PB 88 of 2024
National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (September Update) Instrument 2024
National Health Act 1953
I, NIKOLAI TSYGANOV, Assistant Secretary, 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.
Dated 29 August 2024
NIKOLAI TSYGANOV
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
- Name
- This instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (September Update) Instrument 2024.
- This instrument may also be cited as PB 88 of 2024.
- Commencement
- 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 September 2024 | 1 September 2024 |
Note: This table relates only to the provisions of this instrument as originally made.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.
- 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.
- Authority
This instrument is made under subsection 100(2) of the National Health Act 1953.
- 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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021)
- Schedule 1, entry for Ciclosporin in each of the forms: Capsule 25 mg; Capsule 50 mg; and Capsule 100 mg
insert in alphabetical order in the column headed “Brand”:
| | | CICLOSPORIN-WGR | C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361 | | 120 | 5 |
- Schedule 1, entry for Entecavir in the form Tablet 0.5 mg (as monohydrate)
insert in alphabetical order in the column headed “Brand”:
| | | ENTECAVIR-WGR | C4993 C5036 | | 60 | 5 |
- Schedule 1, entry for Entecavir in the form Tablet 1 mg (as monohydrate)
insert in alphabetical order in the column headed “Brand”:
| | | ENTECAVIR-WGR | C5037 C5044 | | 60 | 5 |
- Schedule 1, entry for Ganciclovir in the form Powder for I.V. infusion 500 mg (as sodium)
- omit from the column headed “Circumstances” (all instances): C4972 C4999
- omit from the column headed “Circumstances” (all instances): C9404 C9526
- insert in numerical order in the column headed “Circumstances” (all instances): C15782 C15784 C15800 C15814
- Schedule 1, entry for Valganciclovir in the form Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL
- omit from the column headed “Circumstances”: C4989 C9316
- insert in numerical order in the column headed “Circumstances”: C15782 C15784 C15800 C15814
- Schedule 1, entry for Valganciclovir in the form Tablet 450 mg (as hydrochloride)
- omit from the column headed “Circumstances” (all instances): C4989 C9316
- insert in numerical order in the column headed “Circumstances” (all instances): C15782 C15784 C15800 C15814
- Schedule 3, entry for Ganciclovir
- omit:
| C4972 | | Cytomegalovirus disease
Prophylaxis
Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4972 |
| C4999 | | Cytomegalovirus disease
Prophylaxis
Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4999 |
- omit:
| C9404 | | Cytomegalovirus disease
Prophylaxis
Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9404 |
| C9526 | | Cytomegalovirus disease
Prophylaxis
Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9526 |
- insert in numerical order after existing text:
| C15782 | | Cytomegalovirus infection and disease Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 15782 |
| C15784 | | Cytomegalovirus infection and disease Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 15784 |
| C15800 | | Cytomegalovirus infection and disease Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 15800 |
| C15814 | | Cytomegalovirus infection and disease Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 15814 |
- Schedule 3, entry for Valganciclovir
- omit:
| C4989 | | Cytomegalovirus infection and disease
Prophylaxis
Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4989 |
| C9316 | | Cytomegalovirus infection and disease
Prophylaxis
Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9316 |
- insert in numerical order after existing text:
| C15782 | | Cytomegalovirus infection and disease Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 15782 |
| C15784 | | Cytomegalovirus infection and disease Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 15784 |
| C15800 | | Cytomegalovirus infection and disease Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 15800 |
| C15814 | | Cytomegalovirus infection and disease Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 15814 |