BlueCross BlueShield of Tennessee Medical Policy Manual

Infliximab

NDC CODE(S)

57894-030-01 - Remicade 20ml (100mg) single use vial (Janssen)

DESCRIPTION

Infliximab is a chimeric (human and mouse) monoclonal antibody that inhibits activity of tumor necrosis factor alpha (TNF-alpha). During inflammation, cells in the immune system release TNF-alpha. It is believed that infliximab reduces inflammation by binding to, and neutralizing TNF-alpha before it reaches its cell-bound receptor. Infliximab is usually administered intravenously in the outpatient setting by a physician or a nurse.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Rheumatoid Arthritis

Up to 10mg/kg every 4 weeks, with loading dose 3mg/kg at weeks 0, 2, 6 and then every 8 weeks thereafter

Crohn’s Disease

Up to 10mg/kg every 8 weeks, with loading dose 5mg/kg at weeks 0, 2, 6 and then every 8 weeks thereafter

Ankylosing Spondylitis

Up to 5mg/kg every 6 weeks, with loading dose 5mg/kg at weeks 0, 2, 6 and then every 6 weeks thereafter

Takayasu’s Arteritis

3 to 5mg/kg every 6 weeks as steroid-sparing agent, with a loading dose of 5mg/kg at weeks 0, 2, 6 and then every 8 weeks thereafter

All other indications

Up to 5mg/kg every 8 weeks, with loading dose 5mg/kg at weeks 0, 2, 6 and then every 8 weeks thereafter

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of infliximab for the treatment of other conditions or diseases.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2014). Infliximab (5.01.15). Retrieved August 26, 2015 from BlueWeb.

Lexi-Comp Online. (2015). AHFS DI. Infliximab. Retrieved August 26, 2015 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series, Drugdex Drug Evaluations. (2015, July ). Infliximab. Retrieved August 26, 2015 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration (2015, January). Center for Drug Evaluation and Research. Remicade® (infliximab). Retrieved August 26, 2015 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103772s5370lbl.pdf.

ORIGINAL EFFECTIVE DATE:  8/1/2000

MOST RECENT REVIEW DATE:  2/27/2018

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

Pharmaceutical Decision Support Tree

Infliximab (Remicade®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #14

  1. Has the individual been evaluated and screened/tested for presence of ALL of the following prior to beginning treatment?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there documentation of understanding of necessity of absence of ALL of the following?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of ankylosing spondylitis with ALL of the following?

If yes, go to question #13

If no, go to question #5

  1. Does the individual have a diagnosis of moderately to severely active Crohn’s disease with ALL of the following?

If yes, go to question #13

If no, go to question #6

  1. Does the individual have a diagnosis of moderately to severely active Fistulizing Crohn’s disease with ALL of the following?

If yes, go to question #13

If no, go to question #7

  1. Does the individual have a diagnosis of plaque psoriasis with ALL of the following?

If yes, go to question #13

If no, go to question #8

  1. Does the individual have a diagnosis of psoriatic arthritis with ALL of the following?

If yes, go to question #13

If no, go to question #9

  1. Does the individual have a diagnosis of rheumatoid arthritis with ALL of the following?

If yes, go to question #13

If no, go to question #10

  1. Does the individual have a diagnosis of Takayasu’s arteritis that is uncontrolled with glucocorticoids?

If yes, go to question #13

If no, go to question #11

  1. Does the individual have a diagnosis of ulcerative colitis with ALL of the following?

If yes, go to question #13

If no, go to question #12

  1. Does the individual have a diagnosis of uveitis associated with Behçet’s Syndrome and the individual’s disease is refractory to immunosuppressive therapy?

If yes, go to question #13

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for billable units (BU) and dosage up to ANY ONE of the following for a 6 month authorization period?

Rheumatoid Arthritis

40 BU at weeks 0, 2, 6 loading dose

100 BU every 4 weeks maintenance

Up to 10mg/kg every 4 weeks, with loading dose 3mg/kg at weeks 0, 2, 6 and then every 8 weeks

Crohn’s Disease

60 BU at weeks 0, 2, 6 loading dose

100 BU every 8 weeks maintenance

Up to 10mg/kg every 8 weeks, with loading dose 5mg/kg at weeks 0, 2, 6 and then every 8 weeks

Ankylosing Spondylitis

60 BU at weeks 0, 2, 6 loading dose

60 BU every 6 weeks maintenance

Up to 5mg/kg every 6 weeks, with loading dose 5mg/kg at weeks 0, 2, 6 and then every 6 weeks

Takayasu’s Arteritis

60 BU at weeks 0, 2, 6 loading dose

60 BU every 8 weeks maintenance

3 to 5mg/kg every 6 weeks, with loading dose of 5mg/kg at weeks 0, 2, 6 and then every 8 weeks

All other indications

60 BU at weeks 0, 2, 6 loading dose

60 BU every 8 weeks maintenance

Up to 5mg/kg every 8 weeks, with loading dose 5mg/kg at weeks 0, 2, 6 and then every 8 weeks

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in questions 2 through 13?

If yes, go to question #15

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity to the agent and continued monitoring for tuberculosis and other serious infections?

If yes, go to question #16

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have disease response to treatment as indicated by a diagnosis of ANY ONE of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.