Rewarding Innovation and Value
What is the Role of Comparative Effectiveness Research?
Recent cases of high-profile failures of products in late-stage pharmaceutical development have clearly highlighted the need for transformational change. Today, new drugs cost as much as $2 billion to develop over eight years or more, with severe attrition at each stage of development. Even those products that gain regulatory approval must often prove their value in health technology assessments (HTAs) or other elements of Comparative Effectiveness Research (CER) by public and private payers.CER is increasingly in the public spotlight as a promising way to help improve the productivity and efficiency of healthcare systems in the United States and abroad.Recent decisions to provide substantial federal funding for CER – $1.1 billion under the 2009 economic stimulus package, and a further $800 million under the 2010 healthcare reform legislation – serve to underline the increasing interest in this approach. In future, CER will change pre-market experimental research design to reflect the requirements of multiple healthcare stakeholders. It will also drive increased investment in post-market observational research on the real-world performance of marketed products.
About the Author
John Doyle, Dr.P.H., MPH, is Vice President and Practice Leader for Market Access with the Consulting group at Quintiles. Previously, he was president and a founder of Analytica International, a global reimbursement, outcomes and market access consulting firm. He previously led the Oncology and Immunology Economics Research Group at Bristol-Myers Squibb. Since 1993, Dr. Doyle has authored over 50 original research articles and abstracts, in a variety of therapeutic areas. As a health economist and epidemiologist, he has lectured on research methodologies for academic and commercial audiences in the U.S., Canada, Europe and Latin America. He has consulted global pharmaceutical and biotech firms on strategic concerns regarding product development, pricing, reimbursement, market valuation and other commercialization issues. Dr. Doyle received a Bachelor of Science degree in Applied Economics with a concentration in the Life Sciences from Cornell University. He received a Master of Public Health degree and a Doctor of Public Health degree in Epidemiology from the Mailman School of Public Health at Columbia University.
