By Turna Ray
Instead of marketing its genomic services directly to consumers, Navigenics has been working with employer-based wellness programs, a strategy the company believes will be able to drive adoption of personalized medicine faster than doctors can by themselves.
"Employers are overlooked but play a central role in a lot of primary care screenings that happen in the US today," Vance Vanier, Navigenics CEO, said at a conference on personalized medicine last week in Mountain View, Calif. "Navigenics in the last few years has focused its business on the employer channel," he added, noting that the company is particularly interested in providing employers with genetic predisposition testing to inspire behavioral change and compliance in their employees.
Among the employers that have offered Navigenics' genomic screening services are Cisco, Intel, Scripps, and several other West Coast health and technology companies.
While Navigenics was still a DTC firm, it was offering its full suite of genomic screening services for around $1,000, and a pared down version for $499. In working with employers, the cost for the service is often subsidized, and therefore the price will vary within different employer wellness programs.
Although gene scans like the ones marketed by Navigenics are not currently covered by insurance companies, Vanier told PGx Reporter this week that employees can use money set aside in employers' health care flexible spending accounts or health savings accounts to pay for the cost of their genetic testing services.
Vanier further noted that even though employers are offering genetic testing services through wellness programs, employees' genetic test results are not shared with employers or any other third party, as mandated by the Genetic Information Nondiscrimination Act.
In its original incarnation, Navigenics was among a handful of high-profile firms that a few years ago launched the direct-to-consumer genomics industry. However, the fact that companies like Navigenics, 23andMe, and Decode Genetics were using web-based marketing to sell genomic analysis services directly to consumers soon became a point of concern for state health regulators in California and New York, who felt that these companies should not be selling unvalidated genetic data that could be used to guide healthcare and make serious medical decisions without the involvement of their physicians (PGx Reporter 06/25/08).
Then, last year, when one DTC genomics firm, Pathway Genomics, tried to market its service in traditional, brick-and-mortar pharmacies, the US Food and Drug Administration and the US Congress stepped in to reign in the rapidly expanding consumer genomics industry (PGx Reporter 07/28/10). After a period of intense regulatory and congressional scrutiny, many of the top companies in the nascent consumer genomics field moved away from the DTC model, including Navigenics, which shifted its strategic focus away from the consumer market and toward physician groups and corporate wellness programs.
While Navigenics still provides information about its DNA testing services on its website, the company informs site visitors that they can only purchase its services through a physician participating in its network. Additionally, people interested in getting genetically tested can contact the company to find out if their employer offers its services.
Navigenics was one of the first consumer genomics firms to partner with a physicians' network, MDVIP, to incorporate its DNA analysis services as part of annual physicals (PGx Reporter 02/04/09).
"One would imagine that pharmacogenomics should be the sole domain of the physician's office and that's really where you would see an acceleration of adoption," Vanier said during his talk at the conference. But, he said, it's actually "employer-facing entities," such as pharmacy benefit managers Medco and CVS Caremark, "that I would argue have done more to raise the level of awareness of adoption and increased level of discourse around pharmacogenomics than any provider-focused entity has done to date."
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According to Vanier, Medco currently has 10 million employed lives under its PGx management program, and CVS Caremark, which launched its personalized medicine program a year after Medco, is projecting that it will have 3 million to 4 million covered lives under its program this year. "If you look at the scope and scale that employers are able to bring, as opposed to the one-at-a-time physician office strategies, it's again a model that's worth thinking about," he said.
Navigenics began experimenting with the employer-based model in 2008, when it began working with Scripps Translational Science Institute, Affymetrix, and Microsoft to conduct a multi-year investigation into whether genomic information inspires behavioral changes in consumers (PGx Reporter 10/17/08).
The results of that clinical trial, recently published by Scripps Translational Science Institute Director Eric Topol and colleagues in the New England Journal of Medicine, showed that information about people's genetic predisposition to various diseases had little impact on their anxiety levels. This finding debunks the belief held by many critics who maintain that giving consumers unfettered access to their genetic data will cause them to worry more about their future health and lead to unnecessary healthcare procedures (PGx Reporter 01/12/11).
Unfortunately for Navigenics' new strategic focus, the interim results of the study also showed that genetic information did not change diet, exercise behavior, or use of screening tests in the overall study population. "The group as a whole did not change lifestyle or diet, but the 25 percent [of study participants] that worked with a physician did change their lifestyle or diet," Vanier said at the conference.
The results of the study suggest that doctors do need to stay involved, but they also make a case for reaching out to employers. "While the physician and provider community are extremely important in driving this change, they are not the only powerful constituency that can help or harm personalized medicine," Vanier said, adding that employers fund 80 percent of the healthcare in the US.
In the genomics industry, employers are still an untapped resource when it comes to driving adoption of emerging technologies and personalized medicine. Navigenics is betting that its screening services will find a place in corporate wellness programs in the same way that mammography screening services are becoming commonplace at some companies.
Vanier cited the example of the brewer Coors, which has set up mammography clinics on site to help women get screened for breast cancer while at work. "The notion is that if a woman can walk downstairs from her place of work, she can have the screening done in 15 minutes, as opposed to the half day she might have to take off to go to the traditional centers such as the physician's office," Vanier said. "What they saw in a few years was an extraordinary compliance rate: 83 percent of women complied and got a mammography, which is about double the rate of compliance US-wide in traditional settings."
Coors isn't the only corporation providing on-site wellness programs. According to Navigenics, 76 percent of US employers offer primary care screenings on site and as of last year 25 percent of them are investing in on-site clinics and screening programs — a potentially profitable market if genomics data can lead people to adopt healthier lifestyles.
Since the Scripps study only reported on behavior change at five months, Vanier is hoping that long-term data will suggest that genetic information does inspire lifestyle modifications. The fact that the initial data from the study showed that participants that discussed their genetic information with their physician did make changes is "extremely promising," Vanier noted. "We're looking forward to following this study over time."
Additionally, the NEJM study demonstrated how employers can be a good source for consumer-supported genetic research, a model that DTC genomics firms believe will spur the kind of large-scale population-based genomics research necessary to prove whether genetic testing improves outcomes and reduces healthcare costs.
As part of the study published in NEJM, the researchers offered employees of San Diego health and technology companies, as well as their friends and families, with discounted genetic testing services from Navigenics for their participation in the clinical trial. The companies that participated in the study were Scripps, Life Technologies, the energy firm Sempra, and the telecommunications company QualComm.
Although the trial design was unorthodox, Vanier pointed out that "several thousand people showed up for the study in the first few months."
Most study participants paid $200 for Navigenics' entire suite of genomic services, which normally costs around $1,000. One company, Sempra, covered the full cost of genetic services for 1,000 employees that participated in the study. Although many Sempra employees were eager to get the test for free, the researchers found that those who did join at no cost were less likely to complete the study surveys about behavioral change.
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