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PBM Power Behind Pharmacogenomics: CVS Caremark Launching Program

Executive Summary

CVS Caremark is expanding its commitment to pharmacogenomics with a new clinical and testing services program being developed in collaboration with newly-formed Generation Health, which describes itself as a genetic benefits management company

CVS Caremark is expanding its commitment to pharmacogenomics with a new clinical and testing services program being developed in collaboration with newly-formed Generation Health, which describes itself as a genetic benefits management company.

Announced Nov. 10, the program initially is expected to focus on predicting how patients respond to about a dozen drugs in therapeutic areas including oncology, cardiovascular disease and HIV treatment.

Clinical services including genetic testing will be introduced to CVS Caremark's health plan and employer clients in the second quarter of 2010. Services could be used for clinical benefits such as identifying patients who do not respond to certain therapies and thereby avoid disease progression from HIV or prevent cancer recurrence. Clients would pay for the testing.

Describing the rationale for the collaboration, CVS Caremark Chief Medical Officer Troyen Brennan said, "Personalized medicine is a fast-growing field, but the process for providing relevant and systematic clinical delivery of service needs to improve and evolve."

"We will integrate Generation Health's unique skills in genomic medicine with the experience in benefit management of both companies to provide clients with a sophisticated, evidence-based clinical approach."

When To Pay For Testing

Generation Health's areas of expertise include: evaluating clinical evidence to determine the clinical utility of tests and generating cost and outcome models to support evidence for reimbursement.

Generation Health has put together a "Best Test" laboratory network to manage testing costs for payers. The firm has also developed data and analytics to review gaps in care among patients, and outreach programs addressing communications between patients, physicians and pharmacists.

The new effort by CVS Caremark expands upon the pharmacogenomic intervention services currently offered through the PBM's specialty drug unit.

Future programs are expected to target use of medical diagnostics, encouraging appropriate and cost-effective testing for certain hereditary diseases and eliminating unnecessary testing where evidence for clinical validity and utility is lacking.

With the Generation Health collaboration, CVS Caremark becomes the second of the major PBMs to publicly boost its commitment to pharmacogenomics. Medco has been a leader in the past few years in promoting personalized medicine through research with outside partners and in programs available to clients. Express Scripts has been reviewing pharmacogenomics but has not yet publicly announced any major new programs.

A total of 170 of Medco's clients, covering seven million individuals, are participating in Medco personalized medicine programs, according to the firm. Medco has supported research on pharmacogenomics that focuses on predicting the way drugs are metabolized based on genetic mutations. Ongoing studies are designed to evaluate the use of genetic testing to help calibrate warfarin dosing and to determine what patients will respond appropriately to tamoxifen in breast cancer.

Other research, released in November 2008, flags a possible reduction in the effectiveness of Bristol Myers-Squibb/Sanofi's Plavix (clopidogrel) when the anti-clotting agent is used concurrently with a proton pump inhibitor (1 "The Pink Sheet" DAILY, Jan. 26, 2009).

Medco also plans a head-to-head comparison of the effectiveness of Plavix versus the new anti-clotting therapy Effient (prasugrel) in those patients who are determined through genetic testing to be good responders to Plavix (2 (Also see "Medco "Genetics For Generics" Research Anticipates Plavix Patent Loss" - Pink Sheet, 26 Oct, 2009.)). Effient is marketed by Lilly and Daiichi Sankyo.

CVS Caremark's project with Generation Health does not involve sponsoring new studies but focuses on practical applications of existing research, Generation Health Chief Marketing Officer Rick Schatzberg said in an interview.

The companies are also looking at areas in which genetic testing is generally accepted by payers and clinicians - such as testing for warfarin dosing prior to elective surgery - as opposed to routine screening prior to initiating warfarin. Generation Health has close ties to Medco: the firm was co-founded by two former Medco executives, Schatzberg and Per Lofberg.

- Cathy Kelly ( 3 [email protected] )

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