Part 1
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Commonwealth legislation
This Act has been repealed and is no longer in force. It is retained for historical reference.
This law sets how the Australian Government subsidises expensive growth‑hormone medicines (e.g. somatropin, somatrogon, mecasermin) through the PBS for eligible children and adults with specified conditions, and for the clinicians who prescribe them. It enforces specialist prescribing, formula‑based dose caps and time‑limited supplies, with lower co‑payments for eligible Indigenous patients, balancing access to costly, life‑changing treatment with clinical oversight and cost control.
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Direct links to the current provisions in National Health (Growth Hormone Program) Special Arrangement 2015.
(1) This Special Arrangement is the National Health (Growth Hormone Program) Special Arrangement 2015. (2) This Special Arrangement may also be cited as PB 85 of 2015.
(1) In this Special Arrangement:
Act means the National Health Act 1953.
adult means a person, who:
is not a child; or
is 18 years of age or older and has late onset growth hormone deficiency.
authorised prescriber
(a) for the initial treatment phase for a child means:
– a specialist or consultant physician in paediatric endocrinology; or
– a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
(b) for the continuing treatment phase for a child means:
– a medical practitioner.
(c) for the recommencement treatment phase for a child, continuing treatment as a reclassified patient phase for a child and recommencement of treatment as a reclassified patient phase for a child means:
– a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or
– a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
(ca) for the changing drug treatment phase for a child means:
– a specialist or consultant physician in paediatric endocrinology; or
– a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
(cb) for the non‑PBS subsidised to PBS subsidised supply treatment phase for a child in relation to a pharmaceutical benefit that has the drug mecasermin or somatrogon means:
– a specialist or consultant physician in paediatric endocrinology; or
– a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
(d) for the initial treatment phase for an adult or the continuing treatment phase for an adult, means a specialist or consultant physician in endocrinology.
CDC 2000 means the growth charts in the document entitled 2000 CDC Growth Charts for the United States: Methods and Development and CDC Extended BMI‑for‑Age Growth Charts, published by the Centers for Disease Control and Prevention, US Department of Health and Human Services, dated December 2022, and available on that Department’s website at http://www.cdc.gov/GROWTHcharts
changing drug treatment phase for a child means a treatment phase to facilitate a change in the prescribed pharmaceutical benefit for a child:
(a) from a pharmaceutical benefit that has the drug somatrogon to a pharmaceutical benefit that has the drug somatropin; or
(b) from a pharmaceutical benefit that has the drug somatropin to a pharmaceutical benefit that has the drug somatrogon.
child means a person, who:
(a) has a non‑mature skeleton; or
(b) has a diagnosis of Prader‑Willi syndrome, with a mature skeleton and is less than 18 years of age.
CTG registered patient means a patient registered under subsection 10(2) of the CTG Special Arrangement.
CTG Special Arrangement means the National Health (Closing the Gap – PBS Co‑payment Program) Special Arrangement 2016.
CTG supplier has the same meaning as in the CTG Special Arrangement.
dispensed price:
(a) for the supply of a pharmaceutical benefit by a hospital authority for a public hospital—has the meaning given by section 16; and
(b) for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital or by an approved pharmacist or by an approved medical practitioner—has the meaning given by section 18.
growth hormone treatment, for a person, means treatment of the person using a pharmaceutical benefit in accordance with this Special Arrangement.
ideal body weight means:
(a) for a person who is male with a height less than or equal to 176.8 centimetres, or female with a height less than or equal to 163.3 centimetres ‑ that person’s 50th percentile weight for height, calculated using CDC 2000;
(b) for a person who is male with a height greater than 176.8 centimetres, or female with a height greater than 163.3 centimetres ‑ that person’s body mass index at the 50th percentile for age multiplied by height (in metres) squared, calculated using CDC 2000.
mature skeleton means:
(a) for a female, where the person has a bone age of 13.5 years or more; and
(b) for a male, where the person has a bone age of 15.5 years or more.
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 11 for the category.
medical practitioner has the meaning it has in the Health Insurance Act 1973.
non‑mature skeleton means:
(a) for a female, where the person has a bone age of less than 13.5 years; and
(b) for a male, where the person has a bone age of less than 15.5 years.
other Special Arrangement means another Special Arrangement under section 100 of the Act.
percentile is a measure used in statistics indicating the value below which a given percentage of observations in a group of observations fall. For the purposes of this Special Arrangement, percentile is used to compare a person’s measurements with the referenced growth standards (eg a body mass index at the 85th percentile means that 85 percent of the population encompassed by the referenced standards have a body mass index below the person’s body mass index).
pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.
Note: Only pharmaceutical benefits mentioned in Part 1 of Schedule 1 may be supplied on a prescription written for a child, and only pharmaceutical benefits mentioned in Part 2 of Schedule 1 may be supplied on a prescription written for an adult: see sections 7A and 9AA.
pharmaceutical benefit has a drug has the same meaning as in Part VII of the Act.
Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.
(1) This Special Arrangement is the National Health (Growth Hormone Program) Special Arrangement 2015. (2) This Special Arrangement may also be cited as PB 85 of 2015.
(1) In this Special Arrangement:
Act means the National Health Act 1953.
adult means a person, who:
is not a child; or
is 18 years of age or older and has late onset growth hormone deficiency.
authorised prescriber
(a) for the initial treatment phase for a child means:
– a specialist or consultant physician in paediatric endocrinology; or
– a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
(b) for the continuing treatment phase for a child means:
– a medical practitioner.
(c) for the recommencement treatment phase for a child, continuing treatment as a reclassified patient phase for a child and recommencement of treatment as a reclassified patient phase for a child means:
– a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or
– a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
(ca) for the changing drug treatment phase for a child means:
– a specialist or consultant physician in paediatric endocrinology; or
– a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
(cb) for the non‑PBS subsidised to PBS subsidised supply treatment phase for a child in relation to a pharmaceutical benefit that has the drug mecasermin or somatrogon means:
– a specialist or consultant physician in paediatric endocrinology; or
– a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
(d) for the initial treatment phase for an adult or the continuing treatment phase for an adult, means a specialist or consultant physician in endocrinology.
CDC 2000 means the growth charts in the document entitled 2000 CDC Growth Charts for the United States: Methods and Development and CDC Extended BMI‑for‑Age Growth Charts, published by the Centers for Disease Control and Prevention, US Department of Health and Human Services, dated December 2022, and available on that Department’s website at http://www.cdc.gov/GROWTHcharts
changing drug treatment phase for a child means a treatment phase to facilitate a change in the prescribed pharmaceutical benefit for a child:
(a) from a pharmaceutical benefit that has the drug somatrogon to a pharmaceutical benefit that has the drug somatropin; or
(b) from a pharmaceutical benefit that has the drug somatropin to a pharmaceutical benefit that has the drug somatrogon.
child means a person, who:
(a) has a non‑mature skeleton; or
(b) has a diagnosis of Prader‑Willi syndrome, with a mature skeleton and is less than 18 years of age.
CTG registered patient means a patient registered under subsection 10(2) of the CTG Special Arrangement.
CTG Special Arrangement means the National Health (Closing the Gap – PBS Co‑payment Program) Special Arrangement 2016.
CTG supplier has the same meaning as in the CTG Special Arrangement.
dispensed price:
(a) for the supply of a pharmaceutical benefit by a hospital authority for a public hospital—has the meaning given by section 16; and
(b) for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital or by an approved pharmacist or by an approved medical practitioner—has the meaning given by section 18.
growth hormone treatment, for a person, means treatment of the person using a pharmaceutical benefit in accordance with this Special Arrangement.
ideal body weight means:
(a) for a person who is male with a height less than or equal to 176.8 centimetres, or female with a height less than or equal to 163.3 centimetres ‑ that person’s 50th percentile weight for height, calculated using CDC 2000;
(b) for a person who is male with a height greater than 176.8 centimetres, or female with a height greater than 163.3 centimetres ‑ that person’s body mass index at the 50th percentile for age multiplied by height (in metres) squared, calculated using CDC 2000.
mature skeleton means:
(a) for a female, where the person has a bone age of 13.5 years or more; and
(b) for a male, where the person has a bone age of 15.5 years or more.
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 11 for the category.
medical practitioner has the meaning it has in the Health Insurance Act 1973.
non‑mature skeleton means:
(a) for a female, where the person has a bone age of less than 13.5 years; and
(b) for a male, where the person has a bone age of less than 15.5 years.
other Special Arrangement means another Special Arrangement under section 100 of the Act.
percentile is a measure used in statistics indicating the value below which a given percentage of observations in a group of observations fall. For the purposes of this Special Arrangement, percentile is used to compare a person’s measurements with the referenced growth standards (eg a body mass index at the 85th percentile means that 85 percent of the population encompassed by the referenced standards have a body mass index below the person’s body mass index).
pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.
Note: Only pharmaceutical benefits mentioned in Part 1 of Schedule 1 may be supplied on a prescription written for a child, and only pharmaceutical benefits mentioned in Part 2 of Schedule 1 may be supplied on a prescription written for an adult: see sections 7A and 9AA.
pharmaceutical benefit has a drug has the same meaning as in Part VII of the Act.
Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.
(1) This Special Arrangement applies to each pharmaceutical benefit mentioned in Schedule 1.
Note: Only pharmaceutical benefits mentioned in Part 1 of Schedule 1 may be supplied on a prescription written for a child, and only pharmaceutical benefits mentioned in Part 2 of Schedule 1 may be supplied on a prescription written for an adult: see sections 7A and 9AA.
(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.
(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.
(1) If the code ‘D(100)’ is mentioned in the column of a table 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.
A pharmaceutical benefit must not be supplied on a prescription written for a person who is a child when the prescription is written unless the pharmaceutical benefit is mentioned in Part 1 of Schedule 1.
