National Health Act 1953 Amendment special arrangements made under subparagraph 100(1)(b)(i) Botulinum Toxin Program (No. PB 58 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 58 of 2009

Amendment special arrangements made under subparagraph 100(1)(b)(i) 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(2) of the National Health Act 1953.

15 June 2009

DECLAN O’CONNOR-COX

Assistant Secretary

Access and Systems Branch

Department of Health and Ageing

Amendment Special Arrangements —Botulinum Toxin Program

1              Commencement

This instrument commences on 1 July 2009.

2              Amendment of PB 122 of 2008

Schedule 1 amends PB 122 of 2008 – National Health Act 1953 – Arrangements made under subparagraph 100(1)(b)(i) – Botulinum Toxin Program.

Schedule 1             Amendments

[1]            Subparagraph 3(A)(i)

Omit from the subparagraph:

(e)     the treatment of moderate to severe spasticity of the upper limbs in cerebral palsy patients 2 years of age or older; or

(f)      the treatment of moderate to severe spasticity (defined as MAS greater than or equal to 3 using the modified Ashworth scale) of the upper limb in adults following a stroke as a second line therapy when standard management has failed (e.g. physiotherapy and/or oral spasticity agents) or as an adjunct to physical therapy.  Maximum number of treatments with botulinum toxin to be authorised is 4 per upper limb per lifetime.  Treatment should not be initiated until 3 to 6 months post-stroke in patients who do not have established severe contracture.  Treatment should be discontinued if the patient does not respond (decrease of MAS greater than 1 in at least one joint) after two treatments.  Contraindications to treatment include established severe contracture and known sensitivity to botulinum toxin.

and substitute:

(e)     the treatment of moderate to severe spasticity of the upper limbs in cerebral palsy patients 2 to 17 years of age inclusive; or

(f)      the continuing PBS-subsidised treatment of moderate to severe spasticity of the upper limb in a cerebral palsy patient 18 years of age or older who was commenced on PBS-subsidised treatment with botulinum toxin type A purified neurotoxin complex as a paediatric patient; or

(g)    the treatment of moderate to severe spasticity (defined as MAS greater than or equal to 3 using modified Ashworth scale) of the upper limb in adults following a stroke, as second line therapy when standard management has failed (eg physiotherapy and/or oral spasticity agents) or as an adjunct to physical therapy.  Maximum number of treatments to be authorised is 4 (total Botox and Dysport) per upper limb per lifetime. Treatment should not be initiated until 3 months-post stroke in patients who do not have established severe contracture.  Treatment should be discontinued if the patient does not respond (decrease of MAS greater than 1 in at least one joint) after two treatments. The date of the stroke must be provided. Contraindications to treatment include established severe contracture, known sensitivity to botulinum toxin.

[2]        Subparagraph 3(A)(ii)

Omit from the  subparagraph

(d)     the treatment of moderate to severe spasticity (defined as MAS greater than or equal to 3 using the modified Ashworth scale) of the upper limb in adults following a stroke as a second line therapy when standard management has failed (e.g. physiotherapy and/or oral spasticity agents) or as an adjunct to physical therapy.  Maximum number of treatments with botulinum toxin to be authorised is 4 per upper limb per lifetime.  Treatment should not be initiated until 3 to 6 months post-stroke in patients who do not have established severe contracture.  Treatment should be discontinued if the patient does not respond (decrease of MAS greater than 1 in at least one joint) after two treatments.  Contraindications to treatment include established severe contracture and known sensitivity to botulinum toxin.

and substitute:

(d)     the treatment of moderate to severe spasticity (defined as MAS greater than or equal to 3 using modified Ashworth scale) of the upper limb in adults following a stroke, as second line therapy when standard management has failed (eg physiotherapy and/or oral spasticity agents) or as an adjunct to physical therapy.  Maximum number of treatments to be authorised is 4 (total Botox and Dysport) per upper limb per lifetime. Treatment should not be initiated until 3 months-post stroke in patients who do not have established severe contracture.  Treatment should be discontinued if the patient does not respond (decrease of MAS greater than 1 in at least one joint) after two treatments. The date of the stroke must be provided. Contraindications to treatment include established severe contracture, known sensitivity to botulinum toxin.