Modifiedsierra health and lifePolicy 2025D0023Y

Lemtrada (alemtuzumab) for relapsing forms of multiple sclerosis

This policy governs medical benefit coverage and prior authorization criteria for Lemtrada (alemtuzumab) for treatment of relapsing forms of multiple sclerosis for UnitedHealthcare Commercial members in North Carolina.

Policy Summary

Payersierra health and life

PolicyLemtrada (alemtuzumab) for relapsing forms of multiple sclerosis

Policy CodePolicy 2025D0023Y

Change TypeApplicable ICD-10 diagnosis codes updatedone code removed

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation of relapsing MS diagnosis and required prior therapy history or prior alemtuzumab response, including planned dosing.

SourceLink

POLICY UPDATE CHANGES

Added ICD-10 diagnosis codes G35.A, G35.B0, G35.B1, G35.B2, G35.C0, G35.C1, G35.C2, and G35.D to the list of applicable diagnosis codes.

Removed ICD-10 code G35 from the applicable diagnosis codes.

12 mginitial daily IV dose

5 daysinitial dosing days

3 daysretreatment dosing days

J0202listed HCPCS code

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Coverage and Medical Necessity Criteria

Medical necessity criteria

Covered when ALL of the following are met

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

Therapy history - treatment-naïve pathway: Patient is treatment-naïve to alemtuzumab AND has history of failure after at least 4 weeks OR intolerance to at least two of the following disease-modifying therapies: interferon beta-1a (Avonex, Rebif), interferon beta-1b (Betaseron, Extavia), glatiramer acetate (Copaxone, Glatopa), dimethyl fumarate (Tecfidera), monomethyl fumarate (Bafiertam), teriflunomide (Aubagio), fingolimod (Gilenya), peginterferon beta-1a (Plegridy), natalizumab (Tysabri), ocrelizumab (Ocrevus), rituximab (Riabni/Rituxan/Ruxience/Truxima), siponimod (Mayzent), ozanimod (Zeposia), ofatumumab (Kesimpta), cladribine (Mavenclad), ublituximab (Briumvi)

Initial dosing for treatment-naïve: 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 doses

Therapy history - treatment-experienced pathway: Patient previously received alemtuzumab AND documentation of positive clinical response to alemtuzumab therapy

Retreatment dosing for experienced patients: 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 doses

Combination therapy restriction: Patient is not receiving alemtuzumab in combination with another disease-modifying agent for multiple sclerosis

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.

When applying this policy, the member specific benefit plan document governs if its terms differ from the standard plan. Verify the member’s benefit plan and any applicable federal or state mandates before determining coverage, because plan language may exclude coverage defined in this policy.

Applicable Codes and Billing

Applicable HCPCS/CPT CodesHCPCS

J0202

Injection, alemtuzumab, 1 mg (Lemtrada)

Applicable ICD-10 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

Applicable ICD-10 Diagnosis CodesICD-10

G35.A	ICD-10 diagnosis code added
G35.B0	ICD-10 diagnosis code added
G35.B1	ICD-10 diagnosis code added
G35.B2	ICD-10 diagnosis code added
G35.C0	ICD-10 diagnosis code added
G35.C1	ICD-10 diagnosis code added
G35.C2	ICD-10 diagnosis code added
G35.D	ICD-10 diagnosis code added
G35	ICD-10 diagnosis code removed

Prior authorization affected codesmixed

affected codes

Placeholder for codes subject to prior authorization or policy application

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required prior to administration of alemtuzumab (Lemtrada). Requests must be submitted and approved before scheduling infusion services.

Initial dosing: 12 mg IV daily x5 (no more than 5 doses; authorization ≤ 12 months)
Retreatment dosing: 12 mg IV daily x3 (no more than 3 doses; authorization ≤ 12 months)

Note

Prior Authorization and Benefit Verification

Verify member eligibility and benefits and confirm medical necessity against the member specific benefit plan before providing services. Authorization approval does not guarantee payment — benefits, member cost‑share, and site‑of‑care rules are determined by the member's plan.

Check for any plan or state/federal mandates that may supersede this policy
Confirm whether the member is enrolled in Medicare Advantage and if MAO-specific rules apply

Clinical Background

Alemtuzumab (Lemtrada) is a humanized monoclonal antibody directed against the cell-surface glycoprotein CD52. It depletes circulating T and B lymphocytes through antibody-dependent cellular cytolysis and complement-mediated lysis and is indicated for relapsing forms of multiple sclerosis. Because of its mechanism and safety profile, use is generally reserved for patients with inadequate response to other disease-modifying therapies and it is subject to a restricted distribution Risk Evaluation and Mitigation Strategy (REMS).

