National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 1) (PB 1 of 2020) (Cth)

Case

PB 1 of 2020

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 1)

National Health Act 1953

________________________________________________________________________

I, THEA DANIEL, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access 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  29th January 2020

THEA DANIEL

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

  1. Name of Instrument

(1)This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 1).

(2)This Instrument may also be cited as PB 1 of 2020.

  1. Commencement

This Instrument commences on 1 February 2020.

  1. 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 70 micrograms colecalciferol

omit:

a APO-Alendronate Plus D3 70 mg/70 mcg TX MP NP C6307 C6315 C6320 4 5 4

  1. Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol

omit:

a APO-Alendronate Plus D3 70 mg/140 mcg TX MP NP C6306 C6319 C6325 4 5 4

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

omit:

a APO-Allopurinol TX MP NP 200 2 200

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

omit:

a APO-Allopurinol TX MP NP 60 2 60

  1. Schedule 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 200 mg

omit:

a GenRx Amiodarone GX MP NP C5665 30 5 30

  1. Schedule 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besilate); and Tablet 10 mg (as besilate)

(a)omit:

a Chem mart Amlodipine CH MP NP 30 5 30

(b)omit:

a Terry White Chemists Amlodipine TW MP NP 30 5 30

  1. Schedule 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate)

(a)omit:

a Chem mart Azithromycin CH MP NP C5637 C5718 C5772 P5718 P5772 2 0 2
a Terry White Chemists Azithromycin TW MP NP C5637 C5718 C5772 P5718 P5772 2 0 2

(b)omit:

a Chem mart Azithromycin CH MP NP C5637 C5718 C5772 P5637 2 2 2
a Terry White Chemists Azithromycin TW MP NP C5637 C5718 C5772 P5637 2 2 2

  1. Schedule 1, entry for Baclofen in each of the forms: Tablet 10 mg; and Tablet 25 mg

omit:

a GenRx Baclofen GX MP NP 100 5 100

  1. Schedule 1, entry for Bisoprolol in each of the forms: Tablet containing bisoprolol fumarate 2.5 mg; Tablet containing bisoprolol fumarate 5 mg; and Tablet containing bisoprolol fumarate 10 mg

omit:

a Chem mart Bisoprolol CH MP NP C5324 28 5 28
a Terry White Chemists Bisoprolol TW MP NP C5324 28 5 28

  1. Schedule 1, entry for Bosentan in each of the forms: Tablet 62.5 mg (as monohydrate); and Tablet 125 mg (as monohydrate)

omit:

a BOSENTAN-DRLA RZ MP See Note 3 See Note 3 See Note 3 See Note 3 60 D(100)

  1. Schedule 1, entry for Carmellose with glycerin

substitute:

Carmellose with glycerin Eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, 15 mL Application to the eye Optive AG AO NP C6097 1 3 1
MP C6079 C6097 P6097 1 3 1
MP C6079 C6097 P6079 1 7 1

  1. Schedule 1, entry for Celecoxib in the form Capsule 100 mg

(a)omit:

a Chem mart Celecoxib CH MP NP C4907 C4962 60 3 60

(b)omit:

a Terry White Chemists Celecoxib TW MP NP C4907 C4962 60 3 60

  1. Schedule 1, entry for Celecoxib in the form Capsule 200 mg

(a)omit:

a Chem mart Celecoxib CH MP NP C4907 C4962 30 3 30

(b)omit:

a Terry White Chemists Celecoxib TW MP NP C4907 C4962 30 3 30

  1. Schedule 1, after entry for Cimetidine in the form Tablet 400 mg

insert:

Cinacalcet Tablet 30 mg (as hydrochloride) Oral Pharmacor Cinacalcet CR MP NP C10068 28 5 28
MP C10063 C10067 C10073 56 5 28 C(100)
Tablet 60 mg (as hydrochloride) Oral Pharmacor Cinacalcet CR MP NP C10068 28 5 28
MP C10063 C10067 C10073 56 5 28 C(100)
Tablet 90 mg (as hydrochloride) Oral Pharmacor Cinacalcet CR MP NP C10068 28 5 28
MP C10063 C10067 C10073 56 5 28 C(100)

