The mechanism by which TECFIDERA exerts therapeutic effects in MS is unknown. TECFIDERA is thought to offer a different approach in relapsing MS by activating the Nrf2 (nuclear factor [erythroid-derived 2]-like 2) pathway. The Nrf2 pathway is involved in the cellular response to oxidative stress.1
TECFIDERA offers twice-daily oral dosing—1 pill in the morning and 1 pill at night. The starting dose (120 mg capsule) is taken twice a day for the first 7 days of treatment. After 7 days, patients are increased to the maintenance dose (240 mg capsule) twice a day.1
In the DEFINE trial, a 2-year, randomized, double-blind, placebo-controlled study of 1234 patients with relapsing-remitting remitting MS1:
In the CONFIRM trial, a 2-year, multicenter, randomized, double-blind, placebo-controlled study that also included an open-label comparator arm of 1417 patients with relapsing-remitting MS1:
*Disability progression was defined as at least a 1-point increase from EDSS of ≥1, OR at least a 1.5-point increase for patients with baseline EDSS of 0 sustained for 12 weeks.1
DEFINE=Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting Multiple Sclerosis2; CONFIRM=Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis3; EDSS=Expanded Disability Status Scale.
CBC=complete blood count.
If you determine TECFIDERA is right for your patient, remember to specify your state's required "Dispense as Written" language in the prescriber signature of the Start Form. When the Start Form is complete, fax it to Biogen Support Services at 1-855-474-3067. It will be sent to a specialty pharmacy that is compatible with your patient's insurance coverage. The specialty pharmacy will work with your patient's insurance company or, if necessary, find alternative funding sources to get your patients on TECFIDERA as quickly as possible. The prescription can then be shipped directly to your patient's home.
Remind your patients that Biogen Case Managers are available to assist with any questions or concerns. Patients can call 1-800-456-2255, Monday through Friday from 8:30 AM until 8:00 PM ET.
Biogen can provide assistance once your patients are prescribed TECFIDERA. Biogen Support Services provides financial and insurance assistance options, including the Biogen Copay Program, which may lower medication cost for eligible patients with commercial insurance.*
*Effective January 1, 2021, there is an annual cap on the amount of assistance that patients can receive over a one year period. Federal and state laws and other factors may prevent or otherwise restrict eligibility. People covered by Medicare, Medicaid, the VA/DoD, or any other federal plans are not eligible to enroll. You are eligible to enroll in the Biogen Copay Program for as long as it is offered and you are treated with a Biogen relapsing MS medication. The Biogen Copay Program is no longer available for TECFIDERA patients in the states of Massachusetts and California.
Your patients have full access to Biogen Support Services, including Biogen Case Managers and Nurse Educators. Biogen Case Managers will reach out to your patients after they are prescribed TECFIDERA and help educate them on financial assistance options. Nurse Educators are available to help your patients understand what to expect during treatment and provide additional resources.