PB 27 of 2014
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 4)
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 9 April 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. 4).
(2) This Instrument may also be cited as PB 27 of 2014.
2 Commencement
This Instrument commences on 1 May 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 Acitretin in each of the forms: Capsule 10 mg; and Capsule 25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Acitretin Actavis
GN
MP
C1363 C1366
100
2
100
[2] Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL [Maximum Quantity: 1; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Amoxycillin
TX
PDP
1
0
1
[3] Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL [Maximum Quantity: 1; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Amoxycillin
TX
MP NP
1
1
1
[4] Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL [Maximum Quantity: 1; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Amoxycillin
TX
PDP
1
0
1
[5] Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL [Maximum Quantity: 1; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Amoxycillin
TX
MP NP
1
1
1
[6] 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) [MaximumQuantity: 10; Number of Repeats: 0]
omit from the column headed “Brand”: Amoxycillin/ Clavulanic Acid 875/125 generichealth substitute: AmoxyClav GH 875/125
[7] 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) [MaximumQuantity: 10; Number of Repeats: 1]
omit from the column headed “Brand”: Amoxycillin/ Clavulanic Acid 875/125 generichealth substitute: AmoxyClav GH 875/125
[8] Schedule 1, entry for Atazanavir
omit:
Capsule 100 mg (as sulfate)
Oral
Reyataz
BQ
MP
See Note 1
C4454 C4455 C4469 C4512
120
5
60
D(100)
[9] Schedule 1, entry for Azathioprine in the form Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Azathioprine
TX
MP NP
100
5
100
[10] Schedule 1, entry for Carbamazepine in the form Tablet 100 mg [Maximum Quantity: 200; Number of Repeats: 0]
omit:
Carbamazepine Sandoz
SZ
PDP
200
0
200
substitute:
Carbamazepine Sandoz
SZ
PDP
200
0
100
PDP
200
0
200
[11] Schedule 1, entry for Carbamazepine in the form Tablet 100 mg [Maximum Quantity: 200; Number of Repeats: 2]
omit:
Carbamazepine Sandoz
SZ
MP NP
200
2
200
substitute:
Carbamazepine Sandoz
SZ
MP NP
200
2
100
MP NP
200
2
200
[12] Schedule 1, entry for Carbomer with Triglyceride Lipids
omit:
Eye gel 2 mg‑10 mg per g, 10 g
Application to the eye
Artelac
BU
MP
C1362 C3036
P1362
1
5
1
NP AO
C1362
1
5
1
MP
C1362 C3036
P3036
1
11
1
[13] Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Cephalexin
TX
PDP
20
0
20
[14] Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Cephalexin
TX
MP NP MW
20
1
20
[15] Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Maximum Quantity: 40; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Cephalexin
TX
MP
C4243
40
2
20
[16] Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Cephalexin
TX
PDP
20
0
20
[17] Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Cephalexin
TX
MP NP MW
20
1
20
[18] Schedule 1, entry for Cephazolin in the form Powder for injection 1 g (as sodium)
omit:
Kefzol
AS
MP NP
C1169 C1846 C1847 C3132
10
0
10
[19] Schedule 1, entry for Dapagliflozin
omit from the column headed “Responsible Person”: BQ substitute: AP
[20] Schedule 1, entry for Docetaxel
omit:
Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent
Injection
AS-Docetaxel
AF
MP
C3888 C3892 C3916 C3956 C4078 C4140 C4160 C4239
See Note 3
See
Note 3
1
D(100)
[21] Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Doxorubicin MYX
YN
MP
See Note 3
See
Note 3
1
D(100)
[22] Schedule 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Duloxetine RBX
RA
MP NP
C1211
28
0
28
[23] Schedule 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Duloxetine RBX
RA
MP NP
C1211
28
5
28
[24] Schedule 1, entry for Enalapril in the form Tablet containing enalapril maleate 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Enalapril Actavis
UA
MP NP
30
5
30
[25] Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Cilopam-S
ER
MP NP
C1211
28
5
28
[26] Schedule 1, entry for Exenatide in each of the forms: Injection solution 5 micrograms per dose in pre‑filled pen, 60 doses; and
Injection solution 10 micrograms per dose in pre‑filled pen, 60 doses
omit from the column headed “Responsible Person”: BQ substitute: AP
[27] Schedule 1, entry for Gabapentin in each of the forms: Capsule 100 mg; Capsule 300 mg; and Capsule 400 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Gabacor
NJ
MP NP
C2664
100
5
100
[28] Schedule 1, entry for Glucose Indicator—Blood
omit:
Test strips, 50 (Omnitest EZ)
