CSL Behring announced today the launch of the Berinert® Expert Network (B.E.N.™ ), a full-service support program for healthcare providers and for hereditary angioedema (HAE) patients and their caregivers. HAE is a rare and serious disorder that causes swelling in various parts of the body. In October the U.S. Food and Drug Administration (FDA) granted marketing approval for Berinert C1-Esterase Inhibitor, Human for the treatment of acute abdominal or facial attacks of HAE, a rare and serious genetic disorder, in adult and adolescent patients. The safety and efficacy of Berinert for prophylactic therapy have not been established. Berinert is now available through specialty pharmacies and distributors in the United States.
B.E.N. provides information and assistance designed to help healthcare providers and patients, including:
- Securing access to Berinert - B.E.N. will assist HAE patients in initiating Berinert therapy when and where it is needed by:
- Helping their providers develop treatment plans that are appropriate for the individual patient
- Connecting patients to a specialty pharmacy that has Berinert available
- Identifying the nearest hospital with access to Berinert
- Guaranteeing the availability of one year's supply of Berinert to the first 1,000 patients who opt in to the B.E.N. program
- Comprehensive service and support on insurance and reimbursement - B.E.N. will help patients address such issues and questions as prior authorizations, coverage appeals and letters of medical necessity
- Educational resources and tools - B.E.N. will provide resources to help patients manage their Berinert therapy, including a journal, patient ID card and magnet with key phone numbers
- Assurance and Assistance -- Serving the rare disease communities for years, the CSL Behring Assurance and Assistance Programs, working through B.E.N., will ensure that:
- Patients who experience a lapse in third-party, private health insurance can access Berinert
- Qualified patients who are uninsured, underinsured, or who cannot afford their prescribed therapy can obtain Berinert.
"The Berinert Expert Network is an excellent example of CSL Behring's commitment to going 'above and beyond' for patients and healthcare professionals by offering innovative products and high-quality support programs designed to meet their needs," said Robert Lefebvre, Vice President and General Manager of U.S. Commercial Operations at CSL Behring. "B.E.N. will ensure that individuals in the HAE community, including healthcare providers, patients and their caregivers, have access to Berinert and will have a single point-of-contact to assist with helping them to manage their medical condition."
Until the approval of Berinert, patients with HAE in the U.S. did not have a safe and effective treatment option that rapidly relieved the symptoms of acute attacks in the face and abdomen. In clinical trials, the median time to onset of relief with Berinert was 48 minutes as compared to more than 4 hours with placebo. HAE can be an isolating health condition, but B.E.N will help patients connect with medical experts who can provide much needed information about their condition, and details on Berinert.
In addition, through B.E.N., HAE patients will be able to connect with other patients via the U.S. Hereditary Angioedema Association (HAEA). In this way, patients can benefit from additional valuable programs and resources designed for and by people with HAE.
For more information on B.E.N. 24 hours a day, seven days a week, call toll-free 1-877-BEN-4HAE (1-877-236-4423).
The approval of Berinert was based on the results of the phase II/III prospective, double-blind placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.), which studied the efficacy and safety of C1-inhibitor (C1-INH) concentrate. The safety and efficacy of Berinert for prophylactic therapy have not been established.
HAE is a genetic disorder caused by a deficiency of C1-INH and is inherited in an autosomal dominant manner. Symptoms of HAE include episodes of edema or swelling in the face and the abdomen. Patients who have abdominal attacks of HAE can experience episodes of severe pain, diarrhea, nausea, and vomiting caused by swelling of the intestinal wall. HAE attacks that involve the face can cause painful distortion and painful swelling. Diagnosis of HAE requires a blood test to confirm low or abnormal levels of C1-INH. There are estimates of 6,000 to 10,000 or more people with HAE in the U.S.
The Berinert Expert Network (B.E.N.) is a comprehensive service and support program for healthcare providers, hereditary angioedema (HAE) patients and their caregivers. Berinert C1-Esterase Inhibitor, Human is approved by the FDA for acute abdominal or facial attacks of HAE, a rare and serious genetic disorder, in adult and adolescent patients. For more information on B.E.N. 24 hours a day, seven days a week, call toll-free 1-877-BEN-4HAE (1-877-236-4423)
Berinert, a plasma-derived intravenous therapy, treats acute facial and abdominal hereditary angioedema (HAE) symptoms by providing C1-INH deficient adult and adolescent patients with the missing human protein. Without C1-INH, patients with HAE suffer from recurrent episodes of rapid swelling of areas of the skin and underlying tissues including the face, mouth and abdomen. For more than 30 years, CSL Behring has manufactured and sold the product in Europe under the trade name Berinert P.
Important Safety Information
Berinert is a plasma derived concentrate of C1 Esterase Inhibitor (Human), indicated for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adult and adolescent patients.
The safety and efficacy of Berinert for prophylactic therapy have not been established. Berinert is contraindicated in individuals who have had an anaphylactic or severe systemic reaction to C1-INH preparations. Monitor patients for early signs of allergic or hypersensitivity reactions (including hives, generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis). If hypersensitivity is suspected, immediately discontinue administration and initiate appropriate treatment. Epinephrine should be immediately available for treatment of acute severe hypersensitivity reactions.
Thrombotic events have occurred in patients receiving off-label high doses of Berinert. Monitor patients with known risk factors for thrombotic events.
Berinert is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
The most serious adverse reaction reported in subjects in clinical studies who received Berinert is an increase in the severity of pain associated with HAE. The most common adverse reactions observed in more than 4 percent of subjects after Berinert treatment were headache, abdominal pain, nausea, muscle spasms, pain, diarrhea, and vomiting.
Berinert has not been evaluated in pregnant women or nursing mothers; benefits of treatment should be weighed against potential risks in pregnant women, and Berinert should be given to nursing mothers only if clearly needed. Safety and efficacy of Berinert have not been established in children (ages 0 through 12) or in the geriatric population. For more information, including full prescribing information, visit www.berinert.com
About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufacturers and markets a range of plasma-derived and recombinant therapies worldwide.
CSL Behring therapies are indicated for the treatment of coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies and inherited respiratory disease. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in newborns. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited (ASX: CSL), a biopharmaceutical company headquartered in Melbourne, Australia. For more information, visit www.cslbehring.com.
Sheila A. Burke, Director
Communications & Public Relations