Coverage for infliximab, cA2 (Remicade)(J1745)  is determined according to individual or group customer benefits. Infliximab is eligible for patients who meet the following criteria:

• Crohn's disease (555.0, 555.1, 555.2, 555.9) - for the reduction in signs and symptoms and inducing and maintaining clinical remission in patients with moderate to severe active Crohn's disease who have not responded to conventional treatment, including corticosteroids, other immunosuppressants, and antibiotic therapy.
  
  
• Pediatric Crohn's disease (555.0, 555.1, 555.2, 555.9) - for the reduction in signs and symptoms and inducing and maintaining clinical remission in pediatric patients age 6 to 17 with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.
  
  
• Fistulizing Crohn's disease (569.81) - for the reduction in the number of draining enterocutaneous and rectovaginal fistulas, and maintaining fistula closure in patients with fistulizing Crohn's disease.
  
  The recommended dose of infliximab for Crohn's disease or fistulizing disease is 5 mg/kg given as an induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of moderate to severe active Crohn's disease or fistulizing disease. For patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg. Patients who do not respond by week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue infliximab in these patients.
  
  
• Rheumatoid arthritis (714.0, 714.1, 714.2, 714.89, 720.0) - in combination with methotrexate for the reduction of signs and symptoms of moderate to severe active rheumatoid arthritis, in patients who have had an inadequate response to methotrexate, the current standard of therapy.
  
  The recommended dose of infliximab in combination with methotrexate for rheumatoid arthritis, is initially 3 mg/kg administered as an intravenous infusion over two hours, followed with additional doses at 2 and 6 weeks, then every 8 weeks thereafter. For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg or treating as often as every four weeks.
  
  Infliximab is not FDA approved for the treatment of rheumatoid arthritis without methotrexate. However, individual consideration will be given to patients who are unable to tolerate methotrexate (e.g., abnormal liver function, depressed hemopoietic function, etc.).

• Ankylosing Spondylitis (720.0) - for the reduction of signs and symptoms in patients with active ankylosing spondylitis.
  
  The recommended dose of infliximab for ankylosing spondylitis is 5 mg/kg given as an intravenous infusion followed with additional similar doses at 2 and 6 weeks after the first infusion, then every 6 weeks thereafter.

• Psoriatic arthritis (696.0) - for the reduction of signs and symptoms in patients with active articular disease defined as five or more swollen and tender joints and either C reactive protein levels of at least 15 mg/l and/or morning stiffness lasting 45 minutes or longer, and
  
  Patients have tried and experienced an inadequate response to at least one disease modifying antirheumatic drug (DMARD)(refer to the Glossary below for DMARD description), and
  
  Patients have active plaque psoriasis with at least one target lesion at least 2 cm in diameter.
  
  The recommended dose of infliximab for psoriatic arthritis is 5 mg/kg given as an intravenous infusion followed with additional similar doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.

• Ulcerative colitis (556.0-556.9) - for the reduction of signs and symptoms, 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 (oral corticosteroids, azathioprine [AZA], 6-mercaptopurine [6-MP], and/or amino salicylates).
  
  The recommended dose of infliximab for ulcerative colitis is 5mg/kg given as an induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5mg/kg every 8 weeks thereafter.
  
  
• Plaque psoriasis (696.1) - for the treatment of adult patients with chronic, severe (i.e., extensive and/or disabling) plaque psoriasis; and,
  
  Patient's plaque psoriasis has been present for more than six months with a minimum body surface involvement of 10%*; and
  
  Patients have failed to adequately respond to standard systemic agents (e.g., methotrexate, cyclosporin); or
  
  Patients have failed to adequately respond to standard phototherapy (e.g., PUVA, UVB).
  
  *In patients with severe disease, localized psoriasis in sensitive areas such as palmar, plantar, and genitalia would meet the 10% body surface involvement definition.
  
  The recommended dose of infliximab for plaque psoriasis is 5 mg/kg given as an intravenous infusion followed by additional doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.

The use of infliximab for any diagnosis not listed on this policy is considered experimental/investigational, and therefore, not covered. A participating, preferred, or network provider can bill the member for the denied service. Other indications under consideration for treatment with infliximab are being investigated in the clinical trial setting with no long-term outcomes available.

Infliximab is not reimbursable under the prescription drug benefit.

Description

Infliximab, cA2 (Remicade) (J1745) is a murine-human chimeric monoclonal antibody, which binds to and neutralizes the effects of tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory cytokine.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient's condition.

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A Short Term Study of Chimeric Monoclonal Antibody cA2 to Tumor Necrosis Factor for Crohn's Disease, The New England Journal of Medicine, Vol. 337, No.15, 10/1997

Crohn's Disease Treatment Approved, Journal of American Medical Association, Vol. 280, No.13, 10/1998

Infliximab for the Treatment of Fistula's in Patients with Crohn's Disease, The New England Journal of Medicine, Vol. 340, No.18, 05/1999

Efficacy and Safety of Retreatment with Anti-Tumor Necrosis Factor Antibody (Infliximab) to Maintain Remission in Crohn's Disease, Gastroenterology, Vol. 117, No.4, 10/1999

Infliximab, USPDI-Vol. I, Edition 26, 2006 Micromedex, Inc.

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Inflammatory Bowel Disease, The New England Journal of Medicine, Vol. 347, No. 6, 08/2002

Use of Biologics for Rheumatoid Arthritis Tempered by Concerns Over Safety, Cost, Journal of American Medical Association, Vol. 289, No. 24, 06/2003

Infliximab Maintenance Therapy for Fistulizing Crohn's Disease, The New England Journal of Medicine, Vol. 350, No. 9, 02/2004

Efficacy of Infliximab in Resistant Psoriatic Arthritis, Arthritis & Rheumatism, Arthritis Care & Research, Vol. 49, No. 4, 08/2003

A Randomized Placebo-Controlled Trial of Infliximab Therapy for Active Ulcerative Colitis: Act I Trial, Gastroenterology, Vol. 128, No. 4, 04/2005

Infliximab Induction and Maintenance Therapy for Ulcerative Colitis: The Act 2 Trial, Gastroenterology, Vol. 128, No. 4, 04/2005

Infliximab Induction and Maintenance Therapy for Moderate-to-Severe Psoriasis; A Phase III, Multicenter, Double-Blind Trial, The Lancet, Vol. 366, No. 9494, 10/2005

Finlay AY. Current severe psoriasis and the role of tens. Br J Dermatol. 2005;152(5):861-867.

Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheumat Dis. 2005;64:ii65-ii68.

Smith CH, Anstey AV, Barker JNWN, Burden AD, et al. British Association of Dermatologists guidelines for use of biological interventions in psoriasis 2005. Br J Dermatol. 2005:153:486-497.

FDA Approves Remicade for Children with Crohn's Disease, US Food and Drug Administration, FDA News, May 19, 2006

Gottlieb A, Korman NJ, Gordon DB, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. J Am Acad Dermatol. 2008;58:851-864.

Remicade [package insert]. Malvern, PA:Centocor, Inc. 05/2008.