Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Migraine headache
Treatment:: Aimovig
The treatment with Aimovig autoinjector 70mg/ml is not medically necessary.

The patient is a female with a several-year history of headaches. Her headaches had worsened in early last year, at which time the headaches occurred four to six times per month, with six to nine headache days. At that time, she rated her pain as ten out of ten (10/10). Her headaches were not helped by sleep and they worsened with routine physical activity.  

The patient was prescribed Trokendi ER along with Maxalt to be used as rescue medication. Zofran was also prescribed for nausea.  Some improvement was noted as of a follow-up with her neurologist, Yuliya Snyder, M.D.  

As of a follow-up with Dr. Snyder, the patient reported worsening of her headaches, with several headaches during the month. Maxalt was switched to zolmitriptan, as the patient's headache frequency was not at goal, and she continued to have multiple headaches per month despite topiramate and venlafaxine.  Dr. Snyder recommended Aimovig be added.  

The statement, "Recommendations on the use of anti-CGRP monoclonal antibodies in children and adolescents," by the American Headache Society indicates the following: "In order to justify taking on the possible risks of the anti-CGRP (calcitonin gene-related peptide) mAbs (monoclonal antibodies) in this population, patients should have had adequate trials of, or contraindications to, established migraine preventive therapies. How many preventives should be tried first is a matter of clinical judgment, and the authors of this manuscript had varied recommendations between two and three prior preventives. Some insurance companies may require patients to have trialed at least two prescription preventive medications that are deemed to have Level A evidence for migraine prevention in adults. Given that the Childhood and Adolescent Migraine Prevention (CHAMP) trial demonstrated similar rates of improvement in children and adolescents treated with placebo as with prescription preventives, we recommend that in these age groups the options for previous preventive treatment trials be expanded beyond prescription preventive medications to include, though not require, trial of cognitive behavioral therapy, which is well-supported by evidence, as well as treatments that have fewer side effects such as neuromodulation devices and supplements (riboflavin, Coenzyme Q10, magnesium, and melatonin)." 

In the patient's case, the medicine requested, Aimovig, is not approved by FDA for the patient's age, and the patient was not tried on neuromodulation, cognitive behavioral therapy, as well as supplements. Therefore, the medicine requested is not within the standards of care, is not generally accepted in pediatric neurology community, and therefore is not medically necessary.

The medicine requested is not approved in children under age 18. There is no evidence that this medicine is more beneficial than the standard preventative medications, such as propranolol or Depakote.

The provider states that there are no approved medications for chronic migraines in children. However, this patient does not meet criteria for chronic migraines being 15 headaches a month, each lasting over four hours. Therefore, the reasoning about the absence of approved medications for chronic migraine in children does not apply to this patient. Additionally, off-label use of the medicine requested is not considered to be appropriate in this case, since the bulk of evidence regarding safety and efficacy in pediatric population is minimal. Literature search regarding Aimovig use in children brings essentially no results. There are no randomized double-blind placebo control studies to indicate that Aimovig is better tolerated or more efficacious than standard migraine preventative medications such as Depakote or propranolol.