Managed Care - May 2008 - (Page 12) LEGISLATION & REGULATION Legislation Would Put Drugs And Other Therapies to a Useful Test A proposed research institute would pit medications against each other instead of against placebos, and that might save $368 billion over 10 years By John Carroll It’s important to have science prevail, says Alissa Fox, of the Blue Cross and Blue Shield Association. It could stop the one-sizefits-all approach to medicine, says Steven Wojcik, of the National Business Group on Health. n many late-stage clinical trials, a new therapy has only to prove that it’s safe and significantly better than a placebo to win approval by the FDA. That system has often spawned therapies that compete against each other — and often leave payers and providers scratching their heads over which are better. Now lawmakers are considering the establishment of an institute charged with sponsoring a host of independent studies to examine the comparative effectiveness of medical therapies. Supporters are gearing up for the debate, equipped with analysis claiming hundreds of billions of dollars of potential savings and an argument for improved outcomes, even as makers of drugs and devices warn against taking a good idea too far. “We are concerned that insurers could use the research to do blanket denials of coverage,” asserts David Nexon, senior executive vice president of the medical technology trade association AdvaMed. In an age when new genetics research is offering almost daily insights into the characteristics of diseases and treatments, the manufacturers say this is no time to adopt the kind of cookie-cutter approach bad legislation could create. Legislation is being worked up in both the Senate and House. It’s a slow process. The Senate bill, introduced in mid-April, has since been pulled, but things seem to be moving along in the House. It’s a good thing, too. The United States is well behind the comparative research curve laid out in other industrialized countries. As the economist Gail Wilensky, PhD, noted in a study late last year, Australia, Canada, Germany, and the United Kingdom already fund public research comparing the efficacy and John Carroll, a freelance writer, has been a contributcost of treatments. CARE for six years. ing editor of MANAGED I An independent group of investigators with a budget of about a billion dollars a year in this country could deliver $368 billion in savings over 10 years, according to an economic analysis completed by the Lewin Group for the Commonwealth Foundation. “There’s a sense in the health care system that there are many services being done that don’t have a corresponding payoff,” says Commonwealth Fund economist Stuart Guterman, who helped write the report. Guterman, though, says that comparative effectiveness research wouldn’t necessarily be a panacea. “When we worked on this estimate, we got pushback from the Lewin Group that just putting information out there wouldn’t necessarily generate savings, because there’s no assurance the information would be used. I personally think people tend to underestimate how effective such information would be,” he adds, “especially if there was a centralized source of that information with high stature in the clinical community. A lot of that information would be useful simply by being available, but there is a gap between availability and use.” To achieve the estimated savings, Guterman says, they assumed that doctors would be required to review alternative treatments with their patients. Who pays? HR 2184 would tap a variety of payers, including Medicare and insurance companies. Guterman feels it is important to share the cost of the research among payers — not only Medicare and Medicaid, but also private insurers and self-insured employers. The center’s budget of $10 billion over 10 years could 12 MANAGED CARE / MAY 2008
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