ModifiedCentenePolicy CP.PHAR.243

Alemtuzumab (Lemtrada)

Defines medical necessity, prior authorization, and dosing limits for alemtuzumab (Lemtrada) for adults with relapsing forms of multiple sclerosis across Centene lines of business.

Policy Summary

PayerCentene

PolicyAlemtuzumab (Lemtrada)

Policy CodePolicy CP.PHAR.243

Change TypeMaterial revision (step therapy and documentation updates)

Effective DateAug 1, 2016

Next Review Date

Key ActionObtain prior authorization and submit documentation showing prior therapy failures and neurologist involvement; reference HCPCS code J0202 when requesting coverage.

SourceLink

POLICY UPDATE CHANGES

Removed requirements for documentation of baseline relapses/EDSS and specific measures of positive response; removed notation that Extavia is preferred for Medicaid as it is no longer available; updated step therapy to require any two MS drugs for Illinois HIM per IL HB 5395.

Clarified interferon-beta product redirections for each line of business.

12 mgsingle-dose vial strength

60 mgfirst-course total

36 mgsubsequent-course total

≥18minimum age

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IL HB 5395IL step therapy

Coverage Criteria for Alemtuzumab (Lemtrada)

Continuation Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Continued Therapy: Member currently receiving medication via Centene benefit or previously met initial approval criteria (or continuity of care applies); member is responding positively to therapy; Lemtrada is not prescribed concurrently with other disease-modifying therapies for MS; at least 12 months have elapsed since completion of the prior treatment course; request does not exceed 1 treatment course; dose does not exceed 12 mg/day for 3 consecutive days (36 mg total per treatment course).

Use of alemtuzumab is not authorized for clinically isolated syndrome (CIS) or primary progressive multiple sclerosis (PPMS).

When there is a conflict between this clinical policy and a state Medicaid coverage provision, the state Medicaid coverage provisions take precedence; refer to the applicable state Medicaid manual for specific coverage details.

Requests for non‑FDA approved indications that are not addressed in this policy are not authorized unless the request includes sufficient documentation of efficacy and safety consistent with the applicable off‑label use policy (see CP.CPA.09, HIM.PA.154, or CP.PMN.53) or other evidence of coverage.

Coding and Dosing

HCPCS CodesHCPCS

J0202

Injection, alemtuzumab, 1 mg

HCPCS CodesHCPCSCovered

J0202

Injection, alemtuzumab, 1 mg

Dose limits per treatment course

First treatment course12 mg per day for 5 consecutive days (60 mg total)

Second treatment course12 mg per day for 3 consecutive days (36 mg total)

Subsequent treatment courses12 mg per day for 3 consecutive days (36 mg total) per course, administered at least 12 months after prior course

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required for Lemtrada (alemtuzumab). Providers must reference this policy and submit prior authorization requests using HCPCS code J0202. Approval is limited to one treatment course when all clinical criteria are met. Provider documentation (office notes, lab results, consultation notes) must be submitted to support that the member meets all approval criteria.

Prior authorization required; use HCPCS code J0202 when submitting requests/claims.
Approval limited to one treatment course per member when criteria met.

Denial Risk

Not Authorized Diagnoses

Requests for indications not addressed by this policy are not authorized. Specifically, Lemtrada is not authorized for clinically isolated syndrome (CIS), primary progressive MS, or other non‑FDA approved indications unless off‑label use documentation meets the referenced off‑label policies.

Background

Alemtuzumab (Lemtrada) is a CD52‑directed cytolytic monoclonal antibody indicated for adults with relapsing forms of multiple sclerosis. Its use is generally reserved for patients with inadequate response to other disease‑modifying therapies because of significant safety risks, and it is available only through a REMS program due to risks including autoimmunity, serious infusion reactions, stroke, and malignancy.

Definitions and Drug Details

Lemtrada (alemtuzumab) — Key attributes

Mechanism of actionCD52-directed cytolytic monoclonal antibody

IndicationTreatment of relapsing forms of multiple sclerosis in adults (relapsing-remitting and active secondary progressive disease); generally reserved for patients with inadequate response to two or more MS drugs

Safety limitationsSignificant safety concerns including autoimmunity, infusion reactions, stroke, malignancies; contraindicated in active infection, HIV, or hypersensitivity to alemtuzumab or excipients

REMS and access restrictionAvailable only through the Lemtrada REMS Program due to risks of autoimmunity, infusion reactions, and malignancies

Policy Summary

PayerCentene

PolicyAlemtuzumab (Lemtrada)

Policy CodePolicy CP.PHAR.243

Change TypeMaterial revision (step therapy and documentation updates)

Effective DateAug 1, 2016

Next Review Date

Key ActionObtain prior authorization and submit documentation showing prior therapy failures and neurologist involvement; reference HCPCS code J0202 when requesting coverage.

SourceLink

On This Page

Not authorized: CIS and primary progressive MS.

Non‑FDA indications require evidence per off‑label use policies referenced above.

Denial Risk

Excess Dosing or Courses

Requests that exceed the allowed number of treatment courses or dosing limits may be denied. Do not request more than one treatment course. Dose limits: first course no more than 12 mg/day for 5 consecutive days (60 mg total); subsequent course(s) no more than 12 mg/day for 3 consecutive days (36 mg total).

Limit: maximum of 1 treatment course per approval.
Dosing limits: first course ≤ 60 mg total; subsequent courses ≤ 36 mg total.

Billing Rule

Coding and Documentation May Affect Coverage

Inclusion or exclusion of codes in this policy is informational only and does not guarantee coverage. Claims or prior authorization requests may be denied if coding or documentation is inconsistent with the coverage criteria. Providers should use current professional coding guidance and ensure supporting clinical documentation accompanies the request.

Codes listed are informational — coverage not guaranteed.
Ensure coding and submitted documentation are consistent with approval criteria to avoid denials.

Note

Follow Current Policy and LOB-Specific Guidance

Follow the most current version of this policy and any line-of-business (LOB) specific guidance or state addendums. Policies are periodically revised (see revision history) — for example, step therapy requirements for Illinois HIM were updated per IL HB 5395. Check LOB/state-specific addendums for continuity of care and product redirections.

Follow LOB/state-specific addendums (e.g., continuity of care provisions).
Recent update: IL HIM step therapy revised per IL HB 5395 (requires failure of any two MS drugs).

Step Therapy

Step Therapy Requirements

Step therapy requirements must be documented as specified. For Illinois HIM requests, the member must have failed two drugs indicated for MS (see Appendices B and D) unless contraindicated or clinically significant adverse effects occurred. For all other requests, failure of the specified set of disease‑modifying therapies (dimethyl fumarate, teriflunomide, fingolimod, and an interferon‑beta agent or glatiramer) at maximally indicated doses is required unless contraindicated or not tolerated.

Illinois HIM: failure of any two MS drugs required (per IL HB 5395) unless contraindicated.
Other lines of business: failure of dimethyl fumarate, teriflunomide, fingolimod, and an interferon‑beta agent or glatiramer at maximally indicated doses (unless contraindicated).
Prior authorization may be required for alternative disease modifying therapies.

Step Therapy

Step Therapy Requirement for Illinois (HIM)

Illinois-specific step therapy: per 2Q 2025 update and IL HB 5395, step therapy for Illinois HIM now requires documented failure of any two MS drugs prior to approval of Lemtrada, unless there are contraindications or intolerable adverse effects. Ensure documentation clearly shows trials of two distinct MS agents.

IL HIM: document failure of two MS drugs (see Appendix B and D) or justification for exemption.
Include dates, doses, duration, and reason for discontinuation in submitted documentation.