Warfarin Dosing Issues Emerge In Early Results From Medco/Mayo Research

Nearly three-fourths of early patient participants in a warfarin research project appear to need non-standard dosing of the drug based on genetic screening, Medco reported during its analyst day presentation Nov. 16.

Preliminary results from the personalized medicine project were reviewed by Medco Senior VP Medical and Analytical Affairs Rob Epstein. The project is a collaborative effort by Medco and the Mayo Clinic.

Based on tests in the first 112 patients, Epstein said, 73 percent "need a dose change; they either need it up or down."

A smaller subgroup of that 73 percent "need a significant lowering of the dose," Epstein said, adding the Mayo Clinic "is actually calling those physicians - not even waiting for the lab slips to get to them - to let them know these people really need attention right away."

Medco announced the collaboration with Mayo in December 2006. The research project aims to determine the appropriate dose of warfarin by using a pharmacogenomic test to predict how certain patients will metabolize the drug. The researchers have approached 400 patients to participate in the study and plan to enroll a total of 1,500.

An analysis of Medco's claims data for patients starting warfarin found that 22 percent wind up in the hospital due to either a clot or a bleed, Epstein noted. Medco has about 700,000 warfarin users in its claims database, he said.

Health Plans On Board

Twenty-six of Medco's health plan clients have expressed interest in getting members tested as they start warfarin therapy, Epstein reported. He added the majority (75 percent) of physicians who have been approached as part of the research project "are very eager" to have their patients tested.

In August, FDA approved revised labeling for the commonly used blood thinning drug that details how genetic variance produced different responses to the drug. Despite the labeling change, only one of the physicians who have been approached thus far to participate in the study "had ever heard of the test," Epstein pointed out.

During his presentation, the Medco exec also provided an update on the firm's other recent foray into personalized medicine - its collaboration with LabCorp on genetic testing that would improve outcomes with the breast cancer drug tamoxifen. The agreement was announced in October ¹ , p. 23).

So far the firm has gotten a somewhat lower acceptance rate for such testing by physicians (60 percent) treating the first 100 patients approached to participate in the study, he noted. The research is expected to enroll 500 patients overall.

Medco's personalized medicine projects are part of a broader, value-added initiative in what the firm calls "therapy management." The pharmacy benefit manager's therapeutic resource center program is providing a basis for building expertise in managing drug use in a number of chronic and complex conditions (² (Also see "Medco Takes Mail To The Next Level With Free Therapeutic Resource Centers" - Pink Sheet, 14 Aug, 2006.), p. 21).

Discussing the business impact of the firm's strategic focus on therapy management, CEO David Snow stated that "what we're doing ... has been a major source of wins in the marketplace for us already, just upon the promise."

Addressing Medco's market position relative to CVS/Caremark, Snow predicted "a new battle, or competitive positioning between the companies as we go forward. And ... it's going to be around clinical value proposition."

Former Caremark President Jim Dickerson, who made a presentation on Medco's behalf, supported the concept. "I've always said that I think the value of a PBM ... is in the front of the pharmacy and not the dispensing," he said.

"My former home has gone the way of merging with someone who's in the dispensing business," he continued. "But I think the issue that payers and employers and ultimately the individuals will be concerned about is, how do I get the right drug to the right individual at the right price? And that's the front of the pharmacy more so than the back." Dickerson is now executive VP of HealthNow, New York, a Blue Cross and Blue Shield plan.

- Cathy Kelly ([email protected])