Highmark Medical Policy Bulletin
Section: Injections
Number: I-28
Topic: Infliximab, cA2 (Remicade)
Effective Date: July 16, 2001
Issued Date: July 16, 2001
Date Last Reviewed: 05/2001

General Policy Guidelines

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 (555.9) who have not responded to conventional treatment, including corticosteroids, other immunosuppressants, and antibiotic therapy, or

  • clinical relapse after successful treatment with infliximab.

The recommended dose of infliximab for Crohn's disease is 5 mg/kg given as a single intravenous infusion over at least two hours.
  • 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 initially 5 mg/kg administered as an intravenous infusion over at least two hours, followed with additional doses at two and six weeks after the first infusion.
  • 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 to be used in 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 Crohn's disease as a maintenance drug for preventative therapy, or for any diagnosis not listed on this policy is considered investigational, and therefore, not eligible for reimbursement.

NOTE: Infliximab is not reimbursable under the prescription drug benefit.

Procedure Codes

J1745     

Traditional (UCR/Fee Schedule) Guidelines

Refer to General Policy Guidelines

FEP Guidelines

Refer to General Policy Guidelines

Comprehensive/Wraparound/PPO Guidelines

Refer to General Policy Guidelines

Managed Care (HMO/POS) Guidelines

Refer to General Policy Guidelines

Publications

PRN References

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

References

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 21, 2001 Micromedex, Inc.

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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.