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PB 85 of 2015 Arrangements as amended, taking into account amendments up to National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2020 (No. 1) (PB 6 of 2020)
Administered by: Health
Registered 06 Feb 2020
Start Date 01 Feb 2020
Table of contents.

Commonwealth Coat of Arms of Australia

National Health (Growth Hormone Program) Special Arrangement 2015 (PB 85 of 2015)

made under subsections 100(1) and (2) of the

National Health Act 1953

Compilation No. 13

Compilation date:                              1 February 2020

Includes amendments up to:            PB 6 of 2020

Registered:                                         6 February 2020

 

About this compilation

This compilation

This is a compilation of the National Health (Growth Hormone Program) Special Arrangement 2015 (PB 85 of 2015) that shows the text of the law as amended and in force on 1 February 2020 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

  

  

  


Contents

Part 1—Preliminary                                                                                                                                        1

1............ Name of Special Arrangement....................................................................................... 1

4............ Definitions..................................................................................................................... 1

Part 2—Pharmaceutical benefits covered by this Special Arrangement                        4

Division 1—General                                                                                                                                4

5............ Pharmaceutical benefits covered by this Special Arrangement...................................... 4

6............ Application of Part VII of the Act................................................................................. 4

7............ Section 100 only supply................................................................................................ 4

Division 2—Prescriptions for pharmaceutical benefits                                                        5

Subdivision A—Prescriptions for children                                                                                    5

7A......... Prescription of pharmaceutical benefits in Part 1 of Schedule 1 for children................. 5

8............ Prescription for child—maximum quantity.................................................................... 5

9............ Prescription for child—maximum number of repeats.................................................... 5

Subdivision B—Prescriptions for adults                                                                                        6

9AA...... Prescription of pharmaceutical benefits in Part 2 of Schedule 1 for adults.................... 6

9AB...... Prescription for adult—maximum quantity.................................................................... 6

9AC...... Prescription for adult—maximum number of repeats.................................................... 6

Subdivision C—Prescriptions for children and adults                                                                6

9AD...... Prescription by authorised prescriber only.................................................................... 6

9A......... Prescription for child or adult—authority required procedures...................................... 6

Part 3—Treatment doses for children                                                                                                 8

Division 1—General                                                                                                                                8

9B......... This Part applies to children.......................................................................................... 8

10.......... Definitions..................................................................................................................... 8

11.......... Assessment of dosage of pharmaceutical benefit........................................................... 9

Division 2—Reclassification                                                                                                              11

12.......... Dose for change of treatment category (reclassification)............................................. 11

Division 3—Recommenced treatment                                                                                          12

13.......... Dose for recommenced treatment................................................................................ 12

Part 4—Payment amounts                                                                                                                        13

Division 1—Payments to suppliers that are approved hospital authorities for public hospitals              13

14.......... Payments to approved hospital authorities for public hospitals................................... 13

Division 2—Payments to suppliers that are approved hospital authorities for private hospitals, approved pharmacies or approved medical practitioners                                            14

15.......... Payments to certain suppliers of pharmaceutical benefits............................................ 14

Part 5—Dispensed price                                                                                                                             15

Division 1—Dispensed price for supply of a pharmaceutical benefit by a hospital authority for a public hospital                                                                                                                               15

16.......... The dispensed price—supply by public hospital......................................................... 15

17.......... Where quantity is less than a pack quantity................................................................. 15

Division 2—Dispensed price for supply of a pharmaceutical benefit by certain suppliers          16

18.......... The dispensed price—supply by an approved hospital authority for a private hospital, an approved pharmacist or an approved medical practitioner...................................................................................... 16

19.......... Mark‑up...................................................................................................................... 16

20.......... Where quantity is less than a pack quantity................................................................. 17

21.......... Dispensing fee............................................................................................................. 17

Division 3—Dispensed price—Other matters                                                                          19

22.......... Rounding up of dispensed price.................................................................................. 19

Part 6—Patient contributions                                                                                                                 20

23.......... Patient contributions.................................................................................................... 20

Part 7—Approved Hospital Authorities                                                                                           21

24.......... Modified application of section 94 approved hospital authorities................................ 21

Schedule 1—Pharmaceutical benefits covered by this Special Arrangement and related information                                                                                                                  22

Part 1—Pharmaceutical benefits for treatment of children                                                 22

Part 2—Pharmaceutical benefits for treatment of adults                                                      26

Endnotes                                                                                                                                                               27

Endnote 1—About the endnotes                                                                                                      27

Endnote 2—Abbreviation key                                                                                                          28

Endnote 3—Legislation history                                                                                                       29

Endnote 4—Amendment history                                                                                                     30

 


Part 1Preliminary

  

1  Name of 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.

4  Definitions

             (1)  In this Special Arrangement:

Act means the National Health Act 1953.

adult means a person, who is any of the following:

                     (a)  is 18 years of age or older and has adult onset growth hormone deficiency; or

                     (b)  has a mature skeleton; or

                     (c)  has a diagnosis of Prader‑Willi syndrome and is aged 18 years or older.

