National Health Act 1953 Amendment determinations under sections 85, 85A and 88 pharmaceutical benefits (No. PB 55 of 2010) (Cth)

Case

COMMONWEALTH OF AUSTRALIA

Instrument number PB 55 of 2010

Amendment determinations under sections 85, 85A and 88 of the National Health Act 1953

I, FELICITY McNEILL, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under sections 85, 85A and 88 of the National Health Act 1953.

Dated 3rd June 2010

FELICITY McNEILL

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination — pharmaceutical benefits

1              Commencement

This instrument commences on 1 July 2010.

2              Amendment of PB 15 of 2010

Schedule 1 amends PB 15 of 2010.

Schedule 1            Amendments

  1. Part 1 of Schedule 1, omit item dealing with Adrenaline

and substitute in the columns in the order indicated:

Adrenaline

Injection 1 mg (as acid tartrate) in 1 mL (1 in 1,000)

Injection

5

1

AstraZeneca Pty Ltd

I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector (EpiPen Jr.)

Injection

1

..

EpiPen Jr.

I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector (Anapen Junior)

Injection

1

..

Anapen Junior

I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector (EpiPen)

Injection

1

..

EpiPen

I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector (Anapen)

Injection

1

..

Anapen

  1. Part 1 of Schedule 1, item dealing with Atenolol in the form Tablet 50 mg

omit from the column headed “Brand”: GenRx Atenolol

  1. Part 1 of Schedule 1, item dealing with Captopril in the form Tablet 12.5 mg

(a)omit from the column headed “Brand”: Captohexal

(b)insert in alphabetical order in the column headed “Brand”: Captopril Sandoz

  1. Part 1 of Schedule 1, item dealing with Dasatinib in the form Tablet 100 mg

omit from the column headed “Maximum quantity”:             60         and substitute:     30

  1. Part 1 of Schedule 1, item dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg

omit from the column headed “Brand”: GenRx Diclofenac

  1. Part 1 of Schedule 1, omit item dealing with Docetaxel

and substitute in the columns in the order indicated:

Docetaxel

Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL with solvent

Injection

1

..

Taxotere

Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent

Injection

1

..

Taxotere

  1. Part 1 of Schedule 1, item dealing with Famciclovir in the form Tablet 125 mg

insert in alphabetical order in the column headed “Brand”: Favic 125

  1. Part 1 of Schedule 1, item dealing with Famciclovir in the form Tablet 250 mg

insert in alphabetical order in the column headed “Brand”: Favic 250

  1. Part 1 of Schedule 1, item dealing with Famciclovir in the form Tablet 500 mg

insert in alphabetical order in the column headed “Brand”: Favic 500

  1. Part 1 of Schedule 1, item dealing with Famotidine in the form Tablet 40 mg

(a)omit from the column headed “Brand”: Famohexal

(b)insert in alphabetical order in the column headed “Brand”: Famotidine Sandoz

  1. Part 1 of Schedule 1, item dealing with Glucose Indicator—Blood

omit from the columns in the order indicated:

Test strips, 50 (Accu-Chek Active)

For external use

2

5

Accu-Chek Active

  1. Part 1 of Schedule 1, after item dealing with Glucose Indicator—Blood in the form Test strips, 50 (CareSens)

insert in the columns in the order indicated:

Test strips, 50 (CareSens N)

For external use

2

5

CareSens N

  1. Part 1 of Schedule 1, after item dealing with Glucose Indicator—Blood in the form Test strips, 50 (WaveSense Jazz)

insert in the columns in the order indicated:

Test strips, 100 (Accu-Chek Active)

For external use

1

5

Accu-Chek Active

  1. Part 1 of Schedule 1, item dealing with Glucose Indicator—Blood

omit from the columns in the order indicated:

Test strips, 100 (SofTact)

For external use

1

5

SofTact

  1. Part 1 of Schedule 1, item dealing with Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg

omit from the column headed “Brand”: Napamide 2.5 mg

  1. Part 1 of Schedule 1, item dealing with Lamotrigine in the form Tablet 200 mg

insert in alphabetical order in the column headed “Brand”: APO-Lamotrigine

  1. Part 1 of Schedule 1, item dealing with Lisinopril in the form Tablet 20 mg

omit from the column headed “Brand”: Lisinopril Hexal

  1. Part 1 of Schedule 1, item dealing with Medroxyprogesterone

omit from the columns in the order indicated:

Injection containing medroxyprogesterone acetate 50 mg in 1 mL Injection 1 1 Depo-Provera

