Standard of Care
“It’s absolutely critical for a diagnostic test to be accepted as a standard of care by clinical guidelines,” insisted Pierre Cassigneul, president and CEO of XDx. “Gaining FDA clearance for AlloMap® (a noninvasive assay to manage the risk of heart transplant rejection) did nothing for reimbursement or clinical adoption. Instead, outcome studies to determine comparative effectiveness made the difference in physician adoption and payer acceptance.”
Since those studies, AlloMap has been added to the protocols of nearly 50 of America’s organ transplant centers. Several insurers, including Aetna and Blue Cross of California, now consider the test medically necessary.
Mickey Urdea, Ph.D., co-founder, chairman, and CSO of Tethys Bioscience, also emphasized the need for physician education so that physicians understand the implications of test results and how to use those results. Tethys identified biomarkers that appear 15 years before patients become diabetic, and has developed a blood test for prediabetics that accurately predicts the onset of diabetes as early as five years before it presents.
“Not all prediabetics develop diabetes,” Dr. Urdea explained. Therefore, physicians can use this test to identify the subset of the prediabetic population most able to benefit from interventions.” Dr. Urdea is working with prevention specialists to develop materials to help physicians apply this technology in their practices. “Work with thought leaders in the field and publish in the best journals you can,” he advised.
CardioDX is speeding adoption by working closely with primary care physicians and payers, according to Dr. Kilpatrick. Using the gene-expression blood test Corus® CAD, labs can quickly identify symptomatic patients who are unlikely to have obstructive coronary artery disease (CAD) and, therefore reduce the number of patients needing coronary angiography. The test also provides gender specific diagnostics—an important feature because, “female patients are typically atypical,” Dr. Kilpatrick said. “About one-fifth of the women undergoing elective heart catheterization actually need it.”
By working with providers, Corus CAD is being reimbursed while outcomes data is gathered. “We’re finding a receptive payer community around coverage with evidenced development,” Dr. Kilpatrick said.
Cancer Comments is doing something similar for oncologists and their patients by capturing information about combination therapies and outcomes from thousands of provider sites, according to Jay “Marty” Tenenbaum, Ph.D., founder of Cancer Comments and chairman of CollabRx .
“To deal with combination therapies, it’s important to capture information from every patient,” he stressed, as only about 5% of cancer patients participate in clinical trials. “It’s the central mission of Cancer Comments to give every patient the best possible outcome by capturing the learnings in the thousands of oncology offices.”
Evidenced development strategies are seen as a strategy that may, sometimes, replace large-scale Phase III trials, particularly for complex diseases and for small patient populations for which large trials are difficult to enroll. After safety is validated, “regulators should allow a drug to be validated in specific populations, and data collected while the drug is on the market,” said Carlos Santos, Ph.D., CSO, Biovest International.
“In the age of very targeted therapies, clinical trials shouldn’t be a block to deliver drugs to patients. There’s a happy medium, but the regulatory and legal landscapes have to evolve.”