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Citing Rise in Erroneous Test Requests, Aetna Investigates BRCA Testing Patterns in Two-Year Study

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By Turna Ray

Following multiple accounts from payors about rising levels of inappropriate BRCA testing to gauge which women are at higher hereditary risk for breast and ovarian cancer, national insurer Aetna said last week that it will survey testing patterns among women treated in a community healthcare setting. The findings of the two-year study, which payors will surely be closely reviewing, could impact how BRACAnalysis, Myriad Genetics' flagship product, is covered by insurers.

Aetna's announcement of the collaborative study with Georgetown University, University of South Florida, and the American Cancer Society follows reports by several insurers that around 20 percent of requests for BRCA testing within their systems do not meet professional society guidelines for hereditary breast and ovarian cancer screening (PGx Reporter 11/04/09).

"We have a hypothesis that a large amount of BRCA testing that is being performed is not being performed in an evidence-based manner," Joanne Armstrong, senior medical director and the head of women's health at Aetna, told PGx Reporter this week. Additionally, "there is suspicion, not in our data, but in data that's being published, that non-adherence to evidence-based guidelines in minority populations is even greater than that in white populations."

In the first national study of its kind, Aetna will review de-identified data on 13,000 of its members who have received BRCA testing in order to gain greater understanding of how physicians are making testing decisions and figure out whether access to such tests is limited for women from lower socioeconomic and minority groups. Additionally, the study will examine the how readily women use risk-reduction and screening services after testing.

Aetna was the first insurer to begin covering BRCA testing, and for more than eight years the insurer has been tracking testing patterns among its members through a prior-authorization schema. Within Aetna's system, orders for BRACAnalysis that don't meet professional society guidelines for cancer screening are "in the neighborhood of about 20 percent" in the general population of women. "That rate is increasing as the years go by," said Armstrong.

Published data suggests that the increase in the number of erroneous testing requests for BRACAnalysis has a direct relationship to Myriad's marketing practices. According to a 2005 Kaiser study, cited by Armstrong, the proportion of referrals for BRCA testing for patients with a high pre-test probability of a BRCA mutation decreased from 69 percent to 45 percent as a result of the company's direct-to-consumer marketing efforts.

As the sole commercial provider in the US of BRCA testing for hereditary breast and ovarian cancer, Myriad claims that approximately 96 percent of its revenue is paid by insurance companies, and 4 percent is paid by private individuals.

The high reimbursement rate for BRACAnalysis is perhaps even more reason for insurers to make sure that they aren't overpaying by covering testing for women whose medical histories don't show a need for it. On average, Myriad is reimbursed by insurers for approximately 92 percent of the $3,340 list price for BRACAnalysis, according to Myriad. Aetna's average reimbursement for BRACAnalysis is $3,120, which is 93 percent of the list price for the test.

Sell! Sell! Sell!

Insurers' concerns about BRCA over-testing haven't given Myriad's selling efforts any pause. On the contrary, in recent months, the company has continued to grow its sales force and increase its marketing activities, hoping to encourage more doctors to test patients with BRACAnalysis.

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During a time when unemployment is high, the number of uninsured is rising, and people are going to their doctors less, Myriad has only pushed harder with its sales force, through direct-to-consumer advertising and physician-to-physician efforts, to drive higher testing rates among doctors. The marketing push at Myriad is particularly focused on increasing testing rates among OB-GYNs, a segment that, according to the company, isn't testing patients nearly as much as it should.

Myriad splits its BRACAnalysis marketing into two segments: testing done by oncologists and OB-GYNs. Currently Myriad estimates that it has penetrated about 50 percent of the BRACAnalysis market in the oncology sector, but its entrance into the OB-GYN community has been much less successful, on the order of 10 percent.

According to Mark Capone, president of Myriad Genetic Laboratories, the company expects to be able to capture 75 percent of the oncology market via three fronts: by urging use of BRACAnalysis to gauge the likelihood that a patient may get ovarian cancer or that their disease might recur; to predict patients who might get a form of non-invasive breast cancer called ductal carcinoma in situ; and to test for the risk of triple-negative breast cancer. There are upwards of 40,000 patients per year in each of these diseases who may be appropriate for testing on BRACAnalysis, Capone said at the UBS Global Life Sciences Conference in New York this week.

On the women's health side, where BRCA testing decisions are made by OB-GYNs and where Aetna is focusing its study, Myriad estimates that there are about 6 million women who are appropriate for the test in the US, and that OB-GYNs should be administering between one to two tests per week (see related story, this issue).

"We've penetrated that market far less than 10 percent," Capone said at the meeeting, noting that for its 2010 fiscal year ended June 30, around 12,000 OB-GYNs in the US ordered BRCA testing, with an average of three to four tests per year.

"So we have a significant opportunity … in those OB-GYNs who are already ordering BRACAnalysis and for the 70 percent [of such doctors] who are not ordering" the test, he added.

