Speaking of costs, milton,
A New Pap Test Will Cost More,
But Some Question if It's Worth It
By LAURA JOHANNES
Staff Reporter of THE WALL STREET JOURNAL
Is an improved Pap test worth an extra $15? That depends on
whom you ask.
For two years, Cytyc Corp. salesman Craig Sands tried to
persuade the country's largest medical insurer to cover his
company's new high-tech test to screen women for cervical
cancer.
Last spring, Mr. Sands met yet again with Arnold W. Cohen,
Aetna/U.S. Health Care's medical director for women's
health. This time, highlighted in yellow in the research paper
he handed to Dr. Cohen, was this: Cytyc's test, ThinPrep,
detected 55% more "high-grade" -- or serious -- precancerous
lesions than the traditional Pap test.
The doctor remained unswayed. The study was "too small a
sample," he says, to convince him the test was worth the
price. ThinPrep, which relies on a new method of sample
taking and preparation, costs $15 to $20 more than the
standard Pap. "There are 50 million Pap smears done a year,"
Dr. Cohen says. "So we're talking about a billion additional
dollars for a technology that has yet to be proven to improve
people's lives."
Early Promise
Cytyc's future looked promising in May 1996, when the test
got U.S. Food and Drug Administration approval. Six months
later, the FDA deemed it "significantly more effective" than
the ubiquitous standard Pap test, invented by George
Papanicolaou and essentially unchanged since its introduction
50 years ago.
But Cytyc is finding that concerns over cost and efficacy have
colored views of what constitutes a major medical advance.
After more than two years on the market, and despite early
optimism, Cytyc's test accounts for only 5% of the Pap
smears being done in the U.S. And although the FDA and
many specialists regard ThinPrep as a significant
improvement in early cancer screening, most health insurers
do not.
Only about 12% of the nation's insurers are willing to pay at
least $15 extra for the test, says Cytyc's Chief Executive
Patrick J. Sullivan. Insurers -- and ThinPrep competitors --
have raised basic questions about how much more effective
the test is in the first place. One insurance-company-funded
analysis on ThinPrep uses an increasingly common
methodology: calculating how much it costs per year of life
saved. Its author, Stanford University economist Alan Garber,
says annual use of ThinPrep would cost more than $300,000
-- borne mostly by insurers -- for every year it prolongs a
woman's life, compared with $27,000 per year saved with a
conventional Pap test.
'Incremental Technologies'
"We have many incremental technologies coming along that
give small benefits and are very expensive," Dr. Garber says.
"It's not going to be feasible in the long term to say 'yes' to
everything that may be better and ignore the costs."
This stance was recently bolstered by the American College
of Obstetricians and Gynecologists. The influential doctors'
group acknowledged that ThinPrep finds more potentially
precancerous abnormalities, but declined to recommend it as a
standard of care, citing high costs and noting that clinical trials
haven't proven that the earlier detection actually saves lives.
Proving this is a tall order. Cervical cancer grows slowly,
often taking 10 years or more from the first signs to the
invasive stage. So even if a woman gets one faulty Pap
reading, her diseased cells will likely be detected in time to
save her life if she returns the next year for screening.
ThinPrep hasn't been proven any better than the standard Pap
in detecting full-blown cancer.
Many insurers say they are better off spending their limited
dollars on reminding women to get the standard low-tech test
regularly. Cytyc charges laboratories $9.75 for each kit, plus
$40,000 for the machine to process it. The company says it's
worth the money, as early detection allows women to get
treatments that are less invasive and less expensive.
Opposing Efforts
Thus Cytyc, which has yet to turn a profit, has waged a
major lobbying and public-relations effort in support of its
main product, to try and win over doctors, insurers, legislators
and women's groups. It has funded research that duels with
research critical of ThinPrep. Meanwhile, competitors,
struggling for the same scarce insurance dollars, are trying to
get the test's FDA approval revoked.