Somatrogon and somatropin (1) Subject to subsection (2), the maximum quantity or number of units of a pharmaceutical benefit that has the drug somatrogon or somatropin that may, in one prescription for a child, be directed to be supplied during an initial treatment phase, a recommencement treatment phase, or a recommencement of treatment as a reclassified patient phase is an amount that is sufficient for 16 weeks of treatment of the child. (2) The total quantity or number of units (including any repeats) of a pharmaceutical benefit that has the drug somatrogon or somatropin that may, in prescriptions for a child, be directed to be supplied for a phase referred to in subsection (1) is an amount that is sufficient for 32 weeks of treatment of the child. (3) Subject to subsection (4), the maximum quantity or number of units of a pharmaceutical benefit that has the drug somatrogon or somatropin that may, in one prescription for a child, be directed to be supplied during a continuing treatment phase, a continuing treatment as a reclassified patient phase, a changing drug treatment phase, or a non‑PBS subsidised to PBS subsidised supply treatment phase is an amount that is sufficient for 13 weeks of treatment of the child. (4) The total quantity or number of units (including any repeats) of a pharmaceutical benefit that has the drug somatrogon or somatropin that may, in prescriptions for a child, be directed to be supplied for a phase referred to in subsection (3) is an amount that is sufficient for 26 weeks of treatment of the child. Mecasermin (5) The maximum quantity or number of units of a pharmaceutical benefit that has the drug mecasermin that may, in one prescription for a child, be directed to be supplied during an initial treatment phase, a continuing treatment phase or a non‑PBS subsidised to PBS subsidised supply treatment phase is an amount that is sufficient for the first month of treatment of the child in that phase.
Somatrogon and somatropin (1) The maximum number of occasions on which the supply of a pharmaceutical benefit that has the drug somatrogon or somatropin may, in one prescription for a child, be directed to be repeated is one. Mecasermin (2) The maximum number of occasions on which the supply of a pharmaceutical benefit that has the drug mecasermin may, in one prescription for a child, be directed to be repeated is 5, with each direction for a repeated supply directing a supply, on one occasion, of pharmaceutical benefit sufficient for one month.
A pharmaceutical benefit must not be supplied on a prescription written for a person who is an adult when the prescription is written unless the pharmaceutical benefit is mentioned in Part 2 of Schedule 1.
The maximum quantity or number of units of the pharmaceutical benefit that may, in one prescription for an adult, be directed to be supplied during an initial treatment period or a continuing treatment period is an amount that is sufficient for the first month of treatment of the adult in that period.
The maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription for an adult, be directed to be repeated is 5, with each direction for a repeated supply directing a supply, on one occasion, of pharmaceutical benefit sufficient for one month.
A pharmaceutical benefit must not be supplied on prescription for a phase of treatment of a person unless the prescription is written by an authorised prescriber for that phase.
This Part applies in relation to: (a) a person who is a child; and (b) a pharmaceutical benefit mentioned in Part 1 of Schedule 1.
(1) For the purposes of table items 1 to 4 of the table in section 11:
dose, for a person and a pharmaceutical benefit, means a dose of pharmaceutical benefit mentioned in the table in section 11 that is measured as a dose that applies to the body surface area of the person for a week, with the body surface area of the person calculated using the formula:
(2) For the purposes of table items 1 to 3 of the table in section 11, the measurement ‘m2’ refers to: (a) where a person is: (i) mentioned in item 1 or 2 in the table in section 11; or (ii) mentioned in item 3 in the table in section 11 and has a body mass index less than the 85th percentile for age and sex; a square metre of the body surface area of the person calculated by weight; or (b) where a person is: (i) mentioned in item 3 in the table in section 11; and (ii) has a body mass index greater than the 85th percentile for age and sex, a square metre of the body surface area of the person, calculated using ideal body weight (kg). (3) For the purposes of table item 4 of the table in section 11, the measurement ‘kg’ refers to: (a) where a person is mentioned in item 4 in the table in section 11 and has a body mass index equal to or less than the 85th percentile for age and sex, the person’s body weight in kilograms; or (b) where a person is mentioned in item 4 in the table in section 11 and has a body mass index greater than the 85th percentile for age and sex, the person’s ideal body weight in kilograms.
(1) The dose of a pharmaceutical benefit that has a drug mentioned in column 1 of an item in the following table and that is prescribed by an authorised prescriber for a person’s condition mentioned in column 2 of that item must: (a) be appropriate for treatment of the person under this Special Arrangement; and (b) subject to subsections (2) and (3), not exceed the dose calculated in accordance with column 3 of that item.
<table cellspacing="0" cellpadding="0" style="margin-left:0.25pt; border-collapse:collapse"><thead><tr><td colspan="4" style="width:404.85pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Dose of pharmaceutical benefit</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p><p class="TableHeading"><span>Drug</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p><p class="TableHeading"><span>Condition</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span></p><p class="TableHeading"><span>Maximum dose</span></p></td></tr></thead><tbody><tr><td style="width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:59.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Somatropin</span></p></td><td style="width:187.65pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of:</span></p><p class="Tablea"><span>(a) short stature and slow growth; or</span></p><p class="Tablea"><span>(b) short stature associated with biochemical growth hormone deficiency; or</span></p><p class="Tablea"><span>(c) growth retardation secondary to an intracranial lesion or cranial irradiation; or</span></p><p class="Tablea"><span>(d) risk of hypoglycaemia secondary to biochemical growth hormone deficiency in neonates/infants; or</span></p><p class="Tablea"><span>(e) biochemical growth hormone deficiency and precocious puberty; or</span></p><p class="Tablea"><span>(f) hypothalamic</span><span>‑</span><span>pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</span></p></td><td style="width:100.3pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>7.5 mg/m</span><span style="font-size:6.67pt; vertical-align:super">2</span><span>/week</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Somatropin</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of:</span></p><p class="Tablea"><span>(a) short stature associated with Turner Syndrome; or</span></p><p class="Tablea"><span>(b) short stature due to short stature homeobox (SHOX) gene disorders; or</span></p><p class="Tablea"><span>(c) short stature associated with chronic renal insufficiency</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>9.5 mg/m</span><span style="font-size:6.67pt; vertical-align:super">2</span><span>/week</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Somatropin</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of short stature and poor body composition due to Prader</span><span>‑</span><span>Willi Syndrome, where the person has a non</span><span>‑</span><span>mature skeleton</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>7.5 mg/m</span><span style="font-size:6.67pt; vertical-align:super">2</span><span>/week</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Somatropin</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of short stature and poor body composition due to Prader</span><span>‑</span><span>Willi Syndrome, where the person has a mature skeleton</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>0.04 mg/kg/week</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Mecasermin</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of severe primary insulin</span><span>‑</span><span>like growth factor 1 deficiency (Primary IGFD)</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>0.12 mg/kg twice daily</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Somatrogon</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of:</span></p><p class="Tablea"><span>(a) short stature associated with biochemical growth hormone deficiency; or</span></p><p class="Tablea"><span>(b) short stature and slow growth</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>0.66 mg/kg/week</span></p></td></tr></tbody></table>
(2) If: (a) the dose is of a pharmaceutical benefit that has the drug somatropin; and (b) the form of the pharmaceutical benefit and the manufacturer’s pack is unable to accommodate the dose calculated in accordance with column 3 of the applicable item of the table; the dose may be up to 3% greater than the dose calculated in accordance with that item of the table. (3) If: (a) the dose is of a pharmaceutical benefit that has the drug somatrogon; and (b) the form of the pharmaceutical benefit and the manufacturer’s pack is unable to accommodate the dose calculated in accordance with column 3 of the applicable item of the table; the dose, once calculated in accordance with that item of the table, may be rounded up to the nearest 0.2 mg or 0.5 mg.
(1) An authorised prescriber must prescribe a dose of pharmaceutical benefit, for a person who is reclassified to a different category for treatment, in accordance with the dose in the table in section 11 that applies to the category to which the person has been reclassified. (2) The dose cannot exceed the maximum dose permitted for the category for treatment to which the person has been reclassified.
(1) This section applies if a person is recommencing growth hormone treatment, in a category mentioned in the table in section 11. (2) The dose cannot exceed the maximum dose permitted for the category for treatment for which the person has recommenced.
(1) An approved hospital authority for a public hospital is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for its supply of the pharmaceutical benefit is greater than the amount that the approved hospital authority was entitled to charge under section 16.
Note: However, see Part 6A in relation to the supply of a pharmaceutical benefit to a CTG registered patient by a CTG supplier.
(2) The dispensed price for the supply of a pharmaceutical benefit by an approved hospital authority for a public hospital must be determined in accordance with Division 1 of Part 5. (3) No mark‑ups may be added to the cost of a pharmaceutical benefit for which payment is claimed by an approved hospital authority for a public hospital.
(1) An approved hospital authority for a private hospital is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for its supply of the pharmaceutical benefit is greater than the amount that the approved hospital authority was entitled to charge under section 18.
Note: However, see Part 6A in relation to the supply of a pharmaceutical benefit to a CTG registered patient by a CTG supplier.
(2) An approved pharmacist or an approved medical practitioner is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of a pharmaceutical benefit is greater than the amount that the approved pharmacist or approved medical practitioner was entitled to charge under section 18. (3) The dispensed price for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital, an approved pharmacist or an approved medical practitioner must be determined in accordance with Division 2 of Part 5.
(1) The dispensed price for the supply of a pharmaceutical benefit by a hospital authority for a public hospital is as follows: (a) if the quantity of the pharmaceutical benefit that is ordered and supplied is equal to a multiple of a pack quantity of the benefit—the sum of the approved ex‑manufacturer price or the proportional ex‑manufacturer price for each pack quantity; (b) if the quantity of the pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit—the amount calculated in accordance with section 17; (c) if the quantity of the pharmaceutical benefit that is ordered and supplied is more than a multiple of a pack quantity of the benefit—the sum of: (i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price for each pack quantity; and (ii) the amount calculated in accordance with section 17 for the remainder of the quantity supplied that is less than a pack quantity.
