National Health (Weighted average disclosed price supplementary disclosure cycle A) Determination 2013 (No. PB 24 of 2013) (Cth)

National Health (Weighted average disclosed price—supplementary disclosure cycle A) Determination 2013 (PB 24 of 2013)

as amended

made under subsection 99ADB(4) and paragraph 99ADH(1)(aa) of the

National Health Act 1953

Compilation start date:                  9 July 2013

Includes amendments up to:         PB 38 of 2013

About this compilation

This compilation

This is a compilation of the National Health (Weighted average disclosed price—supplementary disclosure cycle A) Determination 2013 (PB 24 of 2013) as in force on 9 July 2013. It includes any commenced amendment affecting the compilation to that date.

This compilation was prepared on 16 August 2013.

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of each amended provision.

Uncommenced amendments

The effect of uncommenced amendments is not reflected in the text of the compiled law but the text of the amendments is included in the endnotes.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Modifications

If a provision of the compiled law is affected by a modification that is in force, details are included in the endnotes.

Provisions ceasing to have effect

If a provision of the compiled law has expired or otherwise ceased to have effect in accordance with a provision of the law, details are included in the endnotes.

Contents

1............ Name of Determination................................................................................................. 1

2............ Commencement............................................................................................................. 1

3............ Definitions..................................................................................................................... 1

4............ Weighted average disclosed price for brands of pharmaceutical items—unadjusted price reduction is at least 10%     1

5............ Weighted average disclosed price for brands of pharmaceutical items—unadjusted price reduction is less than 10%  1

6............ Adjusted approved ex‑manufacturer price for brands of pharmaceutical items—unadjusted price reduction is at least 10%...................................................................................................................................... 1

7............ Reduction Day............................................................................................................... 2

Schedule 1—Brands of pharmaceutical items—unadjusted price reduction is at least 10%  3

Schedule 2—Brands of pharmaceutical items—unadjusted price reduction is less than 10%  6

Endnotes7

Endnote 1—About the endnotes  7

Endnote 2—Abbreviation key  8

Endnote 3—Legislation history  9

Endnote 4—Amendment history  10

Endnote 5—Uncommenced amendments [none]  11

Endnote 6—Modifications [none]  11

Endnote 7—Misdescribed amendments [none]  11

Endnote 8—Miscellaneous [none]  11

1  Name of Determination

(1)  This Determination is the National Health (Weighted average disclosed price—supplementary disclosure cycle A) Determination 2013.

(2)  This Determination may also be cited as PB 24 of 2013.

2  Commencement

This Determination commences on the day after it is registered.

3  Definitions

In this Determination:

Act means the National Health Act 1953.

adjusted approved ex‑manufacturer price has the same meaning as in subsection 99ADB(1) of the Act.

supplementary disclosure cycle A has the same meaning as in regulation 37EB(2)(c) of the National Health (Pharmaceutical Benefits) Regulations 1960.

unadjusted price reduction has the same meaning as in subsection 99ADB(1) of the Act.

weighted average disclosed price has the same meaning as in subsection 99ADB(1) of the Act.

4  Weighted average disclosed price for brands of pharmaceutical items—unadjusted price reduction is at least 10%

For subsection 99ADB(4) of the Act, the weighted average disclosed price specified in column 3 of an item in Schedule 1 is the weighted average disclosed price for the brand of pharmaceutical item specified in column 2 of the same item in Schedule 1.

5  Weighted average disclosed price for brands of pharmaceutical items—unadjusted price reduction is less than 10%

For subsection 99ADB(4) of the Act, the weighted average disclosed price specified in column 3 of an item in Schedule 2 is the weighted average disclosed price for the brand of pharmaceutical item specified in column 2 of the same item in Schedule 2.

6  Adjusted approved ex‑manufacturer price for brands of pharmaceutical items—unadjusted price reduction is at least 10%

For paragraph 99ADB(4) of the Act, the adjusted approved ex‑manufacturer price for a brand of pharmaceutical item specified in column 2 of Schedule 1 is an amount equal to the amount of the weighted average disclosed price of that brand of pharmaceutical item determined under section 4 of this instrument.

7  Reduction Day

For paragraph 99ADH(1)(aa) of the Act, a brand of pharmaceutical item in a supplementary disclosure cycle A with a data collection period ending at the end of 31 January 2013 which is mentioned in Schedule 1 or 2 has a reduction day of 1 August 2013.

