Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis:  Migraine headaches.
Treatment:  Nurtec ODT (oral disintegrating tablets) 75 mg (milligram) tablets.
The insurer denied coverage for Nurtec ODT (oral disintegrating tablets) 75 mg (milligrams) tablets.  
The denial is overturned.

This case involves a teenager diagnosed with epilepsy and migraines who is being recommended for Nurtec ODT 75 mg tablets.  The patient previously tried ibuprofen, Tylenol, Benadryl, ondansetron, rizatriptan benzoate 10 mg oral tablets, along with Cefaly and biofeedback, cyproheptadine, amitriptyline, nortriptyline, lamotrigine, magnesium oxide, propranolol, venlafaxine ER (extended release), fluoxetine, and Emgality. The patient received a notice of adverse determination regarding Nurtec ODT, which stated that the medication was denied as Nurtec is not FDA (Food and Drug Administration) approved for the use in patients under the age of 18 and is therefore considered an off-label use. The report stated there was no literature to support the off-label use of this drug. The treating physician responded noting that the patient was having severe headaches that have not responded to multiple treatment options. This was taking a drastic toll on her life and her ability to function. She was missing school several days a week, and all frontline typical medication classes for migraine prophylaxis had either been tried and failed or contraindicated in this situation. The physician stated that the patient's age should not preclude her from getting the medication that is best suited for her needs. The physician also stated that there is literature to support the use of Nurtec ODT in the pediatric population.

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcomes.

Nurtec ODT 75 mg tablets has final approval from the appropriate regulatory bodies for this diagnosis.

This patient is a good candidate for Nurtec ODT 75 mg tablets.

Nurtec ODT 75 mg tablets is the best available treatment for this patient at this time.

The adverse risks are not increased over standard treatment/services.

The requested services likely to be as beneficial or more beneficial than any of the standard treatments/procedures for this patient.

First-line pharmacologic therapies for the elimination of acute migraine in adolescents includes acetaminophen, naproxen, and ibuprofen with triptans also approved by the FDA. The treating physician stated that the patient is 5 feet 1 inch in height, 131 pounds and considered equivalent of a grown woman whose biology is no different from the biology of an adult. Nurtec has been well studied and proven to be effective and safe for the pathology the patient has displayed.  Given the patient's extensive use of other medications with refractory headaches, it was deemed reasonable to trial her on Nurtec ODT at this time. As such, the request for Nurtec ODT 75 mg tablets is supported.

In summary, the denial of Nurtec ODT 75 mg tablets and coverage for the requested treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.