ModifiedUnitedHealthcarePolicy 2026D0023Z

Lemtrada (alemtuzumab) — Medical Benefit Drug Policy (coverage criteria)

Defines UnitedHealthcare Medical Drug Policy coverage and criteria for alemtuzumab (Lemtrada) for members on Commercial, Individual Exchange, and Community Plan benefit products, including initial and retreatment dosing and conditions of medical necessity.

Policy Summary

PayerUnitedHealthcare

PolicyLemtrada (alemtuzumab) — Medical Benefit Drug Policy

Policy CodePolicy 2026D0023Z

Change TypeTemplate update and application added

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization consistent with medical necessity criteria and document diagnosis, prior DMT history, and dosing schedule.

SourceLink

POLICY UPDATE CHANGES

Transferred content to shared policy template that applies to both UnitedHealthcare Commercial and Individual Exchange benefit plans and added an Application section indicating applicability to those plans.

Added Application section to indicate this policy applies to UnitedHealthcare Commercial and Individual Exchange benefit plans.

Updated template and supporting information; archived prior versions.

12 mgInitial daily IV dose

5 daysInitial course length

3 daysRetreatment course length

Once/12 moAdministration frequency limit

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Coverage Criteria for Alemtuzumab (Lemtrada)

Initial Therapy

Covered when ALL of the following are met:

Initial therapy (treatment-naïve to alemtuzumab): Diagnosis of relapsing forms of multiple sclerosis (e.g., relapsing-remitting MS, active secondary-progressive MS); AND patient has not previously been treated with alemtuzumab; AND patient has history of failure following a trial for at least 4 weeks or history of intolerance to at least two of the following disease-modifying therapies: 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; AND patient is not receiving alemtuzumab in combination with another disease-modifying agent for multiple sclerosis; AND initial dosing is 12 mg intravenously daily for 5 consecutive days; AND regimen is administered only once within 12 months; AND initial authorization is for no more than 12 months and no more than 5 doses.

Retreatment Therapy

Covered when ALL of the following are met for retreatment:

Retreatment (treatment-experienced): Patient has previously received treatment with alemtuzumab; AND documentation of positive clinical response to prior alemtuzumab therapy; AND patient is not receiving alemtuzumab in combination with another disease-modifying agent for multiple sclerosis; AND retreatment dosing is 12 mg intravenously daily for 3 consecutive days; AND regimen is administered only once within 12 months; AND authorization is for no more than 12 months and no more than 3 doses.

Unproven Indications

Unproven / Not Medically Necessary Indications: Alemtuzumab is unproven and not medically necessary for the treatment of rheumatoid arthritis; autoimmune neutropenia; autoimmune hemolytic anemia; pure red cell aplasia; immune thrombocytopenic purpura; Evans syndrome; and autoimmune pancytopenia.

Alemtuzumab has been used off-label for a number of autoimmune conditions outside of multiple sclerosis, including rheumatoid arthritis and several autoimmune cytopenias. Published reports and small series describe occasional beneficial effects, but these conditions have not been studied in large, controlled clinical trials and some studies were discontinued because of alemtuzumab‑associated toxicity. As a result, use in these non‑MS indications remains investigational and is not supported by high‑quality evidence.

Before relying on this policy for coverage or prior authorization decisions, providers must verify the member’s specific benefit plan and any applicable federal or state mandates. In the event of a conflict between this Medical Benefit Drug Policy and the member specific benefit plan document, the member specific benefit plan governs. Document verification of member benefits when submitting requests.

Alemtuzumab is considered unproven and not medically necessary for the treatment of the following non‑multiple sclerosis autoimmune conditions: rheumatoid arthritis; autoimmune neutropenia; autoimmune hemolytic anemia; pure red cell aplasia; immune thrombocytopenic purpura; Evans syndrome; and autoimmune pancytopenia. Coverage for these indications is not supported under this policy.

Relevant Procedure and Diagnosis Codes

Applicable HCPCS CodesHCPCS

J0202

Injection, alemtuzumab, 1 mg (Lemtrada)

Applicable Diagnosis CodesICD-10

G35.A	Relapsing-remitting multiple sclerosis
G35.B0	Primary progressive multiple sclerosis, unspecified
G35.B1	Active primary progressive multiple sclerosis
G35.B2	Non-active primary progressive multiple sclerosis
G35.C0	Secondary progressive multiple sclerosis, unspecified
G35.C1	Active secondary progressive multiple sclerosis
G35.C2	Non-active secondary progressive multiple sclerosis
G35.D	Multiple sclerosis, unspecified

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Dosing Limits

Prior authorization is required for alemtuzumab (Lemtrada). Initial authorization is limited to a single initial course of 12 mg IV daily for 5 consecutive days (no more than 5 doses) with authorization for up to 12 months. Retreatment (for patients previously treated with alemtuzumab) is limited to a single retreatment course of 12 mg IV daily for 3 consecutive days (no more than 3 doses) with authorization for up to 12 months. Lemtrada must not be given in combination with another disease-modifying therapy for multiple sclerosis.

Initial dosing: 12 mg IV daily x 5 days; authorization ≤ 12 months; ≤ 5 doses
Retreatment dosing (previously treated patients): 12 mg IV daily x 3 days; authorization ≤ 12 months; ≤ 3 doses
Not to be used concurrently with other disease‑modifying MS agents

Documentation Required

Member Benefit Verification Required

Coverage decisions require verification of the member’s specific benefit plan before applying this policy. The member-specific benefit plan document and any applicable federal or state mandates control coverage and in the event of a conflict, the member-specific plan governs. Providers should confirm eligibility, benefits, and any plan-specific requirements (such as prior authorization submission processes) prior to administration.

Background on Alemtuzumab

Alemtuzumab (Lemtrada) is a humanized monoclonal IgG1 kappa antibody directed against the cell surface glycoprotein CD52, expressed on T and B lymphocytes. Binding to CD52 results in antibody‑dependent and complement‑mediated cytolysis of circulating lymphocytes, producing long‑term alterations in lymphocyte populations. The agent is FDA‑approved for relapsing forms of multiple sclerosis and has demonstrated durable efficacy in clinical trials; however, its use requires careful monitoring because of infusion‑related reactions and the potential for autoimmune adverse effects observed in clinical experience and smaller studies.

Definitions and Reference Tools

Relapsing forms of multiple sclerosis — Definition including relapsing-remitting MS and active secondary progressive MS

DefinitionRelapsing forms of multiple sclerosis include relapsing-remitting MS and active secondary progressive MS as indicated in the Lemtrada FDA indication and this policy.

Clinical implicationIndication reserved for adults with relapsing forms of MS; use generally for patients with inadequate response to two or more MS therapies due to safety profile.

Related treatment contextPolicy criteria require diagnosis of a relapsing form of MS for coverage of alemtuzumab (Lemtrada) for initial and retreatment courses.

Lemtrada (alemtuzumab) references — Prescribing information and REMS as authoritative sources

Prescribing informationLemtrada prescribing information (Lemtrada [prescribing information], Genzyme; May 2024) is an authoritative source for safety and administration details.

Policy Revision History

2026-04-01template_updateLatest

Policy updated to a shared template and an Application section was added specifying applicability to UnitedHealthcare Commercial and Individual Exchange benefit plans; prior versions 2025D0023Y and IEXD0023.09 were archived.

archived_prior_versions

Archived prior policy versions 2025D0023Y and IEXD0023.09.