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Policy and Funding for CER: Making
  Sense of a Confusing Landscape
               Michael Steinman, MD
  Director of Comparative Effectiveness Research
  UCSF Clinical and Translational Science Institute
Panel
• Sheldon Greenfield, MD
      Donald Bren Professor of Medicine
      Executive Co-Director, Health Policy Research Institute
      University of California, Irvine
      Senior Editor, Journal of Comparative Effectiveness Research

• Claire Brindis, DrPH
      Professor of Pediatrics and Health Policy
      Director, Phillip R. Lee Institute for Health Policy Studies
      UCSF

• Len Finocchio, DrPH
      Associate Director
      California Department of Health Care Services
Disclosure
• No conflicts of interest
Outline
•   What is PCORI?
•   PCOR vs. CER
•   PCORI funding opportunities
•   Other funding sources
•   So…what should I be doing?
What is PCORI?
• Prior to several years ago, no coordinated effort for
  CER
• 2009 stimulus package provided $1.1 billion for
  CER
• 2010 health reform legislation created Patient
  Centered Outcomes Research Institute
• Funded by tax on government and private insurers
  for each covered life (~$500 million per year)
What is PCORI?
• Quasi-governmental organization
   – AHRQ almost eliminated in 1990s after published guideline that
     surgery for back pain was unnecessary
   – Provide political protection
   – PCORI funding does not depend on annual Congressional
     appropriation

• No infrastructure for determining funding priorities, issuing
  grant opportunities, reviewing and administering grants
   – Outsourcing (NIH, AHRQ, CMS)
       • Peer review, contract management
       • May receive $ from PCORI to originate grants
   – PCORI will be its own entity
PCOR vs. CER
• Why PCORI, not CERI?
• Political concerns that determining which treatments
  better → “rationing”
   – Restrict patients’ ability to choose inferior treatment
• Compromise focus on patient-centered outcomes
  research
• Legislation barred PCORI from
   – Developing or using QALYs
   – Considering cost in making coverage recommendations
   – In practice, PCORI will not fund cost-effectiveness analyses
Patient-Centered Outcomes Research
• Not just a semantic difference
• Focus on PCOR essential role in shaping funding
  priorities and “rules of the game” for getting funding
• Can’t just replace placebo control with active
  comparison group, do everything else the same
• Distinct elements
   –   Outcomes should be patient-centered
   –   Effectiveness, not efficacy
   –   Heterogeneity of treatment effects
   –   Involvement of stakeholders
Patient-Centered Outcomes Research
• Outcomes should be patient-centered
  – “…outcomes that people notice and care about
    such as survival, function, symptoms, and health-
    related quality of life”
  – Not biomarkers (BP, serum cholesterol, etc.)
Patient-Centered Outcomes Research
• Effectiveness
   – Research done in clinically relevant populations
   – Representative of patients
   – Representative of settings

• Heterogeneity of treatment effects
   – “Given my personal characteristics, conditions and
     preferences, what should I expect will happen to me?”
   – “What are my options and what are the benefits and
     harms of those options?”
Patient-Centered Outcomes Research
• Stakeholders play a key role
  – Should be intimately involved in the study design
    process to identify important outcomes
     • Trials of anti-seizure drugs in children
     • Traditional measure – seizure frequency
     • Patient-centered measure – parent want to know how
       drug will affect school performance
     • Drug ↓ seizures but ↑ sedation may not be preferable
Patient-Centered Outcomes Research
• Decision-makers are stakeholders
   – Government payors and regulators; health plans; AMCs
   – During study design, work with decision-makers to consider how
     results will shape policy and practice
   – May be important to focus on effect size, not just superiority
   – Bayesian approaches – need to account for prior probability
       • Value of information analysis
   – Cost and cost-effectiveness
       • PCORI not allowed to evaluate cost in making coverage
         recommendations, won’t fund “pure” CEA
       • Cost can be studied and used by decision-makers
Patient-Centered Outcomes Research
• Implications for research design
   – RCTs
      • Pragmatic - real-world settings; large N’s to assess subgroups
      • Bayesian and adaptive approaches to design
   – Observational studies
      • Causal inference modeling
      • Tension for studies using pure administrative data – powerful and
        low-cost; lack high-quality patient-centric data
   – Which research method is best suited to which question?
      • Translation table
PCORI Funding Opportunities
• Limited RFAs / RFPs to date
   – Developmental
   – RFPs (Sept 2011)
      • ~$30-$100K each
      • Methods for setting research priorities
   – Pilot Projects Grant Program (Dec 2011)
      •   $13 million in year 1 for ~40 projects
      •   Develop research priorities and methods
      •   Develop ways of bringing stakeholders together
      •   Develop measurement tools for novel patient-centered outcomes
PCORI Funding Opportunities
• $500 million/year
• ?????
   – Likely NOT be “traditional” research
   – Patient-centered outcomes
      • Including developing methods
   – Real-world populations
   – Heterogeneity of treatment effects
   – Involvement of stakeholders
Other Funding Opportunities
• Existence of PCORI does not preclude government agencies or
  foundations from funding CER
• AHRQ has Effective Healthcare Program
   – Large evidence-synthesis and dissemination projects
   – EBPCs, DEcIDE network, CERTS
   – Does not support investigator-initiated projects
• Areas of CER explicitly outside PCORI’s mandate
   – CER with “traditional” outcomes
   – Cost-effectiveness analyses
• Remains to be seen
So…what should I be doing?
• Still many unknowns
   – It’s not just you who doesn’t understand

