National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2014 (No. 1) - PB 14 of 2014

Link to law: https://www.comlaw.gov.au/Details/F2014L00208

PB 14 of 2014
National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2014 (No.1)
National Health Act 1953
I, KIM BESSELL, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.
Dated    25 February 2014
 
 
 
 
 
 
 
 
 
 
 
Mr KIM BESSELL
Assistant Secretary
Pharmaceutical Access Branch
Principal Pharmacy Advisor
Pharmaceutical Benefits Division
Department of Health
 
1          Name of Instrument
            (1)        This Instrument is the National Health (Growth Hormone Program)
            Special Arrangement Amendment Instrument 2014 (No.1).
            (2)        This Instrument may also be cited as PB 14 of 2014.
2          Commencement
This Instrument commences on 1 March 2014.
3          Amendment of PB 88 of 2011
            Schedule 1 amends the National Health (Growth Hormone Program) Special Arrangement 2011 (PB 88 of 2011) (Principal Instrument).
 
 
 
 
 
Schedule 1     Amendments
 
[1]           Subsection 3(1) before the definition of 1st percentile for age and sex
insert:
1st adult height percentile means:
(a) 148.02 cm for a female; and
(b) 160.11 cm for a male.
 
[2]           Subsection 3(1) following definition of 10th adult height percentile
insert:
25th percentile for age and sex – see subsection (6).
[3]           Subsection 3(1) following definition of continuing treatment
insert:
Departmental medical adviser means an employee of the Department who is employed under the classification of ‘Medical Officer’.
 
[4]           Subsection 3(1) following definition of growth hormone treatment
omit:
definition of growth velocity
substitute:
growth velocity means the amount a person has grown in the following period ending on the day on which the person’s treating practitioner takes the measurements that are submitted as growth data for the person in an application under this Special Arrangement:
(a)   if the person is an older child, the period of 6 months; and
(b)   if the person is not an older child;
(i)     if a provision of this Special Arrangement mentions a period for the measurement of growth velocity – that period; or
(ii)    otherwise, 12 months.
 
[5]           Subsection 3(1) definition of maturational or constitutional delay
omit:
(iv) the estimated final height of the person is within the normal range and within the expectations for the family of the person, where the target height range is +/-7.5 cm from mid parental height for a boy and +/-6.0 cm from mid parental height for a girl; and
[6]           Subsection 3(1) following definition of nominated dispenser
omit:
definition of older child
substitute:
non-mature skeleton – see subsection (2A)
older child means:
(a)      if the child is female – the child has:
(i) a chronological age of 10 years or more; or
(ii) a bone age of 8 years or more; and
(b)      if the child is male – the child has:
(i) a chronological age of 12 years or more; or
(ii) a bone age of 10 years or more.
 
[7]           Subsection 3(1) following definition of Turner Syndrome growth curve for girls
insert:
Turner Syndrome – Ranke growth velocity chart means Figure 4: Mean height velocities in patients with Turner Syndrome observed by different investigators (Ranke series) in the document titled Turner Syndrome: Spontaneous growth in 150 cases and review of literature  by Ranke et al, dated 1983 and published in European Journal of Paediatrics, volume 141, pages 81-88.
[8]           Following subsection 3(2)
insert:
                (2A) A person has a non-mature skeleton if:
                        (a) for a female – the person has a bone age of less than 13.5 years; and
                        (b) for a male – the person has a bone age of less than 15.5 years.   
[9]           Omit paragraph 3(4)(a)
insert:
 
(a)   for the height of a person in relation to the person’s age and sex (other than the 1st percentile for age and sex, the 1st adult height percentile, the 25th percentile for age and sex, or the 10th adult height percentile) is determined with reference to CDC 2000; and
 
[10]         Subsection 3(4)(c)
omit:
European
[11]         Omit subsection 3(5)
substitute:
(5) The 1st percentile for age and sex:
(a)   for a person who is younger than 24 months, is determined with reference to the document titled 1st percentile length for age values - children ages 0-3 years, published by the Department in 2011 and updated in 2014; and
(b)   for a person who is older than 2 and younger than 21, is determined with reference to the document titled 1st percentile stature for age values – children ages 2-20 years, published by the Department in 2011 and updated in 2014.
(6) The 25th percentile for age and sex:
(a)   for a person who is younger than 24 months, is determined with reference to the document titled 25th percentile length for age values - children ages 0-3 years, published by the Department in 2014; and
(b)   for a person who is older than 2 and younger than 21, is determined with reference to the document titled 25th percentile stature for age values – children ages 2-20 years, published by the Department in 2014.
[12]         Paragraph 8(1)(a)
omit:
19
substitute:
16
[13]         Paragraph 8(1)(b)
omit:
13
substitute:
16
 