(1) If the quantity of a pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit (a broken quantity), the amount mentioned in paragraph 16(1)(b) and subparagraph 16(1)(c)(ii) is to be calculated by:
(a) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and
(b) applying that percentage to the approved ex‑manufacturer price or proportional ex‑manufacturer price for the pack quantity.
(1) The dispensed price for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital, an approved pharmacist or an approved medical practitioner, is as follows: (a) if the quantity of the pharmaceutical benefit that is ordered and supplied is equal to a multiple of a pack quantity, the sum of: (i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price for each pack quantity, plus the mark‑up mentioned in section 19 taken to the nearest cent, with one half cent being rounded up to 1 cent; and (ii) a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the pharmaceutical benefit; or (b) if a quantity of the pharmaceutical benefit that is ordered and supplied is less than a pack quantity, the sum of: (i) the amount calculated in accordance with section 20; and (ii) a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the pharmaceutical benefit; or
(c) if a quantity of the pharmaceutical benefit that is ordered and supplied is more than a multiple of a pack quantity, the sum of:
(i) for each pack quantity, the approved ex‑manufacturer price or the proportional ex‑manufacturer price for the pack quantity, plus the mark‑up mentioned in section 19 taken to the nearest cent, with one half cent being rounded up to 1 cent; and
(ii) the amount calculated in accordance with section 20 for the remainder of the quantity supplied that is less than a pack quantity; and
(iii) a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the pharmaceutical benefit.
For subparagraphs 18(1)(a)(i) and 18(1)(c)(i) and for paragraph 20(a), the mark‑up for a pack quantity of a ready‑prepared pharmaceutical benefit is:
(a) if the pack quantity for which a mark‑up is to be calculated under this section is equal to a maximum quantity of the pharmaceutical benefit, the mark‑up is the amount mentioned in the table below for the approved ex‑manufacturer price (AEMP) or for the proportional ex‑manufacturer price (PEMP) for that quantity.
(b) if the pack quantity for which a mark‑up is to be calculated under this section is not equal to a maximum quantity of the pharmaceutical benefit, the mark‑up is worked out as follows:
(i) if the mark‑up that would apply to the maximum quantity is shown in the table in paragraph (a) as a monetary amount—the mark‑up for the pack quantity is that monetary amount, reduced proportionately for the relative quantities; and
(ii) if the mark‑up that would apply to the maximum quantity is shown in the table in paragraph (a) as a percentage of AEMP or PEMP—the mark‑up for the pack quantity is that percentage of the AEMP or PEMP for the pack quantity.
If the quantity of a pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit (a broken quantity), the amount mentioned in subparagraph 18(1)(b)(i) and 18(1)(c)(ii) is to be calculated by:
(a) adding the mark‑up mentioned in section 19 to the approved ex‑manufacturer price or the proportional ex‑manufacturer price for the pack quantity, taking the result to the nearest cent, with one half cent being rounded up to 1 cent; and
(b) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and
(c) applying the percentage worked out under subparagraph (b) to the amount worked out under subparagraph (a).
If an eligible medical practitioner, instead of directing a repeated supply of a pharmaceutical benefit, directs the supply on one occasion of a quantity or number of units of the drug, not exceeding the total quantity or number of units that could be prescribed if the eligible medical practitioner directed a repeated supply, the dispensed price for the supply of the pharmaceutical benefit will include only one dispensing fee.
The dispensed price for the supply of a pharmaceutical benefit will in each case be taken to the nearest cent, with one half cent being rounded up to 1 cent.
(1) This section applies if an approved pharmacist, an approved medical practitioner, or an approved hospital authority for a public hospital or a private hospital supplies a pharmaceutical benefit to a patient and makes a claim for payment.
Note: However, see Part 6A in relation to the supply of a pharmaceutical benefit to a CTG registered patient by a CTG supplier.
(2) The approved pharmacist, approved medical practitioner or approved hospital authority may charge the patient an amount equivalent to the amount that may be charged under section 87 of the Act for the supply of a pharmaceutical benefit to the patient.
This Part applies to a supply (the relevant supply) of a pharmaceutical benefit under this Special Arrangement if the relevant supply is made: (a) to a patient who is a CTG registered patient; and (b) by an approved pharmacist, an approved medical practitioner or an approved hospital authority who is a CTG supplier.
(1) Despite sections 14, 15, and 23 of this Special Arrangement, subsections 11(1), (2), (3), (3E) and (4) (co‑payment reduction etc.) and section 13 (payment by Commonwealth) of the CTG Special Arrangement apply in relation to the relevant supply under this Special Arrangement with the modification set out in subsection (2) of this section. (2) A reference in the CTG Special Arrangement to a supply of a pharmaceutical benefit under the CTG Special Arrangement is taken to be a reference to the relevant supply under this Special Arrangement. (3) However, the notes to subsections 11(2) and (3) of the CTG Special Arrangement do not apply in relation to the relevant supply under this Special Arrangement.
Note: The notes to subsections 11(2) and (3) of the CTG Special Arrangement relate to CTG suppliers making claims for payment under the CTG Special Arrangement. Claims for payment in relation to the relevant supply under this Special Arrangement are instead dealt with under section 23C of this Special Arrangement.
(1) If an approved pharmacist, an approved medical practitioner or an approved hospital authority who is a CTG supplier, wants to receive payment from the Commonwealth in relation to the relevant supply under this Special Arrangement, the pharmacist, medical practitioner or hospital authority must make a claim for payment to the Chief Executive Medicare on behalf of the Secretary. (2) The claim must be made in accordance with the rules made under subsections 98AC(4) and 99AAA(8) of thesun Act with the modification set out in subsection (3) of this section. (3) A claim for payment made using the manual system referred to in section 99AAA of the Act must include an indicator that the patient is a CTG registered patient.
(1) Section 94 of the Act applies in a modified manner to pharmaceutical benefits supplied under this Special Arrangement.
(2) An approved hospital authority may supply pharmaceutical benefits that are subject to this Special Arrangement to patients receiving treatment in or at the hospital of which it is the governing body or proprietor, or outside of the hospital of which it is the governing body or proprietor.
(1) This Special Arrangement is the National Health (Growth Hormone Program) Special Arrangement 2015. (2) This Special Arrangement may also be cited as PB 85 of 2015.
(1) In this Special Arrangement:
Act means the National Health Act 1953.
adult means a person, who:
is not a child; or
is 18 years of age or older and has late onset growth hormone deficiency.
authorised prescriber
(a) for the initial treatment phase for a child means:
– a specialist or consultant physician in paediatric endocrinology; or
– a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
(b) for the continuing treatment phase for a child means:
– a medical practitioner.
(c) for the recommencement treatment phase for a child, continuing treatment as a reclassified patient phase for a child and recommencement of treatment as a reclassified patient phase for a child means:
– a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or
– a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
(ca) for the changing drug treatment phase for a child means:
– a specialist or consultant physician in paediatric endocrinology; or
– a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
(cb) for the non‑PBS subsidised to PBS subsidised supply treatment phase for a child in relation to a pharmaceutical benefit that has the drug mecasermin or somatrogon means:
– a specialist or consultant physician in paediatric endocrinology; or
– a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
(d) for the initial treatment phase for an adult or the continuing treatment phase for an adult, means a specialist or consultant physician in endocrinology.
CDC 2000 means the growth charts in the document entitled 2000 CDC Growth Charts for the United States: Methods and Development and CDC Extended BMI‑for‑Age Growth Charts, published by the Centers for Disease Control and Prevention, US Department of Health and Human Services, dated December 2022, and available on that Department’s website at http://www.cdc.gov/GROWTHcharts
changing drug treatment phase for a child means a treatment phase to facilitate a change in the prescribed pharmaceutical benefit for a child:
(a) from a pharmaceutical benefit that has the drug somatrogon to a pharmaceutical benefit that has the drug somatropin; or
(b) from a pharmaceutical benefit that has the drug somatropin to a pharmaceutical benefit that has the drug somatrogon.
child means a person, who:
(a) has a non‑mature skeleton; or
(b) has a diagnosis of Prader‑Willi syndrome, with a mature skeleton and is less than 18 years of age.
CTG registered patient means a patient registered under subsection 10(2) of the CTG Special Arrangement.
CTG Special Arrangement means the National Health (Closing the Gap – PBS Co‑payment Program) Special Arrangement 2016.
CTG supplier has the same meaning as in the CTG Special Arrangement.
dispensed price:
(a) for the supply of a pharmaceutical benefit by a hospital authority for a public hospital—has the meaning given by section 16; and
(b) for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital or by an approved pharmacist or by an approved medical practitioner—has the meaning given by section 18.
growth hormone treatment, for a person, means treatment of the person using a pharmaceutical benefit in accordance with this Special Arrangement.
ideal body weight means:
(a) for a person who is male with a height less than or equal to 176.8 centimetres, or female with a height less than or equal to 163.3 centimetres ‑ that person’s 50th percentile weight for height, calculated using CDC 2000;
(b) for a person who is male with a height greater than 176.8 centimetres, or female with a height greater than 163.3 centimetres ‑ that person’s body mass index at the 50th percentile for age multiplied by height (in metres) squared, calculated using CDC 2000.
mature skeleton means:
(a) for a female, where the person has a bone age of 13.5 years or more; and
(b) for a male, where the person has a bone age of 15.5 years or more.
