Reviewer #3:

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

The patient is a young teenager with request for Nurtec. The final determination notice indicated that Nurtec was denied for pediatric use.

The patient was seen for chronic intractable migraines. She stated that headaches were daily. Past care was listed as intravenous (IV) infusions, medications, and occipital nerve blocks. The patient reported that Nurtec made headaches worse after a few minutes of benefit. The patient also preferred non-orally dispersible tablets over ODT as they made her more likely to vomit. Treatment plan included Nurtec ODT.

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

Nurtec ODT does not have final approval from the appropriate regulatory bodies for this diagnosis in pediatric patients.

This patient is not a good candidate for Nurtec ODT.

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

Adverse risks are increased over standard treatment.

Nurtec is approved by the Food and Drug Administration (FDA) in adults for the treatment of migraine and preventive treatment of episodic migraine. The safety and effectiveness in pediatrics has not been established.

This case involves a pediatric patient who stated that Nurtec made headaches worse and was more likely to make her vomit. The recommendation for ongoing use would not be supported given lack of effectiveness. Therefore, the prior determination is upheld.

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.