Ruconest - UnitedHealthcareOnline.com

UnitedHealthcare Pharmacy
Clinical Pharmacy Programs
Program Number
Program
Medications
P&T Approval Date
Effective Date
1.
2014 P 1142-1
Prior Authorization/Notification
Ruconest® (C1 esterase inhibitor [recombinant])
8/2014
11/1/2014
Background:
Hereditary angioedema (HAE) is an autosomal dominant disease most commonly caused
by a deficiency of the plasma protein C1 esterase inhibitor (C1-INH). When C1-INH is
lacking, unchecked activation of the classic complement pathway occurs. The
coagulation, fibrinoytic, and kallikrein-kinin cascades are also activated. Resulting
elevated plasma levels of bradykinin cause the symptoms of HAE. Patients can present
with any combination of subcutaneous or submucosal edema affecting the face,
extremities, genitals, and gastrointestinal tract. Life-threatening pharyngolaryngeal edema
and acute airway obstruction can also occur.1
Ruconest® (C1 esterase inhibitor [recombinant]) is indicated for the treatment of acute
attacks in adult and adolescent patients with hereditary angioedema (HAE). Effectiveness
was not established in HAE patients with laryngeal attacks.2
2.
Coverage Criteria:
A. Ruconest will be approved based on all of the following criteria:
1. Diagnosis of hereditary angioedema (HAE)
-AND2. For the treatment of acute HAE attacks
-AND3. Not used in combination with other approved treatments for acute HAE attacks
(e.g. Berinert, Firazyr, or Kalbitor)
Authorization of therapy will be issued for 12 months.
Confidential and Proprietary, © 2014 UnitedHealthcare Services, Inc.
1
3.
Additional Clinical Programs:

4.
References:
1. Frank MM. Hereditary Angioedema. Medscape Reference. Available at
http://emedicine.medscape.com/article/135604-overview. Updated April 21, 2014.
Accessed June 23, 2014.
2. Ruconest [package insert]. Raleigh, NC: Santarus, Inc.; July 2014.
Program
8/2014
Supply limitations may be in place.
Prior Authorization/Notification - Ruconest (C1 esterase inhibitor
[recombinant])
Change Control
New program.
Confidential and Proprietary, © 2014 UnitedHealthcare Services, Inc.
2

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