Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Migraine

Treatment: Emgality

The insurer denied coverage for Emgality

The denial is overturned

The patient is a teenager seeking authorization for Emgality. The patient presented for follow-up related to chronic migraines without aura. At that point, the patient was getting 2-3 headaches per week with 1 bad headache weekly. Since then, the patient has been doing better with headaches only every other week. The patient was on topiramate 50 milligrams (mg) twice daily and tolerated it well with no side effects reported. The patient was on Emgality prophylaxis which worked well without side effects. Prior treatment included Excedrin migraine, ibuprofen, Tylenol, Aleve, Maxalt, Zofran, zolmitriptan, naproxen, naratriptan, fluoxetine, nortriptyline, topiramate, and Ajovy. The physical exam findings of the patient were unremarkable. Continuation of Emgality was recommended.

Per the Food and Drug Administration (FDA), Emgality is indicated for the preventative treatment of migraines in adults. The dosage is recommended at 240 mg loading dose administered as 2 consecutive injections of 120 mg each followed by monthly doses of 120 mg. It is not known if Emgality is safe and effective in children. Per the additional cited literature, calcitonin gene related peptide monoclonal antibody medications for the treatment of adolescents with migraine headaches appear to benefit a proportion of adolescents with chronic refractory headache disorders. Treatment may be considered in post pubertal adolescents experiencing frequent migraine headaches with moderate or severe migraine-related disability. The American Headache Society (AHS) has proposed recommendations on the use of calcitonin gene related peptide antagonist (CGRP) drugs for pediatric headache disorders. The authors suggested that the use of CGRP receptor antagonists could be considered in adolescent patients with frequent migraine attacks (&gt;=8 headache days/month), with moderate to severe disability associated with migraine who have failed at least 2 preventive therapies. This case involves an adolescent seeking authorization for Emgality. 

The documentation detailed that the patient previously had daily headaches and was missing 12 days of school every 3 months. The patient had been treated extensively with fluoxetine, which was ineffective for headaches, nortriptyline 10 mg at bedtime with an increase to 25 mg at bedtime which caused dry mouth that was bothersome, topiramate which had been increased to 50 mg twice a day, and Ajovy. On Emgality, the patient's headaches decreased to 2-3 times a week and the headaches were much milder. The patient almost never missed school. The provider recommended continuation of the treatment due to positive response and prior failed treatments. The request does not meet the Food and Drug Administration approved indication as the FDA does not indicate the medication is for patients under the age of 18. However, continuation of the treatment is medically necessary based on standards of care and current literature. As noted in the cited literature, the medication should be considered in adolescent patients with frequent migraine attacks and with moderate to severe disability who have failed at least 2 preventative therapies. The patient reported daily headaches and missed school. The patient had failed at least 2 preventative therapies. The patient was noted to have benefit from the prescribed medication. Cessation of the medication places the patient at risk of worsening symptoms and increased functional deficit as evidenced by prior missed school. Therefore, continuation of the Emgality is medically necessary. 

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Emgality is substantiated.