Myriad expanded its sales force in FY 2010 by 15 reps, bringing its total number of sales representatives to 315. Currently, 150 reps visit oncologists' offices, while 165 reps focus on OB-GYNs. "We will continue to expand our sales force to get access to the rest of those OB-GYNs," Capone said, adding that the company eventually plans to increase the number of reps visiting this segment to 250.

Capone did not address the Aetna study at the conference.

Marketing Beyond Guidelines

The company claims that its marketing practices follow the American College of Obstetricians and Gynecologists' screening guidelines for hereditary breast and ovarian cancer.

ACOG's cancer screening guidelines, issued in March 2009, recommend OB-GYNs to routinely screen their patients for hereditary breast and ovarian cancer risk. The guidelines specifically advise OB-GYNs to conduct the initial screening evaluation by asking questions about personal and family history of breast cancer and ovarian cancer. After this general evaluation by the OB-GYN, however, ACOG advises doctors to send those patients who may be at higher risk to genetics experts for a more in-depth evaluation.

"ACOG's guidelines as [they are] written [are] completely in line with Aetna's approach in this area," Armstrong said. However, Aetna's interpretation of the guidelines doesn't square with Myriad's belief that routine screening of patients should translate into a higher rate of patients being tested.

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The ACOG guidelines "say that hereditary cancer risk assessment should be conducted by a healthcare provider but with expertise in cancer genetics. That's a really big but," Armstrong pointed out.

"Some OB-GYNs are trained and comfortable with providing genetic counseling and some simply are not," she added. "It's time intensive and it takes a lot of skill. The literature changes and it's complex science." As such, not all doctors get it right when screening their patients for hereditary cancer risk.

A 2009 study, conducted by the Fox Chase Cancer Center and published in Genetic Testing and Molecular Biomarkers, surveyed 860 Aetna-contracted primary care physicians and found that while 83 percent reported that they routinely assess hereditary cancer risk, 54 percent reported that only ask about first-degree relatives. In this study, only 33 percent reported that they take a full, three-generation pedigree for risk assessment, which, according to testing guidelines from professional societies across the board, is absolutely necessary to accurately determine who should be tested for BRCA mutations.

"What ACOG says is they expect some level of risk assessment and then they should triage to someone who can formally assess a patient who appears to be at high risk," Armstrong explained. "It does not say that every OB-GYN is supposed to become a tester" of BRCA.

Myriad encourages doctors to perform genetic counseling in most cases, highlighting that by doing the counseling themselves, they can bill insurers directly for the service (PGx Reporter 09/23/09). However, after facing some criticism for this practice, Myriad has claimed that it advises doctors to refer patients with "complex cases" to genetic counselors (PGx Reporter 02/10/10).

Aetna, similar to other insurers, reimburses BRCA testing for women who require it according to professional society treatment guidelines. Additionally, Aetna will pay for testing for family members related to a plan member, in order to better inform the care of a member. Under its prior-authorization scheme for BRACAnalysis, Aetna requires and covers face-to-face or telephonic genetic counseling.

"Our coverage policy matches best practices. You want to get to the person who is going to provide the most information to the whole family below them," Armstrong said. "It's the most efficient and it's the most cost-effective way of doing it."

Recognizing that insurers are interested in the healthcare savings they can realize through appropriate genetic testing, Myriad is also doing cost-effectiveness analysis of its tests. Capone said at the investor meeting this week that Myriad has several cost-effectiveness studies underway for its tests.

Ethnic Disparities

With the results of the two-year study, Aetna hopes to not only identify the causes of inappropriate testing but also figure out the factors causing testing gaps. Specifically, Aetna's study hopes to delve into why access to BRCA testing is particularly challenging for women in lower socioeconomic and minority groups.

A 2005 study published in the Journal of the American Medical Association reported that African American women with a family history of breast or ovarian cancer were five times less likely to undergo genetic counseling for BRCA1 and BRCA2 mutations compared to white women with similar family histories. In the study, this racial disparity persisted after researchers adjusted for differences in the probability of carrying a mutation, socioeconomic characteristics, risk perception or attitudes about risk, and discussion with primary care physicians about testing.

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Another study, published two years ago in Genetics in Medicine, surveyed primary care physicians that serve a large proportion of minority patients, and reported that they are half as likely as MDs serving low-minority populations to have ever ordered a genetic test. While this study was not specific to BRCA testing, Armstrong cited it as an example of the breadth of the problem with regard to access to genetic testing.

"It's not surprising, since we see these differences in other areas of healthcare," Armstrong said. "But why it is [with regard to BRCA testing] remains to be seen.

"Some of it may be mistrust … that exists among minority populations, particularly related to genetics," she added. "It may be due to differences in the physician network that minority patients see versus non-minority patients."

Other factors that may be causing gaps in testing may be patients' distance from primary care providers and genetics experts, a lack of screening tools for doctors, or a dearth of educational materials in this patient population, she said.

"We're hoping to get information through this study that will help us [better guide] the decision making, so that the care that now looks inappropriate and not consistent with guidelines can be attenuated, and the care with gaps, and patients who can benefit from testing who aren't getting it, can be amplified," Armstrong said.

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