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Medical Policy: 05.01.23
Original Effective Date: April 2009
Reviewed: August 2011
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy 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 will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
CINRYZE ™ is a pasteurized, nanofiltered C1 inhibitor indicated for routine prophylaxis against angioedema attacks in adolescents and adult patients with hereditary angioedema.
C1 inhibitor is a normal constituent of human blood and is one of the serine proteinase inhibitors. The primary function of C1 inhibitor is regulation of the activation of the complement and intrinsic coagulation pathway. C1 inhibitor also regulates the fibrinolytic system. Regulation of these systems is performed through the formation of complexes between the proteinase and the inhibitor, resulting in inactivation of both and consumption of the C1 inhibitor.
Patients with hereditary angioedema have low levels of endogenous or functional C1 inhibitor. The actual mediators of acute attacks of angioedema are not well understood. It is believed that increased vascular permeability and the clinical manifestations of angioedema are primarily mediated through contact system activation. Suppression of contact system activation by C1 inhibitor is thought to modulate vascular permeability by preventing the generation of bradykinin. Administration of CINRYZE™ increases plasma levels of C1 inhibitor activity.
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Prior Approval:
Not applicable
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Policy:
CINRYZE™ may be considered medically necessary when administered as a single intravenous dose of 1,000 Units every 3 or 4 days for routine prophylaxis against angioedema attacks in patients with known hereditary angioedema.
CINRYZE™ for any indication other than as described above is considered investigational.
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Procedure Codes and Billing Guidelines:
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To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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J0598 Injection, C1 esterase inhibitor (human), 10 units
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Selected References:
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Bernstein JA. Hereditary angioedema: a current state-of-the-art review, VIII: current status of emerging therapies. Ann Allergy Asthma Immunol. 2008 Jan; 100(1 Suppl 2):S41-6.
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Frank MM, Jiang H. New therapies for hereditary angioedema: disease outlook changes dramatically. J Allergy Clin Immunol. 2008 Jan;121(1): 272-80.
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Epstein TG, Bernstein JA. Current and emerging management options for hereditary angioedema in the US. Drugs. 2008; 68(18):2561-73.
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Davis AE III. New treatments addressing the pathophysiology of angioedema. Clin Mol Allergy. 2008 Apr 14;6:2.
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Bork K, Barnstedt S-E. Treatment of 193 episodes of laryngeal edema with C1-inhibitor concentrate in patients with hereditary angioedema. Arch Intern Med. 2001; 161:714-718.
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Davis AE III. The pathophysiology of hereditary angioedema. Clin Immunol. 2005; 114:3-9.
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Policy History:
Date Reason Action
August 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark 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 Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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