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.

When a benefit, infliximab, cA2 (Remicade) is eligible for patients who meet the following criteria:

• moderate to severe, active Crohn's disease (555.0, 555.1, 555.2, 555.9) - for those who have not responded to conventional treatment, including corticosteroids, other immunosuppressants, and antibiotic therapy.

The recommended dose of infliximab for Crohn's 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 moderately to severely active Crohn's 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.

• fistulizing Crohn's disease (569.81) - for the reduction in the number of draining enterocutaneous fistulas, or
• clinical relapse after successful treatment with infliximab.

The recommended dose of infliximab for fistulizing Crohn's disease is an initial 5 mg/kg followed by additional 5 mg/kg doses at two and six weeks after the first infusion. There are insufficient safety and efficacy data for the use of infliximab for fistulizing Crohn's disease beyond the recommended duration.

• rheumatoid arthritis (714.0,714.1,714.2,714.89,720.0) - for the reduction of signs and symptoms of 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 at least two hours, followed with additional doses at two and six weeks, then every eight 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.).

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.

NOTE:

Infliximab is not reimbursable under the prescription drug benefit.

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’s 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. The use of the FDA approved drug infliximab for conditions other than those listed as eligible on this policy is considered eligible when determined medically necessary based on the patient’s condition.

PRN References

02/2000, Infliximab (Remicade) eligible for certain conditions

Construction and Initial Characterization of a Mouse-Human Chimeric Anti-TNF Antibody, Molecular Immunology, Vol. 30, No.16, 07/1993

Treatment of Crohn's Disease with Anti Tumor Necrosis Factor Chimeric Monoclonal Antibody (cA2), Gastroenterology, Vol. 109, No.1, 07/1995

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 22, 2002 Micromedex, Inc.

Maintenance Infliximab for Crohn's Disease: The Accent 1 Randomized Trial, The Lancet, Vol. 359, No. 9317, 05/2002

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