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

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

1. 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