Credit: Andre E.X. Brown
The UK’s National Institute for Health and Care Excellence (NICE) has issued a draft guidance recommending rivaroxaban (Xarelto) as an option for preventing atherothrombotic events in patients with acute coronary syndrome (ACS).
The agency is recommending rivaroxaban in combination with aspirin plus clopidogrel or aspirin alone to prevent atherothrombotic events in ACS patients with elevated cardiac biomarkers.
This includes patients who have had ST-segment-elevation myocardial infarctions (STEMIs) or non-ST-segment myocardial infarctions (NSTEMIs) but not unstable angina. In unstable angina, damage to the heart is not severe enough to result in the release of biomarkers into the blood, so this condition is not included in the draft guidance.
Because rivaroxaban increases the risk of bleeding, NICE recommends that clinicians undertake a careful assessment of a patient’s bleeding risk prior to treatment and ensure patients understand the benefits and risks associated with rivaroxaban.
Furthermore, clinicians should reassess the relative benefits and risks of continuing rivaroxaban treatment no later than 12 months after starting treatment.
Clinical and cost-effectiveness
An independent appraisal committee advising NICE concluded that rivaroxaban given at 2.5 mg twice daily in combination with aspirin plus clopidogrel or with aspirin alone was more effective than aspirin plus clopidogrel or aspirin alone for preventing further cardiovascular deaths and myocardial infarction in patients with ACS and raised cardiac biomarkers.
“The committee therefore recommended rivaroxaban as a cost-effective use of [National Health Service] resources,” said Carole Longson, NICE Health Technology Evaluation Centre Director.
The committee noted that, according to Bayer Healthcare (makers of rivaroxaban), the base case incremental cost-effectiveness ratio (ICER) was £6203 per quality-adjusted life-year (QALY) gained. The evidence review group’s preferred base case estimate was £5622 per QALY gained.
The committee acknowledged that there is uncertainty about the validity of the results, which were based on the ATLAS-ACS 2-TIMI 51 trial, because of the risk of bias resulting from missing trial data and informative censoring.
However, the committee considered that the ICERs presented were all within the range that could be considered cost-effective, and adjusting for the various types of bias that might have occurred was unlikely to increase the ICER to the extent that it would become unacceptable.
The list price of rivaroxaban is £58.88 per 2.5 mg, 56-capsule pack (excluding value-added tax). The license dose is 2.5 mg twice daily, which equates to a price of £2.10 per day.
Assuming a treatment duration of 12 months, total acquisition costs are £766.50. Costs may vary in different settings because of negotiated procurement discounts.
The draft guidance for rivaroxaban in ACS can be found on the NICE website. The closing date for comments is November 13, 2014.
