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Insurers Say More Evidence Needed for Significant Resource Push Behind PGx

At a conference on personalized medicine last month, an official from Aetna maintained that there is little evidence to suggest that pharmacogenomic strategies reduce healthcare costs.
“If you want people to consume [genomic medicine], if you say there is value, then you have to demonstrate value,” Joanne Armstrong, Aetna’s senior medical director, said at a conference in Boston hosted by the Harvard-Partners Center for Genetics and Genomics.
Armstrong, who developed the genetic counseling program at Aetna, said she was struck by the number of speakers at the conference “who presented, as a point of fact, that personalized medicine will reduce healthcare costs.
“I would say that there is virtually no evidence that that’s the case,” Armstrong maintained. “I believe … intuitively it makes sense, but there is virtually no evidence.”
Among large national insurers, Aetna, which covers nearly 15 million Americans, is in many ways a pioneer in the area of genomics-based personalized medicine policies.
As early as 1998, Aetna developed a comprehensive program of coverage policies, physician education, and privacy provisions around BRCA testing for inherited breast and ovarian cancer. Two years ago, Aetna incorporated genetic testing into its hepatitis C clinical management program based on the National Institutes of Health’s treatment guidelines.
Aetna was also the first insurer to implement a privacy policy for genetic data. The policy, which it enacted in 2002, was adopted by America’s Health Insurance Plans and has became the industry standard. Last year, Aetna adopted an employment genetic nondiscrimination policy, and last month it began offering its members confidential telephone and web-based cancer genetic counseling services as part of benefit plans that cover genetic testing.
While Aetna has in many ways embraced personalized medicine, the insurer also holds a high bar for evidence standards when determining which genetic tests to cover. For instance, Roche Diagnostics’ FDA-approved AmpliChip is one product that has yet to meet Aetna’s evidence requirements for reimbursement.
Even though the test is FDA approved, Aetna notes in its policy that Roche should perform controlled clinical trials to prove that the test will reduce adverse drug reactions. Aetna also has asked that Roche compare the AmpliChip, which interrogates CYP2D6 and CYP2C19 polymorphisms, with standard therapeutic drug-monitoring techniques.
Roche officials have spoken out against insurance companies having too stringent coverage requirements for genetic tests by holding them to the same evidence standards as drugs and other medical products [see PGx Reporter 04-25-2007]. 
Also at the conference, Sam Nussbaum, executive VP and chief medical officer of WellPoint, said that officials from the insurance company met recently to discuss PGx-based dosing for the anticoagulant warfarin. WellPoint, along with Aetna, does not cover genetic testing for warfarin, even though the FDA has approved a genetic test for warfarin sensitivity and asked drug companies to update the drug’s label with genetic testing information.

“So the first challenge … is how do we justify diverting the resources of the organization to promote something that has the potential to drive quality and value, but in fact there is no evidence that there is some value that will be derived from it,”

Nussbaum cited warfarin as an example of the uncertainties surrounding clinical utility of genetic tests. He noted that a trial published in the Nov. 7 issue of Circulation did not reach its primary endpoint of a reduction in bleeding outcomes, as measured by out-of-range international normalized ratio.
To this, Lawrence Lesko, director of FDA’s Office of Clinical Pharmacology countered that insurers were focusing on the negative aspects of the study and ignoring the positive finding that an algorithm guided by pharmacogenetic and clinical factors improved the accuracy and efficiency of warfarin dose initiation [see PGx Reporter 12-05-2007].
“There is a sort of bias in the way we look at personalized medicine to kind of look for reasons why not, instead of the reasons why,” Lesko said.
In the past, Aetna’s Armstrong has asserted that insurers need to see the “value proposition” of genetic tests if they are to cover them. She reiterated similar sentiments at the HPCGG conference, noting that “the real question we should be asking is, ‘What is the value of personalized healthcare?’ How do we define it, how do we measure it, and how do we push the measurement through the system?”
According to Armstrong, given the current state of the science, it is difficult to justify contributing significant resources to covering genomic medicine. For example, she said, if one looks at ICD-9-defined diagnostic tests to determine how significant genomic medicine is in the treatment of Aetna’s members, “it’s miniscule.”
Specifically, a review of ICD-9 codes for genetic tests showed that within the Aetna system, plans spend approximately 30 cents per member per month on genetic tests, representing 0.31 percent of total medical spending. “So the challenge … is how do we justify diverting the resources of the organization to promote something that has the potential to drive quality and value, but in fact, there is no evidence that there is some value that will be derived from it,” she posited.
Armstrong defined “value” as some quantifiable measure in medical and economic outcomes based on what the standard of care is. While Armstrong holds that there is still no appropriate evidence to claim that genomic strategies incur healthcare savings, based on her definition of “value,” the insurer has had first-hand experience of an economic benefit after incorporating genomic technologies for treatment of hepatitis C patients.
After implementing its hepatitis C management plan to include viral genotyping to determine the length of treatment for patients, Aetna determined that 10 percent of members had not been managed appropriately. The company incurred $4.3 million in savings as a result of adopting viral genotyping.
Still, Armstrong outlined several barriers to the more widespread acceptance of genomic medicine for insurers, particularly the need to demonstrate the evidence of efficacy and clinical utility of genetic tests. The clinical utility aspect is the “real bugaboo,” she said. 

In this regard, Aetna is conducting two clinical utility studies, one on Her-2 testing for Herceptin and another on OncotypeDx’s impact on adjuvant chemotherapy decision-making for breast cancer patients. Aetna did not say when these trials would be completed.

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