National Health (Weighted average disclosed price – second transitional disclosure cycle) Determination 2011 (No. PB 82 of 2011) - Legislation

National Health (Weighted average disclosed price—second transitional disclosure cycle) Determination 2011 (PB 82 of 2011)

as amended

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

National Health Act 1953

Compilation start date: 23 March 2012

Includes amendments up to: PB 7 of 2012

About this compilation

This compilation

This is a compilation of the National Health (Weighted average disclosed price—second transitional disclosure cycle) Determination 2011 (PB 82 of 2011) as in force on 23 March 2012. It includes any commenced amendment affecting the legislation to that date.

This compilation was prepared on 29 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

Part 1—Preliminary

1 Name of Determination

2 Commencement

3 Revocation

4 Definitions

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

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

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

8 Adjusted approved price to pharmacists for brands of pharmaceutical items—unadjusted price reduction is at least 10%

9 Reduction Day

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

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

Endnotes

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Endnote 5—Uncommenced amendments [none]

Endnote 6—Modifications [none]

Endnote 7—Misdescribed amendments [none]

Endnote 8—Miscellaneous [none]

Part 1—Preliminary

1 Name of Determination

(1) This Determination is the National Health (Weighted average disclosed price—second transitional disclosure cycle) Determination 2011.

(2) This Determination may also be cited as PB 82 of 2011.

2 Commencement

This Determination commences on the day after it is registered.

3 Revocation

The Determination titled ‘Determination made pursuant to subsections 99ADB(4) and 99ADB(5) of the National Health Act 1953’ made on 22 September 2010 and also cited as PB 85 of 2010 is revoked.

4 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.

adjusted approved price to pharmacists has the same meaning as in subsection 99ADB(1) of the Act.

second transitional disclosure cycle has the same meaning as in Part 2 Transitional, regulation 4, of the National Health (Pharmaceutical Benefits) Amendment Regulations 2010 (No. 5) (296/2010).

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.

5 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.

6 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.

7 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 5 of this instrument.

8 Adjusted approved price to pharmacists for brands of pharmaceutical items—unadjusted price reduction is at least 10%

For paragraph 99ADB(4) of the Act, the adjusted approved price to pharmacists specified in column 4 of an item in Schedule 1 is the adjusted approved price to pharmacists for the brand of pharmaceutical item specified in column 2 of the same item in Schedule 1.

9 Reduction Day

For paragraph 99ADH(1)(aa) of the Act, a brand of pharmaceutical item in the second transitional disclosure cycle with a data collection period ending at the end of 30 September 2011 has a reduction day of 1 April 2012.

