2nd Annual Health Outcomes and Pharmacoeconomics Research Conference • Setting up internal processes to ensure proper Health Technology Assessment (HTA) • Exploring initiatives to translate reported outcomes to ensure proper understanding of data • Assessing the key HTA entities in the U.S. and establishing assessment protocol • Differentiating HTA strategies with new technology assessment strategies to improve assessment processes

1. Evaluating Health Technology Assessment and
New Assessment Techniques to Formulate
Improved Outcomes Data
Bob Parson
Vice President
Pharmacoeconomics & Outcomes Research
Alere, Inc.
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2. Alere’s Total Healthcare Solution
• Alere is a leader in specialized health management services
incorporating in-home monitoring devices for medium- and high-risk
patients and complex case management.
• Our extensive continuum of healthcare services was put together to
help address the needs of patients, while at the same time bending
the trend on ever-rising healthcare costs.
• Our mission is to bring greater clarity to health management by
“leveraging technology to improve healthcare, one person, one touch
at a time.” This translates into the delivery of better outcomes for
consumers, which in turn generates greater savings for you.
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3. Alere’s Total Healthcare Solution
• Provider of Healthcare Home-Monitoring Services
• 5 Strategic Business Units (SBU’s)
• Cardiovascular
• Oncology
• Women’s Health
• Infectious Disease
• Drugs of Abuse
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4. Alere’s Total Healthcare Solution
• Keep program participants as healthy as possible through
programs that improve clinical outcomes, lower costs and
increase productivity
• Ensure that expected numbers of participants are enrolled in
programs
• Ensure programs effect positive change in participant behavior
• Provide reports that are transparent, simple, concise and
demonstrate the positive impact of our programs on employees
and their families
• Beyond the services offered today, we are planning to continue
expanding to build the broadest, most fully-integrated and
patient-centered portfolio of diagnostic and health management
services in our industry.
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5. Agenda
• Setting up internal processes to ensure proper Health
Technology Assessment (HTA)
• Exploring initiatives to translate reported outcomes to
ensure proper understanding of data
• Assessing the key HTA entities in the U.S. and establishing
assessment protocol
• Differentiating HTA strategies with new technology
assessment strategies to improve assessment processes
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6. HTA as an Interdisciplinary Process(es)
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7. What are the tasks and Objectives of HTA
• Evaluation of health benefits and optimization of the health system
• Supply of information with the objective to improve the health status
of the population and to distribute the financial resources more
effectively
• Supply of information as a basis for decisions on the different levels of
the health system
• Examination of established procedures and assessment of new
technologies
• Identification of scientific and of research deficits
• Support concerning the prioritization of future research activities.
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8. Setting up internal processes to ensure proper
Health Technology Assessment (HTA)
 Requires quality assurance methods to be followed
throughout the process
 Desire up-to-date information is used with the intended
population
 Minimize faults in the planning, execution, protocol,
execution, monitoring, and study close-out
 Identifies biases and controls or eliminates them
 Uses technology properly and within its intended use
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9. Setting up internal processes to ensure proper
Health Technology Assessment (HTA)
 HTA for reimbursement, pricing and/or clinical guidelines?
