Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Attention Deficit Hyperactivity Disorder (ADHD)

Treatment: 36 mg (milligrams) of Concerta

The insurer denied coverage for 36 mg (milligrams) of Concerta.

The denial is overturned.

This patient had a diagnosis of attention deficit hyperactivity disorder (ADHD) and was taking brand name Concerta with efficacy and no reported side effects. She reportedly had tried generic Methylphenidate ER [extended release] several times in the past with lack of efficacy and side effects. 
  
This reviewer disagrees with the decision to deny coverage for brand name Concerta 36 mg (milligrams) twice per day as the medical records provided did support that she could not tolerate the generic equivalent of Concerta, Methylphenidate ER, as she had reported side effects after a 30 day period of taking it. It was reported that she had a trial of methylphenidate ER 54 mg per day for 30 days with lack of efficacy and with reports of side effects including severe headache, erratic feelings, increased heart rate, sleeping problems, anxiety symptoms, and impaired driving. It also was reported that she had 30 days of treatment with lack of efficacy and with reports of side effects including severe headache, erratic feelings, increased heart rate, sleeping problems, anxiety symptoms, and impaired driving with Methylphenidate ER 54 mg per day. It also was reported that she tried the generic equivalent again of Concerta as she took Methylphenidate 36 mg twice per day which is 72 mg per day and the FDA (Food and Drug Administration) maximum approved recommended dose for adults for Methylphenidate ER or Concerta. 

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 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% [percent] 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. Concerta (Methylphenidate ER) is an FDA approved medication for treatment of ADHD. This patient did not respond to generic Concerta, which is Methylphenidate ER, and reportedly had lack of efficacy with adequate duration of trials as it was for 30 days twice in the past and also at 72 mg per day of Methylphenidate which was the maximum FDA approved dosage so she did not respond to the methylphenidate generic equivalent. She also had reports of adverse effects including severe headache, erratic feelings, increased heart rate, sleeping problems, anxiety symptoms, and impaired driving. Her impaired driving put her and others at risk of danger. Also, for a subset of patients, there are indications that specific psychotropic medications could have a greater likelihood of response and tolerability based on clinical characteristics such as psychiatric comorbidities, medical comorbidities that could be exacerbated by psychotropic medication side effects, or family member history of response to a particular psychotropic agent. While these clinical characteristics might guide a clinician to select a particular type of first-line drug treatment, for many patients the best treatment match is not clear, and treatment decision making is a process of "trial and error." 

In this case, this patient responded to brand name Concerta and had an improvement in her ADHD symptoms and no reported medication side effects so the request was to take Concerta brand name 36 mg twice per day for the FDA maximum approved dosage. This was considered appropriate treatment and medically necessary treatment. The generic medication was not effective and also resulted in medication side effects. She responded best to the brand name Concerta. Also, this is FDA approved for ADHD and she had a reported diagnosis of ADHD. Furthermore, the fact that she had reported efficacy with ADHD symptoms and had no reported adverse effects including impaired driving which is considered potentially life-threatening danger to self and others is further evidence that brand name Concerta was considered medically necessary treatment. 

It did not appear that the health care plan acted reasonably or in the best interests of the individual.

Based on the above, the medical necessity for the 36 milligrams (mg) of Concerta is substantiated. The insurer's denial is overturned.