Alefacept
DESCRIPTION
Alefacept is a fusion protein designed to bind to the CD2 receptor on T-lymphocytes, inhibiting T-cell activation and proliferation. It is an immunosuppressive agent.
An example of a preparation of alefacept is AmeviveŽ.
REFER TO DECISION SUPPORT TREE
POLICY
Alefacept for the treatment of plaque psoriasis is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Alefacept for the treatment of other conditions/diseases, including, but not limited to, psoriatic arthritis is considered investigational.
MEDICAL APPROPRIATENESS
Alefacept for the treatment of plaque psoriasis is considered medically appropriate if ALL of the following criteria are met:
The individual is 18 years of age or older
Has moderate to severe chronic plaque psoriasis
Is unresponsive to conservative therapy (e.g., topical corticosteroids, coal/tar preparations, and ultraviolet light)
Is a candidate for systemic therapy or phototherapy
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).
There is insufficient evidence to support the use of alefacept in individuals with other types of psoriasis or psoriatic arthritis. The efficacy and safety of alefacept in children has not been determined.
SOURCES
Lexi-Comp Online. (2011). AHFS DI. Alefacept. Retrieved September 20, 2011 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (June, 2011). Alefacept. Retrieved September 20, 2011 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2011, May). Center for Drug Evaluation and Research. Alefacept. Retrieved September 20, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125036s0135lbl.pdf.
ORIGINAL EFFECTIVE DATE: 11/1/2003
MOST RECENT REVIEW DATE: 10/11/2011
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
Is the requested medication being used to treat psoriatic arthritis?
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 plaque psoriasis and evidence of ALL the following?
The individual is 18 years of age or older
Has moderate to severe chronic plaque psoriasis
Is unresponsive to conservative therapy (e.g., topical corticosteroids, coal/tar preparations, and ultraviolet light)
Is a candidate for systemic therapy or phototherapy
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.