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Medco Research Institute to Spearhead PGx Projects; Warfarin Study Results to be Released in March

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Originally published Feb. 25.

By Turna Ray

Medco officials this week shed light on the activities planned for the Medco Research Institute, which the pharmacy-benefits manager launched last fall in an effort to conduct pharmacogenomics studies that could ultimately help the company save money and drive efficiencies in the healthcare system.

"The Medco Research Institute is going to aggregate not only the studies in the pharmacogenomic space and the genetic space as we've done in the past," Medco CEO Dave Snow said during an earnings call announcing the firm's 2009 financials. "We've got a large number of studies going on inside our Therapeutic Resource Centers, which we also believe will be fundamentally important to educating our country around the real things we can do to reform the healthcare system."

Medco Chief Medical Officer Robert Epstein serves as president of the Medco Research Institute.

As one of the largest PBMs in the US serving more than 60 million people, Medco is already offering PGx testing services for widely prescribed drugs, such as warfarin and tamoxifen, to 200 customers serving 7 million lives. Over the last four years, Medco has formed research partnerships with the Mayo Clinic to study patients outcomes when the anticoagulant warfarin is dosed using genotype information; with Celera to evaluate whether testing for the KIF6 gene increases patient adherence to statin therapy; with the Laboratory Corporation of America to gauge the clinical utility of testing breast cancer patients on Roche's AmpliChip ahead of prescribing tamoxifen; and with the US Food and Drug Administration to inform the agency's labeling updates.

During the earnings call, Medco said it will unveil results from the Mayo warfarin study at the American College of Cardiology Meeting, which is scheduled to be held March 14-16 in Atlanta, Ga.

Medco will present the results in a poster titled, "Warfarin dosing algorithm refinements after seven-to-nine days of therapy based on pharmacogenetic, pharmacokinetic, clinical, and laboratory data." Following the presentation, Medco is planning to post a video of Epstein explaining the results of the study and its implications.

Payors have been eagerly awaiting the results of Medco's observational study, launched in 2006, comparing patient outcomes when warfarin is dosed using pharmacogenomic and clinical factors versus just clinical factors [see PGx Reporter 12-06-2006].

Since the FDA first updated the labeling for warfarin three years ago with information about the increased risk of adverse reactions in patients harboring CYP2C9 and VKORC1 genotypes, insurers have largely refused to reimburse for PGx-guided warfarin dosing, maintaining there is not enough clinical utility data showing that the strategy improves outcomes and saves money when compared to the standard of care.

In May, the Centers for Medicare & Medicaid Services decided not to cover PGx-guided warfarin dosing for its Medicare beneficiaries. Instead, CMS proposed a more "appropriate" alternative, employing a "coverage with evidence development" strategy in which it would pay for PGx-based warfarin dosing only for Medicare beneficiaries who are part of a prospectively designed RCT showing pharmacogenomics-guided dosing strategies to improve health outcomes over standard dosing methods [see PGx Reporter 05-06-2009].

More recently this year, the FDA updated for a second time the labeling for warfarin with PGx-guided dosing ranges, but still payors largely remain unconvinced of the utility of genetic testing in this setting [see PGx Reporter 02-03-2010].

Whether the results of Medco's warfarin study are able to nudge payors toward covering genetic testing for the anticoagulant, the pharmacy-benefit manager plans to continue to invest in conducting such collaborative studies to educate physicians about pharmacogenomics and to drive the adoption of personalized medicine within its customer base.

"We've been surprised at the client demand to participate in this kind of research, quite frankly. The phone just rings off the hook," Epstein said. "Actually, we felt, given the clients' demand and interest, along with Medco's interest in really trying to make medicine work smarter by understanding what are the drivers of medications working well or not, that we would call it out and attract more interest and more research."

With the launch of a research institute specifically dedicated to conducting pharmacogenomics studies, Medco seems to be wholly invested in the idea of integrating personalized medicine strategies to incur savings and improve outcomes. Also, through this institute, Medco is hoping to speed the time it takes to incorporate genomic discoveries into patient care.