[14]         Paragraph 9(a)
omit:
no repeats; or
substitute:
one repeat for a prescription that directs a supply, on one occasion, of  pharmaceutical benefit sufficient for a 16 week period; or
 
[15]         Paragraph 12(d) before the word treatment
insert:
initial
[16]         Following subsection 12(f)
omit:
            .
insert:
; or
(g)       the person is applying for initial or continuing treatment in a category mentioned in paragraph 11(2)(a), 11(2)(e), 11(2)(f) or 11(2)(g) and the person’s height has reached or exceeded the 10th adult height percentile.
 
[17]         Following subsection 15(5)
 
omit:
 
Note  The information mentioned in subsections (2), (4) and (5) for a category is in addition to the information required under subsection (1).
insert:
Applications for biochemical growth hormone deficiency
(6)     If the application is for initial treatment for a person in the category of biochemical growth hormone deficiency where the person is diagnosed with hypothalamic-pituitary disease secondary to a structural lesion and associated with other pituitary hormone deficits, the application must also include:
(a)     radiological evidence of structural hypothalamic-pituitary disease; and
(b)     details of other pituitary hormone deficits and adequacy of hormone replacement therapy; and
(c)     biochemical evidence of growth hormone deficiency (peak GH less than 10mU/L) with stable and adequate replacement of other hormone deficits at the time of testing.   
Note  The information mentioned in subsections (2), (4), (5) and (6) for a category is in addition to the information required under subsection (1).
[18]         Omit paragraph 16(4)(a)
substitute:
(a)        the person meets both the eligibility criteria for initial treatment and the continuing treatment criteria for the category for which treatment is being sought (under a provision in Division 5 of Part 2); and
 
[19]         Paragraph 19(1)(e)
omit:
19
substitute:
16
[20]         Following subsection 20(2)
 
insert:
 
(3)   Where:
(a)   a person has lodged an application for continuing treatment in a category (the relevant category); and
(b)   an eligibility criterion for continuing treatment in the relevant category, as set out in Division 5, provides that a person is no longer eligible to receive growth hormone treatment under this Special Arrangement if they have reached skeletal maturity; and
(c)   the Secretary forms the view that the person would otherwise be eligible for continuing treatment, but for the fact they have reached skeletal maturity;
                   the Secretary may
(i)    seek the expert advice of GHAC about whether continuing treatment is clinically appropriate for the person and the likely effectiveness of continuing treatment for the person; and
(ii)   after taking into account the advice from GHAC in subparagraph (i), determine that a person is still eligible to receive growth hormone treatment under this Special Arrangement for a further period of 26 weeks.
Note There is no limit to the times the Secretary may approve continuing treatment for a person under subparagraph 20(3)(c)(ii) in response to an application for continuing treatment in a category under Division 5.
[21]         Following paragraph 21(1)(c)
omit:
.
            insert:
            ;
(d)   the person achieves and maintains mid parental height standard deviation score.
 
[22]         Paragraph 21(3)
omit:
European
 
[23]         Following paragraph 27(1)(b)
insert:
 
Note 1  Where the growth velocity referred to in paragraph 27(1)(b) relates to an older child it will be measured at 6 months only in accordance with the definition of growth velocity in subsection 3(1).
Note 2 The term older child is defined in subsection 3(1).
 
[24]         Paragraph 27(2)(b)
omit:
1st percentile
insert:
            1st adult height percentile
 
[25]         Omit paragraph 28(c)
substitute:
(c)        where the person did not commence initial treatment on the maximum dose of the pharmaceutical benefit relevant to the category, and during the most recent treatment period, the person:
(i)      had been receiving the maximum dose of the pharmaceutical benefit relevant to the category; and
(ii)     did not meet at least one of the 4 response criteria set out in subsection 21(1); or
(d)        where the person commenced initial treatment on the maximum dose of the pharmaceutical benefit relevant to the category, and the person has already received treatment for two treatment periods, during the most recent treatment period, the person:
(i)      had been receiving the maximum dose of the pharmaceutical benefit relevant to the category; and
(ii)     did not meet at least one of the 4 response criteria set out in subsection 21(1).
 
