National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 10) (PB 72 of 2014)

Link to law: https://www.comlaw.gov.au/Details/F2014L01298

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now
PB 72 of 2014
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 10)
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 23 September 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. 10).
            (2)        This Instrument may also be cited as PB 72 of 2014.
2          Commencement
This Instrument commences on 1 October 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 Aciclovir in the form Tablet 200 mg [Maximum Quantity: 90; Number of Repeats: 5]
(a)      omit from the column headed “Purposes” for the brand “Aciclovir 200”:  P3633  
(b)      omit from the column headed “Purposes” for the brand “Aciclovir GH”:  P3633  
(c)      omit from the column headed “Purposes” for the brand “Chem mart Aciclovir”:    P3633  
(d)      omit from the column headed “Purposes” for the brand “Ozvir”:             P3633  
(e)      omit from the column headed “Purposes” for the brand “Terry White Chemists Aciclovir”:  P3633  
[2]           Schedule 1, entry for Aciclovir in the form Tablet 800 mg [Maximum Quantity: 35; Number of Repeats: 0]
(a)      omit from the column headed “Purposes” for the brand “Aciclovir 800”:  P3622  P3631   
(b)      omit from the column headed “Purposes” for the brand “GenRx Aciclovir”:          P3622  P3631   
(c)      omit from the column headed “Purposes” for the brand “Zovirax 800 mg”:           P3622  P3631
[3]           Schedule 1, entry for Acitretin in each of the forms: Capsule 10 mg; and Capsule 25 mg
omit from the column headed “Responsible Person” for the brand “Novatin”:   IA            substitute:             TX
[4]           Schedule 1, entry for Aclidinium
omit from the column headed “Form”:        containing aclidinium bromide 400 micrograms per dose, 60 doses
substitute:             322 micrograms (as bromide) per dose, 60 doses
[5]           Schedule 1, entry for Alendronic Acid
omit:
 
Tablet 40 mg (as alendronate sodium)
Oral
Fosamax 40 mg
MK
MP NP
C3256
 
30
5
30
 
 
[6]           Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Alendronate plus D3-DRLA
RZ
MP NP
C4070 C4087 C4110
 
4
5
4
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
FonatPlus
AF
MP NP
C4070 C4087 C4110
 
4
5
4
 
 
 
[7]           Schedule 1, entry for Alprazolam in each of the forms: Tablet 1 mg; and Tablet 2 mg
omit:
 
 
 
Ralozam
GN
MP NP
C1975
 
50
2
50
 
 
[8]           Schedule 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besylate); and Tablet 10 mg (as besylate)
omit:
 
 
 
Amlodipine-GA
UA
MP NP
 
 
30
5
30
 
 
[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”:
 
 
 
Imazam
ER
MP NP
 
 
100
5
100
 
 
[10]         Schedule 1, entry for Capecitabine in the form Tablet 150 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Xelabine
QA
MP
C1522 C1614 C1738 C1739 C3509 C3942
 
60
2
60
 
 
[11]         Schedule 1, entry for Capecitabine in the form Tablet 500 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Xelabine
QA
MP
C1522 C1614 C1738 C1739 C3509 C3942
 
120
2
120
 
 
[12]         Schedule 1, entry for Carbamazepine in the form Tablet 100 mg [Brand: Carbamazepine Sandoz]
(a)      omit:
 
 
 
 
 
PDP
 
 
200
0
200
 
 
(b)      omit:
 
 
 
 
 
MP NP
 
 
200
2
200
 
 
[13]         Schedule 1, entry for Carbamazepine in the form Tablet 200 mg [Brand: Carbamazepine Sandoz]
(a)      omit:
 
 
 
 
 
PDP
 
 
200
0
200
 
 
(b)      omit:
 
 
 
 
 
MP NP
 
 
200
2
200
 
 
 
[14]         Schedule 1, entry for Ceftriaxone in the form Powder for injection 2 g (as sodium)
omit:
 
 
 
Ceftriaxone ICP
PP
MP NP
C1169 C1846 C1847
 
5
0
1
 
 
[15]         Schedule 1, entry for Doxycycline in the form Tablet 50 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Doxycycline AN
EA
MP NP
C4475 C4529 C4539
 
25
5
25
 
 
[16]         Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as hydrochloride) [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 AN
EA
PDP
 
 
7
0
7
 
 
[17]         Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as hydrochloride) [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 AN
EA
MP NP
 
 
7
1
7
 
 
[18]         Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as hydrochloride) [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 AN
EA
MP NP
 
P4485
21
0
7
 
 
[19]         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”:
 
 
 
Pharmacor Duloxetine 30
CR
MP NP
C1211
 
28
0
28
 
 
[20]         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”:
 
