Medicare is nearing approval of three additional drug compendia that can be used to justify reimbursement for off-label use of cancer drugs, including one that violates agency guidelines on conflict-of-interest disclosure, according toIntegrity in Science Watch.
The National Comprehensive Cancer Network’s Drugs and Biologics Compendium, which is drawn from its Clinical Practice Guidelines, fails to disclose corporate ties of the 20 to 24 experts who sit on its 44 guideline-writing panels. Instead, it lists all the companies which gave money or research support to any committee member without listing any specific member or the amount given, ISW writes.
In 2006, the Medicare Evidence Development and Coverage Advisory Committee recommended that any new compendia approved by the Center for Medicare and Medicaid Services carry public identification of “potential conflicts of interest of the compendia’s parent and sibling organizations, reviewers, and committee members,” ISW continues.
The NCCN website doesn't disclose that Robert Motzer, an investigator at Memorial Sloan-Kettering Cancer Center who chairs the NCCN kidney cancer guideline writing committee committee, receives research support from Genentech, according to ISW. The NCCN Compendium listing for Genentech's Avastin was recently updated to include its use in slowing tumor progression in kidney cancer, although the med wasn't approved by the FDA for that indication.
In addition to the NCCN drug registry, CMS early next month may approve Elsevier’s Clinical Pharmacology and Thomson Healthcare’s DrugDex and its companion DrugPoints, ISW writes. The Elsevier publication relies on in-house scientist-writers who are prohibited from accepting any “gifts or benefits” from drugmakers.
Thomson uses outside experts supervised by its oncology advisory board, many of whom have ties to industry that are disclosed on its web site, ISW writes, citing Thomas Marsland, a Florida community oncologist who chairs the advisory board and reports owning stock in Genentech, as an example.
All three compendia received a critical review from the Agency for Healthcare Research and Quality’s technology assessment program, which analyzed the compendia's reviews of 14 on- and off-label indications for commonly used anti-cancer drugs.
“Compendia claim to use evidence-based methods in their evaluation of therapeutic agents, (but) cited literature was often neither the most recent nor the most valid in terms of study design,” the reviewers noted. DrugDex was more likely than the others to list off-label indications, while the NCCN compendium was chastised for failing to discuss adverse effects.
“There’s an inherent bias in an organization that gets the majority of its funding from pharma,” Thomas Kaye, senior pharmacy director at Passport Health Plan in Kentucky, tells ISW. “Negative things do not get published. We deal a lot with access to care issues, and when we have limited dollars, we want to make sure we’re providing the most value for what we have. I would not like to see NCCN become an official compendium because of possible bias.”
NCCN, a free-standing non-profit created by prestigious medical centers like Sloan-Kettering, M.D. Anderson Cancer Center in Houston, and the Fred Hutchinson Cancer Research Center in Seattle, acknowledged “support from many companies.” Its web site lists 25 drug company supporters, but not the amounts given. NCCN ceo William McGivney was unavailable for comment, ISW writes.
The NCCN Clinical Practice Guidelines and Compendium, which is published by a consortium of 21 leading cancer treatment centers, follows the same policy as the American Society of Clinical Oncology. The ASCO disclosure form lists companies providing funding to researchers, but doesn't say which companies gave how much money to which researcher, ISW notes.