National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 6) (PB 55 of 2016) (Cth)

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PB 55 of 2016

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 6)

National Health Act 1953
___________________________________________________________________________

I, TONY WYND, Acting Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.

Dated 27 June 2016

Tony Wynd
Acting Assistant Secretary

Pharmaceutical Access Branch

Pharmaceutical Benefits Division

Department of Health

___________________________________________________________________________

Part 1        Preliminary

1                  Name of Instrument

(1)This instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 6).

(2)This instrument may also be cited as PB 55 of 2016.

2              Commencement

This instrument commences on 1 July 2016.

3              Amendment

The Schedule amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

Schedule – Amendments

Schedule

National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)

  1. Schedule 1, entry for Darbepoetin alfa

    Omit from the column headed ‘Circumstances’ (all instances): C1957 C3334                      Insert in numerical order: C6260 C6294

  2. Schedule 1, entry for Doxorubicin-pegylated liposomal

    Omit from the column headed ‘Circumstances’ (all instances): C1828 C1829 C3348 C3349Insert in numerical order: C6233 C6234 C6264 C6274

  3. Schedule 1, entry for Epoetin alfa

    Omit from the column headed ‘Circumstances’ (all instances): C1957 C3334   Insert in numerical order: C6260 C6294

  4. Schedule 1, entry for Epoetin beta

    Omit from the column headed ‘Circumstances’ (all instances): C1957 C3334   Insert in numerical order: C6260 C6294

  5. Schedule 1, entry for Epoetin lambda

    Omit from the column headed ‘Circumstances’ (all instances): C1957 C3334   Insert in numerical order: C6245 C6261

  6. Schedule 1, entry for Interferon Gamma-1b

    Omit from the column headed ‘Circumstances’: C1058 C3385                      Insert in numerical order: C6222 C6286

  7. Schedule 1, entry for Methoxy polyethylene glycol-epoetin beta

    Omit from the column headed ‘Circumstances’ (all instances): C1957 C3334   Insert in numerical order: C6260 C6294

  8. Schedule 3, entry for Darbepoetin alfa

    Substitute:

Darbepoetin Alfa C6260 Where the patient is receiving treatment at/from a private hospital
Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist. 		Compliance with Authority Required procedures
C6294 Where the patient is receiving treatment at/from a public hospital
Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist. 		Compliance with Authority Required procedures - Streamlined Authority Code 6294

  1. Schedule 3, entry for Doxorubicin-pegylated liposomal

    Substitute:

Doxorubicin ‑
Pegylated Liposomal 		C6233 Where the patient is receiving treatment at/from a private hospital
Kaposi sarcoma
The condition must be AIDS-related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive visceral involvement. 		Compliance with Authority Required procedures
C6234 Where the patient is receiving treatment at/from a public hospital
Kaposi sarcoma
The condition must be AIDS-related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive mucocutaneous involvement. 		Compliance with Authority Required procedures - Streamlined Authority Code 6234
C6264 Where the patient is receiving treatment at/from a private hospital
Kaposi sarcoma
The condition must be AIDS-related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive mucocutaneous involvement. 		Compliance with Authority Required procedures
C6274 Where the patient is receiving treatment at/from a public hospital
Kaposi sarcoma
The condition must be AIDS-related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive visceral involvement. 		Compliance with Authority Required procedures - Streamlined Authority Code 6274

  1. Schedule 3, entry for Epoetin alfa

    Substitute:

Epoetin Alfa C6260 Where the patient is receiving treatment at/from a private hospital
Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist. 		Compliance with Authority Required procedures
C6294 Where the patient is receiving treatment at/from a public hospital
Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist. 		Compliance with Authority Required procedures - Streamlined Authority Code 6294

  1. Schedule 3, entry for Epoetin beta

    Substitute:

Epoetin Beta C6260 Where the patient is receiving treatment at/from a private hospital
Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist. 		Compliance with Authority Required procedures
C6294 Where the patient is receiving treatment at/from a public hospital
Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist. 		Compliance with Authority Required procedures - Streamlined Authority Code 6294

  1. Schedule 3, entry for Epoetin lambda

    Substitute:

Epoetin Lambda C6245 Where the patient is receiving treatment at/from a public hospital
Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist. 		Compliance with Authority Required procedures - Streamlined Authority Code 6245
C6261 Where the patient is receiving treatment at/from a private hospital
Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist. 		Compliance with Authority Required procedures

  1. Schedule 3, entry for Interferon Gamma-1b

    Substitute:

Interferon Gamma‑1b C6222 Where the patient is receiving treatment at/from a public hospital
Chronic granulomatous disease
Patient must have frequent and severe infections despite adequate prophylaxis with antimicrobial agents. 		Compliance with Authority Required procedures - Streamlined Authority Code 6222
C6286 Where the patient is receiving treatment at/from a private hospital
Chronic granulomatous disease
Patient must have frequent and severe infections despite adequate prophylaxis with antimicrobial agents. 		Compliance with Authority Required procedures

  1. Schedule 3, entry for Methoxy polyethylene glycol-epoetin beta

    Substitute:

Methoxy polyethylene glycol‑epoetin beta C6260 Where the patient is receiving treatment at/from a private hospital
Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist. 		Compliance with Authority Required procedures
C6294 Where the patient is receiving treatment at/from a public hospital
Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist. 		Compliance with Authority Required procedures - Streamlined Authority Code 6294
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