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 124 of 2008) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 124 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 3rd DECEMBER    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 January 2009.

2              Amendment of PB 113 of 2008

Schedule 1 amends PB 113 of 2008.

Schedule 1        Amendments

1. Schedule 1, omit item dealing with Aminoglutethimide

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

insert in “Column 3” after “electrode strips, 50 (Advantage II),”:

electrode strips, 50 (Freestyle),

1. Schedule 1, after item dealing with Hypromellose with Dextran

insert in the columns in the order indicated:

Ibandronic acid Bone metastases from breast cancer

1. Schedule 1, omit item dealing with Piperazine Oestrone

1. Schedule 1, after item dealing with Polyvinyl Alcohol

insert in the columns in the order indicated:

Posaconazole	In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of invasive aspergillosis in patients intolerant to, or with disease refractory to, alternative therapy
Treatment of fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis and mycetoma in patients intolerant to, or with disease refractory to, alternative therapy
Prophylaxis of invasive fungal infections, including both yeasts and moulds, in a patient who is at high risk of developing these infections, defined as follows:
(1) neutropenia — patients with anticipated neutropenia (an absolute neutrophil count of less than 500 cells per cubic millimetre) for at least 10 days, who are receiving chemotherapy for acute myelogenous leukaemia or myelodysplastic syndrome;
treatment should continue until recovery of the neutrophil count to at least 500 cells per cubic millimetre;
patients who have had a previous invasive fungal infection should have secondary prophylaxis during subsequent episodes of neutropenia;
(2) graft versus host disease (GVHD) — patients with acute GVHD grades II to IV or extensive chronic GVHD, who are receiving intensive immunosuppressive therapy after allogeneic haematopoietic stem cell transplant;
PBS-subsidised treatment is limited to a maximum of 6 months therapy per episode

1. Schedule 1, item dealing with Temozolomide

omit from “Column 3”:

In respect of the capsule 5 mg, capsule 20 mg and capsule 100 mg:

and substitute:

In respect of the capsule 5 mg, capsule 20 mg, capsule 100 mg and capsule
140 mg:

1. Schedule 1, item dealing with Zoledronic acid

omit all text from “Column 3” and substitute:

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

Treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in women 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, and where PBS-subsidised treatment is limited to 3 doses per patient, administered as 1 dose a year for 3 consecutive years

Treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in men with hip 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, and where PBS-subsidised treatment is limited to 3 doses per patient, administered as 1 dose a year for 3 consecutive years

1. Schedule 6, omit item dealing with Ibandronic acid