National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 5) (PB 51 of 2015) (Cth)

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

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
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
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

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

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

Schedule 1, Part 2 entry for Bevacizumab:
substitute:

Bevacizumab P4584 900 11

P4587

P4594

P4939

C4968

P4814 900 5

Schedule 1, Part 2 entry for Cetuximab:
substitute:

Cetuximab P4785 880 0

P4794

P4908

P4965

P4788 550 5

P4912 550 18

P4945 550 11

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

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

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National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 5) (PB 51 of 2015) (Cth)

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Solution concentrate for I.V. infusion 80 mg in 4 mL	Injection	Oncotaxel 80	GN	MP	D
Taxotere	SW	MP	D

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

Cetuximab	P4785	880	0
P4794 P4908
P4965
P4788	550	5
P4912	550	18
P4945	550	11

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

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