Mixing Personalized Medicine and CER, One Specialty Pharmacy Plows New Ground.
Year: 2009
Type: article
Abstract: For the past 18 months, Felix Frueh, PhD, has been overseeing the development of an elaborate — and costly — scientific research initiative. Frueh, who was associate director for genomics at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research before being wooed and won by Medco Health Solutions, has been steadily ramping up the PBM’s ambitious personalized medicine R&D organization, using the full weight of its massive database to press for new insights into the ways that drugs work. Medco is building certified laboratories and an R&D complex in Indiana that will be devoted to the advancement of personalized medicine.
“As you know, we have a large longitudinal pharmacy database with 65 million members,” Frueh says. “And for 20 percent of them, we also have clinical outcomes data and claims data.”
For now, Frueh’s team is taking another big stride into R&D territory. They are conducting — without a partner — a comparative effectiveness study for which Medco will recruit 14,000 patients to examine the relative efficacy of the drugs clopidogrel (Plavix) and prasugrel (Effient).
The recent arrival of prasugrel from Eli Lilly/Daiichi Sankyo as a direct competitor to Sanofi-Aventis/Bristol-Myers Squibb’s clopidogrel, which earned $4.9 billion in 2008, has prompted Medco to run an observational study that looks at how a genetically defined group of patients responds to each blood thinner.
Roughly a quarter of the patients taking clopidogrel have a 2C19 enzyme that is a less active metabolizer than most enzymes, which interferes with the effectiveness of the therapy. But prasugrel, because it tracks a different drug pathway, can be more effective than clopidogrel for that segment of the market. Medco and Aetna went a long way in highlighting the pathway effect with their earlier work on the interaction between proton pump inhibitors — popular heartburn medications — and clopidogrel.
In late-stage trials, the data for prasugrel demonstrated that it had greater overall efficacy for the entire patient population but higher rates of bleeding. Medco’s observational study will examine how the two drugs perform in a population restricted to patients who share a common biomarker that indicates they metabolize the drug normally. Researchers will measure rates of cardiovascular deaths, nonfatal heart attacks, and nonfatal strokes over a six-month period. If clopidogrel, which will lose patent protection in 2011, outperforms prasugrel without the increased risk of bleeding, it will remain the preferred drug for the majority of the market —at least until other late-stage drugs, like AstraZeneca’s ticagrelor (Brilinta), hit the marketplace.
Source: PubMed Central
Author: John Carroll
Language: English
Subfield: Pharmacology
Domain: Life Sciences
Open Access status: green
OpenAlex ID: W238344699