National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 1) (PB 129 of 2015) (Cth)
PB 129 of 2015
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2015 (No. 14)
National Health Act 1953
___________________________________________________________________________
I, JULIANNE QUAINE, 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 22 December 2015
Julianne Quaine
Assistant Secretary
Pharmaceutical Access Branch
Pharmaceutical Benefits Division
Department of Health
___________________________________________________________________________
1 Name of Instrument
(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 1).
(2)This Instrument may also be cited as PB 129 of 2015.
2 Commencement
This Instrument commences on 1 January 2016.
3 Amendment
Amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Schedule 1, entry for Clarithromycin
omit:
Clarithromycin Tablet 250 mg Oral Klacid GO EMP C1434 C3325 100 2 C Tablet 500 mg Oral Klacid GO EMP C1434 C3325 100 2 PB
insert:
Clarithromycin Tablet 500 mg Oral APO Clarithromycin TX MP C5873 C5874 100 2 D
Schedule 1, entry for Rituximab
omit:
Rituximab Solution for I.V. infusion 500 mg in 50 mL Injection Mabthera RO MP C5494 C5501 C5502 See
Note 1See
Note 2D insert:
Rituximab
Solution for I.V. infusion 100 mg in 10 mL Injection Mabthera RO MP C5821 C5864 C5872 C5895 See Note 1 See Note 2 D Solution for I.V. infusion 500 mg in 50 mL Injection Mabthera RO MP C5494 C5501 C5502 C5821 C5864 C5872 C5895 See Note 1 See Note 2 D
Schedule 1, entry for Tacrolimus, in the forms Capsule 0.5 mg, Capsule 1 mg and Capsule 5 mg
omit all instances:
TACROLIMUS APOTEX TX MP C5569 C5602 100 5 D
Schedule 3, entry for Clarithromycin
a) omit:
C1434 Where the patient is receiving treatment at/from a private hospital
Treatment of Mycobacterium avium complex infections
Compliance with Written or Telephone Authority Required procedures C3325 Where the patient is receiving treatment at/from a public hospital
Treatment of Mycobacterium avium complex infections
Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 3325 b) insert:
C5873 P5873 Where the patient is receiving treatment at/from a private hospital
Mycobacterium avium complex infection
Compliance with Written or Telephone Authority Required procedures C5874 P5874 Where the patient is receiving treatment at/from a private hospital
Mycobacterium avium complex infection
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5874
[6] Schedule 3, entry for Rituximab
insert in numerical order after C5502:
| C5821 | P5821 | Severe active microscopic polyangiitis Induction of remission The treatment must be for the induction of remission; AND Patient must not have previously received this drug for this condition; OR Patient must have received this drug for this condition prior to 1 January 2016; AND The treatment must in combination with glucocorticoids; AND Patient must be at risk of end-organ damage or mortality; AND Patient must be contraindicated, refractory or unable to tolerate cyclophosphamide. Diagnosis should be made according to the Chapel Hill Consensus Conference Nomenclature of the Vasculitides with anti-neutrophil cytoplasmic antibody (ANCA) positive serology. This drug is not PBS-subsidised for maintenance therapy. | Compliance with modified Authority Required procedures |
| C5864 | P5864 | Severe active granulomatosis with polyangiitis (Wegeners granulomatosis) Re-induction of remission The treatment must be for the re-induction of remission; AND Patient must have previously received and responded to this drug for this condition; AND The treatment must in combination with glucocorticoids; AND Patient must be at risk of end-organ damage or mortality; AND Patient must be contraindicated, refractory or unable to tolerate cyclophosphamide. Diagnosis should be made according to the Chapel Hill Consensus Conference Nomenclature of the Vasculitides with anti-neutrophil cytoplasmic antibody (ANCA) positive serology. This drug is not PBS-subsidised for maintenance of remission | Compliance with modified Authority Required procedures |
| C5872 | P5872 | Severe active microscopic polyangiitis Re-induction of remission The treatment must be for the re-induction of remission; AND Patient must have previously received and responded to this drug for this condition; AND The treatment must in combination with glucocorticoids; AND Patient must be at risk of end-organ damage or mortality; AND Patient must be contraindicated, refractory or unable to tolerate cyclophosphamide. Diagnosis should be made according to the Chapel Hill Consensus Conference Nomenclature of the Vasculitides with anti-neutrophil cytoplasmic antibody (ANCA) positive serology. This drug is not PBS-subsidised for maintenance therapy. | Compliance with modified Authority Required procedures |
| C5895 | P5895 | Severe active granulomatosis with polyangiitis (Wegeners granulomatosis) Induction of remission The treatment must be for the induction of remission; AND Patient must not have previously received this drug for this condition; OR Patient must have received this drug for this condition prior to 1 January 2016; AND The treatment must in combination with glucocorticoids; AND Patient must be at risk of end-organ damage or mortality; AND Patient must be contraindicated, refractory or unable to tolerate cyclophosphamide. Diagnosis should be made according to the Chapel Hill Consensus Conference Nomenclature of the Vasculitides with anti-neutrophil cytoplasmic antibody (ANCA) positive serology. This drug is not PBS-subsidised for maintenance of remission | Compliance with modified Authority Required procedures |
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