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.

                     (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, published by the Centers for Disease Control and Prevention, US Department of Health and Human Services, dated May 2002, and available on that Department’s website at http://www.cdc.gov/GROWTHcharts.

child means a person who, is any of the following:

                     (a)  is not an adult; or

                     (b)  has a diagnosis of Prader‑Willi syndrome and is less than 18 years of age.

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 multipled by height (in metres) squared, calculated using CDC 2000.

main listing instrument means the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, or an instrument made to replace that instrument.

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.

Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.

Part 2Pharmaceutical benefits covered by this Special Arrangement

Division 1General

5  Pharmaceutical benefits covered by this Special Arrangement

             (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.

6  Application of Part VII of the Act

             (1)  Each pharmaceutical benefit supplied in accordance with this Special Arrangement is supplied under Part VII of the Act.

             (2)  A provision of Part VII of the Act, or of regulations or other instruments made for Part VII of the Act, applies subject to this Special Arrangement.

Note:          See subsection 100(3) of the Act.

7  Section 100 only supply

             (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.

Division 2Prescriptions for pharmaceutical benefits

Subdivision APrescriptions for children

7A  Prescription of pharmaceutical benefits in Part 1 of Schedule 1 for children

                   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.

8  Prescription for child—maximum quantity

             (1)  The maximum quantity or number of units of the pharmaceutical benefit that may, in one prescription for a child, be directed to be supplied during an initial treatment period is an amount that is sufficient for:

                     (a)  the first 16 weeks of treatment of the child; or

                     (b)  if a prescription mentioned in paragraph (a) has already been written for the child for the treatment period—the remaining 16 weeks of treatment of the child for that treatment period; or

                     (c)  a total of 32 weeks of treatment of the child.

             (2)  The maximum quantity or number of units of the pharmaceutical benefit that may, in one prescription for a child, be directed to be supplied during a continuing treatment period is an amount that is sufficient for:

                     (a)  the first 13 weeks of treatment of the child; or

                     (b)  if a prescription mentioned in paragraph (a) has already been written for the child for the treatment period—the remaining 13 weeks of treatment of the child for that treatment period; or

                     (c)  a total of 26 weeks of treatment of the child.

             (3)  The maximum quantity or number of units of the pharmaceutical benefit that may, in one prescription for a child, be directed to be supplied during a recommencement treatment period is an amount that is sufficient for:

                     (a)  the first 16 weeks of treatment of the child; or

                     (b)  if a prescription mentioned in paragraph (a) has already been written for the child for the treatment period—the remaining 16 weeks of treatment of the child for that treatment period; or

                     (c)  a total of 32 weeks of  treatment of the child.

9  Prescription for child—maximum number of repeats

             (1)  The maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription for a child, be directed to be repeated is:

                     (a)  for a prescription for initial treatment of the child:

                              (i)  one repeat for a prescription that directs a supply, on one occasion, of  pharmaceutical benefit sufficient for a 16 week period; or

                             (ii)  no repeats for a prescription that directs a supply, on one occasion, of a pharmaceutical benefit sufficient for a 32 week period.

                     (b)  (i)  for a prescription for recommencement treatment of the child:

                                   one repeat for a prescription that directs a supply, on one occasion, of  pharmaceutical benefit sufficient for a 16 week period; or

                             (ii)  no repeats for a prescription that directs a supply, on one occasion, of a pharmaceutical benefit sufficient for a 32 week period.

                     (c)  for a prescription for continuing treatment of the child:

                              (i)  one repeat for a prescription that directs a supply, on one occasion, of a pharmaceutical benefit sufficient for a 13 week period; or

                             (ii)  no repeats for a prescription that directs a supply, on one occasion, of a pharmaceutical benefit sufficient for a 26 week period.

Subdivision BPrescriptions for adults

9AA  Prescription of pharmaceutical benefits in Part 2 of Schedule 1 for adults

                   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.

9AB  Prescription for adult—maximum quantity

                   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.

9AC  Prescription for adult—maximum number of repeats

                   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.

Subdivision CPrescriptions for children and adults

9AD  Prescription by authorised prescriber only

                   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.