The conventional Pap -- in which physicians smear a sample
scraped from the cervix onto a slide, then spray a fixative on
it -- has dramatically reduced the incidence of cervical cancer,
which now kills about 5,000 women a year. It is one of the
most common screening tests for women. But by varied
estimates, 15% to 40% of women with cellular abnormalities
test normal. In a 1995 study, Yale University researchers
estimated that of a large sample of cervical-cancer cases they
studied, 21% occurred in women whose slides had been
misread.
With Cytyc's test, the cervical sample is taken with a spatula
that is then immersed in a vial of preservative fluid -- assuring
that no cells are lost -- as some are when the spatula is thrown
out in a standard Pap. The vial is sent to a laboratory, where
a machine removes blood and mucus and spreads the cells
evenly onto a slide. Many technicians find it easier to read
than a regular Pap, which is often cluttered by debris.
'The Ones You Don't Want to Miss'
When the FDA approved ThinPrep, Cytyc stock more than
doubled to $33.75 a share, giving the company a value of
$459 million. Cytyc hired a sales force of 30 to call on
doctors, and got support from prominent opinion leaders such
as Columbia University pathologist Ralph Richart. Dr.
Richart, initially skeptical, says he changed his mind after
seeing evidence that the test found more high-grade
abnormalities. "Those are the ones you really don't want to
miss because they are likely to become cancer," he says.
The first inklings of how tough the sales job would be came in
September 1996, four months after FDA approval. Mr.
Sands, medical director James Linder and two other company
officials went to see Dr. Cohen in Blue Bell, Pa., armed with
a slick poster presentation to convince the insurer not only to
convert to ThinPrep, but also to feature it in ads aimed at
women.
A few minutes into the meeting, the Cytyc team realized it
was in trouble. Dr. Cohen wasn't impressed that Cytyc's test
detected 19% more abnormalities than the standard Pap. Dr.
Cohen saw Cytyc's advantage in its capacity to discern
"low-grade" problems, which often disappear without
treatment, Mr. Sands said. "He basically came out and said 'I
don't care about the results of low-grade. You've got no
cancers here, and I don't see how this is going to save a
woman's life and it's going to cost me $40 million. Thank you
very much, goodbye,' " Mr. Sands says.
This was before the later study homed in on ThinPrep's
ability to detect high-grade precancerous lesions. (Dr. Cohen
maintains that study isn't convincing and says he is focusing
his limited funds on a letter campaign reminding women to get
regular Paps. That campaign has increased compliance 16%
this year, he says.)
In the same period, a Cytyc-funded study by Quintiles
Transnational Corp., a research firm, concluded that
ThinPrep will save money by detecting abnormalities earlier
and by reducing the number of unreadable tests, which must
be redone.
FDA Boost
Cytyc then got a big boost when the FDA gave the company
the right to call its test "significantly more effective" in
detecting precancerous abnormalities. United HealthCare
Corp., the nation's second-largest insurer, decided to cover it,
and by Nov. 21, 1996, Cytyc stock rose to $28 a share, from
$12 earlier that month, when the stock was down from its
May high, largely on profit-taking by original investors.
But in March 1997, a negative "Physician's Alert" was sent to
gynecologists across Ohio by medical-malpractice underwriter
P.I.E. Mutual Insurance Co., Cleveland. The report warned
that government regulations allow technicians to read twice as
many ThinPrep slides daily as standard Paps and pointed out
that human error from overquick readings had been one cause
of undetected cancers in the past. "While the ThinPrep
process may increase laboratory productivity," the report
concluded, "it may do so at the cost of patient harm and at
the cost of increased liability."
P.I.E. retracted its comments in an April 11 press release.
P.I.E., which Cytyc sued for defamation in U.S. District
Court in Cleveland, says it stands by the truth of the original
report and only retracted it in an attempt to avoid litigation.
The lawsuit is pending, as is a separate suit in U.S. District
Court in White Plains, N.Y., against competitor Neuromedical
Systems Inc., and its then chief executive, Mark Rutenberg.
Cytyc alleges that the report was prepared with help from
Neuromedical, which sells a computer rescreening service
called PapNet.
Mr. Rutenberg says he did meet with the report's author,
P.I.E. medical director Richard Ludgin, prior to preparation of
the report, but that the doctor "did his own investigation" of
the competitor's flaws. He says he initially met with Dr.
