When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.
American Hospital Formulary Service (AHFS). Drug Information 2019. Lemtrada. [Lexicomp Online Web site]. 12/02/20. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed March 6, 2020.
CAMMS223 Trial Investigators. Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. New Engl J Med. 2008;359:1786-801.
Cohen J, Coles A. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet. 2012; 380:1819-28.
Coles A, Twyman C. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet. 2012;380:1829-1839.
Elsevier's Clinical Pharmacology Compendium. Alemtuzumab. [Clinical Pharmacology Web site. 12/03/19. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed March 6, 2020.
Lexi-Drugs Compendium. Alemtuzumab. [Lexicomp Online Web site]. 12/02/19. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed March 6, 2020.
National Institute for Health and Care Excellence (NICE). Technology Appraisal Guidance 312: Alemtuzumab for treating relapsing-remitting multiple sclerosis. [NICE Web site]. May 2014. Available at: https://www.nice.org.uk/guidance/ta312 . Accessed March 6, 2020.
Polman C, Reingold S. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonlad criteria. Ann Neurol. 2011;69:292-301.
Truven Health Analytics. Micromedex® DrugDex® Compendium. Lemtrada. 02/24/20. Greenwood Village, CO. [Micromedex® Solutions Web site]. Available at:
http://www.micromedexsolutions.com/micromedex2/librarian. Accessed March 6, 2020.
US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Alemtuzumab (Lemtrada®). Supplemental Approval for REMS. [FDA Web site]. Last Update: 11/28/18. Available at: https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=340 . Accessed March 6, 2020.
US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs@FDA. Alemtuzumab (Lemtrada®) prescribing information. [FDA Web site]. 10/29/19. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5169s5170lbl.pdf. Accessed March 6, 2020.
Policy: 08.00.64g:Natalizumab (Tysabri®)
Policy: 08.01.22d:Alemtuzumab (Lemtrada®)
Policy: 08.01.38c:Ocrelizumab (Ocrevus®)