Appeal type: Formulary Exception
Decision: Overturned

Diagnosis:  Venous thromboembolism (VTE).
Treatment:  Eliquis (apixaban).

The insurer denied coverage for Eliquis (apixaban).  The denial is overturned.

The patient has been diagnosed with venous thromboembolism (VTE). The patient has been stable on Eliquis. The treating provider has requested a continuation of therapy with Eliquis.

The formulary drug(s) are not likely to cause the patient an adverse reaction.

The formulary drug has not been tried and failed; therefore, there is no indication the formulary drug has been ineffective.     

The requested drug would be more effective than the formulary drug.

The patient has been diagnosed with venous thromboembolism (VTE). The patient is currently taking Eliquis (apixaban). This is a continuation request. The patient is stable on a current regimen. The patient is free of adverse side effects. The patient is tolerating the treatment regimen well, currently with Eliquis (apixaban). The requested, Eliquis (apixaban) is approved for the treatment of venous thromboembolism (VTE) and cerebral vascular accident (CVA) prevention, in the setting of atrial fibrillation (A-FIB). 

The DOACs (Direct oral anticoagulants) differ significantly from vitamin K (potassium) antagonists in their onset of action, half-life, drug-drug interactions, need for monitoring, ability to monitor should this be called into question, as well as availability of antidotes in the case of excessive bleeding. Overall, all-cause mortality from DOACs appears to be lower than that from warfarin, driven primarily by a decrease in fatal intracranial bleeding risks. Compared to Xarelto, the drug Eliquis (apixaban), also has been shown to have reduced rates of bleeding and improved prevention of thrombosis. 

This individual has VTE and is stable on Eliquis (apixaban). Ongoing therapy would be warranted versus changing to alternative agents. Switching medications would jeopardize the patient's clinical stability. Therefore, the request is approved and medically necessary for this patient in this clinical setting.

"Conclusion: In routine care, adults with atrial fibrillation prescribed apixaban had a lower rate of both ischemic stroke or systemic embolism and bleeding compared with those prescribed rivaroxaban." (Fralick, et al., 2020).

"Both apixaban and rivaroxaban have been approved for use in acute venous thromboembolism (VTE). Although indirect comparison through network meta-analyses of randomized trials have been performed to compare the efficacy and safety of these agents, further comparison between these agents was lacking until recently. We sought to systematically review and carry out a meta-analysis of studies to further compare apixaban with rivaroxaban from multiple studies done in the real-world settings. Studies comparing rivaroxaban with apixaban in patients with acute VTE were identified through electronic literature searches of MEDLINE, EMBASE, Scopus, and the Cochrane library up to May 2019. Study-specific risk ratios (RRs) were calculated and combined using a random-effects model meta-analysis. In an analysis involving 24041 patients, recurrent VTE within 6 months occurred in 56 of 4897 patients (1.14%) in the apixaban group and 258 of 19144 patients (1.35%) in the rivaroxaban group (RR, 0.89; 95% confidence interval [CI], 0.67-1.19; P (probability) = .45). Clinically relevant major bleeding occurred in 85 of 11559 patients (0.74%) in the apixaban group and 350 of 33909 patients (1.03%) in the rivaroxaban group (RR, 0.73; 95% CI, 0.58-0.93; P = .01). Clinically relevant nonmajor bleeding occurred in 169 of 3417 patients (4.95%) in the apixaban group and 1094 of 12475 patients (8.77%) in the rivaroxaban group (RR, 0.59; 95% CI, 0.50-0.70; P < .01). Apixaban shows equivalent efficacy in prevention of recurrent VTE but decreased risk of major and minor bleeding events compared with rivaroxaban." (Aryal, et al. 2019).

The carrier's denial of Request for Formulary Exception for Eliquis (apixaban) is overturned.