Since updating drug labels with genetic test information has not encouraged physicians to adopt molecular diagnostics, Dx shops should emulate pharma’s model of reaching out directly to physicians, an FDA official suggested at a recent American Association for Clinical Chemistry meeting.
“What does change physician behavior in study after study is direct selling to physicians, and that is something that doesn’t exist in the business model of today’s diagnostics world,” Larry Lesko, director of FDA’s Office of Clinical Pharmacology & Biopharmaceutics, said during last week’s AACC meeting on clinical applications of pharmacogenomics.
“There are no diagnostics companies that I know of directly selling tests to physicians,” Lesko said. “But that is the success of the pharma companies getting physicians to prescribe their drugs. We have to look into that.”
Because Lesko made his recommendation as the theranostics field is still finding its feet, some industry insiders question whether the diagnostics industry has the sturdy scientific data required to support an aggressive promotional strategy.
Another FDA official has recently said that co-developing drugs and diagnostics, and not necessarily genetic label updates, may be the best way to familiarize physicians with pharmacogenomics [see PGx Reporter 01-03-07].
At least one diagnostic shop has already been employing what Lesko has been touting: Genomic Health has used direct selling with published clinical data to encourage physicians to adopt its Oncotype Dx breast cancer recurrence test.
Genomic Health President Kim Popovits last November said that the company had recently increased its sales force to better familiarize physicians with Oncotype Dx after the company committed itself to conducting and publishing multiple large clinical studies [see PGx Reporter 01-18-06].
Genomic Health began 2006 with 30 representatives targeting oncologists. In the first quarter of 2007 the company plans to expand its direct field sales force to 50 reps.
Genomic Health also appears to be pumping more money into its promotional efforts, having spent $24.6 million in 2006 on sales and marketing, a 60-percent increase over the previous year.
The strategy has helped revenue to surge over the last two years from $327,000 in 2004 to $29.2 million in 2006. In 2006, Genomic Health sold 14,500 of its Oncotype Dx tests, more than double what it sold in 2005.
“The majority of the usage in the quarter has come from physicians who have used the test multiple times and we are seeing increasing penetration in the physician community,” Popovits said [see PGx Reporter 11-08-06].
Ultimately, however, a large sales force won’t have much success convincing doctors to incorporate a diagnostic into their treatment regimen if they don’t feel that they will be reimbursed for it.
On the reimbursement front, Genomic Health has been particularly successful. During a recent earnings call, the company boasted that its Oncotype Dx will be reimbursed by various payors covering nearly 100 million lives.
The company recently penned a national payor contract with UnitedHealthcare and Aetna, and signed contracts for reimbursement with several regional payors as well.
Clinical Data is another dx shop that recognizes the importance of securing reimbursement to help fuel physician adoption. The company began providing its PGxPredict line of homebrew tests last year to PharmaCare — the fourth-largest PBM in the US covering more than 30 million members — to identify patients at risk for being improperly dosed for warfarin or for developing a potentially fatal adverse event when on clozapine.
“The key issue is that incentives are not aligned in the US healthcare system, and therefore other than for clinical reasons, physicians have difficulty complying with new approaches that provide no direct incentive,” Clinical Data CEO Drew Fromkin told Pharmacogenomics Reporter this week.
“Those payors that are providing tools and pay-for-performance opportunities for physicians with respect to adoption and compliance of clinical and quality measures as well as new technologies such as pharmacogenetic testing will align some of these incentives and expedite adoption of these valuable tests,” he said.
“Having large direct sales forces is an unbelievably expensive proposition for Dx companies, especially with the already very burdensome regulatory and anemic reimbursement approaches in place for diagnostics today,” Fromkin added.
Not the ‘Right Answer’
Some, particularly in academia, argue that unleashing armies of sales reps to sell diagnostics directly to physicians may not work.
“There are no diagnostics companies that I know of directly selling tests to physicians, but that is the success of the pharma companies getting physicians to prescribe their drugs. We have to look into that.”
“I do not believe that direct marketing to physicians is the right answer,” Raju Kucherlapati, scientific director of the Harvard Partners Center for Genetics and Genomics, told Pharmacogenomics Reporter. “I think that it is important for physicians and patients to understand that genetic knowledge would help physicians to reach the correct diagnosis and would allow them to craft treatment regimens that have the highest likelihood of success.”
The HPCGG recently launched a study to measure patient outcomes and cost when genetic information is used to make clinical decisions about warfarin [see PGx Reporter 11-15-06]. According to Kucherlapati, the results of these large outcomes studies will be the most convincing to both physicians and payors.
Another strategy is one followed by Connecticut-based pharmacogenomics company Genomas. Gualberto Ruano, the shop’s president, said the company keeps close contact with physicians to promote its technologies.
Genomas markets the DiMS Phyziotype medical-management system, which helps physicians determine a patient’s risk for developing diabetes-related complications for several atypical antipsychotics, and provides options for drug selection or further preventative treatment.
Ruano said Genomas partners with hospitals to ensure that its platforms are “embedded in the health-care delivery system” [see PGx Reporter 01-10-07].
According to Ruano, who was a founder of Gennaissance, Genomas makes presentations at the hospitals and with laboratory distributors and conducts in-practice workshops.
“We go to the practice of the doctor and say, ‘Here is this test, here is this technology, here is this medical need,’” Ruano said.
He also emphasized the importance of publishing real-world examples of how its technology performs and how the tests were developed.
Genomas has recently partnered with mental-health hospitals to conduct a study with two atypical antipsychotics – Eli Lilly’s Zyprexa and Janssen’s Risperdal – using its PhysioGenomics technology platform. Genomas hopes that these partnerships and close interactions with doctors will help attune physicians to using its technology to help them prescribing the drugs. The PhysioGenomics platform is currently under development, and will be on the market in late 2008.
“Our strategy has been to never impose the technology on physicians,” Ruano has previously said. Rather, the company aims to “demonstrate the benefit to the patient. Once you do that I think it will become very clear that this is a way to prescribe these very effective medications [that] have potential side effects.”