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

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Get a Day Pass for only USD$49.99.
National Health (Growth Hormone Program) Special Arrangement 2015 (PB 85 of 2015)
National Health Act 1953
I, STEVE DUNLOP, Acting Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this instrument under subsections 100(1) and (2) of the National Health Act 1953. 
Dated   27 AUGUST 2015
 
 
 
 
STEVE DUNLOP
Acting Assistant Secretary
Pharmaceutical Access Branch
Department of Health
  
Contents
 
Part 1 — Preliminary                                                                                                   1
1  Name of Special Arrangement.................................................................................................. 1
2  Commencement........................................................................................................................ 1
3  Revocation................................................................................................................................ 1
4  Definitions................................................................................................................................ 1
Part 2 – Pharmaceutical benefits covered by this Special Arrangement                 3
Division 1 - General                                                                                                                             3
5  Pharmaceutical benefits covered by this Special Arrangement................................................. 3
6  Application of Part VII of the Act............................................................................................ 3
7  Section 100 only supply........................................................................................................... 3
Division 2 – Prescriptions for pharmaceutical benefits                                                             4
8  Prescription - Maximum quantity............................................................................................. 4
9  Prescription - Maximum number of repeats............................................................................. 5
Part 3 — Treatment dose                                                                                             6
Division 1 — General                                                                                                                          6
10  Definitions.............................................................................................................................. 6
11  Assessment of dosage of pharmaceutical benefit.................................................................... 6
Division 2 — Reclassification                                                                                                           7
12  Dose for change of treatment category (reclassification)........................................................ 7
Division 3 — Recommenced treatment                                                                                           8
13  Dose for recommenced treatment........................................................................................... 8
Part 4 – Payment amounts                                                                                           9
Division 1 -  Payments to suppliers that are approved hospital authorities for public hospitals               9
14  Payments to approved hospital authorities for public hospitals.............................................. 9
Division 2 -    Payments to suppliers that are approved hospital authorities for private hospitals, approved pharmacies or approved medical practitioners                                                  9
15  Payments to certain suppliers of pharmaceutical benefits....................................................... 9
Part 5 – Dispensed price                                                                                             10
Division 1 — Dispensed price for supply of a pharmaceutical benefit by a hospital authority for a public hospital                                                                                                                                       10
16  The dispensed price—supply by public hospital.................................................................. 10
17  Where quantity is less than a pack quantity.......................................................................... 10
Division 2 – Dispensed price for supply of a pharmaceutical benefit by certain suppliers 11
18  The dispensed price—supply by an approved hospital authority for a private hospital, an approved pharmacist or an approved medical practitioner...................................................................................................... 11
19  Mark-up............................................................................................................................... 12
20  Where quantity is less than a pack quantity.......................................................................... 12
21  Dispensing fee...................................................................................................................... 13
Division 3 – Dispensed price – Other matters                                                                             13
22  Rounding up of dispensed price........................................................................................... 13
Part 6 – Patient contributions                                                                                    14
23  Patient contributions............................................................................................................. 14
Part 7 – Approved Hospital Authorities                                                                   15
24  Modified application of section 94 approved hospital authorities......................................... 15
Part 8 — Transitional provisions                                                                               16
25  Definitions............................................................................................................................ 16
26  Pending applications under the old Arrangement................................................................. 16
27  Treatment of patients under the old Arrangement................................................................. 16
28  Claims for payment lodged but not determined under old Arrangement............................... 16
29  Supplies made but not claimed for under old Arrangement.................................................. 17
Schedule 1—Pharmaceutical benefits covered by this Special Arrangement and related information                                                                   18
 
 
Part 1 — Preliminary
  
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.
2  Commencement
                   This Special Arrangement commences on 1 September 2015.
3  Revocation
                   The National Health (Growth Hormone Program) Special Arrangement 2011 (PB 88 of 2011) is revoked.
4  Definitions
             (1)  In this Special Arrangement:
Act means the National Health Act 1953.
authorised prescriber
(a)   for the initial treatment phase 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 means:
–        a medical practitioner.
(c)    for the recommencement treatment phase, continuing treatment as a reclassified patient phase and recommencement of treatment as a reclassified patient phase 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.
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.
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 weight for height, for a person, means the person’s 50th percentile weight for height calculated using the growth charts in 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.
Regulations means the National Health (Pharmaceutical Benefits) Regulations 1960.
       
  
 
Part 2 – Pharmaceutical benefits covered by this Special Arrangement
Division 1 - General
5  Pharmaceutical benefits covered by this Special Arrangement
             (1)  This Special Arrangement applies to each pharmaceutical benefit mentioned in Schedule 1.
             (2)  Each pharmaceutical benefit to which this Special Arrangement applies is a brand of a listed drug mentioned in Schedule 1:
                     (a)  in the form mentioned in Schedule 1 for the listed drug; and
                     (b)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
Note:          Each listed drug mentioned in Schedule 1 has been declared by the Minister under subsection 85(2) of the Act. The form, manner of administration and brand mentioned in Schedule 1 have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.
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 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.
 
(3)   If the code ‘PB(100)’ is mentioned in the column in Schedule 1, headed ‘Section 100 only’ for a pharmaceutical benefit, the pharmaceutical benefit may be supplied only in accordance with this Special Arrangement and with any other Special Arrangement relating to the pharmaceutical benefit. 
 
(4)   A pharmaceutical benefit mentioned in subsection (3) is not available for general supply on the Pharmaceutical Benefits Scheme. 
Note:          The Minister has declared, under paragraph 85(8)(a) of the Act, that  this pharmaceutical benefit can only be supplied under a section 100 Special Arrangement. 
 
