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Medco's New Idea: PGx Program for Generics to Dispense 'Smarter' Treatments and Increase Savings

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By Turna Ray

"Genetics for Generics" is Medco's newest idea for optimizing savings for payors by dispensing off-patent drugs with the aid of genetic tests.

"We have a strategy that we're calling Genetics for Generics," Medco's Chief Medical Officer Robert Epstein told Pharmacogenomics Reporter this week. "It's kind of a Medco idea, which is that if we can make generic drugs work better with genetics, then we are helping the system afford innovative products that address true unmet need."

According to Epstein, the goal of the Genetics for Generics program is to "beef up the profile of a generic drug and make it even smarter."

"The theme is that in each case it will help a generic drug or a drug going generic work better," Epstein said. "We're focusing on using pharmacogenomics to improve the safety and efficacy of a generic drug because that's in the best interest of the payor. It really frees up some affordability that goes after unmet need."

With the ballooning cost of healthcare and a weakened economy, Medco is taking aggressive steps to lower costs, and genetic screening will feature prominently in its plans. In its 2009 Medco Drug Trend Report, the pharmacy benefits manager projected spending increases of between 14.7 percent and 18 percent between 2009 and 2011.

With strategies such as the Genetics for Generics program, Medco is hoping to incur savings during a period when numerous brand name drugs are expected go off-patent. Over the next five years, brand-name drugs with more than $66 billion in annual sales are expected to lose patent protection.

Medco's ongoing PGx studies for warfarin sensitivity and tamoxifen response will fall into the Genetics for Generics program, as will the recently penned collaboration with Celera to evaluate whether testing for the KIF6 gene variant increases patient adherence with statin therapy [see PGx Reporter 12-04-2006; 10-31-2007; 09-23-2009].

The lack of clinical data proving the cost-effectiveness and clinical utility of pharmacogenomics products, such as genetic testing to dose warfarin, has kept payors from fully championing personalized medicine strategies for their customers. However, proponents of personalized medicine are hoping that Medco's studies in this regard will help drive adoption of certain genetic tests.

"We're also about to launch a very large Plavix [clopidogrel] study," under the Genetics for Generics aegis, Epstein added.

Last year, Medco conducted an outcomes study involving clopidogrel, which found that concomitant administration of proton pump inhibitors, such as heartburn drugs, can diminish the anti-clotting effects of clopidogrel. At the time, Medco said in a statement that "since PPIs mimic the effect of a variant gene, which also renders clopidogrel ineffective, this study further suggests a potential role for genetic testing."

Further support for Medco's strategy came from the US Food and Drug Administration earlier this year, when the agency updated labeling for Plavix to note that poor metabolizers of the CYP2C19 gene variant do not respond well to the drug [see PGx Reporter 06-17-2009].

The anti-platelet drug Plavix is Bristol-Myers Squibb's best-selling product, with worldwide net sales of $1.5 billion. Plavix will go off-patent in November 2011. This makes the drug the perfect candidate for Medco's Genetics for Generics program, according to Epstein. "All the research we do around it over the next few years will only help that product as it goes generic," he said.

In addition to the four announced PGx studies for generic drugs — warfarin, tamoxifen, statins, and clopidogrel — Epstein noted that Medco has three or more similar projects under the Genetics for Generics program that it will announce in the next months.

Separate from the Genetics for Generics program, the pharmacy benefit manager is rolling out three new PGx test offerings for its customers: BCR-Abl testing for Gleevec; tropism testing for Selzentry; and HLA-B*5701 testing for Abacavir.

"Those three will be our new programs launching this year or early next year," Epstein said, adding that Medco has started discussions with employers this week regarding these programs.

"What we do is, we see the prescription claim hit the system, and we're able to reach out to the doctors and say, 'Did you know there was a test? Did you try the test? Do you know how to do it?'" Epstein explained. Warfarin sensitivity testing and CYP2D6 testing for tamoxifen are also part of Medco's PGx test offerings to its beneficiaries, which it provides for 200 clients representing 7 million lives.

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