Reimbursement remains a big challenge to the widespread clinical adoption of precision medicine.
"The top challenges facing personalized medicine are reimbursement, reimbursement and reimbursement," said Alexis Borisy, partner in Third Rock Ventures during a Personalized Medicine Coalition conference in 2016.
The 21st Century Cures Act and the Centers for Medicare and Medicaid Services' policy, coding and payment changes over the past three years have not lessened Borisy's statement. Innovation, often seen in spurts, can also be glacially slow.
While the 21st Century Cures Act encourages modernization, there is a lack of a clear regulatory pathway to encourage investment in the field, according to a Personalized Medicine Coalition report released in 2017.
The Department of Health and Human Services is starting to drive more regulation to define reimbursement drivers, said Assaf Halevy, CEO and founder of 2bPrecise.
There remains significant challenges in establishing payment for diagnostic tests that reflect the value of the care, making it difficult for payers to set rates, Halevy said. Insurers need to be able to monitor the value of the payments. Currently, there's about 200 billing codes associated with 70,000 tests.
"The correlation is so limited," Halevy said. "It prevents payers from understanding why the genetic test was ordered."
However, Halevy believes as the government reimburses for innovation, private payers will move forward as well. Reimbursement is moving in the right direction.
"I think this is the beginning for commercial payers," Halevy said.
But while Halevy agrees that so far, "in the big picture, reimbursement is not there," the most pressing challenge to precision medicine's adoption at the point of care is not payment.
"It's more a culture of an organization and leadership and how open they are to disruptive innovation," Halevy said.
Genomics is not currently seamlessly integrated into the clinical workflow, said Halevy, who founded 2bPrecise to close that gap.
Increasingly, patients are coming to physicians with their genetic record, with the expectation that the physician will take it into consideration for care.
"They'll not only ask for it, they'll come with it," Halevy said. "They'll say, 'I did my own test out-of-pocket. Tell me what to do with that.'"
While the number of patients showing up with their genetic record is not yet overwhelming, consumers are getting ahead of their physicians in this space, he said.
"Part of the challenge," Halevy said, "is physicians need to catch up."
In 2017, the Personalized Medicine Coalition issued the Personalized Medicine Report on the status of precision medicine.
Drugs are one example showing that the patient population is not one-size fits all, the report said.
The report gave the percent of the patient population taking a particular drug in its class, for which the drug was ineffective: 38 percent of patients on antidepressants; 40 percent on asthma drugs; 43 percent on diabetes drugs; 50 percent taking arthritis medication; 70 percent of Alzheimer's patients; and 75 percent taking cancer drugs.
Oncology remains among the largest fields for precision medicine focus.
In tackling tumors, the percentage of patients whose tumors are driven by certain genetic mutations that could be targets for specific drugs include 73 percent with melanoma; 56 percent with thyroid cancer; 41 percent with lung cancer; also 41 percent with pancreatic cancer; and 32 percent with breast cancer, among other cancers cited, the PM report said.
"There is a pharmacogenomic potential to optimize quality and safety for each patient," Halevy said. "It faces numerous challenges to widespread, clinical adoption."
One in every four Food and Drug Administration drugs approved from 2014 to 2015 was a personalized medicine, accounting for 27 percent of new drug approvals in 2016, the PM report said. In 2005, this was just 5 percent.
Some health systems are using precision medicine and genomics as a first line of treatment, while others are more conservative and staying within boundaries of standard levels of evidence-based care, according to Halevy.
The difference is not between the large and small groups, as there are small physician groups along with the big academic centers that are embracing precision medicine.
Halevy sees inconsistency across health systems and physician practices. The job is still mainly left at level of chief strategy officer and is not yet part of the IT execution plan, he said.
Halevy recommends that hospitals and physician groups have a precision medicine strategy.
"They should have an opinion what and when they want to do with it," he said.
Providers then need to blend the strategy into their operations and have an educational plan.
The cost of precision medicine is going down and the recognition of its potential value, along with the the number of discoveries, are going up, Halevy said.
"There are quite a few barriers we see that are being resolved gradually," Halevy said. What started as a "disruptive revolution" is moving to "a slower evolution" into mainstream adoption.
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