Ludgin prior to publication of the report to discuss PapNet's
potential role in lessening malpractice risks. Subsequently, Mr.
Rutenberg says, the doctor called him with questions about
competitor ThinPrep, "and I referred him to certain papers
written about Cytyc's technology." Dr. Ludgin, named in the
Ohio suit, stands by the report, his attorney says.
In July last year, seven petitions, largely from people with
links to Cytyc competitors, were filed asking the FDA to
review its decision to approve ThinPrep. The FDA is still
considering the petitions, which came at a critical time for
Cytyc in Washington. There, Medicare officials were deciding
whether to cover ThinPrep. Cytyc's Mr. Sullivan traveled
regularly to the capital, asking key health-care staffers to
support Medicare reimbursement. Lobbyist Mimi Mager
helped get women's groups to write letters supporting
coverage.
Meanwhile, in the Northeast, where new medical techniques
are often adopted first, Cytyc launched an ad campaign.
"Since I have to have a Pap test," the woman in the ad said,
"I want the one that improves detection."
In December, Harvard Pilgrim Health Care, the largest
health-maintenance organization in New England, decided to
cover the test. "This is a women's health issue -- potentially
inflammatory -- and we pride ourselves on our reputation for
women's health care," says Roberta Herman, who heads a
committee that reviews which technologies the HMO will
cover.
Earlier last fall, an influential group of female gynecologists,
Women's Health Connecticut, sent out a letter asking insurers
to cover the new test. All the state's major insurers
subsequently approved coverage.
Medicare also decided to cover the test, effective Jan. 1.
President Clinton highlighted the decision to cover the
"lifesaving technology" in a holiday radio address. But that
was only the beginning of the battle, since Medicare allows
regional administrators to set payment rates, which are used
to set a national rate at the end of a year's time. Cytyc shifted
its focus to getting a high coverage price, hiring lobbyists in a
handful of critical states, including Texas, Florida and
California.
Cards of Protest
James E. Alexander Jr., Medicare medical director for Blue
Cross and Blue Shield of Texas, originally had planned to allot
$7 for each ThinPrep -- the same as a regular Pap -- but soon
found his mailbox full of protest postcards from doctors, who
had mailed them at Cytyc's urging. He also got a letter from
U.S. Rep. Bernice Johnson, a Democrat from Dallas, arguing
that the $7 rate would "severely limit access" to the test, and
an angry call from Raheelah Ashfaq, director of
cytopathology at the University of Texas Southwestern
Medical Center.
Dr. Ashfaq, who helped test ThinPrep, says Dr. Alexander
argued that the real cervical-cancer problem is that women
don't get Paps often enough. She replied, "all the more reason
why they should get the best available test we can give them
when they do come in." Recently, Dr. Alexander raised the
rate to $14.50 -- still below the $20 to $25 labs say they need
to break even.
In mid-1997, Cytyc doubled the number of salesmen calling
on insurers to six and hired 15 more to call on doctors. It also
decided to pay 450 Bristol Myers Squibb Co. salesmen to
pitch ThinPrep with their other products. Then, in February
of this year, came another blow: The study, funded by the
Blue Cross and Blue Shield Association's Technology
Evaluation Center, and written by Dr. Garber, the Stanford
economics professor.
Circulated to about 40 insurers, the study determined that
ThinPrep would add only about five hours to the average
woman's life if used every year instead of the traditional Pap.
Cytyc, which disputes the accuracy of Dr. Garber's report, is
keeping up the pressure. One of its lobbyists recently
convinced a Pennsylvania state representative to file a bill that
would require insurers in the state to cover ThinPrep. And
Cigna Corp., after numerous pitches, decided last month to
cover the test. "We're seeing a light at the end of the tunnel,"
says Mr. Sullivan.
If so, the glow is intermittent. On the day of Cigna's decision
came the American College of Obstetricians and
Gynecologists' decision not to endorse ThinPrep as a standard
of care. "New," says Stanley Zinberg, vice president of the
doctors' group, "does not necessarily always mean better."
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