Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Migraine Headaches
Treatment: Emgality 120mg/ml Pen INJCTR, Pre-service
The insurer denied the Emgality 120mg/ml Pen INJCTR, pre-service.
The denial is upheld.

The patient is a female with migraines. Her headaches began in middle school and worsened over time to the point of being daily for two years. She used MigreLief without improvement. She was then treated with nortriptyline, and the headaches initially improved with lower severity and a frequency of 12 per month. The dose was increased earlier in the year. She then started Ajovy approximately two months later and headaches decreased again to 2-3 per month.

As of the patient's last visit, her headaches were unchanged from the prior visit approximately two months prior. She was getting headaches every other day with severe headaches 1-2 times per week. Active treatments include Ajovy and nortriptyline. She also tried a Cefaly device without improvement. Her neurologist recommended treatment with Emgality.

Coverage for Emgality was denied by the health plan due to patient being below 18 years of age and a lack of failure of a prior treatment with 2 preventative headache medications with different mechanisms for 3 months. The denial was appealed with the argument that Emgality is the best option for the patient despite her age as she is fully developed and other treatments have failed. Also stated is that the remaining options are more expensive (Botox) or relatively contraindicated (topiramate) in patients with depression. The review is in regards to Emgality use.

No, the requested Emgality is not medically necessary.

The treating physician replied that the patient has limited options and those options are contraindicated.

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 inhibitors only in patients 18 years and older. CGRP 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 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 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. 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. There are controlled clinical trials ongoing for this drug class in pediatric patients, but results will not be available until the trials are concluded. Therefore, there is a lack of sufficient data to support the use in this age group. There are other treatment options available as reviewed in the American Academy of Neurology practice guidelines including medications from different classes available to preventative headache treatment, including topiramate and beta blockers.

In summary, there are other treatment options available to the patient. There is a lack of data supporting Emgality use in the patient age due to lack of proven safety or efficacy. Therefore, the request for Emgality is not medically necessary.

Yes, the health plan did act reasonably, with sound medical judgment, and in the best interest of the patient.

As discussed in question 2, there is a lack of data to support Emgality use in the patient's age. Given the lack of safety and efficacy data, Emgality use in the patient's age is not considered standard of care and thus the plan acted with sound medical judgment and in the best interest of the patient.