  1. Schedule 1, entry for Ciprofloxacin in the form Tablet 500 mg (as hydrochloride)

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

a Ciprofloxacin GH HQ MP NP C5614 C5615 C5687 C5688 C5689 C5722 C5780 14 0 14

  1. Schedule 1, entry for Citalopram in each of the forms: Tablet 20 mg (as hydrobromide); and Tablet 40 mg (as hydrobromide)

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

a NOUMED CITALOPRAM VO MP NP C4755 28 5 28

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

omit:

a APO-Clarithromycin TX MP NP 14 1 14

  1. Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)

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

BTC Clopidogrel JB MP NP C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525 28 5 28

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

Clopidogrel APOTEX GX MP NP C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525 28 5 28

  1. Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)

(a)omit: 

Chem mart Clopidogrel CH MP NP C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525 28 5 28

(b)omit:

Terry White Chemists Clopidogrel TW MP NP C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525 28 5 28

  1. Schedule 1, entry for Doxycycline in the form Tablet 50 mg (as hyclate)

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

Doxsig RW MP NP C4475 C4529 C4539 25 5 25

  1. Schedule 1, entry for Doxycycline in the form Tablet 50 mg (as monohydrate)

omit:

GenRx Doxycycline GX MP NP C4475 C4529 C4539 25 5 25

  1. Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate)

(a)omit:

GenRx Doxycycline GX PDP 7 0 7

(b)omit:

GenRx Doxycycline GX MP NP 7 1 7

(c)omit:

GenRx Doxycycline GX MP NP P4485 21 0 21

(d)omit:

GenRx Doxycycline GX MP NP P4514 28 0 7

(e)omit:

GenRx Doxycycline GX MP P6200 28 5 7

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

(a)omit:

a Chem mart Duloxetine CH MP NP C5650 28 0 28

(b)omit:

a Terry White Chemists Duloxetine TW MP NP C5650 28 0 28

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

(a)omit:

a Chem mart Duloxetine CH MP NP C5650 28 5 28

(b)omit:

a Terry White Chemists Duloxetine TW MP NP C5650 28 5 28

  1. Schedule 1, entry for Epoprostenol in the form Powder for I.V. infusion 500 micrograms (as sodium)

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

EPOPROSTENOL SUN RA MP See Note 3 See Note 3 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Epoprostenol in the form Powder for I.V. infusion 1.5 mg (as sodium)

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

EPOPROSTENOL SUN RA MP See Note 3 See Note 3 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)

omit:

a Escitalopram-DRLA RZ MP NP C4755 28 5 28

  1. Schedule 1, entry for Ezetimibe with atorvastatin in the form Tablet 10 mg-10 mg

(a)insert in the column headed “Schedule Equivalent” for the existing brand: a

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

a Ezetimibe/Atorvastatin GH 10/10 GQ MP NP C7958 30 5 30

  1. Schedule 1, entry for Ezetimibe with atorvastatin in the form Tablet 10 mg-20 mg

(a)insert in the column headed “Schedule Equivalent” for the existing brand: a

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

a Ezetimibe/Atorvastatin GH 10/20 GQ MP NP C7957 30 5 30

  1. Schedule 1, entry for Ezetimibe with atorvastatin in the form Tablet 10 mg-40 mg

(a)insert in the column headed “Schedule Equivalent” for the existing brand: a

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

a Ezetimibe/Atorvastatin GH 10/40 GQ MP NP C7957 30 5 30

  1. Schedule 1, entry for Ezetimibe with atorvastatin in the form Tablet 10 mg-80 mg

(a)insert in the column headed “Schedule Equivalent” for the existing brand: a

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

a Ezetimibe/Atorvastatin GH 10/80 GQ MP NP C7957 30 5 30

  1. Schedule 1, entry for Ezetimibe with simvastatin in each of the forms: Tablet 10 mg-10 mg; and Tablet 10 mg-20 mg

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

a EZETORIN RW MP NP C7958 30 5 30

  1. Schedule 1, entry for Ezetimibe with simvastatin in each of the forms: Tablet 10 mg-40 mg; and Tablet 10 mg-80 mg

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

a EZETORIN RW MP NP C7957 30 5 30

  1. Schedule 1, entry for Famciclovir in the form Tablet 125 mg

omit from the column headed “Responsible Person”: HX             substitute: IX

  1. Schedule 1, entry for Famciclovir in each of the forms: Tablet 250 mg; and Tablet 500 mg

omit from the column headed “Responsible Person” (all instances): HX     substitute: IX

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

omit:

a Famotidine Sandoz SZ MP NP 60 5 60

  1. Schedule 1, entry for Famotidine in the form Tablet 40 mg

omit:

a Famotidine Sandoz SZ MP NP 30 5 30

  1. Schedule 1, entry for Fenofibrate in the form Tablet 145 mg [Maximum Quantity: 30; Number of Repeats: 5]

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

a Fenofibrate Sandoz SZ MP NP 30 5 30

  1. Schedule 1, entry for Fenofibrate in the form Tablet 145 mg [Maximum Quantity: 30; Number of Repeats: 11]

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

a Fenofibrate Sandoz SZ MP P7640 30 11 30

  1. Schedule 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)

(a)omit:

a Chem mart Fluoxetine CH MP NP C4755 C6277 28 5 28

(b)omit:

a GenRx Fluoxetine GX MP NP C4755 C6277 28 5 28

(c)omit:

a Terry White Chemists Fluoxetine TW MP NP C4755 C6277 28 5 28

  1. Schedule 1, entry for Furosemide in each of the forms: Tablet 20 mg; and Tablet 40 mg

(a)omit:

a Chem mart Frusemide CH MP NP 100 1 100

(b)omit:

a Terry White Chemists Frusemide TW MP NP 100 1 100

  1. Schedule 1, entry for Gabapentin in each of the forms: Capsule 300 mg; Capsule 400 mg; Tablet 600 mg; and Tablet 800 mg

omit:

a GenRx Gabapentin GX MP NP C4928 100 5 100

  1. Schedule 1, entry for Gliclazide in the form Tablet 80 mg

omit:

a GenRx Gliclazide GX MP NP 100 5 100

  1. Schedule 1, entry for Glyceryl trinitrate

omit:

Tablets 300 micrograms, 100 Buccal/sublingual Nitrostat PF PDP 1 0 1
MP NP 1 5 1

  1. Schedule 1, entry for Glyceryl trinitrate in the form Tablets 600 micrograms, 100

(a)omit:

Nitrostat PF PDP 1 0 1

(b)omit:

Nitrostat PF MP NP 1 5 1

  1. Schedule 1, entry for Hydromorphone in the form Injection containing hydromorphone hydrochloride 2 mg in 1 mL

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

a MEDSURGE HYDROMORPHONE 2 mg/1 mL DZ MP NP 5 0 5

  1. Schedule 1, entry for Hydromorphone in the form Injection containing hydromorphone hydrochloride 10 mg in 1 mL

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

a MEDSURGE HYDROMORPHONE HP 10 mg/
1 mL 		DZ MP NP 5 0 5

  1. Schedule 1, entry for Irbesartan in each the forms: Tablet 75 mg; Tablet 150 mg; and Tablet 300 mg

(a)omit:

a Chem mart Irbesartan CH MP NP 30 5 30

(b)omit:

a Terry White Chemists Irbesartan TW MP NP 30 5 30

  1. Schedule 1, entry for Irbesartan with hydrochlorothiazide in each of the forms: Tablet 150 mg-12.5 mg; Tablet 300 mg-12.5 mg; and
    Tablet 300 mg-25 mg

