This is the text extract for Proposal for leflunomide; Closing Date: Closed; Contact: Jackie Evans, browse documents here.

27 July 2012

Proposal for leflunomide

PHARMAC is seeking feedback on a proposal to reduce the price and subsidy of leflunomide (Arava) through a provisional agreement with Sanofi Aventis. We have also been notified of supplier discontinuations of some leflunomide presentations and brands and therefore propose these products be delisted as a result. Further details of this proposal, including how to provide feedback and background information, can be found below and on the following page.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5 pm Friday, 10 August 2012 to: Jackie Evans Therapeutic Group Manager PHARMAC Email: jackie.evans@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 Chief Executive acting under delegated authority) prior to making a decision on this proposal.

Details of the proposal

Arava price and subsidy reductions  From 1 October 2012 the price and subsidy of Arava (leflunomide 10 mg and 20 mg tablets) listed in Section B, and Part II of Section H, of the Pharmaceutical Schedule would be reduced as follows (all prices are ex-manufacturer and exclude GST):

Brand Arava Arava Pharmaceutical leflunomide leflunomide Presentation Tab 10 mg Tab 20 mg Pack size 30 30 Current Price and Subsidy $79.27 $108.60 Proposed Price and Subsidy $55.00 $76.00



Subject to the continued validity of NZ patent number 331933, Arava 10 mg and 20 mg tablets would have subsidy and delisting protection until 31 March 2017.

Delisting of Arava 100 mg tablets and AFT-Leflunomide 10 mg and 20mg   From 1 July 2014, Arava 100 mg tablets would be delisted from Section B, and Part II of Section H, of the Pharmaceutical Schedule; and From 1 March 2013, AFT-Leflunomide 10 mg and 20 mg tablets would be delisted from Section B, and Part II of Section H, of the Pharmaceutical Schedule.

A523528 - T12-644

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Background

Currently two brands of leflunomide tablets are fully subsidised on the Pharmaceutical Schedule; Arava (10 mg, 20 mg and 100 mg, Sanofi Aventis) and AFT-Leflunomide (10 mg and 20 mg, AFT Pharmaceuticals). The Sanofi brand currently holds approximately 80% market share. We have reached a provisional agreement with Sanofi that would see the list price and subsidy of Arava (10 mg and 20 mg) reduced to the current list price and subsidy of AFTLeflunomide. Sanofi has notified that it intends to discontinue supply of leflunomide 100 mg tablets due to low sales; the existing stock has an expiry date of December 2013. We note that the leflunomide 100mg tablet has very small market share: in the last year only 2 prescriptions have been subsidised, a total of 6 tablets. Given its low use we do not propose sourcing an alternative supplier for this strength of leflunomide. AFT has notified that it will discontinue supply of its brand of leflunomide, 10 mg and 20 mg tablets, AFT-Leflunomide in September 2012. We note that patients currently receiving AFTLeflunomide would be able to receive fully funded Arava instead.

A523528 - T12-644

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