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PB 21 of 2014 Arrangements as made
This instrument amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (No. PB 79 of 2011) to make changes relating to the efficient funding of chemotherapy.
Administered by: Health
Registered 27 Mar 2014
Tabling HistoryDate
Tabled HR13-May-2014
Tabled Senate14-May-2014
Date of repeal 02 Apr 2014
Repealed by Division 1 of Part 5A of the Legislative Instruments Act 2003

 

PB 21 of 2014

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 3)

 

National Health Act 1953

___________________________________________________________________________

 

I, Kim Bessell, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.

 

Dated 24 March 2014

 

 

 

 

 

 

 

 

 

 

 

KIM BESSELL

Assistant Secretary

Pharmaceutical Access Branch

Principal Pharmacy Advisor                                                                     

Pharmaceutical Benefits Division

Department of Health

 

___________________________________________________________________

 

 

1              Name of Instrument

 

(1)                This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 3).

 

(2)                This Instrument may also be cited as PB 21 of 2014.

2             Commencement

                This Instrument commences on 1 April 2014.

3              Amendments to 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]     Schedule 1 Part 1, entry for Cetuximab in the forms ‘Solution for I.V. infusion 100 mg in 20 mL’ and ‘Solution for I.V. infusion 500 mg in 100 mL’ with the manner of administration Injection:

omit from the column headed ‘Circumstances’ (all instances):

C3843 C3844 C3903 C3904

add  after C3921:

C4468 C4477 C4511 C4532

[2]     Schedule 1 Part 1, entry for Doxorubicin - Pegylated Liposomal in the form ‘Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL’ with manner of administration Injection:

omit:

 

 

 

Caelyx

JC

MP

C1568 C1795 C1796 C3905 C3910 C3911

D

 

 

 

 

 

 

 

Lipodox  

ZF

MP

C1568 C1795 C1796 C3905 C3910 C3911

 

D

replace with:

 

Caelyx

JC

MP

C1568 C1795 C1796 C3905 C3910 C3911

D

 

 

Liposomal

Doxorubicin SUN

ZF

MP

C1568 C1795 C1796 C3905 C3910 C3911

 

D

[3]     Schedule 1 Part 1, entry for Doxorubicin-Pegylated Liposomal in the form ‘Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL’ with manner of administration Injection:

omit:

 

 

Caelyx

JC

MP

C1568 C1795 C1796 C3905 C3910 C3911

D

 

 

 

 

Lipodox 50

ZF

MP

C1568 C1795 C1796 C3905 C3910 C3911

 

D

replace with:

 

 

Caelyx

JC

MP

C1568 C1795 C1796 C3905 C3910 C3911

D

 

 

Liposomal

Doxorubicin SUN

ZF

MP

C1568 C1795 C1796 C3905 C3910 C3911

D

 

[4]     Schedule 1 Part 1, entry for Irinotecan in the forms ‘I.V injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL’; ‘I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL’; ‘I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL’ and; ‘I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL’ with manner of administration Injection:

omit from the column headed ‘Circumstances’ (all instances):

C3184

[5]     Schedule 1 Part 1, entry for Oxaliplatin in the forms ‘Powder for I.V. infusion 100 mg’; ‘Powder for I.V. infusion 50 mg’; ‘Solution concentrate for I.V. infusion 100 mg in 20 mL’;  ‘Solution concentrate for I.V. infusion 200 mg in 40 mL’ and; ‘Solution concentrate for I.V. infusion 50 mg in 10 mL’ with the manner of administration Injection:

omit from the column headed ‘Circumstances’ (all instances):

C3900  C3901  C3930  C3939

[6]     Schedule 1, Part 1 after the entry for Paclitaxel, nanoparticle albumin‑bound;

insert in the columns in order indicated:

Panitumumab

Solution concentrate for I.V. infusion 100 mg in 5 mL

Injection

Vectibix

AN

MP

C4462

C4498

C4530 C4543

 

D

[7]     Schedule 1, part 2 entry for Cetuximab:

omit:

Cetuximab

P3844

550

11

 

P3904

 

 

 

P2715

550

5

 

P3921

 

 

 

P2713

880

0

 

P2714

 

 

 

P3843

 

 

 

P3903

 

 

 

P3919

 

 

 

P3920

 

 

      replace with:

Cetuximab

P4511

550

11

 

P4532

 

 

 

P2715

550

5

 

P3921

 

 

 

P2713

880

0

 

P2714

 

 

 

P3919

 

 

 

P3920

P4468

P4477

 

 

[8]     Schedule 1, Part 2 after the entry for Paclitaxel, nanoparticle albumin‑bound;

insert:

Panitumumab

720

5

 

 

 

 

[9]     Schedule 2 entry for Tropisetron:

omit:

         

Capsule 5 mg (as hydrochloride)

Oral

Navoban

NV

EMP

C3050

2

0

I.V. injection 5 mg (as hydrochloride) in 5 mL

Injection

Navoban

NV

EMP

C3050

1

0

 

