National Health Act 1953 Amendment determinations under sections 85, 85A and 88 pharmaceutical benefits (No. PB 21 of 2009) (Cth)

Case

COMMONWEALTH OF AUSTRALIA

Instrument number PB 21 of 2009

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 March   2009

DIANA MACDONELL

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination — pharmaceutical benefits

1              Commencement

This instrument commences on 1 April 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 Aluminium Hydroxide with Magnesium Hydroxide

omit from the columns in the order indicated:

Tablet 200 mg-200 mg Oral 200 5 Mylanta P

  1. Part 1 of Schedule 1, omit item dealing with Amino acid formula without phenylalanine, and vitamins with minerals

  1. Part 1 of Schedule 1, item dealing with Amino acid formula with vitamins and minerals without phenylalanine

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

Sachets containing oral powder 18.2 g, 60 (add-ins) Oral 3 5 add-ins

  1. Part 1 of Schedule 1, after item dealing with Amino acid formula with vitamins and minerals without phenylalanine in the form Oral liquid 250 mL (Easiphen)

insert in the columns in the order indicated:

Oral liquid 62.5 mL, 60 (Lophlex LQ 10) Oral 2 5 Lophlex LQ 10

  1. Part 1 of Schedule 1, after item dealing with Amino acid formula with vitamins and minerals without phenylalanine in the form Oral liquid 125 mL, 30 (Lophlex LQ)

insert in the columns in the order indicated:

Oral liquid 125 mL, 36 (PKU Anamix Junior LQ) Oral 4 5 PKU Anamix Junior LQ

  1. Part 1 of Schedule 1, after item dealing with Amino acid formula with vitamins and minerals without phenylalanine and tyrosine in the form Sachets containing oral powder 25 g, 30 (TYR Express)

insert in the columns in the order indicated:

Sachets containing oral powder 29 g, 30 (TYR Anamix Junior) Oral 4 5 TYR Anamix Junior

  1. Part 1 of Schedule 1, after item dealing with Carbohydrate, fat, vitamins, minerals and trace elements

insert in the columns in the order indicated:

Carbomer Eye gel 2 mg per g, 10 g Application to the eye 1 5

GelTears

PAA

Viscotears
Eye gel 2 mg per g, single dose units 0.6 mL, 30 Application to the eye 3 5 Viscotears

  1. Part 1 of Schedule 1, omit item dealing with Carbomer 980

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

omit from the column headed “Brand”:

APO-Clarithromycin

  1. Part 1 of Schedule 1, after item dealing with Desmopressin in the form Tablet containing desmopressin acetate


    200 micrograms

insert in the columns in the order indicated:

Wafer 120 micrograms (as acetate) Sublingual 30 5 Minirin Melt

  1. Part 1 of Schedule 1, item dealing with Enalapril in the forms Tablet containing enalapril maleate 5 mg,


    Tablet containing enalapril maleate 10 mg and Tablet containing enalapril maleate 20 mg

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

Enalapril generichealth

  1. Part 1 of Schedule 1, item dealing with Enoxaparin in the forms Injection containing enoxaparin sodium 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre-filled syringe, Injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in 0.4 mL pre-filled syringe and Solution for injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in


    0.4 mL

(a) omit from the column headed “Maximum quantity”:

10

and substitute:

20

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

1

and substitute:

. .

  1. Part 1 of Schedule 1, item dealing with Fluvoxamine in the forms Tablet containing fluvoxamine maleate 50 mg and Tablet containing fluvoxamine maleate 100 mg

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

APO-Fluvoxamine

  1. Part 1 of Schedule 1, after item dealing with Gemcitabine in the form Powder for I.V. infusion 200 mg


    (as hydrochloride)

insert in the columns in the order indicated:

Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL Injection 4 2 Gemcitabine Ebewe

  1. Part 1 of Schedule 1, after item dealing with Gemcitabine in the form Powder for I.V. infusion 1 g


    (as hydrochloride)

insert in the columns in the order indicated:

Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL Injection 2 2 Gemcitabine Ebewe

  1. Part 1 of Schedule 1, item dealing with Gliclazide in the form Tablet 30 mg (modified release)

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

Glyade MR

  1. Part 1 of Schedule 1, item dealing with Interferon Beta-1b

omit from the column headed “Form”:

comprising

and substitute:

including

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

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

APO-Lisinopril

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

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

Diaformin XR

  1. Part 1 of Schedule 1, item dealing with Metformin in the form Tablet containing metformin hydrochloride 1 g

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

Metformin-GA

  1. Part 1 of Schedule 1, item dealing with Methylphenidate in the form Tablet containing methylphenidate hydrochloride 10 mg

omit from the column headed “Brand”:

Attenta

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

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

APO-Omeprazole

  1. Part 1 of Schedule 1, after item dealing with Oxycodone in the form Tablet containing oxycodone hydrochloride


    10 mg (controlled release)

insert in the columns in the order indicated:

Tablet containing oxycodone hydrochloride 15 mg (controlled release) Oral 20 . . OxyContin

  1. Part 1 of Schedule 1, after item dealing with Oxycodone in the form Tablet containing oxycodone hydrochloride


    20 mg (controlled release)

insert in the columns in the order indicated:

Tablet containing oxycodone hydrochloride 30 mg (controlled release) Oral 20 . . OxyContin

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


    250 micrograms

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

5

and substitute:

2

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

omit from the column headed “Form”:

3 mg in 0.3 mL

and substitute:

2.3 mg in 0.23 mL

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

insert in the columns in the order indicated:

Zonisamide

Capsule 25 mg

Capsule 50 mg

Capsule 100 mg

Oral

Oral

Oral

56

56

112

5

5

5

Zonegran

Zonegran

Zonegran

  1. Part 2 of Schedule 1, item dealing with Adalimumab in the forms Injection 40 mg in 0.8 mL pre-filled syringe (Maximum Quantity 2, Maximum Number of Repeats 3) and Injection 40 mg in 0.8 mL pre-filled pen (Maximum Quantity 2, Maximum Number of Repeats 3)

(a) omit paragraph (4) from the column headed “Purposes” under the heading “Psoriatic arthritis” (first occurring)

(b) re-number next paragraph (5) as (4)

  1. Part 2 of Schedule 1, omit item dealing with Carbomer 980 and substitute

Carbomer Eye gel 2 mg per g,
10 g 		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

GelTears

PAA

Viscotears

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

  1. Part 2 of Schedule 1, item dealing with Etanercept in the forms Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL (Maximum Quantity 2, Maximum Number of Repeats 3), Injection set containing 4 vials powder for injection 50 mg (Maximum Quantity 1, Maximum Number of Repeats 3) and


    4 pre-filled syringes solvent 1 mL and Injections 50 mg in 1 mL single use pre-filled syringes, 4 (Maximum Quantity 1, Maximum Number of Repeats 3)

(a) omit paragraph (4) from the column headed “Purposes” under the heading “Psoriatic arthritis” (first occurring)

(b) re-number next paragraph (5) as (4)

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

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

APO-Omeprazole

  1. Part 2 of Schedule 1, after item dealing with Oxycodone in the form Tablet containing oxycodone hydrochloride


    10 mg (controlled release)

insert in the columns in the order indicated:

Tablet containing oxycodone hydrochloride 15 mg (controlled release)

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

Chronic severe disabling pain associated with proven malignant neoplasia

 Oral 40 .. OxyContin
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics

  1. Part 2 of Schedule 1, after item dealing with Oxycodone in the form Tablet containing oxycodone hydrochloride


    20 mg (controlled release)

insert in the columns in the order indicated:

Tablet containing oxycodone hydrochloride 30 mg (controlled release)

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

Chronic severe disabling pain associated with proven malignant neoplasia

 Oral 40 .. OxyContin
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics

  1. Part 2 of Schedule 1, after item dealing with Polyvinyl Alcohol

insert in the columns in the order indicated:

Pramipexole Tablet containing pramipexole hydrochloride 125 micrograms Treatment of severe primary restless legs syndrome in a patient who manifests all 4 diagnostic criteria listed below and whose baseline International Restless Legs Syndrome Rating Scale (IRLSRS) score is greater than or equal to 21 points prior to initiation of pramipexole, where the date and IRLSRS score are documented in the patient's medical records at the time pramipexole treatment is initiated, and where the diagnostic criteria for restless legs syndrome are: Oral 30 2 Sifrol
 (a) an urge to move the legs usually accompanied or caused by unpleasant sensations in the legs; and
 (b) the urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting; and
 (c) the urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues; and
 (d) the urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur during the evening or night
Tablet containing pramipexole hydrochloride 250 micrograms Parkinson's disease as adjunctive therapy in patients being treated with levodopa—decarboxylase inhibitor combinations Oral 100 5 Sifrol

  1. Part 1 of Schedule 3, after item dealing with Oxycodone in the form Tablet containing oxycodone hydrochloride


    10 mg (controlled release)

insert in the columns in the order indicated:

Tablet containing oxycodone hydrochloride 15 mg (controlled release) Oral 20 . . OxyContin

  1. Part 1 of Schedule 3, after item dealing with Oxycodone in the form Tablet containing oxycodone hydrochloride


    20 mg (controlled release)

insert in the columns in the order indicated:

Tablet containing oxycodone hydrochloride 30 mg (controlled release) Oral 20 . . OxyContin
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