"Payers often drive the agenda in terms of adoption,” says Kathryn Phillips, professor of health economics and health services research at the University of California at San Francisco. “It's inevitable that we're going to have more personalized medicine, and it has the potential to improve quality and lower costs. But we need to do a lot to realize that potential.”
Lynn Dowling knows this all too well.
A longtime hospital business development consultant, Dowling was diagnosed with breast cancer in 2005. Under American Cancer Society guidelines, Dowling's best course of treatment was chemotherapy. But she began researching chemotherapy's harsh side effects, both short- and long-term, and decided she wanted to avoid chemo if at all possible.
She heard about a test developed by Genomic Health, a Redwood City, Calif.-based pharmaceutical company. Called Oncotype DX, the test can help predict whether a breast cancer patient will benefit from chemotherapy by examining the tumor tissue at the molecular level. The test can also predict risk of recurrence.
Dowling's insurance company wouldn't pay for the test, which at the time cost $3,500. But she thought it was well worth the price out of pocket. Her test results indicated that she had a low risk of cancer recurrence, and that chemotherapy would have no extra benefit. Her 10-year survival rate was 96% if she just took the breast cancer drug tamoxifen. If Dowling chose tamoxifen plus chemotherapy, her 10-year survival rate would rise to 97%, she says.
“I was so impressed with that precision,” Dowling says. “The nasty secret is that my tumor was the most common type of tumor, and that only 4% of women with that tumor benefit from chemotherapy.”
Five years later, Dowling says she is in perfect health, and estimates she saved her insurance company $50,000 in chemotherapy drug costs by paying for that $3,500 test.
In 2007, the American Society of Clinical Oncology included Oncotype DX in its clinical guidelines on the use of tumor markers for breast cancer. Genomic Health last month launched a similar colon cancer test.
As for Dowling, she became a convert to personalized medicine, and began looking for a hospital in the San Francisco Bay area to launch a program. “I started running around like Paul Revere, shouting 'Genomics is coming! Genomics is coming!' ” she says.
Dowling was turned down by several other health systems, and her search led her to El Camino Hospital. She now serves as a consultant to the hospital's Genomic Medicine Institute.
But she recognizes that the hospital must show a return on its investment. Under the program, hospital patients and their families can get free genetic testing, and participate in genomic research. The hospital is not seeking payer reimbursement for these services.
“We've got to be able to show that this activity gives us a competitive advantage and directs business to the hospital that we wouldn't otherwise get,” Dowling says. “I'm confident we can do that.”
El Camino has partnered with DNA Direct to provide testing and genetic counseling to patients. DNA Direct, based in San Francisco, is also partnering with managed-care company Humana to provide genetic counseling to targeted members.
At El Camino, physicians can refer their patients for genetic counseling, and use available tests to help clinical decisionmaking.
Because it is in the heart of Silicon Valley, El Camino hopes to attract partnerships with other companies engaging in personalized medicine, and become a beta test site for companies developing new technologies.
Other health systems across the country are also diving into personalized medicine, including Oakland, Calif.-based Kaiser Permanente, which is creating its own genomic databank. Geisinger Health System in Danville, Pa., has launched MyCode, a personalized medicine project, and is linking members' genomic information to its electronic health-record system. Both Kaiser and Geisinger are integrated systems.
Still, providers face a steep learning curve in this field, and reimbursement is far from ensured today.
It won't be pharma companies or providers that lead the way in personalized medicine, Levy predicts. Companies outside of healthcare could be formidable players—such as Nestle, PepsiCo, Procter & Gamble Co. and Wal-Mart Stores—because of their vast experience targeting consumers and focus on the wellness market.
PricewaterhouseCoopers advises providers to partner with experts in personalized medicine and adopt electronic health records to support further advances in the field.
The upside could be tremendous, Levy says.
“I don't see anything else able to increase the population's productive health—meaning the years people spend leading healthy, productive lives—like biomedical science,” he says. “There is no other thing that comes close.”