• Maintain a diverse portfolio and be flexible

• Triangulate between funding agencies

• Pay close attention to unique priorities and “rules of
  the road” established by PCORI
   – Require substantial changes to the way we traditionally do
     research
Extra slides on following pages
PCORI Definition of PCOR
PCOR questions

1. “Given my personal characteristics, conditions and
   preferences, what should I expect will happen to
   me?”
2. “What are my options and what are the benefits and
   harms of those options?”
3. “What can I do to improve the outcomes that are
   most important to me?”
4. “How can the health care system improve my chances
   of achieving the outcomes I prefer?”
PCORI Definition of PCOR
Characteristics of PCOR that will facilitate answering these questions
• Assesses the benefits and harms of preventive, diagnostic,
  therapeutic, or health delivery system interventions to inform
  decision making, highlighting comparisons and outcomes that
  matter to people;
• Is inclusive of an individual’s preferences, autonomy and needs,
  focusing on outcomes that people notice and care about such as
  survival, function, symptoms, and health-related quality of life;
    – Incorporates a wide variety of settings and diversity of participants to
      address individual differences and barriers to implementation and
      dissemination; and
• Investigates (or may investigate) optimizing outcomes while
  addressing burden to individuals, resources, and other stakeholder
  perspectives
What is CER?
• Comparative effectiveness research is the conduct and
  synthesis of systematic research comparing different
  interventions and strategies to prevent, diagnose, treat
  and monitor health conditions. The purpose of this
  research is to inform patients, providers, and decision-
  makers, responding to their expressed needs, about
  which interventions are most effective for which
  patients under specific circumstances. To provide this
  information, comparative effectiveness research must
  assess a comprehensive array of health-related
  outcomes for diverse patient populations…
   – Federal Coordinating Council for Comparative Effectiveness
     Research, definition; [cited 28 July 2010].

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Policy and Funding for CER: Making Sense of a Confusing Landscape

