The TYSABRI TOUCH® Prescribing Program

Because of the risk of PML, TYSABRI is available only through the TOUCH Prescribing Program, which stands for TYSABRI Outreach: Unified Commitment to Health. TOUCH is a restricted distribution program focused on safety. The goal of the TOUCH Prescribing Program is to minimize the risk of PML.

TOUCH was developed with the help of the Food and Drug Administration (FDA).

• Only prescribers and patients enrolled in the TOUCH Prescribing Program can prescribe and receive TYSABRI
• Only certain pharmacies and infusion sites authorized by the TOUCH Prescribing Program can dispense and infuse TYSABRI

TOUCH requires more interaction with doctors and nurses. Your treatment is closely monitored to help make sure TYSABRI continues to be right for you:

• Once every 4 weeks at each infusion visit
• Plan to see your doctor 3 months after your first infusion, 6 months after your first infusion, and at least as often as every 6 months thereafter

TOUCH assigns you your own specially trained Biogen Idec Case Manager to help:

• Get you started on therapy and answer questions about your therapy
• Find an authorized infusion site in your area
• Provide information about insurance coverage and possible sources of financial assistance, if needed

The TOUCH Prescribing Program Enrollment Process

The process for a patient to receive TYSABRI begins with an appointment with the prescribing neurologist in order to fill out the TOUCH Patient/Prescriber Enrollment Form. By signing this enrollment form, you acknowledge that you understand the potential risks associated with TYSABRI and agree to the requirements of the TOUCH Prescribing Program. This document also serves as your prescription.

At this appointment, the neurologist explains the potential benefits and risks of TYSABRI treatment and gives you time to ask any questions. You must read the Patient Medication Guide and sign the TOUCH Enrollment Form.

Biogen Idec then assigns a patient identification number to you, ensures that all paperwork is properly filled out, and that you have insurance coverage. They help you find an infusion center and notify the infusion center that you have been approved for an infusion.

What is the Pre-infusion Patient Checklist?

Before each infusion, the TOUCH Prescribing Program requires you to review the Patient Medication Guide and complete the Pre-infusion Patient Checklist with the infusion site staff. This checklist includes ensuring that you are enrolled in the TOUCH Prescribing Program. Four questions are read aloud and answered verbally by you. Your answers will decide whether or not you can receive your TYSABRI infusion:

1. Over the past month, have you had any new or worsening medical problems (such as a new or sudden change in your thinking, eyesight, balance, strength, or other problems) that have persisted over several days?
2. Do you have a medical condition that can weaken your immune system, such as HIV infection or AIDS, leukemia or lymphoma, or an organ transplant, that may suggest that your body is not able to fight infections well?
3. In the past month, have you taken medicines to treat cancer or MS or any other medicines that weaken your immune system?
4. In the past month, other than for the treatment of a recent relapse, have you taken any of the following medicines*: Solu-Medrol^®, methylprednisolone, Decadron^®, dexamethasone, Depo-Medrol^®, prednisone, or other steroid medicines?

If you answer yes to any of these questions, the infusion site staff must contact your healthcare professional prior to starting the infusion to determine whether you can go ahead with the infusion or whether it needs to be rescheduled.