ModifiedmhnPolicy CP.PHAR.243

Alemtuzumab (Lemtrada) for relapsing multiple sclerosis

Clinical coverage policy for use of alemtuzumab (Lemtrada) to treat relapsing forms of multiple sclerosis in adults, including initial and continued therapy criteria and dosing limits; applies to Centene-affiliated health plans lines of business listed in the document.

Policy Summary

Payermhn

PolicyAlemtuzumab (Lemtrada) for relapsing multiple sclerosis

Policy CodePolicy CP.PHAR.243

Change Type2Q 2025 annual review — documentation requirements removedstep therapy revised for IL HIM

Effective Date08.01.16

Next Review Date

Key ActionSubmit prior authorization with office notes, labs, and clinical documentation showing the member meets all initial or continued therapy criteria.

SourceLink

POLICY UPDATE CHANGES

Requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response were removed.

Revised step therapy to require any two MS drugs for IL HIM per IL HB 5395.

Notation that Extavia is the preferred interferon was removed.

Updated Appendix C with additional contraindications per revised prescribing information.

12 mg/day × 5 daysFirst treatment course dosing

12 mg/day × 3 daysSubsequent course dosing

≥18Minimum age

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Coverage Criteria

Initial Approval Criteria - Multiple Sclerosis

Covered when ALL of the following are met:

Initial MS criteria: 1. Diagnosis of relapsing-remitting or secondary progressive multiple sclerosis.

Initial MS criteria: 2. Prescribed by or in consultation with a neurologist.

Initial MS criteria: 3. Age ≥ 18 years.

Therapy selection (one of)

a: For Illinois HIM requests only: failure of two drugs indicated for the treatment of MS (see Appendix B and D), unless clinically significant adverse effects are experienced or all are contraindicated.
b
- i: Dimethyl fumarate (generic Tecfidera®).
- ii: Teriflunomide (generic Aubagio®).
- iii: Fingolimod (Gilenya®).
- iv: An interferon-beta agent (Avonex®, Betaseron®/Extavia®, Rebif®, or Plegridy®) or glatiramer (Copaxone®, Glatopa®).

Concurrent therapy: 5. Lemtrada is not prescribed concurrently with other disease modifying therapies for MS (see Appendix D).

Dose limits: 6. Dose does not exceed: a) First treatment course: 12 mg per day for 5 consecutive days (60 mg total); b) Second or subsequent treatment courses: 12 mg per day for 3 consecutive days (36 mg total).

Continued Therapy Criteria - Multiple Sclerosis

Continued therapy is authorized when ALL of the following are met:

Eligibility (one of)

a: Currently receiving medication via Centene benefit or member has previously met initial approval criteria.
b: Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums).

Response: 2. Member is responding positively to therapy.

Concurrent therapy: 3. Lemtrada is not prescribed concurrently with other disease modifying therapies for MS (see Appendix D).

Coverage under this policy does not extend to primary progressive multiple sclerosis (MS). In addition, non‑FDA approved indications are not addressed by this policy and are excluded from coverage unless the request is supported by sufficient documentation of efficacy and safety consistent with the applicable off‑label use policy (see referenced off‑label policies). Requests for off‑label uses should follow the established off‑label documentation and review processes before authorization will be considered. The policy also requires that alemtuzumab not be prescribed concurrently with other disease‑modifying therapies for MS per the approval criteria.

For members covered by Medicaid, state Medicaid coverage provisions take precedence if they conflict with the clinical coverage provisions in this policy. Providers should consult the applicable state Medicaid manual for any state‑specific coverage rules or exceptions before submitting an authorization request.

Use of alemtuzumab for clinically isolated syndrome (CIS) is not recommended because of its safety profile and is therefore not authorized under this policy. More broadly, non‑FDA approved indications are not authorized unless there is sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy (see referenced off‑label policies for required documentation).

Coding and Dosing

HCPCS CodesHCPCS

J0202

Injection, alemtuzumab, 1 mg

Referenced HCPCS CodesHCPCS

J0202

Injection, alemtuzumab, 1 mg

Dose limits per treatment course

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

Second or subsequent treatment courses12 mg per day for 3 consecutive days (36 mg total)

Timing of subsequent coursesSubsequent courses given at least 12 months after completion of a prior course

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for alemtuzumab (HCPCS code J0202). Requests will be reviewed against the medical necessity criteria in this policy and approval depends on meeting all applicable requirements.

HCPCS: J0202 (Injection, alemtuzumab, 1 mg)
Prior authorization required for all lines of business unless otherwise specified

Denial Risk

Requests Not Meeting Criteria May Be Denied

Requests that do not meet all approval criteria, or requests for non‑FDA‑approved (off‑label) indications without sufficient supporting evidence per the applicable off‑label use policy, may be denied.

Non‑FDA indications require documentation of efficacy/safety per off‑label policies
Concurrent use with other disease‑modifying therapies for MS is not authorized

Definitions and Program Notes

REMS — Lemtrada

REMS requirementLemtrada is available only through the Lemtrada REMS Program due to risks of autoimmunity, infusion reactions, and malignancies.

Key risksBoxed warnings include autoimmunity, infusion reactions, stroke, and malignancies.

Contraindications notedHypersensitivity/anaphylaxis to alemtuzumab or excipients, active infection, and HIV infection are contraindications.

Health Plan — definition and administrative notes

DefinitionHealth Plan means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or an affiliate.

ScopePolicy provides guidance on medical necessity to assist coverage decisions and administering benefits but is not a contract or guarantee of payment.

Background

Alemtuzumab (Lemtrada) is a CD52‑directed cytolytic monoclonal antibody indicated for the treatment of relapsing forms of multiple sclerosis in adults, including relapsing‑remitting MS and active secondary progressive MS. Because of safety concerns, including autoimmune events and infusion‑related risks, its use is generally reserved for patients who have had an inadequate response to other multiple sclerosis therapies.

Revision History

2025-05-25annual_review (2Q 2025)Latest

Per 2Q 2025 annual review, removed requirements for documentation of baseline relapses/Expanded Disability Status Scale and specific measures of positive response; removed notation that Extavia is the preferred interferon beta-1b for Medicaid; references reviewed and updated.

2025-04-07step_therapy_revision

Revised step therapy to require any two multiple sclerosis drugs for Illinois HIM in accordance with IL HB 5395.