Drug Compendia in Oncology: Are They Flawed?

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Recent studies have raised concerns about the reliability of four compendia currently used by Medicare and other payers to help determine which cancer drugs will be covered for which off-label indications. Now, experts are looking for ways to improve the compendia, even as oncologists debate their usefulness to guide treatment decisions.

The studies, a series of reports funded by the Centers for Medicare and Medicaid Services (CMS) and conducted by the Agency for Healthcare Research and Quality (AHRQ), have found that the current compendia lack transparency, cite little current evidence, lack systematic methods to review and update evidence, and are replete with conflict-of-interest issues.

The findings would seem to matter. Up to 75% of all uses of cancer therapies are off label, according to a 2005 estimate by the National Comprehensive Cancer Network (NCCN), whose own compendium was later chosen for use by CMS. Louis B. Jacques, M.D., who directs the division of items and devices coverage and analysis group at CMS, emphasizes that compendia—essentially lists of drugs for certain indications—are not a shorthand for coverage. Nevertheless, reimbursement issues were at least partly behind CMS's decision last year to add more compendia to the one then in use for Medicare decisions ( see sidebar).