PB 88 of 2011
National Health (Growth Hormone Program) Special Arrangement 20111
National Health Act 1953
I, FELICITY MCNEILL, Acting First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this Special Arrangement under subsection 100 (1) of the National Health Act 1953.
Dated 28 November 2011
FELICITY MCNEILL
Acting First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing
Contents
Part 1 Preliminary
1 Name of Special Arrangement 4
2 Commencement 4
3 Definitions 4
4 Pharmaceutical benefits covered by this Special Arrangement 9
5 Application of Part VII of the Act 9
6 Responsible person 10
7 Authorised prescriber 10
8 Maximum quantity 11
9 Maximum number of repeats 11
10 Section 100 only supply 12
Part 2 Growth hormone program
Division 1 Eligible persons
11 Eligible persons 13
12 Exclusion criteria 13
Division 2 Applications
Subdivision 1 Applications for initial and continuing treatment
13 Application for initial treatment 14
14 Application for continuing treatment 14
15 Information for applications for initial treatment 15
Subdivision 2 Applications for a change of category
16 Application requesting a change of category 17
17 Information for applications requesting change of category 18
Division 3 Assessing applications
18 Secretary may ask for further information or may reject incomplete application 18
19 Notice of decision on application 19
20 Secretary to consider expert advice and other matters 19
21 Response criteria 20
22 Non-compliance with treatment 20
Division 4 Cessation of treatment and recommencement
23 Ceasing treatment 21
24 Application to recommence treatment 22
25 Recommencement applications — content 23
26 Assessing recommencement applications 23
Division 5 Eligibility criteria for initial treatment and continuing treatment
27 Short stature and slow growth — initial treatment 24
28 Short stature and slow growth — continuing treatment 25
29 Biochemical growth hormone deficiency — initial treatment 25
30 Biochemical growth hormone deficiency — continuing treatment 26
31 Growth retardation secondary to an intracranial lesion or cranial irradiation — initial treatment 27
32 Growth retardation secondary to an intracranial lesion or cranial irradiation — continuing treatment 28
33 Infant at risk of hypoglycaemia secondary to biochemical growth hormone deficiency — initial treatment 28
34 Infant at risk of hypoglycaemia secondary to biochemical growth hormone deficiency — continuing treatment 29
35 Turner Syndrome — initial treatment 29
36 Turner Syndrome — continuing treatment 30
37 Short stature due to short stature homeobox (SHOX) gene disorders — initial treatment 30
38 Short stature due to short stature homeobox (SHOX) gene disorders — continuing treatment 31
39 Chronic renal insufficiency — initial treatment 31
40 Chronic renal insufficiency — continuing treatment 32
41 Growth hormone deficiency and precocious puberty — initial treatment 33
42 Growth hormone deficiency and precocious puberty — continuing treatment 33
43 Prader‑Willi Syndrome — initial treatment 33
44 Prader‑Willi Syndrome — continuing treatment 34
45 Prader‑Willi Syndrome — response criteria 35
Division 6 Dosage of pharmaceutical benefit
Subdivision 1 General
46 Definition 36
47 Assessment of dosage of pharmaceutical benefit 36
48 Compliance with treatment 38
Subdivision 2 Initial treatment dose for items 1 and 3
49 Dose for items 1 and 3 38
Subdivision 3 Assessing dose for continuing treatment
50 Dose for items 1 and 2 — on maximum dose 39
51 Dose for item 1, not on maximum dose — not all response criteria met 39
52 Dose for item 1, not on maximum dose — all response criteria met 40
53 Dose for item 2 — not on maximum dose 40
54 Dose for Prader‑Willi Syndrome 41
Subdivision 4 Assessing dose for change of treatment
55 Dose for change of treatment category 43
Subdivision 5 Assessing dose for recommenced treatment
56 Dose for recommenced treatment in the same category 44
57 Dose for recommenced treatment in different category 45
Division 7 Review of decisions
58 Internal review 47
Part 3 Supply for the growth hormone program
59 No co‑payment 49
60 Supply of PB under this Special Arrangement 49
61 Supply of pharmaceutical benefit — requirements of responsible person, Secretary 50
62 Modifications to the Regulations 51
63 Dispensing PB — first presentation of prescription 51
64 Repeat supplies 52
65 Payment from Commonwealth 52
Part 4 Transitional provisions
66 Pending applications for growth‑hormone treatment 54
67 Next following application for person receiving treatment under Health‑administered GHP 54
68 Pharmaceutical benefit supplied under Health‑administered GHP — claim for payment 55
Schedule 1 Pharmaceutical benefits covered by this Special Arrangement and related information 57
Schedule 2 Responsible person codes 61
Part 1 Preliminary
1 Name of Special Arrangement
(1) This Special Arrangement is the National Health (Growth Hormone Program) Special Arrangement 2011.
(2) This Special Arrangement may also be cited as PB 88 of 2011.
2 Commencement
This Special Arrangement commences on 1 December 2011.
3 Definitions
(1) In this Special Arrangement:
1st percentile for age and sex — see subsection (5).
10th adult height percentile means:
(a) 155.02 cm for a female; and
(b) 167.66 cm for a male.
Act means the National Health Act 1953.
authorised prescriber, for a pharmaceutical benefit, means a person who is a kind of person identified by a prescriber code mentioned in the column in Schedule 1 headed ‘Authorised Prescriber’ for the benefit.
Note Section 4 sets out the pharmaceutical benefits to which this Special Arrangement applies and section 7 sets out the prescriber code for the pharmaceutical benefits.
biochemical growth hormone deficiency means the insufficient production of growth hormone by the body, determined by growth hormone concentrations of less than 10m U/L, in response to:
(a) two pharmacological tests, for example, arginine, clonidine, glucagon, or insulin; or
(b) one pharmacological test and one physiological test, for example, sleep or exercise; or
(c) one test that is either pharmacological or physiological, in combination with other evidence of growth hormone deficiency such as:
(i) structural central nervous system abnormalities known to be associated with growth hormone deficiency; or
(ii) low plasma insulin‑like growth factor 1 levels; or
(iii) insulin‑like growth factor binding protein 3 levels.
category, for treatment of a person, means a category, mentioned in subsection 11 (2), for which the person may be approved to receive growth hormone treatment under this Special Arrangement.
CDC 2000 means the growth charts in the document entitled 2000 CDC Growth Charts for the United States: Methods and Development, published by the Centers for Disease Control and Prevention, US Department of Health and Human Services, dated May 2002, and available on that Department’s website at http://www.cdc.gov/GROWTHcharts.
continuing treatment means:
(a) continuing treatment approved under section 14; or
(b) continuing treatment in a different category for treatment approved under section 16.
eligibility criteria, for a category mentioned in subsection 11 (2), means the criteria set out in Division 5 of Part 2 that a person must meet to be eligible to be approved for treatment under that category.
eligible person means a person who meets the requirements of section 11.
existing stock of pharmaceutical benefit, for a person and a treatment period, means the stock of pharmaceutical benefit that the Department has ordered, from a responsible person in relation to the pharmaceutical benefit, for growth hormone treatment of the person for:
(a) the first 19 weeks of an initial treatment period; or
(b) the first 13 weeks of:
(i) a continuing treatment period; or
(ii) a period of recommenced treatment.
GHAC means the committee in the Department, known as the Growth Hormone Advisory Committee, that:
(a) gives clinical advice to the Department about the matters referred to it under this Special Arrangement; and
(b) includes 5 medical practitioners, each of whom is either a specialist paediatric endocrinologist or a specialist paediatrician.
growth hormone program means:
(a) this Special Arrangement; or
(b) the Health‑administered GHP.
growth hormone treatment, for a person, means treatment of the person using a pharmaceutical benefit in accordance with this Special Arrangement.
growth velocity means the amount a person has grown in the year ending on the day the person’s treating practitioner takes the measurements that are submitted as growth data for the person in an application under this Special Arrangement.
Health‑administered GHP means the Growth Hormone Program that was administered by the Department before the commencement of this Special Arrangement.
ideal weight for height, for a person, means the person’s 50th percentile weight for height calculated using the growth charts in CDC 2000.
initial treatment means treatment approved under section 13.
maturational or constitutional delay means a temporary delay in skeletal growth, and is identified:
(a) for all persons, if:
(i) growth velocity is below the 25th percentile for bone age and sex; and
(ii) there is absence of evidence of pathological conditions that are identified using clinical tests such as growth hormone stimulation tests, thyroid stimulation hormone, free thyroxine 4, coeliac screening or karyotype; and
(iii) bone age is delayed by 2 years or more; and
(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
(b) for a girl who is 12 or older, or a boy who is 14 or older, if:
(i) paragraph (a) applies; and
(ii) the onset of puberty is delayed.
mature skeleton — see subsection (2).
maximum dose, for a category for treatment and a pharmaceutical benefit, means the highest dose of the pharmaceutical benefit that can be approved under the table in section 47 for the category.
medical practitioner has the meaning it has in the Health Insurance Act 1973.
mid parental height — see subsection (3).
National Law means:
(a) for a State or Territory other than Western Australia — the Health Practitioner Regulation National Law set out in the Schedule to the Health Practitioner Regulation National Law Act 2009 of Queensland as it applies (with or without modifications) as a law of the State or Territory; and
(b) for Western Australia — the legislation enacted by the Health Practitioner Regulation National Law (WA) Act 2010 of Western Australia that corresponds to the Health Practitioner Regulation National Law.
nominated dispenser has the meaning given in section 60.
older child means:
(a) if the child is female — the child has:
(i) a chronological age of 12.5 years or more; or
(ii) a bone age of 10.5 years or more; and
(b) if the child is male — the child has:
(i) a chronological age of 14.5 years or more; or
(ii) a bone age of 12.5 years or more.
other Special Arrangement means another Special Arrangement under section 100 of the Act.
percentile — see subsection (4).
pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.
precocious puberty means puberty occurring in a person at an unusually early age, and is identified:
(a) for a female:
(i) by the onset of puberty before the chronological age of 8, demonstrated by Tanner stage 2 breast or pubic hair development; or
(ii) by the onset of menarche before the age of 10; and
(b) for a male, by the onset of puberty before the chronological age of 9, demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mls.
prescriber code has the meaning given by paragraph 7 (3) (c).
recommenced treatment means treatment approved under section 24.
Regulations means the National Health (Pharmaceutical Benefits) Regulations 1960.
response criteria has the meaning given in section 21.
specialist paediatric endocrinologist means a medical practitioner who holds specialist registration under the National Law in the specialty of paediatric endocrinology.
specialist paediatrician means a medical practitioner who holds specialist registration under the National Law in the specialty of general paediatrics.
treating practitioner, of a person:
(a) for Division 6 of Part 2 — has the meaning given in section 46; and
(b) for this Special Arrangement apart from Division 6 of Part 2, means:
(i) the medical practitioner who submitted the most recent application for the person under section 13, 14, 16 or 24; or
(ii) if that medical practitioner is no longer treating the person:
(A) a specialist paediatric endocrinologist or specialist paediatrician who is currently treating the person; or
(B) a medical practitioner who is currently treating the person in consultation with that specialist.
