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Lack of Physician Education, Genetic Counseling Could Ruin Value Proposition of PGx Testing, Insurer Says

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This story has been updated from a previous version to clarify that data from United Healthcare competitors suggest that approximately 80 percent of requests for Myriad Genetics' BRAC Analysis tests are withdrawn after mandatory genetic counseling and precertification procedures.

By Turna Ray

WASHINGTON, DC — Since most physicians lack the experience to decide which of their patients should receive certain pharmacogenetic tests, a major US insurer has begun holding diagnostics developers responsible for making sure the wrong patients are not getting tested.

In the case of Genomic Health's Oncotype DX breast cancer recurrence test, UnitedHealthcare noticed that many women were getting the wrong treatment as a result of inappropriate testing, Lee Newcomer, senior vice president of oncology at UnitedHealthcare, said during a conference here on next-generation diagnostic testing hosted by Cambridge Healthtech Institute.

In response, as a condition for reimbursement, "we made [Genomic Health] screen the patients," Newcomer said.

Under the terms of its agreement with Genomic Health, if the insurer sees the test is being "erroneously used" in too many instances, then UnitedHealthcare may renegotiate its reimbursement contract for Oncotype DX.

Fortunately for Genomic Health, UnitedHealthcare's assessments show that with the company pre-screening to determine which patients are right for Oncotype DX, "the test is being used properly," Newcomer said.

UnitedHealthcare, which provides insurance to 70 million individuals in the US, began covering Oncotype DX in January 2007. On Genomic Health's website for patients, mytreatmentdecisions.com, the company provides an automated decision profiling system that helps determine whether an individual's particular type of breast cancer fits the requirements for testing with Oncotype DX. Regardless of the outcome of the survey, patients are directed to speak with their physician.

According to Newcomer, the limited ability of physicians to determine which patients should receive certain genetic tests often compromises the value proposition of pharmacogenetically guided medicine — even if the diagnostic is shown to be clinically useful and analytically sound.

"Unfortunately, the physician community is not well enough versed in genetics to do the testing," Newcomer said, adding that inaccurate testing keeps the payor from seeing the cost-savings that the technology promises to yield by giving the right drug to the right patient.

Genomic Health's Oncotype DX isn't the only diagnostic that has been impacted by the lack of physician knowledge about genetic testing.

UnitedHealthcare's analysis has revealed that at one point as many as one out of three women received the wrong treatment due to doctors' misinterpretation of HER-2 testing results. "There were between 200 and 300 different ways of reporting HER-2 test results," Newcomer said. "There is no standardization for reporting results."

Additionally, United Healthcare competitors that have mandated precertifications and genetic counseling before covering Myriad Genetics' BRACAnalysis have reported that as much as 80 percent of the requests for the test are withdrawn after this process, according to Newcomer. Myriad does help doctors screen which patients should receive testing by administering a questionnaire at doctors offices and on its consumer website.

Myriad launched a television advertising campaign in September 2007 for its BRACAnalysis test. After Myriad's DTC campaign launched, many doctors complained that their practices were not equipped to handle the resulting influx of patients who saw the ads and wanted to be tested for BRCA mutations.

According to Sue Friedman, executive director of the patient advocacy group Facing Our Risk of Cancer Empowered, a growing number of breast and ovarian cancer patients are reporting instances of receiving either too little or the wrong information about their genetic risk for developing cancer from commercial firms [see PGx Reporter 01-07-2009].

In addition to putting diagnostics developers in charge of pre-screening which patients should be tested, another strategy for avoiding genetic testing errors may be to mandate genetic counseling prior to administering the test, Newcomer suggested. Data from an undisclosed competing insurance company that requires genetic counseling prior to administering BRCA testing shows that 90 percent of those offered BRCA testing after counseling refused to get tested, he added.

Despite the benefits of genetic counseling, few diagnostics firms provide the service to their customers.

In an interview with Pharmacogenomics Reporter, FORCE's Friedman previously said that genetic counseling was the best way to ensure patients are educated about their genetic risk. "Currently, it's very hard for healthcare providers to know what they do and don't know about genetic testing unless they are experts in genetics," Friedman said, adding that "some of the biotech companies that are doing the genetic testing are discouraging a full genetic counseling process with experts who are qualified in genetics and facilitating less accomplished healthcare providers."

Overall, UnitedHealthcare's attitude toward reimbursement of pharmacogenetic testing is similar to the position of other insurers in that coverage decisions are contingent upon whether the intervention changes treatment decisions and incurs savings.

For instance, UnitedHealtcare, as well as competing insurance firms Aetna and WellPoint do not cover PGx-guide warfarin dosing due to a lack of clinical utility data [see PGx Reporter 12-05-2007].

"We need to be able to link what we learn from a test to clinical decisions," Newcomer said.

In his view, UnitedHealthcare does not see the value in preventative genomic screening services, such as those provided by 23andMe, Navigenics, and Decode Genetics. "What do you do with that information? Broad preventative screening does not have enough value to warrant coverage," Newcomer said. "Knowing something is one thing. But knowing something you can do something about is of more value to us."

As an example, he noted that since KRAS testing has shown to yield "tremendous" cost-savings and impact clinical decision-making, UnitedHealthcare has been reimbursing the test for the past three months.

The US Food and Drug Administration recently updated the labeling for colorectal cancer drugs Vectibix and Erbitux to note that patients with KRAS mutations will not benefit from the drug [see PGx Reporter 07-22-2009].

In UnitedHealthcare's view, one strategy that might drive adoption of PGx tests is to use pharmacy-benefit manager-type aggregators that can serve as a single stop for physicians and patients to receive genetic testing. National codes that allow insurers to reimburse each company for a specific diagnostic, as well as reimbursement based on the clinical impact of the test, are other coverage strategies being considered.

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