  1. Part 1 of Schedule 1, item dealing with Mesalazine

omit from the columns in the order indicated:

Suppositories 1 g, 28 Rectal 1 1 Pentasa

and substitute in the columns in the order indicated:

Suppository 1 g Rectal 28 1 Pentasa

  1. Part 1 of Schedule 1, item dealing with Metformin

omit from the columns in the order indicated:

Tablet (extended release) containing metformin hydrochloride 500 mg Oral 90 5

Diabex XR

Diaformin XR

Metex XR

  1. Part 1 of Schedule 1, item dealing with Metformin

omit from the columns in the order indicated:

Tablets (extended release) containing metformin hydrochloride 500 mg, 120 Oral 1 5

Diabex XR

Diaformin XR

Metex XR

and substitute in the columns in the order indicated:

Tablet (extended release) containing metformin hydrochloride 500 mg Oral 120 5

Diabex XR

Diaformin XR

Metex XR

  1. Part 1 of Schedule 1, item dealing with Moclobemide in the form Tablet 300 mg

(a)insert in alphabetical order in the column headed “Brand”: Moclobemide Sandoz

(b)omit from the column headed “Brand”: Mohexal

  1. Part 1 of Schedule 1, item dealing with Oestradiol

omit from the columns in the order indicated:

Transdermal patches 4 mg, 8 Transdermal 1 5 Estraderm 50

  1. Part 1 of Schedule 1, Oestradiol and Oestradiol with Norethisterone

omit from the columns in the order indicated:

Pack containing 4 transdermal patches oestradiol 4 mg and 4 transdermal patches oestradiol 10 mg with norethisterone acetate 30 mg Transdermal 1 5 Estracombi

  1. Part 1 of Schedule 1, item dealing with Oxaliplatin in the form Powder for I.V. infusion 50 mg

insert in alphabetical order in the column headed “Brand”: Oxaliplatin Link

  1. Part 1 of Schedule 1, item dealing with Paclitaxel in 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

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

  1. Part 1 of Schedule 1, item dealing with Paracetamol in the form Tablet 500 mg

omit from the column headed “Brand”: Dymadon P

  1. Part 1 of Schedule 1, item dealing with Posaconazole in the form Oral suspension 40 mg per mL, 105 mL

(a)omit from  the column headed “Maximum quantity”:    6          and substitute:    1

(b)omit from  the column headed “Maximum number of repeats”: 2            and substitute:. .

  1. Part 1 of Schedule 1, item dealing with Pravastatin in the form Tablet containing pravastatin sodium 20 mg

(a)omit from the column headed “Brand”: Liprachol

(b)insert in alphabetical order in the column headed “Brand”: Pravastatin Sandoz

  1. Part 1 of Schedule 1, item dealing with Tamoxifen in the form Tablet 20 mg (as citrate)

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

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

  1. Part 1 of Schedule 1, item dealing with Terbinafine in the form Tablet 250 mg (as hydrochloride)

insert in alphabetical order in the column headed “Brand”: Terbinafine-GA

  1. Part 1 of Schedule 1, item dealing with Topiramate in the forms Tablet 25 mg, Tablet 50 mg, Tablet 100 mg and Tablet 200 mg

insert in alphabetical order in the column headed “Brand”: Topiramate-GA

  1. Part 1 of Schedule 1, item dealing with Voriconazole in the form Powder for oral suspension 40 mg per mL, 70 mL

(a)omit from  the column headed “Maximum quantity”:    4          and substitute:    1

(b)omit from  the column headed “Maximum number of repeats””: 2          and substitute: . .

  1. Part 2 of Schedule 1, item dealing with Aciclovir in the form Tablet 800 mg

omit from the column headed “Brand”: Zovirax 800 mg

  1. Part 2 of Schedule 1, omit item dealing with Adrenaline

  1. Part 2 of Schedule 1, item dealing with Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)

(a)omit from  the column headed “Brand”: APO-Clopidogrel

(b)omit from  the column headed “Brand”: Chem mart Clopidgrel

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

  1. Part 2 of Schedule 1, item dealing with Dasatinib in the form Tablet 100 mg

omit from the column headed “Maximum quantity”:             60         and substitute:     30

  1. Part 2 of Schedule 1, omit item dealing with Docetaxel

and substitute in the columns in the order indicated:

Docetaxel

Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL with solvent

In compliance with authority procedures set out in subparagraph 11 (d):

Adjuvant treatment of node-positive breast cancer in combination with an anthracycline and cyclophosphamide

Advanced breast cancer after failure of prior therapy

Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound

Locally advanced or metastatic non-small cell lung cancer

Treatment of HER2 positive early breast cancer in combination with trastuzumab

Treatment of androgen independent (hormone refractory) metastatic carcinoma of the prostate in a patient with a Karnofsky performance-status score of at least 60%, where docetaxel is used as first-line chemotherapy and administered in three weekly cycles

Adjuvant treatment of operable breast cancer in combination with cyclophosphamide

Injection

2

..

