May 19, 2008
Medicare Nears OK of Cancer Drug Payment Guide
That Doesn't Reveal Conflicts of Interest
Medicare's top officials as early as this morning may sign off on adding three additional drug compendia that can be used to justify reimbursement for the off-label use of anti-cancer drugs, including one that clearly violates the agency’s guidelines on conflict-of-interest disclosure.
The non-profit National Comprehensive Cancer Network’s Drugs and Biologics Compendium, drawn from its trademarked Clinical Practice Guidelines, fails to disclose the corporate ties of the 20 to 24 experts who sit on each of its 44 guideline-writing panels. Instead, it merely lists all the companies which gave money or research support to any of the committee members without reference to any specific member or the amount given.
Oncologists who administer cancer chemotherapy drugs to their patients in offices or free-standing facilities receive reimbursement for those drugs plus a small profit under Medicare's Part B program. Reimbursable drugs include those prescribed off-label as long as they are listed in compendia officially designated by the Center for Medicare and Medicaid Services, Medicare's parent agency. Most private insurers follow Medicare's lead when setting their cancer drugs reimbursement policy.
In 2006, the Medicare Evidence Development and Coverage Advisory Committee recommended that any new compendia approved by CMS carry public identification of “potential conflicts of interest of the compendia’s parent and sibling organizations, reviewers, and committee members.”
The NCCN Clinical Practice Guidelines and Compendium, published by a consortium of 21 of the nation’s leading cancer treatment centers, follow the same non-disclosure disclosure policy as the American Society of Clinical Oncology, which holds its high-profile annual meeting in Chicago starting May 30. Companies financially involved with any of the researchers behind any of the hundreds of studies released at the meeting are listed on the disclosure form. But the disclosure does not reveal which company gave money to which researcher or how much.
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. The Elsevier publication relies on in-house scientist-writers who are prohibited from accepting any “gifts or benefits” from the drug industry. Thomson uses outside experts supervised by its Oncology Advisory Board, many of whom have ties to industry that are disclosed on the company’s website. For instance, Thomas Marsland, a Florida community oncologist who chairs the advisory board, reports owning stock in Genentech, maker of the anti-cancer drug Avastin.
But the NCCN website does not disclose that Robert J. Motzer, an investigator at Memorial Sloan-Kettering Cancer Center in New York who chairs the NCCN kidney cancer guideline writing committee committee (registration required), receives research support from Genentech. The NCCN Compendium listing for Avastin (generic name: bevacizumab) was recently updated to include its use in slowing tumor progression in kidney cancer. The Food and Drug Administration has not approved it for that indication and it has not been shown to prolong life. Avastin, which blocks blood vessel formation, can cost cost as much as $8,800 a month.
All three compendia received a scathing 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. An estimated 60 percent of anti-cancer drugs are used off-label. “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 scored for failing to discuss adverse effects.
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.” It had a $15.5 million budget in 2005. It lists 25 drug company supporters on its website, but not the amounts given.
The drug industry’s financial role in the NCCN program drew a heated response from Thomas Kaye, senior pharmacy director at Passport Health Plan, which serves 155,000 Medicare and Medicaid beneficiaries in Kentucky. “There’s an inherent bias in an organization that gets the majority of its funding from pharma,” the Louisville-based pharmacist said.
“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," he said. "I would not like to see NCCN become an official compendium because of possible bias.”
The consulting firm IMS Health projects global sales of anti-cancer drugs will grow at an annual rate of 12 to 15 percent to $75 to $80 billion by 2012. A number of recent news stories have focused on cancer patients who are having problems affording the co-pays on their increasingly pricey chemotherapy regimens. NCCN CEO William McGivney was traveling last week and unavailable for comment.
This story first appeared in Integrity in Science Watch, a publication of the Center for Science in the Public Interest.
Posted by gooznews at May 19, 2008 09:05 AMI find the Medicare Demonstration Project in Oncology that entails reimbursement to oncologists who report whether their treatment of patients adheres to recommendations in nationally recognized practice guidelines published by either NCCN or ASCO disingenuous. Protecting the status of treatments which are only marginally, minimally and inconsistently effective, prevents serendipitous and fortuitous discovery.
Sometimes I question an occasional guideline message on the basis of profit conflicts. Specialty medical societies work to insure their specialist members get reimbursement for common procedures/treatments, the drug industry works to produce evidence statements that promote use of their brands. I am not comfortable that many clinical trials are unobjective and balanced.
How long would a drug company pay researchers who continued to disappoint with poor drug efficacy trial results? And we know that poor outcomes in drug trials are often not reported to the FDA or the public.
I just love the way medical journals and medical education companies simply list the faculty physicians/authors with their pharmaceutical payment (conflict) history, like this makes every little statement authored, squeaky clean.
If so-called respectible Journals won't publish articles because they have a lock-up on information, don't lay blame on me for my thoughts. The use of clinical trials to establish prescribing guidelines for evidence-based medicine is highly criticized because such trials have little relevance for the individual patient in the real world, the individuality and uniqueness of each patient.
According to the chair of the Community Oncology Alliance's QSP Committee, ASCO has technology assessments that are very limited and updates which are not timely, and NCCN guidelines are fine but many practices use other guidelines or develop evidence-based treatment guidelines for their own individual practices or modify guidelines based on evidence which they use as their defined evidence-based standards for their practices.
It's a lousy system in cancer medicine. The best reform to the system is to totally remove the profit incentive from chemotherapy administration. Take medical oncologists out of the retail pharmacy business and force them to be doctors again. Continuing to do so is egregiously poor scholarship and an egregious disservice to cancer patients.
Posted by: Gregory D. Pawelski at May 19, 2008 10:45 AMInteresting article and comment. I have mixed feelings. I have a friend who says that oncologists are now paid to be drug dealers ... not an ideal situation. Add to that the fact that most cancer drugs don't help most cancer patients ... again, this is not ideal.
As an advocate, I connect with patients all over the country. I've heard from people who've gotten treatment that has no relationship to data - CDC surveys can confirm that. I recommend that people get a second opinion at cancer centers, in the expectation that the treatment will be driven by data.
Having said all this, I find the NCCN guidelines very helpful. And the current CMS compendia situation is ridiculous. Speaking for myself, I think that the addition of NCCN to the compendia will benefit patients.
Industry money is a reality. If we assume that all industry funding taints research findings or professional recommendations, then I don't know what would be 'pure'. A lot of publicly funded trials also receive supplemental industry funding and/or free drug. Without this support, the research won't happen. I don't think that the solution is cutting out industry funding, especially in the current fiscal environment.
Instead, I'd like to see an open discussion of this topic between industry, journals, NCI, FDA, CMS, advocates, professional associations and academia - a discussion that results in meaningful disclosure guidelines that will allow patients and doctors to assess potential conflict of interest. I have been told that current guidelines are sufficient, and I disagree.