(a)omit:

a Chem mart Irbesartan HCTZ CH MP NP C4374 30 5 30

(b)omit:

a Terry White Chemists Irbesartan HCTZ TW MP NP C4374 30 5 30

  1. Schedule 1, entry for Isosorbide mononitrate in the form Tablet 60 mg (sustained release)

(a)omit:

a Chem mart Isosorbide Mononitrate CH MP NP 30 5 30

(b)omit:

a Terry White Chemists Isosorbide Mononitrate TW MP NP 30 5 30

  1. Schedule 1, entry for Lanreotide in the form Injection 120 mg (as acetate) in single dose pre-filled syringe

(a)omit from the column headed “Circumstances”: C8260 C9161

(b)omit from the column headed “Circumstances”: C9323

(c)insert in numerical order in the column headed “Circumstances”: C10061 C10075 C10077

  1. Schedule 1, entry for Lercanidipine in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg; and Tablet containing lercanidipine hydrochloride 20 mg

omit:

a APO-Lercanidipine TX MP NP 28 5 28
a Blooms the Chemist Lercanidipine IB MP NP 28 5 28

  1. Schedule 1, entry for Levetiracetam in each of the forms: Tablet 250 mg; Tablet 500 mg; and Tablet 1 g

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

a NOUMED LEVETIRACETAM VO MP NP C7603 60 5 60

  1. Schedule 1, after entry for Levodopa with carbidopa in the form Tablet (modified release) 200 mg-50 mg (as monohydrate)

insert:

Tablet (prolonged release)
200 mg-50 mg 		Oral Sinemet CR Prolonged-Release Tablets MK MP NP C5253 100 5 60

  1. Schedule 1, entry for Lisdexamfetamine

insert as first entry:

Capsule containing lisdexamfetamine dimesilate
20 mg 		Oral Vyvanse ZI MP NP C5252 30 5 30

  1. Schedule 1, after entry for Lisdexamfetamine in the form Capsule containing lisdexamfetamine dimesilate 30 mg

insert:

Capsule containing lisdexamfetamine dimesilate
40 mg 		Oral Vyvanse ZI MP NP C5252 30 5 30

  1. Schedule 1, after entry for Lisdexamfetamine in the form Capsule containing lisdexamfetamine dimesilate 50 mg

insert:

Capsule containing lisdexamfetamine dimesilate
60 mg 		Oral Vyvanse ZI MP NP C5252 30 5 30

  1. Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30
    [Maximum Quantity: See Note 2; Number of Repeats: See Note 2]

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

a APOHEALTH Macrogol with Electrolytes GX MP See Note 2 See Note 2 See Note 2 See Note 2 1 C(100)

  1. Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30 [Maximum Quantity: 1; Number of Repeats: 5]

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

a APOHEALTH Macrogol with Electrolytes GX MP NP C4576 C4577 C4580 C4596 C4601 C6171 P4576 P4577 P4580 P4596 P4601 1 5 1

  1. Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30 [Maximum Quantity: 2; Number of Repeats: 3]

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

a APOHEALTH Macrogol with Electrolytes GX MP NP C4576 C4577 C4580 C4596 C4601 C6171 P6171 2 3 1

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

(a)omit:

a Chem mart Metformin XR 500 CH MP NP 120 5 120

(b)omit:

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

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

(a)omit:

a Chem mart Metformin XR 1000 CH MP NP 60 5 60

(b)omit:

a Terry White Chemists Metformin XR 1000 TW MP NP 60 5 60

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

omit:

a GenRx Moclobemide GX MP NP C5650 60 5 60

  1. Schedule 1, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg [Maximum Quantity: 150;
    Number of Repeats: 5]

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

a Mycophenolate GH GQ MP 150 5 50

  1. Schedule 1, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg [Maximum Quantity: 300;
    Number of Repeats: 5]

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

a Mycophenolate GH GQ MP P5554 P5795 P9691 P9693 300
CN5554 CN5795 CN9691 CN9693 		5
CN5554 CN5795 CN9691 CN9693 		50 C(100)

