PB 13 of 2014
National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2014 (No. 1)
National Health Act 1953
I, KIM BESSELL, Assistant Secretary, Pharmaceutical Access Branch, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.
Dated    25 February 2014
 
 
 
 
 
 
 
 
 
KIM BESSELL
Assistant Secretary
Pharmaceutical Access Branch
Department of Health
1          Name of Instrument
            (1)        This Instrument is the National Health (Botulinum Toxin Program)
                        Special Arrangement Amendment Instrument 2014 (No.1).
            (2)        This Instrument may also be cited as PB 13 of 2014.
2          Commencement
(1)        This instrument commences on 1 March 2014.
3          Amendment of PB 89 of 2011
            Schedule 1 amends the National Health (Botulinum Toxin Program) Special Arrangement 2011 (PB 89 of 2011).
 
Schedule 1     Amendments
[1]         Subsection 10(1)
omit:
and 12A
insert:
, 12A and 12B
 
[2]         Subsection 12A(2)(a)
omit:
is – (second occurring)
[3]         After section 12
insert:
12B     Entitlement to botulinum toxin pharmaceutical benefits for treatment of chronic migraine
                (1)    This section applies to eligible patients receiving treatment for chronic migraine who:
(a)    are aged 18 years or more, and
(b)   have experienced an average of 15 or more headache days per month, with at least 8 days of migraine, over a period of at least 6 months, prior to commencement of treatment with a botulinum toxin pharmaceutical benefit, and
(c)    have experienced an inadequate response, intolerance or a contraindication to at least three phrophylatic migrane medications prior to commencement of treatment with a botulinum toxin pharmaceutical benefit; and
(d)   have been appropriately managed for medication overuse headache by their medical practitioner prior to treatment with botulinum toxin pharmaceutical benefit.
 
   (2)    A person mentioned in subsection (1) is not eligible to receive a botulinum toxin pharmaceuetical benefit under this Special Arrangement if the person does not achieve and maintain a 50% or greater reduction from baseline in the number of headache days per month after two treatment cycles (each of 12 weeks duration).
 
[4]          After section 17
 
          insert:
 
              Eligible medical practitioner in relation to chronic migraine
 
17A     A medical practitioner who has the specialist qualification of neurology and is an eligible medical practitioner in relation to any condition mentioned in Schedule 3 other than chronic migraine, is taken to be an eligible medical practitioner in relation to chronic migraine.
 
[5]         Omit subsection 18(2)(e)
 
[6]         Subsection 18(3)
omit:
or (6)
insert:
, (6) or (7)
 
[7]         After subsection 18(6)
insert:
(7) If an applicant practitioner is a specialist in neurology and seeks authorisation to administer a botulinum toxin pharmaceutical benefit, under this Special Arrangement, for the treatment of chronic migraine, the applicant practitioner must:
(a)    provide a statement that confirms the applicant practitioner has been:
(i) involved in at least 10 unsupervised procedures administering a botulinum pharmaceutical benefit; or
(ii) the primary operator, under supervision, in at least 6 procedures in administering  botulinum toxin for chronic migraine; or
(iii) provide  a letter from a person who is an eligible medical practitioner for this Special Arrangement, stating that the applicant practitioner has been the primary operator, under supervision in at least 6 procedures, administering botulinum toxin pharmaceutical benefit for chronic migraine; and
(b)   provide a letter from the responsible person stating the applicant practitioner’s experience and/or training in administering a botulinum toxin pharmaceutical benefit for chronic migraine.
[8]               Schedule 3
after:
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
 
insert:
 
10
Treatment of chronic migraine in patients who are 18 years or older.
Botulinum Toxin Type A Purified Neurotoxin Complex
Neurology
 
 
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.