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 11 for the category.
medical practitioner has the meaning it has in the Health Insurance Act 1973.
non‑mature skeleton means:
(a) for a female, where the person has a bone age of less than 13.5 years; and
(b) for a male, where the person has a bone age of less than 15.5 years.
other Special Arrangement means another Special Arrangement under section 100 of the Act.
percentile is a measure used in statistics indicating the value below which a given percentage of observations in a group of observations fall. For the purposes of this Special Arrangement, percentile is used to compare a person’s measurements with the referenced growth standards (eg a body mass index at the 85th percentile means that 85 percent of the population encompassed by the referenced standards have a body mass index below the person’s body mass index).
pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.
Note: Only pharmaceutical benefits mentioned in Part 1 of Schedule 1 may be supplied on a prescription written for a child, and only pharmaceutical benefits mentioned in Part 2 of Schedule 1 may be supplied on a prescription written for an adult: see sections 7A and 9AA.
pharmaceutical benefit has a drug has the same meaning as in Part VII of the Act.
Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.
(1) This Special Arrangement applies to each pharmaceutical benefit mentioned in Schedule 1.
Note: Only pharmaceutical benefits mentioned in Part 1 of Schedule 1 may be supplied on a prescription written for a child, and only pharmaceutical benefits mentioned in Part 2 of Schedule 1 may be supplied on a prescription written for an adult: see sections 7A and 9AA.
(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.
(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.
(1) If the code ‘D(100)’ is mentioned in the column of a table 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.
A pharmaceutical benefit must not be supplied on a prescription written for a person who is a child when the prescription is written unless the pharmaceutical benefit is mentioned in Part 1 of Schedule 1.
Somatrogon and somatropin (1) Subject to subsection (2), the maximum quantity or number of units of a pharmaceutical benefit that has the drug somatrogon or somatropin that may, in one prescription for a child, be directed to be supplied during an initial treatment phase, a recommencement treatment phase, or a recommencement of treatment as a reclassified patient phase is an amount that is sufficient for 16 weeks of treatment of the child. (2) The total quantity or number of units (including any repeats) of a pharmaceutical benefit that has the drug somatrogon or somatropin that may, in prescriptions for a child, be directed to be supplied for a phase referred to in subsection (1) is an amount that is sufficient for 32 weeks of treatment of the child. (3) Subject to subsection (4), the maximum quantity or number of units of a pharmaceutical benefit that has the drug somatrogon or somatropin that may, in one prescription for a child, be directed to be supplied during a continuing treatment phase, a continuing treatment as a reclassified patient phase, a changing drug treatment phase, or a non‑PBS subsidised to PBS subsidised supply treatment phase is an amount that is sufficient for 13 weeks of treatment of the child. (4) The total quantity or number of units (including any repeats) of a pharmaceutical benefit that has the drug somatrogon or somatropin that may, in prescriptions for a child, be directed to be supplied for a phase referred to in subsection (3) is an amount that is sufficient for 26 weeks of treatment of the child. Mecasermin (5) The maximum quantity or number of units of a pharmaceutical benefit that has the drug mecasermin that may, in one prescription for a child, be directed to be supplied during an initial treatment phase, a continuing treatment phase or a non‑PBS subsidised to PBS subsidised supply treatment phase is an amount that is sufficient for the first month of treatment of the child in that phase.
Somatrogon and somatropin (1) The maximum number of occasions on which the supply of a pharmaceutical benefit that has the drug somatrogon or somatropin may, in one prescription for a child, be directed to be repeated is one. Mecasermin (2) The maximum number of occasions on which the supply of a pharmaceutical benefit that has the drug mecasermin may, in one prescription for a child, be directed to be repeated is 5, with each direction for a repeated supply directing a supply, on one occasion, of pharmaceutical benefit sufficient for one month.
A pharmaceutical benefit must not be supplied on a prescription written for a person who is an adult when the prescription is written unless the pharmaceutical benefit is mentioned in Part 2 of Schedule 1.
The maximum quantity or number of units of the pharmaceutical benefit that may, in one prescription for an adult, be directed to be supplied during an initial treatment period or a continuing treatment period is an amount that is sufficient for the first month of treatment of the adult in that period.
The maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription for an adult, be directed to be repeated is 5, with each direction for a repeated supply directing a supply, on one occasion, of pharmaceutical benefit sufficient for one month.
A pharmaceutical benefit must not be supplied on prescription for a phase of treatment of a person unless the prescription is written by an authorised prescriber for that phase.
This Part applies in relation to: (a) a person who is a child; and (b) a pharmaceutical benefit mentioned in Part 1 of Schedule 1.
(1) For the purposes of table items 1 to 4 of the table in section 11:
dose, for a person and a pharmaceutical benefit, means a dose of pharmaceutical benefit mentioned in the table in section 11 that is measured as a dose that applies to the body surface area of the person for a week, with the body surface area of the person calculated using the formula:
(2) For the purposes of table items 1 to 3 of the table in section 11, the measurement ‘m2’ refers to: (a) where a person is: (i) mentioned in item 1 or 2 in the table in section 11; or (ii) mentioned in item 3 in the table in section 11 and has a body mass index less than the 85th percentile for age and sex; a square metre of the body surface area of the person calculated by weight; or (b) where a person is: (i) mentioned in item 3 in the table in section 11; and (ii) has a body mass index greater than the 85th percentile for age and sex, a square metre of the body surface area of the person, calculated using ideal body weight (kg). (3) For the purposes of table item 4 of the table in section 11, the measurement ‘kg’ refers to: (a) where a person is mentioned in item 4 in the table in section 11 and has a body mass index equal to or less than the 85th percentile for age and sex, the person’s body weight in kilograms; or (b) where a person is mentioned in item 4 in the table in section 11 and has a body mass index greater than the 85th percentile for age and sex, the person’s ideal body weight in kilograms.
(1) The dose of a pharmaceutical benefit that has a drug mentioned in column 1 of an item in the following table and that is prescribed by an authorised prescriber for a person’s condition mentioned in column 2 of that item must: (a) be appropriate for treatment of the person under this Special Arrangement; and (b) subject to subsections (2) and (3), not exceed the dose calculated in accordance with column 3 of that item.
<table cellspacing="0" cellpadding="0" style="margin-left:0.25pt; border-collapse:collapse"><thead><tr><td colspan="4" style="width:404.85pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Dose of pharmaceutical benefit</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p><p class="TableHeading"><span>Drug</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p><p class="TableHeading"><span>Condition</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span></p><p class="TableHeading"><span>Maximum dose</span></p></td></tr></thead><tbody><tr><td style="width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:59.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Somatropin</span></p></td><td style="width:187.65pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of:</span></p><p class="Tablea"><span>(a) short stature and slow growth; or</span></p><p class="Tablea"><span>(b) short stature associated with biochemical growth hormone deficiency; or</span></p><p class="Tablea"><span>(c) growth retardation secondary to an intracranial lesion or cranial irradiation; or</span></p><p class="Tablea"><span>(d) risk of hypoglycaemia secondary to biochemical growth hormone deficiency in neonates/infants; or</span></p><p class="Tablea"><span>(e) biochemical growth hormone deficiency and precocious puberty; or</span></p><p class="Tablea"><span>(f) hypothalamic</span><span>‑</span><span>pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</span></p></td><td style="width:100.3pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>7.5 mg/m</span><span style="font-size:6.67pt; vertical-align:super">2</span><span>/week</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Somatropin</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of:</span></p><p class="Tablea"><span>(a) short stature associated with Turner Syndrome; or</span></p><p class="Tablea"><span>(b) short stature due to short stature homeobox (SHOX) gene disorders; or</span></p><p class="Tablea"><span>(c) short stature associated with chronic renal insufficiency</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>9.5 mg/m</span><span style="font-size:6.67pt; vertical-align:super">2</span><span>/week</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Somatropin</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of short stature and poor body composition due to Prader</span><span>‑</span><span>Willi Syndrome, where the person has a non</span><span>‑</span><span>mature skeleton</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>7.5 mg/m</span><span style="font-size:6.67pt; vertical-align:super">2</span><span>/week</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Somatropin</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of short stature and poor body composition due to Prader</span><span>‑</span><span>Willi Syndrome, where the person has a mature skeleton</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>0.04 mg/kg/week</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Mecasermin</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of severe primary insulin</span><span>‑</span><span>like growth factor 1 deficiency (Primary IGFD)</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>0.12 mg/kg twice daily</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Somatrogon</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of:</span></p><p class="Tablea"><span>(a) short stature associated with biochemical growth hormone deficiency; or</span></p><p class="Tablea"><span>(b) short stature and slow growth</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>0.66 mg/kg/week</span></p></td></tr></tbody></table>
(2) If: (a) the dose is of a pharmaceutical benefit that has the drug somatropin; and (b) the form of the pharmaceutical benefit and the manufacturer’s pack is unable to accommodate the dose calculated in accordance with column 3 of the applicable item of the table; the dose may be up to 3% greater than the dose calculated in accordance with that item of the table. (3) If: (a) the dose is of a pharmaceutical benefit that has the drug somatrogon; and (b) the form of the pharmaceutical benefit and the manufacturer’s pack is unable to accommodate the dose calculated in accordance with column 3 of the applicable item of the table; the dose, once calculated in accordance with that item of the table, may be rounded up to the nearest 0.2 mg or 0.5 mg.
(1) An authorised prescriber must prescribe a dose of pharmaceutical benefit, for a person who is reclassified to a different category for treatment, in accordance with the dose in the table in section 11 that applies to the category to which the person has been reclassified. (2) The dose cannot exceed the maximum dose permitted for the category for treatment to which the person has been reclassified.
(1) This section applies if a person is recommencing growth hormone treatment, in a category mentioned in the table in section 11. (2) The dose cannot exceed the maximum dose permitted for the category for treatment for which the person has recommenced.
(1) An approved hospital authority for a public hospital is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for its supply of the pharmaceutical benefit is greater than the amount that the approved hospital authority was entitled to charge under section 16.
