National Health Act 1953 - Amendment special arrangements under subsection 100(1) - Highly Specialised Drugs Program (No. PB 92 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 92 of 2009

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

I, DECLAN O’CONNOR-COX, Assistant Secretary, Access and Systems 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 10 September 2009

DECLAN O’CONNOR-COX

Assistant Secretary

Access and Systems Branch

Department of Health and Ageing

Amendment Special Arrangements — Highly Specialised Drugs Program

1              Commencement

This instrument commences on 1 October 2009.

2              Amendment of PB 54 of 2009

Schedule 1 amends PB 54 of 2009.

Schedule 1                   Amendments

1. Schedule 1, item dealing with Filgrastim

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

A patient with inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx receiving neoadjuvant treatment with docetaxel in combination with cisplatin and fluorouracil who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned

1. Schedule 1, item dealing with Pegfilgrastim

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

A patient with inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx receiving neoadjuvant treatment with docetaxel in combination with cisplatin and fluorouracil who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned

1. Schedule 2, item dealing with Epoetin Beta

omit from the columns in the order indicated:

Injection 30,000 units in 0.6 mL pre-filled syringe Injection NeoRecormon

1. Schedule 2, item dealing with Indinavir

omit from the columns in the order indicated:

Capsule 100 mg (as sulfate)	Oral	Crixivan 100mg
Capsule 200 mg (as sulfate)	Oral	Crixivan 200mg

1. Schedule 2, item dealing with Ribavirin and Peginterferon Alfa-2a

omit from the columns in the order indicated:

Pack containing 84 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon   alfa-2a injection 180 micrograms Injection/oral Pegasys RBV

1. Schedule 3, item dealing with Ribavirin and Peginterferon Alfa-2a

omit from the columns in the order indicated:

Pack containing 84 tablets ribavirin 200 mg and 4 pre-filled syringes  peginterferon alfa-2a injection 180 micrograms