Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Attention deficit hyperactivity disorder (ADHD).
Treatment: Azstarys for the treatment of ADHD.
The insurer denied coverage for Azstarys for the treatment of ADHD.
The denial is overturned.

This adult male reportedly had a diagnosis of ADHD. He reportedly was responding well to Azstarys 39.2 mg (milligrams)/7.8 mg per day and was taking it for 1 month. He reportedly had taken other medications in the past to target ADHD symptoms including Ritalin, Adderall, Vyvanse, Straterra, and Wellbutrin without prolonged reported efficacy. 
 
Azstarys which is serdexmethylphenidate and immediate release dexmethylphenidate was Food and Drug Administration (FDA) approved for the treatment of ADHD. The recommended starting dosage is 39.2mg/7.8mg per day which is what this patient was being prescribed. It also is available in dosage of 52.3 mg/10.4 mg. It comes in capsule form. 

The American Academy of Child and Adolescent Psychiatry (AACAP) Practice Parameters for the Assessment and Treatment of Children, Adolescents, and Adults with Attention Deficit Hyperactivity Disorder reports that pharmacotherapy with psychostimulants are the treatment of choice for ADHD. It reports that short term efficacy of psychopharmacological interventions for ADHD were well established. It also reports that stimulants were considered highly efficacious in the treatment of ADHD with up to 75% (percent) clinical responders. It states that physicians can chose from 2 stimulant types-methylphenidate or amphetamines because evidence suggests equal efficacy in the treatment of ADHD. This medication, Azstarys is serdexmethylphenidate and immediate release dexmethylphenidate, so it is an FDA approved medication. It was reported by the provider that this patient tried and failed several other medications to treat ADHD including Ritalin, Adderall, Vyvanse, Straterra, and Wellbutrin. He reportedly tried other methylphenidate and dextroamphetamine/amphetamine medications as well as Vyvanse which is a brand name medication and is called Lisdexamfetamine dimesylate (generic) and it is an inactive prodrug in which d-amphetamine is pharmacologically activated after oral ingestion and is FDA approved for treatment of ADHD. He also reportedly tried Strattera generic Atomoxetine which is a nonstimulant blocking the presynaptic reuptake of norepinephrine neurons is another FDA approved medication for ADHD. The insurer stated that the patient should try generic preferred drug list including generic Adderall, Ritalin, or Focalin but this patient had tried and failed FDA approved medications from the main psychostimulant classes including methylphenidate and dextroamphetamine/amphetamine products, Vyvanse, and Atomoxetine. The patient reportedly was responding with efficacy for the past month with Azstarys 39.2 mg/7.8 mg per day for treatment of ADHD symptoms and this is an FDA approved medication, so it appears to be medically necessary treatment for this patient. It is in the patient's best interest for him to continue this medication. 

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for Azstarys services is substantiated.