National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (PB 31 of 2015)

Link to law: https://www.comlaw.gov.au/Details/F2015L00434

 
PB 31 of 2015
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 20151
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   27 March 2015
 
 
KIM BESSELL
Assistant Secretary
Pharmaceutical Access Branch
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.
(2)     This instrument may also be cited as PB 31 of 2015.
2              Commencement
                This instrument commences on 1 April 2015.
3              Amendment
                Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Schedule 1—Amendments
[1]   Section 3 (definition of authority prescription)
Repeal the definition, substitute:
authority prescription means a prescription that has been authorised:
                     (a)  in accordance with regulation 13 of the Regulations as modified by this Special Arrangement; or
                     (b)  in accordance with Division 3 of Part 2 of this Special Arrangement.
[2]   Section 3
Insert the definition:
eligible private hospital patient means an eligible patient who is receiving treatment at or from a private hospital.
[3]   Section 3 (definition of infusion medication chart)
Repeal the definition, substitute:
infusion medication chart prescription means a medication chart directing the supply of an infusion.
[4]   Section 3 (definition of medication chart prescription)
Insert the definition:
medication chart prescription has the meaning given by the Regulations, but does not include a medication chart prescription for a person receiving treatment in a residential care service.
[5]   Section 3 (definition of non-approved public hospital authority)
Repeal the definition.
[6]   Section 3
          Insert the definition:
                 residential care service has the meaning given by the Regulations.
[7]   Section 3 (definition of Streamlined Authority Code)
Repeal the definition.
[8]   Section 3 (notes under definition of supplier and definition of under co-payment data)
Repeal the notes under these definitions.
[9]   Section 3 (after definition under co-payment data)
Omit the note, and substitute:
Note:          Terms used in this Special Arrangement have the same meaning as in the Act—see section 13 of the Legislative Instruments Act 2003.  These terms include:
·      approved hospital authority
·      approved medical practitioner
·      approved pharmacist
·      approved supplier
·      pharmaceutical benefit
·      pharmaceutical item
·      public hospital authority.
[10]   Subsection 9(2)
After “infusion medication chart” insert “prescription”.
[11]   Subsection 10(1)
Repeal the subsection.
[12]  Subsection 10(2)
Omit “or medication chart”.
[13]  Subsection 11(2)
After “infusion medication chart” insert “prescription”.
[14]  Subsection 12(1)
Repeal the subsection.
[15]  Subsection 12(2)
Omit “or medication chart”.
[16]  Paragraph 14(1)(b)
Repeal this paragraph , substitute:
                     (b)  preparing an infusion medication chart prescription for an infusion that includes the chemotherapy drug in the chemotherapy pharmaceutical benefit, in accordance with regulation 19AA of the Regulations as modified by section 16.
 
