National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 5) (No. PB 36 of 2014) (Cth)

Case

PB 36 of 2014

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 5)


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 12 May 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. 5).

(2)        This Instrument may also be cited as PB 36 of 2014.

2          Commencement

This Instrument commences on 1 June 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 Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol

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

Fonat Plus AF MP NP C4122 C4123 C4133 4 5 4

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium)

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

Cadivast 5/10 AF MP NP C2449 C2450 C2451 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium)

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

Cadivast 5/20 AF MP NP C2449 C2450 C2451 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium)

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

Cadivast 5/40 AF MP NP C2449 C2450 C2451 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium)

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

Cadivast 5/80 AF MP NP C2449 C2450 C2451 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium)

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

Cadivast 10/10 AF MP NP C2449 C2450 C2451 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium)

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

Cadivast 10/20 AF MP NP C2449 C2450 C2451 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium)

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

Cadivast 10/40 AF MP NP C2449 C2450 C2451 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium)

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

Cadivast 10/80 AF MP NP C2449 C2450 C2451 30 5 30

  1. Schedule 1, entry for Arginine with carbohydrate in each of the forms: Sachets of oral powder 4 g containing 500 mg arginine, 30 (Arginine 500); and Sachets of oral powder 4 g containing 2 g arginine, 30 (Arginine 2000)

omit from the column headed “Circumstances”:          C1458   substitute:          C4555

  1. Schedule 1, after entry for Arginine with carbohydrate in the form Sachets of oral powder 4 g containing 2 g arginine, 30 (Arginine 2000)

insert:

Sachets of oral powder 7.6 g containing 5 g arginine, 30 (Arginine 5000) Oral Arginine 5000 VF MP NP C4555 4 5 1

  1. Schedule 1, entry for Candesartan in each of the forms: Tablet containing candesartan cilexetil 4 mg; Tablet containing candesartan cilexetil 8 mg; Tablet containing candesartan cilexetil 16 mg; and Tablet containing candesartan cilexetil 32 mg

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

Chem mart Candesartan CH MP NP 30 5 30

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

Terry White Chemists Candesartan TW MP NP 30 5 30

  1. Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg

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

Chem mart Candesartan HCTZ 16/12.5 CH MP NP C4374 30 5 30

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

Terry White Chemists Candesartan HCTZ 16/12.5 TW MP NP C4374 30 5 30

  1. Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg

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

Chem mart Candesartan HCTZ 32/12.5 CH MP NP C4374 30 5 30

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

Terry White Chemists Candesartan HCTZ 32/12.5 TW MP NP C4374 30 5 30

  1. Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg

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

Chem mart Candesartan HCTZ 32/25 CH MP NP C4374 30 5 30

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

Terry White Chemists Candesartan HCTZ 32/25 TW MP NP C4374 30 5 30

  1. Schedule 1, entry for Codeine with Paracetamol [Maximum Quantity: 20; Number of Repeats: 0]

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

Paracetamol/ Codeine GH 500/30 GQ MP NP PDP 20 0 20

  1. Schedule 1, entry for Codeine with Paracetamol [Maximum Quantity: 60 CN2064; Number of Repeats: 0]

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

Paracetamol/ Codeine GH 500/30 GQ MP NP P2064 60
CN2064 		0 20

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

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

Diltiazem Actavis UA MP NP 90 5 90

  1. Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; and Tablet containing enalapril maleate
    10 mg

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

Enalapril Actavis UA MP NP 30 5 30

  1. Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL

(a)omit from the column headed “Brand”:          Epirubicin Actavis 100             substitute:          Epirubicin ACT

(b)omit from the column headed “Responsible Person”:     TA        substitute:          VN

  1. Schedule 1, entry for Everolimus in each of the forms: Tablet 5 mg; and Tablet 10 mg

insert in numerical order in  the column headed “Circumstances”:        C4557

  1. Schedule 1, entry for Exemestane

substitute:

Exemestane Tablet 25 mg Oral APO‑Exemestane TX MP C1541 C2457 C4552 30 5 30
NP C1541 C2457 30 5 30
Aromasin PF MP C1541 C2457 C4552 30 5 30
NP C1541 C2457 30 5 30
Exaccord RA MP C1541 C2457 C4552 30 5 30
NP C1541 C2457 30 5 30
Exemestane‑GA GN MP C1541 C2457 C4552 30 5 30
NP C1541 C2457 30 5 30
Exemestane GH GQ MP C1541 C2457 C4552 30 5 30
NP C1541 C2457 30 5 30
Exemestane Pfizer FZ MP C1541 C2457 C4552 30 5 30
NP C1541 C2457 30 5 30
Exemestane Sandoz SZ MP C1541 C2457 C4552 30 5 30
NP C1541 C2457 30 5 30

  1. Schedule 1, after entry for Fentanyl in the form Transdermal patch 16.8 mg [Brand: Fentanyl Sandoz]

insert:

Ferric carboxymaltose Injection 500 mg (iron) in 10 mL Injection ferinject VL MP NP 2 1 1

  1. Schedule 1, entry for Gemfibrozil

(a)omit:

Lopid PF MP C1540 C3047 P1540 60 5 60
NP C1540 60 5 60

(b)omit:

Lopid PF MP C1540 C3047 P3047 60 11 60

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

insert in the columns in the order indicated:

Test strips, 100 (GoodLife) For external use GoodLife JN MP NP 1 5 1
MP P4241 1 11 1

  1. Schedule 1, entry for Lactulose

(a)omit:

Lac‑Dol GN MP NP C1150 C1613 C3642 C3643 P3643 3 0 1

(b)omit:

Lac‑Dol GN MP NP C1150 C1613 C3642 C3643 P3642 3 3 1

(c)omit:

Lac‑Dol GN MP NP C1150 C1613 C3642 C3643 P1150 P1613 1 5 1

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

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

Lamotrigine Aspen 50 FM MP NP C1426 56 5 56

  1. Schedule 1, entry for Mycophenolic Acid in the form Capsule containing mycophenolate mofetil 250 mg

(a)omit:

Imulate QA MP C1765 C1766 300 3 100

(b)omit:

Imulate QA MP
See Note 1 		C1650 C1651 C3355 C3356 600 5 100 C(100)

  1. Schedule 1, entry for Mycophenolic Acid in the form Tablet containing mycophenolate mofetil 500 mg

(a)omit:

Imulate QA MP C1765 C1766 150 3 50

(b)omit:

Imulate QA MP
See Note 1 		C1650 C1651 C3355 C3356 300 5 50 C(100)

  1. Schedule 1, entry for Nandrolone Decanoate

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

  1. Schedule 1, entry for Oestriol in each of the forms: Pessaries 500 micrograms, 15; and Vaginal cream 1 mg per g, 15 g

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

  1. Schedule 1, after entry for Phenoxybenzamine in the form Capsule containing phenoxybenzamine hydrochloride 10 mg

insert in the columns in the order indicated:

Capsule containing 10 mg phenoxybenzamine hydrochloride Oral Dibenzyline BZ MP NP C1239 C1285 100 5 100

  1. Schedule 1, entry for Phenoxybenzamine

omit:

Capsules containing phenoxybenzamine hydrochloride 10 mg, 100 Oral Dibenzyline BZ MP NP C1239 C1285 1 5 1

  1. Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 2]

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

Rabeprazole RBX RA MP NP C1177 C1337 C1533 P1177 30 2 30

  1. Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 5]

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

Rabeprazole RBX RA MP NP C1177 C1337 C1533 P1337 P1533 30 5 30

  1. Schedule 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 2]

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

Risperidone Actavis 2 UA MP NP C1589 C2272 C3083 P3083 60 2 60

  1. Schedule 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 5]

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

Risperidone Actavis 2 UA MP NP C1589 C2272 C3083 P1589 P2272 60 5 60

  1. Schedule 1, entry for Risperidone in the form Tablet 3 mg

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

Risperidone Actavis 3 UA MP NP C1589 C2272 60 5 60

  1. Schedule 1, after entry for Tamoxifen in the form Tablet 20 mg (as citrate) [Brand: Tamoxifen Sandoz]

insert:

Tapentadol Tablet (modified release) 50 mg (as hydrochloride) Oral Palexia SR CS MP NP C4556 28 0 28
Tablet (modified release) 100 mg (as hydrochloride) Oral Palexia SR CS MP NP C4556 28 0 28
Tablet (modified release) 150 mg (as hydrochloride) Oral Palexia SR CS MP NP C4556 28 0 28
Tablet (modified release) 200 mg (as hydrochloride) Oral Palexia SR CS MP NP C4556 28 0 28
Tablet (modified release) 250 mg (as hydrochloride) Oral Palexia SR CS MP NP C4556 28 0 28

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

insert:

JN JNS Biomedical Pty Ltd  79 163 593 833

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

insert:

VL Vifor Pharma Pty Limited  87 086 114 043

  1. Schedule 4, Part 1, entry for Arginine with carbohydrate

substitute:

Arginine with carbohydrate C4555 Urea cycle disorders

  1. Schedule 4, Part 1, entry for Everolimus

insert in numerical order following existing text:

C4557

Metastatic (Stage IV) breast cancer

The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must have acquired endocrine resistance as demonstrated by initial response and then recurrence or progression of disease after treatment with letrozole or anastrozole; AND
The treatment must be in combination with exemestane

Patient must be female; AND
Patient must be post-menopausal

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Exemestane

insert in numerical order following existing text:

C4552

Metastatic (Stage IV) breast cancer

The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
Patient must be receiving PBS-subsidised everolimus concomitantly for this condition

Patient must be female; AND
Patient must be post-menopausal

  1. Schedule 4, Part 1, entry for Plerixafor [Circumstances Code: 4549]

omit from the column headed “Circumstances and Purposes”:

Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per microlitre on the day of planned collection; OR

substitute:

Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per millilitre or less than 10 million per litre on the day of planned collection; OR

  1. Schedule 4, Part 1, entry for Plerixafor [Circumstances Code: 4550]

omit from the column headed “Circumstances and Purposes”:

Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per microlitre on the day of planned collection; OR

substitute:

Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per millilitre or less than 10 million per litre on the day of planned collection; OR

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

insert:

Tapentadol

 C4556

Chronic severe disabling pain

The condition must be unresponsive to non-narcotic analgesics
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