Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Attention deficit hyperactivity disorder (ADHD)
Treatment: Concerta (methylphenidate ER (extended release) osmotic release)
The insurer denied coverage for Concerta (methylphenidate ER osmotic release).
The denial is overturned.

This adult reportedly had a diagnosis of attention deficit hyperactivity disorder (ADHD)-predominately inattentive presentation and was taking Concerta (Methylphenidate ER) with reported efficacy and with tolerability. It was reported that she tried and failed Ritalin, Focalin, and Vyvanse in the past.
  
This reviewer disagrees with the decision to deny coverage for Concerta (Methylphenidate ER osmotic release) as the medical records provided did support that she had efficacy and tolerability to Concerta (Methylphenidate ER osmotic release) and had been taking this for several years, so it was considered effective treatment. Concerta (Methylphenidate ER) is a Food and Drug Administration (FDA) approved medication for treatment of ADHD and this patient had a diagnosis of ADHD. According to the Neuropsychiatric Disorder Treatment 2017: 13: 1741-1751, "Methylphenidate Dose Optimization for ADHD Treatment: Review of Safety, Efficacy, and Clinical Necessity" by Huss, Duhan, Gandhi, Chen, Spannhuth, and Kumar reports that psychostimulants, including methylphenidate and amphetamine-based treatments, are the most commonly prescribed pharmacological treatments for ADHD, and these are also 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 Methyphenidate ER and is a pump OROS-(osmotic release oral system) Methyphenidate using osmotic delivery system in which the tablet is coated with 22 % immediate release Methyphenidate 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.

Also, stopping an FDA approved medication that is effective for another medication trial is considered disruptive to her treatment and care. This medication, Concerta (Methylphenidate ER osmotic release), was considered to be more effective than other medications on formulary because it was effective and she was taking it for years, and also because she had lack of sustained efficacy reported with regular methylphenidate, Ritalin, and also Vyvanse, another formulary FDA approved medication to treat ADHD. It is unclear if a formulary medication would cause an adverse effect but because this patient was taking Concerta (Methylphenidate ER osmotic release) with efficacy and tolerability, it was considered necessary treatment and thus no prior authorization was considered needed. Stopping this effective and tolerable FDA approved medication after taking it for several years would be considered disruptive treatment and not in her best interests. As a result, the recommendation is to reverse the previous decision and approve the request for Concerta (Methylphenidate ER osmotic release).

The formulary drugs might cause adverse effects. 

The formulary drugs were tried, and the patient did have an adverse reaction or contraindication as they were ineffective.

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

The carrier's denial of Request for Formulary Exception for Concerta (methylphenidate ER osmotic release) to treat ADHD is overturned.