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 34 of 2010) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 34 of 2010

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, FELICITY McNEILL, 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 1 April 2010

FELICITY McNEILL

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 May 2010.

2              Amendment of PB 14 of 2010

Schedule 1 amends PB 14 of 2010.

Schedule 1        Amendments

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

omit from the column headed “Circumstances”: (XLYS, LOW TRY Analog)

and substitute: (GA1 Anamix infant)

1. Schedule 1, item dealing with Amino acid formula with vitamins and minerals without methionine

omit from the column headed “Circumstances”: (XMET Analog)

and substitute: (HCU Anamix infant)

1. Schedule 1, omit item dealing with Carmellose with glycerin

and substitute in the columns in the order indicated:

Carmellose with glycerin

In respect of the eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, 15 mL:

Severe dry eye syndrome, including Sjogren's syndrome

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

In respect of the eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, single dose units 0.4 mL, 30:

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

1359

 Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops

1. Schedule 1, after item dealing with Labetalol

insert in the columns in the order indicated:

Lacosamide

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

Treatment, initiated by a neurologist, in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent, of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs in a patient aged 16 years or older with intractable epilepsy;

 the patient must have trialled and failed to achieve satisfactory seizure control with:

 (i) at least one first-line anti-epileptic agent; and

 (ii) at least two second-line adjunctive anti-epileptic agents

Continuing treatment, in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent, of partial epileptic seizures in a patient aged 16 years or older, who has previously been treated with PBS-subsidised lacosamide

1. Schedule 1, omit item dealing with Levodopa with Carbidopa and Entacapone

and substitute in the columns in the order indicated:

Levodopa with Carbidopa and Entacapone	3305	In compliance with authority procedures set out in subparagraph 14 (d):  Parkinson disease in patients being treated with levodopa—decarboxylase inhibitor combinations who are experiencing fluctuations in motor function due to end-of-dose effect
3306	Parkinson disease in patients stabilised on concomitant treatment with levodopa—decarboxylase inhibitor combinations and entacapone

1. Schedule 2A, omit item dealing with Carmellose with glycerin

and substitute in the columns in the order indicated:

Carmellose with glycerin

In respect of the eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, 15 mL:

Severe dry eye syndrome, including Sjogren's syndrome

In respect of the eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, single dose units 0.4 mL, 30:

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

Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops