{"id":"F2011L02703","name":"National Health (Weighted average disclosed price – first transitional disclosure cycle) Determination 2011 (No. PB 81 of 2011)","slug":"national-health-weighted-average-disclosed-price-first-transitional-disclosure-cycle-determination-2","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":89045,"registerId":"commonwealth-F2011L02703-current","compilationNumber":null,"startDate":"2026-04-02","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Part 1","sectionType":"part","heading":"Preliminary","content":"Part 1 Preliminary\n\n","sortOrder":0},{"sectionNumber":"1","sectionType":"section","heading":"Name of Determination","content":"1 Name of Determination\n\n(1) This Determination is the National Health (Weighted average disclosed price – first transitional disclosure cycle) Determination 2011.\n\n(2) This Determination may also be cited as PB 81 of 2011.\n\n","sortOrder":1},{"sectionNumber":"2","sectionType":"section","heading":"Commencement","content":"2 Commencement\n\nThis Determination commences on the day after it is registered.\n\n","sortOrder":2},{"sectionNumber":"3","sectionType":"section","heading":"Revocation","content":"3 Revocation\n\nThe 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 43 of 2010 is revoked.\n\n","sortOrder":3},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"4 Definitions\n\nIn this Determination:\n\nAct means the National Health Act 1953.\n\nadjusted approved ex-manufacturer price has the same meaning as in subsection 99ADB(1) of the Act.\n\nadjusted approved price to pharmacists has the same meaning as in subsection 99ADB(1) of the Act.\n\nfirst 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).\n\nunadjusted price reduction has the same meaning as in subsection 99ADB(1) of the Act.\n\nweighted average disclosed price has the same meaning as in subsection 99ADB(1) of the Act.\n\n","sortOrder":4},{"sectionNumber":"5","sectionType":"section","heading":"Weighted average disclosed price for brands of pharmaceutical items – unadjusted price reduction is at least 10%","content":"5 Weighted average disclosed price for brands of pharmaceutical items – unadjusted price reduction is at least 10%\n\nFor 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.\n\n","sortOrder":5},{"sectionNumber":"6","sectionType":"section","heading":"Weighted average disclosed price for brands of pharmaceutical items – unadjusted price reduction is less than 10%","content":"6 Weighted average disclosed price for brands of pharmaceutical items – unadjusted price reduction is less than 10%\n\nFor 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.\n\n","sortOrder":6},{"sectionNumber":"7","sectionType":"section","heading":"Adjusted approved ex-manufacturer price for brands of pharmaceutical items – unadjusted price reduction is at least 10%","content":"7 Adjusted approved ex-manufacturer price for brands of pharmaceutical items – unadjusted price reduction is at least 10%\n\nFor 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.\n\n","sortOrder":7},{"sectionNumber":"8","sectionType":"section","heading":"Adjusted approved price to pharmacists for brands of pharmaceutical items – unadjusted price reduction is at least 10%","content":"8 Adjusted approved price to pharmacists for brands of pharmaceutical items – unadjusted price reduction is at least 10%\n\nFor 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.\n\n","sortOrder":8},{"sectionNumber":"9","sectionType":"section","heading":"Reduction Day","content":"9 Reduction Day\n\nFor paragraph 99ADH(1)(aa) of the Act, a brand of pharmaceutical item in the first transitional disclosure cycle with a data collection period ending at the end of \n","sortOrder":9},{"sectionNumber":"30","sectionType":"section","heading":"September 2011 has a reduction day of 1 April 2012.","content":"30 September 2011 has a reduction day of 1 April 2012.\n\n","sortOrder":10},{"sectionNumber":"Sch 1","sectionType":"schedule","heading":null,"content":"Schedule 1\n\nBrands of pharmaceutical items – unadjusted price reduction is at least 10%\n\n```html\n

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

Alendronic Acid

Tablet 40 mg (as alendronate sodium)

Oral

Fosamax 40 mg

56.35

60.59

2

Alendronic Acid

Tablet 70 mg (as alendronate sodium)

Oral

Adronat

17.07

18.35

3

Alendronic Acid

Tablet 70 mg (as alendronate sodium)

