Use and coverage of novel cancer agents in managed care.

Cancer is unique because its management depends on novel therapies to a greater extent than most other diseases. State-of-the-art care requires access to physicians and facilities that specialize in cancer treatment; however, such access may be blocked by the gatekeeper in the managed care setting. One possible solution to this problem lies in the use of specialists to determine access to tertiary care facilities. Managed care facilities also may limit access to the comprehensive drug therapy required by cancer patients, often by restricting off-label drug uses. To solve this problem, criteria should be developed for the use of novel cancer therapies, such as whether off-label uses are supported by major medical compendia or peer-reviewed medical literature. Finally, managed care organizations may deny coverage of state-of-the-art care associated with clinical trials, which may limit the patient's ability to participate in clinical trials. Managed care organizations should cover such costs if they meet certain criteria, such as absence of clearly superior treatment. To provide comprehensive, state-of-the-art care for cancer patients, managed care organizations and oncologists must collaborate and find solutions to their mutual problems.