National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 11) (PB 82 of 2014) (Cth)

Case

PB 82 of 2014

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 11)


National Health Act 1953

I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated 20 October 2014

FELICITY McNEILL

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical    Benefits) Amendment Instrument 2014 (No. 11).

(2)        This Instrument may also be cited as PB 82 of 2014.

2          Commencement

This Instrument commences on 1 November 2014.

3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Schedule 1     Amendments

  1. Schedule 1, entry for Abiraterone

omit from the column headed “Circumstances”:       C4245   substitute:             C4654

  1. Schedule 1, after entry for Amino acid formula without phenylalanine in the form Sachets containing oral powder 20 g, 30 (Phlexy-10 Drink Mix)

insert:

Amino acid formula without valine, leucine and isoleucine Sachets containing oral powder 6 g, 30 (MSUD amino5) Oral MSUD amino5 VF MP NP C1220 12 5 1

  1. Schedule 1, entry for Amlodipine with Atorvastatin

substitute:

Amlodipine with Atorvastatin Tablet 5 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium) Oral APO-Amlodipine/ Atorvastatin 5/10 TX MP NP C2449 C2450 C2451 30 5 30
Blooms the Chemist Amlodipine/ Atorvastatin 5/10 IB MP NP C2449 C2450 C2451 30 5 30
Cadatin 5/10 FZ MP NP C2449 C2450 C2451 30 5 30
Cadivast 5/10 AF MP NP C2449 C2450 C2451 30 5 30
Caduet 5/10 PF MP NP C2449 C2450 C2451 30 5 30
Chem mart Amlodipine/ Atorvastatin 5/10 CH MP NP C2449 C2450 C2451 30 5 30
Terry White Chemists Amlodipine/ Atorvastatin 5/10 TW MP NP C2449 C2450 C2451 30 5 30
Tablet 5 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium) Oral APO-Amlodipine/ Atorvastatin 5/20 TX MP NP C2449 C2450 C2451 30 5 30
Blooms the Chemist Amlodipine/ Atorvastatin 5/20 IB MP NP C2449 C2450 C2451 30 5 30
Cadatin 5/20 FZ MP NP C2449 C2450 C2451 30 5 30
Cadivast 5/20 AF MP NP C2449 C2450 C2451 30 5 30
Caduet 5/20 PF MP NP C2449 C2450 C2451 30 5 30
Chem mart Amlodipine/ Atorvastatin 5/20 CH MP NP C2449 C2450 C2451 30 5 30
Terry White Chemists Amlodipine/ Atorvastatin 5/20 TW MP NP C2449 C2450 C2451 30 5 30
Tablet 5 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium) Oral APO-Amlodipine/ Atorvastatin 5/40 TX MP NP C2449 C2450 C2451 30 5 30
Blooms the Chemist Amlodipine/ Atorvastatin 5/40 IB MP NP C2449 C2450 C2451 30 5 30
Cadatin 5/40 FZ MP NP C2449 C2450 C2451 30 5 30
Cadivast 5/40 AF MP NP C2449 C2450 C2451 30 5 30
Caduet 5/40 PF MP NP C2449 C2450 C2451 30 5 30
Chem mart Amlodipine/ Atorvastatin 5/40 CH MP NP C2449 C2450 C2451 30 5 30
Terry White Chemists Amlodipine/ Atorvastatin 5/40 TW MP NP C2449 C2450 C2451 30 5 30
Tablet 5 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium) Oral APO-Amlodipine/ Atorvastatin 5/80 TX MP NP C2449 C2450 C2451 30 5 30
