Tuesday, March 17, 2015

Information from Genzyme

I emailed Genzyme the other day to inquire about how the program works for doctor training, facility training and the FDA mandated monitoring- and a few others. My questions are in Blue. Here are the answers:

Do both docs & centers have to go through training?

Yes, before Lemtrada treatment is initiated, healthcare providers, infusion centers, specialty pharmacies and patients must be enrolled in the Lemtrada REMS (Risk Evaluation and Mitigation Strategy) Program.  

This is a restricted distribution program intended to help educate healthcare providers and patients on the serious risks associated with Lemtrada and the appropriate periodic monitoring required to support the detection of these risks for 48 months after a patient’s last infusion.  

The REMS is based on a developmental risk management program that was successfully implemented in the Phase 2 and Phase 3 trials and allowed for early detection and management of some of the serious risks associated with Lemtrada. 

Lemtrada REMS training has begun and continues to be ongoing.  

For more information on the REMS program, people living with MS as well as healthcare providers can call 1-855-676-6326 or visit www.LEMTRADAREMS.com

Is there a list of approved docs & infusion centers?

Individuals can call the LEMTRADA REMS Program (number above) to see if a specific infusion center or prescriber is REMS enrolled.  

We are also in the process of preparing an update to the Lemtrada REMS website mentioned above, which will include a site locator that will provide information about prescribers and infusion centers enrolled in the REMS program.

Announcement that the first U.S. patients had been treated with Lemtrada: 

News Article About First US Lemtrada Patient

How does the monitoring program work- is this One to One?

MS One to One is separate from the Lemtrada monitoring program. MS One to One is a support resource that Genzyme offers to people living with MS and their care partners 24 hours a day, 7 days a week.  

Financial assistance is available to MS patients through the One to One program. Please call and inquire if you have a large copay or Lemtrada is denied coverage by your insurance program.

For more information about these support services, we encourage people to call the MS One to One line at 1-855-MSOne2One (1-855-676-6326) or visit this site

When the first Patient Live Education forums will start?

Genzyme is not allowed to begin direct-to-patient outreach until six months after the approval of Lemtrada.  So stay tuned – we expect to have information about these types of events in the June timeframe, and information will be posted on www.LEMTRADA.com as it becomes  available.  

The six month wait is now standard, it is based on the code set by PhRMA.

I recommend going to the site and providing your email and/or address 
so you will be notified when these events start.