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
Presentation delivered by Dr Adham Ismail, Regional Adviser, Health Technologies at the 62nd Session of the WHO Regional Committee for the Eastern Mediterranean
Health technology assessment (HTA) is familiar as technique for gauging the value of specific medical technologies or approaches to care. As Adrian Towse points out, however, HTA has a much broader, ‘macro’ role in contributing to the efficiency of health care systems and supporting universal health coverage. This is particularly crucial in the face of increasing demands and limited budgets.
Presentation - New Business Models for Antibiotics: Where Are We Now? 16 Marc...Office of Health Economics
Speaking at the Superbugs & Superdrugs conference in London on 16 March 2016, OHE’s Jorge Mestre-Ferrandiz delivered a presentation on financial and collaborative incentives to accelerate clinical success for antibiotics.
Jorge discussed the economic challenges around antibiotics, and whether there is a need for a new business model. He reviewed of the impact of previous incentives, explaining what has worked in the past, and discussed possible new business models.
Presentation delivered by Dr Adham Ismail, Regional Adviser, Health Technologies at the 62nd Session of the WHO Regional Committee for the Eastern Mediterranean
Health technology assessment (HTA) is familiar as technique for gauging the value of specific medical technologies or approaches to care. As Adrian Towse points out, however, HTA has a much broader, ‘macro’ role in contributing to the efficiency of health care systems and supporting universal health coverage. This is particularly crucial in the face of increasing demands and limited budgets.
Presentation - New Business Models for Antibiotics: Where Are We Now? 16 Marc...Office of Health Economics
Speaking at the Superbugs & Superdrugs conference in London on 16 March 2016, OHE’s Jorge Mestre-Ferrandiz delivered a presentation on financial and collaborative incentives to accelerate clinical success for antibiotics.
Jorge discussed the economic challenges around antibiotics, and whether there is a need for a new business model. He reviewed of the impact of previous incentives, explaining what has worked in the past, and discussed possible new business models.
The world of Regulatory convergence: an Australian reflectionTGA Australia
This presentation provides an overview on recent advances and initiatives on regulatory convergence and the impact on Australian, European and international regulation of therapeutic goods.
Presentation: IGDRP - Mission, scope, how it worksTGA Australia
This presentation provides an overview of the International Generic Drug Regulators Programme (IGDRP), its conception including its mission and objectives, and the activities of its various working group and its future.
Regulatory updates from the TGA Medical Devices Branch - Part 2TGA Australia
Presentation on the regulation of software including software as a medical device, proposed regulatory scheme for personalised medical devices, including 3D Printed Devices, proposed changes to the Essential Principles, Conformity Assessment Procedures, and the requirements for devices used in clinical trials, and clarifying the requirements for systems and procedure packs
Presentation: Risk minimisation in the Australian contextTGA Australia
This presentation describes Risk Minimisation including general principles and the tools available for the development of Risk Minimisation Plans (RMPs)
OHE Lunchtime Seminar with Associate Professor Paula Lorgelly, Deputy Director, Office of Health Economics
From the Antipodes to the Motherland: reflections on HTA decision makers as budget takers and budget makers
Regulatory updates from the TGA Medical Devices Branch - Part 1TGA Australia
Presentation on the review of medicines and medical devices regulation, proposed changes to some definitions and regulation of some products without a medical purpose, reclassification of medical devices (not IVD), Unique Device Identification System and post-market monitoring
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Presentation on the background of medicine shortages, definitions, reporting requirements, assessment and management, Section 19A and the compliance framework
Scaling up innovation in healthcare - A Methodology Framework 2015Marc Lange
This presentation introduce a methodology scaling-up developed by "doers and shapers" internationally known for their expertise in eHealth and digital health
SME Assist: Help to navigate the regulatory mazeTGA Australia
Presentation to provide information on TGA’s SME Assist and what the service offers, details on upcoming SME Assist events and information on where to find more help
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
This is the summary of a webinar I delivered in November 2012 on Health Outcomes Liaisons and their roles in supporting managed care busines and ACO business.
The world of Regulatory convergence: an Australian reflectionTGA Australia
This presentation provides an overview on recent advances and initiatives on regulatory convergence and the impact on Australian, European and international regulation of therapeutic goods.
Presentation: IGDRP - Mission, scope, how it worksTGA Australia
This presentation provides an overview of the International Generic Drug Regulators Programme (IGDRP), its conception including its mission and objectives, and the activities of its various working group and its future.
