
201908-120614
2019
Excellus
Medicaid
Central Nervous System/ Neuromuscular Disorder
Pharmacy/ Prescription Drugs
Experimental/Investigational
Upheld
Case Summary
According to the submitted medical records, the patient is female has a listed diagnosis of chronic migraine without aura. Headaches are reported to have worsened after head trauma. An office visit reports patient has never been on any prophylactic agents. An appeal letter states she had side-effects to topiramate, but those are not detailed. There is no office visit note or any other legible documentation regarding such side-effects. Asthma is mentioned, as is the fact she is on antidepressants. There are no comments or specifics as to why switching current anti depressants to ones known to improve migraines is not feasible or has not been considered.
The health plan's determination is upheld. Emgality is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
There is no evidence from any large, randomized, controlled study to support that Emgality would be superior to all available alternative treatments for this patient, as documented in the medical records.
In fact, there is insufficient evidence, as published in high quality peer reviewed literature to support that Emgality would be safe and effective for this patient.
The CGRP trials, including the ones for Emgality, did not include pediatric patients. Consequently, Emgality is not Food and Drug Administration (FDA) approved for the pediatric population, and its use is not endorsed by the manufacturer for the pediatric population.
A recent review of the treatment of migraines in the pediatric population by Kenneth Mack makes no mention whatsoever of the use of any CGRP blockers including Emgality.