UnitedHealth

FDA to piggyback on insurers' databases

Tue, 15 Apr 2008 06:59:55 -0400

Remember that drug-safety database Congress required the FDA to set up? The idea was for the FDA to actively monitor drugs and possible adverse effects, rather than waiting for doctors and drug companies to report problems. Well, the agency is ready to announce its plans--and they don't include setting up a database. Instead, the FDA will contract with insurers, such as WellPoint and UnitedHealth, to scan their members' records for potential problems. The agency also plans to bring other health systems into the effort.

"We're bringing together all these different groups in a network so that we can ask them to look at the same question at the same time," Janet Woodcock (photo), CDER director, told the Wall Street Journal.

The FDA will use the databases to monitor potential problems that showed up in a less-than-statistically-significant way during clinical trials. The insurers and other network participants also will build computer models to detect signals of potential problems that weren't suspected before. To show that it could do so, WellPoint tested its 1999 data and found that it could have spotted the heart-related problems associated with Vioxx within four months of the drug's introduction.

- read the WSJ story

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Woodcock: FDA wary of Vytorin debate

Wed, 09 Apr 2008 06:59:56 -0400

Expect the FDA to stay out of the Vytorin fray, at least for now. So Janet Woodcock (photo), CDER chief, told FDAWeb in an interview (recounted, in turn, by Pharmalot). The agency is afraid of seeming "defensive" if it weighs in now. But Woodcock did make clear that FDA still considers lowering "bad" cholesterol--which Vytorin did quite well in the Enhance study--to be a valid surrogate for heart-disease prevention.

Scientific nitpicking about LDL is misleading people, Woodcock said: "[T]here is some little point that the scientists are arguing about, and then the media get on it, and they start throwing the baby out with the bathwater," she said. "...[but if] people think we're just being defensive, we wouldn't make a difference in this environment."

Meanwhile, new data is in on the expected drop-off in Vytorin and Zetia scrips. A Deutsche Bank analyst surveyed primary care docs and found that 75 percent expect usage of both drugs will drop in their practices. The analyst now predicts that market share for Vytorin will drop to 9 percent from 16 percent. Zetia, one of the drugs in the Vytorin combo, will see its share drop to 6 percent from 9.5 percent, the analyst concluded.

Some of that drop-off will be in new scrips, some from patients switching. In an investor note, the analyst predicted "increased utilization of other statins, especially [Pfizer's] Crestor."

- see the Woodcock interview excerpt at Pharmalot
- check out the scrip numbers
- see Pharmalot's analysis of Deutsche Bank's predictions

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UnitedHealth stands by Vytorin

Thu, 03 Apr 2008 07:59:57 -0400

We didn't have to wait long for a Vytorin decision from UnitedHealth Group. The largest U.S. insurer says it's keeping the cholesterol med in the same tier on its drug formulary because the company has found "no safety issues" associated with it.

Earlier this week, a panel of cardiologists and the New England Journal of Medicine both recommended that Vytorin be reserved for patients who've tried other cholestrol-controlling meds and failed. But UnitedHealth says that, because no safety issues were raised, patients should stay on the med. "The last thing we want to do is see patients stopping their medication when they need it."

Yesterday, Cigna said that, in light of the Enhance data, it would stop asking patients to try Vytorin before using the more expensive Lipitor (made by Pfizer) and Crestor (AstraZeneca). It and several other insurance and benefits managers are reviewing their policies on the med. UnitedHealth's vote of confidence could help sway other payers to keep paying, too.

- read the New York Times article
- see the Cigna item at the WSJ Health Blog

ALSO: Generic simvastatin may gain the most from questions surrounding the effectiveness of Vytorin and Zetia. The Enhance study that's caused all the brouhaha showed that Vytorin did no better at preventing atherosclerosis than simvastatin did alone. Analysts say that, as Vytorin and Zetia lose sales, plain statins will capture more business. "A good portion of that will go to generic Zocor," one analyst said. Report

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Congress: M/S-P sat on bad news. Report
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Congress: Were Enhance results secret? Report