VITAL Program Launched to Educate Healthcare Providers and Patients On Administration of Subcutaneous Immunoglobulin Therapy

VITAL Program Launched to Educate Healthcare Providers and Patients On Administration of Subcutaneous Immunoglobulin Therapy
April 13, 2007 - 1:54 PM

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KING OF PRUSSIA, Pa., April 11 /PRNewswire-FirstCall/ -- CSL Behring, a worldwide leader in developing subcutaneous immunoglobulin therapies, announced today the launch of a new program to educate healthcare providers and primary immunodeficiency (PI) patients on the proper technique for administering subcutaneous immunoglobulin therapy. The program, named VITAL(TM), an acronym for Vivaglobin Integrated Training And Learning, is being introduced to support the at-home use of Vivaglobin(R) (Immune Globulin Subcutaneous, Human), the first and only U.S. Food and Drug Administration- approved subcutaneous immunoglobulin (Ig) for treatment of patients with primary immunodeficiency. Vivaglobin was approved by the FDA on January 9, 2006.


Until recently, PI patients needed to schedule appointments with a hospital, physician or homecare company to receive intravenous immunoglobulin treatment. With the approval of Vivaglobin, a subcutaneous form of immunoglobulin, PI patients can now self-administer the treatment at home, given the approval of their physician. This new convenient treatment option will require education to teach patients how to properly manage their own therapy.


Through VITAL, CSL Behring offers nurses and physicians various tools and programs to assist them in teaching patients how to self-administer Vivaglobin at home.


"One of CSL Behring's most important goals is to extend professional support and know-how well beyond the point of bringing high quality therapies to patients," said Robert Lefebvre, general manager and vice president of U.S. Commercial Operations at CSL Behring. "We continually seek ways to ensure that consumers who choose our products understand how best to use them. The VITAL program is an excellent example of that commitment."


All patients who start on Vivaglobin receive a patient starter kit to help manage their therapy. The kit includes helpful tools, such as administration guides, product information and a treatment journal.


Specialty pharmacies contracted to dispense Vivaglobin will provide patient training, as well as the drug, infusion pump, needles, tubing and any other supplies needed for treatment. Generally, the average patient requires approximately 4 or 5 educational sessions with a nurse before beginning self- administration independently.


Healthcare providers interested in requesting the VITAL educational program or related materials can access them through the Web site at www.Vivaglobin.com.


About Vivaglobin


Vivaglobin is delivered directly under the skin via a small portable pump. In clinical trials, Vivaglobin was shown to be a safe and effective immunoglobulin replacement therapy for treating patients with PI. The trials also assessed patients for health-related quality of life through at-home self-administration and reported increases in general health with patients expressing a preference for SC administration over IV administration.


Vivaglobin is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents including viruses and - theoretically, the Creutzfeldt-Jakob disease (CJD) agent - cannot be eliminated completely.


The most frequent adverse event reported in clinical trials was injection- site reaction, consisting of mild or moderate swelling, redness and itching. No serious local site reactions were observed and reactions tended to decrease substantially after repeated use. Other adverse events included headache, gastrointestinal disorder, fever, nausea, sore throat and rash. Full prescribing information about Vivaglobin is available at www.Vivaglobin.com.


About CSL Behring


CSL Behring is a global leader in the plasma protein biotherapeutics industry. Passionate about improving the quality of patients' lives, CSL Behring manufactures and markets a range of safe and effective plasma-derived and recombinant products and related services. The company's therapies are used in the treatment of immune deficiency disorders, hemophilia, von Willebrand disease, other bleeding disorders and inherited emphysema. Other products are used for the prevention of hemolytic disease of the newborn, in cardiac surgery, organ transplantation and in the treatment of burns. The company also operates one of the world's largest plasma collection networks, ZLB Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit www.CSLBehring.com.


Source: CSL Behring

CONTACT: Sheila A. Burke, Director of Communications & Public Relation
Communications of CSL Behring, +1-610-878-4209, Sheila.Burke@cslbehring.com;
or John Ruane of Ruane Communications, +1-678-585-0176, jbruane@rcipr.com, for
CSL Behring


Web site: http://www.cslbehring.com/
http://www.vivaglobin.com/

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Plasma bank contributes $1.2 million to local economy

Web-posted Thursday, January 25, 2007
Spin doctors


Plasma bank contributes $1.2 million to local economy

By Jim McBride
jim.mcbride@amarillo.com


Donors pack the lobby at Biomat USA's plasma donor center almost daily in Amarillo, waiting to trade their blood plasma for a few dollars.

Biomat is a subsidiary of Grifols, a Spanish holding company specializing in the hospital and pharmaceutical industries. It collects blood plasma from donors at its Amarillo facility at 520 S.W. 10th Ave.

Spokesman Chris Healey said Biomat relies on repeat donors who provide blood plasma and carefully tracks them to make sure its blood products are safe.

If a donor comes in only once and doesn't come in for another appointment, that donor's plasma is tossed out.

"These people who donate plasma and who work at the centers are life-saving, life-changing."

Kathy Antilla, director of education for the Immune Deficiency Foundation
"We don't pay for their plasma. We compensate them for the time they spend in our facility. If they are donating plasma on a regular basis, we compensate them for that time," he said.

Biomat's plasma donors must fill out a detailed form and answer a series of questions about their health and personal history. They also must have a physical exam, follow special dietary regimens and comply with other instructions before they can donate.

