ModifiedColorado Rocky Mountain Health PlansPolicy CS2026D0023P

Lemtrada (alemtuzumab) Medical Benefit Drug Policy

Defines coverage criteria, dosing, and coding for alemtuzumab (Lemtrada) for treatment of relapsing forms of multiple sclerosis for UnitedHealthcare Community Plan; identifies states where this policy does not apply.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyLemtrada (alemtuzumab) Medical Benefit Drug Policy

Policy CodePolicy CS2026D0023P

Change TypeTemplate update — removed state-specific language

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization limited to initial dosing (12 mg IV daily x5 days) or retreatment dosing (12 mg IV daily x3 days) and document diagnosis plus prior DMT history or prior alemtuzumab response.

SourceLink

POLICY UPDATE CHANGES

Removed content/language pertaining to the state of Louisiana

Template Update — Removed content/language pertaining to the state of Louisiana

12 mginitial daily intravenous dose

5 daysinitial dosing consecutive days

3 daysretreatment dosing consecutive days

J0202procedure code

95.1%

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CARE-MS I extension enroll

Coverage and Medical Necessity Criteria

Initial Therapy (treatment-naïve)

Covered when ALL of the following are met

Initial (treatment-naïve) coverage: Diagnosis of relapsing forms of multiple sclerosis (e.g., relapsing-remitting MS, active secondary-progressive MS); 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 (Avonex or Rebif), interferon beta-1b (Betaseron or Extavia), glatiramer acetate (Copaxone or Glatopa), dimethyl fumarate (Tecfidera), teriflunomide (Aubagio), fingolimod (Gilenya), peginterferon beta-1a (Plegridy), natalizumab (Tysabri), ocrelizumab (Ocrevus), rituximab products (Rituxan, Riabni, Truxima, Ruxience), siponimod (Mayzent), ozanimod (Zeposia), ofatumumab (Kesimpta), monomethyl fumarate (Bafiertam), cladribine (Mavenclad), or ublituximab (Briumvi); AND patient has not been previously treated with alemtuzumab; AND patient is not receiving alemtuzumab in combination with another disease-modifying agent; AND initial dosing is 12 mg IV 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 (treatment-experienced)

Covered when ALL of the following are met

Retreatment coverage: Patient has previously received treatment with alemtuzumab; AND documentation of positive clinical response to alemtuzumab therapy; AND patient is not receiving alemtuzumab in combination with another disease-modifying agent; AND retreatment dosing is 12 mg IV 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

Alemtuzumab is 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.

This policy template was updated to remove language specific to the state of Louisiana.

Use of alemtuzumab for the listed non‑MS autoimmune conditions is considered unproven and not medically necessary and therefore is excluded from coverage.

Procedure and Diagnosis Codes

Procedure CodesHCPCS

J0202

Injection, alemtuzumab, 1 mg (Lemtrada)

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

Prior Authorization, Documentation, and Utilization Management

Prior Authorization

Prior Authorization Required

Prior authorization is required for Lemtrada (alemtuzumab). Initial and retreatment dosing and utilization limits apply. Initial dosing is 12 mg IV daily for 5 consecutive days (authorization limited to no more than 5 doses and up to 12 months). Retreatment dosing is 12 mg IV daily for 3 consecutive days (authorization limited to no more than 3 doses and up to 12 months).

Prior authorization required before treatment initiation
Initial dosing: 12 mg IV daily x5 days; limit: ≤5 doses and authorization ≤12 months
Retreatment dosing: 12 mg IV daily x3 days; limit: ≤3 doses and authorization ≤12 months
Patient must not receive alemtuzumab in combination with another DMT
Treatment-experienced patients must have documentation of prior positive clinical response

Documentation Required

Drug Background and Mechanism

Alemtuzumab is a humanized monoclonal antibody directed against the CD52 antigen on lymphocytes, resulting in lymphocyte depletion. It is indicated for the treatment of relapsing forms of multiple sclerosis. Clinical use is associated with risks including infusion reactions, infections, and immune‑mediated adverse events that require monitoring; for non‑MS autoimmune indications listed in this policy, evidence does not support medical necessity.

