PB 44 of 2012
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012
(No.6)1
National Health Act 1953
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this Instrument under sections 84AF, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 19 July 2012
FELICITY McNEILL
First Assistant Secretary
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 2012 (No. 6).
(2) This Instrument may also be cited as PB 44 of 2012.
2 Commencement
This Instrument commences on 1 August 2012.
3 Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010)
Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).
Schedule 1 Amendments
[1] Schedule 1, entry for Adalimumab in each of the forms: Injection 20 mg in 0.4 mL pre-filled syringe; Injection 40 mg in 0.8 mL pre-filled syringe; Injection 40 mg in 0.8 mL pre-filled pen; Injection 40 mg in 0.8 mL pre-filled syringe, 6; and Injection 40 mg in 0.8 mL pre-filled pen, 6
omit from the column headed “Responsible Person”: AB substitute: VE
[2] Schedule 1, entry for Alendronic Acid in the form Tablet 70 mg (as alendronate sodium)
omit from the column headed “Responsible Person” for the brand “Alendrobell 70mg”: BF substitute: GQ
[3] Schedule 1, entry for Amino acid formula with vitamins and minerals without lysine and low in tryptophan
(a) omit from the column headed “Form”: (GA express) substitute: (GA express 15)
(b) omit from the column headed “Brand”: GA express substitute: GA express 15
[4] Schedule 1, entry for Amino acid formula with vitamins and minerals without methionine
(a) omit from the column headed “Form”: (HCU express) substitute: (HCU express 15)
(b) omit from the column headed “Brand”: HCU express substitute: HCU express 15
[5] Schedule 1, entry for Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine
(a) omit from the column headed “Form”: (MMA/PA express) substitute: (MMA/PA express 15)
(b) omit from the column headed “Brand”: MMA/PA express substitute: MMA/PA express 15
[6] Schedule 1, after entry for Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine in the form Oral powder 500 g (XMTVI Maxamum)
insert in the columns in the order indicated:
Oral liquid 130 mL, 30 (MMA/PA cooler)
Oral
MMA/PA cooler
VF
MP NP
C1225 C1307
4
5
[7] Schedule 1, entry for Amino acid formula with vitamins and minerals without phenylalanine
(a) omit from the column headed “Form”: (PKU Express) substitute: (PKU express 15)
(b) omit from the column headed “Brand”: PKU Express substitute: PKU express 15
[8] Schedule 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine in the form Sachets containing oral powder 29 g, 30 (PKU Anamix Junior)
insert in the columns in the order indicated:
Sachets containing oral powder 34 g, 30
(PKU express 20)
Oral
PKU express 20
VF
MP NP
C1286
4
5
[9] Schedule 1, entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine
(a) omit from the column headed “Form”: (TYR Express) substitute: (TYR express 15)
(b) omit from the column headed “Brand”: TYR Express substitute: TYR express 15
[10] Schedule 1, entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine
(a) omit from the column headed “Form”: (MSUD Express) substitute: (MSUD express 15)
(b) omit from the column headed “Brand”: MSUD Express substitute: MSUD express 15
[11] Schedule 1, after entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine in the form Sachets containing oral powder 29 g, 30 (MSUD Anamix Junior)
insert in the columns in the order indicated:
Sachets containing oral powder 34 g, 30 (MSUD express 20)
Oral
MSUD express 20
VF
MP NP
C1220
4
5
[12] Schedule 1, entry for Aspirin in the form Tablet 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Spren 100
QA
MP NP
112
1
[13] Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Max Quantity 30; Number of Repeats 5]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Atorvastatin SCP 10
RZ
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
STADA Atorvastatin
TD
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[14] Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Max Quantity 30; Number of Repeats 11]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Atorvastatin SCP 10
RZ
MP
C1540 C3047
P3047
30
11
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
STADA Atorvastatin
TD
MP
C1540 C3047
P3047
30
11
[15] Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Max Quantity 30; Number of Repeats 5]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Atorvastatin SCP 20
RZ
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
STADA Atorvastatin
TD
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[16] Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Max Quantity 30; Number of Repeats 11]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Atorvastatin SCP 20
RZ
MP
C1540 C3047
P3047
30
11
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
STADA Atorvastatin
TD
MP
C1540 C3047
P3047
30
11
[17] Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Max Quantity 30; Number of Repeats 5]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Atorvastatin SCP 40
RZ
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
STADA Atorvastatin
TD
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[18] Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Max Quantity 30; Number of Repeats 11]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Atorvastatin SCP 40
RZ
MP
C1540 C3047
P3047
30
11
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
STADA Atorvastatin
TD
MP
C1540 C3047
P3047
30
11
[19] Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Max Quantity 30; Number of Repeats 5]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Atorvastatin SCP 80
RZ
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
STADA Atorvastatin
TD
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[20] Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Max Quantity 30; Number of Repeats 11]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Atorvastatin SCP 80
