CurrentUnitedHealthcarePolicy CS2025D0023N

Lemtrada (alemtuzumab) for relapsing forms of multiple sclerosis

This policy defines UnitedHealthcare medical benefit coverage criteria for use of Lemtrada (alemtuzumab) in adults with relapsing forms of multiple sclerosis and describes indications that are not covered. It applies to commercial plan providers and members, with state-specific exceptions noted.

Policy Summary

PayerUnitedHealthcare

PolicyLemtrada (alemtuzumab) for relapsing forms of multiple sclerosis

Policy CodePolicy CS2025D0023N

Change TypeNo material clinical or coverage changes

Effective DateApr 1, 2025

Next Review Date

Key ActionObtain prior authorization and document diagnosis, prior DMT history or intolerances, and planned 12 mg dosing schedule (initial 5-day or retreatment 3-day course).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 mginitial & retreatment daily dose

5 daysinitial dosing duration

3 daysretreatment dosing duration

12 moauthorization period limit

2+FDA reserve use after 2+ DMTs

Policy Summary

PayerUnitedHealthcare

PolicyLemtrada (alemtuzumab) for relapsing forms of multiple sclerosis

Policy CodePolicy CS2025D0023N

Change TypeNo material clinical or coverage changes

Effective DateApr 1, 2025

Next Review Date

Key ActionObtain prior authorization and document diagnosis, prior DMT history or intolerances, and planned 12 mg dosing schedule (initial 5-day or retreatment 3-day course).

SourceLink

On This Page

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Coverage and Medical Necessity Criteria

Medical Necessity Criteria

Covered when ALL of the following are met

Primary diagnosis: Diagnosis of relapsing forms of multiple sclerosis (e.g., relapsing-remitting MS, active secondary-progressive MS)

Prior therapy requirement for treatment-naive to alemtuzumab: Patient is treatment-naive to alemtuzumab AND has history of failure after a trial of at least 4 weeks or history of intolerance to at least two of the following agents: interferon beta-1a, interferon beta-1b, glatiramer acetate, dimethyl fumarate, teriflunomide, fingolimod, peginterferon beta-1a, natalizumab, ocrelizumab, rituximab, siponimod, ozanimod, ofatumumab, monomethyl fumarate, cladribine, ublituximab>=2 agents or intolerance; >=4 weeks trial

Listed DMTs are drawn from policy

Treatment-experienced with alemtuzumab (alternative path): Patient has previously received alemtuzumab AND documentation of positive clinical response to prior alemtuzumab therapy

Retreatment dosing and limits apply; alemtuzumab must not be given concurrently with another DMT

Combination therapy prohibition: Patient is not receiving alemtuzumab in combination with another disease-modifying agent for multiple sclerosis (examples include interferon beta preparations, glatiramer acetate, natalizumab, fingolimod, teriflunomide, ocrelizumab)

Dosing and authorization limits - initial: Initial dosing: 12 mg IV daily for 5 consecutive days; regimen administered only once within 12 months; initial authorization for no more than 12 months and no more than 5 doses12 mg/day; 5 doses; authorization <=12 months

Dosing and authorization limits - retreatment: Retreatment dosing: 12 mg IV daily for 3 consecutive days; regimen administered only once within 12 months; authorization for no more than 12 months and no more than 3 doses12 mg/day; 3 doses; authorization <=12 months

Alemtuzumab is unproven and not medically necessary for the treatment of the following conditions: rheumatoid arthritis, autoimmune neutropenia, autoimmune hemolytic anemia, pure red cell aplasia, immune thrombocytopenic purpura, Evans syndrome, and autoimmune pancytopenia.

Use of alemtuzumab for the listed non-multiple sclerosis autoimmune and hematologic conditions above is considered not medically necessary due to insufficient evidence from large, controlled clinical trials and concerns about treatment-related toxicity.

Dosing, Drug Information, and Codes

Referenced drug information / prescribing informationmixed

Lemtrada [prescribing information]

Reference prescribing information (no explicit CPT/HCPCS/NDC codes provided in policy)

inv-05: Initial dosing daily dose

Initial dosing daily dose12 mg IV daily

RouteIntravenous (IV)

Authorization limitAdministered only once within 12 months

inv-06: Initial dosing duration

Initial dosing duration5 consecutive days

Maximum initial doses authorizedNo more than 5 doses

Initial authorization periodNo more than 12 months

inv-07: Retreatment dosing daily dose

Retreatment dosing daily dose12 mg IV daily

RouteIntravenous (IV)

Retreatment eligibilityPatient previously treated with alemtuzumab with documented positive clinical response

inv-08: Retreatment dosing duration

Retreatment dosing duration3 consecutive days

Maximum retreatment doses authorizedNo more than 3 doses

Retreatment authorization periodRegimen administered only once within 12 months; authorization for no more than 12 months

Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Lemtrada (alemtuzumab). Coverage is allowed only when clinical and treatment criteria in the policy are met, including documentation of diagnosis, prior disease-modifying therapy (DMT) exposure or intolerance, dosing, and administration limits.

