Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Attention Deficit Hyperactivity Disorder (ADHD)

Treatment: Jornay PM (methylphenidate)

The insurer denied coverage for Jornay PM

The denial is upheld.

This patient has had a diagnosis of ADHD-combined presentation and had difficulty focusing, paying attention, distractibility, listening and it was reported that these symptoms interfered with his functioning and negatively impacted his life. He reportedly was getting A's and B's in school and was attending ninth grade. It was reported that he saw his PCP (primary care physician) and his PCP recommended Jornay PM 20 mg (milligrams) to treat ADHD symptoms. He reportedly was taking Focalin XR (extended release) for 2.5 years with moderate efficacy and side effects of insomnia and decreased appetite.
    
Coverage for Jornay PM 20 mg per day to treat ADHD symptoms is denied as there were several other formulary medications FDA (Food and Drug Administration) approved to treat ADHD which he did not try and fail or have adverse effects to prior to trying a nonformulary FDA approved medication such as Jornay PM. 

Jornay PM (Mehtylphenidate Hydrochloride) is an FDA approved medication for treatment of ADHD that is given at night and the effects are targeted the next morning and throughout the day the next day. Jornay PM efficacy was established in 2 clinical studies according to the FDA. Study 1 was a 6-week open label dose optimization phase followed by 1-week double blind placebo control withdrawal phase in which patients randomized to continue Jornay or switch to placebo. It was reported that Jornay showed improvement. 

In the second study. it was a 3-week multicenter randomized double-blind placebo controlled parallel group study for middle childhood ages. After 3 weeks, ADHD-RS-V [attention deficit hyperactivity disorder rating scale V] total scores were significantly better (lower) for patients using Jornay PM verses placebo. The American Academy of Child and Adolescent Psychiatry (AACAP) Practice Parameters for the Assessment and Treatment of Children and Adolescents 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% (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. 

There was no specific documentation in the medical records showing that this patient tried more than one formulary FDA approved medication for ADHD as it was documented that he took Focalin XR (Dexmethylphenidate).  Jornay PM although FDA approved for the treatment of ADHD was not on formulary for this insurance so there was not adequate specific evidence to support that he did try other formulary medications for ADHD including amphetamine-dextroamphetamine, methylphenidate CD [controlled dose], ER, or LA [long acting], dextroamphetamine ER, vyvanse, or atomoxetine. He did not try other classes of ADHD FDA approved formulary medications. Also, it was reported that he just started Jornay PM. There was no documentation that he tried and failed or had adverse side effects to any other formulary FDA approved medications other than Focalin XR (Dexmethylpheidate). There was no specific evidence showing that other formulary medications would ineffective or cause an adverse reaction or that Jornay would be more effective than other formulary medications. As a result, the recommendation is to uphold the previous decision and deny coverage for Jornay PM 20 mg per day. 

The requested drug is not expected to be more effective than the formulary options.

The insurer's denial for Formulary Exception for Jornay PM to treat attention deficit hyperactivity disorder (ADHD) is upheld.