RZ
MP
C1540 C3047
P3047
30
11
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
STADA Atorvastatin
TD
MP
C1540 C3047
P3047
30
11
[21] Schedule 1, after entry for Auranofin in the form Tablet 3 mg
insert in the columns in the order indicated:
Capsule 3 mg
Oral
Ridaura
BZ
MP NP
60
5
[22] Schedule 1, after entry for Busulfan
insert in the columns in the order indicated:
Cabazitaxel
Concentrated injection 60 mg (as acetone solvate) in 1.5 mL, with diluent
Injection
Jevtana
SW
MP
C7000 C7001
See Note 3
See Note 3
D
[23] Schedule 1, entry for Cefepime in each of the forms: Powder for injection 1 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent); and Powder for injection 2 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Cefepime Sandoz
SZ
MP NP
C1427
10
0
[24] Schedule 1, entry for Ceftriaxone in the form Powder for injection 1 g (as sodium) [Max Pharma Pty Ltd]
(a) omit from the column headed “Brand”: Max Pharma Pty Ltd substitute: Max Pharma Ceftriaxone
(b) omit from the column headed “Responsible Person”: XF substitute: GQ
[25] Schedule 1, after entry for Cefuroxime in the form Tablet 250 mg (as axetil)
insert in the columns in the order indicated:
Powder for oral suspension 125 mg (as axetil) per 5 mL, 70 mL
Oral
Zinnat
GK
PDP
1
0
MP
1
1
[26] Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous)
(a) omit:
Cephabell
BF
PDP
20
0
(b) omit:
Cephabell
BF
MP NP MW
20
1
[27] Schedule 1, entry for Ciprofloxacin in each of the forms: Tablet 500 mg (as hydrochloride); and Tablet 750 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Ciprofloxacin-BW”: BF substitute: GQ
[28] Schedule 1, entry for Citalopram in the form Tablet 20 mg (as hydrobromide)
omit:
Citalobell
BF
MP NP
C1211
28
5
[29] Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Plavicor 75
MI
MP NP
C1719 C1720 C1721 C1722 C1723 C1724
28
5
[30] 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”:
STADA Clopidogrel
TD
MP NP
C1719 C1720 C1721 C1722 C1723 C1724
28
5
[31] Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Cyprocur 100
QA
MP
C1014 C1404
50
5
[32] Schedule 1, entry for Denosumab in the form Injection 60 mg in 1 mL pre-filled syringe
omit from the column headed “Circumstances”:
C2758
insert in numerical order:
C4054
[33] Schedule 1, entry for Diltiazem in the form Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg
(a) omit from the column headed “Responsible Person” for the brand “Diltahexal CD”: SZ substitute: HX
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Diltiazem Sandoz CD
SZ
MP NP
30
5
[34] Schedule 1, entry for Diltiazem in the form Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg
(a) omit from the column headed “Responsible Person” for the brand “Diltahexal CD”: SZ substitute: HX
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Diltiazem Sandoz CD
SZ
MP NP
30
5
[35] Schedule 1, entry for Docetaxel
omit from the column headed “Circumstances” (all instances):
C3884
insert in numerical order:
C7002
[36] Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; Tablet containing enalapril maleate 10 mg; and Tablet containing enalapril maleate 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Enalapril-PS
FZ
MP NP
30
5
[37] Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes
solvent 1 mL
(a) insert in numerical order in the column headed “Circumstances” (twice occurring):
C4057 C4058 C4059 C4060
(b) insert in numerical order in the column headed “Purposes” where the Max Quantity is 2; Number of repeats 3:
P4057 P4058 P4059 P4060
[38] Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4
(a) insert in numerical order in the column headed “Circumstances” (twice occurring):
C4057 C4058 C4059 C4060
(b) insert in numerical order in the column headed “Purposes” where the Max Quantity is 1; Number of repeats 3:
P4057 P4058 P4059 P4060
[39] Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4
(a) insert in numerical order in the column headed “Circumstances” (twice occurring):
C4057 C4058 C4059 C4060
(b) insert in numerical order in the column headed “Purposes” where the Max Quantity is 1; Number of repeats 3:
P4057 P4058 P4059 P4060
[40] Schedule 1, entry for Galantamine in each of the forms: Capsule (prolonged release) 8 mg (as hydrobromide); Capsule (prolonged release) 16 mg (as hydrobromide); and Capsule (prolonged release) 24 mg (as hydrobromide)
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Galantamine MR
TX
MP NP
C2934 C2938 C3875 C3876
28
5
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Gamine XR
QA
MP NP
C2934 C2938 C3875 C3876
28
5
[41] Schedule 1, entry for Gliclazide in the form Tablet 80 mg
omit:
Mellihexal
SZ
MP NP
100
5
[42] Schedule 1, entry for Hydroxychloroquine
substitute:
Hydroxychloroquine
Tablet containing hydroxychloroquine sulfate 200 mg
Oral
APO-Hydroxychloroquine
TX
MP NP
100
1
Chem mart Hydroxychloroquine
CH
MP NP
100
1
Plaquenil
SW
MP NP
100
1
Terry White Chemist Hydroxychloroquine
TW
MP NP
100
1
[43] Schedule 1, after entry for Ibuprofen
insert in the columns in the order indicated:
Icatibant
Injection 30 mg (as acetate) in 3 mL single use pre-filled syringe
Injection
Firazyr
ZI
MP
C4055 C4056
1
1
[44] Schedule 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Indapamide-PS
FZ
MP NP
90
1
[45] Schedule 1, entry for Lamivudine in the form Tablet 150 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Lamivudine RBX
RA
MP
See Note 1
C3586 C3587
C3588 C3589
120
5
D
[46] Schedule 1, entry for Lamivudine in the form Tablet 300 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Lamivudine RBX
RA
MP
See Note 1
C3586 C3587
C3588 C3589
60
5
D
[47] Schedule 1, entry for Latanoprost in the form Eye drops 50 micrograms per mL, 2.5 mL
substitute:
Latanoprost
Eye drops 50 micrograms per mL, 2.5 mL
Application to the eye
APO-Latanoprost
TX
MP AO
1
5
