National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 5) (No. PB 21 of 2013) (Cth)

Case

PB 21 of 2013

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 5)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 22 April 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. 5).

(2)        This Instrument may also be cited as PB 21 of 2013.

2          Commencement

This Instrument commences on 1 May 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 Alendronic Acid in the form Tablet 70 mg (as alendronate sodium)

omit:

Fosamax Once Weekly MK MP NP C4122 C4123 C4133 4 5 4

  1. Schedule 1, entry for Amino acid formula with vitamins and minerals without phenylalanine in the form Oral liquid 250 mL (Easiphen)

omit from the column headed “Pack Quantity”:          1              substitute:             18

  1. Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 500 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”:

Pharmacor AmoxyClav 500/125 CR PDP C1836 C1837 10 0 10

  1. Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 500 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”:

Pharmacor AmoxyClav 500/125 CR MP NP MW C1836 C1837 10 1 10

  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]

(a)omit:

Clavycillin 875/125 CR PDP C1836 C1837 10 0 10

(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Pharmacor AmoxyClav 875/125 CR PDP C1836 C1837 10 0 10

  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 1]

(a)omit:

Clavycillin 875/125 CR MP NP C1836 C1837 10 1 10

(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Pharmacor AmoxyClav 875/125 CR MP NP C1836 C1837 10 1 10

  1. Schedule 1, entry for Aprepitant

insert as first item in the columns in the order indicated:

Capsule 165 mg Oral Emend MK MP
See Note 1 		C4211 C4213 C4215 C4216 C4217 C4223 1 5 1 C(100)
NP C4211 C4213 C4215 1 5 1

  1. Schedule 1, entry for Arginine with carbohydrate

substitute:

Arginine with carbohydrate Sachets of oral powder 4 g containing 500 mg arginine, 30 (Arginine 500) Oral Arginine 500 VF MP NP C1458 4 5 1
Sachets of oral powder 4 g containing 2 g arginine, 30 (Arginine 2000) Oral Arginine 2000 VF MP NP C1458 4 5 1

  1. Schedule 1, entry for Betamethasone

omit:

Betamethasone Injection containing betamethasone acetate 3 mg with betamethasone sodium phosphate 3.9 mg in 1 mL Injection Celestone Chronodose MK MP NP C1020 C1102 C1146 C1189 C1191 C1192 C1197 C1237 C1465 5 0 1
Celestone Chronodose MK PDP C1102 C1189 C1191 5 0 5

substitute:

Betamethasone Injection containing betamethasone acetate 3 mg with betamethasone sodium phosphate 3.9 mg in 1 mL Injection Celestone Chronodose MK MP NP C1020 C1102 C1146 C1189 C1191 C1192 C1197 C1237 C1465 5 0 5
PDP C1102 C1189 C1191 5 0 5

  1. Schedule 1, entry for Bisacodyl in the form Tablet 5 mg

omit:

Bisalax AS MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 1 C(100)
Lax-Tab AE MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 1 C(100)

substitute:

Bisalax AS MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 200 C(100)
Lax-Tab AE MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 200 C(100)

  1. Schedule 1, entry for Bisacodyl in the form Enemas 10 mg in 5 mL, 25

omit:

Petrus Bisacodyl Suppositories PP NP C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643
See Note 2 		P3642
See Note 2

 3
See Note 2 		5
See Note 2 		1

  1. Schedule 1, entry for Bromocriptine in the form Tablet 2.5 mg (as mesylate) [Maximum Quantity 60; Number of Repeats 5]

omit from the column headed “Pack Quantity”:          60           substitute:             30

  1. Schedule 1, entry for Bromocriptine

omit:

Capsule 10 mg (as mesylate) Oral Kripton 10 AF MP C1001 C1255 C1841 C1842 C1843 C1844 100 5 100

  1. Schedule 1, entry for Buprenorphine in the form Tablet (sublingual) 8 mg (as hydrochloride)

omit from the column headed “Pack Quantity”:          2              substitute:             7

  1. Schedule 1, entry for Cefotaxime in the form Powder for injection 1 g (as sodium)

omit from the column headed “Pack Quantity” for the brand “Hospira Pty Limited”:       1              substitute:             10

  1. Schedule 1, entry for Cefotaxime in the form Powder for injection 2 g (as sodium)

omit from the column headed “Pack Quantity” for the brand “Cefotaxime Sandoz”:         10           substitute:             1

  1. Schedule 1, entry for Cefuroxime in the form Powder for oral suspension 125 mg (as axetil) per 5 mL, 70 mL

omit from the column headed “Responsible Person”:                 GK          substitute:             AS

