Covance Study Highlights Continued Need for Off-Label Drug Use in Oncology Practice

Download a printable version at http://www.covance.com/docs/pr091505.pdf.

Gaithersburg, Maryland, — In a recent study conducted by Covance Market Access Services, physicians who want to prescribe off-label drugs for cancer treatment may feel limited by coverage policies, which can delay patient care. These findings were released today at the Association of Community Cancer Centers' 22nd National Oncology Economics Conference in Portland, Oregon.

Oncologists consistently report that off-label use of anti-cancer therapies is essential in helping patients with rare and advanced cancers, according to the study, which was commissioned by Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO) and the Association of Community Cancer Centers (ACCC).

Many oncologists reported that restrictive coverage policies cause them to alter their decisions regarding preferred treatment. Fifteen of 28 oncologists interviewed reported that Medicare non-coverage frequently or very frequently causes them to alter their treatment decisions, while eight reported that private payer policies have this effect.

"It is important to recognize that timely patient access to the full-range of up-to-date and medically appropriate uses of drugs approved for sale in the U.S. can be limited by reimbursement policies promulgated by both public and private insurance programs," said Luis T. Gutierrez, Jr., General Manager of Covance Market Access Services Inc.

"The study was based on a geographically representative sample of oncologists and oncology practice managers, and the findings are directionally consistent with other such studies, including a large 1991 GAO study, which highlighted issues regarding access to off-label use of oncology therapies and a 1998 study reported by the American Cancer Society and the American Enterprise Institute, which reported that 60 percent of oncologists surveyed prescribe drugs for cancer patients for off-label uses," said Thomas Goss, Pharm.D., a vice president with Covance Market Access Services. "Further study is needed to assess the extent to which coverage and reimbursement policy impairs patients' ability to receive off-label anti-cancer therapies."

For its study, Covance researched coverage and reimbursement policies followed by local Medicare carriers and private payers for off-label anti-cancer therapies. Findings revealed that nearly 70 percent of oncologists interviewed think off-label use of cancer treatments is important in optimizing the overall treatment plans for their patients.

Covance Market Access Services Inc., a subsidiary of Covance Inc., offers global reimbursement policy and health economics consulting services that examine issues related to reimbursement policy and patient access to healthcare. Covance Inc., with headquarters in Princeton, New Jersey, is one of the world's largest and most comprehensive drug development services companies with 2004 net revenues of over $1 billion, global operations in 18 countries, and approximately 7,000 employees worldwide. Information on Covance's products and services, recent press releases, and SEC filings can be obtained through the Covance website at http://www.covance.com .