National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 1) (PB 4 of 2015)

Link to law: https://www.comlaw.gov.au/Details/F2015L00083

 
PB 4 of 2015
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 1)
 
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   28  January 2015
 
 
 
 
 
 
 
 
 
 
 
 
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 2015 (No.1).
 
(2)                This Instrument may also be cited as PB 4 of 2015.
2             Commencement
                This Instrument commences on 1 February 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
 
[1]     Schedule 1 Part 1 entry for ‘Arsenic’ in the form ‘Injection concentrate containing arsenic trioxide 10 mg in 10 mL’ with manner of administration Injection:
omit from the column headed ‘Circumstances’: C3150 C3891
insert in the column headed ‘Circumstances’: C4793
[2]     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:
omit from the column headed ‘Circumstances’ (all instances): C4585 C4588 C4589 C4597
[3]     Schedule 1 Part 1 entry for ‘Cabazitaxel’ in the form ‘Concentrated injection 60 mg (as acetone solvate) in 1.5 mL, with diluent’ with manner of administration Injection:
omit from the column headed ‘Circumstances’: C4661
[4]     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): C2713 C2714 C2715 C3919 C3920 C3921 C4775 C4780
insert in the column headed ‘Circumstances’ (all instances): C4785 C4788 C4794
[5]     Schedule 1 Part 1 entry for ‘Doxorubicin – Pegylated Liposomal’ in each of the forms ‘Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL’ and ‘Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL’ with manner of administration Injection:
omit from the column headed ‘Circumstances’ (all instances): C1568 C1795 C1796 C3905 C3910 C3911
insert in the column headed ‘Circumstances’ (all instances): C4786 C4787 C4791
[6]     Schedule 1 Part 1 entry for ‘Ipilimumab’ in each of the forms ‘Injection concentrate for I.V. infusion 50 mg in 10 mL’ and ‘Injection concentrate for I.V. infusion 200 mg in 40 mL’ with manner of administration Injection:
omit from the column headed ‘Circumstances’ (all instances): C4235 C4236 C4256 C4265
[7]     Schedule 1 Part 1 after the entry for ‘Irinotecan’ in the form ‘I.V injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL’ with manner of administration Injection and brand ‘Irinotecan Kabi’:
insert:
Irinotecan MYX
YN
MP
 
D
[8]     Schedule 1 Part 1 after the entry for ‘Methotrexate’ in the form ‘Injection 50 mg in 2 mL vial’ with manner of administration Injection and brand ‘Methaccord’:
insert:
Methotrexate MYX
YN
MP
 
D
[9]     Schedule 1 Part 1 after the entry for ‘Methotrexate’ in the form ‘Solution concentrate for I.V. infusion 1000 mg in 10 mL vial’ with manner of administration Injection and brand ‘Methotrexate Ebewe’:
insert:
Methotrexate MYX
YN
MP
 
D
[10]  Schedule 1 Part 1 after the entry for ‘Oxaliplatin’ in the form ‘Solution concentrate for I.V. infusion 100 mg in 20 mL’ with manner of administration Injection and brand ‘Oxaliplatin Kabi’:
insert:
Oxaliplatin MYX
YN
MP
 
D
[11]  Schedule 1 Part 1 entry for ‘Panitumumab’ in each of the forms ‘Solution concentrate for I.V. infusion 100 mg in 5 mL’ and ‘Solution concentrate for I.V. infusion 400 mg in 20 mL’ with manner of administration Injection:
omit from the column headed ‘Circumstances’ (all instances): C4774 C4776
[12]  Schedule 1 Part 1 entry for ‘Pemetrexed’ in each of the forms ‘Powder for I.V. infusion 100 mg (as disodium heptahydrate)’ and ‘Powder for I.V. infusion 500 mg (as disodium heptahydrate)’ with manner of administration Injection:
omit from the column headed ‘Circumstances’ (all instances): C2957 C2958 C3885 C3886
insert in the column headed ‘Circumstances’ (all instances): C4789 C4792
[13]  Schedule 1 Part 1 entry for ‘Rituximab’ in each of the forms ‘Solution for I.V. infusion 100 mg in 10 mL’ and ‘Solution for I.V. infusion 500 mg in 50 mL’ with manner of administration Injection:
omit from the column headed ‘Circumstances’ (all instances): C4671 C4679 C4687 C4727 C4728 C4752 C4765
[14]  Schedule 1, Part 2 entry for Bevacizumab:
substitute:
Bevacizumab
 
