Introduction and guidance

Prasugrel (Efient, Eli Lilly) is an oral inhibitor of platelet activation and aggregation. Prasugrel, coadministered with acetylsalicylic acid, has marketing authorisation for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI).

National Institute for Health and Clinical Excellence (NICE) technology appraisal guidance on the use of prasugrel for patients undergoing PCI was published in October 2009.1 Prasugrel, in combination with aspirin, is recommended as an option for patients when:

• immediate primary PCI for ST-segment-elevation myocardial infarction is necessary or

• stent thrombosis has occurred during clopidogrel treatment or

• the patient has diabetes mellitus.

The following sections present evidence on use of prasugrel and an overview of the independent advisory Appraisal Committee's considerations in developing its guidance for NICE. The importance of expert and stakeholder involvement in the development of NICE guidance is also explained.

Development of the guidance

Prasugrel was considered under the NICE single technology appraisal process.2 In this process, the manufacturer provides an evidence submission, which comprises a report (structured according to a template set by NICE) and economic model. The structured report sets out the evidence base for the drug, and the economic model assesses its cost-effectiveness compared to current standard practice – in this case the use of clopidogrel. The manufacturer's submission, therefore, forms the core evidence source for the Appraisal Committee's considerations. In addition, an academic group, the Evidence Review Group (in this case, the Liverpool Reviews and Implementation Group, University of Liverpool) is commissioned to critique the manufacturer's submission, and produce a report of its findings.3 The Evidence Review Group may also undertake exploratory analyses using the submitted materials and report these to the Appraisal Committee.

The Appraisal Committee developed recommendations for the use of prasugrel in two stages. First, it met to consider the available evidence and the …