  • 1. Policy and Funding for CER: Making Sense of a Confusing Landscape Michael Steinman, MD Director of Comparative Effectiveness Research UCSF Clinical and Translational Science Institute
  • 2. Panel • Sheldon Greenfield, MD Donald Bren Professor of Medicine Executive Co-Director, Health Policy Research Institute University of California, Irvine Senior Editor, Journal of Comparative Effectiveness Research • Claire Brindis, DrPH Professor of Pediatrics and Health Policy Director, Phillip R. Lee Institute for Health Policy Studies UCSF • Len Finocchio, DrPH Associate Director California Department of Health Care Services
  • 4. Outline • What is PCORI? • PCOR vs. CER • PCORI funding opportunities • Other funding sources • So…what should I be doing?
  • 5. What is PCORI? • Prior to several years ago, no coordinated effort for CER • 2009 stimulus package provided $1.1 billion for CER • 2010 health reform legislation created Patient Centered Outcomes Research Institute • Funded by tax on government and private insurers for each covered life (~$500 million per year)
  • 6. What is PCORI? • Quasi-governmental organization – AHRQ almost eliminated in 1990s after published guideline that surgery for back pain was unnecessary – Provide political protection – PCORI funding does not depend on annual Congressional appropriation • No infrastructure for determining funding priorities, issuing grant opportunities, reviewing and administering grants – Outsourcing (NIH, AHRQ, CMS) • Peer review, contract management • May receive $ from PCORI to originate grants – PCORI will be its own entity
  • 7. PCOR vs. CER • Why PCORI, not CERI? • Political concerns that determining which treatments better → “rationing” – Restrict patients’ ability to choose inferior treatment • Compromise focus on patient-centered outcomes research • Legislation barred PCORI from – Developing or using QALYs – Considering cost in making coverage recommendations – In practice, PCORI will not fund cost-effectiveness analyses
  • 8. Patient-Centered Outcomes Research • Not just a semantic difference • Focus on PCOR essential role in shaping funding priorities and “rules of the game” for getting funding • Can’t just replace placebo control with active comparison group, do everything else the same • Distinct elements – Outcomes should be patient-centered – Effectiveness, not efficacy – Heterogeneity of treatment effects – Involvement of stakeholders
  • 9. Patient-Centered Outcomes Research • Outcomes should be patient-centered – “…outcomes that people notice and care about such as survival, function, symptoms, and health- related quality of life” – Not biomarkers (BP, serum cholesterol, etc.)
  • 10. Patient-Centered Outcomes Research • Effectiveness – Research done in clinically relevant populations – Representative of patients – Representative of settings • Heterogeneity of treatment effects – “Given my personal characteristics, conditions and preferences, what should I expect will happen to me?” – “What are my options and what are the benefits and harms of those options?”
  • 11. Patient-Centered Outcomes Research • Stakeholders play a key role – Should be intimately involved in the study design process to identify important outcomes • Trials of anti-seizure drugs in children • Traditional measure – seizure frequency • Patient-centered measure – parent want to know how drug will affect school performance • Drug ↓ seizures but ↑ sedation may not be preferable
  • 12. Patient-Centered Outcomes Research • Decision-makers are stakeholders – Government payors and regulators; health plans; AMCs – During study design, work with decision-makers to consider how results will shape policy and practice – May be important to focus on effect size, not just superiority – Bayesian approaches – need to account for prior probability • Value of information analysis – Cost and cost-effectiveness • PCORI not allowed to evaluate cost in making coverage recommendations, won’t fund “pure” CEA • Cost can be studied and used by decision-makers
  • 13. Patient-Centered Outcomes Research • Implications for research design – RCTs • Pragmatic - real-world settings; large N’s to assess subgroups • Bayesian and adaptive approaches to design – Observational studies • Causal inference modeling • Tension for studies using pure administrative data – powerful and low-cost; lack high-quality patient-centric data – Which research method is best suited to which question? • Translation table
  • 14. PCORI Funding Opportunities • Limited RFAs / RFPs to date – Developmental – RFPs (Sept 2011) • ~$30-$100K each • Methods for setting research priorities – Pilot Projects Grant Program (Dec 2011) • $13 million in year 1 for ~40 projects • Develop research priorities and methods • Develop ways of bringing stakeholders together • Develop measurement tools for novel patient-centered outcomes
  • 15. PCORI Funding Opportunities • $500 million/year • ????? – Likely NOT be “traditional” research – Patient-centered outcomes • Including developing methods – Real-world populations – Heterogeneity of treatment effects – Involvement of stakeholders
  • 16. Other Funding Opportunities • Existence of PCORI does not preclude government agencies or foundations from funding CER • AHRQ has Effective Healthcare Program – Large evidence-synthesis and dissemination projects – EBPCs, DEcIDE network, CERTS – Does not support investigator-initiated projects • Areas of CER explicitly outside PCORI’s mandate – CER with “traditional” outcomes – Cost-effectiveness analyses • Remains to be seen
  • 17. So…what should I be doing? • Still many unknowns – It’s not just you who doesn’t understand • Maintain a diverse portfolio and be flexible • Triangulate between funding agencies • Pay close attention to unique priorities and “rules of the road” established by PCORI – Require substantial changes to the way we traditionally do research
  • 18. Extra slides on following pages
  • 19. PCORI Definition of PCOR PCOR questions 1. “Given my personal characteristics, conditions and preferences, what should I expect will happen to me?” 2. “What are my options and what are the benefits and harms of those options?” 3. “What can I do to improve the outcomes that are most important to me?” 4. “How can the health care system improve my chances of achieving the outcomes I prefer?”
  • 20. PCORI Definition of PCOR Characteristics of PCOR that will facilitate answering these questions • Assesses the benefits and harms of preventive, diagnostic, therapeutic, or health delivery system interventions to inform decision making, highlighting comparisons and outcomes that matter to people; • Is inclusive of an individual’s preferences, autonomy and needs, focusing on outcomes that people notice and care about such as survival, function, symptoms, and health-related quality of life; – Incorporates a wide variety of settings and diversity of participants to address individual differences and barriers to implementation and dissemination; and • Investigates (or may investigate) optimizing outcomes while addressing burden to individuals, resources, and other stakeholder perspectives
  • 21. What is CER? • Comparative effectiveness research is the conduct and synthesis of systematic research comparing different interventions and strategies to prevent, diagnose, treat and monitor health conditions. The purpose of this research is to inform patients, providers, and decision- makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances. To provide this information, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations… – Federal Coordinating Council for Comparative Effectiveness Research, definition; [cited 28 July 2010].