Definitions and Program Requirements

Relapsing forms of multiple sclerosis — definition / examples

DefinitionRelapsing forms of multiple sclerosis include relapsing-remitting MS and active secondary progressive MS as described by the FDA indication for Lemtrada (alemtuzumab).

Clinical contextLemtrada is indicated for adults with relapsing forms of MS and is generally reserved for patients with inadequate response to two or more MS drugs due to its safety profile.

ExamplesRelapsing-remitting multiple sclerosis; active secondary progressive multiple sclerosis.

REMS — restricted distribution program information

DefinitionREMS = Risk Evaluation and Mitigation Strategy; a restricted distribution program required for Lemtrada because of risks of autoimmunity, infusion reactions, and malignancies.

Access implication

Policy Revision History and Changes

2025-10-01codes_updatedLatest

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.

2025-10-01operational

Archived previous policy version 2025D0023X.

Policy Summary

Payersierra health and life

PolicyLemtrada (alemtuzumab) for relapsing forms of multiple sclerosis

Policy CodePolicy 2025D0023Y

Change TypeApplicable ICD-10 diagnosis codes updatedone code removed

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation of relapsing MS diagnosis and required prior therapy history or prior alemtuzumab response, including planned dosing.

SourceLink

On This Page

Note

Coverage Determinations Must Reference Member Plan

Coverage determinations and prior authorization decisions must reference the member specific benefit plan and any applicable federal or state mandates. In case of conflict, the member specific benefit plan governs.

Document the specific benefit plan referenced in the authorization request or decision
If a Medicare Advantage member, note applicable NCD/LCD or MAO rationale when used

Documentation Required

When Deciding Coverage, Reference the Member Plan and Clinical Criteria

When deciding coverage, reference the member specific benefit plan document and applicable laws or mandates. Use objective, evidence‑based criteria and document how the request meets the policy's clinical criteria for relapsing forms of MS.

Document the MS diagnosis (specific ICD-10 code) and prior DMT history or prior response to alemtuzumab as applicable
Include dosing schedule and number of doses requested

Step Therapy

Step Therapy Requirement

Step therapy requirements apply when the policy criteria specify failure or intolerance to alternative disease‑modifying therapies prior to alemtuzumab for treatment‑naïve patients. Ensure documentation shows trials of the required therapies and reasons for discontinuation.

Document trial duration (e.g., ≥4 weeks) or intolerance for listed DMTs (interferons, glatiramer acetate, dimethyl fumarate, teriflunomide, fingolimod, etc.)
If exceptions are requested, provide clinical justification and supporting documentation

Documentation Required

Required Clinical Documentation

Required clinical documentation should be submitted with the authorization request to support medical necessity and dosing: diagnosis (ICD-10), prior treatment history, response to prior alemtuzumab if retreatment, planned dosing regimen, and any supportive laboratory or specialty consult notes.

Relevant diagnosis code(s) from the policy (e.g., G35 series)
Medication code J0202 and requested number of mg/doses
For treatment‑experienced patients, documentation of prior positive clinical response and statement that alemtuzumab is not being given concurrently with another DMT

Denial Risk

Denial Triggers

Authorization denials may be triggered by lack of required prior authorization, absence of documentation of required prior therapies or intolerance, dosing that exceeds policy limits (more than 5 initial doses or more than 3 retreatment doses within 12 months), or concurrent use with other disease‑modifying agents.

Requests exceeding dosing/regimen limits
Missing documentation of prior DMT trials or positive response when required
Concurrent administration with another MS disease‑modifying therapy

Note

Provider Actions — Reference the Member Plan in Coverage Determinations

All coverage decisions and provider notifications should explicitly reference the member specific benefit plan and any applicable mandates used to reach the determination. Providers should be informed of the specific reason(s) for denial and citation to the plan or mandate when applicable.

Include the plan document or mandate citation in denial letters or authorization notes
Advise providers to resubmit with missing documentation or clinical justification tied to the member plan

Lemtrada is available only through the REMS program; providers must follow REMS requirements to prescribe and dispense.

ReferenceAdditional REMS details available at the Lemtrada REMS website: https://www.lemtradahcp.com/rems.

disease-modifying therapies (DMTs) — definition / context

DefinitionDisease-modifying therapies (DMTs) are treatments evaluated for relapsing-remitting MS in systematic reviews and guidelines; they modify disease course rather than solely treating symptoms.

Clinical roleDMTs are the prior therapies that patients are generally required to have an inadequate response or intolerance to (two or more) before Lemtrada is considered.

Evidence sourcesSystematic reviews and guideline summaries (e.g., Cochrane review; AAN comprehensive systematic review) evaluate DMTs for adults with MS.