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Medical Policy: 05.01.11
Original Effective Date: May 2006
Reviewed: August 2011
Revised: April 2009
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:
Abatacept, marketed under the trade name Orencia®, is a selective costimulation modulator, administered by IV infusion, which inhibits T-cell activation and interrupts the process leading to inflammation in rheumatoid arthritis.
Abatacept is indicated for reducing signs and symptoms, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis that has failed to adequately respond to one or more disease modifying anti-rheumatoid drugs (DMARDs) or tumor necrosis factor (TNF) antagonists.
In 2008, the U.S. Food and Drug Administration approved abatacept for reducing signs and symptoms in pediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis. Abatacept may be used as monotherapy or concomitantly with methotrexate (MTX).
In 2011, the FDA approved a subcutaneous formulation of abatacept for treatment of adults with moderate-to-severe rheumatoid arthritis. The new self-injectable formulation is a fixed 125mg dose administered subcutaneously once a week following a single intravenous loading dose of approximately 10mg/kg. Patients unable to receive an intravenous dose may initiate without the loading dose. Those transitioning from intravenous to subcutaneous should give first subcutaneous dose instead of the next intravenous dose.
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Prior Approval:
Prior approval is recommended. Submit a prior approval/treatment request now. ( 110KB)
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Policy:
Abatacept (intravenous or subcutaneous formulation) may be considered medically necessary when used as monotherapy or concomitantly with DMARDs other than TNF antagonists, in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate or allergic response to one or more DMARDs.
Abatacept (intravenous formulation only) may be considered medically necessary when used as monotherapy or concomitantly with methotrexate in pediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis.
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Procedure Codes and Billing Guidelines:
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Selected References:
- Genovese MC, Becker JC, Schiff M et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. N Engl J Med. 2005;353(11):1114-23.
- Kremer JM, Dougados M, Emery P et al. Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve-month results of a phase iib, double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 2005;52(8):2263-71.
- Allison C. Abatacept as add-on therapy for rheumatoid arthritis. Issues Emerg Health Technol. 2005;73:1-4.
- Emery P. Abatacept has beneficial effects in rheumatoid arthritis patients with an inadequate response to anti-TNF alpha therapy. Clin Exp Rheumatol. 2005;23(6):767-8.
- Teng GG, Turkiewicz AM, Moreland LW, Abatacept: a costimulatory inhibitor for treatment of rheumatoid arthritis. Expert Opin Biol Ther. 2005;5(9):1245-54.
- Ruderman EM, Pope RM, The evolving clinical profile of abatacept (CTLA4-Ig): a novel co-stimulatory modulator for the treatment of rheumatoid arthritis. Arthritis Res. Ther. 2005;7(Suppl 2):S21-5.
- Emery P; Kosinski m;Treatment of Rheumatoid Arthritis patient with abatacept and Methotrexate significantly improve the quality of life. J Rheumatol 2006 Apr:33(4):681-9.
- Kremer JM; Genant HK; Effects of Abatacept inpatients with methotrexate-Resistant Active Rheumatoid Arthritis. Annals of Internal Medicine 2006 June144(12):865-76.
- Venkateshan SP, Sidhu S, Malhotra S et al. Efficacy of biologics in the treatment of rheumatoid arthritis. A meta-analysis. Pharmacology. 2009;83(1).
- Ruperto N, Lovell DJ, Quartier P et al. Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo controlled withdrawal trial. Lancet. 2008 Aug 2; 372(9636):383-91.
- Lagana B, Vinciguerra M, D’Amelio R. Modulation of T-cell co-stimulation in rheumatoid arthritis: clinical experience with abatacept. Clin Drug Investig. 2009;29(3):185-202.
- Wells GA, Boers M, Li T et al. Investigating the validity of the minimal disease state activity for patients with rheumatoid arthritis treated with abatacept. J Rheumatol. 2009 Feb;36(2):260-5.
- Genovese M, Covarrubias A, Leon G et al. Subcutaneous abatacept versus intravenous abatacept: A phase IIIb non-inferiority study in patients with an inadequate response to methotrexate.
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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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