National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 12) (No. PB 104 of 2014) (Cth)

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

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

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

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

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

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

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

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Citations

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 12) (No. PB 104 of 2014) (Cth)

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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

Cetuximab	P4771	550	11
P4780
P2715	550	5
P3921
P2713	880	0
P2714
P3919
P3920 P4775 P4779

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

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