ispor international initiatives on the...
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ISPOR International Initiatives on the Assessment of the Value of Medical Technologies
Lou Garrison, PhD ISPOR Immediate Past PresidentProfessor EmeritusUniversity of Washington, Seattle, WA
Agenda
§ Background on ISPOR§ Member interest and activities in MD&D/Medical
Technologies—Past and Recent§ Assessing Medical Technologies—Key Features, Challenges,
and Opportunities§ ISPOR Initiatives on the Assessment of Value of Medical
Technologies: Need and plans for an international initiative
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Founded in 1995 with 300 members, ISPOR has now grown to 20,000 individual and Chapter members worldwide.
Mission:To promote health economics and outcomes research excellence to improve decision making for health globally.
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International Society for Pharmacoeconomics and Outcomes Research
ISPOR is a nonprofit, international, educational and scientific organization that promotes health economics and outcomes research excellence to improve decision making for health globally
Individual Members Regional Chapter Members
ISPOR Global Membership
20,000
20,000 ISPOR Members
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
ISPOR’s Global Stakeholders
Many HTA agencies include patients in their assessments
Researchers are actively seeking patients’ views
Major health tech producers have
established patient-focused
departments
EMA & FDA includes patients
in reviews
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ISPOR Current Medical Technologies Membership
• Nearly 700 members working in the medical device and diagnostic spaceo About 0.7% of ISPOR’s membership, representing 59 countries
USA 214
Switzerland 47 England, UK
40France
39 Germany 28
Italy 24 Brazil
19Denmark
18Spain
17Colombia
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0
50
100
150
200
250
Num
ber o
f ISP
OR
Mem
bers
Countries
Top 10 Countries with ISPOR Members Focusing on Medical Devices
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ISPOR Past Medical Technologies Activities
• Book- Therapeutic and Diagnostic Device Outcomes Research – published 2011
• Special Interest Group- Health Technology Assessment for Molecular Diagnostics: Practices,
Challenges, and Recommendations from the Medical Devices and Diagnostics Special Interest Group published in Value Health 2016; (July/August)19: 577–587
- Comments to FDA’s public consultation on “Use of Real-World Evidence to Support Regulatory Decision making for Medical Devices” -submitted October 2016
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66 82 89 94 10214622
28 26 38 34118
110156
187148
0
50
100
150
200
250
300
350
2012 2013 2014 2015 2016 2017
NU
MB
ER O
F PR
ESEN
TATI
ON
S
YEARS
Total 'Medical Technologies' Presentations at ISPOR Meetings including Research Posters and
Podiums
International Regional European
*Note. 2017 data for Regional and European meetings are n/a.
Medical Technologies (MT) Accepted Presentations for the past 5 years at ISPOR Meetings (2012 – 2017*)
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0
1
2
3
4
5
6
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2012 2013 2014 2015 2016 2017
Plenaries, Issue Panels, Workshops, Forum and Open Meetings "Medical Technologies"
at ISPOR
Plenary Issue Panel Workshop Forum Open Meeting
5.4% of total sessions 6.3% of total presentations
ISPOR Current Activities in Medical Technologies
• ISPOR MD&D Special Interest Group- The Value Assessment of Medical Devices WG
- ISPOR Global Health Care Systems Road Map
• HTA Council WG: - International Initiatives on the Assessment of the Value of Medical
Technologies§Abstract submitted & accepted - 3rd Global Forum on Medical Devices in Geneva, Switzerland from 10-12th of May, 2017
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ISPOR MD&D Special Interest Group—Current
The Value Assessment of Medical Devices WG - Currently finalizing a 2-part manuscript:§ Paper 1: Key Considerations and Issues in Value Assessment of Medical
Devices§ Identifies the key considerations and issues in developing value assessments for
medical devices
§ Paper 2: Generating Appropriate and Reliable Evidence for the Value Assessment of Medical Devices§ Identifies alternative tools and techniques for medical device value assessment
Open Meeting at ISPOR Glasgow, Tuesday, 7 November 12:30-13:30- Discussing new upcoming project:
§ ISPOR Global Health Care Systems Road Map§ Interested in developing new roadmaps for medical devices and updating out-of-
date medical device roadmaps on our webpage
§Other topics members identify
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Key Features of Medical Technologies—Important and Unique
§ Contribute significantly to modern health services by supporting the management of care from prevention to detection, treatment, alleviation, and follow-up
§ Cover a range of diverse modalities categorized into national and international classification systems
§ More than 500,000 medical technology products registered worldwide
§ Life cycle of medical technologies likely to involve continuous evolution in performance – rapid refinements in response to experiences derived from clinical
practice (device iteration)
§ Evolving methods to evaluate their safety, cost-effectiveness, and consequences for health systems and society