Note: However, see Part 6A in relation to the supply of a pharmaceutical benefit to a CTG registered patient by a CTG supplier.
(2) The dispensed price for the supply of a pharmaceutical benefit by an approved hospital authority for a public hospital must be determined in accordance with Division 1 of Part 5. (3) No mark‑ups may be added to the cost of a pharmaceutical benefit for which payment is claimed by an approved hospital authority for a public hospital.
(1) An approved hospital authority for a private hospital is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for its supply of the pharmaceutical benefit is greater than the amount that the approved hospital authority was entitled to charge under section 18.
Note: However, see Part 6A in relation to the supply of a pharmaceutical benefit to a CTG registered patient by a CTG supplier.
(2) An approved pharmacist or an approved medical practitioner is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of a pharmaceutical benefit is greater than the amount that the approved pharmacist or approved medical practitioner was entitled to charge under section 18. (3) The dispensed price for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital, an approved pharmacist or an approved medical practitioner must be determined in accordance with Division 2 of Part 5.
(1) The dispensed price for the supply of a pharmaceutical benefit by a hospital authority for a public hospital is as follows: (a) if the quantity of the pharmaceutical benefit that is ordered and supplied is equal to a multiple of a pack quantity of the benefit—the sum of the approved ex‑manufacturer price or the proportional ex‑manufacturer price for each pack quantity; (b) if the quantity of the pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit—the amount calculated in accordance with section 17; (c) if the quantity of the pharmaceutical benefit that is ordered and supplied is more than a multiple of a pack quantity of the benefit—the sum of: (i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price for each pack quantity; and (ii) the amount calculated in accordance with section 17 for the remainder of the quantity supplied that is less than a pack quantity.
(1) If the quantity of a pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit (a broken quantity), the amount mentioned in paragraph 16(1)(b) and subparagraph 16(1)(c)(ii) is to be calculated by:
(a) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and
(b) applying that percentage to the approved ex‑manufacturer price or proportional ex‑manufacturer price for the pack quantity.
(1) The dispensed price for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital, an approved pharmacist or an approved medical practitioner, is as follows: (a) if the quantity of the pharmaceutical benefit that is ordered and supplied is equal to a multiple of a pack quantity, the sum of: (i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price for each pack quantity, plus the mark‑up mentioned in section 19 taken to the nearest cent, with one half cent being rounded up to 1 cent; and (ii) a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the pharmaceutical benefit; or (b) if a quantity of the pharmaceutical benefit that is ordered and supplied is less than a pack quantity, the sum of: (i) the amount calculated in accordance with section 20; and (ii) a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the pharmaceutical benefit; or
(c) if a quantity of the pharmaceutical benefit that is ordered and supplied is more than a multiple of a pack quantity, the sum of:
(i) for each pack quantity, the approved ex‑manufacturer price or the proportional ex‑manufacturer price for the pack quantity, plus the mark‑up mentioned in section 19 taken to the nearest cent, with one half cent being rounded up to 1 cent; and
(ii) the amount calculated in accordance with section 20 for the remainder of the quantity supplied that is less than a pack quantity; and
(iii) a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the pharmaceutical benefit.
For subparagraphs 18(1)(a)(i) and 18(1)(c)(i) and for paragraph 20(a), the mark‑up for a pack quantity of a ready‑prepared pharmaceutical benefit is:
(a) if the pack quantity for which a mark‑up is to be calculated under this section is equal to a maximum quantity of the pharmaceutical benefit, the mark‑up is the amount mentioned in the table below for the approved ex‑manufacturer price (AEMP) or for the proportional ex‑manufacturer price (PEMP) for that quantity.
(b) if the pack quantity for which a mark‑up is to be calculated under this section is not equal to a maximum quantity of the pharmaceutical benefit, the mark‑up is worked out as follows:
(i) if the mark‑up that would apply to the maximum quantity is shown in the table in paragraph (a) as a monetary amount—the mark‑up for the pack quantity is that monetary amount, reduced proportionately for the relative quantities; and
(ii) if the mark‑up that would apply to the maximum quantity is shown in the table in paragraph (a) as a percentage of AEMP or PEMP—the mark‑up for the pack quantity is that percentage of the AEMP or PEMP for the pack quantity.
If the quantity of a pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit (a broken quantity), the amount mentioned in subparagraph 18(1)(b)(i) and 18(1)(c)(ii) is to be calculated by:
(a) adding the mark‑up mentioned in section 19 to the approved ex‑manufacturer price or the proportional ex‑manufacturer price for the pack quantity, taking the result to the nearest cent, with one half cent being rounded up to 1 cent; and
(b) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and
(c) applying the percentage worked out under subparagraph (b) to the amount worked out under subparagraph (a).
If an eligible medical practitioner, instead of directing a repeated supply of a pharmaceutical benefit, directs the supply on one occasion of a quantity or number of units of the drug, not exceeding the total quantity or number of units that could be prescribed if the eligible medical practitioner directed a repeated supply, the dispensed price for the supply of the pharmaceutical benefit will include only one dispensing fee.
The dispensed price for the supply of a pharmaceutical benefit will in each case be taken to the nearest cent, with one half cent being rounded up to 1 cent.
(1) This section applies if an approved pharmacist, an approved medical practitioner, or an approved hospital authority for a public hospital or a private hospital supplies a pharmaceutical benefit to a patient and makes a claim for payment.
Note: However, see Part 6A in relation to the supply of a pharmaceutical benefit to a CTG registered patient by a CTG supplier.
(2) The approved pharmacist, approved medical practitioner or approved hospital authority may charge the patient an amount equivalent to the amount that may be charged under section 87 of the Act for the supply of a pharmaceutical benefit to the patient.
This Part applies to a supply (the relevant supply) of a pharmaceutical benefit under this Special Arrangement if the relevant supply is made: (a) to a patient who is a CTG registered patient; and (b) by an approved pharmacist, an approved medical practitioner or an approved hospital authority who is a CTG supplier.
(1) Despite sections 14, 15, and 23 of this Special Arrangement, subsections 11(1), (2), (3), (3E) and (4) (co‑payment reduction etc.) and section 13 (payment by Commonwealth) of the CTG Special Arrangement apply in relation to the relevant supply under this Special Arrangement with the modification set out in subsection (2) of this section. (2) A reference in the CTG Special Arrangement to a supply of a pharmaceutical benefit under the CTG Special Arrangement is taken to be a reference to the relevant supply under this Special Arrangement. (3) However, the notes to subsections 11(2) and (3) of the CTG Special Arrangement do not apply in relation to the relevant supply under this Special Arrangement.
Note: The notes to subsections 11(2) and (3) of the CTG Special Arrangement relate to CTG suppliers making claims for payment under the CTG Special Arrangement. Claims for payment in relation to the relevant supply under this Special Arrangement are instead dealt with under section 23C of this Special Arrangement.
(1) If an approved pharmacist, an approved medical practitioner or an approved hospital authority who is a CTG supplier, wants to receive payment from the Commonwealth in relation to the relevant supply under this Special Arrangement, the pharmacist, medical practitioner or hospital authority must make a claim for payment to the Chief Executive Medicare on behalf of the Secretary. (2) The claim must be made in accordance with the rules made under subsections 98AC(4) and 99AAA(8) of thesun Act with the modification set out in subsection (3) of this section. (3) A claim for payment made using the manual system referred to in section 99AAA of the Act must include an indicator that the patient is a CTG registered patient.
(1) Section 94 of the Act applies in a modified manner to pharmaceutical benefits supplied under this Special Arrangement.
(2) An approved hospital authority may supply pharmaceutical benefits that are subject to this Special Arrangement to patients receiving treatment in or at the hospital of which it is the governing body or proprietor, or outside of the hospital of which it is the governing body or proprietor.
(1) This Special Arrangement applies to each pharmaceutical benefit mentioned in Schedule 1.
Note: Only pharmaceutical benefits mentioned in Part 1 of Schedule 1 may be supplied on a prescription written for a child, and only pharmaceutical benefits mentioned in Part 2 of Schedule 1 may be supplied on a prescription written for an adult: see sections 7A and 9AA.
(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.
(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.
(1) If the code ‘D(100)’ is mentioned in the column of a table 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.
(1) This Special Arrangement is the National Health (Growth Hormone Program) Special Arrangement 2015. (2) This Special Arrangement may also be cited as PB 85 of 2015.
(1) In this Special Arrangement:
Act means the National Health Act 1953.
adult means a person, who:
is not a child; or
is 18 years of age or older and has late onset growth hormone deficiency.
authorised prescriber
(a) for the initial treatment phase for a child means:
– a specialist or consultant physician in paediatric endocrinology; or
– a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
(b) for the continuing treatment phase for a child means:
– a medical practitioner.
(c) for the recommencement treatment phase for a child, continuing treatment as a reclassified patient phase for a child and recommencement of treatment as a reclassified patient phase for a child means:
– a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or
– a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
(ca) for the changing drug treatment phase for a child means:
– a specialist or consultant physician in paediatric endocrinology; or
– a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
(cb) for the non‑PBS subsidised to PBS subsidised supply treatment phase for a child in relation to a pharmaceutical benefit that has the drug mecasermin or somatrogon means:
– a specialist or consultant physician in paediatric endocrinology; or
– a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
(d) for the initial treatment phase for an adult or the continuing treatment phase for an adult, means a specialist or consultant physician in endocrinology.
CDC 2000 means the growth charts in the document entitled 2000 CDC Growth Charts for the United States: Methods and Development and CDC Extended BMI‑for‑Age Growth Charts, published by the Centers for Disease Control and Prevention, US Department of Health and Human Services, dated December 2022, and available on that Department’s website at http://www.cdc.gov/GROWTHcharts
changing drug treatment phase for a child means a treatment phase to facilitate a change in the prescribed pharmaceutical benefit for a child:
(a) from a pharmaceutical benefit that has the drug somatrogon to a pharmaceutical benefit that has the drug somatropin; or
(b) from a pharmaceutical benefit that has the drug somatropin to a pharmaceutical benefit that has the drug somatrogon.
child means a person, who:
(a) has a non‑mature skeleton; or
(b) has a diagnosis of Prader‑Willi syndrome, with a mature skeleton and is less than 18 years of age.
