![]() ![]() 4,5Additionally, ongoing studies have demonstrated a limited adverse effect profile, with reported adverse effects primarily consisting of infusion-related reactions, such as flushing. For instance, when the drug has been administered to patients with ICH, mortality has been found to decrease from a baseline of 35% to 48% to a reduced rate of 12%. The 2 most common reasons for administration are intracranial hemorrhages (ICHs) and gastrointestinal bleeds (GIBs), and study results in these populations have been promising. Two randomized phase 3 trials have already been conducted with the therapy and have demonstrated a more than 90% decrease of factor Xa activity from baseline levels within 2 to 5 minutes. 2 It is specifically approved by the US Food and Drug Administration to provide acute reversal of these 2 agents in life-threatening situations or other acute uncontrolled bleeding events. 2Īndexxa is a recombinant decoy protein that rapidly reverses the anticoagulant effects of 2 direct oral anticoagulants, apixaban and rivaroxaban. 4 Fortunately, the entry of andexanet alfa (Andexxa) to the market in May 2018 may prove groundbreaking this is the first known reversal agent for a subset of direct factor Xa inhibitors. The 30-day mortality rate is 15% to 20% for patients who develop a major bleed while anticoagulated on these medications. 3 After the bleeding begins, the risk of death or disability can be high. This is in large part because more than 84,000 patients taking direct factor Xa inhibitors are hospitalized every year in the United States due to major bleeds. 2 Although this newer class of drugs represents an important advancement in anticoagulation therapy and is touted as revolutionary, concern over the lack of reversal agents has hampered enthusiasm for its use. Administration indications include stroke prevention in patients with nonvalvular atrial fibrillation, as well as secondary prevention of deep-vein thrombosis and pulmonary embolism. 1 These oral anticoagulants provided efficacious alternatives over traditional warfarin due to their comparative safety profile, ease of use, and practical advantage of not requiring routine coagulation monitoring. This was followed by the ratification of direct factor Xa inhibitors, which included rivaroxaban, apixaban, and edoxaban, within a 5-year time span. The use of direct oral anticoagulants has continued to increase since the approval of the direct thrombin inhibitor, dabigatran, in 2010. #Antidote for eliquis trialSensitivity analyses further indicated that while Andexxa may be cost-effective to treat gastrointestinal bleeds, medication trial data will likely need to show significant impact on a patient’s quality of life and relative risk of death following an intracranial bleed to be cost-effective.ĭiscussion: Although the application of these findings is restricted due to limited trial data, beginning to understand the cost-effectiveness of Andexxa provides policymakers important insight into the economic value of the intervention. Results: The Markov model showed that the incremental cost-effectiveness ratio of Andexxa over the standard of care is $211,056 for an intracranial hemorrhage and $40,718 for a gastrointestinal bleed. The model included a hypothetical cohort of patients aged 65 years at an increased risk of stroke due to nonvalvular atrial fibrillation and with no contraindication to anticoagulation. ![]() Multiple 1-way and 2-way sensitivity analyses were also constructed to delineate the impact Andexxa would need to have on mortality rates and health-related quality of life to meet the willingness-to-pay thresholds ranging between $50,000 and $150,000. Methods: To explore the cost-effectiveness of Andexxa, a Markov model was generated using existing Andexxa trial data and related literature. Andexxa is costly, however, ranging between US $24,750 and $49,500 for treatment. It has been reported to substantially reduce mortality rates for patients who experience a major bleed while taking rivaroxaban or apixaban. In May 2018, the US Food and Drug Administration approved andexanet alfa (Andexxa), the first known reversal agent for a subset of direct factor Xa inhibitors. Introduction: Tens of thousands of patients die of major life-threatening bleeds every year while taking direct factor Xa inhibitors, a class of anticoagulant medications that until now had no reversal agent. ![]()
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