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

Column 1	Column 2				Column 3	Column 4
Item	Brand of Pharmaceutical Item				Weighted average disclosed price	Adjusted approved price to pharmacists
Item	Listed Drug	Form	Manner of administration	Brand
1	Carvedilol	Tablet 12.5 mg	Oral	APO-Carvedilol	30.57	32.87
2	Carvedilol	Tablet 12.5 mg	Oral	Carvedilol generichealth	30.57	32.87
3	Carvedilol	Tablet 12.5 mg	Oral	Carvedilol Sandoz	30.57	32.87
4	Carvedilol	Tablet 12.5 mg	Oral	Chem mart Carvedilol 12.5 mg	30.57	32.87
5	Carvedilol	Tablet 12.5 mg	Oral	Dicarz	30.57	32.87
6	Carvedilol	Tablet 12.5 mg	Oral	Dilasig 12.5	30.57	32.87
7	Carvedilol	Tablet 12.5 mg	Oral	Dilatrend 12.5	30.57	32.87
8	Carvedilol	Tablet 12.5 mg	Oral	GenRx Carvedilol	30.57	32.87
9	Carvedilol	Tablet 12.5 mg	Oral	GN-Carvedilol	30.57	32.87
10	Carvedilol	Tablet 12.5 mg	Oral	Terry White Chemists Carvedilol 12.5 mg	30.57	32.87
11	Carvedilol	Tablet 12.5 mg	Oral	Vedilol 12.5	30.57	32.87
12	Carvedilol	Tablet 25 mg	Oral	APO-Carvedilol	38.21	41.08
13	Carvedilol	Tablet 25 mg	Oral	Carvedilol generichealth	38.21	41.08
14	Carvedilol	Tablet 25 mg	Oral	Carvedilol Sandoz	38.21	41.08
15	Carvedilol	Tablet 25 mg	Oral	Chem mart Carvedilol 25 mg	38.21	41.08
16	Carvedilol	Tablet 25 mg	Oral	Dicarz	38.21	41.08
17	Carvedilol	Tablet 25 mg	Oral	Dilasig 25	38.21	41.08
18	Carvedilol	Tablet 25 mg	Oral	Dilatrend 25	38.21	41.08
19	Carvedilol	Tablet 25 mg	Oral	GenRx Carvedilol	38.21	41.08
20	Carvedilol	Tablet 25 mg	Oral	GN-Carvedilol	38.21	41.08
21	Carvedilol	Tablet 25 mg	Oral	Terry White Chemists Carvedilol 25 mg	38.21	41.08
22	Carvedilol	Tablet 25 mg	Oral	Vedilol 25	38.21	41.08
23	Carvedilol	Tablet 3.125 mg	Oral	APO-Carvedilol	5.17	5.56
24	Carvedilol	Tablet 3.125 mg	Oral	Chem mart Carvedilol 3.125 mg	5.17	5.56
25	Carvedilol	Tablet 3.125 mg	Oral	Dilasig 3.125	5.17	5.56
26	Carvedilol	Tablet 3.125 mg	Oral	Dilatrend 3.125	5.17	5.56
27	Carvedilol	Tablet 3.125 mg	Oral	GenRx Carvedilol	5.17	5.56
28	Carvedilol	Tablet 3.125 mg	Oral	GN-Carvedilol	5.17	5.56
29	Carvedilol	Tablet 3.125 mg	Oral	Kredex	5.17	5.56
30	Carvedilol	Tablet 3.125 mg	Oral	Terry White Chemists Carvedilol 3.125 mg	5.17	5.56
31	Carvedilol	Tablet 3.125 mg	Oral	Vedilol 3.125	5.17	5.56
32	Carvedilol	Tablet 6.25 mg	Oral	APO-Carvedilol	24.45	26.29
33	Carvedilol	Tablet 6.25 mg	Oral	Carvedilol generichealth	24.45	26.29
34	Carvedilol	Tablet 6.25 mg	Oral	Carvedilol Sandoz	24.45	26.29
35	Carvedilol	Tablet 6.25 mg	Oral	Chem mart Carvedilol 6.25 mg	24.45	26.29
36	Carvedilol	Tablet 6.25 mg	Oral	Dicarz	24.45	26.29
37	Carvedilol	Tablet 6.25 mg	Oral	Dilasig 6.25	24.45	26.29
38	Carvedilol	Tablet 6.25 mg	Oral	Dilatrend 6.25	24.45	26.29
39	Carvedilol	Tablet 6.25 mg	Oral	GenRx Carvedilol	24.45	26.29
40	Carvedilol	Tablet 6.25 mg	Oral	GN-Carvedilol	24.45	26.29
41	Carvedilol	Tablet 6.25 mg	Oral	Terry White Chemists Carvedilol 6.25 mg	24.45	26.29
42	Carvedilol	Tablet 6.25 mg	Oral	Vedilol 6.25	24.45	26.29
43	Clopidogrel	Tablet 75 mg	Oral	Clopidogrel-DRLA	36.39	39.13
44	Clopidogrel	Tablet 75 mg (as besilate)	Oral	Clopidogrel Actavis	36.39	39.13
45	Clopidogrel	Tablet 75 mg (as besilate)	Oral	Clopidogrel-GA	36.39	39.13
46	Clopidogrel	Tablet 75 mg (as besilate)	Oral	Clovix 75	36.39	39.13
47	Clopidogrel	Tablet 75 mg (as hydrogen sulfate)	Oral	APO-Clopidogrel	36.39	39.13
48	Clopidogrel	Tablet 75 mg (as hydrogen sulfate)	Oral	Chem mart Clopidogrel	36.39	39.13
49	Clopidogrel	Tablet 75 mg (as hydrogen sulfate)	Oral	Clopidogrel RBX	36.39	39.13
50	Clopidogrel	Tablet 75 mg (as hydrogen sulfate)	Oral	Clopidogrel Sandoz	36.39	39.13
51	Clopidogrel	Tablet 75 mg (as hydrogen sulfate)	Oral	Clopidogrel Winthrop	36.39	39.13
52	Clopidogrel	Tablet 75 mg (as hydrogen sulfate)	Oral	Iscover	36.39	39.13
53	Clopidogrel	Tablet 75 mg (as hydrogen sulfate)	Oral	Piax	36.39	39.13
54	Clopidogrel	Tablet 75 mg (as hydrogen sulfate)	Oral	Plavix	36.39	39.13
55	Clopidogrel	Tablet 75 mg (as hydrogen sulfate)	Oral	Terry White Chemists Clopidogrel	36.39	39.13
56	Gemcitabine	Powder for I.V. infusion 1 g (as hydrochloride)	Injection	DBL Gemcitabine for Injection	60.81	65.38
57	Gemcitabine	Powder for I.V. infusion 1 g (as hydrochloride)	Injection	Gemcitabine Actavis	60.81	65.38
58	Gemcitabine	Powder for I.V. infusion 1 g (as hydrochloride)	Injection	Gemcitabine Ebewe	60.81	65.38
59	Gemcitabine	Powder for I.V. infusion 1 g (as hydrochloride)	Injection	Gemcitabine Kabi	60.81	65.38
60	Gemcitabine	Powder for I.V. infusion 1 g (as hydrochloride)	Injection	Gemcitabine Sun	60.81	65.38
61	Gemcitabine	Powder for I.V. infusion 1 g (as hydrochloride)	Injection	Gemcite	60.81	65.38
62	Gemcitabine	Powder for I.V. infusion 1 g (as hydrochloride)	Injection	Gemplan	60.81	65.38
63	Gemcitabine	Powder for I.V. infusion 1 g (as hydrochloride)	Injection	Gemzar	60.81	65.38
64	Gemcitabine	Powder for I.V. infusion 2 g (as hydrochloride)	Injection	DBL Gemcitabine for Injection	121.90	131.07
