Download CER and PCOR - Academy of Managed Care Pharmacy

Comparative Effectiveness
Research (CER) and PatientCentered Outcomes Research
(PCOR)
Presentation Developed for the
Academy of Managed Care Pharmacy
Updated: February 2016
Topics Covered
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Background
Definitions
Goals of CER and PCOR
Stakeholders
Funding sources
Challenges
CER study design and user tools
Background
• Early draft of the Affordable Care Act (ACA) included provisions
for comparative effectiveness research (CER)
– “CER” changed to “Patient-Centered Outcomes Research” (PCOR)
in legislation based on voter input
– Many entities view terms as interchangeable; however, the
definitions do differ
• ACA established a Patient-Centered Outcomes Research
Institute (PCORI)
– Funded through the general fund of the US treasury and in small
part by assessments on Medicare, private health insurance, and
self-insured plans
Definitions: CER
• CER and PCOR are not synonymous
CER
• Includes any type of medical or pharmaceutical intervention (e.g. lab
tests, procedures, medications, etc.)
• Institutes of Medicine (IOM) definition: generation and synthesis of
evidence that compares the benefits and harms of alternative methods to
prevent, diagnose, treat, and monitor a clinical condition or to improve the
delivery of care
• Kaiser Family Foundation definition: compares two or more different
methods for preventing, diagnosing, and treating health conditions. Such
research is performed using methods such as practical clinical trials,
analyses of claims records, computer modeling, and systematic reviews of
existing literature
Definitions: PCOR
• ACA established a Patient-Centered Outcomes Research Institute
(PCORI)
• Funded through the general fund of the US treasury and in small part by
assessments on Medicare, private health insurance, and self-insured plans
• PCORI’s working definition states that PCOR:
Assesses the benefits and harms of preventive,
diagnostic, therapeutic, palliative, 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, availability of services, technology,
and personnel, and other stakeholder
perspectives
Goals of CER and PCOR
• CER and PCOR definitions differ, but goals are similar
CER:
PCOR:
• IOM: assist consumers, clinicians,
purchasers, and policy makers to make
informed decisions that will improve
health care at both the individual and
population levels
• Kaiser Family Foundation: improve health
outcomes by developing and
disseminating evidence based information
to patients, providers, and health care
decision-makers about the effectiveness
of treatments relative to other options.
Identifying the most effective and efficient
interventions has the potential to reduce
unnecessary treatments, which in turn,
may help lower costs
• PCORI: help people and their caregivers
communicate and make informed
healthcare decisions, allowing their voices
to be heard in assessing the value of
healthcare options
Stakeholders
Patients:
• Understand
risks/benefits of
treatment options
• Make informed
healthcare
decisions
Providers:
• Make informed
treatment
recommendations
• Facilitate patientshared decisionmaking
Managed care
organizations:
• Support
benefit/formulary
changes
• Educate members
and providers
United States
Healthcare System
• Improve health of
U.S. population
• Decrease variability
in clinical practice
across the country
• Decrease
healthcare costs
Funding Sources
– To date, most CER and PCOR projects have been
funded through grants
• PCORI
– Awards research grants for PCOR from federal funds
• US Department of Health & Human Services (HHS)
– Agency for Healthcare Research and Quality (AHRQ)
– Funding to train researchers to conduct CER and
PCOR has been provided by
• The PhRMA Foundation
Challenges
• CER and PCOR require special skill sets:
– Researchers
• Focus on new approaches to research to inform decision making by patients
and caregivers
– Educators
• Training researches to conduct CER and PCOR
– Clinical decision-makers and
• Assessing the validity and applicability of CER and PCOR output
• Interpreting and applying the resulting body of evidence
– Policy-makers
• Establish policy based on a body of evidence that is valid and applicable to
their population
– Payers
• Make payment decisions based on the most effective treatment options based
on individual patient characteristics
CER Study Design and User Tools
• Study design:
– Individual studies:
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Prospective randomized or observational trials
Retrospective observational trials
Indirect treatment comparisons
Network meta-analyses
Modeling studies
– Evaluate the overall body of evidence
• User tools:
– AMCP/ISPOR/NPC collaborative: www.cercollaborative.org
– AMCP CER Certificate Program
CER Certificate Program
• Advance evidence assessment expertise with
new research designs and study data
• Learn about tools to help assess current
questions in real-world settings
• Developed by the CER Collaborative
• Certificate Program Details
– 19 Contact Hours
– Five - Online Modules
– One – 4 hour workshop – with live
presentations at one of AMCP’s national
meetings
– Student Fee $400
– Additional information:
http://www.amcp.org/CERCertificate/
Modules
Introduction to Comparative
Effectiveness Research
Value of Prospective &
Retrospective Observational
Studies in Comparative
Effectiveness Research
Modeling Studies
Indirect Treatment Comparisons
Synthesizing a Body of Evidence in
Comparative Effectiveness
Demonstrating Skills in Assessing
CER Studies and Synthesizing CER
Literature
References
1. Patient-Centered Outcomes Research Institute (website).
Accessed on: February 23, 2016. Available at:
http://www.pcori.org/
2. Selby JV, Beal AC, Frank L. The Patient-Centered Outcomes
Research Institute (PCORI) national priorities for research
and initial research agenda. JAMA. 2012 Apr;307(15):1583-4.
3. Institutes of Medicine. Initial national priorities for
comparative effectiveness research. June 30, 2009. Accessed
on: February 23, 2016. Available at:
http://www.iom.edu/Reports/2009/ComparativeEffectivenes
sResearchPriorities.aspx
4. The Henry J. Kaiser Family foundation. Explaining health
reform: what is comparative effectiveness research?
September 29, 2009. Accessed on: February 23, 2016.
Available at: http://kff.org/health-costs/issuebrief/explaining-health-care-reform-what-is-comparative/
Thank you to AMCP members
Carly Rodriguez and Cheryl Kaltz
for creating this slide deck.
Thank you to AMCP member
Melissa McCart for updating this
presentation for 2016.