CTG registered patient means a patient registered under subsection 10(2) of the CTG Special Arrangement.
CTG Special Arrangement means the National Health (Closing the Gap – PBS Co‑payment Program) Special Arrangement 2016.
CTG supplier has the same meaning as in the CTG Special Arrangement.
dispensed price:
(a) for the supply of a pharmaceutical benefit by a hospital authority for a public hospital—has the meaning given by section 16; and
(b) for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital or by an approved pharmacist or by an approved medical practitioner—has the meaning given by section 18.
growth hormone treatment, for a person, means treatment of the person using a pharmaceutical benefit in accordance with this Special Arrangement.
ideal body weight means:
(a) for a person who is male with a height less than or equal to 176.8 centimetres, or female with a height less than or equal to 163.3 centimetres ‑ that person’s 50th percentile weight for height, calculated using CDC 2000;
(b) for a person who is male with a height greater than 176.8 centimetres, or female with a height greater than 163.3 centimetres ‑ that person’s body mass index at the 50th percentile for age multiplied by height (in metres) squared, calculated using CDC 2000.
mature skeleton means:
(a) for a female, where the person has a bone age of 13.5 years or more; and
(b) for a male, where the person has a bone age of 15.5 years or more.
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 11 for the category.
medical practitioner has the meaning it has in the Health Insurance Act 1973.
non‑mature skeleton means:
(a) for a female, where the person has a bone age of less than 13.5 years; and
(b) for a male, where the person has a bone age of less than 15.5 years.
other Special Arrangement means another Special Arrangement under section 100 of the Act.
percentile is a measure used in statistics indicating the value below which a given percentage of observations in a group of observations fall. For the purposes of this Special Arrangement, percentile is used to compare a person’s measurements with the referenced growth standards (eg a body mass index at the 85th percentile means that 85 percent of the population encompassed by the referenced standards have a body mass index below the person’s body mass index).
pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.
Note: Only pharmaceutical benefits mentioned in Part 1 of Schedule 1 may be supplied on a prescription written for a child, and only pharmaceutical benefits mentioned in Part 2 of Schedule 1 may be supplied on a prescription written for an adult: see sections 7A and 9AA.
pharmaceutical benefit has a drug has the same meaning as in Part VII of the Act.
Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.
(1) This Special Arrangement applies to each pharmaceutical benefit mentioned in Schedule 1.
Note: Only pharmaceutical benefits mentioned in Part 1 of Schedule 1 may be supplied on a prescription written for a child, and only pharmaceutical benefits mentioned in Part 2 of Schedule 1 may be supplied on a prescription written for an adult: see sections 7A and 9AA.
(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.
(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.
(1) If the code ‘D(100)’ is mentioned in the column of a table 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.
A pharmaceutical benefit must not be supplied on a prescription written for a person who is a child when the prescription is written unless the pharmaceutical benefit is mentioned in Part 1 of Schedule 1.
Somatrogon and somatropin (1) Subject to subsection (2), the maximum quantity or number of units of a pharmaceutical benefit that has the drug somatrogon or somatropin that may, in one prescription for a child, be directed to be supplied during an initial treatment phase, a recommencement treatment phase, or a recommencement of treatment as a reclassified patient phase is an amount that is sufficient for 16 weeks of treatment of the child. (2) The total quantity or number of units (including any repeats) of a pharmaceutical benefit that has the drug somatrogon or somatropin that may, in prescriptions for a child, be directed to be supplied for a phase referred to in subsection (1) is an amount that is sufficient for 32 weeks of treatment of the child. (3) Subject to subsection (4), the maximum quantity or number of units of a pharmaceutical benefit that has the drug somatrogon or somatropin that may, in one prescription for a child, be directed to be supplied during a continuing treatment phase, a continuing treatment as a reclassified patient phase, a changing drug treatment phase, or a non‑PBS subsidised to PBS subsidised supply treatment phase is an amount that is sufficient for 13 weeks of treatment of the child. (4) The total quantity or number of units (including any repeats) of a pharmaceutical benefit that has the drug somatrogon or somatropin that may, in prescriptions for a child, be directed to be supplied for a phase referred to in subsection (3) is an amount that is sufficient for 26 weeks of treatment of the child. Mecasermin (5) The maximum quantity or number of units of a pharmaceutical benefit that has the drug mecasermin that may, in one prescription for a child, be directed to be supplied during an initial treatment phase, a continuing treatment phase or a non‑PBS subsidised to PBS subsidised supply treatment phase is an amount that is sufficient for the first month of treatment of the child in that phase.
Somatrogon and somatropin (1) The maximum number of occasions on which the supply of a pharmaceutical benefit that has the drug somatrogon or somatropin may, in one prescription for a child, be directed to be repeated is one. Mecasermin (2) The maximum number of occasions on which the supply of a pharmaceutical benefit that has the drug mecasermin may, in one prescription for a child, be directed to be repeated is 5, with each direction for a repeated supply directing a supply, on one occasion, of pharmaceutical benefit sufficient for one month.
A pharmaceutical benefit must not be supplied on a prescription written for a person who is an adult when the prescription is written unless the pharmaceutical benefit is mentioned in Part 2 of Schedule 1.
The maximum quantity or number of units of the pharmaceutical benefit that may, in one prescription for an adult, be directed to be supplied during an initial treatment period or a continuing treatment period is an amount that is sufficient for the first month of treatment of the adult in that period.
The maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription for an adult, be directed to be repeated is 5, with each direction for a repeated supply directing a supply, on one occasion, of pharmaceutical benefit sufficient for one month.
A pharmaceutical benefit must not be supplied on prescription for a phase of treatment of a person unless the prescription is written by an authorised prescriber for that phase.
This Part applies in relation to: (a) a person who is a child; and (b) a pharmaceutical benefit mentioned in Part 1 of Schedule 1.
(1) For the purposes of table items 1 to 4 of the table in section 11:
dose, for a person and a pharmaceutical benefit, means a dose of pharmaceutical benefit mentioned in the table in section 11 that is measured as a dose that applies to the body surface area of the person for a week, with the body surface area of the person calculated using the formula:
(2) For the purposes of table items 1 to 3 of the table in section 11, the measurement ‘m2’ refers to: (a) where a person is: (i) mentioned in item 1 or 2 in the table in section 11; or (ii) mentioned in item 3 in the table in section 11 and has a body mass index less than the 85th percentile for age and sex; a square metre of the body surface area of the person calculated by weight; or (b) where a person is: (i) mentioned in item 3 in the table in section 11; and (ii) has a body mass index greater than the 85th percentile for age and sex, a square metre of the body surface area of the person, calculated using ideal body weight (kg). (3) For the purposes of table item 4 of the table in section 11, the measurement ‘kg’ refers to: (a) where a person is mentioned in item 4 in the table in section 11 and has a body mass index equal to or less than the 85th percentile for age and sex, the person’s body weight in kilograms; or (b) where a person is mentioned in item 4 in the table in section 11 and has a body mass index greater than the 85th percentile for age and sex, the person’s ideal body weight in kilograms.
(1) The dose of a pharmaceutical benefit that has a drug mentioned in column 1 of an item in the following table and that is prescribed by an authorised prescriber for a person’s condition mentioned in column 2 of that item must: (a) be appropriate for treatment of the person under this Special Arrangement; and (b) subject to subsections (2) and (3), not exceed the dose calculated in accordance with column 3 of that item.
<table cellspacing="0" cellpadding="0" style="margin-left:0.25pt; border-collapse:collapse"><thead><tr><td colspan="4" style="width:404.85pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Dose of pharmaceutical benefit</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p><p class="TableHeading"><span>Drug</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p><p class="TableHeading"><span>Condition</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span></p><p class="TableHeading"><span>Maximum dose</span></p></td></tr></thead><tbody><tr><td style="width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:59.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Somatropin</span></p></td><td style="width:187.65pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of:</span></p><p class="Tablea"><span>(a) short stature and slow growth; or</span></p><p class="Tablea"><span>(b) short stature associated with biochemical growth hormone deficiency; or</span></p><p class="Tablea"><span>(c) growth retardation secondary to an intracranial lesion or cranial irradiation; or</span></p><p class="Tablea"><span>(d) risk of hypoglycaemia secondary to biochemical growth hormone deficiency in neonates/infants; or</span></p><p class="Tablea"><span>(e) biochemical growth hormone deficiency and precocious puberty; or</span></p><p class="Tablea"><span>(f) hypothalamic</span><span>‑</span><span>pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</span></p></td><td style="width:100.3pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>7.5 mg/m</span><span style="font-size:6.67pt; vertical-align:super">2</span><span>/week</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Somatropin</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of:</span></p><p class="Tablea"><span>(a) short stature associated with Turner Syndrome; or</span></p><p class="Tablea"><span>(b) short stature due to short stature homeobox (SHOX) gene disorders; or</span></p><p class="Tablea"><span>(c) short stature associated with chronic renal insufficiency</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>9.5 mg/m</span><span style="font-size:6.67pt; vertical-align:super">2</span><span>/week</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Somatropin</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of short stature and poor body composition due to Prader</span><span>‑</span><span>Willi Syndrome, where the person has a non</span><span>‑</span><span>mature skeleton</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>7.5 mg/m</span><span style="font-size:6.67pt; vertical-align:super">2</span><span>/week</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Somatropin</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of short stature and poor body composition due to Prader</span><span>‑</span><span>Willi Syndrome, where the person has a mature skeleton</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>0.04 mg/kg/week</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Mecasermin</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of severe primary insulin</span><span>‑</span><span>like growth factor 1 deficiency (Primary IGFD)</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>0.12 mg/kg twice daily</span></p></td></tr><tr><td style="width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td style="width:59.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Somatrogon</span></p></td><td style="width:187.65pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>In the category of:</span></p><p class="Tablea"><span>(a) short stature associated with biochemical growth hormone deficiency; or</span></p><p class="Tablea"><span>(b) short stature and slow growth</span></p></td><td style="width:100.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>0.66 mg/kg/week</span></p></td></tr></tbody></table>
(2) If: (a) the dose is of a pharmaceutical benefit that has the drug somatropin; and (b) the form of the pharmaceutical benefit and the manufacturer’s pack is unable to accommodate the dose calculated in accordance with column 3 of the applicable item of the table; the dose may be up to 3% greater than the dose calculated in accordance with that item of the table. (3) If: (a) the dose is of a pharmaceutical benefit that has the drug somatrogon; and (b) the form of the pharmaceutical benefit and the manufacturer’s pack is unable to accommodate the dose calculated in accordance with column 3 of the applicable item of the table; the dose, once calculated in accordance with that item of the table, may be rounded up to the nearest 0.2 mg or 0.5 mg.
