PB 67 of 2013
National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2013 (No. 1)
National Health Act 1953
I, STEVE DUNLOP, Acting Assistant Secretary, Pharmaceutical Access Branch, Department of Health and Ageing, delegate of the Minister for Health, make this Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.
Dated   23 September 2013
 
 
 
 
 
 
 
 
 
STEVE DUNLOP
Acting Assistant Secretary
Pharmaceutical Access Branch
Department of Health and Ageing
1          Name of Instrument
            (1)        This Instrument is the National Health (Botulinum Toxin Program)
                        Special Arrangement Amendment Instrument 2013 (No.1).
            (2)        This Instrument may also be cited as PB 67 of 2013.
2          Commencement
(1)       This instrument commences on 1 October 2013.
3          Amendment of PB 89 of 2011
            Schedule 1 amends the National Health (Botulinum Toxin Program) Special Arrangement 2011 (PB 89 of 2011).
4          Transitional
For an applicant practitioner who is a specialist in urology or urogynaecology and has applied for authorisation to administer botulinum toxin pharmaceutical benefits for the treatment of urinary continence due to neurogenic detrusor overactivity, as demonstrated by urodynamic study in patients who have multiple sclerosis, or a spinal cord injury, or who are 18 years or older and have spina bifida, prior to commencement of this Instrument, the applicant practitioner does not need to have provided the information in paragraphs 18(2)(c) and (d) and subsection 18(6) of PB 89 of 2011 to be authorised. Instead the applicant practitioner must have provided the following information:
(a)           a Declaration Statement from the applicant practitioner that outlines their confirmation of their involvement in at least 10 procedures administering the botulinum toxin pharmaceutical benefit;
(b)          evidence of 10 recent patient names where the applicant practitioner has administered the botulinum toxin pharmaceutical benefit for the treatment of urinary incontinence; and
(c)           a Declaration Statement from the applicant practitioner that outlines their confirmation of involvement in a course of training relating to the treatment of urinary incontinence due to neurogenic detrusor overactivity.
 
 
 
 
 
Schedule 1     Amendments
[1]         Subsection 10(1)
omit:
and 12
insert:
, 12 and 12A
 
[2]        After section 12
insert:
12A         Entitlement to botulinum toxin pharmaceutical benefits for treatment of urinary incontinence due to neurogenic detrusor overactivity, as demonstrated by urodynamic study etc
          (1)  This section applies to eligible patients receiving treatment of urinary continence due to neurogenic detrusor overactivity, as demonstrated by urodynamic study in patients who have
                (a)    multiple sclerosis, or
               (b)    a spinal cord injury, or
                (c)    who are 18 years or older and have spina bifida.
          (2)  A person mentioned in subsection (1) is not eligible to receive a botulinum toxin pharmaceutical benefit under this Special Arrangement unless:
                (a)    the condition is is inadequately controlled by anti-cholinergic therapy,
               (b)    the person has experienced at least 14 episodes of urinary incontinence per week prior to commencement of treatment with a botulinum toxin pharmaceutical benefit, and
   (c)     the person is willing and able to self-catheterise.
          (3)  A person mentioned in subsection (1) is not eligible to receive a botulinum toxin pharmaceutical benefit under this Special Arrangement if the person does not achieve a 50% or greater reduction from baseline in urinary incontinence episodes 6-12 weeks after the first treatment.
[3]         Subsection 18(3)
omit:
or (5)
insert:
, (5) or (6)
 
[4]        After subsection 18(5)
insert:
          (6)  If an applicant practitioner is a specialist in urology or urogynaecology and seeks authorisation to administer a botulinum toxin pharmaceutical benefit, under this Special Arrangement, for the treatment of urinary incontinence due to neurogenic detrusor overactivity, as demonstrated by urodynamic study for patients with multiple sclerosis, spinal cord injury or who are 18 years or older and have spina bifida, the applicant practitioner must:
(a)    have been trained by a specialist in the same speciality as the applicant practitioner in the administration of botulinum toxin pharmaceutical benefits to treat urinary incontinence due to neurogenic detrusor overactivity; and
(b)    provide evidence of the applicant practitioner’s training in the form of a letter from a person who is an eligible medical practitioner for this Special Arrangement, stating that the applicant practitioner has been involved in at least 10 procedures, having been the primary operator, under supervision, in at least 5 procedures administering a botulinum toxin pharmaceutical benefit.
 
[5]               Schedule 3
after:
8
Treatment of severe primary axillary hyperhidrosis in patients aged 12 or more if, after treatment with topical aluminium chloride hexahydrate, patient is intolerant to topical aluminium chloride hexahydrate or the patient has not responded to the treatment.
Botulinum Toxin Type A Purified Neurotoxin Complex
Dematology
Neurology
Paediatrics
insert:
9
Treatment of urinary incontinence due to neurogenic detrusor overactivity, as demonstrated by urodynamic study in patients who have multiple sclerosis, or a spinal cord injury, or who are 18 years or older and have spina bifida. 
Botulinum Toxin Type A Purified Neurotoxin Complex
Urology
Urogynaecology
 
1Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.  See http://www.comlaw.gov.au.