National Health Act 1953 Amendment declaration under subsections 85(2) and 85(2AA) Amendment determination under subsection 85(2A) drugs and medicinal preparations (No. PB 47 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 47 of 2009

Amendment declaration under subsections 85(2) and 85(2AA) of the National Health Act 1953

Amendment determination under subsection 85(2A) 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 subsections 85(2), 85(2A) and 85(2AA) of the National Health Act 1953.

Dated 4 June 2009

LINDA JACKSON

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment declaration and determination — drugs and medicinal preparations

1              Commencement

This instrument commences on 1 July 2009.

2              Amendment of PB 113 of 2008

Schedule 1 amends PB 113 of 2008.

Schedule 1        Amendments

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

in the column headed “Circumstances” insert before the existing text:

In respect of the sachets containing oral powder 20 g, 30 (GA gel):

A child aged from 6 months up to 10 years with proven glutaric aciduria type 1

1. Schedule 1, omit item dealing with Anecortave

1. Schedule 1, after item dealing with Aprepitant

insert in the columns in the order indicated:

Arginine with carbohydrate Urea cycle disorders

1. Schedule 1, after item dealing with Atovaquone

insert in the columns in the order indicated:

Atovaquone with proguanil

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of suspected or confirmed Plasmodium falciparum malaria in a patient aged 3 years or older where quinine containing regimens are inappropriate

1. Schedule 1, after item dealing with Bethanechol

insert in the columns in the order indicated:

Bevacizumab	In compliance with authority procedures set out in subparagraph 14 (d):
Initial PBS-subsidised treatment, in combination with first-line chemotherapy, of a patient with previously untreated metastatic colorectal cancer with a World Health Organisation performance status of 0 or 1
Continuing PBS-subsidised treatment, in combination with first-line chemotherapy, of a patient with metastatic colorectal cancer who has previously been issued with an authority prescription for bevacizumab and who does not have progressive disease and who remains on first-line chemotherapy

1. Schedule 1, item dealing with Cephazolin

in the column headed “Circumstances” insert below the existing text:

Cellulitis

1. Schedule 1, item dealing with Imatinib

omit from the column headed “Circumstances”:

Acute lymphoblastic leukaemia

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (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 substitute:

Acute lymphoblastic leukaemia

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (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. Schedule 1, item dealing with Latanoprost with Timolol

omit all text from the column headed “Circumstances” and substitute:

Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol eye drops containing 5 mg timolol (as maleate) per mL or prostaglandin or prostamide analogue monotherapies

Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol eye drops containing 5 mg timolol (as maleate) per mL or prostaglandin or prostamide analogue monotherapies

1. Schedule 1, item dealing with Modafinil

omit all text from the column headed “Circumstances” and substitute:

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment, by a qualified sleep medicine practitioner or neurologist, of patients with narcolepsy where:

 (i) intolerance to dexamphetamine sulfate of a severity necessitating treatment withdrawal develops; or

 (ii) therapy with dexamphetamine sulfate poses an unacceptable medical risk, as indicated by the presence of any 1 of the following:

 (a) a psychiatric disorder;

 (b) a cardiovascular disorder;

 (c) a history of substance abuse;

 (d) glaucoma;

 (e) any other absolute contraindication to dexamphetamine sulfate as specified in the Therapeutic Goods Administration-approved Product Information; and

 where the patient meets the following definition of narcolepsy:

 excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months, and:

 (i) a definite history of cataplexy; or

 a mean sleep latency less than or equal to 10 minutes on a Multiple Sleep Latency Test (MSLT), where the MSLT is preceded by nocturnal polysomnography and sleep prior to the MSLT is at least 6 hours in duration; or

 an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep; and

 (ii) absence of any medical or psychiatric disorder that could otherwise account for the hypersomnia; and

 where the authority application includes the following:

 (a) a completed copy of the appropriate Modafinil (Modavigil) PBS Authority Application - Supporting Information Form; and