 
 
Pharmacor Duloxetine 60
CR
MP NP
C1211
 
28
5
28
 
 
[21]         Schedule 1, after entry for Eptifibatide in the form Solution for I.V. infusion 75 mg (as acetate) in 100 mL
insert:
Eribulin
Solution for I.V. injection containing eribulin mesilate 1 mg in 2 mL
Injection
Halaven
EI
MP
C4646 C4649
 
See Note 3
See Note 3
1
 
D(100)
 
[22]         Schedule 1, entry for Escitalopram in the form Tablet 10 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
 
 
[23]         Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [Maximum Quantity: 30; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Esomeprazole GxP
AF
MP NP
C1337 C1629 C2273 C3429
P2273
30
1
30
 
 
[24]         Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Esomeprazole GxP
AF
MP NP
C1337 C1629 C2273 C3429
P1337 P1629 P3429
30
5
30
 
 
[25]         Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [Maximum Quantity: 30; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Esomeprazole GxP
AF
MP NP
C1337 C1628 C3429
P1628
30
1
30
 
 
[26]         Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Esomeprazole GxP
AF
MP NP
C1337 C1628 C3429
P1337 P3429
30
5
30
 
 
[27]         Schedule 1, entry for Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg
omit:
 
 
 
Fosinopril/HCTZ-
GA 10/12.5
GN
MP NP
C4389
 
30
5
30
 
 
[28]         Schedule 1, entry for Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg
omit:
 
 
 
Fosinopril/HCTZ-
GA 20/12.5
GN
MP NP
C4389
 
30
5
30
 
 
[29]         Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 50 (CareSens N)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
Test strips, 50 (EasyMate II)
For external use
EasyMate II
WI
MP NP
 
 
2
5
1
 
 

 
 
 
 
 
MP
 
P4241
2
11
1
 
 

[30]         Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 100 (Contour)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
Test strips, 100 (EasyMate II)
For external use
EasyMate II
WI
MP NP
 
 
1
5
1
 
 

 
 
 
 
 
MP
 
P4241
1
11
1
 
 

[31]         Schedule 1, entry for Lamotrigine in each of the forms: Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Lamotrigine AN
EA
MP NP
C1426
 
56
5
56
 
 
[32]         Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30
[Maximum Quantity: 1; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Macrovic
QA
MP NP
See Note 1
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4576 P4577 P4580 P4596 P4601
See Note 2
1
See Note 2
5
See
Note 2
1
 
 
[33]         Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30
[Maximum Quantity: 2; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Macrovic
QA
MP NP
See Note 1
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4590
See Note 2
2
See Note 2
0
See
Note 2
1
 
 
[34]         Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30
[Maximum Quantity: 2; Number of Repeats: 3]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Macrovic
QA
MP NP
See Note 1
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4595
See Note 2
2
See Note 2
3
See
Note 2
1
 
 
[35]         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 generichealth
GQ
MP NP
C4214 C4218 C4221
 
56
5
56
 
 
[36]         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 generichealth
GQ
MP NP
C4214 C4218 C4221
 
28
5
28
 
 
[37]         Schedule 1, entry for Methylprednisolone in each of the forms: Cream containing methylprednisolone aceponate 1 mg per g, 15 g; Ointment containing methylprednisolone aceponate 1 mg per g, 15 g; Fatty ointment containing methylprednisolone aceponate 1 mg
per g, 15 g; and Lotion containing methylprednisolone aceponate 1 mg per g, 20 g
omit from the column headed “Responsible Person”:             CS          substitute:             BN
[38]         Schedule 1, entry for Mianserin in the form Tablet containing mianserin hydrochloride 20 mg
omit:
 
 
 
Tolvon
MK
MP NP
C1355
 
50
5
50
 
 
[39]          Schedule 1, entry for Mirtazapine in the form Tablet 30 mg
omit:
 
 
 
Mirtazapine‑DP
UA
MP NP
C1211
 
30
5
30
 
 
[40]         Schedule 1, entry for Moclobemide in the form Tablet 150 mg
omit from the column headed “Responsible Person” for the brand “Aurorix”:   VP          substitute:             HM
[41]         Schedule 1, entry for Moclobemide in the form Tablet 300 mg
omit from the column headed “Responsible Person” for the brand “Aurorix 300 mg”:     VP          substitute:             HM
[42]         Schedule 1, entry for Oestradiol and Oestradiol with Dydrogesterone
insert as first item in the columns in the order indicated:
 
Pack containing 14 tablets oestradiol 1 mg and 14 tablets oestradiol 1 mg with dydrogesterone 10 mg
Oral
Femoston 1/10
AB
MP NP
 
