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Clinical Pharmacy Program Guidelines for Multaq Program Medications Pharmacy & Therapeutics Approval Date Effective Date Prior Authorization Multaq (dronedarone) 6/2016 9/1/2016 1 . Background: Multaq (dronedarone) is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF). 2 . Coverage Criteria: A. Multaq 1. Diagnosis of one of the following: a. Paroxysmal atrial fibrillation (AF) -ORb. Persistent AF defined as AF less than 6 months duration -AND- 2. One of the following: a. Patient is in sinus rhythm -ORb. Patient is planned to undergo cardioversion to sinus rhythm -AND3. Patient is currently receiving appropriate antithrombotic therapy -AND4. Patient does not have any of the following: NYHA Class IV heart failure Symptomatic heart failure with recent decompensation requiring hospitalization Authorization will be issued for 12 months. Confidential and Proprietary, © 2016 UnitedHealthcare Services Inc. 1 3 . References 1. Multaq Prescribing Information. Sanofi-Aventis, September 2012. 2. Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, et al. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines. J Am Coll Cardiol 2006;48:e149-e246. 3. Kober L, Torp-Pedersen C, McMurray JJV, et al. Increased mortality after dronedarone therapy for severe heart failure. N Engl J Med. 2008;358:2678-2687. 4. Hohnloser SH, Crijns HJGM, van Eickels M, et al., for the ATHENA Investigators. Effect of dronedarone on cardiovascular events in atrial fibrillation. NEJM. 2009;360:668-678. 5. Wann LS, Curtis AB, January CT, et al. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (updating the 2006 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011;123:104-123. 6. Connolly SJ, Camm AJ, Halperin JL, et al. Dronedarone in high-risk permanent atrial fibrillation. N Engl J Med. Nov. 2011;365(24):2268-76 Program Prior Authorization – Multaq (dronedarone) Change Control 1/2010 New Policy 5/2010 Added criteria for patients failing/intolerance/ contraindication to amiodarone 5/2010 Changed closed ended risk factor requirement to open ended cardiovascular risk factor requirement (III. Guideline A6). 3/2011 Annual Review 3/2012 Updated criteria to include new safety warnings for patients who have permanent atrial fibrillation. Removed alternative criteria for trial and failure of amiodarone. 6/2013 Converted policy to new UnitedHealthcare enterprise wide formatting; Reworded requirement for permanent atrial fibrillation (see section 1 of criteria); Removed requirement that the patient has one CV risk factor; Removed prescriber requirement; Added requirement that the patient is currently receiving antithrombotic therapy; Added requirement that the patient is in normal sinus rhythm or conversion to normal sinus rhythm is planned Confidential and Proprietary, © 2016 UnitedHealthcare Services Inc. 2 12/2014 Annual Review 5/2016 Updated policy template. Confidential and Proprietary, © 2016 UnitedHealthcare Services Inc. 3