Note Division 6 of Part 2 contains provisions about the dosage of pharmaceutical benefit that can be approved for a person following an application.
treatment period means:
(a) an initial treatment period, approved under section 13; or
(b) a continuing treatment period, approved under section 14; or
(c) a continuing treatment period in a different category for treatment, approved under section 16; or
(d) a period of recommenced treatment, approved under section 24.
Turner Syndrome growth curve for girls means the Turner Syndrome height charts in the document titled Growth curve for girls with Turner Syndrome by AJ Lyon, MA Preece and DB Grant, dated 1985 and published in Archives of Disease in Childhood, volume 60.
uncontrolled morbid obesity, means a body weight high enough to pose a severe risk to health, and is identified if a person’s body weight is greater than 200% of ideal weight for height.
Note Terms used in this Special Arrangement have the same meaning as in the Act — see section 13 of the Legislative Instruments Act 2003. These terms include:
· approved medical practitioner
· brand
· listed drug
· pharmaceutical benefit
· pharmaceutical item
· responsible person.
(2) A person has a mature skeleton if:
(a) for a female — the person has a bone age of 13.5 years or more; and
(b) for a male — the person has a bone age of 15.5 years or more.
(3) The mid parental height of a person is calculated by:
(a) adding together the height of the person’s biological parents; and
(b) if the person is female — subtracting 13 cm; and
(c) if the person is male — adding 13 cm; and
(d) dividing the result by 2.
(4) The percentile:
(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, or the 10th adult height percentile) is determined with reference to CDC 2000; and
(b) in relation to the body mass index of a person, is determined with reference to CDC 2000; and
(c) for the growth velocity of a person as it relates the person’s bone age and sex is determined using the charts of Tanner and Davies, published in the European Journal of Paediatrics, Volume 107, Issue 3 in September 1985.
(5) The 1st percentile for age and sex:
(a) for a person who is 1 or younger, is determined with reference to the document titled 1st percentile height values — children ages 0‑3 years, published by the Department in 2011; and
(b) for a person who is older than 1 and younger than 21, is determined with reference to the document titled 1st percentile height values — children ages 2‑20 years, published by the Department in 2011.
Note The documents mentioned in subsection (5) are available on the Department’s website at www.health.gov.au.
4 Pharmaceutical benefits covered by this Special Arrangement
(1) This Special Arrangement applies to each pharmaceutical benefit mentioned in Schedule 1.
(2) Each pharmaceutical benefit to which this Special Arrangement applies is a brand of a listed drug mentioned in Schedule 1:
(a) in the form mentioned in Schedule 1 for the listed drug; and
(b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
Note Each listed drug mentioned in Schedule 1 has been declared by the Minister under subsection 85 (2) of the Act. The form, manner of administration and brand mentioned in Schedule 1 have been determined by the Minister under subsections 85 (3), (5) and (6) of the Act respectively.
5 Application of Part VII of the Act
(1) Each pharmaceutical benefit supplied in accordance with this Special Arrangement is supplied under Part VII of the Act.
(2) A provision of Part VII of the Act, or of regulations or other instruments made for Part VII of the Act, applies subject to this Special Arrangement.
Note See subsection 100 (3) of the Act.
6 Responsible person
(1) If a code is mentioned in the column in Schedule 1 headed ‘Responsible Person’ for a brand of a pharmaceutical item, the person mentioned in paragraph (2) (a) is the responsible person for the brand of the pharmaceutical item.
(2) For subsection (1):
(a) the person is the person mentioned in Schedule 2 for the code, with the ABN, if any, mentioned in Schedule 2 for the person; and
(b) the pharmaceutical item is the listed drug mentioned in Schedule 1:
(i) in the form mentioned in Schedule 1 for the listed drug; and
(ii) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
Note 1 A person identified by a code in the column in Schedule 1 headed ‘Responsible Person’ in Schedule 1 has been determined by the Minister, under section 84AF of the Act, to be the responsible person for the brand of the pharmaceutical item.
Note 2 The pharmaceutical benefits mentioned in Schedule 1 are also brands of a pharmaceutical item: see paragraph (d) of the definition of pharmaceutical benefit in section 84 of the Act.
7 Authorised prescriber
(1) Only an authorised prescriber may write a prescription for the supply of a pharmaceutical benefit to an eligible person under this Special Arrangement.
(2) For subsection (1), the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:
(a) in the form mentioned in Schedule 1 for the listed drug; and
(b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
(3) For this Special Arrangement:
(a) an authorised medical practitioner is a practitioner mentioned in subsection (4) or (5); and
(b) only an authorised medical practitioner is an authorised prescriber; and
(c) the prescriber code for the authorised prescriber is the letters ‘AMP’.
(4) A specialist paediatric endocrinologist or specialist paediatrician is an authorised medical practitioner:
(a) for a person approved to receive initial treatment under section 13; and
(b) for a person approved to receive continuing treatment in a different category for treatment under section 16; and
(c) for a person approved to receive recommenced treatment under section 24.
(5) A specialist paediatric endocrinologist or specialist paediatrician (the specialist practitioner), or a medical practitioner in consultation with a specialist practitioner, is an authorised medical practitioner for a person approved to receive continuing treatment under section 14.
(6) An authorised prescriber:
(a) must not, for any week, prescribe more than the dose of a pharmaceutical benefit approved for a person under Division 6 of Part 2; and
(b) may prescribe less than the dose approved as mentioned in paragraph (a).
(7) Subsection 88 (1) of the Act does not apply to a supply of a pharmaceutical benefit under this Special Arrangement.
8 Maximum quantity
(1) The maximum quantity or number of units of the pharmaceutical benefit that may, in one prescription, be directed to be supplied on any one occasion is an amount that is sufficient for:
(a) the first 19 weeks of treatment of a person during an initial treatment period; or
(b) if a prescription mentioned in paragraph (a) has already been written for the person for the treatment period — the remaining 13 weeks of treatment of the person for that treatment period; or
(c) 13 weeks of treatment of a person during a continuing treatment period or a period of recommenced treatment.
(2) However, the maximum quantity or number of units that may, in one prescription, be directed to be supplied on any one occasion may be an amount that is sufficient for treatment of a person for the whole of a treatment period, if:
(a) there are exceptional circumstances; and
(b) it is approved by the Secretary.
9 Maximum number of repeats
The maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated is:
(a) for a prescription for initial treatment of a person — no repeats; or
(b) for a prescription for continuing treatment or recommenced treatment of a person:
(i) one repeat for a prescription that directs a supply, on one occasion, of pharmaceutical benefit sufficient for a 13 week period; or
(ii) no repeats for a prescription that directs a supply, on one occasion, of pharmaceutical benefit sufficient for a 26 week period.
10 Section 100 only supply
(1) If the letter ‘D’ is mentioned in the column in Schedule 1 headed ‘Section 100 only’ for a listed drug, the listed drug may be supplied only in accordance with this Special Arrangement and any other Special Arrangement relating to the listed drug.
(2) A pharmaceutical benefit that has a drug mentioned in subsection (1) is not available for general supply on the Pharmaceutical Benefits Scheme.
Note The Minister has declared, under subsection 85 (2A) of the Act, that the listed drug can only be supplied under a section 100 Special Arrangement.
Part 2 Growth hormone program
Division 1 Eligible persons
11 Eligible persons
(1) A person is eligible to receive a pharmaceutical benefit under this Special Arrangement only if the person:
(a) is an eligible person within the meaning of the Health Insurance Act 1973; and
(b) is not excluded from growth hormone treatment under section 12; and
(c) is approved by the Secretary under section 13, 14, 16 or 24 to receive growth hormone treatment in a category mentioned in subsection (2).
(2) For subsection (1), the categories are as follows:
(a) short stature and slow growth;
(b) biochemical growth hormone deficiency;
(c) growth retardation secondary to an intracranial lesion, or secondary to cranial irradiation for the lesion;
(d) infant at risk of hypoglycaemia secondary to biochemical growth hormone deficiency;
(e) Turner Syndrome;
(f) short stature due to short stature homeobox (SHOX) gene disorders;
(g) chronic renal insufficiency;
(h) growth hormone deficiency and precocious puberty;
(i) Prader‑Willi Syndrome.
12 Exclusion criteria
A person is excluded from growth hormone treatment if any of the following apply:
(a) the person has a known malignancy or has a heightened risk of developing a malignancy, including as a result of a chromosomal abnormality such as Down Syndrome or Bloom Syndrome;
(b) the person has an active tumour or there is evidence of tumour growth or tumour activity for the person;
(c) the person is diagnosed with diabetes mellitus, unless the person is applying for treatment under the biochemical growth hormone deficiency category;
(d) the person is applying for treatment under any category mentioned in subsection 11 (2) other than Prader‑Willi Syndrome and has:
(i) skeletal maturity; or
(ii) maturational or constitutional delay and an estimated mature height in at least the 1st percentile;
(e) if the person is the subject of an application for initial treatment under section 13 — the person has previously received treatment under the growth hormone program;
(f) the Secretary considers that treatment with the pharmaceutical benefit would be unsafe for the person for a reason not dealt with in the eligibility criteria for the category applied for.
Note A person whose growth hormone treatment has ceased may apply for the recommencement of treatment under section 24.
Division 2 Applications
Subdivision 1 Applications for initial and continuing treatment
13 Application for initial treatment
(1) The treating specialist paediatric endocrinologist or specialist paediatrician of a person may apply to the Secretary for approval of growth hormone treatment for the person in a category mentioned in subsection 11 (2).
(2) The application must:
(a) be in a form approved by the Secretary for this section; and
(b) include the information mentioned in section 15.
(3) The Secretary may approve the treatment only:
(a) if the person meets the eligibility criteria for initial treatment for the category under a provision in Division 5; and
(b) if the expert advice of GHAC or a Departmental medical adviser is required under the eligibility criteria — if the Secretary thinks appropriate after considering the advice; and
(c) for a period of 32 weeks (the initial treatment period).
Note Sections 27, 29, 31, 33, 35, 37, 39, 41 and 43 set out the eligibility criteria for initial treatment for the categories mentioned in subsection 11 (2).
(4) Within 6 weeks after receiving the application, the Secretary must tell the applicant, in writing:
(a) whether the Secretary approves the treatment; or
(b) that the Secretary requires an additional time to consider the application.
14 Application for continuing treatment
(1) The treating specialist paediatric endocrinologist or specialist paediatrician of a person who is receiving growth hormone treatment in a category may apply to the Secretary to approve continuing treatment for the person under that category.
(2) The application may instead be made by a medical practitioner in consultation with the person’s treating specialist paediatric endocrinologist or specialist paediatrician.
