By Alex Nussbaum, Meg Tirrell and Pat Wechsler
March 25 (Bloomberg) -- Page 1,617 of the 2,400-page law signed by President Barack Obama this week -- the most sweeping change to U.S. health-care in 45 years -- sparked little of the debate surrounding the expansion of coverage to 32 million Americans or its tax on employees’ “Cadillac” insurance plans.
Yet the 43-page measure tucked inside the bill may have a far greater effect on medical care.
The overhaul creates an institute, funded with $500 million or more annually, to spur studies of which drugs, devices and medical procedures work best. The boost for comparative- effectiveness research, as the field is known among health experts, will increase scrutiny on treatments used by millions of Americans, including cholesterol drugs led by Pfizer Inc.’s Lipitor and heart stents from Medtronic Inc., said John Sullivan, an analyst at Leerink Swann & Co.
The findings may add scientific rigor to doctors’ decisions sometimes influenced more by marketing, said Jeffrey Lerner of the ECRI Institute, a nonprofit that conducts such research. In a health overhaul attacked by critics as too pricey, it’s one of the few measures with a chance to rein in U.S. medical spending that soared to $2.5 trillion last year, Sullivan said.
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The institute will be run by a 19-member board of governors with three representatives of drug, device and diagnostic- testing companies as well as patient advocates, doctors and the National Institutes of Health. The U.S. Comptroller General, a presidential appointee, must name the board within six months.
Its funding will start at $10 million this year and reach about $500 million in 2013 when money from Medicare and a new insurer tax kicks in, according to an estimate from the Brookings Institution, a Washington-based research center. The budget may increase if insurance rolls grow, Brookings estimates.
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Still, “the savings can be substantial if you’re drawing a clinical study conclusion that a generic drug works as well as a branded drug,” said Leerink Swann’s Sullivan, offering one example of research that may be done. Therapies used by large numbers of people are likely to be investigators’ first targets.
“You’re talking about saving not pennies on the dollar, but very substantial savings” if patients can replace a branded drug with a generic, he said.
Along with statins such as New York-based Pfizer’s Lipitor, Sullivan cited anti-inflammatory drugs that include Remicade, made by Johnson & Johnson of New Brunswick, New Jersey, and heart stents manufactured by Minneapolis-based Medtronic and Boston Scientific Corp. of Natick, Massachusetts.
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“The companies are now going to have to not just launch new products with marketing hype, but they’re going to have to demonstrate evidence of superior clinical effectiveness,” said Vivian Coates, an ECRI vice-president.
The fallout from a 2005 study of antipsychotic medications shows the most effective treatment doesn’t always win, said Robert Rosenheck, a psychiatry professor at Yale University School of Medicine in New Haven, Connecticut.
The U.S.-backed study found a 50-year-old drug that may cost about $2.50 a day worked as well as newer medicines priced eight times higher, Rosenheck said. Sales of the next-generation antipsychotics, led by AstraZeneca Plc’s Seroquel, Eli Lilly & Co.’s Zyprexa and Johnson & Johnson’s Risperdal, nonetheless jumped 43 percent in four years to $14.75 billion by 2009, according to IMS Health Inc., a collector of prescription-drug data based in Norwalk, Connecticut.
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http://www.bloomberg.com/apps/news?pid=20601109&sid=aWaqUjSAjgAg&pos=11
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