Eculizumab
DESCRIPTION
Eculizumab, a recombinant monoclonal antibody, binds to the complement protein C5 and inhibits its cleavage to C5a and C5b preventing the generation of terminal complement complex C5b-9. The complement system of proteins, which is part of the immune system, destroys abnormal red blood cells. Eculizumab prevents destruction of red blood cells that are deficient in terminal complement inhibitors.
An example of a preparation of eculizumab is Soliris®.
REFER TO DECISION SUPPORT TREE
POLICY
Eculizumab for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Paroxysmal nocturnal hemoglobinuria
Atypical hemolytic uremic syndrome (aHUS)
Eculizumab for the treatment of other conditions/diseases, including, but not limited to, Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS) is considered investigational.
MEDICAL APPROPRIATENESS
Eculizumab for the treatment of ANY ONE of the following is considered medically appropriate if the criteria are met:
Paroxysmal nocturnal hemoglobinuria if individual is ALL of the following:
Immunized against Neisseria meningitidis at minimum 2 weeks before beginning treatment
Free from unresolved serious infection with Neisseria meningitidis
Requiring reduction of hemolysis
Atypical hemolytic uremic syndrome (aHUS) if individual is ALL of the following:
Immunized against Neisseria meningitidis at minimum 2 weeks before beginning treatment
Free from unresolved serious infection with Neisseria meningitidis
Requiring inhibition of complement-mediated thrombotic microangiopathy
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 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).
In a review of the published literature, no controlled studies were found to validate the use of eculizumab in the treatment or prevention of any other conditions or diseases.
SOURCES
Lexi-Comp Online. (2011, November). AHFS DI. Soliris®. Retrieved November 23, 2011 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2011, October). Eculizumab. Retrieved November 23, 2011 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2011, September). Center for Drug Evaluation and Research. Soliris® (eculizumab). Retrieved November 23, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125166s172lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/8/2007
MOST RECENT REVIEW DATE: 2/7/2012
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
Eculizumab (Soliris®)
If yes, this does not meet medical necessity and/or medical appropriateness criteria
If no, go to question #2
Has the individual registered in the special risk management plan (i.e., Soliris Safety Registry)?
If yes, go to question #3
If no, this does not meet medical necessity and/or medical appropriateness criteria
Is the individual immunized against Neisseria meningitidis at least 2 weeks before the beginning of treatment and free from unresolved severe infection with Neisseria meningitidis?
If yes, go to question #4
If no, this does not meet medical necessity and/or medical appropriateness criteria
Does the individual have a diagnosis of paroxysmal nocturnal hemoglobinuria (PNH) requiring reduction of hemolysis?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #5
Does the individual have a diagnosis of atypical hemolytic uremic syndrome (aHUS) requiring inhibition of complement-mediated thrombotic microangiopathy?
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.