  1. Schedule 1, entry for Octreotide in the form Injection (modified release) 30 mg (as acetate), vial and diluent syringe

insert in numerical order in the column headed “Circumstances”: C10061 C10075 C10077

  1. Schedule 1, entry for Olanzapine in the form Tablet 5 mg (orally disintegrating)

omit:

Olanzapine ODT-DRLA RZ MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Olanzapine in the form Tablet 10 mg (orally disintegrating)

omit:

Olanzapine ODT-DRLA RZ MP NP C5856 C5869 28 5 28

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

(a)omit:

a APOTEX-Pantoprazole GX MP NP C5444 C5512 C5529 30 5 30

(b)omit:

a Pantofast 20 RZ MP NP C5444 C5512 C5529 30 5 30

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
    Number of Repeats: 1]

omit:

a APOTEX-Pantoprazole GX MP NP C8774 C8775 C8776 C8780 C8866 P8774 P8775 30 1 30

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
    Number of Repeats: 5]

omit:

a APOTEX-Pantoprazole GX MP NP C8774 C8775 C8776 C8780 C8866 P8776 P8780 P8866 30 5 30

  1. Schedule 1, entry for Paroxetine

omit:

a GenRx Paroxetine GX MP NP C4755 C6277 C6636 30 5 30

  1. Schedule 1, entry for Pemetrexed in the form Powder for I.V. infusion 100 mg (as disodium)

omit:

PEMETREXED-DRLA RZ MP See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Pemetrexed in the form Powder for I.V. infusion 500 mg (as disodium)

omit:

Pemetrexed DRLA RZ MP See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Piroxicam in the form Capsule 10 mg

(a)omit:

a GenRx Piroxicam GX PDP C6214 50 0 50

(b)omit:

a GenRx Piroxicam GX MP NP C6214 50 3 50

  1. Schedule 1, entry for Piroxicam in the form Capsule 20 mg

(a)omit:

a GenRx Piroxicam GX PDP C6214 25 0 25

(b)omit:

a GenRx Piroxicam GX MP NP C6214 25 3 25

  1. Schedule 1, entry for Pregabalin in each of the forms: Capsule 25 mg; Capsule 75 mg; Capsule 150 mg; and Capsule 300 mg

omit:

a APO-Pregabalin TX MP NP C4172 56 5 56
a Blooms The Chemist Pregabalin IB MP NP C4172 56 5 56

  1. Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 10 mg (enteric coated)

omit:

a Rabeprazole-DRLA RZ MP NP C5444 C5512 28 5 28

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

(a)omit:

a Chem mart Rabeprazole CH MP NP C8774 C8775 C8776 C8780 P8774 P8775 30 1 30

(b)omit:

a Rabeprazole-DRLA RZ MP NP C8774 C8775 C8776 C8780 P8774 P8775 30 1 30
a Terry White Chemists Rabeprazole TW MP NP C8774 C8775 C8776 C8780 P8774 P8775 30 1 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]

(a)omit:

a Chem mart Rabeprazole CH MP NP C8774 C8775 C8776 C8780 P8776 P8780 30 5 30

(b)omit:

a Rabeprazole-DRLA RZ MP NP C8774 C8775 C8776 C8780 P8776 P8780 30 5 30
a Terry White Chemists Rabeprazole TW MP NP C8774 C8775 C8776 C8780 P8776 P8780 30 5 30

  1. Schedule 1, entry for Ranitidine

omit:

Tablet, effervescent, 150 mg (as hydrochloride) Oral Zantac AS MP NP 60 5 30

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

(a)omit:

Chem mart Ranitidine CH MP NP MW 60 5 60

(b)omit:

Terry White Chemists Ranitidine TW MP NP MW 60 5 60

(c)insert in the column headed “Schedule Equivalent” for all remaining brands: a

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

(a)omit:

a Chem mart Ranitidine CH MP NP 30 5 30

(b)omit:

a Terry White Chemists Ranitidine TW MP NP 30 5 30

  1. Schedule 1, entry for Rituximab in the form Solution for I.V. infusion 100 mg in 10 mL [Circumstances: See Note 3; Purposes: See Note 3]

