Therakos, Inc., Announces Expanded Coverage By Medicare For Extracorporeal Photopheresis

Main Category: Medicare / Medicaid / SCHIP
Also Included In: Immune System / Vaccines;  Transplants / Organ Donations;  Blood / Hematology
Article Date: 19 Mar 2007 - 0:00 PDT

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Therakos, Inc., a Johnson & Johnson company, announced today that the Centers for Medicare & Medicaid Services (CMS) has agreed to expand insurance coverage for extracorporeal photopheresis (ECP), a therapy targeting specific cells of the immune system.

In a decision memorandum published in December 2006, CMS determined ECP is "reasonable and necessary for patients with acute cardiac allograft rejection whose disease is refractory to standard immunosuppressive drug treatment and for patients with chronic graft verses host disease (cGvHD) whose disease is refractory to standard immunosuppressive drug treatment." The policy became effective December 19, 2006.

"This is good news and a new option for physicians and their Medicare patients who experience rejection of a heart transplant or cGvHD complications from a bone marrow transplant when standard therapy has failed," said Ingrid Clark Durfy, general manager of Therakos, Inc.

ECP is a therapeutic procedure in which white blood cells are removed from the patient's blood during a leukopheresis procedure and treated with UVADEX (methoxsalen), a photoactivatable drug, and then re-infused into the patient. When exposed to ultraviolet light, the drug becomes activated and destroys diseased white blood cells. ECP is administered with the UVAR® XTS™ Photopheresis System, an automated apheresis-like device usually performed on an outpatient basis over several treatment visits.

Prior to this decision, CMS covered ECP only for palliative treatment of the skin manifestations of Cutaneous T Cell Lymphoma (CTCL) that have not responded to other therapy. Coverage for this indication remains unchanged.

GVHD is a life threatening complication of bone marrow transplantation where donor cells attack the patient's organs and tissue, causing an inflammatory reaction resulting in persistent rash, dry eyes and mouth, hair loss, lung and gastrointestinal disorders and in severe cases, death. Most patients who develop GvHD are effectively treated with immunosuppressive drug therapy. According the International Center for Blood and Marrow Research, of the 14,000 allogeneic transplants conducted world-wide, approximately 50 percent of patients will develop cGvHD.

Refractory acute cardiac transplant rejection occurs when a patient's immune system rejects a transplanted heart. Like cGVHD, most of these cases are effectively treated with immunosuppressive drug therapy. However, this condition can lead to death and other serious complications in patients where the disease is not responsive to standard immunosuppressive therapy. According the International Society for Heart and Lung Transplantation, approximately 3,000 heart transplants are performed annually.

UVADEX in conjunction with the Therakos UVAR®XTS™ Photopheresis system is the only extracorporeal photopheresis system approved by Food and Drug Administration; it is approved by FDA in the palliative treatment of the skin manifestations of Cutaneous T-cell Lymphoma that is unresponsive to other forms of treatment.

Therakos, Inc., a Johnson & Johnson company, focuses on immune cell therapies. Based in Exton, PA, in the United States and Ascot in the United Kingdom, Therakos markets the world's only approved integrated system for Extracorporeal Photopheresis. Therakos is currently conducting multiple sponsored clinical trials of ECP across a wide range of immune mediated inflammatory diseases.

Johnson & Johnson company
http://www.jnj.com/home.htm

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