  1. Schedule 1, entry for Cimetidine

omit:

Tablet 800 mg Oral Magicul 800 AF MP NP 30 5 30

  1. Schedule 1, entry for Citrulline with carbohydrate

substitute:

Citrulline with carbohydrate Sachets of oral powder 4 g containing 1 g citrulline, 30 (Citrulline 1000) Oral Citrulline 1000 VF MP NP C3679 4 5 1

  1. Schedule 1, entry for Cladribine in each of the forms: Injection 10 mg in 5 mL; and Solution for I.V. infusion 10 mg in 10 mL
    single use vial

omit from the column headed “Pack Quantity”:          7              substitute:             1

  1. Schedule 1, entry for Cystine with carbohydrate

substitute:

Cystine with carbohydrate Sachets of oral powder 4 g containing 500 mg cystine, 30 (Cystine 500) Oral Cystine 500 VF MP NP C1314 4 5 1

  1. Schedule 1, entry for Dasatinib in the form Tablet 100 mg

omit from the column headed “Pack Quantity” (twice occurring):          60           substitute:             30

  1. Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL

omit:

Docetaxel Ebewe HX MP C3888 C3916 C4078 C4140 C4155 C4160 See Note 3 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL

omit:

Docetaxel Ebewe HX MP C3888 C3916 C4078 C4140 C4155 C4160 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Donepezil in each of the forms: Tablet containing donepezil hydrochloride 5 mg; and Tablet containing donepezil hydrochloride 10 mg

omit:

Donepezil-Synthon ZT MP NP C2934 C2938 C3875 C3876 28 5 28

  1. Schedule 1, entry for Donepezil

omit from the column headed “Circumstances” (all instances):

C2934 C2938
C3875 C3876

substitute:

C4219 C4220
C4224

  1. Schedule 1, entry for Dothiepin in the form Tablet containing dothiepin hydrochloride 75 mg

omit from the column headed “Pack Quantity”:          50           substitute:             30

  1. Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Doxorubicin SZ HX MP See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Doxorubicin SZ HX MP See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)

(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Drulox GM MP NP C1211 28 0 28

(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Duloxetine-DRLA RZ MP NP C1211 28 0 28

  1. Schedule 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)

(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Drulox GM MP NP C1211 28 5 28

(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Duloxetine-DRLA RZ MP NP C1211 28 5 28

  1. Schedule 1, entry for Exenatide in each of the forms: Injection solution 5 micrograms per dose in pre-filled pen, 60 doses; and
    Injection solution 10 micrograms per dose in pre-filled pen, 60 doses

omit from the column headed “Responsible Person”:                 LY          substitute:             BQ

  1. Schedule 1, entry for Ferrous fumarate

omit from the column headed “Form”:           67.5 mg                substitute:             65.7 mg

  1. Schedule 1, entry for Fluticasone with Salmeterol in each of the forms: Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation); and Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose,
    60 doses

omit from the column headed “Pack Quantity”:          28           substitute:             1

  1. Schedule 1, entry for Folic Acid in the form Tablet 500 micrograms

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Foltabs 500 PP MP NP 200 0 100

  1. Schedule 1, entry for Frusemide in the form Tablet 20 mg

omit from the column headed “Pack Quantity” for the brands “Lasix-M” and “Urex-M”:                100         substitute:             50

  1. Schedule 1, entry for Galantamine

omit from the column headed “Circumstances” (all instances):

C2934 C2938
C3875 C3876

substitute:

C4219 C4220
C4224

  1. Schedule 1, entry for Gemcitabine in the form Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Gemcitabine-AS YA MP See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Gemcitabine in the form Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Gemcitabine-AS YA MP See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Hydrochlorothiazide with Amiloride

omit from the column headed “Pack Quantity”:          100         substitute:             50

  1. Schedule 1, entry for Ibandronic acid in the form Concentrated injection for I.V. infusion 6 mg (as ibandronate sodium monohydrate)
    in 6 mL

omit from the column headed “Pack Quantity”:          30           substitute:             1

  1. Schedule 1, entry for Iloprost

omit from the column headed “Pack Quantity”:          1              substitute:             30

  1. Schedule 1, entry for Imipramine in the form Tablet containing imipramine hydrochloride 25 mg

omit from the column headed “Pack Quantity” for the brand “Tolerade 25”:      1              substitute:             50

