BlueCross BlueShield of Tennessee Medical Policy Manual

Alemtuzumab

NDC CODE(S)

58468-0200-XX - Lemtrada 12 MG/1.2 SOLN (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.

Alemtuzumab is not commercially available for antineoplastic use but may be available for clinical use in treatment of neoplastic disease as Campath®.  That use is NOT addressed in this policy.

POLICY

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

All indications

Administered by intravenous infusion over 4 hours

First course: 12 mg/day on 5 consecutive days (60 mg total dose)

Second course: 12 mg/day on 3 consecutive days (36 mg total dose) administered 12 months after first treatment course

Subsequent courses: 12 mg/day on 3 consecutive days (36 mg total dose), administered , as needed, at least 12 months after the last dose of any prior treatment course.

Patients should receive anti-viral herpetic prophylaxis therapy during treatment.

LENGTH OF AUTHORIZATION

Coverage will be approved initially for 5 doses and may be renewed for 3 doses annually thereafter

Refer to DOSAGE LIMITS below

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).

SOURCES

Lexicomp Online. (2019). AHFS DI. Alemtuzumab. Retrieved February 7, 2019 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019, January). Alemtuzumab. Retrieved February 7, 2019 from MICROMEDEX Healthcare Series.

Thompson, A.J., Banwell, B. L., Barkhof, F., Carroll, W. L., Coetzee, T., Comi, G., et al. (2017). International Panel on Diagnosis of Multiple Sclerosis. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurology, 2018 Feb 17 (2), 162-173.

U. S. Food and Drug Administration. (2019, January). Center for Drug Evaluation and Research. Lemtrada® (alemtuzumab) injection, for intravenous use. Retrieved February 7, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5163s5164slbl.pdf.

ORIGINAL EFFECTIVE DATE:  2/5/2015

MOST RECENT REVIEW DATE:  5/31/2019

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.

This document has been classified as public information.

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 1 mg

DIAGNOSIS

MAXIMUM UNITS

 Multiple Sclerosis

First Course

60 billable units total (1 dose daily x 5 days) during the first 12 months

Second/Subsequent Courses

36 billable units (1 dose daily x 3 days) every 12 months thereafter