National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 7) (No. PB 43 of 2013) (Cth)

PB 43 of 2013

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 7)

National Health Act 1953

___________________________________________________________________________

I, Steve Dunlop, Acting Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health and Medical Research, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.

Dated 25 July 2013

STEVE DUNLOP

Acting Assistant Secretary

Pharmaceutical Access Branch

Pharmaceutical Benefits Division

Department of Health and Ageing

___________________________________________________________________

1 Name of Instrument

(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No.7).

(2)This Instrument may also be cited as PB 43 of 2013.

2 Commencement

This Instrument commences on 1 August 2013.

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 Cabazitaxel in the form Concentrated injection 60mg (as acetone solvate) in 1.5 mL, with diluent with the manner of administration Injection

omit from the column headed “Circumstances”:

C4073 C4138

substitute:

C4237 C4262

Schedule 1 Part 1, entry for Docetaxel in the form Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent with the manner of administration Injection

omit from the column headed “Circumstances” (all instances):

C4155

insert after C4160 (all instances):

C4239

Schedule 1 Part 1, entry for Docetaxel in the form Powder for I.V. infusion 20 mg with solvent with the manner of administration Injection

omit from the column headed “Circumstances”:

C4155

insert after C4160:

C4239

Schedule 1 Part 1, entry for Docetaxel in the form Powder for I.V. infusion 80 mg with solvent with the manner of administration Injection

omit from the column headed “Circumstances”:

C4155

insert after C4160:

C4239

Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 140 mg in 7 mL with the manner of administration Injection

omit from the column headed “Circumstances”:

C4155

insert after C4160:

C4239

Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 160 mg in 16 mL with the manner of administration Injection

omit from the column headed “Circumstances”:

C4155

insert after C4160:

C4239

Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 1 mL with the manner of administration Injection

omit from the column headed “Circumstances” (all instances):

C4155

insert after C4160 (all instances):

C4239

Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL with the manner of administration Injection

omit from the column headed “Circumstances” (all instances):

C4155

insert after C4160 (all instances):

C4239

Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 4 mL with the manner of administration Injection

omit from the column headed “Circumstances” (all instances):

C4155

insert after C4160 (all instances):

C4239

[10]Schedule 1 Part 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL with the manner of administration Injection

omit from the column headed “Circumstances” (all instances):

C4155

insert after C4160 (all instances):

C4239

[11] Schedule 1 Part 1, entry for Gemcitabine in the form Powder for I.V. infusion 2 g (as hydrochloride) with manner of administration Injection

omit:

Gemcitabine Actavis
2000
WQ MP
D

[12] Schedule 1 Part 1, after entry for Ifosfamide

insert in the columns in the order indicated:

Ipilimumab

Injection concentrate for I.V. infusion 50 mg
in 10 mL

Injection concentrate for I.V. infusion 200 mg
in 40 mL

Injection

Yervoy

BQ

MP

C4235
C4236
C4251
C4252
C4254
C4256
C4261
C4265

D

[13] Schedule 1 Part 2, after entry for Ifosfamide

insert in the columns in the order indicated:

Ipilimumab	P4251 P4252 P4256 P4265	360	2
P4235 P4236 P4254 P4261	360	3

[14] Schedule 2, entry for "BCG Immunotherapeutic" (Bacillus Calmette-Guérin/ Connaught strain)

omit from the column headed “listed drug”:

"BCG Immunotherapeutic" (Bacillus Calmette-Guérin/ Connaught strain)

substitute:

Bacillus Calmette and Guerin, Connaught strain

[15] Schedule 2, entry for "BCG-Tice" (Bacillus Calmette-Guérin/ Tice strain)

omit from the column headed “listed drug”:

"BCG-Tice" (Bacillus Calmette-Guérin/ Tice strain)

substitute:

Bacillus Calmette and Guerin, Tice strain

[16] Schedule 4, entry for "BCG Immunotherapeutic" (Bacillus Calmette-Guérin/ Connaught strain)

omit from the column headed “listed drug”:

"BCG Immunotherapeutic" (Bacillus Calmette-Guérin/ Connaught strain)

substitute:

Bacillus Calmette and Guerin, Connaught strain

[17] Schedule 4, entry for "BCG-Tice" (Bacillus Calmette-Guérin/ Tice strain)

omit from the column headed “listed drug”:

"BCG-Tice" (Bacillus Calmette-Guérin/ Tice strain)

substitute:

Bacillus Calmette and Guerin, Tice strain

[18] Schedule 4, entry for Cabazitaxel

omit:

Cabazitaxel	C4073	Castration resistant metastatic carcinoma of the prostate The treatment must be in combination with prednisone or prednisolone, Patient must have failed treatment with docetaxel due to resistance or intolerance, Patient must have a WHO performance status of 2 or less.	Compliance with Written or Telephone Authority Required procedures Compliance with Electronic Authority Required procedures
C4138	Castration resistant metastatic carcinoma of the prostate The treatment must be in combination with prednisone or prednisolone, Patient must have failed treatment with docetaxel due to resistance or intolerance, Patient must have a WHO performance status of 2 or less.	Compliance with Authority Required procedures - Streamlined Authority Code 4138

substitute:

Cabazitaxel	C4237	Castration resistant metastatic carcinoma of the prostate The treatment must be in combination with prednisone or prednisolone, The treatment must not be used in combination with abiraterone, Patient must have failed treatment with docetaxel due to resistance or intolerance, Patient must have a WHO performance status of 2 or less, Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel.	Compliance with Authority Required procedures
C4262	Castration resistant metastatic carcinoma of the prostate: The treatment must be in combination with prednisone or prednisolone, The treatment must not be used in combination with abiraterone, Patient must have failed treatment with docetaxel due to resistance or intolerance, Patient must have a WHO performance status of 2 or less, Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel.	Compliance with Authority Required procedures - Streamlined Authority Code 4262

[19] Schedule 4, entry for Docetaxel

omit:

C4155 Androgen independent (castration resistant) metastatic carcinoma of the prostate
Patient must have a Karnofsky performance status score of at least 60%,
The treatment must be used as first‑line chemotherapy,
The treatment must be administered in three weekly cycles,
Patient must not receive more than 10 cycles of treatment with docetaxel under this restriction. Compliance with Authority Required procedures ‑ Streamlined Authority Code 4155

insert after C4160:

C4239 Androgen independent (castration resistant) metastatic carcinoma of the prostate
Patient must have a Karnofsky performance status score of at least 60%,
The treatment must be used as first‑line chemotherapy,
The treatment must be administered in three weekly cycles,
Patient must not receive more than 10 cycles of treatment with docetaxel under this restriction. Compliance with Authority Required procedures ‑ Streamlined Authority Code 4239

[20] Schedule 4, after entry for Ifosfamide

insert in the columns in the order indicated:

Ipilimumab C4235 P4235
Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
The treatment must be as monotherapy,
Patient must not have received prior treatment with ipilimumab,
The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
Compliance with Authority Required procedures

C4236 P4236
Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Unresectable Stage III or Stage IV malignant melanoma
Re-induction treatment
The treatment must be as monotherapy,
Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction),
The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
Compliance with Authority Required procedures

C4251 P4251
Where the patient is receiving treatment at/from a Public Hospital

Unresectable Stage III or Stage IV malignant melanoma
Completion of induction treatment
The treatment must be as monotherapy,
The treatment must be for completion of induction treatment in a patient who commenced induction treatment with ipilimumab prior to 1 August 2013,
The treatment must not exceed a total of 4 doses (combined PBS-subsidised and non-PBS-subsidised) at a maximum dose of 3 mg per kg every 3 weeks.
Compliance with Authority Required procedures - Streamlined Authority Code 4251

C4252 P4252
Where the patient is receiving treatment at/from a Public Hospital

Unresectable Stage III or Stage IV malignant melanoma
Completion of re-induction treatment
The treatment must be as monotherapy,
Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction) received prior to 1 August 2013,
The treatment must be for completion of re-induction treatment in a patient who commenced re-induction treatment with ipilimumab prior to 1 August 2013,
The treatment must not exceed a total of 4 doses (combined PBS-subsidised and non-PBS-subsidised) at a maximum dose of 3 mg per kg every 3 weeks.
Compliance with Authority Required procedures - Streamlined Authority Code 4252

C4254 P4254
Where the patient is receiving treatment at/from a Public Hospital

Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
The treatment must be as monotherapy,
Patient must not have received prior treatment with ipilimumab,
The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.