  1. Schedule 1, entry for Indacaterol in the form Capsule containing powder for oral inhalation 300 micrograms (as maleate)
    (for use in Breezhaler)

omit from the column headed “Pack Quantity”:          90           substitute:             30

  1. Schedule 1, entry for Interferon Alfa-2b in the form Solution for injection 10,000,000 I.U. in 1 mL single dose vial

omit from the column headed “Pack Quantity”:          1              substitute:             5

  1. Schedule 1, entry for Irbesartan in the form Tablet 75 mg [Manner of Administration Oral; Brand Irbesat]

insert after Irbesat in the column headed “Brand”:   GH

  1. Schedule 1, entry for Irbesartan in the form Tablet 75 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

STADA Irbesartan TD MP NP 30 5 30

  1. Schedule 1, entry for Irbesartan in the form Tablet 150 mg [Manner of Administration Oral; Brand Irbesat]

insert after Irbesat in the column headed “Brand”:   GH

  1. Schedule 1, entry for Irbesartan in the form Tablet 150 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

STADA Irbesartan TD MP NP 30 5 30

  1. Schedule 1, entry for Irbesartan in the form Tablet 300 mg [Manner of Administration Oral; Brand Irbesat]

insert after Irbesat in the column headed “Brand”:   GH

  1. Schedule 1, entry for Irbesartan in the form Tablet 300 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

STADA Irbesartan TD MP NP 30 5 30

  1. Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 150 mg-12.5 mg [Manner of Administration Oral;
    Brand Irbesatzide 150/12.5]

insert after Irbesatzide in the column headed “Brand”:          GH

  1. Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-12.5 mg [Manner of Administration Oral;
    Brand Irbesatzide 300/12.5]

insert after Irbesatzide in the column headed “Brand”:          GH

  1. Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-25 mg [Manner of Administration Oral;
    Brand Irbesatzide 300/25]

insert after Irbesatzide in the column headed “Brand”:          GH

  1. Schedule 1, entry for Isoleucine with carbohydrate

substitute:

Isoleucine with carbohydrate Sachets of oral powder 4 g containing 50 mg isoleucine, 30 (Isoleucine 50) Oral Isoleucine 50 VF MP NP C1220 4 5 1
Sachets of oral powder 4 g containing 1 g isoleucine, 30 (Isoleucine 1000) Oral Isoleucine 1000 VF MP NP C1220 4 5 1

  1. Schedule 1, entry for Lapatinib

delete second row of entry which incorrectly displays only the value:   1              in the column headed “Pack Quantity”

  1. Schedule 1, entry for Levonorgestrel with Ethinyloestradiol

omit:

Pack containing 21 tablets 100 micrograms-20 micrograms and 7 inert tablets Oral Femme-Tab ED 20/100 AE MP NP 4 2 4

  1. Schedule 1, entry for Macrogol 3350 in the form Powder for oral solution 510 g

(a)omit:

MediHealth ClearLax ON MP NP C1263 C1613 C2693 C2823 C3642 C3643 P3643 2 0 1

(b)omit:

MediHealth ClearLax ON MP NP C1263 C1613 C2693 C2823 C3642 C3643 P3642 2 3 1

(c)omit:

MediHealth ClearLax ON MP NP C1263 C1613 C2693 C2823 C3642 C3643 P1263 P1613 P2693 P2823 1 5 1

  1. Schedule 1, entry for Meloxicam in the form Tablet 7.5 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Meloxiauro 7.5 DO MP NP C1547 C1848 30 3 30

  1. Schedule 1, entry for Meloxicam in the form Tablet 15 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Meloxiauro 15 DO MP NP C1547 C1848 30 3 30

  1. Schedule 1, entry for Memantine

omit from the column headed “Circumstances” (all instances):

C2609 C2611
C3877 C3878

substitute:

C4214 C4218
C4221

  1. Schedule 1, entry for Mesalazine in the form Sachet containing prolonged release granules, 1 g per sachet

omit from the column headed “Pack Quantity”:          60           substitute:             120

  1. Schedule 1, entry for Mesalazine

omit from the column headed “Form”:

Suppository 1 g (moulded)

substitute:

Suppository (moulded) 1 g

  1. Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg

omit:

Glucophage MQ MP NP 100 5 100

  1. Schedule 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 500 mg

(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

APO-Metformin XR 500 TX MP NP 120 5 120

(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Chem mart Metformin XR 500 CH MP NP 120 5 120

(c)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Terry White Chemists Metformin XR 500 TW MP NP 120 5 120

  1. 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 “Responsible Person”:                 GK          substitute:             YN

  1. Schedule 1, entry for Naloxone

omit:

Injection containing naloxone hydrochloride 2 mg in 5 mL disposable injection set Injection Naloxone Min-I-Jet CS MP NP PDP 1 0 1

  1. Schedule 1, entry for Naproxen

omit from the column headed “Form”:

Oral suspension 125 mg per mL, 474 mL

substitute:

Oral suspension 125 mg per 5 mL, 474 mL

  1. Schedule 1, entry for Nitrazepam

omit from the column headed “Pack Quantity” (all instances):                                50           substitute:             25

  1. Schedule 1, entry for Pancreatic Extract in the form Capsule (containing enteric coated minimicrospheres) providing not less than 10,000 BP units of lipase activity

omit from the column headed “Pack Quantity”:          1              substitute:             100

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

(a)omit:

Pantoloc TE MP NP C1177 C1337 C1476 C1533 P1177 30 2 30

(b)omit:

Pantoloc TE MP NP C1177 C1337 C1476 C1533 P1337 P1476 P1533 30 5 30

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

omit:

Pantoloc TE MP NP C1337 C1476 C1533 30 5 30

  1. Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity 300; Number of Repeats 4]

omit from the column headed “Pack Quantity” (all instances):   1              substitute:             100

  1. Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Indosyl Mono 2 FM MP NP 30 5 30

  1. Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Indosyl Mono 4 FM MP NP 30 5 30

  1. Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Indosyl Mono 8 FM MP NP 30 5 30

  1. Schedule 1, entry for Phenoxymethylpenicillin in the form Tablet 250 mg phenoxymethylpenicillin (as potassium)

omit from the column headed “Pack Quantity” (twice occurring):          50           substitute:             25

  1. Schedule 1, entry for Phenoxymethylpenicillin in the form Tablet 500 mg phenoxymethylpenicillin (as potassium)

omit from the column headed “Pack Quantity”:          50           substitute:             25

  1. Schedule 1, entry for Phenylalanine with carbohydrate

substitute:

Phenylalanine with carbohydrate Sachets of oral powder 4 g containing 50 mg phenylalanine, 30 (Phenylalanine 50) Oral Phenylalanine 50 VF MP NP C1453 4 5 1

  1. Schedule 1, entry for Pyridostigmine in the form Tablet containing pyridostigmine bromide 180 mg (modified release)

omit from the column headed “Pack Quantity”:          100         substitute:             50

  1. Schedule 1, entry for Rivastigmine

omit from the column headed “Circumstances” (all instances):

C2934 C2938
C3875 C3876

substitute:

C4219 C4220
C4224

  1. Schedule 1, entry for Somatropin in the form Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen

omit:

Norditropin NordiFlex NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Somatropin in the form Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen

omit:

Norditropin NordiFlex NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Somatropin in the form Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen

omit:

Norditropin NordiFlex NO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Temozolomide [Note: This amendment is for the purpose of order only and to accommodate listing of Capsule 180 mg]

omit:

Temozolomide Capsule 140 mg Oral Astromide WQ MP C1736 C1737 C2100 C2101 P1736 P1737 P2101 5 5 5
Orion Temozolomide ON MP C1736 C1737 C2100 C2101 P1736 P1737 P2101 5 5 5
Temizole 140 QA MP C1736 C1737 C2100 C2101 P1736 P1737 P2101 5 5 5
Temodal MK MP C1736 C1737 C2100 C2101 P1736 P1737 P2101 5 5 5
Astromide WQ MP C1736 C1737 C2100 C2101 P2100 15 2 5
Orion Temozolomide ON MP C1736 C1737 C2100 C2101 P2100 15 2 5
Temizole 140 QA MP C1736 C1737 C2100 C2101 P2100 15 2 5
Temodal MK MP C1736 C1737 C2100 C2101 P2100 15 2 5
Capsule 5 mg Oral Astromide WQ MP C1736 C1737 C2100 C2101 P1736 P1737 P2101 5 5 5
Orion Temozolomide ON MP C1736 C1737 C2100 C2101 P1736 P1737 P2101 5 5 5
Temizole 5 QA MP C1736 C1737 C2100 C2101 P1736 P1737 P2101 5 5 5
Temodal MK MP C1736 C1737 C2100 C2101 P1736 P1737 P2101 5 5 5
Astromide WQ MP C1736 C1737 C2100 C2101 P2100 15 2 5
Orion Temozolomide ON MP C1736 C1737 C2100 C2101 P2100 15 2 5
Temizole 5 QA MP C1736 C1737 C2100 C2101 P2100 15 2 5
Temodal MK MP C1736 C1737 C2100 C2101 P2100 15 2 5

substitute:

Temozolomide Capsule 5 mg Oral Astromide WQ MP C1736 C1737 C2100 C2101 P1736 P1737 P2101 5 5 5
Orion Temozolomide ON MP C1736 C1737 C2100 C2101 P1736 P1737 P2101 5 5 5
Temizole 5 QA MP C1736 C1737 C2100 C2101 P1736 P1737 P2101 5 5 5
Temodal MK MP C1736 C1737 C2100 C2101 P1736 P1737 P2101 5 5 5
Astromide WQ MP C1736 C1737 C2100 C2101 P2100 15 2 5
Orion Temozolomide ON MP C1736 C1737 C2100 C2101 P2100 15 2 5
Temizole 5 QA MP C1736 C1737 C2100 C2101 P2100 15 2 5
Temodal MK MP C1736 C1737 C2100 C2101 P2100 15 2 5

  1. Schedule 1, after entry for Temozolomide in the form Capsule 100 mg [Temodal; Maximum Quantity 15; Number of Repeats 2]

insert in the columns in the order indicated:

Capsule 140 mg Oral Astromide WQ MP C1736 C1737 C2100 C2101 P1736 P1737 P2101 5 5 5
Orion Temozolomide ON MP C1736 C1737 C2100 C2101 P1736 P1737 P2101 5 5 5
Temizole 140 QA MP C1736 C1737 C2100 C2101 P1736 P1737 P2101 5 5 5
Temodal MK MP C1736 C1737 C2100 C2101 P1736 P1737 P2101 5 5 5
Astromide WQ MP C1736 C1737 C2100 C2101 P2100 15 2 5
Orion Temozolomide ON MP C1736 C1737 C2100 C2101 P2100 15 2 5
Temizole 140 QA MP C1736 C1737 C2100 C2101 P2100 15 2 5
Temodal MK MP C1736 C1737 C2100 C2101 P2100 15 2 5
Capsule 180 mg Oral Temodal MK MP C1736 C1737 C2101 5 5 5

  1. Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride)

(a)omit:

Terbihexal HX MP NP C2191 C2865 C3244 P2865 P3244 42 0 42

(b)omit:

Terbihexal HX MP NP C2191 C2865 C3244 P2191 42 1 42

  1. Schedule 1, entry for Testosterone in the form Subcutaneous implant 100 mg

omit from the column headed “Brand”:         Schering-Plough Pty Limited    substitute:             Merck Sharp & Dohme (Australia) Pty Ltd

  1. Schedule 1, entry for Thalidomide in the form Capsule 50 mg

omit from the column headed “Pack Quantity”:          112         substitute:             28

  1. Schedule 1, entry for Tobramycin in each of the forms: Injection 80 mg (as sulfate) in 2 mL; and Injection 80 mg (as sulfate) in 2 mL (without preservative)

omit from the column headed “Pack Quantity”:          1              substitute:             5

  1. Schedule 1, entry for Tobramycin in the form Injection 500 mg (as sulfate) in 5 mL (without preservative)

omit from the column headed “Pack Quantity”:          1              substitute:             10

  1. Schedule 1, entry for Topotecan

omit from the column headed “Brand” for the brand “Topotecan”:       Topotecan          substitute:             Topotecan Kabi

  1. Schedule 1, entry for Trimethoprim with Sulfamethoxazole in the form Tablet 160 mg-800 mg [Maximum Quantity 10;
    Number of Repeats 1]

omit from the column headed “Pack Quantity” for the brand “Septrin Forte”:   1              substitute:             10

  1. Schedule 1, entry for Tyrosine with carbohydrate

substitute:

Tyrosine with carbohydrate Sachets of oral powder 4 g containing 1 g tyrosine, 30 (Tyrosine 1000) Oral Tyrosine 1000 VF MP NP C1286 4 5 1

  1. Schedule 1, entry for Valine with carbohydrate

substitute:

Valine with carbohydrate Sachets of oral powder 4 g containing 50 mg valine, 30 (Valine 50) Oral Valine 50 VF MP NP C1220 4 5 1
Sachets of oral powder 4 g containing 1 g valine, 30 (Valine 1000) Oral Valine 1000 VF MP NP C1220 4 5 1

  1. Schedule 4, Part 1, entry for Aprepitant

insert in numerical order following existing text:

C4211

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat malignancy;
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone;
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following agents: altretamine;carmustine; cisplatin when a single dose constitutes a cycle of chemotherapy; cyclophosphamide at a dose of 1500 mg per square metre per day or greater; dacarbazine; procarbazine when a single dose constitutes a cycle of chemotherapy; streptozocin

