Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Narcolepsy
Treatment: Formulary exception Nuvigil
The insurer denied: Formulary exception Nuvigil
The denial is upheld

The patient is an adult female. She was reported to have been diagnosed with narcolepsy without cataplexy (G47.419). The patient's provider is requesting the use of the non-formulary medication, Nuvigil (armodafinil) 250 mg (milligrams) for treatment of the patient's excessive daytime sleepiness associated with narcolepsy.
The requested medication (Nuvigil) was noted to have been previously denied coverage by the health plan, as there was no indication that the patient had failed to respond to at least three formulary alternatives or had contraindications of adverse effects to other preferred formulary alternatives available for treatment of excessive daytime sleepiness associated with narcolepsy. The 
preferred formulary alternatives indicated include armodafinil, modafinil, Sunosi (solriamfetol), Wakix (pitolisant) and Xywav (oxybate salts).
The patient's provider is appealing the previous denial indicating that Nuvigil is medically necessary for the patient. An appeal letter provided by the treating provider indicates that the patient is diagnosed with narcolepsy. The provider states that the patient has been taking Nuvigil 250 mg (milligrams) for excessive daytime sleepiness with good response. The provider further 
states that without the medication, the patient sleepiness is disabling. The appeal letter does not address why the patient is unable to utilize any of the preferred formulary alternatives.
The patient was reported to have been initially diagnosed with narcolepsy 38 years ago. She was reported to have been treated with Nuvigil 250 mg (milligrams)/day with no side effects. The patient was reported to have been previously treated with Provigil (modafinil) and was switched to Nuvigil (armodafinil) 5 years ago. The patient was not reported to have any sleep-related hallucinations. She was reported to have an increase in sleep paralysis since she has been off the medication. The patient was not reported to have any symptoms of cataplexy. The patient was reported to have had most recent sleep study performed 6 years ago which indicated mild obstructive sleep apnea. She was reported to have been prescribed continuous positive airway pressure (CPAP). However, the patient was reported to have been unable to tolerate CPAP (continuous positive airway pressure). She was noted to have scored 10 on the Epworth sleepiness scale (ESS) indicating significant daytime sleepiness with medication. The patient was reported to have had a diagnostic polysomnogram (PSG) performed 25 years ago which indicated an apnea hypopnea index (AHI) of 6.4. A type III portable sleep study (home sleep study) performed 6 years ago was noted to have indicated an AHI (apnea-hypopnea index) of 14.8.

The health plan should not cover the formulary exception for brand Nuvigil 250 mg (milligrams) tablet.

Based on current peer reviewed, evidence-based medical literature, the requested non-formulary medication, Nuvigil 250 mg (milligrams) tablet was not found to be exclusively medically necessary for treatment of excessive daytime sleepiness associated with narcolepsy in this patient. There is no indication that other preferred formulary medications would be ineffective, not as effective or would have more adverse effects for treatment of the patient's condition. There is no evidence in current peer reviewed, evidence-based medical literature to indicate that brand Nuvigil would be more effective or would have less adverse effects than other covered formulary medications. Therefore, based on current peer reviewed, evidence-based medical literature, the requested nonformulary medication, Nuvigil 250 mg (milligrams) tablet was not found to be exclusively medically necessary for treatment of excessive daytime sleepiness associated with narcolepsy in this patient.