(1) An authorised prescriber must prescribe a dose of pharmaceutical benefit, for a person who is reclassified to a different category for treatment, in accordance with the dose in the table in section 11 that applies to the category to which the person has been reclassified. (2) The dose cannot exceed the maximum dose permitted for the category for treatment to which the person has been reclassified.
(1) This section applies if a person is recommencing growth hormone treatment, in a category mentioned in the table in section 11. (2) The dose cannot exceed the maximum dose permitted for the category for treatment for which the person has recommenced.
(1) An approved hospital authority for a public hospital is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for its supply of the pharmaceutical benefit is greater than the amount that the approved hospital authority was entitled to charge under section 16.
Note: However, see Part 6A in relation to the supply of a pharmaceutical benefit to a CTG registered patient by a CTG supplier.
(2) The dispensed price for the supply of a pharmaceutical benefit by an approved hospital authority for a public hospital must be determined in accordance with Division 1 of Part 5. (3) No mark‑ups may be added to the cost of a pharmaceutical benefit for which payment is claimed by an approved hospital authority for a public hospital.
(1) An approved hospital authority for a private hospital is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for its supply of the pharmaceutical benefit is greater than the amount that the approved hospital authority was entitled to charge under section 18.
Note: However, see Part 6A in relation to the supply of a pharmaceutical benefit to a CTG registered patient by a CTG supplier.
(2) An approved pharmacist or an approved medical practitioner is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of a pharmaceutical benefit is greater than the amount that the approved pharmacist or approved medical practitioner was entitled to charge under section 18. (3) The dispensed price for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital, an approved pharmacist or an approved medical practitioner must be determined in accordance with Division 2 of Part 5.
(1) The dispensed price for the supply of a pharmaceutical benefit by a hospital authority for a public hospital is as follows: (a) if the quantity of the pharmaceutical benefit that is ordered and supplied is equal to a multiple of a pack quantity of the benefit—the sum of the approved ex‑manufacturer price or the proportional ex‑manufacturer price for each pack quantity; (b) if the quantity of the pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit—the amount calculated in accordance with section 17; (c) if the quantity of the pharmaceutical benefit that is ordered and supplied is more than a multiple of a pack quantity of the benefit—the sum of: (i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price for each pack quantity; and (ii) the amount calculated in accordance with section 17 for the remainder of the quantity supplied that is less than a pack quantity.
(1) If the quantity of a pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit (a broken quantity), the amount mentioned in paragraph 16(1)(b) and subparagraph 16(1)(c)(ii) is to be calculated by:
(a) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and
(b) applying that percentage to the approved ex‑manufacturer price or proportional ex‑manufacturer price for the pack quantity.
(1) The dispensed price for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital, an approved pharmacist or an approved medical practitioner, is as follows: (a) if the quantity of the pharmaceutical benefit that is ordered and supplied is equal to a multiple of a pack quantity, the sum of: (i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price for each pack quantity, plus the mark‑up mentioned in section 19 taken to the nearest cent, with one half cent being rounded up to 1 cent; and (ii) a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the pharmaceutical benefit; or (b) if a quantity of the pharmaceutical benefit that is ordered and supplied is less than a pack quantity, the sum of: (i) the amount calculated in accordance with section 20; and (ii) a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the pharmaceutical benefit; or
(c) if a quantity of the pharmaceutical benefit that is ordered and supplied is more than a multiple of a pack quantity, the sum of:
(i) for each pack quantity, the approved ex‑manufacturer price or the proportional ex‑manufacturer price for the pack quantity, plus the mark‑up mentioned in section 19 taken to the nearest cent, with one half cent being rounded up to 1 cent; and
(ii) the amount calculated in accordance with section 20 for the remainder of the quantity supplied that is less than a pack quantity; and
(iii) a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the pharmaceutical benefit.
For subparagraphs 18(1)(a)(i) and 18(1)(c)(i) and for paragraph 20(a), the mark‑up for a pack quantity of a ready‑prepared pharmaceutical benefit is:
(a) if the pack quantity for which a mark‑up is to be calculated under this section is equal to a maximum quantity of the pharmaceutical benefit, the mark‑up is the amount mentioned in the table below for the approved ex‑manufacturer price (AEMP) or for the proportional ex‑manufacturer price (PEMP) for that quantity.
(b) if the pack quantity for which a mark‑up is to be calculated under this section is not equal to a maximum quantity of the pharmaceutical benefit, the mark‑up is worked out as follows:
(i) if the mark‑up that would apply to the maximum quantity is shown in the table in paragraph (a) as a monetary amount—the mark‑up for the pack quantity is that monetary amount, reduced proportionately for the relative quantities; and
(ii) if the mark‑up that would apply to the maximum quantity is shown in the table in paragraph (a) as a percentage of AEMP or PEMP—the mark‑up for the pack quantity is that percentage of the AEMP or PEMP for the pack quantity.
If the quantity of a pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit (a broken quantity), the amount mentioned in subparagraph 18(1)(b)(i) and 18(1)(c)(ii) is to be calculated by:
(a) adding the mark‑up mentioned in section 19 to the approved ex‑manufacturer price or the proportional ex‑manufacturer price for the pack quantity, taking the result to the nearest cent, with one half cent being rounded up to 1 cent; and
(b) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and
(c) applying the percentage worked out under subparagraph (b) to the amount worked out under subparagraph (a).
If an eligible medical practitioner, instead of directing a repeated supply of a pharmaceutical benefit, directs the supply on one occasion of a quantity or number of units of the drug, not exceeding the total quantity or number of units that could be prescribed if the eligible medical practitioner directed a repeated supply, the dispensed price for the supply of the pharmaceutical benefit will include only one dispensing fee.
The dispensed price for the supply of a pharmaceutical benefit will in each case be taken to the nearest cent, with one half cent being rounded up to 1 cent.
(1) This section applies if an approved pharmacist, an approved medical practitioner, or an approved hospital authority for a public hospital or a private hospital supplies a pharmaceutical benefit to a patient and makes a claim for payment.
Note: However, see Part 6A in relation to the supply of a pharmaceutical benefit to a CTG registered patient by a CTG supplier.
(2) The approved pharmacist, approved medical practitioner or approved hospital authority may charge the patient an amount equivalent to the amount that may be charged under section 87 of the Act for the supply of a pharmaceutical benefit to the patient.
This Part applies to a supply (the relevant supply) of a pharmaceutical benefit under this Special Arrangement if the relevant supply is made: (a) to a patient who is a CTG registered patient; and (b) by an approved pharmacist, an approved medical practitioner or an approved hospital authority who is a CTG supplier.
(1) Despite sections 14, 15, and 23 of this Special Arrangement, subsections 11(1), (2), (3), (3E) and (4) (co‑payment reduction etc.) and section 13 (payment by Commonwealth) of the CTG Special Arrangement apply in relation to the relevant supply under this Special Arrangement with the modification set out in subsection (2) of this section. (2) A reference in the CTG Special Arrangement to a supply of a pharmaceutical benefit under the CTG Special Arrangement is taken to be a reference to the relevant supply under this Special Arrangement. (3) However, the notes to subsections 11(2) and (3) of the CTG Special Arrangement do not apply in relation to the relevant supply under this Special Arrangement.
Note: The notes to subsections 11(2) and (3) of the CTG Special Arrangement relate to CTG suppliers making claims for payment under the CTG Special Arrangement. Claims for payment in relation to the relevant supply under this Special Arrangement are instead dealt with under section 23C of this Special Arrangement.
(1) If an approved pharmacist, an approved medical practitioner or an approved hospital authority who is a CTG supplier, wants to receive payment from the Commonwealth in relation to the relevant supply under this Special Arrangement, the pharmacist, medical practitioner or hospital authority must make a claim for payment to the Chief Executive Medicare on behalf of the Secretary. (2) The claim must be made in accordance with the rules made under subsections 98AC(4) and 99AAA(8) of thesun Act with the modification set out in subsection (3) of this section. (3) A claim for payment made using the manual system referred to in section 99AAA of the Act must include an indicator that the patient is a CTG registered patient.
(1) Section 94 of the Act applies in a modified manner to pharmaceutical benefits supplied under this Special Arrangement.
(2) An approved hospital authority may supply pharmaceutical benefits that are subject to this Special Arrangement to patients receiving treatment in or at the hospital of which it is the governing body or proprietor, or outside of the hospital of which it is the governing body or proprietor.
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
(1) This Special Arrangement is the National Health (Growth Hormone Program) Special Arrangement 2015. (2) This Special Arrangement may also be cited as PB 85 of 2015.