No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy

 Compliance with Authority Required procedures - Streamlined Authority Code 4211
C4213

Nausea and vomiting

The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy;
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle;
Patient must have had a prior episode of chemotherapy induced nausea or vomiting;
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following intravenous chemotherapy agents: arsenic trioxide; azacitidine; carboplatin; cyclophosphamide at a dose of less than 1500 mg per square metre per day; cytarabine at a dose of greater than 1 g per square metre per day; dactinomycin; daunorubicin; doxorubicin; epirubicin; fotemustine; idarubicin; ifosfamide; irinotecan; melphalan; methotrexate at a dose of 250 mg to 1 g per square metre; oxaliplatin; raltitrexed

No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy
Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle

 Compliance with Authority Required procedures - Streamlined Authority Code 4213
C4215

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer;
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone;
Patient must be scheduled to be co-administered cyclophosphamide and an anthracycline

No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy

 Compliance with Authority Required procedures - Streamlined Authority Code 4215
C4216

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer;
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone;
Patient must be scheduled to be co-administered cyclophosphamide and an anthracycline

No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy

 Compliance with Authority Required procedures - Streamlined Authority Code 4216
C4217

Nausea and vomiting

The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy;
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle;
Patient must have had a prior episode of chemotherapy induced nausea or vomiting;
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following intravenous chemotherapy agents: arsenic trioxide; azacitidine; carboplatin; cyclophosphamide at a dose of less than 1500 mg per square metre per day; cytarabine at a dose of greater than 1 g per square metre per day; dactinomycin; daunorubicin; doxorubicin; epirubicin; fotemustine; idarubicin; ifosfamide; irinotecan; melphalan; methotrexate at a dose of 250 mg to 1 g per square metre; oxaliplatin; raltitrexed

No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy
Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle

 Compliance with Authority Required procedures - Streamlined Authority Code 4217
C4223

Nausea and vomiting

The condition must be associated with cytotoxic chemotherapy being used to treat malignancy;
The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone;
Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following agents: altretamine;carmustine; cisplatin when a single dose constitutes a cycle of chemotherapy; cyclophosphamide at a dose of 1500 mg per square metre per day or greater; dacarbazine; procarbazine when a single dose constitutes a cycle of chemotherapy; streptozocin

No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy

 Compliance with Authority Required procedures - Streamlined Authority Code 4223

  1. Schedule 4, Part 1, entry for Donepezil

substitute:

Donepezil C4219

Mild to moderately severe Alzheimer disease

Continuing treatment

Patient must have received six months of sole PBS-subsidised initial therapy with this drug;
Patient must demonstrate a clinically meaningful response to the initial treatment;
The treatment must be the sole PBS-subsidised therapy for this condition

Prior to continuing treatment, a comprehensive assessment must be undertaken and documented, involving the patient, the patient's family or carer and the treating physician to establish agreement that treatment is continuing to produce worthwhile benefit
Treatment should cease if there is no agreement of benefit as there is always the possibility of harm from unnecessary use
Re-assessments for a clinically meaningful response are to be undertaken and documented every six months
Clinically meaningful response to treatment is demonstrated in the following areas:
Patient's quality of life including but not limited to level of independence and happiness;
Patient's cognitive function including but not limited to memory, recognition and interest in environment;
Patient's behavioural symptoms, including but not limited to hallucination, delusions, anxiety, marked agitation or associated aggressive behaviour

 Compliance with Authority Required procedures - Streamlined Authority Code 4219
C4220

Mild to moderately severe Alzheimer disease
Initial treatment

Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less;
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist);
The treatment must be the sole PBS-subsidised therapy for this condition

A patient who is unable to register a score of 10 or more for reasons other than their Alzheimer disease, as specified below
Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs
Patients who qualify under this criterion are from 1 or more of the following groups:
(1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
(2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
(3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test;
(4) Intellectual (developmental or acquired) disability, eg Down's syndrome;
(5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test;
(6) Prominent dysphasia, out of proportion to other cognitive and functional impairment
The application must be made in writing, but initial supply may be sought by telephone
For telephone applications, up to a maximum of 2 months' initial therapy will be authorised. This telephone application must be followed by a written authority application for no more than 1 month's therapy and sufficient repeats to complete a maximum of up to 6 months' initial treatment
For written applications where no prior telephone approval has been issued, up to a maximum of 1 month's therapy plus 5 repeats will be authorised

