National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2014 (No. 4) (PB 30 of 2014)

Link to law: https://www.comlaw.gov.au/Details/F2014L00449

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PB 30 of 2014
National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2014 (No. 4)
 
National Health Act 1953
___________________________________________________________________________
 
 
I, FELICITY MCNEILL, First Assistant Secretary, 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 19 April 2014
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FELICITY MCNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health
___________________________________________________________________________
 
 
1       Name of Instrument
 
(1)                This Instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2014 (No.4).
 
(2)                This Instrument may also be cited as PB 30 of 2014.
 
2              Commencement
This Instrument commences on 1 May 2014.
3              Amendments to PB 116 of 2010
Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010).
 
 
Schedule 1       Amendments
 [1]     Schedule 1, entry for Atazanavir, in the form capsule 100 mg (as sulphate), brand name Reyataz
Omit
[2]      Schedule 1, after entry for Peginterferon Alfa-2a
Insert:
Plerixafor
Injection 24 mg in 1.2 mL
Injection
Mozobil
GZ
EMP
C4549 C4550
 
1
1
D
[3]      Schedule 1, after entry for Tenofovir with emtricitabine and efavirenz
Insert:
Tenofovir with emtricitabine, elvitegravir and cobicistat
Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg, elvitegravir 150 mg and cobicistat 150 mg
Oral
Stribild
GI
EMP
C4470 C4494 C4522 C4533
 
60
5
D
[4]      Schedule 3, after entry for Peginterferon Alfa-2a
Insert:
Plerixafor
C4549
 
Where the patient is receiving treatment at/from a public hospital
 
Mobilisation of haematopoietic stem cells
The treatment must be in combination with granulocyte-colony stimulating factor (G-CSF); AND
Patient must have lymphoma; OR
Patient must have multiple myeloma; AND
Patient must require autologous stem cell transplantation; AND
Patient must have failed previous stem cell collection; OR
Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per microlitre on the day of planned collection; OR
Patient must be undergoing chemotherapy plus G-CSF mobilisation and the first apheresis has yielded less than 1 million CD34+ cells/kg.
Evidence that the patient meets the PBS restriction criteria must be recorded in the patient's medical records
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4549
 
 
C4550
 
Where the patient is receiving treatment at/from a private hospital
 
Mobilisation of haematopoietic stem cells
The treatment must be in combination with granulocyte-colony stimulating factor (G-CSF); AND
Patient must have lymphoma; OR
Patient must have multiple myeloma; AND
Patient must require autologous stem cell transplantation; AND
Patient must have failed previous stem cell collection; OR
Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per microlitre on the day of planned collection; OR
Patient must be undergoing chemotherapy plus G-CSF mobilisation and the first apheresis has yielded less than 1 million CD34+ cells/kg.
 
Evidence that the patient meets the PBS restriction criteria must be recorded in the patient's medical records.
Compliance with Written or Telephone Authority Required procedures

 
 
[5]      Schedule 3, after entry for Tenofovir with emtricitabine and efavirenz
Insert:
Tenofovir with emtricitabine, elvitegravir and cobicistat
C4470
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection.
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4470

 
C4494
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection.
Compliance with Written or Telephone Authority Required procedures


 
C4522
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naive.
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4522

 
C4533
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naive.
Compliance with Written and Telephone Authority Required procedures