Regulatory updates from the TGA Medical Devices Branch - Part 2TGA Australia
Presentation on the regulation of software including software as a medical device, proposed regulatory scheme for personalised medical devices, including 3D Printed Devices, proposed changes to the Essential Principles, Conformity Assessment Procedures, and the requirements for devices used in clinical trials, and clarifying the requirements for systems and procedure packs
Presentation: Risk minimisation in the Australian contextTGA Australia
This presentation describes Risk Minimisation including general principles and the tools available for the development of Risk Minimisation Plans (RMPs)
OHE Lunchtime Seminar with Associate Professor Paula Lorgelly, Deputy Director, Office of Health Economics
From the Antipodes to the Motherland: reflections on HTA decision makers as budget takers and budget makers
Regulatory updates from the TGA Medical Devices Branch - Part 1TGA Australia
Presentation on the review of medicines and medical devices regulation, proposed changes to some definitions and regulation of some products without a medical purpose, reclassification of medical devices (not IVD), Unique Device Identification System and post-market monitoring
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Presentation on the background of medicine shortages, definitions, reporting requirements, assessment and management, Section 19A and the compliance framework
Scaling up innovation in healthcare - A Methodology Framework 2015Marc Lange
This presentation introduce a methodology scaling-up developed by "doers and shapers" internationally known for their expertise in eHealth and digital health
SME Assist: Help to navigate the regulatory mazeTGA Australia
Presentation to provide information on TGA’s SME Assist and what the service offers, details on upcoming SME Assist events and information on where to find more help
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
This is the summary of a webinar I delivered in November 2012 on Health Outcomes Liaisons and their roles in supporting managed care busines and ACO business.
The revised OECD Health Systems Performance Framework: methodological issues ...Sax Institute
The OECD is a leading organization in the international measurement of health system performance. The OECD Expert Group on Health Care Quality Indicators (HCQI) has recently revised its performance framework, identifying core indicators and highlighting new directions. Although improving, the capacity of countries to deliver more accurate standardized indicators still needs to be fostered. A particular aspect that deserves attention is the design, planning and implementation of public performance reporting. Such activity, strictly interrelated to the capacity of the information infrastructure, also depends from cultural, organizational and political conditions that can be differently present at the international level. The applicability of standardized principles and the evidence of improved outcomes due to public reporting systems is still questioned to a large extent. A first international conference on the topic of hospital performance reporting has been organized in Rome, Italy in 2014, followed by a second event held in Seoul, South Korea, in 2015. In his talk, Fabrizio Carinci will present recent developments of OECD projects, including:
• state of the art in the definition of OECD performance indicators
• challenges emerging from OECD R&D studies
• transferability and use of definitions at sub-national and provider level
• applicability for hospital performance benchmarking and geographical variation
• limitations imposed by the legislation on privacy and data protection
• an overarching vision of “essential levels of health information”
Through practical examples drawn from his direct experience as Member of the Bureau of the HCQI and other relevant Boards, Prof. Fabrizio Carinci will discuss the state of the art, the role played by national governments (including Australia), and potential avenues for mutual collaboration.
www.interlinkconsultancy.com
Healthcare industry challenges and pharmacoeconomic solutions.The pharma industry product pipelines are drying up, leading to a high dependence on existing products for survival. The branded generic drugs segment has become commoditized due to ever increasing and fierce
competition.Price plays a major role in drug prescription and buying decisions. High price may not always assure high quality or more benefits and companies are finding it difficult to substantiate higher prices..
Four strategies to upgrade clinical trial quality in this computerized world ...Pubrica
• Biostatistics Services is important for collecting, reviewing, presenting, and interpreting data in clinical research.
• Applications of clinical biostatistics services are in different areas, such as epidemiology, clinical trials, population genetics, the biology of structures, and more.
Reference : https://pubrica.com/services/research-services/biostatistics-and-statistical-programming-services/
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> Why HEOR?
> Costs, Consequences and Perspectives
> Key Stakeholders in HEOR
> What is Health Economics and Pharmaco-economic Research?
