CurrentNeighborhood Health Plan of Rhode IslandPolicy A55310

Lemtrada (alemtuzumab) — coverage criteria

Policy governing coverage criteria, dosing, and monitoring requirements for intravenous alemtuzumab (Lemtrada) for adults with relapsing forms of multiple sclerosis across Medicaid, Commercial, and Medicare lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLemtrada (alemtuzumab) — coverage criteria

Policy CodePolicy A55310

Change TypeNo material change

Effective DateJan 1, 2020

Next Review DateJan 10, 2024

Key ActionObtain prior authorization documenting age ≥18, neurologist prescription or consultation, baseline VZV screening/vaccination, required baseline labs/ECG, REMS enrollment, and prior-therapy failure/intolerance as specified.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 dosesinitial approval course

3 doses/yearrenewal dosing

J0202HCPCS

12/dayunits/day (first)

≥18min age

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Coverage Criteria for Lemtrada (alemtuzumab)

Initial Approval Criteria

Covered when ALL of the following are met:

Age and prescriber: Patient is at least 18 years of age AND Lemtrada is prescribed by or in consultation with a neurologist.

Baseline screening and monitoring: Patient has been evaluated and screened for varicella zoster virus (VZV) and vaccinated if required; has a baseline ECG; has been screened for tuberculosis (TB) and will receive ongoing TB monitoring; has baseline skin exam with plans for yearly skin exams; has baseline urine protein/creatinine ratio and TSH with ongoing laboratory monitoring; will not receive live vaccines while on therapy or within 6 weeks of initiation; prescriber and patient are enrolled in the LEMTRADA REMS program; and will receive antiviral prophylaxis for herpetic infections starting on day 1 and continued for two months (or until CD4+ >200 cells/µL).

MS diagnosis: Confirmed diagnosis of a relapsing form of multiple sclerosis (relapsing‑remitting MS or active secondary progressive MS) documented by MRI or other laboratory report consistent with dissemination in time and space (McDonald criteria); not to be used for clinically isolated syndrome (CIS).

Prior therapy requirements (member‑type specific): For Medicare and Commercial members: documented failure, intolerance, or contraindication to ocrelizumab (Ocrevus) and natalizumab (Tysabri). For Medicaid members: inadequate response, intolerance, or contraindication to natalizumab (Tysabri) and one additional MS drug.

Renewal Criteria

Renewal covered when ALL of the following are met:

Ongoing eligibility: Patient continues to meet the universal and indication‑specific criteria in section IV and has not received a dose of alemtuzumab within the past 12 months.

Toxicity: No unacceptable toxicity from treatment (examples include immune thrombocytopenia, anti‑GBM disease and other glomerular nephropathies, thyroid disorders and other autoimmune conditions, severe infusion reactions including anaphylaxis, ischemic or hemorrhagic stroke, progressive multifocal leukoencephalopathy, thrombotic thrombocytopenic purpura, hemophagocytic lymphohistiocytosis, severe colitis, lymphoma, and similar serious adverse events).

Clinical benefit monitoring: Continuous monitoring demonstrates clinical benefit (for example, reductions in annualized relapse rate, absence of increased disease activity such as no >=2 unequivocally new MRI lesions or no meaningful increase in disability over one year as measured by EDSS, T25‑FW, or 9‑HPT).

Indication Summary

Indication: Indicated for the treatment of relapsing forms of multiple sclerosis in adults, to include relapsing‑remitting MS and active secondary progressive MS.

General coverage approach

Coverage criteria for Lemtrada are based on FDA labeling and relevant clinical literature and were adopted by the P&T Committee; Medicare members are subject to NCD/LCD where applicable.

P&T criteria application: Coverage decisions follow clinical criteria adopted by the Neighborhood P&T Committee to align use with FDA‑approved labeling and relevant literature; prescribers may submit information for individual consideration when applicable.N/A

Medicare coverage determinations will follow applicable NCDs/LCDs/LCAs.

Lemtrada (alemtuzumab) is not to be used for treatment of clinically isolated syndrome (CIS). Coverage is restricted to patients with a confirmed diagnosis of a relapsing form of multiple sclerosis (for example, relapsing-remitting MS or active secondary progressive MS) and requires documentation such as MRI or other laboratory reports to support the diagnosis.

