This is the text extract for Proposal to widen access to prasugrel; Closing Date: Closed; Contact: Sue Anne Yee, browse documents here.

20 April 2012

Proposal to widen access to prasugrel

PHARMAC is seeking feedback on a proposal to widen access to funded prasugrel from 1 June 2012 for patients who experience cardiac stent thrombosis whilst on clopidogrel.

Feedback sought PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Monday, 7 May 2012 to: Sue Anne Yee Therapeutic Group Manager PHARMAC PO Box 10 254 Wellington 6143 Email: sueanne.yee@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. Details of the proposal  From 1 June 2012, the Special Authority criteria applying to prasugrel (5 mg and 10 mg tablets) would be amended as follows (additions in bold):

Special Authority for Subsidy Initial application - (coronary angioplasty and bare metal stent) from any relevant practitioner. Approvals valid for 6 months where the patient has undergone coronary angioplasty or had a bare metal cardiac stent inserted in the previous 4 weeks and is clopidogrel-allergic*. Initial application - (drug eluting stent) from any relevant practitioner. Approvals valid for 12 months where the patient has had a drug-eluting cardiac stent inserted in the previous 4 weeks and is clopidogrel-allergic*. Initial application – (stent thrombosis) from any relevant practitioner. Approvals valid without further renewal unless notified where the patient has experienced cardiac stent thrombosis whilst on clopidogrel. Renewal - (coronary angioplasty and bare metal stent) from any relevant practitioner. Approvals valid for 6 months where the patient has undergone coronary angioplasty or had a bare metal cardiac stent inserted in the previous 4 weeks and is clopidogrel-allergic*. Renewal - (drug eluting stent) from any relevant practitioner. Approvals valid for 12 months where the patient has had a drug-eluting cardiac stent inserted in the previous 4 weeks and is clopidogrel-allergic*. Note: *Clopidogrel allergy is defined as a history of anaphylaxis, urticaria, generalised rash or asthma (in non-asthmatic patients) developing soon after clopidogrel is started and is considered unlikely to be caused by any other treatment.

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Background Prasugrel (Effient) is an antiplatelet agent indicated for the prevention of atherothrombotic events in patients with acute coronary syndromes who are to undergo percutaneous coronary intervention (PCI). Prasugrel has been reviewed by PTAC and its Cardiovascular Subcommittee on a number of occasions. PTAC, in February 2012 recommended that it be funded with medium priority for patients who developed stent thrombosis whilst on clopidogrel and the minutes can be found at: http://www.pharmac.govt.nz/2012/04/20/2012. PTAC considered that evidence is lacking as to what benefit prasugrel would provide over continued treatment with clopidogrel in patients who have experienced stent thrombosis whilst on clopidogrel. However, it did acknowledge that it is unlikely that any trial evidence for this patient group would become available. This is a small patient group with a high clinical need. We also received feedback, when we consulted on a proposal (in February 2012) to fund prasugrel for clopidogrel-allergic patients undergoing percutaneous coronary intervention, that this proposal would be clinically appropriate.

A499447T12-623

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