Chem mart Latanoprost
CH
MP AO
1
5
Latanoprost Pfizer
FZ
MP AO
1
5
Latanoprost Sandoz
SZ
MP AO
1
5
Terry White Chemists Latanoprost
TW
MP AO
1
5
Xalatan
PF
MP AO
1
5
[48] Schedule 1, entry for Latanoprost with Timolol in the form Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Latanocom
FZ
MP AO
C3426 C3427
1
5
[49] Schedule 1, entry for Letrozole in the form Tablet 2.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Lezole
WQ
MP NP
C1608 C2691 C2692
30
5
[50] Schedule 1, entry for Leuprorelin in the form I.M. injection (modified release), powder for injection containing leuprorelin acetate 7.5 mg with diluent in pre-filled dual-chamber syringe
omit from the column headed “Responsible Person”: AB substitute: VE
[51] Schedule 1, entry for Leuprorelin in the form I.M. injection (modified release), powder for injection containing leuprorelin acetate 22.5 mg with diluent in pre-filled dual-chamber syringe
omit from the column headed “Responsible Person”: AB substitute: VE
[52] Schedule 1, entry for Leuprorelin in the form I.M. injection (modified release), powder for injection containing leuprorelin acetate 30 mg with diluent in pre-filled dual-chamber syringe
omit from the column headed “Responsible Person”: AB substitute: VE
[53] Schedule 1, entry for Levodopa with Carbidopa in the form Intestinal gel 20 mg-5 mg per mL, 100 mL
omit from the column headed “Responsible Person”: AB substitute: VE
[54] Schedule 1, entry for Lopinavir with Ritonavir in each of the forms: Tablet 100 mg-25 mg; Tablet 200 mg-50 mg; and Oral liquid 400 mg-100 mg per 5 mL, 60 mL
omit from the column headed “Responsible Person” for the brand “Kaletra” : AB substitute: VE
[55] Schedule 1, after entry for Magnesium
insert in the columns in the order indicated:
Mannitol
Pack containing 280 capsules containing powder for inhalation 40 mg and 2 inhalers
Inhalation by mouth
bronchitol
XA
MP
See Note 1
C4061 C4062 C4063 C4064
4
5
D
[56] Schedule 1, entry for Meloxicam in the form Tablet 7.5 mg
(a) omit from the column headed “Responsible Person” for the brand “Meloxibell”: BF substitute: GQ
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Meloxicam-PS
FZ
MP NP
C1547 C1848
30
3
[57] Schedule 1, entry for Meloxicam in the form Tablet 15 mg
(a) omit from the column headed “Responsible Person” for the brand “Meloxibell”: BF substitute: GQ
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Meloxicam-PS
FZ
MP NP
C1547 C1848
30
3
[58] Schedule 1, entry for Meloxicam in the form Capsule 7.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Melox 7.5
GM
MP NP
C1547 C1848
30
3
[59] Schedule 1, entry for Meloxicam in the form Capsule 15 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Melox 15
GM
MP NP
C1547 C1848
30
3
[60] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Formet Aspen 500
AS
MP NP
100
5
[61] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Formet Aspen 850
AS
MP NP
60
5
[62] Schedule 1, entry for Mirtazapine in each of the forms: Tablet 15 mg (orally disintegrating); Tablet 30 mg (orally disintegrating); and Tablet 45 mg (orally disintegrating);
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Remeron SolTab
FR
MP NP
C1211
30
5
[63] Schedule 1, entry for Morphine in each of the forms: Capsule containing morphine sulfate 10 mg (containing sustained release pellets); Capsule containing morphine sulfate 20 mg (containing sustained release pellets); Capsule containing morphine sulfate 50 mg (containing sustained release pellets); and Capsule containing morphine sulfate 100 mg (containing sustained release pellets)
omit from the column headed “Max Quantity”: 20 substitute: 28
[64] Schedule 1, entry for Norfloxacin in the form Tablet 400 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Norfloxacin-PS
FZ
MP NP
C1002 C1070
14
1
[65] Schedule 1, entry for Octreotide in each of the forms: Injection 50 micrograms (as acetate) in 1 mL; Injection 100 micrograms (as acetate) in 1 mL; and Injection 500 micrograms (as acetate) in 1 mL
omit from the column headed “Responsible Person” for the brand “Octreotide MaxRx”: XF substitute: GQ
[66] Schedule 1, entry for Oestradiol
omit:
Transdermal patches 2 mg, 8
Transdermal
Estraderm 25
NV
MP NP
1
5
[67] Schedule 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg (as benzoate); Tablet 5 mg (as benzoate); Tablet 7.5 mg (as benzoate); and Tablet 10 mg (as benzoate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
STADA Olanzapine
TD
MP NP
C1589 C2044
28
5
[68] Schedule 1, entry for Omeprazole in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Omeprazole-PS
FZ
MP NP
C1177 C1337 C1476 C1533
P1337 P1476 P1533
30
5
[69] Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 125 micrograms
omit:
Sifrol
BY
MP NP
C3088 C3216
P3216
30
0
MP NP
C3088 C3216
P3088
30
2
substitute:
Sifrol
BY
MP NP
C3088 C3216
P3216
30
0
Simipex 0.125
QA
MP NP
C3088 C3216
P3216
30
0
Sifrol
BY
MP NP
C3088 C3216
P3088
30
2
[70] Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 250 micrograms [Max Quantity 100; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simipex 0.25
QA
MP NP
C3088 C3216
P3216
100
5
[71] 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”:
Simipex 1
QA
MP NP
C3216
100
5
[72] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Max Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pravastatin-PS
FZ
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[73] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Max Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pravastatin-PS
FZ
MP
C1540 C3047
P3047
30
11
[74] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pravastatin-PS
FZ
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[75] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pravastatin-PS
FZ
MP
C1540 C3047
P3047
30
11
[76] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pravastatin-PS
FZ
