Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan
Subject: Qelbree PA 4681-A P12-2025
Drug
QELBREE(viloxazine extended-release)
Policy:
Indications
FDA-approved Indications
Qelbree is indicated for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.
Coverage Criteria
Attention-Deficit/Hyperactivity Disorder (ADHD) or Attention Deficit Disorder (ADD)
Authorization may be granted when the patient has a diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD) or Attention Deficit Disorder (ADD) when ALL of the following criteria are met:
The diagnosis has been appropriately documented (e.g., evaluated by a complete clinical assessment, using DSM-5, standardized rating scales, interviews/questionnaires).
The patient will be monitored closely for suicidal thinking or behavior, clinical worsening, and unusual changes in behavior.
The patient meets ONE of the following:
The patient has experienced an inadequate treatment response to ONE of the following: Strattera (atomoxetine), an amphetamine product (e.g., amphetamine, amphetamine-dextroamphetamine, dextroamphetamine, methamphetamine, lisdexamfetamine), a methylphenidate product (e.g., methylphenidate, dexmethylphenidate).
The patient has experienced an intolerance to ONE of the following: Strattera (atomoxetine), an amphetamine product (e.g., amphetamine, amphetamine-dextroamphetamine, dextroamphetamine, methamphetamine, lisdexamfetamine), a methylphenidate product (e.g., methylphenidate, dexmethylphenidate).
The patient has a contraindication that would prohibit a trial of ALL of the following: Strattera (atomoxetine), an amphetamine product (e.g., amphetamine, amphetamine-dextroamphetamine, dextroamphetamine, methamphetamine, lisdexamfetamine), a methylphenidate product (e.g., methylphenidate, dexmethylphenidate).
Continuation of Therapy
Attention-Deficit/Hyperactivity Disorder (ADHD) or Attention Deficit Disorder (ADD)
Authorization may be granted when the patient has a diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD) or Attention Deficit Disorder (ADD) when ALL of the following criteria are met:
The patient has achieved or maintained improvement in their signs and symptoms of ADHD/ADD from baseline.
The patient’s need for continued therapy has been assessed within the previous year.
The patient will continue to be monitored closely for suicidal thinking or behavior, clinical worsening, and unusual changes in behavior.
Duration of Approval (DOA)
4681-A: DOA: 12 months
Place of Service:
Outpatient
The above policy is based on the following references:
Qelbree [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.; January 2025.
Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2025. https://online.lexi.com. Accessed October 9, 2025.
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision. Arlington, Virginia. American Psychiatric Association; 2022.
Pliszka S. Practice Parameter for the Assessment and Treatment of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2007;46(7):894-921.
Wolraich ML, Hagan JF, Allan C, et al. AAP Subcommittee On Children And Adolescents With Attention-Deficit/Hyperactive Disorder. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics. 2019;144(4):e20192528.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
