Biotechnology Healthcare - July/August 2008 - (Page 10)

HEALTH PLAN CONFIDENTIAL sources of information for payers to consider. Perhaps not coincidentally, the FDA draft guidance emerged on the heels of the AHRQ report, although it came a full two years after oncologists had made their feelings known. In a 2006 editorial in the Journal of Clinical Oncology, the American Society of Clinical Oncology pressed CMS to identify peer-reviewed journals that have become “significant sources of credible information about medically appropriate off-label uses,” and to recognize those journals as legitimate sources for basing coverage determinations. Otherwise, oncologists may be unwilling to try therapies not listed in the compendia, even if there is compelling evidence in the medical literature for their use. In fact, 54 percent of oncologists interviewed for a survey commissioned by the Biotechnology Industry Organization, Pharmaceutical Research and Manufacturers of America, and the Association of Community Cancer Centers said that noncoverage by Medicare “frequently” or “very frequently” caused them to alter their treatment plans. The resultant quality of care — considering the potential for outdated or incomplete data in a compendium — is unknown. looking at CMS’s national coverage decisions and its fee schedule and, when it makes sense, they will align their policies with those of CMS,” she says. WHAT DO WE WANT? Berg thinks part of the off-label debate goes to the question of what we should expect from drug manufacturers. “We want them to develop new drugs for all sorts of treatments on a regular basis,” she says, but often there are no incentives for drug makers to pursue costly clinical trials to confirm the safety and efficacy of new indications. Extensive off-label use can create a “Why bother?” attitude toward the regulatory pathway. “One big incentive for drug companies to start doing these kinds of studies and getting [FDA] approval will be if insurance companies start saying ‘We will not cover a drug if it is not being used for a technically approved use,’” Berg adds. Part of the problem, she thinks, is that the system is set up to be ineffective. “We have for-profit drug companies, and [so we cannot] say to the drug company, ‘Even though you have obligations to your The end game may stock holders, we want you to do business GOOD REASON wind up being the contrary to that business model.’” Payers, patients, and physicians, of course, have creation of a federal Berg also thinks that society expects good reason to be wary of off-label uses that do not technology assesstoo much from the FDA. “Many believe appear in compendia; reports of safety concerns rethat the agency functions as this amazing sulting from aggressive use of erythropoiesis-stimu- ment agency, similar to Britain’s NICE, safety agency and makes sure that everylating agents (ESAs) is a case in point. Last spring, says Elan Rubinstein, thing used in medicine really is safe and one of the recognized compendia changed its indiPharmD, MPH. appropriate,” says Berg. But in the United cation status for the use of epoetin alfa to treat aneStates, she says, no system guarantees that mia in cancer patients from “accepted” to “unacevery drug will be safe for a variety of uses. cepted,” triggering a chain of events that led to Medicare Though news of safety issues arising from off-label uses restrictions on payment for higher doses. Rubinstein thinks have turned public sentiment — and some members of CMS had been looking for a reason to reduce epoetin alfa utilization for some time, making the timing of the ESA safety Congress — against the FDA, Rubinstein points out that reports serendipitous. “Epogen and Procrit are some of the the FDA has become more assertive in recent years, given most expensive drugs for part B,” he says. “These have been the withdrawal of several drugs on the basis of postmarket a very big line item for CMS. I assume they were a target.” data and the narrowing of labeling. For Medicare, though, There was a time not long ago when safety alone — the game will ultimately be cost control — and restricting whether it stemmed from an off-label use or was the reoff-label use is an important component of that. sult of a preventable medical error — would not have been “Pressure is building for a solution,” Rubinstein says, a reason for Medicare to reject a claim. “If anything has who notes that it is getting harder to pay for all beneficial changed, it’s CMS’s diligence in looking at safety issues,” healthcare services and equally as hard to reduce benefits. Fleming says. “CMS has made a commitment and a very An evidence-based evaluator, he says — not in the form of conscious decision to review all the data available on uses compendia but possibly a national technology assessment and outcomes associated with ESAs. In the past, CMS was agency, similar to those in the European Union, Canada, not as sensitized to these issues and didn’t have the reand Britain — might ultimately provide payers with a resources to devote to assessing similar concerns.” liable source of guidance for coverage decisions. Fleming does not think CMS anticipated such a dramatic ripple effect in the private sector, but insurers have Amanda Brower is a freelance business writer in Cleveland been quick to follow CMS’s lead. “Health plans are always Heights, Ohio. 10 BIOTECHNOLOGY HEALTHCARE · JULY/AUGUST 2008

Table of Contents Feed for the Digital Edition of Biotechnology Healthcare - July/August 2008

Biotechnology Healthcare - July/August 2008 Openers Contents Editorial/David B. Nash, MD, MBA Drug Track Health Plan Confidential Rheumatoid Arthritis A Decade of Trial, Error, False Starts, and Hope What Path Will Comparative Effectiveness Research Take? RA Therapies in Development: A New Generation of Relief Assessing the Full Impact of RA on Employers and Payers Stem Cells: Health Insurance You Can Bank On Specialty Pharmacy Employer to Employer Personalized Medicine Trends Clinical Briefs

Biotechnology Healthcare - July/August 2008

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