ModifiedUnitedHealthcarePolicy CS2025D0023O

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

Defines medical benefit drug coverage criteria for alemtuzumab (Lemtrada) for adults with relapsing forms of multiple sclerosis under UnitedHealthcare Community Plan; indicates states with exceptions and references applicable coding. Affects prescribers, infusion centers, and prior authorization teams.

Policy Summary

PayerUnitedHealthcare

PolicyLemtrada (alemtuzumab) — Medical Benefit Drug Policy

Policy CodePolicy CS2025D0023O

Change TypeICD-10 code list update

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization with documentation of relapsing MS diagnosis and prior therapy history showing failure or intolerance to at least two listed disease-modifying therapies.

SourceLink

POLICY UPDATE CHANGES

Updated list of applicable ICD-10 diagnosis codes to reflect annual edits: Added G35.A, G35.B0, G35.B1, G35.B2, G35.C0, G35.C1, G35.C2, and G35.D; Removed G35.

12 mginitial daily IV dose

5initial dosing days

3retreatment dosing days

J0202HCPCS

REMS

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Coverage Criteria for Alemtuzumab (Lemtrada)

Initial Therapy

Covered when ALL of the following are met for treatment-naïve patients:

Initial course criteria: Diagnosis of relapsing forms of multiple sclerosis (e.g., relapsing‑remitting MS, active secondary‑progressive MS); patient is treatment‑naïve to alemtuzumab; 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 products, siponimod (examples as listed in policy); patient has not been previously treated with alemtuzumab; patient is not receiving alemtuzumab in combination with another disease‑modifying agent for multiple sclerosis; initial dosing: 12 mg IV daily for 5 consecutive days; regimen administered only once within 12 months; initial authorization limited to no more than 12 months and no more than 5 doses.

Listed DMT examples as provided in policy (see source).

Retreatment / Treatment-experienced

Covered when ALL of the following are met for retreatment (treatment-experienced) patients:

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

Not Medically Necessary / Unproven Indications

Not medically necessary for the following non-MS indications:

Non-covered indications: Rheumatoid arthritis; autoimmune neutropenia; autoimmune hemolytic anemia; pure red cell aplasia; immune thrombocytopenic purpura; Evans syndrome; autoimmune pancytopenia.

Alemtuzumab use for these conditions is considered unproven and not medically necessary.

This policy segment does not replace or override specific benefit plan or regulatory mandates. Providers and reviewers must reference applicable federal, state, or contractual benefit plan requirements when applying these criteria; in the event of conflict, those requirements govern coverage determinations.

Alemtuzumab is considered unproven and not medically necessary for 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. The rationale notes limited evidence from small reports and the absence of large, controlled trials, as well as safety concerns cited in the policy history and miscellaneous discussion.

There are no additional explicit not medically necessary statements within this segment beyond those listed for non‑MS autoimmune conditions. Reviewers should follow the cited non‑MS exclusions and consult plan‑specific terms for any further limitations.

Coding and Dosing Information

Applicable HCPCSHCPCS

J0202

Injection, alemtuzumab, 1 mg (Lemtrada)

Applicable Diagnosis Codes (ICD-10)ICD-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

Applicable ICD-10 Diagnosis Codes - editsICD-10

G35.A	added ICD-10 diagnosis code (as listed in policy history)
G35.B0	added ICD-10 diagnosis code (as listed in policy history)
G35.B1	added ICD-10 diagnosis code (as listed in policy history)
G35.B2	added ICD-10 diagnosis code (as listed in policy history)
G35.C0	added ICD-10 diagnosis code (as listed in policy history)
G35.C1	added ICD-10 diagnosis code (as listed in policy history)
G35.C2	added ICD-10 diagnosis code (as listed in policy history)
G35.D	added ICD-10 diagnosis code (as listed in policy history)
G35	removed ICD-10 diagnosis code (as listed in policy history)

Initial vs retreatment dosing

Initial dosing (treatment‑naive)12 mg IV once daily for 5 consecutive days, administered as a single initial course (regimen given only once within 12 months). Initial authorization limited to no more than 12 months and up to 5 doses.

Retreatment dosing (treatment‑experienced)12 mg IV once daily for 3 consecutive days, administered as a single retreatment course (regimen given only once within 12 months). Authorization limited to no more than 12 months and up to 3 doses.

Dosing frequency restrictionEach course (initial or retreatment) may be administered only once within a 12‑month period.

Combination therapy exclusionAlemtuzumab must not be given in combination with another disease‑modifying agent for MS when meeting coverage criteria.

Provider Actions, Prior Authorization, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for Lemtrada (alemtuzumab). Submit authorization requests using HCPCS J0202 (Injection, alemtuzumab, 1 mg). Initial authorization is limited to no more than 12 months and no more than 5 doses (12 mg IV daily for 5 consecutive days). Retreatment authorization is limited to no more than 12 months and no more than 3 doses (12 mg IV daily for 3 consecutive days).

Prior authorization required — HCPCS: J0202
Initial authorization: ≤ 12 months and ≤ 5 doses (12 mg IV daily × 5 days)
Retreatment authorization: ≤ 12 months and ≤ 3 doses (12 mg IV daily × 3 days)

Denial Risk

Requests Missing Required Documentation May Be Denied

Requests that do not include a documented diagnosis of relapsing forms of multiple sclerosis (e.g., relapsing‑remitting MS, active secondary‑progressive MS) or that lack required documentation of prior treatment history, trials, failures, or intolerances may be denied. Treatment‑naïve requests must document failure or intolerance to at least two listed DMTs; treatment‑experienced requests must document prior alemtuzumab treatment and positive clinical response.

Definitions

Relapsing forms of MS — definition / examples

DefinitionRelapsing forms of multiple sclerosis include relapsing‑remitting MS and active secondary‑progressive MS.

Examples citedRelapsing‑remitting multiple sclerosis; active secondary‑progressive multiple sclerosis.

Context for coveragePolicy coverage is limited to patients with a diagnosis of relapsing forms of MS as specified (e.g., relapsing‑remitting MS, active secondary‑progressive MS).

Alemtuzumab — drug identity

Generic and brand namesAlemtuzumab (Campath).

Mechanism/characterizationCD52‑directed cytolytic (monoclonal) antibody; depletes T and B lymphocytes via antibody‑dependent cellular cytolysis and complement‑mediated lysis.

Background

Alemtuzumab (Lemtrada) is a humanized IgG1 kappa monoclonal antibody directed against the cell‑surface glycoprotein CD52. Its mechanism of action involves antibody‑dependent cellular cytolysis and complement‑mediated lysis leading to depletion of T and B lymphocytes and other immune cells. Because of its safety profile, alemtuzumab is indicated for select patients with relapsing forms of multiple sclerosis and is subject to restricted distribution and monitoring programs.

Revision History and Policy Changes

2025-10-01ICD-10 code list updateLatest

Updated applicable ICD-10 diagnosis codes: added G35.A, G35.B0, G35.B1, G35.B2, G35.C0, G35.C1, G35.C2, and G35.D; removed G35; archived previous policy version CS2025D0023N.