Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Migraine Headaches
Treatment: Emgality 120mg/ml Pen Injection
The insurer denied: Emgality 120mg/ml Pen Injection
The denial is overturned.

The patient is a teenaged female with chronic migraine headaches. She has no relevant comorbidities. MRI (magnetic resonance imaging) brain without IV (intravenous) contrast was normal. Past treatments include amitriptyline which made her tired, magnesium which was ineffective, nortriptyline which led to insufficient response, topiramate which was discontinued due to side effect of paresthesia. She was prescribed Emgality which has been effective without side effects. Her current subjective complaints are headaches 4 times per week, 1-2 moderate to severe headaches which have improved since starting Emgality from 5 headaches a week, with 3 severe headaches per week.
The request is for Emgality for migraine headache prevention.

The requested Emgality is medically necessary. 

Presently, there are no CGRP (calcitonin gene-related peptide)-targeting treatments that have received FDA (United States Food and Drug Administration) approval for chronic migraine. In pediatric disorders, specialists utilize on available randomized controlled trials, expert opinion and clinical judgment to determine to appropriateness of utilization of medications without pediatric indications to treat pediatric patients. In the case of CGRP (calcitonin gene-related peptide)-targeting treatments, there is a growing body of literature utilizing cohort studies and expert opinion which support usage of CGRP (calcitonin gene-related peptide)-targeting treatments for pediatric patients with chronic and episodic migraine.
Szperka CL et al 2018, is an expert opinion paper by the global experts on migraine and pediatric migraine. The consensus opinion is that it is reasonable to consider anti-CGRP (calcitonin gene related peptide) monoclonal antibody therapy with careful monitoring a younger child with severe chronic migraine that has been proven refractory to multiple migraine preventive trials. This paper also made recommendation for the type of clinical studies that would fortify the literature for the safety and efficacy of CGRP (calcitonin gene-related peptide)-targeting treatments in the pediatric population.
Following the Szperka paper, Greene KA et al in 2020 performed a retrospective multisite cohort study of patients less than 18 years of age who received a CGRP (calcitonin gene-related peptide) monoclonal antibody for headache prevention. There was clinically meaningful reduction in headache days and severity, and clinically meaningful improvement in functional impairment as measured by a validated pediatric migraine measure of function (pediMIDAS). The patient has initiated treatment with Emgality 5 months ago and had a positive clinical response without adverse effects. If the patient is unable to obtain this medication it is reasonable to conclude that her symptoms would worsen and return to the baseline headache frequency and severity. Therefore, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient, based on the medical record, the status of the medical literature and accepted clinical practice in the specialty of child neurology. For these reasons, the requested Emgality is medically necessary.