National Health Act 1953 Amendment determinations under sections 85, 85A and 88 pharmaceutical benefits (No. PB 32 of 2009) (Cth)

Case

COMMONWEALTH OF AUSTRALIA

Instrument number PB 32 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 2nd April 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 May 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 Amoxycillin in the forms Capsule 250 mg (as trihydrate) and


    Capsule 500 mg (as trihydrate)

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

Amoxycillin Ranbaxy

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

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

Powder for I.V. infusion containing etoposide phosphate 113.6 mg

and substitute:

Powder for I.V. infusion 100 mg (as phosphate)

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

Powder for I.V. infusion containing etoposide phosphate 1.136 g

and substitute:

Powder for I.V. infusion 1 g (as phosphate)

  1. Part 1 of Schedule 1, item dealing with Fluconazole in the form Capsule 200 mg

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

APO-Fluconazole

  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:

DBL Gemcitabine for Injection

  1. Part 1 of Schedule 1, after item dealing with Gemcitabine in the form Solution concentrate for I.V. infusion 1000 mg


    (as hydrochloride) in 100 mL

insert in the columns in the order indicated:

Powder for I.V. infusion 2 g (as hydrochloride) Injection 1 2 DBL Gemcitabine for Injection

  1. Part 1 of Schedule 1, after item dealing with Hydromorphone in the form Tablet containing hydromorphone hydrochloride 8 mg

insert in the columns in the order indicated:

Tablet (modified release) containing hydromorphone hydrochloride 8 mg Oral 10 . . Jurnista
Tablet (modified release) containing hydromorphone hydrochloride 16 mg Oral 10 . . Jurnista
Tablet (modified release) containing hydromorphone hydrochloride 32 mg Oral 10 . . Jurnista
Tablet (modified release) containing hydromorphone hydrochloride 64 mg Oral 10 . . Jurnista

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

insert in the columns in the order indicated:

I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL Injection 1 3 Camptosar

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

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

Lamotrust 25

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

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

Lamotrust 50

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

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

Lamotrust 100

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

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

Lamotrust 200

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

insert in the columns in the order indicated:

Lanthanum Tablet, chewable, 500 mg (as carbonate hydrate) Oral 90 5 Fosrenol
Tablet, chewable, 750 mg (as carbonate hydrate) Oral 90 5 Fosrenol
Tablet, chewable, 1000 mg (as carbonate hydrate) Oral 90 5 Fosrenol

  1. Part 1 of Schedule 1, item dealing with Ondansetron in the forms Tablet 4 mg (as hydrochloride dihydrate) and Tablet 8 mg (as hydrochloride dihydrate)

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

APO-Ondansetron

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

insert in the columns in the order indicated:

Paclitaxel, nanoparticle albumin-bound Powder for I.V. injection containing 100 mg paclitaxel Injection 1 . . Abraxane

  1. Part 1 of Schedule 1, after item dealing with Pancreatic Extract in the form Capsule (containing enteric coated minimicrospheres) providing not less than 25,000 BP units of lipase activity

insert in the columns in the order indicated:

Capsule (containing enteric coated minimicrospheres) providing not less than 40,000 BP units of lipase activity Oral 200 10 Creon 40,000

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

omit from the column headed “Brand”:

Feldene-D

  1. Part 1 of Schedule 1, item dealing with Simvastatin in the forms Tablet 10 mg, Tablet 20 mg, Tablet 40 mg


    and Tablet 80 mg

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

APO-Simvastatin

  1. Part 1 of Schedule 1, item dealing with Sodium Lactate Compound

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

I.V. infusion containing approximately 65 mmol sodium (as lactate and chloride), 2.7 mmol potassium (as chloride),
0.9 mmol calcium (as chloride), 14 mmol bicarbonate (as lactate) and 56 mmol chloride per 500 mL, 500 mL 		Injection 5 1 B. Braun Australia Pty Ltd

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

insert in the columns in the order indicated:

Sunitinib

Capsule 12.5 mg (as malate)

Capsule 25 mg (as malate)

Capsule 50 mg (as malate)

