President Barack Obama announced in his 2015 State of the Union address that he was introducing a new Precision Medicine Initiative, supported with over $200 million in the proposed 2016 federal budget. “Precision Medicine” and “Personalized Medicine” are often used as interchangeable terms. Sylvia Burwell, Secretary of the Department of Health and Human Services (HHS), referenced the common description for these terms, and the hopes and expectations for the concepts they reflect, in an HHS blog entry:
The promise of precision medicine is delivering the right treatments, at the right time, to the right person. It is through this promise that we are given one of the greatest opportunities for new medical breakthroughs that we have ever seen.
On September 17, 2015, the federal National Institutes for Health (NIH), one of the operational components of the HHS that is leading implementation of the Precision Medicine Initiative, announced that it intends to enroll one million volunteers from diverse ages, ethnicities and other demographic groups. The information these volunteers provide to NIH will help to identify the risk of disease in certain populations, population responses from commonly used drugs, and biomarkers (in essence, biological “red flags”) that may suggest an increased or decreased risk for developing certain diseases. As another part of the Precision Medicine Initiative, the National Cancer Institute, also a component of HHS, would receive $70 million for advancing targeted oncology treatments under the proposed budget.
It is important to note that many diagnostic tests and targeted therapies are already available for patient use. In fact, many of these tests and therapies have already been approved for payment by the federal Medicare program, typically known as a conservative payer, and one that requires medical necessity and reasonableness as statutory conditions for coverage. For example, genetic testing for certain cancers is addressed in Noridian’s Local Coverage Determination L24308. The Molecular Diagnostic Services Program (MolDX™) was developed in 2012 to identify and establish coverage and reimbursement for molecular diagnostic tests.
“Traditional” healthcare providers (including hospitals, physicians, and oncology centers) are already utilizing personalized medicine’s tools to provide better care for their patients, and patient demand for these exciting technologies is likely to grow with an ever-expanding access to information about their treatment options.
For More Information
While the future for personalized medicine is bright, development of these products can be a business challenge that slows access and may discourage innovation. The 2015 Personalized Medicine Summit will address these challenges and examine strategies which can lead to success. The Summit will be co-hosted by Foley & Lardner LLP, the Personalized Medicine Coalition, AmerisourceBergen, and the California Life Sciences Association, and will take place on Wednesday, October 7, at the South San Francisco Conference Center in South San Francisco, California, the birthplace of biotechnology.
Register now to hear how some of the industry’s best and brightest are tackling today’s business challenges and what they envision for the future of personalized medicine. Plus, enjoy a special closing keynote presentation with John Parise, Director & Associate General Counsel at Genentech, and Steven Kafka, PhD, President & Chief Operating Officer at Foundation Medicine, as they highlight Roche’s $1 billion majority stake in the genomic cancer diagnostics firm.
For a complete speaker roster, program agenda and to register, visit the Personalized Medicine Summit website.