Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Dofetilide (Tikosyn®) Use in the Inpatient Setting

Policy #:08.00.49d

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

An inpatient admission for the initiation or reinitiation of dofetilide (Tikosyn®) is considered medically necessary and, therefore, covered for either of the following indications:
  • For conversion of atrial fibrillation (AF) and atrial flutter (AFL) (AF/AFL) to normal sinus rhythm (NSR)
  • For the maintenance of NSR (delay in time recurrence of AF/AFL) in individuals with AF/AFL of greater than one week's duration who have been converted to NSR

Dofetilide (Tikosyn®) should be reserved for individuals in whom AF/AFL is highly symptomatic because the drug can cause life-threatening ventricular arrhythmias.

Therapy with dofetilide (Tikosyn®) must be initiated (and, if necessary, reinitiated) according to the product labeling, for a minimum of three days in an inpatient setting that provides continuous electrocardiographic (ECG) monitoring in the presence of personnel trained in the management of serious ventricular arrhythmias. Additionally, individuals should not be discharged within 12 hours of electrical or pharmacologic conversion to NSR.
  • For information on maintenance therapy with dofetilide (Tikosyn®), refer to the Guidelines section of this policy.

NOT MEDICALLY NECESSARY

Dofetilide (Tikosyn®) has not been shown to be effective in individuals with paroxysmal atrial fibrillation; therefore, it is considered not medically necessary and is not covered for this condition.

EXPERIMENTAL/INVESTIGATIONAL

All other uses of dofetilide (Tikosyn®) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.
Guidelines

Dofetilide (Tikosyn®) has arrhythmogenic potential and may cause serious ventricular arrhythmias, principally polymorphic ventricular tachycardia associated with QT-interval prolongation (i.e., torsades de pointes). Because an increased QT interval and the risk of ventricular arrhythmias are directly related to plasma dofetilide concentrations, electrocardiographic (ECG) monitoring for excessive increases in the QT interval, dosage adjustment based on calculated creatinine clearance, and avoidance of certain medications with known drug interactions are essential.

According to the manufacturer, initiation of therapy with dofetilide (Tikosyn®) and any subsequent increase in dosage should be performed in a hospital setting where cardiac resuscitation can be performed and where the individual can be monitored by personnel trained in the management of serious ventricular arrhythmias. Continuous ECG monitoring should be performed for a minimum of three days (until steady-state plasma concentrations are obtained), or for a minimum of 12 hours after electrical or pharmacologic conversion to normal sinus rhythm, whichever is greater. A previously successful increase in the dosage of dofetilide (Tikosyn®) does not eliminate the need for rehospitalization for a subsequent dosage increase.

BLACK BOX WARNINGS

Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, an inpatient admission for the initiation or reinitiation of dofetilide (Tikosyn®) is covered under the medical benefits of the Company's products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as not medically necessary are not eligible for coverage or reimbursement by the Company.

Following discharge from an inpatient setting, maintenance therapy with dofetilide (Tikosyn®) is available solely under the pharmacy benefit and is not covered under the medical benefit. Members must have a pharmacy benefit to be eligible for coverage of maintenance therapy with dofetilide (Tikosyn®). Prior authorization is not required for the use of dofetilide (Tikosyn®) under the pharmacy benefit.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The FDA approved the use of dofetilide (Tikosyn®) for the labeled indications in October 1999.

Description

Dofetilide (Tikosyn®) is an oral antiarrhythmic drug with Class III properties, which can cause cardiac action potential prolongation. The mechanism of action is the blockade of the cardiac ion channel that carries the rapid component of the delayed rectifier potassium current, IKr. At concentrations covering several orders of magnitude, dofetilide (Tikosyn®) blocks only IKr, with no relevant block of the other repolarizing potassium currents (e.g., IKs, IK1). At clinically relevant concentrations, dofetilide (Tikosyn®) has no effect on sodium channels (associated with Class I effect), adrenergic alpha-receptors, or adrenergic beta-receptors (associated with Class II effect). This causes the refractory period of atrial tissue to increase, hence its effectiveness in the treatment of atrial fibrillation and atrial flutter.

Dofetilide (Tikosyn®) can also cause serious ventricular arrhythmias, primarily Torsade de pointes (TdP), a type of ventricular tachycardia associated with QT prolongation.

