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New HTA Decisions in England
November 2019
Drug name
XARELTO® (rivaroxaban)
Company
Bayer
Decision date
31/07/2019
Therapeutic area
Cardiovascular conditions
Therapeutic sub area
Acute coronary syndromes
Decision
Recommended
Indication
Rivaroxaban plus aspirin is recommended within its marketing authorisation, as an option for preventing atherothrombotic events in adults with coronary artery disease or symptomatic peripheral artery disease who are at high risk of ischaemic events.
Decision Detail
For people with coronary artery disease, high risk of ischaemic events is defined as: - aged 65 or over, or - atherosclerosis in at least 2 vascular territories (such as coronary, cerebrovascular, or peripheral arteries), or - 2 or more of the following risk factors: current smoking diabetes kidney dysfunction with an estimated glomerular filtration rate (eGFR) of less than 60 ml/min (note that rivaroxaban is contraindicated if the eGFR is less than 15 ml/min) heart failure previous non-lacunar ischaemic stroke. Assess the person's risk of bleeding before considering rivaroxaban. Treatment should only be started after an informed discussion with them about the risks and benefits of rivaroxaban, weighing up the risk of atherothrombotic events against the risk of bleeding. The risks and benefits of continuing treatment with rivaroxaban should be regularly reviewed.
Summary
The clinical evidence for rivaroxaban was presented from COMPASS, a double-blind randomised clinical trial comparing rivaroxaban plus aspirin against aspirin alone in people with stable coronary artery disease or peripheral artery disease who are at high risk of ischaemic events. The company presented data for the overall trial population and also for 3 sub-populations that it identified as being at especially high baseline risk of ischaemic events: people with coronary artery disease and peripheral artery disease, people with coronary artery disease and heart failure, and people with coronary artery disease and poor kidney function. The primary efficacy outcome in COMPASS was a composite of 3 major cardiovascular events: myocardial infarction, ischaemic stroke and 'cardiovascular death'. The committee noted that rivaroxaban plus aspirin showed a statistically significant relative risk reduction of 24% in major cardiovascular events compared with aspirin (HR 0.76, 95% confidence interval [CI] 0.66 to 0.86; p<0.001). Two of the individual components of the primary composite outcome also showed statistically significant relative risk reductions in the treatment arm: 42% for ischaemic stroke (HR 0.58, 95% CI 0.44 to 0.76; p<0.001) and 22% for cardiovascular death (HR 0.78, 95% CI 0.64 to 0.96; p=0.02). The committee concluded that rivaroxaban plus aspirin reduces the risk of cardiovascular events compared with aspirin alone, and that the greatest effect is for ischaemic stroke. However, it increases the risk of bleeding. The company's base-case incremental cost-effectiveness ratio (ICER) for rivaroxaban plus aspirin compared with aspirin alone is £14,185 per quality-adjusted life year gained. The cost effectiveness of rivaroxaban is within the range that is considered an acceptable use of NHS resources. Aspirin plus rivaroxaban is therefore recommended as a treatment option for people at high risk of having atherothrombotic events, who are not identified as having an increased risk of bleeding.