National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 7) (No. PB 35 of 2013)

Link to law: https://www.comlaw.gov.au/Details/F2013L00922

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now
PB 35 of 2013
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 7)1
National Health Act 1953
I, ADRIANA PLATONA, First Assistant Secretary (Acting), Pharmaceutical Benefits Division, Department of Health and Ageing, 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 3 June 2013
 
 
 
 
 
 
 
 
 
 
 
ADRIANA PLATONA
First Assistant Secretary (Acting)
Pharmaceutical Benefits Division
Department of Health and Ageing
 
1          Name of Instrument
            (1)        This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 7).
            (2)        This Instrument may also be cited as PB 35 of 2013.
2          Commencement
This Instrument commences on 1 July 2013.
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) [Maximum Quantity 10; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Amoxycillin and Clavulanic Acid
TX
PDP
C1836 C1837
 
10
0
10
 
 
[2]           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”:
 
 
 
APO-Amoxycillin and Clavulanic Acid
TX
MP NP
C1836 C1837
 
10
1
10
 
 
[3]           Schedule 1, entry for Cefalotin
(a)      omit:
 
 
 
Keflin Neutral
AS
PDP
 
 
10
0
10
 
 
(b)      omit:
 
 
 
Keflin Neutral
AS
MP NP
 
 
10
1
10
 
 
[4]           Schedule 1, entry for Donepezil in the form Tablet containing donepezil hydrochloride 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Donepezil 5
CR
MP NP
C4219 C4220 C4224
 
28
5
28
 
 
[5]           Schedule 1, entry for Donepezil in the form Tablet containing donepezil hydrochloride 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Donepezil 10
CR
MP NP
C4219 C4220 C4224
 
28
5
28
 
 
[6]           Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity 7; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Doxycycline Sandoz
HX
PDP
 
7
0
7
 
[7]           Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity 7; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Doxycycline Sandoz
HX
MP NP
 
7
1
7
 
 
[8]           Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity 21; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Doxycycline Sandoz
HX
MP NP
P1459
21
0
7
 
 
[9]           Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity 28; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Doxycycline Sandoz
HX
MP NP
P1279
28
0
7
 
[10]         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”:
 
 
 
Coperin
AF
MP NP
C1211
 
28
0
28
 
[11]         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”:
 
 
 
Coperin
AF
MP NP
C1211
 
28
5
28
 
[12]         Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL
omit:
 
 
 
Epirubicin SZ
HX
MP
 
See Note 3
See Note 3
1
D(100)
[13]         Schedule 1, entry for Imiquimod
insert as first entry in the columns in the order indicated:
 
Cream 50 mg per g, 2 g, 2
Application
Aldara Pump
IA
MP
C4229
 
1
1
1
 
 
[14]         Schedule 1, entry for Imiquimod in the form Cream 50 mg per g, 250 mg single use sachets, 12
omit from the column headed “Circumstances” (twice occurring):       C2816   substitute:             C4229
[15]         Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL
omit:
 
 
 
Irinotecan SZ
HX
MP
C3184
 
See Note 3
See Note 3
1
D(100)
[16]         Schedule 1, entry for Levonorgestrel with Ethinyloestradiol
insert as first entry in the columns in the order indicated:
 
Pack containing 21 tablets 100 micrograms-20 micrograms and 7 inert tablets
Oral
Femme-Tab ED 20/100
AE
MP NP
 
4
2
4
 
 
[17]         Schedule 1, entry for Lisinopril in each of the forms: Tablet 5 mg; Tablet 10 mg; and Tablet 20 mg
omit:
 
 
 
Lisodur
AF
MP NP
 
30
5
30
 
 
[18]         Schedule 1, entry for Nicotine in the form Transdermal patch 24.9 mg
omit from the column headed “Circumstances”:
C3042 C3447 C3448
substitute:
C4231  C4232  C4233
[19]         Schedule 1, entry for Nicotine in the form Transdermal patch 114 mg
omit from the column headed “Circumstances”:
C3042 C3447 C3448
substitute:
C4231  C4232  C4233
[20]         Schedule 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg; Tablet 5 mg; Tablet 7.5 mg and Tablet 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacy Choice Olanzapine
RI
MP NP
C1589 C2044
 
28
5
28
 
 
 
[21]         Schedule 1, entry for Olanzapine in each of the forms: Tablet 5 mg (orally disintegrating); and Tablet 10 mg (orally disintegrating)
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Olanzapine RBX ODT
RA
MP NP
C1589 C2044
 
28
5
28
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacy Choice Olanzapine ODT
RI
MP NP
C1589 C2044
 
