Potential New Roles for Insurers in Shaping the National Clinical Research Enterprise: A New Clinica

1
Potential New Roles for Insurers in Shaping the
National Clinical Research EnterpriseA New
Clinical Efficacy Network

• Clinical Research Forum Annual Meeting
• April 10, 2008

2
Covering America
Blue Plans cover every community in the nation

• 39 Blue Cross and Blue Shield Plans

• 100 million members

BCBSA

• Contract with 90 of hospitals, 80 of doctors

• Largest processor of Medicare claims in the nation

• 4-million member FEP Program Largest private
  health insurance product in world

3
Technology assessment supports health plans and
other stakeholders in developing evidence-based
policies

• Coverage Policy
• Determined by purchasers of health plan products
• Cost-effectiveness considered

Payment Policy Contract between health plans and
medical professionals and providers

• Medical Policy
• Based on scientific evidence
• Costs and coverage NOT considered

4
(No Transcript)
5
Good clinical studies are like good accounting
and financial practices

• Deviation from standards leads to unreliable
  results and misinformed decisions

6
Challenges in Assessing Outcomes

• Quality of randomized controlled trials
• Inconsistent reporting of adverse effects
• Availability of robust evidence of effects and
  comparative effects
• Selective reporting and publication bias
• See CONSORT Statement 2001

7
Outcome Measures

• Intermediate vs. health outcomes
• Tumor response vs. survival (ABMT for breast
  cancer)
• Define clinically significant improvement in
  trial protocol
• Critical for soft measures (mortality vs. pain)
• Pain (mean vs. patients achieving 50 change)
• TEC Special Report Measuring and Reporting Pain
  Outcomes http//bcbs.com/tec/vol21/21_11.html
• Validated scales or consensus outcomes
• Unpublished scales tend to show larger effect
  than published, validated scales
• Composite outcome may be driven by least
  important outcome
• (TIA vs. stroke restenosis vs. MI)

8
Surrogate Outcomes

• A correlate does not a surrogate make
• Disease has multiple causal pathways
• Marker not in causal pathway of disease
• Intervention has unintended adverse effects
• Hierarchy of outcomes
• True health outcome
• Validated surrogate reliably predicts benefit
• Nonvalidated surrogate reasonably likely
• Correlate of biological activity
• Fleming, T. Surrogate endpoints and FDAs and
  accelerated approval process. Health Affairs
  Vol. 21 No. 1 (2005) 67-78.

9
Misplaced Emphasis

• "...journal articles reporting clinical trials
  tend to dedicate more space to listing the
  authors names than to listing possible side
  effects associated with the drug.
• "Weighing up the evidence" by Heidi Ledford -
  Nature, 2007 447(7144)512

10
Robust Evidence of Effects

• High-quality trials
• Long-term follow up to assess benefits and harms
• Surrogate outcomes may be misleading
• Comparative trials
• Drug vs. drug
• Drug vs. surgery
• vs. radiotherapy
• Early vs. late

11
Cost, Cost Effectiveness andAffordability

• Clinical effectiveness is cornerstone of Plan
  medical and coverage policy
• New technologies may bring small benefit at high
  cost
• Cost-effectiveness and affordability are pressing
  issues
• TEC is leading and educating on
  cost-effectiveness analysis methods
• But no clear cost-effectiveness threshold can
  you afford everything that is a good buy?

12

• Health plans want to make evidence-based
  decisions
• Considerable challenges in obtaining good
  evidence on outcomes
• Cost effectiveness and affordability are pressing
  concerns

13
Blue Distinction Centers
Blues achieve national presence, with nearly 800
Blue Distinction Centers spanning 42 states
Blue Distinction Centers for Cardiac CareSM Blue
Distinction Centers for Bariatric SurgerySM Blue
Distinction Centersfor TransplantsSM Blue
Distinction Centers Complex Rare CancersSM
14
Blue Distinction Centers
Blues achieve national presence, with nearly 800
Blue Distinction Centers spanning 42 states
Blue Distinction Centers for Cardiac CareSM Blue
Distinction Centers for Bariatric SurgerySM Blue
Distinction Centersfor TransplantsSM Blue
Distinction Centers Complex Rare CancersSM
15
Blue Distinction Centers
Blues achieve national presence, with nearly 800
Blue Distinction Centers spanning 42 states
Blue Distinction Centers for Cardiac CareSM Blue
Distinction Centers for Bariatric SurgerySM Blue
Distinction Centersfor TransplantsSM Blue
Distinction Centers Complex Rare CancersSM
16
Blue Distinction Centers
Blues achieve national presence, with nearly 800
Blue Distinction Centers spanning 42 states

