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CVS Caremark, Generation Health Unveil 13 Drugs for PGx Testing Program, But Not Warfarin

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By Turna Ray

CVS Caremark this week announced the 13 drugs for which the pharmacy services provider will provide pharmacogenomic testing as part of a pilot program slated for launch in July.

Although CVS Caremark is offering PGx testing for many of the drugs that competitor Medco includes in its service, one major difference is that CVS Caremark will not be offering genetic testing to gauge warfarin sensitivity.

Late last year, CVS Caremark took a majority stake in the genetics benefits management company Generation Health to provide PGx testing services to its pharmacy benefits management customers (PGx Reporter 12/23/09). Although the initial program will be available to a limited group of customers in the coming months, PGx testing will be offered to all CVS Caremark customers starting next year.

The drugs in the pilot program include five generic drugs, including the immunosuppressant azathioprine, breast cancer hormone therapy tamoxifen, acute nonlymphocytic leukemia treatment thioguanine, seizure disorder drug carbamezepine, HIV drug abacavir, and soon to be generic anti-platelet drug Plavix (clopidogrel, manufactured by Sanofi-Aventis/Bristol-Myers Squibb).

PGx testing will also be offered for seven drugs dispensed through CVS Caremark's specialty pharmacy business, including hepatitis C treatments Pegasys (Genentech) and Copegus (Genentech); chronic myeloid leukemia drugs Gleevec (Novartis), Tasigna (Novartis), Sprycel (Bristol-Myers Squibb); non-small cell lung cancer drug Tarceva (Genentech/OSI); and the EGFR/HER2 dual inhibitor breast cancer treatment Tykerb (GlaxoSmithKline).

Rick Schatzberg, CEO of Generation Health, explained that the 13 drugs in CVS Caremark's PGx program were chosen through an internal process to identify “well-validated molecular tests that identify genetic variants which have the ability to predict drug response linked to meaningful clinical outcomes and that is actionable in the outpatient setting.“

After drugs are vetted internally by Generation Health experts for possible inclusion in the program, Generation Health's independent clinical advisory board reviews the PGx evidence on these treatments to determine whether the genetic testing would be medically actionable. Then a third round of review is led by CVS Caremark, which may sometimes involve the input of external experts. “Every opportunity is evaluated for four things: clinical evidence, clinical value, economic impact, and the ability to intervene,” Schatzberg told Pharmacogenomics Reporter this week.

In addition to announcing the 13 drugs to be included in its PGx testing services, CVS Caremark said it will expand its expand its genetics benefits management services in collaboration with Generation Health.

“For each drug therapy, testing will be coordinated through the industry’s first Best Test Genetics Network, a preferred provider organization of high-quality diagnostic service providers that offer evidence-based genetic and molecular testing,” CVS Caremark said in a statement.

The Best Test Genetics Network is the name CVS Caremark has given to its laboratory PPO. “As you know, many labs offer the same or similar tests,” Schatzberg added in an e-mail. “What we have seen, however, is that in addition to there being substantial pricing variation among labs, there is also significant variation in experience, testing turn-around time, technology used to conduct tests, the use of proficiency testing (internal and external), and the quality of their result reports. Lab and test-level credentialing ensure that the labs that support our programs meet the highest standards in each of these areas."

The Best Test Genetics Network is being launched to “manage the rapid growth of testing costs for payors,” the company added in a statement.

CVS Caremark is the largest pharmacy services provider in the country, operating 7,000 CVS/pharmacy and Longs Drugs stores; its Caremark Pharmacy Services division, which includes pharmacy benefit management, mail order, and specialty pharmacy; its retail-based health clinic subsidiary, MinuteClinic; and its online pharmacy, CVS.com. The GBM firm Generation Health was founded in 2008, with an aim to drive adoption of genetic tests among employers and payors.

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Medco's Moves

A few years before CVS Caremark entered the personalized medicine space, Medco began running pharmacogenomic studies for drugs such as warfarin and tamoxifen within a limited group of its customers to investigate the savings and efficiencies it could garner and to test the feasibility of rolling out such programs and services to a broader customer base.

The experiment seems to have worked. Medco recently announced that starting in July it will expand its PGx testing services to all of its customers, including employers, health plans, and other benefit programs. Through a new genomic services effort, called Precision Health Solutions, Medco is planning to offer clients PGx tests for the anticoagulant warfarin, tamoxifen, abacavir, Plavix, Gleevec, Sprycel, Tasigna, and Pfizer's HIV treatment Selzentry.

Like CVS Caremark, Medco initially rolled out its PGx testing services to a limited set of its customers, approximately 200 clients representing 7 million lives. With the launch of Precision Health Solutions, which also provides customers access to genetic counselors and online tools to guide physicians through pharmacogenomic and reimbursement decisions, all of Medco customers representing 60 million lives will have the option to enroll in the PGx testing program (PGx Reporter 05/26/10).

The standout difference between the PGx testing offerings from CVS Caremark and Medco is that CVS Caremark isn't offering genetic testing to dose warfarin.

Medco presented data in March from an observational pharmacogenomic warfarin dosing study, in which researchers found that hospitalizations due to any cause and due to blood clots or excessive bleeding for heart patients taking warfarin dropped by approximately 30 percent when genetic information was available to doctors (PGx Reporter 03/17/10).

Although many doctors in and outside of Medco's system have said that based on the study results they would adopt genetic testing as a tool for dosing the highly variable anticoagulant, many doctors and researchers have expressed dissatisfaction with the study as it was not a randomized-controlled trial. Another barrier to adoption for healthcare providers and payors when it comes to warfarin is that the turnaround time for genetic testing results isn't quick enough for the procedure to be meaningful in an acute setting.

The problem with delayed turnaround times is the reason pharmacogenetic testing for warfarin didn't pass through CVS Caremark and Generation Health's vetting process.

In the outpatient setting, by the time the test results come back, they are "no longer actionable,” Schatzberg said, adding that even in the Medco study the turnaround time was as long as 30 days — a factor that Medco acknowledged as an unfavorable feature of its study.

“In this case, the INR is a well established surrogate biomarker used to titrate Coumadin,” Schatzberg said, adding that Generation Health will “continue to explore opportunities for these tests in the inpatient setting prior to initial Coumadin administration/loading dose.”

CVS Caremark plans to carefully monitor, during the first six months of the initial rollout of its program, "the effectiveness of the scripts used by our pharmacists and benefit specialists with physicians and members; the length of physician and member calls, as well as the volume of in-bound calls received in order to staff the program for the expanded roll out," Schatzberg said.

“We don't just test everyone on these drugs; we have 'gating' criteria which differs for each test and we make this determination by consulting with the prescribing physician,” he said. “This adds to the complexity of the call but it assures that testing utilization is appropriate so that the program is cost-effective for our clients.”

Under the pilot program, approximately 150,000 eligible members will have the option to sign up for PGx testing through CVS Caremark starting in July. The company plans to add clients representing up to a million lives over the course of the following few months.

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