Compliance with Authority Required procedures - Streamlined Authority Code 4254

C4256 P4256
Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Unresectable Stage III or Stage IV malignant melanoma
Completion of re-induction treatment
The treatment must be as monotherapy,
Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction) received prior to 1 August 2013,
The treatment must be for completion of re-induction treatment in a patient who commenced re-induction treatment with ipilimumab prior to 1 August 2013,
The treatment must not exceed a total of 4 doses (combined PBS-subsidised and non-PBS-subsidised) at a maximum dose of 3 mg per kg every 3 weeks.
Compliance with Authority Required procedures

C4261 P4261
Where the patient is receiving treatment at/from a Public Hospital

Unresectable Stage III or Stage IV malignant melanoma
Re-induction treatment
The treatment must be as monotherapy,
Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction),
The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
Compliance with Authority Required procedures - Streamlined Authority Code 4261

C4265 P4265
Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Unresectable Stage III or Stage IV malignant melanoma
Completion of induction treatment
The treatment must be as monotherapy,
The treatment must be for completion of induction treatment in a patient who commenced induction treatment with ipilimumab prior to 1 August 2013,
The treatment must not exceed a total of 4 doses (combined PBS-subsidised and non-PBS-subsidised) at a maximum dose of 3 mg per kg every 3 weeks.
Compliance with Authority Required procedures

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Citations

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 7) (No. PB 43 of 2013) (Cth)

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Ipilimumab	C4235	P4235	Where the patient is receiving treatment in the community setting or at/from a Private Hospital Unresectable Stage III or Stage IV malignant melanoma Induction treatment The treatment must be as monotherapy, Patient must not have received prior treatment with ipilimumab, The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.	Compliance with Authority Required procedures
C4236	P4236	Where the patient is receiving treatment in the community setting or at/from a Private Hospital Unresectable Stage III or Stage IV malignant melanoma Re-induction treatment The treatment must be as monotherapy, Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction), The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.	Compliance with Authority Required procedures
C4251	P4251	Where the patient is receiving treatment at/from a Public Hospital Unresectable Stage III or Stage IV malignant melanoma Completion of induction treatment The treatment must be as monotherapy, The treatment must be for completion of induction treatment in a patient who commenced induction treatment with ipilimumab prior to 1 August 2013, The treatment must not exceed a total of 4 doses (combined PBS-subsidised and non-PBS-subsidised) at a maximum dose of 3 mg per kg every 3 weeks.	Compliance with Authority Required procedures - Streamlined Authority Code 4251
C4252	P4252	Where the patient is receiving treatment at/from a Public Hospital Unresectable Stage III or Stage IV malignant melanoma Completion of re-induction treatment The treatment must be as monotherapy, Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction) received prior to 1 August 2013, The treatment must be for completion of re-induction treatment in a patient who commenced re-induction treatment with ipilimumab prior to 1 August 2013, The treatment must not exceed a total of 4 doses (combined PBS-subsidised and non-PBS-subsidised) at a maximum dose of 3 mg per kg every 3 weeks.	Compliance with Authority Required procedures - Streamlined Authority Code 4252
C4254	P4254	Where the patient is receiving treatment at/from a Public Hospital Unresectable Stage III or Stage IV malignant melanoma Induction treatment The treatment must be as monotherapy, Patient must not have received prior treatment with ipilimumab, The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.	Compliance with Authority Required procedures - Streamlined Authority Code 4254
C4256	P4256	Where the patient is receiving treatment in the community setting or at/from a Private Hospital Unresectable Stage III or Stage IV malignant melanoma Completion of re-induction treatment The treatment must be as monotherapy, Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction) received prior to 1 August 2013, The treatment must be for completion of re-induction treatment in a patient who commenced re-induction treatment with ipilimumab prior to 1 August 2013, The treatment must not exceed a total of 4 doses (combined PBS-subsidised and non-PBS-subsidised) at a maximum dose of 3 mg per kg every 3 weeks.	Compliance with Authority Required procedures
C4261	P4261	Where the patient is receiving treatment at/from a Public Hospital Unresectable Stage III or Stage IV malignant melanoma Re-induction treatment The treatment must be as monotherapy, Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction), The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.	Compliance with Authority Required procedures - Streamlined Authority Code 4261
C4265	P4265	Where the patient is receiving treatment in the community setting or at/from a Private Hospital Unresectable Stage III or Stage IV malignant melanoma Completion of induction treatment The treatment must be as monotherapy, The treatment must be for completion of induction treatment in a patient who commenced induction treatment with ipilimumab prior to 1 August 2013, The treatment must not exceed a total of 4 doses (combined PBS-subsidised and non-PBS-subsidised) at a maximum dose of 3 mg per kg every 3 weeks.	Compliance with Authority Required procedures