Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Attention Deficit Disorder

Treatment: Medication: Concerta 

Denial of formulary exception for Concerta 

Outcome: Insurer decision overturned

This patient had problems with attention and impulsivity and had a reported diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) combined type. She reportedly tried Methylphenidate ER [extended release] generic and Dexmethylphenidate ER with lack of efficacy as well as Vyvanse and Quillivant. It was reported that she had been taking Concerta brand name since 2017 with efficacy and tolerability. She also had anxiety and a diagnosis of Unspecified Anxiety Disorder. According to her provider, brand name, Concerta which is also a methylphenidate ER but brand, was considered necessary treatment for the patient to target her ADHD symptoms. It was reported by the provider that without this medication her symptoms likely would worsen and that it was crucial to the patient's safety for her to continue with this medication. She reportedly was also taking Guanfacine 2 mg per day in addition to the 36 milligram (mg) of brand name Concerta to target ADHD symptoms. She reportedly was attending 9th grade.

According to Huss, et al., psychostimulants, including methylphenidate and amphetamine-based treatments, are the most commonly prescribed pharmacological treatments for ADHD, and these are also Food and Drug Administration (FDA) approved for the treatment of ADHD. It also states that response to methylphenidate treatment varies significantly between patients and certain patients may not achieve adequate symptoms control. Concerta is brand name Methylphenidate Emergency Room (ER) is a pump OROS-osmotic release oral system Methylphenidate using osmotic delivery system in which the tablet is coated with 22% (percent) immediate release Methylphenidate for the initial dosing and the long duration component is delivered by osmotic pump that gradually releases Methylphenidate producing an ascending serum concentration to approximate a 3 times daily dosing schedule. 

In this case this patient responded to brand name Concerta and the generic Concerta (Methylphenidate ER) and Dexmethylphenidate ER which were both on formulary and FDA approved medication for the treatment of ADHD in child/adolescents and were tried in the past with lack of efficacy as well as Vyvanse which is lisdexamfetamine and is FDA approved for ADHD treatment in children and adolescents, and also tried Quillivant which is another methylphenidate product FDA approved for treatment of ADHD. She reportedly tried several FDA approved medications with lack of efficacy. Also, there was a risk that a dextroamphetamine product such as dextroamphetamine/amphetamine or dextroamphetamine would not be as efficacious or tolerated as the brand name Concerta was for this patient. 

Notes on 10/9/2023 reported that she had a good response to the medications as she was taking brand name Concerta 36 mg per day for ADHD as well as Guanfacine 2 mg per day for ADHD and Effexor for anxiety. It was reported that her academic performance and behaviors improved significantly with this medication regimen

The formulary drugs are not expected to cause adverse effects. However, they were tried and were ineffective.
The non formulary drug is expected to be more effective than the formulary alternatives. The patient has been taking brand name Concerta Methylphenidate ER since 2017 with efficacy and tolerability. 

The carrier's denial of a request for a Formulary Exception for Concerta (methylphenidate ER Osmotic Release) is reversed.