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Biotechnol Healthc. 2010 Summer; 7(2): 29–30.
PMCID: PMC2899799

Diagnostics Come of Age

John Carroll, Senior Contributing Editor

March 12 was a red-letter day for Edward Abrahams. That was the date the U.S. Food and Drug Administration relabeled Plavix, a widely used blood thinner, to note that anyone with low levels of a particular liver enzyme —CYP2C19 — wouldn’t benefit from the drug. As a result, anywhere from 2 percent of whites to 14 percent of people of Chinese ancestry cannot properly metabolize the drug — vital information for patients with heart disease who rely on the therapy to stay alive.

“Plavix is taken by 25 million people,” says Abrahams, president of the Personalized Medicine Coalition in New York. “Millions of people are now exposed to the principles of personalized medicine. They may infer that there’s a better paradigm than one-size-fits-all for a drug. In the not-too-distant future, patients will demand to know if a particular drug will work for them.”

And an avalanche of new molecular diagnostics tests is on its way to help guide them.

“My crystal ball says this is going to explode,” says Robert Epstein, MS, chief medical officer for Medco. “There are a few reasons. First, the cost of the tests is coming down dramatically. Access is easier and the practical implications are becoming apparent. With more labels and guidelines, physicians are more likely to utilize the technology.”

Medco and other PBMs also are acutely aware of what’s at stake for their industry.

“We see molecular diagnostics being a significant opportunity for the PBMs,” says Matthew Rosamond, a director in PricewaterhouseCoopers’ health industries practice. Strategically, the new wave of diagnostics will help PBMs deploy a powerful new tool to help payers control costs, just as the hard push that’s delivered a bonanza of savings from generics begins to lose steam.

Adds Rosamond: “I see the wave of growth in generic drug prescriptions beginning to slow down over the next few years, as well as molecular diagnostics offering further cost savings. Certainly it’s a growing market.”

That’s a lesson that two of the largest PBMs in the country have taken to heart. Both Medco and CVS Caremark have concentrated heavily on boosting their knowledge of the field, with CVS Caremark recently snagging a majority interest in Generation Health just after they inked a deal to offer pharmacogenomic tests to match patients and drugs for cancer, cardiovascular ailments, and HIV.

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“Millions of people are now exposed to the principles of personalized medicine,” Edward Abrahams, president of the Personalized Medicine Coalition in New York, points out. “In the not-too distant future, patients will demand to know if a particular drug will work for them.”

PHOTOGRAPH BY ROB CRANDALL

100 MILLION AND COUNTING

“The entry of the PBMs into personalized medicine using diagnostic tests to better target therapies and thereby increase efficacy for patients and decrease expenses for payers is potentially transformative,” says Abrahams. “Medco and CVS Caremark have the ability to touch over 100 million lives in the United States. Their understanding of the power of personalized medicine that allows them to do this is catalytic in my estimation. Whereas before we had individual companies, labs, or hospitals providing one-off developments to impact disease and potentially lower costs, here we have large agents of change that are proposing a better, more efficient paradigm.”

But there are plenty of hurdles that remain. Although a whole host of research programs are underway to identify how best to match patients with new and experimental medications, there’s a long way to go before diagnostics becomes a mature industry. And costs remain a considerable barrier when a test is in place.

“I think, based on this, that people will do more genetic testing,” Louis Teichholz, MD, head of cardiology at Hackensack University Medical Center, commented after hearing about the new black-box warning related to Plavix. But rather than run a test for around $500, he said, some doctors may just switch patients to the newer Effient.

That kind of sticker price, though, can look like a paltry sum compared to the kind of costs associated with a drug that either doesn’t work or actually damages a patient.

“Many health plans and employers just need to understand the story behind each of those tests,” says Epstein. “What’s the utility, what’s published, what’s confusing, and what are the nuances they should be careful with? The lettering is so close that doctors can misorder the tests. Some tests need to be done only once in a lifetime, and we need to make sure a person doesn’t order it a second time.”

Adds Epstein, “It’s all new — how we manage these tests, the growth of technology assessments, the coverage, as well as selecting labs of choice.”

Managing therapies, of course, is all about what big PBMs can do best, provided payers are sold on the benefits.

“Some tests are and some aren’t covered by employers,” says Epstein. “It’s a patchwork quilt. In one of the more common areas like cancer, it’s often covered. For fertility or genetic disease predisposition testing, it’s 50-50.”

“The genetic stories around some of these drugs are becoming clearer,” adds Epstein, which will help persuade companies to sponsor broader use of diagnostics. Meanwhile, the FDA has become more aggressive about requiring new label warnings that spell out the genetic profiles of prospective patients better. “There’s also been more genetic testing in phase 2 and phase 3 trials.”

THE RESEARCH

Medco, with more than 65 million lives in its database, is helping to fill in some of the R&D blank spaces.

Not only did Medco get involved in the studies on Plavix, the PBM concluded just last March in a new study that the genetic test for warfarin sensitivity reduced hospitalizations linked to the therapy by a large margin.

In the comparative effectiveness study, doses of warfarin were adjusted for 900 adult patients based on the outcome of the genetic test. Over a 6-month period, their hospitalization rate was 31 percent lower than that seen in the control group. The rates of hospitalization for bleeding or thromboembolism were, respectively, 33 percent and 43 percent lower. “Warfarin has now been relabeled twice, with very specific instructions this year.”

Medco also has conducted prospective research on the need to relabel tamoxifen. Their research on the interplay between the anticancer drug and antidepressants shows a significantly higher risk of breast cancer recurrence among patients taking antidepressants that were potent or moderate inhibitors of CYP2D6.

The prospective savings haven’t gone unnoticed among sponsors.

“Two years after the program launched, there are more than 220 paying clients with more than 10 million lives,” says the chief medical officer. “This is the fastest takeoff of a program we ever offered. While we were alone four years ago on genetic tests for therapeutics, a lot of other plans and payers are now looking at this question.”

“We’re digging into each new technology, even those tests not on the market,” says Epstein. But Medco is staying focused on where patients can find the right drug, rather than finding a test that will show there’s nothing that can be done for them. “If we only have so many resources, we’re more interested in which drug or dose or duration is right for you. We don’t have the resources to do it all.”

According to the latest estimate, there are around 1,700 genetic-based tests being offered, says Rosamond, with a growth of 100 new tests projected per year. “We expect to see continued growth going forward as technology facilitates the research. Cost savings can be pretty significant.”

Getting that message across to providers and consumers, though, could be a challenge.

“The real hurdle is physician and consumer education around these tests,” says Epstein. “It’s new 21st century medicine. We’ve partnered with the AMA to do a survey. More than 90 percent of genes relate to drug response, and most don’t know how to order it or do that.”

Even if they do know how to order it, there’s still a perceived cost barrier.

“Some of these genetic-based tests can be relatively expensive,” says Epstein, “$3,000 or $4,000 upward.” Even so, “they’re still generating savings, either because it reduces the risk of an adverse drug reaction or identifies individuals who wouldn’t benefit from a drug-based therapy. For an oncology drug, where the cost can be $40,000 or $50,000 a year, that can generate a material cost savings.”

“I think there’s definitely potential for PBMs to play a significant role in rolling out tests and gaining adoption of some of these molecular diagnostics. As the number of tests grow — and there’s so much complexity — it’s difficult for the doctor to stay on top of what test should be provided at what point. PBMs will play that coordinator/navigator role.”


Articles from Biotechnology Healthcare are provided here courtesy of MediMedia, USA