 (b) details of the contraindication or intolerance to dexamphetamine sulfate; and

 (c) either:

 (i) the result and date of the polysomnography test and MSLT, conducted by, or under the supervision of, a qualified sleep medicine practitioner; or

 (ii) the result and date of the EEG, conducted by, or under the supervision of, a neurologist; and

 where the polysomnography and MSLT, or the EEG, test reports are provided with the authority application

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

 Continuing treatment of narcolepsy, where the patient has previously been issued with an authority prescription for this drug

1. Schedule 1, after item dealing with Moxonidine

insert in the columns in the order indicated:

Mupirocin	In compliance with authority procedures set out in subparagraph 14 (d):
3136	Nasal colonisation with Staphylococcus aureus in an Aboriginal or a Torres Strait Islander person

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

omit from the column headed “Circumstances”:

In respect of the pack containing 12 tablets oestradiol 2 mg, 10 tablets oestradiol 2 mg with norethisterone acetate 1 mg and 6 tablets oestradiol 1 mg:

—

In respect of the pack containing 4 transdermal patches 780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate, pack containing 4 transdermal patches 780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate and pack containing 4 transdermal patches oestradiol 4 mg and 4 transdermal patches oestradiol 10 mg with norethisterone acetate 30 mg:

1. Schedule 1, item dealing with Oestradiol with Norethisterone

omit from the column headed “Circumstances”:

In respect of the tablets containing 1 mg oestradiol (as hemihydrate) with 500 micrograms norethisterone acetate, 28 and tablets containing 2 mg oestradiol (as hemihydrate) with 1 mg norethisterone acetate, 28:

—

In respect of the transdermal patches containing 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate, 8 and transdermal patches containing 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate, 8:

1. Schedule 1, item dealing with Ondansetron

omit all text from the column headed “Circumstances” and substitute:

Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration

In compliance with authority procedures set out in subparagraph 14 (d):

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

1. Schedule 1, item dealing with Risedronic Acid

omit from the column headed “Circumstances”:

In respect of the tablet containing risedronate sodium 5 mg and tablet containing risedronate sodium 35 mg:

and substitute:

In respect of the tablet containing risedronate sodium 5 mg, tablet containing risedronate sodium 35 mg and tablet containing risedronate sodium 150 mg:

1. Schedule 1, item dealing with Travoprost with Timolol

omit all text from the column headed “Circumstances” and substitute:

Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol eye drops containing 5 mg timolol (as maleate) per mL or prostaglandin or prostamide analogue monotherapies

Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol eye drops containing 5 mg timolol (as maleate) per mL or prostaglandin or prostamide analogue monotherapies

1. Schedule 2A, after item dealing with Flurbiprofen

insert in the columns in the order indicated:

Framycetin —

1. Schedule 2A, item dealing with Latanoprost with Timolol

omit all text from the column headed “Circumstances” and substitute:

Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol eye drops containing 5 mg timolol (as maleate) per mL or prostaglandin or prostamide analogue monotherapies

Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol eye drops containing 5 mg timolol (as maleate) per mL or prostaglandin or prostamide analogue monotherapies

[18]     Schedule 2A, item dealing with Travoprost with Timolol

omit all text from the column headed “Circumstances” and substitute:

Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol eye drops containing 5 mg timolol (as maleate) per mL or prostaglandin or prostamide analogue monotherapies

Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol eye drops containing 5 mg timolol (as maleate) per mL or prostaglandin or prostamide analogue monotherapies

[19]     Schedule 3, after item dealing with Atorvastatin

insert in the columns in the order indicated:

Atovaquone Atovaquone with proguanil

[20]     Schedule 3, after item dealing with Prednisolone

insert in the columns in the order indicated:

Proguanil Atovaquone with proguanil

[21]     Schedule 6, after item dealing with Epoprostenol

insert:

Etravirine