Taxotere

  1. Part 2 of Schedule 1, omit item dealing with Esomeprazole

and substiture  in the columns in the order indicated:

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Maintenance of healed gastro-oesophageal reflux disease

Scleroderma oesophagus

Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion

Oral

30

5

Nexium

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

In compliance with authority procedures set out in subparagraph 11 (d):

Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion

Oral

30

5

Nexium

  1. Part 2 of Schedule 1, item dealing with Famciclovir in the form Tablet 250 mg [two instances]

insert in alphabetical order in the column headed “Brand”: Favic 250

  1. Part 2 of Schedule 1, after item dealing with Famciclovir in the form Tablet 500 mg

insert in alphabetical order in the column headed “Brand”: Favic 500

  1. Part 2 of Schedule 1, item dealing with Glucose Indicator—Blood

omit from the columns in the order indicated:

Test strips, 50 (Accu-Chek Active)

For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

For external use

2

11

Accu-Chek Active

  1. Part 2 of Schedule 1, after item dealing with Glucose Indicator—Blood in the form Test strips, 50 (CareSens)

insert in the columns in the order indicated:

Test strips, 50 (CareSens N)

For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

For external use

2

11

CareSens N

  1. Part 2 of Schedule 1, after item dealing with Glucose Indicator—Blood in the form Test strips, 50 (WaveSense Jazz)

insert in the columns in the order indicated:

Test strips, 100 (Accu-Chek Active)

For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

For external use

1

11

Accu-Chek Active

  1. Part 2 of Schedule 1, item dealing with Glucose Indicator—Blood

omit from the columns in the order indicated:

Test strips, 100 (SofTact) For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements For external use 1 11 SofTact

  1. Part 2 of Schedule 1, item dealing with Paracetamol in the form Tablet 500 mg

omit from the column headed “Brand”: Dymadon P

  1. Part 1 of Schedule 1, item dealing with Pravastatin in the form Tablet containing pravastatin sodium 20 mg

(a)omit from the column headed “Brand”: Liprachol

(b)insert in alphabetical order in the column headed “Brand”: Pravastatin Sandoz

  1. Part 2 of Schedule 1, after item dealing with Rivaroxaban

insert in the columns in the order indicated:

Rosuvastatin Tablet 5 mg (as calcium) For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements Oral 30 11 Crestor
Tablet 10 mg (as calcium) For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements Oral 30 11 Crestor
Tablet 20 mg (as calcium) For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements Oral 30 11 Crestor
Tablet 40 mg (as calcium) For use in accordance with paragraph 14 in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements Oral 30 11 Crestor

  1. Part 2 of Schedule 1, item dealing with Terbinafine in the form Tablet 250 mg (as hydrochloride)

insert in alphabetical order in the column headed “Brand”: Terbinafine-GA

  1. Part 1 of Schedule 2, item dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg

omit from the column headed “Brand”: GenRx Diclofenac

  1. Part 2 of Schedule 2, item dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg

omit from the column headed “Brand”: GenRx Diclofenac

  1. Part 1 of Schedule 3, item dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg

omit from the column headed “Brand”: GenRx Diclofenac

  1. Part 1 of Schedule 3, item dealing with Paracetamol in the form Tablet 500 mg

omit from the column headed “Brand”: Dymadon P

  1. Part 1 of Schedule 3, after item dealing with Promethazine

insert in the columns in the order indicated:

Roxithromycin

Tablet for oral suspension 50 mg

Oral

10

..

Rulide D

Tablet 150 mg

Oral

10

..

APO-Roxithromycin

Biaxsig

Chem mart Roxithromycin

Roxar 150

Roxide

Roximycin

Roxithromycin-GA

Rulide

Terry White Chemists Roxithromycin

Tablet 300 mg

Oral

5

..

APO-Roxithromycin

Biaxsig

Chem mart Roxithromycin

Roxar 300

Roxide

Roximycin

Roxithromycin-GA

Rulide

Terry White Chemists Roxithromycin

  1. Part 2 of Schedule 3, item dealing with Paracetamol in the form Tablet 500 mg

omit from the column headed “Brand”: Dymadon P

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