 
 

 
P4598
900
5

 
P4584
900
11

 
P4587
 
 

 
P4594
 
 

[15]  Schedule 1, Part 2 entry for Cetuximab:
substitute:
Cetuximab
P4771
550
11

 
P4788
550
5

 
P4779
880
0

 
P4785
 
 

 
P4794
 
 

 
 
[16]  Schedule 1, Part 2 entry for Rituximab:
substitute:
Rituximab
P4686
800
7

 
P4701
 
 

 
P4726
 
 

 
P4677
800
3

 
P4678
 
 

 
P4706
1100
5

 
P4674
800
11

[17]  Schedule 4, entry for Arsenic:
substitute:
C4793
Acute promyelocytic leukaemia. Treatment Phase: Induction and consolidation treatment. The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript, the condition must be relapsed, and the patient must be arsenic naive at induction.
Compliance with Authority Required procedures - Streamlined Authority Code 4793
 
[18]  Schedule 4, entry for Bevacizumab:
omit:
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

 

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

 

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

 

 
[19]  Schedule 4, entry for Cabazitaxel:
omit:
C4661
 
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

 
 
[20]  Schedule 4, entry for Cetuximab:
substitute:
Cetuximab
C4771
P4771
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. Patient must not have progressive disease, treatment must be as monotherapy; or treatment must be in combination with an irinotecan based therapy. 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 4771


 
C4779
P4779
Metastatic colorectal cancer. Treatment Phase: Initial treatment
Patient must have RAS wild-type metastatic colorectal cancer, and must have a WHO performance status of 2 or less. The condition must have failed to respond to first-line chemotherapy, treatment must be as monotherapy; or in combination with an irinotecan based therapy, and 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 4779


 
C4785
P4785
Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx. Treatment Phase: Initial treatment. 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. Treatment must be in combination with radiotherapy. 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. Treatment must be for the week prior to radiotherapy.
Patient must have a contraindication to cisplatin according to the TGA-approved Product Information.
Compliance with Authority Required procedures - Streamlined Authority Code 4794

 
[21]  Schedule 4, entry for Doxorubicin – Pegylated Liposomal:
substitute:
Doxorubicin - pegylated liposomal
C4786
P4786
Advanced epithelial ovarian cancer. Patient must have failed a first-line platinum-based chemotherapy regimen.
Compliance with Authority Required procedures - Streamlined Authority Code 4786

 
C4787
P4787
Metastatic breast cancer. Treatment must be as monotherapy. Patient must have a contraindication to therapy with capecitabine and/or a taxane.

Compliance with Authority Required procedures - Streamlined Authority Code 4787

 
C4791
P4791
Metastatic breast cancer. Treatment must be as monotherapy. Patient must have failed prior therapy which included capecitabine and a taxane.

Compliance with Authority Required procedures - Streamlined Authority Code 4791

[22]  Schedule 4, entry for Ipilimumab:
substitute:
Ipilimumab
C4251
P4251
Unresectable Stage III or Stage IV malignant melanoma. Treatment Phase: Completion of induction treatment. Treatment must be as monotherapy, and must be for completion of induction treatment in a patient who commenced induction treatment with ipilimumab prior to 1 August 2013. 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. The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. For patients who commenced induction treatment with ipilimumab prior to 1 August 2013 prescribers should request the appropriate number of repeats to provide a total of 4 doses of ipilimumab (combined PBS-subsidised and non-PBS subsidised).
Compliance with Authority Required procedures - Streamlined Authority Code 4251


 
C4252
P4252
Unresectable Stage III or Stage IV malignant melanoma. Treatment Phase: Completion of re-induction treatment. 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. Treatment must be for completion of re-induction treatment in a patient who commenced re-induction treatment with ipilimumab prior to 1 August 2013, and 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.
An initial objective response to treatment is defined as either:
(i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or
(ii) a partial or complete response.
The patient's body weight must be documented in the patient's medical records at the time treatment with ipilimumab is initiated. For patients who commenced re-induction treatment with ipilimumab prior to 1 August 2013 prescribers should request the appropriate number of repeats to provide a maximum of 4 doses of ipilimumab (combined PBS-subsidised and non-PBS-subsidised).
Compliance with Authority Required procedures - Streamlined Authority Code 4252


