PB 104 of 2014
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 12)
 
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  22 December 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.12).
 
(2)                This Instrument may also be cited as PB 104 of 2014.
2             Commencement
                This Instrument commences on 1 January 2015.
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 each of the forms ‘Solution for I.V. injection 100 mg in 20 mL’ and ‘Solution for I.V. injection 500 mg in 100 mL’ with manner of administration Injection:
omit from the column headed ‘Circumstances’ (all instances):
C4468 C4477 C4511 C4532
insert in the column headed ‘Circumstances’ (all instances) :
C4771 C4775 C4779 C4780
[2]     Schedule 1 Part 1 entry for ‘Docetaxel’:
omit:
Powder for I.V. infusion 20 mg with solvent
Injection
Docetaxel SUN
ZF
MP
 
D

Powder for I.V. infusion 80 mg with solvent
Injection
Docetaxel SUN
ZF
MP
 
D

 
[3]     Schedule 1 Part 1 entry for ‘Panitumumab’ in each of the forms ‘Solution concentrate for I.V. infusion 100 mg in 5 mL’ and ‘Solution concentrate for I.V. infusion 400 mg in 20 mL’ with manner of administration Injection:
omit from the column headed ‘Circumstances’ (all instances):
C4462 C4498 C4530 C4535
insert in the column headed ‘Circumstances’ (all instances) :
C4774 C4776 C4783 C4784
[4]     Schedule 1, Part 2 entry for Cetuximab:
substitute:
Cetuximab
P4771
550
11

 
P4780
 
 

 
P2715
550
5

 
P3921
 
 

 
P2713
880
0

 
P2714
 
 

 
P3919
 
 

 
P3920
P4775
P4779
 
 

 
 
 
 

 
[5]     Schedule 4, entry for Cetuximab :
omit:
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

 

insert:
 

C4771
P4771
Metastatic colorectal cancer. Treatment Phase: Continuing treatment
Patient must have received an initial authority prescription for this drug for treatment of 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 4771


C4775
P4775
Metastatic colorectal cancer. Treatment Phase: Initial treatment
Patient must have 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


C4779
P779
Metastatic colorectal cancer. Treatment Phase: Initial treatment
Patient must have 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 4779


C4780
P4780
Metastatic colorectal cancer. Treatment Phase: Continuing treatment
Patient must have received an initial authority prescription for cetuximab for treatment of 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


 
[6]     Schedule 4, entry for Panitumumab :
substitute:
Panitumumab
C4774
 
Metastatic colorectal cancer. Treatment Phase: Continuing treatment
Patient must have received an initial authority prescription for panitumumab for treatment of 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


 
C4776
 
Metastatic colorectal cancer. Treatment Phase: Initial treatment
Patient must have 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


 
C4783
 
Metastatic colorectal cancer. Treatment Phase: Continuing treatment
Patient must have received an initial authority prescription for panitumumab for treatment  of 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 4783

 
C4784
 
Metastatic colorectal cancer. Treatment Phase: Initial treatment
Patient must have 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 4784