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ABOVE MSTM—SUPPORT FOR YOU AND YOUR PATIENTS

The Above MSTM program from Biogen is here for you and your patients with tips, tools, and more.

There are many benefits to joining the Above MS program. As members, your patients will get extra help from those who understand relapsing MS, including:

  • Specially tailored information from people like them who are living with relapsing MS, but are also experts in areas such as financial planning, cooking, exercise, and many others
  • One-on-one relapsing MS support over the phone
  • A community of peers
  • Information about TECFIDERA treatment and support services
  • Access to Nurse Educators
  • Insurance and financial support, if eligible

The Above MS program can be a great resource for your patients. However, your patients should always come to you with any questions related to their relapsing MS and their treatment.

SUPPORT COORDINATORS

For people taking a Biogen relapsing MS treatment, our Support Coordinators can help them understand and access a number of different resources along their journey with MS. They offer a broad range of services, including general MS information, one-on-one MS support over the phone, and insurance and financial assistance support.

To talk to one of our Support Coordinators, patients can call 1-800-456-2255. They can be reached Monday through Friday from 8:30 AM until 8 PM ET.

NURSE EDUCATORS

Whether your patients are just starting therapy or have been on therapy for a while, Nurse Educators are there to provide additional support to you and your patients and to respond to questions they may have. Nurse Educators are available by phone 24 hours a day, 7 days a week, regardless of which Biogen relapsing MS treatment your patients take. They can be reached by calling 1-800-456-2255. Although they can be a great resource for patients, please keep in mind that you are always their primary resource when it comes to their MS and their treatment.

PEER COMMUNITY

For people living with MS, it can be helpful to find and talk to someone who knows what it’s like to live with MS. Our Peer Community connects people with MS so that they can share their personal experiences and help each other stay positive and motivated.

INSURANCE AND FINANCIAL ASSISTANCE SUPPORT

Biogen wants to be sure that you choose the therapy that’s right for your patients and their fight against relapsing multiple sclerosis (MS), and that they have options regarding their financial situation. The Above MS™ program from Biogen helps patients understand their insurance coverage, and if financial assistance is needed, tries to identify the best financial assistance solution for them. Insurance and financial assistance services also include insurance counseling, benefit investigation, Prior Authorization assistance,* and our $0 Copay Program.*

*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 that they can receive over one year. 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. Patients are eligible to enroll in the $0 Copay Program for as long as they are treated with a Biogen relapsing MS medication.

$0 COPAY PROGRAM

With the $0 Copay Program* from Biogen, your patients pay $0 a month for their relapsing MS medication if eligible.

The $0 Copay Program has:

  • No income requirements*—eligible patients can enroll in the $0 Copay Program regardless of income
  • No time limit—your patients can re-enroll every year for as long as they’re taking the medication
  • No waiting—your patients’ specialty pharmacies can enroll them immediately into the program so they can get their relapsing MS medication right away

*$0 Copay details and eligibility:

  • Please note that the $0 Copay Program provides a monthly supply of relapsing MS medication. Your patients are eligible to enroll in the $0 Copay Program for as long as they are treated with a Biogen relapsing MS medication
  • 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 your patients are not eligible or not sure of their eligibility, they should call 1-800-456-2255. There are charitable programs and even a free drug program sponsored by Biogen that may be able to help your patients with the cost
  • Depending on your 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 that your patients can receive during a year

LEADING ACCESS

TECFIDERA® has preferred formulary coverage by many of the country's top insurance providers for your patients with relapsing MS with no step-therapy restrictions. It is therefore available for treatment-naive patients, as well as patients converting from another product.

Formulary access
for TECFIDERA
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If your patients have any questions or want to learn more, they can call 1-800-456-2255, Monday to Friday, 8:30 AM to 8 PM ET, or visit AboveMS.com.