[26]         Following paragraph 29(1)(c)
omit:
      .
insert:
; and
(d)       where the person has been diagnosed with hypothalamic-pituitary disease secondary to a structural lesion and associated with other pituitary hormone deficits:
(i)    there has been 12 months of observation of the person by a medical practitioner after completed treatment for the lesion including surgery, chemotherapy or radiotherapy, or a combination of these; or
(ii)  if a medical practitioner has advised that it was not safe to treat the lesion – there has been 12 months of observation of the person by a medical practitioner beginning from the diagnosis of the lesion.
 
[27]         Omit the Note following subsection 29(1)
  substitute:
Note 1 The term biochemical growth hormone deficiency is defined in subsection 3(1).
Note 2  Where the growth velocity referred to in paragraph 29(1)(b) relates to an older child it will be measured at 6 months only in accordance with the definition of growth velocity in subsection 3(1).
Note 3  The term older child is defined in subsection 3(1).
 
[28]         Following subsection 29(3)
insert:
                Eligibility for person with hypothalamic-pituitary disease secondary to a structural lesion and associated with other pituitary hormone deficits
 
(3A) The Secretary must assess a person’s eligibility for this category under section 20 (expert advice etc) if the person is diagnosed with hypothalamic-pituitary disease secondary to a structural lesion and associated with other pituitary hormone deficits and meets the criterion mentioned in paragraph (1) (c) but does not meet the criteria in paragraph (1) (a) or (b). 
 
[29]         Omit subsection 30(b)
substitute:
(b)        where the person did not commence initial treatment on the maximum dose of the pharmaceutical benefit relevant to the category, and during the most recent treatment period, the person:
(i)      had been receiving the maximum dose of the pharmaceutical benefit relevant to the category; and
(ii)     did not meet at least one of the 4 response criteria set out in subsection 21(1); or
(c)        where the person commenced initial treatment on the maximum dose of the pharmaceutical benefit relevant to the category, and the person has already received treatment for two treatment periods, during the most recent treatment period, the person:
(i)      had been receiving the maximum dose of the pharmaceutical benefit relevant to the category; and
(ii)     did not meet at least one of the 4 response criteria set out in subsection 21(1).
 
[30]         Following subsection 31(1)
   insert:
Note 1 Where the growth velocity referred to in paragraph 31(1)(c) relates to an older child it will be measured at 6 months only in accordance with the definition of growth velocity in subsection 3(1).
   Note 2 The term older child is defined in subsection 3(1).
 
[31]         Omit subparagraph 31(3)(b)(i)
substitute:
(i)                 has received cranial irradiation; and
 
[32]         Omit paragraph 32(b)
substitute:
(b)        where the person did not commence initial treatment on the maximum dose of the pharmaceutical benefit relevant to the category, and during the most recent treatment period, the person:
(i)      had been receiving the maximum dose of the pharmaceutical benefit relevant to the category; and
(ii)     did not meet at least one of the 4 response criteria set out in subsection 21(1); or
(c)        where the person commenced initial treatment on the maximum dose of the pharmaceutical benefit relevant to the category, and the person has already received treatment for two treatment periods, during the most recent treatment period, the person:
(i)      had been receiving the maximum dose of the pharmaceutical benefit relevant to the category; and
(ii)     did not meet at least one of the 4 response criteria set out in subsection 21(1).
 
[33]         Omit subsection 33(3)
 
substitute:
(3) However;
(a)     where section 20 refers to the GHAC, for the purposes of this section that reference includes a reference to any individual member of the GHAC; and
(b)     the Secretary may only assess the eligibility of the person under this category if the Secretary accepts, after receiving advice from the GHAC or any individual member of the GHAC, that the person’s hypoglycaemia is secondary to biochemical growth hormone deficiency.
[34]         Omit paragraph 34(1)(b)
substitute:
(b)        where the person did not commence initial treatment on the maximum dose of the pharmaceutical benefit relevant to the category, and during the most recent treatment period, the person:
(i)      had been receiving the maximum dose of the pharmaceutical benefit relevant to the category; and
(ii)     did not meet at least one of the 4 response criteria set out in subsection 21(1); or
(c)        where the person commenced initial treatment on the maximum dose of the pharmaceutical benefit relevant to the category, and the person has already received treatment for two treatment periods, during the most recent treatment period, the person:
(i)      had been receiving the maximum dose of the pharmaceutical benefit relevant to the category; and
(ii)     did not meet at least one of the 4 response criteria set out in subsection 21(1).
 
