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Dx Shops Have to ‘Pound the Pavement’ Like Big Pharma, Genomic Health Official Says

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SAN FRANCISCO – Multiple studies, peer-reviewed publications, and pounding the pavement with an aggressive sales force like big pharma is the strategy behind Genomic Health’s success in getting physicians to adopt and insurance companies to cover its breast cancer recurrence test OncotypeDX.
 
“We see sales where we have a sales force,” Genomic Health CEO Randy Scott said at a conference hosted by Burrill & Company here this week. “The pharma industry is not stupid. With a new technology like this, this is the way forward: Get reps to pound the streets and keep reminding, educating, winning over the physician community.”
 
Over the past year, Genomic Health increased its sales force by 67 percent, from 30 reps at the start of 2006 to 50 reps this year. President Kim Popovits last November said that by increasing the sales force the company aimed to better familiarize physicians with OncotypeDX following the publication of multiple large clinical studies supporting the test [see PGx Reporter 01-18-06].
 
The strategy appears to be working. Sales of OncotypeDX for the three months ended Sept. 30 surged almost 130 percent to $15.8 million from $6.9 million in the year-ago period. Since the test launched in early 2004, more than 6,600 physicians in the US have used it to help plan breast cancer treatment for 39,000 patients, according to the company.
 
The view that the road to profitability for diagnostics shops is the sales model paved by pharma is gaining increasing traction in the industry. Myriad Genetics in September launched a big pharma-style advertising campaign for its BRACAnalysis test to gauge patients’ risk of developing breast and ovarian cancer [see PGx Reporter 09-12-2007]. 
 
Even regulators have noted that updating labels with genetic testing information, particularly for drugs that have been out on the market for many years like the anticoagulant warfarin or the oncologic tamoxifen, may not impact physician behavior. However, what will fuel physician adoption of genetic tests, according to Larry Lesko, director of FDA’s Office of Clinical Pharmacology & Biopharmaceutics, is promoting these products directly to physicians as pharma does [see PGx Reporter 03-07-2007]. 
 
Genomic Health’s Strategy
 
According to Popovits, more than half of all insured individuals in the US are now covered for OncotypeDX. During the third quarter, the company signed reimbursement contracts with CareFirst Blue Cross Blue Shield, which insures 3.2 million people, and Blue Cross Blue Shield of Arizona, which insures 1.1 million people. In addition, the company signed a contract with WellPoint to cover OncotypeDX with certain restrictions.
 
Despite the company’s successes, company officials have made no secret of the fact that “the number one barrier to usage remains reimbursement” [see PGx Reporter 11-30-2007].
 
Payors often balk at covering genetic tests in the absence of prospectively defined clinical data assuring that the product is medically necessary or has significant clinical utility. Such studies are expensive, require a large cohort of patients, and take years to complete.
 
However, Genomic Health has attempted to drive reimbursement and physician adoption through a strategy that combines science and selling. OncotypeDX is being validated in a prospective study of 10,000 early-stage breast cancer patients, called the Trial Assigning Individualized Options for Treatment, or TAILORx, sponsored by the National Cancer Institute and administered by the Eastern Cooperative Oncology Group.
 
“When we started out, we basically started out with a fundamental Genentech business model, which said, ‘Good science will drive success,’” Scott said.
 
He noted, however, that in conversations with payors, the company quickly realized that payors were not swayed by a single study, no matter how strong the data. “Payors have said, ‘Well, we’ve been burned before and good science should be repeatable. So, we want to see multiple clinical studies,’” Scott noted.
 

“The pharma industry is not stupid. With a new technology like this, this is the way forward: Get [sales] reps to pound the streets and keep reminding, educating, winning over the physician community.”

“So, we built our program around multiple, clinical improvements around clinical studies.” The company also performed a validation study for OncotypeDX with Kaiser Permanente, following which the insurer came on board to cover the test, Scott recounted.
 
The American Society of Clinical Oncology – a group representing 25,000 oncology practitioners and all oncology disciplines – recently updated its treatment guidelines for breast cancer to include genetic testing on OncotypeDX, based on multiple independent clinical studies of more than 2,600 breast cancer patients, including a large validation study published in the New England Journal of Medicine and a chemotherapy benefit study published in the Journal of Clinical Oncology.
 
Also, the Annual San Antonio Breast Cancer Symposium, to be held in December, has accepted three abstracts on OncotypeDX authored by company researchers and collaborators. And last month during the ASCO Breast Cancer Symposium in San Francisco, Genomic Health announced results from three studies that support the use of quantitative real-time PCR, like the kind used in OncotypeDX, to measure estrogen receptors and progesterone receptors in early breast cancer.
 
Finally, preliminary results from an OncotypeDX study in women with node-positive, hormone receptor-positive breast cancer conducted by the Southwest Oncology Group and Genomic Health suggest the test’s utility in predicting survival without breast cancer recurrence and chemotherapy benefit for both node-positive and node-negative breast cancer. Genomic Health plans to present this data at the San Antonio Breast Cancer Symposium.
 
Scott noted that these types of studies are critical to getting reimbursement for OncotypeDX, since payors usually won’t cover a test that costs over $200 without clinical validity and utility data. OncotypeDX costs between $3,200 and $3,500.
 
Despite the cost of the test, Scott said “it’s no accident that the company is now getting reimbursement from over half of the major payors,” in the US. “The clinical community really went to bat for our test.”
 
Reputation Management
 
However, while big pharma’s promotional strategies have bolstered drug sales, concern over serious adverse events to popular drugs for depression and erectile dysfunction, has also painted the industry as being more concerned with profits than with public health. In this regard, selling too aggressively like big pharma could result in a backlash from the physicians’ community.
 
Following the launch of Myriad’s four-city advertising campaign for BRCAnalysis in September, healthcare professionals expressed concern that the promotional blitz would increase requests for BRCA1 and BRCA2 genetic testing to an unmanageable volume and that they wouldn’t have enough time or expertise to appropriately counsel these women.
 
According to reports, health officials feared that the ads may encourage women at low risk for developing breast and ovarian cancer to take unnecessary medical measures.
 
Furthermore, Connecticut Attorney General Richard Blumenthal has said his office has received reports from healthcare professionals that BRCAnalysis has a potential for “misinterpretation and overreaction” and is investigating the accuracy of Myriad’s claims in its ads for the test.

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