(3) The application must:
(a) be in a form approved by the Secretary for this section; and
(b) be given to the Secretary at least 4 weeks, or a shorter time agreed by the Secretary, before the pharmaceutical benefit supplied for the person’s current treatment period is due to run out.
(4) The Secretary may approve the continuing treatment only:
(a) if the person is eligible to be approved for continuing treatment for the category under a provision in Division 5; and
(b) for a person mentioned in subsection 34 (2) — if the Secretary thinks appropriate after considering expert advice about the person from GHAC or a Departmental medical adviser; and
(c) if subsection 22 (2) (about non‑compliance with treatment) does not apply to the person.
Note Sections 28, 30, 32, 34, 36, 38, 42 and 44 provide for when a person is eligible to be approved to receive continuing treatment in a category mentioned in subsection 11 (2).
(5) The Secretary may approve the continuing treatment only for a further period of 26 weeks (the continuing treatment period):
(a) beginning on the expiration of the person’s current treatment period; or
(b) if the person’s most recent treatment period has ended — beginning on the date the Secretary approves the application.
(6) Within 4 weeks after receiving the application, the Secretary must tell the applicant, in writing;
(a) whether the Secretary approves the continuing treatment; or
(b) that the Secretary requires an additional time to consider the application.
15 Information for applications for initial treatment
General
(1) An application for initial treatment made under section 13 must include a letter with details of the person’s medical history, including the following information relevant to the category for treatment for which the person is applying:
(a) medical history;
(b) social history;
(c) investigations;
(d) concurrent medication.
Applications for hypoglycaemia secondary to biochemical growth hormone deficiency
(2) If the application is for initial treatment for a person in the category of infant at risk of hypoglycaemia secondary to biochemical growth hormone deficiency, it must also contain the following information:
(a) the clinical risk factors for the person, for example, birth asphyxia, breech birth, severe central nervous system infection, midline central nervous system defect or tumour;
(b) clinical evidence of pituitary insufficiency for the person;
(c) biochemical data for the person, including serum concentrations of growth hormone and cortisol during hypoglycaemia, or serum concentrations of Free thyroxine 4 and Thyroid stimulation hormone or both;
(d) the results of any central nervous system imaging if they are available for the person.
Examples for paragraph (2) (b)
(3) For paragraph (2) (b), examples of evidence are as follows:
(a) prolonged neonatal jaundice;
(b) neonatal hypoglycaemia or a history that is suggestive of subsequent hypoglycaemia;
(c) temperature instability;
(d) evidence of a mid-line defect such as cleft palate, high arched palate or mid‑facial hypoplasia;
(e) presence of micropenis;
(f) documented diabetes insipidus.
Applications for growth hormone deficiency and precocious puberty
(4) If the application is for initial treatment for a person in the category of growth hormone deficiency and precocious puberty, it must also contain:
(a) information about Gonadotrophin Releasing Hormone or other similar therapy that the person has received or is receiving; and
(b) the date of the commencement of that therapy; and
(c) information about the adequacy of pubertal suppression.
Applications for Prader‑Willi Syndrome
(5) If the application is for initial treatment for a person in the category of Prader‑Willi Syndrome, it must also contain growth data taken on 2 separate occasions in the immediately preceding 6 months.
Note The information mentioned in subsections (2), (4) and (5) for a category is in addition to the information required under subsection (1).
Subdivision 2 Applications for a change of category
16 Application requesting a change of category
(1) The treating specialist paediatric endocrinologist or specialist paediatrician of a person who is receiving growth hormone treatment in a category may apply to the Secretary to approve treatment for the person in a different category.
(2) The Secretary may seek the advice of GHAC or a Departmental medical adviser about whether a change of category is appropriate for the person.
(3) The Secretary may approve the treatment only if subsection (4) or (5) applies to the person.
(4) This subsection applies if:
(a) the person meets the eligibility criteria for initial treatment for the category for which treatment is being sought (under a provision in Division 5); and
(b) the Secretary thinks treatment would be appropriate after considering any expert advice provided by GHAC or a Departmental medical adviser:
(i) that is required under the eligibility criteria; or
(ii) under subsection (2); and
(c) subsection 22 (2) (about non‑compliance with treatment) does not apply to the person.
Note Sections 27, 29, 31, 33, 35, 37, 39, 41 and 43 set out the eligibility criteria for initial treatment for the categories mentioned in subsection 11 (2).
(5) This subsection applies if the person does not meet the eligibility criteria for initial treatment for the category for which treatment is being sought (under a provision in Division 5), but:
(a) the Secretary is satisfied that the person would have met the eligibility criteria for initial treatment in the category had the person not previously received treatment with the drug Somatropin; and
(b) the Secretary thinks treatment would be appropriate after considering any expert advice provided by GHAC or a Departmental medical adviser under subsection (2); and
(c) subsection 22 (2) (about non‑compliance with treatment) does not apply to the person.
(6) The application must be given to the Secretary at least 4 weeks, or a shorter time agreed by the Secretary, before the pharmaceutical benefit supplied for the person’s current treatment period is due to run out.
(7) The Secretary may approve the continuing treatment for a further period of 26 weeks only (the continuing treatment period):
(a) beginning on the expiration of the person’s current treatment period; or
(b) if the person’s most recent treatment period has ended — beginning on the date the Secretary approves the application.
(8) Within 4 weeks after receiving the application, the Secretary must tell the applicant, in writing:
(a) whether the Secretary approves the continuing treatment; or
(b) that the Secretary requires an additional time to consider the application.
17 Information for applications requesting change of category
Categories other than Prader‑Willi Syndrome
(1) An application under section 16 need not include data or information that has already been submitted for the person in a previous application under the growth hormone program if the request is for a category other than Prader‑Willi Syndrome.
(2) If an application under section 16 requests a change to a category that has data or information requirements under subsection 15 (2) or (4), the application must include that data or information unless it has been submitted in a previous application for the person.
Prader‑Willi Syndrome
(3) An application under section 16 requesting approval for Prader‑Willi Syndrome:
(a) must be in a form approved for that category under subsection 13 (2); and
(b) must include the following information about the person the subject of the application:
(i) medical history;
(ii) social history;
(iii) investigations;
(iv) concurrent medication;
(v) growth data taken on 2 separate occasions in the immediately preceding 6 months.
Division 3 Assessing applications
18 Secretary may ask for further information or may reject incomplete application
(1) The Secretary may ask the applicant for any further information the Secretary considers necessary in considering an application under section 13, 14, 16 or 24.
(2) The time mentioned in subsection 13 (4), 14 (6), 16 (8) or 24 (7) is suspended until the Secretary receives the further information.
(3) Despite subsection (1), the Secretary may reject an application if the applicant has not provided the data or information required under this Special Arrangement for the application.
19 Notice of decision on application
(1) If the Secretary approves growth hormone treatment for a person on application made under section 13, 14, 16 or 24, the notification of the Secretary’s decision to the applicant must include:
(a) the category for which the person has been approved; and
(b) the pharmaceutical benefit that has been approved; and
(c) the dose of pharmaceutical benefit that has been approved for the person under Division 6; and
(d) the dates the treatment period begins and ends; and
(e) if the person has been approved for initial treatment — the date that the amount of pharmaceutical benefit that is sufficient for the first 19 weeks of treatment of the person is expected to run out; and
(f) if the person has been approved for continuing treatment or for recommenced treatment — the date that the amount of pharmaceutical benefit that is sufficient for the first 13 weeks of treatment of the person is expected to run out.
(2) The Secretary must give a copy of the notice to the person nominated in the application as the nominated dispenser.
(3) If the pharmaceutical benefit approved as mentioned in paragraph (1) (b) is not available, the Secretary:
(a) may approve another pharmaceutical benefit; and
(b) may amend the notice as required; and
(c) must give a copy of the amended notice to the applicant and the nominated dispenser as soon as practicable after its amendment.
Example for subsection (3)
A pharmaceutical benefit is not available if it is not available for supply within the time required for the growth hormone treatment of a person.
20 Secretary to consider expert advice and other matters
(1) If an eligibility criterion in a category for treatment under Division 5 requires that the Secretary assess the eligibility of a person under this section, the Secretary must determine whether growth hormone treatment is appropriate for the person taking into account the matters mentioned in subsection (2).
(2) The matters are:
(a) the expert advice of GHAC or a Departmental medical adviser, or both, about:
(i) whether treatment is clinically appropriate for the person; and
(ii) the likely effectiveness of treatment for the person; and
(b) whether further information is required from the applicant before eligibility can be determined; and
(c) whether there are factors indicated by the product information document agreed with the Therapeutic Goods Administration for a pharmaceutical benefit that would exclude the person from the treatment; and
(d) any other information about the person and his or her medical condition that the Secretary considers relevant.
21 Response criteria
(1) A person’s response to growth hormone treatment, for a treatment period, is assessed against the following criteria (the response criteria):
(a) the person achieves 50th percentile growth velocity for bone age and sex;
(b) the person has an increase in height standard deviation score for the person’s chronological age;
(c) the person achieves a minimum growth velocity of 4 cm a year.
(2) However, if a person receives treatment in the category of Prader‑Willi Syndrome:
(a) the response criteria for the person for a treatment period in the category are as mentioned in section 45; and
(b) the criteria mentioned in subsection (1) do not apply for that treatment.
(3) For paragraph (1) (a), the person’s growth velocity is determined by comparing the person’s current growth velocity for the person’s bone age and sex to the growth standards in the charts of Tanner and Davies, published in the European Journal of Paediatrics, Volume 107, Issue 3 in September 1985.
Note The term growth velocity is defined in subsection 3 (1).
22 Non-compliance with treatment
(1) This section applies if:
(a) a person receives growth hormone treatment; and
(b) the person’s use of a pharmaceutical benefit has resulted in a supply running out early or lasting longer than expected by a significant amount, indicating that the person:
(i) stopped taking the pharmaceutical benefit for a period; or
(ii) skipped doses of the pharmaceutical benefit; or
(iii) administered an incorrect dose of the pharmaceutical benefit.
(2) The person does not comply with the treatment if:
(a) the Secretary is satisfied of the matters in paragraph (1) (b); and
(b) the Secretary has raised those matters with the treating practitioner; and
(c) in the Secretary’s opinion:
(i) the matters have not been resolved; and
(ii) there is recurring, serious, non‑compliance.
(3) In this section:
incorrect dose, for a person and a pharmaceutical benefit in a treatment period, means an amount of the pharmaceutical benefit, administered to the person as a dose that is either higher or lower than the dose approved by the Secretary for the treatment period.
significant amount, for a person and a pharmaceutical benefit, means an amount that indicates that the supply of the pharmaceutical benefit to the person either ran out early by at least 6 weeks or lasted for at least 6 weeks longer than would be reasonable given the dosage amounts.
