Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Narcolepsy and Cataplexy
Treatment: Formulary exception for Adderall XR 15mg (milligrams) #60/30 days
The insurer denied: Formulary exception for Adderall XR 15mg (milligrams) #60/30 days
The denial is upheld.

The patient is an adult male who was reported to have been diagnosed with narcolepsy with cataplexy (G47.411). The patient's provider is requesting the use of the non-formulary medication, Adderall XR (extended-release amphetamine/dextroamphetamine) 15 milligrams capsule, #60 for 30 days for treatment of the patient's excessive daytime sleepiness associated with narcolepsy with cataplexy. The requested medication 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 3 formulary alternatives or had contraindications or adverse effects to the preferred formulary alternatives available for treatment. The preferred formulary alternatives indicated include extended-release amphetamine/dextroamphetamine, extended-release dexmethylphenidate, extended-release methylphenidate, Azstarys (serdexmethylphenidate/dexmethylphenidate), and Vyvanse (lisdexamfetamine). The clinical information provided does not indicate that the patient was treated with any of the 
formulary medications or had contraindications or adverse effects to the preferred formulary medications. An appeal letter provided by the treating provider states that the patient was treated for narcolepsy with cataplexy. The provider indicates that the diagnosis was confirmed following multiple sleep latency test (MSLT). The patient was reported to have functional impairments related to excessive daytime sleepiness. The provider indicates that the patient was treated with Adderall XR (extended release) 15 mg (milligrams) twice daily for excessive daytime sleepiness. The provider further states that the patient had failed trials of other medications including methylphenidate, armodafinil and Xyrem (sodium oxybate). The medications were noted to have resulted in adverse effects or lack of efficacy. The provider states that the patient has been stable on Adderall XR (extended release) 15 mg twice daily. The provider included medical literature supporting the use of amphetamine-based stimulants for treatment of narcolepsy. The clinical documentation indicates that the patient has been stable on Adderall XR (extended release) 15 milligrams twice daily and venlafaxine 37.5 milligrams every morning. He was not reported to have any significant excessive daytime sleepiness or episodes of cataplexy. He was recommended to continue Adderall XR (extended release) 15 milligrams twice daily and venlafaxine. The clinical documentation from previous years, indicates that the patient was treated with Adderall XR (extended release) and venlafaxine.

The health plan should not cover the formulary exception request.

The clinical information provided does not indicate that the patient was treated with any of the formulary medications or had contraindications or adverse effects to the preferred formulary medications. There is significant evidence for the use of central nervous system stimulant medications including modafinil, armodafinil, methylphenidate and amphetamine-based stimulants, in addition to Wakix (pitolisant) for treatment of excessive daytime sleepiness associated with narcolepsy. Central nervous system stimulants other than Wakix (pitolisant) do not treat symptoms of cataplexy. However, there are several formulations of methylphenidate and amphetamine-based stimulants that may be used for treatment of excessive daytime sleepiness associated with narcolepsy. Adderall XR (extended release) is an extended-release amphetamine/dextroamphetamine formulation that may be used for the treatment of narcolepsy. However, there is no evidence in current peer-reviewed, evidence-based medical literature to 
indicate that brand Adderall XR (extended release) would be more effective or would have less adverse effects than other stimulant formulations that may be used for treatment of excessive daytime sleepiness associated with narcolepsy. Therefore, the health plan should not cover the formulary exception for Adderall XR (extended release) 15 milligrams capsule twice daily, #60 for 30 days). There is no indication that the patient was unable to utilize the preferred formulary alternatives.