Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Migraine Headaches. 
Treatment: Nurtec Tablet Disintegrating 75mg (milligrams). 
The insurer denied Nurtec Tablet Disintegrating 75mg. 
The determination is overturned. 

The patient is a female who has been diagnosed with chronic migraine. According to a letter by her treating pediatric neurologist, she has had an increase in the frequency and severity of her headaches, so that she is now having at least 15 days per month when she has migraines. 
She experiences pounding pain in her temples and forehead, with associated nausea, dizziness/vertigo, photophobia and phonophobia. 
She has tried numerous preventative medications which have not resulted in improvement in her headaches. Medications have included riboflavin, magnesium, amitriptyline, topiramate, propranolol, gabapentin, and nortriptyline. Acute abortive medications have included ibuprofen, rizatriptan, sumatriptan, zolmitriptan, diclofenac, almotriptan, flurbiprofen, tizanidine and ondansetron. She has recently started Aimovig injections. Her provider would like to start her on Nurtec oral disintegrating tablet (ODT) (Rimegepant), an oral inhibitor of the calcitonin gene-related peptide (CGRP) receptor. The health plan has denied the medication because it is not Food and Drug Administration (FDA)-approved for individuals less than 18 years old. 
At issue in this review is the medical necessity of Nurtec Tablet Disintegrating 75 milligrams (mg). 
The requested health service/treatment of Nurtec Tablet Disintegrating 75 mg is medically necessary for this patient. 
Nurtec ODT (Rimegepant) is an oral medication which blocks the activity of calcitonin gene-related peptide (CGRP). CGRP and its receptor play a key role in migraine. Edvinsson described that monoclonal antibodies against calcitonin gene-related peptide (CGRP) or its receptor offer considerable improvements over existing drugs in migraine prophylaxis and are the first designed to act on the trigeminal pain system. 
Migraine is common in children and adolescents. 
In order to justify taking on the possible risks of the anti-CGRP 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 judgement and the authors of this manuscript had varied recommendations between two and three prior preventives." 

Although the patient is below the age of 18, she is anatomically and physiologically an adult. There is adequate support in the medical literature of the use of anti-CGRP monoclonal antibodies being safe and effective treatments for refractory chronic migraine in adolescents. Szperka described that a consortium of pediatric headache specialists in the US supported the use of the drugs following adequate trials of alternative, FDA-approved medications, which this patient has has had. Greene et al demonstrated their safety and efficacy in a cohort of 112 adolescents. A clinical trial on use of rimegepant in pediatric subjects is currently underway. 
Use of drugs off-label in children that are FDA-approved for adult use is very common. The Committee on Drugs of the American Academy of Pediatrics has addressed the off-label use of drugs in children in a Policy Statement: does not necessarily mean that the drug's use is improper for that age or disorder. Rather, it only means that the evidence required by law to allow inclusion in the label has not been approved by the FDA. Additionally, in no way does a lack of labeling signify that therapy is unsupported by clinical experience or data in children. Instead, it specifically means that evidence for drug efficacy and safety in the pediatric population has not been submitted to FDA for review or has not met the regulatory standards of "substantial evidence" for FDA approval."