Full article reprinted from "The Pink Sheet" October 27, 2009
Medco is working to generate cost effectiveness data for Bristol-Myers Squibb's anti-clotting blockbuster Plavix in anticipation of the launch of clopidogrel generics in 2011. Read on...
Full article reprinted from "The Pink Sheet" October 27, 2009
The pharmacy benefit manager plans a large observational study comparing Plavix with the recently launched Effient (prasugrel) in acute coronary syndrome patients. Effient is marketed by Lilly and Daiichi Sankyo.
Announced by the pharmacy benefit manager Oct. 20, the "Genotype-Guided Comparison of Clopidogrel and Prasugrel Outcomes Study" (GeCCO) will follow 14,000 patients over a six-month period.
The firm describes the study as part of its "Genetics for Generics" project. Medco's ongoing pharmacogenomic studies on warfarin dosing and tamoxifen response are also part of that program 1 ('The Pink Sheet,' Aug. 24, 2009).
In the GeCCO study, Medco will compare rates of death, non-fatal myocardial infarction and non-fatal stroke between the two blood thinners using its large integrated database of medical and pharmacy claims. The company has integrated data for one-third of its members.
Results To Quickly Follow Generic Launch
Results are expected to be announced in early 2012. Given the November 2011 expected patent expiration date for Plavix, Medco is "under the gun" to get the research done in time to help promote use of generic clopidogrel, Medco Chief Medical Officer Robert Epstein said in an interview.
As part of the study, Medco will use genetic testing to focus on individuals who respond to clopidogrel.
Approximately 70 to 75 percent of patients with cardiovascular disease are thought to be "extensive metabolizers" of clopidogrel because they possess a normal functioning version of the CYP2C19 gene. Plavix labeling includes a warning that certain individuals do not metabolize the drug and so may receive sub-optimal therapy.
Effient is not metabolized by the 2C19 pathway, which has been a key element in messaging supporting the launch of the drug. Lilly has played up the drug's metabolism advantage over Plavix, justifying the new product's higher price point with the promise of fewer cardiovascular events.
In head-to-head clinical trials, Effient has shown greater efficacy than Plavix. But Medco expects results could vary "substantially" in a comparison limited to those patients who successfully metabolize Plavix.
Medco will pay for the genetic test and use its own lab to evaluate results. The PBM is confident the investment will pay off and expects the data on clopidogrel can also be used in comparisons with other branded anti-thrombotics that come along.
"The differential cost of the brand versus the generic is many times over the cost of the test," Epstein pointed out.
Effient was introduced in July and so far has gotten off to a relatively slow start. U.S. sales were $21 million in the third quarter, a fraction of the $4.9 billion generated by Plavix in the U.S. in 2008.
Growing Body Of Research
The GeCCO project builds on a growing body of research into genetic variations that predict which patients will benefit from clopidogrel. A study by University of Maryland researcher Alan Shuldiner and colleagues, presented earlier in 2009, made a strong case for the CYP2C19 theory and attracted widespread attention.
Medco has also conducted research into the genetic basis for therapy non-response with a large database study involving co-administration of Plavix with a proton pump inhibitor. The study found the PPI, which is metabolized using the same pathway as Plavix, muted the efficacy of the anti-thrombotic. The findings led to an FDA safety alert 4.
Medco is also collaborating with FDA on research aimed at updating drug labeling with genomic information. However, the agency was not involved in the design of the GeCCO study, Epstein said.
- Cathy Kelly
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