Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Attention Deficit Hyperactivity Disorder. 
Treatment: Mydayis (amphetamine-dextroamphetamine). 
The insurer denied coverage for Mydayis (amphetamine-dextroamphetamine). 
The denial is overturned. 

This is a pediatric patient who reportedly has a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) with combined presentation. It was reported that the patient took several medications for ADHD but either had lack of sustained efficacy or side effects. It was reported that the patient had taken Concerta (Methylphenidate extended release [ER]) for several months but had side effects of headache and had to stop; Vyvanse for almost two years but had to stop due to side effects of headache and appetite suppression, and Focalin extended-release (XR) (Dexmethylphenidate) for a month but had to stop due to lack of efficacy and side effects of headache. The patient reportedly has been taking Mydayis for over two years with reported efficacy and tolerability. The patient reportedly was taking Mydayis 50 milligrams (mg) 24-hour release capsules per day. 

The insurer denied coverage for Mydayis 50 mg 24-hour release capsules stating that the patient did not try the required amount of formulary medications with lack of efficacy or reported side effects and intolerability or contraindication. They stated that formulary medications included amphetamine/dextroamphetamine ER, dexmethylphenidate ER, methylphenidate ER, or Aztarys. 

The medical records provided for review did provide enough specific evidence to support that the patient was responding well to this Food and Drug Administration (FDA) approved ADHD medication and had tolerability to it and no adverse effects since taking it. This patient reportedly tried 4 different ADHD medications including 2 formulary medications, Methylphenidate ER and Dexmethylphenidate ER, another methylphenidate medication in Quillivant ER, as well as another class of psychostimulant medication in Vyvanse with reported lack of efficacy or side effects. Since the patient had efficacy and tolerability for over two years to a long acting FDA approved medication to treat ADHD and required long acting coverage due to their schedule of classes during the evening, this medication, Mydayis was considered medically necessary treatment. 

This medication was in the amphetamine/dextroamphetamine class with long duration effects that the patient needed so this medication was considered more likely to be effective and tolerated than other formulary medications that the patient did not try yet. It was reported recently that the patient was doing well in school and was involved with school and community activities and that this medication was effective without reported side effects. Since the patient tried and had lack of sustained efficacy or side effects to 2 different classes of FDA approved ADHD medications and two formulary medications and a total of 4 FDA approved medications, the requested medication, Mydayis 50 mg 24-hour capsule was considered to be more effective and tolerated than formulary medications. 

The formulary drugs are expected to cause adverse effects. 

The formulary drugs were tried, and the patient did have an adverse reaction or contraindication. 

The formulary drug is expected to be ineffective. 

The non-formulary drug is expected to be more effective than the formulary alternatives. 

The carrier's denial of a request for a Formulary Exception for Mydayis (amphetamine-dextroamphetamine) is reversed.