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PB 65 of 2021 Arrangements as made
This instrument amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) to add, delete and make changes to drugs, forms, manners of administration, brands, responsible person codes, authorised prescribers, maximum quantities/amounts and repeats and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).
Administered by: Health
Registered 30 Jun 2021
Tabling HistoryDate
Tabled HR03-Aug-2021
Tabled Senate03-Aug-2021
Date of repeal 19 Oct 2021
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

PB 65 of 2021

 

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No. 6)

 

National Health Act 1953

___________________________________________________________________________

 

I, MARIANA CRANK, Assistant Secretary (Acting), Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under subsection 100(2) of the National Health Act 1953.

 

Dated              29 JUNE 2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MARIANA CRANK

Assistant Secretary (Acting)

Pharmacy Branch

Technology Assessment and Access Division

Department of Health


___________________________________________________________________________

1          Name of Instrument

(1)          This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No. 6).

(2)          This Instrument may also be cited as PB 65 of 2021.

2          Commencement

This Instrument commences on 1 July 2021.

3          Amendment of National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)

Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).

 

 


Schedule 1     Amendments

[1]        Part 1, Division 1, Section 3, definition for “diluent fee

omit: $5.44              substitute: $5.50

[2]        Part 1, Division 1, Section 3, definition for “dispensing fee”

omit: $7.74              substitute: $7.78

[3]        Part 1, Division 1, Section 3, definition for “distribution fee”

omit: $27.45            substitute: $27.75

[4]        Part 1, Division 1, Section 3, definition for “preparation fee”

omit: $85.78            substitute: $86.28

[5]        Schedule 1, Part 1, after entry for Cabazitaxel in the form Concentrated injection 60 mg (as acetone solvate) in 1.5 mL, with diluent

insert:

 

Solution concentrate for I.V. infusion 60 mg in 6 mL

Injection

Cabazitaxel Ever Pharma

IT

MP

C4662

D

[6]        Schedule 1, Part 1, entry for Carboplatin

omit:

 

Solution for I.V. injection 150 mg in 15 mL

Injection

DBL Carboplatin

PF

MP

 

D

[7]        Schedule 1, Part 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 50 mg in 10 mL

insert in numerical order in the column headed “Circumstances”: C11930

[8]        Schedule 1, Part 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL

insert in numerical order in the column headed “Circumstances”: C11985

[9]        Schedule 1, Part 2, entry for Ipilimumab [Maximum Amount: 120; Number of Repeats: 3]

insert in numerical order in the column headed “Purposes”: P11930    

[10]      Schedule 1, Part 2, after entry for Nivolumab [Maximum Amount: 360; Number of Repeats: 3]

insert:

 

P11985

360

8

[11]      Schedule 3, after details relevant to Responsible Person code HX

insert:

IT

InterPharma Pty Ltd

19    99 877 899

[12]      Schedule 3, details relevant to the Responsible Person codes; OC and OD

omit from the column headed “Responsible Person”: Accord Healthcare Pty Ltd          substitute: Accord Healthcare Pty. Ltd.

[13]      Schedule 4, entry for Ipilimumab

insert in numerical order after existing text:

 

C11930

P11930

Unresectable malignant mesothelioma
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be in combination with PBS-subsidised nivolumab for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must not exceed a maximum total of 24 months in a lifetime for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 11930

[14]      Schedule 4, entry for Nivolumab

insert in numerical order after existing text:

 

C11985

P11985

Unresectable malignant mesothelioma
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be in combination with PBS-subsidised ipilimumab, unless an intolerance to ipilimumab of a severity necessitating permanent treatment withdrawal of ipilimumab; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must not exceed a maximum total of 24 months in a lifetime for this condition.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 11985