9A  Prescription for child or adult—authority required procedures

             (1)  For the purposes of the main listing instrument, a prescription for a pharmaceutical benefit is also taken to have been submitted in accordance with section 12 of that instrument where the authorised prescriber submits details of that prescription in accordance with subsection (2) of this section.

             (2)  The details must be:

(a)  given to the Chief Executive Medicare in writing; and

(b)  by means of an electronic communication; and

(c)  in a form approved by the Chief Executive Medicare; and

(d)  in accordance with any other requirements that would need to be met in order for the requirements to give the information in writing to be taken to have been met under the Electronic Transactions Act 1999.

             (3)  For the purposes of the main listing instrument, a prescription submitted in accordance with subsection (2) is also taken to have been authorised under subsection 13(3) of the main listing instrument where the Chief Executive Medicare sends his or her authorisation, by electronic communication, including computer automated electronic communication, to the authorised prescriber.

Part 3Treatment doses for children

Division 1General

9B  This Part applies to children

                   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.

10  Definitions

             (1)  In this Part:

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)  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)  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.

11  Assessment of dosage of pharmaceutical benefit

             (1)  The authorised prescriber must prescribe a dose of pharmaceutical benefit that is appropriate for treatment of a person under this Special Arrangement in accordance with the table in this section and this Division.

 

Item

Person’s condition

Dose of a pharmaceutical benefit

1

in the category of:

(a) short stature and slow growth; or

(b) short stature associated with biochemical growth hormone deficiency; or

(c) growth retardation secondary to an intracranial lesion or cranial irradiation; or

(d risk of hypoglycaemia secondary to biochemical growth hormone deficiency in neonates/infants; or

(e) biochemical growth hormone deficiency and precocious puberty; or

(f) hypothalamic‑pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth

Up to 7.5mg/m2/week

2

in the category of:

(a) short stature associated with Turner Syndrome; or

(b) short stature due to short stature homeobox (SHOX) gene disorders; or

(c) short stature associated with chronic renal insufficiency

Up to 9.5mg/m2/week

3

in the category of short stature and poor body composition due to Prader‑Willi Syndrome, where the person has a non‑mature skeleton

Up to 7.5mg/m2/week

4

in the category of short stature and poor body composition due to Prader‑Willi Syndrome, where the person has a mature skeleton

0.04mg/kg/week

(2)  The dose mentioned in the table in this section for a category of treatment mentioned in any of the items of that table, is the maximum dose that can be used for any person.

(3)  However, if the form of the pharmaceutical benefit and the manufacturer’s pack is unable to accommodate the dose mentioned in the item of the table that applies to a person, the dose of pharmaceutical benefit may be within 3% of the maximum dose for the item of the table that applies to the person.

             (4)  For items 3 and 4 of the table in this section, if the person’s body mass index is greater than the 85th percentile for age and sex, the dose prescribed for the person must be calculated using the person’s ideal body weight in kilograms.

Division 2Reclassification

12  Dose for change of treatment category (reclassification)

(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.

Division 3Recommenced treatment

13  Dose for recommenced treatment

             (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.

Part 4Payment amounts

Division 1Payments to suppliers that are approved hospital authorities for public hospitals

14  Payments to approved hospital authorities for public hospitals

             (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.

             (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. 

Division 2Payments to suppliers that are approved hospital authorities for private hospitals, approved pharmacies or approved medical practitioners

15  Payments to certain suppliers of pharmaceutical benefits

             (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. 

             (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. 

Part 5Dispensed price

Division 1Dispensed price for supply of a pharmaceutical benefit by a hospital authority for a public hospital

16  The dispensed price—supply by public hospital

             (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.

17  Where quantity 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.

Division 2Dispensed price for supply of a pharmaceutical benefit by certain suppliers

18  The dispensed price—supply by an approved hospital authority for a private hospital, an approved pharmacist or an approved medical practitioner

             (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.

19  Mark‑up

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.

20  Where quantity is less than a 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).

21  Dispensing fee

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.

Division 3Dispensed price—Other matters

22  Rounding up of dispensed price

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. 

Part 6Patient contributions

  

23  Patient contributions

(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.

(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.

Part 7Approved Hospital Authorities

  

24  Modified application of section 94 approved hospital authorities

(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.


Schedule 1Pharmaceutical benefits covered by this Special Arrangement and related information

Note:       See sections 5, 7, 7A and 9AA.

