FOR IMMEDIATE RELEASE
October 24, 2007
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AdvaMed Releases Principles on Comparative Effectiveness
Provisions Essential to Protecting Patient Access to Quality Care
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WASHINGTON, D.C.– Comparative effectiveness research can provide valuable information to guide patients and physicians in health care decision making but it is essential that policy makers protect patient access to quality care, acknowledge patient differences and allow for continued innovation in health care by including key principles released today by AdvaMed – the Advanced Medical Technology Association.
“Patients today often have many options to consider, and benefits and risks to weigh before making critical health care decisions. Comparative effectiveness research can play a role in guiding that decision making,” said Stephen J. Ubl, President and CEO of AdvaMed. “We are deeply concerned, however, that if misused, comparative effectiveness may result in denying seniors coverage of treatment options best suited for their unique needs.”
That is why AdvaMed developed, and its Board of Directors approved, key principles on comparative effectiveness research to help Congress and others consider the best ways to use this information as they develop policies that may profoundly change what type of care patients receive.
“Comparative effectiveness research often looks at what works on average across a population. One of the key principles we have adopted today is the preservation of independent medical judgment. Physicians should decide what care is best for the patient and their medical judgment should not be arbitrarily limited by data that may not take into consideration unique patient differences” said Michael A. Mussallem, Edwards Lifesciences' Chairman and CEO and Chair of AdvaMed’s Board Payment and Health Care Delivery Committee.
AdvaMed is strongly committed to the principles of evidence-based medicine and we support comparative effectiveness research as a means to improve clinical outcomes. However, comparative effectiveness research should not be used to deny coverage; it should be focused on clinical-effectiveness, not cost-effectiveness; and it should be transparent and explicitly include all stakeholders.
Other principles include:
• Supporting advances in health care service delivery.
• Setting priorities with pre-stated objectives, research questions, and stakeholder input.
• Creating robust databases and analysis.
• Studying clinical effectiveness only.
• Recognizing the unique iterative process of medical device innovation.
• Providing for transparency and stakeholder input.
Additional considerations:
• Defining quality and benefit appropriately.
• Supporting personalized medicine.
• Communicating findings and conclusions adequately and clearly.
• Providing for Congressional oversight.
“We hope the health policy community embraces these principles to help protect the delivery of quality care and future medical innovation. We look forward to working with all stakeholders on this important issue as comparative effectiveness proposals such as the one in the current Medicare legislation move forward,” said Ubl.
Please visit www.advamed.org for a full copy of the
principles.
# # # AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit
www.advamed.org .