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 41 of 2008) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 41 of 2008

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

Dated    Second of April   2008

DIANA MACDONELL

Acting 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 2008.

2              Amendment of PB 88 of 2007

Schedule 1 amends PB 88 of 2007.

Schedule 1        Amendments

[1]       Schedule 1, item dealing with Flucloxacillin

omit from “Column 3”:

In respect of the capsule 250 mg (as sodium), capsule 500 mg (as sodium), powder for oral suspension 125 mg (as magnesium) per 5 mL, 100 mL and powder for oral suspension 250 mg (as magnesium) per 5 mL, 100 mL:

and substitute:

In respect of the capsule 250 mg (as sodium), capsule 500 mg (as sodium), powder for oral suspension 125 mg (as magnesium) per 5 mL, 100 mL, powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL, powder for oral suspension 250 mg (as magnesium) per 5 mL, 100 mL and powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL:

[2]       Schedule 1, after item dealing with Lansoprazole

insert in the columns in the order indicated:

Lapatinib

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

Initial treatment, in combination with capecitabine, of a patient with HER2 positive metastatic breast cancer (equivalent to Stage IIIC or Stage IV) who has received prior therapy with an anthracycline and a taxane, each for at least 3 cycles, and whose disease has progressed despite treatment with trastuzumab for metastatic disease, and where the authority application includes:

 (a) a pathology report demonstrating HER2 positivity has been demonstrated by in situ hybridisation (ISH); and

 (b) date of last treatment with a taxane and total number of cycles; and

 (c) date of last treatment with an anthracycline and total number of cycles; and

 (d) a signed patient acknowledgment; and

 (e) dates of treatment with trastuzumab; and

 (f) date of demonstration of disease progression whilst on treatment with trastuzumab

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

Initial treatment, in combination with capecitabine, of a patient with HER2 positive metastatic breast cancer who was receiving treatment with lapatinib prior to 1 May 2008, and where the authority application includes:

 (a) a pathology report demonstrating that HER2 positivity has been demonstrated by in situ hybridisation (ISH); and

 (b) a signed patient acknowledgment; and

 (c) the date the patient commenced non-PBS-subsidised treatment with lapatinib

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

Continuing treatment, in combination with capecitabine, of a patient with HER2 positive metastatic breast cancer who has previously received treatment with PBS-subsidised lapatinib and who does not have progressive disease, and where the authority application includes a statement from the prescribing doctor that the disease has not progressed

[3]       Schedule 1, after item dealing with Lercanidipine

insert in the columns in the order indicated:

Lercanidipine with enalapril Hypertension in a patient who is not adequately controlled with either lercanidipine hydrochloride or enalapril maleate monotherapy

[4]       Schedule 1, item dealing with Macrogol 3350

insert in “Column 3” as next paragraph after “Constipation in patients with malignant neoplasia”:

Chronic constipation or faecal impaction not adequately controlled with first line interventions such as bulk-forming agents

[5]       Schedule 1, after item dealing with Risedronic Acid and Calcium

insert in the columns in the order indicated:

Risedronic acid and calcium with colecalciferol	In compliance with authority procedures set out in subparagraph 14 (d):
2645	Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated
2646	Treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body

[6]       Schedule 2, item dealing with Flucloxacillin

omit from “Column 3”:

In respect of the capsule 250 mg (as sodium), capsule 500 mg (as sodium), powder for oral suspension 125 mg (as magnesium) per 5 mL, 100 mL and powder for oral suspension 250 mg (as magnesium) per 5 mL, 100 mL:

and substitute:

In respect of the capsule 250 mg (as sodium), capsule 500 mg (as sodium), powder for oral suspension 125 mg (as magnesium) per 5 mL, 100 mL, powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL, powder for oral suspension 250 mg (as magnesium) per 5 mL, 100 mL and powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL:

[7]       Schedule 3, after item dealing with Buprenorphine

insert in the columns in the order indicated:

Calcium Calcium with colecalciferol

[8]       Schedule 3, item dealing with Colecalciferol

insert in “Column 2” as next entry after “Alendronic Acid with Colecalciferol”:

Calcium with colecalciferol

[9]       Schedule 3, item dealing with Enalapril

insert in “Column 2” as next entry after “Enalapril with Hydrochlorothiazide”:

Lercanidipine with enalapril

[10]     Schedule 3, after item dealing with Latanoprost

insert in the columns in the order indicated:

Lercanidipine Lercanidipine with enalapril