• Blue Distinction Centers for Cardiac CareSM
• Blue Distinction Centers for Bariatric SurgerySM
• Blue Distinction Centersfor TransplantsSM
• Blue Distinction Centers Complex Rare CancersSM

17
Widespread Interest in Comparative Effectiveness
Research
Background

• CER has been a hot public policy topic in last 12
  months
• Obama and Clinton include in their health care
  reform platforms
• H.R. 3162 (CHAMP Act), Section 904
• Senators Conrad (D-ND)/Baucus (D-MT) developing
  legislation
• Subject of reports by Congressional Budget
  Office, MedPAC, and Institute of Medicine

18
BCBSA Proposal
BCBSA Proposal

• Congress should enact legislation creating an
  independent Institute to support research on the
  comparative effectiveness of procedures, drugs,
  devices, biologics, and other interventions
• All payers, public and private, should contribute
  funding
• Broad range of research should be supported
• Public/private stakeholder board should govern
  the Institute
• Significant education/incentives needed to
  translate research into practice

19
Research Role
BCBSA Proposal

• The Institute should have flexibility to
  prioritize and fund a range of research
• Procedures, drugs, devices, biologics, other
  interventions, etc.
• Clinical trials, cohort studies, systematic
  reviews, etc.
• Clinical effectiveness primary focus option for
  cost effectiveness
• The Institute should promote efficiency among
  researchers receiving contracts

• Reasoning
• No government agency (AHRQ, NIH) has a
  well-funded and dedicated focus on comparative
  research
• High clinical trial costs make it unlikely that
  others will sponsor

20
Structure/Governance
BCBSA Proposal

• The Institute should be an independent, nonprofit
  entity chartered by Congress
• The Institutes board should include government
  and private sector reps
• Private stakeholders providers,
  patients/consumers, insurers, employers, and
  manufacturers
• Accountability ensured through government
  oversight and public reporting by Institute

• Reasoning
• The Institute should be insulated from excessive
  political pressures
• E.g., 1995 AHRQ defunding effort over spinal
  fusion surgery study
• An independent Institute would have more
  flexibility than a government agency to respond
  to pressing research needs

21
Funding
BCBSA Proposal

• All payers insurers, self-funded plans,
  Medicare should help fund the Institute
• Budget should be no more than 375 million when
  activities are fully ramped-up

• Reasoning
• All payers should help pay for information that
  will benefit the health care system as a whole
• The budget should be no higher than 375M until
  the Institute demonstrates value and it is clear
  that the research infrastructure can handle the
  increased workload

22
Incentives and Education
BCBSA Proposal

• Incentives and education are needed to ensure
  that the Institutes research impacts clinical
  research
• Research published in technical and consumer
  formats
• Institute should work with providers to
  facilitate the development of consensus
  guidelines using research
• Consensus guidelines should support EHRs, provide
  basis for med mal reform and similar protections
  for payers, inform government health program
  policymaking (P4P, coverage, etc.)

23
A Caveat
BCBSA Proposal

• BCBS Plans
• 88 MLR
• 3-4 taxes, reserves
• 8 overhead
• Academic Medical Centers
• ?
• We want value for the 375 Million.

24
If Congress Wont Act

• NICE
• Northern European Nations
• Asian Nations

25
Challenge

• Could those who finance
• And those who create
• collectively come to a solution that benefits all?

26
Next Steps

• Are up to us.

27
Contact

• Allan M. Korn, MD, FACP
• Senior Vice President Chief Medical Officer
  Clinical Affairs
• BlueCross BlueShield Association
• allan.korn_at_bcbsa.com