CurrentCommunity-CarePolicy N/A

Lemtrada (alemtuzumab) Medical Benefit Medication Utilization Policy

Defines medical benefit coverage criteria, quantity limits, authorization period, and billing code guidance for alemtuzumab (Lemtrada) for treatment of relapsing forms of multiple sclerosis for members covered by the payer.

Policy Summary

PayerCommunity-Care

PolicyLemtrada (alemtuzumab) Medical Benefit Medication Utilization Policy

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization showing relapsing MS diagnosis, neurologist involvement, and trials of ≥2 disease-modifying therapies were ineffective.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥2DMT trials required

6 mLLoading dose (first 12 mo)

3.6 mLMaintenance per 12 mo

lifetimeAuthorization period

J0202HCPCS

Coverage Criteria for Lemtrada (alemtuzumab)

Initial Approval Criteria

Covered when ALL of the following are met

Initial approval: Diagnosis of a relapsing form of multiple sclerosis (e.g., relapsing-remitting or active secondary-progressive); Prescribed by, or in consultation with, a neurologist; Trial of at least 2 disease-modifying therapies approved for the treatment of multiple sclerosis were ineffective; Patient is not infected with human immunodeficiency virus (HIV); Alemtuzumab will not be used in combination with other disease-modifying treatments for multiple sclerosis.

All elements required for approval per policy.

Quantity Limits

If approved, authorize per the following limits

Quantity limits: Loading dose: up to 6 mL (5 vials) for the first year (12 months). Maintenance dose: up to 3.6 mL (3 vials) per year (12 months).

Limits apply per 12-month periods as specified.

Policy Summary

PayerCommunity-Care

PolicyLemtrada (alemtuzumab) Medical Benefit Medication Utilization Policy

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization showing relapsing MS diagnosis, neurologist involvement, and trials of ≥2 disease-modifying therapies were ineffective.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Provider Requirements and Authorization Workflow

Prior Authorization

Prior Authorization Required

Prior authorization is required before administration of alemtuzumab (Lemtrada) for multiple sclerosis. Requests must demonstrate that the patient meets coverage criteria, including a diagnosis of a relapsing form of multiple sclerosis, care by or consultation with a neurologist, and documentation that at least two disease-modifying therapies (DMTs) were tried and found ineffective. Include relevant clinical records, prior therapy details (agents, doses, dates, and reason for discontinuation), and HIV testing results.

Required for multiple sclerosis indication
Document neurologist involvement or consult
Document trial and failure of >=2 DMTs (agent, dates, reason for failure)
Include HIV test/result showing patient is not HIV-infected
Quantity/administration plan (loading vs maintenance) if known

Denial Risk

Denial Triggers and Documentation Risks

Requests may be denied if required criteria or documentation are not provided. Common triggers for denial include absence of a relapsing MS diagnosis (e.g., primary progressive without active relapses), lack of documentation of neurologist involvement, insufficient evidence of trials/failures of at least two DMTs, use in combination with other DMTs, or evidence of HIV infection. Failure to provide supporting clinical records, prior therapy details, or required laboratory results may result in denial.

No documentation of relapsing MS diagnosis (relapsing‑remitting or active secondary‑progressive)
No neurologist as prescriber or no documented consult
Insufficient trials of ≥2 DMTs with reasons for ineffectiveness
Evidence of concurrent use of other disease‑modifying MS treatments
Positive HIV test or lack of HIV testing documentation

Background

Alemtuzumab (Lemtrada) is a monoclonal antibody therapy indicated for certain relapsing forms of multiple sclerosis. This policy limits coverage to members with a documented relapsing form of multiple sclerosis (for example, relapsing-remitting or active secondary-progressive disease) and requires that treatment be prescribed by or in consultation with a neurologist. Prior to approval, the member must have had a trial of at least two disease-modifying therapies for multiple sclerosis that were ineffective. The policy also specifies exclusions and safeguards, including that the patient is not infected with HIV and that alemtuzumab will not be used concurrently with other disease-modifying MS treatments. When criteria are met, the policy authorizes dosing limits and a lifetime authorization period (subject to benefit changes).

OpenPayer

Lemtrada (alemtuzumab) Medical Benefit Medication Utilization Policy

Coverage Criteria for Lemtrada (alemtuzumab)

Coding and Dosing Guidance

Provider Requirements and Authorization Workflow

Background

Definitions