Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Narcolepsy, Anxiety and Depression
Treatment: Modafinil 200Mg (2 tablets twice daily)
The insurer denied: Modafinil 200Mg (2 tablets twice daily)
The denial is upheld

The patient is an adult female who was reported to have been diagnosed with narcolepsy. She was also reported to have been diagnosed with obsessive-compulsive disorder, generalized anxiety disorder and unspecified depressive disorder. The patient's provider is requesting the use of modafinil 200 mg (milligrams) tablet, 2 tablets twice daily for a total daily dosage of 800 mg (milligrams) modafinil (4 tablets daily) for treatment of symptoms related to narcolepsy. The requested medication (modafinil) was noted to have been previously denied coverage by the health plan, as the requested quantity of 4 tablets daily exceed the maximum allowed by the plan of 1 tablet daily. The requested dosage was not noted to be approved by the Food and Drug Administration (FDA) or supported in approved compendia.
Clinical documentation provided indicates that the patient was initially seen for an intake. She was noted to have presented for medication management and counseling. The patient was reported to have a behavioral health history significant for obsessive-compulsive disorder, generalized anxiety disorder and dysthymia. She was also reported to have been diagnosed with narcolepsy. The patient was reported to have been using positive airway pressure therapy.
The patient was reported to have been previously treated with modafinil 400 mg (milligrams) every morning and immediate release amphetamine/dextroamphetamine as needed in the afternoon. Over time, the patient was reported to have been prescribed modafinil 400 mg (milligrams) twice daily in addition to immediate release amphetamine/dextroamphetamine as needed. Most recently, the patient was noted to have been treated with fluoxetine, extended-release methylphenidate (Concerta) and modafinil. Clinical literature indicating the benefit of dosages up to 800 mg (milligrams) of modafinil was included. The patient was reported to have scored 16 on the Epworth Sleepiness Scale (ESS).

The requested treatment (modafinil 200 mg (milligrams) tablet, 2 tablets twice daily for a total daily dosage of 800 mg (milligrams) modafinil (4 tablets daily) is not medically necessary.

The patient is an adult female who was reported to have been diagnosed with narcolepsy. She was also reported to have been diagnosed with obsessive-compulsive disorder, generalized anxiety disorder and unspecified depressive disorder. The patient's provider is requesting the use of modafinil 200 mg (milligrams) tablet, 2 tablets twice daily for a total daily dosage of 800 mg (milligrams) modafinil (4 tablets daily) for treatment of symptoms related to narcolepsy. The patient was reported to have been previously treated with higher than recommended doses of modafinil.

Modafinil is a central nervous system stimulant that is indicated for treatment of excessive daytime sleepiness associated with narcolepsy. The maximum recommended dosage of modafinil is 200 mg (milligrams) per day. However, there is evidence for the safety of up to 400 mg (milligrams) per day of modafinil although no additional clinical benefit was noted. Although there is some medical literature indicating the safety and clinical benefit of higher than recommended doses of modafinil, there is no clear evidence for the safety or efficacy of more than 200 mg (milligrams) per day of modafinil. There is a potential for significant adverse effects with higher than recommended doses of central nervous system stimulants. Therefore, the proposed treatment (modafinil 200 mg (milligrams) tablet, 2 tablets twice daily for a total daily dosage of 800 mg (milligrams) modafinil (4 tablets daily) was not found to be medically necessary.