND
The treatment must be the sole PBS-subsidised therapy for this condition
Applications for continuing therapy may be made by telephone
Compliance with Authority Required procedures
C4439
P4439
Advanced (unresectable and/or metastatic) soft tissue sarcoma
Continuing treatment beyond 3 months
Patient must have previously been issued with an authority prescription for pazopanib; AND
Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND
Patient must require dose adjustment; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Applications for continuing therapy may be made by telephone
Compliance with Authority Required procedures
C4444
P4444
Advanced (unresectable and/or metastatic) soft tissue sarcoma
Initial treatment
Patient must have a WHO performance status of 2 or less; AND
Patient must have received prior chemotherapy treatment including an anthracycline; AND
Patient must not have received prior treatment with an angiogenesis inhibitor; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Patient must not have any of the following conditions:
adipocytic soft tissue sarcoma;
gastrointestinal stromal tumour (GIST);
rhabdomyosarcoma other than alveolar or pleomorphic;
chondrosarcoma;
osteosarcoma;
Ewings tumour/primitive neuroectodermal tumour;
dermofibromatosis sarcoma protuberans;
inflammatory myofibroblastic sarcoma;
malignant mesothelioma;
mixed mesodermal tumour of the uterus
The authority application must be made in writing
Compliance with written Authority Required procedures
[86] Schedule 4, Part 1, after entry for Saxagliptin
insert:
Saxagliptin with metformin
C4423
Diabetes mellitus type 2
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; 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 metformin
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 does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination
Compliance with Authority Required procedures - Streamlined Authority Code 4423
C4451
Diabetes mellitus type 2
Continuing treatment
Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and saxagliptin
Compliance with Authority Required procedures - Streamlined Authority Code 4451
[87] Schedule 4, Part 1, after entry for Triamcinolone
insert:
Triglycerides, long chain
C4437
Ketogenic diet
Patient must have intractable seizures requiring treatment with a ketogenic diet; OR
Patient must have a glucose transport protein defect; OR
Patient must have pyruvate dehydrogenase deficiency
Carbzero should only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist
[88] Schedule 4, Part 1, entry for Triglycerides, medium chain
insert in numerical order following existing text:
C4443
Ketogenic diet
Patient must have intractable seizures requiring treatment with a ketogenic diet; OR
Patient must have a glucose transport protein defect; OR
Patient must have pyruvate dehydrogenase deficiency
Compliance with Authority Required procedures
C4447
Dietary management of conditions requiring a source of medium chain triglycerides
Patient must have chylous ascites; OR
Patient must have chylothorax; OR
Patient must have hyperlipoproteinaemia type 1; OR
Patient must have long chain fatty acid oxidation disorders; OR
Patient must have fat malabsorption due to liver disease; OR
Patient must have fat malabsorption due to short gut syndrome; OR
Patient must have fat malabsorption due to cystic fibrosis; OR
Patient must have fat malabsorption due to gastrointestinal disorders
Compliance with Authority Required procedures