Policy Number: CS2025D0023N
Effective Date: 2025-04-01

Documentation Required

Clinical Documentation Must Demonstrate

Clinical documentation must demonstrate the diagnosis of a relapsing form of multiple sclerosis and a detailed prior treatment history (including trials, durations, and intolerances) as described below. Requests that do not include the required documentation or that exceed dosing/administration limits will be denied.

Diagnosis: relapsing forms of MS (e.g., relapsing‑remitting MS, active secondary‑progressive MS).
Prior treatment history: list of prior DMTs tried, dates, duration of trial (minimums where required), and reason for discontinuation (e.g., intolerance, lack of efficacy).
Denial risk: Missing or incomplete documentation of diagnosis or prior therapy, or requests that exceed specified dosing/regimen limits.

Documentation Required

Treatment‑Naïve to Alemtuzumab — Provider Actions

For patients who are treatment‑naïve to alemtuzumab, documentation must show failure following a trial of at least 4 weeks or intolerance to at least two of the specified DMTs prior to initiation of alemtuzumab. Also document that the patient has not been previously treated with alemtuzumab and is not receiving alemtuzumab in combination with another DMT.

Required prior DMTs (examples include, but are not limited to): Interferon beta‑1a (Avonex, Rebif), Interferon beta‑1b (Betaseron, Extavia), Glatiramer acetate (Copaxone, Glatopa), Dimethyl fumarate (Tecfidera), Teriflunomide (Aubagio), Fingolimod (Gilenya), Peginterferon beta‑1a (Plegridy), Natalizumab (Tysabri), Ocrelizumab (Ocrevus), Rituximab (Rituxan, Riabni, Truxima, Ruxience), Siponimod (Mayzent), Ozanimod (Zeposia), Ofatumumab (Kesimpta), Monomethyl fumarate (Bafiertam), Cladribine (Mavenclad), Ublituximab (Briumvi).
Documentation must confirm: no prior alemtuzumab exposure and no concomitant use with other DMTs.

Documentation Required

Treatment‑Experienced to Alemtuzumab — Provider Actions

For patients previously treated with alemtuzumab, provide documentation of prior alemtuzumab exposure and evidence of positive clinical response. Ensure dosing and administration requests conform to policy limits; requests that do not meet these criteria will be denied.

Treatment‑experienced documentation: prior alemtuzumab treatment dates and evidence of clinical benefit.
Dosing limits: Initial course = 12 mg IV daily for 5 consecutive days (administered once within 12 months; initial authorization ≤12 months and ≤5 doses). Retreatments = 12 mg IV daily for 3 consecutive days (administered once within 12 months; authorization ≤12 months and ≤3 doses).
Not allowed: concomitant use with other DMTs.

Denial Risk

Requests Not Meeting Coverage Criteria Will Be Denied

Requests that do not meet coverage criteria, including insufficient prior treatment history, lack of required clinical documentation, or dosing/administration beyond policy limits, will be denied.

Examples of denial conditions: no documentation of relapsing MS diagnosis, no documentation of trials/intolerances to required DMTs for treatment‑naïve patients, prior alemtuzumab exposure not documented for retreatment, requests for concomitant DMT use, or requests exceeding the specified dose/regimen limits.

Clinical and Mechanism Background

Alemtuzumab is a humanized recombinant IgG1 kappa monoclonal antibody directed against the cell-surface glycoprotein CD52 expressed on T and B lymphocytes. Binding to CD52 results in lymphocyte depletion through antibody-dependent cellular cytolysis and complement-mediated lysis. It is indicated for adults with relapsing forms of multiple sclerosis (for example, relapsing‑remitting MS and active secondary‑progressive MS) and has demonstrated efficacy versus interferon beta-1a in clinical studies; however, use requires careful monitoring because of the risk of infusion reactions, infections, and autoimmune adverse events. Alemtuzumab has also been used experimentally in other autoimmune hematologic disorders, but those uses lack robust, controlled-trial evidence and have been limited by toxicity concerns.

OpenPayer

Lemtrada (alemtuzumab) for relapsing forms of multiple sclerosis

Coverage and Medical Necessity Criteria

Dosing, Drug Information, and Codes

Authorization, Documentation, and Operational Requirements

Key Definitions

Clinical and Mechanism Background