Part 1Pharmaceutical benefits for treatment of children

  

 

Listed Drug

Form

Manner of Administration

Brand

Section 100 only

Somatropin

Injection 0.4 mg (1.2 i.u.) with diluent in single use syringe (without preservative)

Injection

Genotropin MiniQuick

D(100)

 

Injection 0.6 mg (1.8 i.u.) with diluent in single use syringe (without preservative)

Injection

Genotropin MiniQuick

D(100)

 

Injection 0.8 mg (2.4 i.u.) with diluent in single use syringe (without preservative)

Injection

Genotropin MiniQuick

D(100)

 

Injection 1 mg (3 i.u.) with diluent in single use syringe (without preservative)

Injection

Genotropin MiniQuick

D(100)

 

Injection 1.2 mg (3.6 i.u.) with diluent in single use syringe (without preservative)

Injection

Genotropin MiniQuick

D(100)

 

Injection 1.4 mg (4.2 i.u.) with diluent in single use syringe (without preservative)

Injection

Genotropin MiniQuick

D(100)

 

Injection 1.6 mg (4.8 i.u.) with diluent in single use syringe (without preservative)

Injection

Genotropin MiniQuick

D(100)

 

Injection 1.8 mg (5.4 i.u.) with diluent in single use syringe (without preservative)

Injection

Genotropin MiniQuick

D(100)

 

Injection 2 mg (6 i.u.) with diluent in single use syringe (without preservative)

Injection

Genotropin MiniQuick

D(100)

 

Injection 4 mg (12 i.u.) vial with diluent (with preservative)

Injection

Zomacton

D(100)

 

Injection 18 i.u. (6 mg) cartridge with 3.15 mL diluent (with preservative)

Injection

Humatrope

D(100)

 

Injection 36 i.u. (12 mg) cartridge with 3.15 mL diluent (with preservative)

Injection

Humatrope

D(100)

 

Injection 72 i.u. (24 mg) cartridge with 3.15 mL diluent (with preservative)

Injection

Humatrope

D(100)

 

Powder for injection 5 mg (15 i.u.) with diluent in pre‑filled pen (with preservative)

Injection

Genotropin

GoQuick

D(100)

 

Powder for injection 12 mg (36 i.u.) with diluent in pre‑filled pen (with preservative)

Injection

Genotropin

GoQuick

D(100)

 

Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative)

Injection

Norditropin

SimpleXx

D(100)

 

 

 

Omnitrope Surepal 5

D(100)

 

 

 

Scitropin A

D(100)

 

Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in a
pre‑filled pen

Injection

Norditropin

FlexPro

D(100)

 

Solution for injection 6 mg (18 i.u.) in 1.03 mL cartridge (with preservative)

Injection

Saizen

D(100)

 

Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative)

Injection

Norditropin

SimpleXx

D(100)

 

 

 

Omnitrope Surepal 10

D(100)

 

 

 

SciTropin A

D(100)

 

Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) in a
pre‑filled pen

Injection

Norditropin

FlexPro

D(100)

 

Solution for injection 10 mg (30 i.u.) in 2 mL cartridge (with preservative)

Injection

NutropinAq

D(100)

 

Solution for injection 12 mg (36 i.u.) in 1.5 mL cartridge (with preservative)

Injection

Saizen

D(100)

 

Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative)

Injection

Norditropin

SimpleXx

D(100)

 

 

 

Omnitrope Surepal 15

D(100)

 

Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) in a
pre‑filled pen

Injection

Norditropin

FlexPro

D(100)

 

Solution for injection 20 mg (60 i.u.) in 2.5 mL cartridge (with preservative)

Injection

Saizen

D(100)

 

Part 2Pharmaceutical benefits for treatment of adults

  

Listed Drug

Form

Manner of Administration

Brand

Section 100 only

Somatropin

Powder for injection 5 mg (15 i.u.) with diluent in pre‑filled pen (with preservative)

Injection

Genotropin GoQuick

D(100)

 

Powder for injection 12 mg (36 i.u.) with diluent in pre‑filled pen (with preservative)

Injection

Genotropin GoQuick

D(100)

 

Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre‑filled pen

Injection

Norditropin FlexPro

D(100)

 

Solution for injection 10 mg (30 i.u.) in 2 mL cartridge (with preservative)

Injection

NutropinAq

D(100)

 


Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Editorial changes

The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.

If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.

