Lemtrada (alemtuzumab) coverage
Defines prior-authorization medical necessity criteria, dosing limits, and site-of-care for Lemtrada (alemtuzumab) for treatment of relapsing forms of multiple sclerosis for members of the payer in Arkansas PASSE program.
Changed to trial of 2 drugs or highly active disease; added disqualifiers, positive clinical response to renewal criteria, and dosing information for renewal doses.
Coverage Criteria
Initial Therapy
Covered when ALL of the following are met for initial authorization:
Initial dosing: 12 mg IV daily x 5 days (60 mg total). Quantity limit: 5 vials per 365 days. If criteria met, approve for 12 months.
Continuation / Re-treatment
Covered when ALL of the following are met for reauthorization:
Quantity limit: 3 vials per 365 days. If criteria met, approve for an additional 12 months.
CareSource considers alemtuzumab (Lemtrada) not medically necessary for indications not listed in this policy. Requests for use outside the documented indications should be evaluated under the payer's Off‑Label policy and will be denied when that policy does not support coverage.
Lemtrada is not recommended for clinically isolated syndrome (CIS) and, because of its safety profile (including autoimmune conditions, infusion reactions, stroke, and malignancies) and REMS requirements, is generally reserved for patients with an inadequate response to two or more MS therapies or for those with prescriber‑documented highly active (aggressive/rapidly evolving) disease.
Initial Therapy — Requirements and Dosing
Provider Actions / Billing and Denial Triggers
Prior authorization required. Submit documentation of prior therapies, neurologist involvement, diagnoses, baseline labs, and dosing. Claims without prior authorization or missing required documentation may be denied.
- Prior authorization is required before initiation.
- Include documentation of trials of prior MS therapies or, if applicable, prescriber rationale for highly active disease.
- Billing: adhere to applicable HCPCS/NDC coding and quantity limits (see dosing/QL).
Initial Therapy — Requirements and Dosing
Initial therapy — patient eligibility, diagnostic and documentation requirements, and dosing
ALL of the following
- Medication is prescribed by, or in consultation with, a neurologist.
- Member is 17 years of age or older.
Diagnosis (one of)
- Relapsing-remitting multiple sclerosis with at least one relapse in the past year.
- Active secondary progressive multiple sclerosis.
- Clinically isolated syndrome (CIS).
Disease activity / prior therapy (one of)
- Documentation of inadequate response to two or more drugs indicated for the treatment of multiple sclerosis (step-therapy requirement).
Document agent names, dates, and reason for discontinuation or inadequate response.
- Prescriber documents highly active (aggressive or rapidly evolving) disease and provides clinical rationale for bypassing the two-drug trial requirement.
Baseline assessments
- Complete blood count has been performed or will be performed.
- Thyroid function test (e.g., TSH) has been performed or will be performed.
- Serum creatinine and urinalysis have been performed or will be performed.
- Negative tuberculosis test or documentation of TB screening.
Exclusions (none of)
- Active infection present.
- Human immunodeficiency virus (HIV) infection.
- Initial dosing: 12 mg/day IV infusion on 5 consecutive days (60 mg total).
- Quantity limit: up to 5 vials per 365 days.
- Authorization duration: if criteria met, approval for 12 months.
Step Therapy — Required Trials or Exception
Step therapy requirement: document trials of two or more MS therapies OR document that the member has highly active disease and include prescriber rationale.
- If the prescriber documents highly active disease, the two-drug trial requirement may be waived.
- Provide medication names, dates of use, and reason for failure/intolerance for each prior therapy trial.
Continuation / Re-treatment Criteria
Re-treatment
Re-treatment (authorization for subsequent course):
Quantity limit: 3 vials per 365 days. If criteria met, approve for an additional 12 months.
Coding and Age Limits
| J0202 | alemtuzumab |
Quantity Limits and Dosing Limits
Provider Actions, Documentation & Billing
Prior authorization required; bill as J0202 (medical benefit, outpatient hospital)
Obtain prior authorization before furnishing Lemtrada; bill using HCPCS code J0202. Lemtrada is covered as a medical benefit and billed/provided through the outpatient hospital setting.
- Billing code: Lemtrada (alemtuzumab) = J0202.
- Benefit type: Medical.
- Site of service allowed: Outpatient_hospital.
- Status: Prior_Authorization Required.
Required documentation: neurologist, age, diagnosis, relapse history/highly active disease
Include documentation of neurologist involvement (prescribed by or in consultation with a neurologist), member age ≥17, and MS diagnosis meeting policy criteria; also provide relapse history or prescriber documentation of highly active disease as applicable.
- Medication must be prescribed by, or in consultation with, a neurologist.
- Member must be 17 years of age or older.
- Diagnosis must be relapsing‑remitting MS (with at least one relapse in the past year) or active secondary progressive MS.
- Document either inadequate response to two or more MS drugs OR prescriber statement of highly active disease.
Denial triggers: missing age, neurologist involvement, qualifying diagnosis, or required trial history
Requests may be denied if the record does not show member age ≥17, lack of neurologist prescription/consultation, an eligible MS subtype (RRMS with required relapse history or active secondary progressive MS), or absence of documentation showing inadequate response to ≥2 MS drugs or prescriber documentation of highly active disease.
- Missing documentation of age ≥17.
- No documentation that medication was prescribed by or in consultation with a neurologist.
- No qualifying MS diagnosis or required relapse history.
- No documentation of trials of two or more MS therapies or prescriber statement of highly active disease.
Definitions
Site of Care
Site of care: outpatient hospital administration allowed
Administration is allowed in the hospital outpatient setting per the site-of-care policy.
- Site of service allowed: Outpatient_hospital (hospital outpatient).
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. Due to significant safety concerns and REMS program requirements, its use is limited to patients meeting specific clinical and monitoring criteria and is typically reserved for those who have not adequately responded to other disease‑modifying therapies.
Revision History
Policy effective date recorded.
Transferred to new template; changed to trial of 2 drugs or highly active disease; added disqualifiers; added positive clinical response to renewal criteria; added dosing information for renewal doses; added requirement of at least one relapse in past year for RRMS; added baseline monitoring.
Age coverage expanded; confirmation of diagnosis based on McDonald criteria no longer required.
New policy for Lemtrada created; initial policy required trials of two formulary agents and listed not-covered diagnoses.
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