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[77] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pravastatin-PS
FZ
MP
C1540 C3047
P3047
30
11
[78] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg [Max Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pravastatin-PS
FZ
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[79] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg [Max Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pravastatin-PS
FZ
MP
C1540 C3047
P3047
30
11
[80] Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Quetiapine-Synthon
ZT
MP NP
C1589 C2044 C2765
60
5
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
STADA Quetiapine
TD
MP NP
C1589 C2044 C2765
60
5
[81] Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Quetiapine-Synthon
ZT
MP NP
C1589 C2044 C2765
90
5
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
STADA Quetiapine
TD
MP NP
C1589 C2044 C2765
90
5
[82] Schedule 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Quetiapine-Synthon
ZT
MP NP
C1589 C2044 C2765
60
5
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
STADA Quetiapine
TD
MP NP
C1589 C2044 C2765
60
5
[83] Schedule 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Quetiapine-Synthon
ZT
MP NP
C1589 C2044 C2765
60
5
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
STADA Quetiapine
TD
MP NP
C1589 C2044 C2765
60
5
[84] Schedule 1, entry for Ramipril in the form Capsule 1.25 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Ramipril
TX
MP NP
30
5
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Chem mart Ramipril
CH
MP NP
30
5
(c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Terry White Chemists Ramipril
TW
MP NP
30
5
[85] Schedule 1, entry for Ramipril in the form Capsule 2.5 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Ramipril
TX
MP NP
30
5
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Chem mart Ramipril
CH
MP NP
30
5
(c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Terry White Chemists Ramipril
TW
MP NP
30
5
[86] Schedule 1, entry for Ramipril in the form Capsule 5 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Ramipril
TX
MP NP
30
5
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Chem mart Ramipril
CH
MP NP
30
5
(c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Terry White Chemists Ramipril
TW
MP NP
30
5
[87] Schedule 1, after entry for Ranitidine in the form Syrup 150 mg (as hydrochloride) per 10 mL, 300 mL
insert:
Rasagiline
Tablet 1 mg (as mesilate)
Oral
Azilect
LU
MP NP
C4053
30
5
[88] Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 35 mg
omit:
Actonel Once-a-Week
SW
MP NP
C2645 C2646 C3070
4
5
[89] Schedule 1, entry for Risedronic Acid and Calcium in the form Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate)
omit:
Actonel Combi
SW
MP NP
C2645 C2646 C3070
1
5
[90] Schedule 1, entry for Ritonavir in each of the forms: Tablet 100 mg; and Oral solution 600 mg per 7.5 mL (80 mg per mL), 90 mL
omit from the column headed “Responsible Person” for the brand “Norvir”: AB substitute: VE
[91] Schedule 1, entry for Roxithromycin in the form Tablet 150 mg [Max Quantity 10; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Roxithromycin-PS
FZ
PDP
10
0
[92] Schedule 1, entry for Roxithromycin in the form Tablet 150 mg [Max Quantity 10; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Roxithromycin-PS
FZ
MP NP
10
1
[93] Schedule 1, entry for Roxithromycin in the form Tablet 300 mg [Max Quantity 5; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Roxithromycin-PS
FZ
PDP
5
0
[94] Schedule 1, entry for Roxithromycin in the form Tablet 300 mg [Max Quantity 5; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Roxithromycin-PS
FZ
MP NP
5
1
[95] Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simvastatin-DRLA
RZ
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[96] Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simvastatin-DRLA
RZ
MP
C1540 C3047
P3047
30
11
[97] Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simvastatin-DRLA
RZ
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[98] Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simvastatin-DRLA
RZ
MP
C1540 C3047
P3047
30
11
[99] Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 5]
(a) omit:
Simvahexal
HX
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simvastatin-DRLA
RZ
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[100] Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 11]
(a) omit:
Simvahexal
HX
MP
C1540 C3047
P3047
30
11
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simvastatin-DRLA
RZ
MP
C1540 C3047
P3407
30
11
[101] Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simvastatin-DRLA
RZ
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[102] Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Simvastatin-DRLA
RZ
MP
C1540 C3047
P3047
30
11
[103] Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Sumagran Aspen 50
AS
MP NP
C3233
4
5
[104] Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Max Quantity 5; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Orion Temozolomide
ON
MP
C1736 C1737 C2100 C2101
P1736 P1737 P2101
5
5
[105] Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Max Quantity 15; Number of Repeats 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Orion Temozolomide
ON
MP
C1736 C1737 C2100 C2101
P2100
15
2
[106] Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Max Quantity 5; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Orion Temozolomide
ON
MP
C1736 C1737 C2100 C2101
P1736 P1737 P2101
5
5
[107] Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Max Quantity 15; Number of Repeats 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Orion Temozolomide
ON
MP
C1736 C1737 C2100 C2101
P2100
15
2
[108] Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Max Quantity 5; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Orion Temozolomide
ON
MP
C1736 C1737 C2100 C2101
