National Health Act 1953 Amendment determinations under sections 85, 85A and 88 pharmaceutical benefits (No. PB 107 of 2009) (Cth)

Case

COMMONWEALTH OF AUSTRALIA

Instrument number PB 107 of 2009

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

I, LINDA JACKSON, 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 12 November 2009

LINDA JACKSON

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination — pharmaceutical benefits

1              Commencement

This instrument commences on 1 December 2009.

2              Amendment of PB 114 of 2008

Schedule 1 amends PB 114 of 2008.

Schedule 1            Amendments

  1. Part 1 of Schedule 1, after item dealing with Amino acid formula with vitamins and minerals without valine, leucine and isoleucine

insert in the columns in the order indicated:

Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexanoic acid Oral liquid 125 mL, 36 (MSUD Anamix Junior LQ) Oral 4 5 MSUD Anamix Junior LQ

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

insert in the columns in the order indicated:

Artemether with lumefantrine Tablet 20 mg-120 mg Oral 24 .. Riamet

  1. Part 1 of Schedule 1, item dealing with Cabergoline in the form Tablet 500 micrograms

omit from the column headed “Brand”: Tinexa

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

omit from the columns in the order indicated:

Ointment 50 micrograms per g, 30 g Application 1 1 Daivonex

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

insert in the columns in the order indicated:

Calcipotriol with betamethasone Ointment containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g Application 1 1 Daivobet

  1. Part 1 of Schedule 1, after item dealing with Calcium in the form Tablet, chewable, 500 mg (as carbonate)

insert in the columns in the order indicated:

Tablet 600 mg (as carbonate) Oral 240 1 Calci-Tab 600

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

omit from the column headed “Brand”: Tagamet

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

insert in the columns in the order indicated:

Clopidogrel with aspirin Tablet 75 mg (as hydrogen sulfate)-100 mg Oral 30 5

CoPlavix

DuoCover

  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: APO-Diclofenac

  1. Part 1 of Schedule 1, item dealing with Fluconazole in the forms Capsule 100 mg and Capsule 200 mg

omit from the column headed “Brand”: Fluconazole Hexal 

and substitute:  Fluconazole Sandoz

  1. Part 1 of Schedule 1, item dealing with Glucose in the form I.V. infusion 69.5 mmol (anhydrous) per 250 mL, 250 mL

in the column headed “Brand” insert in alphabetical order: Glucose 5% Freeflex

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

insert in the columns in the order indicated:

Reagent strips, 50 (Lifeline Attest) For external use 2 5 Lifeline Attest

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

insert in the columns in the order indicated:

Hydroxyethyl starch 130/0.4 I.V. infusion 30 g per 500 mL, 500 mL Injection 3 .. Voluven 6%

  1. Part 1 of Schedule 1, item dealing with Irinotecan in the forms I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL and I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL

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

  1. Part 1 of Schedule 1, after item dealing with Olanzapine in the form Wafer 10 mg

insert in the columns in the order indicated:

Powder for injection 210 mg (as pamoate monohydrate) with diluent Injection 2 5 Zyprexa Relprevv
Powder for injection 300 mg (as pamoate monohydrate) with diluent Injection 2 5 Zyprexa Relprevv

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

omit from the columns in the order indicated:

Tablet 12 mg (prolonged release) Oral 28 5 Invega

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

omit from the column headed “Brand”: Chem mart Chemadol  

and substitute: Chem mart Paracetamol

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

omit from the column headed “Brand”: Paroxetine Winthrop

  1. Part 1 of Schedule 1, after item dealing with Pneumococcal Vaccine - Polyvalent

insert in the columns in the order indicated:

Polyethylene glycol 400 Eye drops 2.5 mg per mL, 15 mL Application to the eye 1 5 Blink Intensive Tears
Eye drops 2.5 mg per mL, single dose units 0.4 mL, 20 Application to the eye 5 5 Blink Intensive Tears

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

insert in the columns in the order indicated:

Prasugrel Tablet 5 mg (as hydrochloride) Oral 28 5 Effient
Tablet 10 mg (as hydrochloride) Oral 28 5 Effient

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

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

  1. Part 1 of Schedule 1, item dealing with Quinine in the form Tablet containing quinine sulfate 300 mg

omit from the column headed “Brand”: Quinsul

  1. Part 1 of Schedule 1, item dealing with Sertraline in the form Tablet 100 mg (as hydrochloride)

omit from the column headed “Brand”: Sertraline Winthrop

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

in the column headed “Brand” insert in alphabetical order: Simvastatin-GA 20

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

in the column headed “Brand” insert in alphabetical order:  Simvastatin-GA 40

  1. Part 1 of Schedule 1, item dealing with Simvastatin in the form Tablet 80 mg

in the column headed “Brand” insert in alphabetical order: Simvastatin-GA 80

  1. Part 1 of Schedule 1, item dealing with Sodium Chloride in the form I.V. infusion 38.5 mmol per 250 mL, 250 mL

in the column headed “Brand” insert in alphabetical order: Sodium Chloride 0.9% Freeflex