(5)   If the code ‘C(100)’ is mentioned in the column in Schedule 1, headed ‘Section 100 only’ for a pharmaceutical benefit, and a circumstances code is mentioned for the pharmaceutical benefit in the column headed ‘Circumstances’, the pharmaceutical benefit can only be supplied in the circumstances identified in the instrument made under section 85A of the Act and in accordance with this Special Arrangement.
 
(6)   A pharmaceutical benefit mentioned in subsection (5) is not available for general supply on the Pharmaceutical Benefits Scheme.
Note:          The Minister has declared, under paragraph 85(8)(b) of the Act, that 1 or more of the circumstances in which a  prescription for the supply of the pharmaceutical benefit may be written are circumstances in which the benefit can only be supplied under a section 100 Special Arrangement. 
 
Division 2 – Prescriptions for pharmaceutical benefits
8  Prescription - Maximum quantity
             (1)  The maximum quantity or number of units of the pharmaceutical benefit that may, in one prescription, 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 a person; or
                     (b)  if a prescription mentioned in paragraph (a) has already been written for the person for the treatment period—the remaining 16 weeks of treatment of the person for that treatment period;  or
                     (c)  a total of 32 weeks of treatment of a person.
             (2)  The maximum quantity or number of units of the pharmaceutical benefit that may, in one prescription, 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 a person; or
                     (b)  if a prescription mentioned in paragraph (a) has already been written for the person for the continuing treatment period—the remaining 13 weeks of treatment of the person; or
                     (c)  a total of 26 weeks of treatment of a person.
 
             (3)  The maximum quantity or number of units of the pharmaceutical benefit that may, in one prescription, 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 a person; or
                     (b)  if a prescription mentioned in paragraph (a) has already been written for the person for the recommencement treatment period—the remaining 16 weeks of treatment of the person; or
                     (c)  a total of 32 weeks of  treatment of a person.
 
 
9  Prescription - Maximum number of repeats
             (1)  The maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated is:
                     (a)  for a prescription for initial treatment of a person:
                            (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 a person:
                            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 a person:
                            (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.
 
Part 3 — Treatment dose
  
Division 1 — General
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 meter of the body surface of the person area 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 weight for height (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 weight for height.
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 patient.
(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 weight for height.
Division 2 — Reclassification
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 3 — Recommenced 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 4 – Payment amounts
Division 1 -  Payments 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 2 -   Payments 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 5 – Dispensed price
Division 1 — Dispensed 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 2 – Dispensed 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 3 – Dispensed 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 6 – Patient 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 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 7 – Approved 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. 
 
Part 8 — Transitional provisions
  
25  Definitions
                   In this part:
old Arrangement means the National Health (Growth Hormone Program) Special Arrangement 2011 (PB 88 of 2011), as in force immediately before 1 September  2015.
growth hormone treatment, for a person, means treatment of the person using a pharmaceutical benefit in accordance with the old Arrangement.
26  Pending applications under the old Arrangement
Applications to approve treatment
(1)  An application to the Secretary to approve initial growth hormone treatment or continuing growth hormone treatment or to recommence growth hormone treatment, of a person under the old Arrangement, which was not processed by the Secretary as at 1 September 2015, ceases to be a valid application under the old Arrangement. 
Applications to change patient category
(2)  An application to the Secretary to change the category of a patient to receive growth hormone treatment under the old Arrangement, which was not processed by the Secretary as at 1 September 2015, ceases to be a valid application under the old Arrangement.
Applications for internal review
(3)  An application to the Secretary for internal review of decisions under section 58 of the old Arrangement which was not processed by the Secretary as at 1 September 2015, ceases to be a valid application under the old Arrangement.
27  Treatment of patients under the old Arrangement
             (1)  A person that has been approved to receive growth hormone treatment under the old Arrangement can continue to be treated, with the pharmaceutical benefit specified under the old Arrangement, until the end of that person’s treatment period.
Note: Decisions of the Secretary made under the old Arrangement were required to specify the date the treatment period began and ended under paragraph 19(1)(e ) of the old Arrangement.
             (2)  At the end of the treatment period, a person will not be eligible to receive any further growth hormone treatment under the old Arrangement.
28  Claims for payment lodged but not determined under the old Arrangement
             (1)  A claim for payment that was lodged under the old Arrangement, but a decision on whether or not to pay the claim was not made before 1 September 2015 is, after the commencement of this Special Arrangement, to be processed under the old Arrangement.
29  Supplies made but not claimed for under the old Arrangement
             (1)  If a claim for payment is lodged for an old supply after commencement of this Special Arrangement, the claim will be processed under the old Arrangement.
             (2)  In this section:
                   old supply means a supply of a growth hormone pharmaceutical benefit that was made under the old Arrangement, but for which no claim has been lodged prior to the commencement of this Special Arrangement.
 
Schedule 1—Pharmaceutical benefits covered by this Special Arrangement and related information
(sections 5 and 7)
  
 
Listed Drug
Form
Manner of Administration
Brand
Section 100 only

Somatropin
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 8 mg (24 i.u.) vial with 1.37 mL diluent cartridge (with preservative) (for use with one.click auto‑injector)
Injection
Saizen 8 mg click.easy
D(100)

 
Injection 10 mg (30 i.u.) vial with diluent (with preservative)
Injection
Zomacton
D(100)

 
Injection 12 mg (36 i.u.) in 1 mL cartridge (with preservative)
Injection
Genotropin
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
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
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
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)

 
 
 
 
 

 

Related Laws