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Evidence, HTA and Comparative Effectiveness in the U.S. Presentation at AMCP. March 28, 2007 Peter J. Neumann Tufts-New England Medical Center. Overview. HTA around the world American exceptionalism? A new U.S. Center for Comparative Effectiveness? Looking ahead (implications for VA).
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Evidence, HTA and Comparative Effectiveness in the U.S. Presentation at AMCP March 28, 2007 Peter J. Neumann Tufts-New England Medical Center
Overview • HTA around the world • American exceptionalism? • A new U.S. Center for Comparative Effectiveness? • Looking ahead (implications for VA)
Explaining American exceptionalism in health care • The values argument • The “system” argument • The political obstructionist argument
The U.S. Landscape • Medicare • AHRQ • Medicaid (the DERP) • Regional efforts • Other (VA!)
Medicare spending trends Medicare Spending Per Beneficiary Total Part A Part B Part D Source: 2006 Medicare Trustees Report
Activities of a Comparative Effectiveness Center • Conducting and/or sponsoring research • Setting research priorities • Providing a forum for methodological and other issues
Placement Options • Within CMS • Within AHRQ • Within NIH • Within FDA • Creation of a new government agency • Creation of a quasi-public organization
Governance, Oversight, and Funding • Institutional independence • Separation of assessment from decision making • Funding
Substantive Issues • Methodological rigor • Analytic perspective • Objectivity and independence • Transparency • Stakeholder input • Appeals process • Identifying research priorities • Updating conclusions over time
Implications • For the collection of evidence • For patient access • For innovation • For patient health
Key issues • Level of evidence required • Tradeoff between rigor and timeliness • The process for evaluation and decision making • Role of CEA in HTA
NICE Decisions by Cost-Effectiveness Threshold (1999-2003) >30 >30 20-30 >30 20-30 20-30 < 20 < 20 < 20
Selected cost-effectiveness ratios for technologies covered by Medicare • Implantable cardioverter defibrillators: $30,000-$85,000/QALY • Lung-volume reduction surgery: $98,000-$330,000/QALY • Left-ventricular assist devices: $500,000-$1.4 million/QALY • PET for Alzheimer’s disease (Over $500,000) Source: Neumann et al., 2005
Why don’t Americans use CEA? • Conflicting/weak incentives • Quality of evidence is problematic • Regulatory/legal barriers • Ethical concerns • Lack of infrastructure • Lack of cultural acceptance
Six trends to watch… • Rise of HTA organizations and evidence requirements • Increasing parsing of clinical evidence • Coverage with evidence development • Cost-effectiveness requirements • Flexible evidentiary standards • Quantification of risks/benefits • Adaptive clinical trials • Linking evidence to payment