(1) In this Special Arrangement:
Act means the National Health Act 1953.
adult means a person, who:
is not a child; or
is 18 years of age or older and has late onset growth hormone deficiency.
authorised prescriber
(a) for the initial treatment phase for a child means:
– a specialist or consultant physician in paediatric endocrinology; or
– a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
(b) for the continuing treatment phase for a child means:
– a medical practitioner.
(c) for the recommencement treatment phase for a child, continuing treatment as a reclassified patient phase for a child and recommencement of treatment as a reclassified patient phase for a child means:
– a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or
– a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
(ca) for the changing drug treatment phase for a child means:
– a specialist or consultant physician in paediatric endocrinology; or
– a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
(cb) for the non‑PBS subsidised to PBS subsidised supply treatment phase for a child in relation to a pharmaceutical benefit that has the drug mecasermin or somatrogon means:
– a specialist or consultant physician in paediatric endocrinology; or
– a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
(d) for the initial treatment phase for an adult or the continuing treatment phase for an adult, means a specialist or consultant physician in endocrinology.
CDC 2000 means the growth charts in the document entitled 2000 CDC Growth Charts for the United States: Methods and Development and CDC Extended BMI‑for‑Age Growth Charts, published by the Centers for Disease Control and Prevention, US Department of Health and Human Services, dated December 2022, and available on that Department’s website at http://www.cdc.gov/GROWTHcharts
changing drug treatment phase for a child means a treatment phase to facilitate a change in the prescribed pharmaceutical benefit for a child:
(a) from a pharmaceutical benefit that has the drug somatrogon to a pharmaceutical benefit that has the drug somatropin; or
(b) from a pharmaceutical benefit that has the drug somatropin to a pharmaceutical benefit that has the drug somatrogon.
child means a person, who:
(a) has a non‑mature skeleton; or
(b) has a diagnosis of Prader‑Willi syndrome, with a mature skeleton and is less than 18 years of age.
CTG registered patient means a patient registered under subsection 10(2) of the CTG Special Arrangement.
CTG Special Arrangement means the National Health (Closing the Gap – PBS Co‑payment Program) Special Arrangement 2016.
CTG supplier has the same meaning as in the CTG Special Arrangement.
dispensed price:
(a) for the supply of a pharmaceutical benefit by a hospital authority for a public hospital—has the meaning given by section 16; and
(b) for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital or by an approved pharmacist or by an approved medical practitioner—has the meaning given by section 18.
growth hormone treatment, for a person, means treatment of the person using a pharmaceutical benefit in accordance with this Special Arrangement.
ideal body weight means:
(a) for a person who is male with a height less than or equal to 176.8 centimetres, or female with a height less than or equal to 163.3 centimetres ‑ that person’s 50th percentile weight for height, calculated using CDC 2000;
(b) for a person who is male with a height greater than 176.8 centimetres, or female with a height greater than 163.3 centimetres ‑ that person’s body mass index at the 50th percentile for age multiplied by height (in metres) squared, calculated using CDC 2000.
mature skeleton means:
(a) for a female, where the person has a bone age of 13.5 years or more; and
(b) for a male, where the person has a bone age of 15.5 years or more.
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 11 for the category.
medical practitioner has the meaning it has in the Health Insurance Act 1973.
non‑mature skeleton means:
(a) for a female, where the person has a bone age of less than 13.5 years; and
(b) for a male, where the person has a bone age of less than 15.5 years.
other Special Arrangement means another Special Arrangement under section 100 of the Act.
percentile is a measure used in statistics indicating the value below which a given percentage of observations in a group of observations fall. For the purposes of this Special Arrangement, percentile is used to compare a person’s measurements with the referenced growth standards (eg a body mass index at the 85th percentile means that 85 percent of the population encompassed by the referenced standards have a body mass index below the person’s body mass index).
pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.
Note: Only pharmaceutical benefits mentioned in Part 1 of Schedule 1 may be supplied on a prescription written for a child, and only pharmaceutical benefits mentioned in Part 2 of Schedule 1 may be supplied on a prescription written for an adult: see sections 7A and 9AA.
pharmaceutical benefit has a drug has the same meaning as in Part VII of the Act.
Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.
(1) This Special Arrangement is the National Health (Growth Hormone Program) Special Arrangement 2015. (2) This Special Arrangement may also be cited as PB 85 of 2015.
(1) In this Special Arrangement:
Act means the National Health Act 1953.
adult means a person, who:
is not a child; or
is 18 years of age or older and has late onset growth hormone deficiency.
authorised prescriber
(a) for the initial treatment phase for a child means:
– a specialist or consultant physician in paediatric endocrinology; or
– a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
(b) for the continuing treatment phase for a child means:
– a medical practitioner.
(c) for the recommencement treatment phase for a child, continuing treatment as a reclassified patient phase for a child and recommencement of treatment as a reclassified patient phase for a child means:
– a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or
– a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
(ca) for the changing drug treatment phase for a child means:
– a specialist or consultant physician in paediatric endocrinology; or
– a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
(cb) for the non‑PBS subsidised to PBS subsidised supply treatment phase for a child in relation to a pharmaceutical benefit that has the drug mecasermin or somatrogon means:
– a specialist or consultant physician in paediatric endocrinology; or
– a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
(d) for the initial treatment phase for an adult or the continuing treatment phase for an adult, means a specialist or consultant physician in endocrinology.
CDC 2000 means the growth charts in the document entitled 2000 CDC Growth Charts for the United States: Methods and Development and CDC Extended BMI‑for‑Age Growth Charts, published by the Centers for Disease Control and Prevention, US Department of Health and Human Services, dated December 2022, and available on that Department’s website at http://www.cdc.gov/GROWTHcharts
changing drug treatment phase for a child means a treatment phase to facilitate a change in the prescribed pharmaceutical benefit for a child:
(a) from a pharmaceutical benefit that has the drug somatrogon to a pharmaceutical benefit that has the drug somatropin; or
(b) from a pharmaceutical benefit that has the drug somatropin to a pharmaceutical benefit that has the drug somatrogon.
child means a person, who:
(a) has a non‑mature skeleton; or
(b) has a diagnosis of Prader‑Willi syndrome, with a mature skeleton and is less than 18 years of age.
CTG registered patient means a patient registered under subsection 10(2) of the CTG Special Arrangement.
CTG Special Arrangement means the National Health (Closing the Gap – PBS Co‑payment Program) Special Arrangement 2016.
CTG supplier has the same meaning as in the CTG Special Arrangement.
dispensed price:
(a) for the supply of a pharmaceutical benefit by a hospital authority for a public hospital—has the meaning given by section 16; and
(b) for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital or by an approved pharmacist or by an approved medical practitioner—has the meaning given by section 18.
growth hormone treatment, for a person, means treatment of the person using a pharmaceutical benefit in accordance with this Special Arrangement.
ideal body weight means:
(a) for a person who is male with a height less than or equal to 176.8 centimetres, or female with a height less than or equal to 163.3 centimetres ‑ that person’s 50th percentile weight for height, calculated using CDC 2000;
(b) for a person who is male with a height greater than 176.8 centimetres, or female with a height greater than 163.3 centimetres ‑ that person’s body mass index at the 50th percentile for age multiplied by height (in metres) squared, calculated using CDC 2000.
mature skeleton means:
(a) for a female, where the person has a bone age of 13.5 years or more; and
(b) for a male, where the person has a bone age of 15.5 years or more.
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 11 for the category.
medical practitioner has the meaning it has in the Health Insurance Act 1973.
non‑mature skeleton means:
(a) for a female, where the person has a bone age of less than 13.5 years; and
(b) for a male, where the person has a bone age of less than 15.5 years.
other Special Arrangement means another Special Arrangement under section 100 of the Act.
percentile is a measure used in statistics indicating the value below which a given percentage of observations in a group of observations fall. For the purposes of this Special Arrangement, percentile is used to compare a person’s measurements with the referenced growth standards (eg a body mass index at the 85th percentile means that 85 percent of the population encompassed by the referenced standards have a body mass index below the person’s body mass index).
pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.
Note: Only pharmaceutical benefits mentioned in Part 1 of Schedule 1 may be supplied on a prescription written for a child, and only pharmaceutical benefits mentioned in Part 2 of Schedule 1 may be supplied on a prescription written for an adult: see sections 7A and 9AA.
pharmaceutical benefit has a drug has the same meaning as in Part VII of the Act.
Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.
(1) This Special Arrangement applies to each pharmaceutical benefit mentioned in Schedule 1.
Note: Only pharmaceutical benefits mentioned in Part 1 of Schedule 1 may be supplied on a prescription written for a child, and only pharmaceutical benefits mentioned in Part 2 of Schedule 1 may be supplied on a prescription written for an adult: see sections 7A and 9AA.
(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.
(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.
(1) If the code ‘D(100)’ is mentioned in the column of a table 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.
A pharmaceutical benefit must not be supplied on a prescription written for a person who is a child when the prescription is written unless the pharmaceutical benefit is mentioned in Part 1 of Schedule 1.
Somatrogon and somatropin (1) Subject to subsection (2), the maximum quantity or number of units of a pharmaceutical benefit that has the drug somatrogon or somatropin that may, in one prescription for a child, be directed to be supplied during an initial treatment phase, a recommencement treatment phase, or a recommencement of treatment as a reclassified patient phase is an amount that is sufficient for 16 weeks of treatment of the child. (2) The total quantity or number of units (including any repeats) of a pharmaceutical benefit that has the drug somatrogon or somatropin that may, in prescriptions for a child, be directed to be supplied for a phase referred to in subsection (1) is an amount that is sufficient for 32 weeks of treatment of the child. (3) Subject to subsection (4), the maximum quantity or number of units of a pharmaceutical benefit that has the dru
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