[35]         Omit paragraph 35(1)(b)
 
[36]         Omit subsections 35(2), (3) and (4)
 
substitute:
(2) However the Secretary must assess a person’s eligibility for this category under section 20 (expert advice etc) if the person:
(a)     has a chronological age or bone age of less than 2.5 years; or
(b)     is exhibiting significant catch-up growth, measured as either:
(i)    growth upwardly crossing height percentiles, as determined for the person with reference to the Turner Syndrome growth curve for girls, over the 12 months (or the six months where only six months of data is available for an older child) ending on the date the application is made; or
(ii)   growth velocity greater than the 50th percentile for bone age and sex, measured at both 12 month and 6 month intervals.
Note 1  Where the growth velocity referred to in paragraph 35(2)(b)(ii) relates to an older child it will be measured at 6 months only in accordance with the definition of growth velocity in subsection 3(1).
Note 2 The term older child is defined in subsection 3(1).
 
[37]         Omit paragraph 36(c)
substitute:
(c)        where the person did not commence initial treatment on the maximum dose of the pharmaceutical benefit relevant to the category, and during the most recent treatment period, the person:
(i)      had been receiving the maximum dose of the pharmaceutical benefit relevant to the category; and
(ii)     did not meet at least one of the response criteria set out in subparagraph 21(1)(a), (b) or (c); and
(iii)    growth velocity for bone age for the person is below the mean height velocity for age for a person who has Turner Syndrome and has not received growth hormone treatment, as determined using the Turner Syndrome –Ranke growth velocity chart; or
(d)        where the person commenced initial treatment on the maximum dose of the pharmaceutical benefit relevant to the category, and the person has already received treatment for two treatment periods, during the most recent treatment period, the person:
(i)      had been receiving the maximum dose of the pharmaceutical benefit relevant to the category; and
(ii)     did not meet at least one of the response criteria set out in subparagraph 21(1)(a), (b) or (c); and
(iii)    growth velocity for bone age for the person is below the mean height velocity for age for a person who has Turner Syndrome and has not received growth hormone treatment, as determined using the Turner Syndrome – Ranke growth velocity chart.
Note:   The term Turner Syndrome – Ranke growth velocity chart is defined in subsection 3(1).
[38]         Following subsection 37(1)
   insert:
Note 1  Where the growth velocity referred to in paragraph 37(1)(b) relates to  an older child it will be measured at 6 months only in accordance with the definition of growth velocity in subsection 3(1).  
   Note 2  The term older child is defined in subsection 3(1).
[39]         Omit paragraph 38(c)
substitute:
(c)        where the person did not commence initial treatment on the maximum dose of the pharmaceutical benefit relevant to the category, and during the most recent treatment period, the person:
(i)      had been receiving the maximum dose of the pharmaceutical benefit relevant to the category; and
(ii)     did not meet at least one of the 4 response criteria set out in subsection 21(1); or
(d)        where the person commenced initial treatment on the maximum dose of the pharmaceutical benefit relevant to the category, and the person has already received treatment for two treatment periods, during the most recent treatment period, the person:
(i)      had been receiving the maximum dose of the pharmaceutical benefit relevant to the category; and
(ii)     did not meet at least one of the 4 response criteria set out in subsection 21(1).
[40]         Following subsection 39(1)
   insert:
Note 1  Where the growth velocity referred to in paragraph 39(1)(b) relates to  an older child it will be measured at 6 months only in accordance with the definition of growth velocity in subsection 3(1).
Note 2  The term older child is defined in subsection 3(1).
[41]         Omit paragraph 40(c)
substitute:
(c)        where the person did not commence initial treatment on the maximum dose of the pharmaceutical benefit relevant to the category, and during the most recent treatment period, the person:
(i)      had been receiving the maximum dose of the pharmaceutical benefit relevant to the category; and
(ii)     did not meet at least one of the 4 response criteria set out in subsection 21(1); or
(d)        where the person commenced initial treatment on the maximum dose of the pharmaceutical benefit relevant to the category, and the person has already received treatment for two treatment periods, during the most recent treatment period, the person:
(i)      had been receiving the maximum dose of the pharmaceutical benefit relevant to the category; and
(ii)     did not meet at least one of the 4 response criteria set out in subsection 21(1).
 
