CurrentUnitedHealthcarePolicy 2025D0023X

Lemtrada (alemtuzumab) for relapsing forms of multiple sclerosis

UnitedHealthcare medical benefit drug policy for Lemtrada (alemtuzumab) defining medical necessity criteria, dosing/regimen limits, applicable HCPCS and diagnosis codes, background, evidence, REMS note, and policy history for treatment of relapsing forms of multiple sclerosis.

Policy Summary

PayerUnitedHealthcare

PolicyLemtrada (alemtuzumab) for relapsing forms of multiple sclerosis

Policy CodePolicy 2025D0023X

Change TypeRevised (supporting info) and Template Update

Effective DateApr 1, 2025

Next Review Date

Key ActionObtain authorization with dosing/regimen limits and document prior DMT trials or prior alemtuzumab response and ensure REMS program compliance.

POLICY UPDATE CHANGES

04/01/2025 - Updated Clinical Evidence and References sections to reflect the most current information; archived previous policy version 2024D0023W.

07/01/2025 - Template Update; Updated Benefit Considerations section.

1Primary HCPCS code listed

1Primary diagnosis code listed

2Authorization regimens (initial vs retreatment)

Coverage Summary & Medical Necessity Criteria

Coverage summary: UnitedHealthcare covers Lemtrada (alemtuzumab) as covered_with_criteria for adults with relapsing forms of multiple sclerosis when the policy's medical necessity criteria are met, including documented diagnosis of relapsing MS and either prior DMT failure/intolerance (treatment‑naïve pathway) or documentation of prior alemtuzumab response for retreatment. Initial dosing limits are 12 mg IV daily for 5 consecutive days (authorization no more than 12 months and no more than 5 doses); retreatment dosing limits are 12 mg IV daily for 3 consecutive days (authorization no more than 12 months and no more than 3 doses and regimen only once within 12 months).

Authorization, Documentation & REMS Requirements

Prior Authorization

Authorization required with dosing and regimen limits

Initial authorization is limited to 12 mg IV daily for 5 consecutive days (no more than 5 doses) with authorization for no more than 12 months. Retreatment (for patients previously treated with alemtuzumab) is limited to 12 mg IV daily for 3 consecutive days (no more than 3 doses); the retreatment regimen may be administered only once within 12 months and authorization is for no more than 12 months.

Affected HCPCS code: J0202
Initial authorization: ≤5 doses, ≤12 months
Retreatment authorization: ≤3 doses, administered only once within 12 months, ≤12 months

Documentation Required

Documentation of prior therapy and response required

For patients naïve to alemtuzumab, document a trial and failure or intolerance to at least two of the listed disease‑modifying therapies (or a trial of ≥4 weeks). For retreatment, document prior receipt of alemtuzumab, documentation of a positive clinical response to prior alemtuzumab therapy, and that the patient is not receiving alemtuzumab in combination with another disease‑modifying agent for MS.

See list of DMTs used for failure/intolerance criteria

Documentation Required

REMS program compliance

Ensure compliance with the Lemtrada (alemtuzumab) REMS program because of risks of autoimmunity, infusion reactions, and malignancies before prescribing or administering therapy.

Evidence Summary

Evidence summary: The CARE‑MS II trial reported that alemtuzumab 12 mg produced greater improvement in disability measures versus subcutaneous interferon β‑1a, including significantly higher rates of 6‑month confirmed disability improvement (28.8% vs 12.9%) and favorable changes on EDSS, MSFC and SLCLA. A Cochrane review (2017/2023) found low‑ to moderate‑quality evidence that annual IV cycles of alemtuzumab reduce relapses and disease progression versus IFN beta‑1a over 24–36 months, but emphasized safety concerns — notably infusion‑associated reactions, infections and autoimmune events — and that careful monitoring is required to detect and manage potentially serious adverse effects.

Background & Definitions

Background: Alemtuzumab is a humanized IgG1 monoclonal antibody directed against CD52 on T and B lymphocytes (and other immune cells) that produces antibody‑dependent and complement‑mediated cell lysis. It is indicated for treatment of relapsing forms of multiple sclerosis in adults. Because of risks including autoimmunity, infusion reactions, and malignancies, Lemtrada is available only through a restricted distribution REMS program to ensure appropriate monitoring and risk mitigation.