Subject: Qelbree PA Policy 4681-A 12-2022

Drug

QELBREE  (viloxazine extended-release)

Policy:

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
The requested drug will be covered with prior authorization when the following criteria are met:
•    The patient has a diagnosis of Attention-Deficit/Hyperactivity
      Disorder (ADHD) or Attention Deficit Disorder (ADD)
AND
          º  The diagnosis has been appropriately documented (e.g.,
              evaluated by a complete clinical assessment, using DSM-5,
              standardized rating scales, interviews/questionnaires)
              AND
          º  The patient will be monitored closely for suicidal thinking or
              behavior, clinical worsening, and unusual changes in behavior
              AND
          º  The patient has experienced an inadequate response to
              Strattera (atomoxetine)
              OR
          º  The patient has experienced an intolerance to Strattera
              (atomoxetine)
              OR
          º  The patient has a contraindication that would prohibit a trial of
              Strattera (atomoxetine)

OR
          º  The patient has difficulty swallowing oral capsules
              OR
          º  The request is for continuation of therapy
              AND
          º  The patient achieved or maintained improvement in their
              signs and symptoms of ADHD/ADD (Attention-
              Deficit/Hyperactivity Disorder or Attention Deficit Disorder)
              from baseline
              AND
          º  The patient’s need for continued therapy has been assessed
              within the previous year
              AND
          º  The patient will continue to be monitored closely for suicidal
              thinking or behavior, clinical worsening, and unusual changes
              in behavior

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Qelbree [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.; April 2022.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed October 7, 2022.
3. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed October 7, 2022.

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.

June 07, 2023