Subject: Qelbree PA Policy 4681-A UDR 12-2023

Drug

QELBREE  (viloxazine extended-release)

Policy:

FDA-APPROVED INDICATION
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
               °   The request is NOT for continuation of therapy
               AND
               °   The diagnosis has been appropriately documented (e.g., evaluated by a complete clinical
                    assessment, using DSM-5, standardized rating scales, interviews/questionnaires)
                    AND
                         •   The patient will be monitored closely for suicidal thinking or behavior, clinical
                              worsening, and unusual changes in behavior
                          AND
                             •   The patient has experienced an inadequate treatment response to Strattera
                                  (atomoxetine)
                                  OR
                                  °   The patient has experienced an intolerance to Strattera (atomoxetine)
                                  OR
                                  °   The patient has a contraindication that would prohibit a trial of Strattera
                                      (atomoxetine)
                                  OR
                                  °   The patient has difficulty swallowing oral capsules
          OR
           •   The request is for continuation of therapy
               AND
                    °   The patient has achieved or maintained improvement in their signs and symptoms of
                         ADHD/ADD (Attention-Deficit/Hyperactivity Disorder or Attention Deficit Disorder)
                         from baseline
               AND
                    °   The patient’s need for continued therapy has been assessed within the previous year
               AND
                    °   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:

1. Qelbree [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.; April 2022.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2023. https://online.lexi.com. Accessed November 8, 2023.
3. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 11/08/2023).
4. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision. Arlington, Virginia. American Psychiatric Association; 2022.
5. 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.

April 14, 2024