Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Severe Headaches
Treatment: Emgality Pen 120mg/ml Pen Injector
The insurer denied the Emgality Pen 120mg/ml Pen Injector.
The denial is upheld.

The patient is a female with migraine headaches. She receives Emgality as headache preventative treatment. Her headaches are improved since starting this treatment. She previously failed Ajovy, celexa, and gabapentin. There is no documented history she has used amitriptyline, topiramate, valproic acid, or beta blockers. Her neurologist requested treatment with Emgality.  The prior denial reason was that the patient is below the documented age for use.  The reason for appeal is that there is data to support Emgality use in her age. This review is in regards to Emgality use.

No, the health plan should not cover the requested Emgality.
There is a lack of controlled clinical trial data supporting Emgality use in patients below 18 years of age. 

No, the requested Emgality is not more beneficial.
Emgality is a calcitonin gene-related peptide (CGRP) inhibitor. This medication is currently FDA (United States Food and Drug Administration) approved for the preventive treatment of migraines in patients 18 years and older, for which it has proven efficacy and safety data.

A recently published review by the American Headache Society supports using CGRP (calcitonin gene-related peptide) inhibitors only in patients 18 years and older. CGRP (calcitonin gene-related peptide) inhibitors are not a recommended treatment for the preventative treatment of migraine by the most recent American Academy of Neurology practice guidelines (Oskoui). There is a recent publication from a special interest group within the American Headache Society providing expert level support for using CGRP (calcitonin gene-related peptide) inhibitors in patients below 18 years of age. However, there are no controlled studies to provide efficacy or safety data in patients below 18 years of age to support this recommendation. In addition, the opinion expressed is of the members and does not represent the opinion of the American Headache Society (Szperka).

There is a retrospective study of CGRP (calcitonin gene-related peptide) inhibitors used for prevention of migraine in adolescent patients, which showed an improvement in the number of headache days and functioning compared to their baseline (Greene). However, the level of supporting data for efficacy is low, as there was no control group. Thus, comparison to placebo could not be assessed. There are controlled clinical trials ongoing for this drug class in pediatric patients, but results will not be available until the trials are concluded. This is important data to obtain, as there is a very high rate of placebo response to headache preventative treatments in the pediatric age group.

Current standard of care treatment options for pediatric migraine prevention likely to provide a benefit, per AAN (American Academy of Neurology) guidelines include amitriptyline with cognitive behavioral therapy, cinnarizine, topiramate, and possible propranolol. In addition, standard non-pharmacological treatments include assessment and treatment or modification of sleep problems, anxiety, stress, and other health and lifestyle factors (Burch, Qubty). Emgality cannot be determined to be superior to any of these therapies as it lacks supporting controlled clinical trial data. The documentation does not reflect these factors as being assessed and reassessed on follow up. In summary, as the patient is below 18 years of age and there is a lack of sufficient data to support Emgality use in this age, Emgality cannot be determined to be superior to any standard therapies.