WASHINGTON (July 7, 2016)
The Personalized Medicine Coalition (PMC) today applauds the Obama administration for steps it announced last night to further the Precision Medicine Initiative (PMI). PMC President Edward Abrahams said these steps are “important but insufficient to advance personalized medicine as fast as patients wish.”
As part of the administration’s work on the PMI, the National Institutes of Health (NIH) has awarded $55 million to health care provider organizations, technology developers and community health centers to establish the necessary infrastructure to build and leverage a cohort of one million volunteers. In addition, the U.S. Food and Drug Administration (FDA) has released draft guidance documents on the oversight of next-generation sequencing (NGS) tests.
Abrahams applauded these initiatives and said he agrees with Obama, whose op-ed in today’s Boston Globe states that "precision medicine gives us the chance to marry what’s unique about America — our spirit of innovation, our courage to take risks, our collaborative instincts — with what’s unique about Americans — every individual’s distinctive genetic makeup, lifestyles and health needs.”
But, Abrahams said, fulfilling that promise will also require broader regulatory changes that encourage innovation as well as supportive reimbursement policies. The Centers for Medicare and Medicaid Services (CMS), he said, has often been reluctant to pay for the personalized diagnostics and therapies the administration champions.
PMC is not the only stakeholder arguing for additional efforts in regulation and reimbursement. In an editorial published by Science in April of this year, Harold Varmus, M.D., former director of the U.S. National Cancer Institute, recommended that the administration "exercise its regulatory authority — most potently, to direct [CMS] to allow reimbursement for molecular profiling of cancers.” Varmus argues that doing so would "vastly increase the data available for analysis, accelerate interpretation of genetic profiles, provide a test bed for true sharing of clinical information and allow future coverage determinations by CMS to be made more quickly and sensibly.”
"The Obama administration is right to focus resources on developing and aggregating data and streamlining regulation for NGS tests,” Abrahams said. "But unless ongoing efforts to demonstrate the value of personalized medicine to patients and the health system are supplemented by public policies that are aligned to encourage its advancement, progress will be slower than we would like.”
Christopher J. Wells
About the Personalized Medicine Coalition:
The Personalized Medicine Coalition, representing innovators, scientists, patients, providers and payers, promotes the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system. For more information about PMC, please visit www.personalizedmedicinecoalition.org.