Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Attention Deficit Hyperactivity Disorder.
Treatment: Viloxazine Extended-Release Capsules (Qelbree).
The insurer denied: Viloxazine Extended-Release Capsules (Qelbree).
The denial is overturned.

The patient is an adult female who was reported to have been diagnosed with attention deficit hyperactivity disorder and anxiety disorder. 
An appeal letter provided by the treating provider indicates that the patient was seen for an initial evaluation earlier this year. The provider indicates that the patient is diagnosed with major depressive disorder, recurrent, moderate, social anxiety disorder, panic disorder and attention deficit hyperactivity disorder, predominantly inattentive type. The provider indicates that the patient was treated with Strattera (atomoxetine). However, she was reported to have had gastrointestinal issues and rash. She was reported to have been treated with selective serotonin reuptake inhibitors including paroxetine, citalopram, sertraline and escitalopram. Trials of other psychotropic medications noted include bupropion, venlafaxine, desvenlafaxine, duloxetine, brexpiprazole, lamotrigine and vortioxetine. The provider further indicates that the patient was previously treated with Vyvanse (lisdexamfetamine), Focalin (dexmethylphenidate), Dexedrine (dextroamphetamine), Adderall amphetamine/dextroamphetamine and Ritalin (methylphenidate). 

The requested Qelbree (viloxazine) 200mg (milligrams) capsules is medically necessary.

The patient's provider is requesting the use of the medication Qelbree ER (extended release) (viloxazine) 200 mg (milligrams) capsules for treatment of symptoms related to attention deficit hyperactivity disorder. The requested medication (Qelbree ER [extended release]) was noted to have been previously denied due to lack of clinical documentation including history of previous medications to include dates of use and outcomes. The previous denial is being appealed with extensive clinical documentation indicating trials of previous medications. Medical documentation provided indicates that the patient was previously treated with several stimulant and non-stimulant medications for treatment of attention deficit hyperactivity disorder. She was noted to have been previously treated with amphetamine/dextroamphetamine, dexmethylphenidate, dextroamphetamine, lisdexamfetamine, methylphenidate and atomoxetine. Extensive clinical documentation provided indicates trials of the above stimulant and non-stimulant medications. The patient was noted to have had adverse effects or lack of efficacy with the above medications. She was also noted to have been treated with multiple antidepressant medications, atypical antipsychotic medications and mood stabilizers for mood and anxiety symptoms. Qelbree (viloxazine) is a selective norepinephrine reuptake inhibitor that is indicated for treatment of attention deficit hyperactivity disorder. The medication was initially approved for treatment of attention deficit hyperactivity disorder in children between the ages of 6 and 17. However, the medication has now been approved by the Food and Drug Administration (FDA) for treatment of attention deficit hyperactivity disorder in adults. There is significant evidence in current peer-reviewed, evidence-based medical literature to indicate the safety and efficacy of Qelbree (viloxazine) for treatment of attention deficit hyperactivity disorder. The patient was noted to have failed trials of multiple amphetamine and methylphenidate-based stimulant medications and atomoxetine which is also a norepinephrine reuptake inhibitor. Therefore, it is reasonable and medically necessary for the patient to have a trial of an alternative medication such as Qelbree (viloxazine). The mechanism of action of the medication may also help with the patient's anxiety and depression. Therefore, the requested treatment (Qelbree 200 mg [milligrams] capsules) is medically necessary.