Evaluating Health Technology Assessment and       New Assessment Techniques to Formulate               Improved Outcomes D...
Alere’s Total Healthcare Solution        • Alere is a leader in specialized health management services          incorporat...
Alere’s Total Healthcare Solution      • Provider of Healthcare Home-Monitoring Services      • 5 Strategic Business Units...
Alere’s Total Healthcare Solution         • Keep program participants as healthy as possible through           programs th...
Agenda        • Setting up internal processes to ensure proper Health          Technology Assessment (HTA)        • Explor...
HTA as an Interdisciplinary Process(es)2nd Annual Health Outcomes and Pharmacoeconomics Conference                        ...
What are the tasks and Objectives of HTA        • Evaluation of health benefits and optimization of the health system     ...
Setting up internal processes to ensure proper        Health Technology Assessment (HTA)         Requires quality assuran...
Setting up internal processes to ensure proper        Health Technology Assessment (HTA)            HTA for reimbursement...
Key Principles for HTA Improvements        Structure of HTA Programs        1) The goal and scope should be explicit and r...
Key Principles for HTA Improvements        Processes for Conducting HTA        10) Actively engage all key stakeholder gro...
The Role Quality Assurance Plays in HTA       The purpose of quality assurance is to ensure that the best       available ...
Early “View” of HTA Process2nd Annual Health Outcomes and Pharmacoeconomics Conference                                    ...
HTA ProcessSource: Busse et al., 20022nd Annual Health Outcomes and Pharmacoeconomics Conference                          ...
Five Principles of Lean Management        1)          Value is defined from the consumer’s                    perspective ...
German Institute of Medical Documentation and Information   The HTA process is a continuous procedure and is composed of a...
Six Steps In Evaluating Medicine        1)         Identify the problems        2)         Build the partnerships        3...
Exploring initiatives to translate reported       outcomes to ensure proper understanding of data        • Outcomes-Based ...
Need to expand HTA decision making activities across public       and private sectors.        Private-Sector         Tech...
Need to expand HTA decision making activities across the        organization           Public-Sector            Medicare ...
Internal / External Key Stakeholders        • Core Staff        • Multidisciplinary HTA Committee representing clinical,  ...
Differentiating HTA strategies with new technology       assessment to improve assessment processes         HTA to Suppor...
Thank You!!                                Bob Parson                         robert.parson@alere.com                     ...
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Evaluating Health Technology Assessment Reports and New Assessment Techniques to Formulate Improved Outcomes Data

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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

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Evaluating Health Technology Assessment Reports and New Assessment Techniques to Formulate Improved Outcomes Data

  1. 1. Evaluating Health Technology Assessment and New Assessment Techniques to Formulate Improved Outcomes Data Bob Parson Vice President Pharmacoeconomics & Outcomes Research Alere, Inc.2nd Annual Health Outcomes and Pharmacoeconomics Conference 1
  2. 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.2nd Annual Health Outcomes and Pharmacoeconomics Conference 2
  3. 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 Abuse2nd Annual Health Outcomes and Pharmacoeconomics Conference 3
  4. 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.2nd Annual Health Outcomes and Pharmacoeconomics Conference 4
  5. 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 processes2nd Annual Health Outcomes and Pharmacoeconomics Conference 5
  6. 6. HTA as an Interdisciplinary Process(es)2nd Annual Health Outcomes and Pharmacoeconomics Conference 6
  7. 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.2nd Annual Health Outcomes and Pharmacoeconomics Conference 7
  8. 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 use2nd Annual Health Outcomes and Pharmacoeconomics Conference 8
  9. 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 HTA2nd Annual Health Outcomes and Pharmacoeconomics Conference 9
  10. 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)2nd Annual Health Outcomes and Pharmacoeconomics Conference 10
  11. 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)2nd Annual Health Outcomes and Pharmacoeconomics Conference 11
  12. 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 management2nd Annual Health Outcomes and Pharmacoeconomics Conference 12
  13. 13. Early “View” of HTA Process2nd Annual Health Outcomes and Pharmacoeconomics Conference 13
  14. 14. HTA ProcessSource: Busse et al., 20022nd Annual Health Outcomes and Pharmacoeconomics Conference 14
  15. 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)2nd Annual Health Outcomes and Pharmacoeconomics Conference 15
  16. 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.2nd Annual Health Outcomes and Pharmacoeconomics Conference 16
  17. 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)2nd Annual Health Outcomes and Pharmacoeconomics Conference 17
  18. 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)2nd Annual Health Outcomes and Pharmacoeconomics Conference 18
  19. 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)2nd Annual Health Outcomes and Pharmacoeconomics Conference 19
  20. 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)  EUnetHTA2nd Annual Health Outcomes and Pharmacoeconomics Conference 20
  21. 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.2nd Annual Health Outcomes and Pharmacoeconomics Conference 21
  22. 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  Combination2nd Annual Health Outcomes and Pharmacoeconomics Conference 22
  23. 23. Thank You!! Bob Parson robert.parson@alere.com 858-805-3103 (office) 858-357-6491(cell) 9975 Summers Ridge Road San Diego, CA 921212nd Annual Health Outcomes and Pharmacoeconomics Conference 23

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