Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Migraine Headaches. 
Treatment: Aimovig. 

The insurer denied the Aimovig. 
The denial is upheld. 

The patient is a female with migraines. Emgality was started earlier this year and the headaches decreased from 2-3 per week to 3-4 per month. As of her last clinic visit, her headaches had worsened and became daily for about two months. She reported severe headaches 3-4 times per week. She reported daily nausea. As of that visit she was taking rizatriptan 2-4 times per week for abortive migraine treatment. She has previously tried cyproheptadine, amitriptyline, nortriptyline, and fluoxetine.  Her neurologist recommended a change from Emgality to Aimovig. 

Aimovig was denied by the plan as not medically necessary, due to the patient's age being below 18 years old and a requirement to try and fail two medications from two different classes. The plan requires medication trials from tricyclic antidepressants, beta blockers, anticonvulsants, or Botox. The ordering physician appealed this decision, stating the patient had failed first line therapies and other therapies were more expensive or relatively contraindicated and Aimovig was the patient's best option. This review is in regards to Aimovig use. 

No, the Aimovig is not medically necessary. 

Aimovig 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. Thus, current published guidelines and studies support the plan's reasoning for denial of Aimovig due to the patient's age being below 18 years of age. 

In regards to the plan's requirement of a failure of 2 medications from 2 different medication classes, these classes include medications supported as treatment options by the American Academy of Neurology (AAN) practice guidelines. The patient has failed medications from the tricyclic medication class, but has not failed treatment with beta-blockers or anticonvulsants. Propranolol and topiramate are listed as potential treatments to consider per the AAN treatment guidelines for preventive pediatric migraine treatment. Thus, the plan's listed treatment alternatives are within standards of care. 

Therefore, as the patient is below 18 years of age and there is a lack of sufficient data to support Aimovig use in this age range, the request for Aimovig 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 above, there is a lack of data to support efficacy and safety of migraine preventative treatment with CGRP inhibitors in patients below 18 years of age. Thus this class of medications, including Aimovig, is not a standard of care treatment in patients below 18 years old. As Aimovig lacks safety and efficacy data in this age, the health plan did act reasonably, with sound medical judgment, and in the best interest of the patient.