Infliximab*

Medical Policy: 05.01.05 
Original Effective Date: May 1999 
Reviewed: March 2012 
Revised: April 2008 

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: 

Infliximab, marketed under the trade name Remicade®, is a monoclonal antibody directed against tumor necrosis factor (TNF) alpha that was originally approved in 1998 by the U. S. Food and Drug Administration (FDA) for intravenous treatment of Crohn’s disease, refractory to other treatments.

Infliximab is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

Infliximab is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.

Infliximab is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease.

Infliximab is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.

Infliximab is indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

Infliximab is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis.

Infliximab, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis.

Infliximab is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

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Prior Approval: 

Prior approval is recommended. Submit a prior approval/treatment request now. ( 163KB)

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Policy: 

Ankylosing Spondylitis

Infliximab for the treatment of ankylosing spondylitis may be considered medically necessary in patients refractory to one or more conventional treatment.

Crohn's Disease

Infliximab for the treatment of moderate to severe active Crohn’s disease may be considered medically necessary patients refractory to one or more conventional treatments. 

Inflammatory Polyarthropathy

Infliximab for the treatment of inflammatory polyarthropathy may be considered medically necessary in patients refractory to one or more conventional treatments.

Plaque Psoriasis

Infliximab for the treatment of chronic severe plaque psoriasis may be considered medically necessary in adults (age 18 years or older) meeting the following criteria:

• treatment resistant chronic plaque psoriasis covering at least 10% of body surface area OR psoriasis affecting the hands, feet, face or genitals AND
• have failed or are intolerant to, but are candidates for, other systemic therapies or phototherapy

Psoriatic Arthritis

Infliximab for the treatment of psoriatic arthritis may be considered medically necessary in patients refractory to one or more conventional treatments.

Rheumatoid Arthritis

Infliximab for the treatment of refractory rheumatoid arthritis may be considered medically necessary, alone or in combination with methotrexate, in patients refractory to one or more conventional treatments.

Ulcerative Colitis

Infliximab for the treatment of moderate to severe active ulcerative colitis may be considered medically necessary in patients refractory to one or more conventional treatments. 

Infliximab is considered investigational for the treatment of all other indications not listed above.

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Procedure Codes and Billing Guidelines: 

• To report provider services, use appropriate CPT** codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
• J1745 Injection, infliximab, 10mg

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Selected References: 

