National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 3) (No. PB 21 of 2014) (Cth)

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

1. 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

1. 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

1. 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

1. 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

1. 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

1. 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

1. Schedule 1, Part 2 after the entry for Paclitaxel, nanoparticle albumin‑bound;

insert:

Panitumumab 720 5

1. 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