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Which drug works? Depends on genetics


Pharmacy benefit managers and employers are looking to genetic testing as a way to fine-tune prescription benefits.

At least 200 employers nationwide are working with Medco Health Solutions Inc. to test whether certain patients should receive two particular drugs—warfarin and tamoxifen—and, if so, in what dosages.

Apparently, it's tricky to get the right dosage for warfarin, a blood thinner. As a result, many patients have serious complications such as excessive bleeding or blood clots that often require hospitalization. As for tamoxifen, used to prevent recurrence of breast cancer, certain women do not metabolize the drug, rendering it useless.

In addition to Medco, Woonsocket, R.I.-based CVS Caremark Corp. is preparing to introduce a similar program in May after acquiring a majority stake in Generation Health Inc., a genetic benefit management company in Upper Saddle River, N.J. The companies last fall formed a strategic partnership to expand pharmacogenomic clinical and testing services for CVS Caremark PBM clients to improve care for patients who either don't respond to their medications or have adverse reactions.

In the Medco and CVS programs, the employer generally picks up the tab for the largely voluntary testing of how genetic variation affects response to drugs.

While the testing “is not cheap,” said Dr. Martin Sepulveda, vp-integrated health services at Armonk, N.Y.-based IBM Corp., “the return is very high if it is done on the patient who needs it.”

The genetic tests cost about $300 on average, said Kristin Begley, national pharmacy practice leader at Hewitt Associates Inc. in Los Angeles.

But if just one patient benefits from the genetic test for warfarin use, IBM saves between $12,000 and $13,000 by avoiding a hospitalization due to an adverse drug reaction, Dr. Sepulveda estimated.

IBM was among early users of Medco's personalized medicine services in a pilot program involving 27 employers that began in 2008.

“The pilot demonstrated to us that it could be provided in a way that was considered of value and respecting of patients and physicians to make decisions,” Dr. Sepulveda said.

In the Medco pilot and program, the PBM directly contacts doctors after receiving notification that either warfarin or tamoxifen have been prescribed.

Those drugs were targeted because Medco's medical data showed that 25% of people who started warfarin either had excessive bleeding or a blood clot within the first six months, said Dr. Jane Barlow, vp of business solutions at the Franklin Lakes, N.J.-based PBM.

Other Medco research showed that about 10% of women don't metabolize tamoxifen, she said. “In those poor metabolizers, the rate of (breast cancer) recurrence is 30% higher within two years” than women who metabolize the drug, Dr. Barlow said.

Although Medco's personalized medicine program is limited to those two drugs, it is researching other drugs, such as those used to treat HIV, cardiovascular disease and cancer “to determine whether a particular drug is safe for a person to take, whether it's the right dose and whether they'll metabolize it correctly,” Dr. Barlow said.

CVS' personalized medicine program will be introduced to a handful of large, self-insured employers and several health plans in the second quarter, said Dr. Troy Brennan, the PBM's chief medical officer in Woonsocket, R.I.

Initially, it will involve genetic testing for two drugs: Herceptin, used to treat cancer, and Plavix, an arterial plaque-reducing drug, he said.

Dr. Brennan said the involvement of PBMs in genetic testing is a natural extension of their services. Aside from ensuring the most efficacious treatment, testing also lowers pharmacy costs, particularly for expensive specialty drugs, he said.

“Most of the drugs are in the specialty area,” such as oncology drugs. The pharmaceutical industry “wants the drugs to be used for all patients. The whole design here is to target them to the most appropriate people,” Dr. Brennan said.

Commenting on the program, Mike Thompson, a principal at PricewaterhouseCoopers L.L.P. in New York, said: “This is where patient safety, cost and quality all congregate. We pay for drugs if they're on a formulary, but we don't check to make sure if that drug is the best for a particular individual. To the extent that you can improve patient safety, quality and save money, that's a winning combination.”

While some employers embrace personalized medicine, other employers are hesitant, said Ritu Malhotra, Chicago-based vp and clinical pharmacy consultant at Segal Co.

“We think it's an exciting new benefit focus. What we haven't seen is a lot of our clients at the point where they have enough supportive evidence to fund the genetic testing,” Ms. Malhotra said. “There needs to be more research and clinical evidence,” she said.

But Amy Miller, public policy director at the Washington-based Personalized Medicine Coalition, an education and advocacy group of which Medco and CVS are members, said the list of drugs and available genetic tests has grown in recent years, particularly specialty drugs.

In fact, the U.S. Food and Drug Administration has published a list of drugs for which genetic testing should be considered, she said. The FDA also includes such recommendations in the drug information that pharmacies package with the drugs, she added.

“What we don't yet know is how to personalize drugs used to treat more common conditions such as hypertension, diabetes or (reflux disease), Ms. Miller said.

The Genetic Information Nondiscrimination Act of 2008 also may play a role in advancing personalized medicine, which includes this form of genetic testing, she added.

“Before GINA was passed, people avoided genetic tests because they thought the information would be used against them or their families in getting insurance or even jobs,” Ms. Miller said. But now, “an employer can't discriminate against you and your health insurer can't drop you.”