Indication

Tecfidera® (dimethyl fumarate) is indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Important Safety Information

TECFIDERA is contraindicated in patients with known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. TECFIDERA can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Patients experiencing signs and symptoms of anaphylaxis and angioedema (which have included difficulty breathing, urticaria, and swelling of the throat and tongue) should discontinue TECFIDERA and seek immediate medical care.

Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with TECFIDERA. PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. A fatal case of PML occurred in a patient who received TECFIDERA in a clinical trial. PML has also occurred in the postmarketing setting in the presence of lymphopenia (<0.8x109/L) persisting for more than 6 months. While the role of lymphopenia in these cases is uncertain, the majority of cases occurred in patients with lymphocyte counts <0.5x109/L. The symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. At the first sign or symptom suggestive of PML, withhold TECFIDERA and perform an appropriate diagnostic evaluation. MRI findings may be apparent before clinical signs or symptoms.

TECFIDERA may decrease lymphocyte counts; in clinical trials there was a mean decrease of ~30% in lymphocyte counts during the first year which then remained stable. Four weeks after stopping TECFIDERA, mean lymphocyte counts increased but not to baseline. Six percent of TECFIDERA patients and <1% of placebo patients had lymphocyte counts <0.5x109/L. TECFIDERA has not been studied in patients with pre-existing low lymphocyte counts.

There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x109/L or 0.5x109/L in controlled trials, although one patient in an extension study developed PML in the setting of prolonged lymphopenia (lymphocyte counts predominantly <0.5x109/L for 3.5 years). In controlled and uncontrolled clinical trials, 2% of patients experienced lymphocyte counts <0.5x109/L for at least six months. In these patients, the majority of lymphocyte counts remained <0.5x109/L with continued therapy. A complete blood count including lymphocyte count should be obtained before initiating treatment, 6 months after starting, every 6 to 12 months thereafter and as clinically indicated. Consider treatment interruption if lymphocyte counts <0.5x109/L persist for more than six months and follow lymphocyte counts until lymphopenia is resolved. Consider withholding treatment in patients with serious infections until resolved. Decisions about whether or not to restart TECFIDERA should be based on clinical circumstances.

Clinically significant cases of liver injury have been reported in patients treated with TECFIDERA in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed. These abnormalities resolved upon treatment discontinuation. Some cases required hospitalization. None of the reported cases resulted in liver failure, liver transplant, or death. However, the combination of new serum aminotransferase elevations with increased levels of bilirubin caused by drug-induced hepatocellular injury is an important predictor of serious liver injury that may lead to acute liver failure, liver transplant, or death in some patients.

Elevations of hepatic transaminases (most no greater than 3 times the upper limit of normal) were observed during controlled trials.

Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating TECFIDERA and during treatment, as clinically indicated. Discontinue TECFIDERA if clinically significant liver injury induced by TECFIDERA is suspected.

TECFIDERA may cause flushing (e.g. warmth, redness, itching, and/or burning sensation). 40% of patients taking TECFIDERA reported flushing, which was mostly mild to moderate in severity. Three percent of patients discontinued TECFIDERA for flushing and <1% had serious flushing events that led to hospitalization. Taking TECFIDERA with food may reduce flushing. Alternatively, administration of non-enteric coated aspirin prior to dosing may reduce the incidence or severity of flushing.

TECFIDERA may cause gastrointestinal (GI) events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). Four percent of TECFIDERA patients and <1% of placebo patients discontinued due to GI events. The incidence of serious GI events was 1%. The most common adverse reactions associated with TECFIDERA versus placebo are flushing (40% vs 6%) and GI events: abdominal pain (18% vs 10%), diarrhea (14% vs 11%), nausea (12% vs 9%).

A transient increase in mean eosinophil counts was seen during the first two months.

TECFIDERA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Encourage patients who become pregnant while taking TECFIDERA to enroll in the TECFIDERA pregnancy registry by calling 1-866-810-1462 or visiting www.TECFIDERApregnancyregistry.com.

Please see full Prescribing Information and Patient Information for additional Important Safety Information.