Diagnosis: Deep vein thrombosis
Treatment: Eliquis
The insurer denied Eliquis.
The denial is upheld.

The patient is a female with a history of deep vein thrombosis (DVT) treated with Xarelto. About one week later, she presented to the emergency room with vaginal bleeding. The vital signs were non-contributory, she was in no distress, and the physical exam revealed vaginal bleeding. The hemoglobin and hematocrit were normal. Ultrasound revealed a thickened endometrial stripe, and a right complex ovarian cyst. Rivaroxaban (Xarelto) was discontinued, and the patient was discharged on Lovenox. The patient was evaluated by a hematologist. The medication history documented the discontinuation of Xarelto and the initiation of Lovenox and Eliquis. There were no complaints of continued bleeding or bruising noted, and there was no bruising noted on physical exam. Additional laboratory studies were ordered, and a plan was made to return to the clinic in about 2 months. The subject under review is the request for use of the non-formulary drug Eliquis.

The health plan's determination is upheld.

There is no clear evidence that the formulary drug warfarin will be or has been ineffective, would not be as effective as the non-formulary drug (Eliquis), or would have more adverse effects.

All oral anticoagulants have risks of bleeding. Studies have shown that the direct oral anticoagulant medications, such as apixaban (Eliquis) and rivaroxaban (Xarelto) are similar to warfarin in efficacy with a lower risk of intracranial bleeding. There is no clear evidence that the direct oral anticoagulants have a lower risk of other bleeding, such as vaginal bleeding. The patient's plan requires that the patient try and fail both preferred formulary agents, Xarelto and warfarin. The records show that the patient had vaginal bleeding on Xarelto. However, the medical records provided do not clearly document evidence that the patient has tried warfarin, and if she did, whether it was ineffective or caused significant complications.

Therefore, based on the plan formulary, the standard of care, as well as the peer reviewed literature, it cannot be stipulated that the formulary drug warfarin will be or has been ineffective, or that it will cause more adverse effects.