Use of Targeted Therapies and
Challenges for Health Payers
Clinical Utility, Clinical
Effectiveness, and Value
Carole Flamm, MD, MPH
Executive Medical Director
Center for Clinical Value
June 30,2015
A presentation of the Blue Cross and Blue Shield Association. All rights reserved.
Conflict of Interest Disclosure
• Full-time employee of Blue Cross Blue Shield Association
• Nothing else to disclose
A presentation of the Blue Cross and Blue Shield Association. All rights reserved.
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Overview
• BCBSA Center for Clinical Effectiveness
• Collaboration to Improve Quality, Value and
Affordability
A presentation of the Blue Cross and Blue Shield Association. All rights reserved.
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BCBSA Center for Clinical Effectiveness
• 36 Blue Cross and/or Blue Shield
Plans
• More than 106 million members
• 1985 Technology Evaluation Center
• Center for Clinical Effectiveness
• Systematic review of clinical
evidence: Does this technology
improve health?
• Independent, expert Medical
Advisory Panel
• TEC Assessments 3-year inventory
(www.bcbs.com/tec)
A presentation of the Blue Cross and Blue Shield Association. All rights reserved.
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Technology Assessment Supports Health Plans
and Other Stakeholders in Developing Evidencebased Policies
Medical Policy
• Based on scientific
evidence
• Costs and
coverage NOT
considered
Coverage Policy
• Determined by
purchasers of health
plan products
• Cost effectiveness
considered
A presentation of the Blue Cross and Blue Shield Association. All rights reserved.
Payment Policy
• Contract between
health plans and
medical professionals
and providers
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TEC Criteria
Five criteria used to assess whether a technology improves health
outcomes such as length of life, quality of life and functional ability.
1. The technology must have final approval from the appropriate
governmental regulatory bodies.
2. The scientific evidence must permit conclusions concerning
the effect of the technology on health outcomes.
3. The technology must improve the net health outcome.
4. The technology must be as beneficial as any established
alternatives.
5. The improvement must be attainable outside the
investigational settings.
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Ideal … Direct Evidence
Test
Treat accordingly
Randomize
No Test
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Measure
Outcomes
Compare
Treat accordingly
Measure
Outcomes
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Reality…. Indirect Evidence
Test results should improve clinical decisions, management, and
outcomes.
Test Performance
Sensitivity
Specificity
Positive Predictive Value
Negative Predictive Value
Change in
Management
Decision analytic
modeling
Effect on Outcomes
(Qualitative
Conclusions)
Causal chain analysis
Observational evidence
Issues when no true gold
standard
• Evidence-based approach to technology evaluation and adoption for emerging
medical tests and treatments faces limitations of technology-by-technology
evaluation, rather than comparison of clinical management strategies applicable to
a well-defined clinical setting.
A presentation of the Blue Cross and Blue Shield Association. All rights reserved.
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Framework for Evaluating Evidence
The ACCE evaluation process for genetic testing
http://www.cdc.gov/genomics/gtesting/ACCE/index.htm
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Déjà vu All Over Again
Diagnostic Model a Continuum for Efficacy
Paraphrased
• Level 1: Technical efficacy
Pretty Picture
• Level 2: Diagnostic accuracy efficacy
Improved Accuracy
• Level 3: Diagnostic thinking efficacy
Improved Diagnosis
• Level 4: Therapeutic efficacy
Improved Treatment
• Level 5: Patient outcome efficacy
Improved Health
• Level 6: Societal efficacy
Improved Efficiency
Fryback & Thornbury (1991) Med Dec Making, 11:88-94
A presentation of the Blue Cross and Blue Shield Association. All rights reserved.
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Adoption of Breast Imaging Technologies
• Gold et al. traced the timeline for adoption of breast
imaging technologies considering the chronology of:
– Peer-reviewed journal articles,
– FDA clearance or approval for marketing,
– insurance reimbursement, and
– incorporation into clinical practice guidelines.
• Gold et al. found that use of new imaging technologies
was driven mainly by:
– regulatory approval and payment by health plans
– “rather than evidence that they provide benefits to patients”
Gold, L.S., G. Klein, L. Carr, et al. 2012. The emergence of diagnostic imaging technologies in breast cancer: discovery, regulatory
approval, reimbursement, and adoption in clinical guidelines. Cancer Imaging 12: 13–24.
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Aronson, N. (2015), Making personalized medicine more affordable. Annals of the New York Academy of Sciences. doi: 10.1111/nyas.12614
A presentation of the Blue Cross and Blue Shield Association. All rights reserved.
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Considerations to Make Personalized Medicine
More Affordable?
Transition from a
Clinical
Care
Social
Support
System
PatientCentered
Care
technology-centered to a
patient-centered approach
to evidence to generate
knowledge of clinical utility
Evidence
Base
Leverage
innovative
approaches to
improve
efficiency in
evidence
development.
Health
Plan
Aronson, N. (2015), Making personalized medicine more affordable. Annals of the New York Academy of Sciences. doi: 10.1111/nyas.12614
A presentation of the Blue Cross and Blue Shield Association. All rights reserved.
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Considerations to Make Personalized Medicine
More Affordable?
Societal
Value
All participants in the
healthcare system need
to recognize that value
cannot be severed from
affordability without
sacrificing
sustainability.
Clinical
Care
Social
Support
System
Societal
Ethics
PatientCentered
Care
Health
Plan
Evidence
Base
Although such change is
challenging, there are
presently efforts underway
to generate patient- and
decision-centered
evidence, to innovate in
evidence development,
and to recognize the
necessity of sustainability.
Societal
Sustainability
Aronson, N. (2015), Making personalized medicine more affordable. Annals of the New York Academy of Sciences. doi: 10.1111/nyas.12614
A presentation of the Blue Cross and Blue Shield Association. All rights reserved.
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Innovation and Collaboration to
Improve Quality, Value and Affordability
• Care management initiatives
• Alternative Payment Models focused on quality and value
– Episode based payments
– Shared savings models
– Global population based payments
A presentation of the Blue Cross and Blue Shield Association. All rights reserved.
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Use of Targeted Therapies and Challenges for
All Stakeholders
Promise to
Improve Patient
Care
Proof of
Meaningful
Benefit
Value and
Sustainability
for Society
A presentation of the Blue Cross and Blue Shield Association. All rights reserved.
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Merci
Contact Information
Carole Flamm, MD, MPH
[email protected]
312.297.5905
A presentation of the Blue Cross and Blue Shield Association. All rights reserved.
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