Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Attention deficit hyperactivity disorder

Treatment: Maximum Allowable Cost Penalty (MAC) exception for the prescription drug, Concerta 54 milligrams (mg)

The insurer denied coverage for Maximum Allowable Cost Penalty (MAC) exception for the prescription drug, Concerta 54 milligrams (mg)

The denial is overturned.

This pediatric patient has a diagnosis of attention deficit hyperactivity disorder (ADHD) and was taking Concerta 54 milligrams (mg) every morning to target inattention, hyperactivity, impulsivity, and hyperkinesis. The patient reportedly was tolerating and benefitting from this medication. The patient was also prescribed Intuniv for reactivity of ADHD, Clonidine for sleep, and Methylphenidate 10 mg as needed in the afternoon for ADHD symptoms. The patient reportedly had taken Metadate in the past. It was reported that the patient has taken Concerta for several years. It was reported that the patient was taking generic Methylphenidate Extended Release (ER) 54 mg which provided the Osmotic-controlled release oral delivery system (OROS) mechanism. The pharmacy did not have Methylphenidate ER available and had the brand name Concerta instead. Concerta also provided the OROS delivery mechanism which was effective for this patient. 
 
The medical records provide enough specific evidence to support that Concerta is considered a medically necessary treatment for this patient. It was reported that the patient was taking generic Methylphenidate ER 54 mg which provided the OROS delivery mechanism, but the pharmacy did not have the medication available and instead had the brand name Concerta. Concerta also provides the OROS delivery mechanism which was effective for this patient. The patient reportedly tried Metadate in the past without reported sustained efficacy. Prior authorization was not considered necessary as the brand name Concerta was considered a medically necessary treatment for this patient. The patient responded to this OROS delivery mechanism medication and has been taking the medication for several years. 

It is not in the patient's best interest to stop this effective Food and Drug Administration (FDA) approved medication for ADHD. According to Huss, Duhan, Gandhi, Chen, Spannhuth, and Kumar, psychostimulants including methylphenidate and amphetamine-based treatments, are the most commonly prescribed pharmacological treatments for ADHD and are FDA approved for the treatment of ADHD. It also states that response to methylphenidate treatment varies significantly between patients. Certain patients may not achieve adequate symptom control. Concerta is brand name Methylphenidate ER. 

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 the ADHD symptoms with no reported significant medication side effects. As a result, the recommendation is to overturn the previous decision and approve the request for brand name Concerta 54 mg per day. 

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Maximum Allowable Cost Penalty (MAC) exception for the prescription drug, Concerta 54 milligrams (mg) is substantiated.