Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Attention Deficit Hyperactivity Disorder. 
Treatment: Jornay PM [methylphenidate ER (extended release)]. 
The insurer denied coverage for Jornay PM (methylphenidate ER). 
The denial is upheld. 

This teenaged patient reportedly had a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) and was taking Jornay PM due to the psychostimulant shortage of Methylphenidate products. According to a letter by the patient's provider, it was reported that the patient is currently stable on their current dose of Jornay PM and without this medication their ability to function academically and socially will be compromised. It was also stated that due to the psychostimulant shortage it was considered medically necessary treatment for the patient to continue with this medication. 
  
The insurer denied coverage for formulary exception for Jornay PM (Methylphenidate extended-release [ER]) stating that it did not meet prior authorization criteria of being unable to take, having intolerance to, or contraindication to, or having tried and failed formulary preferred medications. 
  
The reviewer agrees with the decision to deny coverage for Jornay PM to treat ADHD symptoms according to the insurer's criteria as there were several other formulary medications that are Food and Drug Administration (FDA) approved to treat ADHD which the patient reportedly did not try and fail or have adverse effects, contraindication, or intolerance to prior to trying a non-formulary FDA approved medication such as Jornay PM. Jornay PM (Methylphenidate Hydrochloride) is an FDA approved medication for the 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 were randomized to continue Jornay or switch to placebo. It was reported that Jornay showed improvement 9 am through 7 pm the next day. The second study was a 3-week multicenter randomized double-blind placebo controlled parallel group study for ages 6-12. After 3 weeks, Attention-Deficit Hyperactivity Disorder Rating Scale-5 (ADHD-RS-V) total scores were significantly better (lower) for patients using Jornay PM versus placebo.  

There was no mention in the medical records for review that there was a shortage of dexmethylphenidate or Aztarys but rather it stated that there was a shortage of methylphenidate products without specific mention of which ones. Also, there was no medical records reporting that the patient tried and failed or with adverse effects to, contraindication, or intolerance to amphetamine/dextroamphetamine products such as amphetamine/dextroamphetamine mixed salts ER or dextroamphetamine ER which were both on formulary and on the preferred list. Although Jornay PM is FDA approved for the treatment of ADHD, it was not on formulary or preferred list for this insurance so there was not adequate specific evidence to support that Jornay was considered medically necessary treatment rather than an FDA approved preferred medication as mentioned above. There was no specific evidence showing that the other formulary medications would ineffective or cause an adverse reaction or have intolerance or contraindication or that Jornay would be more effective than other formulary medications FDA approved for treatment of ADHD. 

The formulary drugs are not expected to cause adverse effects. 

The formulary drugs were not tried, and the patient did not have an adverse reaction or contraindication. 

The formulary drug is not expected to be ineffective. 

The non formulary drug is not expected to be more effective than the formulary alternatives. 

The carrier's denial of a request for a Formulary Exception for Jornay PM (methylphenidate ER) to treat ADHD is upheld.