 

Tropisetron-AFT

AE

EMP

C3050

1

0

replace with:

 

I.V. injection 5 mg (as hydrochloride) in 5 mL

Injection

Tropisetron-AFT

AE

EMP

C3050

1

0

 

[10]  Schedule 3, Responsible Person codes, after entry for AF:

insert:

AN

Amgen Australia Pty Ltd

 31 051 057 428 

[11]  Schedule 3, Responsible Person codes, after entry for MK:

omit:

NV

Novartis Pharmaceuticals Australia Pty Limited

 18 004 244 160

[12]  Schedule 4 entry for Cetuximab:

omit:

C3843

P3843

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

P3844

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

C3903

P3903

Where the patient is receiving treatment at/from a Public 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 ‑ Streamlined Authority Code 3903

C3904

P3904

Where the patient is receiving treatment at/from a Public 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 ‑ Streamlined Authority Code 3904

 

insert after entry for C3921:

C4468

P4468

Metastatic colorectal cancer
Treatment Phase: Initial treatment
Patient must have K-RAS wild-type metastatic colorectal cancer,
Patient must have a WHO performance status of 2 or less,
The condition must have failed to respond to first-line chemotherapy,
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy,
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab.
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.

Compliance with Authority Required procedures - Streamlined Authority Code 4468


C4477

P4477

Metastatic colorectal cancer
Treatment Phase: Initial treatment
Patient must have K-RAS wild-type metastatic colorectal cancer,
Patient must have a WHO performance status of 2 or less,
The condition must have failed to respond to first-line chemotherapy,
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy,
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.

Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab.

Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.

Compliance with Authority Required procedures


C4511

P4511

Metastatic colorectal cancer
Treatment Phase: Continuing treatment
Patient must have received an initial authority prescription for cetuximab for treatment of K-RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy,
Patient must not have progressive disease,
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy,
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.

Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab.

Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.

Compliance with Authority Required procedures


C4532

P4532

Metastatic colorectal cancer
Treatment Phase: Continuing treatment
Patient must have received an initial authority prescription for cetuximab for treatment of K-RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy,
Patient must not have progressive disease,
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy,
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab.
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.

Compliance with Authority Required procedures - Streamlined Authority Code 4532


[13]  Schedule 4 following the entry for Interferon Alfa‑2b:

omit:

Irinotecan

C3184

Metastatic colorectal cancer in patients with a World Health Organisation performance status of 2 or less

Compliance with Authority Required procedures ‑ Streamlined Authority Code 3184

[14]  Schedule 4 following the entry for Ondansetron:

omit:

 Oxaliplatin

C3900

Metastatic colorectal cancer in a patient with a World Health Organisation performance status of 2 or less, when used in combination with capecitabine

Compliance with Authority Required procedures ‑ Streamlined Authority Code 3900

 

C3901

Metastatic colorectal cancer in a patient with a World Health Organisation performance status of 2 or less, when used in combination with fluorouracil and folinic acid

Compliance with Authority Required procedures ‑ Streamlined Authority Code 3901

 

C3930

Adjuvant treatment of stage III (Dukes C) colon cancer following complete resection of      the primary tumour used in combination with capecitabine

Compliance with Authority Required procedures ‑ Streamlined Authority Code 3930

 

C3939

Adjuvant treatment of stage III (Dukes C) colon cancer following complete resection of      the primary tumour used in combination with 5‑fluorouracil and folinic acid

Compliance with Authority Required procedures ‑ Streamlined Authority Code 3939

[15]  Schedule 4, after the entry for Paclitaxel, nanoparticle albumin‑bound;

insert in the columns in the order indicated:

 

Panitumumab

C4462

Metastatic colorectal cancer
Treatment Phase: Initial treatment
Patient must have K-RAS wild-type metastatic colorectal cancer,
Patient must have a WHO performance status of 2 or less,
The condition must have failed to respond to first-line chemotherapy,
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan-based therapy,
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.

Compliance with Authority Required  procedures - Streamlined Authority Code 4462

 

C4498

Metastatic colorectal cancer
Treatment Phase: Continuing treatment
Patient must have received an initial authority prescription for panitumumab for       treatment  of K-RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy,
Patient must not have progressive disease,
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy,
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.

Compliance with Authority Required procedures - Streamlined Authority Code 4498

 

C4530

Metastatic colorectal cancer
Treatment Phase: Initial treatment
Patient must have K-RAS wild-type metastatic colorectal cancer,
Patient must have a WHO performance status of 2 or less,
The condition must have failed to respond to first-line chemotherapy,
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy,
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.

Compliance with Authority Required procedures

 

C4543

Metastatic colorectal cancer
Treatment Phase: Continuing treatment
Patient must have received an initial authority prescription for panitumumab for       treatment of K-RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy,
Patient must not have progressive disease,
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy,
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.
Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.

Compliance with Authority Required procedures