Blooms the Chemist Amlodipine/ Atorvastatin 5/80 IB MP NP C2449 C2450 C2451 30 5 30
Cadatin 5/80 FZ MP NP C2449 C2450 C2451 30 5 30
Cadivast 5/80 AF MP NP C2449 C2450 C2451 30 5 30
Caduet 5/80 PF MP NP C2449 C2450 C2451 30 5 30
Chem mart Amlodipine/ Atorvastatin 5/80 CH MP NP C2449 C2450 C2451 30 5 30
Terry White Chemists Amlodipine/ Atorvastatin 5/80 TW MP NP C2449 C2450 C2451 30 5 30
Tablet 10 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium) Oral APO-Amlodipine/ Atorvastatin 10/10 TX MP NP C2449 C2450 C2451 30 5 30
Blooms the Chemist Amlodipine/ Atorvastatin 10/10 IB MP NP C2449 C2450 C2451 30 5 30
Cadatin 10/10 FZ MP NP C2449 C2450 C2451 30 5 30
Cadivast 10/10 AF MP NP C2449 C2450 C2451 30 5 30
Caduet 10/10 PF MP NP C2449 C2450 C2451 30 5 30
Chem mart Amlodipine/ Atorvastatin 10/10 CH MP NP C2449 C2450 C2451 30 5 30
Terry White Chemists Amlodipine/ Atorvastatin 10/10 TW MP NP C2449 C2450 C2451 30 5 30
Tablet 10 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium) Oral APO-Amlodipine/ Atorvastatin 10/20 TX MP NP C2449 C2450 C2451 30 5 30
Blooms the Chemist Amlodipine/ Atorvastatin 10/20 IB MP NP C2449 C2450 C2451 30 5 30
Cadatin 10/20 FZ MP NP C2449 C2450 C2451 30 5 30
Cadivast 10/20 AF MP NP C2449 C2450 C2451 30 5 30
Caduet 10/20 PF MP NP C2449 C2450 C2451 30 5 30
Chem mart Amlodipine/ Atorvastatin 10/20 CH MP NP C2449 C2450 C2451 30 5 30
Terry White Chemists Amlodipine/ Atorvastatin 10/20 TW MP NP C2449 C2450 C2451 30 5 30
Tablet 10 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium) Oral APO-Amlodipine/ Atorvastatin 10/40 TX MP NP C2449 C2450 C2451 30 5 30
Blooms the Chemist Amlodipine/ Atorvastatin 10/40 IB MP NP C2449 C2450 C2451 30 5 30
Cadatin 10/40 FZ MP NP C2449 C2450 C2451 30 5 30
Cadivast 10/40 AF MP NP C2449 C2450 C2451 30 5 30
Caduet 10/40 PF MP NP C2449 C2450 C2451 30 5 30
Chem mart Amlodipine/ Atorvastatin 10/40 CH MP NP C2449 C2450 C2451 30 5 30
Terry White Chemists Amlodipine/ Atorvastatin 10/40 TW MP NP C2449 C2450 C2451 30 5 30
Tablet 10 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium) Oral APO-Amlodipine/ Atorvastatin 10/80 TX MP NP C2449 C2450 C2451 30 5 30
Blooms the Chemist Amlodipine/ Atorvastatin 10/80 IB MP NP C2449 C2450 C2451 30 5 30
Cadatin 10/80 FZ MP NP C2449 C2450 C2451 30 5 30
Cadivast 10/80 AF MP NP C2449 C2450 C2451 30 5 30
Caduet 10/80 PF MP NP C2449 C2450 C2451 30 5 30
Chem mart Amlodipine/ Atorvastatin 10/80 CH MP NP C2449 C2450 C2451 30 5 30
Terry White Chemists Amlodipine/ Atorvastatin 10/80 TW MP NP C2449 C2450 C2451 30 5 30

  1. Schedule 1, entry for Azathioprine in the form Tablet 50 mg

omit from the column headed “Brand”:      Imazam            substitute:             Imazan

  1. Schedule 1, entry for Baclofen in the form Tablet 10 mg

(a)omit:

Chem mart Baclofen CH MP NP 100 5 100

(b)omit:

GenRx Baclofen GX MP NP 100 5 100

(c)omit:

Terry White Chemists Baclofen TW MP NP 100 5 100

  1. Schedule 1, entry for Baclofen in the form Tablet 25 mg

(a)omit:

Chem mart Baclofen CH MP NP 100 5 100

(b)omit:

GenRx Baclofen GX MP NP 100 5 100

  1. Schedule 1, entry for Cabazitaxel

omit from the column headed “Circumstances”:       C4237  C4262    substitute:             C4661  C4662

  1. Schedule 1, entry for Carboplatin in the form Solution for I.V. injection 450 mg in 45 mL

omit:

Pfizer Australia Pty Ltd PF MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Cefaclor in the form Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL

(a)omit:

Chem mart Cefaclor CH PDP 1 0 1

(b)omit:

Terry White Chemists Cefaclor TW PDP 1 0 1

(c)omit:

Chem mart Cefaclor CH MP 1 1 1

(d)omit:

Terry White Chemists Cefaclor TW MP 1 1 1

  1. Schedule 1, entry for Cefaclor in the form Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL

(a)omit:

Chem mart Cefaclor CH PDP 1 0 1

(b)omit:

Terry White Chemists Cefaclor TW PDP 1 0 1

(c)omit:

Chem mart Cefaclor CH MP 1 1 1

(d)omit:

Terry White Chemists Cefaclor TW MP 1 1 1

  1. Schedule 1, entry for Citalopram in the form Tablet 10 mg (as hydrobromide)

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

Citalopram Actavis UA MP NP C1211 28 5 28

  1. Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg [Maximum Quantity: 100;
    Number of Repeats: 0]

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

Diclofenac AN EA MP NP C1036 C1054 C3645 C3646 P3646 100 0 50
PDP C1036 C1054 100 0 50

  1. Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg [Maximum Quantity: 100;
    Number of Repeats: 3]

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

Diclofenac AN EA MP NP C1036 C1054 C3645 C3646 P1036 P1054 P3645 100 3 50

  1. Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg [Maximum Quantity: 50;
    Number of Repeats: 0]

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

Diclofenac AN EA MP NP C1036 C1054 C3645 C3646 P3646 50 0 50
PDP C1036 C1054 50 0 50

  1. Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg [Maximum Quantity: 50;
    Number of Repeats: 3]

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

Diclofenac AN EA MP NP C1036 C1054 C3645 C3646 P1036 P1054 P3645 50 3 50

  1. Schedule 1, entry for Diltiazem in the form Tablet containing diltiazem hydrochloride 60 mg

(a)omit:

Chem mart Diltiazem CH MP NP 90 5 90

(b)omit:

GenRx Diltiazem GX MP NP 90 5 90

(c)omit:

Terry White Chemists Diltiazem TW MP NP 90 5 90

  1. Schedule 1, entry for Docetaxel in each of the forms: Solution concentrate for I.V. infusion 140 mg in 7 mL; and Solution concentrate for I.V. infusion 160 mg in 16 mL

omit from the column headed “Circumstances”:       C3888  C3892  C3916  C3956  C4078  C4140  C4160  C4239

  1. Schedule 1, entry for Docetaxel in each of the forms: Powder for I.V. infusion 20 mg with solvent; and Powder for I.V. infusion 80 mg
    with solvent

omit from the column headed “Circumstances”:       C4078  C4140  C4160  C4239

  1. Schedule 1, entry for Docetaxel in each of the forms: Solution concentrate for I.V. infusion 20 mg in 1 mL; Solution concentrate for I.V. infusion 20 mg in 2 mL; Solution concentrate for I.V. infusion 80 mg in 4 mL; and Solution concentrate for I.V. infusion 80 mg in 8 mL

omit from the column headed “Circumstances” (all instances):           C3888  C3892  C3916  C3956  C4078  C4140  C4160  C4239