65	Gemcitabine	Powder for I.V. infusion 2 g (as hydrochloride)	Injection	Gemcitabine Kabi	121.90	131.07
66	Gemcitabine	Powder for I.V. infusion 200 mg (as hydrochloride)	Injection	DBL Gemcitabine for Injection	12.31	13.24
67	Gemcitabine	Powder for I.V. infusion 200 mg (as hydrochloride)	Injection	Gemcitabine Actavis	12.31	13.24
68	Gemcitabine	Powder for I.V. infusion 200 mg (as hydrochloride)	Injection	Gemcitabine Ebewe	12.31	13.24
69	Gemcitabine	Powder for I.V. infusion 200 mg (as hydrochloride)	Injection	Gemcitabine Kabi	12.31	13.24
70	Gemcitabine	Powder for I.V. infusion 200 mg (as hydrochloride)	Injection	Gemcitabine Sun	12.31	13.24
71	Gemcitabine	Powder for I.V. infusion 200 mg (as hydrochloride)	Injection	Gemcite	12.31	13.24
72	Gemcitabine	Powder for I.V. infusion 200 mg (as hydrochloride)	Injection	Gemplan	12.31	13.24
73	Gemcitabine	Powder for I.V. infusion 200 mg (as hydrochloride)	Injection	Gemzar	12.31	13.24
74	Gemcitabine	Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL	Injection	Gemcitabine Ebewe	60.81	65.38
75	Gemcitabine	Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL	Injection	Gemcitabine Ebewe	12.31	13.24
76	Gemcitabine	Solution concentrate for I.V. infusion 500 mg (as hydrochloride) in 50 mL	Injection	Gemcitabine Ebewe	30.41	32.70
76A	Gemcitabine	Solution concentrate for I.V. infusion 1g (as hydrochloride) in 25 mL	Injection	Gemcitabine Ebewe	60.81	65.38
76B	Gemcitabine	Solution concentrate for I.V. infusion 2 g (as hydrochloride) in 50 mL	Injection	Gemcitabine Ebewe	121.90	131.07
76C	Gemcitabine	Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 5 mL	Injection	Gemcitabine Ebewe	12.31	13.24
76D	Gemcitabine	Solution for injection 1 g (as hydrochloride) in 26.3 mL	Injection	DBL Gemcitabine Injection	60.81	65.38
76E	Gemcitabine	Solution for injection 2 g (as hydrochloride) in 52.6 mL	Injection	DBL Gemcitabine Injection	121.90	131.07
76F	Gemcitabine	Solution for injection 200 mg (as hydrochloride) in 5.3 mL	Injection	DBL Gemcitabine Injection	12.31	13.24
77	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL	Injection	Camptosar	37.95	40.80
78	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL	Injection	Hospira Pty Limited	37.95	40.80
79	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL	Injection	Irinotecan Actavis	37.95	40.80
80	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL	Injection	Irinotecan Alphapharm	37.95	40.80
81	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL	Injection	Irinotecan Ebewe	37.95	40.80
82	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL	Injection	Irinotecan Kabi	37.95	40.80
83	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL	Injection	Omegapharm Irinotecan	37.95	40.80
84	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL	Injection	Tecan	37.95	40.80
85	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL	Injection	Camptosar	113.74	122.29
86	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL	Injection	Irinotecan Ebewe	113.74	122.29
87	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL	Injection	Camptosar	15.18	16.32
88	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL	Injection	Hospira Pty Limited	15.18	16.32
89	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL	Injection	Irinotecan Actavis	15.18	16.32
90	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL	Injection	Irinotecan Alphapharm	15.18	16.32
91	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL	Injection	Irinotecan Ebewe	15.18	16.32
92	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL	Injection	Irinotecan Kabi	15.18	16.32
93	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL	Injection	Omegapharm Irinotecan	15.18	16.32
94	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL	Injection	Tecan	15.18	16.32
95	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL	Injection	Hospira Pty Limited	194.45	209.07
96	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL	Injection	Irinotecan Actavis 500	194.45	209.07
96A	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL	Injection	Tecan	194.45	209.07
97	Irinotecan	I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL	Injection	Irinotecan Ebewe	194.45	209.07
98	Vinorelbine	Solution for I.V. infusion 10 mg (as tartrate) in 1 mL	Injection	Hospira Pty Limited	22.38	24.06
99	Vinorelbine	Solution for I.V. infusion 10 mg (as tartrate) in 1 mL	Injection	Navelbine	22.38	24.06
100	Vinorelbine	Solution for I.V. infusion 10 mg (as tartrate) in 1 mL	Injection	Vinorelbine Ebewe	22.38	24.06
101	Vinorelbine	Solution for I.V. infusion 50 mg (as tartrate) in 5 mL	Injection	Hospira Pty Limited	93.38	100.40
102	Vinorelbine	Solution for I.V. infusion 50 mg (as tartrate) in 5 mL	Injection	Navelbine	93.38	100.40
103	Vinorelbine	Solution for I.V. infusion 50 mg (as tartrate) in 5 mL	Injection	Vinorelbine Ebewe	93.38	100.40
104	Vinorelbine	Solution for I.V. infusion 50 mg (as tartrate) in 5 mL	Injection	Vinorelbine Kabi	93.38	100.40