Note A person who does not comply with treatment is not eligible to receive continuing treatment for the person’s condition: see paragraphs 14 (4) (c) and 16 (4) (c) and (5) (c).
Division 4 Cessation of treatment and recommencement
23 Ceasing treatment
(1) A treating practitioner may cease growth hormone treatment of a person.
(2) If a treating practitioner ceases growth hormone treatment of the person, the practitioner must tell the Secretary, in writing:
(a) the date the treatment ceased for the person; and
(b) the reason for ceasing the treatment; and
(c) the final measurements of the person at the time of the cessation; and
(d) the quantity of the person’s unused supplies of pharmaceutical benefit remaining with the nominated dispenser.
Note The terms nominated dispenser and treating practitioner are defined in subsection 3 (1).
24 Application to recommence treatment
(1) If growth hormone treatment of a person ceases under section 23, or for any other reason, the person’s treating specialist paediatric endocrinologist or specialist paediatrician (the treating specialist) may apply to the Secretary to approve:
(a) the recommencement of treatment in the category for which the person had been approved in the person’s most recent treatment period (the same category); or
(b) the recommencement of treatment in a category different to the category under which the person had been approved in his or her most recent treatment period (a different category).
(2) The application must be in a form approved by the Secretary for this section.
(3) The Secretary may approve the recommencement of treatment only:
(a) if satisfied of the matters in subsection 25 (1) and that it is appropriate for treatment to recommence having regard to those matters; and
(b) in the circumstances mentioned in either paragraph (4) (a) or (b); and
(c) if the Secretary thinks appropriate after considering any expert advice by GHAC or a Departmental medical adviser given under this Division.
Note 1 Expert advice from GHAC or a Departmental medical adviser:
(a) may be given under subsections 25 (2) and (5); and
(b) must be given under paragraph 26 (4) (b).
Note 2 A person is not eligible to receive a pharmaceutical benefit if the person is excluded under section 12: see paragraph 11 (1) (b).
(4) For paragraph (3) (b), the circumstances are:
(a) as follows:
(i) a person meets the eligibility criteria, under a provision in Division 5, for initial treatment in the category being applied for;
(ii) if the expert advice of GHAC or a Departmental medical adviser is required under those eligibility criteria — the Secretary thinks it is appropriate for treatment to recommence after considering the advice; or
(b) as follows:
(i) a person does not meet the eligibility criteria for initial treatment in the category of treatment being applied for;
(ii) for a person who is applying for recommencement of treatment in the same category — the Secretary is satisfied of the matters in subsection 26 (2);
(iii) for a person who is applying for recommencement of treatment in a different category — the Secretary is satisfied of the matters in subsection 26 (4).
Note Sections 27, 29, 31, 33, 35, 37, 39, 41 and 43 set out the eligibility criteria for initial treatment for the categories mentioned in subsection 11 (2).
(5) For paragraph (3) (a) the Secretary may consider the likely benefits to the person compared to the likely risks to the person.
(6) The Secretary may approve the recommencement of treatment for a period of up to 26 weeks only.
(7) Within 6 weeks after receiving the application, the Secretary must tell the applicant, in writing:
(a) whether the Secretary approves the recommencement of treatment; or
(b) that the Secretary requires an additional time to consider the application.
25 Recommencement applications — content
(1) The treating specialist of a person must demonstrate to the satisfaction of the Secretary, in an application made under section 24, that:
(a) the treatment was adversely affected for a reason as follows, and the issue has been resolved:
(i) the person had a significant medical illness;
(ii) the person underwent major surgery;
(iii) the person’s compliance with the treatment was affected by family or social issues; or
(b) the person had an adverse reaction to the pharmaceutical benefit, which, based on a period of observation of the person, is unlikely to continue.
(2) The Secretary may request the advice of GHAC or a Departmental medical adviser about the matters in subsection (1).
(3) In this section:
treating specialist has the meaning it has in section 24.
26 Assessing recommencement applications
Same category — eligibility
(1) Subsection (2) applies to a person who:
(a) is the subject of an application under paragraph 24 (1) (a) to recommence treatment in the same category; and
(b) does not meet the eligibility criteria for initial treatment in the category being applied for.
(2) For subparagraph 24 (4) (b) (ii) the Secretary must be satisfied that the person would have met the eligibility criteria for initial treatment in the category, had the person not previously received treatment with the drug Somatropin.
Different category — eligibility
(3) Subsection (4) applies to a person who:
(a) is the subject of an application under paragraph 24 (1) (b) to recommence treatment in a different category; and
(b) does not meet the eligibility criteria for initial treatment in the category being applied for.
(4) For subparagraph 24 (4) (b) (iii), the Secretary must:
(a) be satisfied that the person would have met the eligibility criteria for initial treatment in the category had the person not previously received treatment with the drug Somatropin; and
(b) seek the advice of GHAC or a Departmental medical adviser about whether the proposed change of category is appropriate for the person.
Discretion to seek expert advice
(5) The Secretary may also seek advice from GHAC or a Departmental medical adviser about whether a proposed change of category is appropriate for a person who:
(a) is the subject of an application under paragraph 24 (1) (b) to recommence treatment in a different category; and
(b) does meet the eligibility criteria for initial treatment in the category being applied for.
Division 5 Eligibility criteria for initial treatment and continuing treatment
27 Short stature and slow growth — initial treatment
(1) The eligibility criteria for initial treatment of a person for the category of short stature and slow growth are that:
(a) the person has a current height below the 1st percentile for age and sex; and
(b) the person has a growth velocity below the 25th percentile for bone age and sex, measured at both 12 month and 6 month intervals.
(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 a bone age of less than 2.5 years; or
(b) has maturational or constitutional delay with an estimated mature height below the 1st percentile.
(3) If subsection (2) applies to a person, the Secretary:
(a) must consider whether the person meets the eligibility criteria mentioned in subsection (1); and
(b) may take that into account when determining the person’s eligibility.
Note This section is affected by subsection 39 (5).
28 Short stature and slow growth — continuing treatment
A person who has been receiving treatment under the short stature and slow growth category is eligible to be approved for continuing treatment under the category unless:
(a) the person has reached skeletal maturity; or
(b) the person’s height has reached or exceeded the 10th adult height percentile; or
(c) 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 3 response criteria set out in subsection 21 (1); and
(iii) did not achieve and maintain mid parental height standard deviation score.
Note The terms 10th adult height percentile and maximum dose are defined in subsection 3 (1).
29 Biochemical growth hormone deficiency — initial treatment
Eligibility criteria — general
(1) The eligibility criteria for initial treatment of a person for the category of biochemical growth hormone deficiency are that:
(a) the person has a current height below the 1st percentile for age and sex; and
(b) the person has a growth velocity below the 25th percentile for bone age and sex measured at 12 month and 6 month intervals; and
(c) there is evidence of biochemical growth hormone deficiency.
Note The term biochemical growth hormone deficiency is defined in subsection 3 (1).
Eligibility assessed using expert advice
(2) The Secretary must assess a person’s eligibility for this category under section 20 (expert advice etc) if the person:
(a) meets the criteria mentioned in paragraphs (1) (a) and (c) but the Secretary cannot determine whether the person meets the criterion mentioned in paragraph (1) (b); and
(b) has a bone age of less than 2.5 years; and
(c) has an annual growth velocity of greater than 8 cm a year.
(3) The Secretary must assess a person’s eligibility for this category under section 20 (expert advice etc) if the person meets the criteria mentioned in paragraphs (1) (b) and (c) but does not meet the criterion mentioned in paragraph (1) (a).
Eligibility for person with diabetes mellitus
(4) If a person has been diagnosed with diabetes mellitus by a medical practitioner:
(a) the person must meet the eligibility criteria mentioned in subsection (1); and
(b) the Secretary may approve treatment for the person in this category only if:
(i) GHAC, after considering the person’s application, makes a recommendation that there are exceptional circumstances that warrant the commencement of growth hormone treatment for the person; and
(ii) the Secretary accepts the recommendation.
Eligibility if person has bone age of less than 2.5 years and annual growth velocity of 8 cm or less
(5) Subsection (6) applies if a person:
(a) has a bone age of less than 2.5 years; and
(b) has an annual growth velocity of 8 cm a year or less.
(6) The person is eligible to receive initial treatment in this category if the person meets the criteria mentioned in paragraphs (1) (a) and (c).
30 Biochemical growth hormone deficiency — continuing treatment
A person who has been receiving treatment under the biochemical growth hormone deficiency category is eligible to be approved for continuing treatment under the category unless:
(a) the person has reached skeletal maturity; or
(b) 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 3 response criteria set out in subsection 21 (1); and
(iii) did not achieve and maintain mid parental height standard deviation score.
31 Growth retardation secondary to an intracranial lesion or cranial irradiation — initial treatment
Eligibility criteria — general
(1) The eligibility criteria for initial treatment of a person for the category of growth retardation secondary to an intracranial lesion, or secondary to cranial irradiation for the lesion, are that:
(a) the lesion is in remission; and
(b) there is evidence of biochemical growth hormone deficiency for the person; and
(c) the person has a growth velocity below the 25th percentile for bone age and sex measured at both 12 month and 6 month intervals; and
(d) either:
(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 had 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.
Eligibility assessed using expert advice
(2) However, if subsection (3) applies to a person, the Secretary must assess the person’s eligibility for this category under section 20 (expert advice etc).
(3) This subsection applies if:
(a) the person:
(i) has a bone age of less than 2.5 years and an annual growth velocity of greater than 8 cm a year; and
(ii) meets the criteria mentioned in paragraphs (1) (a), (b) and (d), but the Secretary cannot determine whether the person meets the criterion mentioned in paragraph (1) (c); or
(b) the person:
(i) has received cranial irradiation of more than 30 Gray (Gy); and
(ii) fails to meet the criterion mentioned in paragraph (1) (b) but meets the other criteria mentioned in subsection (1); or
(c) the person fails to meet the criterion mentioned in paragraph (1) (d) but meets the other criteria mentioned in subsection (1).
Eligibility if person has bone age of less than 2.5 years and annual growth velocity of 8 cm or less
(4) Subsection (5) applies if a person:
(a) has a bone age of less than 2.5 years; and
(b) has an annual growth velocity of 8 cm a year or less.
(5) The person is eligible to receive initial treatment in this category if the person meets the criteria mentioned in paragraphs (1) (a), (b) and (d).
32 Growth retardation secondary to an intracranial lesion or cranial irradiation — continuing treatment
A person who has been receiving treatment under the category of growth retardation secondary to an intracranial lesion, or secondary to cranial irradiation for the lesion, is eligible to be approved for continuing treatment under the category unless:
(a) the person has reached skeletal maturity; or
(b) 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 3 response criteria set out in subsection 21 (1); and
(iii) did not achieve and maintain mid parental height standard deviation score.
