National Health Act 1953 Amendment determinations under sections 85, 85A and 88 pharmaceutical benefits (No. PB 48 of 2009) (Cth)

Case

COMMONWEALTH OF AUSTRALIA

Instrument number PB 48 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 4 June 2009

LINDA JACKSON

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination — pharmaceutical benefits

1              Commencement

This instrument commences on 1 July 2009.

2              Amendment of PB 114 of 2008

Schedule 1 amends PB 114 of 2008.

Schedule 1        Amendments

  1. Part 1 of Schedule 1, item dealing with Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol

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

Dronalen Plus

  1. Part 1 of Schedule 1, item dealing with Amino acid formula with vitamins and minerals without lysine and low in tryptophan

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

Sachets containing oral powder 20 g, 30 (GA gel) Oral 4 5 GA gel

  1. Part 1 of Schedule 1, item dealing with Amoxycillin in the forms Capsule 500 mg (as trihydrate) and Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

omit from the column headed “Brand”:

Amohexal

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

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

insert in the columns in the order indicated:

Arginine with carbohydrate Sachets of oral powder 4 g containing 500 mg arginine, 30 (Arginine Amino Acid Supplement) Oral 4 5 Arginine Amino Acid Supplement

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

insert in the columns in the order indicated:

Atovaquone with proguanil Tablet containing atovaquone 250 mg with proguanil hydrochloride 100 mg Oral 12 . . Malarone

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

insert in the columns in the order indicated:

Bevacizumab Solution for I.V. infusion 100 mg in 4 mL Injection 1 . . Avastin
Solution for I.V. infusion 400 mg in 16 mL Injection 1 . . Avastin

  1. Part 1 of Schedule 1, item dealing with Enalapril in the form Tablet containing enalapril maleate 10 mg

omit from the column headed “Brand”:

Amprace 10

  1. Part 1 of Schedule 1, item dealing with Enalapril in the form Tablet containing enalapril maleate 20 mg

omit from the column headed “Brand”:

Amprace 20

  1. Part 1 of Schedule 1, item dealing with Escitalopram in the forms Tablet 10 mg (as oxalate) and Tablet 20 mg (as oxalate)

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

APO-Escitalopram

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

Chem mart Escitalopram

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

Terry White Chemists Escitalopram

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

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

Fluoxetine generichealth

  1. Part 1 of Schedule 1, item dealing with Gemcitabine in the forms Powder for I.V. infusion 200 mg (as hydrochloride) and Powder for I.V. infusion 1 g (as hydrochloride)

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

Gemcite

  1. Part 1 of Schedule 1, item dealing with Insulin Lispro in the form Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5

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

Humalog Pen

  1. Part 1 of Schedule 1, item dealing with Insulin Lispro with Insulin Lispro Protamine Suspension in the form Injections (human analogue), cartridges, 25 units-75 units per mL, 3 mL, 5

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

Humalog Mix25 Pen

  1. Part 1 of Schedule 1, item dealing with Insulin Lispro with Insulin Lispro Protamine Suspension in the form Injections (human analogue), cartridges, 50 units-50 units per mL, 3 mL, 5

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

Humalog Mix50 Pen

  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 Actavis

  1. Part 1 of Schedule 1, after item dealing with Isoleucine with carbohydrate in the form Sachets of oral powder 4 g containing 50 mg isoleucine, 30 (Isoleucine Amino Acid Supplement)

insert in the columns in the order indicated:

Sachets of oral powder 4 g containing 1g isoleucine, 30 (Isoleucine 1000 Amino Acid Supplement) Oral 4 5 Isoleucine 1000 Amino Acid Supplement

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

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

Lisinopril-GA

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

insert in the columns in the order indicated:

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

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

insert in the columns in the order indicated:

Mupirocin Nasal ointment 20 mg (as calcium) per g, 3 g Nasal 1 . . Bactroban

  1. Part 1 of Schedule 1, item dealing with Nifedipine in the form Tablet 10 mg

omit from the column headed “Brand”:

Nypine 10

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

omit from the column headed “Brand”:

Nypine 20

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

omit from the columns in the order indicated:

Pack containing 12 tablets oestradiol 2 mg, 10 tablets oestradiol 2 mg with norethisterone acetate 1 mg and 6 tablets oestradiol 1 mg Oral 1 5 Trisequens

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

omit from the columns in the order indicated:

Tablets containing 1 mg oestradiol (as hemihydrate) with 500 micrograms norethisterone acetate, 28 Oral 1 5 Kliovance
Tablets containing 2 mg oestradiol (as hemihydrate) with
1 mg norethisterone acetate, 28 		Oral 1 5 Kliogest

  1. Part 1 of Schedule 1, item dealing with Ondansetron in the form Syrup 4 mg (as hydrochloride dihydrate)


    per 5 mL, 50 mL

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

1

and substitute:

. .

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

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

Oxaliplatin Actavis

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

Winthrop Oxaliplatin

  1. Part 1 of Schedule 1, item dealing with Oxaliplatin in the form Powder for I.V. infusion 100 mg

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

Oxaliplatin Actavis

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

omit from the column headed “Brand”:

Parahexal

  1. Part 1 of Schedule 1, item dealing with Perindopril in the forms Tablet containing perindopril erbumine 2 mg, Tablet containing perindopril erbumine 4 mg and Tablet containing perindopril erbumine 8 mg

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

Ozapace

  1. Part 1 of Schedule 1, after item dealing with Risedronic Acid in the form Tablet containing risedronate sodium


    35 mg

insert in the columns in the order indicated:

Tablet containing risedronate sodium 150 mg

Oral

1

5

Actonel Once-a-Month

  1. Part 1 of Schedule 1, item dealing with Risperidone in the forms Tablet 0.5 mg, Tablet 1 mg, Tablet 2 mg,


    Tablet 3 mg and Tablet 4 mg

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

Ozidal

  1. Part 1 of Schedule 1, item dealing with Tramadol in the forms Tablet (sustained release) containing tramadol hydrochloride 100 mg, Tablet (sustained release) containing tramadol hydrochloride 150 mg and Tablet (sustained release) containing tramadol hydrochloride 200 mg

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

APO-Tramadol SR

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

Chem mart Tramadol SR

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

Terry White Chemists Tramadol SR

  1. Part 1 of Schedule 1, item dealing with Trandolapril in the forms Capsule 500 micrograms, Capsule 1 mg,


    Capsule 2 mg and Capsule 4 mg

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

Trandolapril generichealth

  1. Part 1 of Schedule 1, after item dealing with Valine with carbohydrate in the form Sachets of oral powder 4 g containing 50 mg valine, 30 (Valine Amino Acid Supplement)

insert in the columns in the order indicated:

Sachets of oral powder 4 g containing 1 g valine, 30 (Valine 1000 Amino Acid Supplement) Oral 4 5 Valine 1000 Amino Acid Supplement

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

insert in the columns in the order indicated:

Escitalopram Tablet 10 mg (as oxalate) Moderate to severe generalised anxiety disorder (GAD), as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and for whom a GP Mental Health Care Plan, as described under item 2710 of the Medicare Benefits Schedule, has been prepared Oral 28 5

Esipram

Esitalo

Lexapro
Moderate to severe generalised anxiety disorder (GAD), as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and who has been assessed by a psychiatrist
Continuing PBS-subsidised treatment, for moderate to severe generalised anxiety disorder (GAD), of a patient commenced on escitalopram prior to 1 March 2008
Moderate to severe social anxiety disorder (social phobia, SAD), as described by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and for whom a GP Mental Health Care Plan, as described under item 2710 of the Medicare Benefits Schedule, has been prepared
Moderate to severe social anxiety disorder (social phobia, SAD), as described by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and who has been assessed by a psychiatrist
Continuing PBS-subsidised treatment, for moderate to severe social anxiety disorder (social phobia, SAD), of a patient commenced on escitalopram prior to 1 March 2008
Tablet 20 mg (as oxalate) Moderate to severe generalised anxiety disorder (GAD), as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and for whom a GP Mental Health Care Plan, as described under item 2710 of the Medicare Benefits Schedule, has been prepared Oral 28 5