For external use
Omnitest EZ
BR
MP NP
2
5
1
MP
P4241
2
11
1
[29] Schedule 1, entry for Latanoprost with timolol
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Latanoprost/ Timolol Sandoz 50/5
SZ
MP
C4343
1
5
1
AO
C4326
1
5
1
[30] Schedule 1, entry for Letrozole
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Gynotril
ER
MP NP
C1608 C2691 C2692
30
5
30
[31] Schedule 1, entry for Levetiracetam in each of the forms: Tablet 250 mg; Tablet 500 mg; and Tablet 1 g
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Levactam
ER
MP NP
C2664
60
5
60
[32] Schedule 1, entry for Levonorgestrel with Ethinyloestradiol in the form Pack containing 21 tablets 150 micrograms-30 micrograms and
7 inert tablets
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Micronelle 30 ED
TX
MP NP
4
2
4
[33] Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Molaxole
HM
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643 See Note 2
P3643
See Note 2
2
See Note 2
0
See Note 2
1
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643 See Note 2
P3642
See Note 2
2
See Note 2
3
See Note 2
1
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643 See Note 2
P1263 P1613 P2693 P2823
See Note 2
1
See Note 2
5
See Note 2
1
[34] Schedule 1, omit entry for Methysergide
[35] Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Mistrom
ER
MP NP
100
5
100
[36] Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Mistrom
ER
MP NP
60
5
60
[37] Schedule 1, entry for Metronidazole in the form I.V. infusion 500 mg in 100 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Metronidazole Sandoz IV
SZ
MP NP
C4167 C4168 C4169
10
0
10
PDP
C4169
10
0
10
[38] Schedule 1, entry for Mirtazapine in the form Tablet 30 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Mirtazapine
TX
MP NP
C1211
30
5
30
[39] Schedule 1, entry for Olanzapine in the form Tablet 7.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Olanzapine GH
GQ
MP NP
C1589 C2044
28
5
28
[40] Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Panthron
ER
MP NP
C1337 C1476 C1533
30
5
30
[41] Schedule 1, omit entry for Pergolide
[42] Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Perindopril Actavis 2
UA
MP NP
30
5
30
(b) omit:
Perindopril‑DP
GN
MP NP
30
5
30
Perindopril‑GA
UA
MP NP
30
5
30
[43] Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Perindopril Actavis 4
UA
MP NP
30
5
30
(b) omit:
Perindopril‑DP
GN
MP NP
30
5
30
Perindopril‑GA
UA
MP NP
30
5
30
[44] Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Perindopril Actavis 8
UA
MP NP
30
5
30
(b) omit:
Perindopril‑DP
GN
MP NP
30
5
30
Perindopril‑GA
UA
MP NP
30
5
30
[45] Schedule 1, after entry for Pizotifen
insert:
Plerixafor
Injection 24 mg in 1.2 mL
Injection
Mozobil
GZ
MP
See Note 1
C4549 C4550
1
1
1
D(100)
[46] Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pharmacor Quetiapine 25
CR
MP NP
C4385 C4391 C4396
60
0
60
[47] Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pharmacor Quetiapine 100
CR
MP NP
C1589 C2044 C2765
90
5
90
[48] Schedule 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pharmacor Quetiapine 200
CR
MP NP
C1589 C2044 C2765
60
5
60
[49] Schedule 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pharmacor Quetiapine 300
CR
MP NP
C1589 C2044 C2765
60
5
60
[50] Schedule 1, after entry for Salmeterol
insert:
Sapropterin
Tablet (soluble) containing sapropterin dihydrochloride 100 mg
Oral
Kuvan
SG
MP
C4547 C4548
P4547
180
0
30
MP
C4547 C4548
P4548
180
5
30
[51] Schedule 1, entry for Saxagliptin
omit from the column headed “Responsible Person”: BQ substitute: AP
[52] Schedule 1, entry for Saxagliptin with metformin in each of the forms: Tablet (modified release) containing 2.5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride; Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with
500 mg metformin hydrochloride; and Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride
omit from the column headed “Responsible Person”: BQ substitute: AP
[53] Schedule 1, after entry for Sitagliptin with metformin in the form Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride
insert in the columns in the order indicated:
Tablet (modified release) containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride
Oral
Janumet XR
MK
MP NP
C4309 C4423
56
5
56
Tablet (modified release) containing 100 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride
Oral
Janumet XR
MK
MP NP
C4309 C4423
28
5
28
[54] Schedule 1, after entry for Tenofovir with Emtricitabine and Rilpivirine
insert:
Tenofovir with emtricitabine, elvitegravir and cobicistat
Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg, elvitegravir 150 mg and cobicistat 150 mg
