Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Attention deficit hyperactivity disorder. 
Treatment: Concerta. 

The insurer denied: Concerta. 
The denial is overturned. 

This case involves an adult female diagnosed with attention deficit hyperactivity disorder (ADHD)-unspecified type. The patient has been prescribed brand Concerta in order to achieve sustained benefit regarding symptoms of attention deficit hyperactivity disorder and functioning. The patient failed treatment with generic formulation of Concerta (methylphenidate extended release) as well as other stimulants due to adverse effects and intolerance including anxiety and palpitations. The health plan has denied coverage of the requested Concerta (methylphenidate HCL [OSM] extended-release formulation) at the current dosage based on plan criteria and prior authorization guidelines that requires treatment failure with at least two formulary alternatives before a coverage exception is allowed. The denial determination indicates that plan criteria are not met with formulary alternatives outlined in the denial which include generic formulations of Adderall and Focalin, and Azstarys, Jornay PM, Mydayis, and Vyvanse. 
The denial determination indicates that there is no evidence that the non-formulary medication is superior to formulary alternatives. 

The prescribing physician is requesting coverage for continued treatment with brand Concerta. The appeal indicates that the prescribed brand Concerta (methylphenidate extended release osmotic release [OR] tab) addresses core symptoms of attention deficit hyperactivity disorder with improved functioning and tolerability. Additionally, generic formulation of Concerta produced adverse effects including increased anxiety, a sense of uneasiness, and palpitations. The patient has been treated with Concerta for six months with a positive therapeutic response and tolerability. The appeal references the need to maintain uninterrupted treatment. The issue under review is brand Concerta (methylphenidate hydrochloride extended release 
osmotic release tab).

The proposed treatment is medically necessary for this patient. 

The requested benefit of treatment with brand Concerta (methylphenidate HCL extended-release tablet) at a clinically appropriate dose is provided for the purpose of treating attention deficit hyperactivity disorder, as clinically appropriate and indicated; and the use of Concerta is entirely consistent with nationally recognized scientific evidence as available, and prevailing medical standards and published clinical guidelines, referenced below. Additionally, Concerta has been effectively prescribed for six months following failure to respond to the generic formulation due to adverse effects, as well as failure with several other unspecified medications targeting symptoms of attention deficit hyperactivity disorder. The use of Concerta resulted in a positive therapeutic effect and tolerability with improved functioning. The requested medication would be likely to be more effective than other formulary alternatives in this case scenario, and the appeal reasonably argues that it is in the best interest of the patient to continue treatment with the Concerta which provides a positive therapeutic effect. This answer is in keeping with published guidelines and scientific literature, referenced below, and in keeping with prevailing standards of medical practice for the treatment of the condition diagnosed in this case, and is in keeping with New York State instruction for this medical necessity review including instructions pertaining to a formulary exception request.