Schedule 1—Brands of pharmaceutical items—unadjusted price reduction is at least 10%

Column 1	Column 2				Column 3
Item	Brand of Pharmaceutical Item				Weighted average disclosed price
Drug	Form	Manner of administration	Brand
1	Dexamethasone	Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL	Injection	Dexmethsone	6.77
2	Dexamethasone	Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL	Injection	Hospira Pty Limited	6.77
3	Dexamethasone	Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL	Injection	Dexmethsone	12.3
4	Dexamethasone	Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL	Injection	Hospira Pty Limited	12.3
5	Temozolomide	Capsule 100 mg	Oral	Orion Temozolomide	455.17
6	Temozolomide	Capsule 100 mg	Oral	Temodal	455.17
7	Temozolomide	Capsule 100 mg	Oral	Temizole 100	455.17
8	Temozolomide	Capsule 100 mg	Oral	Astromide	455.17
9	Temozolomide	Capsule 140 mg	Oral	Astromide	627.72
10	Temozolomide	Capsule 140 mg	Oral	Orion Temozolomide	627.72
11	Temozolomide	Capsule 140 mg	Oral	Temodal	627.72
12	Temozolomide	Capsule 140 mg	Oral	Temizole 140	627.72
12A	Temozolomide	Capsule 180 mg	Oral	Temodal	795.30
13	Temozolomide	Capsule 20 mg	Oral	Astromide	106.25
14	Temozolomide	Capsule 20 mg	Oral	Temizole 20	106.25
15	Temozolomide	Capsule 20 mg	Oral	Orion Temozolomide	106.25
16	Temozolomide	Capsule 20 mg	Oral	Temodal	106.25
17	Temozolomide	Capsule 250 mg	Oral	Astromide	1081.44
18	Temozolomide	Capsule 250 mg	Oral	Temodal	1081.44
19	Temozolomide	Capsule 250 mg	Oral	Temizole 250	1081.44
20	Temozolomide	Capsule 250 mg	Oral	Orion Temozolomide	1081.44
21	Temozolomide	Capsule 5 mg	Oral	Temizole 5	36.14
22	Temozolomide	Capsule 5 mg	Oral	Astromide	36.14
23	Temozolomide	Capsule 5 mg	Oral	Orion Temozolomide	36.14
24	Temozolomide	Capsule 5 mg	Oral	Temodal	36.14

Schedule 2—Brands of pharmaceutical items—unadjusted price reduction is less than 10%

Column 1	Column 2				Column 3
Item	Brand of Pharmaceutical Item				Weighted average disclosed price
Listed Drug	Form	Manner of administration	Brand
1	Dexamethasone	Eye drops 1 mg per mL, 5 mL	Application to the eye	Maxidex	3.38
2	Dexamethasone	Tablet 4 mg	Oral	Dexmethsone	4.45
3	Dexamethasone	Tablet 500 micrograms	Oral	Dexmethsone	1.79

Endnotes

Endnote 1—About the endnotes

The endnotes provide details of the history of this legislation and its provisions. The following endnotes are included in each compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Endnote 5—Uncommenced amendments

Endnote 6—Modifications

Endnote 7—Misdescribed amendments

Endnote 8—Miscellaneous

If there is no information under a particular endnote, the word “none” will appear in square brackets after the endnote heading.

Abbreviation key—Endnote 2

The abbreviation key in this endnote sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended the compiled law. The information includes commencement information for amending laws and details of application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision level. It also includes information about any provisions that have expired or otherwise ceased to have effect in accordance with a provision of the compiled law.

Uncommenced amendments—Endnote 5

The effect of uncommenced amendments is not reflected in the text of the compiled law, but the text of the amendments is included in endnote 5.

Modifications—Endnote 6

If the compiled law is affected by a modification that is in force, details of the modification are included in endnote 6.

Misdescribed amendments—Endnote 7

An amendment is a misdescribed amendment if the effect of the amendment cannot be incorporated into the text of the compilation. Any misdescribed amendment is included in endnote 7.

Miscellaneous—Endnote 8

Endnote 8 includes any additional information that may be helpful for a reader of the compilation.

Endnote 2—Abbreviation key

ad = added or inserted	pres = present
am = amended	prev = previous
c = clause(s)	(prev) = previously
Ch = Chapter(s)	Pt = Part(s)
def = definition(s)	r = regulation(s)/rule(s)
Dict = Dictionary	Reg = Regulation/Regulations
disallowed = disallowed by Parliament	reloc = relocated
Div = Division(s)	renum = renumbered
exp = expired or ceased to have effect	rep = repealed
hdg = heading(s)	rs = repealed and substituted
LI = Legislative Instrument	s = section(s)
LIA = Legislative Instruments Act 2003	Sch = Schedule(s)
mod = modified/modification	Sdiv = Subdivision(s)
No. = Number(s)	SLI = Select Legislative Instrument
o = order(s)	SR = Statutory Rules
Ord = Ordinance	Sub-Ch = Sub-Chapter(s)
orig = original	SubPt = Subpart(s)
par = paragraph(s)/subparagraph(s)
sub-subparagraph(s)

Endnote 3—Legislation history

Title	FRLI registration	Commencement	Application, saving and transitional provisions
PB 24 of 2013	26 Apr 2013 (see F2013L00688)	27 Apr 2013
PB 38 of 2013	8 July 2013 (see F2013L01328)	9 July 2013	—

Endnote 4—Amendment history

ad. = added or inserted    am. = amended    rep. = repealed    rs. = repealed and substituted    exp. = expired or ceased to have effect
Provision affected	How affected
Sch 1
Sch 1.................................	am PB 38 of 2013

Endnote 5—Uncommenced amendments [none]

Endnote 6—Modifications [none]

Endnote 7—Misdescribed amendments [none]

Endnote 8—Miscellaneous [none]