PB 93 of 2022
National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2022 (No. 1)
National Health Act 1953
I, NIKOLAI TSYGANOV, Assistant Secretary (Acting), Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, delegate of the Minister for Health and Aged Care, make this Instrument under subsection 100(2) of the National Health Act 1953.
Date 29 September 2022
NIKOLAI TSYGANOV
Assistant Secretary (Acting)
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Contents
1......... Name............................................................................................................................... 1
2......... Commencement............................................................................................................... 1
3......... Authority......................................................................................................................... 1
4......... Schedules......................................................................................................................... 1
Schedule 1—Amendments 2
National Health (Growth Hormone Program) Special Arrangement 2015
(PB 85 of 2015) 2
1 Name
(1) This instrument is the National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2022 (No. 1).
(2) This instrument may also be cited as PB 93 of 2022.
2 Commencement
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
| Commencement information |
| Column 1 | Column 2 | Column 3 |
| Provisions | Commencement | Date/Details |
| 1. The whole of this instrument | 1 October 2022, immediately after the commencement of the National Health (Growth Hormone Program) Special Arrangement Amendment (Mecasermin and Somatrogon) Instrument 2022 (PB 92 of 2022) | 1 October 2022 |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3 Authority
This instrument is made under subsection 100(2) of the National Health Act 1953.
4 Schedules
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1 Amendments
National Health (Growth Hormone Program) Special Arrangement 2015 (PB 85 of 2015)
[1] Schedule 1, Part 1, Pharmaceutical benefits for treatment of children
substitute:
Part 1 – Pharmaceutical benefits for treatment of children
| Listed Drug | Form | Manner of Administration | Brand | Section 100 only |
| Mecasermin | Solution for injection 40 mg in 4 mL (10 mg per mL) | Injection | Increlex | D(100) |
| Somatrogon | Injection 24 mg in 1.2 mL single use pre-filled pen | Injection | Ngenla | D(100) |
| | Injection 60 mg in 1.2 mL single use pre-filled pen | Injection | Ngenla | D(100) |
| 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 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 | 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 | 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 | 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) |