National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 7) (PB 56 of 2014) (Cth)

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

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

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

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

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

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

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

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

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

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

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Citations

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 7) (PB 56 of 2014) (Cth)

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Bevacizumab	P4589	900	5
P4598
P4584	900	11
P4585
P4587 P4588 P4594 P4597

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

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