Subject: dofetilide-Tikosyn 1873-A SGM P2024

Drug

TIKOSYN  (dofetilide)

dofetilide

Policy:

      I.  INDICATIONS

          The indications below including FDA-approved indications and compendial uses are
          considered a covered benefit provided that all the approval criteria are met and the member
          has no exclusions to the prescribed therapy.

          A.  FDA-Approved Indications
               1.  Maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial
                    flutter [AF/AFI]) in patients with AF/AFl of greater than one week duration who have been
                    converted to normal sinus rhythm
               2.  Conversion of AF/AFI to normal sinus rhythm

          B.  Compendial Uses
               1.  Supraventricular tachycardia
               2.  Ventricular tachyarrhythmia

          All other indications are considered experimental/investigational and not medically necessary.


    II.  CRITERIA FOR APPROVAL

          A.  Atrial Flutter/Atrial fibrillation
               Authorization of 12 months may be granted for the maintenance of, or conversion to, normal
               sinus rhythm after atrial flutter or atrial fibrillation.

          B.  Supraventricular tachycardia
               Authorization of 12 months may be granted for treatment and prevention of supraventricular
               tachycardia.

          C.  Ventricular tachyarrhythmia
               Authorization of 12 months may be granted for treatment and prevention of ventricular
               tachyarrhythmia.


   III.  CONTINUATION OF THERAPY

          All members (including new members) requesting authorization for continuation of therapy
          must meet all initial authorization criteria.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Tikosyn [package insert]. New York, NY: Pfizer Labs; August 2023.
2. Dofetilide [package insert]. Durham, NC: Accord Healthcare, Inc.; February 2022.
3. Micromedex® [electronic version]. Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/. Accessed April 1, 2024.
4. Page RL, Joglar JA, Caldwell MA, et al. 2015 ACC/AHA/HRS Guideline for the Management of adult patients with supraventricular tachycardia. A report of the American College of Cardiology/American Heart Association Task Force on clinical practice guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2016;67(13).
5. Fuster V, Ryden LE, Asinger RW, et al. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation: Executive summary. A report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the European Society of Cardiology committee for practice guidelines and policy conferences (Committee to develop guidelines for the management of patients with atrial fibrillation) developed in collaboration with the North American Society of Pacing and Electrophysiology. 2001;104(17):2118-50.

 

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.

October 30, 2024