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

a Truxima EW MP See Note 3 See Note 3 See Note 3 See Note 3 2 PB(100)

  1. Schedule 1, entry for Rituximab in the form Solution for I.V. infusion 500 mg in 50 mL [Circumstances: See Note 3; Purposes: See Note 3]

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

a Truxima EW MP See Note 3 See Note 3 See Note 3 See Note 3 1 PB(100)

  1. Schedule 1, entry for Rosuvastatin in each of the forms: Tablet 5 mg (as calcium); Tablet 10 mg (as calcium); Tablet 20 mg (as calcium); and Tablet 40 mg (as calcium)

(a)omit:

a Rosuvastatin-DRLA RI MP NP 30 5 30

(b)omit:

a Rosuvastatin-DRLA RI MP P7598 30 11 30

  1. Schedule 1, entry for Sapropterin

substitute:

Sapropterin Tablet (soluble) containing sapropterin dihydrochloride
100 mg 		Oral Kuvan IO MP C8897 C8898 C8926 C8988 C10076 C10081 P8898 90 0 30
MP C8897 C8898 C8926 C8988 C10076 C10081 P8988 P10076 180 0 30
NP C8897 C8926 C8988 C10081 P8988 180 0 30
MP C8897 C8898 C8926 C8988 C10076 C10081 P8897 P8926 P10081 180 5 30
NP C8897 C8926 C8988 C10081 P8897 P8926 P10081 180 5 30

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

(a)omit:

a Chem mart Sertraline CH MP NP C4755 30 5 30

(b)omit:

a Terry White Chemists Sertraline TW MP NP C4755 30 5 30

  1. Schedule 1, entry for Sildenafil

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

a SILDATIO PHT RW MP See Note 3 See Note 3 See Note 3 See Note 3 90 D(100)

(b)omit:

a SILDENAFIL-DRx RZ MP See Note 3 See Note 3 See Note 3 See Note 3 90 D(100)

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

(a)omit from the column headed “Circumstances”: C10012

(b)insert in numerical order in the column headed “Circumstances”: C10074

  1. Schedule 1, entry for Somatropin in the form Powder for injection 12 mg (36 i.u.) with diluent in pre-filled pen (with preservative)

(a)omit from the column headed “Circumstances”: C10012

(b)insert in numerical order in the column headed “Circumstances”: C10074

  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

insert in numerical order in the column headed “Circumstances”: C10011 C10027 C10042 C10074

  1. Schedule 1, entry for Somatropin in the form Solution for injection 10 mg (30 i.u.) in 2 mL cartridge (with preservative)

(a)omit from the column headed “Circumstances”: C10012

(b)insert in numerical order in the column headed “Circumstances”:C10074

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

(a)omit:

a GenRx Terbinafine GX MP NP C6395 C6404 C6453 P6404 P6453 42 0 42

(b)omit:

a GenRx Terbinafine GX MP NP C6395 C6404 C6453 P6395 42 1 42

  1. Schedule 1, entry for Tiotropium

insert as first entry:

Capsule containing powder for oral inhalation 13 micrograms (as bromide) (for use in Zonda device) Inhalation by mouth Braltus TB MP NP C6352 30 5 30

  1. Schedule 1, entry for Venlafaxine in each of the forms: Capsule (modified release) 75 mg (as hydrochloride); and Capsule (modified release)
    150 mg (as hydrochloride)

(a)omit:

a Chem mart Venlafaxine XR CH MP NP C5650 28 5 28

(b)omit:

a Terry White Chemists Venlafaxine XR TW MP NP C5650 28 5 28

  1. Schedule 4, Part 1, entry for Carmellose with glycerin

(a)omit:

C6072 P6072 Severe dry eye syndrome, including Sjogren's syndrome

(b)insert in the column headed “Purposes Code” for the circumstance code “C6097”: P6097

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

insert:

Cinacalcet C10063 Secondary hyperparathyroidism
Continuing treatment
Must be treated by a nephrologist.
Patient must have chronic kidney disease; AND
Patient must be on dialysis; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition.
During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.
During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient's response and tolerability. 		Compliance with Authority Required procedures - Streamlined Authority Code 10063
C10067 Secondary hyperparathyroidism
Continuing treatment
Must be treated by a nephrologist.
Patient must have chronic kidney disease; AND
Patient must be on dialysis; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition.
During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.
During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient's response and tolerability. 		Compliance with Authority Required procedures - Streamlined Authority Code 10067
C10068 Secondary hyperparathyroidism
Continuing treatment
Patient must have chronic kidney disease; AND
Patient must be on dialysis; AND
Patient must have achieved a decrease of at least 30% in intact parathyroid hormone (iPTH) concentrations after 6 months treatment; OR
Patient must have an intact parathyroid (iPTH) concentration greater than 15 pmol/L and an (adjusted) serum calcium concentration of less than 2.6 mmol/L after 6 months.
During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.
During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient's response and tolerability. 		Compliance with Authority Required procedures - Streamlined Authority Code 10068
C10073 Secondary hyperparathyroidism
Initial treatment
Must be treated by a nephrologist.
Patient must have chronic kidney disease; AND
Patient must be on dialysis; AND
Patient must have failed to respond to conventional therapy; AND
Patient must have sustained hyperparathyroidism with iPTH of at least 50 pmol per L; OR
Patient must have sustained hyperparathyroidism with iPTH of at least 15 pmol per L and less than 50 pmol per L and an (adjusted) serum calcium concentration at least 2.6 mmol per L.
During the titration phase, intact PTH (iPTH) should be monitored 4 weekly (measured at least 12 hours post dose) and dose titrated until an appropriate iPTH concentration is achieved.
During the titration phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment at a time, with doses between 30 and 180 mg per day according to the patient's response and tolerability. 		Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Lanreotide

(a)omit:

C8260 Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be as monotherapy.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.
Lanreotide is not PBS-subsidised for use in combination with everolimus or sunitinib for this condition. 		Compliance with Authority Required procedures - Streamlined Authority Code 8260
C9161 Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be as monotherapy.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.
Lanreotide is not PBS-subsidised for use in combination with everolimus or sunitinib for this condition. 		Compliance with Authority Required procedures - Streamlined Authority Code 9161

(b)omit:

C9323 Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be as monotherapy.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.
Lanreotide is not PBS-subsidised for use in combination with everolimus or sunitinib for this condition. 		Compliance with Authority Required procedures - Streamlined Authority Code 9323

(c)insert in numerical order after existing text:

C10061 Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20. 		Compliance with Authority Required procedures - Streamlined Authority Code 10061
C10075 Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20. 		Compliance with Authority Required procedures - Streamlined Authority Code 10075
C10077 Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20. 		Compliance with Authority Required procedures - Streamlined Authority Code 10077

  1. Schedule 4, Part 1, entry for Octreotide

insert in numerical order after existing text:

C10061 Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20. 		Compliance with Authority Required procedures - Streamlined Authority Code 10061
C10075 Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20. 		Compliance with Authority Required procedures - Streamlined Authority Code 10075
C10077 Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20. 		Compliance with Authority Required procedures - Streamlined Authority Code 10077

  1. Schedule 4, Part 1, entry for Sapropterin

(a)omit:

C4773 P4773 Hyperphenylalaninaemia
Continuing
Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND
Patient must have previously been issued with an authority prescription for this drug; OR
Patient must have accessed non-PBS-subsidised treatment prior to 1 May 2014.
Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.
The authority application must be made in writing. 		Compliance with Written Authority Required procedures
C4921 P4921 Hyperphenylalaninaemia
Initial
Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency.
Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.
The authority application must be made in writing. 		Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C10076 P10076 Hyperphenylalaninaemia
Initial treatment
Must be treated by a metabolic physician.
Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency.
Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured. 		Compliance with Authority Required procedures
C10081 P10081 Hyperphenylalaninaemia
Continuing treatment
Must be treated by a metabolic physician; OR
Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician.
Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND
Patient must have previously been issued with an authority prescription for this drug; OR
Patient must have accessed non-PBS-subsidised treatment prior to 1 May 2014.
Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured. 		Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Somatropin

