Subject: Dofetilide-Tikosyn 1873-A SGM P2021

Drug

TIKOSYN  (dofetilide)

dofetilide (generic)

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 flutter/atrial fibrillation [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

1.   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.

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

3.   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 Inc.; August 2019.
2. Dofetilide [package insert]. East Windsor, NJ: Aurobindo Pharma USA, Inc.; September 2019.
3. Micromedex Solutions [database online]. Cambridge, MA: IBM Watson Health. Updated periodically. www.micromedexsolutions.com [available with subscription]. Last Modified: April 05, 2021. Accessed April 14, 2021.
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).

 

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 05, 2021