 Compliance with Written or Telephone Authority Required procedures
C4224

Mild to moderately severe Alzheimer disease
Initial treatment

Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more;
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist);
The treatment must be the sole PBS-subsidised therapy for this condition

The authority application must include the result of the baseline MMSE or SMMSE. If this score is 25 - 30 points, the result of a baseline Alzheimer Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) may also be specified
The application must be made in writing, but initial supply may be sought by telephone
For telephone applications, up to a maximum of 2 months' initial therapy will be authorised. This telephone application must be followed by a written authority application for no more than 1 month's therapy and sufficient repeats to complete a maximum of up to 6 months' initial treatment
For written applications where no prior telephone approval has been issued, up to a maximum of 1 month's therapy plus 5 repeats will be authorised

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Galantamine

substitute:

Galantamine C4219

Mild to moderately severe Alzheimer disease

Continuing treatment

Patient must have received six months of sole PBS-subsidised initial therapy with this drug;
Patient must demonstrate a clinically meaningful response to the initial treatment;
The treatment must be the sole PBS-subsidised therapy for this condition

Prior to continuing treatment, a comprehensive assessment must be undertaken and documented, involving the patient, the patient's family or carer and the treating physician to establish agreement that treatment is continuing to produce worthwhile benefit
Treatment should cease if there is no agreement of benefit as there is always the possibility of harm from unnecessary use
Re-assessments for a clinically meaningful response are to be undertaken and documented every six months
Clinically meaningful response to treatment is demonstrated in the following areas:
Patient's quality of life including but not limited to level of independence and happiness;
Patient's cognitive function including but not limited to memory, recognition and interest in environment;
Patient's behavioural symptoms, including but not limited to hallucination, delusions, anxiety, marked agitation or associated aggressive behaviour

 Compliance with Authority Required procedures - Streamlined Authority Code 4219
C4220

Mild to moderately severe Alzheimer disease
Initial treatment

Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less;
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist);
The treatment must be the sole PBS-subsidised therapy for this condition

A patient who is unable to register a score of 10 or more for reasons other than their Alzheimer disease, as specified below
Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs
Patients who qualify under this criterion are from 1 or more of the following groups:
(1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
(2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
(3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test;
(4) Intellectual (developmental or acquired) disability, eg Down's syndrome;
(5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test;
(6) Prominent dysphasia, out of proportion to other cognitive and functional impairment
The application must be made in writing, but initial supply may be sought by telephone
For telephone applications, up to a maximum of 2 months' initial therapy will be authorised. This telephone application must be followed by a written authority application for no more than 1 month's therapy and sufficient repeats to complete a maximum of up to 6 months' initial treatment
For written applications where no prior telephone approval has been issued, up to a maximum of 1 month's therapy plus 5 repeats will be authorised

 Compliance with Written or Telephone Authority Required procedures
C4224

Mild to moderately severe Alzheimer disease
Initial treatment

Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more;
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist);
The treatment must be the sole PBS-subsidised therapy for this condition

The authority application must include the result of the baseline MMSE or SMMSE. If this score is 25 - 30 points, the result of a baseline Alzheimer Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) may also be specified
The application must be made in writing, but initial supply may be sought by telephone
For telephone applications, up to a maximum of 2 months' initial therapy will be authorised. This telephone application must be followed by a written authority application for no more than 1 month's therapy and sufficient repeats to complete a maximum of up to 6 months' initial treatment
For written applications where no prior telephone approval has been issued, up to a maximum of 1 month's therapy plus 5 repeats will be authorised

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Memantine

substitute:

Memantine C4214

Moderately severe Alzheimer disease
Continuing treatment

Patient must have received six months of sole PBS-subsidised initial therapy with this drug;
Patient must demonstrate a clinically meaningful response to the initial treatment;
The treatment must be the sole PBS-subsidised therapy for this condition

Prior to continuing treatment, a comprehensive assessment must be undertaken and documented, involving the patient, the patient's family or carer and the treating physician to establish agreement that treatment is continuing to produce worthwhile benefit.
Treatment should cease if there is no agreement of benefit as there is always the possibility of harm from unnecessary use.
Re-assessments for a clinically meaningful response are to be undertaken and documented every six months.
Clinically meaningful response to treatment is demonstrated in the following areas:
Patient's quality of life including but not limited to level of independence and happiness;
Patient's cognitive function including but not limited to memory, recognition and interest in environment;
Patient's behavioural symptoms, including but not limited to hallucination, delusions, anxiety, marked agitation or associated aggressive behaviour