Definitions and Policy Type

Relapsing forms of multiple sclerosis

DefinitionRelapsing forms of multiple sclerosis includes relapsing‑remitting MS and active secondary progressive MS as specified in the FDA indication for alemtuzumab (Lemtrada).

ScopeApplies to adult patients with relapsing forms of MS being considered for alemtuzumab therapy.

Clinical contextAlemtuzumab is a CD52‑directed cytolytic antibody; because of safety risks (autoimmunity, infusion reactions, malignancies) its use is generally reserved for patients with inadequate response to two or more MS drugs and is distributed under a REMS program.

Implication for coveragePolicy coverage criteria require a diagnosis consistent with relapsing forms of MS (eg, relapsing‑remitting or active secondary progressive) before authorization of alemtuzumab.

Medical Benefit Drug Policy

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyLemtrada (alemtuzumab) Medical Benefit Drug Policy

Policy CodePolicy CS2026D0023P

Change TypeTemplate update — removed state-specific language

Effective DateApr 1, 2026

Next Review DateN/A

SourceLink

On This Page

Required Clinical Documentation

Documentation must clearly support diagnosis of a relapsing form of multiple sclerosis and required prior treatment history or prior response as applicable. For treatment‑naïve patients, document failure or intolerance to at least two listed disease-modifying therapies (examples include interferon betas, glatiramer acetate, dimethyl fumarate, teriflunomide, fingolimod, natalizumab, ocrelizumab, rituximab, siponimod, ozanimod, ofatumumab, cladribine, ublituximab, monomethyl fumarate). For treatment‑experienced patients, provide records demonstrating previous alemtuzumab administration and positive clinical response.

Diagnosis of relapsing forms of MS (e.g., relapsing‑remitting MS, active secondary‑progressive MS)
For treatment‑naïve: documentation of failure or intolerance to ≥2 listed DMTs (list available in policy)
For treatment‑experienced: documentation of prior alemtuzumab treatment and demonstrated positive clinical response
Medication administration records showing dosing schedule and number of doses

Note

Reference Plan-Specific Requirements

Follow plan-specific and contractual requirements when submitting prior authorization requests and supporting documentation. Check the member's federal, state, or contractual benefit plan for any differing requirements; those requirements govern if there is a conflict with this policy. UnitedHealthcare (and delegated payers) may use external tools (e.g., InterQual) to assist coverage determinations.

Verify member-specific benefit plan terms prior to authorization
When plan or contractual requirements differ from this policy, the federal/state/contractual requirements take precedence
Billing codes (e.g., J0202) are provided for reference; confirm applicable billing and prior authorization codes with the payer

Denial Risk

Coverage Criteria Not Met / Denial Risk

Requests that do not meet the documented coverage criteria, lack required clinical documentation, or conflict with plan-specific contractual requirements may be denied or considered not covered. Providers should ensure all required documentation accompanies the prior authorization request to reduce risk of denial.

Denial risk if documentation does not show required prior DMT failures/intolerances or prior positive response where applicable
Denial risk if dosing or utilization limits exceed specified limits (initial: >5 doses or >12 months; retreatment: >3 doses or >12 months)
If conflict exists between this policy and the member's benefit plan, the benefit plan governs and may lead to denial

Billing Rule

Prior Authorization and Utilization Management

For any uncertainties about required codes, authorization workflows, or additional plan edits, contact the payer to confirm plan-specific prior authorization procedures and supported billing/coding. This policy provides guidance but is not a substitute for verifying member-specific coverage rules.

Confirm required prior authorization forms, portals, and supporting attachments with the payer
Verify the exact billing and prior authorization codes the plan requires (e.g., J0202 reference) before claim submission
When in doubt, obtain pre-authorization confirmation in writing

Medical Benefit Drug Policy (interprets UnitedHealthcare standard benefit plans).

Primary useProvides guidance for coverage determinations and utilization management for medical‑administered drugs (eg, alemtuzumab).

Plan conflict noteFederal, state, or contractual benefit plan requirements govern if they conflict with this policy; check plan‑specific requirements before applying the policy.

Decision supportUnitedHealthcare may use third‑party tools (eg, InterQual) to assist in administering benefits; the policy is informational and not medical advice.