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INDEX:



Effective Date: 11/01/2013	Title: Antibodies to Infliximab
Revision Date:	Document: BI425:00
CPT Code(s): 84999
Public Statement
*Effective Date:* a) This policy will apply to all services performed on or after the above revision date which will become the new effective date. b) For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply. Tests for antibodies to infliximab (ATIs), with or without infliximab levels, is considered experimental and investigational and is not covered. One such test is the PROMETHEUS® Anser™ IFX test.
Medical Statement
1) Measurement of antibodies to infliximab (ATIs), with or without infliximab levels, is considered experimental/investigational and is not covered. 2) There is mixed evidence on the association between ATIs and loss of response to infliximab. It is unclear under what circumstances, if any, such measurement should change therapy in an individual patient. While use of combined measurement of infliximab and ATIs have some value in predicting loss of efficacy, it remains to be seen whether such use improves outcome compared to using clinical markers of efficacy. Codes Used In This BI: 84999 Unlisted Chemistry Procedure
Background
Infliximab is a chimeric monoclonal antibody directed against tumor necrosis factor alpha. When used in inflammatory bowel disease, primary nonresponse is found in at least 10% of patients, with secondary loss of response occurring in an additional 10-15% per year. It has been suggested that this may be related to development of antibodies to infliximab (ATIs). Lee et al, in a meta-analysis involving 3326 patients, demonstrated that the presence or absence of ATIs did not affect the rates of clinical remission. Patients with ATIs do have a higher risk of infusion reactions. Over half of patients with rheumatoid arthritis treated with infliximab develop ATIs. Those who do have a higher risk of adverse events and are less likely to achieve sustained disease response. (Krintel 2013). However, it is common for RA patients to have low infliximab levels with low disease activity.
Reference
1) Krintel SB, et.al. The frequency of anti-infliximab antibodies in patients with rheumatoid arthritis treated in routine care and the associations with adverse drug reactions and treatment failure. Rheumatology Jul 2013; 52(7): 1245-53. 2) Lee LY, Sanderson JD, Irving PM. Anti-infliximab antibodies in inflammatory bowel disease: prevalence, infusion reactions, immunosuppression and response, a meta-analysis. Eur J Gastroenterol Hepatol Sep 2012; 24(9): 1078-85. 3) Lichtenstein, GR. Letter from the Editor. Gastro Hepato Feb 2012. 4) Rutgeerts, P, et.al. Infliximab for induction and maintenance therapy for ulcerative colitis. NEJM 2005; 353:2462-76 5) Steenholdt C, et.al. Cut-off levels and diagnostic accuracy of infliximab trough levels and anti-infliximab antibodies in Crohn’s disease. Scan J Gastroenterol Mar 2011; 46(3):310-8 6) NCT00851565, Use of combined measurements of serum infliximab and anti-infliximab antibodies in the treatment of patients with Crohns disease failing infliximab therapy; ongoing study; accessed at www.clinicaltrials.gov on 7 August 2013.
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.

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