> Economic Evaluations
> Incremental Cost Effectiveness Ratio (ICER)
> Concept of HRQoL
> Comparative Effectiveness Research (CER)
> Pragmatic Clinical Trials
> Observational Studies
> Systematic Reviews and Meta-Analysis
> Application of CER
> Health Technology Assessment (HTA)
> Real World Evidence (RWE)
> Patient Reported Outcomes (PROs)
> Patient Focused Drug Development (PFDD)
> Application of Health Economic Evaluations
> Challenges and Barriers
What’s Next in US Payor Communications: The Impact of FDA's Proposed Guidance...Nathan White, CPC
The recent enactment of the 21st Century Cures Act has profound immediate and long-term implications for development and communication of HEOR/RWE in the US, particularly in relation to communications with payors about healthcare economic information (HCEI). In January, the FDA released draft guidance for public comment to outline its thinking around communication to payors of HCEI, but there are still unanswered questions to be addressed in the final guidance. Industry will need to quickly establish new policies and procedures to maintain compliance with the new regulations, especially in relation to OPDP submission requirements – a steep transition from a space that has largely been unregulated.
Paying for performance to improve the delivery of health interventions in LMICsReBUILD for Resilience
This presentation from Sophie Witter & Karin Diaconu of Queen Margaret University, UK outlines the findings from a Cochrane review undertaken by the team on paying for performance to improve the delivery of health interventions in low and middle-income countries.
Dr Brent James: quality improvement techniques at the frontlineNuffield Trust
Dr Brent James, Intermountain Institute for Healthcare Delivery Research, presents to the Health Policy Summit 2015 on delivering quality improvement techniques at the frontline.
Evidence-Based PracticeEvidence-based Practice Progra.docxelbanglis
Evidence-Based
Practice
Evidence-based Practice
Program
The Agency for Healthcare Research and
Quality (AHRQ), through its Evidence-
based Practice Centers (EPCs), sponsors
the development of evidence reports and
technology assessments to assist public-
and private-sector organizations in their
efforts to improve the quality of health
care in the United States. The reports
and assessments provide organizations
with comprehensive, science-based
information on common, costly
medical conditions and new health care
technologies. The EPCs systematically
review the relevant scientific literature
on topics assigned to them by AHRQ
and conduct additional analyses when
appropriate prior to developing their
reports and assessments.
AHRQ expects that the EPC evidence
reports and technology assessments will
inform individual health plans, providers,
and purchasers as well as the health care
system as a whole by providing important
information to help improve health care
quality.
The full report and this summary are
available at www.effectivehealthcare.
ahrq.gov/reports/final.cfm.
Background
The United States spends a greater proportion
of its gross domestic product on health care
than any other country in the world (17.6
percent in 2009),1 yet often fails to provide
high-quality and efficient health care.2-6 U.S.
health care has traditionally been based on a
solid foundation of primary care to meet the
majority of preventive, acute, and chronic
health care needs of its population; however,
the recent challenges facing health care in
the United States have been particularly
magnified within the primary care setting.
Access to primary care is limited in many
areas, particularly rural communities. Fewer
U.S. physicians are choosing primary care as
a profession, and satisfaction among primary
care physicians has waned amid the growing
demands of office-based practice.7 There has
been growing concern that current models
of primary care will not be sustainable for
meeting the broad health care needs of the
American population.
The patient-centered medical home (PCMH)
is a model of primary care transformation that
seeks to meet the variety of health care needs
of patients and to improve patient and staff
experiences, outcomes, safety, and system
efficiency.8-11 The term “medical home”
was first used by the American Academy of
Pediatrics in 1967 to describe the concept of a
single centralized source of care and medical
record for children with special health care
Evidence Report/Technology Assessment
Number 208
2. The Patient-Centered Medical Home
Closing the Quality Gap: Revisiting the State of the Science
Executive Summary
2
needs.12 The current concept of PCMH has been greatly
expanded and is based on 40 years of previous efforts to
redesign primary care to provide the highest quality of care
possible.13,14 The chronic care model,15,16 a conceptual
model for organizing chronic illness ...
Regulatory requirements for drug approval unit3Aman chourasia
New Drug Application (NDA) is an application submitted to the individual regulatory authority for authorization to market a new drug i.e. innovative product. To gain this permission a sponsor submits preclinical and clinical test data for analyzing the drug information, description of manufacturing trials.
This resource summarizes the eight recommendations outlined in the Institute of Medicine's a new consensus study entitled, Improving Diagnosis in Health Care. The recommendations are aimed at making diagnoses more accurate, reliable, efficient, and safe. This work is a continuation of the IOM’s Quality Chasm series.
Quality improvement and patient safety in anesthesia
Evaluating Health Technology Assessment Reports and New Assessment Techniques to Formulate Improved Outcomes Data
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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