P1736 P1737 P2101
5
5
[109] Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Max Quantity 15; Number of Repeats 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Orion Temozolomide
ON
MP
C1736 C1737 C2100 C2101
P2100
15
2
[110] Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Max Quantity 5; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Orion Temozolomide
ON
MP
C1736 C1737 C2100 C2101
P1736 P1737 P2101
5
5
[111] Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Max Quantity 15; Number of Repeats 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Orion Temozolomide
ON
MP
C1736 C1737 C2100 C2101
P2100
15
2
[112] 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”:
Orion Temozolomide
ON
MP
C1736 C1737 C2101
5
5
[113] Schedule 1, after entry for Tiaprofenic Acid
insert:
Ticagrelor
Tablet 90 mg
Oral
Brilinta
AP
MP NP
C3879
56
5
[114] Schedule 1, entry for Tipranavir
omit:
Oral liquid 100 mg per mL, 95 mL
Oral
Aptivus
BY
MP
See Note 1
C3602 C3603
7
5
D
[115] Schedule 1, entry for Topotecan
insert in the columns in the order indicated:
Topotecan
PK
MP
C3186
See Note 3
See Note 3
D
[116] Schedule 1, after entry for Triglycerides – medium chain, formula in the form Sachets containing oral powder 16 g, 30 (MCT Pro-Cal)
insert in the columns in the order indicated:
Oral powder 400 g (Lipistart)
Oral
Lipistart
VF
MP NP
C1068 C1511 C1513 C1670 C1671
8
5
[117] Schedule 3
omit:
BF
Bellwether Pharma Ltd
15 109 403 287
[118] Schedule 3, after details relevant to Responsible person code TA
insert:
TD
STADA Pharmaceuticals Australia Pty Limited
73 154 966 944
[119] Schedule 3, after details relevant to Responsible person code UC
insert:
VE
AbbVie Pty Ltd
48 156 384 262
[120] Schedule 3, after details relevant to Responsible person code WQ
insert:
XA
Pharmaxis Ltd
75 082 811 630
[121] Schedule 3
omit:
XF
Max Pharma Pty Ltd
93 121 857 878
[122] Schedule 4, Part 1, after entry for Bupropion
insert:
Cabazitaxel
C7000
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Treatment, in combination with prednisone or prednisolone, of castration resistant metastatic carcinoma of the prostate in a patient who has failed treatment with docetaxel due to resistance or intolerance and has a World Health Organisation performance status of 2 or less
Compliance with Authority Required procedures
C7001
Where the patient is receiving treatment at/from a Public Hospital
Treatment, in combination with prednisone or prednisolone, of castration resistant metastatic carcinoma of the prostate in a patient who has failed treatment with docetaxel due to resistance or intolerance and has a World Health Organisation performance status of 2 or less
Compliance with Authority Required procedures – Streamlined Authority Code 7001
[123] Schedule 4, Part 1, entry for Denosumab
(a) omit:
C2758
Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a woman aged 70 years or older with a bone mineral density T-score of -3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures – Streamlined Authority Code 2758
(b) insert in numerical order after existing text:
C4054
Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a woman aged 70 years of age or older with a bone mineral density T-score of -2.5 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures – Streamlined Authority Code 4054
[124] Schedule 4, Part 1, entry for Docetaxel
(a) omit:
C3884
Treatment of androgen independent (hormone refractory) metastatic carcinoma of the prostate in a patient with a Karnofsky performance-status score of at least 60%, where docetaxel is used as first-line chemotherapy and administered in three weekly cycles
Compliance with Authority Required procedures – Streamlined Authority Code 3884
(b) insert in numerical order after existing text:
C7002
Treatment of androgen independent (castration resistant) metastatic carcinoma of the prostate in a patient with a Karnofsky performance-status score of at least 60%, where docetaxel is used as first-line chemotherapy and administered in three weekly cycles
Compliance with Authority Required procedures – Streamlined Authority Code 7002
[125] Schedule 4, Part 1, entry for Etanercept
insert in numerical order after existing text:
C4057
P4057
Chronic plaque psoriasis (Whole body) [Initial treatment — No prior biological agent]
Initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who:
(a) has severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and
(b) has not received any prior PBS-subsidised treatment with etanercept for this condition; and
(c) whose parent or authorised guardian has signed a patient acknowledgement; and
(d) has failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 3 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; and/or
(iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or where phototherapy is contraindicated, please provide details at the time of application
If intolerance to treatment with phototherapy, methotrexate or acitretin develops during the relevant period of use, which is of a severity to necessitate permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application
The following initiation criterion indicates failure to achieve an adequate response and must be demonstrated in all patients at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment
(c) The most recent PASI assessment must be no more than 1 month old at the time of application
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and
(iii) the parent or authorised guardian signed patient and prescriber acknowledgements
A maximum of 24 weeks of treatment with etanercept will be authorised under this restriction. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance of treatment, a further 8 weeks treatment, will be authorised if the submitted PASI assessment shows an adequate demonstrated response to treatment
