Revised guidance from the National Institute for Health and Care Excellence (NICE), recommends once-daily, oral antiplatelet prasugrel (Efient), in combination with aspirin, as a cost-effective option when compared to generic clopidogrel, for a wider group of acute coronary syndrome patients having primary or delayed percutaneous coronary intervention (PCI).
Prasugrel, will now also be available for preventing atherothrombotic events for adults with acute coronary syndrome with unstable angina or non-ST-segment elevation myocardial infarction (NSTEMI) having PCI. This latest recommendation builds on initial NICE guidance in October 2009, which recommended prasugrel for acute coronary syndrome patients having PCI when immediate primary PCI for ST-segment elevation myocardial infarction (STEMI) is necessary, or when stent thrombosis has occurred during clopidogrel treatment, or if the patient has diabetes mellitus.
Tim Kinnaird, consultant cardiologist at University College Cardiff, who acted as an adviser to the NICE appraisal committee says: “This recommendation is very welcome as it offers clinicians a wider choice to protect acute coronary syndrome patients against atherothrombotic events when undergoing PCI. It is important that all suitable treatment options are available so the most appropriate clinical decision to manage patients can be made particularly for higher-risk patients with other co-morbidities, such as diabetes. Having another cost effective option for unstable angina and NSTEMI patients undergoing PCI is particularly relevant to the UK, as this patient population is generally treated poorly compared to STEMI patients undergoing PCI.”
The NICE Assessment Group reported that the TRITON-TIMI 38 trial (comparing prasugrel with clopidogrel in 13,608 patients with moderate- to high-risk ACS scheduled to have PCI), was robustly designed and of strong methodological quality. For patients in the core clinical cohort (younger than 75 years, weighing 60kg or more and with no history of stroke or transient ischaemic attack), prasugrel demonstrated a clinically significant and robust reduction in the primary end point compared with clopidogrel.
Jean-Michel Cosséry, vice president and managing director – Lilly UK and Northern Europe says: “We welcome this recognition from NICE that prasugrel is a cost effective option when compared to generic clopidogrel. The extended guidance means that both STEMI and NSTEMI patients can benefit from this effective treatment.”
“We welcome this latest recommendation from NICE and the assessment is based on the strong clinical trial data for prasugrel demonstrating efficacy across all subgroups,” says Simon Clough, managing director of Daiichi Sankyo UK. “We are glad that NSTEMI and unstable angina patients in England and Wales will have another therapy option and this latest decision now puts England and Wales in line with the health and policy recommendations for prasugrel in other European countries.”