National Health (Weighted average disclosed price supplementary disclosure cycle A) Determination 2014 (No. PB 26 of 2014) (Cth)

Case

PB 26 of 2014

National Health (Weighted average disclosed price – supplementary disclosure cycle A) Determination 2014

National Health Act 1953

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

Dated:        14 April 2014

FELICITY MCNEILL

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

  1. Name of Determination

(1)     This Determination is the National Health (Weighted average disclosed price –supplementary disclosure cycle A) Determination 2014.

(2)     This Determination may also be cited as PB 26 of 2014.

  1. Commencement

This Determination commences on the day after it is registered.

  1. Revocation

This Determination revokes:

(a)the National Health (Weighted average disclosed price – supplementary disclosure cycle A) Determination 2013 (PB 24 of 2013);

(b)the National Health (Weighted average disclosed price – supplementary disclosure cycle B) Determination 2013 (PB 55 of 2013); and

(c)the National Health (Weighted average disclosed price – main disclosure cycle) Determination 2013 (No. 2) (PB 82 of 2013);

  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.

supplementary disclosure cycle A has the same meaning as in regulation 37EB(2)(c) 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 5 of this instrument.

  1. Reduction Day

For paragraph 99ADH(1)(aa) of the Act, a brand of pharmaceutical item in the supplementary disclosure cycle A with a data collection period ending at the end of
31 January 2014 which is mentioned in Schedule 1 or 2 has a reduction day of
1 August 2014.



Schedule 1            

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

Column 1 Column 2 Column 3
Item Brand of Pharmaceutical Item Weighted average disclosed price
Drug Form Manner of administration Brand
1 Riluzole Tablet 50 mg Oral APO-Riluzole 396.89
2 Riluzole Tablet 50 mg Oral Rilutek 396.89
3 Riluzole Tablet 50 mg Oral Riluzole Sandoz 396.89

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 Amlodipine with valsartan Tablet 10 mg (as besylate)-160 mg Oral Exforge 10/160 17.84
2 Amlodipine with valsartan Tablet 10 mg (as besylate)-320 mg Oral Exforge 10/320 20.92
3 Amlodipine with valsartan Tablet 5 mg (as besylate)-160 mg Oral Exforge 5/160 14.99
4 Amlodipine with valsartan Tablet 5 mg (as besylate)-320 mg Oral Exforge 5/320 18.08
5 Amlodipine with valsartan Tablet 5 mg (as besylate)-80 mg Oral Exforge 5/80 12.53
6 Amlodipine with valsartan Tablet 5 mg (as besylate)-80 mg Oral Valsartan/Amlodipine Sandoz 80/5 12.53
7 Amlodipine with valsartan and hydrochlorothiazide Tablet 10 mg (as besylate)-160 mg-12.5 mg Oral Exforge HCT 10/160/12.5 19.26
8 Amlodipine with valsartan and hydrochlorothiazide Tablet 10 mg (as besylate)-160 mg-25 mg Oral Exforge HCT 10/160/25 20.66
9 Amlodipine with valsartan and hydrochlorothiazide Tablet 10 mg (as besylate)-320 mg-25 mg Oral Exforge HCT 10/320/25 23.76
10 Amlodipine with valsartan and hydrochlorothiazide Tablet 5 mg (as besylate)-160 mg-12.5 mg Oral Exforge HCT 5/160/12.5 16.41
11 Amlodipine with valsartan and hydrochlorothiazide Tablet 5 mg (as besylate)-160 mg-12.5 mg Oral Valsartan/Amlodipine/HCT Sandoz 160/5/12.5 16.41
12 Amlodipine with valsartan and hydrochlorothiazide Tablet 5 mg (as besylate)-160 mg-25 mg Oral Exforge HCT 5/160/25 17.82
13 Imiquimod Cream 50 mg per g, 2 g, 2 Application Aldara Pump 102.57
14 Imiquimod Cream 50 mg per g, 250 mg single use sachets, 12 Application Aldara 102.57
15 Imiquimod Cream 50 mg per g, 250 mg single use sachets, 12 Application APO-Imiquimod 102.57
16 Nevirapine Tablet 200 mg Oral Nevirapine Alphapharm 215.24
17 Nevirapine Tablet 200 mg Oral Nevirapine RBX 215.24
18 Nevirapine Tablet 200 mg Oral Viramune 215.24
19 Nevirapine Tablet 400 mg (extended release) Oral Viramune XR 215.24

Note

1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See

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