Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Sleep apnea, daytime sleepiness
Treatment: Sunosi 150 mg (milligram) tablet
The insurer denied the Sunosi 150 mg tablet.
The determination is upheld.

This is a female patient with mild sleep apnea and daytime sleepiness. The treating provider is requesting the coverage of Sunosi. The patient is on continuous positive airway pressure (CPAP). The patient was diagnosed with fibromyalgia and chronic fatigue syndrome. At issue is the medical necessity of Sunosi.

The requested health service/treatment of Sunosi 150 mg tablet is not medically necessary for this patient.

This patient was given the diagnosis of sleep apnea with residual sleepiness. The review of the available documents did not include a sleep study to verify the diagnosis of the patient. There is no evidence that the patient continues to have daytime sleepiness despite good compliance with the CPAP. The submitted medical information does not show any objective evidence in terms of progress note, office visit notes or pharmacy log that the patient tried and failed or has been intolerant or has contraindication to formulary medications.

Schweitzer et al evaluated the efficacy and safety of solriamfetol (Sunosi), a selective dopamine and norepinephrine reuptake inhibitor for the treatment of excessive sleepiness in participants with obstructive sleep apnea with current or prior sleep apnea treatment. The use of Sunosi resulted in higher percentages of participants reporting improvement in patients' symptoms. The final conclusion was that Solriamfetol significantly increased wakefulness and reduced sleepiness (when compared to placebo) in participants with obstructive sleep apnea and excessive sleepiness Abad et al, reviewed the results of three Phase 3 trials using Sunosi for the Treatment of OSA and Narcolepsy related Excessive Sleepiness. The final conclusion was that Solriamfetol shows promise as adjunctive therapy in obstructive sleep apnea (OSA). It is well tolerated and effective in reducing sleepiness. Unlike stimulants like methylphenidate or dextroamphetamine, it does not have cardiac effects, rebound hypersomnia, or withdrawal effects. The United States (US) Food and Drug Administration (FDA) approved the Sunosi for the treatment of excessive sleepiness in OSA and narcolepsy patients. Modafinil and armodafinil were also approved for the treatment of sleep apnea related daytime sleepiness.

There is no evidence in the submitted records that the patient's sleep apnea was confirmed by appropriate testing. There is no compliance report submitted with this review to confirm that the patient continues to have sleepiness despite good compliance with the CPAP. The Sunosi was prescribed to improve the residual daytime sleepiness. However, there are no adequate or well-conducted randomized controlled or cohort trials in the prevailing peer-reviewed published medical literature that established the long term efficacy and safety of Sunosi over formulary medications for the treatment of this patient medical condition. There is no high-quality literature showing an improvement in health outcomes with the use of Sunosi over formulary medications for this patient condition. Therefore, the patient does not meet medical necessity for the requested medication.