 
[17]  Subsections 14(2), (3) and (4)
Repeals these subsections, substitute:
             (2) However, an infusion medication chart prescription may only be prepared for an eligible public hospital patient or eligible private hospital patient.
             (3)  However, chemotherapy pharmaceutical benefits containing the following chemotherapy drugs may only be prescribed by writing an infusion prescription:
                     (a)  bortezomib;
                     (b)  trastuzumab.
             (4)  An infusion prescription written in accordance with section 15 or an infusion medication chart prescription written in accordance with section 16 is taken to be a duly written prescription for regulation 19 or 19AA of the Regulations.
             (5)  Paragraph 19(2)(a) of the Regulations does not apply to an infusion prescription.
                         Note: Regulation 19AA does not prohibit same day prescribing for infusion medication chart prescriptions.
[18]  Section 15
Repeal the heading, substitute:
15 Information to be included in infusion prescription, other than infusion medication chart prescriptions.
[19]  Paragraphs 15(2)(c) and (d)
Repeal the paragraphs, substitute:
                     (c)  if supply of the infusion is to be repeated—the number of times it is to be repeated.
[20]  Section 16
Repeal the section, substitute:
16 Information to be included in infusion medication chart prescription
             (1)  For paragraph 14(1)(b) this section modifies the requirements of regulation 19AA of the Regulations.
             (2)  An infusion medication chart prescription must include the following information:
                     (a)  the name of each chemotherapy drug included in the infusion; and
                     (b)  for each chemotherapy drug – the dose, the frequency of administration and the route of administration.
             (3)  An infusion medication chart prescription does not need to include the form of the chemotherapy drug supplied.
Note:    If the medication chart includes information about the form or brand of a chemotherapy drug to be supplied, or the quantity, number of units or number of repeats of a particular pharmaceutical benefit to be supplied, a supplier is not required to follow the prescriber’s directions except if they relate to the method of administering the chemotherapy drug—see section 33.
[21]  Paragraphs 17(1)(a) and (b)
Repeal the paragraphs, substitute:
(a)    for an infusion prescription written in accordance with paragraph 14(1)(a); or
(b)   for an infusion medication chart prescription written in accordance with paragraph 14(1)(b),
the prescription must be authorised in accordance with the procedures set out in regulation 13 of the Regulations as modified by subsection (2).
[22]  Paragraphs 17(3)(a) and (b)
Repeal the paragraph, substitute:
(a)    for an infusion prescription written in accordance with paragraph 14(1)(a); or
(b)   for an infusion medication chart prescription written in accordance with paragraph 14(1)(b),
the prescription must be authorised in accordance with the procedures set out in regulation 13 of the Regulations as modified by subsection (4).
[23]  Subsection 18(1)
After “infusion medication chart” insert “prescription”.
[24]  Subsection 18(3)
After “infusion medication chart” insert “prescription”.
[25]  Paragraph 19(1)(b)
Repeal the paragraph, substitute:
                     (b)  writing a medication chart prescription for the related pharmaceutical benefit in accordance with regulation 19AA of the Regulations.
[26]  Subsection 19(2)
Repeal the subsection.
[27]  Section 20
Repeal the section.
[28]  Section 21
Repeal the section.
[29]  Subsection 22(1)
After “infusion medication chart” insert “prescription”.
[30]  Subsection 22(2)
Omit “or medication chart”, substitute “(including a medication chart prescription)”.
[31]  Subsection 22(3)
Repeal the subsection, substitute:
             (3)  The authority required procedures set out in sections 11 to 14 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 are to be followed.
Note:            See section 14 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 for Streamlined Authority Code.
[32]  Subsection 22(4)
Repeal the subsection, substitute:
             (4)  In addition to the requirements of subsection (3) where ‘Compliance with modified Written Authority Required procedures’  appears in the circumstances mentioned in Schedule 4 for the code, any other requirement included in the circumstances is to be followed as part of the authority required procedures. 
Example:  The circumstances in Schedule 4 may require additional documents to be submitted along with the prescription.
[33]  Subsection 22(5)
Repeal the subsection.
[34]  Section 23
Repeal the section.
[35]  Section 24
Repeal the section.
[36]  Section 25
Repeal the section.
[37]  Section 26
Repeal the section.
[38]  Section 27
Repeal the section.
[39]  Section 28
Repeal the section.
[40]  Section 29
Repeal the section.
[41]  Paragraph 31(1)(c)
After “hospital;” insert “or”.
[42]  Subsection 31(3)
Repeal the subsection, substitute:
             (3)  However, an infusion medication chart prescription cannot be supplied by:
                     (a)  an approved medical practitioner;  or
                     (b)  a public hospital authority that is not a participating hospital authority. 
[43]  Subsection 33(1)
After “infusion medication chart” insert “prescription”.
[44]  Subsection 33(2)
After “infusion medication chart” insert “prescription”.
[45]  Subsection 33(3)
After “infusion medication chart” insert “prescription”.
[46]  Subsection 33(6) note
In the note after “each chemotherapy drug and” insert “for an infusion prescription”.
[47]  Subsection 33(7)
After “infusion medication chart” insert “prescription”.
[48]  Subsection 33(7) note
Omit the note.
[49]  Subsection 34(3)
Omit “infusion” insert “infusion for an infusion prescription”.
[50]  After subsection 34(3)
Insert:
Note: Regulations 24 and 26A already do not apply to infusion medication chart prescriptions.
[51]  Subsection 34(5)
Repeal the subsection and subheading.
[52]  Section 35
Repeal the section.
[53]  Subsection 36(2)
Repeal the subsection.
[54]  Section 38
Repeal the section.
[55]  Paragraph 39(c)(iii)
Repeal the paragraph.
[56]  Paragraph 39(d) (note)
Repeal the note.
[57]  Section 40
Repeal the section.
[58]  Section 44
Repeal the section.
[59]  Subsection 52(1)
After “to an eligible” insert “public hospital”.
[60]  Section 56
Repeal the section.
[61]  Subsection 57(1)
Omit “eligible patient” insert “eligible public hospital patient”.
[62]  Subsection 57(2)
Omit “eligible patient” insert “eligible public hospital patient”.
[63]  Subsection 57(3)
Omit “eligible patient” insert “eligible public hospital patient”.
[64]  Paragraph 59(c)
Repeal the paragraph.
[65]  Section 60
Repeal the section, substitute:
60    Transitional provisions for existing medication chart prescribing
             (1)  An authorised prescriber may prescribe a pharmaceutical benefit for an eligible public hospital patient by writing:
(a)     an infusion medication chart, or
(b)   a medication chart,
                             before 1 April 2017, by following the requirements for prescribing from an infusion medication chart or medication chart in the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 as in force immediately before 1 April 2015.
             (2)  A participating hospital authority can supply a pharmaceutical benefit prescribed under subsection (1).
             (3)  The provisions for prescribing, supplying and claiming from an infusion medication chart or medication chart set out in the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 as in force immediately before 1 April 2015, continue to apply in relation to an infusion medication chart or a medication chart written under subsection (1).
             (4)  However, this section does not apply if the participating hospital authority referred to in subsection (2) is a listed approved hospital under regulation 59 of the Regulations and supplying from infusion medication chart prescriptions under this Special Arrangement.
             (5)  If this section applies, the supply certification referred to in subrule 5(1A) of the rules made under subsections 98AC(4) and 99AAA(8) of the Act is allowed, and then required, as indicated in transitional rule 12 of those rules. 
 