Most donations take about 45 minutes. A staffer inserts a needle into the donor's arm, which is hooked up to sterile, disposable tubing and a centrifuge.

"It will take out a volume of roughly a coffee cup of the blood, spin it down, we collect what we want and it returns the red blood cells through the same needle line back to the individual, pulls it out again, separates and does that process until we accumulate the weight that we need," said Facility Manager Gordon Woods Jr.

The center has about 25 employees and pumps about $1.2 million a year in donor fees, taxes and employee salaries into the Amarillo economy, Woods said.

Biomat USA facilities nationwide generate about 1.5 million liters of plasma every year, enough to fill nearly two Olympic-size swimming pools.

The plasma can be turned into several products.

Biomat also tests donations for viruses and other impurities before its products are frozen and shipped to anywhere from California to Spain.

"The donor is actually paid cash at the end of their donation for their time. It's very simple, quick, and we have the purity and the safety to follow it up and make sure that that product that's going into another human being is the best on the market," he said.

A donor can give plasma up to twice a week and can earn up to $240 a month.

Healey said paying people to donate ensures they come back and gives them an incentive to remain healthy.

It also helps keep adequate blood products in supply.

"If there weren't compensated donors, there wouldn't be enough plasma therapies for sick people who need them," he said.

Human plasma is used to make life-saving medicines to treat rare diseases, such as hemophilia, primary immune deficiencies, genetic emphysema and shock, trauma or burns.

A major plasma product is known as IVIG, or intravenous immune globulin. It's a blood product that helps patients with immune deficiencies.

"That product is extracted from the plasma that we collect at the plasma centers like the one in Amarillo. It's one of the main medicines we take out of the plasma," Healey said. "Without this medicine, patients get sick; they get all kinds of infections, and they can die."

Kathy Antilla, director of education for the Immune Deficiency Foundation in Maryland, said plasma products that come from facilities like Biomat in Amarillo help patients whose bodies cannot make antibodies needed to fight off disease.

Antilla said her son, now 15, first began receiving intravenous plasma products about 10 years ago. He receives an intravenous infusion of plasma about every two weeks that replaces certain blood cells and gives him the antibodies he needs.

"As parents, we saw the change in him from the first infusion. All of a sudden he stopped coughing all night long, stopped vomiting when he ran, and there was a sparkle in his eye," she said. "These people who donate plasma and who work at the centers are life-saving, life-changing."

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IDF Survey Helps Persuade CMS to Temporarily Stop Reductions for IVIG Medicare Payments

40 W. CHESAPEAKE AVENUE
SUITE 308
TOWSON, MD 21204
410.321.6647
1.800.296.4433
FAX 410.321.9165
www.primaryimmune.org idf@primaryimmune.org
FOR
IMMEDIATE
RELEASE
November 1, 2006
IDF Survey Helps Persuade CMS to Temporarily Stop Reductions for
IVIG Medicare Payments
TOWSON, MDThe Immune Deficiency Foundation (IDF) patient survey helped persuade the Centers for Medicare
and Medicaid Services (CMS) to issue final rules that grant a critical reprieve for patients with primary immune
deficiency diseases (PIDD). On November 1, CMS issued a ruling that will continue the temporary
"preadministration-related services" add-on for IVIG in 2007 for both physician services and hospital outpatient
department (OPD) reimbursements for IVIG. CMS had established this additional payment for IVIG in 2006 to
compensate physicians and hospital OPDs for extra resources needed for locating and obtaining appropriate IVIG
products. It was also used for scheduling patient infusions during a period "where there may be temporary instability."
CMS also withdrew another separate proposal to reduce Medicare's payment for IVIG in the hospital OPD setting.

In its final rules, CMS cited the IDF patient survey as offering evidence of the hardships that many PIDD patients have
had to deal with because of reductions in Medicare payments for IVIG. Some of the findings from the survey include
patients reporting that they have had to change the site of their infusions, postpone infusions, increase intervals
between infusions, and reduce dosage of IVIG as the result of changes in Medicare reimbursement methodology for
IVIG.

IDF wishes to thank the over one thousand PIDD patients who took the time to respond to our survey this year. We
believe that the survey's results made the difference in providing hard, empirical data that CMS needed to withdraw its
proposed reductions. IDF also acknowledges the hundreds of patients and family members from the PIDD community
who have contacted their Members of Congress about this critical issue through our online advocacy program, Action
Alert. These personal contacts and our patient survey demonstrate that an individual's input can make a difference on
policy making in Washington.

While this reprieve from reductions is vital to patients with PIDD, IDF does not believe that it goes far enough to bring
stability for Medicare beneficiaries. We are taking the same patient survey findings to Congressional Committees and
Members of Congress to show them the kinds of dislocations Medicare IVIG users are experiencing as a result of
changes in reimbursement policies enacted in 2003. We believe that a permanent adjustment needs to be made in the
way Medicare pays for IVIG to assure access to care and choice of provider. Congress may need to take legislative
action to make sure this happens.

We celebrate this temporary reprieve for the PIDD community, but recognize that it is not a time to become
complacent. IDF urges all of you to again visit our Web site and make your voice heard. Log on to IDF Action Alert
at
www.primaryimmune.org
to contact your Members of Congress and let them know how important access to IVIG is
to your health.
# # #

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