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 But there's a catch: Major insurance companies including Aetna,
Anthem and Cigna are declining to pay for the latest generation of
tests, known as multi-gene panel tests, Reuters has learned. The
insurers say that the tests are unproven and may lead patients to
seek out medical care they don't need.
That's a dangerous miscalculation, a range of doctors, genetic
counselors, academics and diagnostics companies said. While they
acknowledge that multi-gene tests produce data that may not be
useful from a diagnostic standpoint, they say that by refusing or
delaying coverage, insurance companies are endangering patients who
could be undergoing screenings or changing their diets if they knew
about the possible risks.
The tests have come a long way since Jolie, 39, went public in 2013,
revealing that she underwent a double mastectomy after a genetic
test found she carried mutations in the BRCA1 and BRCA2 genes,
indicating a high risk of breast and ovarian cancer. She disclosed
last month that she had her ovaries and fallopian tubes removed.
The new panel tests, which can cost between $2,000 to $4,900,
analyze 20 or more genes at once. That allows healthcare
professionals to establish possible DNA links to other
cancer-related conditions such as Lynch syndrome and Li-Fraumeni
Syndrome earlier. Humans have about 23,000 genes.
Susan Kutner, a surgeon at a Kaiser Permanente hospital in San Jose,
California, who serves on a U.S. Centers for Disease Control and
Prevention advisory committee on young women and breast cancer, said
more women with a family history of cancer should be able get these
tests.
"If we have members who are not being tested in a timely manner, we
know that their risk of cancer in the long run costs us and them a
lot more," Kutner said.
Kaiser, which insures its own members, covers panel tests for
patients with family histories of cancer.
That's not so at three of the four largest managed care companies.
Aetna Inc, Anthem Inc and Cigna Corp state in their policies that in
most cases they don't cover multi-gene panel tests. The fourth,
UnitedHealth Group, covers the tests if patients meet certain
criteria.
All insurers cover screenings for BRCA1 and BRCA2 and for certain
other genes for women who have family histories of cancer. Indeed,
such coverage is mandated by the Affordable Care Act, known as
Obamacare.
But many insurers said they simply don't know enough about the
specific risk of other mutations to justify coverage of the new
family of tests.
They also say that the tests may find mutations with a
well-established link to a disease, but which are difficult to
interpret. These results could lead to patients taking misguided
actions about medical care, such as preventive chemotherapy and
surgery.
Aetna's medical director of quality management, Robert McDonough,
said Aetna pays for testing of individual genes but that "the
routine application of a panel would be considered unproven."
Cigna's David Finley, national medical officer for enterprise
affordability, said multi-gene tests are more likely to find unknown
mutations for which there are no care guidelines.
"This is where there is controversy and disagreement," Finley said.
"My problem is what do you do with that information?"
Instead, he said, there need to be more clinical trials and research
to establish exact risks and medical guidelines for each type of
gene mutation.
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Healthcare professionals said that while they recognize the downside
of patients getting unclear information about their genetic makeup,
genetic counseling and support from doctors can mitigate risks.
CATCH-22
Mary Daly, a physician who chairs the National Comprehensive
Cancer Network guidelines panel for breast and ovarian cancer,
oversees the process for setting guidelines that most doctors in
this field follow. She points to what is, in effect, a "Catch 22:"
Without insurance coverage of these tests, there isn't enough data
to analyze how effective they are.
"If we don't start looking at these genes, we'll never obtain the
data we need," she said.
Leading academics in genetic research also dispute the claim that
multi-gene tests produce too much confusing information, saying they
often lead to beneficial steps such as cancer screenings.
"The utility of panel testing is that we know there are a lot more
genes beyond BRCA1 and BRCA2 that are associated with cancer
predisposition," said Colin Pritchard, a University of Washington
geneticist.
Pritchard said the understanding of the link between genetic
mutations and cancer is evolving quickly. A recent study in the New
England Journal of Medicine established rates of breast cancer
associated with a mutation in one of the genes included in many of
these panel tests, known as the PALB2 gene.
Hereditary cancers are expected to account for about 5 percent of
the 230,000 cases of invasive breast cancer that will be diagnosed
this year in the United States. In the year Jolie went public about
her testing, an AARP Public Policy Institute study found that BRCA
testing had risen 40 percent. Jolie’s spokesperson did not return a
call requesting comment on the multi-gene testing trend.
Myriad Genetics Inc, which accounts for 90 percent of the hereditary
cancer-testing market, said 15 of the 25 genes that National
Comprehensive Cancer Network guidelines indicate should be included
in multi-gene testing are in its "MyRisk" panel test. The business
represents a $5 billion global market opportunity for Myriad, the
company said in January.
Other lab companies including Ambry Genetics, Quest Diagnostics Inc
and Invitae Corp each offer a variety of panels that start at about
seven genes and go up to 40 genes.
"In general, the trend is moving toward more genes,” said Carin
Espenschied, a senior products manager at Ambry and a genetic
counselor. "Research and insurance companies kind of just have to
catch up."
(Reporting by Caroline Humer, editing by Michele Gershberg, Eric
Effron and John Pickering)
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