A PASI assessment of the patient's response to the initial 16 week course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment under this restriction, must be submitted to the Chief Executive Medicare no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept
An adequate response to treatment is defined as:
Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, when compared with the pre-etanercept treatment baseline value
Compliance with Written Authority Required procedures
Continuation of initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who has severe chronic plaque psoriasis and who, although qualifying for an initial 16 week course of treatment with etanercept under the criteria specified above, has previously been issued with an authority prescription for less than 16 weeks of etanercept treatment, and where approval of the application would enable the patient to complete the initial 16 week treatment course
Compliance with Written or Telephone Authority Required procedures
C4058
P4058
Chronic plaque psoriasis (Whole body) [Re-Treatment — Received prior etanercept under PBS]
Treatment as systemic monotherapy (other than methotrexate) by a dermatologist for a patient under 18 years who has:
(a) a documented history of severe chronic plaque psoriasis; and
(b) received prior PBS-subsidised treatment with etanercept for this condition; and
(c) not failed PBS-subsidised therapy with etanercept for the treatment of this condition more than once in the current Treatment Cycle
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior etanercept treatment, including date
A total maximum of 24 weeks of treatment with etanercept will be authorised under this restriction. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance of treatment, a further 8 weeks treatment, will be authorised if the submitted PASI assessment shows an adequate demonstrated response to treatment
A PASI assessment of the patient's response to the initial 16 week course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment under this restriction, must be submitted to the Chief Executive Medicare no later than 1 month from the date of completion of this course of treatment. Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept
Compliance with Written Authority Required procedures
Continuation of initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who has a documented history of severe chronic plaque psoriasis, who has previously received PBS-subsidised treatment with etanercept for this condition, and who, although qualifying for an initial 16 week course of treatment with etanercept under the criteria specified above, has previously been issued with an authority prescription for less than 16 weeks of etanercept treatment, and where approval of the application would enable the patient to complete the initial 16 week treatment course
Compliance with Written or Telephone Authority Required procedures
C4059
P4059
Chronic plaque psoriasis (Face, hand, foot) [Initial treatment — No prior biological agent]
Initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who:
(a) has severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and
(b) has not received any prior PBS-subsidised treatment with etanercept for this condition; and
(c) whose parent or authorised guardian has signed a patient acknowledgement; and
(d) has failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 3 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; and/or
(iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or where phototherapy is contraindicated, please provide details at the time of application
If intolerance to treatment with phototherapy, methotrexate or acitretin develops during the relevant period of use, which is of a severity to necessitate permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application
The following initiation criterion indicates failure to achieve an adequate response and must be demonstrated in all patients at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment
(c) The most recent PASI assessment must be no more than 1 month old at the time of application
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and
(iii) the parent or authorised guardian signed patient and prescriber acknowledgements
A maximum of 24 weeks of treatment with etanercept will be authorised under this restriction. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance of treatment, a further 8 weeks treatment, will be authorised if the submitted PASI assessment shows an adequate demonstrated response to treatment
A PASI assessment of the patient's response to the initial 16 week course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment under this restriction, must be submitted to the Chief Executive Medicare no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, when compared with the pre-etanercept treatment baseline value
Compliance with Written Authority Required procedures
Continuation of initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who has severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot and who, although qualifying for an initial 16 week course of treatment with etanercept under the criteria specified above, has previously been issued with an authority prescription for less than 16 weeks of etanercept treatment, and where approval of the application would enable the patient to complete the initial 16 week treatment course
Compliance with Written or Telephone Authority Required procedures
C4060
P4060
Chronic plaque psoriasis (Face, hand, foot) [Re-Treatment — Received prior etanercept under PBS]
Treatment as systemic monotherapy (other than methotrexate) by a dermatologist for a patient under 18 years who has:
(a) a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
(b) received prior PBS-subsidised treatment with etanercept for this condition; and
