Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #1:

Diagnosis: Pediatric migraine headaches

Treatment: Nurtec ODT (oral disintegrating tablet) 75 mg (milligram) TAB (tablet) RAPDIS 8.0 for 30 days

The insurer denied coverage for Nurtec ODT 75 mg TAB RAPDIS 8.0 for 30 days

The denial is upheld 

Patient is a young teenager, with chronic migraines. Patient has tried occipital nerve block, Compazine, Aimovig, propranolol, venlafaxine, and biofeedback. Abortive therapy has included ibuprofen, Zomig, Benadryl, Zofran, Sudafed, Sumatriptan, Maxalt, CBD (Cannabidiol) gummies, Naratriptan, Naproxen and Nurtec. Prophylactic therapy has included magnesium oxide, CoQ10 (Coenzyme Q10), Topamax, Amitriptyline, and Prozac. The magnetic resonance imaging (MRI) of the brain was normal. The use of Nurtec was prescribed and provides relief for a few minutes.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcomes.

There is insufficient strong literature to support improvement in health outcomes with Nurtec for pediatric patients with migraines.

According to Oskoui, et al., (2019), "Fifteen Class I-III studies on migraine prevention in children and adolescents met inclusion criteria. There is insufficient evidence to determine if children and adolescents receiving divalproex, onabotulinumtoxinA, amitriptyline, nimodipine, or flunarizine are more or less likely than those receiving placebo to have a reduction in headache frequency. Children with migraine receiving propranolol are possibly more likely than those receiving placebo to have an at least 50% reduction in headache frequency. Children and adolescents receiving topiramate and cinnarizine are probably more likely than those receiving placebo to have a decrease in headache frequency. Children with migraine receiving amitriptyline plus cognitive behavioral therapy are more likely than those receiving amitriptyline plus headache education to have a reduction in headache frequency."

According to Szperka C. (2021), "Consistent lifestyle habits may help to minimize migraine triggers and should be discussed with all patients. Factors outside the child's control may preclude the development of healthy lifestyle habits, including school start time, homework, and work schedules of parent(s)/guardian(s). Even when children intend to follow the advice, adherence is difficult. Furthermore, little evidence is available to guide which specific changes actually impact headache frequency. Preventive treatment should be considered in all children who have frequent headaches or significant headache-related disability, or both. High placebo response in trials limits the ability to demonstrate efficacy of a medication. However, in clinical practice, placebo response can be beneficial, as the goal is patient improvement without harm. The guidelines recommend consideration of topiramate, propranolol, and amitriptyline combined with cognitive-behavioral therapy, which was demonstrated to be superior to amitriptyline plus headache education."      

Nurtec is not approved for pediatric patients with migraines.     

There is insufficient evidence to support using Nurtec in pediatric patients with migraines; therefore, this patient is not a good candidate for Nurtec ODT.     

Nurtec ODT is not the best available treatment for this patient at this time.

There are other available treatments indicated for pediatric patients with migraines.     

The adverse risks are increased over standard treatment/services since there are no strong data detailing adverse risks for Nurtec in pediatric patients.     

Nurtec is not likely to be more beneficial than any of the standard treatments for this patient.

In summary, the denial of Nurtec ODT 75 mg TAB RAPDIS 8.0 for 30 days should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are substantially increased over standard treatments.