 

Endnote 2—Abbreviation key

 

ad = added or inserted

o = order(s)

am = amended

Ord = Ordinance

amdt = amendment

orig = original

c = clause(s)

par = paragraph(s)/subparagraph(s)

C[x] = Compilation No. x

    /sub‑subparagraph(s)

Ch = Chapter(s)

pres = present

def = definition(s)

prev = previous

Dict = Dictionary

(prev…) = previously

disallowed = disallowed by Parliament

Pt = Part(s)

Div = Division(s)

r = regulation(s)/rule(s)

ed = editorial change

reloc = relocated

exp = expires/expired or ceases/ceased to have

renum = renumbered

    effect

rep = repealed

F = Federal Register of Legislation

rs = repealed and substituted

gaz = gazette

s = section(s)/subsection(s)

LA = Legislation Act 2003

Sch = Schedule(s)

LIA = Legislative Instruments Act 2003

Sdiv = Subdivision(s)

(md) = misdescribed amendment can be given

SLI = Select Legislative Instrument

    effect

SR = Statutory Rules

(md not incorp) = misdescribed amendment

Sub‑Ch = Sub‑Chapter(s)

    cannot be given effect

SubPt = Subpart(s)

mod = modified/modification

underlining = whole or part not

No. = Number(s)

    commenced or to be commenced

 

 

Endnote 3—Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

PB 85 of 2015

1 Sept 2015 (F2015L01368)

1 Sept 2015 (s 2)

 

PB 96 of 2015

1 Dec 2015 (F2015L01904)

1 Dec 2015 (s 2)

PB 87 of 2016

30 Sept 2016 (F2016L01553)

1 Oct 2016 (s 2)

PB 116 of 2016

22 Dec 2016 (F2016L02029)

1 Jan 2017 (s 2)

PB 78 of 2017

26 Sept 2017 (F2017L01263)

1 Oct 2017 (s 2)

PB 91 of 2017

31 Oct 2017 (F2017L01405)

1 Nov 2017 (s 2)

PB 28 of 2018

28 Mar 2018 (F2018L00429)

1 Apr 2018 (s 2)

PB 35 of 2018

30 Apr 2018 (F2018L00548)

1 May 2018 (s 2)

PB 96 of 2018

29 Nov 2018 (F2018L01634)

1 Dec 2018 (s 2(1) item 1)

PB 113 of 2018

20 Dec 2018 (F2018L01815)

1 Jan 2019 (s 2)

PB 22 of 2019

28 Mar 2019 (F2019L00452)

1 Apr 2019 (s 2)

PB 80 of 2019

30 Sept 2019 (F2019L01299)

1 Oct 2019 (s 2)

PB 109 of 2019

20 Dec 2019 (F2019L01679)

1 Jan 2020 (s 2(1) item 1)

PB 6 of 2020

31 Jan 2020 (F2020L00071)

1 Feb 2020 (s 2)

 

Endnote 4—Amendment history

 

Provision affected

How affected

Part 1

 

s 2.............................................

rep LIA s 48D

s 3.............................................

rep LIA s 48C

s 4.............................................

am PB 91 of 2017; PB 96 of 2018; PB 109 of 2019

Part 2

 

Division 1

 

s 5.............................................

am PB 96 of 2018

s 7.............................................

am PB 96 of 2018

Division 2

 

Subdivision A

 

Subdivision A heading..............

ad PB 96 of 2018

s 7A..........................................

ad PB 96 of 2018

s 8.............................................

am PB 96 of 2018

s 9.............................................

am PB 96 of 2018

Subdivision B

 

Subdivision B...........................

ad PB 96 of 2018

s 9AA.......................................

ad PB 96 of 2018

s 9AB........................................

ad PB 96 of 2018

s 9AC........................................

ad PB 96 of 2018

Subdivision C

 

Subdivision C heading..............

ad PB 96 of 2018

s 9AD.......................................

ad PB 96 of 2018

s 9A..........................................

ad PB 91 of 2017

 

am PB 96 of 2018

Part 3

 

Part 3 heading...........................

rs PB 96 of 2018

Division 1

 

s 9B..........................................

ad PB 96 of 2018

s 10...........................................

am PB 91 of 2017; PB 96 of 2018

s 11...........................................

am PB 91 of 2017; PB 96 of 2018

Part 6

 

s 23...........................................

am PB 96 of 2018

Part 8........................................

rep PB 96 of 2018

s 25...........................................

rep PB 96 of 2018

s 26...........................................

rep PB 96 of 2018

s 27...........................................

rep PB 96 of 2018

s 28...........................................

rep PB 96 of 2018

s 29...........................................

rep PB 96 of 2018

Schedule 1

 

Schedule 1................................

am PB 96 of 2015; PB 87 of 2016; PB 116 of 2016; PB 78 of 2017; PB 28 of 2018; PB 35 of 2018; PB 96 of 2018; PB 113 of 2018; PB 22 of 2019

 

ed C10

 

am PB 80 of 2019; PB 6 of 2020