[66]  Schedule 1 Part 1 entry for ‘Docetaxel’ in the form ‘Solution concentrate for I.V. infusion 20 mg in 1 mL’ with manner of administration Injection:
substitute:
Solution concentrate for I.V. infusion 20 mg in 1 mL
Injection
Dotax
RZ
MP
D
 

 
 
Taxotere
SW
MP
D
 

[67]  Schedule 1 Part 1 entry for ‘Docetaxel’ in the form ‘Solution concentrate for I.V. infusion 20 mg in 2 mL’ with manner of administration Injection:
omit :
Docetaxel Sandoz
SZ
MP
 
D
 
 
[68]  Schedule 1 Part 1 after the entry for ‘Docetaxel’ in the form ‘Solution concentrate for I.V. infusion 80 mg in 4 mL’ with manner of administration Injection:
substitute:
Solution concentrate for I.V. infusion 80 mg in 4 mL
Injection
Dotax
RZ
MP
D
 

 
 
Oncotaxel 80
GN
MP
D
 

 
 
Taxotere
SW
MP
D
 

[69]  Schedule 1 Part 1, entry for ‘Doxorubicin’ in the forms ‘Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial’; ‘Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial’;  and ‘Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial’ with manner of administration Injection/intravesical:
omit :
Doxorubicin Ebewe
SZ
MP
 
D
[70]  Schedule 1 Part 1, entry for ‘Epirubicin’ in the forms ‘Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL’; ‘Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL’;  ‘Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL’; and ‘Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL’ with manner of administration Injection/intravesical:
omit :
Epirubicin Ebewe
SZ
MP
 
D
 
[71]  Schedule 1 Part 1, entry for ‘Fluorouracil’ in the form ‘Injection 500 mg in 10 mL’ with manner of administration Injection:
omit :
Fluorouracil Ebewe
SZ
MP
C3923
D

 
 
 
C3924
 

[72]  Schedule 1 Part 1, entry for ‘Methotrexate’ in the form ‘Solution concentrate for I.V. infusion 1000 mg in 10 mL vial’ with manner of administration Injection:
omit :
Methotrexate Ebewe
SZ
MP
 
D
[73]  Schedule 1, Part 1 after the entry for Mitozantrone;
insert:
Ofatumumab
Solution concentrate for I.V. 100 mg in 5 mL
Injection
Arzerra
GK
MP
C4828
D

 
Solution concentrate for I.V. 1000 mg in 50 mL
Injection
Arzerra
GK
MP
C4828
C4858
D

[74]  Schedule 1 Part 1, entry for ‘Oxaliplatin’ in the forms ‘Powder for I.V. infusion 100 mg’; and ‘Powder for I.V. infusion 50 mg’ with manner of administration Injection:
omit :
Oxaliplatin Ebewe
SZ
MP
 
D
[75]  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:
omit :
Paclitaxel Ebewe
SZ
MP
 
D
[76]  Schedule 1, Part 2 after the entry for Mitozantrone:
insert:
Ofatumumab
P4828
300
0

 
 
1000
5

 
P4858
1000
5

[77]  Schedule 2, entry for ‘Folinic Acid’ in the form ‘Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 ml’ with manner of administration Injection:
omit :
Calcium Folinate Ebewe
SZ
EMP
 
 
10
2
 
 
[78]  Schedule 4, after the entry for Methotrexate:
   insert in the columns in the order indicated:
 
Ofatumumab
C4828
P4828
Chronic lymphocytic leukaemia (CLL)
Treatment Phase: Initial treatment
The condition must be CD20 positive chronic lymphocytic leukaemia (CLL), must be previously untreated, and must be in combination with chlorambucil. Patient must be inappropriate for fludarabine based therapy.
Compliance with Authority Required procedures - Streamlined Authority Code 4828


 
C4858
P4858
Chronic lymphocytic leukaemia (CLL)
Treatment Phase: Continuing treatment
The condition must be CD20 positive chronic lymphocytic leukaemia (CLL). The patient must have previously been issued with an authority prescription for this drug, must not have progressive disease, and must be inappropriate for fludarabine based therapy. Treatment must be in combination with chlorambucil.

Compliance with Authority Required procedures - Streamlined Authority Code 4858


 
 
 
 
 
 
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