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

Link to law: https://www.comlaw.gov.au/Details/F2013L01453

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now
 
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
 
 
[1]    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
[2]    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
 
[3]    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
 
[4]    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
 
 
 
[5]    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
 
[6]    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
 
[7]    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
 
[8]    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
 
[9]    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
 
 
 
 
 
 
 
 
Injection
Yervoy
 
 
 
 
 
 
 
 
Yervoy
BQ
 
 
 
 
 
 
 
 
BQ
MP
 
 
 
 
 
 
 
 
MP
C4235
C4236
C4251
C4252
C4254
C4256
C4261
C4265
 
C4235       
C4236
C4251
C4252
C4254
C4256
C4261
C4265
 
D
 
 
 
 
 
 
 
 
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