BlueCross BlueShield of Tennessee Medical Policy Manual

Alemtuzumab

NDC CODE(S)

58468-0200-01 - Lemtrada 12 mg/1.2 ml  (Genzyme)

DESCRIPTION

Alemtuzumab is a recombinant humanized IgG1 kappa monoclonal antibody specific for the cell surface glycoprotein CD52.  The precise action of alemtuzumab is unknown, but it is thought to involve binding to CD52 glycoproteins which appear on the surfaces of T and B lymphocytes, natural killer cells, monocytes and macrophages.  This results in antibody-dependent cellular cytolysis and complement-mediated lysis.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE

All Indications

Administered by intravenous infusion over 4 hours for 2 treatment courses:

  • First course: 12 mg/day on 5 consecutive days

  • Second course: 12 mg/day on 3 consecutive days 12 months after first treatment course (For a total of 8 doses MAXIMUM)

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 chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

Alemtuzumab is available only through a restricted program under a Risk Evaluation Mitigation Strategy (REMS) Program called the Lemtrada® REMS program due to the risks of autoimmunity, infusion reactions and malignancies.

No controlled studies were found in the published literature that validate the use of alemtuzumab marketed as Lemtrada® for the treatment of other conditions and diseases.

SOURCES

Lexicomp Online. (2016). AHFS DI. Alemtuzumab. Retrieved September 15, 2016 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, August). Alemtuzumab. Retrieved September 15, 2016 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2014, November). Center for Drug Evaluation and Research. Lemtrada® (alemtuzumab) injection, for intravenous use. Retrieved September 15, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103948s5139lbl.pdf.

ORIGINAL EFFECTIVE DATE:  2/5/2015

MOST RECENT REVIEW DATE:  2/6/2017

ID_MRx

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

Alemtuzumab (Lemtrada®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of multiple sclerosis if ALL of the following?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 12 billable units per day x 5 days (60 billable units per 12 months) for dosage of a first course: 12 mg/day on 5 consecutive days with a second course 12 mg/day on 3 consecutive days 12 months after first treatment course? (8 doses MAXIMUM)?

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.