PB 56 of 2014
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 7)
 
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 July 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.7).
 
(2)                This Instrument may also be cited as PB 56 of 2014.
2             Commencement
                This Instrument commences on 1 August 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 ‘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, in the column headed ‘Circumstances’
omit: C3430 C3431 C3894 C3896                                        
insert: C4584 C4585 C4587 C4588 C4589 C4594 C4597 C4598
 
[2]     Schedule 1 Part 1 entry for ‘Carboplatin’ in the form ‘Solution concentrate for I.V. injection 450 mg in 45 mL’ with manner of administration Injection:
omit :
Carbaccord
 
GN
 
MP
 
 
D
 
[3]     Schedule 1 Part 1 entry for ‘Epirubicin’ in each of the forms ‘Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL’;  ‘Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL’; ‘Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL’; and ‘Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL’ with manner of administration Injection/Intravesical:
omit :
Epiccord
 
GN
 
MP
 
 
D
 
[4]     Schedule 1 Part 1 entry for ‘Gemcitabine’ in the form ‘Powder for I.V. infusion 1 g (as hydrochloride)’ with manner of administration Injection:
omit :
Gemplan
GN
 
MP
 
 
D
 
[5]     Schedule 1 Part 1 entry for ‘Gemcitabine’ in the form ‘Powder for I.V. infusion 200 mg (as hydrochloride)’ with manner of administration Injection:
omit :
Gemcitabine Actavis
GN
MP
 
D
 

Gemplan
GN
MP
 
D
 

[6]     Schedule 1 Part 1 entry for ‘Oxaliplatin’ in each of the forms ‘Powder for I.V. infusion 100 mg’ and ‘Powder for I.V. infusion 50 mg’ with manner of administration Injection:
omit :
Xalox
GN
 
MP
 
 
D
 
[7]     Schedule 1 Part 1 after the entry for ‘Panitumumab’ in the form ‘Solution concentrate for I.V. infusion 100 mg in 5 mL’ with manner of administration Injection:
insert:
Solution concentrate for I.V. infusion 400 mg in 20 mL
Injection
Vectibix
AN
MP
C4462 C4498 C4530 C4543
D
 
[8]     Schedule 1 Part 2, entry for Bevacizumab:
omit:
Bevacizumab
 
900
11
insert in the columns in the order indicated:
Bevacizumab
P4589
900
5

 
P4598
 
 

 
P4584
900
11

 
P4585
 
 

 
P4587
P4588
P4594
P4597
 
 

[9]     Schedule 4, entry for Bevacizumab
omit:
Bevacizumab
C3430
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Initial PBS‑subsidised treatment, in combination with first‑line chemotherapy, of a patient with previously untreated metastatic colorectal cancer with a World Health Organisation performance status of 0 or 1, where the patient's dose of bevacizumab does not exceed 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks
Compliance with Authority Required Procedures

 
C3431
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Continuing PBS‑subsidised treatment, in combination with first‑line chemotherapy, of a patient with metastatic colorectal cancer who has who has previously been issued with an authority prescription for bevacizumab and who does not have progressive disease and who remains on first‑line chemotherapy, where the patient's dose of bevacizumab does not exceed 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks
Compliance with Authority Required Procedures

 
C3894
 
Where the patient is receiving treatment at/from a Public Hospital
Initial PBS‑subsidised treatment, in combination with first‑line chemotherapy, of a patient with previously untreated metastatic colorectal cancer with a World Health Organisation performance status of 0 or 1, where the patient's dose of bevacizumab does not exceed 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks, and where the patient's WHO performance status and body weight is recorded in the patient's medical records at the time the treatment cycle is initiated
Compliance with Authority Required procedures ‑ Streamlined Authority Code 3894

 
C3896
 
Where the patient is receiving treatment at/from a Public Hospital
Continuing PBS‑subsidised treatment, in combination with first‑line chemotherapy, of a patient with metastatic colorectal cancer who has previously received PBS‑subsidised treatment with bevacizumab and who does not have progressive disease and who remains on first‑line chemotherapy, where the patient's dose of bevacizumab does not exceed 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks, and where the patient's body weight is documented in the patient's medical records at the time the treatment cycle is initiated
Compliance with Authority Required procedures ‑ Streamlined Authority Code 3896

insert:
Bevacizumab
C4584
P4584
Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Treatment Phase: Continuing treatment
Patient must have previously received PBS-subsidised treatment with bevacizumab for this condition, patient must not have progressive disease, and the treatment must not exceed a dose of 7.5 mg per kg every 3 weeks, the treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer.

Compliance with Authority Required procedures - Streamlined Authority Code 4584


 
C4585
P4585
Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Treatment Phase: Continuing treatment
Patient must have previously received PBS-subsidised treatment with bevacizumab for this condition, patient must not have progressive disease, the treatment must not exceed a dose of 7.5 mg per kg every 3 weeks, the treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer.

Compliance with Authority Required procedures


 
C4587
P4587
Metastatic colorectal cancer; treatment Phase: Continuing treatment
Patient must have previously received PBS-subsidised treatment with bevacizumab for this condition, patient must not have progressive disease, the treatment must be in combination with first-line chemotherapy. The treatment must not exceed a dose of 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks. The patient's body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 4587


 
C4588
P4588
Metastatic colorectal cancer, treatment Phase: Continuing treatment
Patient must have previously received PBS-subsidised treatment with bevacizumab for this condition, patient must not have progressive disease, and the treatment must be in combination with first-line chemotherapy. The treatment must not exceed a dose of 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks.

Compliance with Authority Required procedures


 
C4589
P4589
Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Treatment Phase: Initial treatment
The condition must be suboptimally debulked (maximum diameter of any gross residual disease greater than 1 cm), patient must have a WHO performance status of 2 or less,
and the condition must be previously untreated; treatment must be commenced in combination with platinum-based chemotherapy.  The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks and a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer. The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.

Compliance with Authority Required procedures


 
C4594
P4594
Metastatic colorectal cancer; treatment Phase: Initial treatment
The condition must be previously untreated, patient must have a WHO performance status of 0 or 1, and treatment must be in combination with first-line chemotherapy,
The treatment must not exceed a dose of 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks. The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 4594


 
C4597
P4597
Metastatic colorectal cancer; Treatment Phase: Initial treatment
The condition must be previously untreated, patient must have a WHO performance status of 0 or 1, and treatment must be in combination with first-line chemotherapy,
The treatment must not exceed a dose of 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks.

Compliance with Authority Required procedures


 
C4598
P4598
Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Treatment Phase: Initial treatment
The condition must be suboptimally debulked (maximum diameter of any gross residual disease greater than 1 cm), patient must have a WHO performance status of 2 or less,
and the condition must be previously untreated. The treatment must be commenced in combination with platinum-based chemotherapy, and must not exceed a dose of 7.5 mg per kg every 3 weeks, with a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer. The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 4598