33 Infant at risk of hypoglycaemia secondary to biochemical growth hormone deficiency — initial treatment
(1) This section applies to a person who has, or is at risk of, hypoglycaemia secondary to biochemical growth hormone deficiency, if:
(a) the hypoglycaemia, or the risk of it, has been documented by a specialist paediatric endocrinologist or specialist paediatrician; and
(b) the person is younger than 2.
(2) The Secretary must assess the person’s eligibility for this category under section 20 (expert advice etc).
(3) However, the Secretary may only assess the eligibility of the person under this category if the Secretary accepts, after receiving advice from GHAC, that the person’s hypoglycaemia is secondary to biochemical growth hormone deficiency.
Note The term biochemical growth hormone deficiency is defined in subsection 3 (1).
34 Infant at risk of hypoglycaemia secondary to biochemical growth hormone deficiency — continuing treatment
(1) A person who has been receiving treatment for the category of infant at risk of hypoglycaemia secondary to biochemical growth hormone deficiency is eligible to be approved for continuing treatment under the category unless:
(a) the person is 5 or older; or
(b) 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 3 response criteria set out in subsection 21 (1); and
(iii) did not achieve and maintain mid parental height standard deviation score.
(2) However, if a person is 5 or older, the Secretary must assess the person’s eligibility for continuing treatment in this category under section 20 (expert advice etc).
(3) For a person mentioned in subsection (2), GHAC must give advice to the Secretary, based on the clinical, biochemical and radiological evidence available, about whether it considers:
(a) the person should be reclassified and instead of treatment for this category receive treatment for the biochemical growth hormone deficiency category; or
(b) there should be further evaluation of the hypothalamic/pituitary axis by undertaking magnetic resonance imaging of the hypothalamic-pituitary region of the brain; or
(c) growth hormone treatment for the person should cease.
35 Turner Syndrome — initial treatment
(1) The eligibility criteria for initial treatment of a person for the category of Turner Syndrome are that:
(a) the current height of the person is at or below the 95th percentile on the Turner Syndrome growth curve for girls; and
(b) the person has not exhibited significant catch up growth; and
(c) diagnostic results for the person are consistent with Turner Syndrome.
(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 bone age of less than 2.5 years; and
(b) has an annual growth velocity of greater than 8 cm a year; and
(c) meets the criteria mentioned in paragraphs (1) (a) and (c) but the Secretary cannot determine whether the person meets the criterion mentioned in paragraph (1) (b).
Meaning of significant catch up growth
(3) For paragraph (1) (b), a person does not exhibit significant catch‑up growth if, in the 6 months ending on the date the application is made:
(a) growth does not upwardly cross height percentiles, as determined for the person with reference to the Turner Syndrome growth curve for girls; or
(b) growth velocity is less than the 25th percentile for bone age and sex.
(4) The criterion mentioned in paragraph (3) (b) may be determined using the charts of Tanner and Davies, published in the European Journal of Paediatrics, Volume 107, Issue 3 in September 1985.
36 Turner Syndrome — continuing treatment
A person who has been receiving treatment for the category of Turner Syndrome is eligible to be approved for continuing treatment under the category unless:
(a) the person has reached skeletal maturity; or
(b) the person’s height is at or above the 10th adult height percentile; or
(c) during the most recent treatment period:
(i) the person had been receiving the maximum dose of the pharmaceutical benefit relevant to the category; and
(ii) the person did not meet at least one of the 3 response criteria set out in subsection 21 (1); and
(iii) growth velocity for bone age and sex for the person is below the mean growth velocity for bone age and sex for a person who has Turner Syndrome and has not received any treatment using the drug Somatropin.
37 Short stature due to short stature homeobox (SHOX) gene disorders — initial treatment
Eligibility criteria — general
(1) The eligibility criteria for initial treatment of a person for the category of short stature due to short stature homeobox (SHOX) gene disorders are that:
(a) the person has a current height below the 1st percentile for age and sex; and
(b) growth velocity for the person is below the 25th percentile for bone age and sex measured at both 12 month and 6 month intervals; and
(c) diagnostic results for the person are consistent with SHOX mutation or SHOX deletion and include mosaic sex chromosome abnormalities.
(2) In this section:
mosaic sex chromosome abnormalities includes 45XO cell lines.
Eligibility assessed using expert advice
(3) However, the Secretary must assess a person’s eligibility for this category under section 20 (expert advice etc) if the person:
(a) meets the criteria mentioned in paragraphs (1) (a) and (c), but the Secretary cannot determine whether the person meets the criterion mentioned in paragraph (1) (b); and
(b) has a bone age of less than 2.5 years; and
(c) has an annual growth of velocity greater than 8 cm a year.
Eligibility if person has bone age of less than 2.5 years and annual growth velocity of 8 cm or less
(4) Subsection (5) applies if a person:
(a) has a bone age of less than 2.5 years; and
(b) has an annual growth velocity of 8 cm a year or less.
(5) The person is eligible to receive initial treatment in this category if the person meets the criteria mentioned in paragraphs (1) (a) and (c).
38 Short stature due to short stature homeobox (SHOX) gene disorders — continuing treatment
A person who has been receiving treatment for the category of short stature due to short stature homeobox (SHOX) gene disorders is eligible to be approved for continuing treatment under the category unless:
(a) the person has reached skeletal maturity; or
(b) the person’s height is at or above the 10th adult height percentile; or
(c) 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 3 response criteria set out in subsection 21 (1); and
(iii) did not achieve and maintain mid parental height standard deviation score.
39 Chronic renal insufficiency — initial treatment
Eligibility criteria — general
(1) The eligibility criteria for initial treatment of a person for the category of chronic renal insufficiency are that:
(a) the person has a current height at or below the 25th percentile for age and sex; and
(b) growth velocity for the person is at or below the 25th percentile for bone age and sex, measured at both 12 month and 6 month intervals; and
(c) the person has an estimated glomerular filtration rate of less than 30mL/minute/1.73m2;and
(d) if the person has had a renal transplant — the transplant took place at least a year before the date of application.
Eligibility assessed using expert advice
(2) However, the Secretary must assess a person’s eligibility for this category under section 20 (expert advice etc) if:
(a) the person:
(i) meets the criteria mentioned in paragraphs (1) (a), (c) and (d), but the Secretary cannot determine if the criterion mentioned in paragraph (1) (b) is met; and
(ii) has a bone age of less than 2.5 years; and
(iii) has an annual growth velocity of greater than 8 cm a year; or
(b) the person does not meet the criterion mentioned in paragraph (1) (d) but meets the other criteria mentioned in subsection (1).
Eligibility if person has bone age of less than 2.5 years and annual growth velocity of 8 cm or less
(3) Subsection (4) applies if a person:
(a) has a bone age of less than 2.5 years; and
(b) has an annual growth velocity of 8 cm a year or less.
(4) The person is eligible to receive initial treatment in this category if the person meets the criteria mentioned in paragraphs (1) (a), (c) and (d).
Secretary to assess under another category
(5) The Secretary must assess a person’s eligibility for initial treatment under the category for short stature and slow growth if:
(a) the person is the subject of an application for initial treatment under the category of chronic renal insufficiency; and
(b) the person does not meet the criterion mentioned in paragraph (1) (c).
Note Section 27 provides for the eligibility criteria for initial treatment for the short stature and slow growth category.
40 Chronic renal insufficiency — continuing treatment
A person who has been receiving treatment for the category of chronic renal insufficiency is eligible to be approved for continuing treatment under the category unless:
(a) the person has reached skeletal maturity; or
(b) the person’s height is at or above the 10th adult height percentile; or
(c) 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 3 response criteria set out in subsection 21 (1); and
(iii) did not achieve and maintain mid parental height standard deviation score.
41 Growth hormone deficiency and precocious puberty — initial treatment
The eligibility criteria for initial treatment of a person for the category of growth hormone deficiency and precocious puberty are that:
(a) there is evidence, for the person, of biochemical growth hormone deficiency; and
(b) the person has been diagnosed with precocious puberty; and
(c) the person is undertaking pubertal suppression therapy.
Note The terms biochemical growth hormone deficiency and precocious puberty are defined in subsection 3 (1).
42 Growth hormone deficiency and precocious puberty — continuing treatment
A person who has been receiving treatment for the category of growth hormone deficiency and precocious puberty is eligible to be approved for continuing treatment under the category unless:
(a) the person has reached skeletal maturity; or
(b) 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 3 response criteria set out in subsection 21 (1); and
(iii) did not achieve and maintain mid parental height standard deviation score.
43 Prader‑Willi Syndrome — initial treatment
(1) The eligibility criteria for initial treatment of a person for the category of Prader‑Willi Syndrome are that:
(a) the person is younger than 18; and
(b) Prader‑Willi Syndrome has been genetically proven for the person; and
(c) the person has been evaluated for airway obstruction and apnoea, including through polysomnography (overnight sleep study), in the 12 months ending on the date the application is made; and
(d) if the evaluation identifies that the person has a sleep disorder that requires treatment — the person has received treatment for the disorder or is being treated; and
(e) the person does not have uncontrolled morbid obesity.
Note The term uncontrolled morbid obesity is defined in subsection 3 (1).
(2) However, if a person does not meet the criterion mentioned in paragraph (1) (b) but meets the other criteria mentioned in subsection (1), the Secretary must assess the person’s eligibility for this category under section 20 (expert advice etc).
44 Prader‑Willi Syndrome — continuing treatment
General rule
(1) A person who has been receiving treatment for the category of Prader‑Willi Syndrome is eligible to be approved for continuing treatment under the category unless:
(a) the person is 18 or older; or
(b) if, during the person’s 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.
First continuing treatment application
(2) However, if, in the person’s most recent treatment period, the person has been receiving initial treatment for the category of Prader‑Willi Syndrome, then, in addition to satisfying the requirements of subsection (1), the person must have had a sleep study test performed during the treatment period.
45 Prader‑Willi Syndrome — response criteria
(1) The response to treatment of a person receiving treatment in the category of Prader‑Willi Syndrome, for a treatment period, is assessed against the criteria in the following table.
Item
The response to treatment with the pharmaceutical benefit, for a person with ...
... is measured for the person against the following criteria (the response criteria):
1
a non-mature skeleton who has had less than the maximum dose of the pharmaceutical benefit for the most recent treatment period
(a) improving height percentile (CDC 2000);
(b) improving body mass index standard deviation score (CDC 2000);
(c) improving the waist circumference standard deviation score or the waist/height ratio, or both;
(d) crossing height percentiles upwardly on untreated PWS standards;
(e) improving age standardised measures of body composition using dual energy X‑ray absorptiometry or bioelectrical impedance
2
a non‑mature skeleton who has had the maximum dose of the pharmaceutical benefit for the most recent treatment period
(a) maintaining or improving height percentile (CDC 2000);
(b) maintaining or improving body mass index standard deviation score (CDC 2000);
(c) maintaining or improving the waist circumference standard deviation score or the waist/height ratio, or both;
(d) crossing height percentiles upwardly on untreated PWS standards;
(e) maintaining or improving age standardised measures of body composition using dual energy X‑ray absorptiometry or bioelectrical impedance
3
a mature skeleton
(a) maintaining or improving body mass index or the body mass index standard deviation score (CDC 2000);
(b) maintaining or improving:
(i) waist circumference; or
(ii) the waist circumference standard deviation score; or
(iii) the waist to height ratio;
(c) maintaining or improving the weight standard deviation score;
(d) maintaining or improving standardised measures of body composition using dual energy X‑ray absorptiometry or bioelectrical impedance
(2) For the table in subsection (1), a response is maintained if it is within 5% of the previous measurement.
