National Health (Weighted average disclosed price interim supplementary disclosure cycle) Determination 2012 (No. PB 58 of 2012) (Cth)

Case

PB 58 of 2012

National Health (Weighted average disclosed price – interim supplementary disclosure cycle) Determination 2012

as amended

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

National Health Act 1953

This compilation was prepared on 5 November 2012
taking into account amendments up to PB 98 of 2012

Prepared by the Office of Parliamentary Counsel, Canberra

Contents

1Name of Determination [see Note 1]   3

2Commencement [see Note 1]   3

3Definitions   3

4Weighted average disclosed price for brands of pharmaceutical items – unadjusted price reduction is at least 10%   3

5Weighted average disclosed price for brands of pharmaceutical items – unadjusted price reduction is less than 10%   3

6Adjusted approved ex‑manufacturer price for brands of pharmaceutical items – unadjusted price reduction is at least 10%   4

7Adjusted approved price to pharmacists for brands of pharmaceutical items – unadjusted price reduction is at least 10%   4

8Reduction Day   4

Schedule 1Brands of pharmaceutical items – unadjusted price reduction is at least 10%        5

Schedule 2Brands of pharmaceutical items – unadjusted price reduction is less than 10%     12

Notes    14

  1. Name of Determination [see Note 1]

(1)   This Determination is the National Health (Weighted average disclosed price – interim supplementary disclosure cycle) Determination 2012.

(2)   This Determination may also be cited as PB 58 of 2012.

  1. Commencement [see Note 1]

This Determination commences on the day after it is registered.

  1. 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.

interim supplementary disclosure cycle has the same meaning as paragraph 37EB (2) (b), 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.

  1. 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.

  1. 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.

  1. 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.

  1. 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.

