National Health Act 1953 Amendment determinations under sections 85, 85A and 88 pharmaceutical benefits (No. PB 125 of 2008) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 125 of 2008

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

I, DIANA MACDONELL, 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 3rd DECEMBER 2008

DIANA MACDONELL

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination — pharmaceutical benefits

1 Commencement

This instrument commences on 1 January 2009.

2 Amendment of PB 114 of 2008

Schedule 1 amends PB 114 of 2008.

Schedule 1 Amendments

Omit item dealing with Aminoglutethimide

Part 1 of Schedule 1, item dealing with Amiodarone in the form Tablet containing amiodarone hydrochloride

100 mg

omit from the column headed “Brand”:

GenRx Amiodarone

Part 1 of Schedule 1, item dealing with Amoxycillin in the form Capsule 500 mg (as trihydrate)

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

Amoxycillin Sandoz

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”:

Clavulin Duo

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”:

Clavulin Duo Forte

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”:

Clavulin

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”:

Clavulin Duo 400

Part 1 of Schedule 1, item dealing with Bupropion

omit from the column headed “Brand”:

Bupropion-RL

Part 1 of Schedule 1, item dealing with Captopril in the forms Tablet 12.5 mg, Tablet 25 mg and Tablet 50 mg

omit from the column headed “Brand”:

Chem mart Captopril

Terry White Chemists Captopril

Part 1 of Schedule 1, item dealing with Carboplatin in the form Solution for I.V. injection 450 mg in 45 mL

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

Baxter Carboplatin

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

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

APO-Clarithromycin

Part 1 of Schedule 1, item dealing with Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg

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

APO-Fosinopril HCTZ 10/12.5

Part 1 of Schedule 1, item dealing with Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg

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

APO-Fosinopril HCTZ 20/12.5

Fosetic 20/12.5

Part 1 of Schedule 1, after item dealing with Glucose Indicator—Blood in the form Electrode strips, 50

(Advantage II)

insert in the columns in the order indicated:

Electrode strips, 50 (FreeStyle)

For external use

FreeStyle

Part 1 of Schedule 1, after item dealing with Hypromellose with Dextran

insert in the columns in the order indicated:

Ibandronic acid

Tablet 50 mg (as ibandronate sodium monohydrate)

Oral

Bondronat

Part 1 of Schedule 1, item dealing with Ipratropium in 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

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

APO- Ipratropium

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

Chem mart Ipratropium

GenRx Ipratropium

Terry White Chemists Ipratropium

Part 1 of Schedule 1, item dealing with Isotretinoin in the form Capsule 10 mg

omit from the column headed “Brand”:

GenRx Isotretinoin

Part 1 of Schedule 1, item dealing with Lamotrigine in the forms Tablet 5 mg, Tablet 25 mg, Tablet 50 mg, Tablet 100 mg and Tablet 200 mg

omit from the column headed “Brand”:

Elmendos

Lamitrin

Part 1 of Schedule 1, item dealing with Metformin in the form Tablet containing metformin hydrochloride 500 mg (extended release)

(a) omit from the column headed “Form”:

Tablet containing metformin hydrochloride 500 mg (extended release)

and substitute:

Tablet (extended release) containing metformin hydrochloride 500 mg

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

Metex XR

Part 1 of Schedule 1, item dealing with Mirtazapine in the form Tablet 45 mg

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

APO-Mirtazapine

Chem mart Mirtazapine

Terry White Chemists Mirtazapine

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

omit from the column headed “Brand”:

Chem mart Nifedipine

Terry White Chemists Nifedipine

Part 1 of Schedule 1, item dealing with Paclitaxel in the forms Solution concentrate for I.V. infusion 30 mg in 5 mL vial, Solution concentrate for I.V. infusion 100 mg in 16.7 mL vial, Solution concentrate for I.V. infusion 150 mg in 25 mL vial and Solution concentrate for I.V. infusion 300 mg in 50 mL vial

omit from the column headed “Form”:

vial

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 and Solution concentrate for I.V. infusion 300 mg in 50 mL

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

Baxter Paclitaxel

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

omit from the column headed “Brand”:

Tylenol

Part 1 of Schedule 1, omit item dealing with Piperazine Oestrone

Part 1 of Schedule 1, item dealing with Piroxicam in the form Dispersible tablet 10 mg

omit from the column headed “Brand”:

GenRx Piroxicam Dispersible

Part 1 of Schedule 1, item dealing with Piroxicam in the form Dispersible tablet 20 mg

omit from the column headed “Brand”:

Chem mart Piroxicam Dispersible

GenRx Piroxicam Dispersible

Terry White Chemists Piroxicam Dispersible

Part 1 of Schedule 1, after item dealing with Polyvinyl Alcohol

insert in the columns in the order indicated:

Posaconazole

Oral suspension 40 mg per mL, 105 mL

Oral

Noxafil

Part 1 of Schedule 1, item dealing with Pravastatin in the form Tablet containing pravastatin sodium 80 mg

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

APO-Pravastatin

Chem mart Pravastatin

Terry White Chemists Pravastatin

Part 1 of Schedule 1, item dealing with Salbutamol in the forms Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 and Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30

omit from the column headed “Brand”:

Chem mart Salbutamol

Terry White Chemists Salbutamol

Part 1 of Schedule 1, item dealing with Sumatriptan in the form Tablet 50 mg (as succinate)

omit from the column headed “Brand”:

Suvalan 50

Part 1 of Schedule 1, item dealing with Tamoxifen in the form Tablet 10 mg (as citrate)

omit from the column headed “Brand”:

Nolvadex

Part 1 of Schedule 1, after item dealing with Temozolomide in the form Capsule 100 mg

insert in the columns in the order indicated:

Capsule 140 mg

Oral

Temodal

Part 1 of Schedule 1, item dealing with Trimethoprim with Sulfamethoxazole in the form Tablet 160 mg-800 mg

omit from the column headed “Brand”:

Chem mart Trimethoprim with Sulfamethoxazole DS

GenRx Trimethoprim with Sulfamethoxazole DS

Terry White Chemists Trimethoprim with Sulfamethoxazole DS

Part 2 of Schedule 1, item dealing with Bupropion

omit from the column headed “Brand”:

Bupropion-RL

Part 2 of Schedule 1, after item dealing with Colestipol

insert in the columns in the order indicated:

Copper sulfate

Tablets, diagnostic compound, 36

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

Clinitest

Part 2 of Schedule 1, after item dealing with Gemfibrozil

insert in the columns in the order indicated:

Glucose and Ketone Indicator—Urine	Reagent strips, 50 (Keto-Diabur-Test 5000)	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	4	Keto-Diabur-Test 5000
Reagent strips, 50 (Keto-Diastix)	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	4	Keto-Diastix
Glucose Indicator—Blood	Electrode strips, 25 (On-Call Plus)	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	4	11	On-Call Plus
Electrode strips, 50 (Accu-Chek Performa)	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 Performa
Electrode strips, 50 (Advantage II)	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	Advantage II
Electrode strips, 50 (FreeStyle)	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	FreeStyle
Electrode strips, 50 (Freestyle Papillon)	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	Freestyle Papillon
Electrode strips, 50 (Glucoboy)	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	Glucoboy
Electrode strips, 50 (Glucocard 01 Sensor)	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	Glucocard 01 Sensor
Electrode strips, 50 (GlucoCare Super Sensor)	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	GlucoCare Super Sensor
Electrode strips, 50 (GlucoOz)	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	GlucoOz
Electrode strips, 50 (MWD Pen Sensor Strips)	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	MWD Pen Sensor Strips
Electrode strips, 50 (Omnitest EZ)	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	Omnitest EZ
Electrode strips, 50 (Omnitest Plus)	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	Omnitest Plus
Electrode strips, 50 (Optium Omega)	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	Optium Omega
Electrode strips, 50 (TrueTrack)	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	TrueTrack
Electrode strips, 100 (FreeStyle Lite)	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	FreeStyle Lite
Electrode strips, 100 (Optium glucose)	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	Optium glucose
Electrode 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
Electrode strips, 100 (TrueSense)	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	TrueSense
Reagent 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
Reagent strips, 50 (Accu-Chek Go)	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 Go
Reagent strips, 51 (Accu-Chek Integra)	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 Integra
Reagent strips, 50 (Betachek)	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	Betachek
Reagent strips, 50 (Betachek G5)	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	Betachek G5
Reagent strips, 50 (CareSens)	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
Reagent strips, 50 (Glucoflex-R)	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	Glucoflex-R
Reagent strips, 50 (Glucostix)	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	Glucostix
Reagent strips, 50 (SensoCard)	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	SensoCard
Glucose Indicator—Urine	Reagent strips, 50 (Clinistix)	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	4	Clinistix
Reagent strips, 50 (Diastix)	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	4	Diastix

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

omit from the column headed “Brand”:

Tylenol

Part 2 of Schedule 1, item dealing with Pravastatin in the form Tablet containing pravastatin sodium 80 mg

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

APO-Pravastatin

Chem mart Pravastatin

Terry White Chemists Pravastatin

Part 2 of Schedule 1, after item dealing with Temozolomide in the form Capsule 100 mg

insert in the columns in the order indicated:

Capsule 140 mg

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

Recurrence of anaplastic astrocytoma following standard therapy

Oral

Temodal

Recurrence of glioblastoma multiforme following standard therapy

Glioblastoma multiforme following radiotherapy

Part 1 of Schedule 3, item dealing with Amoxycillin in the form Capsule 500 mg (as trihydrate)

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

Amoxycillin Sandoz

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”:

Clavulin Duo

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”:

Clavulin Duo Forte

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”:

Clavulin

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”:

Clavulin Duo 400

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

omit from the column headed “Brand”:

Tylenol

Part 1 of Schedule 3, item dealing with Piroxicam in the form Dispersible tablet 10 mg

omit from the column headed “Brand”:

GenRx Piroxicam Dispersible

Part 1 of Schedule 3, item dealing with Piroxicam in the form Dispersible tablet 20 mg

omit from the column headed “Brand”:

Chem mart Piroxicam Dispersible

GenRx Piroxicam Dispersible

Terry White Chemists Piroxicam Dispersible

Part 1 of Schedule 3, item dealing with Trimethoprim with Sulfamethoxazole in the form Tablet 160 mg-800 mg

omit from the column headed “Brand”:

Chem mart Trimethoprim with Sulfamethoxazole DS

GenRx Trimethoprim with Sulfamethoxazole DS

Terry White Chemists Trimethoprim with Sulfamethoxazole DS

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

omit from the column headed “Brand”:

Tylenol