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	Enalapril with Hydrochlorothiazide	Tablet containing enalapril maleate 20 mg with hydrochlorothiazide 6 mg	Oral	Enalapril/HCT Sandoz	16.50
2	Enalapril with Hydrochlorothiazide	Tablet containing enalapril maleate 20 mg with hydrochlorothiazide 6 mg	Oral	Renitec Plus 20/6	16.50
3	Memantine	Tablet containing memantine hydrochloride 10 mg	Oral	APO-Memantine	79.50
4	Memantine	Tablet containing memantine hydrochloride 10 mg	Oral	Ebixa	79.50
5	Memantine	Tablet containing memantine hydrochloride 10 mg	Oral	Memanxa	79.50
6	Memantine	Tablet containing memantine hydrochloride 20 mg	Oral	Ebixa	79.50

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 82 of 2011	15 Dec 2011 (see F2011L02688)	16 Dec 2011
PB 7 of 2012	22 Mar 2012 (see F2012L00655)	23 Mar 2012	—

Endnote 4—Amendment history

Provision affected	How affected
Sch 1
Sch 1...................	am PB 7 of 2012

Endnote 5—Uncommenced amendments [none]

Endnote 6—Modifications [none]

Endnote 7—Misdescribed amendments [none]

Endnote 8—Miscellaneous [none]

National Health (Weighted average disclosed price – second transitional disclosure cycle) Determination 2011 (No. PB 82 of 2011)

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