Medicare members are subject to applicable Centers for Medicare & Medicaid Services policies. National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may govern coverage and claims payment for Medicare Part B drugs and can supersede the plan's non‑Medicare coverage guidance where applicable; providers should follow the relevant NCD/LCD/LCA when making coverage decisions for Medicare beneficiaries.

Coverage excludes patients with certain infectious conditions or vaccination risks. Specifically, Lemtrada is not covered for patients who have HIV infection, who have an active infection, or who will receive live vaccines within 6 weeks before initiation. Prior to treatment, patients must be screened for tuberculosis and other infections, receive baseline evaluations (including skin exam and baseline labs), and be enrolled in the LEMTRADA REMS program; failure to meet these requirements may result in denial of coverage.

Coding and Billing

Covered HCPCS CodesHCPCSCovered

J0202

Injection, alemtuzumab, 1 mg

NDCNDC

58468-0200-xx

Lemtrada 12 mg/1.2 mL single-dose vial

Covered Diagnosis CodesICD-10Covered

ICD-10: Multiple Sclerosis

Multiple Sclerosis

inv-11: Billable units per day (first course)

Billable units (first course)12 billable units daily for 5 days (during the first 12 months)

HCPCS unit mappingJ0202 = Injection, alemtuzumab, 1 mg (1 billable unit per 1 mg)

Course descriptionApplies to the initial treatment course (first course) of alemtuzumab

inv-12: Billable units per day (subsequent yearly courses)

Billable units (subsequent yearly courses)12 billable units daily for 3 days every 12 months

TimingApplies to second and subsequent courses administered after the first 12 months

Provider Requirements, Prior Authorization, and Step Therapy

Denial Risk

Medicare coverage override risk

Medicare coverage may be governed by Centers for Medicare & Medicaid Services (CMS) National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Local Coverage Articles (LCAs), or Medicare Administrative Contractor (MAC) policies. Where an applicable NCD/LCD/LCA exists, that guidance takes precedence over the plan's non‑Medicare policy language for Medicare members. Providers should verify Medicare-specific coverage and claims payment rules (including contractor jurisdiction) prior to submission.

Search for NCD/LCD/LCA documents via CMS contractor resources before relying on plan criteria
When NCD/LCD/LCA exists, Medicare claims/payment follow that guidance rather than this non‑Medicare policy
Neighborhood will consider individual exceptions, but Medicare determinations remain subject to NCD/LCD/LCA applicability

Background and Clinical Context

Alemtuzumab (Lemtrada) is a CD52‑directed cytolytic monoclonal antibody indicated for the treatment of relapsing forms of multiple sclerosis. Clinical trials demonstrated reductions in relapse rates and decreased risk of sustained disability accumulation compared with comparator therapies. Because of its safety profile, use of Lemtrada requires enrollment in a Risk Evaluation and Mitigation Strategy (REMS) and careful baseline and ongoing monitoring for infusion reactions, infections, autoimmune conditions (for example, immune thrombocytopenia, anti‑GBM disease, thyroid disorders), and malignancy. Prior to initiation, recommended evaluations include VZV screening and vaccination if indicated, TB screening, baseline skin exam, baseline urine protein/creatinine and TSH, and enrollment in the REMS program; antiviral prophylaxis for herpetic infections should be started on day 1 and continued per protocol.

Definitions and Safety Programs

inv-22: REMS

REMS requirementLemtrada requires a Risk Evaluation and Mitigation Strategy (REMS) due to its safety profile including serious autoimmune conditions, infusion reactions, and increased cancer risk.

Safety risks prompting REMSIncludes risk of emergent autoimmune diseases, severe infusion reactions, infections, and malignancy

Enrollment implicationPrescriber and patient must be enrolled in the LEMTRADA REMS program as part of prior authorization and monitoring requirements

inv-23: Active secondary progressive MS (SPMS)

EDSS thresholdExpanded Disability Status Scale (EDSS) score ≥ 3.0

Relapse or progression requirementEither ≥1 relapse within the previous 2 years OR disease progression for ≥3 months after an initial relapsing-remitting course (defined as EDSS increase of 1.0 if baseline EDSS <5.5, or 0.5 if baseline EDSS ≥5.5)