This is the text extract for Consultation on provisional agreement with CSL Biotherapies; Closing Date: Closed; Contact: Greg Williams, browse documents here.

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22 September 2011

Proposal relating to betamethasone diproprionate with calcipotriol, calcipotriol, fusidic acid and bumetanide.

PHARMAC is seeking feedback on a proposal to fund betamethasone diproprionate with calcipotriol (Daivobet) through a provisional agreement with CSL Biotherapies (NZ) Limited. This proposal would also amend the terms of listing of calcipotriol (Daivonex), fusidic acid (Fucidin and Fucithalmic) and bumetanide (Burinex) through the same provisional agreement. All proposed changes would be implemented from 1 December 2011. In summary, the effect of this proposal would be as follows:  Betamethasone diproprionate with calcipotriol (Daivobet) ointment and gel would be funded. The price and subsidy for calcipotriol (Daivonex) cream, ointment and solution would be reduced, remaining full subsidised. The price for fusidic acid (Fucithalmic) eye drops would be reduced to the current subsidy resulting in Fucithalmic being fully subsidised. Fusidic acid (Fucidin) tablets and bumetanide (Burinex) tablets would remain fully subsidised at the current price. All pharmaceuticals in the proposal would have subsidy and delisting protection until 30 June 2015.

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Further details, including how to provide feedback on this proposal, can be found below and on the following pages. Feedback sought PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Thursday, 6 October 2011 to: Greg Williams Therapeutic Group Manager PHARMAC Email: Greg.Williams@pharmac.govt.nz Fax: 04 460 4995 Post: PO Box 10 254, Wellington 6143

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

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Details of the proposal All proposed changes would occur from 1 December 2011. Betamethasone diproprionate with calcipotriol (Daivobet) Daivobet ointment and gel would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows (ex-manufacturer, excluding GST):

Pack Size 30 g OP Proposed price and subsidy $26.12

Product Betamethasone with calcipotriol

Brand

Form and Strength Oint 500 g with calcipotriol 50 g

Daivobet

Betamethasone with calcipotriol

Daivobet

Gel 500 g with calcipotriol 50 g

30 g OP

$26.12

Daivobet would have subsidy and delisting protection until 30 June 2015. Calcipotriol (Daivonex) Daivonex cream, ointment and solution would have price and subsidy reductions for all presentations in Section B and Part II of Section H of the Pharmaceutical Schedule, as follows (ex-manufacturer, excluding GST):

Product Calcipotriol Calcipotriol Calcipotriol Calcipotriol

Brand Daivonex Daivonex Daivonex Daivonex

Form and Strength Crm 50 g per g Crm 50 g per g Oint 50 g per g Soln 50 g per g

Pack Size 30 g OP 100 g OP 100 g OP 30 ml OP

Current price and subsidy $20.20 $56.32 $56.32 $20.22

Proposed price and subsidy $16.00 $45.00 $45.00 $16.00

Daivonex would have subsidy and delisting protection until 30 June 2015. Fusidic acid (Fucithalmic) eye drops The price of Fucithalmic eye drops would reduce in Section B and Part II of Section H of the Pharmaceutical Schedule to the level of the current subsidy, as follows (ex-manufacturer, excluding GST):

Pack Size Current subsidy (price) Proposed price and subsidy

Product

Brand

Form and Strength

A453397T09-364

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Fusidic acid

Fucithalmic

Eye drops 1%

5 g OP

$4.50 ($)11.52

$4.50

Fucithalmic eye drops would have subsidy and delisting protection until 30 June 2015. Fusidic acid (Fucidin) and bumetanide (Burinex) Fucidin and Burinex tablets would continue to be listed in Section B and Part II of Section H of the Pharmaceutical Schedule, as follows (ex-manufacturer, excluding GST):

Pack Size 12 100 Current price and subsidy $34.50 $16.36 Proposed price and subsidy $34.50 $16.36

Product Fusidic acid Bumetanide

Brand Fucidin Burinex

Form and Strength Tab 250 mg Tab 1 mg

Fucidin tablets and Burinex tablets would have subsidy and delisting protection until 30 June 2015. Background In response to PHARMAC’s consultation on the proposed 2011/12 Invitation to Tender product list, CSL Biotherapies (NZ) Limited submitted an alternative commercial proposal (ACP) involving betamethasone diproprionate with calcipotriol, calcipotriol, fusidic acid and bumetanide. This ACP forms the basis of PHARMAC’s provisional agreement with CSL and would result in the funding of Daivobet, Daivonex, Fucithalmic, Fucidin and Burinex until at least 30 June 2015. The Pharmacological and Therapeutics Advisory Committee (PTAC) reviewed an application for listing of Daivobet at its July 2008 meeting. The full minute relating to Daivobet can be found on the PHARMAC website at www.pharmac.govt.nz/2008/10/08. PTAC recommended that Daivobet be listed on the Pharmaceutical Schedule only if it was cost-neutral compared to the individual components of calcipotriol and betamethasone dipropionate. We estimate that the proposal would represent a saving to the Pharmaceutical Schedule.

A453397T09-364

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