MDS Nordion's TheraSphere(R) for Unresectable Liver Cancer (HCC) Now Covered
by Two Large U.S. Insurers
Health Insurance Companies Amend Policy on Radioembolization Coverage
These changes in policy mark the largest such favorable determinations for reimbursement coverage of radioembolization for liver cancer treatment by U.S. insurers. Medicare and many other commercial insurance carriers also reimburse TheraSphere when medically necessary.
"The decisions by these two large insurers underline the growing acceptance of the role that radioembolization, which includes the use of TheraSphere, plays in the treatment of certain types of liver cancer patients," said
Radioembolization refers to a process by which small beads or microspheres, containing the radioactive element yttrium-90, are delivered directly to the tumor using the tumor's own blood supply. TheraSphere is one form of radioembolization. Another name for this type of treatment is selective internal radiation therapy (SIRT).
"Radioembolization can offer options to patients who are not eligible for surgery," said
About 22,600 cases of primary liver cancer are diagnosed each year in the U.S., according to the American Cancer Society. About 1 million cases are diagnosed each year globally. The most common form of primary liver cancer is hepatocellular carcinoma (HCC), which in the U.S. is commonly caused by alcohol abuse or by the hepatitis B or hepatitis C virus. HCC is the fifth most common form of cancer in the world and is increasing globally due to an increase in the incidence of hepatitis.
Treatment options for patients with primary liver cancer are limited. HCC is usually unresectable, meaning that it cannot be surgically removed. Unlike TheraSphere, many of the treatments offered for unresectable HCC require inpatient hospitalization and also produce strong side effects that can reduce a patient's quality of life.
"I'm so pleased there will now be major private insurance coverage for TheraSphere," said
TheraSphere is typically an outpatient procedure that does not require inpatient hospitalization. It is also well tolerated by patients, with side-effects that are normally milder than with many other treatments for unresectable HCC. Because the procedure is directed to the tumor, there is minimal injury to non-targeted tissue. After treatment, most TheraSphere patients are eligible for further therapeutic options because the procedure preserves liver vascularity.
About TheraSphere(R)
TheraSphere is a low toxicity, liver cancer therapy that consists of millions of micro-glass beads containing radioactive yttrium-90. The product is injected by physicians into the main artery of the patient's liver through a catheter, which allows the treatment to be delivered directly to the tumor via blood vessels. The TheraSphere treatment can generally be administered on an outpatient basis and does not usually require an overnight hospital stay. TheraSphere, 100% reimbursed by Medicare and many commercial health insurers, is authorized in the U.S. as a Humanitarian Use Device for the treatment of hepatocellular carcinoma, also referred to as primary liver cancer, and is further authorized for patients who also have partial or branch portal vein thrombosis and who are identified as suitable candidates by their physicians. Humanitarian Use Device approvals are based on demonstrated safety and probable clinical benefit, however, effectiveness in the indication has not been established.
TheraSphere treatment has some common side effects, including mild to moderate fatigue, pain and nausea for about a week. Physicians describe these symptoms as similar to those of the common flu. Some patients will experience some loss of appetite and temporary changes in several blood tests. For details on rare or more severe side effects, please refer to the TheraSphere package insert at www.mdsnordion.com/TheraSphere.
About MDS Nordion
MDS Nordion, a business unit of MDS Inc., is a global leader in providing products and services for medical imaging and radiotherapeutics, and sterilization technologies for the prevention, diagnosis and treatment of disease. MDS Nordion's products and services are used on a daily basis by pharmaceutical and biotechnology companies, medical-device manufacturers, hospitals, clinics and research laboratories and benefit the lives of millions of people in more than 70 countries around the world. Find out more at www.mdsnordion.com.
About MDS
MDS Inc. (TSX: MDS; NYSE: MDZ) is a global life sciences company that provides market-leading products and services that our customers need for the development of drugs, and the diagnosis and treatment of disease. We are a leading global provider of innovative technologies for use in medical imaging and radiotherapeutics, sterilization, and pharmaceutical contract research. MDS has more than 2,400 highly skilled people in nine countries. Find out more at www.mdsinc.com or by calling 1-888-MDS-7222, 24 hours a day.
For further information: Media: Shelley Maclean, (613) 592-3400, ext. 2414, [email protected]; Investors: Catherine Love, (905) 267-4230, [email protected]
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