ATLANTA — The reality in life sciences is that you need physician buy in for any new medical technology. The gee whiz factor just doesn't count unless the docs say "OK."
That's the conundrum presented by the makers of non-invasive diagnostic tests: a potential boon for patients, but an economic slap for many physician practices. Strategies to overcome these challenges were addressed by a panel at BIO2009, the annual meeting of the Biotechnology Industry Organization (Washington).
"The important fact is that we have a powerful wind at our back because there is a palpable level of patient interest in genetic testing," said Vance Vanier, MD, chief medical officer, Navigenics (Redwood Shores, California), a genetic service company that gives customers information about their chances of developing up to 18 common conditions (MDD, June 4, 2008).
"Most of the 700,000 physicians in the U.S. didn't have any genetics as part of their curriculum," Vanier said. "Plus, there's no long-term outcome studies that prove if physicians use this risk information, it will affect their patients outcomes down the road."
Direct-to-consumer genetic tests are indeed a challenge to market to doctors. But Vanier cited a recent survey of 1,000 adults done by Johns Hopkins University (Baltimore) in which 91% said they would want to have a genetic test. "How can we address this consumer interest to affect physician adoption? Most physicians come to us because consumers are asking them about genetic testing," Vanier said.
His company has taken that opportunity to educate and partner with physicians. And to prove the value of predictive genomics testing, the company launched a nationwide trial last year in Southern California in which 10,000 patients will have the Navigenics test and then be followed for 20 years to find out if their behaviors changed according to what they learned from the test. What's most unique about this test – and a sign of the active consumer interest is that patients paid to enter the trial.
Aside from the rampant consumer interest, what are the practical steps that medical technology companies can take to insure adoption of new, specifically non-invasive, diagnostics tests? Ellen Sheets, MD, chief medical officer, Predictive Biosciences (Lexington, Massachusetts), a developer of diagnostics for cancer management, said that in addition to building a case of the strength of a new test, device makers have to shepherd a change in clinical patterns of care as well as reimbursement challenges.
"You have to build the case," Sheets said. "You want white papers and reviews of the technology, but company sponsored data is often looked on skeptically. So at Predictive, we launch a Clinical Laboratory Improvement Amendments (CLIA) lab to have doctors kick the tires early in the process. Regarding FDA approval, spend the money early to understand the FDA expectations and what your competitors are doing."
Predictive has also taken an approach to market its cancer tests with a different twist. The company makes use of a very traditional biomarker, but with a different way of looking at it: negative predictive value. They did this because doctors want to be able to assure patients that they don't have cancer.
"Don't tell physicians not to do cystoscopy, it's the only way to really see bladder cancer and they get reimbursed," Sheets said. "But when they think about it, they don't want to do an invasive procedure. And patients don't want to undergo this test repeatedly either. But when you change a pattern of practice, you have to convince physicians that it's going to become a normal practice flow."
Predictive's bladder cancer test will allow physicians to determine the presence or absence of cancer. This information, incorporated into current standard clinical practice, is expected to lead to more effective use of existing diagnostic tools – possibly fewer cytoscopic examinations – and ultimately better outcomes for patients. The assays are designed to detect urinary biomarkers associated with the physiological changes resulting from cancer development and progression. The initial focus for these tests will be the growing cancer survivor population and the large number of individuals undergoing clinical workups for cancer.
Regarding the loss of potential income if a non-invasive test replaces multiple cytoscopies, Sheet's said, "Doctors will walk away from certain income, depending on risk profile."
Mara Aspinall, president/CEO, Vivir Biosciences (Boston), said that there are three key elements that prompt physician adoption of new technologies: It starts with fear of the unknown and inability to help patients with existing diagnostics, then proving the value of the new technology and, finally, acceptance.
"We're not here to vilify physicians, but to ask how to get them interested and intrigued and not threatened by the market," Aspinall said. "The world has changed today and there is a more complex model of adoption."
She pointed out that CABG was introduced in 1979 but took 20 years to attain widespread adoption. PCI was introduced in 1987, but took 15 years to reach full adoption. And, diabetic self testing was first introduced in the 1980s but is only recently commonly recommended by doctors.
"Adoption often boils down to the clinical care pathways," Sheet said. "Sometimes physicians are antagonistic and sometimes cooperative. To convince them, start with the key option leaders in a field."
Douglas Onsi, partner, HealthCare Ventures (Cambridge, Massachusetts), addressed the reasons why there are difficulties adopting new technology from the standpoint of a venture capitalist.
"We worry that a therapeutic is 15% effective, but then we worry if a test isn't 100% effective," Onsi points out. "If you are venture capital investor, you have to imagine the path, we can't wait for physician guidelines."
But guidelines are often the last thing to change. Sheets reiterated that the key to physician adoption of new diagnostics tests is education and strong data.
"When you see quick adoption of a new test, it's because of the weight of the data," Sheets said. "Physicians won't wait for the guidelines."
Vanier agreed that physician education is key, especially for molecular diagnostics and genetics.
"This is not a field where you can give a one-hour CME course and wish them luck," Vanier said. "We built an in-house team of genetic counselors. Initially we hired them because the notion was that they would do counseling with patients. What's happened is that they will spend 60% of time with physicians who confer with them before the patients come into their offices."