(3) In this section:
untreated PWS standards means the charts in the document entitled Standards for Selected Anthropometric Measurements in Prader‑Willi Syndrome, by Merlin G. Butler and John Meaney, published in Pediatrics, Volume 88, Number 4 in October 1991.
Note The terms CDC 2000 and mature skeleton are defined in section 3.
Division 6 Dosage of pharmaceutical benefit
Subdivision 1 General
46 Definition
(1) In this Division:
dose level, for a person and a pharmaceutical benefit, means a dose of pharmaceutical benefit mentioned in the table in section 47 that is measured as a level that applies to the body surface area of the person for a week, with the body surface area of the person worked out using the formula:
treating practitioner, of a person, means the medical practitioner who submitted the most recent application for the person under section 13, 14, 16 or 24.
(2) The measurement ‘m2’, in the table in section 47, refers to a square metre of the body surface area of a person.
47 Assessment of dosage of pharmaceutical benefit
(1) The Secretary must determine, for each application made under section 13, 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 following table and this Division.
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) 5.5mg/m2/week (dose level 2); or
(c) 6.5mg/m2/week (dose level 3); or
(d) 7.5mg/m2/week (dose level 4)
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 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) 6mg/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 (2).
Note The term mature skeleton is defined in subsection 3 (2).
(2) However, the dose of pharmaceutical benefit that the Secretary determines:
(a) may be within 3% of a dose level mentioned in the item of the table that applies to a person, if the form of the pharmaceutical benefit and the manufacturer’s pack is unable to accommodate the dose level mentioned in the item; and
(b) if paragraph (a) applies — the dose determined by the Secretary is taken to be the dose level mentioned in the item.
(3) For paragraph (b) of item 4 of the table, the Secretary may approve a higher dose only if:
(a) the dose approval is for the continuing treatment of a person mentioned in that item; and
(b) the person reached skeletal maturity during the person’s most recent treatment period; and
(c) GHAC has advised that the person requires a phased dose reduction.
48 Compliance with treatment
(1) This section applies if paragraphs 22 (2) (a) and (b) apply to a person, but the Secretary has not decided that there is serious recurring non-compliance by the person under paragraph 22 (2) (c).
Note A person who does not comply with treatment under subsection 22 (2) is not eligible to receive continuing treatment: see Division 5.
(2) If a person is mentioned in subsection (1), the Secretary must, despite any other provision in this Division, not approve the person to receive continuing treatment at higher than the dose the person was receiving in his or her most recent treatment period.
Subdivision 2 Initial treatment dose for items 1 and 3
49 Dose for items 1 and 3
(1) This section applies if the Secretary is determining the dose of pharmaceutical benefit for the initial treatment of a person mentioned in item 1 or 3 of the table in section 47.
Dose level 1
(2) The Secretary may approve only dose level 1 for the person, unless the person is eligible for a higher dose under subsection (3) or (4).
Dose higher than dose level 1
(3) A person is eligible for a dose level higher than dose level 1 if:
(a) the person’s treating practitioner requests a higher dose; and
(b) GHAC or a Departmental medical adviser thinks there are exceptional circumstances that justify the higher dose; and
(c) the Secretary thinks a higher dose for the person is appropriate after having regard to the advice of GHAC or the Departmental medical adviser.
(4) A person is eligible for a dose level higher than dose level 1 if:
(a) the person is an older child; and
(b) the person’s treating practitioner requests the higher dose.
Note The term older child is defined in subsection 3 (1).
(5) The higher dose mentioned in subsection (3) and (4) cannot exceed the maximum dose that is permitted for the category of treatment the person has been approved for.
Note The term maximum dose is defined in subsection 3 (1).
Subdivision 3 Assessing dose for continuing treatment
50 Dose for items 1 and 2 — on maximum dose
(1) Subsection (2) applies if the Secretary is determining the dose of pharmaceutical benefit for the continuing treatment of a person who:
(a) is mentioned in item 1 or 2 of the table in section 47; and
(b) had been on the maximum dose of a pharmaceutical benefit in the person’s most recent treatment period; 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.
Maximum dose to continue
(2) The Secretary may approve the person to continue to receive the maximum dose only.
Note A person who does not meet at least one of the response criteria and does not achieve and maintain mid parental height standard, while on maximum dose for a treatment period, is not eligible to be approved for continuing treatment: see the continuing treatment provisions for the relevant categories in Division 5 of Part 2.
51 Dose for item 1, not on maximum dose — not all response criteria met
Next available dose
(1) The Secretary may approve a person who is mentioned in item 1 of the table in section 47 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 has not been on the maximum dose of a pharmaceutical benefit in the person’s most recent treatment period; and
(b) the person has failed to meet at least one of the response criteria.
Higher than next available dose
(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
(b) GHAC or a Departmental medical adviser thinks there are exceptional circumstances that justify the higher dose; and
(c) the Secretary thinks a higher dose for the person is appropriate after having regard to the advice of GHAC or the Departmental medical adviser.
(3) The higher dose mentioned in subsection (2) cannot exceed the maximum dose that is permitted under the table in section 47 for a category for treatment mentioned in item 1 of that table.
52 Dose for item 1, not on maximum dose — all response criteria met
(1) This section applies if the Secretary is determining the dose of a pharmaceutical benefit for the continuing treatment of a person who:
(a) is mentioned in item 1 of the table in section 47; and
(b) has not been on the maximum dose of a pharmaceutical benefit in the person’s most recent treatment period; and
(c) has met all of the response criteria.
Same dose or higher
(2) The Secretary may approve the person:
(a) to receive the same dose of pharmaceutical benefit approved for the person’s most recently completed treatment period; or
(b) to receive a higher dose than that mentioned in paragraph (a) but only if:
(i) the person’s treating practitioner requests a higher dose; and
(ii) GHAC or a Departmental medical adviser thinks there are exceptional circumstances that justify the higher dose; and
(iii) the Secretary thinks a higher dose for the person is appropriate after having regard to the advice of GHAC or the Departmental medical adviser.
(3) The higher dose mentioned in paragraph (2) (b) cannot exceed the maximum dose that is permitted under the table in section 47 for a category for treatment mentioned in item 1 of that table.
53 Dose for item 2 — not on maximum dose
(1) This section applies if the Secretary is determining the dose of pharmaceutical benefit for the continuing treatment of a person who:
(a) is mentioned in item 2 of the table in section 47;
(b) has not been on the maximum dose of a pharmaceutical benefit in the person’s most recent treatment period.
Same dose
(2) Unless subsection (3) applies to the person, the Secretary must approve the person to receive only the same dose of pharmaceutical benefit approved for the person’s most recently completed treatment period.
Higher dose
(3) The Secretary may approve a person to receive a higher dose of pharmaceutical benefit than that approved for the person’s most recently completed treatment only if:
(a) the person’s treating practitioner has requested a higher dose; and
(b) the higher dose comes within the dosage range in item 2 of the table in section 47.
54 Dose for Prader‑Willi Syndrome
The Secretary must determine the dose of pharmaceutical benefit for the continuing treatment of a person in the category of Prader‑Willi Syndrome in accordance with the following table.
Item
If the person:
.... and has a body mass index that is:
the Secretary may approve the person:
1
(a) has a non‑mature skeleton; and
(b) had not been on the maximum dose of pharmaceutical benefit in the person’s most recent treatment period; and
(c) has met all of the response criteria
less than the 85th percentile for age and sex
to receive the same dose level as approved for the previous treatment period, calculated using the person’s current body weight
2
(a) has a non‑mature skeleton; and
(b) had not been on the maximum dose of pharmaceutical benefit in the person’s most recent treatment period; and
(c) has met all of the response criteria
greater than the 85th percentile for age and sex
to receive the same dose level as approved for the previous treatment period, calculated using ideal weight for height
3
(a) has a non‑mature skeleton; and
(b) had not been on the maximum dose of pharmaceutical benefit in the person’s most recent treatment period; and
(c) has failed to meet at least one of the response criteria
less than the 85th percentile for age and sex
to receive the next available dose level, calculated using the person’s current body weight
4
(a) has a non‑mature skeleton; and
(b) had not been on the maximum dose of pharmaceutical benefit in the person’s most recent treatment period; and
(c) has failed to meet at least one of the response criteria
greater than the 85th percentile for age and sex
to receive the next available a dose level, calculated using ideal weight for height
5
(a) has a non‑mature skeleton; and
(b) had been on the maximum dose of pharmaceutical benefit in the person’s most recent treatment period; and
(c) meets at least one of the response criteria
less than the 85th percentile for age and sex
to receive the maximum dose level, calculated using the person’s current body weight
6
(a) has a non‑mature skeleton; and
(b) has been on the maximum dose of pharmaceutical benefit in the person’s most recent treatment period; and
(c) meets at least one of the response criteria
greater than the 85th percentile for age and sex
to receive the maximum dose level, calculated using ideal weight for height
7
(a) has a mature skeleton; and
(b) meets at least one of the response criteria
less than the 85th percentile for age and sex
to receive a dose, calculated using the person’s current body weight:
(a) of 0.04mg/kg/week; or
(b) a higher dose if approved under subsection 47 (2)
8
(a) has a mature skeleton; and
(b) meets at least one of the response criteria
greater than the 85th percentile for age and sex
to receive a dose, calculated using ideal weight for height:
(a) of 0.04mg/kg/week; or
(b) a higher dose if approved under subsection 47 (2)
Note 1 The terms ideal weight for height, mature skeleton and percentile are defined in section 3.
Note 2 The response criteria for a person in the category of Prader‑Willi Syndrome are set out in section 46: see section 21.
Subdivision 4 Assessing dose for change of treatment
55 Dose for change of treatment category
(1) The Secretary must determine the dose of pharmaceutical benefit, for a person for whom the Secretary has approved treatment in a different category under section 16:
(a) in accordance with:
(i) the dose levels or the dosage range in the table in section 47 that applies to the category for which the person has been approved under section 16; and
(ii) any other provisions in this Division that apply to continuing treatment in the category for which the person has been approved under section 16; and
(b) taking into account the person’s response to treatment using the response criteria relevant to the person’s most recently completed treatment period; and
(c) treating the dose level approved for the person’s most recently completed treatment period as if it applied to the category for which the person has been approved.
