Infliximab
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.
An example of a preparation of infliximab is Remicade®.
REFER TO DECISION SUPPORT TREE
POLICY
Infliximab for the treatment of the following conditions is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Crohn’s disease
Rheumatoid arthritis
Psoriatic arthritis
Ulcerative colitis
Ankylosing spondylitis
Plaque psoriasis
Wegener's granulomatosis
Infliximab for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Infliximab is considered medically appropriate for the treatment of ANY ONE of the following:
Crohn’s disease if ANY ONE of the following criteria are met:
Moderately to severely active fistulizing Crohn's with ALL of the following:
The individual is 18 years of age or older
Has have completed a formal consultation with a gastroenterologist
Inadequate response to conventional therapy
Moderately to severely active Crohn's with ALL of the following:
Is 6 years of age or older
Has completed a formal consultation with a gastroenterologist,
Inadequate response to conventional therapy (Note: The FDA states: “REMICADE has not been studied in children with Crohn's disease < 6 years of age. The longer term (greater than one year) safety and effectiveness of REMICADE in pediatric Crohn's disease patients have not been established in clinical trials.)”
Rheumatoid arthritis if ALL of the following are met:
The individual is 18 years of age or older
Has moderately to severely active rheumatoid arthritis
Has completed a formal consultation with a rheumatologist
The agent is used alone or in combination with methotrexate if tolerated
Psoriatic arthritis if ALL of the following are met:
The individual is 18 years of age or older
Disease is active
Has completed a formal consultation with a rheumatologist and/or dermatologist
Ulcerative colitis if ALL of the following are met:
The individual is 6 years of age or older
Has moderately to severely active ulcerative colitis
Has had an inadequate response to conventional therapy
Has completed a formal consultation with a gastroenterologist
Ankylosing spondylitis if ALL of the following are met:
The individual is 18 years of age or older
Has active ankylosing spondylitis
Is refractory to conventional therapies
Has completed a formal consultation with a rheumatologist
Plaque psoriasis if ALL of the following are met:
The individual is 18 years of age or older
Has chronic severe (i.e., extensive and/or disabling) plaque psoriasis
Is a candidate for systemic therapy
Other systemic therapies are medically less appropriate
Has completed a formal consultation with a dermatologist
Wegener's granulomatosis if ALL of the following are met:
The individual is 18 years of age or older
Refractory to conventional immunosuppressant and corticosteroid therapy
Is being used in combination with corticosteroids
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies withTennessee 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 dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
There is insufficient evidence supporting the use of infliximab for the treatment of other conditions/diseases.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2009). Off-label uses of infliximab (5.01.15). Retrieved September 27, 2011 from BlueWeb.
Lexi-Comp Online. (May, 2011). AHFS DI. Remicade®. Retrieved October 4, 2011 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series, Drugdex Drug Evaluations. (September, 2011). Infliximab. Retrieved October 5, 2011 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration (2011, September). Center for Drug Evaluation and Research. Remicade® (infliximab). Retrieved October 4, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5301lbl.pdf.
ORIGINAL EFFECTIVE DATE: 8/1/2000
MOST RECENT REVIEW DATE: 12/16/2011
ID_BT
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
Does the individual have a diagnosis of Crohn’s disease and ANY ONE of the following?
Moderately to severely active fistulizing Crohn's with ALL of the following:
The individual is 18 years of age or older
Has have completed a formal consultation with a gastroenterologist
Inadequate response to conventional therapy
Moderately to severely active Crohn's with ALL of the following:
Is 6 years of age or older
Has completed a formal consultation with a gastroenterologist,
Inadequate response to conventional therapy (Note: The FDA states: “REMICADE has not been studied in children with Crohn's disease < 6 years of age. The longer term (greater than one year) safety and effectiveness of REMICADE in pediatric Crohn's disease patients have not been established in clinical trials.)”
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #2
Does the individual have a diagnosis of rheumatoid arthritis and ALL of the following?
The individual is 18 years of age or older
Has moderately to severely active rheumatoid arthritis
Has completed a formal consultation with a rheumatologist
The agent is used alone or in combination with methotrexate if tolerated
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #3
Does the individual have a diagnosis of psoriatic arthritis and ALL of the following?
The individual is 18 years of age or older
Disease is active
Has completed a formal consultation with a rheumatologist and/or dermatologist
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #4
Does the individual have a diagnosis of ulcerative colitis and ALL of the following?
The individual is 6 years of age or older
Has moderately to severely active ulcerative colitis
Has had an inadequate response to conventional therapy
Has completed a formal consultation with a gastroenterologist
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #5
Does the individual have a diagnosis of ankylosing spondylitis and ALL of the following?
The individual is 18 years of age or older
Has active ankylosing spondylitis
Is refractory to conventional therapies
Has completed a formal consultation with a rheumatologist
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #6
Does the individual have a diagnosis of plaque psoriasis and ALL of the following?
The individual is 18 years of age or older
Has chronic severe (i.e., extensive and/or disabling) plaque psoriasis
Is a candidate for systemic therapy
Other systemic therapies are medically less appropriate
Has completed a formal consultation with a dermatologist
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #7
Does the individual have a diagnosis of Wegener's granulomatosis and ALL of the following?
The individual is 18 years of age or older
Refractory to conventional immunosuppressant and corticosteroid therapy
Is being used in combination with corticosteroids
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.