Cost-effectiveness Considerations in the Approval and Adoption of New Health Technologies: Final Report and Case Studies
January 2007
DHHS, Office of the Assistant Secretary for Planning and Evaluation (ASPE)
Lewin contact: Clifford Goodman
The Office of the Assistant Secretary for Planning and Evaluation commissioned The Lewin Group to determine how and to what extent cost-effectiveness (CE) considerations are incorporated in the approval and adoption of new health technologies and the implications of not incorporating such considerations. This report examines the use of CE and other cost-health tradeoff evidence by federal and nonfederal health stakeholders, paying particular attention to the scope of authority, range and/or circumstances of use, and responsibilities for regulating CE and other economic information by the Food and Drug Administration. The role of economic evidence in decision-making also is explored in case studies of four contemporary health technologies: nucleic acid testing, Relenza (zanamivir), drug-eluting stents, and implantable cardioverter-defibrillators.