(2) The dose cannot exceed the maximum dose permitted for the category for treatment for which the person has been approved under section 16.
Note The table in subsection 47 (1) provides for the maximum dose that is available for a category of growth hormone treatment.
Subdivision 5 Assessing dose for recommenced treatment
56 Dose for recommenced treatment in the same category
(1) This section applies if a person has been approved for recommencement of growth hormone treatment, under section 24, in the same category for which the person had last received treatment under the growth hormone program.
(2) The Secretary may approve only the dose of pharmaceutical benefit that had most recently been approved for the person before the person’s most recent treatment had ceased, unless the person is eligible for a higher dose under subsection (3), (4) or (5).
(3) A person is eligible for a dose that is higher than the dose mentioned in subsection (2), if:
(a) the person is recommencing treatment in a category mentioned in item 1 or 3 of the table in section 47; and
(b) the person’s treating practitioner requests the higher dose; and
(c) GHAC or a Departmental medical adviser thinks there are exceptional circumstances that justify the higher dose; and
(d) the Secretary thinks a higher dose for the person is appropriate after having regard to the advice of GHAC or the Departmental medical adviser.
(4) A person is eligible for a dose that is higher than the dose mentioned in subsection (2), if:
(a) the person is recommencing treatment in a category mentioned in item 1 or 3 of the table in section 47; and
(b) the person is an older child; and
(c) the person’s treating practitioner requests the higher dose.
Note The term older child is defined in subsection 3 (1).
(5) A person is eligible for a dose that is higher than the dose mentioned in subsection (2) if:
(a) the person is recommencing treatment in a category mentioned in item 2 of the table in section 47; and
(b) the person’s treating practitioner requests the higher dose; and
(c) the Secretary thinks the higher dose is appropriate for the person.
(6) The higher dose mentioned in subsection (3), (4) or (5) cannot exceed the maximum dose permitted for the person’s approved category of treatment in the relevant item of the table in section 47.
57 Dose for recommenced treatment in different category
(1) This section applies if a person has been approved for recommencement of growth hormone treatment under section 24, in a different category to the one for which the person had last received treatment under the growth hormone program.
(2) The Secretary must determine a dose of pharmaceutical benefit for the treatment of the person in accordance with the following table and this section.
Item
If, in the treatment period in which a person last received growth hormone treatment...
and the person has been approved under section 24 for...
the Secretary may approve the person to receive:
1
item 1 of the table in section 47 applied to the person
any other category mentioned in item 1 of the table in section 47
(a) the same dose level approved for the person in his or her most recent treatment period; or
(b) a higher dose if it is approved under subsection (5); or
(c) if the person is an older child — a higher dose if subsection (6) applies
2
item 1 of the table in section 47 applied to the person
any category mentioned in item 2 of the table in section 47
(a) the same dose approved for the person in his or her most recent treatment period; or
(b) a higher dose if it is approved under subsection (4)
3
item 1 or 2 of the table in section 47 applied to the person
the category of Prader‑Willi Syndrome, and has a non‑mature skeleton (ie, is a person to whom item 3 of the table in section 47 applies)
(a) the dose level mentioned in item 3 of the table in section 47 that is closest to the dose in item 1 or item 2 of the table that the person had been approved for in his or her most recent treatment period; or
(b) a higher dose if it is approved under subsection (5); or
(c) if the person is an older child — a higher dose if subsection (6) applies
4
item 1, 2 or 3 of the table in section 47 applied to the person
the category of Prader‑Willi Syndrome, and has a mature skeleton (ie, is a person to whom item 4 of the table in section 47 applies)
(a) the dose mentioned in paragraph (a) of item 4 of the table in section 47; or
(b) a higher dose if it is approved under subsection 47 (2)
5
item 2 of the table in section 47 applied to the person
any other category mentioned in item 2 of the table in section 47
(a) the same dose approved for the person in his or her most recent treatment period; or
(b) a higher dose if it is approved under subsection (4)
6
item 2 of the table in section 47 applied to the person
any category mentioned in item 1 or 3 of the table in section 47
(a) the dose level in item 1 or 3 that is closest to the dose the person had been approved for in the person’s most recent treatment period; or
(b) a higher dose if it is approved under subsection (5); or
(c) if the person is an older child — a higher dose if subsection (6) applies
7
item 3 of the table in section 47 applied to the person
any category mentioned in item 1 or 2 of the table in section 47
(a) the dose in item 1 or 2 that is closest to the dose the person had been approved for in the person’s most recent treatment period; or
(b) a higher dose if it is approved under subsection (5); or
(c) if the person is an older child — a higher dose if subsection (6) applies
(3) However, if the dose of pharmaceutical benefit worked out under this section for the person would exceed the maximum dose that is permitted for the category for treatment the person has been approved for, the Secretary must approve no more than that maximum dose.
Note The table in section 47 provides for the maximum dose that is available for a category of growth hormone treatment.
(4) For items 2 and 5 of the table in this section, a person may be approved to receive a higher dose if:
(a) the person’s treating practitioner requests the higher dose; and
(b) the Secretary thinks the higher dose is appropriate for the person.
(5) For items 1, 3, 6 and 7 of the table in this section, a person may be approved to receive a higher dose if:
(a) the person’s treating practitioner requests the higher dose; and
(b) GHAC or a Departmental medical adviser thinks that there are exceptional circumstances that justify the higher dose; and
(c) the Secretary thinks that the higher dose for the person is appropriate after having regard to the advice of GHAC or the Departmental medical adviser.
(6) If a person mentioned in the table in this section is an older child, the person may be approved to receive a higher dose if:
(a) the person’s treating practitioner requests the higher dose; and
(b) the higher dose does not exceed the maximum dose that is permitted for the category of treatment the person has been approved for.
Division 7 Review of decisions
58 Internal review
(1) A medical practitioner who makes an application under this Special Arrangement may apply to the Secretary for the review of:
(a) a decision not to approve initial treatment under section 13; or
(b) a decision not to approve continuing treatment under section 14; or
(c) a decision not to approve treatment for a different category for treatment under section 16; or
(d) a decision under section 24 not to approve the recommencement of treatment; or
(e) a decision under Division 6 of Part 2 determining the dose of pharmaceutical benefit for the growth hormone treatment of a person the subject of an application.
(2) The application must:
(a) be made, in writing, within 6 months after the date the original decision was notified in writing to the medical practitioner; and
(b) set out the medical practitioner’s reasons:
(i) to support growth hormone treatment for the person; or
(ii) for a decision mentioned in paragraph (1) (e) — to support a different dose of pharmaceutical benefit for the person; and
(c) include information supporting the application that is in addition to any information already provided about the person to the Secretary.
(3) The Secretary must:
(a) review the decision within 6 weeks after receiving the application; and
(b) may:
(i) affirm, vary or revoke the reviewable decision; and
(ii) if the Secretary revokes the decision — make any other decision the Secretary thinks appropriate; and
(c) must, within 7 days of doing so, give written notice to the applicant.
(4) The Secretary:
(a) may seek expert advice from GHAC or a Departmental medical adviser about whether growth hormone treatment is appropriate for the person; and
(b) must take the advice (if any) into account when reviewing a decision under subsection (3).
(5) For subsection (3), the person in the Department who carries out the review must not have been involved in the original decision.
Part 3 Supply for the growth hormone program
59 No co‑payment
(1) An eligible person is entitled to receive a pharmaceutical benefit under this Special Arrangement without payment or other consideration.
(2) Section 87 of the Act does not apply to a supply of a pharmaceutical benefit under this Special Arrangement.
60 Supply of PB under this Special Arrangement
(1) A pharmaceutical benefit may be supplied under this Special Arrangement:
(a) by the responsible person for the brand of the pharmaceutical item in the pharmaceutical benefit, to a person nominated as the dispenser (the nominated dispenser) in an application made under section 13, 14, 16 or 24; and
(b) in accordance with subsection (3).
(2) A medical practitioner making the application may nominate only one of the following to be the dispenser for a person the subject of the application:
(a) a pharmacist (whether or not approved under the Act);
(b) a hospital authority (whether or not approved under the Act);
(c) an approved medical practitioner;
(d) a medical practitioner who is not an approved medical practitioner under the Act if:
(i) there are exceptional circumstances; and
(ii) a request has been made, in writing, to the Secretary for the medical practitioner to be approved as the nominated dispenser in those circumstances; and
(iii) the Secretary has approved the request, in writing;
(e) an Aboriginal Health Service if:
(i) a request has been made to the Secretary, in writing, to approve the Aboriginal Health Service as the nominated dispenser; and
(ii) the Secretary has approved the request, in writing.
Note The term approved medical practitioner is defined in the Act.
(3) The responsible person must supply the pharmaceutical benefit to the nominated dispenser:
(a) if the person the subject of the application becomes an eligible person; and
(b) if the Secretary has ordered a supply of the pharmaceutical benefit from the responsible person for the person.
(4) A nominated dispenser must tell the Department, if:
(a) pharmaceutical benefits that have been ordered by the Department for an eligible person have been delivered to the nominated dispenser; and
(b) the dispenser has not dispensed the pharmaceutical benefits to the eligible person within 35 days of the delivery.
(5) The nominated dispenser may only dispense the pharmaceutical benefit to an eligible person on presentation of a prescription.
(6) The nominated dispenser must comply with any conditions notified to the dispenser by the responsible person for the handling and storage of the pharmaceutical benefit.
(7) In this section:
Aboriginal Health Service means an Aboriginal Health Service that satisfies the requirements of section 4 of the National Health (Remote Aboriginal Health Services Program) Special Arrangements Instrument 2010.
61 Supply of pharmaceutical benefit — requirements of responsible person, Secretary
(1) The responsible person must supply the pharmaceutical benefit to a nominated dispenser within the time specified by the Secretary in the order mentioned in paragraph 60 (3) (b).
(2) The Secretary must not specify a time less than 48 hours for supply for a person unless the Secretary thinks that an urgent supply is necessary for the growth hormone treatment of the person.
(3) If the responsible person is unable to supply the pharmaceutical benefit within the specified time because of a natural disaster or other emergency, the responsible person must:
(a) notify the Department; and
(b) supply the pharmaceutical benefit to the nominated dispenser, using alternative means of supply if necessary, as soon as it is practicable.
(4) The Secretary may:
(a) cancel an order that is affected by subsection (3); and
(b) order the supply of a different pharmaceutical benefit.
Note If there is another responsible person who becomes available to supply an order, subsection (4) would permit the Secretary to order the supply from that other responsible person.
62 Modifications to the Regulations
(1) Regulation 21, 22 and 26 of the Regulations (other than the provisions mentioned in paragraphs (2) (d) and (e) of this section) as modified under this Part, apply under this Special Arrangement:
(a) as if the following references were a reference to a nominated dispenser:
(i) approved pharmacist;
(ii) approved medical practitioner;
(iii) approved hospital authority; and
(b) as if a reference to one of those persons supplying a pharmaceutical benefit were a reference to the nominated dispenser dispensing a pharmaceutical benefit.
