By Turna Ray
Medco is steadily becoming the go-to organization for diagnostics developers looking to gather clinical data on whether their pharmacogenetic tests improve patient outcomes. However, it is still unclear whether the results of Medco's outcome studies will improve reimbursement and adoption of PGx tests.
Celera this week announced it is collaborating with the pharmacy benefit manager to conduct a prospective, randomized study to evaluate whether testing for the KIF6 gene variant increases patient adherence with statin therapy.
This is the fourth collaboration to study the outcomes of pharmacogenetic tests that Medco has disclosed in the last three years.
Medco, the second largest PBM in the US with 60 million beneficiaries, is working with the Mayo Clinic to study whether PGx-guided warfarin dosing affects patient outcomes and with the Laboratory Corporation of American to determine if Roche's AmpliChip improves dosing for tamoxifen [see PGx Reporter 12-04-06, 10-31-2007].
Even the US Food and Drug Administration is using Medco's large patient databases to assess the pharmacogenomic safety and efficacy of currently marketed and investigational drugs, and to determine which drug labels should be updated to include genetic risk information [see PGx Reporter 08-20-2008].
Celera and Medco's 1,300-patient study is slated to begin this fall. The KIF6 testing is currently offered through Celera subsidiary Berkeley HeartLab's CLIA-certified laboratory, which analyzes blood and buccal samples. The company is planning to seek regulatory clearance for the test from the FDA.
In the Medco/Celera study, researchers will investigate whether patient adherence to statin drugs is higher in those patients tested for KIF6 status than in those who are not offered the test. Medco plans to test 650 of its beneficiaries for the gene variant and compare statin adherence to a group of the same size who weren't offered the test. Testing will be conducted by BHL, and Medco will monitor statin adherence.
Last year, Celera tested the market for the KIF6 test by offering it to a limited group of physicians and patients. At the time, Celera officials noted that in the test population, uptake of the test was strong and predicted insurers would be willing to reimburse for the test.
At the UBS Global Life Sciences Conference in New York this week, David Speechly, Celera's VP of corporate affairs, said that since launching the test as a homebrew last year, the company has analyzed 130,000 samples, receiving an average reimbursement of around $100 per test from private insurers and around $80 per test from Medicare.
Celera declined to comment on whether it hopes to drive further adoption and improve the reimbursement prospects for the KIF6 test by garnering positive outcomes data through the research collaboration with Medco.
"As this is a research study, it does not have any impact on commercial activities," Speechly told Pharmacogenomics Reporter by e-mail. "It would be premature to think about the outcomes until the study concludes."
Studies have shown that the KIF6 gene variant, present in approximately 60 percent of the population, confers a 55 percent increased risk for coronary heart disease, independent of other risk factors such as age, gender, smoking status, diabetes, and lipid levels. Simultaneously, those who carry the gene variant have also shown in studies to see a greater than average benefit from statin therapy, an outcome independent of cholesterol lowering, resulting in fewer cardiovascular events.
On the other hand, studies have shown that only between 50 percent and 60 percent of patients who receive a statin prescription continue to take the medication after six months. Compliance falls to between 30 percent and 40 percent after two years in patients with coronary artery disease.
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Ultimately, since statin adherence is lowest among heart disease patients, in conducting the outcomes study with Medco, researchers are investigating whether carriers of KIF6, after knowing their genetic risk factor and therapeutic advantage, will stick to taking their statin drugs.
Payors have resisted reimbursing for certain pharmacogenetic tests, such as those for warfarin dosing, unconvinced by what they feel is scant clinical evidence confirming that such tests improve patient health and incur savings.
Although insurers will watch for the Celera/Medco study results with interest, it is not entirely clear what impact the data will have in improving reimbursement and driving adoption of the KIF6 test.
At a conference in August, an official from United Healthcare asked Felix Frueh, Medco's VP of research and development of personalized medicine, whether he thought Medco's outcome study on PGx-based warfarin dosing was going "to be the last word" on whether such testing is adopted. To that, Frueh responded it was very difficult to predict how the market would respond to Medco's findings.
The impact on adoption and reimbursement from Medco's studies will be better known once it has reported results from its studies looking at PGx testing prior to warfarin and tamoxifen administration. Medco's Chief Medical Officer Robert Epstein told Pharmacogenomics Reporer this week that Medco will release full results for both studies in the first quarter of 2010.
Ideally, if the Celera/Medco study shows that genetic risk data does improve adherence to taking statins, it could encourage more insurers to reimburse for the test. Inevitably, insurers will pay attention when the results of the 18-month study are announced.
The fact that Celera is conducting a prospective, randomized trial may be particularly convincing for insurers.
Earlier this year, the Centers for Medicare & Medicaid Services said it would cover PGx-based warfarin dosing only for Medicare beneficiaries who are part of a prospectively designed, randomized-controlled trial showing pharmacogenomics-guided dosing strategies improve health outcomes over standard dosing methods [see PGx Reporter 05-06-2009].
At the time, many observers noted that an RCT-design was not appropriate to answer the question of whether warfarin testing improves patient outcomes.
Medco's Frueh has previously said Medco's two observational studies looking at the clinical utility of pharmacogenetic testing prior to treating patients with the anticoagulant warfarin and oncologic tamoxifen may provide an alternative model to RCTs that is more suitable for assessing the benefits of diagnostic tests [see PGx Reporter 08-19-2009].
However, the fact the Celera/Medco study is prospective and randomized in design may not be to simply appease insurers, even though if the study is successful, its design will be a favorable point with payors.
Celera maintains the study design was appropriate in the case of its KIF6 test.
"This is a research collaboration and the design was chosen to answer the adherence question," Speechly said.
Furthermore, Medco's Epstein said that the PBM has "a number of studies either underway or about to launch that are prospective in nature, some randomized and some not."