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

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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

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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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• 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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• 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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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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HTA as an Interdisciplinary Process(es)


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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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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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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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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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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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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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Early “View” of HTA Process


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HTA Process

Source: Busse et al., 2002


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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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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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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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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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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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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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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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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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Thank You!!

Bob Parson

[email protected]

858-805-3103 (office)

858-357-6491(cell)

9975 Summers Ridge Road

San Diego, CA 92121


mailto:[email protected]

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