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ISPOR 11TH ANNUAL INTERNATIONAL MEETING
Medical Device & Diagnostics Forum
May 20-24, 2006
Marriott Philadelphia, Philadelphia, PA
ISPOR MEDICAL DEVICE & DIAGNOSTICS OUTCOMES
RESEARCH: ISSUES & GOOD RESEARCH PRACTICES
ISPOR has launched an initiative to address methodological issues and good
research practices when conducting outcomes research for medical devices and
diagnostics. The product of this initiative is a book titled: Medical Device
& Diagnostics Outcomes Research: Issues & Good Research Practices. This book
will address issues related to current health technology assessment
methodologies and recommend good outcomes research practices that are
specifically "tailored" for fast-paced, medical device and diagnostics
technology environment. This initiative is a joint project of the ISPOR US
Medical Device & Diagnostics Council and the ISPOR European Medical Device &
Diagnostics Council with input from the Asia-Pacific Medical Device &
Diagnostics Council.
Moderators: Stephen Hull, Chair, US ISPOR Medical Device & Diagnostics
Council, and Vice President, Business Development, Vice President, Global
Strategy and Analysis, Advanced Medical Technology Association, Washington,
DC, USA, and Stacey Ackerman MSE, PhD, Medical Device & Diagnostics Outcomes
Research: Issues & Good Research Practices Co-editor & Vice President,
Covance Health Economics & Outcomes Services, San Diego, CA, USA
Research Differentiation & Evidence Hierarchy
Speaker: Randel Richner MPH, Medical Device & Diagnostics Outcomes Research:
Issues & Good Research Practices Chapter Author & VP of Government Affairs,
Boston Scientific, Boston, MA, USA
Clinical Outcomes
Speaker: David Polly MD, Medical Device & Diagnostics Outcomes Research:
Issues & Good Research Practice Section Editor & Professor and Chief of
Spine Surgery, Department of Orthopedic Surgery, University of Minnesota,
Minneapolis, MN, USA
Economic Outcomes
Speaker: Seema Sonnad, PhD, Medical Device & Diagnostics Outcomes Research:
Issues & Good Research Practice Section Editor & Associate Professor, Dept
of Surgery, University of Pennsylvania, Philadelphia, PA USA
Patient Reported Outcomes
Speaker: Susan Mathias MPH, Medical Device & Diagnostics Outcomes Research:
Issues & Good Research Practice Chapter Author & Vice President, Ovation
Research Group, San Francisco, CA USA
ISPOR 10TH ANNUAL INTERNATIONAL MEETING
Medical Device & Diagnostics Forum
May 17, 2005
Marriott Wardman Park, Washington, DC, USA
THE APPLICATION OF POST-MARKET REGISTRIES AND OTHER EVIDENCE FOR MEDICAL DEVICES
Moderator: Stephen Hull, Vice President, Global Strategy and Analysis Department, Advanced medical Technology Association, Washington, DC, USA
FDA Perspective: What Is the FDA’s Experience with Post Approval Device Studies? What Is the Primary Evidentiary Role of These Studies?
Speaker: Neal Muni MD, MSPH, Medical Officer, US Food and Drug Administration, Rockville, MD, USA
The usefulness of post market studies for medical devices, including a view on time, cost and application of the evidence, will be presented.
CMS Perspective: What Is CMS's View On The Role of Postmarket Evidence in Coverage for Medical Device?
Speaker: Steven Phurrough MD, MPA, Director, Coverage and Analysis Group, Office of Clinical Standards & Quality Center for Medicare and Medicaid Services, Baltimore, MD, USA
The role of post-market evidence in coverage for medical devices from the perspective of the Center for Medicaid and Medicare, Department of Health and Human Services will be presented.
What Are the Limitations of Post-Market Studies? In What Conditions Are They Best Applied? Practical Realities of Postmarket Research?
Speaker: Clifford Goodman PhD, Vice President, The Lewin Group, Falls Church, VA, USA
The practical realities of post-market research will be presented.
Panel Discussion
ISPOR 9TH ANNUAL INTERNATIONAL MEETING
Medical Device & Diagnostics Forum
May 18, 2004
Crystal Gateway Marriot, Arlington, VA, USA
PATIENT-REPORT OUTCOMES (PROS) IN DEVICE EVALUATION: SCIENTIFIC AND REGULATORY
CHALLENGES
Introduction to the Issue – Common Challenges, Uncommon Solutions
Moderator & Speaker: Nancy Kline Leidy PhD, President and CEO, MEDTAP International,
Bethesda, MD, USA
The need to communicate value through rigorous scientific evidence common challenge to all areas of health
care, including pharma & device, will be discussed.
Overview of PRO Challenges – The Device Industry Perspective
Speaker: Randel Richner MPH, BSN, Vice President, Federal Affairs, Reimbursement
and Outcomes Planning, Boston Scientific, Natick, MA, USA
Unique challenges of the medical device industry will be presented.
Accumulation & Presentation Of Scientific Evidence – Regulatory Perspective
Speaker: Neal I. Muni, MD, MSPH, Medical Officer, FDA, Rockville, MD, USA
Making QOL claims for cardiovascular technologies - collaborative efforts between academia,
industry, and the FDA…and more.
Panel Discussion
ISPOR 7TH ANNUAL INTERNATIONAL MEETING
Medical Device & Diagnostics Forum
May 20, 2002
Crystal Gateway
Marriot, Arlington, VA, USA
USING MEDICAL DEVICE AND DIAGNOSTICS OUTCOMES
RESEARCH TO SUPPORT HEALTH POLICY & REIMBURSEMENT DECISIONS
Using Outcomes Research Studies to Support Improved Productivity
Moderator: Pamela Koo, Director, Global Reimbursement Policy Welch Allyn, Inc
Speaker: Sean Sullivan, President & CEO, Institute for Health and Productivity Management, Scottsdale, AZ, USA
Private payers are using HEDIS measurements to
imply greater productivity to employers. This presentation will focus on how
outcomes research studies can be used to support improved workplace
productivity.
