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For US Healthcare Professionals Sanofi Genzyme

Support Services

For Your LEMTRADA Patients

Dedicated MS One to One Case Managers:

  • Patients receive a dedicated MS One to One Case Manager who is available 24/7 to help them understand the risks and benefits of LEMTRADA, answer questions about MS, access financial support resources, prepare for the infusion process, and remember required monthly monitoring

Financial Support:

  • MS One to One provides information on benefits verification and financial assistance programs (e.g., Patient Assistance Program, Medicaid or Low-Income Subsidies, or charitable funding)
  • Eligible patients may receive LEMTRADA at $0 out-of-pocket cost through the LEMTRADA Co-Pay Program
  • Eligible patients may receive reimbursement for their infusion-related, out-of-pocket costs

Monitoring & Lab Collection Assistance:

  • Sanofi Genzyme covers the cost of lab services and testing until 48 months after the last treatment course and offers 2 ways to complete monitoring. Lab samples can be drawn:
    • At any LabCorp® or Quest Diagnostics facility
    • In the HCP’s office*
  • Patients will determine which option is best for their individual needs

*For HCP office samples, patients may incur a co-pay to cover the cost of the lab draw and office visit, which is not covered by Sanofi Genzyme.

For You to Support Your Patients

Designated Case Managers:

  • Designated Case Managers can assist with insurance investigation and verification, claims management and appeals, and provide prior authorization assistance for your patients

Process Support:

  • MS One to One can help enroll HCPs in the LEMTRADA REMS, review procurement options, answer questions about billing, reimbursement, and coding, and provide training and education about infusion protocol

Monitoring & Lab Collection Assistance:

  • By enrolling yourself and patients into the LEMTRADA Central Lab Program, your patients’ cost of lab services is covered until 48 months after the last treatment course
  • Patients receive assistance with required monitoring, and prescribers can receive monthly reports of lab test results and compliance data

Infusion Support and Preparation

Designated Case Managers:

  • Case Managers are available to answer questions about LEMTRADA infusion preparation and considerations
  • Case Managers can provide detailed information about the LEMTRADA REMS, REMS enrollment status, authorization status to receive LEMTRADA, post-infusion instructions and monitoring requirements, and billing processes, reimbursement, and coding related to LEMTRADA

Infusion Preparation:

  • MS One to One can help arrange infusion facility appointments, answer questions about infusion site arrangements, and deliver preinfusion reminders
  • Prior to the infusion, an MS One to One Case Manager will remind the patient to:
    • Ensure lab work and premedication requirements have been fulfilled
    • Arrange for necessary time off from work
    • Organize transportation to and from the infusion site
    • Contact the infusion site to discuss policies on having visitors, food, blankets, or additional items from home as well as any other practical considerations
    • Arrange for family, elder, and/or child care

Please call MS One to One at 1–855–676–6326 to learn more about support services.

Sanofi Genzyme reserves the right at any time and without notice to modify or change eligibility criteria or discontinue this program.

INDICATION

LEMTRADA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, the use of LEMTRADA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

Limitations of Use: LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.

IMPORTANT SAFETY INFORMATION

WARNING: AUTOIMMUNITY, INFUSION REACTIONS, STROKE AND MALIGNANCIES

CONTRAINDICATIONS

LEMTRADA is contraindicated in patients:

WARNINGS AND PRECAUTIONS

Most Common Adverse Reactions

In controlled clinical trials, the most common adverse reactions (incidence ≥10% and >interferon beta-1a) with LEMTRADA vs interferon beta-1a were: rash (53% vs 6%), headache (52% vs 23%), pyrexia (29% vs 9%), nasopharyngitis (25% vs 19%), nausea (21% vs 9%), urinary tract infection (19% vs 8%), fatigue (18% vs 13%), insomnia (16% vs 15%), upper respiratory tract infection (16% vs 13%), herpes viral infection (16% vs 3%), urticaria (16% vs 2%), pruritus (14% vs 2%), thyroid gland disorders (13% vs 3%), fungal infection (13% vs 4%), arthralgia (12% vs 9%), pain in extremity (12% vs 9%), back pain (12% vs 8%), diarrhea (12% vs 6%), sinusitis (11% vs 8%), oropharyngeal pain (11% vs 5%), paresthesia (10% vs 8%), dizziness (10% vs 5%), abdominal pain (10% vs 5%), flushing (10% vs 4%), and vomiting (10% vs 3%).

Use in Specific Populations

Physicians are encouraged to register patients in the pregnancy exposure registry by calling 1-866-758-2990. Antibodies, including anti-CD52 and autoantibodies, may be transferred from the mother to the fetus during pregnancy. Placental transfer of anti-thyroid antibodies resulting in neonatal Graves’ disease has been reported.

Safety and effectiveness in pediatric patients less than 17 years of age have not been established. Use of LEMTRADA is not recommended in pediatric patients due to the risks of autoimmunity and infusion reactions, stroke, and because it may increase the risk of malignancies.

Please see full Prescribing Information, including Boxed WARNING.

Indication

LEMTRADA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, the use of LEMTRADA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

Limitations of Use: LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.

IMPORTANT SAFETY INFORMATION

WARNING: AUTOIMMUNITY, INFUSION REACTIONS, STROKE AND MALIGNANCIES

  • LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane (anti-GBM) disease. Monitor complete blood counts with differential, serum
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