  1. Schedule 1, entry for Donepezil in the form Tablet containing donepezil hydrochloride 5 mg

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

Aridon APN 5 FM MP NP C4219 C4220 C4224 28 5 28

  1. Schedule 1, entry for Donepezil in the form Tablet containing donepezil hydrochloride 10 mg

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

Aridon APN 10 FM MP NP C4219 C4220 C4224 28 5 28

  1. Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial

omit:

Adriamycin Solution PF 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

omit:

Adriamycin PF MP See Note 3 See
Note 3 		1 D(100)

  1. 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 AN EA MP NP 30 5 30

  1. Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL

omit:

Pharmorubicin Solution PF MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Fluconazole in each of the forms: Solution for I.V. infusion 100 mg in 50 mL; and Solution for I.V. infusion 200 mg
    in 100 mL

omit:

Diflucan PF MP NP C3613 C3614 C3615 C3616 C3617 C3618 7 0 1

  1. Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 100 (Contour)

insert in the columns in the order indicated:

Test strips, 100 (Contour next) For external use Contour next IK MP NP 1 5 1
MP P4241 1 11 1

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

insert:

Indacaterol with glycopyrronium Capsule containing powder for oral inhalation indacaterol 110 micrograms (as maleate) with glycopyrronium 50 micrograms (as bromide) (for use in Breezhaler) Inhalation by mouth ultibro breezhaler 110/50 NV MP NP C4655 30 5 30

  1. Schedule 1, entry for Indapamide

omit:

Tablet containing indapamide hemihydrate 1.5 mg (sustained release) Oral Natrilix SR SE MP NP 90 1 90

substitute:

Tablet containing indapamide hemihydrate 1.5 mg (sustained release) Oral APO-Indapamide SR TX MP NP 90 1 90
Chem mart Indapamide SR CH MP NP 90 1 90
Natrilix SR SE MP NP 90 1 90
Terry White Chemists Indapamide SR TW MP NP 90 1 90

  1. Schedule 1, entry for Interferon Beta-1b

omit:

Extavia NV MP C1175 C1751 15 5 15

  1. Schedule 1, entry for Ipratropium in each of the forms: Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) in 1 mL single dose units, 30; and Nebuliser solution containing ipratropium bromide 500 micrograms (anhydrous) in 1 mL single dose units, 30

omit:

Ipravent PF MP NP C1754 C1755 2 5 1

  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”:

Irbesartan Actavis 75 UA MP NP 30 5 30

  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”:

Irbesartan Actavis 300 UA MP NP 30 5 30

  1. Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL

omit:

Camptosar PF MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Lactulose

(a)omit:

GenRx Lactulose GX MP NP C1150 C1613 C3642 C3643 P3643 3 0 1

(b)omit:

GenRx Lactulose GX MP NP C1150 C1613 C3642 C3643 P3642 3 3 1

(c)omit:

GenRx Lactulose GX MP NP C1150 C1613 C3642 C3643 P1150 P1613 1 5 1

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

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

Diaformin XR 1000 AF MP NP 60 5 60

  1. Schedule 1, entry for Methotrexate in the form Injection 50 mg in 2 mL vial

omit:

Pfizer Australia Pty Ltd PF MP See Note 2 5
See Note 2 		5
See
Note 2 		5

  1. Schedule 1, entry for Metoclopramide in the form Tablet containing metoclopramide hydrochloride 10 mg

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

Metoclopramide AN EA MP NP MW PDP 25 0 25

  1. Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg

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

Metoprolol AN EA MP NP 100 5 100

  1. Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg

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

Metoprolol AN EA MP NP 60 5 60

  1. Schedule 1, entry for Mometasone in the form Cream containing mometasone furoate 1 mg per g, 15 g

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

Momasone QA MP NP C1422 1 0 1

  1. Schedule 1, entry for Norethisterone with Ethinyloestradiol

omit:

Pack containing 12 tablets 500 micrograms‑35 micrograms, 9 tablets 1 mg‑35 micrograms and 7 inert tablets Oral Improvil 28 Day FZ MP NP 4 2 4

