Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Attention deficit hyperactivity disorder (ADHD)

Treatment: Mydayis 50 mg (milligrams)

The insurer denied coverage for Mydayis 50 mg (milligrams)

The denial is overturned

This female reportedly had a diagnosis of ADHD-combined presentation and Major Depressive Disorder-in full remission. She reportedly tried and failed 3 formulary medications including Adderall XR (extended release) 25 mg per day, Ritalin LA (long acting) 20 mg per day, and Concerta 18 mg per day. The patient reportedly had an insurance change as it was reported that he was seeing a psychiatrist in the past. The recommendation was for Mydayis 50 mg per day to treat ADHD symptoms. 
    
The reviewer disagrees with the decision to deny Mydayis 50 mg per day as the medical records reported that he tried and failed 3 formulary medications and Mydayis is an FDA approved medication for the treatment of ADHD with a longer acting duration than other FDA approved psychostimulants. The Food and Drug Administration (FDA) reportedly approved Mydayis for the treatment of ADHD in people 13 years old and older. This patient had a reported diagnosis of ADHD- so this medication was considered appropriate treatment for this patient.  It also stated that there were 3 randomized double-blind placebo-controlled studies in children 13-17 and adults 18-55 years old and it established efficacy in the treatment of ADHD. Mydayis reportedly is a mixed salt with a mixture of 3:1 dextro to levo amphetamine. It comes in dosages of 12.5, 25, 37.5, and 50 mg. It is FDA approved for ages 13 and older. It has 3 types of drug releasing beads with one intermediate and 2 different delayed release beads. It reportedly reaches peak plasma levels in 8 hours for adults and 7-10 hours in pediatric patients. A steady state reportedly is achieved in 7-8 days.  It is advantageous for longer duration of time coverage, and it is dispensed once per day. The medical records provided for review did report that the patient tried 3 formulary medication for treatment of ADHD including Adderall XR 25 mg per day, Ritalin LA 20 mg per day, and Concerta 18 mg per day so the request for Mydayis was appropriate and considered a medically necessary treatment option for this patient then.  Mydayis is unique in that it has coverage that could last up to 16 hours, so it was considered more beneficial than other formulary medications that the patient did not try and that did not have this duration of coverage for this patient. Also, the American Academy of Child and Adolescent Psychiatry (AACAP) Practice Parameters for the Assessment and Treatment of Children and Adolescents and Adults with ADHD 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% 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. In this case this patient reportedly tried Adderall which is dextroamphetamine/amphetamine and had lack of efficacy.  An advantage of Mydayis is that it has longer duration of time coverage and according to the FDA could last up to 16 hours per day and it is dispensed once per day. Mydayis is an FDA approved medication for ADHD, and this patient had a diagnosis of ADHD and needed a long duration of coverage for ADHD.  As a result, the recommendation is to reverse the previous decision and approve coverage for Mydayis 50 mg per day.  It did not appear that the insurer acted in the best interests of the patient then.

The health plan did not act reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for Mydayis 50 mg (milligram) OR CP24 is overturned. Medical Necessity is substantiated.