  1. Reduction Day

For paragraph 99ADH(1)(aa) of the Act, a brand of pharmaceutical item in the interim supplementary disclosure cycle with a data collection period ending at the end of 31 May 2012 has a reduction day of 1 December 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
2 Docetaxel Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent Injection Taxotere 267.72
3 Docetaxel Powder for I.V. infusion 20 mg with solvent Injection Docetaxel SUN 66.80
4 Docetaxel Powder for I.V. infusion 80 mg with solvent Injection Docetaxel SUN 267.72
5 Docetaxel Solution concentrate for I.V. infusion 140 mg in 7 mL Injection Oncotaxel 140 466.48
6 Docetaxel Solution concentrate for I.V. infusion 160 mg in 16 mL Injection DBL Docetaxel Concentrated Injection 535.44
7 Docetaxel Solution concentrate for I.V. infusion 20 mg in 1 mL Injection Oncotaxel 20 66.80
8 Docetaxel Solution concentrate for I.V. infusion 20 mg in 1 mL Injection Taxotere 66.80
9 Docetaxel Solution concentrate for I.V. infusion 20 mg in 2 mL Injection DBL Docetaxel Concentrated Injection 66.80
10 Docetaxel Solution concentrate for I.V. infusion 20 mg in 2 mL Injection Docetaxel Ebewe 66.80
11 Docetaxel Solution concentrate for I.V. infusion 20 mg in 2 mL Injection Docetaxel Sandoz 66.80
12 Docetaxel Solution concentrate for I.V. infusion 80 mg in 4 mL Injection Oncotaxel 80 267.72
13 Docetaxel Solution concentrate for I.V. infusion 80 mg in 4 mL Injection Taxotere 267.72
14 Docetaxel Solution concentrate for I.V. infusion 80 mg in 8 mL Injection DBL Docetaxel Concentrated Injection 267.72
15 Docetaxel Solution concentrate for I.V. infusion 80 mg in 8 mL Injection Docetaxel Ebewe 267.72
16 Docetaxel Solution concentrate for I.V. infusion 80 mg in 8 mL Injection Docetaxel Sandoz 267.72
17 Pioglitazone Tablet 15 mg (as hydrochloride) Oral Acpio 15 27.74 29.83
18 Pioglitazone Tablet 15 mg (as hydrochloride) Oral Actos 27.74 29.83
19 Pioglitazone Tablet 15 mg (as hydrochloride) Oral APOTEX‑Pioglitazone 27.74 29.83
20 Pioglitazone Tablet 15 mg (as hydrochloride) Oral Chem mart Pioglitazone 27.74 29.83
21 Pioglitazone Tablet 15 mg (as hydrochloride) Oral Pharmacor Pioglitazone 15 27.74 29.83
22 Pioglitazone Tablet 15 mg (as hydrochloride) Oral Pioglitazone generichealth 15 27.74 29.83
23 Pioglitazone Tablet 15 mg (as hydrochloride) Oral Pioglitazone Sandoz 27.74 29.83
24 Pioglitazone Tablet 15 mg (as hydrochloride) Oral Pioglitazone‑GA 27.74 29.83
25 Pioglitazone Tablet 15 mg (as hydrochloride) Oral Pizaccord 27.74 29.83
25A Pioglitazone Tablet 15 mg (as hydrochloride) Oral Prioten 15 27.74 29.83
26 Pioglitazone Tablet 15 mg (as hydrochloride) Oral Terry White Chemists Pioglitazone 27.74 29.83
27 Pioglitazone Tablet 15 mg (as hydrochloride) Oral Vexazone 27.74 29.83
28 Pioglitazone Tablet 30 mg (as hydrochloride) Oral Acpio 30 42.67 45.88
29 Pioglitazone Tablet 30 mg (as hydrochloride) Oral Actos 42.67 45.88
30 Pioglitazone Tablet 30 mg (as hydrochloride) Oral APOTEX‑Pioglitazone 42.67 45.88
31 Pioglitazone Tablet 30 mg (as hydrochloride) Oral Chem mart Pioglitazone 42.67 45.88
32 Pioglitazone Tablet 30 mg (as hydrochloride) Oral Pharmacor Pioglitazone 30 42.67 45.88
33 Pioglitazone Tablet 30 mg (as hydrochloride) Oral Pioglitazone generichealth 30 42.67 45.88
34 Pioglitazone Tablet 30 mg (as hydrochloride) Oral Pioglitazone Sandoz 42.67 45.88
35 Pioglitazone Tablet 30 mg (as hydrochloride) Oral Pioglitazone‑GA 42.67 45.88
36 Pioglitazone Tablet 30 mg (as hydrochloride) Oral Pizaccord 42.67 45.88
36A Pioglitazone Tablet 30 mg (as hydrochloride) Oral Prioten 30 42.67 45.88
37 Pioglitazone Tablet 30 mg (as hydrochloride) Oral Terry White Chemists Pioglitazone 42.67 45.88
38 Pioglitazone Tablet 30 mg (as hydrochloride) Oral Vexazone 42.67 45.88
39 Pioglitazone Tablet 45 mg (as hydrochloride) Oral Acpio 45 55.48 59.65
40 Pioglitazone Tablet 45 mg (as hydrochloride) Oral Actos 55.48 59.65
41 Pioglitazone Tablet 45 mg (as hydrochloride) Oral APOTEX‑Pioglitazone 55.48 59.65
42 Pioglitazone Tablet 45 mg (as hydrochloride) Oral Chem mart Pioglitazone 55.48 59.65
43 Pioglitazone Tablet 45 mg (as hydrochloride) Oral Pharmacor Pioglitazone 45 55.48 59.65
44 Pioglitazone Tablet 45 mg (as hydrochloride) Oral Pioglitazone generichealth 45 55.48 59.65
45 Pioglitazone Tablet 45 mg (as hydrochloride) Oral Pioglitazone Sandoz 55.48 59.65
46 Pioglitazone Tablet 45 mg (as hydrochloride) Oral Pioglitazone‑GA 55.48 59.65
47 Pioglitazone Tablet 45 mg (as hydrochloride) Oral Pizaccord 55.48 59.65
47A Pioglitazone Tablet 45 mg (as hydrochloride) Oral Prioten 45 55.48 59.65
48 Pioglitazone Tablet 45 mg (as hydrochloride) Oral Terry White Chemists Pioglitazone 55.48 59.65
49 Pioglitazone Tablet 45 mg (as hydrochloride) Oral Vexazone 55.48 59.65
50 Risedronic Acid Tablet (enteric coated) containing risedronate sodium 35 mg Oral Actonel EC 25.49
51 Risedronic Acid Tablet containing risedronate sodium 150 mg Oral Actonel Once-a-Month 27.62
52 Risedronic Acid Tablet containing risedronate sodium 30 mg Oral Actonel 168.36
53 Risedronic Acid Tablet containing risedronate sodium 35 mg Oral Acris Once-a-Week 25.49
54 Risedronic Acid Tablet containing risedronate sodium 35 mg Oral APO-Risedronate 25.49
55 Risedronic Acid Tablet containing risedronate sodium 35 mg Oral Chem mart Risedronate 25.49
56 Risedronic Acid Tablet containing risedronate sodium 35 mg Oral Risedro once a week 25.49
57 Risedronic Acid Tablet containing risedronate sodium 35 mg Oral Risedronate Sandoz 25.49
58 Risedronic Acid Tablet containing risedronate sodium 35 mg Oral Risedronate-GA 25.49
59 Risedronic Acid Tablet containing risedronate sodium 35 mg Oral Terry White Chemists Risedronate 25.49
60 Risedronic Acid Tablet containing risedronate sodium 5 mg Oral Actonel 25.49

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 Perindopril with amlodipine Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besylate) Oral Coveram 27.36
2 Perindopril with amlodipine Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besylate) Oral Reaptan 10/10 27.36
3 Perindopril with amlodipine Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besylate) Oral Coveram 21.45
4 Perindopril with amlodipine Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besylate) Oral Reaptan 10/5 21.45
5 Perindopril with amlodipine Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besylate) Oral Coveram 22.67
6 Perindopril with amlodipine Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besylate) Oral Reaptan 5/10 22.67
7 Perindopril with amlodipine Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besylate) Oral Coveram 16.73
8 Perindopril with amlodipine Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besylate) Oral Reaptan 5/5 16.73

Notes to the National Health (Weighted average disclosed price – interim supplementary disclosure cycle) Determination 2012 (PB 58 of 2012)

Note 1

The National Health (Weighted average disclosed price – interim supplementary disclosure cycle) Determination 2012 (PB 58 of 2012) (in force under subsection 99ADB(4) and paragraph 99ADH(1)(aa) of the National Health Act 1953) as shown in this compilation is amended as indicated in the Tables below.

Table of Instruments

Title

Date of FRLI registration

Date of
commencement

Application, saving or
transitional provisions
PB 58 of 2012 22 Aug 2012 (see F2012L01731) 23 Aug 2012
PB 70 of 2012 21 Sept 2012 (see F2012L01907) 22 Sept 2012 —
PB 98 of 2012 5 Nov 2012 (see F2012L02147) 5 Nov 2012 —

Table of Amendments

ad. = added or inserted      am. = amended      rep. = repealed      rs. = repealed and substituted

Provision affected

How affected
Schedule 1
Schedule 1............................ am. PB 70 and 98 of 2012
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