How to Support Reimbursement Of Off-Label Use Of Medical Devices And Diagnostics: Will Outcomes Research Help?
Moderators: Randel Richner RN, MPH, Vice President, Federal Affairs, Reimbursement and Outcomes Planning, Boston Scientific Corporation, Natick, MA, USA and Sarah Wells, Boston Scientific Corporation, Boston,
Natick MA, USA
Speaker: Stuart Langbein Esq., Partner, Hogan & Hartson L.L.P. Washington, DC, USA
During the diffusion of innovation process, new medical technologies are used to
treat or reduce symptoms in ways other than described on the labeling. This presentation will focus on off-label use of medical and diagnostic technologies, associated reimbursement issues, as well as research opportunities to support reimbursement decisions.
Questions and Answers
ISPOR 6TH ANNUAL INTERNATIONAL MEETING
Medical Device & Diagnostics Forum
May 20, 2001
Hyatt Regency Crystal City, Arlington
HEALTH TECHNOLOGY ASSESSMENT AND ITS EFFECT ON PATIENT ACCESS
Medical Technology Assessment by Health Plans
Speaker: Jonathan Freudman MD, Medical Advisor, Blue Shield of California, San Francisco, CA, USA
Health Plans do technology assessment because of their desire to see our members
receive safe and effective treatments. Not all treatment modalities fall
under the scrutiny of the FDA (off label etc). FDA clearance of devices does
not necessarily assure efficacy. While some technologies are well studied and
have been proven to be effective, others have received clearance based on
limited clinical data. Insurance coverage is viewed as an endorsement of a
treatment modality. When a treatment is eligible for coverage, further
research on the treatment slows or stops.
During the year 2000 the FDA approved several new devices used in the treatment of
gastroesophageal reflux (GERD) based on very limited human clinical data, as
well as brachytherapy to treat in-stent restenosis of coronary artery disease
based on significant controlled clinical trials.
We are more likely to look at a new technology if there is a new way to perform a
procedure, if there is doubt about the efficacy, or if the current procedure is invasive or costly.
New technologies come to our attention via information from the medical device
manufacturing industry, requests for coverage, inquiries from network physicians and health plan members, and the news media including the internet.
A technology will be judged by its safety and efficacy based on the results of
clinical trials. Clinical trials must be appropriately designed and have an
adequate control group.
The Blue Cross Blue Shield Association (BCBSA) criteria are the following:
- Final approval from regulatory body
- Scientific evidence that permits conclusions on effectiveness regarding health outcomes
- Must improve net health outcomes
- Must be as beneficial as any established alternatives
- Improvement must be attainable outside the investigational setting
The evidence is received through Medline searches, monitoring of the clinical literature, the press and the Internet, and communication with the manufacturers and physicians. Common problems with Clinical trials are lack of control groups, small studies with too few patients to reach a scientifically valid conclusion, insufficient use of randomized control groups and blinded evaluation of results, and lack of clearly defined objective measures.
The following are examples of clinical trials with positive influence on coverage:
**Photodynamic therapy of subfoveal choroidal neovascularization [macular
degeneration] (TAP Study Group; Arch Ophthamology Vol 117 October 1999)
- Double masked, placebo controlled, and randomized
- The Gold Standard
- Not possible with all technologies
**Sacral nerve stimulation for the treatment of refractory urinary urge
incontinence (Schmidt et al Journal of Urology August 1999)
- Cross-over design of this clinical trial
- Other medical devices can be studied in trials with similar design
**Endovascular repair of abdominal aortic aneurysms (Annals of Surgery , 1999 Vol 320, 20)
Without technology assessment there would be less outcome data on which to base
clinical decisions, marketing would play an even greater role in the
dissemination of new technologies, the cost of health insurance would rise
even faster, and the rising cost of health insurance is a threat to access new
technologies. In Summation, given our current health care system, technology
assessment by health plans is playing an important role.
Effect of Health Technology Assessment on Patient Access
Speaker: Clifford Goodman PhD, Senior Scientist, Medical Technology, The Lewin Group, Falls Church, VA, USA
Health care technology assessment (HTA) involves the systematic evaluation of properties, effects, or
other impacts of health care technology, including safety,
efficacy/effectiveness, and other aspects. The main purpose of HTA is to
inform policy-making for technology in health care. Among these types of
policy-making are market approval/clearance, third-party payment, clinical
practice guidelines, procurement/acquisition, investment, and others. The
increased emphasis on evidence-based health care has enhanced the role of HTA.
Further, the number of HTA agencies and related functions, such as technology
“horizon scanning” and “early warning systems”, is increasing worldwide, in
particular to support payment decisions by government and private sector
third-party payers. While evidence requirements and methods for assessment of
pharmaceuticals are generally well-developed and accepted, there is less
understanding and greater variation in implementing these for assessment of
medical devices and diagnostics on the part of HTA organizations as well as
technology companies. This can lengthen the time to market access for these
technologies, particularly the time between market clearance and gaining
adequate payment. Of particular importance are differences between evidence
for satisfying regulatory requirements for market approval and for satisfying
third-party payment requirements. While market clearance generally applies
widely in large countries or regions (e.g., FDA approval in the US and CE
marking the Europe), the number of payers and their respective requirements
for coverage, coding, and reimbursement can pose a far more complicated set of
challenges in the same areas. These factors increase uncertainty and
financial risk for technology companies and can delay access to patients.
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