Download Clinical Pharmacy Program Guidelines for Multaq Program Prior

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.
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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.
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12/2014
Annual Review
5/2016
Updated policy template.
Confidential and Proprietary, © 2016 UnitedHealthcare Services Inc.
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