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National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 9) (No. PB 64 of 2013)

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PB 64 of 2013
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 9)
 
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      23 September 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.9).
 
(2)                This Instrument may also be cited as PB 64 of 2013.
 
2             Commencement
                This Instrument commences on 1 October 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 Bleomycin in the form Powder for injection containing bleomycin sulfate 15,000 I.U. and brand Bleo 15K:
omit from the column headed “Responsible Person”: WQ              substitute: GN
 
         Schedule 1 Part 1 entry for Carboplatin in each of the forms: Solution for I.V. injection 150 mg in 15 mL; Solution for I.V. injection 450 mg in 45 mL; and Solution for I.V. injection 50 mg in 5 mL and brand Carbaccord:
omit from the column headed “Responsible Person”: WQ              substitute: GN
 
         Schedule 1 Part 1 entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 ml single dose vial and brand Accord Doxorubicin:
omit from the column headed “Responsible Person”: WQ              substitute: GN
 
         Schedule 1 Part 1 entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 ml single dose vial and brand Accord Doxorubicin:
omit from the column headed “Responsible Person”: WQ              substitute: GN
 
         Schedule 1 Part 1 entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL and brand Epiccord:
omit from the column headed “Responsible Person”: WQ              substitute: GN
 
         Schedule 1 Part 1 entry for Epirubicin in each of the forms: Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL; Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL; and Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL and brand Epiccord:
omit from the column headed “Responsible Person”: WQ              substitute: GN
 
         Schedule 1 Part 1 entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg and brand Farine:
omit from the column headed “Responsible Person”: WQ              substitute: GN
 
 
 
 
 
 
         Schedule 1 Part 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride) with manner of administration Injection:
(a)   omit:
AS‑Gemcitabine
YA
MP
 
D
 
 
(b)   omit from the column headed “Responsible Person” for the brand “Gemaccord”: WQ                              substitute: GN
(c)   omit from the column headed “Responsible Person” for the brand “Gemcitabine Actavis”:WQ               substitute: GN
(d)   omit from the column headed “Responsible Person” for the brand “Gemplan”: WQ                                  substitute: GN
 
         Schedule 1 Part 1, entry for Gemcitabine in the form Powder for I.V. infusion 2 g (as hydrochloride) with manner of administration Injection:
(a)   omit:
AS‑Gemcitabine
YA
MP
 
D
 
 
(b) omit from the column headed “Responsible Person” for the brand “Gemcitabine Actavis 2000”: WQ   substitute: GN
 
                                                      Schedule 1 Part 1, after entry for Gemcitabine in the form Powder for I.V. infusion 200 mg  (as hydrochloride) with manner of administration Injection:
(a)   omit:
AS‑Gemcitabine
YA
MP
 
D
(b)   omit from the column headed “Responsible Person” for the brand “Gemaccord”: WQ                              substitute: GN
(c)   omit from the column headed “Responsible Person” for the brand “Gemcitabine Actavis”: WQ              substitute: GN
(d)   omit from the column headed “Responsible Person” for the brand “Gemplan”: WQ                                  substitute: GN
 
                                                      Schedule 1 Part 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL:
           (a) omit from the column headed “Responsible Person” for the brand “Irinoccord”: WQ                                substitute: GN
          (b) omit from the column headed “Responsible Person” for the brand “Tecan”: WQ                                        substitute: GN
 
                                                      Schedule 1 Part 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL:
           (a) omit from the column headed “Responsible Person” for the brand “Irinoccord”:WQ                                 substitute: GN
          (b) omit from the column headed “Responsible Person” for the brand “Tecan”: WQ                                        substitute: GN
 
                                                      Schedule 1 Part 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL:
 omit from the column headed “Responsible Person” for the brand “Tecan”: WQ                                               substitute: GN
 
         Schedule 1 Part 1 entry for Methotrexate in each of the forms: Injection 50 mg in 2 mL vial; Solution concentrate for I.V. infusion 1000 mg in 10 mL vial and brand Methaccord:
omit from the column headed “Responsible Person”: WQ              substitute: GN
 
         Schedule 1 Part 1 entry for Oxaliplatin in each of the forms: Powder for I.V. infusion 100 mg; Powder for I.V. infusion 50 mg and brand Xalox:
omit from the column headed “Responsible Person”: WQ              substitute: GN
 
         Schedule 1 Part 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL with manner of administration Injection:
           (a)    omit:
AS‑Oxaliplatin
YA
MP
C3900 C3901 C3930 C3939
D
          (b)    omit from the column headed “Responsible Person” for the brand “Oxaliccord”: WQ                substitute: GN
 
         Schedule 1 Part 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 200 mg in 40 mL with manner of administration Injection:
omit:
AS‑Oxaliplatin
YA
MP
C3900 C3901 C3930 C3939
 
D
         Schedule 1 Part 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 50 mg in 10 mL with manner of administration Injection:
           (a)    omit:
AS‑Oxaliplatin
YA
MP
C3900 C3901 C3930 C3939
D
          (b)    omit from the column headed “Responsible Person” for the brand “Oxaliccord”: WQ                substitute: GN
 
 
 
 
         Schedule 1 Part 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 100 mg in 16.7 mL with manner of administration Injection:
           (a)    omit:
GN‑Paclitaxel
YA
MP
C3186 C3890 C3902 C3917 C3955 C3956
D
          (b)    omit from the column headed “Responsible Person” for the brand “Plaxel”: WQ            substitute: GN
 
          Schedule 1 Part 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 150 mg in 25 mL and brand Plaxel
omit from the column headed “Responsible Person: WQ                substitute: GN
 
         Schedule 1 Part 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 30 mg in 5 mL with manner of administration Injection:
           (a)    omit:
GN‑Paclitaxel
YA
MP
C3186 C3890 C3902 C3917 C3955 C3956
D
          (b)    omit from the column headed “Responsible Person” for the brand “Plaxel”: WQ            substitute:      GN
 
         Schedule 1 Part 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL with manner of administration Injection:
           (a)    omit:
GN‑Paclitaxel
YA
MP
C3186 C3890 C3902 C3917 C3955 C3956
D
          (b)    omit from the column headed “Responsible Person” for the brand “Plaxel”: WQ            substitute: GN
 
         Schedule 1 Part 1, entry for Vinorelbine in the form Solution concentrate for I.V. infusion 10 mg (as tartrate) in 1 mL with manner of administration Injection:
omit:
AS‑Vinorelbine
YA
MP
C3890 C3907
 
PB
 
         Schedule 1 Part 1, entry for Vinorelbine in the form Solution concentrate for I.V. infusion 50 mg (as tartrate) in 5 mL with manner of administration Injection:
omit:
AS‑Vinorelbine
YA
MP
C3890 C3907
PB
 
 
[25] Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg and brand Onsetron ODT 4:
omit from the column headed “Responsible Person”: WQ              substitute: GN
 
[26] Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg and brand Onsetron ODT 8:
omit from the column headed “Responsible Person”: WQ              substitute: GN
 
[27] Schedule 3, after the entry for the code GK:
 (a)   omit:
GM
Ascent Pharma Pty Ltd
 68 118 734 795
(b)   insert:
GN
Actavis Pty Ltd
 17 003 854 626
 
[28] Schedule 3, after the entry for TX:
omit:
WQ
Willow Pharmaceuticals Pty Ltd
 80 118 534 704