October 15, 2008
Talecris Biotherapeutics Helps Patients Receive Gamunex(R) During Lapses in Private Insurance Coverage
Under a new program introduced by Talecris Biotherapeutics, patients who regularly use Gamunex (Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified) may be able to receive continuing treatment in the event of a lapse in private insurance coverage.
Gamunex is an immunoglobulin intravenous (IGIV) therapy that contains antibodies purified from the donated blood plasma of thousands of people. Gamunex is indicated as replacement therapy of primary humoral immunodeficiency disease (PI), and as immunomodulatory therapy for both idiopathic thrombocytopenic purpura (ITP) and chronic inflammatory demyelinating polyneuropathy (CIDP).
People with PI require IGIV on a regular basis to maintain their fragile balance of immunity. Without regular treatments, which can be disrupted in the often complex and challenging health insurance environment, PI patients can suffer from serious infections and illnesses.
For this reason, Talecris developed the Gamunex Connexions Certificate Program, to help ensure that patients can temporarily continue to receive their therapy during times of uncertainty.
The Gamunex Connexions Certificate Program was designed as a service to patients with PI or ITP who may be affected by a temporary lapse in their private health insurance. A lapse in insurance may occur as a result of a change in employment, place of residence, or other changes.
"The Gamunex Connexions Certificate Program demonstrates the commitment of Talecris to the needs of patients who rely on Gamunex," said Marcia Boyle, founder and president of the Immune Deficiency Foundation (IDF), the national patient organization dedicated to improving the diagnosis, treatment and quality of life of persons with primary immunodeficiency diseases. "One of our biggest concerns is that patients have access to their life-saving therapy and this program ensures that even when health insurance has lapsed, patients can still get their product."
Fred Modell, co-founder of the Jeffrey Modell Foundation (JMF), said, "For patients with primary immunodeficiency, early diagnosis and continuous treatment are critical to avoid infection and illness. This program may provide an added measure of security for patients who take Gamunex."
To qualify for the Gamunex Connexions Certificate Program, a patient must have third-party, private health insurance as their primary health insurance and be using Gamunex regularly for PI or ITP.
A patient with PI or ITP who enrolls and is accepted into the program can earn one certificate for every four months of documented continuous usage of Gamunex. If the patient experiences a lapse in private insurance coverage, the patient or caregiver can redeem each certificate for a one-month supply of the patient's current dose of Gamunex, subject to certain limits.
Patients who are eligible to participate will also receive milestone awards over time. Full details about the program are available by calling 1-888-263-8243.
Participation in the program is voluntary and free. Participation or non-participation has no bearing on a patient's routine access to Gamunex therapy. Only in the event of a lapse in insurance coverage do participating patients gain the benefit of redeeming the certificates they have earned.
On September 12, 2008, the U.S. Food and Drug Administration (FDA) approved Gamunex for the treatment of a neurological condition, chronic inflammatory demyelinating polyneuropathy (CIDP), to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse. Talecris is currently in the process of evaluating whether the certificate program can be expanded to this patient population.
Talecris is committed to the patient communities who rely on its products and to the healthcare professionals who treat those patients. To further ensure the reliable supply and safety of its products, Talecris continues to invest substantially in a network of plasma collection centers, known as Talecris Plasma Resources, Inc. (TPR).
Gamunex is an IGIV therapy that contains antibodies purified from the donated blood plasma of thousands of people. Gamunex is indicated as replacement therapy of primary humoral immunodeficiency disease (PI), and as immunomodulatory therapy for both idiopathic thrombocytopenic purpura (ITP) and chronic inflammatory demyelinating polyneuropathy (CIDP).
Important Safety Information
Gamunex is contraindicated in individuals with known anaphylactic or severe systemic response to Immune Globulin (Human). Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients should be instructed to immediately report symptoms of decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath (which may suggest kidney damage) to their physicians. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Gamunex does not contain sucrose. Glycine, a natural amino acid, is used as a stabilizer.
There have been reports of noncardiogenic pulmonary edema, rare reports of hemolytic anemia, and very rare reports of aseptic meningitis in patients administered with IGIV. Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. The most common side effects noted during clinical trials included headache, vomiting, fever, nausea, rash, and back pain. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated.
For additional information about Gamunex, please see www.gamunex.com for Full Prescribing Information. The package insert is currently being revised to incorporate the CIDP indication and supporting information.
About Talecris Biotherapeutics: Inspiration. Dedication. Innovation.
Talecris Biotherapeutics is a global biotherapeutic and biotechnology company that discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, neurology, pulmonology, and hemostasis. Talecris is proudly building upon a 60-year legacy of innovation and a commitment to improving the lives of people who rely on its therapeutic products. With an emphasis on scientific inquiry and technological excellence, Talecris is expanding its current portfolio of products, programs, and services through its own world-class product development organization as well as through strategic initiatives that leverage its strengths with those of its partners.
Talecris, with revenues of approximately $1.2 billion in 2007, is headquartered in biotech hub Research Triangle Park, N.C., and employs more than 4,500 talented people worldwide.
To learn more about Talecris and how its employees are making a difference in the lives of patients and the healthcare community, visit www.talecris.com.