Biotechnology Healthcare - June 2008 - (Page 22) Translating Cancer Trial Endpoints Into the Language of Managed Care Oncology endpoints are an essential component of cancer trials, but often they are confusing, making it difficult to evaluate cancer therapies based on trial data. As more oncology agents hit the market and as indications expand for existing products, familiarity with these endpoints is critical for payers when making coverage decisions. BY ALLAN JAY KOGAN, MD, AND MELINDA HAREN, RN ayer management of oncology is in flux, as evolving Medicare coverage and payment initiatives continue to provide private health plans with potential new direction in managing the cost of cancer treatments. These changes are taking place against a background of new oncologic product introductions, rapid expansions of indications for existing therapies, and controversies over reimbursement methodologies. Management of and payment for oncologic agents is further complicated by the lack of data examining the impact of reimbursement policies on oncology outcomes. As payers seek to keep pace with groundbreaking changes in the oncology arena, it is critical that they have a solid understanding of how oncology clinical trial endpoints can or should be used to guide decisions about the care that patients receive. This article explains the most commonly used endpoints in cancer trials, and summarizes the U.S. Food and Drug Administration’s assessment of their clinical utility and applicability to review by payers. Allan Jay Kogan, MD, is vice president and regional medical director for Great-West Healthcare, in Dallas. Great-West is a Cigna company. Melinda Haren, RN, is director of business content for The Zitter Group, in Millburn, N.J. Pete Lacker P When determining coverage policies, payers would do well to seek input from experts who can interpret the significance of oncology clinical trial data, says co-author Allan Jay Kogan, MD, medical director of Great-West Healthcare, a national MCO. Only then, he says, can decisions be made that meet the needs of all stakeholders. 22 BIOTECHNOLOGY HEALTHCARE · MAY/JUNE 2008
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