• Kornbluth A. Professional affair and public policy, Infliximab approved for use in Crohn’s disease: A report on the FDA GI Advisory Committee Conference. Inflammatory Bowel Disease. 4(4):328-329; 1998 Crohn’s and colitis foundation of America Inc.
• Technology assessment brief, Hayes Technology, Infliximab for the treatment of Crohn’s disease. Volume II, number 1999.
• Hanauer SB, Cohen RD, Becker RV, Larson LR, Vreeland MG. Advances in the management of Crohn’s disease: Economic and clinical potential of Infliximab. Clinical Therapeutics. Vol 20, No.5, 1998;1009-1028.
• From Food and Drug Administration. JAMA. 1998; vol 280, #13;1128.
• Baeten D. et al Immunomodulatory effects of anti-tumor necrosis factor & Therapy on synovium in spondylarthropathy. Arthritis and Rheumatism 2001; vol.44, #1: 186-195.
• Patel S, Veale D, FitzGerald O, McHugh NJ Editorial: Psoriatic arthritis-emerging concepts. Rheumatology 2001; 40:243-246.
• Ilowite NT Current treatment of juvenile rheumatoid arthritis. Pediatrics 2002; 109(1):109-115.
• Valle E, Gross M, Bickston SJ Infliximab. Expert Opin Pharmacother 2001; 2(6):1015-1025.
• Hamilton J, Capell H The treatment of juvenile arthritis. Expert Opin Pharmacother 2001; 2(7):1085-1092.
• Probert CS, Hearing SD, et al. Infliximab in moderately severe glucocorticoid resistant ulcerative colitis: a randomized controlled trial. Gut. 2003 Jul.;52(7):998-1002.
• Armuzzi A, De Pascals B, et al. Infliximab in the treatment of steroid-dependent ulcerative colitis. Euro Rev Med Pharmacol Sci. 2004 Sep-Oct;8(5):231-3.
• Jarnerot G, Hertervig E, Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: a randomized, placebo-controlled study. Gastroenterology. 2005 Jun;128(7):1805-11.
• From Food and Drug Administration: jnj.com/new/jnj_news/20060926_1555540, FDA Approves Remicade® for Treatment of Chronic Severe Plaque Psoriasis.
• Willert RP, Lawrance IC. Use of infliximab in the prevention and delay of colectomy in severe steroid dependant and refractory ulcerative colitis. World J Gastroenterol. 2008 Apr 28;14(16):2544-9.
•  Mitoma H, Horiuchi T, Tsukamoto H et al. Mechanisms for cytotoxic effects of anti-tumor necrosis factor agents on transmembrane tumor necrosis factor alpha-expressing cells: Comparison among infliximab, etanercept, and adalimumab. Arthritis Rheum. 2008 Apr 25;25;5895):1248-1257. [Epub ahead of print].
• Caprilli R, Angelucci E, Clemente V. Recent advances in the management of Crohn’s disease. Dig Liver Dis. 2008 Apr 18 [Epub ahead of print].
• Reed MR, Taylor AL. Tumor necrosis factor inhibitors in ankylosing spondylitis. Intern Med J. 2008 Apr 14 [Epub ahead of print].
• Alonso-Ruiz A Pijoan JI, Ansuategui E et al. Tumor necrosis factor alpha drugs in rheumatoid arthritis: systematic review and metaanalysis of efficacy and safety. BMC Musculoskelet Disord. 2008 Apr 17;9(1):52 [Epub ahead of print].
• Strand V, Singh JA. Improved health-related quality of life with effective disease-modifying antirheumatic drugs: evidence from randomized controlled trials. Am J Manag Care. 2008 Apr;14(4):234-54.
• Lass K, Peltomaa R, Kautiainen H et al. Clinical impact of switching from infliximab to etanercept in patients with rheumatoid arthritis. Clin Rheumatol. 2008 Apr 15 [Epub ahead of print].
• Prendiville CA, O’Doherty M, Moriarty P et al. The use of infliximab in ocular inflammation. Br J Ophthalmol. 2008 Apr 11 [Epub ahead of print].
• Antoni CE, Kavanaugh A, van der Heijde D et al. Two-year efficacy and Safety of infliximab treatment in patients with active psoriatic arthritis: findings of the infliximab multinational psoriatic arthritis controlled trial (IMPACT). J Rheumatol. 2008 Mar 15 [Epub ahead of print].
• Kuriya B, Arkema EV, Bykerk VP et al. Efficacy of initial methotrexate monotherapy versus combination therapy with a biological agent in early rheumatoid arthritis: a meta-analysis of clinical and radiographic remission. Ann Rheum Dis. 2010 Jul; 69(7):1298-304. Epub 2010 Apr 26.
• van den Broek M, Klarenbeek NB, Dirven L et al. Discontinuation of infliximab and potential predictors of persistent low disease activity in patients with early rheumatoid arthritis and disease activity score-steered therapy: sub analysis of the BeST study. Ann Rheum Dis. 2011 Aug; 70(8):1389-94. Epub 2011 Apr 24.
• van der Kooij SM, le Cessie S, Goekoop-Ruiterman YP et al. Clinical and radiological efficacy of initial vs delayed treatment with infliximab plus methotrexate in patients with early rheumatoid arthritis. Ann Rheum Dis. 2009 Jul; 68(7):1153-8. Epub Oct 17. 

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Policy History: 

Date                                        Reason                               Action

April 2011                              Annual review                     Policy renewed

March 2012                           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 © 2012 American Medical Association. All Rights Reserved.