Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Attention deficit hyperactivity disorder
Treatment: Azstarys 39.2-7.8 mg (milligrams) Capsule
The insurer denied coverage for Azstarys 39.2-7.8 mg Capsule
The denial is overturned.

This pediatric patient with a diagnosis of attention deficit hyperactivity disorder (ADHD) has difficulties focusing, is hyperactive and fidgety, and had trouble remaining seated with difficulty performing academically in school. The child reportedly also had emotional outbursts. The child was taking Evekeo (Amphetamine Sulfate tablets) with no further efficacy. The child was taking Atomoxetine and was still struggling with ADHD symptoms. It was also reported that the child tried Adderall Extended-Release (XR) and Methylphenidate ER/CD (extended-release/controlled delivery) in the past as well with lack of reported sustained efficacy. The request was for Azstarys 39.2-7.8 milligrams (mg) capsules to treat ADHD as it is a once per day dosed medication and the patient was struggling more in the afternoon. The child also reportedly has a diagnosis of autism spectrum disorder (ASD) and was taking Risperidone.

The reviewer disagrees with the decision to deny Azstarys 39.2-7.8 mg capsules to treat ADHD as this is a long-acting Food and Drug Administration (FDA) approved medication and this patient was struggling throughout the entire day with ADHD symptoms which is not controlled with 2 FDA approved medications including Atomoxetine (Strattera) and Evekeo (Amphetamine Sulfate tablets). The patient reportedly also had developmental delays and emotional outbursts and had a diagnosis of (ASD). 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 considered first line treatment for ADHD. This patient has a diagnosis of ADHD and Azstarys is considered an FDA approved medication for ADHD and has a long duration of action. The psychostimulants include Methyphenidate products, amphetamine/dextroamphetamine products which include Adderall, Vyvanse (Lisdexamfetamine dimesylate), and Strattera (Atomoxetine) which is a norepinephrine reuptake inhibitor. This patient reportedly took 3 formulary FDA medications from different classes including Adderall which is dextroamphetamine/amphetamine and methylphenidate ER and CD as well as atomoxetine which is Strattera and is a nonstimulant blocking the presynaptic reuptake of norepinephrine neurons is another FDA approved medication for ADHD. 

Trying Azstarys 39.2-7.8 mg capsules, is considered a medically necessary treatment. This medication is serdexmethylphenidate which is an extended release and also dexmethylphenidate immediate release. It comes in dosages of 26.1 mg serdexmethylphenidate and 5.2 mg dexmethylphenidate immediate release, 39.2 mg serdexmethylphenidate and 7.8 mg dexmethylphenidate immediate release, and 52.3 mg serdexmethylphenidate and 10.4 mg dexmethylphenidate immediate release. The request was for Azstarys 39.2-7.8 mg capsules which is considered standard and appropriate treatment to treat this patient's ADHD symptoms. The recommendation is to overturn the previous decision and approve coverage for Azstarys 39.2-7.8 mg capsules. It did not appear that the insurer acted in the best interests of the patient.

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 39.2-7.8 mg Capsule is substantiated.