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 62 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 62 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 6 July 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 August 2009.

2              Amendment of PB 113 of 2008

Schedule 1 amends PB 113 of 2008.

Schedule 1        Amendments

1. Schedule 1, after item dealing with Aripiprazole

insert in the columns in the order indicated:

Arsenic

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

Induction and consolidation treatment of relapsed acute promyelocytic leukaemia (characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript) in a patient who is arsenic naive at induction

1. Schedule 1, after item dealing with Bimatoprost

insert in the columns in the order indicated:

Bimatoprost with timolol	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 Chorionic Gonadotrophin

omit from the column headed “Circumstances”:

In respect of the injection set containing 3 ampoules powder for injection 500
units and 3 ampoules solvent 1 mL:
Anovulatory infertility
For the treatment of infertility in males due to hypogonadotrophic hypogonadism
For the treatment of infertility in males associated with isolated luteinising
hormone deficiency
For the treatment of males who have combined deficiency of human growth
hormone and gonadotrophins and in whom the absence of secondary sexual
characteristics indicates a lag in maturation
For the treatment, for a period not exceeding 6 months, of males over the age of
16 years who show clinical evidence of hypogonadism or delayed puberty
Cryptorchism not due to organic obstruction in boys over 12 months of age

In respect of the injection set containing 3 ampoules powder for injection 1,500

units and 3 ampoules solvent 1 mL:

1. Schedule 1 item dealing with Clopidogrel

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

3146  Treatment in combination with aspirin following cardiac stent insertion

1. Schedule 1, item dealing with Glucose Indicator—Blood

(a) insert in the column headed “Circumstances” after “(MWD Pen Sensor Strips),”:      

electrode strips, 50 (MyGlucoHealth),

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

electrode strips, 100 (TrueSense),

1. Schedule 1, after item dealing with Hexamine

insert in the columns in the order indicated:

High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate

Patients with intractable seizures requiring treatment with a ketogenic diet

Glucose transport protein defects

Pyruvate dehydrogenase deficiency

1. Schedule 1, item dealing with Oxybutynin

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

In respect of the tablet containing oxybutynin hydrochloride 5 mg:

Detrusor overactivity

In respect of the transdermal patches 36 mg, 8:

Detrusor overactivity in a patient who cannot tolerate oral oxybutynin, or who cannot swallow oral oxybutynin

1. Schedule 1, after item dealing with Pravastatin

insert in the columns in the order indicated:

Praziquantel	In compliance with authority procedures set out in subparagraph 14 (d):
3147	Schistosomiasis

1. Schedule 1, item dealing with Quetiapine

after:

2765  Monotherapy, for up to 6 months, of an episode of acute mania associated with bipolar I disorder

insert in the columns in the order indicated:

3151  Maintenance treatment of bipolar I disorder, in combination with lithium or sodium valproate

1. Schedule 1, after item dealing with Rituximab

insert in the columns in the order indicated:

Rivaroxaban

In respect of the tablet 10 mg, 30:

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

Prevention of venous thromboembolism in a patient undergoing total hip replacement

In respect of the tablet 10 mg and tablet 10 mg, 15:

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

Prevention of venous thromboembolism in a patient undergoing total knee replacement

Prevention of venous thromboembolism in a patient undergoing total hip replacement

1. Schedule 1, after item dealing with Sitagliptin

insert in the columns in the order indicated:

Sitagliptin with metformin	In compliance with authority procedures set out in subparagraph 14 (d):
3148	Treatment of type 2 diabetes in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and:
(a) whose glycosylated haemoglobin (HbA1c) prior to initiation of sitagliptin is greater than 7%, despite treatment with metformin; or
(b) in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of sitagliptin shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with metformin; and
where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstance, are documented in the patient's medical records, and are no more than 4 months old, at the time sitagliptin treatment is initiated
3149	Continuation of therapy in type 2 diabetes mellitus in a patient who has previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and sitagliptin

1. Schedule 1, after item dealing with Sotalol

insert in the columns in the order indicated:

Soy lecithin	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 1A, after item dealing with Hyoscine

insert in the columns in the order indicated:

Hypromellose	In compliance with authority procedures set out in subparagraph 14 (d):
Continuing supply for palliative care patients where dry mouth is a symptom
Initial supply, for up to 4 months, for palliative care patients where dry mouth is a symptom
Continuing supply for palliative care patients where dry mouth is a symptom, and where consultation with a palliative care specialist or service has occurred

1. Schedule 2A, after item dealing with Bimatoprost

insert in the columns in the order indicated:

Bimatoprost with timolol	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

[15]   Schedule 2A, item dealing with Carbomer

omit from “Column 2” :

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

[16]   Schedule 2A, after item dealing with Polyvinyl Alcohol

insert in the columns in the order indicated:

Soy lecithin

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

[17]     Schedule 3, after item dealing with Benserazide

insert in the columns in the order indicated:

Bimatoprost Bimatoprost with Timolol

[18]     Schedule 3, item dealing with Metformin

insert in the column headed “Allowable compounds” after “Rosiglitazone with Metformin”:

Sitagliptin with Metformin

[19]     Schedule 3, after item dealing with Simvastatin

insert in the columns in the order indicated:

Sitagliptin Sitagliptin with Metformin

[20]     Schedule 3, item dealing with Timolol

insert as first entry in the column headed “Allowable compounds”:

Bimatoprost with Timolol

[21]     Schedule 3, after item dealing with Verapamil

insert in the columns in the order indicated:

Voriconazole Voriconazole with Water —Purified BP

[22]     Schedule 3, item dealing with Water — Purified BP

insert as last entry in the column headed “Allowable compounds”:

Voriconazole with Water —Purified BP