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

Link to law: https://www.comlaw.gov.au/Details/F2014L00360

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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