 
1
5
1
 
 
[43]         Schedule 1, after entry for Oestradiol and Oestradiol with Norethisterone in the form Pack containing 4 transdermal patches
780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate
insert:
Oestradiol with dydrogesterone
Tablet 1 mg-5 mg
Oral
Femoston-Conti
AB
MP NP
 
 
28
5
28
 
 
[44]         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”:
 
 
 
Sozol
QA
MP NP
C1337 C1476 C1533
 
30
5
30
 
 
[45]         Schedule 1, omit entry for Polyethylene glycol 400
[46]         Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 125 micrograms [Maximum Quantity: 30; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pramipexole AN
EA
MP NP
C3216
 
30
0
30
 
 
[47]         Schedule 1, entry for Pramipexole
omit:
 
Tablet containing pramipexole hydrochloride 250 micrograms
Oral
Sifrol
BY
MP NP
C3088 C3216
P3088
100
2
100
 
 

 
 
 
 
 
MP NP
C3088 C3216
P3216
100
5
100
 
 

 
 
 
Simipex 0.25
QA
MP NP
C3216
 
100
5
100
 
 

substitute:
 
Tablet containing pramipexole hydrochloride 250 micrograms
Oral
Sifrol
BY
MP NP
C3088 C3216
P3088
100
2
100
 
 

 
 
 
Pramipexole AN
EA
MP NP
C3216
 
100
5
100
 
 

 
 
 
Sifrol
BY
MP NP
C3088 C3216
P3216
100
5
100
 
 

 
 
 
Simipex 0.25
QA
MP NP
C3216
 
100
5
100
 
 

[48]         Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 1 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pramipexole AN
EA
MP NP
C3216
 
100
5
100
 
 
[49]         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”:
 
 
 
Kaptan
ER
MP NP
C4385 C4391 C4396
 
60
0
60
 
 
[50]         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”:
 
 
 
Kaptan
ER
MP NP
C1589 C2044 C2765
 
90
5
90
 
 
[51]         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”:
 
 
 
Kaptan
ER
MP NP
C1589 C2044 C2765
 
60
5
60
 
 
[52]         Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 10 mg (enteric coated)
omit:
 
 
 
Rabzole
JS
MP NP
C1337 C1533
 
28
5
28
 
 
[53]         Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated)
(a)      omit:
 
 
 
Rabzole
JS
MP NP
C1177 C1337 C1533
P1177
30
2
30
 
 
(b)      omit:
 
 
 
Rabzole
JS
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
 
 
[54]         Schedule 1, entry for Riluzole in the form Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Riluzole
CR
MP NP
C1762 C2718
 
56
5
56
 
 
[55]         Schedule 1, entry for Salbutamol
(a)      omit:
 
Capsule containing powder for oral inhalation 200 micrograms (as sulfate) (for use in Ventolin Rotahaler)
Inhalation by mouth
Ventolin Rotacaps
GK
MP NP
 
200
5
100
 
(b)      substitute:
 
Capsule containing powder for oral inhalation 200 micrograms (as sulfate) (for use in Ventolin Rotahaler)
Inhalation by mouth
Ventolin Rotacaps
GK
MP NP
 
256
4
128
 
[56]         Schedule 1, entry for Salbutamol in the form Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation)
omit:
 
 
 
Airomir
IA
MP NP
 
2
5
1
 
 
[57]         Schedule 1, entry for Salbutamol in each of the forms: Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30; and Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Salbutamol Actavis
UA
MP NP
C1754 C1755
 
2
5
1
 
 
[58]         Schedule 1, entry for Strontium
(a)      omit from the column headed “Authorised Prescriber”:  NP
(b)      omit from the column headed “Circumstances”:            C4123   substitute:          C4644
[59]         Schedule 1, entry for Telmisartan in each of the forms: Tablet 40 mg; and Tablet 80 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Telmisartan RBX
RA
MP NP
 
 
28
5
28
 
 
[60]         Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride)
(a)      omit:
 
 
 
Terbinafine‑GA
UA
MP NP
C2191 C2865 C3244
P2865 P3244
42
0
42
 
 
(b)      omit:
 
 
 
Terbinafine‑GA
UA
MP NP
C2191 C2865 C3244
P2191
42
1
42
 
 
[61]         Schedule 1, entry for Testosterone in the form Transdermal gel 50 mg in 5 g sachet, 30
omit from the column headed “Responsible Person”:             BN          substitute:             HB
[62]         Schedule 1, entry for Topiramate in each of the forms: Tablet 25 mg; and Tablet 50 mg
omit:
 
 
 
Topiramate-GA
GN
MP NP
C2797 C2799
 
60
5
60
 
 
[63]         Schedule 1, entry for Topiramate in each of the forms: Tablet 100 mg; and Tablet 200 mg
omit:
 