Oral

Alendro Once Weekly

17.07

18.35

4

Alendronic Acid

Tablet 70 mg (as alendronate sodium)

Oral

Alendrobell 70mg

17.07

18.35

5

Alendronic Acid

Tablet 70 mg (as alendronate sodium)

Oral

Alendronate Sandoz

17.07

18.35

6

Alendronic Acid

Tablet 70 mg (as alendronate sodium)

Oral

Alendronate-GA

17.07

18.35

7

Alendronic Acid

Tablet 70 mg (as alendronate sodium)

Oral

APO-Alendronate

17.07

18.35

8

Alendronic Acid

Tablet 70 mg (as alendronate sodium)

Oral

Chem mart Alendronate 70mg

17.07

18.35

9

Alendronic Acid

Tablet 70 mg (as alendronate sodium)

Oral

Fosamax Once Weekly

17.07

18.35

10

Alendronic Acid

Tablet 70 mg (as alendronate sodium)

Oral

Ossmax 70mg

17.07

18.35

11

Alendronic Acid

Tablet 70 mg (as alendronate sodium)

Oral

Terry White Chemists Alendronate 70mg

17.07

18.35

12

Cisplatin

I.V. injection 10 mg in 10 mL

Injection

Pfizer Australia Pty Ltd

2.78

2.99

13

Cisplatin

I.V. injection 100 mg in 100 mL

Injection

Cisplatin Ebewe

18.79

20.20

14

Cisplatin

I.V. injection 100 mg in 100 mL

Injection

Hospira Pty Limited

18.79

20.20

15

Cisplatin

I.V. injection 100 mg in 100 mL

Injection

Pfizer Australia Pty Ltd

18.79

20.20

16

Cisplatin

I.V. injection 50 mg in 50 mL

Injection

Hospira Pty Limited

7.46

8.02

17

Cisplatin

I.V. injection 50 mg in 50 mL

Injection

Pfizer Australia Pty Ltd

7.46

8.02

18

Fluconazole

Capsule 100 mg

Oral

DBL Fluconazole

55.24

59.39

19

Fluconazole

Capsule 100 mg

Oral

Diflucan

55.24

59.39

20

Fluconazole

Capsule 100 mg

Oral

Dizole 100

55.24

59.39

21

Fluconazole

Capsule 100 mg

Oral

Fluconazole Sandoz

55.24

59.39

22

Fluconazole

Capsule 100 mg

Oral

Ozole

55.24

59.39

23

Fluconazole

Capsule 200 mg

Oral

APO-Fluconazole

107.61

115.70

24

Fluconazole

Capsule 200 mg

Oral

DBL Fluconazole

107.61

115.70

25

Fluconazole

Capsule 200 mg

Oral

Diflucan

107.61

115.70

26

Fluconazole

Capsule 200 mg

Oral

Dizole 200

107.61

115.70

27

Fluconazole

Capsule 200 mg

Oral

Fluconazole Sandoz

107.61

115.70

28

Fluconazole

Capsule 200 mg

Oral

Fluzole 200

107.61

115.70

29

Fluconazole

Capsule 200 mg

Oral

Ozole

107.61

115.70

30

Fluconazole

Capsule 50 mg

Oral

DBL Fluconazole

28.36

30.49

31

Fluconazole

Capsule 50 mg

Oral

Diflucan

28.36

30.49

32

Fluconazole

Capsule 50 mg

Oral

Dizole 50

28.36

30.49

33

Fluconazole

Capsule 50 mg

Oral

Fluconazole Sandoz

28.36

30.49

34

Fluconazole

Capsule 50 mg

Oral

Fluzole 50

28.36

30.49

35

Fluconazole

Capsule 50 mg

Oral

Ozole

28.36

30.49

36

Topiramate

Capsule 15 mg

Oral

Topamax Sprinkle

17.68

19.01

37

Topiramate

Capsule 25 mg

Oral

Topamax Sprinkle

23.90

25.70

38

Topiramate

Capsule 50 mg

Oral

Topamax Sprinkle

39.84

42.84