 Identifies barriers to HTA
 Patient-based HTA vs. generic-based HTA
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10. Key Principles for HTA Improvements
Structure of HTA Programs
1) The goal and scope should be explicit and relevant to its use
2) Unbiased and transparent exercise
3) Include all relevant technologies
4) A clear system for setting priorities for HTA should exist
Methods of HTA
5) Incorporate appropriate methods for assessing costs and
benefits
6) Consider a wide range of evidence and outcomes
7) A full societal perspective should be considered
8) Explicitly characterize uncertainty surrounding estimates
9) Consider and address issues of generalizability and
transferability
Drummond et al, IJTAIHC,24:3(2008)
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11. Key Principles for HTA Improvements
Processes for Conducting HTA
10) Actively engage all key stakeholder groups
11) Actively seek all available data
12) Implementation of HTA findings needs to be monitored
Use of HTA In Decision Making
13) HTA should be timely
14) HTA findings need to be communicated appropriately to
different decision makers
15) The link between HTA findings and decision-making
processes needs to be transparent and clearly defined
Drummond et al, IJTAIHC,24:3(2008)
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12. The Role Quality Assurance Plays in HTA
The purpose of quality assurance is to ensure that the best
available knowledge concerning the use of the technology to
improve health outcomes is properly used. It involves the
implementation of health care standards:
• Correct, reduce variations or otherwise improve health care
practices relative to these standards
• Continuous quality improvement (CQI) and total quality
management (TQM)
• The contemporary systematic approaches to quality assurance
following use of clinical pathways, disease and care
management
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13. Early “View” of HTA Process
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14. HTA Process
Source: Busse et al., 2002
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15. Five Principles of Lean Management
1) Value is defined from the consumer’s
perspective
2) All stages of production are known as the
value stream
3) We need to ensure that the value stream
flows
4) Products should be pulled (as opposed to
pushed) through the system
5) The production process needs to strive for
perfection
John F.P. Bridges, Pharmacoeconomics;24:2(2006)
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16. German Institute of Medical Documentation and Information
The HTA process is a continuous procedure and is composed of a set of
individual steps. The public is often only aware of parts of this process – the
HTA reports. The process is not concluded with the ending of an HTA report,
in fact, it is the beginning of an observation which might end with the update
of a report.
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17. Six Steps In Evaluating Medicine
1) Identify the problems
2) Build the partnerships
3) Focus on the patient
4) Focus on the entire healthcare portfolio
5) Develop the necessary processes
6) Strive for perfection
John F.P. Bridges, Pharmacoeconomics;24:2(2006)
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18. Exploring initiatives to translate reported
outcomes to ensure proper understanding of data
• Outcomes-Based Evaluations
• Traditional approach to HTA (CEA, Budget Impact,
Economic)
• Meta-Analyses, Hypothesis testing
• Goals-Based Evaluations
• Reverse engineering in which the goal is to improve
certain aspects of the health status of the patient
• More of a holistic approach to evaluation
• Process-Based Evaluations
• What are the processes in which the technology
operates in.
• Optimization (errors) or minimization (time to result)
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19. Need to expand HTA decision making activities across public
and private sectors.
Private-Sector
 Technology Evaluation Center (TEC), Blue Cross/Blue Shield Assoc.
 Kaiser Permanente Technology Assessment, Aetna
 Emergency Care Research Institute (ECRI)
 Hayes, Inc.
 Drug Effectiveness Review Project (DERP), OHSU
 California Healthcare Institute (CHI)
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20. Need to expand HTA decision making activities across the
organization
Public-Sector
 Medicare coverage policies by CMS
 NIH consensus development
 Technology Assessment by AHRQ
 Department of Veteran’s Affairs (VA)
 Minnesota Health Technology Advisory Committee (HTAC)
 Oregon Medical Technology Assessment Program (MedTAP)
 Heath Technology Assessment Program, Washington State Health
Care Authority
 National Information Center on Health Services Research and Health
Technology (NICHSR)
 The Cochrane Collaboration
 National Guideline Clearinghouse (NGC)
 National Institute of Clinical Effectiveness (NICE)
 International Network of Agencies for HTA (INAHTA)
 EUnetHTA
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21. Internal / External Key Stakeholders
• Core Staff
• Multidisciplinary HTA Committee representing clinical,
nursing, lab, pharmacy, allied health, biomedical
engineering, R&D.
• Interaction with external CRO’s, consultants,
KOL’s, strategic business units (SBU’s)
and capital planning committees.
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22. Differentiating HTA strategies with new technology
assessment to improve assessment processes
 HTA to Support / Evaluate:
 Funding / reimbursement decisions
 Medical decision making
 Assess the delivery of healthcare services
 Clinic outreach to the patient community
 HTA Assessment Period
 Specific Period (week,month, years)
 Continuous / patients passing through
 Endpoints
 Direct
 Indirect / Surrogate
 Combination
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23. Thank You!!
Bob Parson
robert.parson@alere.com
858-805-3103 (office)
858-357-6491(cell)
9975 Summers Ridge Road
San Diego, CA 92121
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