 
 
Topiramate-GA
GN
MP NP
C2797
 
60
5
60
 
 
[64]         Schedule 1, entry for Tramadol in each of the forms: Tablet (sustained release) containing tramadol hydrochloride 100 mg; Tablet (sustained release) containing tramadol hydrochloride 150 mg; and Tablet (sustained release) containing tramadol hydrochloride 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Tramadol AN SR
EA
MP NP
C1537
 
20
0
20
 
 
 
[65]         Schedule 1, entry for Varenicline in the form Box containing 11 tablets 0.5 mg (as tartrate) and 14 tablets 1 mg (as tartrate) in the first pack and 28 tablets 1 mg (as tartrate) in the second pack
omit from the column headed “Circumstances”:        C2774  C2775     substitute:             C4645
[66]         Schedule 1, entry for Varenicline in the form Tablet 1 mg (as tartrate) [Maximum Quantity: 56; Number of Repeats: 2]
(a)      omit from the column headed “Circumstances”:            C3670  C3671    substitute:          C4647  C4648
(b)      omit from the column headed “Purposes”:       P3671   substitute:          P4647
[67]         Schedule 1, entry for Varenicline in the form Tablet 1 mg (as tartrate) [Maximum Quantity: 112; Number of Repeats: 0]
(a)      omit from the column headed “Circumstances”:            C3670  C3671    substitute:          C4647  C4648
(b)      omit from the column headed “Purposes”:       P3670   substitute:          P4648
[68]         Schedule 3
omit:
AO
AMO Australia Pty Limited
 95 099 963 194
[69]         Schedule 3, after details relevant to Responsible Person code EH
insert:
EI
Eisai Australia Pty Ltd
 73 117 970 993
[70]         Schedule 3, after details relevant to Responsible Person code GZ
insert:
HB
Besins Healthcare Australia Pty Ltd
 68 164 882 062
[71]         Schedule 3
omit:
JS
Janssen‑Cilag Pty Ltd
 47 000 129 975
[72]         Schedule 3
omit:
VP
Meda Valeant Pharma Australia Pty Ltd
 61 140 839 658
[73]         Schedule 3, after details relevant to Responsible Person code WA
insert:
WI
Wincot Pty. Limited
 14 003 526 930
 
[74]         Schedule 4, Part 1, entry for Alendronic Acid
omit:
 
C3256
 
 
Symptomatic Paget disease of bone
Compliance with Authority Required procedures – Streamlined Authority Code 3256
[75]         Schedule 4, Part 1, after entry for Eptifibatide
insert:

Eribulin
C4646
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Locally advanced or metastatic breast cancer
Patient must have progressive disease; AND
Patient must have failed at least two prior chemotherapeutic regimens for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Compliance with Authority Required procedures

 
C4649
 
 
Where the patient is receiving treatment at/from a Public Hospital
Locally advanced or metastatic breast cancer
Patient must have progressive disease; AND
Patient must have failed at least two prior chemotherapeutic regimens for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Compliance with Authority Required procedures - Streamlined Authority Code 4649


[76]         Schedule 4, Part 1, entry for Polyethylene glycol 400
[77]         Schedule 4, Part 1, entry for Strontium
substitute:
Strontium
C4644
 
 
Severe established osteoporosis
Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition; AND
Patient must be at high risk of fracture; AND
Patient must be unable to use other medications for the treatment of osteoporosis due to contraindications or intolerance
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Compliance with Authority Required procedures
[78]         Schedule 4, Part 1, entry for Varenicline
substitute:

Varenicline
C4645
 
 
Nicotine dependence
Commencement of a short-term (12 weeks or 24 weeks) course of treatment
The treatment must be as an aid to achieving abstinence from smoking; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have indicated they are ready to cease smoking
Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program or is about to enter such a program at the time the Authority application is requested
Details of the support and counselling program must be documented in the patient's medical records at the time treatment is initiated
Clinical review is recommended within 2 to 3 weeks of the initial prescription being requested
Compliance with Authority Required procedures


 
C4647
P4647
 
Nicotine dependence
Completion of a short-term (24 weeks) course of treatment
The treatment must be as an aid to achieving abstinence from smoking; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been issued with an authority prescription for this drug during this current course of treatment; AND
Patient must have ceased smoking following an initial 12-weeks of PBS-subsidised treatment with this drug in the current course of treatment
Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program
Compliance with Authority Required procedures


 
C4648
P4648
 
Nicotine dependence
Continuation of a short-term (12 weeks or 24 weeks) course of treatment
The treatment must be as an aid to achieving abstinence from smoking; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been issued with an authority prescription for this drug during this current course of treatment
Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program
Compliance with Authority Required procedures