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Moda Health Plan, Inc.
Subject: Remicade (infliximab)
Medical Necessity Criteria
Page 1 of 6
Developed By: Medical Criteria Committee Approved:
Mary Engrav, MD
Date: 12/1/2013

Description:
Remicade® (Infliximab) is a tumor necrosis factor (TNF) blocker indicated to reduce the signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate, active psoriatic arthritis, active ankylosing spondylitis, chronic severe (i.e., extensive and/or disabling) plaque psoriasis (PsO). Remicade® (Infliximab) is indicated to reduce signs and inducing and maintaining clinical remission in adult and pediatric patients with moderately to severely active crohn’s disease (CD) and reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease. Remicade® (Infliximab) is indicated to reduce signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active ulcerative colitis (UC). Remicade® (Infliximab) is indicated to reduce signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active crohn’s disease (CD). Criteria:
Remicade is medical y necessary as indicated by 1 or more of the following: a. Crohn’s disease with ALL of the fol owing ii. Documented moderate to severe disease iii. Evaluated and screened for the presence of latent TB infection prior to initiating iv. Documented trial and failure on ONE conventional oral agent for at least 3 months, unless use is contraindicated, such as mesalamine, corticosteroids, 6- v. Not on concurrent treatment of another TNF inhibitor b. Pediatric Crohn’s disease with ALL of the following ii. Documented moderate to severe disease iii. Evaluated and screened for the presence of latent TB infection prior to initiating iv. Documented trial and failure of ONE conventional oral therapy such as corticosteroids, 6-mercaptopurine or azathioprince v. Not on concurrent treatment with another TNF inhibitor c. Ulcerative Colitis with ALL of the following ii. Documented moderate to severe disease iii. Evaluated and screened for the presence of latent TB infection prior to initiating iv. Documented trial and failure on ONE conventional oral therapy as corticosteroids, 6- v. Not on concurrent treatment with another TNF inhibitor d. Pediatric Ulcerative Colitis with ALL of the following ii. Documented moderate to severe disease iii. Patient has been evaluated and screened for the presence of latent TB infection iv. Documented trial and failure on ONE conventional therapy such as corticosteroids, e. Fistulizing Crohn’s disease with ALL of the following ii. Patient has been evaluated and screened for the presence of latent TB infection iii. Documented trial and failure on ONE conventional oral therapy such as corticosteroids, 6-mercaptopurine or azathioprine iv. Not on concurrent therapy with another TNF inhibitor f. Rheumatoid Arthritis with ALL of the fol owing ii. Patient has been evaluated and screened for the presence of latent TB infection iii. Documented moderate to severe disease iv. Patient has had at least a 3 month trial and failed previous therapy with ONE oral disease modifying anti-rheumatic agent (DMARD) such as methotrexate, Imuran, Ridaura, Plaquenil, Cuprimine, Azulfidine or Arave v. Previous failure with preferred self-injectable TNF antagonist vi. Used in combination with methotrexate (MTX) unless contraindicated vii. Not on concurrent treatment with another TNF inhibitor g. Psoriatic Arthritis with ALL of the following ii. Patient has been evaluated and screened for the presence of latent TB infection iii. Documented moderate to severe active disease iv. Patient has tried and failed at least a 3 month trail of ONE oral disease-modifying anti-rheumatic agent (DMARD) such as methotrexate, azathioprine, sulfasalazine, or v. Not on concurrent treatment with another TNF inhibitor h. Ankylosing Spondylitis with ALL of the following ii. Patient has been evaluated and screened for the presence of latent TB infection iv. Patient had an adequate trial and failure of at least TWO (2) non-steroidal anti- inflammatory agents (NSAIDS), unless use is contraindicated v. Not on concurrent treatment with another TNF inhibitor i. Plaque psoriasis with ALL of the following i. Documented moderate to severe chronic disease (for at least 1 year) ii. Evaluated and screened for the presence of latent TB infection prior to initiating iv. Patient must have plaques covering >10% of their body surface area or <10% if BSA, but with involvement of palms, soles, head and neck, or genitalia which causes v. Topical therapy is no longer tolerated or effective with agents such as corticosteroids, anthralin, calcipotriene, or tazaotene vi. Previous treatment failure with phototherapy: (Psoralens with UVA light (PUVA) or vii. Patient is a candidate for systemic therapy (i.e., Acitretin, methotrexate, or cyclosporine) with adequate trail and failure or intolerance to treatment viii. Not on concurrent treatment with another TNF inhibitor j. Uveitis Associated with Behcet’s Syndrome with the fol owing i. Patient’s disease is refractory to immunosuppressive therapy k. Renewal of Remicade is medically necessary with ALL of the following i. Patient continues to meet criteria identified in section I iii. Absence of unacceptable toxicity from the drug a. Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due b. Discontinue REMICADE if a patient develops a serious infection c. Perform test for latent TB; if positive, start treatment for TB prior to starting REMICADE. Monitor all patients for active TB during treatment, even if initial latent TB is negative d. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including REMICADE e. Postmarketing cases of fatal hepatosplenic T-cel lymphoma (HSTCL) have been reported in patients treated with TNF blockers, including REMICADE. Al REMICADE cases were reported in patients with Crohn’s disease or ulcerative colitis, the majority of whom were adolescent or young male adults. Al had received azathioprine or 6-mercaptopurine concomitantly Dosage/Administration
Indication
Loading Dose:
RA – 3mg/kg at weeks 0, 2, 6 and then every 8 week thereafter All other indications – 5mg/kg at weeks 0, 2, 6 and then every 8 week thereafter
Information to be Submitted with Pre-Authorization Request:


Applicable CPT Codes:

JCode:
J1745 – Remicade (Janssen) 100mg vial injection: 1 billable unit = 10 mg
Max Units: Rheumatoid Arthritis (RA) and Crohn’s Disease Male Indications other than Rheumatoid Arthritis (RA) and Crohn’s Disease Male Diagnosis
Regional enteritis of small intestine with large intestine Other rheumatoid arthritis with visceral or systemic involvement Other specified inflammatory polyarthropathies Unspecified inflammatory polyarthropathy
References:
• Remicade [package insert]. Horsham, PA; Janssen Biotech, Inc; March 2013. • Present DH, Rutgeerts P, Targan S, et al. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med 1999;340:1398-1405. • Targan SR, Hanauer SB, van Deventer SJH, et al. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. N • Hanauer SB, Fegan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomized trial. Lancet 2002;359:1541-1549. • Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American Col ege of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2012 May;64(5):625-39. • Saag KG, Teng GG, Patkar NM, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum 2008;59:762-84. • Antoni C, Krueger GG, de Vlam K, et al. Infliximab improves signs and symptoms of psoriatic arthritis: results of the IMPACT 2 trial. Ann Rheum Dis 2005;64:1150- • Menter A, Feldman SR, Weinstein GD, et al. A randomized comparison of continuous vs intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis. J Am Acad Dermatol • Niccoli L, Nannini C, Benucci M, Chindamo D, Cassarà E, Salvarani C, Cimino L, Gini G, Lenzetti I, Cantini F. Long-term efficacy of infliximab in refractory posterior uveitis of Behcet's disease: a 24-month follow-up study. Rheumatology (Oxford). 2007 Jul;46(7):1161-4. Epub 2007 May 3. • Tugal-Tutkun I, Mudun A, Urgancioglu M, Kamali S, Kasapoglu E, Inanc M, Gül A. Efficacy of infliximab in the treatment of uveitis that is resistant to treatment with the combination of azathioprine, cyclosporine, and corticosteroids in Behçet's disease: an open-label trial. Arthritis Rheum. 2005 Aug;52(8):2478-84. • Lichtenstein GR, Hanauer SB, Sandborn WJ, Practice Parameters Committee of American Col ege of Gastroenterology. Management of Crohn's disease in adults. Am J Gastroenterol. 2009;104(2):465. • Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102.

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