 Compliance with Authority Required procedures - Streamlined Authority Code 4214
C4218

Moderately severe Alzheimer disease
Initial treatment

Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less;
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist);
The treatment must be the sole PBS-subsidised therapy for this condition

A patient who is unable to register a score of 10 to 14 for reasons other than their Alzheimer disease, as specified below
Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs
Patients who qualify under this criterion are from 1 or more of the following groups:
(1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
(2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
(3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test;
(4) Intellectual (developmental or acquired) disability, eg Down's syndrome;
(5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test;
(6) Prominent dysphasia, out of proportion to other cognitive and functional impairment
The application must be made in writing, but initial supply may be sought by telephone
For telephone applications, up to a maximum of 2 months' initial therapy will be authorised. This telephone application must be followed by a written authority application for no more than 1 month's therapy and sufficient repeats to complete a maximum of up to 6 months' initial treatment
For written applications where no prior telephone approval has been issued, up to a maximum of 1 month's therapy plus 5 repeats will be authorised

 Compliance with Written or Telephone Authority Required procedures
C4221

Moderately severe Alzheimer disease
Initial treatment

Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14;
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist);
The treatment must be the sole PBS-subsidised therapy for this condition

The authority application must include the result of the baseline MMSE or SMMSE of 10 to 14
The application must be made in writing, but initial supply may be sought by telephone
For telephone applications, up to a maximum of 2 months' initial therapy will be authorised. This telephone application must be followed by a written authority application for no more than 1 month's therapy and sufficient repeats to complete a maximum of up to 6 months' initial treatment
For written applications where no prior telephone approval has been issued, up to a maximum of 1 month's therapy plus 5 repeats will be authorised

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Rivastigmine

substitute:

Rivastigmine C4219

Mild to moderately severe Alzheimer disease

Continuing treatment

Patient must have received six months of sole PBS-subsidised initial therapy with this drug;
Patient must demonstrate a clinically meaningful response to the initial treatment;
The treatment must be the sole PBS-subsidised therapy for this condition

Prior to continuing treatment, a comprehensive assessment must be undertaken and documented, involving the patient, the patient's family or carer and the treating physician to establish agreement that treatment is continuing to produce worthwhile benefit
Treatment should cease if there is no agreement of benefit as there is always the possibility of harm from unnecessary use
Re-assessments for a clinically meaningful response are to be undertaken and documented every six months
Clinically meaningful response to treatment is demonstrated in the following areas:
Patient's quality of life including but not limited to level of independence and happiness;
Patient's cognitive function including but not limited to memory, recognition and interest in environment;
Patient's behavioural symptoms, including but not limited to hallucination, delusions, anxiety, marked agitation or associated aggressive behaviour

 Compliance with Authority Required procedures - Streamlined Authority Code 4219
C4220

Mild to moderately severe Alzheimer disease
Initial treatment

Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less;
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist);
The treatment must be the sole PBS-subsidised therapy for this condition

A patient who is unable to register a score of 10 or more for reasons other than their Alzheimer disease, as specified below
Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs
Patients who qualify under this criterion are from 1 or more of the following groups:
(1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
(2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
(3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test;
(4) Intellectual (developmental or acquired) disability, eg Down's syndrome;
(5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test;
(6) Prominent dysphasia, out of proportion to other cognitive and functional impairment
The application must be made in writing, but initial supply may be sought by telephone
For telephone applications, up to a maximum of 2 months' initial therapy will be authorised. This telephone application must be followed by a written authority application for no more than 1 month's therapy and sufficient repeats to complete a maximum of up to 6 months' initial treatment
For written applications where no prior telephone approval has been issued, up to a maximum of 1 month's therapy plus 5 repeats will be authorised

 Compliance with Written or Telephone Authority Required procedures
C4224

Mild to moderately severe Alzheimer disease
Initial treatment

Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more;
The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist);
The treatment must be the sole PBS-subsidised therapy for this condition

The authority application must include the result of the baseline MMSE or SMMSE. If this score is 25 - 30 points, the result of a baseline Alzheimer Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) may also be specified
The application must be made in writing, but initial supply may be sought by telephone
For telephone applications, up to a maximum of 2 months' initial therapy will be authorised. This telephone application must be followed by a written authority application for no more than 1 month's therapy and sufficient repeats to complete a maximum of up to 6 months' initial treatment
For written applications where no prior telephone approval has been issued, up to a maximum of 1 month's therapy plus 5 repeats will be authorised

 Compliance with Written or Telephone Authority Required procedures

1Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.

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