This is the text extract for Candesartan - Access widening and sole supply; Closing Date: Closed; Contact: Stephen Woodruffe, browse documents here.

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27 October 2011

Candesartan – Access Widening and Sole Supply

PHARMAC is seeking feedback on the following proposals relating to candesartan following a Request for Proposals issued in September 2011. In summary, these proposals would result in: Price and Subsidy Reduction for Candesartan  The price and subsidy for Mylan’s brand of candesartan (Candestar) would reduce from 1 August 2012. The subsidy for the Atacand brand of candesartan would be reduced to the same level as Candestar from 1 August 2012 via reference pricing.

Access Changes  From 1 August 2012 the candesartan Special Authority would be widened and the daily dose dispensing restrictions would be removed.

Sole Supply of Candesartan  Mylan’s brand of candesartan (Candestar) would be the Sole Supply (only funded) brand of candesartan from 1 November 2012 until 30 June 2015 (Atacand would be delisted).

The proposed changes would create estimated savings in excess of $13 million per year which would be used to fund other medicines.

Feedback sought PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Friday, 11 November 2011 to: Stephen Woodruffe Therapeutic Group Manager PHARMAC PO Box 10 254 Wellington 6143 Email: stephen.woodruffe@pharmac.govt.nz Fax: 04 460 4995

All feedback received before the closing date will be considered by PHARMAC’s Board (or Chief Executive acting under delegated authority) prior to making a decision on this proposal.

A462493T11-601

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Details of the proposal Following a Sole Supply competitive process we propose that Mylan’s brand of candesartan tablets (Candestar) is awarded Sole Supply Status and Hospital Supply Status, meaning it would be the only brand of candesartan tablets subsidised in the Pharmaceutical Schedule, and the only brand available in DHB hospitals (subject to a 1% Discretionary Variance Limit). In addition, we propose that the candesartan Special Authority is widened and the daily dose dispensing restrictions are removed. The new Special Authority would be as follows:

The proposed implementation timelines are as follows:  1 August 2012 – Price reductions for Candestar, reference pricing of Atacand, implementation of new Special Authority criteria and removal of the current daily dose dispensing restrictions. 1 November 2012 – Delisting of Atacand from the Pharmaceutical Schedule. 1 November 2012 until 30 June 2015 – Candestar would have Sole Supply Status and a 1% Discretionary Variance Limit would apply to Candestar in DHB hospitals.

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The timing of the proposed changes to the prices and subsidies (ex-manufacturer, excluding GST) for candesartan in the Pharmaceutical Schedule are shown below:

Strength Brand Pack Size Subsidy and Price* (Price in brackets if different to subsidy) Current 1 August 2012 to 1 November 31 October 2012 2012 $48.66 $16.22 $57.90 $19.30 $70.62 $23.54 $115.50 $38.50 $4.13 $1.38 ($16.22)** $6.10 $2.03 ($19.30)** $10.18 $3.39 ($23.54)** $17.66 $5.89 ($38.50)** $4.13 Delisted $6.10 Delisted $10.18 Delisted $17.66 Delisted

Candestar 4 mg tablet Atacand Candestar 8 mg tablet Atacand Candestar 16 mg tablet Atacand Candestar 32 mg tablet Atacand

90 30 90 30 90 30 90 30

*Subsidies and prices ex-manufacturer, excluding GST **This is the current price, it is at the suppliers discretion as to whether this would be reduced to the subsidy level

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Background Currently candesartan has the following Special Authority and daily dose dispensing restrictions: Special Authority:

Daily dose dispensing restrictions:

Tablet Strength 4 mg 8 mg 16 mg 32 mg Daily dose restriction No more than 1.5 tab per day No more than 1.5 tab per day No more than 1 tab per day No more than 1 tab per day

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