  1. Schedule 1, entry for Paclitaxel in each of the forms: Solution concentrate for I.V. infusion 30 mg in 5 mL; Solution concentrate for I.V. infusion 100 mg in 16.7 mL; Solution concentrate for I.V. infusion 150 mg in 25 mL; and Solution concentrate for I.V. infusion 300 mg
    in 50 mL

omit from the column headed “Circumstances” (all instances):           C3186  C3890  C3902  C3917  C3955  C3956        

  1. Schedule 1, entry for Paclitaxel, nanoparticle albumin-bound

insert in numerical order in the column headed “Circumstances”:      C4657

  1. Schedule 1, after entry for Penicillamine in the form Tablet 250 mg

insert:

Perampanel Tablet 2 mg (as hemisesquihydrate) Oral Fycompa EI MP C4656 14 1 7
Tablet 4 mg (as hemisesquihydrate) Oral Fycompa EI MP NP C4658 28 5 28
Tablet 6 mg (as hemisesquihydrate) Oral Fycompa EI MP NP C4658 28 5 28
Tablet 8 mg (as hemisesquihydrate) Oral Fycompa EI MP NP C4658 28 5 28
Tablet 10 mg (as hemisesquihydrate) Oral Fycompa EI MP NP C4658 28 5 28
Tablet 12 mg (as hemisesquihydrate) Oral Fycompa EI MP NP C4658 28 5 28

  1. Schedule 1, entry for Perindopril with Indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg

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

Perindopril Combi Actavis 4/1.25 GN MP NP C4375 30 5 30

  1. Schedule 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)

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

APO-Ranitidine TX MP NP MW 60 5 60

  1. Schedule 1, entry for Ranitidine in the form Tablet 300 mg (as hydrochloride)

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

APO-Ranitidine TX MP NP 30 5 30

  1. Schedule 1, entry for Roxithromycin in the form Tablet 150 mg [Maximum Quantity: 10; Number of Repeats: 0]

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

Roxithromycin AN EA PDP 10 0 10

  1. Schedule 1, entry for Roxithromycin in the form Tablet 150 mg [Maximum Quantity: 10; Number of Repeats: 1]

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

Roxithromycin AN EA MP NP 10 1 10

  1. Schedule 1, entry for Roxithromycin in the form Tablet 300 mg [Maximum Quantity: 5; Number of Repeats: 0]

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

Roxithromycin AN EA PDP 5 0 5

  1. Schedule 1, entry for Roxithromycin in the form Tablet 300 mg [Maximum Quantity: 5; Number of Repeats: 1]

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

Roxithromycin AN EA MP NP 5 1 5

  1. Schedule 1, entry for Sertraline in each of the forms: Tablet 50 mg (as hydrochloride); and Tablet 100 mg (as hydrochloride)

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

Sertraline AN EA MP NP C1211 C1241 C1975 30 5 30

  1. Schedule 1, entry for Triglycerides―medium chain, formula in each of the forms: Oral powder 400 g (Lipistart); and Oral powder 400 g (Monogen)

omit from the column headed “Circumstances”:          C1068  C1511  C1513  C1670  C1671

substitute:             C4651  C4652  C4653  C4659  C4660

  1. Schedule 1, after entry for Triglycerides―medium chain, formula in the form Oral powder 400 g (Monogen)

insert in the columns in the order indicated:

Oral powder 400 g (Peptamen Junior) Oral Peptamen Junior NT MP NP C4660 8 5 1

  1. Schedule 1, after entry for Vitamins, minerals and trace elements with carbohydrate in the form Oral powder 200 g (Paediatric Seravit)

insert in the columns in the order indicated:

Sachets containing oral powder 6 g, 30 (FruitiVits) Oral FruitiVits VF MP NP C4663 1 5 1

  1. Schedule 1, entry for Zolmitriptan

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

APO-Zolmitriptan TX MP NP C4573 4 5 2

  1. Schedule 3, after details relevant to Responsible Person code IA

insert:

IB Apotex Pty Ltd  52 096 916 148

  1. Schedule 4, Part 1, entry for Abiraterone

substitute:

Abiraterone C4654

Castration resistant metastatic carcinoma of the prostate

The treatment must be in combination with prednisone or prednisolone; AND
The treatment must not be used in combination with chemotherapy; AND
Patient must have failed treatment with docetaxel due to resistance or intolerance; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not receive PBS-subsidised abiraterone if progressive disease develops while on abiraterone

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Cabazitaxel

substitute:

Cabazitaxel C4661

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Castration resistant metastatic carcinoma of the prostate

The treatment must be in combination with prednisone or prednisolone; AND
The treatment must not be used in combination with abiraterone; AND
Patient must have failed treatment with docetaxel due to resistance or intolerance; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel

 Compliance with Authority Required procedures
C4662

Where the patient is receiving treatment at/from a Public Hospital

Castration resistant metastatic carcinoma of the prostate

The treatment must be in combination with prednisone or prednisolone; AND
The treatment must not be used in combination with abiraterone; AND
Patient must have failed treatment with docetaxel due to resistance or intolerance; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel

 Compliance with Authority Required procedures - Streamlined Authority Code 4662

  1. Schedule 4, Part 1, omit entry for Docetaxel

  1. Schedule 4, Part 1, after entry for Indacaterol

insert:

Indacaterol with glycopyrronium C4655

Chronic obstructive pulmonary disease (COPD)

Patient must have been stabilised on a combination of a long acting muscarinic antagonist and long acting beta-2 agonist.

 Compliance with Authority Required procedures - Streamlined Authority Code 4655

  1. Schedule 4, Part 1, omit entry for Paclitaxel

  1. Schedule 4, Part 1, entry for Paclitaxel, nanoparticle albumin-bound

insert in numerical order following existing text:

C4657

Stage IV (metastatic) adenocarcinoma of the pancreas

The treatment must be in combination with gemcitabine; AND
The condition must not have been treated previously with PBS-subsidised therapy; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less

A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug

 Compliance with Authority Required procedures - Streamlined Authority Code 4657

  1. Schedule 4, Part 1, after entry for Pemetrexed

insert:

Perampanel C4656

Intractable partial epileptic seizures

Initial treatment

The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent; AND
The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs, which includes at least one first-line anti-epileptic agent and at least two second-line adjunctive anti-epileptic agents

Must be treated by a neurologist

 Compliance with Authority Required procedures - Streamlined Authority Code 4656
C4658

Intractable partial epileptic seizures

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug

 Compliance with Authority Required procedures - Streamlined Authority Code 4658

  1. Schedule 4, Part 1, omit entry for Polyethylene glycol 400

  1. Schedule 4, Part 1, entry for Triglycerides―medium chain, formula

insert in numerical order following existing text:

C4651 Hyperlipoproteinaemia type 1
C4652 Chylous ascites
C4653 Chylothorax
C4659 Long chain fatty acid oxidation disorders
C4660

Dietary management of conditions requiring a source of medium chain triglycerides

Patient must have fat malabsorption due to liver disease; OR
Patient must have fat malabsorption due to short gut syndrome; OR
Patient must have fat malabsorption due to cystic fibrosis; OR
Patient must have fat malabsorption due to gastrointestinal disorders

  1. Schedule 4, Part 1, entry for Vitamins, minerals and trace elements with carbohydrate

insert in numerical order following existing text:

C4663

Dietary management of conditions requiring a highly restrictive therapeutic diet

Patient must have insufficient vitamin and mineral intake due to a specific diagnosis requiring a highly restrictive therapeutic diet; AND
Patient must be unable to adequately meet vitamin, mineral and trace element needs with other proprietary vitamin and mineral preparations

Patient must be aged 3 years or older

 Compliance with Authority Required procedures
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