(c) not failed PBS-subsidised therapy with etanercept for the treatment of this condition more than once in the current Treatment Cycle
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis in Patients Less Than 18 Years PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior etanercept treatment, including date
A total maximum of 24 weeks of treatment with etanercept will be authorised under this restriction. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance of treatment, a further 8 weeks treatment, will be authorised if the submitted PASI assessment shows an adequate demonstrated response to treatment
A PASI assessment of the patient's response to the initial 16 week course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for a further 8 weeks of treatment under this restriction, must be submitted to the Chief Executive Medicare no later than 1 month from the date of completion of this course of treatment. Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept
Compliance with Written Authority Required procedures
Continuation of initial treatment as systemic monotherapy (other than methotrexate) by a dermatologist of a patient under 18 years who has a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, who has previously received PBS-subsidised treatment with etanercept for this condition, and who, although qualifying for an initial 16 week course of treatment with etanercept under the criteria specified above, has previously been issued with an authority prescription for less than 16 weeks of etanercept treatment, and where approval of the application would enable the patient to complete the initial 16 week treatment course
Compliance with Written or Telephone Authority Required procedures
[126] Schedule 4, Part 1, after entry for Ibuprofen
insert:
Icatibant
C4055
Initial supply for anticipated emergency treatment of an acute attack of hereditary angioedema in a patient with confirmed diagnosis of C1-esterase inhibitor deficiency who has been assessed to be at significant risk of an acute attack of hereditary angioedema by or in consultation with a clinical immunologist, respiratory physician, specialist allergist or general physician experienced in the management of patients with hereditary angioedema
The name of the specialist consulted must be provided at the time of application for initial supply
The name of the Approved Pathology Authority and date of the diagnosing pathology test must be included in the authority application
Compliance with Authority Required procedures
C4056
Continuing supply for anticipated emergency treatment of an acute attack of hereditary angioedema, where the patient has previously been issued with an authority prescription for this drug
Compliance with Authority Required procedures
[127] Schedule 4, Part 1, after entry for Magnesium
insert:
Mannitol
C4061
Where the patient is receiving treatment at/from a private hospital
Treatment of cystic fibrosis in a patient who satisfies all of the following criteria:
(1) Prior to mannitol therapy, the patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved PI mannitol initiation dose assessment. If the patient has a negative hyperresponsiveness test they may be eligible for PBS subsidised treatment with mannitol;
(2) Is 6 years of age or older;
(3) Has a FEV1 greater than 30% predicted for age, gender and height;
(4) Is intolerant or inadequately responsive to dornase alfa;
(5) Has evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease);
(6) Is participating in a 4 week trial, as detailed below, or has achieved a 10% or greater improvement in FEV1 (compared to baseline established prior to mannitol treatment) after a 4 week trial
In order for patients to be eligible for participation in the HSD program, the following conditions must be met:
(1) Patients must be assessed at cystic fibrosis clinics/centres which are under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis and the prescribing of mannitol therapy under the HSD program is limited to such physicians. If attendance at such units is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit;
(2) The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at established lung function testing laboratories, unless this is not possible because of geographical isolation;
(3) Prior to mannitol therapy, a baseline measurement of FEV1 must be undertaken during a stable period of the disease;
(4) Initial therapy is limited to 4 weeks' treatment with mannitol at a dose of 400 mg twice daily;
(5) At or towards the end of the initial 4 weeks' trial, patients must be reassessed and a further FEV1 measurement be undertaken (single test under conditions as above). Patients who achieve a 10% or greater improvement in FEV1 (compared to baseline established prior to mannitol treatment) are eligible for continued subsidy under the HSD program at a dose of 400mg twice daily;
(6) Patients who fail to meet a 10% or greater improvement in FEV1 after the initial 4 weeks' treatment at a dose of 400 mg twice daily, may have 1 further trial in the next 12 months but not before 3 months after the initial trial;
(7) Following an initial 6 months' therapy, a global assessment must be undertaken involving the patient, the patient's family (in the case of paediatric patients) and the treating physician(s) to establish that all agree that mannitol powder for inhalation treatment is continuing to produce worthwhile benefits. (Mannitol therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.) Further reassessments are to be undertaken at six-monthly intervals;
(8) Other aspects of treatment, such as physiotherapy, must be continued;
(9) Where there is documented evidence that a patient already receiving mannitol therapy would have met the criteria for subsidy (i.e. satisfied the criteria for the 4 week trial and achieved a 10% or greater improvement in FEV1) then the patient is eligible to continue treatment under the HSD program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period)
