Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Excessive Daytime Sleepiness

Treatment: Modafinil 100 milligrams (mg)

The insurer denied coverage for Modafinil 100 milligrams (mg).

The denial is upheld. 

The medical records indicate the patient has severe obstructive sleep apnea (OSA) and is treated with continuous positive airway pressure (CPAP) therapy. The patient also has a history of autoimmune encephalitis with resultant seizures, which their provider states is contributing to their excessive daytime sleepiness. The patient underwent a doppler, stress test, and echocardiogram, which were all normal. 

The patient's provider is requesting approval of Modafinil to treat their severe excessive daytime sleepiness from OSA.

The medical records state that the patient has excessive daytime sleepiness due to OSA and autoimmune encephalitis.  Modafinil is approved to treat residual excessive daytime sleepiness in OSA only if primary treatment has failed to resolve the excessive daytime sleepiness. The medical records do not state if the patient's CPAP is adequately treating their OSA and/or if the patient is compliant with CPAP; thus, CPAP may need optimization and if so, the patient's sleepiness may resolve without the need for additional medication. Also, Modafinil is not approved for the treatment of excessive daytime sleepiness related to autoimmune encephalitis.

Modafinil is approved by the Food and Drug Administration (FDA) for the treatment of excessive daytime sleepiness due to OSA; however, only if primary OSA treatment fails to resolve the excessive daytime sleepiness. 

"Modafinil is a non-amphetamine central nervous system (CNS) stimulant with wakefulness-promoting properties. It is used in the treatment of conditions which cause excessive daytime sleepiness. In the United States, modafinil is FDA (Food and Drug Administration)-approved for the treatment of the following in adults: narcolepsy, sleep work shift disorder, and obstructive sleep apnea (adjunct to continuous positive airway pressure [CPAP])" (Greenblatt, K., & Adams, N. 2023).

"Many patients with obstructive sleep apnea (OSA) experience excessive daytime sleepiness (EDS)" and "Although EDS can be reduced with primary OSA treatment, such as continuous positive airway pressure (CPAP) therapy, a significant proportion of patients continue to experience EDS despite receiving optimized therapy for OSA."  The study states that "Patients who experience residual EDS despite primary OSA therapy may benefit from wake-promoting pharmacotherapy. Agents that inhibit reuptake of dopamine or of dopamine and norepinephrine (modafinil/armodafinil and solriamfetol, respectively) have demonstrated efficacy in reducing EDS and improving quality of life in patients with OSA" (Lal, C., et al., 2021).

Furthermore a systematic review and meta-analysis by Chapman J. et al. (2016) "performed a meta-analysis of all randomised controlled trials of modafinil in res-OSA to quantify efficacy and safety." The review found that "Modafinil/armodafinil improved the Epworth Sleepiness Scale score (2.2 points, 95% [percent] confidence interval [CI] 1.5-2.9) and the Maintenance of Wakefulness Test over placebo (3 min, 95% [percent] CI 2.1-3.8 min)."  It concluded that "Modafinil and armodafinil improve subjective and objective daytime sleepiness in res-OSA."

In conclusion, Modafinil may be medically necessary if this patient still experiences excessive daytime sleepiness despite adequate compliance with CPAP and response to CPAP, though this information is not provided in the documents reviewed; thus, without this information, Modafinil is not medically necessary in this case. 

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Modafinil 100 milligrams (mg) is not substantiated.