[42]         Omit paragraph 42(b)
insert:
(b)        where the person did not commence initial treatment on the maximum dose of the pharmaceutical benefit relevant to the category, and during the most recent treatment period, the person:
(i)      had been receiving the maximum dose of the pharmaceutical benefit relevant to the category; and
(ii)     did not meet at least one of the 4 response criteria set out in subsection 21(1); or
(c)        where the person commenced initial treatment on the maximum dose of the pharmaceutical benefit relevant to the category, and the person has already received treatment for two treatment periods, during the most recent treatment period, the person:
(i)      had been receiving the maximum dose of the pharmaceutical benefit relevant to the category; and
(ii)     did not meet at least one of the 4 response criteria set out in subsection 21(1).
 
[43]         Omit paragraph 44(1)(b)
insert:
(b)        if the person did not commence initial treatment on the maximum dose of the pharmaceutical benefit relevant to the category, and during the most recent treatment period the person:
(i)      had been receiving the maximum dose of the pharmaceutical benefit relevant to the category; and
(ii)     did not meet at least one of the response criteria set out in the item of the table in subsection 45(1) that applies to the person; or
(c)        if the person commenced initial treatment on the maximum dose of the pharmaceutical benefit relevant to the category, and the person has already received treatment for two treatment periods, during the most recent treatment period, the person:
(i)      had been receiving the maximum dose of the pharmaceutical benefit relevant to the category; and
(ii)     did not meet at least one of the  response criteria set out in the item of the table in subsection 45(1) that applies to the person.
 
[44]         Following subsection 44(2)
insert:
Persons with uncontrolled morbid obesity
(3)        If a person has uncontrolled morbid obesity the Secretary must assess the person’s eligibility for this category under section 20 (expert advice etc).
Note The term uncontrolled morbid obesity is defined in subsection 3(1).
 
[45]         Omit subsection 46(2)
substitute:
(2)        The measurement ‘m2’, in the table in section 47, refers to:
(a) where a person is:
(i) mentioned in item 1 or 2, ; or
(ii) mentioned in item 3 or 4 and has a body mass index less than the 85th percentile for age and sex;
a square meter of the body surface of the person area calculated by weight; or
(b) where a person is:
(i) mentioned in item 3 or 4 of the table; and
(ii) has a body mass index greater than the 85th percentile for age and sex, 
a square metre of the body surface area of the person, calculated by ideal weight for height (kg).
Note:   This Division is not relevant for a person who is not approved by the Secretary for initial or continuing treatment.
 
[46]         Omit subsection 47(1)
insert:
(1)          The Secretary must determine, for each application made under section 13 that the Secretary approves, the dose of pharmaceutical benefit that is appropriate for treatment of the person the subject of the application, in accordance with the table in this section and this Division.
 
(1A) The Secretary must determine, for each application made under section 14, 16 or 24 that the Secretary approves, the dose of pharmaceutical benefit that is appropriate for treatment of the person the subject of the application, in accordance with the table in this section and this Division, which may be:
(a)    a continuation of the dose the person was receiving during their most recent treatment period; or
(b)   an increase on the dose the person was receiving during their most recent treatment period; or
(c)    a decrease on the dose the person was receiving during their most recent treatment period.
 
[47]         Omit the table in subsection 47(1)
substitute:
 
Item
A person approved for treatment ...
... may be approved for the following dose level of a pharmaceutical benefit:

1
in the category of:
(a) short stature and slow growth; or
(b) biochemical growth hormone deficiency; or
(c) growth retardation secondary to an intracranial lesion or secondary to cranial irradiation for the lesion; or
(d) infant at risk of hypoglycaemia secondary to biochemical growth hormone deficiency; or
(e) growth hormone deficiency and precocious puberty
(a) 4.5mg/m2/week (dose level 1); or
(b) 6.0mg/m2/week (dose level 2); or
(c) 7.5mg/m2/week (dose level 3).

