Abatacept
DESCRIPTION
Abatacept, a biological response modifier, displays anti-inflammatory affects by inhibiting T cell (T lymphocyte) activation by binding to CD80 (i.e., antigen) and CD86, thus blocking interaction with CD28. This interaction provides a costimulatory signal necessary for full activation of T lymphocytes, implicated in the pathogenesis of rheumatoid arthritis (RA). Activated T lymphocytes are found in the synovium of individuals with rheumatoid arthritis.
An example of a preparation of abatacept is Orencia®.
REFER TO DECISION SUPPORT TREE
POLICY
Abatacept for the treatment of arthritis is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Abatacept for the treatment of other conditions/diseases, including, but not limited to, the following: systemic lupus erythematosus, relapsing-remitting multiple sclerosis, psoriasis, transplant rejection, graft-versus-host disease, tumor immunity and infectious diseases is considered investigational.
MEDICAL APPROPRIATENESS
Abatacept for the treatment of arthritis is considered medically appropriate for ANY ONE of the following:
Rheumatoid arthritis with ALL of the following:
The individual is 18 years of age or older
Has moderately to severely active rheumatoid arthritis
Juvenile idiopathic arthritis (i.e., juvenile rheumatoid arthritis) with ALL of the following:
The individual is 6 years of age or older
Has moderately to severely active polyarticular juvenile idiopathic arthritis
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.
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).
The evidence in the literature is insufficient to permit conclusions on the health outcomes and effects of abatacept for any of the other conditions/diseases.
SOURCES
Drugs for rheumatoid arthritis. (2009, May). Treatment Guidelines From The Medical Letter, 7 (Issue 81), 1-13.
Lexi-Comp Online. (2009). AHFS DI. Orencia®. Retrieved September 22, 2009 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2009). Abatacept. Retrieved September 22, 2009 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2009, August). Center for Drug Evaluation and Research. Label and Approval History. Orencia® (abatacept). Retrieved September 22, 2009 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125118s0086lbl.pdf.
ORIGINAL EFFECTIVE DATE: 7/8/2006
MOST RECENT REVIEW DATE: 12/18/2009
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
Abatacept (Orencia®)
Is the requested medication being used to treat a diagnosis of systemic lupus erythematosus, relapsing-remitting multiple sclerosis, psoriasis, transplant rejection, graft-versus-host disease, tumor immunity or infectious diseases?
If yes, this does not meet medical necessity and/or medical appropriateness criteria
If no, go to question #2
Does the individual have a diagnosis of rheumatoid arthritis and evidence of ALL the following?
The individual is 18 years of age or older
Has moderately to severely active rheumatoid arthritis
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #3
Does the individual have a diagnosis of juvenile idiopathic arthritis (i.e., juvenile rheumatoid arthritis) and evidence of ALL the following?
The individual is 6 years of age or older
Has moderately to severely active polyarticular juvenile idiopathic arthritis
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.