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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Repealed by National Health (Weighted average disclosure price - main disclosure cycle) Determination 2012 (No. PB 107 of 2012)

 

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.