Prasugrel for the treatment of acute coronary artery syndromes with percutaneous coronary intervention

• Published in: Health technology assessment (Winchester, England) England), 2010-05, Vol.14 Suppl 1 (Suppl 1), p.31-38
• Main Authors: Greenhalgh, J, Bagust, A, Boland, A, Saborido, C M, Fleeman, N, McLeod, C, Dundar, Y, Dickson, R, Proudlove, C, Kolamunnage-Dona, R, Fisher, M
• Format: Article
• Language: English
• Subjects: Acute Coronary Syndrome - drug therapy; Acute Coronary Syndrome - economics; Acute Coronary Syndrome - therapy; Angioplasty, Balloon, Coronary - adverse effects; Angioplasty, Balloon, Coronary - statistics & numerical data; Cost-Benefit Analysis; Humans; Models, Economic; Piperazines - adverse effects; Piperazines - economics; Piperazines - therapeutic use; Platelet Aggregation Inhibitors - economics; Platelet Aggregation Inhibitors - therapeutic use; Prasugrel Hydrochloride; Purinergic P2Y Receptor Antagonists - adverse effects; Purinergic P2Y Receptor Antagonists - economics; Purinergic P2Y Receptor Antagonists - therapeutic use; Quality of Life; Quality-Adjusted Life Years; Risk Assessment; Thiophenes - adverse effects; Thiophenes - economics; Thiophenes - therapeutic use; Ticlopidine - adverse effects; Ticlopidine - analogs & derivatives; Ticlopidine - economics; Ticlopidine - therapeutic use; United Kingdom
• ISSN: 1366-5278; 2046-4924
• DOI: 10.3310/hta14suppl1/05

This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of prasugrel for the treatment of coronary artery syndromes with percutaneous coronary intervention, based upon the evidence submission from Eli Lilly to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal process. The submitted clinical evidence was based on a phase III double-blind, double-dummy randomised controlled trial which compared the use of prasugrel with clopidogrel. The primary clinical outcome measure was a composite end point of death from cardiovascular causes, non-fatal myocardial infarction (MI) or non-fatal stroke at 15 months. Secondary outcomes included the primary end point at 30 days and 90 days; a composite end point of death from cardiovascular causes, non-fatal MI or urgent target vessel revascularisation; a composite end point of death from cardiovascular causes, non-fatal MI, non-fatal stroke or rehospitalisation due to a cardiac ischaemic event; and stent thrombosis. For the overall trial cohort during the 15 month follow-up period, the results of the trial demonstrated a statistically significant benefit of prasugrel compared with clopidogrel on the primary outcome. The efficacy difference between treatment groups was, in the main, due to a statistically significant lower incidence of non-fatal MIs in the prasugrel group than in the clopidogrel group. No statistically significant differences were found for death from cardiovascular causes or non-fatal stroke. For the fully licensed and target populations, there was a statistically significant lower incidence of non-fatal MIs in the prasugrel group than in the clopidogrel group; there was no statistically significant difference in bleeding rates. The ERG recalculated the base-case cost-effectiveness results taking changes in parameters and assumptions into account: for example, revised drug costs, mid-cycle correction, amended relative risk mortality. Subgroup and threshold analyses were also explored by the ERG. For the fully licensed population (i.e. excluding patients with prior stroke or TIA), the manufacturer reported an incremental cost-effectiveness ratio (ICER) of 159,358 pounds per quality-adjusted life-year (QALY) gained at 12 months and an ICER of 3,220 pounds per QALY gained at 40 years. Considering the 15-month clinical trial data available for the fully licensed and target populations