(a)omit:

C10012 Severe growth hormone deficiency
Continuing treatment in adults
Must be treated by an endocrinologist or in consultation with an endocrinologist.
Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; OR
Patient must have adult onset growth hormone deficiency secondary to organic hypothalamic or pituitary disease; AND
Patient must maintain IGF-1 levels within the normal range for age and sex.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
A serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application. 		Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C10074 Severe growth hormone deficiency
Continuing treatment in a person with a mature skeleton or aged 18 years or older
Must be treated by an endocrinologist or in consultation with an endocrinologist.
Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause in a patient with a mature skeleton; OR
Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to adult onset growth hormone deficiency secondary to organic hypothalamic or pituitary disease in a patient aged 18 years or older; AND
Patient must maintain IGF-1 levels within the normal range for age and sex.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
A serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application. 		Compliance with Written Authority Required procedures

  1. Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as besilate) [GRP-15475]

(a)insert in alphabetical order in the column headed “Brand”: BTC Clopidogrel

(b)insert in alphabetical order in the column headed “Brand”: Clopidogrel APOTEX

  1. Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate) [GRP-15475]

(a)omit from the column headed “Brand”: Chem mart Clopidogrel

(b)omit from the column headed “Brand”: Terry White Chemists Clopidogrel

  1. Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as besilate) [GRP-17110]

(a)insert in alphabetical order in the column headed “Brand”: BTC Clopidogrel

(b)insert in alphabetical order in the column headed “Brand”: Clopidogrel APOTEX

  1. Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate) [GRP-17110] 

(a)omit from the column headed “Brand”: Chem mart Clopidogrel

(b)omit from the column headed “Brand”: Terry White Chemists Clopidogrel

  1. Schedule 5, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [GRP-14639]

omit from the column headed “Brand”: GenRx Doxycycline

  1. Schedule 5, entry for Doxycycline in the form Tablet 50 mg (as hyclate) [GRP-15635]

insert in alphabetical order in the column headed “Brand”: Doxsig

  1. Schedule 5, entry for Doxycycline in the form Tablet 50 mg (as monohydrate) [GRP-15635] 

omit from the column headed “Brand”: GenRx Doxycycline

  1. Schedule 5, after entry for Doxycycline

insert:

Epoprostenol GRP-16914 Powder for I.V. infusion 500 micrograms (as sodium) Injection EPOPROSTENOL SUN
Veletri
Powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL Injection Flolan
GRP-16976 Powder for I.V. infusion 1.5 mg (as sodium) Injection EPOPROSTENOL SUN
Veletri
Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL Injection Flolan

  1. Schedule 5, after entry for Levodopa with carbidopa in the form Tablet (modified release) 200 mg-50 mg (as monohydrate) [GRP-22957]

insert:

Tablet (prolonged release) 200 mg-50 mg Oral Sinemet CR Prolonged-Release Tablets

  1. Schedule 5, entry for Olanzapine in the form Tablet 10 mg (orally disintegrating) [GRP-15723]

omit from the column headed “Brand”: Olanzapine ODT-DRLA

  1. Schedule 5, entry for Olanzapine in the form Tablet 5 mg (orally disintegrating) [GRP-15797]

omit from the column headed “Brand”: Olanzapine ODT-DRLA

  1. Schedule 5, omit entry for Ranitidine

  1. Schedule 5, after entry for Tenofovir with emtricitabine and efavirenz

insert:

Tiotropium GRP-23704 Capsule containing powder for oral inhalation 13 micrograms (as bromide) (for use in Zonda device) Inhalation by mouth Braltus
Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in HandiHaler) Inhalation by mouth Spiriva
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