Esipram

Esitalo

Lexapro
Moderate to severe generalised anxiety disorder (GAD), as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and who has been assessed by a psychiatrist
Continuing PBS-subsidised treatment, for moderate to severe generalised anxiety disorder (GAD), of a patient commenced on escitalopram prior to 1 March 2008
Moderate to severe social anxiety disorder (social phobia, SAD), as described by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and for whom a GP Mental Health Care Plan, as described under item 2710 of the Medicare Benefits Schedule, has been prepared
Moderate to severe social anxiety disorder (social phobia, SAD), as described by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and who has been assessed by a psychiatrist
Continuing PBS-subsidised treatment, for moderate to severe social anxiety disorder (social phobia, SAD), of a patient commenced on escitalopram prior to 1 March 2008

  1. Part 2 of Schedule 1, item dealing with Imatinib, in the third instance of the form Tablet 100 mg (as mesylate) and in the third instance of the form Tablet 400 mg (as mesylate)

omit from the column headed “Purposes”:

Acute lymphoblastic leukaemia

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

 Continuing treatment in combination with chemotherapy as maintenance of first complete remission of patients with acute lymphoblastic leukaemia (ALL) bearing the Philadelphia chromosome or expressing the transcript, BCR-ABL;
 where PBS-subsidised imatinib mesylate is available with a lifetime maximum of 24 months of therapy for patients with acute lymphoblastic leukaemia

and insert:

Acute lymphoblastic leukaemia

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

 Continuing treatment in combination with chemotherapy as maintenance of first complete remission of patients with acute lymphoblastic leukaemia (ALL) bearing the Philadelphia chromosome or expressing the transcript, BCR-ABL;
 imatinib mesylate is available with a lifetime maximum of 24 months for continuing treatment with imatinib mesylate therapy for patients with acute lymphoblastic leukaemia reimbursed through the PBS

  1. Part 2 of Schedule 1, after item dealing with Ondansetron in the form Wafer 8 mg

insert in the columns in the order indicated:

Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL

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

Management of nausea and vomiting associated with radiotherapy being used to treat malignancy

 Oral 1 1 Zofran syrup
50 mL

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

omit from the column headed “Brand”:

Parahexal

  1. Part 2 of Schedule 1, item dealing with Risperidone in the forms Tablet 0.5 mg, Tablet 1 mg and Tablet 2 mg

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

Ozidal

  1. Part 2 of Schedule 1, item dealing with Tramadol in the forms Tablet (sustained release) containing tramadol hydrochloride 100 mg, Tablet (sustained release) containing tramadol hydrochloride 150 mg and Tablet (sustained release) containing tramadol hydrochloride 200 mg

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

APO-Tramadol SR

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

Chem mart Tramadol SR

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

Terry White Chemists Tramadol SR

  1. Part 1 of Schedule 3, item dealing with Amoxycillin in the forms Capsule 500 mg (as trihydrate) and Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

omit from the column headed “Brand”:

Amohexal

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

omit from the column headed “Brand”:

Parahexal

  1. Part 1 of Schedule 3, item dealing with Tramadol in the forms Tablet (sustained release) containing tramadol hydrochloride 100 mg, Tablet (sustained release) containing tramadol hydrochloride 150 mg and Tablet (sustained release) containing tramadol hydrochloride 200 mg

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

APO-Tramadol SR

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

Chem mart Tramadol SR

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

Terry White Chemists Tramadol SR

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

omit from the column headed “Brand”:

Parahexal

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