 
C4254
P4254
Unresectable Stage III or Stage IV malignant melanoma. Treatment Phase: Induction treatment
Treatment must be as monotherapy, and must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks. Patient must not have received prior treatment with ipilimumab,
and the patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
Compliance with Authority Required procedures - Streamlined Authority Code 4254


 
C4261
P4261
Unresectable Stage III or Stage IV malignant melanoma. Treatment Phase: Re-induction treatment
Treatment must be as monotherapy, and must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks. Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction).
An initial objective response to treatment is defined as either:
(i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or
(ii) a partial or complete response.
The patient's body weight must be documented in the patient's medical records at the time treatment with ipilimumab is initiated.
Compliance with Authority Required procedures - Streamlined Authority Code 4261


 
[23]  Schedule 4, entry for Panitumumab:
substitute:
Panitumumab
C4783
 
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 must not have progressive disease. Treatment must be as monotherapy; or in combination with an irinotecan based therapy. Treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition. Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab. Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.
Compliance with Authority Required procedures - Streamlined Authority Code 4783


 
C4784
 
Metastatic colorectal cancer. Treatment Phase: Initial treatment. Patient must have RAS wild-type metastatic colorectal cancer, and have a WHO performance status of 2 or less. The condition must have failed to respond to first-line chemotherapy. Treatment must be as monotherapy; or in combination with an irinotecan based therapy. Treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition. Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab. Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.
Compliance with Authority Required procedures - Streamlined Authority Code 4784


[24]  Schedule 4, entry for Pemetrexed:
substitute:
Pemetrexed
C4789
 
Mesothelioma. Treatment must be in combination with cisplatin. The patient's body surface area (BSA) must be documented in the patient's medical records at the time the treatment cycle is initiated. Doses greater than 500 mg per metre squared BSA are not PBS-subsidised.
Compliance with Authority Required procedures - Streamlined Authority Code 4789

 
C4792
 
Locally advanced or metastatic non-small cell lung cancer. Patient must have received prior treatment with platinum-based chemotherapy. The patient's body surface area (BSA) must be documented in the patient's medical records at the time the treatment cycle is initiated. Doses greater than 500 mg per metre squared BSA are not PBS-subsidised
Compliance with Authority Required procedures - Streamlined Authority Code 4792

[25]  Schedule 4, entry for Rituximab:
substitute:
Rituximab
C4674
P4674
Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma. Treatment Phase: Maintenance therapy. Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application, and must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction. Treatment must be maintenance therapy.
Compliance with Authority Required procedures - Streamlined Authority Code 4674


 
C4677
P4677
Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma. Treatment Phase: Re-induction treatment. Treatment must be for re-induction treatment purposes only, and the condition must have relapsed or be refractory to treatment. Patient must not receive more than 4 doses under this restriction.
Compliance with Authority Required procedures - Streamlined Authority Code 4677

 
C4678
P4678
Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma. Treatment Phase: Re-induction treatment
The treatment must be for re-induction treatment purposes only, and the condition must have relapsed or be refractory to treatment. Patient must not receive more than 4 doses under this restriction.
Compliance with Authority Required procedures - Streamlined Authority Code 4678

 
C4686
P4686
Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma. Treatment Phase: Maintenance therapy. Treatment must be maintenance therapy.  Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application, andmust not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.
Compliance with Authority Required procedures - Streamlined Authority Code 4686


 
C4701
P4701
Previously untreated CD20 positive diffuse large B-cell non-Hodgkin's lymphoma. Treatment Phase: Induction treatment. Treatment must be in combination with chemotherapy.The condition must be previously untreated, must be symptomatic, and must be for induction treatment purposes only. Patient must not receive more than 8 doses under this restriction.
Compliance with Authority Required procedures - Streamlined Authority Code 4701

 
C4706
P4706
Chronic lymphocytic leukaemia (CLL). The condition must be CD20 positive chronic lymphocytic leukaemia (CLL), and treatment must be in combination with chemotherapy.

Compliance with Authority Required procedures - Streamlined Authority Code 4706

 
C4726
P4726
Previously untreated Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma. Treatment Phase: Induction treatment. Treatment must be in combination with chemotherapy. The condition must be previously untreated, must be symptomatic, and must be for induction treatment purposes only. Patient must not receive more than 8 doses under this restriction.
Compliance with Authority Required procedures - Streamlined Authority Code 4726

 
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