CurrentMass General Brigham Health PlanPolicy N/A

Lemtrada (alemtuzumab) — Prior Authorization and Step Therapy Criteria

Defines prior authorization, step therapy, and quantity/authorization limits for Lemtrada (alemtuzumab) for Mass General Brigham Health Plan members, including clinical requirements and prescriber qualifications.

Policy Summary

PayerMass General Brigham Health Plan

PolicyLemtrada (alemtuzumab) — Prior Authorization and Step Therapy Criteria

Policy CodePolicy N/A

Change TypeAdministrative updatestep therapy revisions

Effective DateMay 12, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis, documentation of inadequate response to two listed DMTs (or contraindication to all), and prescriber neurology attestation.

SourceLink

POLICY UPDATE CHANGES

Ocrevus Zunovo will be added as a trial option in place of Ocrevus.

Briumvi was added as another step through option.

Matched MassHealth UPPL criteria to be in compliance with the unified formulary requirements.

12 monthsAuthorization duration

2+Prior therapies required

NeurologistPrescriber requirement

5d / 3dTypical dosing

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Coverage Criteria for Lemtrada (alemtuzumab)

Initial authorization criteria

Authorization may be granted for members when ALL of the following are met:

Main criteria: Member has relapsing-remitting multiple sclerosis OR confirmed active secondary-progressive multiple sclerosis; prescriber is a neurologist or neurology consult notes are provided; paid claims or physician attestation of inadequate response or adverse reaction to TWO of the listed disease-modifying multiple sclerosis agents OR contraindication to ALL listed agents; requested dose matches one of the approved dosing regimens.see child nodes

Initial authorizations granted for 12 months per policy.

Diagnosis

Relapsing-remitting MS: Relapsing-remitting multiple sclerosis.
Active SPMS: Confirmed active secondary-progressive multiple sclerosis.
Prescriber attestation of active disease required for SPMS.

Prior therapy requirement

Listed DMTs: teriflunomide; ublituximab-xiiy (Briumvi) or ocrelizumab/Ocrevus Zunovo; dimethyl fumarate or Vumerity; fingolimod capsule; interferon therapy; glatiramer acetate therapy; natalizumab (Tysabri).

Prescriber requirement: Prescriber is a neurologist or neurology consult notes are provided.

Dose requirement

Year 1 dosing: 12 mg daily for 5 days in the first year of therapy.
Year 2 dosing: 12 mg daily for 3 days in the second year of therapy.

Continuation of Therapy

Continuation (reauthorization) criteria

Reauthorization by prescriber will infer a positive response to therapy.

Initial authorizations and reauthorizations are granted for 12 months.

SPMS reauthorization: For members with secondary-progressive MS, prescriber must provide attestation confirming active disease.

Coverage for Lemtrada (alemtuzumab) is managed under prior authorization. Some agents in this therapeutic class are processed through the pharmacy benefit; when applicable, refer to the MassHealth Drug List for coverage and criteria. Contact information for commercial/exchange pharmacy benefit support is available for plan-specific questions.

Use of Lemtrada is limited to adults with relapsing‑remitting multiple sclerosis (RRMS) or active secondary‑progressive multiple sclerosis (SPMS) as described by the prescribing clinician. Because of Lemtrada’s safety profile, the policy reserves use for patients who have had an inadequate response to two or more MS therapies or who have contraindications to the listed agents. Use for indications other than RRMS or active SPMS in adults, or use in patients without the required prior‑therapy history, is not supported by this policy.

Dosing, Codes, and Prior Agents

Covered dosing regimensneutralCovered

alemtuzumab dosing

12 mg daily for 5 days in 1st year; 12 mg daily for 3 days in 2nd year

Required prior multiple sclerosis agents (step options)mixed

teriflunomide	Required prior therapy option
ublituximab-xiiy (Briumvi)	Required prior therapy option (added as step option)
ocrelizumab / Ocrevus Zunovo	Required prior therapy option (Ocrevus Zunovo added as trial option)
dimethyl fumarate / Vumerity	Required prior therapy option
fingolimod capsule	Required prior therapy option
interferon therapy	Required prior therapy option
glatiramer acetate therapy	Required prior therapy option
natalizumab (Tysabri)	Required prior therapy option

inv-07: Prior therapies tried

RequirementPaid claims or physician attestation of inadequate response or adverse reaction to TWO of the listed disease-modifying multiple sclerosis agents, OR contraindication to ALL listed agents.

Number requiredTwo (inadequate response or adverse reaction) or all (if contraindicated)

Acceptable documentationPaid pharmacy/medical claims or physician attestation documenting inadequate response or adverse reaction.

Applies toListed DMTs: teriflunomide; ublituximab-xiiy (Briumvi) or Ocrevus Zunovo (ocrelizumab/hyaluronidase-ocsq); dimethyl fumarate or Vumerity; fingolimod capsule; interferon therapy; glatiramer acetate therapy; Tysabri (natalizumab).

Provider Requirements, Prior Authorization, and Denial Triggers

Prior Authorization

Prior authorization required

Prior authorization is required for Lemtrada (alemtuzumab). Authorization requests will be reviewed on a case-by-case basis for members new to the plan who are currently receiving treatment with the requested medication (excluding product obtained as samples or via manufacturer's patient assistance programs).

Contact: All Plans Phone: 877-519-1908 Fax: 855-540-3693 (Specialty/medical benefit)
Requests for members new to the plan who are currently receiving treatment may be approved with documentation of ongoing therapy.

Step Therapy

Step therapy / Prior therapies

Use of Lemtrada is generally reserved for patients with inadequate response or adverse reaction to two or more disease-modifying multiple sclerosis (DMT) agents, or contraindication to all listed agents. Prescriber must be a neurologist or provide neurology consult notes.

Required prior agents (trial or contraindication to ALL): teriflunomide; ublituximab (Briumvi) or ocrelizumab (Ocrevus/Zunovo); dimethyl fumarate or Vumerity; fingolimod; interferon therapy; glatiramer acetate; natalizumab (Tysabri).

Background and Clinical Context

Lemtrada (alemtuzumab) is a monoclonal antibody disease‑modifying therapy indicated for relapsing‑remitting multiple sclerosis (RRMS) and for active secondary‑progressive multiple sclerosis (SPMS) in adults. Due to its safety profile, the policy generally reserves Lemtrada for patients with an inadequate response to two or more drugs indicated for MS; prior authorization is required and clinicians should document prior treatment history and prescriber qualifications when requesting coverage.

Definitions and Diagnostic Criteria

inv-13: Active secondary-progressive multiple sclerosis (SPMS)

DefinitionSecondary‑progressive multiple sclerosis (SPMS) with clinical or documented evidence of active disease as confirmed by prescriber attestation.

Required attestationPrescriber must attest that SPMS is active (clinical or documented evidence) when requesting therapy.

When requiredAttestation is required for both initial authorization and reauthorization for members with SPMS.

ContextLemtrada is indicated for relapsing‑remitting MS and active SPMS in adults; use generally reserved for patients with inadequate response to two or more MS therapies.