Diagnosis: Migraine Headaches.
Treatment: Botox.

The insurer denied the Botox. The denial is upheld.

The patient is a female with chronic migraine headache disorder. She is treated with Emgality and Botox (abobotulinumtoxinA) to prevent migraine.

No, the treatment with Botox (abobotulinumtoxinA) is not medically necessary.

There are no high-quality clinical studies or standard-of-care guidelines demonstrating that Botox (abobotulinumtoxinA) is safe or effective when used with a CGRP (calcitonin gene-related peptide) inhibitor, as requested here. The pivotal trial leading to the FDA (Food and Drug Administration) approval of Emgality for migraine prevention excluded persons who were treated with Botox (abobotulinumtoxinA) at study commencement. Therefore, the safety and efficacy of Botox (abobotulinumtoxinA) combined with Emgality remains undetermined. A recent review article (Pellesi et al.) concluded that the there is no clinical evidence to support using both agents concurrently and that, "Rigorous studies evaluating clinical efficacy, safety...are needed."