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Through Medco's PGx studies, "we are discovering an awful lot," Snow said. "We're going to continue to do things like this and what we really want to do is eliminate the 17-year gap that exists from the time landmark evidence is produced to the time it actually becomes the standard of practice in medicine.

"I think it's a noble cause … but it is fundamentally important for the members we serve and the clients we serve, because by getting it right we really do see that we can improve outcomes and reduce costs," Snow said. "That's behind everything we're doing here."

During 2009, Medco's revenue climbed 17 percent over 2008, to nearly $60 billion. The PBM reported dispensing 899 million mail-order prescriptions, an increase of 13 percent from the previous year. "Mail-order [prescription] volume reflects a decline in brand name drugs of 8.6 percent, partially offset by a 2.4 percent increase in generic drugs, where clients and members benefit from the highest savings," Medco said in a statement.

In an effort to drive down healthcare costs and incur savings for its customers from greater use of generic drugs, Medco launched the Genetics for Generics program last year. The program aims to use genetic testing to increase healthcare savings in the administration of certain generic drugs [see PGx Reporter 10-07-2009]. In 2009, Medco's generic dispensing rate increased 68 percent, whereas in 2008 generic dispensing increased by 65 percent.

Medco is also leading the way when it comes to educating physicians on how to apply pharmacogenomics in their own practices. In January, the PBM introduced a new information system at its Therapeutic Resource Center headquartered in Whitestown, Ind., that would alert specialist pharmacists of pharmacogenomic opportunities within a customer's medical record, allowing the pharmacist to become an intermediary between doctors, labs, and the patient to facilitate genetic testing [see PGx Reporter 01-27-2010].

Another one of Medco's major efforts in the area of personalized medicine is its acquisition in February of the genetics education and testing utilization management firm, DNA Direct. The California-based firm has proprietary algorithms built around roughly 2,000 tests, as well as its own customer base, through collaborations with El Camino Hospital, Humana, and LabCorp. DNA Direct's services will be rolled out to Medco's customers in the spring.

"Since the acquisition of DNA Direct, we've dramatically taken a leap ahead to all genetic tests, whether they're pharmacogenomic or not, and quite frankly, it was our embedded customer base who asked us to do that," Epstein said. "They were satisfied with our pharmacogenomic support services, but said the whole field of genetic testing can do things both to our members and our doctors … DNA Direct was a great partner there because they have already been out doing it, not just thinking about it, but doing it."

According to Epstein, with the acquisition of DNA Direct, Medco has received a number of proposals to study the value of genetic testing in pharmacy benefits management. "As the number of tests grows and the dollars associated with that number of tests grow, we're going to see more and more interest in the kinds of services we can provide here," Epstein said.

Although, ultimately it’s a payor's decision whether to cover a particular test, Snow noted that Medco's real contribution in the area of personalized medicine is to advance the body of knowledge about this burgeoning field.

Since "genetics and pharmacogenomics are relatively new sciences, one of the valuable things Medco is doing right now is putting substantial scientific data on the table to support a protocol around these things," Snow said. "When these protocols are out there and developed and the standard of practice is defined, it's going to move from a payor's individual decision to something that becomes standard of practice and I see that happening at an accelerating pace over time.

"Medco is building [its internal] 'intel' that helps drive and guide the appropriate decisions so that we can better manage the diseases that are driving the costs in healthcare," he said.

According to Snow, Medco's involvement in personalized medicine is not only good for its clients but also for the company's financial strength. "We're doing the right thing relative to our clients and the members we serve. That drives sales. It drives fundamental growth because we do the right thing on behalf of the payors and the patients so that's always first and foremost," Snow said. "There is an independent revenue source tied to this level of service that over time will become meaningful, but those are the priorities and the way I think about it."

─ Bernadette Toner, GenomeWeb editorial director, contributed reporting to this article.

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