28
5
28
 
 
[22]         Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 5 mg perindopril arginine with 5 mg amlodipine
(as besylate)
omit from the column headed “Brand”:         Coveram              substitute:             Coveram 5/5
[23]         Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 5 mg perindopril arginine with 10 mg amlodipine
(as besylate)
omit from the column headed “Brand”:         Coveram              substitute:             Coveram 5/10
[24]         Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 10 mg perindopril arginine with 5 mg amlodipine
(as besylate)
omit from the column headed “Brand”:         Coveram              substitute:             Coveram 10/5
[25]         Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 10 mg perindopril arginine with 10 mg amlodipine
(as besylate)
omit from the column headed “Brand”:         Coveram              substitute:             Coveram 10/10
[26]         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”:
 
 
 
Pharmacy Choice Quetiapine
RI
MP NP
C1589 C2044 C2765
 
60
5
60
 
 
[27]         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”:
 
 
 
Pharmacy Choice Quetiapine
RI
MP NP
C1589 C2044 C2765
 
90
5
90
 
 
[28]         Schedule 1, entry for Quetiapine in each of the forms: Tablet 200 mg (as fumarate); and Tablet 300 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacy Choice Quetiapine
RI
MP NP
C1589 C2044 C2765
 
60
5
60
 
 
[29]         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”:
 
 
 
Rabeprazole Actavis 20
TA
MP NP
C1177 C1337 C1533
P1177
30
2
30
 
 
[30]         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”:
 
 
 
Rabeprazole Actavis 20
TA
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
 
 
[31]         Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 150 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Acris Once-a-Month
AF
MP NP
C4117 C4122 C4123
 
1
5
1
 
 
[32]         Schedule 1, entry for Sorafenib
omit from the column headed “Circumstances”:
C3071  C3072
substitute:
C4230  C4234
[33]         Schedule 1, entry for Tetrabenazine
(a)      omit from the column headed “Brand”:               Orphan Australia Pty Ltd             substitute:             iNova Pharmaceuticals (Australia) Pty Ltd
(b)      omit from the column headed “Responsible Person”:      OA          substitute:             IA
[34]         Schedule 4, Part 1, entry for Imiquimod
substitute:
Imiquimod
C4229
 
 
Superficial basal cell carcinoma
The condition must be previously untreated;
The condition must be confirmed by biopsy;
Patient must have normal immune function;
The condition must not be suitable for treatment with cryotherapy; OR
The condition must not be suitable for treatment with curettage with diathermy; OR
The condition must not be suitable for treatment with surgical excision,
Patient must require topical drug therapy
The date of the pathology report and name of the Approved Pathology Authority must be provided at the time of application
Compliance with Authority Required procedures
[35]         Schedule 4, Part 1, entry for Nicotine
insert in numerical order after existing text:

 
C4231
 
 
Nicotine dependence
The treatment must be the sole PBS-subsidised therapy for this condition;
Patient must have indicated they are ready to cease smoking;
Patient must have entered a comprehensive support and counselling program;
Patient must not receive more than 12 weeks of PBS-subsidised nicotine replacement therapy per year
Details of the support and counselling program must be specified in the initial authority application
Compliance with Authority Required procedures


 
C4232
 
 
Nicotine dependence
Patient must be an Aboriginal or a Torres Strait Islander person;
The treatment must be the sole PBS-subsidised therapy for this condition
Compliance with Authority Required procedures

 
C4233
 
 
Nicotine dependence
The treatment must be the sole PBS-subsidised therapy for this condition;
Patient must have indicated they are ready to cease smoking;
Patient must be entering a comprehensive support and counselling program during the consultation at which this authority is requested;
Patient must not receive more than 12 weeks of PBS-subsidised nicotine replacement therapy per year
Details of the support and counselling program must be specified in the initial authority application
Compliance with Authority Required procedures


[36]         Schedule 4, Part 1, entry for Sorafenib
substitute:

Sorafenib
C4230
 
 
Advanced Barcelona Clinic Liver Cancer Stage C hepatocellular carcinoma
Initial treatment
The treatment must be the sole PBS-subsidised therapy for this condition;
Patient must have a WHO performance status of 2 or less;
Patient must have Child Pugh class A
Compliance with Authority Required procedures - Streamlined Authority Code 4230


 
C4234
 
 
Advanced Barcelona Clinic Liver Cancer Stage C hepatocellular carcinoma
Continuing treatment
The treatment must be the sole PBS-subsidised therapy for this condition;
Patient must have previously been treated with PBS-subsidised sorafenib;,
Patient must not have progressive disease
Compliance with Authority Required procedures - Streamlined Authority Code 4234


 
 
 
 
1Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. 
See http://www.comlaw.gov.au