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For US Healthcare Professionals Only.

The Above MS™ program from Biogen is here for patients with tips, tools, and information for their relapsing multiple sclerosis (MS)—and so much 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 other areas
  • One-on-one relapsing MS support over the phone
  • A community of peers
  • Information about TECFIDERA treatment and support services
  • Access to Nurse Educators
  • Financial and insurance 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

As your patients continue on a relapsing MS therapy as prescribed by you, they may need extra support. For patients taking a Biogen relapsing MS treatment, our Support Coordinators can help them understand and access the resources they may need along their journey with relapsing MS.

The Support Coordinators from Biogen offer a broad range of services:

  • General relapsing MS information
  • One-on-one relapsing MS support over the phone
  • Tips to support living with relapsing MS
  • Insurance Benefit Investigation and researching financial assistance options
  • Recommendations for free educational events in their area that allow your patients to learn from experts and other people living with relapsing MS
  • Follow-up calls as necessary

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

The Above MSTM program from Biogen has Nurse Educators available by phone 24 hours a day, 7 days a week.

Whether your patients are just starting therapy or have been on therapy for a while, Nurse Educators are there to provide additional support for patients and their care partners and answer questions related to relapsing MS and treatment. Along with their doctor, Nurse Educators can offer patients ongoing support throughout therapy.

Nurse Educators 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.

Nurse Educators are available throughout the United States to offer phone counseling 24 hours a day, 7 days a week:

  • Learning to live with relapsing MS is an ongoing process. Along with their doctor, a Nurse Educator can provide additional support regarding your patients’ questions about relapsing MS treatment, common symptoms, and side effects
  • Nurse Educators can provide your patients with support through MS education, help them plan for their next doctor visit, and connect them with the services and support that are available to them. Your patients can call 1-800-456-2255 to connect with a Nurse Educator 24 hours a day, 7 days a week

About Nurse Educators

Nurse Educators are all registered nurses, and many are MS-certified or working toward their MS certification. A Nurse Educator can help your patients by sharing information on the services and support available to them. 

These nurses are available day or night. They are familiar with the challenges your patients may be facing with relapsing MS, as well as how to support them throughout their journey.

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.

FINANCIAL & INSURANCE SUPPORT

Get financial and insurance support for your patients’ relapsing MS treatment. The Above MS™ program from Biogen gives patients access to Support Coordinators who can help them understand their insurance coverage and try to identify the best financial assistance solution for them. Our goal is that no one has to forgo treatment based solely on financial limitations.

Financial and insurance services include:

  • Benefit Investigation to clarify your patients’ coverage options
  • Insurance counseling to help patients understand their coverage, along with help navigating changes due to the healthcare reform law
  • $0 Copay Program with no income requirements and no enrollment time limit for eligible patients.* Patients can call 1-800-456-2255 to see if they’re eligible
  • Free Drug Program for eligible patients in need
  • Support finding assistance through charitable organizations

To learn more about the financial services offered, patients can call one of our Support Coordinators at 1-800-456-2255, Monday through Friday, 8:30 AM to 8 PM ET.

*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.

$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

INSURANCE ASSISTANCE

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.

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.