Compliance with Written or Telephone Authority Required procedures
C4062
Where the patient is receiving treatment at/from a private hospital
Grandfather — for patients who initiated mannitol treatment prior to 1 August 2012
Continuation of treatment of cystic fibrosis in a patient 6 years of age or older, who initiated treatment with mannitol prior to 1 August 2012 and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis team, documents agreement that mannitol treatment is continuing to produce worthwhile benefit. Further reassessments are to be undertaken and documented yearly. Treatment with mannitol should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use
Compliance with Written or Telephone Authority Required procedures
C4063
Where the patient is receiving treatment at/from a public hospital
Treatment of cystic fibrosis in a patient who satisfies all of the following criteria:
(1) Prior to mannitol therapy, the patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved PI mannitol initiation dose assessment. If the patient has a negative hyperresponsiveness test they may be eligible for PBS subsidised treatment with mannitol;
(2) Is 6 years of age or older;
(3) Has a FEV1 greater than 30% predicted for age, gender and height;
(4) Is intolerant or inadequately responsive to dornase alfa;
(5) Has evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease);
(6) Is participating in a 4 week trial, as detailed below, or has achieved a 10% or greater improvement in FEV1 (compared to baseline established prior to mannitol treatment) after a 4 week trial
In order for patients to be eligible for participation in the HSD program, the following conditions must be met:
(1) Patients must be assessed at cystic fibrosis clinics/centres which are under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis and the prescribing of mannitol therapy under the HSD program is limited to such physicians. If attendance at such units is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit;
(2) The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at established lung function testing laboratories, unless this is not possible because of geographical isolation;
(3) Prior to mannitol therapy, a baseline measurement of FEV1 must be undertaken during a stable period of the disease;
(4) Initial therapy is limited to 4 weeks' treatment with mannitol at a dose of 400 mg twice daily;
(5) At or towards the end of the initial 4 weeks' trial, patients must be reassessed and a further FEV1 measurement be undertaken (single test under conditions as above). Patients who achieve a 10% or greater improvement in FEV1 (compared to baseline established prior to mannitol treatment) are eligible for continued subsidy under the HSD program at a dose of 400mg twice daily;
(6) Patients who fail to meet a 10% or greater improvement in FEV1 after the initial 4 weeks' treatment at a dose of 400 mg twice daily, may have 1 further trial in the next 12 months but not before 3 months after the initial trial;
(7) Following an initial 6 months' therapy, a global assessment must be undertaken involving the patient, the patient's family (in the case of paediatric patients) and the treating physician(s) to establish that all agree that mannitol powder for inhalation treatment is continuing to produce worthwhile benefits. (Mannitol therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.) Further reassessments are to be undertaken at six-monthly intervals;
(8) Other aspects of treatment, such as physiotherapy, must be continued;
(9) Where there is documented evidence that a patient already receiving mannitol therapy would have met the criteria for subsidy (i.e. satisfied the criteria for the 4 week trial and achieved a 10% or greater improvement in FEV1) then the patient is eligible to continue treatment under the HSD program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period)
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4063
C4064
Where the patient is receiving treatment at/from a public hospital
Grandfather — for patients who initiated mannitol treatment prior to 1 August 2012
Continuation of treatment of cystic fibrosis in a patient 6 years of age or older, who initiated treatment with mannitol prior to 1 August 2012 and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis team, documents agreement that mannitol treatment is continuing to produce worthwhile benefit. Further reassessments are to be undertaken and documented yearly. Treatment with mannitol should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4064
[128] Schedule 4, Part 1, after entry for Ranitidine
insert:
Rasagiline
C4053
Parkinson disease
Compliance with Authority Required procedures – Streamlined Authority Code 4053
[129] Schedule 4, Part 1, after entry for Tiaprofenic acid
insert:
Ticagrelor
C3879
Treatment of acute coronary syndrome (myocardial infarction or unstable angina) in combination with aspirin
Compliance with Authority Required procedures – Streamlined Authority Code 3879
[130] Schedule 4, Part 1, entry for Tipranavir
omit:
C3602
Where the patient is receiving treatment at/from a private hospital
Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with ritonavir in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity
Compliance with Written or Telephone Authority Authority Required procedures
C3603
Where the patient is receiving treatment at/from a public hospital
Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with ritonavir in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity
Compliance with Written or Telephone Authority Authority Required procedures - Streamlined Authority Code 3603
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.frli.gov.au.