Oral
Stribild
GI
MP
See Note 1
C4470 C4494 C4522 C4533
60
5
30
D(100)
[55] Schedule 1, entry for Timolol
omit:
Eye drops 2.5 mg (as maleate) per mL, 5 mL
Application to the eye
Tenopt
QA
MP AO
1
5
1
[56] Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg [Maximum Quantity: 20;
Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Tramadol Actavis
UA
MP NP
C1497 C1615
P1497
20
0
20
PDP
C1497 C1615
20
0
20
[57] Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg [Maximum Quantity: 20;
Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Tramadol Actavis
UA
MP NP
C1497 C1615
P1615
20
2
20
[58] Schedule 1, entry for Tramadol in the form Injection containing tramadol hydrochloride 100 mg in 2 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Tramadol ACT
GN
MP NP PDP
C1378
5
0
5
[59] Schedule 1, entry for Venlafaxine in the form Capsule (modified release) 37.5 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Venlafaxine Actavis XR
UA
MP NP
C1211
28
0
28
[60] 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”:
Venlafaxine Actavis XR
UA
MP NP
C1211
28
5
28
[61] Schedule 1, entry for Verapamil in the form Tablet containing verapamil hydrochloride 40 mg
omit:
Isoptin
AB
MP NP
100
5
100
[62] Schedule 1, entry for Verapamil
omit:
Tablet containing verapamil hydrochloride 120 mg
Oral
Isoptin
AB
MP NP
100
5
100
[63] Schedule 4, Part 1, entry for Carbomer with Triglyceride Lipids
(a) omit:
C1362
P1362
Severe dry eye syndrome, including Sjogren’s syndrome
(b) omit:
C3036
P3036
For use in patients who have severe dry eye syndrome, including Sjogren’s syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements
[64] Schedule 4, Part 1, omit entry for Pergolide
[65] Schedule 4, Part 1, after entry for Piroxicam
insert:
Plerixafor
C4549
Where the patient is receiving treatment at/from a public hospital
Mobilisation of haematopoietic stem cells
The treatment must be in combination with granulocyte-colony stimulating factor (G-CSF); AND
Patient must have lymphoma; OR
Patient must have multiple myeloma; AND
Patient must require autologous stem cell transplantation; AND
Patient must have failed previous stem cell collection; OR
Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per microlitre on the day of planned collection; OR
Patient must be undergoing chemotherapy plus G-CSF mobilisation and the first apheresis has yielded less than 1 million CD34+ cells/kg
Evidence that the patient meets the PBS restriction criteria must be recorded in the patient's medical records
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4549
C4550
Where the patient is receiving treatment at/from a private hospital
Mobilisation of haematopoietic stem cells
The treatment must be in combination with granulocyte-colony stimulating factor (G-CSF); AND
Patient must have lymphoma; OR
Patient must have multiple myeloma; AND
Patient must require autologous stem cell transplantation; AND
Patient must have failed previous stem cell collection; OR
Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per microlitre on the day of planned collection; OR
Patient must be undergoing chemotherapy plus G-CSF mobilisation and the first apheresis has yielded less than 1 million CD34+ cells/kg
Evidence that the patient meets the PBS restriction criteria must be recorded in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
[66] Schedule 4, Part 1, after entry for Salmeterol
insert:
Sapropterin
C4547
P4547
Hyperphenylalaninaemia
Initial treatment
Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency
Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured
The authority application must be made in writing
Compliance with Written Authority Required procedures
C4548
P4548
Hyperphenylalaninaemia
Continuing treatment
Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND
Patient must have demonstrated a 30% or greater reduction in blood phenylalanine levels in response to treatment with sapropterin; OR
Patient must have accessed non-PBS-subsidised treatment prior to 1 May 2014
Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured
The authority application must be made in writing
Compliance with Written Authority Required procedures
[67] Schedule 4, Part 1, after entry for Tenofovir with Emtricitabine and Rilpivirine
insert:
Tenofovir with emtricitabine, elvitegravir and cobicistat
C4470
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4470
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
C4522
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naive
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4522
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
