UnitedHealth Group’s claims databases track every diagnosis subscribers get during doctor visits, every incident that leads them to the emergency room, every hospitalization. They also track every prescription drug each person takes, including the dose and length of treatment.
The nation’s largest health insurer, serving 55 million Americans through UnitedHealthcare and five other subsidiaries, United now has one of the biggest health data banks available. And through its high-tech Ingenix subsidiary, the company uses the data to gauge the effectiveness of different drugs and procedures, sometimes selling the analyses to others.
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Now United is taking that line of business to the next level.
Launched late last month, the new i3 Aperio Drug Registry will make analyses on specific prescription drugs available to drug manufacturers and regulators – for a fee – to help them more quickly identify potential safety problems with newly introduced drugs.
Drawing from claims data for 11 million people, the i3 Aperio Drug Registry will allow clients to compare large samples of United subscribers taking a drug with others taking a different drug, said Donato Tramuto, CEO of i3, the pharmaceutical research division of Ingenix.
In addition, the registry will have six months’ worth of retrospective information, so if, say, 20 percent of people taking Drug A are also diagnosed with high blood pressure, you can tell whether it’s a condition they had beforehand, or whether it may be tied to the drug.
“It’s a unique proposition in terms of ensuring a safer drug environment,” Tramuto said in an interview. Despite all the clinical trials conducted for every drug, he noted, “it can take years for you to aggregate the number of lives” to draw reliable conclusions.
“Fortunately we have a large number of lives, the technology and the expertise” to analyze the data, Tramuto said. “United processes over 1 million claims a day, 38 million a month…. Because of our size, we can obtain large-scale data on the safety of newly introduced drugs before comparable clinical trial data is available.”
And unlike clinical trials, which deliberately cover narrowly defined samples, i3 senior scientist Dr. K. Arnold Chan said, the new registry will provide “real-world prescription drug experience,” including patients with multiple illnesses and/or prescriptions.
The U.S. Food and Drug Administration has recognized the value of such data, and has been talking with United and Kaiser Permanente, the nation’s largest HMO, among others, about accessing their information, the Wall Street Journal recently reported. Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, told the Journal the agency was interested in using registries such as i3 Aperio “to the extent we have the funding.”
Because United has an open formulary – meaning it pays for all prescription drugs, even if it does set preferred rates for some – the registry’s scope is, potentially, unlimited. As soon as 750 United subscribers are on a drug, it will be added, Tramuto said. And for most drugs, the sample will quickly become much larger, even in the hundreds of thousands.
If i3 scientists identify a potential problem with a drug, Tramuto said, Ingenix has detailed information about subscribers – all “de-identified,” so it can’t be traced to specific people – so drug companies and regulators can narrow down if, for example, a drug is only causing problems for children who take it, or for people who also have heart disease.
There are limitations, Tramuto acknowledged: If a drug causes headaches and patients don’t tell their doctors but just take over-the-counter Advil, for example, it wouldn’t show up in the claims data. But i3 Aperio will still cover more ground, he said, than most clinical trials.
The drug registry information will be available in two formats: quarterly, Web-based files suitable for manipulation and analysis by informed users, as well as an annual report of static data. It will not be available to consumers, the company said, because it requires “an understanding of the data and skill in interpretation that is not available to the casual user.”
The first set of reports will be available by the third quarter of 2005. Tramuto was reluctant to name specific drugs in a PBN interview, but the Wall Street Journal reported that initial studies include a comparison of the erectile dysfunction drugs Viagra and Cialis and studies of the antibiotic Ketek, the antidepressant Cymbalta and the pulmonary drug Spiriva.