39

Topiramate

Tablet 100 mg

Oral

APO-Topiramate

62.75

67.47

40

Topiramate

Tablet 100 mg

Oral

Epiramax 100

62.75

67.47

41

Topiramate

Tablet 100 mg

Oral

RBX Topiramate

62.75

67.47

42

Topiramate

Tablet 100 mg

Oral

Tamate

62.75

67.47

43

Topiramate

Tablet 100 mg

Oral

Topamax

62.75

67.47

44

Topiramate

Tablet 100 mg

Oral

Topiramate generichealth

62.75

67.47

45

Topiramate

Tablet 100 mg

Oral

Topiramate Sandoz

62.75

67.47

46

Topiramate

Tablet 100 mg

Oral

Topiramate-GA

62.75

67.47

47

Topiramate

Tablet 200 mg

Oral

APO-Topiramate

105.41

113.34

48

Topiramate

Tablet 200 mg

Oral

Epiramax 200

105.41

113.34

49

Topiramate

Tablet 200 mg

Oral

RBX Topiramate

105.41

113.34

50

Topiramate

Tablet 200 mg

Oral

Tamate

105.41

113.34

51

Topiramate

Tablet 200 mg

Oral

Topamax

105.41

113.34

52

Topiramate

Tablet 200 mg

Oral

Topiramate generichealth

105.41

113.34

53

Topiramate

Tablet 200 mg

Oral

Topiramate Sandoz

105.41

113.34

54

Topiramate

Tablet 200 mg

Oral

Topiramate-GA

105.41

113.34

55

Topiramate

Tablet 25 mg

Oral

APO-Topiramate

24.30

26.13

56

Topiramate

Tablet 25 mg

Oral

Epiramax 25

24.30

26.13

57

Topiramate

Tablet 25 mg

Oral

RBX Topiramate

24.30

26.13

58

Topiramate

Tablet 25 mg

Oral

Tamate

24.30

26.13

59

Topiramate

Tablet 25 mg

Oral

Topamax

24.30

26.13

60

Topiramate

Tablet 25 mg

Oral

Topiramate generichealth

24.30

26.13

61

Topiramate

Tablet 25 mg

Oral

Topiramate Sandoz

24.30

26.13

62

Topiramate

Tablet 25 mg

Oral

Topiramate-GA

24.30

26.13

63

Topiramate

Tablet 50 mg

Oral

APO-Topiramate

39.89

42.89

64

Topiramate

Tablet 50 mg

Oral

Epiramax 50

39.89

42.89

65

Topiramate

Tablet 50 mg

Oral

RBX Topiramate

39.89

42.89

66

Topiramate

Tablet 50 mg

Oral

Tamate

39.89

42.89

67

Topiramate

Tablet 50 mg

Oral

Topamax

39.89

42.89

68

Topiramate

Tablet 50 mg

Oral

Topiramate generichealth

39.89

42.89

69

Topiramate

Tablet 50 mg

Oral

Topiramate Sandoz

39.89

42.89

70

Topiramate

Tablet 50 mg

Oral

Topiramate-GA

39.89

42.89

\n```\n\n","sortOrder":11},{"sectionNumber":"Sch 2","sectionType":"schedule","heading":null,"content":"Schedule 2\n\nBrands of pharmaceutical items – unadjusted price reduction is less than 10%\n\n```html\n

Column 1

Column 2

Column 3

Item

Brand of Pharmaceutical Item

Weighted average disclosed price

Listed Drug

Form

Manner of administration

Brand

1

Levodopa with Carbidopa

Tablet 100 mg-25 mg (anhydrous)

Oral

Kinson

25.47

2

Levodopa with Carbidopa

Tablet 100 mg-25 mg (anhydrous)

Oral

Sinemet 100/25

25.47

3

Levodopa with Carbidopa

Tablet 250 mg-25 mg (anhydrous)

Oral

Levo/Carbidopa Sandoz

31.41

4

Levodopa with Carbidopa

Tablet 250 mg-25 mg (anhydrous)