§ Subject to initiatives to reform healthcare towards a value-based health care and measure benefits that matter to patients
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§ Wide spectrum of medical technologies: diagnostic, procedures, devices, screening
§ Range of risk across the different medical technologies
§ Life-cycle: Incremental innovation and iteration
§ Learning curve of the device user
§ Organizational implications (i.e., training, upgrading facilities)
§ Few undergo health technology assessment
§ Reimbursement can vary depending on device type and facility level
§ Evidence is mainly regulatory rather than focusing on clinical and cost effectiveness (e.g., accuracy data only for diagnostic tests)
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Challenges in Assessing Medical Technologies
Potential Opportunities for Improving the Assessment of Medical Technologies - I
§ Review international risk classification for MDs
§ Determine appropriate levels of evidentiary requirements by risk category
§ Identify areas with respect to data requirements for devices where alignment of regulatory and HTA processes can occur
§ Consider an iterative process for the evaluation of devices as additional evidence and learning emerges over time- Explore conditional coverage with evidence development decisions
§ Consider evidence generation for HTA by integrating data from different sources including the synthesis of real-world evidence with trial data through modeling
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§ Consider the likely prospects of research and who should pay for it- Many medical device manufacturers are small-medium enterprises
(SMEs) and generation of additional data is costly to develop and collect
§ Establish high-quality device registries for the long-term study of the effectiveness and safety of MD&Ds- Design registries to support comparative analysis of treatment
patterns and outcomes
§ Develop an approach that can use appropriate surrogate outcomes
§ A future vision of the role of HTA should include consideration of the total product lifecycle and access model of medical technologies.
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Potential Opportunities for Improving the Assessment of Medical Technologies - II
A New International Initiative Is Needed!
ConclusionSeveral organizations foresee roles of HTA at different stages of medical technologies’ lifecycle; however, there are still many underdeveloped areas of research and interest.
There is a great need to improve the process of HTA for medical technologies, representing complex interventions, which require different methods of evaluation and inform different decisions
ObjectiveIdentify the current role of HTA and other tools/ approaches/methods used to assess the value of medical technologies globally and locally; and develop recommendations for a future role that HTA and other tools could have in assessing medical technologies throughout their lifecycle to inform decisions and health care policies.
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International Organizations: WHO, ISPOR, OECDHTA Bodies: EUnetHTA JA3, NICE, LBI-HTA, Norwegian Directorate of HealthResearch/Academia: US National Institute of Health/National Institute of Cancer (NIH/NIC)University of Berlin, Germany; University of Bocconi, Italy Regulators: US Food and Drug Administration (FDA)Public/Private Partnership: Medical Device Innovation Consortium (MDIC)Industry: MedTech Europe, AdvaMed,
(additional partners expected)16
Participating Organizations to Date
Several international organizations will cooperate to approach these challenges with the following focal points:
§ Perform a gap analysis– Identification of existing documentation and reports from related initiatives – Mapping of HTA, regulatory processes, and risk classification systems – Conduct a literature search – Conduct a country or regional review of specific evidence required (if
needed)
§ Develop recommendations– Future roles of HTA and other tools to assess the value of medical
technologies in a life cycle perspective – Evidence generation– Capacity building– Other recommendations as identified
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Approach
Key Deliverable
A manuscript for Value in Health as a guidance document on the assessment of the value of medical technologies, including the role of HTA and other tools, at different stages of the lifecycle.
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Timeline
Preparatory Phase November 2016 – September 2017Phase 1: Gap Analysis* October 2017 – May 2018Analysis from mapping completed; Update of proposal accordingly
July – October 2018
Presentation of gap analysis at ISPOR Congress
November 2018
Phase II: Recommendations November 2018 – June 2019Presentation of final results at ISPOR Annual Meeting
May 2019
Submit manuscript for publication in Value in Health
September 2019
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* Includes identification of existing document, mapping, literature review, country or regional review
Activity Deadline
Thank You Interested to learn more about the ISPOR International Initiatives on the International Assessment of the Value of Medical Technologies
Go to https://www.ispor.org/councils/HTAC-Intl-Initiatives-on-Medical-Devices.asp
Or email [email protected]
Nadia NaamanSenior Director, Scientific & Health Policy [email protected]
Theresa Tesoro, MSNAssociate Director, Scientific & Health Policy [email protected]