2
in the category of:
(a) Turner Syndrome; or
(b) short stature due to short stature homeobox (SHOX) gene disorders; or
(c) chronic renal insufficiency
between 4.5mg/m2/week and 9.5mg/m2/week

3
in the category of Prader‑Willi Syndrome, who has a non‑mature skeleton
(a) 4.5mg/m2/week (dose level 1); or
(b) 6.0mg/m2/week (dose level 2); or
(c) 7.5mg/m2/week (dose level 3)

4
in the category of Prader‑Willi Syndrome, who has a mature skeleton
(a) 0.04mg/kg/week; or
(b) a higher dose if it is approved under subsection (3); or
(c) a lower dose if it is approved under subsection (4).

 
[48]         Following Subsection 47(3)
insert:
(4)   For paragraph (c) of item 4 of the table in this section, the Secretary must approve a lower dose, calculated as 0.04mg by ideal weight for height (kg) by week, if the person’s body mass index is greater than the 85th percentile for age and sex.
 
[49]         Subsection 49(2) following ‘(4)’
Insert:
or (4A)
 
[50]          Following the note under subsection 49(4)
Insert:
            (4A)     A person is eligible for dose level 2 if:
(a)    the person is an older child; and
(b)   the person is in the category of:
(i)   biochemical growth hormone deficiency; or
(ii) growth retardation secondary to an intracranial lesion or secondary to cranial irradiation for the lesion; or
(iii) growth hormone deficiency and precocious puberty.
 
[51]         Subsection 50(1), following (b)
omit:
                ; and
(c) either:
  (i) meets at least one of the response criteria; or
  (ii) achieves and maintains mid parental height standard deviation score.
Note:       The term response criteria is explained in section 21.
insert:
.
[52]         Omit the note following subsection 50(2)
substitute:
Note: This Division 6 is not relevant for a person who does not meet the continuing treatment provisions for the relevant category in Division 5.
[53]         Omit heading to section 51
Insert:
Dose for item 1 – not on maximum dose during the most recent treatment period
[54]         Omit subsection 51(1)
            substitute:
(1)        The Secretary may approve a person who is mentioned in item 1 of the table in section 47 and who has not been on the maximum dose of a pharmaceutical benefits in the person’s most recent treatment period, to receive, for a continuing treatment period, a pharmaceutical benefit at the next highest dose level listed in the table for that item (the next available dose) only if:
(a)   the person’s treating practitioner requests a higher dose and the person is an older child; or
(b)   the person has a bone age reading of 2.5 years or greater; and
(i)  failed to achieve growth velocity greater than the 90th percentile for bone age and sex measured over the most recent six month period where the person has received treatment for two or less treatment periods; or
(ii)   failed to achieve growth velocity greater than the 75th percentile for bone age and sex over the most recent treatment period where the person has received treatment for three or more treatment periods; or
(c)   the person has:
(i)   a bone age reading of less than 2.5 years; and
(ii) a height standard deviation score that is 0.25 standard deviations or less than the person’s height standard deviation score prior to the most recent treatment period; or
(d)   the person’s treating practitioner requests a higher dose; and
(i)    GHAC or a Departmental medical adviser advises there are exceptional circumstances that justify the higher dose; and
(ii)   the Secretary determines a higher dose for the person is appropriate after having regard to the advice of the GHAC or the Departmental medical adviser.
 
[55]         Omit subsection 51(2)
substitute:
(2)        However, the Secretary may approve a person to receive a higher dose than the next available dose, but only if:
(a)  the person’s treating practitioner requests a higher dose and the person is an older child; or
(b)  the person’s treating practitioner requests a higher dose; and
(i) GHAC or a Departmental medical adviser advises there are exceptional circumstances that justify the higher dose; and
(ii) the Secretary determines a higher dose for the person is appropriate after having regard to the advice of GHAC or the Departmental medical adviser.
 
