National Health Act 1953 Amendment Special Arrangements under subsection 100(1) Highly Specialised Drugs Program (No. PB 35 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 35 of 2009

Amendment special arrangements under subsection 100(1) 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 subsection 100(1) of the National Health Act 1953.

Dated 2nd April 2009

DIANA MACDONELL

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment Special Arrangements — Highly Specialised Drugs Program

1              Commencement

This instrument commences on 1 May 2009.

2              Amendment of PB 120 of 2008

Schedule 1 amends PB 120 of 2008.

Schedule 1        Amendments

1. Schedule 1, after item dealing with Lanreotide

insert in the columns in the order indicated:

Lanthanum

Management (which includes initiation, stabilisation and review of therapy as required) of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where serum phosphate is greater than 1.6 mmol per L at the commencement of therapy

Management (which includes initiation, stabilisation and review of therapy as required) of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where the serum calcium times phosphate product is greater than 4.0 at the commencement of therapy

1. Schedule 1, item dealing with Sevelamer

omit from the column headed “Circumstances” (twice occurring):

other products

and substitute:

calcium

1. Schedule 2, after item dealing with Lanreotide

insert in the columns in the order indicated:

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