Federal Register of Legislation - Australian Government

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PB 95 of 2011 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (No. PB 108 of 2010) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS) and related matters.
Administered by: Health
Registered 30 Nov 2011
Tabling HistoryDate
Tabled HR07-Feb-2012
Tabled Senate07-Feb-2012
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

PB 95 of 2011

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011
(No.13)1

National Health Act 1953

I, FELICITY McNEILL, First Assistant Secretary (Acting), Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this Instrument under sections 84AF, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated 30 November 2011

 

 

 

 

 

 

 

 

 

 

 

FELICITY McNEILL

First Assistant Secretary (Acting)

Pharmaceutical Benefits Division

Department of Health and Ageing


 


1          Name of Instrument

            (1)        This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 13).

            (2)        This Instrument may also be cited as PB 95 of 2011.

2          Commencement

This instrument commences 1 December 2011, immediately following commencement of PB 83 of 2011.

3          Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010)

            Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).



Schedule 1     Amendments

 

[1]           Schedule 4, Part 1, entry for Cetuximab

omit:

Cetuximab

C2713

 

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Initial PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with a World Health Organisation performance status of 2 or less and with K-RAS wild type metastatic colorectal cancer after failure of first-line chemotherapy

Compliance with Authority Required procedures

 

C2714

 

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Continuing PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with K-RAS wild type metastatic colorectal cancer who has previously been issued with an authority prescription for cetuximab and who does not have progressive disease

Compliance with Authority Required procedures

 

C2715

 

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx for the week prior to radiotherapy, where cisplatin is contraindicated according to the Therapeutic Goods Administration-approved Product Information

Compliance with Authority Required procedures

 

C3843

 

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is not tolerated

Compliance with Authority Required procedures

 

C3844

 

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated

Compliance with Authority Required procedures

 

substitute:

Cetuximab

C2713

 

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx for the week prior to radiotherapy, where cisplatin is contraindicated according to the Therapeutic Goods Administration-approved Product Information

Compliance with Authority Required procedures


 

 

C2714

 

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is not tolerated

Compliance with Authority Required procedures

 

C2715

 

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated

Compliance with Authority Required procedures

 

C3843

 

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Initial PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with a World Health Organisation performance status of 2 or less and with K-RAS wild type metastatic colorectal cancer after failure of first-line chemotherapy

Compliance with Authority Required procedures

 

C3844

 

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Continuing PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with K-RAS wild type metastatic colorectal cancer who has previously been issued with an authority prescription for cetuximab and who does not have progressive disease

Compliance with Authority Required procedures

 

 

 

 

 

 

 

 

 

1Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. 

See http://www.frli.gov.au.