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

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

- F2011L02688
No longer in force
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PB 82 of 2011 Determinations/Health as made

This instrument makes certain determinations relating to price disclosure for brands of pharmaceutical items in the second transitional disclosure cycle with a data collection period ending 30 September 2011 (second transitional cycle).

Administered by: Health

Made	13 Dec 2011
Registered	15 Dec 2011
Tabled HR	07 Feb 2012
Tabled Senate	07 Feb 2012
Date of repeal	21 Dec 2012
Repealed by	National Health (Weighted average disclosure price - main disclosure cycle) Determination 2012 (No. PB 107 of 2012)

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National Health (Weighted average disclosed price – second transitional disclosure cycle) Determination 2011

Instrument number PB 82 of 2011

National Health Act 1953

I, FELICITY McNEILL, First Assistant Secretary (Acting), Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this determination under subsection 99ADB(4) and paragraph 99ADH(1)(aa) of the National Health Act 1953.

Dated 13 December 2011

FELICITY McNEILL

First Assistant Secretary (Acting)

Pharmaceutical Benefits Division

Department of Health and Ageing

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
	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
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
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

Note

1. All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au.

Federal Register of Legislation - Australian Government

Primary content

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