Oral

Sinemet

31.41

5

Naltrexone

Tablet containing naltrexone hydrochloride 50 mg

Oral

Naltrexone generichealth

108.89

6

Naltrexone

Tablet containing naltrexone hydrochloride 50 mg

Oral

ReVia

108.89

\n```\n\n> Note\n\n> 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.","sortOrder":12}],"analysis":{"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":false,"description":"The instrument continues the statutory task of specifying weighted average disclosed prices for the first transitional disclosure cycle under the Act. It revokes the earlier PB 43 of 2010 (s 3) and updates the concrete price figures and the Reduction Day (ss 5–9), but does not expand or narrow the legal scope of the Minister's power under subsections 99ADB(4) and paragraph 99ADH(1)(aa)."},"complexity_factors":["Cross‑references to the National Health Act 1953 definitions and price concepts (see Definitions, s 4; references to subsections 99ADB(1), 99ADB(4) and 99ADH(1)(aa)).","Two treatment paths depending on the unadjusted price reduction threshold (items with unadjusted reduction >=10% handled by Schedules 1 and ss 5–8; those <10% handled by Schedule 2 and s 6).","Large, granular schedules of brand‑level numeric prices that must be applied exactly (Schedule 1 lists items through Item 70; Schedule 2 lists separate entries) — implementation requires mapping each listed brand to the correct columned price.","Numeric adjustments span multiple price types (weighted average disclosed price, adjusted approved ex‑manufacturer price, adjusted approved price to pharmacists) so recordkeeping and billing systems must use the correct column (ss 5–8).","Temporal enforcement: a specified Reduction Day (s 9) creates a firm compliance date tied to a particular data collection period, giving limited lead time for operational changes.","Revocation of an earlier determination (s 3) requires transition planning: affected parties must update to the new figures and stop relying on PB 43 of 2010.","Delegation and administrative discretion: instrument made by a delegate of the Minister (instrument header) — practical queries and administrative interactions will be with the Pharmaceutical Benefits Division."],"plain_english_summary":"This Determination fixes the official weighted‑average disclosed prices and the associated adjusted approved prices (ex‑manufacturer and to pharmacists) for named medicine brands in the first transitional disclosure cycle under the National Health Act 1953, and replaces an earlier determination. It affects medicine sponsors, wholesalers and pharmacists because those fixed figures are the prices the law uses for subsidy and price‑reduction calculations, and it sets a 1 April 2012 reduction day for items with data to 30 September 2011."},"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-realtime","completionTokens":2221},"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"The determination remains tightly scoped to its original purpose of implementing the first transitional disclosure cycle price adjustments for specific pharmaceutical brands under the PBS price disclosure reforms."},"complexity_factors":["Technical pharmaceutical pricing terminology requiring knowledge of PBS mechanisms (weighted average disclosed price, adjusted approved ex-manufacturer price)","Cross-references to multiple sections of the National Health Act 1953 and related regulations","Bifurcated structure with different legal consequences based on percentage price reduction thresholds (10% cutoff)","Detailed tabular schedules listing specific drug brands with precise monetary values down to two decimal places"],"plain_english_summary":"This determination sets weighted average disclosed prices for specific PBS‑listed medicines from the first transitional disclosure cycle and takes effect 1 April 2012. For products with price falls ≥10% it also sets adjusted pharmacy prices; smaller falls only yield disclosed averages.\n\nIt affects manufacturers, pharmacists and patients by aligning PBS subsidies with actual market prices—reducing government spending where companies cut prices while maintaining subsidised access."}},"importantCases":[],"_links":{"self":"/api/acts/national-health-weighted-average-disclosed-price-first-transitional-disclosure-cycle-determination-2","history":"/api/acts/national-health-weighted-average-disclosed-price-first-transitional-disclosure-cycle-determination-2/history","analysis":"/api/acts/national-health-weighted-average-disclosed-price-first-transitional-disclosure-cycle-determination-2/analysis","conflicts":"/api/acts/national-health-weighted-average-disclosed-price-first-transitional-disclosure-cycle-determination-2/conflicts","importantCases":"/api/acts/national-health-weighted-average-disclosed-price-first-transitional-disclosure-cycle-determination-2/important-cases","documents":"/api/acts/national-health-weighted-average-disclosed-price-first-transitional-disclosure-cycle-determination-2/documents"}}