National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2015 (No. 1) (PB 33 of 2015)

Link to law: https://www.comlaw.gov.au/Details/F2015L00431

PB 33 of 2015
National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2015 (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 26 March 2015
 
 
 
 
 
 
 
 
 
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 2015 (No.1).
            (2)        This Instrument may also be cited as PB 33 of 2015.
2          Commencement
(1)        This instrument commences on 1 April 2015.
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 8(2)
omit entire subsection and substitute with:
(2)     If a botulinum toxin pharmaceutical benefit is supplied in accordance with this Special Arrangement, regulations 13, 19, 19AA, 21, 21A, 22, 24, 25, 26, 26A, 28 and 31 of the Regulations do not apply to the supply.
 
[2]        After subsection 11(1):
insert:
(2)     The maximum number of treatment periods of botulinum toxin pharmacecutical benefits a person mentioned in subsection (1) is eligible to receive is 4 (total Botulinum Toxin Type A Purified Neurotoxin Complex, Clostridium Botulinum Type A Toxin-Haemagglutinin Complex and IncobotulinumtoxinA) per upper limb per lifetime.
 
[3]        Subsection 11(2):
omit:
if the person has previously received botulinum toxin pharmaceutical benefit for 4 treatment periods to the same upper limb.
substitute:
if the person has previously received the maximum number of treatment periods of botulinum toxin pharmaceutical benefits mentioned in subsection (2) to the same upper limb.
 
[4]        Subsection 11(4)(a), after ‘benefit’
insert:
(total Botulinum Toxin Type A Purified Neurotoxin Complex, Clostridium Botulinum Type A Toxin-Haemagglutinin Complex and IncobotulinumtoxinA) per upper limb
 
[5]        Subsection 11(4)(b)(ii)
omit:
either
substitute:
any
 
[6]        After subsection 11(4)(b)(ii)(B):
insert:
(C)    IncobotulinumtoxinA
 
[7]        After subsection 11(5)
insert:
(7)     A person to whom subparagraph 11(5)(a) applies is considered to have not responded to the treatment if the person has not had a decrease in spasticity rating of greater than 1, using the modified Ashworth scale (MAS), in at least one joint.
 
[8]        Subsection 11(2):
omit:
(2)
substitute:
(3)
 
[9]        Subsection 11(3):
omit:
(3)
substitute:
(4)
 
[10]      Subsection 11(4):
omit:
(4)
substitute:
(5)
 
[11]     Subsection 11(5)
omit:
(5)
substitute:
(6)
 
[12]      Subsection 12B(1)(c)
omit:
phrophylatic
substitute:
prophylactic
 
[13]      Subsection 12B(1)(c)
omit:
migrane
substitute:
migraine
 
[14]     Subsection 17B, in the subsection title
omit:
overctive
substitute:
overactive
 
[15]      Subsection 18(4)(b)(ii), after ‘1A’
insert:
and/or 1B
 
[16]     Subsection 18(5)(b)(ii), after ‘1A’
insert:
and/or 1B
 
[17]      After subsection 26(4)
insert:
(5)     An eligible medical practitioner who is authorised, under this Special Arrangement, to administer a botulinum toxin pharmaceuctical benefit that has the listed drug IncobotulinumtoxinA to treat a treatment condition numbered 1B, 4A or 7 in the column in Schedule 3 headed ‘Treatment Condition Number’ must not hold more than 5 vials of a botulinum toxin pharmaceutical benefit with the IncobotulinumtoxinA drug.
 
[18]      Subsection 26(5)
omit:
(5)
substitute:
(6)
 
[19]      Subsection 26(6)
omit:
(6)
substitute:
(7)
 
[20]     Subsection 26(7)
omit:
(7)
substitute:
(8)
 
[21]      Subsection 26(8)
omit:
(8)
substitute:
(9)
 
[22]      Subsection 26(9)
omit:
(9)
substitute:
(10)
 
[23]      Schedule 1, after the entry for Clostridium Botulinum Type A Toxin-Haemagglutinin Complex in the form Lyophilised powder for injection 500 units:
insert:
IncobotulinumtoxinA
Lyophilised powder for injection 100 units
Injection
Xeomin
EZ
D
 
[24]      Schedule 2, after the entry for Ipsen Pty Ltd:
insert:
EZ
Merz Australia Pty Ltd
62 151 073 559
 
[25]      Schedule 3, after the entry for treatment condition number 1A
insert:
1B
Treatment of blepharospasm in an adult
IncobotulinumtoxinA
Neurology
Opthalmology
Otolaryngology head and neck surgery
Plastic surgery
 
[26]     Schedule 3, after the entry for treatment condition number 4
insert:
4A
Treatment of spasmodic torticollis in an adult, either as monotherapy or as adjunctive therapy to current standard care
IncobotulinumtoxinA
Neurology
Plastic surgery
Rehabilitation
 
[27]      Schedule 3, at the entry for Treatment Condition Number ‘7’, in the column Listed Drug in Relevant Pharmaceutical Benefit, after the entry ‘Clostridium Botulinum Type A Toxin–Haemagglutinin Complex’
insert:
IncobotulinumtoxinA
 
 
 
 
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