58468-0200-XX - Lemtrada 12 MG/1.2 SOLN (GENZYME)
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.
Alemtuzumab is considered medically necessary for the treatment of the following if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Diagnosis of Multiple Sclerosis (MS) if ALL of the following:
Individual is 18 years of age or older
Baseline skin exam performed for melanoma
Individual does not have human immunodeficiency virus infection
Individual has been evaluated and screened for the presence of varicella zoster virus (VZV)
and vaccinated, if required, prior to initiating treatment
Individual is screened for the presence of tuberculosis according to local guidelines
Not to be administered concurrently or within 6 weeks prior to treatment with live vaccines
Administered with anti-viral prophylaxis for herpetic viral infections initiated on the first day of treatment and continued for two months following treatment (or until the CD4+ lymphocyte count is ≥ 200 cells/mcL)
Individual has baseline urine protein-to-creatinine ratio measured prior to initiation of treatment
Individual has a baseline thyroid-stimulating hormone (TSH) level prior to initiation of treatment
Confirmed diagnosis of MS as documented by MRI, unless contraindicated, then documented by other laboratory report
Definitive diagnosis of relapsing-remitting form of MS, e.g., relapsing-remitting disease (RRMS) or secondary progressive MS (SPMS) with relapses, based upon ALL of the following:
Dissemination in time, i.e., the development/appearance of new CNS lesions over time as evidenced by ANY ONE of the following:
Two or more clinical attacks
One clinical attack and ANY ONE of the following:
MRI indicating simultaneous presence of gadolinium-enhancing and non-enhancing lesions at any time or by a new T2- hyperintense or gadolinium-enhancing lesion on follow-up MRI compared to baseline scan
CSF-specific oligoclonal bands
Dissemination in space, i.e., the development of lesions in distinct anatomical locations within the CNS or multifocal, as evidenced by ANY ONE of the following:
Two or more lesions
One lesion and ANY ONE of the following:
Clear-cut historical evidence of a previous attack involving a lesion in a distinct anatomical location
MRI indicating ≥ 1 T2-hyperintense lesions characteristic of MS in ≥ 2 of 4 areas of the CNS (periventricular, cortical or juxtacortical, infratentorial or spinal cord)
Individual has had an inadequate response to a minimum of two drugs indicated for the treatment of multiple sclerosis (e.g., dimethyl fumarate, fingolimod, glatiramer acetate, interferon beta-1a, interferon beta-1b, mitoxantrone, natalizumab, peginterferon beta-1a, teriflunomide [list not all inclusive])
Prescriber and individual must be enrolled in and meet conditions of the Lemtrada® REMS program
Treatment is as single agent
Alemtuzumab for the treatment of other conditions/diseases is considered investigational.
Alemtuzumab is considered medically appropriate for renewal therapy for 6 months if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Individual has not received a dose of alemtuzumab within the past 12 months
Individual is receiving ongoing monitoring for presence of TB or other active infections
Individual is receiving ongoing laboratory monitoring (e.g., TSH levels, urine protein-to-creatinine ratio, etc.) and physical examinations (melanoma exam, malignancies, infection, etc.) as indicated
Absence of unacceptable toxicity from the drug, e.g., immune thrombocytopenia, glomerular nephropathies, thyroid disorders, autoimmune conditions, severe infusion reactions, ischemic or hemorrhagic strokes, malignancies, etc.
Continuous monitoring of response to therapy (manifestations of MS disease activity include, but are not limited to, an increase in annualized relapse rate [ARR], development of new/worsening T2 hyperintensities or enhancing lesions on brain/spinal MRI, and progression of sustained impairment as evidenced by EDSS, timed 25-foot walk [T25-FW], 9-hole peg test [9-HPT])
Inadequate response, in those who have been adherent and receiving therapy for sufficient time to realize the full treatment effect, is defined as ≥ 1 relapse, ≥ 2 unequivocally new MRI-detected lesions, or increased disability on examination over a one-year period
DOSAGE & ADMINISTRATION
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.
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.
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).
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
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.
Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 1 mg