[56]         Omit section 52
substitute
52 - Dose for item 1 – same dose level
 (1)       This section applies if the Secretary is determining the dose of pharmaceutical benefit for the continuing treatment of a person who is mentioned in item 1 of the table in section 47.
 (2)       Unless section 51 applies to the person, the Secretary must approve the person to receive only the same dose level of pharmaceutical benefit approved for the person’s most recently completed treatment period.
[57]                     Subsection 53(1) following the words ‘benefit for the’
insert:
            initial or
[58]         Following Subsection 53(3)
insert:
(4)     The higher dose mentioned in subsection (3) cannot exceed the maximum dose that is permitted under the table in section 47 for a category of treatment mentioned in item 2 of that table.
[59]         Note 2 following the table in section 54                                
omit:
            46
            insert:
            45
[60]         Paragraph 55(1)(b) following ‘using the’
            omit:
            response
[61]         Omit the note at the end of subsection 55(2)
            substitute:
Note 1 The table in subsection 47(1) provides for the maximum dose that is available for a category of growth hormone treatment.
Note 2 For the purposes of paragraph 55(1)(b), the criteria relevant to the person’s most recently completed treatment period are described in sections 49 to 54.
[62]         Omit sections 56 and 57
substitute:
56  Dose for recommenced treatment –  category other than Prader-Willi Syndrome
(1)  This section applies if a person has been approved for recommencement of growth hormone treatment, under section 24 (including if a change in patient category has been approved under subsection 24 (1) (b)), in a category mentioned in item 1 or 2 in the table in section 47.
(2)  The Secretary may approve only the dose level of pharmaceutical benefit that has most recently been approved for the person before the person’s most recent treatment had ceased, unless the person is eligible for another dose under the dose provisions mentioned in the table in section 47 or the dose provisions set out in sections 49-53.
            57 Dose for recommenced treatment – Prader-Willi Syndrome
(1)   This section  applies if a person has been approved for recommencement of growth hormone treatment, under section 24 (including if a change in patient category has been approved under subsection 24 (1) (b)), in a category mentioned in item 3 or 4 in the table in section 47.
(2)  The Secretary may approve only the dose level of pharmaceutical benefit that has most recently been approved for the person before the person’s most recent treatment had ceased, unless the person is eligible for another dose under the dose provisions mentioned in the table in section 47 or the dose provisions set out in sections 49 and 54.
[63]         Subsection 64(3)
            omit:
            first 19 weeks
            Substitute:
            first 16 weeks
 
[64]         Omit sections 66, 67 and 68
            substitute:
 
66        Pending decisions under this Special Arrangement
(1)     This section applies if the Secretary has received from a treating practitioner of a person an application for approval of growth hormone treatment for the person under section 13, 14, 16 or 24 prior to 1 March 2014.
 
Applications to approve treatment
(2)     When making a decision to:
(a)   approve a person to receive growth hormone treatment under section 13, 14, 16 or 24; or
(b)   determine the dose of pharmaceutical benefit for the growth hormone treatment of a person subject of an application under Division 6 of Part 2;
the Secretary must apply this Special Arrangement as in force at 28 February 2014.
 
Applications for internal review
(3)     Under section 58 when reviewing a decision:
(a)   not to approve a person to receive growth hormone treatment under section 13, 14, 16 or 24; or
(b)   under Division 6 of Part 2 determining the dose of pharmaceutical benefit for the growth hormone treatment of a person subject of an application:
the Secretary must apply this Special Arrangement as in force at 28 February 2014.
Note  For the purposes of subsection 66(3), the application for internal review under subsection 58(2) may be made any time after 28 February 2014 pursuant to the requirement in paragraph 58(2)(a).  
 
67        Transitional dose provisions for patients on dose level 2, 3 or 4
 
(1)       If immediately before 1 March 2014 a person was receiving dose level 2 or dose level 3, and on or after 1 March 2014 the person becomes eligible for an incremental dose increase, then at the time of that incremental dose increase the person will be eligible to receive dose level 3 as set out in the table in section 47.
(2)        If immediately before 1 March 2014 a person was receiving dose level 4 and
on or after 1 March 2014 the Secretary approves growth hormone treatment for the person under sections 14, 16 or 24, then the person will be eligible to receive dose level 3 as set out in the table in section 47.          
 
[65]         Schedule 1, omit entry for:
Somatropin with Form ‘Injection 5mg (15 i.u.) in 1 mL cartridge (with preservative)’ Manner of Administration ‘Injection’ and Brand ‘Genotropin’.
 
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