Federal Register of Legislation - Australian Government

Primary content

PB 13 of 2014 Arrangements as made
This instrument amends the National Health (Botulinum Toxin Program) Special Arrangement 2011 - PB 89 of 2011 to allow for botulinum toxin to be supplied to specific patients through eligible medical practitioners.
Administered by: Health
Registered 27 Feb 2014
Tabling HistoryDate
Tabled HR04-Mar-2014
Tabled Senate04-Mar-2014
Date of repeal 02 Mar 2014
Repealed by Division 1 of Part 5A of the Legislative Instruments Act 2003

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.