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 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 Sclerosis.3
CBC=complete blood count.
Biogen is committed to getting your patients on therapy as soon as possible. When your patient is ready to start on TECFIDERA, you can complete a TECFIDERA Start Form and fax it to Above MSTM at 1-855-474-3067. When the TECFIDERA Start Form is received, 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 patient on TECFIDERA as quickly as possible. The prescription can then be shipped directly to your patient's home.
The QuickStart Program benefits your eligible TECFIDERA patients. This program is designed to get commercially insured patients (non-Medicare/Medicaid) on therapy as soon as possible by providing a limited, no-cost supply to eligible patients who have not yet received access to TECFIDERA from their insurance provider promptly upon submission of the prescription. If necessary, a limited number of subsequent supplies of TECFIDERA are given at no cost to eligible patients to help ensure that no patient experiences a gap in treatment.
Remind your patients that Above MS Support Coordinators 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 PM ET.
The TECFIDERA Above MS program can allow your patients to focus on TECFIDERA treatment and not its cost. Above MS offers insurance counseling—with help sorting through benefits, including Medicare—and financial assistance programs. A $0 Copay Program is available for eligible patients.* Above MS can also provide TECFIDERA for free to those who are truly in need. You or your patients can learn more about Above MS by calling 1-800-456-2255.
*Copay details and eligibility:
Please note that the $0 Copay Program provides a monthly supply of TECFIDERA. Patients are eligible to enroll in the $0 Copay Program for as long as they are treated with TECFIDERA. Federal and state laws may prevent eligibility. People covered by Medicare, Medicaid, the VA/DoD, or any other federal plans are not eligible to enroll. In addition, some insurance providers may prevent eligibility or restrict eligibility to people with demonstrated financial need. If patients are not eligible or not sure of their eligibility, they can call Above MSTM. There are charitable programs and even a free drug program sponsored by Biogen that may be able to help with the cost. Depending on patients' income or, in some cases, if their medication is obtained from an out-of-network provider, there may be an annual cap that limits the amount of assistance they can receive over one year.
Patients can receive a Patient Information Brochure to help them learn more about TECFIDERA, as well as a Welcome Kit to help them get started on TECFIDERA. Your patients also have access to support services that offer financial assistance, a 24/7 Nurse Educator hotline, and the latest information on local MS events. For the most information, your patients can visit our patient website at TECFIDERA.com.
References: 1. TECFIDERA Prescribing Information, Biogen, Cambridge, MA. 2. Gold R, et al. N Engl J Med. 2012;367(12):1098-1107. Erratum in: N Engl J Med. 2012;367(24):2362. 3. Fox RJ, et al. N Engl J Med. 2012;367(12):1087-1097. Erratum in: N Engl J Med. 2012;367(17):1673.