Oral

Oral

Oral

28

28

28

1

1

1

Sutent

Sutent

Sutent

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

insert in the columns in the order indicated:

Teriparatide Injection 250 micrograms per mL, 3 mL in multi-dose
pre-filled pen 		Injection 1 5 Forteo

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

  1. Part 2 of Schedule 1, after item dealing with Hydromorphone in the form Tablet containing hydromorphone hydrochloride 8 mg

insert in the columns in the order indicated:

Tablet (modified release) containing hydromorphone hydrochloride 8 mg

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

Chronic severe disabling pain associated with proven malignant neoplasia

 Oral 20 .. Jurnista
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
Tablet (modified release) containing hydromorphone hydrochloride 16 mg

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

Chronic severe disabling pain associated with proven malignant neoplasia

 Oral 20 .. Jurnista
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
Tablet (modified release) containing hydromorphone hydrochloride 32 mg

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

Chronic severe disabling pain associated with proven malignant neoplasia

 Oral 20 .. Jurnista
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
Tablet (modified release) containing hydromorphone hydrochloride 64 mg

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

Chronic severe disabling pain associated with proven malignant neoplasia

 Oral 20 .. Jurnista
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, item dealing with Ondansetron in the forms Tablet 4 mg (as hydrochloride dihydrate) and Tablet 8 mg (as hydrochloride dihydrate)

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

APO-Ondansetron

  1. Part 2 of Schedule 1, after item dealing with Pancreatic Extract in the form Capsule (containing enteric coated minimicrospheres) providing not less than 25,000 BP units of lipase activity

insert in the columns in the order indicated:

Capsule (containing enteric coated minimicrospheres) providing not less than 40,000 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 200 21 Creon 40,000

  1. Part 2 of Schedule 1, item dealing with Simvastatin in the forms Tablet 10 mg, Tablet 20 mg, Tablet 40 mg


    and Tablet 80 mg

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

APO-Simvastatin

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

insert in the columns in the order indicated:

Sunitinib Capsule 12.5 mg (as malate)

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

Continuing treatment beyond 3 months, as the sole PBS-subsidised therapy, of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who has previously been issued with an authority prescription for sunitinib and who has stable or responding disease according to RECIST (Response Evaluation Criteria in Solid Tumours) criteria

Initial treatment, as the sole PBS-subsidised therapy, of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who was receiving treatment with sunitinib prior to 1 May 2009

 Oral 28 3 Sutent
Capsule 25 mg (as malate)

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

Continuing treatment beyond 3 months, as the sole PBS-subsidised therapy, of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who has previously been issued with an authority prescription for sunitinib and who has stable or responding disease according to RECIST (Response Evaluation Criteria in Solid Tumours) criteria

Initial treatment, as the sole PBS-subsidised therapy, of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who was receiving treatment with sunitinib prior to 1 May 2009

 Oral 28 3 Sutent
Capsule 50 mg (as malate)

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

Continuing treatment beyond 3 months, as the sole PBS-subsidised therapy, of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who has previously been issued with an authority prescription for sunitinib and who has stable or responding disease according to RECIST (Response Evaluation Criteria in Solid Tumours) criteria

Initial treatment, as the sole PBS-subsidised therapy, of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who was receiving treatment with sunitinib prior to 1 May 2009

 Oral 28 3 Sutent

  1. Part 1 of Schedule 3, item dealing with Amoxycillin in the forms Capsule 250 mg (as trihydrate) and


    Capsule 500 mg (as trihydrate)

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

Amoxycillin Ranbaxy

  1. Part 1 of Schedule 3, after item dealing with Hydromorphone in the form Tablet containing hydromorphone hydrochloride 8 mg

insert in the columns in the order indicated:

Tablet (modified release) containing hydromorphone hydrochloride 8 mg Oral 10 . . Jurnista
Tablet (modified release) containing hydromorphone hydrochloride 16 mg Oral 10 . . Jurnista
Tablet (modified release) containing hydromorphone hydrochloride 32 mg Oral 10 . . Jurnista
Tablet (modified release) containing hydromorphone hydrochloride 64 mg Oral 10 . . Jurnista

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

omit from the column headed “Brand”:

          Feldene-D

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