National Health Act 1953 Amendment determinations under sections 85, 85A and 88 pharmaceutical benefits (No. PB 9 of 2009) (Cth)

Case

COMMONWEALTH OF AUSTRALIA

Instrument number PB 9 of 2009

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

I, ADRIANA PLATONA, Acting 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 30 January 2009

ADRIANA PLATONA

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination — pharmaceutical benefits

1              Commencement

This instrument commences on 1 March 2009.

2              Amendment of PB 114 of 2008

Schedule 1 amends PB 114 of 2008.

Schedule 1        Amendments

  1. Subparagraph 3(c)

omit:

olmesartan or telmisartan

and substitute:

olmesartan, telmisartan or valsartan

  1. Part 1 of Schedule 1, after item dealing with Amlodipine with Atorvastatin

insert in the columns in the order indicated:

Amlodipine with valsartan

Tablet 5 mg (as besylate)-80 mg

Tablet 5 mg (as besylate)-160 mg

Tablet 10 mg (as besylate)-160 mg

Oral

Oral

Oral

28

28

28

5

5

5

Exforge 5/80

Exforge 5/160

Exforge 10/160

  1. Part 1 of Schedule 1, item dealing with Amoxycillin in the form Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

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

Amoxycillin Sandoz

  1. Part 1 of Schedule 1, item dealing with Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

omit from the column headed “Brand”:

Clamohexal Duo 500mg/125mg

  1. Part 1 of Schedule 1, item dealing with Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

omit from the column headed “Brand”:

Clamohexal Duo Forte 875mg/125mg

  1. Part 1 of Schedule 1, item dealing with Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL

omit from the column headed “Brand”:

Clamohexal 125mg/31.25mg/5mL

  1. Part 1 of Schedule 1, item dealing with Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL,


    60 mL

omit from the column headed “Brand”:

Clamohexal Duo 400mg/57mg/5mL

  1. Part 1 of Schedule 1, after item dealing with Ampicillin

insert in the columns in the order indicated:

Amylopectin, modified long chain Sachets containing oral powder 60 g, 30 (Glycosade) Oral 4 5 Glycosade

  1. Part 1 of Schedule 1, item dealing with Baclofen in the forms Tablet 10 mg and Tablet 25 mg

omit from the column headed “Brand”:

Baclohexal

  1. Part 1 of Schedule 1, item dealing with Carmellose with glycerin

omit from the column headed “Maximum number of repeats”:

2

and substitute:

3

  1. Part 1 of Schedule 1, item dealing with Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate)

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

Cefaclor-GA

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


    sodium 25 mg

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

Diclofenac-GA

  1. Part 1 of Schedule 1, after item dealing with Essential amino acids formula with minerals and vitamin C

insert in the columns in the order indicated:

Essential amino acids formula with vitamins and minerals Sachets containing oral powder 12.5 g, 50
(EAA Supplement) 		Oral 4 5 EAA Supplement

  1. Part 1 of Schedule 1, item dealing with Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL

omit from the column headed “Brand”:

Irinotecan-GA

  1. Part 1 of Schedule 1, item dealing with Mesalazine in the form Tablet 500 mg (prolonged release)

omit from the column headed “Maximum quantity”:

100

and substitute:

200

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

omit from the columns in the order indicated:

Capsule (containing enteric coated microspheres) providing not less than 10,000 BP units of lipase activity Oral 500 10 Cotazym-S Forte

  1. Part 1 of Schedule 1, after item dealing with Phenoxymethylpenicillin

insert in the columns in the order indicated:

Phenylalanine with carbohydrate Sachets of oral powder 4 g containing 50 mg phenylalanine, 30 (Phenylalanine Amino Acid Supplement) Oral 4 5 Phenylalanine Amino Acid Supplement

  1. Part 1 of Schedule 1, item dealing with Salbutamol in the form Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation)

omit from the column headed “Brand”:

Epaq

  1. Part 1 of Schedule 1, after item dealing with Telmisartan with Hydrochlorothiazide in the form


    Tablet 80 mg-12.5 mg

insert in the columns in the order indicated:

Tablet 80 mg-25 mg Oral 28 5 Micardis Plus 80/25 mg

  1. Part 1 of Schedule 1, item dealing with Trandolapril with Verapamil

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

Tablet containing trandolapril 2 mg with verapamil hydrochloride 180 mg (sustained release) Oral 28 5 Tarka 2/180

  1. Part 1 of Schedule 1, item dealing with Triglycerides — medium chain, formula

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

Sachets containing oral powder 16 g, 25 (MCT Pro-Cal) Oral 4 5 MCT Pro-Cal

  1. Part 1 of Schedule 1, item dealing with Ursodeoxycholic Acid

omit from the column headed “Maximum quantity”:

100

and substitute:

200

  1. Part 1 of Schedule 1, after item dealing with Valproic Acid

insert in the columns in the order indicated:

Valsartan

Tablet 40 mg

Tablet 80 mg

Tablet 160 mg

Tablet 320 mg

Oral

Oral

Oral

Oral

28

28

28

28

. .

5

5

5

Diovan

Diovan

Diovan

Diovan
Valsartan with hydrochlorothiazide

Tablet 80 mg-12.5 mg

Tablet 160 mg-12.5 mg

Tablet 160 mg-25 mg

Oral

Oral

Oral

28

28

28

5

5

5

Co-Diovan 80/12.5

Co-Diovan 160/12.5

Co-Diovan 160/25

  1. Part 1 of Schedule 1, item dealing with Vinorelbine in the form Solution for I.V. infusion 10 mg (as tartrate) in 1 mL

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

Vinorelbine 10 Link

  1. Part 1 of Schedule 1, item dealing with Vinorelbine in the form Solution for I.V. infusion 50 mg (as tartrate) in 5 mL

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

Vinorelbine 50 Link

  1. Part 1 of Schedule 1, after item dealing with Warfarin

insert in the columns in the order indicated:

Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose Sachets containing oral powder 100 g, 10 (RenaStart) Oral 8 5 RenaStart

  1. Part 2 of Schedule 1, item dealing with Carmellose with glycerin

omit from the column headed “Maximum number of repeats”:

5

and substitute:

7

  1. Part 2 of Schedule 1, item dealing with Dasatinib in the forms Tablet 20 mg, Tablet 50 mg and Tablet 70 mg

omit from the column headed “Purposes” under the first occurrence of the heading “Chronic myeloid leukaemia”:

(iii) loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing in value by at least 5 fold to a level of greater than 1% confirmed on a subsequent test); or

and substitute:

(iii) loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing in value by at least 5 fold to a level of greater than 1% confirmed on a subsequent test), during ongoing imatinib therapy; or

  1. Part 2 of Schedule 1, item dealing with Pancrelipase

omit from the columns in the order indicated:

Capsule (containing enteric coated microspheres) providing not less than 10,000 BP units of lipase activity For use in patients with cystic fibrosis, and 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 500 21 Cotazym-S Forte

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


    sodium 25 mg

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

Diclofenac-GA

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


    sodium 25 mg

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

Diclofenac-GA

  1. Part 1 of Schedule 3, item dealing with Amoxycillin in the form Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

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

Amoxycillin Sandoz

  1. Part 1 of Schedule 3, item dealing with Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

omit from the column headed “Brand”:

Clamohexal Duo 500mg/125mg

  1. Part 1 of Schedule 3, item dealing with Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

omit from the column headed “Brand”:

Clamohexal Duo Forte 875mg/125mg

  1. Part 1 of Schedule 3, item dealing with Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL

omit from the column headed “Brand”:

Clamohexal 125mg/31.25mg/5mL

  1. Part 1 of Schedule 3, item dealing with Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL,


    60 mL

omit from the column headed “Brand”:

Clamohexal Duo 400mg/57mg/5mL

  1. Part 1 of Schedule 3, item dealing with Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate)

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

Cefaclor-GA

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


    sodium 25 mg

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

Diclofenac-GA

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