Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Narcolepsy and cataplexy
Treatment: Mydayis 50 milligrams (mg)
The insurer denied coverage for Mydayis 50 mg.
The denial is upheld. 

The patient is an adult who was reported to have been diagnosed with narcolepsy with cataplexy and attention deficit hyperactivity disorder (ADHD). The patient was noted to have had a diagnostic polysomnogram (PSG) performed. The patient was noted to have had an overall apnea hypopnea index (AHI) of 1.5/hour with no significant oxygen desaturation. The subsequent multiple sleep latency test (MSLT) performed was noted to have indicated a mean sleep latency of one minute with two sleep onset rapid eye movement periods. The MSLT was noted to have been diagnostic for narcolepsy. The patient was noted to have a body mass index (BMI) of 28.5 at the time of the study. The patient was noted to have been seen for a clinical encounter by the treating provider. Diagnoses indicated include narcolepsy, ADHD, and mild obstructive sleep apnea. The patient was noted to have been treated with multiple medications including Mydayis (extended-release amphetamine/dextroamphetamine), Wakix (pitolisant), Effexor (venlafaxine), Sunosi (solriamfetol), Xywav (oxybate salts), and Adderall XR (extended-release amphetamine/dextroamphetamine).

The provider indicates that the patient requires a combination of Xywav, Mydayis, Adderall XR, and Sunosi for optimal functioning during the daytime. However, no clinical documentation or pharmacy paid claims reports were provided to indicate trials of any previous medications including dosages prescribed, duration of treatment or reasons for discontinuation.

There is no evidence in current peer-reviewed, evidence-based medical literature to indicate that Mydayis would have less adverse effects than optimal doses of other extended-release stimulant medications. 

There are several extended-release stimulant formulations that are available for treatment of narcolepsy and ADHD including multiple formulations of methylphenidate and amphetamines. The side effect profile of Mydayis is expected to be similar to other, long-acting stimulant formulations. Therefore, there is no evidence that all formulary drugs are likely to cause adverse reactions for the patient.      

The formulary drugs are not expected to cause adverse effects. 

Some of the formulary drugs were tried, and the patient is reported to have had an adverse reaction or lack of efficacy with modafinil, Vyvanse, and Ritalin. There are not expected to be contraindications to the other formulary alternatives.

The formulary drugs are not expected to be ineffective. There was no indication that the patient was treated with extended-release formulations of dexmethylphenidate, methylphenidate, or dextroamphetamine. 

The clinical documentation provided does not indicate a clear rationale for the use of the combination of multiple formulations of extended-release amphetamine/dextroamphetamine. 

There was no evidence that the dosage of Adderall XR was optimized. The clinical documentation provided does not indicate that the patient was treated with other preferred formulary medications including other preferred formulations of long-acting stimulants. Therefore, there is no evidence that the formulary drugs have been ineffective based on the patient's clinical history.     
  
The non-formulary drug is not expected to be more effective than the formulary alternatives.

The carrier's denial of a request for a formulary exception for Mydayis 50 milligrams (mg) to treat narcolepsy with cataplexy is upheld.