Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Attention Deficit Hyperactivity Disorder (ADHD). 
Treatment: Daytrana 20mg/9HR TD PTCH. 

The insurer denied the Daytrana 20mg/9HR TD PTCH. 
The denial is overturned. 

The patient is case involves an adult male diagnosed with attention deficit hyperactivity disorder (ADHD). The patient is prescribed Daytrana (methylphenidate TD patch) once daily with benefit from this medication and tolerability noted by the patient's prescribing clinician. The patient has failed to benefit from several alternatives including Adderall (amphetamine-dextroamphetamine mixed salts) and Concerta. The use of Daytrana (methylphenidate TD patch) has effectively addressed the patient's symptoms of ADHD (attention deficit hyperactivity disorder) with improved functioning. 

The health plan denied coverage for the requested Daytrana (methylphenidate TD patch) indicating that Daytrana is not FDA (United States Food and Drug Administration) approved for individuals over the age of 17 years. Additionally, formulary alternatives include Ritalin LA, metadate CD, Focalin XR and Straterra. 

The patient's clinician is requesting coverage on appeal for continued treatment with Daytrana (methylphenidate TD patch) indicating that Daytrana is more effective and better tolerated for this patient who has demonstrated tolerability problems or lack of efficacy with Concerta and oral amphetamine formulations for the treatment of ADD (attention deficit disorder)/ADHD (attention deficit hyperactivity disorder). 

Yes, the requested treatment with Daytrana is medically necessary. 

In keeping with New York State instruction for this review, the treatment provided is in keeping with prevailing standards of medical practice for the condition under treatment in this case with an evidence-based treatment and in keeping with an FDA (United States Food and Drug Administration) approved indication for ADHD (attention deficit hyperactivity disorder) with off-label use in an adult who has been treatment with Daytrana "for years" with success. The requested services/treatment being provided in this case are clinically appropriate as an off label use of Daytrana, and are backed by credible scientific evidence known to benefit patients with the condition diagnosed in this case.

Specifically, in this case, the patient has demonstrated a clinical response to the requested treatment with tolerability and improved functioning. Thus, it is in the patient's best interest to remain on this medication that has the potential to provide clear therapeutic benefit, especially with respect to daily functioning and continued symptom relief. The requested benefit with Daytrana is provided for the purpose of treating ADHD (attention deficit hyperactivity disorder), as clinically appropriate and indicated; and is entirely consistent with nationally recognized scientific evidence as available, and prevailing medical standards and the scientific literature, referenced below. 

The treatment provided is in keeping with prevailing standards of medical practice for the condition under treatment in this case with an evidence-base treatment and in keeping with an FDA (United States Food and Drug Administration) approved indication for ADHD (attention deficit hyperactivity disorder) with off label use in an adult who has been treatment with Daytrana "for years" with success. The requested services/treatment being provided in this case are clinically appropriate as an off-label use of Daytrana, and are backed by credible scientific evidence known to benefit patients with the condition diagnosed in this case. 

Thus, the off-label use of Daytrana is reasonable as opposed to the health plan reason for denial noted below which is entirely based upon the patient's age with regard to the FDA (United States Food and Drug Administration) approved use of Daytrana in children and adolescents. Moreover the health plan's suggested alternative treatments with more oral formulations is not reasonable or in the patient's best interest, as amphetamine formulations and oral methylphenidate was ineffective, and the health plan alternatives are not as likely to be as effective or tolerated with a reasonable degree of medical certainty. In this regard, to switch a patient from a medication that is well-tolerated and effective would be potentially detrimental as the prescribing physician argues on appeal-noted below. 

It is recommended that Daytrana be approved for this patient for a duration of 12 months, as the medication is being prescribed for a chronic condition that will require ongoing maintenance therapy in keeping with published guidelines, referenced below, and in keeping with prevailing standards of medical practice.