ATRIAL FIBRILLATION/ATRIAL FLUTTER

Dofetilide (Tikosyn®) is indicated for highly symptomatic atrial fibrillation or atrial flutter (irregular heartbeats). Tikosyn® has also been shown to be effective in converting the irregular heartbeats to normal rhythm. In addition, dofetilide (Tikosyn®) may help maintain the normal rhythm for a longer period of time.

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
References


American Hospital Formulary Service (AHFS). Drug Information 2018. [Lexi-comp Web site]. Dofetilide. 06/20/2018. Available at: http://online.lexi.com/lco/action/home# [via subscription only]. Accessed October 05, 2018.

Anon. Progress in clinical trials; DIAMOND (Danish Investigations of Arrhythmia and Mortality ON Dofetilide). Clin Cardiol.1998; 21:52-54.

Brendorp B, Elming H, Jun L, et al. QTc interval as a guide to select those patients with congestive heart failure and reduced left ventricular systolic function who will benefit from antiarrhythmic treatment with dofetilide. Circulation. 2001; 103:1422-1427.

Elsevier Gold's Standard Clinical Pharmacology Compendium. Dofetilide. [ClinicalKey Web site]. 03/18/2016. Available at: https://www.clinicalkey.com/#!/content/drug_monograph/6-s2.0-705?scrollTo=%23References. [via subscription only]. Accessed October 05, 2018.

Kaber L. Dofetilide, a new class III antiarrhythmic drug reduces hospital admissions for congestive heart failure - Secondary endpoints of the DIAMOND-CHF study (abstract). J Am Coll Cardiol. 1998; 31(suppl 2A):31.

Kober L, Bloch Thomsen PE, Moller M, et al. Effect of dofetilide in patients with recent myocardial infarction and left-ventricular dysfunction: a randomised trial. Lancet. 2000; 356:2052-2058.

Lexi-Drugs Compendium. Dofetilide. [Lexicomp Online Web site]. 04/28/2016. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed October 05, 2018.

Micromedex® 2.0 Healthcare Series. DrugDex®. [Micromedex Web site]. 05/04/2016. Available at: http://www.micromedexsolutions.com/micromedex2/librarian/ [via subscription only]. Accessed October 05, 2018.

Pedersen OD, Bagger H, Keller N, et al. Efficacy of dofetilide in the treatment of atrial fibrillation-flutter in patients with reduced left ventricular function. A Danish Investigations of Arrhythmia and Mortality ON Dofetilide (DIAMOND) substudy. Circulation. 2001; 104:292- 296.

Pfizer, Inc. Tikosyn® (dofetilide) FAQs. [Pfizer Web site]. New York, NY; 2016. Available at: https://www.pfizerpro.com/product/tikosyn/af/support/faqs. Accessed October 05, 2018.

Pfizer, Inc. Tikosyn® (dofetilide) [prescribing information]. New York, NY; Revised October 2016. Available at: http://labeling.pfizer.com/ShowLabeling.aspx?id=639. Accessed October 05, 2018.

Rousseau MF, Massart PE, Galanti L, et al. Contrasting effects of intravenous dofetilide and amiodarone on cardiac sympathetic drive in patients with congestive heart failure (abstract). J Am Coll Cardiol. 1998; 31(suppl 2A):32.

Torp-Pedersen C. Dofetilide: a new class III antiarrhythmic drug which is safe in patients with congestive heart failure (abstract). J Am Coll Cardiol. 1998; 31(suppl 2A):160.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs @ FDA. Drug details: Tikosyn. [FDA Web site]. 03/08/2016. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm . Accessed October 05, 2018.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs @ FDA. Supplemental approval letter. Dofetilide (Tikosyn®). [FDA Web site]. 03/08/2016. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020931Orig1s007ltr.pdf . Accessed October 05, 2018.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

MEDICALLY NECESSARY

I48.1 Persistent atrial fibrillation

I48.2 Chronic atrial fibrillation

I48.3 Typical atrial flutter

I48.4 Atypical atrial flutter


NOT MEDICALLY NECESSARY

I48.0 Paroxysmal atrial fibrillation



HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

08.00.49d
11/07/2018This policy became effective 06/29/2016. It has been reviewed and reissued to communicate the Company’s continuing position on Dofetilide (Tikosyn®) Use in the Inpatient Setting.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 06/29/2016
Version Issued Date: 06/29/2016
Version Reissued Date: 11/07/2018

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