(2) The following provisions in the Regulations do not apply to the supply of a pharmaceutical benefit under this Special Arrangement:
(a) regulation 13;
(b) regulation 24;
(c) subregulations 25 (2), (3) and (4);
(d) subparagraph 26 (1A) (b) (ii);
(e) paragraphs 26 (2) (b) and (c);
(f) regulation 26A;
(g) regulation 28.
63 Dispensing PB — first presentation of prescription
(1) Regulation 21 of the Regulations applies to the supply of a pharmaceutical benefit under this Special Arrangement subject to the modification of the following provisions in that regulation by this section:
(a) paragraphs 21 (1) (aa) and (2) (aa); and
(b) subparagraphs 21 (1) (b) (i) and (2) (b) (i).
(2) The nominated dispenser may not, on first presentation of a prescription, dispense a pharmaceutical benefit to an eligible person if:
(a) the day the prescription was written is more than 35 days before the presentation of the prescription; or
(b) there is uncollected stock of pharmaceutical benefit, that had been ordered by the Secretary for the person for an earlier treatment period, remaining with the dispenser.
(3) However, the nominated dispenser may dispense a pharmaceutical benefit in the circumstances mentioned in paragraph (2) (a) or (b) if:
(a) the dispenser asks the Secretary for approval to dispense; and
(b) the dispenser is notified by the Secretary that it is appropriate to dispense the pharmaceutical benefit.
(4) Subparagraphs 21 (1) (b) (i) and (2) (b) (i) of the Regulations do not apply to the supply of a pharmaceutical benefit under this Special Arrangement.
64 Repeat supplies
(1) A pharmaceutical benefit must not be supplied a number of times greater than the number specified in the prescription.
(2) A nominated dispenser may dispense, for a treatment period, the repeat supply of a pharmaceutical benefit under subparagraph 9 (b) (i) to a person only if there are less than 21 days remaining before the date the person’s existing stock of pharmaceutical benefit for the treatment period is expected to run out (the run out date).
Note The term existing stock of pharmaceutical benefit is defined in subsection 3 (1).
(3) For subsection (2), the run out date is the date that pharmaceutical benefit for treatment of a person for the first 19 weeks of an initial treatment period, or the first 13 weeks of a continuing or a recommenced treatment period, is expected to run out, as notified to the nominated dispenser under paragraphs 19 (1) (e) or (f).
(4) Subsection (5) applies if an eligible person requires an additional supply of a pharmaceutical benefit for a treatment period because the pharmaceutical benefit previously supplied to the person for the treatment period was destroyed, lost or stolen.
(5) The nominated dispenser may dispense an additional supply to the person only if:
(a) the person’s treating practitioner first seeks approval from the Secretary; and
(b) the Secretary approves the supply and orders, for growth hormone treatment of the person, a further stock of pharmaceutical benefit from the responsible person for the brand of the pharmaceutical item in the pharmaceutical benefit used for the treatment.
Note Section 9 provides for repeat prescriptions under this Special Arrangement.
65 Payment from Commonwealth
(1) The responsible person for a brand of a pharmaceutical item in a pharmaceutical benefit, who supplies the pharmaceutical benefit under this Special Arrangement:
(a) may make a claim for payment to the Department by:
(i) submitting an invoice for each supply of pharmaceutical benefit delivered to the nominated dispenser; and
(ii) providing proof of delivery verifying that the pharmaceutical benefit that was delivered, and its quantity, match what was ordered by the Department; and
(b) is entitled to be paid by the Commonwealth at the price ex‑manufacturer for the pharmaceutical benefit.
(2) Sections 99 and 99AAA of the Act do not apply to the supply of a pharmaceutical benefit under this Special Arrangement.
Part 4 Transitional provisions
66 Pending applications for growth hormone treatment
(1) This section applies if:
(a) a medical practitioner applied, under the Health‑administered GHP, for a person to receive growth hormone treatment under that program; and
(b) immediately before this Special Arrangement commenced, no decision had been made about that application.
(2) The application is taken to have been made under:
(a) for an application requesting initial treatment for the person — section 13; and
(b) for an application requesting continuing treatment for the person — section 14; and
(c) for an application requesting treatment for the person in a category different from the category for which the person had been receiving treatment — section 16; and
(d) for an application requesting growth hormone treatment for the person to recommence after having ceased — section 24.
Additional information required
(3) However, if the application does not include information required by the provision the application is taken to have been made under, the applicant must provide the information required by the provision.
Meaning of treating practitioner
(4) The medical practitioner mentioned in paragraph (1) (a) is taken to be the person’s treating practitioner for this Special Arrangement.
67 Next following application for person receiving treatment under Health‑administered GHP
Scope of this section
(1) This section applies for the next following application for growth hormone treatment for a person who was receiving growth hormone treatment under the Health‑administered GHP immediately before this Special Arrangement commenced.
Treatment
(2) The treatment that the person was receiving under the Health‑administered GHP (the GHP treatment) is taken to have been received under the provision listed below that most closely corresponds to that GHP treatment:
(a) section 13; or
(b) section 14; or
(c) section 16; or
(d) section 24.
Category
(3) The person is taken to have received growth hormone treatment in the category under this Special Arrangement mentioned in subsection 11 (2) that most closely corresponds to a category the person had been receiving treatment for under the Health‑administered GHP.
Dose of pharmaceutical benefit
(4) The dose that the person was receiving under the Health‑administered GHP is taken to have been approved under Division 6 of Part 2 of this Special Arrangement.
68 Pharmaceutical benefit supplied under Health‑administered GHP — claim for payment
(1) Subsection (2) applies if, immediately before this Special Arrangement commenced:
(a) a responsible person for a brand of a pharmaceutical item in a pharmaceutical benefit mentioned in Schedule 1 had made a claim for payment for the supply of the pharmaceutical benefit; and
(b) no decision had been made about the payment of the claim.
(2) The claim is taken to have been made under subsection 65 (1).
(3) However, if the claim does not include the material required by subparagraphs 65 (1) (a) (i) and (ii), the responsible person must provide the material.
(4) Subsection (5) applies if, immediately before this Special Arrangement commenced:
(a) a supply of pharmaceutical benefit mentioned in Schedule 1 had been made by the responsible person (for the brand of pharmaceutical item in the pharmaceutical benefit) to a person who had been eligible to receive the pharmaceutical benefit under the Health‑administered GHP; and
(b) the responsible person has not made a claim for payment for the supply.
(5) Section 65 applies for the supply, and the responsible person may make a claim for payment to the Department under subsection (1) of that section.
Schedule 1 Pharmaceutical benefits covered by this Special Arrangement and related information
(section 4 and subsection 6 (1))
Listed Drug
Form
Manner of Administration
Brand
Responsible Person
Authorised Prescriber
Section 100 only
Somatropin
Injection 4 mg (12 i.u.) vial with diluent (with preservative)
Injection
Zomacton
FP
AMP
D
Injection 5 mg (15 i.u.) in 1 mL cartridge (with preservative)
Injection
Genotropin
PF
AMP
D
Powder for injection 5 mg (15 i.u.) with diluent in pre‑filled pen (with preservative)
Injection
Genotropin GoQuick
PF
AMP
D
Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative)
Injection
Norditropin NordiFlex
NO
AMP
D
Norditropin FlexPro
NO
AMP
D
Norditropin SimpleXx
NO
AMP
D
Omnitrope
SZ
AMP
D
Injection 18 i.u. (6 mg) cartridge with 3.15 mL diluent (with preservative)
Injection
Humatrope
LY
AMP
D
Injection 8 mg (24 i.u.) vial with 1.37 mL diluent cartridge (with preservative) (for use with one.click auto‑injector)
Injection
Saizen 8 mg click.easy
SG
AMP
D
Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative)
Injection
Norditropin NordiFlex
NO
AMP
D
Norditropin FlexPro
NO
AMP
D
Norditropin SimpleXx
NO
AMP
D
Omnitrope
SZ
AMP
D
Solution for injection 10 mg (30 i.u.) in 2 mL cartridge (with preservative)
Injection
NutropinAq
IS
AMP
D
Injection 10 mg (30 i.u.) vial with diluent (with preservative)
Injection
Zomacton
FP
AMP
D
Injection 36 i.u. (12 mg) cartridge with 3.15 mL diluent (with preservative)
Injection
Humatrope
LY
AMP
D
Injection 12 mg (36 i.u.) in 1 mL cartridge (with preservative)
Injection
Genotropin
PF
AMP
D
Powder for injection 12 mg (36 i.u.) with diluent in pre‑filled pen (with preservative)
Injection
Genotropin GoQuick
PF
AMP
D
Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative)
Injection
Norditropin NordiFlex
NO
AMP
D
Norditropin FlexPro
NO
AMP
D
Norditropin SimpleXx
NO
AMP
D
Injection 72 i.u. (24 mg) cartridge with 3.15 mL diluent (with preservative)
Injection
Humatrope
LY
AMP
D
Injection 0.6 mg (1.8 i.u.) with diluent in single use syringe (without preservative)
Injection
Genotropin MiniQuick
PF
AMP
D
Injection 0.8 mg (2.4 i.u.) with diluent in single use syringe (without preservative)
Injection
Genotropin MiniQuick
PF
AMP
D
Injection 1 mg (3 i.u.) with diluent in single use syringe (without preservative)
Injection
Genotropin MiniQuick
PF
AMP
D
Injection 1.2 mg (3.6 i.u.) with diluent in single use syringe (without preservative)
Injection
Genotropin MiniQuick
PF
AMP
D
Injection 1.4 mg (4.2 i.u.) with diluent in single use syringe (without preservative)
Injection
Genotropin MiniQuick
PF
AMP
D
Injection 1.6 mg (4.8 i.u.) with diluent in single use syringe (without preservative)
Injection
Genotropin MiniQuick
PF
AMP
D
Injection 1.8 mg (5.4 i.u.) with diluent in single use syringe (without preservative)
Injection
Genotropin MiniQuick
PF
AMP
D
Injection 2 mg (6 i.u.) with diluent in single use syringe (without preservative)
Injection
Genotropin MiniQuick
PF
AMP
D
Schedule 2 Responsible person codes
(subsection 6 (2))
Code
Responsible Person
Australian Business Number
FP
Ferring Pharmaceuticals Pty Limited
87 003 037 170
IS
Ipsen Pty Ltd
47 095 036 909
LY
Eli Lilly Australia Pty Ltd
39 000 233 992
NO
Novo Nordisk Pharmaceuticals Pty. Limited
40 002 879 996
PF
Pfizer Australia Pty Ltd
50 008 422 348
SG
Merck Serono Australia Pty Ltd
72 006 900 830
SZ
Sandoz Pty Ltd
60 075 449 553
Note
1. All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au.
