National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 12) (No. PB 93 of 2013)

Link to law: https://www.comlaw.gov.au/Details/F2013L02195

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PB 93 of 2013
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 12)
 
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 20 December 2013
 
 
 
 
 
 
 
 
 
 
 
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 2013 (No.12).
 
(2)                This Instrument may also be cited as PB 93 of 2013.
 
2             Commencement
                This Instrument commences on 1 January 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 2, entry for Aprepitant:
omit:
                                                                                                                 
Pack containing 1 capsule 125 mg and 2 capsules 80 mg
Oral
Emend
MK
EMP
C3619 C3620 C3621
 
1
5

Capsule 165 mg
Oral
Emend
MK
EMP
C4216
C4217
C4223
 
1
5
 
 

insert:
 
 
 
 
 
 
 
 
 

Capsule 165 mg
Oral
Emend
MK
EMP
C4216
C4217
C4223
 
1
5
 
 
 

         Schedule 4, after the entry for Aprepitant:
omit:
 
C3619
 
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy, in combination with a 5‑hydroxytryptamine type 3 receptor antagonist and dexamethasone, where any 1 of the following chemotherapy agents are to be administered:
(a) altretamine;
(b) carmustine;
(c) cisplatin, when a single dose constitutes a cycle of chemotherapy;
(d) cyclophosphamide, at a dose of 1500 mg per square metre per day or greater;
(e) dacarbazine;
(f) procarbazine, when a single dose constitutes a cycle of chemotherapy;
(g) streptozocin; and
where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy
 
 
Compliance with Authority Required procedures – Streamlined Authority Code 3619

 
C3620
 
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat breast cancer, in combination with a 5‑hydroxytryptamine type 3 receptor antagonist and dexamethasone, where cyclophosphamide and an anthracycline are to be co‑administered, and where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy
Compliance with Authority Required procedures – Streamlined Authority Code 3620
 
C3621
 
Management of nausea and vomiting associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy, in combination with a 5‑hydroxytryptamine type 3 receptor (5HT3) antagonist and dexamethasone on day 1, where the patient has had a prior episode of chemotherapy induced nausea or vomiting where any 1 of the following intravenous chemotherapy agents is to be administered:
(a) arsenic trioxide;
(b) azacitidine;
(c) carboplatin;
(d) cyclophosphamide, at a dose of less than 1500 mg per square metre per day;
(e) cytarabine, at a dose of greater than 1 g per square metre per day;
(f) dactinomycin;
(g) daunorubicin;
(h) doxorubicin;
(i) epirubicin;
(j) fotemustine;
(k) idarubicin;
(l) ifosfamide;
(m) irinotecan;
(n) melphalan;
(o) methotrexate, at a dose of 250 mg to 1 g per square metre;
(p) oxaliplatin;
(q) raltitrexed; and
where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy, and where concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle
Compliance with Authority Required procedures ‑ Streamlined Authority
Code 3621