BlueCross BlueShield of Tennessee Medical Policy Manual

Abatacept

DESCRIPTION

Abatacept is a biological response modifier that has anti-inflammatory properties. It is a soluble fusion protein which acts as a selective costimulation modulator in the formation of activated T lymphocytes or T cells, an initiating mechanism in the inflammatory process.

One pathway to activated T lymphocytes begins with a costimulatory signal sent from interaction of the antigen-presenting cells CD80-CD86 with the T cell receptor CD28. Abatacept binds to CD80 and CD86 blocking interaction with CD28 inhibiting activation of T lymphocytes. Activated T cells are thought to play a role in the development of rheumatoid arthritis and are found in the synovium of those with the disease.

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 is considered investigational:

Systemic lupus erythematosus
Relapsing-remitting multiple sclerosis
Psoriasis
Transplant rejection
Graft-versus-host disease
Tumor immunity
Infectious diseases

MEDICAL APPROPRIATENESS

Abatacept for the treatment of arthritis is considered medically appropriate for ANY ONE of the following:

Rheumatoid arthritis (RA) if ALL of the following:

Individual is 18 years of age or older
Disease is moderately to severely active

Juvenile idiopathic arthritis (JIA) (i.e., juvenile rheumatoid arthritis) if ALL of the following:

Individual is 6 years of age or older
Disease is moderately to severely active polyarticular JIA

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.

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).

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

Lexi-Comp Online. (2011, March). AHFS DI. Abatacept. Retrieved April 5, 2011 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2011, March). Abatacept. Retrieved April 5, 2011 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2009, August). Center for Drug Evaluation and Research. Orencia® (abatacept). Retrieved April 5, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125118s0086lbl.pdf.

ORIGINAL EFFECTIVE DATE: 7/8/2006

MOST RECENT REVIEW DATE: 6/9/2011

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

Abatacept (Orencia®)

Is the requested medication being used to treat ANY ONE of the following?

Systemic lupus erythematosus
Relapsing-remitting multiple sclerosis
Psoriasis
Transplant rejection
Graft-versus-host disease
Tumor immunity
Infectious diseases

If yes, this does not meet medical necessity and/or medical appropriateness criteria

If no, go to question #2

Is the individual 18 years of age or older with a diagnosis of moderately to severely active rheumatoid arthritis?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, go to question #3

Is the individual 6 years of age or older with a diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis (i.e., juvenile rheumatoid 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.