  1. Part 1 of Schedule 1, omit item dealing with Tamarindus indica seed polysaccharide

  1. Part 1 of Schedule 1, item dealing with Topiramate in the form Tablet 25 mg

in the column headed “Brand” insert in alphabetical order: Epiramax 25

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

in the column headed “Brand” insert in alphabetical order: Epiramax 50

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

in the column headed “Brand” insert in alphabetical order: Epiramax 100

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

in the column headed “Brand” insert in alphabetical order: Epiramax 200

  1. Part 1 of Schedule 1, item dealing with Tramadol in the form Injection containing tramadol hydrochloride 100 mg in 2 mL

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

  1. Part 1 of Schedule 1, item dealing with Valproic Acid in the form Tablet (enteric coated) containing sodium valproate 200 mg

in the column headed “Brand” insert in alphabetical order: Valprease 200

  1. Part 1 of Schedule 1, item dealing with Valproic Acid in the form Tablet (enteric coated) containing sodium valproate 500 mg

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

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

omit from the column headed “Brand”: Tinexa

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

insert in the columns in the order indicated:

Reagent strips, 50 (Lifeline Attest) 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 Lifeline Attest

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

omit from the column headed “Brand”: Chem mart Chemadol 

and substitute: Chem mart Paracetamol

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

insert in the columns in the order indicated:

Polyethylene glycol 400 Eye drops 2.5 mg per mL, 15 mL For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, 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 Application to the eye 1 11 Blink Intensive Tears

  1. Part 2 of Schedule 1, item dealing with Pramipexole in the form Tablet containing pramipexole hydrochloride 250 micrograms

omit from the column headed “Purposes”:

Parkinson's disease as adjunctive therapy in patients being treated with levodopa—decarboxylase inhibitor combinations

and substitute:

Parkinson disease

  1. Part 2 of Schedule 1, item dealing with Simvastatin in the form Tablet 20 mg

in the column headed “Brand” insert in alphabetical order: Simvastatin-GA 20

  1. Part 2 of Schedule 1, item dealing with Simvastatin in the form Tablet 40 mg

in the column headed “Brand” insert in alphabetical order: Simvastatin-GA 40

  1. Part 2 of Schedule 1, item dealing with Simvastatin in the form Tablet 80 mg

in the column headed “Brand” insert in alphabetical order: Simvastatin-GA 80

  1. Part 2 of Schedule 1, after item dealing with Sunitinib in the form Capsule 12.5 mg (as malate)

insert in the columns in the order indicated:

Capsule 12.5 mg (as malate)

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

Initial PBS-subsidised treatment as monotherapy of a patient with World Health Organisation performance status of 2 or less with a metastatic or unresectable malignant gastrointestinal stromal tumour after failure of imatinib mesylate treatment due to resistance or intolerance, and where the application for authorisation includes:

 Oral 28 1 Sutent
 (1)  a completed copy of the appropriate Sunitinib Malate (Sutent) PBS Authority Application for Use in the Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form; and
 (2)  a signed patient acknowledgement

In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):

 Continuing PBS-subsidised treatment as monotherapy of a patient with World Health Organisation performance status of 2 or less with a metastatic or unresectable malignant gastrointestinal stromal tumour who has previously been issued with an authority prescription for sunitinib and who does not have progressive disease on sunitinib

  1. Part 2 of Schedule 1, after item dealing with Sunitinib in the form Capsule 25 mg (as malate)

insert in the columns in the order indicated:

Capsule 25 mg (as malate)

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

Initial PBS-subsidised treatment as monotherapy of a patient with World Health Organisation performance status of 2 or less with a metastatic or unresectable malignant gastrointestinal stromal tumour after failure of imatinib mesylate treatment due to resistance or intolerance, and where the application for authorisation includes:

 Oral 28 1 Sutent
 (1)  a completed copy of the appropriate Sunitinib Malate (Sutent) PBS Authority Application for Use in the Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form; and
 (2)  a signed patient acknowledgement

In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):

 Continuing PBS-subsidised treatment as monotherapy of a patient with World Health Organisation performance status of 2 or less with a metastatic or unresectable malignant gastrointestinal stromal tumour who has previously been issued with an authority prescription for sunitinib and who does not have progressive disease on sunitinib

  1. Part 2 of Schedule 1, after item dealing with Sunitinib in the form Capsule 50 mg (as malate)

insert in the columns in the order indicated:

Capsule 50 mg (as malate)

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

Initial PBS-subsidised treatment as monotherapy of a patient with World Health Organisation performance status of 2 or less with a metastatic or unresectable malignant gastrointestinal stromal tumour after failure of imatinib mesylate treatment due to resistance or intolerance, and where the application for authorisation includes:

 Oral 28 1 Sutent
 (1)  a completed copy of the appropriate Sunitinib Malate (Sutent) PBS Authority Application for Use in the Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form; and
 (2)  a signed patient acknowledgement

In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):

 Continuing PBS-subsidised treatment as monotherapy of a patient with World Health Organisation performance status of 2 or less with a metastatic or unresectable malignant gastrointestinal stromal tumour who has previously been issued with an authority prescription for sunitinib and who does not have progressive disease on sunitinib

  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: APO-Diclofenac

  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: APO-Diclofenac

  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: APO-Diclofenac

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

omit from the column headed “Brand”: Chem mart Chemadol

and substitute:                Chem mart Paracetamol

  1. Part 1 of Schedule 3, item dealing with Tramadol in the form Injection containing tramadol hydrochloride 100 mg in 2 mL

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

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

omit from the column headed “Brand”: Chem mart Chemadol

and substitute:                Chem mart Paracetamol

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