UNASSIGNED: As part of its Single Technology Appraisal process, the National Institute for Health and Care Excellence (NICE) invited the company that manufactures @entity3925 (Xarelto, Bayer) to submit evidence of the clinical and cost effectiveness of @entity3925 for the prevention of adverse outcomes in @entity1 after the acute management of @entity1187 ( @entity1187 ). The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a critical review of the evidence for the clinical and cost effectiveness of the technology, based upon the company's submission to NICE. The evidence was derived mainly from a randomised, double-blind, phase  III, placebo-controlled trial of @entity3925 (either 2.5 or 5  mg twice daily) in @entity1 with recent @entity1187 [unstable @entity951 , @entity583 ( @entity583 ) or @entity10260 @entity583 ( @entity583 )]. In addition, all patients received antiplatelet therapy [ @entity117 alone or @entity117 and a @entity1747 either as @entity1397 (approximately 99  %) or @entity1396 (approximately 1  %) according to national or local guidelines]. The higher dose of @entity3925 (5  mg twice daily) did not form part of the marketing authorisation. A post hoc subgroup analysis of the licensed @entity1 who had @entity1187 with elevated cardiac biomarkers (that is, @entity1 with @entity583 and @entity583 ) without prior @entity64 or transient @entity64 showed that compared with standard care, the addition of @entity3925 (2.5  mg twice daily) to existing antiplatelet therapy reduced the composite endpoint of cardiovascular mortality, @entity583 or @entity64 , but increased the risk of major @entity548 and @entity932 . However, there were a number of limitations in the evidence base that warrant caution in its interpretation. In particular, the evidence may be confounded because of the post hoc subgroup analysis, modified intention-to-treat analyses, high dropout rates and missing vital status data. Results from the company's economic evaluation showed that the deterministic incremental cost-effectiveness ratio (ICER) for @entity3925 in combination with @entity117 plus @entity1397 or with @entity117 alone compared with @entity117 plus @entity1397 or @entity117 alone was   6203 per quality-adjusted life-year (QALY) gained. In contrast, the ERG's preferred base case estimate was   5622 per QALY gained. The ICER did not rise above   10,000 per QALY gained in any of the sensitivity analyses undertaken by the ERG, although the inflexibility of the company's economic model precluded the ERG from formally undertaking all desired exploratory analyses. As such, only a crude exploration of the impact of additional @entity548 events could be undertaken. The NICE Appraisal Committee concluded that the ICERs presented were all within the range that could be considered cost effective and that the results of the ERG's exploratory sensitivity and scenario analyses suggested that the ICER was unlikely to increase to the extent that it would become unacceptable. The Appraisal Committee therefore concluded that @entity3925 in combination with @entity117 plus @entity1397 , or with @entity117 alone, was a cost-effective use of National Health Service (NHS) resources for preventing atherothrombotic events in @entity1 with @entity1187 and elevated cardiac biomarkers.

@entity3925 for Preventing Atherothrombotic Events in XXXX with @entity1187 and Elevated Cardiac Biomarkers: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

@entity1 :: ('9606', 'Species') :: ['patients', 'people'] @entity1187 :: ('MESH:D054058', 'Disease') :: ['ACS', 'acute coronary syndrome'] @entity64 :: ('MESH:D020521', 'Disease') :: ['stroke', 'ischaemic stroke'] @entity932 :: ('MESH:D020300', 'Disease') :: ['intracranial haemorrhage'] @entity1396 :: ('MESH:D013988', 'Chemical') :: ['ticlopidine'] @entity548 :: ('MESH:D006470', 'Disease') :: ['bleeding'] @entity1397 :: ('MESH:C055162', 'Chemical') :: ['clopidogrel'] @entity117 :: ('MESH:D001241', 'Chemical') :: ['aspirin'] @entity10260 :: ('MESH:C535661', 'Disease') :: ['ST'] @entity1747 :: ('MESH:C446540', 'Chemical') :: ['thienopyridine'] @entity3925 :: ('MESH:C503223', 'Chemical') :: ['rivaroxaban'] @entity951 :: ('MESH:D000787', 'Disease') :: ['angina'] @entity583 :: ('MESH:D009203', 'Disease') :: ['NSTEMI', 'STEMI', 'myocardial infarction', 'segment elevation myocardial infarction', 'non-ST segment elevation myocardial infarction']
@entity1 :: (9606,Species) :: ['People']
