PB 51 of 2015
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 5)
 
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 29 May 2015
 
 
 
 
 
 
 
 
 
 
 
 
KIM BESSELL
Assistant Secretary
Pharmaceutical Access Branch       
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 2015 (No.5).
 
(2)                This Instrument may also be cited as PB 51 of 2015.
2             Commencement
                This Instrument commences on 1 June 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 ‘Bevacizumab’ in each of the forms ‘Solution for I.V. infusion 100 mg in 4 mL’ and ‘Solution for I.V. infusion 400 mg in 16 mL’ with manner of administration Injection:
insert in the column headed ‘Circumstances’ (all instances): C4939 C4968
[2]     Schedule 1 Part 1 entry for ‘Cetuximab’ in each of the forms ‘Solution for I.V. infusion 100 mg in 20 mL’ and ‘Solution for I.V. infusion 500 mg in 100 mL’ with manner of administration Injection:
omit from the column headed ‘Circumstances’ (all instances): C4771 C4779
insert in the column headed ‘Circumstances’ (all instances): C4908 C4912 C4945 C4965
[3]     Schedule 1 Part 1 entry for ‘Docetaxel’ in the form ‘Solution concentrate for I.V. infusion 20 mg in 1 mL’ and manner of administration ‘Injection’:
substitute:
Solution concentrate for I.V. infusion 20 mg in 1 mL
Injection
Taxotere
SW
MP
 
D
[4]     Schedule 1 Part 1 entry for ‘Docetaxel’ in the form ‘Solution concentrate for I.V. infusion 80 mg in 4 mL’ and manner of administration ‘Injection’:
substitute:
Solution concentrate for I.V. infusion 80 mg in 4 mL
Injection
Oncotaxel 80
GN
MP
 
D

 
 
 
Taxotere
SW
MP
 
D

[5]     Schedule 1 Part 1 entry for ‘Oxaliplatin’:
omit:
Powder for I.V. infusion 100 mg
Injection
Hospira Pty Limited
HH
MP
 
D

Powder for I.V. infusion 50 mg
Injection
Hospira Pty Limited
HH
MP
 
D

[6]     Schedule 1, Part 2 entry for Bevacizumab:
substitute:
Bevacizumab
P4584
900
11

 
P4587
 
 

 
P4594
 
 

 
P4939
 
 

 
C4968
 
 

 
P4814
900
5

 
 
 
 

 
 
[7]     Schedule 1, Part 2 entry for Cetuximab:
substitute:
Cetuximab
P4785
880
0

 
P4794
P4908
 
 

 
P4965
 
 

 
P4788
550
5

 
P4912
550
18

 
P4945
550
11

[8]     Schedule 2, after the entry for ‘Ondansetron’ in each of the forms ‘Tablet 4 mg (as hydrochloride dihydrate)’ and ‘Tablet 8 mg (as hydrochloride dihydrate)’ and brand ‘Ondansteron-DRLA’ with manner of administration ‘Oral’:
insert:
Ondansetron SZ
HX
EMP
C3050
 
4
0
[9]     Schedule 2, after the entry for ‘Ondansetron’ in each of the forms ‘Tablet (orally disintegrating) 4 mg’ and ‘Tablet (orally disintegrating) 8 mg’ and brand ‘Ondansteron AN ODT’ with manner of administration ‘Oral’:
insert:
Ondansetron SZ ODT
HX
EMP
C3050
 
4
0
[10]  Schedule 2, entry for ‘Ondansetron’ in each of the forms ‘I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL’ and ‘I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL’ with manner of administration ‘Injection’:
omit:
Ondaz
SZ
EMP
C3050
 
1
0
[11]  Schedule 4, entry for Bevacizumab:
Insert (in numerical order):
C4939
P4939
Metastatic colorectal cancer;Treatment Phase: Initial treatment
Patient must have RAS wild-type metastatic colorectal cancer,
AND
Patient must be previously treated with PBS-subsidised first-line anti-EGFR antibodies,
AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition,
AND
Patient must have a WHO performance status of 0 or 1,
AND
The treatment must be in combination with second-line chemotherapy,
AND
The treatment must not exceed a dose of 5 mg per kg every 2 weeks; OR
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks.
Compliance with Authority Required procedures - Streamlined Authority Code 4939


C4968
P4968
Metastatic colorectal cancer; Treatment Phase: Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition,
AND
Patient must not have progressive disease,
AND
The treatment must be in combination with second-line chemotherapy,
AND
The treatment must not exceed a dose of 5 mg per kg every 2 weeks; OR
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks.
Compliance with Authority Required procedures - Streamlined Authority Code 4968


[12]  Schedule 4, entry for Cetuximab:
substitute:
Cetuximab
C4785
P4785
Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx
Treatment Phase: Initial treatment
The treatment must be in combination with radiotherapy,
AND
Patient must be unable to tolerate cisplatin.
Compliance with Authority Required procedures - Streamlined Authority Code 4785


 
C4788
P4788
Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx
Treatment Phase: Continuing treatment
The treatment must be in combination with radiotherapy,
AND
Patient must be unable to tolerate cisplatin; OR
Patient must have a contraindication to cisplatin according to the TGA-approved Product Information.
Compliance with Authority Required procedures - Streamlined Authority Code 4788


 
C4794
P4794
Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx
Treatment Phase: Initial treatment
The treatment must be for the week prior to radiotherapy,
AND
Patient must have a contraindication to cisplatin according to the TGA-approved Product Information.
Compliance with Authority Required procedures - Streamlined Authority Code 4794


 
C4908
P4908
Metastatic colorectal cancer
Treatment Phase: Initial treatment
Patient must have RAS wild-type metastatic colorectal cancer,
AND
Patient must have a WHO performance status of 0 or 1,
AND
The condition must be previously untreated,
AND
The treatment must be in combination with first-line chemotherapy,
AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Compliance with Authority Required procedures - Streamlined Authority Code 4908


 
C4912
P4912
Metastatic colorectal cancer
Treatment Phase: Continuing treatment
Patient must have received an initial authority prescription for this drug for first-line treatment of RAS wild-type metastatic colorectal cancer,
AND
Patient must not have progressive disease,
AND
The treatment must be in combination with first-line chemotherapy,
AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
Compliance with Authority Required procedures - Streamlined Authority Code 4912


 
C4945
P4945
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,
AND
Patient must not have progressive disease,
AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy,
AND
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 4945


 
C4965
P4965
Metastatic colorectal cancer
Treatment Phase: Initial treatment
Patient must have RAS wild-type metastatic colorectal cancer,
AND
Patient must have a WHO performance status of 2 or less,
AND
The condition must have failed to respond to first-line chemotherapy,
AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy,
AND
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 4965