Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Attention deficit hyperactivity disorder
Treatment: Formulary exception for Focalin XR (dexmethylphenidate ER)
The insurer denied: Formulary exception for Focalin XR (dexmethylphenidate ER)
The denial is upheld.

The patient is a teenage male who was reported to have been diagnosed with attention deficit hyperactivity disorder, combined type (F90.2). The patient's provider is requesting the use of the 
nonformulary medication, brand Focalin XR (extended release dexmethylphenidate) 20 mg (milligrams) capsule for treatment of the patient's symptoms related to attention deficit hyperactivity disorder. The requested medication, Focalin XR (extended release) was noted to have been previously denied coverage by the health plan, as there was no indication that the patient was unable to take the required number of formulary alternatives available for treatment of attention deficit hyperactivity disorder. There was no indication that the patient had failed to respond or had contraindications of adverse effects to the preferred formulary alternatives. The preferred formulary alternatives 
indicated include extended-release amphetamine/dextroamphetamine, extended-release dexmethylphenidate, extended-release dextroamphetamine, extended-release methylphenidate, Azstarys (serdexmethylphenidate/dexmethylphenidate), Jornay PM (extended-release methylphenidate), Mydayis (extended-release amphetamine/dextroamphetamine) and Vyvanse (lisdexamfetamine).
An appeal letter provided by the treating provider states that the generic formulation of extended release dexmethylphenidate is not available. The provider states that brand Focalin XR (extended release) was requested for continuation of care. Clinical information provided does not indicate that the patient was treated with any other stimulant or nonstimulant medications for attention deficit hyperactivity disorder. No other clinical documentation was provided to indicate the patient's ongoing symptoms, history of treatment including medications or response to any previous treatment. There was no indication that the patient had any contraindications or adverse effects to 
the use of other long-acting stimulant medications available for treatment of attention deficit hyperactivity disorder.

The health plan should not cover the formulary exception.

Based on current peer-reviewed, evidence-based medical literature, there is no evidence that all preferred formulary drugs would be ineffective, would not be as effective or would have adverse effects for treatment of the patient's symptoms related to attention deficit hyperactivity disorder. The patient was reported to have been previously treated with extended release dexmethylphenidate. There was no indication that the patient was treated with any other stimulant or nonstimulant medications for treatment of attention deficit hyperactivity disorder. Focalin XR (extended-release dexmethylphenidate) is a long-acting stimulant formulation that is indicated for treatment of attention deficit hyperactivity disorder in children. However, there is no evidence in current peer-reviewed, evidence-based medical literature to indicate that Focalin XR (extended release) would be more effective or would have less adverse effects than other preferred formulary medications. The safety and efficacy of Focalin XR (extended release) is expected to be similar to other stimulant medications, including long-acting formulations. There was no indication that the patient had any adverse effects or contraindications to the use of other preferred formulary medications. Therefore, based on current peer-reviewed, evidence-based medical literature, there is no evidence that all preferred formulary drugs would be ineffective, would not be as effective or would have adverse effects for treatment of the patient's symptoms related to attention deficit hyperactivity disorder.